Health Research Group Publications

Founded in 1971 by Sidney Wolfe, M.D. and Ralph Nader, Public Citizen’s Health Research Group promotes research-based, system-wide changes in health-care policy and drug safety. The work that we have done since 1995 is listed on this page in chronological order.

Jump to year: 2019 – 2018 – 2017 – 2016 – 2015 – 2014 – 2013 – 2012 – 2011 – 2010 – 2009

2019

Time to End Physician Sexual Abuse of Patients: Calling the U.S. Medical Community to Action (HRG Publication #2482)
A timely Perspective article published today by the Journal of General Internal Medicine sheds light on sexual abuse of patients at the hands of their physicians. The article describes evidence on the extent of this ethical problem and the factor that explain its persistence in the U.S. and recommends 11 keys steps that medical community, starting with medical boards, can take to better protect the public from physician sexual abuse.
[Created on 5/2/2019]

Letter to the OHRP Calling for a Halt to Unethical NIH-Funded Sepsis Clinical Trial Until NIH Stops Interfering in OHRP’s Evaluation of the Trial (HRG Publication #2481)
Public Citizen called on the Office for Human Research Protections (OHRP) to immediately cease its ethics-undermining subservience to the National Institutes of Health (NIH), invoke its authority under the U.S. Department of Health and Human Services human subjects protection regulations, and suspend the NIH-funded CLOVERS trial until the NIH allows two senior scientists at the NIH Clinical Center to speak to OHRP staff and the agency has completed its compliance oversight evaluation of the trial.
[Created on 5/1/2019]

Letter to the HHS Office of Inspector General Calling for an Investigation of NIH Leadership’s Obstruction of OHRP Probe of Unethical, Reckless Sepsis Clinical Trial (HRG Publication #2480)
Public Citizen called on the Department of Health and Human Services (HHS) Inspector General to immediately investigate the actions taken by senior National Institutes of Health (NIH) officials, including the agency’s Principal Deputy Director, to muzzle the agency’s own scientific experts, thereby effectively interfering with the HHS Office for Human Research Protections’ (OHRP’s) compliance oversight evaluation of ethical and regulatory lapses involving a major ongoing NIH-funded sepsis clinical trial.
[Created on 4/29/2019]

Press Statement: FDA Bans Dangerous Surgical Mesh for Pelvic Repair, Following Public Citizen Urging (HRG Publication #2479)
Although Public Citizen welcomes this long-overdue action, this ban comes too late for the thousands of women who have been irreparably harmed by these devices, long after the FDA knew the devices had “not demonstrated a reasonable assurance of safety.”
[Created on 4/16/2019]

Petition to the FDA to Require a Black-Box Warning for the Osteoporosis Drug Prolia (HRG Publication #2478)
Public Citizen petitioned the Food and Drug Administration (FDA) to add a black-box warning to the product labeling for the osteoporosis drug, Prolia (denosumab), to alert doctors and patients about the risk of vertebral fractures associated with cessation of the drug and need for alternative osteoporosis treatment after stopping the drug.
[Created on 4/16/2019]

Letter to the FDA Urging the Agency Not to Approve the De Novo Premarket Application for neuroAD Therapy System for the Treatment of Alzheimer’s Dementia (HRG Publication #2477)
Public Citizen urged the Food and Drug Administration (FDA) not to approve the do novo premarket application for the neuroAD Therapy System from Neuronix as an adjunctive treatment of mild-to-moderate Alzheimer’s Dementia because the data from the clinical trials demonstrated that the device does not offer any clinically meaningful benefits.
[Created on 4/9/2019]

Press Release: Responses of Dr. Sidney Wolfe, Founder and Senior Adviser, Public Citizen’s Health Research Group, to Gottlieb Testimony on Opioids (HRG Publication #2476)
Scott Gottlieb, Food and Drug Administration (FDA) commissioner, today testified about opioids at a hearing of the U.S. Senate Appropriations Committee’s Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies. His testimony included several misleading statements and omissions.
[Created on 3/28/2019]

Testimony Before the FDA’s General and Plastic Surgery Devices Panel Regarding Breast Implants (HRG Publication #2475)
In testimony before the Food and Drug Administration’s (FDA’s) General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee, Public Citizen highlighted the serious health problems linked to breast implants and the inadequate regulation of these and other permanently implanted medical devices over the past several decades. The history of breast implants reminds us why much more extensive mandatory pre-approval testing of permanently implanted devices, like breast implants, is necessary; otherwise, patients are serving as unwitting guinea pigs.
[Created on 3/26/2019]

Petition to the FDA for a Moratorium on Approval of New Opioids or New Opioid Formulations (HRG Publication #2474)
Public Citizen petitioned the Food and Drug Administration (FDA) to immediately impose a moratorium on approval of all new drug applications for new opioids or new opioid formulations, not to be lifted until the FDA has implemented the elements recommended by the National Academies of Sciences, Engineering, and Medicine for inclusion in a currently non-existent opioid regulatory framework that is intended to prevent a continuation of dangerous past regulatory errors that clearly have contributed to the current deadly opioid crisis in the U.S.
[Created on 3/21/2019]

Letter to the FDA Urging the Agency Not to Approve the New Drug Application for Sotagliflozin for Treating Type 1 Diabetes (HRG Publication #2473)
Public Citizen strongly urged the Food and Drug Administration (FDA) not to approve the new drug application (NDA) for sotagliflozin (ZYNQUISTA) for use as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes because the data from the phase 3 clinical trials presented in the NDA show that the drug causes an unacceptable eight-fold increased risk of life-threatening diabetic ketoacidosis in subjects with type 1 diabetes given the drug, compared with those given a placebo.
[Created on 3/11/2019]

Press Statement: Good Riddance to FDA Commissioner Scott Gottlieb (HRG Publication #2472)
Scott Gottlieb was entangled in an unprecedented web of Big Pharma ties when he was nominated in 2017 to be FDA commissioner. Not surprisingly, his tenure as commissioner was marked by regulatory decision making regarding medications and medical devices that tilted further in favor of industry’s financial interests rather than the interests of public health.
[Created on 3/5/2019]

Letter to the FDA Urging the Agency Not to Approve the New Drug Application for Esketamine for the Treatment of Treatment-Resistant Depression (HRG Publication #2471)
Public Citizen strongly urged the Food and Drug Administration (FDA) not to approve the new drug application (NDA) for the drug-device combination of esketamine (SPRAVATO) for intranasal administration for the treatment of treatment-resistant depression because the data from the clinical trials presented in the NDA failed to provide substantial evidence that the drug is effective for its proposed indication for use and there is clear evidence that the drug has serious risks of harm.
[Created on 2/27/2019]

Letter to the Maryland Senate’s Education, Health, and Environmental Affairs Committee Opposing a Bill That Would Shield Bad Doctors Who Engaged in Serious Misconduct (HRG Publication #2470)
Public Citizen strongly urged Maryland Senate’s Education, Health, and Environmental Affairs Committee to soundly reject Senate Bill 372 because it would (a) seriously compromise patient access to nearly half of the information about important disciplinary actions taken by the Maryland Board of Physicians against physicians who may have been found to have engaged in serious misconduct, (b) make it more difficult for the Board to investigate and discipline physicians under certain circumstances, and (c) ultimately, undermine patient safety protections in Maryland.
[Created on 2/22/2019]

Comments on the FDA’s Proposed Rule for Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations (HRG Publication #2469)
Public Citizen is deeply concerned that once the Food and Drug (FDA) finalizes the proposed rule, clinical investigators inappropriately will seek, and IRBs inappropriately will grant, waivers of informed consent for clinical investigations that involve greater than minimal risk to the subjects.
[Created on 2/13/2019]

Testimony Before the FDA’s Obstetrics and Gynecology Devices Panel Regarding Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse (HRG Publication #2468)
In testimony before the Food and Drug Administration’s (FDA’s) Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee, Public Citizen urged the FDA to reject the premarket approval applications for the three mesh products for transvaginal repair of pelvic organ prolapse (POP) that are still on the market because these devices offer no clinically significant benefits in comparison with non-mesh repair of POP and have high rates of serious complications. Surgical mesh for transvaginal POP repair is a quintessential example of the fundamental deficiencies in the FDA’s oversight of medical devices, particularly those that are permanently implanted.
[Created on 2/12/2019]

Press Release: Arizona Nurse Arrested for Assault on Incapacitated Patient Highlights How Few Nurses Face Punishment for Abuse (HRG Publication #2467)
The arrest of a male nurse for the sexual assault of an incapacitated female patient in Arizona underscores what Public Citizen found in a groundbreaking study last month: State nursing boards are failing to protect patients from nurses who engage in sexual misconduct.
[Created on 1/23/2019]

Testimony Before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding Sotagliflozin (HRG Publication #2466)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Endocrinologic and Metabolic Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject Sanofi’s new drug application for sotagliflozin for treatment of type 1 diabetes because the drug offers minimal benefits that do not outweigh the significantly increased risk of life-threatening diabetic ketoacidosis.
[Created on 1/17/2019]

Testimony Before the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee Regarding Romosozumab (HRG Publication #2465)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Bone, Reproductive and Urologic Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject Amgen’s new drug application for romosozumab for treatment of osteoporosis in postmenopausal women at high risk for fracture because of clinical trial data linking the drug to an increased risk of serious adverse cardiovascular events.
[Created on 1/16/2019]

Testimony Before the FDA’s Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding Febuxostat (HRG Publication #2464)
In testimony before a joint meeting of the Food and Drug Administration’s Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee, Public Citizen urged the committees to recommend that the FDA immediately remove from the market the widely used gout medication febuxostat because it poses unique, serious risks – include the risk of dying from cardiovascular disease – but offers no unique benefit. Public Citizen had requested such action in a citizen petition submitted to the agency on June 21, 2018.
[Created on 1/11/2019]

2018

Crossing the Line: Sexual Misconduct by Nurses Reported to the National Practitioner Data Bank (HRG Publication #2463)
A groundbreaking study published by Public Citizen in the journal Public Health Nursing showed that state nursing boards are failing to protect patients from nurses who engage in sexual misconduct. According to the study, only 882 U.S. registered licensed practical or vocational nurses have been reported to the National Practitioner Data Bank over 14 years (from 2003 through 2016) because of such misconduct.
[Created on 12/17/2018]

Press Statement: FDA Rule Withdrawal Fails to Modernize Generic Labeling and Endangers Patient Safety (HRG Publication #2462)
The FDA’s withdrawal of its proposed rule that would have allowed generic drug makers to immediately update safety labels to describe new risks to consumers without prior agency approval represents a flagrant disregard for public health and common sense because it continues to immunize generic manufacturers from any liability if patients are injured or killed by a generic medication, even when warnings about serious risks known to the companies are missing from the labels.
[Created on 12/13/2018]

Letter to the FDA Commissioner Refuting Claims Made in His Public Statement Justifying the Approval of Sufentanil Sublingual Tablets (Dsuvia) (HRG Publication #2461)
In a letter to Dr. Scott Gottlieb, the Food and Drug Administration (FDA) Commissioner, Public Citizen and the chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee explain how the Commissioner misled the public regarding potential “unique” benefits of Dsuvia, a controversial, highly potent opioid pain relief medication.
[Created on 12/11/2018]

Comments on the FDA’s Revised Draft Guidance on Insanitary Conditions at Compounding Facilities (HRG Publication #2460)
Public Citizen, in general, supports the Food and Drug Administration’s (FDA’s) draft guidance for industry “Insanitary Conditions at Compounding Facilities (Revision 1).” The numerous detailed examples of insanitary conditions provided in the draft guidance should assist compounding facilities in identifying and remediating insanitary conditions. However, Public Citizen strongly objects to the FDA’s addition of a statement indicating that for physician compounding or repackaging of drug products, the agency does not intend to enforce legal requirements that prohibit the preparation, packing, and holding of drugs under insanitary conditions.
[Created on 11/26/2018]

Op-Ed in The Washington Post Regarding the FDA’s Approval of Sufentanil Sublingual Tablets: The FDA Made the Wrong Call on This Powerful, New Opioid (HRG Publication #2459)
In a joint op-ed, Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, and Dr. Raeford Brown, chair of the Food and Drug Administration’s (FDA’s) Anesthetic and Analgesic Drug Products Advisory Committee, are highly critical of the FDA’s reckless decision to approve sufentanil sublingual tablets, a new opioid that will be sold under the brand name Dsuvia.
[Created on 11/16/2018]

Testimony Before the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding a Purportedly Abuse-Deterrent, Immediate-Release Form of Oxycodone (HRG Publication #2458)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject new drug application submitted by SpecGx for an immediate-release oral tablet formulation of oxycodone that is intended to be abuse-deterrent for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
[Created on 11/14/2018]

Letter to the Florida Attorney General Regarding Utopia Wellness’s Dissemination of False Advertisements Promoting Cesium Chloride for Treatment of Cancer (HRG Publication #2457)
Public Citizen sent a letter to the Florida Attorney General requesting an investigation of the use of falsified scientific citations in the advertisement and promotion of an illegal heart-toxic drug for treatment of cancer by Utopia Wellness, a Florida-based medical center. The medical’s website materials misleadingly claim that cesium chloride is safe and effective for treating cancer but offers no evidence from well-controlled clinical tests to support its claims.
[Created on 11/7/2018]

Letter to the Director of Medicine at Utopia Wellness Regarding Its Promotion of Cesium Chloride for Treatment of Cancer (HRG Publication #2456)
Public Citizen sent a letter to Dr. Carlos M. Garcia, the Director of Medicine at Utopia Wellness, informing him that Public Citizen had submitted complaint letters to the Federal Trade Commission, Food and Drug Administration, and Florida Board of Medicine regarding his medical center’s dissemination of false and misleading advertisements that promote the use of cesium chloride.
[Created on 11/5/2018]

Press Release: FDA Makes Wrong Call; Super-Strong Opioid Medication Will Be Abused and Kill People (HRG Publication #2455)
The Food and Drug Administration (FDA) is recklessly and needlessly endangering people by approving a super-strong opioid, Public Citizen and the head of a key FDA advisory committee said today. The FDA gave the green light for the medication, which is called sufentanil sublingual tablet (brand name Dsuvia) and is to be used to treat moderate-to-severe acute pain in a medically supervised setting. It is five to 10 times more potent than fentanyl and 1,000 times more potent than morphine.
[Created on 11/2/2018]

Comments on the FDA’s Proposal to Exclude Bumetanide, Nicardipine Hydrochloride, and Vasopressin from the 503B Bulks List for Pharmacy Compounding by Outsourcing Facilities (HRG Publication #2454)
Public Citizen strongly supports the Food and Drug Administration’s (FDA’s) proposal to exclude bumetanide, nicardipine hydrochloride, and vasopressin from the list of bulk drug substances for which there is a clinical need under Section 503B of the Federal Food, Drug, and Cosmetic Act for pharmacy compounding by outsourcing facilities. Each of the nominated bulk drug substances is a component of one or more FDA-approved drug products, and the nominators have failed to demonstrate that there is a clinical need for outsourcing facilities to compound drug products using the nominated bulk drug substances.
[Created on 10/29/2018]

Second Follow-up Letter to the FDA and OHRP Regarding Unethical High-Risk Clinical Trials That Tested Ketamine for Management of Agitation (HRG Publication #2453)
Public Citizen, joined by two bioethicists from the University of Minnesota, wrote to the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) to highlight key observations made by FDA inspectors during an inspection of the Hennepin County Medical Center’s (HCMC’s) institutional review board from August 7 to August 23, 2018. The inspection confirmed that HCMC violated federal regulations when it conducted high-risk clinical trials that involved testing the safety and effectiveness of the ketamine compared with other potent sedative drugs for management of pre-hospital agitation without the informed consent of the subjects.
[Created on 10/29/2018]

Letter to the Florida Board of Medicine Regarding the Director of Medicine at Utopia Wellness, Which Promotes and Uses Cesium Chloride for Treatment of Cancer (HRG Publication #2452)
Public Citizen sent a letter to the Florida Board of Medicine requesting an investigation into the medical practice of Dr. Carlos Garcia, M.D., the Director of Medicine at Utopia Wellness. We specifically requested that the board investigate (1) Dr. Garcia’s role in Utopia Wellness’s dissemination of false and misleading advertisements that promote the use of compounded intravenous (IV) cesium chloride as a treatment for cancer and (2) whether Dr. Garcia and his staff have continued to treat cancer patients with compounded IV cesium chloride since late July 2018, when the Food and Drug Administration took action that prohibited pharmacy compounding using bulk cesium chloride.
[Created on 10/23/2018]

Letter to the FDA Urging the Agency Not to Approve the New Drug Application for Sufentanil Sublingual Tablets, a Super-Potent Opioid (HRG Publication #2451)
In a letter to the Food and Drug Administration (FDA), the chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee joined three Public Citizen experts in urging the agency to reject Acer Pharmaceuticals’ new drug application for sufentanil sublingual tablets for treatment of moderate-to-severe acute pain in a medically supervised setting. This opioid, which is five to 10 times more potent than fentanyl and 1,000 times more potent than morphine, would be abused and start killing people as soon as it hits the market.
[Created on 10/18/2018]

Testimony Before the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee Regarding Sublingual Sufentanil Tablets (HRG Publication #2450)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Anesthetic and Analgesic Drug Products Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject new drug application submitted by AcelRx Pharmaceuticals for sufentanil sublingual tablets because the drug is a dangerous, high potency opioid that does not provide any unique advantages over currently available opioids, but does pose unique risks.
[Created on 10/12/2018]

Letter to the FDA Regarding Utopia Wellness’s Promotion and Use of Cesium Chloride for Treatment of Cancer (HRG Publication #2449)
Public Citizen sent a letter to the Food and Drug Administration (FDA) requesting an investigation of the promotion and use of an illegal cesium chloride drug for treatment of cancer by Utopia Wellness, a Florida-based medical center. Under current FDA policies governing pharmacy compounding, no State-licensed pharmacy or licensed physician affiliated with Utopia Wellness currently may legally compound cesium chloride.
[Created on 10/9/2018]

Letter to the FTC Regarding Utopia Wellness’s Dissemination of False Advertisements Promoting Cesium Chloride for Treatment of Cancer (HRG Publication #2448)
Public Citizen sent a letter to the Federal Trade Commission (FTC) requesting an investigation of the use of falsified scientific citations in the advertisement and promotion of an illegal heart-toxic drug for treatment of cancer by Utopia Wellness, a Florida-based medical center. The medical’s website materials misleadingly claim that cesium chloride is safe and effective for treating cancer but offers no evidence from well-controlled clinical tests to support its claims.
[Created on 10/9/2018]

Letter to the Vanderbilt University Medical Center IRB Chairs Regarding Sepsis Clinical Trial Funded by NIH (HRG Publication #2447)
Public Citizen called on the Vanderbilt University Medical Center institutional review board (IRB) that approved the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis trial (CLOVERS) to (a) immediately review our letter to the Office for Human Research Protections in which we identified serious ethical and regulatory lapses related to the design and sample consent form of CLOVERS and (b) suspend the IRB’s approval of CLOVERS and direct the CLOVERS investigators to cease enrolling subjects in the trial.
[Created on 8/29/2018]

Letter to OHRP Calling for a Halt to Unethical, Reckless Sepsis Clinical Trial Funded by NIH (HRG Publication #2446)
Public Citizen called on the Office for Human Research Protections (OHRP) to immediately direct the National Heart, Lung, and Blood Institute to terminate enrollment in the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis trial (CLOVERS) and launch a compliance oversight investigation of the trial. The design of CLOVERS is deeply flawed and exposes subjects to unacceptable dangers, included increased risks of organ failure and death.
[Created on 8/28/2018]

Comments on the FDA’s Draft Guidance on the Assessment of Pressor Effects of Drugs (HRG Publication #2445)
Public Citizen, joined by two academic physicians, urged the Food and Drug Administration (FDA) to revised its draft guidance on the assessment of pressor effects of drugs to specify, among other things, the following: (a) a time interval that distinguishes short-term drug use from long-term use; (b) what constitutes a large blood pressure increase for drugs intended for short-term use; and (c) for drugs intended for long-term use, a requirement for premarket cardiovascular safety data for drugs that raise SBP more than 2 mm Hg or that raise DBP more than 1 mm Hg compared with a placebo.
[Created on 7/30/2018]

Follow-up Letter to the FDA and OHRP Regarding Unethical High-Risk Clinical Trials That Tested Ketamine for Management of Agitation (HRG Publication #2444)
Public Citizen wrote to the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) to bring to their attention the July 26, 2018, report, MPD Involvement in Pre-Hospital Sedation, which was issued by the Office of Police Conduct Review in Minneapolis. The report contains new information pertinent to two prospective clinical trials that involved testing the dangerous general anesthetic ketamine and powerful sedatives on agitated patients without their consent.
[Created on 7/30/2018]

Letter to the Association for the Accreditation of Human Research Protection Programs Regarding the Hennepin County Medical Center’s Human Subjects Protection (HRG Publication #2443)
Public Citizen requests that the Association for the Accreditation of Human Research Protection Programs immediately rescind its no longer justifiable accreditation of the human subjects protection program at the Minneapolis Medical Research Foundation and the Hennepin County Medical Center. Such action is need because of unacceptable regulatory and ethical lapses in the oversight and conduct of the two prospective clinical trials that involved testing the safety and effectiveness of the general anesthetic ketamine compared with those of other potent sedative drugs for management of prehospital agitation.
[Created on 7/26/2018]

Letter to the FDA and OHRP Calling for Investigations of Unethical High-Risk Clinical Trials That Tested Ketamine for Management of Agitation (HRG Publication #2442)
Public Citizen and 64 doctors, bioethicists, and academics called on the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) to immediately investigate two prospective clinical trials that involved testing the dangerous general anesthetic ketamine and powerful sedatives on agitated patients without their consent. Disturbingly, these experiments were incorrectly determined by the researchers and the Hennepin County Medical Center’s institutional review board (IRB) to involve no more than minimal risk to the subjects and, based on that determination, the IRB waived the informed consent requirements.
[Created on 7/25/2018]

Press Statement: FDA Agrees With Public Citizen, Responds to Petition by Taking Action to Prohibit Pharmacy Compounding of Cesium Chloride (HRG Publication #2441)
Although Public Citizen supports the Food and Drug Administration’s (FDA’s) belated action to block pharmacy compounding of cesium chloride, the agency should have acted more than two years ago when its own reviewers concluded that cesium chloride is “not safe for human use” and “has not been shown to be efficacious for the prevention or treatment of any form of cancer.”
[Created on 7/23/2018]

Petition to the FDA to Ban All Cesium Dietary Supplements (HRG Publication #2440)
Public Citizen petitioned the Food and Drug Administration (FDA) to ban the sale of all dietary supplements containing the chemical cesium chloride or any other cesium salt because they present a significant and unreasonable risk of illness or injury. Cesium can cause serious, life-threatening adverse cardiovascular events, and the FDA has declared cesium chloride to be unsafe for human use. These products have been promoted as treatments for cancer, despite the lack of evidence demonstrating cesium’s proposed cancer-treating properties.
[Created on 7/23/2018]

Petition to OSHA to Implement a Federal Standard to Protect Workers from Occupational Exposure to Excessive Heat (HRG Publication #2439)
Public Citizen, Farmworker Justice, United Farm Workers, two former Occupational Safety and Health Administration (OSHA) administrators, a former California-OSHA director, and 131 other organizations petitioned OSHA to initiate a rulemaking process to establish the first federal standards protecting workers from the dangers of heat stress. As climate change results in more frequent days of extreme heat and record-breaking summers become the norm, outdoor and indoor workers in workplaces including farms, construction sites, steel mills, warehouses, meat-packing plants, and vehicles will be at greater risk for workplace heat stress.
[Created on 7/17/2018]

Testimony Before the HHS Secretary’s Advisory Committee on Human Research Protections Regarding the July 2017 HHS Office of Inspector General Report on OHRP’s Compliance Activities (HRG Publication #2438)
In testimony before the Department of Health and Human Services (HHS) Secretary’s Advisory Committee on Human Research Protections, Public Citizen stated that the July 2017 HHS Office of Inspector General (OIG) report assessing the Office for Human Research Protections’ (OHRP’s) compliance activities revealed that OHRP’s enforcement of regulations for the protection of human subjects has literally become moribund. The OIG report demonstrated that OHRP is abusing its discretion when deciding whether to initiate formal for-cause compliance evaluations of substantive written allegations.
[Created on 7/10/2018]

Follow-up Complaint Letter to the OHRP and the VA Office of Research Oversight Regarding a Potentially Unethical Clinical Trial Involving Heart Attack Patients (HRG Publication #2437)
Public Citizen called on the Office for Human Research Protections (OHRP) and the Department of Veterans Affairs (VA) Office of Research Oversight to take additional actions to address serious noncompliance with federal regulations for the protection of human subjects related to the conduct of the National Institutes of Health-funded Myocardial Ischemia and Transfusion Trial.
[Created on 7/5/2018]

Public Citizen Urges OSHA Not To Delay Important Beryllium Protections For General Industry Workers (HRG Publication #2436)
Public Citizen submitted comments strongly urging the Occupational Safety and Health Administration (OSHA) not to finalize a proposed rule that would delay for at least several months the compliance date for certain ancillary requirements of the general industry beryllium standard. Such delays would unnecessarily ensure the occurrence of even more cases of beryllium sensitization, chronic beryllium disease, and lung cancer among general industry workers exposed to beryllium.
[Created on 6/29/2018]

Testimony Before the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Regarding Extended Release Oxycodone (HRG Publication #2435)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject new drug application submitted by Pain Therapeutics for oxycodone extended-release capsules for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
[Created on 6/26/2018]

Petition to the FDA to Ban the Gout Medication Febuxostat (Uloric) (HRG Publication #2434)
Public Citizen petitioned the Food and Drug Administration (FDA) to ban the sale of the widely prescribed gout drug febuxostat (sold under the brand name Uloric) because use of the drug increases the risk of death compared with alternative therapies and there exist other effective medications that have been approved by the FDA for treatment of gout that have a lower risk of death.
[Created on 6/21/2018]

Press Statement: Public Citizen Supports NIH Advisory Panel’s Recommendation to Terminate Ongoing Alcohol Health Study Being Funded by Industry (HRG Publication #2433)
Public Citizen strongly supports the NIH advisory committee’s recommendation to terminate the NIAAA-sponsored alcohol study because the industry funding – and the manner in which that funding was solicited – already had irreparably undermined public trust in the design and integrity of the study.
[Created on 6/15/2018]

Press Release: Public Citizen Complaint Prompts Changes to Potentially Unethical Clinical Trial Involving Heart Attack Patients (HRG Publication #2432)
Substantive changes have been made to the protocol and consent forms for the NIH-funded Myocardial Ischemia and Transfusion (MINT) trial in response to a complaint filed by Public Citizen over potentially serious ethical violations, the Department of Health and Human Services’ Office for Human Research Protections and the Department of Veterans Affairs’ Office of Research Oversight said in a letter delivered to Public Citizen.
[Created on 6/12/2018]

Comments on the FDA’s Draft Guidance Regarding Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act (HRG Publication #2431)
In general, Public Citizen strongly supports the policies proposed in the draft guidance document. In particular, the proposed guidance seeks to appropriately limit, under section 503B, the use of bulk drug substances by outsourcing facilities in pharmacy compounding of human drug products that are not on the FDA’s drug shortage list.
[Created on 5/25/2018]

Press Statement: FDA Agrees With Public Citizen, Responds to Petition by Telling Companies to Stop Marketing Over-the-Counter Benzocaine Teething Products (HRG Publication #2430)
The Food and Drug Administration (FDA) agreed with Public Citizen that over-the-counter oral health care products containing benzocaine should never be used in infants under any circumstances, even with the advice and supervision of a health care professional, because of the risk of methemoglobinemia, a life-threatening blood disorder that impairs the body’s ability to use oxygen.
[Created on 5/25/2018]

Press Statement: FDA’s Action to Protect Infants From Serious Blood Disorder Caused by Over-the-Counter Benzocaine Teething Products Is Long Overdue (HRG Publication #2429)
The FDA’s action today to protect infants and children from exposure to over-the-counter oral health products containing benzocaine, which can cause methemoglobinemia, a life-threatening blood disorder that impairs the body’s ability to use oxygen, comes too late for some infants and children.
[Created on 5/23/2018]

Press Statement: By Approving the Senate’s Version of the False Hope Act, House Lawmakers Open a More Dangerous Pathway for Experimental Medications (HRG Publication #2428)
The House of Representatives’ passage of S. 204, the Senate’s seriously flawed False Hope legislation, opens the gate to a dangerous, uncharted pathway for accessing experimental medications that have not been shown to be safe or effective. The bill passed today will expose vulnerable patients to risks of serious harm, including dying earlier and more painfully than they otherwise would have, without appropriate safeguards.
[Created on 5/22/2018]

Testimony Before the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Regarding Buprenorphine Sublingual Spray (HRG Publication #2427)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject INSYS Development Company’s new drug application for buprenorphine sublingual spray for the treatment of moderate-to-severe acute pain where the use of an opioid analgesic is appropriate because the risks of the drug outweigh the benefits.
[Created on 5/22/2018]

Letter to the U.S. House of Representatives Opposing Passage of the Senate’s “False Hope” Legislation (HRG Publication #2426)
Public Citizen urged members of the U.S. House of Representatives to oppose S. 204, the version of “False Hope” legislation that was passed by the Senate in August 2017. Importantly, although H.R. 5247 — the House of Representatives-passed version of this legislation — has significant flaws that would endanger patients, it nevertheless would provide substantially stronger safeguards for patients who would receive investigational drugs under the Right-to-Try pathway than those provided by S. 204.
[Created on 5/21/2018]

Statement by Dr. Sidney Wolfe at Press Conference Regarding Sweeping Pharmaceutical Reform Proposal Published in the British Medical Journal (HRG Publication #2425)
At a press conference unveiling a comprehensive proposal to ensure universal access to safe, innovative, and affordable medications that was published in the British Medical Journal, Dr. Sidney Wolfe highlighted three situations related to the pharmaceutical system that undermine public health.
[Created on 5/17/2018]

Press Statement: Public Citizen Applauds HHS Inspector General Review of Conduct of NIH Officials Who Sought Alcohol Industry Funding for Alcohol Health Study (HRG Publication #2424)
Public Citizen applauds the decision by the U.S. Department of Health and Human Services Office of Inspector General to look into the serious allegations that National Institutes of Health officials orchestrated a campaign to obtain funding from alcoholic beverage manufacturers to fund a $100 million National Institute on Alcohol Abuse and Alcoholism study that is intended to assess the cardiovascular health effects of moderate alcohol consumption.
[Created on 5/9/2018]

Editorial in the Journal of General Internal Medicine Regarding Hospital Profit Margins (HRG Publication #2423)
U.S. hospitals, most of which are nonprofit, are mired in a toxic cycle that rewards bad behavior from their leaders, neglects patient needs and promotes an obsession with increasing profits, according to an editorial by Public Citizen Health Research Group founder and senior adviser, Dr. Sidney Wolfe, and colleagues Drs. Steffie Woolhandler and David Himmelstein at the City University of New York at Hunter College, published in the Journal of General Internal Medicine. The editorial is in response to an article by researchers Dan Ly and David Cutler, who examined how successful hospitals improved operating margins and patient care.
[Created on 5/1/2018]

Letter to the DEA Requesting an Investigation of White House Physician Dr. Ronny L. Jackson (HRG Publication #2422)
Public Citizen called on the Drug Enforcement Administration (DEA) to launch a formal investigation into the conduct of Dr. Ronny Lynn Jackson who, according to recent media reports, has a history of “casually dispensing Ambien for sleep and Provigil for arousal, both of which are dangerous controlled substances with a potential for addiction.” If true, such conduct would be “illegal” according to a spokesperson for the DEA and would warrant immediate revocation of Dr. Jackson’s DEA registration.
[Created on 4/30/2018]

Letter to the Virginia Board of Medicine Requesting an Investigation of White House Physician Dr. Ronny L. Jackson (HRG Publication #2421)
Public Citizen called on the Virginia Board of Medicine to launch a formal investigation into the medical practice of Dr. Ronny Lynn Jackson who, according to recent media reports, has a history of “casually dispensing Ambien for sleep and Provigil for arousal, both of which are dangerous controlled substances with a potential for addiction.” If true, such conduct would represent unethical and dangerous medical practice and warrant immediate revocation of Dr. Jackson’s Virginia medical license.
[Created on 4/27/2018]

Testimony Before the FDA’s Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding Celecoxib (HRG Publication #2420)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee, Public Citizen argued that because of the major limitations of the PRECISION trial, no meaningful conclusions can be drawn from the trial regarding the cardiovascular safety of celecoxib relative to ibuprofen and naproxen.
[Created on 4/25/2018]

Research Group Study Examines Use of Placebos in Clinical Trials Testing New Drugs for Life-Threatening Diseases (HRG Publication #2419)
Published in Open Access Journal of Clinical Trials, our study found that the use of placebos in clinical trials testing new drugs for life-threatening diseases for which treatments proven to be effective are already available is widespread and can put human subjects at increased risk of harm.
[Created on 4/24/2018]

Testimony Before the FDA’s Arthritis Advisory Committee Regarding Baricitinib (HRG Publication #2418)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Arthritis Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject Eli Lilly and Company’s new drug application for baricitinib for treatment of rheumatoid arthritis because it lacks any unique benefit over the very similar FDA-approved drug tofacitinib but causes unique life-threatening harms.
[Created on 4/23/2018]

Letter to HHS Secretary Calling for an Independent Investigation of NIH Officials Who Sought Alcohol Industry Funding for Alcohol Health Study (HRG Publication #2417)
Public Citizen and 13 other groups sent a letter to the U.S. Department of Health and Human Services (HHS) Secretary urging him to request that the HHS Inspector General launch an investigation into the conduct of National Institutes of Health (NIH) officials who allegedly were involved in soliciting donations from alcoholic beverage companies to fund a major study that is intended to assess the health effects of moderate alcohol consumption.
[Created on 4/11/2018]

Letter to Louisiana State Legislature Opposing a Bill That Would Weaken the Louisiana State Board of Medical Examiners (HRG Publication #2416)
Public Citizen calls on the Louisiana State Legislature to reject Senate Bill No. 286 because it would seriously compromise patient safety in Louisiana. In particular, multiple provisions of the proposed legislation would substantially impede the Louisiana State Board of Medical Examiners’ ability to appropriately investigate allegations of physician incompetence or unprofessional conduct and thereby to protect the public from dangerous doctors.
[Created on 4/10/2018]

Press Statement: Director of National Institute on Alcohol Abuse and Alcoholism Must Be Removed (HRG Publication #2415)
In light of the disturbing revelations that National Institute on Alcohol Abuse and Alcoholism Director Dr. George Koob has been doing the bidding of the alcohol industry, National Institutes of Health Director Dr. Frances Collins should immediately demand his resignation or fire him.
[Created on 4/5/2018]

Testimony Before the FDA’s Psychopharmacologic Drugs Advisory Committee Regarding Lofexidine (HRG Publication #2414)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Psychopharmacologic Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject WorldMeds’s new drug application for lofexidine for the symptomatic treatment of opioid withdrawal because the maximum dose for which approval is being sought is significantly more dangerous but no more effective than lower doses used in the UK.
[Created on 3/27/2018]

Letter to the Editor of The Washington Post Criticizing NIH Director’s Plan for Internal Probe of Its Own Alcohol Study (HRG Publication #2413)
In a letter to the editor of The Washington Post, Public Citizen attacked National Institutes of Health (NIH) Director Francis Collins’s plan for an internal investigation into allegations that senior NIH officials orchestrated a concerted campaign to obtain funding from the alcoholic beverage industry for a $100 million study of the health effects of moderate alcohol consumption.
[Created on 3/25/2018]

Follow-up Letter to the HHS Office of Inspector General Regarding the Need for an Independent Investigation Into NIH’s Solicitation of Donations From the Alcoholic Beverage Industry for Alcohol Research Study (HRG Publication #2412)
In response to an announcement by the National Institutes of Health (NIH) director that he had initiated an internal investigation into the conduct of NIH officials who allegedly were involved in soliciting donations from alcoholic beverage companies to fund a major study on the health effects of moderate alcohol consumption, Public Citizen urged the Department of Health and Human Services (HHS) Inspector General not to allow this announcement to dissuade him from opening the type of independent Inspector General’s investigation that these circumstances demand.
[Created on 3/22/2018]

Press Statement: By Approving the False Hope Act, House Lawmakers Create Dangerous Pathway for Experimental Medications (HRG Publication #2411)
The House’s passage of the seriously flawed False Hope legislation takes us one step closer to the creation of a dangerous, uncharted pathway for accessing experimental medications that have not been shown to be safe or effective.
[Created on 3/21/2018]

Letter to the HHS Office of Inspector General Requesting an Investigation Into NIH’s Solicitation of Donations From the Alcoholic Beverage Industry for Alcohol Research Study (HRG Publication #2410)
Public Citizen called on the Department of Health and Human Services (HHS) Inspector General to immediately launch a formal investigation into the conduct of National Institutes of Health (NIH) officials who allegedly were involved in soliciting donations from alcoholic beverage companies to fund a major study that is intended to assess the health effects of moderate alcohol consumption.
[Created on 3/19/2018]

AHCJ Blog Post: New Report on Big Pharma Settlements Highlights Need for Tougher Enforcement (HRG Publication #2409)
In an invited commentary for the Association of Health Care Journalists’ (AHCJ’s) Sunshine Week, Dr. Michael Carome, director of Public Citizen’s Health Research Group, discuss Public Citizen’s updated report cataloging all major financial settlements that the pharmaceutical industry has been forced to sign with federal and state governments from 1991 through 2017 for illegal activities.
[Created on 3/14/2018]

Twenty-Seven Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991 Through 2017 (HRG Publication #2408)
Public Citizen published a report that catalogues all major financial settlements and court judgments between pharmaceutical companies and federal and state governments from 1991 through 2017. The report found that drugmakers entered into 412 settlements totaling $38.6 billion in criminal and civil penalties, but that the number and size of federal and state settlements against the pharmaceutical industry remained low in 2016 and 2017, with federal criminal penalties nearly disappearing.
[Created on 3/14/2018]

Press Statement: By Rejecting False Hope Act, Lawmakers Spare Patients Serious Harm (HRG Publication #2407)
We applaud the House members who voted against the seriously flawed False Hope legislation, which would have created a dangerous, uncharted pathway for accessing experimental medications that have not been shown to be safe or effective.
[Created on 3/13/2018]

Letter to the U.S. House of Representatives Opposing the Newest “False Hope” Legislation (HRG Publication #2406)
In a letter to the U.S. House of Representatives, Public Citizen strongly opposed the “Right to Try Act of 2018.” Although the bill has several improvements over the Senate-passed version of this legislation (S. 204), it still has fundamental flaws that make it dangerous for patients. In particular, the bill would offer false hope to patients by creating a dangerous pathway for access to experimental drugs and biological products that bypasses the Food and Drug Administration’s existing Expanded Access program.
[Created on 3/12/2018]

Press Statement: The U.S. House of Representatives Should Reject the Newest Version of False Hope Act (HRG Publication #2405)
Public Citizen strongly opposes the newest version of the “False Hope” Act (the “Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2018”). Although the legislation has several improvements over the U.S. Senate-passed version (S. 204), the bill still would offer false hope to patients by creating a dangerous pathway for access to experimental medications and biological products that bypasses the Food and Drug Administration’s existing Expanded Access program.
[Created on 3/12/2018]

Comments on the FDA’s Proposed Voluntary Malfunction Summary Reporting Program for Manufacturers (HRG Publication #2404)
Public Citizen strongly opposes the Food and Drug Administration’s (FDA’s) proposal to allow voluntary, quarterly malfunction summary reporting for class III devices and those class II devices that are permanently implantable, life-supporting, or life-sustaining.
[Created on 2/26/2018]

Supplement to the Petition to the FDA to Ban Olmesartan-Containing Hypertension Medications (HRG Publication #2403)
Public Citizen submitted a supplement to its petition the Food and Drug Administration (FDA) to ban the sale of all medication containing the widely prescribed angiotensin II receptor blocker (ARB) olmesartan medoxomil because it can cause a severe gastrointestinal disorder that leads to severe and chronic diarrhea, vomiting, abdominal pain and weight loss. Since the submission of our petition, a new large cohort study was published that provides additional evidence showing that use of olmesartan is associated with a higher rate of sprue-like enteropathy compared with the use of other ARBs.
[Created on 2/1/2018]

Letter Calling on Senator Chuck Grassley to Examine OHRP’s Failure to Adequately Protect Human Research Subjects (HRG Publication #2402)
Public Citizen sent a letter to Senator Chuck Grassley urging him to broadly examine the adequacy of the Office for Human Research Protections’ (OHRP’s) compliance oversight activities and demand that the agency cease abusing its discretion when deciding whether to initiate evaluations of noncompliance allegations. The letter noted that OHRP now routinely bypasses its own procedures for investigating allegations of misconduct, which in turn signals to the research community that there is little chance the agency will investigate even serious allegations of regulatory violations.
[Created on 2/1/2018]

Letter to Congress Opposing the Proposal to Grant Two Years of Exclusivity for Certain Over-the-Counter Drugs (HRG Publication #2401)
Public Citizen expressed concerns with the proposal to grant two years of exclusivity for certain over-the-counter (OTC) drugs that is included in the September 11, 2017, House of Representatives’ discussion draft of the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018. While Public Citizen supports many of the measures included in the Act that would enable the Food and Drug Administration to better ensure that OTC drugs are safe and effective, we are concerned that the proposal to grant two years of exclusivity for certain OTC drugs could have negative repercussions for consumers.
[Created on 1/16/2018]

Letter to Congress Opposing Legislation That Would Expand Promotion of Drugs for Unapproved Uses (HRG Publication #2400)
Public Citizen sent a letter to members of U.S. House of Representatives’ Energy and Commerce Committee urging them to oppose legislation that would further erode the restrictions on the promotion of drugs for unapproved (off-label) uses that have been approved by the Food and Drug Administration for at least one use. The bill would threaten patient health and safety by undermining the current regulatory regime for ensuring that drugs are safe and effective for each intended use.
[Created on 1/16/2018]

Panel Presentation at the Johns Hopkins University Bloomberg School of Public Health Symposium: Transparency at the U.S. Food and Drug Administration (HRG Publication #2399)
Public Citizen advocated that the Food and Drug Administration follow the lead of its European and Canadian counterpart agencies and: 1) notify the public when an application to market a new drug or new use for an already-marketed drug is rejected by the agency or withdrawn by the company; and 2) release its analyses of data submitted in support of such rejected or withdrawn applications.
[Created on 1/16/2018]

STAT First Opinion: Right-to-Try Legislation Offers False Hope and Would Endanger Patients (HRG Publication #2398)
In an invited commentary, Dr. Michael Carome, director of Public Citizen’s Health Research Group, explains why so-called “right-to-try” legislation that was passed by the U.S. Senate and is now being considered by the U.S. House of Representatives would create a dangerous, uncharted pathway for patients to access experimental medications. The legislation would effectively undermine the FDA’s safety rules regarding the use of experimental drugs outside the context of a clinical trial, putting countless patients at risk.
[Created on 1/16/2018]

Commentary Advocating That the FDA Disclose Information Related to Rejected or Withdrawn New Drug Applications (HRG Publication #2397)
Public Citizen’s Health Research Group published a commentary in the Journal of Law, Medicine & Ethics advocating that the Food and Drug Administration (FDA) follow the lead of its European and Canadian counterpart agencies and: 1) notify the public when an application to market a new drug or new use for an already-marketed drug is rejected by the agency or withdrawn by the company; and 2) release its analyses of data submitted in support of such rejected or withdrawn applications.
[Created on 1/16/2018]

Press Statement: Public Citizen Applauds European Medicines Agency Committee Recommendation to Ban Dangerous IV Solutions, Calls on FDA to Immediately Follow Suit (HRG Publication #2396)
Public Citizen applauds the decision by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee to recommend removing all hydroxyethyl starch (HES) intravenous (IV) solutions from the market, although this action comes nearly five years too late. The Food and Drug Administration (FDA) must now follow suit with an immediate ban on HES solutions in the U.S.
[Created on 1/12/2018]

Comments to the FDA Supporting Draft Guidance Restricting Orphan Drug Designations for Pediatric Uses (HRG Publication #2395)
Public Citizen filed comments supporting a Food and Drug Administration (FDA) draft guidance, in which the FDA declared that it would no longer grant orphan drug designation to drugs for use in pediatric subpopulations of common diseases or conditions unless: 1) The disease in the pediatric population constitutes a valid orphan subset, or 2) the disease in the pediatric subpopulation is a different disease from the disease in the adult population.
[Created on 1/11/2018]

Testimony Before the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee Regarding Testosterone Undecanoate (Tlando) (HRG Publication #2394)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Bone, Reproductive and Urologic Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject Lipocine’s oral testosterone undecanoate capsules (Tlando) because of serious safety concerns.
[Created on 1/10/2018]

2017

Petition to the FDA to Ban Pharmacy Compounding of Cesium Chloride (HRG Publication #2393)
Public Citizen petitioned the Food and Drug Administration (FDA) to ban the use of the cancer treatment ingredient cesium chloride in pharmacy compounding because of serious health risks. FDA staff determined more than 18 months ago that cesium chloride has not been shown to be effective for “the prevention or treatment of any form of cancer,” presented “serious safety concerns,” and is “not safe for human use.”
[Created on 12/6/2017]

Letter to Congress Opposing the Proposal to Grant Two Years of Exclusivity for Certain Over-the-Counter Drugs (HRG Publication #2392)
Public Citizen expressed concerns with the proposal to grant two years of exclusivity for certain over-the-counter (OTC) drugs that is included in the September 11, 2017, House of Representatives’ discussion draft of the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2017.
While Public Citizen supports many of the measures included in the Act that would enable the Food and Drug Administration to better ensure that OTC drugs are safe and effective, we are concerned that the proposal to grant two years of exclusivity for certain OTC drugs could have negative repercussions for consumers.
[Created on 11/20/2017]

Comments to the FDA on the Presentation of Risk Information in Prescription Drug Direct-to-Consumer Broadcast Ads (HRG Publication #2391)
Public Citizen submitted comments to the Food and Drug Administration (FDA) pointing out that a study commissioned by the agency to justify its potential proposal to decrease the amount of risk information required to be disclosed in prescription drug direct-to-consumer (DTC) broadcast ads is fundamentally incomplete, flawed, and overly narrow in scope. Public Citizen urged the agency to issue a legally binding final rule regarding DTC broadcast ads that would: 1) maintain its current requirements regarding which risks must be disclosed, while requiring that severe, serious, or actionable risks be disclosed more prominently; 2) require all risk information to be disclosed in both audio and visual formats; and 3) ban the use of distracting imagery and sounds during the disclosure of risk information.
[Created on 11/20/2017]

Petition to the FDA to Ban Olmesartan-Containing Hypertension Medications (HRG Publication #2390)
Public Citizen petitioned the Food and Drug Administration (FDA) to ban the sale of olmesartan medoxomil – an angiotensin II receptor blocker (ARB) found in the widely prescribed hypertension medications marketed under the brand names Azor, Benicar, Benicar HCT and Tribenzor, as well as in other generic versions – because it can cause a severe gastrointestinal disorder that leads to severe and chronic diarrhea, vomiting, abdominal pain and weight loss.
[Created on 11/15/2017]

Comments to the EMA’s Pharmacovigilance Risk Assessment Committee Regarding the Safety of Hydroxyethyl Starch Solutions (HRG Publication #2389)
Public Citizen calls on the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) to follow the example of Sweden’s Medical Products Agency and require the immediate removal of hydroxyethyl starch (HES) solutions from the market in Europe because the solutions cause kidney failure, bleeding, and death and there are safer alternatives available. Recent drug utilization studies in 10 European Union countries indicate the futility of the PRAC’s 2013 decision to restrict the use of HES products in Europe.
[Created on 11/14/2017]

Comments on FDA Guidance Regarding IRB Waiver of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects (HRG Publication #2388)
Public Citizen urged the Food and Drug Administration (FDA) to issue expanded guidance that includes a discussion of the types of clinical investigations for which the agency might consider an institutional review board’s (IRB’s) waiver of informed consent to be appropriate from both an ethical and regulatory perspective.
[Created on 9/22/2017]

What Does a Pro-Patient, Pro-Public Health Regulatory Agency Look Like? (HRG Publication #2387)
In a post to Yale University’s CRITical Thinking blog, we discuss key features of a pro-patient, pro-public health agenda for the regulation of medical products. The blog post is derived from a presentation made at the June 2017 international conference hosted by the Yale Collaboration for Research Integrity and Transparency (CRIT) titled “Ensuring Safety, Efficacy, and Access to Medical Products in the Age of Global Deregulation.”
[Created on 9/13/2017]

Testimony Before the FDA’s Medical Imaging Drugs Advisory Committee Regarding the Safety of Linear Gadolinium-based Contrast Agents (HRG Publication #2386)
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Medical Imaging Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA adopt the approach of the European Medicines Agency and ban and restrict linear gadolinium-based contrast agents used in MRIs because they can remain deposited in the brain for months or even years and, with certain exceptions, offer no unique benefits over potentially safer, more widely used macrocyclic gadolinium-based products.
[Created on 9/8/2017]

Letter to the U.S. House of Representatives Opposing Senate Bill That Would Provide False Hope to Seriously Ill Patients (HRG Publication #2385)
Public Citizen and 16 other groups sent a letter to members of the U.S. House of Representatives urging them to oppose S. 204, which is deceptively titled the “Right to Try Act of 2017” but should instead be called the “False Hope Act of 2017.” The legislation, as amended and passed by the U.S. Senate on August 3, 2017, would put countless patients at risk by undermining important FDA safety rules related to the use and oversight of unapproved, experimental medications.
[Created on 9/5/2017]

Public Citizen Urges OSHA Not To Eliminate Most Beryllium Protections for Construction, Shipyard Workers (HRG Publication #2384)
Public Citizen submitted comments strongly urging the Occupational Safety and Health Administration (OSHA) not to: 1) finalize its proposal to rescind, for construction and shipyard workers, all ancillary provisions from its final 2017 beryllium rule; 2) delay for one year the deadline for compliance by construction and shipyard employers with the final beryllium standard; or 3) abdicate its duty to protect workers by refusing to enforce the final beryllium rule for construction and shipyard workers while this latest proposal is pending.
[Created on 8/28/2017]

Letter to Congress Opposing Legislation That Would Provide False Hope to Terminally Ill Patients (HRG Publication #2383)
Public Citizen and 17 other groups sent a letter to members of Congress urging them to oppose legislation that would most appropriately each be titled the “False Hope Act of 2017.” The legislation would put countless patients at risk by dramatically undermining the FDA’s role in ensuring that medical products are safe and effective before they become widely used.
[Created on 8/2/2017]

Complaint Letter to the OHRP and the VA Office of Research Oversight Regarding an Unethical Clinical Trial Involving Heart Attack Patients (HRG Publication #2382)
Public Citizen calls on the Office for Human Research Protections (OHRP) and the Department of Veterans Affairs (VA) Office of Research Oversight to immediately suspend the National Institutes of Health-funded Myocardial Ischemia and Transfusion (MINT) trial that is expected to involve 3,500 heart attack patients throughout the U.S. and Canada because of potentially serious ethical and regulatory violations.
[Created on 8/1/2017]

Testimony Before the FDA’s Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees Regarding A New Extended-Release Oxycodone Product (HRG Publication #2381)
In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees, Public Citizen urges the FDA to reject Intellipharmaceutics’ new version of oxycodone because, contrary to agency guidelines, the company has not conducted any human abuse potential studies of the drug to support a labeling claim that the drug deters intravenous abuse.
[Created on 7/26/2017]

Letter to FDA Opposing Approval of Liraglutide (Victoza) for Cardiovascular Risk Reduction (HRG Publication #2380)
In a letter to the Food and Drug Administration (FDA), Public Citizen urged the FDA not to approve liraglutide (Victoza) for the additional indication of reducing cardiovascular risk in type 2 diabetes patients because the clinical trial to support such approval failed to show any benefit in the 2,500 U.S. subjects in the trial. The study only showed a significant benefit in non-U.S. subjects.
[Created on 7/18/2017]

New Study Shows Medicare ACOs Won’t Tell How They Pay Doctors (HRG Publication #2379)
Ninety-one percent of the accountable care organizations (ACOs) that provide care to 9 million Medicare enrollees refuse to disclose their physician payment incentives, according to new research published today in the American Journal of Public Health. The study was conducted by researchers from Montefiore Medical Center in New York, City University of New York at Hunter College, and Public Citizen.
[Created on 7/12/2017]

Letter to Congress Opposing Draft Legislation That Would Expand Promotion of Medical Products for Unapproved Uses (HRG Publication #2378)
Public Citizen sent a letter to members of Health Subcommittee of the U.S. House of Representatives’ Energy and Commerce Committee urging them to oppose draft legislation that would significantly expand marketing for unapproved uses of drugs and medical devices that have been approved or cleared by the FDA for at least one use. The legislation would undermine regulatory standards for ensuring that drugs and medical devices are safe and effective for each marketed use.
[Created on 7/11/2017]

Public Citizen Opposes OSHA’s Proposal to Delay Compliance With Its New Workplace Injury Reporting Rule (HRG Publication #2377)
Public Citizen opposes the Occupational Safety and Health Administration’s (OSHA’s) proposal to delay the deadline, from July 1 to December 1, 2017, for certain employers to submit injury and illness data electronically under its final rule entitled “Improve Tracking of Workplace Injuries and Illnesses”. The proposed postponement is unnecessary and will impede identification of workplace health and safety hazards.
[Created on 7/7/2017]

Op-Ed in RealClearHealth on the Trump Administration’s Proposal to Weaken OSHA’s Beryllium Standard (HRG Publication #2376)
In an op-ed in RealClearHealth, Public Citizen harshly criticized a Trump administration proposal to eliminate the “ancillary provisions” of the Occupational Safety and Health Administration’s beryllium rule that would have extended specific new protections to construction and shipyard workers, including exposure assessments, personal protective equipment, medical surveillance and protected work areas.
[Created on 6/30/2017]

Public Citizen Harshly Criticizes Proposal to Roll Back Parts of the Beryllium Rule (HRG Publication #2375)
Proposal Would Continue to Put Workers in Construction and Shipyard Industries at Risk of Cancer and Chronic Beryllium Disease
[Created on 6/23/2017]

Testimony Before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding Liraglutide (Victoza) for Cardiovascular Risk Reduction (HRG Publication #2374)
Public Citizen testified against the additional approval of liraglutide (Victoza) for reducing cardiovascular risk in diabetes patients because the clinical trial to support such approval failed to show any benefit in the 2,500 American subjects in the trial. The study only showed a significant benefit in non-U.S. subjects.
[Created on 6/20/2017]

Letter to the OHRP Regarding Major Ethical and Regulatory Lapses in the Conduct of the SUPPORT Trial (HRG Publication #2373)
Public Citizen requests that the Office for Human Research Protections (OHRP) immediately expand its ongoing compliance oversight investigation of the Surfactant Positive Airway Pressure and Pulse Oximetry Trial in Extremely Low Birth Weight Infants (SUPPORT) trial to evaluate newly uncovered information — recently obtained by Public Citizen under the Freedom of Information Act — that reveals additional major ethical lapses and failures to materially comply with key requirements of federal regulations for the protection of human subjects.
[Created on 6/14/2017]

Press Statement: The FDA Should Never Have Approved Opana ER (HRG Publication #2372)
Public Citizen today applauded the U.S. Food and Drug Administration (FDA) for urging Endo to take Opana ER off the market, while criticizing the fact that the FDA approved it and blasting Endo Pharmaceuticals’ defiant response to the request.
[Created on 6/9/2017]

Letter to Congress Opposing Legislation That Would Expand Promotion of Medical Products for Unapproved Uses (HRG Publication #2371)
Public Citizen and 12 other groups sent a letter to members of U.S. House of Representatives’ Energy and Commerce Committee urging them to oppose two bills that would significantly expand marketing for unapproved uses of drugs and medical devices that have been approved or cleared by the FDA for at least one use. The legislation would undermine regulatory standards for ensuring that drugs and medical devices are safe and effective for each marketed use.
[Created on 6/5/2017]

Are We Finally Ready to Do Something About Big Pharma’s Price-Gouging? (HRG Publication #2370)
Public Citizen published an article on Other98.com that outlines the true causes for high drug prices in the U.S. and makes the case for why consumers should rally behind the recently introduced Affordable Meds Act to rein in monopoly abuses by Big Pharma and make medicines affordable.
[Created on 5/19/2017]

Letter to the Editor of The Hill Criticizing a Recent Op-Ed on OSHA’s Beryllium Rule (HRG Publication #2369)
In a letter to the editor of The Hill, Public Citizen criticized a recent op-ed (“Beryllium broadside: Obama’s last-minute rule-making will cost jobs”) for unfairly decrying the U.S. Occupational Safety and Health Administration’s (OSHA’s) efforts to protect workers from exposure to beryllium in the workplace.
[Created on 5/17/2017]

Comments to the FDA on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (HRG Publication #2368)
In comments to the Food and Drug Administration (FDA) on manufacturer communications regarding unapproved uses of approved or cleared medical products, Public Citizen discusses the risks to patients when manufacturers promote their products for unapproved uses and the unreliability of journal articles as a basis for physicians’ decisionmaking. We also explain that the First Amendment does not support the industry call for relaxation of the restrictions on promoting products for uses that the FDA has not approved as safe and effective for patients.
[Created on 4/19/2017]

Letter to the FDA About the Agency’s Failure to Provide Timely Notice of an Advisory Committee Meeting (HRG Publication #2367)
Public Citizen expressed serious concern regarding the Food and Drug Administration’s (FDA’s) failure to provide timely notice in the Federal Register of the April 13, 2017, meeting of the Antimicrobial Drugs Advisory Committee in accordance with the requirements of the agency’s own regulations. In the event that the agency fails to provide timely notice of advisory committee meetings in accordance with all regulatory requirements with respect to future advisory committee meetings, we will pursue available legal avenues to ensure compliance.
[Created on 4/13/2017]

Press Statement: Venture Capitalist Gottlieb Has Too Many Conflicts to Run FDA; We Need a Nominee Who Will Protect Public Health Instead of Industry (HRG Publication #2366)
Dr. Gottlieb’s appointment as FDA Commissioner would further accelerate a decades-long trend in which agency leadership too often makes decisions that are aligned more with the interests of industry than those of patients. We urge other senators to oppose Dr. Gottlieb’s nomination. The Senate should demand a nominee who is better suited to protect public health, rather than a venture capitalist who is ridden with conflicts of interest.
[Created on 4/4/2017]

Testimony Before the FDA’s Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees Regarding Reformulated Opana ER (HRG Publication #2365)
In testimony before a joint meeting of the Food and Drug Administration’s Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees, Public Citizen concludes that the risks of reformulated Opana ER (extended release oxymorphone) outweigh its benefits and recommends that the drug be withdrawn from the market.
[Created on 3/14/2017]

Public Citizen Urges OSHA Not to Further Delay Beryllium Rule’s Implementation (HRG Publication #2364a)
Public Citizen filed comments urging the Occupational Safety and Health Administration (OSHA) to reject a proposal to delay the effective date of its final beryllium rule. The proposal would postpone the effective date of the rule by 60 days, from the current date of March 21, 2017 to May 20, 2017, and would therefore put workers’ lives at risk.
[Created on 3/13/2017]

Press Statement: Trump’s FDA Pick Has Extensive Industry Ties and Dangerous Deregulatory Ideas (HRG Publication #2364)
Dr. Scott Gottlieb, President Trump’s pick to be Commissioner of the Food and Drug Administration (FDA), is entangled in an unprecedented web of Big Pharma ties. He has spent most of his career dedicated to promoting the financial interests of the pharmaceutical industry, and the U.S. Senate must reject him.
[Created on 3/10/2017]

Press Statements From Experts in Response to the ACGME Board’s Reckless Vote to Loosen Medical Resident Work Hour Rules (HRG Publication #2363)
The ACGME announced that effective July 1, 2017, it has rescinded the current 16-hour shift limit for first-year medical residents (also known as interns) and will allow them to work 28-hour or longer shifts without sleep.
[Created on 3/10/2017]

Letter to Congress Opposing Legislation That Would Provide False Hope to Terminally Ill Patients (HRG Publication #2362)
Public Citizen sent a letter to members of Congress urging them to oppose three bills with various names — S. 204, H.R. 878 and H.R. 1020 —that would most appropriately each be titled the “False Hope Act of 2017.” These bills provide false hope to patients and are related to a nationwide lobbying effort funded by the Goldwater Institute, which has deceptively branded such laws as “Right to Try” legislation. The legislation would put countless patients at risk by dramatically undermining the FDA’s role in ensuring that medical products are safe and effective before they become widely used.
[Created on 3/6/2017]

Press Statement: Trump’s Joint Address Attack on FDA Signals Complete Ignorance of Medication Approval Process (HRG Publication #2361)
President Trump’s claims that the U.S. Food and Drug Administration’s approval process for medical products is “slow and burdensome” and “keeps too many advances … from reaching those in need” reflect complete ignorance about the FDA’s current regulatory schemes for ensuring that medications and medical devices are safe and effective.
[Created on 3/1/2017]

Press Statement: DeLauro Proposal Would Close Dangerous Gap in FDA Regulatory Authority (HRG Publication #2360)
Public Citizen applauds Rep. Rosa DeLauro for introducing commonsense legislation that would finally give the FDA the authority to order recalls of potentially tainted medications that pose an unacceptable health risk to patients.
[Created on 2/16/2017]

Letter to the EMA Urging a Ban of Hydroxyethyl Starch Solutions in Europe (HRG Publication #2359)
Public Citizen and two leading medical experts sent a letter to the European Medicines Agency (EMA), urging the agency to ban hydroxethyl starch (HES) solutions from the European market because the solutions cause kidney failure, bleeding, and death and there are safer alternatives available. Public Citizen and the two experts also sent the agency a copy of a petition submitted on the same day to the Food and Drug Administration (FDA) that asked the FDA to remove HES solutions from the U.S. market.
[Created on 2/8/2017]

Petition to the FDA to Ban Hydroxyethyl Starch Solutions (HRG Publication #2358)
Public Citizen and two leading medical experts petitioned the Food and Drug Administration (FDA) to remove hydroxethyl starch (HES) solutions from the market because the solutions cause kidney failure, bleeding, and death and there are safer alternatives available.
[Created on 2/8/2017]

Petitions Delivered to the ACGME Urging Rejection of a Dangerous Resident Work Hours Proposal (HRG Publication #2357)
Board Expected to Vote on Dangerous Proposal Within the Next Few Weeks
[Created on 2/3/2017]

Press Statements: Trump Proposal to Eviscerate FDA Regulations Would Endanger Public Health (HRG Publication #2356)
Statements of Public Citizen Experts
[Created on 1/31/2017]

Public Citizen Applauds OSHA’s Final Beryllium Rule (HRG Publication #2355)
New Rule Will Save 94 Lives, Prevent 46 New Cases of Chronic Beryllium Disease Each Year
[Created on 1/6/2017]

2016

Petition to the FDA to Require a Warning About a Dangerous Drug Interaction Between Clopidogrel (Plavix) and Repaglinide (Prandin) in the Label for Both Drugs (HRG Publication #2354)
Public Citizen petitions the Food and Drug Administration (FDA) to require that the labels of the anti-clotting drug clopidogrel (Plavix) and the diabetes drug repaglinide (Prandin) warn doctors and patients that taking the drugs together can cause dangerously low blood sugar levels. The petition also asks that the drugs’ labels include a statement that the two drugs should never be taken together under any circumstances.
[Created on 12/21/2016]

Press Release: FDA Wrong to Remove Chantix’s Black Box Warning Based on One Flawed Study, Sets Dangerous Precedent for Future Medication Safety (HRG Publication #2353)
Smoking Cessation Medication Can Cause Psychiatric and Neurologic Side Effects
[Created on 12/19/2016]

Comments on a Proposal by an ACGME Task Force to Loosen Medical Resident Duty-hour Requirements (HRG Publication #2352)
Public Citizen commented on a proposal by an Accreditation Council for Graduate Medical Education (ACGME) task force to revise the requirements on medical resident work hours. Public Citizen strongly opposed several dangerous provisions, including allowing first-year residents to work 28 or more hours without sleep (up from the current limit of 16 hours), allowing all residents to work longer than even the 28-hour maximum shift length without needing to document or monitor such instances, removing the 8-hour minimum time off after shifts of less than 24 hours in length, and removing the cap of six night shifts in a row. These provisions are an alarming step back and further endanger the health and safety of residents and their patients.
[Created on 12/15/2016]

Presentation at the Meeting of the Committee on Issues in Organ Donor Intervention Research, National Academies of Sciences • Engineering • Medicine (HRG Publication #2351)
Public Citizen explained to the Committee on Issues in Organ Donor Intervention Research why such research clearly involves human subjects research. Such research must be reviewed and approved by an institutional review board, and researchers must obtain the informed consent of the organ transplant recipients who are the subjects of this research.
[Created on 12/14/2016]

Press Statement: Pharma, Medical Device Industries Got an Early Christmas Present, But Not Everything on Their List (HRG Publication #2350)
Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group
[Created on 12/7/2016]

Press Statement: 21st Century Cures: Bad Deal for Patients. Senate Should Reject (HRG Publication #2349)
Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group
[Created on 11/30/2016]

Comments on the FDA’s Draft Guidance on Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees (HRG Publication #2348)
Public Citizen and seven other groups expressed serious concerns that the proposed guidance would encourage the Food and Drug Administration (FDA) to continue inappropriately excluding advisory committee members from participating in committee meetings based on an “intellectual bias” — a phrase that does not appear in the draft guidance but that the FDA now routinely uses when screening individual advisory committee members for conflicts of interest prior to committee meetings.
[Created on 11/25/2016]

Testimony Before the FDA’s Public Hearing on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (HRG Publication #2347)
Public Citizen testified at a Food and Drug Administration (FDA) public hearing on “off-label marketing” – the pharmaceutical and medical device industry practice of marketing medications and medical devices for unapproved uses. Public Citizen experts explain that restrictions on marketing for unapproved uses are crucial to protecting patient health. Promotion of medical products for unapproved uses threatens patients because it undermines the long-standing regulatory framework for ensuring that medications and medical devices are safe and effective for their intended uses.
[Created on 11/9/2016]

Press Release: Proposal to Allow First-Year Resident Physicians to Work 28 Hours in a Row Puts Residents, Patients, Public at Risk of Serious Injury, Death (HRG Publication #2346)
Americans Overwhelmingly Oppose ACGME Work-Hour Proposal
[Created on 11/4/2016]

Public Citizen Urges Congress to Abandon the Dangerous 21st Century Cure Act (HRG Publication #2345)
Public Citizen and 12 other groups sent a letter to Congressional leaders urging them to abandon the dangerous 21st Century Cures Act. The legislation includes a grab bag of goodies for Big Pharma and medical device companies that would undermine requirements for ensuring safe and effective drugs and medical devices and the affordability of these medical products.
[Created on 11/3/2016]

Press Release: Federal Officials Agree With Public Citizen: Kidney Transplant Experiment Violated Federal Human Research Rules (HRG Publication #2344)
Public Citizen Had Called for Investigation Into Blatant Ethics Violations and for Disclosure to Patients Who Were Unwitting Experimental Subjects
[Created on 10/27/2016]

Comments on the FDA’s Draft Guidance on Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B (HRG Publication #2343)
Public Citizen, in general, supports the policies expressed in the Food and Drug Administration’s (FDA’s) draft guidance document. In particular, the proposed guidance appropriately seeks to tightly limit, under section 503B, pharmacy compounding of drug products that are essentially copies of approved drug products. Stringent limits on such pharmacy compounding under section 503B are critically important to protecting public health. We suggest some minor changes to strengthen the guidance.
[Created on 10/11/2016]

Comments on the FDA’s Draft Guidance on Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A (HRG Publication #2342)
Public Citizen, in general, supports the policies expressed in the Food and Drug Administration’s (FDA’s) draft guidance document. In particular, the proposed guidance appropriately seeks to tightly limit, under section 503A, pharmacy compounding of drug products that are essentially copies of a commercially available drug product. Stringent limits on such pharmacy compounding under section 503A are critically important to protecting public health. We suggest some minor changes to strengthen the guidance.
[Created on 10/11/2016]

Press Statement: Patient Safety Threatened by HHS Refusal to Close Dangerous Loophole That Allows Health Care Providers to Evade Malpractice Reporting (HRG Publication #2341)
Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group
[Created on 9/22/2016]

Testimony Before the FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding the Black Box Warning on the Smoking Cessation Drug Varenicline (Chantix) (HRG Publication #2340)
In testimony presented at a joint meeting of the Food and Drug Administration’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee discussing whether to remove a boxed warning on the smoking cessation drug varenicline (Chantix), Public Citizen urged the committees to retain the boxed warning as a critical reminder to patients and their doctors that varenicline can cause potentially life-threatening psychiatric and neurologic side effects. The committees are considering whether to remove the boxed warning based on a single clinical trial that was fundamentally flawed and incapable of detecting the increased risk of such side effects, thousands of which have been reported to the FDA since varenicline’s approval in 2006.
[Created on 9/14/2016]

Letter to the University of Pennsylvania, Johns Hopkins Bloomberg School of Public Health (HRG Publication #2339)
Public Citizen and the American Medical Student Association urged the lead institutions for the iCOMPARE trial to immediately take whatever actions are necessary to terminate the trial. Allowing the continued unwitting enrollment of tens of thousands of patient subjects in the trial, in the face of national poll data showing that the vast majority of the adult public would want to be informed of this experiment if they were admitted to one of the experimental-group hospitals, would constitute an egregious, knowing disregard for the basic ethical principle of respect for persons.
[Created on 9/13/2016]

Letter to Northwestern University Presenting Results of a National Poll Question Related to the Unethical FIRST Trial Comparing Standard and Long Work Schedules for General Surgery Residents (HRG Publication #2338)
Public Citizen and the American Medical Student Association urged Northwestern University to immediately take whatever actions are necessary to terminate the FIRST trial. Allowing the continued unwitting enrollment of tens of thousands of patient subjects in the trial, in the face of national poll data showing that the vast majority of the adult public would want to be informed of this experiment if they were admitted to one of the experimental-group hospitals, would constitute an egregious, knowing disregard for the basic ethical principle of respect for persons.
[Created on 9/13/2016]

Letter to OHRP Presenting Results of a National Poll Question Related to the Unethical FIRST and iCOMPARE Trials Comparing Standard and Long Work Schedules for Medical Residents (HRG Publication #2337)
Public Citizen and the American Medical Student Association again called on the Office for Human Research Protections (OHRP) to launch formal investigations into the FIRST and iCOMPARE trials and to use its legal authority to suspend the iCOMPARE trial. Allowing the continued unwitting enrollment of tens of thousands of patient subjects in these trials, in the face of national poll data showing that the vast majority of the adult public would want to be informed of this experiment if they were admitted to one of the experimental-group hospitals, would constitute an egregious, knowing disregard for the basic ethical principle of respect for persons.
[Created on 9/13/2016]

Letter to the ACGME Regarding Public Citizen’s Report, Bipartisan Consensus: The Public Wants Well-Rested Medical Residents to Help Ensure Safe Patient Care (HRG Publication #2336)
Public Citizen and the American Medical Student Association (AMSA) provided the Accreditation Council for Graduate Medical Education (ACGME) with the results of a national poll showing that Americans overwhelmingly oppose any weakening of the current 16-hour shift limit for first-year residents (interns) and support a similar cap on upper-level residents’ work shifts. Public Citizen and AMSA urged the ACGME to (1) maintain its 16-hour cap for interns and extend the 16-hour cap to all residents; and (2) take action to stop the unethical iCOMPARE and FIRST trials.
[Created on 9/13/2016]

Public Citizen Report: Bipartisan Consensus: The Public Wants Well-Rested Medical Residents to Help Ensure Safe Patient Care (HRG Publication #2335)
Public Citizen released a report on the results of a new national poll showing that the vast majority of the American public favors restricting medical resident work shifts to no more than 16 straight hours without sleep. The report also summarizes research conducted to date on the dangers of sleep deprivation in residents to both the residents and their patients. The poll comes as the Accreditation Council for Graduate Medical Education (ACGME) is facing intense pressure from dozens of physician organizations to lift the current 16-hour shift cap for first-year medical residents and allow them to work 28 or more hours in a row without sleep.
[Created on 9/13/2016]

Comments on the FDA’s Draft Guidance on Updating Generic Drug Labeling After The Marketing Application For The Reference Listed Drug Has Been Withdrawn (HRG Publication #2334)
The draft guidance is a small step toward filling the safety gap that exists because generic drug manufacturers lack authority to initiate labeling changes based on new safety information. To more fully address the problem, we urge the Food and Drug Administration (FDA) to move promptly to finalize the November 2013 proposed rule entitled “Supplemental Applications Proposing Labeling Changes For Approved Drugs And Biological Products.”
[Created on 9/9/2016]

Op-Ed in the Pensacola News Journal Regarding the Incarceration of Seriously Mentally Ill Individuals (HRG Publication #2333)
In a joint op-ed, Public Citizen and the Treatment Advocacy Center discuss results of their recent report on a comprehensive national survey that captured the perspectives of county jail staff about inmates with serious mental illnesses. The op-ed highlights the need to stop the enduring tragedy that jails have become warehouses for the seriously mentally ill.
[Created on 8/7/2016]

Testimony Before the FDA’s Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees Regarding Extended-Release Morphine Sulfate (Arymo) (HRG Publication #2332)
In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee, Public Citizen opposed approval of extended-release morphine sulfate (Arymo) because of serious concerns about increased risk of abuse, given its easy manipulability and unsatisfactory performance in oral human abuse likeability studies. We also urged that the FDA’s guidance for industry, “Abuse-Deterrent Opioids—Evaluation and Labeling,” be withdrawn and replaced with a regulation more favorable to patients than to opioid makers.
[Created on 8/4/2016]

Comments on the FDA’s Draft Guidances on the Prescription Requirement Under Section 503A and the Facilities Definition Under Section 503B (HRG Publication #2331)
Public Citizen supports policies contained in these two recent FDA guidances, which generally serve to clarify the line between traditional pharmacy compounding and drug manufacturing. In particular, we agree that Section 503A limits traditional compounding pharmacies from selling “office stock” in bulk to healthcare practitioners, approve of clear limitations on anticipatory compounding, and approve of the requirement that all products produced by outsourcing facilities comply with current good manufacturing practices.
[Created on 7/18/2016]

Individuals With Serious Mental Illnesses in County Jails: A Survey of Jail Staff’s Perspectives (HRG Publication #2330)
Public Citizen and the Treatment Advocacy Center are releasing a comprehensive national survey that captures the perspectives of county jail staff about inmates with serious mental illnesses. According to the report, 21 percent of the surveyed county jails reported that 16 percent or more of their inmates were seriously mentally ill. The report presents the challenges faced by county jail staff, including the limited training they are given to address the needs of these inmates, who do not belong in jails to begin with.
[Created on 7/14/2016]

Letter to U.S. Congress Conference Committee for the Comprehensive Addiction and Recovery Act (HRG Publication #2329)
Public Citizen strongly opposed a section of the House version of the Comprehensive Addiction and Recovery Act that would increase payments under Medicaid programs to opioid manufacturers for “abuse-deterrent” formulations of opioid drugs. This provision is a misguided handout to an industry that needs no additional incentives to develop and market new abuse-deterrent opioids.
[Created on 7/1/2016]

Petition to the FDA to Require a Black-Box Warning for Dopamine Agonist Drugs (HRG Publication #2328)
Public Citizen petitions the Food and Drug Administration (FDA) to add stronger warnings to the labeling for dopamine agonist drugs (apomorphine, bromocriptine, cabergoline, pramipexole, ropinirole, and rotigotine) to alert doctors and patients to the risk of impulse-control problems and compulsive behaviors, including pathological gambling, hypersexuality, and compulsive shopping and eating.
[Created on 6/29/2016]

Comments on the FDA’s Proposed Rule to Ban All Powdered Medical Gloves (HRG Publication #2327)
Public Citizen supports the Food and Drug Administration’s (FDA’s) proposed rule that would ban all powdered surgeon’s and patient examination gloves. We strongly disagree with how long this proposal has taken to be put forth. FDA’s history of past, inexcusable and dangerous delays is cause for concern about how promptly this proposed ban will be finalized.
[Created on 6/20/2016]

Testimony Before the FDA’s Drug Safety and Risk Management Committee and Anesthetic and Analgesic Drug Products Advisory Committee Regarding ALO-02 (Oxycodone/Naltrexone) (HRG Publication #2326)
In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee, Public Citizen opposed approval of the combination opioid product ALO-02 because of serious concerns about increased risk of abuse, given its easy manipulability. We also urged that the FDA’s guidance for industry, “Abuse-Deterrent Opioids —Evaluation and Labeling,” be withdrawn and replaced with a regulation more favorable to patients than to opioid makers.
[Created on 6/8/2016]

Press Statement: Energy Department Outpaces OSHA in Protecting Workers from Beryllium (HRG Publication #2325)
Public Citizen applauds the U.S. Department of Energy (DOE) for issuing a proposed rule that, for the second time in 17 years, would bring its Chronic Beryllium Disease Prevention Program in line with current evidence on the dangers of beryllium. The DOE’s proposal stands in sharp contrast with the actions of the U.S. Occupational Safety and Health Administration (OSHA), which has yet to lower its workplace beryllium limit from an outdated level set in 1971.
[Created on 6/7/2016]

Public Citizen Statement to the FDA on Pharmacy Compounding Issues Related to Use of Bulk Substances and Office Stock (HRG Publication #2324)
In a statement to Food and Drug Administration (FDA) officials during a listening session with consumer groups, Public Citizen urged the FDA to prevent compounding using bulk drug substances that have been identified as unsafe or ineffective by FDA reviewers. We also expressed strong support for the FDA’s proposal to prevent compounding pharmacies from engaging in compounding large quantities of products for sale to healthcare providers as office stock.
[Created on 6/6/2016]

Public Citizen Comments on Proposed FDA Guidance on Labeling for Biosimilars (HRG Publication #2323)
Public Citizen supports the Food and Drug Administration’s (FDA’s) proposal to keep the labels of biosimilars free of data from clinical trials used to demonstrate biosimilarity, similar to the labeling approach taken with generic drugs. We also support the FDA’s proposal to require that manufacturers of biosimilars promptly update the labeling of such products with new safety and efficacy information, as this policy will allow important new warnings to reach patients and doctors promptly.
[Created on 6/3/2016]

Press Statement: Lawmakers’ Proposal Would Turn Patients Into Guinea Pigs (HRG Publication #2322)
A letter from U.S. Representatives Fred Upton (R-Mich.) and Joseph Pitts (R-Pa.) shows a lack of appreciation for the role of the Food and Drug Administration (FDA) in protecting patient health and a naive view of industry marketing practices. The threat to patient health posed by the draft bill attached to their letter is tremendous.
[Created on 5/27/2016]

New Study Shows NIH-Funded Oxygen Experiment on Premature Babies Was Unethical, Parents of Babies Were Misled (HRG Publication #2321)
Contrary to statements made in consent forms signed by the parents of most premature babies enrolled in a controversial government clinical trial, some key procedures being used in the experiment were inconsistent with usual or standard care for such babies, a new study published by researchers at Public Citizen and National Institutes of Health (NIH) study published in the medical journal PLOS ONE shows.
[Created on 5/19/2016]

Press Statement: Delay in Generics Labeling Rule Leaves Patients at Risk (HRG Publication #2320)
The Food and Drug Administration’s (FDA’s) postponement to April 2017 of an important patient safety rule endangers the millions of us who take prescription medications. The FDA is plainly bowing to industry pressure and, in the process, prioritizing industry profits over patient health and safety. At this point, we worry about the agency’s commitment to finalizing the rule, which it acknowledged in 2013 would improve drug safety.
[Created on 5/19/2016]

Press Statement: Keeping Limits on Medical Resident Work Hours Is the Right Thing to do, but the Unethical FIRST Trial Must End (HRG Publication #2319)
We are relieved to hear that the Accreditation Council for Graduate Medical Education (ACGME) will not be loosening restrictions on medical resident work hours for the upcoming academic year. However, we are disturbed to learn that the ACGME is extending the waiver of some of the organization’s current key work hour restrictions and providing funding to allow the continuation of the highly unethical Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) trial for a third year.
[Created on 5/18/2016]

Press Statement: Safety Issues Prompt NIH Overhaul of Clinical Center Leadersh (HRG Publication #2318)
The findings of the just-released Clinical Center Working Group report highlight a stunning failure of National Institutes of Health (NIH) leadership at the highest levels. In particular, the report found that NIH has fostered a culture in which protecting patients and human research subjects from risk sometimes takes a back seat to the demands of researchers.
[Created on 5/11/2016]

Additional Comments Submitted on OSHA’s Proposed Beryllium Rule (HRG Publication #2317)
In response to a request from the Occupational Safety and Health Administration (OSHA) for additional comments on its proposed standard to protect workers from beryllium, Public Citizen submitted final comments on the standard. Public Citizen’s Dr. Sammy Almashat and Emily Gardner commented on provisions of the rule relating to outdoor workers, such as abrasive blasters, and the medical surveillance of all workers exposed to beryllium. The comments supplemented recent testimony by Almashat and Gardner at a hearing held by OSHA on the proposed standard.
[Created on 5/6/2016]

Testimony Before the FDA’s Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Regarding Opioid Analgesics (HRG Publication #2316)
In testimony before a joint meeting of the Food and Drug Administration’s Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee, Public Citizen called for legally mandated training for doctors who prescribe powerful opioid painkillers as a condition of obtaining or renewing their Drug Enforcement Agency narcotics licenses.
[Created on 5/4/2016]

Complaint Letter to the Office for Human Research Protections and the Department of Veterans Affairs Regarding an Unethical Kidney Transplant Experiment (HRG Publication #2315)
Public Citizen called on the Office for Human Research Protections and the U.S. Department of Veterans Affairs’ (VA’s) Office of Research Oversight to investigate a clinical trial involving kidney transplant patients that was unethical and violated rules for the protection of human subjects. The major problem is that the institutional review board (IRB) at the lead institution for the study incorrectly determined that this research constituted “nonhuman subjects research under U.S. federal law.” As a result of this clear error, the IRB failed to adequately review and approve the trial in accordance with regulations to protect human subjects and failed to ensure that the researchers obtained the voluntary informed consent from the subjects.
[Created on 4/20/2016]

Letters to CMS and the Joint Commission Requesting Roll Back of Pain Assessment Requirements That Foster Dangerous Overprescribing of Opioids (HRG Publication #2314)
In an effort to reduce overprescribing of opioid pain relievers, dozens of health care organizations, medical experts and consumer advocacy groups – including Public Citizen – sent petitions today to the Joint Commission, an agency that accredits health care organizations, and to the Centers for Medicare and Medicaid Services (CMS). Petition signers are requesting changes to requirements for assessing patients’ pain that they believe foster dangerous opioid analgesic prescribing practices.
[Created on 4/13/2016]

Letter to the Editor of The Washington Post Criticizing a Recent Op-Ed on Cuba (HRG Publication #2313)
In a letter to the editor of The Washington Post, Public Citizen pointed out that a Mar. 27th Op-Ed (“5 Myths About Cuba”) critiquing Cuba’s healthcare system relied solely on anecdotes and conflicted with the overwhelming evidence demonstrating Cuba’s healthcare advances in the face of a five-decade-old U.S. embargo.
[Created on 4/8/2016]

Letter to the Texas State Board of Pharmacy Asking the Agency to Shut Down a Dangerous Compounding Pharmacy in Texas (HRG Publication #2312)
Public Citizen strongly urges the Texas State Board of Pharmacy to suspend immediately the pharmacy license for I.V. Specialty — a compounding pharmacy based in Austin that produces a wide range of sterile drugs for home infusion — and the licenses of all pharmacists employed by the company. These state regulatory actions are urgently needed to protect patients from potentially life-threatening infections: A recent inspection of I.V. Specialty by the Food and Drug Administration (FDA) found multiple serious violations of standard procedures for producing sterile injectable drugs, and the company recklessly refused to follow the FDA’s recommendations to discontinue production of injectable drugs and to recall all of its unexpired injectable drug products.
[Created on 4/6/2016]

Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991 Through 2015 (HRG Publication #2311)
Public Citizen published a report that catalogues all major financial settlements and court judgments between pharmaceutical companies and federal and state governments from 1991 through 2015. The report found that drugmakers entered into 373 settlements totaling $35.7 billion in criminal and civil penalties, but that both the number and size of settlements decreased significantly in 2014 and 2015.
[Created on 3/31/2016]

Press Statement: Eighteen Years Too Late: FDA Finally Heeds Public Citizen’s Call, Moves to Ban Powdered Latex Surgical Gloves – and All Powdered Medical Gloves (HRG Publication #2310)
Statement of Dr. Sidney Wolfe, Founder and Senior Adviser, Public Citizen’s Health Research Group
[Created on 3/21/2016]

Testimony at OSHA Hearing on the Agency’s Proposed Beryllium Rule (HRG Publication #2309)
Sammy Almashat and Emily Gardner testified at the Occupational Safety and Health Administration’s (OSHA’s) two-day public hearing on OSHA’s proposed rule to update its regulation on airborne beryllium exposures in the workplace. Dr. Almashat urged OSHA to lower its proposed exposure limit even further in order to adequately protect as many workers as possible, while Ms. Gardner noted that the more than 23,000 construction and shipyard workers regularly exposed to beryllium also must be protected under the new rule.
[Created on 3/21/2016]

Testimony Before the FDA Workshop on Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy (HRG Publication #2308)
Two overarching problems are highlighted by the INRatio/ROCKET AF case: (1) The inadequacy of the low Food and Drug Administration (FDA) legal standard of substantial equivalence [510(k)] for devices needed to monitor life-threatening conditions; and (2) The dangerous failure of parties involved — the FDA, the Rocket AF investigators, Janssen/Bayer, and the INRatio manufacturers — to promptly investigate, communicate serious device warnings to all other parties, and take appropriate, necessary actions.
[Created on 3/18/2016]

Testimony Before the FDA’s Circulatory System Devices Panel Regarding the AngelMed Guardian System (HRG Publication #2307)
Public Citizen strongly opposes approval of the premarket approval application for the AngelMed Guardian System. The results of the single pivotal randomized, controlled trial for the device, the ALERTS study, fail to provide a reasonable assurance that the device is effective for the proposed indication, and the conduct of the study was marred by serious protocol violations and post hoc modifications. The device also has serious risks that are not justifiable given the lack of evidence of effectiveness.
[Created on 3/16/2016]

Press Statement: Effort to Weaken Rules on Resident Physician Work Hours Threatens Safety of Residents and Their Patients (HRG Publication #2306)
On March 16, the Accreditation Council for Graduate Medical Education (ACGME) is convening a two-day, invitation-only National Congress to discuss limits on medical resident work hours. Any effort to increase the number of consecutive hours resident physicians can work without sleep threatens the health of both residents and their patients, and should be rejected.
[Created on 3/15/2016]

Letter to the HHS Acting Assistant Secretary for Health Regarding the Unethical iCOMPARE Trial (HRG Publication #2305)
Public Citizen and the American Medical Student Association request an urgent meeting with the Department of Health and Human Services’ (HHS) Acting Assistant Secretary for Health and the Director of the Office for Human Research Protections to discuss OHRP’s failures to suspend the unethical iCOMPARE trial and to launch an investigation into the research. In light of the increasingly overwhelming evidence of widespread, serious ethical and regulatory violations involving the trial, a decision by OHRP to not initiate a formal for-cause compliance oversight evaluation of all institutions participating in this unethical trial would constitute an unacceptable abuse of the agency’s discretion and an abrogation of its fundamental responsibility to protect human subjects.
[Created on 3/9/2016]

Second Follow-up Letter to OHRP Regarding the Unethical iCOMPARE Trial (HRG Publication #2304)
Public Citizen and the American Medical Student Association express dismay at the failures of the Office for Human Research Protections (OHRP) to suspend the unethical iCOMPARE trial and to launch an investigation into the research. Newly obtained government documents regarding the trial, which forces some first-year medical residents to work dangerously long shifts, provide further evidence that the trial violates basic ethical principles and federal regulatory requirements for the protection of human subjects.
[Created on 3/9/2016]

Statement Before the Science Board to the Food and Drug Administration Regarding Opioid Drug Products (HRG Publication #2303)
If today’s meeting is more than a public relations effort for the Food and Drug Administration (FDA) to show that it is concerned about opioids, then maybe the FDA will listen to the Science Board. The board needs to let the FDA know that the Risk Evaluation and Mitigation Strategy (REMS) programs for opioids require an overhaul. Prescriber education will be ineffective unless past misinformation is explicitly and forcefully corrected.
[Created on 3/1/2016]

Public Citizen, Partners Petition FDA for Black-Box Warnings on Opioids, Benzodiazepines About Dangers of Concurrent Use (HRG Publication #2302a)
Public Citizen and partners including several representatives of state health departments petition the Food and Drug Administration (FDA) to require black-box warnings on the labels of opioid painkillers and benzodiazepine tranquilizers to warn of the dangers of concurrent use. There are more than 14,000 deaths in the U.S. each year due to overdose of prescription opioid painkillers, and a rapidly increasing proportion of these deaths occurs in people prescribed benzodiazepines as well as opioids. This increase is not registering with prescribing doctors, however, necessitating a change in the labeling of these medications to better inform and protect patients.
[Created on 2/22/2016]

Follow-up Letter to OHRP Regarding the Unethical iCOMPARE Trial Comparing Standard and Long Work Schedules for Internal Medicine Residents (HRG Publication #2302)
Public Citizen and the American Medical Student Association again call on the Office for Human Research Protections (OHRP) to immediately suspend the iCOMPARE trial and to launch an investigation into the research. Documents recently obtained by Public Citizen from NIH provide additional clear evidence that the iCOMPARE trial, as designed and currently being conducted, violates basic ethical principles and federal regulatory requirements related to the protection of human subjects. OHRP’s failure to take action is troubling, and the agency’s continued inaction makes it a culpable party in this unethical research.
[Created on 2/11/2016]

Public Citizen Opposes Medical Device Bills to Be Marked Up Before Senate Committee (HRG Publication #2301)
Public Citizen writes to the Senate Health, Education, Labor, and Pensions Committee to oppose two bills that are scheduled to be marked up March 9, 2016. The bills would advance dangerous provisions weakening the Food and Drug Administration’s (FDA’s) power to regulate medical devices. One measure would lower approval standards for products that combine devices with drugs or biological products, and the other would pressure the FDA to take shortcuts that would lower the quality of information available for FDA review of medical devices. Both bills should be rejected, and no Senate-passed measures should be combined with the 21st Century Cures legislation, which would put patient lives at risk and compromise public health.
[Created on 2/8/2016]

New Health Research Group Study Examines Physician Sexual Misconduct in the National Practitioner Data Bank (HRG Publication #2300)
Published today in PLOS ONE, the study shows that only a small number of physicians (n=1,039) were reported to the National Practitioner Data Bank due to sexual misconduct — that have led to sanctions by medical boards, hospitals or other health care organizations, or have led to malpractice payments — over a recent almost 10-year period. Interestingly, state medical boards did not take any actions against two thirds of the physicians with sanctions by hospitals or other health care organizations or malpractice payments related to this unethical behavior.
[Created on 2/3/2016]

Press Statement: New England Journal of Medicine Violates Its Own Policy, Publishes Results of Unethical FIRST Trial That Put Resident Doctors at Risk (HRG Publication #2299)
The New England Journal of Medicine editors’ decision to publish the results of the unethical, seriously flawed Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) trial violates the journal’s own policy requiring authors to provide assurances related to the protection of human subjects. Furthermore, the trial yielded the self-serving results sought by the trial’s researchers, whose stated goal before the trial began was to roll back mandatory limits on physician resident work hours that were adopted in 2011 to protect both the residents and their patients from serious harm.
[Created on 2/2/2016]

Comments on the CDC’s Proposed 2016 Guideline for Prescribing Opioids for Chronic Pain (HRG Publication #2298)
Public Citizen strongly supports the Centers for Disease Control and Prevention’s (CDC’s) proposed 2016 Guideline for Prescribing Opioids for Chronic Pain. The proposed guideline provides common-sense, evidence-based recommendations for primary care providers who prescribe opioids for chronic pain and would represent an important step forward in efforts to address the severe drug addiction epidemic in the U.S. that has been fueled by overprescribing of opioids.
[Created on 1/13/2016]

Complaint Letters to the Department of Veterans Affairs Regarding the Unethical CHAMPION PHOENIX Clinical Trial (HRG Publication #2297)
Public Citizen called on the Department of Veterans Affairs’ (VA) Office of Research Oversight to investigate the unethical CHAMPION PHOENIX clinical trial, which involved three VA medical centers. The trial needlessly increased the risk of death, heart attack and other adverse cardiac events for subjects placed in the control group of the trial by exposing them to substandard care. In a separate letter to the VA’s Office of Inspector General, Public Citizen called for an investigation into whether the inappropriate care provided to subjects in the CHAMPION PHOENIX trial extended to clinical care of patients who did not participate in the trial.
[Created on 1/7/2016]

Comments on the Proposed Revisions to the Federal Regulations for the Protection of Human Subjects (HRG Publication #2296)
Public Citizen provides detailed comments on the notice of proposed rulemaking (NPRM) that would extensively revised the Federal Policy for the Protection of Human Subjects. The NPRM would transform the regulations — which are currently written in clear, concise, and, in most respects, easily understood language — into a document that is exceedingly confusing, overly complex, and written in very opaque language in multiple sections.
[Created on 1/6/2016]

2015

Comments on the FDA’s Draft Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (HRG Publication #2295)
Public Citizen objects to the Food and Drug Administration’s (FDA’s) proposed interim policy that will allow outsourcing facilities to mass-produce drugs using bulk drug substances that are not currently on a list of drug shortages maintained by the FDA or on a list of bulk drug substances developed for which there is a clinical need. The proposed interim policy poses a threat to public health.
[Created on 12/22/2015]

Comments on the FDA’s Draft Interim Policy on Compounding Drugs Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act (HRG Publication #2294)
Public Citizen objects to the Food and Drug Administration’s (FDA’s) proposed interim policy that will allow pharmacies to compound drugs using bulk drug substances that that are not components of drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act, the subject of U.S. Pharmacopeia or National Formulary monographs, or drug substances appearing on the 503A bulk list while the agency undertakes the task of evaluating nominations for the 503A bulk list. The proposed interim policy poses a threat to public health.
[Created on 12/22/2015]

Letter Responding to the ACGME’s Defense of the iCOMPARE and FIRST Trials Comparing Standard and Long Work Schedules for Medical Residents (HRG Publication #2293)
The Accreditation Council for Graduate Medical Education (ACGME) response to Public Citizen and the American Medical Student Association’s November 19, 2015, letter regarding the iCOMPARE and FIRST trials fails to substantively address the major concerns about the trials’ serious ethical lapses and instead represents a misleading attempt by the ACGME to absolve itself of any responsibility for its central role in this unethical research. Public Citizen renewed its call for the ACGME to rescind its waivers of important work hour limits for medical residents that it granted to hospitals and residency training programs participating in the iCOMPARE and FIRST trials.
[Created on 12/16/2015]

Testimony Before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding Simvastatin/Ezetimibe (HRG Publication #2292)
Public Citizen opposes approval of ezetimibe in combination with simvastatin for the proposed indication of reducing the risk of cardiovascular events in patients with coronary heart disease. Results of the IMPROVE-IT study failed to provide substantial evidence to support approval for this indication.
[Created on 12/14/2015]

Press Statement: Unseemly and Inappropriate: FDA Joined With the Medical Device Industry in Drafting Cures Legislation (HRG Publication #2291)
It should be unimaginable that the most senior Food and Drug Administration (FDA) officials would collude with the lead medical device trade association to write legislation to weaken the agency’s regulatory oversight and approval standards for medical devices. But that is exactly what appears to have happened. The result is contained within the House-passed 21st Century Cures Act – more accurately known as the False Cures Act – which would eviscerate the already far-too-weak safety rules for medical devices.
[Created on 12/11/2015]

Letter to FDA on Serious Problems With INRatio Measuring Device Used in ROCKET AF Anticoagulant Trial (HRG Publication #2290)
Public Citizen urges the FDA to investigate the possible impact of inaccurate measurements, by a device called INRatio, on subjects’ anticoagulation during the ROCKET AF trial, which sought to compare the standard anticoagulant warfarin with the newer drug rivaroxiban (Xarelto). Public Citizen has found 1,445 injury and almost 10,000 FDA malfunction reports connected with this device , raising serious questions about the validity of the study’s findings. FDA Commissioner nominee Dr. Robert Califf co-chaired the steering committee advising Johnson and Johnson on the study and should thus recuse himself from any investigation.
[Created on 12/10/2015]

Public Citizen Report: House Orphan Drug Proposal: A Windfall for Pharma, False ‘Cure’ for Patients (HRG Publication #2289)
In July 2015, the U.S. House of Representatives passed the 21st Century Cures Act, a bill purported to provide “help and hope for patients through biomedical innovation.” Yet in many ways the “cure” presented by the bill is a false one. For example, one provision of the bill would give an extra six months of monopoly protection to manufacturers for brand-name medications granted an additional approval to treat an orphan disease. Public Citizen’s report explains how this provision could cost U.S. taxpayers, private insurers, and patients nearly $12 billion over the next ten years, while accelerating the current trend of non-innovative research into orphan drugs.
[Created on 12/8/2015]

Letter to the FDA Urging the Agency not to Approve the New Drug Application for Lesinurad (HRG Publication #2288)
Public Citizen opposes Food and Drug Administration (FDA) approval of the new drug application for lesinurad for treatment of hyperuricemia associated with gout because the drug offers meager clinically meaningful benefits relative to placebo for gout patients with hyperuricemia and has serious risks, including definite significant kidney toxicity and possible cardiovascular toxicity. FDA approval — with reliance on warnings in the product labeling, a risk evaluation and mitigation strategy, and postmarket safety studies — would be a reckless approach and would not be in the interests of public health.
[Created on 12/7/2015]

Press Statement: FDA Delay in Safety Rule Leaves Patients Nationwide at Risk (HRG Publication #2287)
The Food and Drug Administration (FDA)’s postponement to July 2016 of a significant patient safety rule leaves open a safety gap for the millions of patients who take generic medications. The agency proposed the rule in 2013 in response to a 2011 Public Citizen petition.
[Created on 12/3/2015]

Testimony Before the FDA’s Psychopharmacologic Drugs Advisory Committee Regarding Gepirone (HRG Publication #2286)
Public Citizen strongly opposes Food and Drug Administration (FDA) approval of gepirone for treatment of depression. The drug showed such poor results in clinical testing that its approval by the FDA would effectively weaken standards for approval of new antidepressants.
[Created on 12/1/2015]

Letter to the ACGME Regarding the iCOMPARE and FIRST Trials Comparing Standard and Long Work Schedules for Medical Residents (HRG Publication #2285)
Public Citizen and the American Medical Student Association urge the Accreditation Council for Graduate Medical Education (ACGME) to rescind waivers of its work hour limits for medical residents that it granted to hospitals and residency training programs participating in the iCOMPARE and FIRST trials. Neither of these unethical trials could have proceeded without the ACGME’s waivers.
[Created on 11/19/2015]

Letter to OHRP Regarding the FIRST Trial Comparing Standard and Long Work Schedules for General Surgery Residents (HRG Publication #2284)
Public Citizen and the American Medical Student Association call on the Office for Human Research Protections to immediately launch an investigation of the FIRST trial and to sanction all hospitals that participated in the trial. The trial — an experiment involving general surgery residents and their patients without their consent — was highly unethical and failed to comply with federal regulations for the protection of human subjects involved in research.
[Created on 11/19/2015]

Letter to OHRP Regarding the iCOMPARE Trial Comparing Standard and Long Work Schedules for Internal Medicine Residents (HRG Publication #2283)
Public Citizen and the American Medical Student Association call on the Office for Human Research Protections to immediately suspend the iCOMPARE trial and to launch an investigation of the research. The trial — an experiment involving internal medicine residents and their patients without their consent — is highly unethical and fails to comply with federal regulations for the protection of human subjects involved in research.
[Created on 11/19/2015]

Testimony Before the FDA’s Antimicrobial Drugs and Drug Safety and Risk Management Advisory Committees Regarding Fluoroquinolone Antibiotics (HRG Publication #2282)
Public Citizen is concerned about the significant overprescribing of fluoroquinolones. We recommend that the Food and Drug Administration (FDA) require the addition of black-box warnings to the labels of all such antibiotics about the risk of life-threatening abnormal heart rhythms.
[Created on 11/5/2015]

Comments Urging OSHA to Finalize a More Protective Beryllium Rule (HRG Publication #2281)
Public Citizen filed comments urging the U.S. Occupational Safety and Health Administration (OSHA) to finalize a safer beryllium rule than the one it proposed, specifically one that would: a) include a lower permissible exposure limit to airborne beryllium of 0.1 micrograms per cubic meter of air (μg/m3) and a short-term exposure limit of 1.0 μg/m3; and b) cover construction and shipyard workers who comprise 40 percent of all beryllium-exposed workers. Public Citizen also encouraged OSHA to commission or conduct a feasibility study assessing the feasibility of compliance with a permissible exposure limit of 0.05 μg/m3 consistent with the evidence-based recommendation of the American Conference of Governmental Industrial Hygienists.
[Created on 11/5/2015]

Comments to the FDA on Biosimilar Naming (HRG Publication #2280)
Public Citizen issued comments to the Food and Drug Administration (FDA) concerning its draft guidance on the naming of biosimilar medications. The comments largely agree with the FDA’s proposals in the guidance, while urging the agency to engage in greater pharmacovigilance efforts and to assign identical names for interchangeable biosimilars, in order to facilitate their use.
[Created on 10/27/2015]

Testimony Before the FDA’s Arthritis Advisory Committee Regarding Lesinurad (HRG Publication #2279)
Public Citizen opposes Food and Drug Administration (FDA) approval of the new drug application for lesinurad for treatment of hyperuricemia associated with gout because the drug offers meager clinically meaningful benefits relative to placebo for gout patients with hyperuricemia and has serious risks, including definite significant renal toxicity and possible cardiovascular toxicity. As a result, the drug would cause much more harm than benefit.
[Created on 10/23/2015]

Testimony Before the FDA’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Regarding the Essure Female Sterilization Device (HRG Publication #2278)
The Food and Drug Administration (FDA) should withdraw approval for the female sterilization device, Essure, because it causes long-term, debilitating pain and other chronic side effects in some women. Additionally, Public Citizen raised significant concerns regarding how serious adverse events and patient satisfaction were assessed during clinical testing of the device.
[Created on 9/24/2015]

Letter to California Governor Endorsing Four Bills to Regulate Psychotropic Medication Use in Foster Children (HRG Publication #2277)
Thousands of California foster children are medicated with psychotropic drugs with little oversight and without assurance that the treatments are safe and appropriate and that other, safer treatments have been tried first. Public Citizen’s Health Research Group urges the governor of California to sign Senate Bills (SBs) 238, 319, and 484, and to direct his staff to resolve any outstanding issues on SB 253, which, together, address and more stringently regulate this dangerous medication overuse.
[Created on 9/21/2015]

Press Statement: Senate Should Reject President’s Nominee to Be the Next FDA Commissioner (HRG Publication #2276)
The Senate should reject President Barack Obama’s nomination of Dr. Robert Califf to be the next commissioner of the U.S. Food and Drug Administration (FDA). His nomination undoubtedly comes as welcome news to the pharmaceutical and medical device manufacturers, but is bad news for patients and public health.
[Created on 9/16/2015]

Coalition Letter to U.S. Senate Finance Committee Calls for Release of Findings of Investigation of Opioid Makers (HRG Publication #2275)
In a letter sent to the U.S. Senate Finance Committee, 36 physician groups, addiction agencies and consumer advocacy organizations, including Public Citizen, request public release of the results of a 2012 investigation by the committee into financial ties between producers of pain medications and organizations that aggressively promote the medications.
[Created on 9/16/2015]

Press Statement: The New England Journal of Medicine Continues to Defend Unethical Clinical Trial Involving Premature Babies (HRG Publication #2274)
Public Citizen responds to a series of baseless accusations leveled by the editors of The New England Journal of Medicine. The editors have accused Public Citizen of misinforming the public by drawing attention to an unethical clinical trial involving 1,316 premature infants, whose parents were not properly informed of the true nature and purpose of the research or its risks. In our rebuttal, we criticize the editors for continuing to publish misleading and unbalanced assessments of the study, which are beneath the standards of this prestigious journal.
[Created on 9/3/2015]

Press Statement: HHS Proposal Leaves Many Human Subjects at Risk (HRG Publication #2273)
Today, the U.S. Department of Health and Human Services (HHS), along with 15 other federal departments and agencies, issued a proposed rule that would revise federal requirements for the protection of human subjects in scientific research. The long-awaited rule from HHS, which has been under development for more than four years, represents a mixed bag of changes.
[Created on 9/2/2015]

Press Release: FDA’s Big Mistake: Expect Flibanserin to Be Pulled From the Market in a Few Years (HRG Publication #2272)
The U.S. Food and Drug Administration’s (FDA’s) decision to approve flibanserin as a treatment for women with hypoactive sexual desire presents serious dangers to women, with little benefit, and recklessly disregards the worrisome risk information in the agency’s briefing package to the advisory committees that met on June 4 to review the drug.
[Created on 8/19/2015]

Public Citizen Urges the FDA to Retract Industry-Centered “Patient Preference” Guidance (HRG Publication #2271)
In comments submitted today, Public Citizen urges the Food and Drug Administration (FDA) to retract its recent draft guidance discussing how the agency will use “patient preference” information when making decisions about whether to approve high-risk medical devices. We argue that the guidance was heavily influenced by members of regulated industry and would lower approval standards for high-risk medical devices.
[Created on 8/17/2015]

Press Release: After 14-Year Delay, OSHA Finally Proposes Lowering Legal Limit for Permissible Workplace Beryllium Exposure (HRG Publication #2270)
The U.S. Occupational Safety and Health Administration (OSHA) issued a proposed rule to modernize the beryllium workplace exposure limit. OSHA’s announcement comes 14 years after Public Citizen first petitioned for stronger protections for workers exposed to toxic levels of beryllium in a variety of workplace settings.
[Created on 8/6/2015]

Report: Medicare Part D Pays Needlessly High Brand-Name Drug Prices Compared with Other Developed Countries and with U.S. Government Programs (HRG Publication #2269)
Because of congressional restrictions on the government’s ability to negotiate with the pharmaceutical industry, Medicare Part D drug prices are significantly higher than those in either Medicaid or the Veterans Health Administration (VHA) and 30 other countries, a study by Carleton University and Public Citizen finds.
[Created on 7/23/2015]

Letter to the Editor of The Wall Street Journal Criticizing a Recent Editorial Promoting Lower Approval Standards for Antibiotics (HRG Publication #2268)
In a letter to the editor of The Wall Street Journal, “Undue Haste Rarely Yields Good Medicine,” Public Citizen strongly criticized the July 3 editorial “How to End the Regulatory Slowdown for New Antibiotics” supporting two bills in Congress designed to lower approval standards in order to speed up the approval process. The bill would be a significant step backward for drug safety in the U.S.
[Created on 7/12/2015]

Letter to U.S. House of Representatives Opposing the 21st Century Cures Act and Commenting on Proposed Amendments to the Act (HRG Publication #2267)
Public Citizen continues to strongly oppose H.R. 6, the 21st Century Cures Act, because the legislation still carries several provisions that would undermine public health and threaten patient safety. Unfortunately, several proposed amendments, which would have mitigated some of the damage that would result if H.R. 6 is enacted, were not allowed to be considered during debate of the bill on the House floor.
[Created on 7/9/2015]

Petition to the FDA to Ban the Medical Device Seprafilm (HRG Publication #2266)
Public Citizen petitions the Food and Drug Administration (FDA) to immediately remove the medical device Seprafilm from the market because it has not been shown to be safe and effective and has been associated with death and severe injury.
[Created on 7/7/2015]

Petition to FDA Concerning the Inappropriately Expanded Approval of the Sleep Drug Tasimelteon (Hetlioz) (HRG Publication #2265)
Public Citizen petitions the Food and Drug Administration (FDA) to reverse its decision to expand the approval of the sleep medication tasimelteon (Hetlioz) to patients who are not blind, as the relevant clinical trials for the drug were conducted only in totally blind patients with non-24-hour sleep-wake disorder. The petition also requests that FDA include certain animal toxicity data in the drug’s label.
[Created on 6/11/2015]

Testimony Before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding Evolocumab (HRG Publication #2264)
Public Citizen opposes Food and Drug Administration (FDA) approval of the new drug application for evolocumab for treatment of lipid disorders because there is insufficient information to evaluate the benefit-risk balance of the drug.
[Created on 6/10/2015]

Testimony Before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding Alirocumab (HRG Publication #2263)
Public Citizen opposes Food and Drug Administration (FDA) approval of the new drug application for alirocumab for treatment of lipid disorders because there is insufficient information to evaluate that benefit-risk balance of the drug.
[Created on 6/9/2015]

Testimony Before the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Regarding Flibanserin (HRG Publication #2262)
Public Citizen strongly opposes Food and Drug Administration (FDA) approval of the new drug application for flibanserin for treatment of hypoactive sexual desire disorder in premenopausal women. The FDA previously rejected approval of the drug in 2010 and 2013. There is now considerably more evidence that the drug’s risks outweigh its benefits.
[Created on 6/4/2015]

Public Citizen Joins Coalition Urging Congress to Withhold Support for 21st Century Cures Act (HRG Publication #2261)
Public Citizen joins seven other groups representing consumers, physicians, researchers, and public health experts in urging Congressmembers to withhold support for the 21st Century Cures Act, as the draft legislation as written would allow for approval of unsafe and ineffective drugs, encourage the overuse of new antibiotics, undermine the Physician Payment Sunshine Act, and increase barriers for patients’ access to care.
[Created on 5/21/2015]

Public Citizen Presents before Senate Working Group on Medical Innovation (HRG Publication #2260)
Public Citizen offered a presentation before a Senate working group on medical innovation, encouraging the group to consider a bill requiring publication of the clinical trial data that forms the basis of Food and Drug Administration (FDA) drug approval decisions, and cautioning against attempting to speed up FDA approval by lowering standards for safety and effectiveness.
[Created on 5/21/2015]

Public Citizen Offers Comments on FDA’s Guidance Documents for the Pharmacy Compounding and Outsourcing Industries (HRG Publication #2259)
Public Citizen comments on three draft guidance documents put out by the Food and Drug Administration intended to offer guidance to industry on the repackaging of drugs, the mixing, diluting, and repackaging biological products, and adverse event reporting by outsourcing facilities. Public Citizen generally supports the proposed documents, but urges FDA to impose tighter requirements in some areas to protect public health.
[Created on 5/20/2015]

Public Citizen to Congress: Seven Provisions That Must Come Out Before 21st Century Cures Act Can Move Forward (HRG Publication #2258)
Public Citizen writes to Congress to express serious concerns with the latest version of the 21st Century Cures Act. The bill has been scaled back from the original publicly released draft but still carries seven provisions that would undermine public health and threaten patient safety.
[Created on 5/14/2015]

Letter to HHS Secretary Regarding Failure of OHRP to Launch Investigation of University of Minnesota’s Human Research Protection Program (HRG Publication #2257)
Public Citizen expressed alarm regarding the Office for Human Research Protections’ (OHRP) recent decisions (a) not to launch a formal investigation into the human subjects protection program at the University of Minnesota (UM); and (b) not to require UM to suspend enrollment in all ongoing human subjects research, particularly high-risk clinical trials, that had inadequate review by the UM institutional review board.
[Created on 5/13/2015]

Letter to Louisiana State Legislature Opposing a House of Representatives Bill That Would Weaken the Louisiana State Board of Medical Examiners (HRG Publication #2256)
Public Citizen calls on the Louisiana State Legislature to reject House of Representatives Bill No. 573 because it would seriously compromise patient safety in Louisiana. In particular, multiple provisions of the proposed legislation would substantially impede the Louisiana State Board of Medical Examiners’ ability to appropriately investigate allegations of physician incompetence or unprofessional conduct, to subsequently discipline physicians determined to have engaged in such misconduct, and thereby to protect the public from dangerous doctors.
[Created on 5/5/2015]

Additional Comments on the FDA’s Proposed Generic Drug Labeling Rule and an Industry Alternative (HRG Publication #2255)
Public Citizen strongly supports the Food and Drug Administration’s proposed rule, which will enable generic drug manufacturers to update product labeling with newly discovered risk information, and we urge the agency to move promptly to finalize the proposal. The industry alternative would exacerbate, rather than solve, the safety problem that the FDA proposal seeks to address.
[Created on 4/27/2015]

Testimony before the FDA’s Cardiovascular and Renal Drugs Advisory Committee Regarding the Drug Cangrelor (HRG Publication #2254)
Public Citizen strongly opposes approval of the anti-platelet drug cangrelor for use in patients undergoing coronary artery stenting. The key clinical trial failed to show that cangrelor is as safe and effective as other available treatments for these uses, and the design of the trial was unethical because subjects assigned to the control group received substandard anti-platelet management. The FDA again should reject the drug, as it did one year ago.
[Created on 4/15/2015]

Testimony Before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding the Diabetes Drug Saxagliptin (HRG Publication #2253)
The Food and Drug Administration (FDA) should withdraw saxagliptin from the market because the large postmarket SAVOR trial demonstrated that the drug has unacceptable cardiovascular risks.
[Created on 4/14/2015]

Statement on FDA’s Denial of Public Citizen’s 2012 Petition for a Black Box Warning Recommending Against Combination Therapy with ACE Inhibitors, ARBs, and Aliskiren (HRG Publication #2252)
FDA’s denial of petition guarantees that hundreds of thousands of patients will continue to be unnecessarily exposed to the risks of combination therapy, with no added benefit over an angiotensin-converting enzyme (ACE) inhibitor, angiotensin II receptor blocker (ARB), or aliskiren given alone.
[Created on 4/8/2015]

Release of First Comprehensive State Occupational Safety and Health Standards Database (HRG Publication #2251)
Public Citizen and the Robert Wood Johnson Foundation’s Public Health Law Research program released the first comprehensive database of state occupational safety and health standards in the 25 states with a federally-approved occupational safety and health enforcement agency. The database contains all regulations and laws that have not been adopted identically from the federal Occupational Safety and Health Administration (OSHA) and that are meant to protect workers from specific workplace safety and health hazards.
[Created on 4/1/2015]

Letter to FDA on the Off-Label Promotion of Several Diabetes Drugs (HRG Publication #2250)
Public Citizen calls on the Food and Drug Administration’s (FDA’s) Office of Prescription Drug Promotion to halt the dissemination of direct-to-consumer advertisements for five prescription drugs approved only for the treatment of Type 2 diabetes. The ads promote the drugs for the off-label uses of weight loss and blood pressure reduction. Public Citizen also calls on the agency to fine the companies responsible for issuing the ads, an action that it has never before taken in response to such violative ads.
[Created on 3/31/2015]

Presentation at the FDA’s Public Meeting on the Proposed Rule Regarding Generic Drug Labeling (HRG Publication #2249)
Public Citizen strongly endorses the Food and Drug Administration’s proposed rule to revise regulations on generic drug labeling, an action requested in a 2011 Public Citizen petition. When finalized, the rule will allow generic drug manufacturers to update their products’ labeling to include recently acquired safety information without prior agency approval, which current FDA regulations do not allow them to do. The proposed rule will fill a longstanding, dangerous regulatory gap and provide added protection to the tens of millions of people who use generic drugs. An industry alternative proposal will not close this safety gap.
[Created on 3/27/2015]

Testimony Before a Joint Meeting of the FDA’s Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding Fluticasone Furoate/Vilanterol (Breo Ellipta) for Asthma (HRG Publication #2248)
The FDA should not approve the combination therapy, fluticasone furoate/vilanterol (Breo Ellipta) for the treatment of asthma, because the combination medicine may be dangerous in adolescents and little is known about its safety in adults. Breo Ellipta should not be approved for asthma until a large, adequately designed clinical trial is completed demonstrating that the combination therapy is as safe as the single ingredient fluticasone furoate for both adult and adolescent patients.
[Created on 3/19/2015]

Letter to the Association for the Accreditation of Human Research Protection Programs Regarding the University of Minnesota’s Human Research Protection Program (HRG Publication #2247)
Public Citizen calls on the Accreditation of Human Research Protection Programs to immediately rescind its accreditation of the human subjects protection program at the University of Minnesota after a recent report apparently revealed the university’s failure to adequately protect human research subjects.
[Created on 3/16/2015]

Letter to OHRP Regarding the University of Minnesota’s Human Research Protection Program (HRG Publication #2246)
Public Citizen calls on the U.S. Department of Health and Human Services’ Office for Human Research Protections (OHRP) to launch an investigation after a recent report apparently revealed the University of Minnesota’s failure to adequately protect human research subjects.
[Created on 3/16/2015]

Letter to the Secretary of Health and Human Services Urging Withdrawal of FDA Guidance on Distribution of Risk Information (HRG Publication #2245)
Nearly 1,800 people or organizations — including individual consumers, doctors and other health professionals, academics, people working in the drug industry, pharmaceutical companies and other organizations — have responded to the Food and Drug Administration’s (FDA’s) June 2014 proposed Guidance concerning information about the safety of prescription drugs. The response, by over 99 percent, was strong opposition. The proposed guidance would undermine the authority of the agency and put patients at risk.
[Created on 3/11/2015]

Follow-up Letter to the FDA Regarding Use of Experimental Pulse Oximeter Devices in the SUPPORT Study (HRG Publication #2244)
Public Citizen presses the Food and Drug Administration for answers to key questions regarding the use of experimental oxygen monitoring devices in the SUPPORT study, which involved extremely premature babies, and the inclusion of one particularly misleading statement in many of the institutional review board-approved SUPPORT study consent forms regarding these devices.
[Created on 3/10/2015]

Testimony Before the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee Regarding Deoxycholic Acid Injection (HRG Publication #2243)
Public Citizen strongly opposes Food and Drug Administration (FDA) approval of deoxycholic acid injection for cosmetic procedures to remove chin fat because the limited benefits of the drug are outweighed by its risks. In particular, the clinical trials of the drug demonstrate that it cause nerve damage and difficulty swallowing.
[Created on 3/9/2015]

Press Statement: FDA Belatedly Warns About Testosterone Risks of Heart Attack and Stroke (HRG Publication #2242)
The U.S. Food and Drug Administration (FDA) belatedly announced today that testosterone medications have “a possible increased risk of heart attack and stroke with use.” Public Citizen petitioned the FDA for a black box warning concerning this cardiovascular risk on Feb. 25 of last year, but the FDA rejected this petition on July 16, arguing that there was “insufficient evidence” of the link between testosterone and cardiovascular risks for either a black box warning or a patient medication guide, which we had also requested.
[Created on 3/3/2015]

Petition to the FDA to Ban All Oral Forms of the Anti-Fungal Drug Ketoconazole (HRG Publication #2241)
Public Citizen petitions the Food and Drug Administration (FDA) to immediately require that the oral forms of the antifungal agent ketoconazole be removed from the market because the drug’s risks of fatal liver failure and adrenal insufficiency, and its numerous drug interactions, outweigh its limited benefits in treating fungal infections.
[Created on 2/24/2015]

Letters to 73 Hospitals Asking Them to End Their Partnerships With Life Line Screening (HRG Publication #2240)
Public Citizen today urged 73 hospitals in 24 states to sever their partnerships with Life Line Screening and stop promoting the company’s community-wide cardiovascular disease and osteoporosis screening package, which is unethical and much more likely to do harm than good.
[Created on 2/19/2015]

Press Statement: Under Hamburg, FDA Cozied Up to Industries It Regulates, Protected Corporations More Than Patients (HRG Publication #2239)
The pending resignation of U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg will end a six-year period of weak and ineffective leadership at one of the most important public health agencies in the country.
[Created on 2/5/2015]

Public Citizen Tells Federal Health Agencies: Government Should Have Acted Faster to Warn About Fake Injectable Saline (HRG Publication #2238)
Public Citizen sent a letter today to the heads of the U.S. Department of Health and Human Services, the U.S. Food and Drug Administration, and Centers for Disease Control and Prevention, accusing the agencies of failing to act swiftly and aggressively when the agencies learned that fake saline solution had been distributed to health care facilities across the country and given to patients.
[Created on 1/28/2015]

Comments on OHRP’s Draft Guidance for Disclosing Risks in Research Evaluating Standards of Care and the SUPPORT Trial (HRG Publication #2237)
Public Citizen generally supports the positions expressed by the Office for Human Research Protections (OHRP) in the draft guidance regarding the disclosure of reasonably foreseeable risks in research evaluating “standard of care” or usual care interventions. However, the draft guidance is too narrowly constrained in its scope and fundamental position statement and lacks clarity with respect to several important points.
[Created on 1/22/2015]

Letter to the FTC Regarding the Life Line Screening’s Advertising of Its Cardiovascular Disease and Osteoporosis Screening Package (HRG Publication #2236)
Public Citizen urges the Federal Trade Commission (FTC) to investigate the direct-to-consumer advertising and promotional activities of the cardiovascular disease screening company Life Line Screening. The company’s advertising materials make unsubstantiated claims about the medical benefits of its cardiovascular disease and osteoporosis screening package and omit information about the risks of adverse health-related outcomes and financial harms that may result from the screenings.
[Created on 1/22/2015]

Testimony before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding Desmopressin for Nocturia (HRG Publication #2235)
Public Citizen strongly oppose Food and Drug Administration (FDA) approval of Nocdurna (desmopressin) — a drug already twice rejected by the FDA — for treatment of nocturia due to nocturnal polyuria in adults because the drug’s serious risks far outweighs its meager clinical benefits.
[Created on 1/12/2015]

2014

Comments Before the Institute of Medicine Workshop: Ethical Review and Oversight Issues in Research Involving Standard of Care Interventions (HRG Publication #2234)
In comments presented at an Institute of Medicine workshop on research involving standard of care interventions, Public Citizen emphasized the need for institutional review boards to be skeptical when investigators assert that their randomized trials are limited to standard of care interventions.
[Created on 12/2/2014]

Testimony before the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee Regarding Epidural Steroid Injections (HRG Publication #2233)
Public Citizen urges the committee to recommend that the Food and Drug Administration (FDA) require a boxed warning and contraindication against the use of steroids for epidural injection, based on the fact that there is a class-wide risk of rare but catastrophic adverse neurologic events that cannot be eliminated through current mitigation strategies. This risk far outweighs any limited benefits of such injections.
[Created on 11/24/2014]

Letter to the HHS Secretary Regarding Corruption of the Process for Revising Federal Regulations for the Protection of Human Subjects (HRG Publication #2232)
Public Citizen today called on Secretary of Health and Human Services Sylvia Mathews Burwell to immediately reverse the recent decision by one or more senior officials in her immediate office, including at least her chief of staff, to abruptly transfer from the Office for Human Research Protections (OHRP) to the National Institutes of Health (NIH) the responsibility for rewriting key sections of a draft proposal to extensively revise the federal rules for the protection of human subjects. Given NIH’s obvious direct conflict of interest, such HHS action has corrupted the rulemaking process and undermined the authority of OHRP.
[Created on 11/20/2014]

Press Statement: FDA’s Partial Approval of Public Citizen’s Petition for Stronger Warnings on Certain Proton Pump Inhibitor Products Comes Too Late (HRG Publication #2231)
Although we are disappointed in the rejection of certain requests, the portions of the petition granted by the Food and Drug Administration (FDA) are important and will make the products safer. At the same time, it is unconscionable that the agency took more than three years to respond.
[Created on 11/3/2014]

Testimony Before the Secretary’s Advisory Committee on Human Research Protections Regarding OHRP’s Draft Guidance on Disclosing Risks in Research Evaluating Standards of Care and the SUPPORT Trial (HRG Publication #2230)
Public Citizen applauds the Office for Human Research Protections (OHRP) for strongly reaffirming in its October 24 Federal Register notice announcing the release of its draft guidance on risks in research evaluating standard of care that the parents of premature infants enrolled in the NIH-funded Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial (SUPPPORT) were not informed of the trial’s reasonably foreseeable risks, including risks of blindness and death.
[Created on 10/29/2014]

Public Citizen to Congress: FDA’s Device Tracking Regulations Weaker than First Proposed (HRG Publication #2229)
On October 28, 2014, Public Citizen expressed concerns to the Senate Health, Education, Labor & Pensions (HELP) Committee that FDA’s final rule requiring Unique Device Identifiers (UDIs) for certain medical devices was weaker that the rule the agency had proposed previously.
[Created on 10/29/2014]

Letter to the Editor Published in Clinical Pharmacokinetics: Hepatotoxicity of Alogliptin (HRG Publication #2228)
Public Citizen criticizes a recent article published in Clinical Pharmacokinetics that concluded that “no hepatotoxicity has been reported” during the development of the diabetes drug alogliptin. However, after analyzing phase 2 and 3 pre-approval trials of alogliptin and post-marketing surveillance data for the drug from Japan, the Food and Drug Administration and European Medicines Agency concluded that the drug’s potential hepatotoxicity warranted inclusion of warning language in the drug’s label.
[Created on 10/22/2014]

Press Statement: Government Agency Confirms Parents Were Not Given Adequate Information About the Risks Posed to Their Premature Babies in NIH Trial (HRG Publication #2227)
Public Citizen applauds the position taken by the Office for Human Research Protections confirming that parents of premature infants enrolled in a government-funded study were not given adequate notice of the trial’s risks. The position comes in a Federal Register notice today announcing the availability of the agency’s draft guidance document, “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.”
[Created on 10/22/2014]

Letter to HHS Secretary Opposing FDA Guidance for Distribution of Risk Information (HRG Publication #2226)
The U.S. Food and Drug Administration (FDA) should release all comments to the public that were submitted about a recent proposal to allow the pharmaceutical industry to circumvent labeling rules and tell doctors that its products have fewer risks than those described in FDA-approved labeling, Public Citizen said in a letter to Secretary of Health and Human Services Sylvia Mathews Burwell today. Public Citizen calls on the Secretary to order the FDA to withdraw the dangerous proposal.
[Created on 10/22/2014]

Petition to the FDA Requesting a Stronger Boxed Warning and New Restrictions on the Use of Varenicline (Chantix) (HRG Publication #2225)
Public Citizen joins four other organizations in petitioning the Food and Drug Administration (FDA) to require a more informative and comprehensive Black Box Warning for the smoking cessation drug varenicline (Chantix). The petition also asks that the FDA add restrictions to the Indications section of the product label warning against the drug’s use by individuals in sensitive or hazardous occupations, such as pilots, emergency medical workers, and others, in whom the neurological and psychiatric adverse effects of varenicline could pose a danger to themselves or others.
[Created on 10/8/2014]

Letter to Bon Secours Virginia Asking the Health System to End Its Partnerships With HealthFair (HRG Publication #2224)
Public Citizen today urged Bon Secours Virginia to sever its relationships with HealthFair because the company’s heavily promoted, community-wide cardiovascular health screening programs are unethical and are much more likely to do harm than good. A growing chorus of medical experts and leaders of prominent professional medical organizations are voicing strong opposition to HealthFair’s screening programs.
[Created on 10/7/2014]

Letter to HHS Secretary Regarding the Agency’s Decision Requiring Reporting of All HHS Malpractice Payments to the National Practitioner Data Bank (HRG Publication #2223)
When it comes to its own doctors and other health care providers, the Department of Health and Human Services (HHS) has been breaking its own policy requiring all malpractice payments to be reported to the National Practitioner Data Bank (NPDB). Public Citizen applauds the recent determination by HHS that reaffirmed a 1990 HHS policy requiring that all malpractice payments made as a result of a claim or suit filed against the U.S. government related to care provided by HHS health care practitioners be reported to the NPDB. However, we have some concerns regarding the HHS plan for implementation of the policy decision.
[Created on 9/30/2014]

Comments Supporting a More Protective Heat Stress Rule for All California Workers (HRG Publication #2222)
Public Citizen filed comments with the California Department of Industrial Relations’ Occupational Safety and Health Standards Board supporting proposed revisions to California’s occupational heat stress regulation. In addition, Public Citizen urged the Board to go further and adopt WorkSafe’s recommendations for more adequate protections from the deadly effects of extreme heat for all of California’s workers.
[Created on 9/25/2014]

Testimony before the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding Testosterone Products (HRG Publication #2221)
Public Citizen urges the Food and Drug Administration (FDA) to require that the product labels of all testosterone-containing medications available in the U.S. be revised to include warnings about the increased risk of heart attacks and other life-threatening cardiovascular dangers.
[Created on 9/17/2014]

Statement: Whitewash: Inspector General Review of Agency Misconduct Ignores Serious Ethical Lapses by Senior HHS Officials; Congress Should Act (HRG Publication #2220)
The Department of Health and Human Services (HHS) Office of Inspector General issued a report in response to a complaint filed by Public Citizen over interference by the National Institutes of Health in an ongoing investigation of the SUPPORT study, a controversial clinical trial involving premature infants. The inspector general’s failure to find any impropriety by high-ranking HHS officials is extremely disturbing and represents a complete whitewash. In failing to take stronger action, the OIG has become part of the problem of inadequate HHS oversight of research involving people.
[Created on 9/16/2014]

Testimony before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding Liraglutide for Weight Loss (HRG Publication #2219)
Public Citizen strongly opposes the approval of liraglutide (Saxenda) for weight loss because the drug, currently approved for type 2 diabetes, has already been shown to be toxic at a lower dose than that which is being considered for weight loss, while conferring only marginal benefits on weight reduction and no proven long-term health benefits.
[Created on 9/11/2014]

Letter to the FDA Concerning its Advisory Committee-Industry Revolving Door (HRG Publication #2218)
Public Citizen called on the Food and Drug Administration to develop and implement a policy restricting current and former voting members of its advisory committees from accepting paid speaking and consulting roles on behalf of product sponsors before FDA advisory committees.
[Created on 9/10/2014]

Letter to the FTC Regarding the HealthFair’s Advertising of Its Cardiovascular Disease Screening Packages (HRG Publication #2217)
Public Citizen urges the Federal Trade Commission (FTC) to investigate the direct-to-consumer advertising and promotional activities of the cardiovascular disease screening company HealthFair. The company’s advertising materials make unsubstantiated claims about the medical benefits of its screening packages and omit information about the risks of adverse health-related outcomes and financial harms that may result from the screenings.
[Created on 9/4/2014]

Follow-up Letters to Twenty Hospitals and Medical Institutions That Are or Were Partnered With HealthFair (HRG Publication #2216)
Public Citizen today applauded the decision of three hospitals to end their partnerships with HealthFair and again urged 20 hospitals and medical institutions in eight states to sever their relationships with the company because the its heavily promoted, community-wide cardiovascular health screening programs are unethical and are much more likely to do harm than good. A growing chorus of medical experts and leaders of prominent professional medical organizations are voicing strong opposition to HealthFair’s screening programs.
[Created on 9/4/2014]

Public Citizen Opposes FDA Guidance for Distribution of Risk Information (HRG Publication #2215)
Public Citizen strongly opposes the Food and Drug Administration’s (FDA’s) draft guidance on distributing publications on risk information for prescription drugs and biological products. The FDA is proposing to allow pharmaceutical company salespeople to promote drugs to doctors with printed information that claims the medications are less risky than FDA-approved labeling says they are. This would seriously undermine FDA’s existing drug safety laws and regulations.
[Created on 8/25/2014]

Press Release: FDA Draft Guidance Would Let Pharmaceutical Industry Tell Doctors Medications Are Safer Than They Really Are (HRG Publication #2214)
The U.S. Food and Drug Administration (FDA) recently issued draft guidance that would let the pharmaceutical industry essentially circumvent drug labeling rules and tell doctors that its products have fewer risks than those described in the FDA-approved labeling. This is discussed by Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, in a Journal of the American Medical Association Internal Medicine article.
[Created on 8/15/2014]

Statement: Another Reckless FDA Action: Approval of Suvorexant (Belsomra) (HRG Publication #2213)
The U.S. Food and Drug Administration (FDA) has approved suvorexant (brand name: Belsomra), a dangerous and habit-forming sleep medication. The lowest doses of suvorexant were approved despite having never been tested in large clinical studies that are a standard requirement for all modern medication – and dosage – approvals, while the higher doses demonstrated only marginal benefits and caused serious next-day driving impairment.
[Created on 8/14/2014]

Testimony Before the FDA’s Pulmonary-Allergy Drugs Advisory Committee on Tiotropium (Spiriva Respimat) (HRG Publication #2212)
Public Citizen opposes the Food and Drug Administration’s approval of tiotropium (Spiriva Respimat) because the drug (1) offers no unique advantages over the currently available Spiriva HandiHaler; and (2) appears to have a greater risk of fatal myocardial infarction than Spiriva HandiHaler.
[Created on 8/14/2014]

Letter to HHS Secretary Regarding the Agency’s Decision Requiring Reporting of Malpractice Payments to the National Practitioner Data Bank Under Medical Malpractice Reforms in Oregon and Massachusetts (HRG Publication #2211)
Public Citizen applauds the recent determination by the Department of Health and Human Services (HHS) regarding reporting of medical malpractice payments to the National Practitioner Data Bank (NPDB). The HHS determination closes loopholes in requirements for reporting medical malpractice payments to the NPDB that were created under recently enacted laws in Oregon and Massachusetts. The HHS action is an important first step toward preserving the integrity and viability of the NPDB as a comprehensive, reliable source of data regarding malpractice payouts made on behalf of physicians and other health care practitioners.
[Created on 8/12/2014]

Comments on the FDA’s Proposed Order to Reclassify Surgical Mesh for Repair of Pelvic Organ Prolaspe (HRG Publication #2210)
Public Citizen strongly supports the Food and Drug Administration’s (FDA’s) proposed orders to up-classify surgical mesh for transvaginal repair of pelvic organ prolapse (POP) and to require the filing of premarket approval applications for these medical devices. Unfortunately, the FDA’s reckless delays and inadequate action regarding surgical mesh for POP repair have resulted, and will continue to result, in thousands of women being unnecessarily exposed to a wide array of serious risks, many of which can permanently alter their quality of life.
[Created on 7/28/2014]

Petition to the FDA to Not Allow Marketing of Over-The-Counter Benzocaine Products for Teething in Infants (HRG Publication #2209)
Public Citizen petitions the Food and Drug Administration to no longer allow over-the-counter (OTC) benzocaine products to be marketed for treating teething in infants and toddlers because they can prompt a rare but deadly adverse reaction. In addition, the agency should require a warning about this adverse reaction on all other OTC benzocaine products intended for use in older children and adults.
[Created on 7/28/2014]

Statement: Contrasting Actions by Health Canada and the FDA on Testosterone (HRG Publication #2208)
In a response to the Food and Drug Administration’s (FDA’s) denial of a petition to add a black-box warning to the product labels of all testosterone-containing drugs on the market in the U.S., Public Citizen notes that Health Canada took drastically different action in the same week. The Canadian agency issued a health warning to patients and health care providers about the serious cardiovascular risks of testosterone products, but the FDA declined to offer a similar warning, leading to the conclusion that the FDA is more sensitive to pressure from prescribing doctors and drug companies than they are to the nation’s public health needs.
[Created on 7/16/2014]

Letter to The Joint Commission Regarding HealthFair’s Unethical Cardiovascular Screening Programs (HRG Publication #2207)
Public Citizen urges The Joint Commission to investigate whether HealthFair — or any of its partnered hospitals and health care organizations — has ever misled consumers to believe that the company and its screening programs were accredited by The Joint Commission at a time when they were not. We also asked the Commission to reject any application for accreditation from HealthFair and to suspend the accreditation of any health care organization still partnered with HealthFair.
[Created on 6/30/2014]

Letters to Twenty Hospitals and Medical Institutions Asking Them to End Their Partnerships With HealthFair (HRG Publication #2206)
Public Citizen today urged 20 hospitals and medical institutions in eight states to sever their relationships with HealthFair because the company’s heavily promoted, community-wide cardiovascular health screening programs are unethical and are much more likely to do harm than good.
[Created on 6/19/2014]

Letter to the University of Minnesota President Calling for an Investigation of Psychiatric Clinical Trials (HRG Publication #2205)
Public Citizen strongly urges the University of Minnesota (UM) President to finally heed the repeated calls for an independent, transparent, and detailed inquiry into the events surrounding the horrific suicide of a human subject during his involvement in a clinical trial involving patients with schizophrenia. The scope of this inquiry must include concerns about misconduct in other psychiatric clinical trials at UM.
[Created on 6/16/2014]

Acute Pancreatitis With Liraglutide: An analysis of MedWatch adverse event reports submitted to the Food and Drug Administration (HRG Publication #2204)
A new study by Public Citizen of MedWatch adverse event reports sent to the Food and Drug Administration (FDA) reinforces the case that the diabetes drug liraglutide (brand name: Victoza), one of a class of drugs known as incretin mimetics, can cause acute pancreatitis and should be banned immediately by the FDA. Public Citizen referenced the study in a letter it sent to the FDA responding to the agency’s recent denial of Public Citizen’s 2012 petition to ban liraglutide.
[Created on 6/5/2014]

Petition to HHS to Close the Corporate Shield Loophole for Reporting Medical Practice Payments to the NPDB (HRG Publication #2203)
Public Citizen petitioned the U.S. Department of Health and Human Services (HHS) to close a loophole — known as the “corporate shield” loophole — that has allowed physicians and other health care providers to evade having medical malpractice payment reports submitted to the National Practitioner Data Bank (NPDB). Such evasions deprive users of the data bank, such as hospitals and state licensing boards, of important information about health care providers and jeopardize patient health and welfare.
[Created on 5/29/2014]

Statement: HHS Response to Public Citizen’s Finding of Agency Misconduct Doesn’t Add Up (HRG Publication #2202)
The Department of Health and Human Services (HHS) response to Public Citizen’s letter to the HHS inspector general shows a continuing attempt to cover up the unprecedented and unethical HHS/National Institutes of Health (NIH) interference in Office for Human Research Protections’ (OHRP’s) responsibility to ensure that human research is ethical. Public Citizen’s letter called for a formal investigation of NIH’s interference in OHRP’s probe of the SUPPORT study. In an initial reaction to the letter, HHS spokesperson Tait Sye, according to media reports, argued that the NIH merely worked to correct “incomplete information” in the first report issued by OHRP and that such communication was not “uncommon.” That response is not credible.
[Created on 5/20/2014]

Letter to the HHS Inspector General Calling for an Investigation Into Inappropriate Conduct by Senior HHS Officials Related to the SUPPORT Study (HRG Publication #2201)
Public Citizen, joined by nine prominent scholars in bioethics, law and history, called for an immediate investigation by the U.S. Department of Health and Human Services (HHS) Office of Inspector General into the conduct of senior HHS officials, who, according to an email trail, permitted top National Institutes of Health (NIH) officials to edit drafts of a letter documenting findings of what should have been an independent inquiry by the Office for Human Research Protections into serious ethical lapses in a major NIH trial.
[Created on 5/20/2014]

Letter to OSHA’s Advisory Committee on Construction Safety and Health on an Updated Beryllium Standard (HRG Publication #2200)
Public Citizen implores the Advisory Committee on Construction Safety and Health to recommend that the Occupational Safety and Health Administration (OSHA) include the strongest possible protections for construction workers within a new beryllium standard and to implore OSHA to move as quickly as possible to finalize the new rule.
[Created on 5/8/2014]

Public Citizen Again Opposes Reclassification of Extracorporeal Membrane Oxygenation (ECMO) Devices (HRG Publication #2199)
Public Citizen testified before the FDA’s Circulatory System Devices Panel reiterating its opposition to the reclassification of ECMO devices from Class III to Class II for two pediatric indications and opposing a potential further Class II reclassification for acute catastrophic cardiogenic shock in adult patients. The FDA should instead publish a proposed final rule maintaining the devices’ Class III classification for all indications and set an effective date requiring the submission of evidence that the device is safe and effective for all current uses.
[Created on 5/7/2014]

Testimony Before the FDA’s Nonprescription Drugs Advisory Committee on Montelukast (Singulair Allergy) (HRG Publication #2198)
Public Citizen strongly oppose Food and Drug Administration (FDA) approval of over-the-counter (OTC) montelukast because, relative to existing FDA-approved OTC products for allergic rhinitis, the drug: (1) offers marginal clinical benefit relative to placebo and generally appears to have inferior effectiveness compared to existing FDA-approved OTC allergy products and (2) poses significantly greater risk, both to patients who meet the proposed indication and to those likely to use the drug for off-label indications.
[Created on 5/2/2014]

Commentary in The New York Times’ “Room for Debate” Series on Physicians Who Participate in Capital Punishment (HRG Publication #2197)
In an invited commentary as part of The New York Times’ “Room for Debate” series, Public Citizen speaks to the ethical grounds for physicians to participate in the practice of capital punishment. Dr. Sidney Wolfe urges the revoking of medical licenses, as the practice flies in the face of a physician’s ethical code to heal and not to hurt.
[Created on 5/1/2014]

Public Citizen Sues FDA for Failing to Take Action on Petition Concerning Dangerous Proton Pump Inhibitors (HRG Publication #2196)
Public Citizen sued the U.S. Food and Drug Administration (FDA) today for failing to respond to the organization’s petition requesting black box warnings on common but dangerous anti-stomach acid drugs, known as proton pump inhibitors (PPIs). Although more than two and a half years have passed since Public Citizen filed its petition, the FDA has neither granted nor denied it, and has not required adequate warnings on the drugs.
[Created on 4/30/2014]

Statement: Too Little, Too Late: FDA Belatedly Initiates Limited Action to Address Unsafe and Ineffective Surgical Mesh Used in Pelvic Repair Procedures, as Requested by Public Citizen (HRG Publication #2195)
Public Citizen welcomes today’s long-overdue issuance of a proposed order by the U.S. Food and Drug Administration (FDA) that, if finalized, would reclassify surgical mesh for transvaginal pelvic repair organ prolapse (POP) from a moderate-risk device (class II) to a high-risk device (class III). This would subject these devices to a more rigorous approval process that would require manufacturers to submit to the agency premarket approval applications with evidence from clinical trials that the devices are safe and effective. However, the FDA’s action today is troubling both in its scope and timing.
[Created on 4/29/2014]

Testimony Before the FDA’s Analgesic and Anesthetic Drug Products Advisory Committee Meeting on Moxduo (HRG Publication #2194)
Public Citizen strongly opposes the approval of Moxduo, a drug combination containing the opioids morphine and oxycodone. Moxduo was shown to be no more effective or safer than either morphine or oxycodone alone for treating acute pain. HRG also argues that approval of this drug could further contribute to the epidemic of opioid abuse in the U.S.
[Created on 4/22/2014]

Public Citizen Urges FDA to Take Action for Sale of Misbranded Brain Stent Device (HRG Publication #2193)
Public Citizen is urging the Food and Drug Administration (FDA) to take action against Stryker Neurovascular and Boston Scientific for publishing false and misleading information on their websites regarding Wingspan Stent System devices, medical devices used to prop open narrowed blood vessels in the brains of certain types of stroke patients. The websites falsely expands the FDA-approved use of the device and also fail to report information from a critically important study that found dangers for patients using the device.
[Created on 4/3/2014]

Testimony Before the FDA’s Cardiovascular and Renal Drugs Advisory Committee Regarding the Drug Serelaxin (HRG Publication #2192)
Public Citizen strongly opposes the approval of serelaxin for acute heart failure because it has exceedingly marginal, if any, benefits on subjective, transient, shortness of breath symptoms and no proven benefits on any objective cardiovascular outcomes. The FDA should follow the lead of a key committee of the European Medicines Agency and the recommendation of its own clinical reviewer in rejecting the drug unless it ultimately demonstrates a clinically meaningful benefit in a larger, ongoing trial.
[Created on 3/27/2014]

Letter to Senator Joe Manchin Urging Him to Investigate FDA’s Decision to Approve Dangerous High-Dose Opioid (HRG Publication #2191)
Public Citizen commended Senator Manchin for his efforts to (a) overturn the reckless decision by the Food and Drug Administration (FDA) to approve the dangerous, high-dose, non-tamper-resistant opioid drug Zohydro ER; and (b) develop legislation that would target such seriously flawed decision-making by the agency. We also urge him to investigate why newly disclosed information about a tamper-resistant, single-drug hydrocodone product that is in the advanced stages of development failed to sway the FDA against approving Zohydro.
[Created on 3/14/2014]

Public Citizen’s Comments on the CMS Proposed Rule About the Prescriber Changes to Medicare Part D (HRG Publication #2190)
Public Citizen supports the proposed changes to the Part D program that will require all eligible prescribes to be enrolled in the Medicare Fee For Service program to be able to prescribe covered Part D drugs. Suggestions were also offered regarding the criteria to identify abusive prescribers.
[Created on 3/7/2014]

Letter to the FDA Protesting Aveed (HRG Publication #2189)
Letter to FDA protesting decision announced today to approve a long-lasting testosterone injection drug, Aveed.
[Created on 3/6/2014]

Public Citizen asks the FDA to Prohibit Traditional Compounding Pharmacies from Engaging in High Risk Sterile Compounding (HRG Publication #2188)
Public Citizen has requested that the Food and Drug Administration (FDA) prohibit traditional compounding pharmacies from engaging in nonsterile-to-sterile compounding, a particularly high-risk form of compounding, by identifying these drugs as demonstrably difficult to compound. Public Citizen also recommended that the FDA restrict compounding of metered dose inhalers, dry powder inhalers, transdermal delivery systems, sustained or time-released dosage forms, and enteric-coated preparations.
[Created on 3/4/2014]

Comments on NIOSH’s Latest Criteria for a Recommended Heat Stress Standard and Letter to OSHA Imploring Their Adoption Within a Federal Standard (HRG Publication #2187)
From 1992 to 2012 (the most recent year for which federal data are available), at least 655 workers have died and 53,564 have been severely injured by heat stress injuries. Public Citizen applauds the latest evidence-based draft criteria for a recommended heat stress standard issued by the National Institute for Occupational Safety and Health (NIOSH). We also urge the Occupational Safety and Health Administration (OSHA) to adopt NIOSH’s latest criteria recommendations on heat stress, once finalized, as the basis for a federal heat stress standard.
[Created on 2/25/2014]

Letter to the Executive Director of the European Medicines Agency on Testosterone Products (HRG Publication #2186)
On Feb. 25, 2014, Public Citizen sent a petition to the Food and Drug Administration, urging the agency to place a black box warning on all testosterone products, warning of increased risks of heart attacks and other cardiovascular dangers. In this letter to the European Medicines Agency, we urge that agency to add a similar warning due to the overwhelming evidence for such risks.
[Created on 2/25/2014]

Letter to the FDA Asking the Agency to Keep Dangerous High-Dose Opioid Drug Off the Market (HRG Publication #2185)
Public Citizen joins with more than 40 consumer organizations, health care agencies, addiction treatment providers, and community-based drug and alcohol prevention programs today in calling on the Food and Drug Administration to revoke its approval of Zohydro (oxycodone), an opioid so powerful that a single dose could kill a child.
[Created on 2/26/2014]

Petition to the FDA for Black Box Warnings on All Testosterone Products (HRG Publication #2184)
Public Citizen petitions the Food and Drug Administration to add a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs presently on the market in the U.S.
[Created on 2/25/2014]

Testimony before the FDA’s Cardiovascular and Renal Drugs Advisory Committee Regarding the Drug Cangrelor (HRG Publication #2183)
Public Citizen strongly opposes approval of the anti-platelet drug cangrelor for use in patients undergoing coronary artery stenting procedures and for patients who need an IV anti-platelet drug while awaiting surgery. The clinical trials failed to show that cangrelor is effective for these uses, and the design of these trials was unethical because subjects assigned to the control group received substandard anti-platelet management.
[Created on 2/12/2014]

Letter to the FDA Opposing Approval of the New Drug Application for Droxidopa (HRG Publication #2182)
In a letter to the Food and Drug Administration (FDA) Public Citizen urges the agency to not approve the new drug application for droxidopa for treatment of patients with neurogenic orthostatic hypotension. There is insufficient evidence that the drug is effective or that the benefits of its use outweigh the risks. Given the lack of evidence that droxidopa is effective, FDA approval of the drug would undermine the integrity and meaningfulness of its own standard for approving drugs and cause immeasurable harm to the agency’s reputation.
[Created on 2/5/2014]

Letter to the FDA Criticizing the Agency’s Inappropriate Redaction of Advisory Committee Member Curricula Vitae (HRG Publication #2181)
In a letter to Food and Drug Administration (FDA) Commissioner Margaret Hamburg and Chief Counsel Elizabeth Dickinson, Public Citizen expresses concern about redactions of the curricula vitae (CVs) of advisory committee members that are posted on the FDA’s website. A great many of the members’ CVs have significant redactions with the notation either (b)(4) or (b)(6), referring to the Freedom of Information Act (FOIA) exemptions from disclosure that protect confidential commercial information and personal privacy. These redactions are unjustified under FOIA, and Public Citizen asks that the FDA promptly revise the web pages so that CVs appear in full.
[Created on 2/4/2014]

Public Citizen Asks the Food and Drug Administration (FDA) to Clarify the Line Between Pharmacy Compounding and Drug Manufacturing (HRG Publication #2180)
Public Citizen provided comments to the FDA regarding the agency’s draft guidance on pharmacy compounding under section 503A of the Food, Drug and Cosmetics Act. Although generally supportive of the guidance, Public Citizen raises the concern that the existing draft fails to clarify the main statutory criteria distinguishing between compounded drugs, which are intended to be individually tailored for a specifically identified patient to meet a unique or unusual clinical need, and manufactured drugs, which are mass-produced, standardized products intended for a population that shares a common set of clinical needs.
[Created on 2/3/2014]

Public Citizen’s Comments on the Draft Revision of the National Practitioner Data Bank Guidebook (HRG Publication #2179)
Public Citizen provides comments to the Health Resources and Services Administration regarding the draft revision of the National Practitioner Data Bank Guidebook. Several suggestion for improving the clarity of the Guidebook are offered.
[Created on 1/31/2014]

Letter to the FDA Calling For Black Box Warnings for the Drug Vorapaxar as a Condition of Approval (HRG Publication #2178)
Public Citizen urged the Food and Drug Administration that if it decides to approve the drug vorapaxar, as a condition of approval the agency should require a black box warning in the drug’s label. The warning should indicate that patients with prior history of stroke or transient ischemic attack should not use the drug due to the risk of drug-induced strokes. The warning also should state that patients with a body weight of less than 60 kilograms (kg) should not use the drug because of an unfavorable risk-benefit profile.
[Created on 1/29/2014]

Letter to U.S. Secretary of Health and Human Services Regarding Unethical Trial Involving Premature Infants (HRG Publication #2177)
In a letter to Health and Human Services Secretary Kathleen Sebelius, Public Citizen presents an analysis highlighting problems with the design of a clinical trial involving premature infants, known as the SUPPORT study. These problems involved inadequate monitoring for adverse events. As a result, the study design was unethical.
[Created on 1/27/2014]

2013

Presentation on Pharmacy Compounding before the Food and Drug Law Institute Enforcement, Litigation, and Compliance Conference (HRG Publication #2176)
Public Citizen Attorney Sarah Sorscher spoke on pharmacy compounding at a conference focused on enforcement by the Food and Drug Administration (FDA). Public Citizen has pushed heavily for the FDA to respond more aggressively when compounding pharmacies violate federal law. The presentation includes several examples of areas where the FDA failed to enforce federal law against compounding pharmacies in the past. The presentation also highlights Public Citizen’s concerns moving forward as the FDA implements the Drug Quality and Security Act, a new statute governing compounding that was signed into law by President Obama on November 27, 2013.
[Created on 12/18/2013]

Letter to FDA Commissioner Margaret Hamburg Criticizing Agency Messages Endorsing Compounded Drugs Made by Outsourcing Facilities (HRG Publication #2175)
Public Citizen urged the Food and Drug Administration (FDA) to stop making misleading statements that could lead health care providers to treat patients with compounded drugs produced by outsourcing facilities without understanding that they are not as safe as FDA-approved drugs.
[Created on 12/17/2013]

Letter to the FDA Calling for Public Disclosure of Meta-Analyses Performed by the Agency (HRG Publication #2174)
Public Citizen urged the Food and Drug Administration (FDA) to disclose to the public all currently completed and future FDA meta-analyses of randomized controlled clinical trials that concern the safety of FDA-regulated human drugs and biologics. In addition to disclosure of the meta-analyses, results of the individual studies that comprise the meta-analyses, and all other related data, also need to be disclosed.
[Created on 12/16/2013]

Testimony to FDA Endocrinologic and Metabolic Drugs Advisory Committee on Dapagliflozin for Treatment of Type 2 Diabetes Mellitus (HRG Publication #2173)
Public Citizen urges the agency not to approve dapagliflozin, a member of a new chemical class of drugs to treat type 2 diabetes mellitus, because it is no more effective than a similar diabetes drug, canagliflozin, approved by the FDA in March 2013, but does appear to pose additional safety hazards not seen with canagliflozin, including risks of bladder cancer and liver toxicity.
[Created on 12/12/2013]

Letter to the FDA Opposing Approval of the CardioMEMS Champion Heart Failure Monitoring System (HRG Publication #2172)
In a letter to the Food and Drug Administration Public Citizen urges the agency to not approve the CardioMEMS System for monitoring heart failure patients. There is insufficient evidence that the device is effective or that the benefits of its use outweigh the risks related to its implantation.
[Created on 12/2/2013]

Commentary in The New York Times “Room for Debate” Series on Trying Newly Approved Medications (HRG Publication #2171)
In an invited commentary as part of The New York Times’ “Room for Debate” series, Public Citizen answers the question, “How do you know whom to trust?” when it comes to drug safety. Dr. Sidney Wolfe urges patients to determine whether the maker of a drug paid for its research and to seek independent advice. Wolfe also advocates following the “seven-year rule,” which advises patients not to take a new drug for at least seven years from the drug’s release date (except in cases of rare “breakthrough” drugs with known advantages over older drugs).
[Created on 11/18/2013]

Testimony to the FDA Peripheral and Central Nervous Systems Drugs Advisory Committee on Tasimelteon for the Treatment of Blind Persons with Non-24 Hour Sleep Disorder (HRG Publication #2170)
Approval of tasimelteon, given the magnitude of post-hoc changes to the clinical trial protocol, timed so close to the end of data collection, would set an ominous precedent for future new drug development programs.
[Created on 11/14/2013]

Statement: FDA Grants Public Citizen Petition, Issues Proposed Rule on Generic Drug Safety (HRG Publication #2169)
The Food and Drug Administration (FDA) today issued a proposed rule to revise regulations on generic drug labeling, responding to a 2011 Public Citizen petition. When finalized, the rule will allow generic drug manufacturers to update their products’ labeling to include recently acquired safety information without prior agency approval, which current FDA regulations do not allow them to do. The proposed rule will fill a longstanding, dangerous regulatory gap and provide added protection to the tens of millions of people who use generic drugs.
[Created on 11/8/2013]

Statement: Johnson & Johnson Settlement Nothing New for Company; Small Fine Unlikely to Prompt Change in Behavior (HRG Publication #2168)
The announcement that Johnson & Johnson will pay $2.2 billion in criminal and civil fines to the federal and state governments is the latest in a long line of multibillion-dollar health fraud settlements. Despite the seemingly large sums, the fines imposed on pharmaceutical companies for dangerous and illegal conduct pale in comparison to the profits generated from such activity.
[Created on 11/4/2013]

Follow-Up Letter to FDA Commissioner Hamburg about FDA Advisory Committee Chair Just-Cancelled Participation in Pharmaceutical Industry Conference (HRG Publication #2167)
On Oct. 24, 2013, Public Citizen’s Dr. Sidney Wolfe informed Food and Drug Administration (FDA) Commissioner Margaret Hamburg of an FDA advisory committee chair’s planned participation in a pharmaceutical industry conference. The issue received national media attention, and the chairperson, Dr. Lynn Drake, subsequently promised to withdraw from the event. In this follow-up letter to Hamburg, Wolfe highlights conflicting statements made to the press by the FDA, Drake, and the conference organizer. The contradictory nature of the statements illuminates the urgent need for a written policy to address inadequate ethics training of FDA advisory committee members.
[Created on 10/30/2013]

Letter to FDA Commissioner Hamburg on FDA Advisory Committee Chair Participation in Pharmaceutical Industry Conference (HRG Publication #2166)
In a letter to Food and Drug Administration (FDA) Commissioner Margaret Hamburg, Public Citizen’s Dr. Sidney Wolfe raises concerns regarding the participation of an FDA Advisory Committee chairperson in a pharmaceutical industry conference. In her conference presentation, the chairperson will be advising industry employees on ways to improve the likelihood of a drug’s receiving FDA approval. Such pro-industry activity on the part of an advisory committee representative could undermine public confidence both in FDA advisory committees and in the agency itself.
[Created on 10/24/2013]

Letter to HHS Secretary and Assistant Secretary for Health Criticizing Revised Policy on Remuneration of Human Research Subjects (HRG Publication #2165)
The sudden removal of a key clause from a Department of Health and Human Services guidance document issued by the Office for Human Research Protections could lead to human subjects of research being pressured to take on greater risks that they would not otherwise have accepted because they could now be offered greater remuneration in exchange for accepting risk. This change undermines protections for human subjects, increases the potential for exploitation, and should have been subject to public input before being implemented.
[Created on 10/23/2013]

Testimony to the FDA’s Circulatory System Devices Panel on the Premarket Approval (PMA) Application for the CardioMEMS Champion HF Monitoring System (HRG Publication #2164)
Public Citizen urges the Food and Drug Administration to not approve the CardioMEMS System for monitoring heart failure patients. There is insufficient evidence that the device is effective or that the benefits of its use outweigh the risks related to its implantation.
[Created on 10/9/2013]

Public Citizen Supports European Policy on Publication of Clinical Trials Data (HRG Publication #2163)
Public Citizen writes to the European Medicines Agency (EMA), the European Union agency that carries out premarket approval for drugs, to support the EMA’s proposed policy that would provide for the publication of clinical-trial data submitted to the EMA in the future. This policy will enable independent expert groups to review the benefits of and risks of EMA-approved drugs, which are often also approved for marketing in the United States. The proposed policy will promote transparency and the opportunity for independent review, two cornerstones of sound medical research and good regulatory decision-making, while will adequately protecting patient privacy.
[Created on 9/30/2013]

Statement: An Inexcusable Delay: FDA Finally Approves Black Box Warning for Antibiotic Tygacil, as Called for by Public Citizen (HRG Publication #2162)
Public Citizen welcomes the announcement by the Food and Drug Administration (FDA) that the agency has approved a new black box warning for the antibiotic tigecycline (brand name: Tygacil). The warning indicates that clinical trials have found an increased risk of death with tigecycline in comparison to other antibiotics and that the drug should thus be used only when alternative treatments are not suitable. Public Citizen first requested this warning in a November 2011 citizen petition to the FDA.
[Created on 9/27/2013]

Statement: Proposed Compromise Compounding Bill Threatens Patient Safety by Allowing ‘Outsourcing Facilities’ to Manufacture Drugs Without New Drug Approval (HRG Publication #2161)
A year after a deadly disease outbreak linked to tainted compounded drugs, a newly proposed Congressional bill would make it easier for companies like the one behind the outbreak to manufacture substandard drugs without Food and Drug Administration approval, under the guise of pharmacy compounding.
[Created on 9/27/2013]

Statement: FDA’s Unique Device Identifier Rule Years Delayed but a Welcome Step Forward for Medical Device Safety (HRG Publication #2160)
Public Citizen applauds the long-overdue announcement by the Food and Drug Administration (FDA) that it will soon require a unique device identifier (UDI) system for medical devices. The system will improve the tracking and analysis of adverse events related to medical devices. It also will facilitate more efficient, effective and complete implementation of device-related recalls. Public Citizen has strongly advocated for a UDI system as a key step toward improving the safety of medical devices.
[Created on 9/20/2013]

Public Citizen Opposes Reclassification of Extracorporeal Membrane Oxygenation (ECMO) Devices (HRG Publication #2159)
Public Citizen testified before the FDA’s Circulatory System Devices Panel opposing the reclassification of ECMO devices from Class III to Class II for conditions in which imminent death is threatened by cardiopulmonary failure in neonates and infants or where cardiopulmonary failure results in the inability to separate from cardiopulmonary bypass following cardiac surgery in pediatric patients. The FDA should instead publish a proposed final rule maintaining the devices’ Class III classification for all indications and set an effective date requiring the submission of evidence that the device is safe and effective for all current uses.
[Created on 9/12/2013]

Statement: FDA Action Benefits Industry, Perpetuates Unsafe Use of Opioid Pain Medications (HRG Publication #2158)
The Food and Drug Administration (FDA) recently announced new safety requirements for certain opioid pain medications. The action represents a small step in the right direction, but it ultimately fails to adequately ensure the safety of chronic pain patients, and it favors the interests of the pharmaceutical industry over those of the public’s health.
[Created on 9/11/2013]

Public Citizen Opposes Reclassification of External Cardiac Compressor Devices (HRG Publication #2157)
Public Citizen testified before the FDA’s Circulatory System Devices Panel opposing the reclassification of External Cardiac Compressor (ECC) devices from Class III, requiring premarket approval, to Class I or II, which do not require premarket approval. The best-designed study of these devices, the ASPIRE study, provided strong evidence that death and neurological injury are more common with use of this device compared to manual CPR. Public Citizen recommends that FDA require that these devices be approved through the FDA’s premarket approval process because more testing is needed to show that the devices are safe and effective.
[Created on 9/11/2013]

Testimony before the FDA’s Pulmonary and Allergy Drugs Advisory Committee on umeclidinium/vilanterol (proposed trade name Anoro Ellipta) for the long-term treatment of patients with chronic obstructive pulmonary disease (COPD) (HRG Publication #2156)
Public Citizen opposes the approval of the combination therapy umeclidinium/vilanterol (proposed trade name Anoro Ellipta) for the treatment of COPD because the drug led to a higher rate of abnormal heart rhythms and non-fatal heart attacks in the pre-approval clinical trials.
[Created on 9/10/2013]

Letter to HHS Secretary Regarding Impact of Oregon Law on National National Practitioner Data Bank (HRG Publication #2155)
Public Citizen is writing to express serious concern that a law recently enacted by the state of Oregon threatens the viability of the National Practitioner Data Bank as a comprehensive and reliable source of data regarding malpractice payouts, particularly if other states follow Oregon’s lead. The Oregon law seeks to create a loophole that would allow physicians to avoid reporting to the Data Bank any malpractice payments that are negotiated through a mediation process specified under the new law.
[Created on 9/10/2013]

Testimony Before the FDA Pediatric Ethics Subcommittee of the Pediatric Advisory Committee (HRG Publication #2154)
Pre-event clinical trials in children testing greater-than-minimal-risk experimental medical countermeasures against unlikely exposures to various biologic or chemical agents, such as the proposed clinical trial involving exposure of children to the anthrax vaccine, are unethical and should not be permitted by the Food and Drug Administration or the Department of Health and Human Services.
[Created on 9/9/2013]

Comments to HHS Responding to Questions About Informed Consent for Human Subjects Research (HRG Publication #2153)
Public Citizen responds to the request for comments on the protection of human research subjects, as well as research studying “standard of care” interventions. These written comments supplement the testimony we provided at the August 28 public meeting convened by the Department of Health and Human Services (HHS).
[Created on 9/6/2013]

Testimony before HHS Panel on Informed Consent for Human Subjects Research (HRG Publication #2152)
In light of recent, high profile instances of serious ethical breaches involving infants, Public Citizen Health Research Group Director Michael Carome and Health Research Group Founder Sidney Wolfe testify before the Department of Health and Human Services regarding “standard of care” interventions in human subjects.
[Created on 8/28/2013]

Press Release: In Wake of Controversy Over Unethical NIH-Funded Premature Baby Trial, HHS Seeks Way Forward (HRG Publication #2151)
Publicity over an unethical NIH-funded trial conducted on premature infants has sparked an unusual Aug. 28 public forum at the Department of Health and Human Services (HHS), designed to solicit comments from experts and the public about what risks should be disclosed to participants when research is focused on standard-of-care treatment. The outcome of the HHS public meeting could weaken rules for protecting human research subjects.
[Created on 8/21/2013]

Letter to HHS Secretary Sebelius on a New NIH-Funded Premature Infant Study Lacking Compliance with Ethical Consent Standards (HRG Publication #2150)
Only months after exposing an unethical, federally funded experiment conducted on premature infants, Public Citizen has learned of a similar trial also posing known risks to premature babies without fully informing the parents about those risks. In a letter to Health and Human Services (HHS) Secretary Sebelius, Public Citizen urges that recruitment for the trial, which started only recently, be halted, and that the parents of babies already enrolled in the study be contacted regarding the consent-form deficiencies.
[Created on 8/22/2013]

Public Citizen Petition to FDA to Warn Against Prolonged Use of Clopidogrel (Plavix) in Cardiac-Stent Patients Because of Lethal Side Effects, No Benefit (HRG Publication #2149)
Public Citizen petitions the Food and Drug Administration to warn patients and doctors that taking the widely prescribed drug clopidogrel (brand name: Plavix) for more than a year after having a drug-eluting stent implanted can lead to potentially fatal bleeding without providing further benefits.
[Created on 8/21/2013]

Letter to HHS Secretary Sebelius Regarding Specialty Compounding (HRG Publication #2148)
Public Citizen urges Secretary of Health and Human Services Kathleen Sebelius to direct the Food and Drug Administration (FDA) to seek an injunction against Specialty Compounding, a Texas compounding pharmacy cited by FDA inspectors for multiple sterility concerns in March 2013. We also urge that the Inspector General conduct an investigation to determine why the FDA did not request an earlier voluntary recall, issue a public safety alert, or seek an injunction after inspectors noted the serious quality control problems. Further actions should be initiated against all pharmacies with quality control problems similar to those of Specialty Compounding. Since fall of 2012, “significant objectionable conditions” have been identified at 50 compounding pharmacy facilities, yet only 16 of these facilities have initiated a product recall or been the subject of an FDA enforcement action.
[Created on 8/14/2013]

Public Citizen Opposes Approval of Drug with Liver Toxicity Risks at FDA Advisory Committee Meeting (HRG Publication #2147)
In testimony before the Food and Drug Administration, Public Citizen spoke against approval of the drug tolvaptan for use in polycystic kidney disease, citing its liver toxicity risks and that it does not meet essential elements of efficacy needed for drug approval.
[Created on 8/5/2013]

Letter to the FDA Regarding Use of Experimental Pulse Oximeter Devices in the SUPPORT Study (HRG Publication #2146)
Public Citizen previously sent letters to Secretary of Health and Human Services Kathleen Sebelius raising serious concerns about the neonatal SUPPORT study. These letters highlighted important omissions, as well as misleading statements regarding the nature and risks of the research, in the consent forms used in the study. We now pose questions regarding the intentionally miscalibrated pulse oximeter devices used to measure the blood oxygen levels of the premature infants in the SUPPORT Study.
[Created on 8/2/2013]

Press Release: Patients Should Beware When New Drug for Overactive Bladder Soon Becomes Available Over-the-Counter (HRG Publication #2145)
The latest edition of Worst Pills, Best Pills News, Public Citizen’s drug safety newsletter and website, advises that when a new version of oxybutynin (Oxytrol for Women) for overactive bladder becomes available without a prescription in the fall, people should avoid it if they haven’t first talked with their doctor.
[Created on 8/1/2013]

Public Citizen Criticizes Dangerous, Flawed FDA Risk-Mitigation Program, Citing Examples of Five Drugs (HRG Publication #2144)
In testimony before the Food and Drug Administration (FDA), Public Citizen criticizes the agency’s Risk Evaluation and Mitigation Strategies (REMS) program, citing several areas of failure of the program and noting five drugs that exemplify these failures.
[Created on 7/26/2013]

Letter to CMS Supporting Proposed Decision to Severely Restrict Coverage for β-Amyloid PET Imaging in Dementia (HRG Publication #2143)
Public Citizen strongly supports the Centers for Medicare & Medicaid Services’ (CMS’s) proposed decision to only cover positron emission tomography (PET) amyloid-beta (Aβ) imaging in dementia and neurodegenerative disease for a limited set of circumstances. There is insufficient clinical-trial data to support that this technology changes the health outcomes of patients who display early symptoms or signs of cognitive dysfunction, or in any other patient population.
[Created on 7/23/2013]

Public Citizen Comments for House Regarding Compounding Pharmacy Legislation (HRG Publication #2142)
Public Citizen expresses our grave concerns with all three pending pieces of legislation on pharmacy compounding. There may be significant differences between these three proposals, but all of them put patients at risk by permitting compounding pharmacies to engage in drug manufacturing activity without seeking a new drug approval from the Food and Drug Administration (FDA) or complying with important federal drug labeling requirements.
[Created on 7/15/2013]

Testimony to the FDA Drug Safety and Risk Management Advisory Committee on the Restrictions on the Use of Lotronex (HRG Publication #2141)
Public Citizen recommends that restrictions on Lotronex (alosetron) be tightened, rather than loosened, due to its high risk of life-threatening adverse reactions compared with its marginal benefits.
[Created on 7/10/2013]

Statement: FDA Proposal to Revise Drug Labeling Regulations Is Welcome News, Will Improve Drug Safety (HRG Publication #2140)
Public Citizen is extremely pleased to see that the Food and Drug Administration sent to the Office of Management and Budget a proposed rule to revise FDA regulations about prescription drug labeling. When finalized, the revisions will fill a regulatory gap related to generic drug labeling that poses a risk to patient safety.
[Created on 7/3/2013]

Public Citizen comments on regulatory classification of automated external defibrillator (AED) devices (HRG Publication #2139)
Public Citizen supports the Food and Drug Administration’s (FDA’s) proposed order requiring premarket approval applications for automated external defibrillator (AED) devices. Public Citizen’s Health Research Group previously offered testimony before the FDA Panel on Circulatory System Devices of the Medical Devices Advisory Committee on January 25, 2011, urging the panel to recommend that AED devices remain in Class III and be reviewed through the premarket approval (PMA) process, a recommendation that the panel ultimately adopted.
[Created on 6/24/2013]

Generic Drug Labeling: A Report on Serious Warnings Added to Approved Drugs and on Generic Drugs Marketed Without a Brand-Name Equivalent (HRG Publication #2138)
Today, the majority of prescriptions filled in the United States are filled with generic drugs, making prescription drugs more affordable for patients. Many potential hazards are not discovered until years after drugs have been on the market, yet under current FDA regulations, generic drug manufacturers can do little to warn doctors and patients about newly discovered information, putting patients at risk. In this report, Public Citizen lists 53 drugs approved by the Food and Drug Administration more than 10 years ago that have required new black-box warnings over the past five years and also provides a list of more than 400 drugs for which the brand-name product is no longer sold.
[Created on 6/20/2013]

Public Citizen Comments on Draft Revision of the Declaration of Helsinki (HRG Publication #2137)
Public Citizen supports many of the proposed revisions to the World Health Organization’s Declaration of Helsinki. However, Public Citizen expresses concern regarding one important statement — “the well-being of the individual research subject must take precedence over all other interests” — being characterized as “intended to be aspirational.” Such a comment undermines the value of this specific statement and the force of the entire document as a guide for physicians engaged in medical research.
[Created on 6/14/2013]

Letter to the FDA Opposing Approval of the Sleep Medicine Suvorexant (HRG Publication #2136)
This letter was sent to the U.S. Food and Drug Administration (FDA) as a follow-up to our testimony at the May 22, 2013 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee that voted in favor of approval of the dangerous sleep medicine, suvorexant. We again urge the FDA not to approve suvorexant because the drug’s long-lasting risks – both to patients and the general public – outweigh any short-term benefits on sleep.
[Created on 6/14/2013]

Letter to HHS Secretary Sebelius Regarding the SUPPORT Study and Censorship of an NIH Expert (HRG Publication #2135)
Public Citizen informed Health and Human Services Secretary Sebelius that it is deeply troubled to learn that NIH has silenced an expert within the agency who has previously raised serious concerns about the ethics of clinical trials with designs that are very similar, if not identical, to that of the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT study) involving extremely premature babies.
[Created on 6/13/2013]

Testimony to FDA Drug Safety and Risk Management and Endocrine and Metabolic Drugs Advisory Committees Regarding Rosiglitazone Safety (HRG Publication #2134)
Public Citizen argues that not only should the current restrictions on the use of the diabetes drug rosiglitazone (Avandia) not be lifted, the drug should be removed from the U.S. market given its unique risks and the absence of any unique benefits. Among older patients with diabetes, rosiglitazone is associated with a significantly higher risk of heart failure and death compared to pioglitazone.
[Created on 6/6/2013]

Statement: The Office for Human Research Protections Reaffirms Main Findings of Inadequate Informed Consent for Premature Baby Study, But Bows to Political Pressure and Puts Enforcement Actions on Hold (HRG Publication #2133)
The federal government has taken an important step toward addressing a highly unethical trial involving premature babies but still is leaving infants and other subjects at risk by permitting current similar trials to continue.
[Created on 6/5/2013]

Problems with Office of Inspector General Exclusion Reports Undermine the Usefulness of the National Practitioner Data Bank (HRG Publication #2132)
Public Citizen issued a report finding that Because of problems with the reports provided to the National Practitioner Data Bank by the Office of Inspector General at the U.S. Department of Health and Human Services, entities using the data bank to conduct background checks may not learn that health care providers have been excluded from Medicare or Medicaid for such things as substandard services and fraud.
[Created on 6/4/2013]

Statement: Stepping Aside But Not Out: Well-Known Consumer Health Advocate Dr. Sidney Wolfe Hands Over Reins to Deputy (HRG Publication #2131)
After leading Public Citizen’s Health Research Group for more than 40 years through everything from pitched battles against the pharmaceutical industry to groundbreaking research on dangerous doctors, Dr. Sidney Wolfe, founder and longtime director of the program, is handing over leadership of it to his deputy today.
[Created on 6/3/2013]

Statement: Immigrants Deserve Better Health Coverage (HRG Publication #2130)
A Harvard University/City University of New York Health Affairs study published today shows that although immigrants contributed about $115.2 billion more to the Medicare Trust Fund than they took out between 2002 and 2009, one out of three were uninsured.
[Created on 5/29/2013]

Testimony to the FDA Peripheral and Central Nervous Systems Drugs Advisory Committee on Suvorexant (HRG Publication #2129)
The U.S. Food and Drug Administration should not approve the latest sleep medicine suvorexant because the drug’s long-lasting risks – both to patients and the general public – outweigh any short-term benefits on sleep.
[Created on 5/22/2013]

Public Citizen Commentary on the SUPPORT Study Involving Premature Babies (HRG Publication #2128)
In a commentary published by The Hastings Center on-line Bioethics Forum, Public Citizen responded to another recent commentary written by a pediatric bioethicist attacking our position that that the conduct of the SUPPORT study involving premature babies was unethical because parents of babies enrolled in the study were not informed of the purpose, nature, and risks of the research.
[Created on 5/21/2013]

Public Citizen to Congress: New Bill on Pharmacy Compounding a Major Step Backward for U.S. Drug Safety (HRG Publication #2127)
On May 3, 2013, Public Citizen expressed grave concerns to the Senate Health, Education, Labor & Pensions (HELP) Committee that its draft proposal on pharmacy compounding would weaken existing laws governing drug manufacturing. The proposal would create a new regulatory class of drug manufacturers, confusingly called “compounding manufacturers,” that would be exempt from federal premarket approval and related labeling requirements. The bill on pharmacy compounding, S. 959, introduced in the Senate on May 15, offers no significant improvement over the draft. The American public deserves much better.
[Created on 5/16/2013]

Letter to the Editor of The Washington Post Criticizing a Recent Editorial Lauding U.S. Senate Legislation on Compounding Pharmacies (HRG Publication #2126)
In a letter to the editor of The Washington Post, Public Citizen strongly criticized the May 6 editorial “Concocting a cure” supporting draft U.S. Senate legislation on pharmacy compounding. The bill would be a significant step backward for drug safety in the U.S.
[Created on 5/12/2013]

Public Citizen Petitions the Consumer Product Safety Commission to Ban Adult Portable Bedrails due to Strangulation Risks (HRG Publication #2125)
Public Citizen sent a petition today to the Consumer Product Safety Commission (CPSC) asking for a ban on adult portable bedrails. Portable rails are designed to slip under an ordinary mattress and are advertised as making beds “safer” for seniors who have trouble getting in and out of bed unassisted. The CPSC reported in 2012 that bed rails have been associated with at least 155 fatalities, mostly from strangulation incidents where an elderly victim became stuck, wedged, or trapped between the mattress and bed rail. There is also no evidence that bedrails actually help prevent falls. Public Citizen has asked the CPSC to ban adult portable bedrails because the product cannot be re-designed to eliminate the strangulation risk.
[Created on 5/9/2013]

Public Citizen Report Documents Lack of Informed Consent for Risky Study on Premature Babies (HRG Publication #2124)
In a report submitted to Secretary of Health and Human Services Kathleen Sebelius, Public Citizen presents an independent analysis of the complete protocol and informed consent documents for the SUPPORT study, which involved extremely premature babies. The key finding in the report is that parents of babies enrolled in the study were not told the dangers of the study’s experimental procedures.
[Created on 5/8/2013]

Letter to the Council of the District of Columbia Supporting Passage of the Patient Protection Act (HRG Publication #2123)
Public Citizen President Robert Weissman and Deputy Director of Health Research Group Michael Carome praise the DC City Council for introducing the Patient Protection Act. They urge the Council to pass the legislation, which would combat the ill effects of hospital understaffing on patient health and help avoid preventable hospital readmissions.
[Created on 5/6/2013]

Comments on Sorbent Hemoperfusion, Cranial Electrotherapy Stimulators, and Transilluminators for Breast Evaluation (HRG Publication #2122)
Public Citizen opposes the FDA’s proposed order reclassifying sorbent hemoperfusion devices into Class II for the treatment of poisoning and drug overdose, based on concerns that the devices carry severe, life-threatening risks, and insufficient clinical evidence exists to determine whether they are effective compared with alternatives. We support the FDA’s proposal to retain these devices in Class III (requiring premarket approval) for the treatment of hepatic coma and metabolic disturbances. We also support the FDA’s proposal to retain cranial electrotherapy stimulators and transilluminators for breast evaluation in Class III, as safety and efficacy for these devices has also not been established.
[Created on 5/6/2013]

Public Citizen’s Comments on Senate HELP Committee Draft Proposal for Regulatory Oversight of Compounding Pharmacies (HRG Publication #2121)
Public Citizen expresses grave concerns with the Committee’s draft legislative proposal which will weaken existing laws governing drug manufacturing by creating an entirely new regulatory class of drug manufacturers that would be subject to substandard requirements for ensuring the efficacy, safety, quality, and labeling of drugs.
[Created on 5/3/2013]

Statement to Congress: Proposed Compounding Pharmacy Legislation Would Be a Major Step Backward for U.S. Drug Safety (HRG Publication #2120)
Draft legislation on pharmacy compounding released by the U.S. Senate Committee on Health, Education, Labor, and Pensions would dramatically weaken patient protections by creating an extremely dangerous new class of drug manufacturers, confusingly called “compounding manufacturers.” These second-tier manufacturers would be permitted to mass-produce standardized drugs without obtaining FDA approval or meeting federal labeling requirements intended to ensure the safe use of drugs.
[Created on 5/1/2013]

Letter to FDA Opposing Approval of Fluticasone Furoate/Vilanterol (FF/VI) for COPD (HRG Publication #2119)
These comments are being submitted in follow-up to Public Citizen’s testimony presented at the April 17, 2013, meeting of the FDA Pulmonary-Allergy Drugs Advisory Committee (PADAC) opposing approval of the combination drug fluticasone furoate/vilanterol (FF/VI; proposed trade name Breo Ellipta). This combination offers no clinically meaningful benefit but clearly causes increased risks compared with the bronchodilator vilanterol alone. In addition, two of the four pivotal trials upon which this new drug application is based were unethical, withholding critical, long-acting bronchodilator therapy from patients in the placebo and inhaled corticosteroid arms.
[Created on 4/30/2013]

Comments to the Docket for FDA Proposed Guidance for Industry on Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease (HRG Publication #2118)
Public Citizen submits comments on the FDA’s proposed industry guidance for Treatment of Early Stage Alzheimer’s Disease, including its absence of discussion of the effectiveness of physical and mental exercise and a critique of the Guidance itself because it lacks a scientific basis for either accurately diagnosing or measuring the effects of treatment on people with such early disease.
[Created on 4/25/2013]

Letter to FDA Demanding Explanation for Dangerous Delay Between Identifying Problems and Public Recall of Potentially Contaminated Products Distributed by Balanced Solutions Compounding Pharmacy (HRG Publication #2117)
Public Citizen requests an explanation for the unacceptable one-month delay between the Food and Drug Administration’s (FDA’s) inspection of Axium Healthcare Pharmacy (dba Balanced Solutions Compounding Pharmacy), which was finished on March 15, 2013 and identified serious quality control problems related to the production of sterile drugs, and the subsequent nationwide voluntary recall of all lots of sterile products compounded by this pharmacy on April 17, 2013.
[Created on 4/22/2013]

Letter to the Editor of The Washington Post Criticizing FDA for its Failure to Regulate Drug Manufacturing by Compounding Pharmacies (HRG Publication #2116)
In a letter to the editor of The Washington Post, Public Citizen responded to the April 12 front-page article “FDA finds safety problems at specialized pharmacies.” The Food and Drug Administration must ensure that companies that engage in drug manufacturing under the guise of pharmacy compounding either scale down their operations or adhere to current federal regulations governing drug manufacturing.
[Created on 4/21/2013]

Letter to the Assistant Secretary for Health and the OHRP Director Regarding Neonatal Research Network Trials (HRG Publication #2115)
Public Citizen requests emergency action by the Office for Human Research Protections (OHRP) to ensure that newborn premature and term infants are being adequately protected in seven current randomized trials being conducted by the Neonatal Research Network (NRN).
[Created on 4/18/2013]

Testimony on Fluticasone/Vilanterol Combination Therapy to the FDA’s Pulmonary-Allergy Drugs Advisory Committee (HRG Publication #2114)
The Food and Drug Administration (FDA) should not approve the proposed combination therapy, fluticasone/vilanterol (proposed trade name: Breo Ellipta) for the treatment of chronic obstructive pulmonary disease (COPD), because the drug is largely ineffective and causes serious side effects compared with vilanterol given alone, and was studied in a series of unethical clinical trials.
[Created on 4/17/2013]

Letter to Secretary of Health and Human Services Regarding Ongoing Clinical Trials Conducted by the Neonatal Research Network (HRG Publication #2113)
In a letter to Health and Human Services Secretary Kathleen Sebelius, Public Citizen demanded that, in light of disturbing revelations about the unethical SUPPORT study involving premature babies, the Department of Human Health and Services should release details about ongoing clinical trials involving infants conducted by the Neonatal Research Network and suspend enrollment in them until they are independently assessed by ethicists and others.
[Created on 4/15/2013]

Letter to Dr. Richard Marchase at the University of Alabama at Birmingham Criticizing His Misleading Statements to the Media Regarding the Unethical SUPPORT Study (HRG Publication #2112)
Public Citizen sent a letter to Dr. Richard Marchase, Vice President for Research & Economic Development at the University of Alabama at Birmingham criticizing him for making statement to the media that have misled reporters just as the egregious deficiencies in the consent forms misled the parents of the premature babies enrolled in the SUPPORT study with regard to the purpose, nature, and risks of the research.
[Created on 4/11/2013]

Letter to Secretary of Health and Human Services Regarding Unethical Trial Involving Premature Infants (HRG Publication #2111)
In a letter to Health and Human Services Secretary Kathleen Sebelius, Public Citizen urged the secretary to personally apologize to the parents of 1,316 premature infants who were exposed to an increased risk of blindness and death as part of a clinical trial funded by the National Institutes of Health and held throughout the U.S. several years ago – because their parents were not informed about the risks or true nature and purpose of the research.
[Created on 4/10/2013]

Comments Submitted to the FDA Regarding Extracorporeal Membrane Oxygenation (ECMO) Devices (HRG Publication #2110)
Public Citizen urges the FDA to withdraw its proposal for Class II reclassification of ECMO devices for conditions in which imminent death is threatened by cardiopulmonary failure in neonates and infants or where cardiopulmonary failure results in the inability to separate from cardiopulmonary bypass following cardiac surgery. The FDA should instead publish a proposed final rule maintaining the devices’ Class III classification for all indications and set an effective date requiring the submission of evidence that the device is safe and effective for all current uses.
[Created on 4/8/2013]

Comments Submitted to the FDA Regarding Automated External Cardiac Compressor Devices (HRG Publication #2109)
Public Citizen urges the FDA to withdraw its proposal for Class II reclassification of automatic external cardiac compressor devices for chest compressions during cardiopulmonary resuscitation (CPR) because there is a lack of evidence that they are safe and effective. The FDA should instead publish a proposed final rule maintaining the devices’ Class III designation and set an effective date requiring the submission of evidence that the devices are safe and effective.
[Created on 4/8/2013]

Follow-up Letter to the Texas Medical Board Regarding the LipoTron Device (HRG Publication #2108)
Public Citizen has previously brought to the attention of the Texas Medical Board the apparent illegal distribution, sale, and promotion of the LipoTron medical device by a list of Texas Physicians. We now emphasize the fact that the FDA recently issued a warning to the makers of the LipoTron device that it is considered by the agency to be both adulterated and misbranded.
[Created on 3/25/2013]

Press Release: New Study Underscores Increased Dangers of Certain Diabetes Treatments (HRG Publication #2107)
New scientific evidence published today reveals an association between the development of precancerous lesions in the pancreas and use of a class of diabetes drugs known as incretins, which include Byetta (exenatide), Victoza (liraglutide) and Januvia (sitagliptin). These new findings are in accord with the rapidly increasing number of reports to the Food and Drug Administration of pancreatic cancer in patients using these drugs compared with diabetics using other drugs for diabetes.
[Created on 3/22/2013]

Letter to CMS Opposing Medicare Coverage for β-Amyloid PET Imaging in Dementia (HRG Publication #2106)
Public Citizen urges the Centers for Medicare & Medicaid Services (CMS) to maintain its current exclusion of coverage for β-amyloid positron emission tomography (PET) imaging in dementia and neurodegenerative disease because there is a lack of adequate evidence to determine whether such imaging changes the health outcomes of any patient population.
[Created on 3/21/2013]

Testimony Before FDA’s Circulatory System Devices Panel Regarding the Abbott Vascular MitraClip Clip Delivery System (HRG Publication #2105)
Public Citizen’s Health Research Group strongly opposes the Food and Drug Administration’s (FDA) approval of the MitraClip Clip Delivery System (MitraClip) in high-risk patients due to a lack of evidence that the device’s benefits outweigh its risks, not limited to bleeding, cardiac arrest, and death.
[Created on 3/20/2013]

Press Release: Good Move, But Years Late: FDA Warns Maker of ‘Fat-Burning’ Device to Stop Marketing Unapproved Product (HRG Publication #2104)
The Food and Drug Administration (FDA) is doing the right thing by warning RevecoMED International, the maker of the LipoTron “fat-burning” device, to stop marketing the device, which has not been FDA-approved for “fat-burning.” However, the action comes years too late.
[Created on 3/19/2013]

Comments Submitted to the FDA’s Drug Shortages Task Force (HRG Publication #2103)
Strengthened enforcement over compounding pharmacies who are acting as drug manufacturers would help to alleviate drug shortages by creating incentives for mainstream drug manufacturers to produce high-quality, Food and Drug Administration-approved medication.
[Created on 3/14/2013]

Petition to FDA from Eight Public Health and Consumer Advocacy Organizations to Expand Monitoring of Tobacco Products (HRG Publication #2102)
Public Citizen and seven other organizations call upon the FDA to implement a tracking system on tobacco products so that the agency may fulfill its obligations under the Federal Food, Drug, and Cosmetic Act and help prevent illegal activity, such as tobacco product smuggling and trafficking.
[Created on 3/8/2013]

Testimony to the FDA’s Advisory Committee on Reproductive Health Drugs on Nasal Calcitonin for Osteoporosis (HRG Publication #2101)
Calcitonin nasal spray, prescribed to treat osteoporosis since 1994, should be removed from the market because is not very effective for preventing fractures and may cause cancer and other serious side effects.
[Created on 3/5/2013]

Testimony to the FDA’s Advisory Committee on Reproductive Health Drugs on paroxetine for menopausal symptoms (HRG Publication #2100)
Public Citizen strongly opposes the Food and Drug Administration’s (FDA’s) approval of paroxetine for treatment of menopause-related vasomotor symptoms (VMS, which includes hot flashes and flushing) due to the drug’s questionable benefits and well-established risks.
[Created on 3/4/2013]

Testimony to the FDA’s Advisory Committee on Reproductive Health Drugs on gabapentin for menopausal symptoms (HRG Publication #2099)
Public Citizen strongly opposes the Food and Drug Administration’s (FDA’s) approval of gabapentin for treatment of menopause-related vasomotor symptoms (VMS, which includes hot flashes and flushing) due to the drug’s questionable benefits and well-established risks.
[Created on 3/4/2013]

Letter to OHRP Alleging Inadequate Informed Consent for Study Involving Diabetic Children (HRG Publication #2098)
Public Citizen, for the third time, calls upon the Office for Human Research Protections (OHRP) to investigate all institutions engaged in a risky NIH-funded research study involving diabetic children because the risks, benefits and nature of the research was not adequately described to the subjects and the parents of child subjects.
[Created on 2/27/2013]

Keynote Address by Sidney Wolfe, MD at “Selling Sickness” Conference (HRG Publication #2097)
Public Citizen’s presentation to the “Selling Sickness” conference regarding the drug companies’ strategy of promoting dangerous products to treat routine ailments and the FDA’s collusion in this practice.
[Created on 2/21/2013]

Letter to the Executive Director of the European Medicines Agency on Bedaquiline (HRG Publication #2096)
Public Citizen urges the European Medicines Agency not to approve the new tuberculosis drug bedaquiline, which in clinical tests has shown significantly higher mortality rates.
[Created on 2/13/2013]

Letter to Department of Health and Human Services Regarding the Chronic Fatigue Syndrome Advisory Committee (HRG Publication #2095)
Public Citizen has been alerted that important transparency requirements for federal advisory committees are being ignored by the HHS advisory committee on chronic fatigue syndrome.
[Created on 2/14/2013]

Letter to FDA on IABP Regulatory Classification (HRG Publication #2094)
Public Citizen strongly urges the Food and Drug Administration (FDA) to withdraw its proposal to reclassify the intra-aortic balloon pump pre-amendment Class III device to Class II (special controls) for three common indications and to publish a notice immediately that proposes a final regulation requiring the device to remain in Class III for all indications, and require pre-market approval applications for new intra-aortic balloon pumps.
[Created on 2/13/2013]

Letter to the FDA Criticizing the Decision to Keep the Wingspan Stent System on the Market (HRG Publication #2093)
Public Citizen sent a letter to the FDA today criticizing the agency’s August 2012 decision to keep a dangerous brain stent, the Wingspan Stent System, on the market after a high-quality clinical trial showed that the device causes death and stroke. The FDA acknowledged in August that the stent was dangerous for most patients, but chose to approve the device for a limited group of patients rather than ban the device outright. Public Citizen condemns the FDA for making the decision without evidence that the device would be any less dangerous for those people in the limited patient group than it is for most patients, and for failing to adequately warn doctors and patients of the deadly risks.
[Created on 1/28/2013]

Testimony to Drug Safety and Risk Management Advisory Committee on Overprescription of Hydrocodone (HRG Publication #2092)
Ninety-nine percent of the hydrocodone in the world is manufactured and used in the United States – evidence that hydrocodone products are being overprescribed and should be severely restricted, Public Citizen told the FDA today.
[Created on 1/25/2013]

Testimony on Canagliflozin to the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (HRG Publication #2091)
Public Citizen opposes the FDA’s approval of the new diabetes drug canagliflozin because it demonstrates no evidence of any improved clinical outcomes while creating increased risks of dangerous side-effects, including cardiovascular events.
[Created on 1/10/2013]

Letter to the Secretary of Health and Human Services Criticizing Recent Action Taken by the Office for Human Research Protections (HRG Publication #2090)
Public Citizen expresses serious concern with the recent dangerously lax compliance oversight determinations made by the Office for Human Research Protections (OHRP) — a program office within the Office of the Secretary of Health and Human Services — that, unless overturned, will seriously undermine the regulatory protections for children provided under the Department of Health and Human Services (HHS) human-subjects protection regulations.
[Created on 1/9/2013]

Testimony of Sidney Wolfe at FDA Hearing on Ampligen (HRG Publication #2089)
Public Citizen presented evidence from a study on Ampligen that failed to show that the drug was safe or effective for the treatment of Chronic Fatigue Syndrome.
[Created on 12/20/2012]

2012

Letter to FDA Opposing Approval of Bedaquiline (HRG Publication #2088)
Public Citizen strongly opposes the accelerated approval of bedaquiline because patients taking the drug, in addition to standard TB treatment, during a phase 2 clinical trial were five times likelier to die than those who took a placebo.
[Created on 12/21/2012]

Letter to HHS Secretary Regarding the FDA Commissioner’s Congressional Testimony on Compounded Drugs (HRG Publication #2087)
Description: Public Citizen criticized FDA Commissioner Margaret Hamburg for both undermining her agency’s authority in congressional testimony last month and offering a plan that would effectively weaken the agency’s oversight of drug manufacturing.
[Created on 12/18/2012]

Comments to Senate Committee on Health, Education, Labor, and Pensions on the FDA’s Flawed Proposal for Oversight of Compounding Pharmacies (HRG Publication #2086)
In response to the recent fungal meningitis outbreak, the FDA proposed a new regulatory framework for compounding pharmacies that would weaken, rather than strengthen, existing laws governing drug manufacturing. Public Citizen believes it wiser to strengthen existing laws by clarifying the line between traditional pharmacy compounding and drug manufacturing and clarifying the federal standards governing traditional compounding. All drug manufactures must be held to the same rigorous safety and quality standards.
[Created on 11/30/2012]

Letter to the FDA Urging Re-Inspection of Compounding Pharmacies with Serious Safety Violations (HRG Publication #2085)
The dangers of unregulated compounding pharmacies have been made tragically clear in the wake of the recent fungal meningitis outbreak. Public Citizen urges the Food and Drug Administration to promptly re-inspect each of the 16 compounding pharmacy facilities where serious safety concerns were uncovered in earlier inspections and initiate a systematic program to determine whether other compounding pharmacies are engaged in illegal practices.
[Created on 11/29/2012]

Letter to the Secretary of Health and Human Services Calling for Expanded Investigation Into Deadly Meningitis Outbreak (HRG Publication #2084)
Secretary of Health and Human Services Kathleen Sebelius should appoint an independent entity – such as the Office of Inspector General – to investigate whether financial incentives created by drug compounding reimbursement policies of the Centers for Medicare and Medicaid Services (CMS) – combined with inadequate Food and Drug Administration action – fostered the recent outbreak of life-threatening fungal meningitis caused by tainted steroid injections. CMS, through its inconsistent Medicare drug reimbursement policies concerning compounded drugs and decisions allowing routine coverage for such drugs, appears to have created inadvertent financial incentives that helped large-scale production by compounding pharmacies to flourish.
[Created on 11/19/2012]

Press Release: FDA Rejects Petition to Ban Aricept 23: Did Drug Companies, FDA Collude in Approving Dangerous Alzheimer’s Drug? (HRG Publication #2083)
By rejecting Public Citizen’s petition to ban Aricept-23, the FDA has sided with Pfizer to allow a dangerous drug to remain on the market.
[Created on 11/6/2012]

Response to Senate HELP Committee’s Questions Regarding Compounding Pharmacies (HRG Publication #2082)
Public Citizen responds to the questions regarding pharmacy compounding that were posed by the Senate Committee on Health, Education, Labor, and Pensions (HELP Committee). The HELP Committee and other congressional committees responsible for overseeing the activities of the FDA should fully investigate the role this agency, as well as others, played in allowing the widespread fungal meningitis outbreak linked to contaminated injectable steroids produced by the New England Compounding Center to occur.
[Created on 11/2/2012]

Statement: FDA Still Offering Excuses and Dodging Responsibility for Its Failed Oversight that Allowed Fungal Meningitis Outbreak to Occur (HRG Publication #2081)
Public Citizen again calls on Congress and the Department of Health and Human Services’ Office of Inspector General to conduct independent investigations into the role of the FDA’s lack of oversight as a factor that contributed to the fungal meningitis outbreak.
[Created on 11/2/2012]

Letter to Secretary of Health and Human Services on FDA Oversight Failures in Light of Meningitis Outbreak (HRG Publication #2080)
Public Citizen urges the Department of Health and Human Services (HHS) to appoint an independent entity, such as the HHS Office of Inspector General, to conduct a thorough investigation into how the Food and Drug Administration failed to use its established regulatory authority to protect the public from the dangerous practice of large-scale drug compounding that lead to the widening fungal meningitis outbreak caused by tainted steroid injections.
[Created on 10/24/2012]

Testimony on Mipomersen to the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (HRG Publication #2079)
The Food and Drug Administration (FDA) should not approve the proposed cholesterol drug mipomersen because the study supporting approval was unethical and withheld an effective therapy from patients with a rare disease, while the drug itself causes a plethora of serious side effects.
[Created on 10/18/2012]

Testimony on Lomitapide to the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (HRG Publication #2078)
Public Citizen opposes the Food and Drug Administration’s approval of lomitapide because of the inadequacy of the clinical trial testing the drug and the lack of an effective risk management strategy for restricting use of the drug.
[Created on 10/17/2012]

Commentary on CNN.com: Deadly Meningitis Outbreak was Completely Avoidable (HRG Publication #2077)
In an invited commentary, Public Citizen reports that the ever-expanding outbreak of life-threatening fungal meningitis in back pain patients linked to steroid injections prepared by a compounding pharmacy, which so far has sickened at least 214 people and killed 15 in 15 states, is a public health catastrophe. What is particularly tragic for those who have been sickened or killed by the tainted drug and for their loved ones is that this situation was completely avoidable.
[Created on 10/16/2012]

Statement: Steroid-Linked Fungal Meningitis Outbreak Reveals Serious Failures in the Oversight of Compounding Pharmacies (HRG Publication #2076)
The widely publicized outbreak of life-threatening fungal meningitis in back-pain patients linked to steroid injections highlights the failure of the Food and Drug Administration’s (FDA’s) regulatory oversight of drugs prepared and sold by compounding pharmacies.
[Created on 10/9/2012]

Petition to the FDA for Black Box Warnings on ACE Inhibitors, ARBs, and Aliskiren (HRG Publication #2075)
Public Citizen petitions the Food and Drug Administration to place black box warnings on all ACE inhibitors, ARBs, and aliskiren, warning against the use of the medications in combination with one another. The drugs, given individually, are effective in treating high blood pressure, but when used in combination, cause life-threatening side effects with no added benefit.
[Created on 10/4/2012]

Letter to the the Secretary of Health and Human Services Regarding Professional Society Reporting to the National Practitioner Data Bank (HRG Publication #2074)
Public Citizen requests that the Department of Health and Human Services amend either the HHS regulations at 45 C.F.R. part 60 (National Practitioner Data Bank [NPDB] for Adverse Information on Physicians and Other Health Care Practitioners) or the department’s policy interpretation of these regulations to require the reporting to the NPDB of physicians who voluntarily resign from membership in professional societies while under formal peer-review investigation by such societies for allegations of unethical conduct.
[Created on 9/27/2012]

Pharmaceutical Industry Criminal and Civil Penalties: An Update (HRG Publication #2073)
In December 2010, Public Citizen published a report that documented the almost $20 billion paid out by the pharmaceutical industry to settle allegations of numerous violations, including illegal, off-label marketing and the deliberate overcharging of taxpayer-funded health programs, such as Medicare and Medicaid. The past two years have seen a continuation of the recent trend of record settlements between the federal and state governments and pharmaceutical manufacturers.
[Created on 9/27/2012]

Petition to the FDA to Revoke its Policy Regarding Minor Deletions from Documents Requested Under the Freedom of Information Act (HRG Publication #2072)
The Food and Drug Administration must stop its longstanding practice of redacting portions of documents released to Freedom of Information Act (FOIA) requesters without giving requesters an immediate right to appeal within the agency. The practice violates FOIA because “minor deletions” from requested documents are not considered formal denials of information requests and, therefore, do not trigger a requester’s immediate right to appeal.
[Created on 9/19/2012]

Commentary in The New York Times “Room for Debate” Series on Whether More Drugs Should be Available Over the Counter (HRG Publication #2071)
In an invited commentary as part of The New York Times “Room for Debate” series, Public Citizen argued that drugs should only be available over the counter if two commonsense criteria for ensuring patient safety are satisfied. Some classes of drugs, such as antihistamines, clearly meet these criteria and should be sold over the counter. Others, such as statin drugs, don’t.
[Created on 9/16/2012]

Letter to the Secretary of Health and Human Services Requesting an Independent Investigation of NIH’s Failure to Promptly Disclose Superbug Outbreak (HRG Publication #2070)
The Department of Health and Human Services (HHS) should open an independent investigation into the National Institutes of Health’s (NIH) handling of information related to a deadly outbreak of multi-antibiotic-resistant Klebsiella bacterial infections at the research agency’s hospital facility known as the Clinical Center, in Bethesda, MD, Public Citizen said today in a letter addressed to HHS secretary Kathleen Sebelius.
[Created on 9/10/2012]

Letter Asking the Federal Trade Commission to order Bed Handles, Inc. to Stop its Deceptive Advertising (HRG Publication #2069)
Public Citizen and the National Consumer Voice for Quality Long-Term Care request that the Federal Trade Commission (FTC) order Bed Handles, Inc., to stop its deceptive advertising of Bedside Assistant bed handles, who promotes Bedside Assistant bed handles as “[making] any bed a safer bed,” whereas, in fact, it poses an unreasonable risk of injury and has resulted in the deaths of at least four adults.
[Created on 9/6/2012]

Lawsuit to prevent dangerous Alzheimer’s treatment (HRG Publication #2068)
Public Citizen files suit to compel The Food and Drug Administration (FDA) to act on our petition calling on the agency to stop allowing the drug Aricept to be marketed at doses that can cause severe – and even fatal – side effects.
[Created on 9/5/2012]

Addressing the Response to Public Citizen’s Report Regarding Texas Medical Board Deficiencies (HRG Publication #2067)
Public Citizen responds to the letter sent by the Texas Medical Board in response to our letter and report sent August 22, 2012.
[Created on 8/28/2012]

Letter to the Presidential Commission for the Study of Bioethical Issues Opposing Unethical Anthrax Vaccine Studies in Children (HRG Publication #2066)
Public Citizen urges the Commission to recommend that the Secretary of Health and Human Services oppose the conduct of pre-event clinical trials in children of the medical countermeasures against exposures to various biologic and chemical agents, such as the pre-event clinical trials of the anthrax vaccine in children that was endorsed by the Office of the Assistant Secretary for Preparedness and Response and the National Biodefense Science Board.
[Created on 8/27/2012]

Letter to OHRP Criticizing the Agency’s Position Allowing CMS to Require Medicare Beneficiaries Undergoing Transthoracic Aortic Valve Replacement to Participate in Research (HRG Publication #2065)
In a letter to the Office for Human Research Protections, Public Citizen criticized the agency’s interpretation of the federal regulations for the protection of human subjects that allowed the Centers for Medicare and Medicaid Services to require Medicare patients to participate in research as a condition of coverage for transcatheter aortic valve replacement.
[Created on 8/27/2012]

Letter to the editor of The Washington Post criticizing NIH for its failure to alert public to an outbreak of a multi-antibiotic-resistant “superbug” (HRG Publication #2064)
In a letter to the editor of The Washington Post, Public Citizen responded to the August 23 front-page article, “Deadly bacteria stalked hospital.” NIH failed to meet its ethical obligation to inform the public about this dangerous threat to public health.
[Created on 8/27/2012]

Letter to Governor Perry Regarding Serious Deficiencies of the Texas Medical Board (HRG Publication #2063)
Public Citizen calls upon Texas Governor Rick Perry to initiate immediate action to improve the performance of the Texas Medical Board and protect patients in Texas from physicians who should have been, but were not, disciplined.
[Created on 8/22/2012]

Statement: FDA Ignores Evidence Linking Wingspan Stent System to Stroke and Death, Keeps Dangerous Device on the Market (HRG Publication #2062)
For every 11 patients treated with the Wingspan system and aggressive medical therapy, one additional patient dies or suffers a stroke within 30 days, compared to patients treated with aggressive medical therapy alone.
[Created on 8/8/2012]

Letter to the Oklahoma State Department of Health Regarding the LipoTron Device (HRG Publication #2061)
Public Citizen calls upon the Oklahoma State Department of Health to promptly investigate health spas that are actively promoting and using the LipoTron medical device, which has not been cleared or approved by the Food and Drug Administration.
[Created on 8/3/2012]

Letter to the Oklahoma Board of Osteopathic Examiners Regarding the LipoTron Device (HRG Publication #2060)
Public Citizen calls upon the Oklahoma Board of Osteopathic Examiners to promptly investigate two physicians who are actively promoting and using the LipoTron medical device, which has not been cleared or approved by the Food and Drug Administration.
[Created on 8/3/2012]

Letter to the Oklahoma Board of Medical Licensure and Supervision Regarding the LipoTron Device (HRG Publication #2059)
Public Citizen calls upon the Oklahoma Board of Medical Licensure and Supervision to promptly investigate three physicians who are actively promoting and using the LipoTron medical device, which has not been cleared or approved by the Food and Drug Administration.
[Created on 8/3/2012]

Letter to the Alabama Department of Public Health Regarding the LipoTron Device (HRG Publication #2058)
Public Citizen calls upon the Alabama Department of Public Health to promptly investigate health spas that are actively promoting and using the LipoTron medical device, which has not been cleared or approved by the Food and Drug Administration.
[Created on 8/3/2012]

Letter to the Alabama Board of Medical Examiners Regarding the LipoTron Device (HRG Publication #2057)
Public Citizen calls upon the Alabama Board of Medical Examiners to promptly investigate two physicians who are actively promoting and using the LipoTron medical device, which has not been cleared or approved by the Food and Drug Administration.
[Created on 8/3/2012]

Letter to the Medical Board of California Regarding the LipoTron Device (HRG Publication #2056)
Public Citizen calls upon the Medical Board of California to promptly investigate a physician who is actively promoting and using the LipoTron medical device, which has not been cleared or approved by the Food and Drug Administration.
[Created on 8/3/2012]

Letter to the Texas Department of State Health Services regarding the LipoTron Device (HRG Publication #2055)
Public Citizen calls upon the Texas Department of State Health Services to promptly investigate several health spas that are actively promoting and using the LipoTron medical device, which has not been cleared or approved by the Food and Drug Administration.
[Created on 8/1/2012]

Letter to the Texas Medical Board regarding the LipoTron Device (HRG Publication #2054)
Public Citizen calls upon the Texas Medical Board to promptly investigate 11 physicians who are actively promoting and using the LipoTron medical device, which has not been cleared or approved by the Food and Drug Administration.
[Created on 8/1/2012]

Letter to the Arkansas Department of Health regarding the LipoTron Device (HRG Publication #2053)
Public Citizen calls upon the Arkansas Department of Health to promptly investigate several health spas that are actively promoting and using the LipoTron medical device, which has not been cleared or approved by the Food and Drug Administration.
[Created on 7/30/2012]

Letter to the Arkansas State Medical Board regarding the LipoTron Device (HRG Publication #2052)
Public Citizen calls upon the Arkansas State Medical Board to promptly investigate two physicians who are actively promoting and using the LipoTron medical device, which has not been cleared or approved by the Food and Drug Administration.
[Created on 7/30/2012]

Letter to the Michigan Department of Community Health regarding the LipoTron Device (HRG Publication #2051)
Public Citizen calls upon the Michigan Department of Community Health to promptly investigate two health spas that are actively promoting and using the LipoTron medical device, which has not been cleared or approved by the Food and Drug Administration.
[Created on 7/26/2012]

Letter to the Florida Department of Health Regarding the LipoTron Device (HRG Publication #2050)
Public Citizen calls upon the Florida Department of Health to promptly investigate four health spas that are actively promoting and using the LipoTron medical device, which has not been cleared or approved by the Food and Drug Administration.
[Created on 7/26/2012]

Letter to the Florida Board of Medicine Regarding the LipoTron Device (HRG Publication #2049)
Public Citizen calls upon the Florida Board of Medicine to promptly investigate two Florida physicians who are actively promoting and using the LipoTron medical device, which has not been cleared or approved by the Food and Drug Administration.
[Created on 7/26/2012]

Press Release: Doctors, Researchers and Health Officials Call on FDA to Change Labels on Opioid Painkillers to Deter Misprescribing (HRG Publication #2048)
Drug companies should not be permitted to advertise long-term opioids for non-cancer pain, experts say
[Created on 7/25/2012]

Follow-Up Letter to FDA Regarding LipoTron Device (HRG Publication #2047)
Public Citizen calls on the Food and Drug Administration to target Profit Solutions MD in addition to Advanced Aesthetic Concepts (AAC) for apparent illegal promotion of the unapproved LipoTron device because AAC and Profit Solutions MD are the same company. We recently recommended that the FDA immediately seize all LipoTron devices in the U.S. and order the manufacturer and its distributors to cease and desist all activities related to its distribution, sale, and promotion.
[Created on 7/23/2012]

Letter to the New Jersey State Board of Medical Examiners Regarding the LipoTron Device (HRG Publication #2046)
Public Citizen calls upon the New Jersey State Board of Medical Examiners to promptly investigate a New Jersey plastic surgeon who is actively promoting the LipoTron medical device for uses not approved by the Food and Drug Administration.
[Created on 7/23/2012]

Letter to FDA Addressing Recent Failures to Disclose New Drug Application Approval Packages in Timely Manner (HRG Publication #2045)
Public Citizen seeks a commitment from the FDA to publicly disclose new drug application (NDA) approval packages on its website within three months of approval. In recent months, the affirmative public disclosure of NDA approval packages by the FDA has either decreased or, in some cases, been greatly delayed.
[Created on 7/23/2012]

Letter to the FDA Regarding the Apparent Illegal Marketing and Promotion of the LipoTron Medical Device (HRG Publication #2044)
For several years, the Food and Drug Administration (FDA) has been aware of the apparent illegal distribution, sale, and promotion of the LipoTron medical device without the approval or clearance of the FDA.
[Created on 7/18/2012]

Statement: FDA Approval of Diet Drug Qnexa Is Reckless (HRG Publication #2043)
The U.S. Food and Drug Administration today approved Qnexa (renamed “Qsymia”), a diet pill made by Vivus, despite evidence that it poses significant risks but has little evidence of long-lasting weight loss.
[Created on 7/18/2012]

Statement: With Hundreds of Workers Dying, OSHA’s Denial of Petition for a Heat Stress Standard Is Shortsighted (HRG Publication #2042)
The Occupational Safety and Health Administration (OSHA) has denied yet another petition from Public Citizen calling for a life-saving regulation.
[Created on 7/5/2012]

Statement: GlaxoSmithKline Settlement Still Not Enough to Deter Illegal Behavior by Pharmaceutical Industry (HRG Publication #2041)
The seemingly large fines imposed on pharmaceutical companies for dangerous and illegal conduct pale in comparison to the profits generated from such activity.
[Created on 7/2/2012]

In Approving New Diet Drug, FDA Ignores Crucial Safety Data: Statement of Dr. Sidney Wolfe, Director, Public Citizen’s Health Research Group (HRG Publication #2040)
The Food and Drug Administration (FDA) today recklessly approved another diet drug, lorcaserin, the latest in a series of obesity-related pharmaceuticals that pose serious health threats.
[Created on 6/27/2012]

Letter to FDA: New reasons to reject diet drug lorcaserin (HRG Publication #2039)
Our letter urging FDA Commissioner Margaret A. Hamburg to not approve the new diet drug lorcaserin (Lorqess).
[Created on 6/26/2012]

Press Release: House and Senate Negotiators Agree on Final Legislation That Would Weaken Medical Device and Drug Safety (HRG Publication #2038)
Legislation agreed to by lawmakers from the U.S. House of Representatives and U.S. Senate bows to the powerful interests of industry by weakening medical device and prescription drug safety, Public Citizen said today. The bill could be approved by the House as soon as tomorrow. But after months of appeals to Congress identifying the dire threats to patient safety of some of the proposals in the original drafts of the bill, Public Citizen and other consumer and patient groups persuaded lawmakers to eliminate some of the most harmful provisions from the final version.
[Created on 6/19/2012]

Letter Urging Senators to Oppose Senator Coburn’s Amendment Creating Perverse Incentives for Speedier Reviews by FDA Scientific Reviewers (HRG Publication #2037)
Public Citizen urges Senators to oppose Amendment SA 2132 to the Food and Drug Administration Safety and Innovation Act (S. 3187), introduced by Senator Coburn. This amendment would weaken prescription drug and medical device safety by offering annual financial bonuses to Food and Drug Administration (FDA) scientific reviewers in exchange for speedier reviews of drugs and devices.
[Created on 5/24/2012]

Letter Urging Senators to Oppose Senator Burr’s Amendment Politicizing FDA-Industry Use-Fee Negotiations (HRG Publication #2036)
Public Citizen urges Senators to oppose Amendment SA 2130 to the Food and Drug Administration Safety and Innovation Act (S. 3187), introduced by Senator Burr. This amendment would greatly politicize the process for negotiating user-fee agreements between the Food and Drug Administration (FDA) and the drug and medical device industry, undermining the integrity of the process in ways that could threaten prescription drug and medical device safety.
[Created on 5/24/2012]

Statement and Letter from Public Citizen Supporting Sen. Bernie Sanders’ Amendment Holding Pharmaceutical Companies Accountable for Fraud (HRG Publication #2035)
Pharmaceutical Companies Must Be Held Fully Accountable for Defrauding the Government; Statement of Public Citizen’s Sammy Almashat in support of Sen. Bernie Sanders’ PDUFA amendment.
[Created on 5/22/2012]

Ranking of State Medical Boards’ Disciplinary Actions: 2009-2011 (HRG Publication #2034)
Every year, we evaluate how well each state medical board is protecting the public by disciplining doctors.
[Created on 5/17/2012]

Supplement to Petition to FDA for Tigecycline Black Box Warning (HRG Publication #2033)
Public Citizen submitted additional data supporting its October 2011 petition to the Food and Drug Administration to immediately require the addition of a black box warning to the label for tigecycline (Tygacil) indicating that the antibiotic: a) has an increased risk of death in comparison to many other antibiotics when used to treat a variety of serious infections; and b) should be used only as a last-resort antibiotic in the treatment of serious infections, and then only in combination with one or more bactericidal antibiotics.
[Created on 5/15/2012]

Statement of Dr. Michael Carome on Key House Committee to Vote on Legislation That Would Weaken Medical Device and Prescription Drug Regulations (HRG Publication #2032)
The U.S. House of Representatives Energy and Commerce Committee will meet today to deliberate and vote on legislation to renew and expand the FDA user-fee programs that bows to the powerful interests of industry by weakening medical device and prescription drug safety.
[Created on 5/10/2012]

Letter to House Energy and Commerce Committee Expressing Serious Concerns Regarding Legislation Renewing FDA User-Fee Programs (HRG Publication #2031)
Public Citizen offers the following comments regarding the expansion of the Food and Drug Administration’s (FDA’s) user-fee programs for prescription drugs and medical devices.
[Created on 5/9/2012]

Testimony on Rilonacept (ARCALYST) to the FDA’s Arthritis Advisory Committee (HRG Publication #2030)
Public Citizen strongly opposes the FDA’s approval of rilonacept for the prevention of gout flares because the drug provides no unique advantages over current treatment options and has known risks of serious infections and signals related to malignancies and adverse cardiovascular events.
[Created on 5/8/2012]

Medical Device Industry at a Crossroads: Will Industry Profits Trump Patient Safety? (HRG Publication #2029)
This spring, Congress is considering sweeping changes to the way the medical device industry is overseen. But instead of considering improvements to device safety, more often than not, lawmakers have endorsed industry-backed changes that could lead to more dangerous devices being given to patients, and therefore, more injuries and deaths.
[Created on 5/7/2012]

Public Citizen Comment on Corrective Ad Study (HRG Publication #2028)
Public Citizen comments on a notice by the Food and Drug Administration describing research on corrective advertising. Public Citizen has concerns that the study described in this notice would fail to provide useful information to policymakers, and proposes an alternative study design.
[Created on 4/27/2012]

Letter to the FDA opposing approval of the drug mirabegron (HRG Publication #2027)
Public Citizen strongly opposes Food and Drug Administration (FDA) approval of the new drug application for mirabegron — submitted by Astellas Pharma Global Development and considered by the FDA’s Advisory Committee for Reproductive Health Drugs on April 5, 2012 — because (1) the drug is not a major breakthrough treatment, has no unique advantages over current treatment options, and offers only marginal symptomatic benefits for overactive bladder, a disorder that is not life-threatening; and (2) there are serious safety signals indicating risk of potentially life-threatening harm to patients.
[Created on 4/27/2012]

Statement of Dr. Sammy Almashat: Shame on Obama Administration for Sacrificing Children to Keep Agribusiness Happy (HRG Publication #2026)
The Obama administration on Thursday once again sided with industry instead of workers on regulations and withdrew the Department of Labor’s (DOL) proposed rules that would have restricted child workers from the most dangerous tasks in agriculture.
[Created on 4/27/2012]

Comments on FDA Guidance on Substantial Equivalence (HRG Publication #2025)
Public Citizen opposes the FDA’s draft guidance on evaluating substantial equivalence of medical devices reviewed under the 510(k) premarket notification process because it would perpetuate the agency’s long-standing, overly permissive interpretations of substantial equivalence. Such interpretations have allowed the agency to clear many novel moderate- to high-risk devices that differ significantly from their already-marketed predicate devices without such new devices undergoing the appropriate clinical testing.
[Created on 4/26/2012]

Letter of support for Senator Sanders’ PDUFA amendment on pharmaceutical fraud (HRG Publication #2024)
We support Senator Sanders’ first amendment to the Prescription Drug User Fee Act (PDUFA) package concerning pharmaceutical fraud (Sanders/Amendment #1). The amendment would rescind exclusivity rights granted under the federal Food, Drug, and Cosmetic Act (FD&C Act) for any future pharmaceutical product, if the company marketing the product has been found, or admits to, engaging in unlawful activity involving the drug.
[Created on 4/24/2012]

Letter to Senate HELP Committee Expressing Serious Concerns Regarding the Proposed Food and Drug Administration Safety and Innovation Act (HRG Publication #2023)
Public Citizen has serious concerns about some of the provisions in the April 23 Manager’s Amendment of the Food and Drug Administration Safety and Innovation Act, which will be considered by the Senate Committee on Health, Education, Labor, and Pensions (HELP Committee) when it convenes in executive session on April 25.
[Created on 4/24/2012]

Letter to Senate HELP Committee Opposing the PATIENTS’ FDA Act (HRG Publication #2022)
Public Citizen strongly opposes the Promoting Accountability, Transparency, Innovation, Efficiency, and Timeliness at the FDA Act of 2012 (the PATIENTS’ FDA Act), drafted by Senators Richard Burr and Tom Coburn, because the bill would substantially weaken the Food and Drug Administration’s (FDA’s) regulatory oversight of medical products — particularly those related to medical devices — and thus poses a significant threat to the health and lives of patients.
[Created on 4/23/2012]

Statement of Sammy Almashat at The National Press Club Regarding Child Labor on Farms in the U.S. (HRG Publication #2021)
On American farms children as young as 12 can be hired to perform dangerous work. Their bodies are structured fundamentally differently, leaving them uniquely vulnerable to a number of different hazards, many of which go unnoticed by the employer, the child, and parent alike resulting in one of the highest child mortality rates of any industry.
[Created on 4/19/2012]

Petition to Ban Diabetes Drug Liraglutide (Victoza) (HRG Publication #2020)
Public Citizen petitions the Food and Drug Administration (FDA) to immediately remove from the market the diabetes drug liraglutide (Victoza; Novo Nordisk) because the known increased risks of thyroid cancer and pancreatitis outweigh any documented clinical benefits.
[Created on 4/19/2012]

Letter to the House Subcommittee on Health of the Committee on Energy and Commerce Opposing Legislation Proposing to Amend the Food, Drug and Cosmetic Act (HRG Publication #2019)
Public Citizen strongly opposes the Subcommittee on Health’s draft legislation proposing to renew the Food and Drug Administration’s (FDA’s) user fee program and to make other amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) regarding the regulation of medical devices and drugs.
[Created on 4/17/2012]

Letter to the FDA Opposing Resumption of Clinical Trials Testing Anti-Nerve Growth Factor Drugs (HRG Publication #2018)
The Food and Drug Administration (FDA) should reject the recommendation of the Arthritis Advisory Committee to resume clinical development of anti-nerve growth factor drugs for management of chronic pain. Further human studies of these drugs would be unethical and not approvable under FDA regulations for the protection of human subjects because the risks outweigh the potential benefits to subjects and the importance of the knowledge that is expected to result.
[Created on 4/16/2012]

Letter to the Senate HELP Committee Opposing Draft Legislation Proposing Incentives for Antibiotic Development (HRG Publication #2017)
Public Citizen comments on the March 29 discussion draft of legislation amending the Federal Food, Drug, and Cosmetic Act to incentivize new antibiotic development that was prepared by the Senate Committee on Health, Education, Labor, and Pensions that would provide drug companies with large financial incentives to develop new antibiotics and mandate that the Food and Drug Administration (FDA) review these drugs more rapidly.
[Created on 4/9/2012]

Statement of Dr. Michael Carome on Sheridan Hospital’s Response in Wake of Public Disclosure of Inadequate Sterilization of Surgical Equipment (HRG Publication #2016)
Public Citizen prompts Wyoming hospital to act responsibly in responding to patient exposures to inadequately sterilized equipment.
[Created on 4/5/2012]

Comments Submitted to the Centers for Medicare and Medicaid Services (CMS) Regarding the Emergency Medical Treatment and Active Labor Act (EMTALA) (HRG Publication #2015)
Public Citizen and the National Women’s Health Network (NWHN) submitted comments to CMS asserting that EMTALA requires hospitals with specialized capabilities to accept an appropriate transfer of a patient with an emergency medical condition who has already been admitted as an inpatient to another hospital. Public Citizen and the NWHN urged CMS to issue regulations implementing this requirement.
[Created on 4/3/2012]

Recommendations on the Senate HELP Committee Draft Medical Device Bill (HRG Publication #2014)
Public Citizen comments on the March 16 discussion draft of medical device policy legislation prepared by the Senate Committee on Health, Education, Labor, and Pensions (the HELP Committee) concerning a number of provisions in the discussion draft legislation to amend the Federal Food, Drug, and Cosmetic Act (FDCA).
[Created on 4/2/2012]

Comments on National Practitioner Data Bank (NPDB) NPRM, Feb. 15, 2012, Federal Register/Vol. 77, No. 31, pages 9138-9161 (HRG Publication #2013)
Public Citizen provided comments on a Feb. 15, 2012, Federal Register Notice of Proposed Rulemaking that addressed over-lap between the National Practitioner Data Bank (NPDB) and the HealthCare Integrity and Protection Data Bank. Our comments recommended that the Department of Health & Human Services (HHS) require Medicare Quality Improvement Organizations to report to the NPDB. We also recommended that HHS expand the definition of a “reportable event” so that more adverse actions by medical boards and health care organizations would be submitted to the NPDB.
[Created on 3/29/2012]

Testimony Before FDA Endocrinologic and Metabolic Drugs Advisory Committee Meeting on Cardiovascular Risk Assessment of Obesity Drugs (HRG Publication #2012)
A dangerously low approval standard for diet drugs has created a history of recalls, injuries, and needless deaths.
[Created on 3/29/2012]

Testimony to the FDA’s Neurological Devices Panel of the Medical Devices Advisory Committee Regarding the Wingspan Stent System (HRG Publication #2011)
An NIH-funded study of the Wingspan Stent System conclusively demonstrated that treatment of high-risk patients with intracranial artery stenosis with the Wingspan Stent System plus aggressive medical therapy causes significantly more harm and is no more effective in comparison to aggressive medical treatment alone. Therefore, the criteria for withdrawal of humanitarian device exemption approval under FDA regulations have been met for this device..
[Created on 3/23/2012]

Letter to Sheridan Memorial Hospital (HRG Publication #2010)
Our letter to Sheridan Memorial Hospital (SMH) regarding the inaccurate and misleading public statements issued by the hospital following the public disclosure of SMH’s failure to properly sterilize or disinfect reusable laryngeal mask airways between uses in patients undergoing surgery. This SMH failure was characterized by the Wyoming Department of Health as “an immediate jeopardy situation.”
[Created on 3/20/2012]

Letter to the Editor of the Casper Star-Tribune Regarding Sheridan Memorial Hospital and the Wyoming Department of Health (HRG Publication #2009)
In a letter to the editor of the Casper Star-Tribune, Public Citizen responded to the March 14 article, “Report shows Sheridan hospital failed to sterilize equipment last year.” Claims by Sheridan Memorial Hospital and the Wyoming Department of Health that there have been no infections or complications reported in relation to the hospital’s failure to adequately sterilize the laryngeal airway masks between surgical patient uses is ludicrous for two reasons.
[Created on 3/16/2012]

Letter to Wyoming Department of Health Regarding Sheridan Memorial Hospital (HRG Publication #2008)
Public Citizen recently learned from an internal hospital memo and other sources of information that in a November 2011 inspection at Wyoming’s Sheridan Memorial Hospital in Sheridan, the Wyoming Department of Health discovered that the hospital was no longer properly sterilizing or disinfecting reusable laryngeal mask airways (LMAs) between uses in patients undergoing surgery. As a result, several hundred patients undergoing surgery at a Wyoming hospital may have been exposed to a variety of infectious viral and bacterial agents over a period of several months.
[Created on 3/13/2012]

Testimony to the FDA’s Arthritis Advisory Committee on Safety Issues Related to Anti-Nerve Growth Factor Agents (HRG Publication #2007)
We strongly urge the Food and Drug Administration (FDA) to permanently suspend the clinical development of these anti-nerve growth factor (anti-NGF) agents for the treatment of pain because of the dramatic safety signal seen in clinical studies of these agents demonstrating an unusually high incidence of rapid joint destruction.
[Created on 3/12/2012]

Substantially Unsafe: Medical Devices Pose Great Threat to Patients; Safeguards Must be Strengthened, Not Weakened (HRG Publication #2006)
The medical device industry is engaging in a massive lobbying effort designed to weaken already lax oversight and speed already quick review of its high-risk products, a new Public Citizen study finds.
[Created on 2/15/2012]

Letter to OHRP Regarding Testing the Drug Canakinumab in Diabetic Children Without Adequate Informed Consent/Parental Permission (HRG Publication #2005)
In a follow-up letter to the Office for Human Research Protections regarding a clinical study testing the drug canakinumab in children with type I diabetes, Public Citizen reported that its review of the research protocol and informed consent document for this study reaffirms and provides evidence for Public Citizen’s initial allegation that this research was not conducted in compliance with the requirements of HHS human subjects protection. Furthermore, Public Citizen’s review of the sample informed consent/parental permission form for the study reveals that the description of the risks and benefits of the research failed to satisfy the requirements of HHS regulations regarding informed consent for research.
[Created on 2/28/2012]

Letter to CMS and OHRP Opposing Proposal to Require Medicare Beneficiaries Undergoing an Aortic Valve Replacement Procedure to Participate in Research Without Their Informed Consent (HRG Publication #2004)
In a letter to the Centers for Medicare and Medicaid Services (CMS) and the Office for Human Research Protections, Public Citizen objected to CMS’s proposal to require Medicare patients to participate in research as a condition of coverage for transcatheter aortic valve replacement because the policy as proposed fails to comply with the requirements for obtaining informed consent for research.
[Created on 2/28/2012]

Letter to the FDA Opposing Reclassification of Cranial Electrotherapy Stimulator Devices (HRG Publication #2003)
In a letter to the Food and Drug Administration, Public Citizen opposed the reclassification of cranial electrotherapy stimulator devices—which are indicated for the treatment of depression, anxiety, and insomnia—from the high-risk class III category to the moderate-risk class II category.
[Created on 2/28/2012]

Comments to FDA on Direct-to-Consumer Drug Advertisements (HRG Publication #2002)
Direct-to-consumer advertising should be carefully regulated and required to include clear, specific, and easy-to-understand audio and visual explanations of the product’s risks and benefits, along with the risks and benefits of alternative therapies. A recent FDA-funded study on distraction in direct-to-consumer drug advertising was not well-designed to detect the effects of distraction on consumer comprehension of risks, and cannot be used as a guide for policymaking.
[Created on 2/27/2012]

Testimony Before FDA Endocrinologic and Metabolic Drugs Advisory Committee Meeting on Qnexa (HRG Publication #2001)
The new weight loss drug combination phentermine and topiramate (Qnexa) causes serious adverse events and should again be rejected by the FDA.
[Created on 2/22/2012]

Statement to the Subcommittee on Health of the House Energy and Commerce Committee Advocating for Legislation to Improve Medical Device Safety (HRG Publication #2000)
Public Citizen’s Health Research Group urges Subcommittee on Health of the House Energy and Commerce Committee members to support bills such as H.R. 3847, the Safety of Untested and New Devices Act (the SOUND Devices Act) of 2012, that would improve patient safety — rather than threaten it.
[Created on 2/15/2012]

Letter to Medicare and Medicaid on Wingspan Stent System (HRG Publication #1999)
Public Citizen urges the Centers for Medicare and Medicaid Services to withdraw coverage for the Wingspan Stent System and similar systems, because new data reveals that these systems provide no benefits and dramatically increase the risk of stroke or death.
[Created on 2/14/2012]

Letter to FDA on Wingspan Stent System (HRG Publication #1998)
Public Citizen states that FDA should not categorize future investigations using the Wingspan Stent System or similar systems as Category B, because it is a class III device and underlying questions of safety and effectiveness have not been resolved.
[Created on 2/14/2012]

Letter to FDA Opposing Approval of Loxapine Inhalation Powder (Adasuve) (HRG Publication #1997)
Public Citizen’s Health Research Group strongly opposes FDA approval of loxapine (Adasuve) inhalation powder for treatment of schizophrenia or bipolar I disorder in adults due to no evidence from clinical trials that it offers any benefits over currently-available treatments and that it can cause life-threatening pulmonary toxicity.
[Created on 1/23/2012]

Letter to FDA Opposing Premarket Approval Application for the CardioMEMS Champion Heart Failure Monitoring System (HRG Publication #1996)
Comments from the Health Research Group at Public Citizen submitted in follow-up to our testimony presented at the December 8, 2011 meeting of the Food and Drug Administration’s (FDA’s) Circulatory System Devices Panel of the Medical Devices Advisory Committee regarding Premarket Approval (PMA) application for the CardioMEMS Champion Heart Failure Monitoring System (the CardioMEMS System).
[Created on 1/19/2012]

Public Citizen Comment on External Pacemaker Reclassification (HRG Publication #1995)
Public Citizen strongly urges the Food and Drug Administration (FDA) to withdraw its proposed rule to reclassify the external pacemaker pulse generator preamendment Class III device arbitrarily to Class II (special controls) and to publish a new notice immediately that proposes a final regulation requiring the device to remain in Class III, and requiring premarket approval applications for new external pacemaker pulse generators.
[Created on 1/17/2012]

Supplement to Petition to FDA to Withdraw Approval of Wingspan Stent System (HRG Publication #1994)
Public Citizen wishes to supplement its December 21, 2011 petition to the Food and Drug Administration (FDA).
[Created on 1/12/2012]

Letter Regarding FDA’s Unreasonable Delay in Fining Red Cross for Blood Banking Violations (HRG Publication #1993)
The Food and Drug Administration (FDA) should immediately impose a nearly $10 million fine on the American Red Cross because of hundreds of violations the agency found in a 2010 inspection of a donor support center in Philadelphia, Public Citizen said in a letter sent to Health and Human Services Secretary Kathleen Sebelius.
[Created on 1/6/2012]

2011

Petition to FDA to Withdraw Approval of Wingspan Stent System (HRG Publication #1992)
The Food and Drug Administration (FDA) should immediately withdraw its approval of a medical device that is supposed to prevent strokes in people who already have had one because a recent study found that the device actually increases the risk of subsequent strokes and death.
[Created on 12/21/2011]

Supplement to Petition to Ban Bedside Assistant Bed Handles and Similar Medical Devices (HRG Publication #1991)
Our recent review of the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database revealed a September 13, 2011 report of a patient who died from strangulation and suffocation on February 5, 2011, after becoming entrapped by a Home Bed Assist Rail, model number 15064, manufactured by Drive.
[Created on 12/13/2011]

Letter in Science – Rethinking Clinical Trials: Phase 1 Studies Insufficient (HRG Publication #1990)
In his editorial “Rethinking Clinical Trails”, A. Grove proposes returning to the dangerous era before the enactment of the 1938 Federal Food, Drug, and Cosmetic Act, when new drugs were marketed in the United States without evidence that they were safe or effective.
[Created on 12/9/2011]

Testimony on Ethinyl Estradiol/Norelgestromin (Ortho-Evra) (HRG Publication #1989)
If the Ortha Evra patch has no unique benefits and, relative to equally effective oral contraceptives with lower estrogen doses, has a higher risk of blood clots, there is no reason to leave it on the market. Although prescriptions have dropped markedly in the past seven years, more than a million prescriptions a year are still filled for the patch. Women using these prescriptions are at increased risk with no significant, documented benefit.
[Created on 12/9/2011]

Testimony to FDA on CardioMEMS Champion HF Monitoring System (HRG Publication #1988)
Public Citizen strongly recommends that the FDA, in order to protect public health, not approve the premarket approval (PMA) application for the CardioMEMS System.
[Created on 12/8/2011]

Removal of Consumer Advocate From Dec. 8 Advisory Committee Meeting Is Bad Policy (HRG Publication #1987)
This morning, less than 48 hours from the beginning of Thursday’s Food and Drug Administration (FDA) advisory committee meeting to discuss the risks of blood clots from the birth control pills Yaz and Yasmin, Health Research Group director Dr. Sidney Wolfe was notified in a phone call from FDA’s Office of Advisors and Consultants that he could not participate as a member of the Drug Safety and Risk Management Advisory Committee in that meeting because of what the agency calls his “intellectual conflict of interest.”
[Created on 12/6/2011]

Comments on Proposed Rule on Agricultural Child-Labor Regulations (HRG Publication #1986)
Public Citizen is requesting that the Department of Labor institute protections against extreme heat exposure for all child farmworkers under the age of 16.
[Created on 12/1/2011]

Statement: FDA’s Rejection of Public Citizen’s Petition to Ban Rosiglitazone (Avandia) Translates to More Harm to Patients (HRG Publication #1985)
Late yesterday, the FDA faxed Public Citizen its letter rejecting our October 30, 2008 petition in which we asked the FDA to ban rosiglitazone (Avandia) because its benefits were greatly outweighed by its multiple risks, including increased heart attacks, heart failure, fractures, vision-threatening macular edema and other serious problems.
[Created on 11/22/2011]

Statement: Restoration of Doctor Discipline Database Excludes Some Reporters (HRG Publication #1984)
For users of these data such as Public Citizen, academic researchers and journalists, the restoration of the National Practitioner Data Bank’s Public Use File is an important step in the right direction since the file has been down for more than two months. The downside, however, is that as a new condition of obtaining the data, users will have to agree not to use this entirely confidential information (not identifying any physician by name) in combination with publicly available information to identify and develop extended profiles on specific doctors.
[Created on 11/9/2011]

Letter Opposing Draft Guidance Regarding Use of Exculpatory Language in Informed Consent for Research (HRG Publication #1983)
Public Citizen strongly opposes the proposed draft guidance on exculpatory language in informed consent because, contrary to the Federal Register notice announcing the availability of this draft guidance document for comment (76 FR 55390) – which states that the Office for Human Research Protections and the Food and Drug Administration are seeking to “enhance human subjects protection” by “actively working to harmonize the agencies’ regulatory requirements and guidance for human subjects research” – the proposed guidance would weaken protections for human subjects.
[Created on 11/7/2011]

Testimony Against the Removal of National Practitioner Data Bank (NPDB) Public Use Data File (HRG Publication #1982)
On September 1, 2011, the Department of Health and Human Services unwisely decided to remove the NPDB Public Use Data File from the Internet because of a complaint by a physician in Kansas that an investigation by a local reporter, combining publicly available information about the Kansas physician with unidentifiable information from the NPDB, had made it possible to provide a more complete summary of actions taken involving the physician.
[Created on 11/3/2011]

Letter Responding to OSHA’s Denial of Resident Work Hours Petition (HRG Publication #1981)
OSHA has opted out of its legal obligation to protect residents from excessive work hours, deferring instead to a largely unaccountable private entity, the Accreditation Council for Graduate Medical Education.
[Created on 11/3/2011]

Letter Opposing Senate Bill S. 1700 (HRG Publication #1980)
Public Citizen strongly opposes Senate Bill S. 1700, the Medical Device Regulatory Improvement Act, because, contrary to the bill’s title, the proposed amendments to the Federal Food, Drug, and Cosmetic Act would weaken the already inadequate regulatory requirements for medical devices approved under the premarket approval process or cleared under the 510(k) premarket clearance process.
[Created on 11/1/2011]

Letter Opposing Unethical Anthrax Vaccine Studies on Children (HRG Publication #1979)
Public Citizen urges you to reject the National Biodefense Science Board’s recommendation to conduct pre-event clinical trials of the anthrax vaccine in children. Such trials would be unethical and are prohibited under the Department of Health and Human Services and Food and Drug Administration regulations for the protection of human subjects.
[Created on 11/1/2011]

Comments on Proposals to Revise the Regulations for Protecting Human Research Subjects (HRG Publication #1978)
Public Citizen’s comments in response to Advance Notice of Proposed Rulemaking (ANPRM) – Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators (Docket number HHS-OPHS-2011-0005).
[Created on 10/26/2011]

Petition Requesting Black Box Warning on Tigecycline (Tygacil) (HRG Publication #1977)
Public Citizen petitions the Food and Drug Administration to immediately require the addition of a black box warning to the label for tigecycline (Tygacil) indicating that the antibiotic: a) has an increased risk of death in comparison to many other antibiotics when used to treat a variety of serious infections; and b) should be used only as a last-resort antibiotic in the treatment of serious infections, and then only in combination with one or more bactericidal antibiotics.
[Created on 10/26/2011]

Letter to HHS and Department of Defense Urging Investigation Into Procedures Leading to Blood Platelet Transfusion Deaths (HRG Publication #1976)
The purpose of this letter is to urge an immediate external investigation in order to stop unequivocally dangerous procedures at the Bethesda National Naval Medical Center (NNMC), now the Walter Reed National Military Medical Center, and possible problems at the National Institutes of Health (NIH) that have resulted in the recent deaths (in August and September) of two NIH patients because they were given transfusions of blood platelets (blood cells that help to stop bleeding) previously determined and labeled by the NNMC blood bank to be infected with bacteria.
[Created on 10/25/2011]

Letter to FDA Urging Rejection of Florbetapir F18 Injection (Amyvid) Based on Newly Published Expert Analysis (HRG Publication #1975)
[Created on 10/21/2011]

Letter to FDA Opposing Approval of Rivaroxaban (Xarelto) for Anticoagulation Therapy in Patients With Atrial Fibrillation (HRG Publication #1974)
We strongly oppose FDA approval of Johnson & Johnson’s NDA for rivaroxaban for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, a condition for which two proven therapies already exist.
[Created on 10/20/2011]

Letter to FDA Opposing Approval of Deferiprone (HRG Publication #1973)
We strongly oppose FDA approval of ApoPharma’s NDA for deferiprone for treatment of patients with transfusional iron overload when current chelation therapy is inadequate because the data presented by the sponsor in support of the NDA were grossly insufficient and fail to demonstrate that deferiprone is safe and effective in the intended patient population (i.e., any patient with transfusional iron overload), even under the standards permitted under FDA regulations at 21 C.F.R. Part 314, Subpart H (“Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses”).
[Created on 10/12/2011]

Public Citizen poses serious concerns to the FDA about the testing of liraglutide in children (HRG Publication #1972)
Public Citizen believes that the required pediatric studies for Novo Nordisk’s new drug liraglutide (Victoza) are unethical and fail to satisfy the requirements of the FDA regulations for pediatric testing.
[Created on 9/15/2011]

Letter Regarding NPDB Public Use File Availability (HRG Publication #1971)
Public Citizen is quite concerned that the Health Resources and Services Administration (HRSA) recently removed the National Practitioner Data Bank (NPDB) Public Use Data File from the NPDB’s website.
[Created on 9/13/2011]

Testimony Regarding Bisphosphonates (HRG Publication #1970)
We urge the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee to recommend the following to the Food and Drug Administration (FDA): 1) long-term use of bisphosphonates for the prevention of osteoporotic fractures must be limited to 5 years, and 2) the indication for bisphosphonate treatment for osteopenic women must be removed, unless the patient has a significant 10-year fracture risk as determined by the World Health Organization’s (WHO) FRAX algorithm.
[Created on 9/9/2011]

Testimony on Non-Absorbable Synthetic Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse (HRG Publication #1969)
We endorse the FDA’s belated proposal to reclassify non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of POP to class III and require PMA evaluations, but this action alone is insufficient. To properly protect the public health, the FDA also must immediately (1) ban all such mesh products currently available, and (2) require manufactures to recall these dangerous and ineffective devices. A grace period allowing continued marketing of these devices would recklessly endanger women. Further clinical trials with current devices, as requested by the FDA, would be highly unethical.
[Created on 9/8/2011]

Statement: Medical Schools Provide Their Students With Inadequate Coverage for Mental Health and Substance Abuse Treatment (HRG Publication #1968)
Public Citizen strongly endorses the recommendation by the authors of the JAMA study that U.S. medical schools move immediately to improve student insurance coverage for mental health and substance abuse disorders.
[Created on 9/2/2011]

Comments Regarding the IOM’s Report, Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years (HRG Publication #1967)
Public Citizen’s Health Research Group completely agrees with the main conclusion of the Institute of Medicine’s (IOM) Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process (the committee) that the Food and Drug Administration (FDA) 510(k) process for clearing medical devices is broken and cannot be fixed.
[Created on 9/2/2011]

Petition for a Heat Standard (HRG Publication #1966)
Public Citizen petitions the Occupational Safety and Health Administration (OSHA), pursuant to section 6(c) of the Occupational Safety and Health Act, 29 U.S.C. § 655(c), to issue an Emergency Temporary Standard (ETS) for a heat stress threshold that will protect workers from suffering unnecessary and entirely preventable health effects, including death, from excessive indoor and outdoor heat exposure. We are also requesting that OSHA immediately initiate the usual rulemaking process for a permanent heat stress standard, pursuant to 29 U.S.C. § 655(b) that would include the heat threshold above, in addition to multiple other proven protective measures from extreme heat.
[Created on 9/1/2011]

Food and Drug Administration Petition on Generic Drug Labeling (HRG Publication #1965)
Public Citizen requests that the FDA authorize generic drug manufacturers to revise generic drug labeling through the changes-being-effected (CBE) and prior-approval-supplement (PAS) procedures.
[Created on 8/29/2011]

Petition Urging FDA to Add Warnings to Proton Pump Inhibitors (HRG Publication #1964)
Public Citizen petitions the FDA to immediately add black box warnings and other safety information concerning several severe risks to the product labels of all proton pump inhibitors (PPIs) presently on the market in the U.S. In addition, the serious nature of so many of these adverse reactions also mandates the requirement for FDA-approved patient Medication Guides, none of which exist now, for all of these drugs.
[Created on 8/23/2011]

Petition to Ban Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse (HRG Publication #1963)
Public Citizen petitions the FDA to ban the marketing of all currently available non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of pelvic organ prolapse (POP), order all manufacturers of these devices to recall these products and require that any non-absorbable surgical mesh product specifically designed and labeled for transvaginal repair of POP that is proposed for marketing in the future be classified as a class III device and be approved for marketing only under a premarket approval application that includes data from well-designed, prospective clinical trials that provide a reasonable assurance that the surgical mesh product is safe and effective.
[Created on 8/25/2011]

Letter Regarding Performance of Medical Board of California (HRG Publication #1962)
Public Citizen is very concerned that 1) the Medical Board of California has failed to take any disciplinary action against 710 physicians who have been disciplined by hospital or other peer review; 2) there has been a significant decline in the Medical Board’s rate of serious discipline of physicians, as determined by Public Citizen’s annual ranking of medical boards; and 3) significant recommendations, including recommendations to give priority to such peer review actions against doctors, from the Enforcement Monitor’s 2005 final report remain unimplemented.
[Created on 8/9/2011]

Comments to CMS Regarding End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP) for Payment Years (PY) 2013 and 2014: Provisions for Assessing the Quality of Anemia Management with Erythropoiesis-Stimulating Agents (ESAs) (HRG Publication #1961)
Public Citizen’s Health Research Group has comments regarding the provisions of the proposed rule referenced above that relate to assessing the quality of anemia management with ESAs in chronic kidney disease patients on dialysis.
[Created on 8/1/2011]

Statement on IOM Report on 510(k) Clearance Process (HRG Publication #1960)
Public Citizen applauds the critically important July 29, 2011, report of the Institute of Medicine’s Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, which concluded that the FDA’s 510(k) process for clearing medical devices is broken and cannot be fixed.
[Created on 7/29/2011]

Letter Requesting Extension of ANPRM Comment Period (HRG Publication #1959)
Regarding the Advance Notice of Proposed Rulemaking (ANPRM) on HHS-OPHS-2011-0005 (Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators), we call upon HHS to promptly issue an amended ANPRM that extends the comment period from 60 days to a minimum of 120 days.
[Created on 7/26/2011]

Petition Requesting Warnings on the Labels of Glucocorticosteroids (HRG Publication #1958)
The FDA should immediately require that the labels for all brands of prednisone and other glucocorticosteroids currently on the market in the U.S. be revised to include central serous chorioretinopathy as one of the ophthalmic adverse reactions reported with these medications if not already included. The FDA should also ensure that other important information regarding the use and safety of these medications is presented in a consistent manner across all labels.
[Created on 7/26/2011]

Testimony on Dapagliflozin (HRG Publication #1957)
A drug proposed to treat patients with diabetes should not be approved because it has serious risks and no evidence of clinical benefit.
[Created on 7/19/2011]

Letter to OHRP Regarding Canakinumab (Ilaris) (HRG Publication #1956)
We hereby request that the Office for Human Research Protections (OHRP) promptly conduct a compliance oversight investigation of an ongoing research study that is entirely supported by the Department of Health and Human Services (HHS).
[Created on 7/19/2011]

Follow-Up Letter to FDA Regarding Canakinumab (Ilaris) (HRG Publication #1955)
These comments from the Public Citizen Health Research Group (HRG) are being submitted to follow up on our testimony presented at the June 21, 2011 meeting of the Food and Drug Administration’s (FDA) Arthritis Advisory Committee (AAC) regarding the supplemental Biologics License Application (sBLA) #125319 for the drug canakinumab (Ilaris).
[Created on 7/19/2011]

Press Release: OSHA Drags Its Feet on Study Regarding Workers’ Exposure to Toxic Substance (HRG Publication #1954)
The release of the Occupational Health and Safety Administration’s (OSHA) regulatory agenda today reveals that the agency has failed to take any concrete steps since last year on limiting workers’ exposure to the toxic substance beryllium and has no plans to do so anytime soon.
[Created on 7/7/2011]

Follow-up Letter to CMS Regarding Erythropoiesis-Stimulating Agents (ESAs) in Chronic Kidney Disease (CKD) Patients (HRG Publication #1953)
It is imperative that the Center for Medicare & Medicaid Services (CMS) follow the Food and Drug Administration’s (FDA) lead and issue a national coverage decision for ESAs that fully aligns with FDA’s new, more conservative recommendations regarding the dosing of ESAs and the upper limit of target hemoglobin levels in patients with chronic kidney disease.
[Created on 6/22/2011]

FDA Should Have Advised Women Against Getting Silicone Breast Implants for Cosmetic Reasons (HRG Publication #1952)
The Food and Drug Administration’s (FDA) update today stating that although silicone breast implants have “a reasonable assurance of safety … the longer a woman has breast implants, the more likely she is to experience local complications or adverse outcomes,” is unquestionably shortsighted as well as contradictory.
[Created on 6/22/2011]

Testimony on Ilaris (Canakinumab) (HRG Publication #1951)
We oppose the Food and Drug Administration’s (FDA) approval of canakinumab, a potent immunosuppressant agent, for the treatment of patients with gouty arthritis attacks because the drug has serious, life-threatening risks that far outweigh the drug’s clinical benefits, which are limited primarily to relief of pain from acute gout flares in this patient population.
[Created on 6/21/2011]

Petition to Ban 23 Milligram Dose of Donepezil (Aricept) (HRG Publication #1950)
The 23 milligram dose of donepezil (Aricept), which is used to treat moderate or severe cases of Alzheimer’s disease, should be removed from the market immediately because of its risk of serious adverse effects and its lack of effectiveness.
[Created on 5/18/2011]

Ranking of the Rate of State Medical Boards’ Serious Disciplinary Actions, 2008-2010 (HRG Publication #1949)
[Created on 5/12/2011]

Public Citizen Exposes Serious Omissions in Published Study of Experimental Procedure for Diagnosing Alzheimer’s Disease (HRG Publication #1948)
In a letter published today in the Journal of the American Medical Association (JAMA), Public Citizen criticized the authors of a study in the January 19, 2011 issue of the journal who tested the effectiveness of brain scans using an experimental dye for detecting brain abnormalities found in patients with Alzheimer’s disease. The authors withheld critically important data from the Journal when documenting the extent to which interpretation of these scans varies from one physician to another, Public Citizen said.
[Created on 5/10/2011]

Petition to Ban Bedside Assistant Bed Handles, Model Numbers BA10W and BA10W-6, Manufactured by Bed Handles, Inc. (HRG Publication #1947)
Public Citizen petitions the Food and Drug Administration (FDA) to immediately ban the marketing of Bedside Assistant® bed handles, model numbers BA10W and BA10W-6, manufactured by Bed Handles, Inc., because these devices have directly caused the deaths of at least four adult patients through entrapment and subsequent strangulation or positional asphyxia and therefore present “an unreasonable and substantial risk of illness or injury,” the standard for the FDA to institute proceedings to ban a device under the device law.
[Created on 5/4/2011]

Letter to HHS Regarding OHRP Failure to Investigate Unethical Placebo-Controlled Trials of Indacaterol Maleate (Arcapta Neohaler) (HRG Publication #1946)
The Public Citizen Health Research Group urges the Department of Health and Human Services (HHS) to direct the Office for Human Research Protections (OHRP) to assert its leadership and regulatory authority by opening a compliance oversight evaluation of a series of unethical, placebo-controlled clinical trials testing the experimental drug indacaterol in human subjects with moderate to severe chronic obstructive pulmonary disease; or alternatively, refer the matter to another independent entity, such as the HHS Office of the Inspector General, to evaluate the matter.
[Created on 4/28/2011]

Petition to FDA to Ban Powdered and Latex Surgeon’s and Patient Examination Gloves (HRG Publication #1945)
Public Citizen petitions the Food and Drug Administration (FDA) to immediately (a) ban the use of cornstarch powder on all surgeon’s and patient examination gloves, and (b) ban the use of all natural latex rubber surgeon’s and patient examination gloves, because of the serious threat posed by these products to patients and healthcare workers and the ready availability of widely used safer alternatives (i.e., powder-free synthetic gloves).
[Created on 4/25/2011]

Researching the Backgrounds of Health Professionals (HRG Publication #1944)
Dr. Wolfe advises members of the Association of Health Care Journalists on how to research the backgrounds of health professionals.
[Created on 4/16/2011]

Letter to CMS Opposing Proposal Not to Issue a National Coverage Decision Regarding Erythropoiesis Stimulating Agents (ESAs) (HRG Publication #1943)
We strongly oppose the proposal that the Center for Medicare and Medicaid Services (CMS) not issue a national coverage determination at this time for Erythropoiesis Stimulating Agents (ESAs) for treatment of anemia regarding ESAs for the treatment of anemia in adults with chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.
[Created on 4/15/2011]

Petition to Ban Orlistat (Alli, Xenical) (HRG Publication #1942)
Public Citizen petitions the Food and Drug Administration (FDA) to immediately ban both the prescription drug, Xenical (orlistat; Hoffman-La Roche), and the over-the-counter (OTC) drug, Alli (orlistat; GlaxoSmithKline), because they expose patients to serious risks that greatly outweigh their minimal clinical benefits.
[Created on 4/14/2011]

Testimony on Disciplinary Actions by the New Jersey Board of Medical Examiners (HRG Publication #1941)
Dr. Wolfe discusses the board’s failure to discipline 183 doctors who had serious admitting privilege actions taken against them by hospitals, the performance of the board for the past 20 years and what the board can do to improve its performance.
[Created on 4/11/2011]

Comments on FDA Medical Device Innovation Initiative (HRG Publication #1940)
We caution the Food and Drug Administration (FDA) to take steps to ensure (a) the safety of human subjects and patients, and (b) integrity of the review process under the proposed Innovation Pathway.
[Created on 4/7/2011]

Letter to OHRP on Unethical Trials of Indacaterol Maleate (Arcapta Neohaler) (HRG Publication #1939)
We hereby request that the Office for Human Research Protections (OHRP) conduct a compliance oversight evaluation of several unethicals trials of indacaterol maleate (Arcapta Neohaler).
[Created on 3/16/2011]

Letter to FDA on Indacaterol Maleate (Arcapta Neohaler) (HRG Publication #1938)
These comments from the Public Citizen Health Research Group are being submitted in follow-up to our testimony presented at the March 8, 2011 meeting of the Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) regarding the drug indacaterol maleate (Arcapta™ Neohaler™).
[Created on 3/16/2011]

State Medical Boards Fail To Discipline Doctors With Hospital Actions Against Them (HRG Publication #1937)
An analysis of the National Practitioner Data Bank Public Use File for 1990-2009 found that of a total of 10,672 physicians in the data bank with one or more clinical privilege actions — revocation or restriction of their clinical privileges — 45% also had one or more state licensing actions. However 5,887, or 55%, of these physicians — more than half — had no state licensing actions.
[Created on 3/15/2011]

Letter on Failure to Warn U.S. Doctors and Patients of Zoledronic Acid (Reclast) Dangers (HRG Publication #1936)
In order to adequately protect the public health, the Food and Drug Administration (FDA) must immediately require that Novartis issue a “Dear Doctor Letter” to all physicians in the U.S. that communicates the same information provided to Canadian health care professionals on October 12, 2010. In addition, the FDA should issue an alert to patients in this country similar to the October 14, 2010 alert in Canada.
[Created on 3/10/2011]

Testimony on Indacaterol Maleate (Arcapta Neohaler) (HRG Publication #1935)
In the interests of protecting the public health, the Food and Drug Administration (FDA) should not approve indacaterol at the proposed doses of 75 and 150 mcg.
[Created on 3/8/2011]

Statement: Misleading Communications Regarding Breast Implant-Related Cancer to Be Removed From Websites of Leading Plastic Surgery Organizations (HRG Publication #1934)
The Food and Drug Administration (FDA) has taken laudable action by prompting two leading plastic surgery associations to remove misleading information regarding breast implant-related cancer from the organizations’ websites.
[Created on 2/24/2011]

Letter Regarding Appropriate Classification of Electroconvulsive Therapy (ECT) Devices (HRG Publication #1933)
In order to protect the health and welfare of patients, electroconvulsive (ECT) devices should remain classified as class III, and FDA should require that rigorous, ethically justifiable clinical trials be conducted to evaluate the safety and effectiveness of ECT devices, and that data from such trials be submitted to FDA for review and evaluation under a Premarket Approval Application (PMA).
[Created on 2/24/2011]

Letter Urging Rejection of Florbetapir F18 Injection (Amyvid) (HRG Publication #1932)
The Food and Drug Administration (FDA), based on current evidence, should not approve florbetapir for the evaluation of patients suspected of having Alzheimer’s disease.
[Created on 2/21/2011]

Letter on Inaccurate Communications Regarding Risks of Breast Implant-Related Cancer (HRG Publication #1931)
A concerned plastic surgeon has just sent us portions of a transcript from a members-only webinar held on February 3, in which the presidents of the two leading plastic surgery organizations, the American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS), essentially urged members to inaccurately downplay the significance of recent evidence about the risks of breast implant-related cancer when speaking to female patients.
[Created on 2/17/2011]

Letter on Liprotamase (Sollpura) (HRG Publication #1930)
These comments from Public Citizen Health Research Group are being submitted in follow-up to our testimony presented at the January 12, 2011 meeting of the Food and Drug Administration (FDA) Gastrointestinal Drug Advisory Committee regarding the drug liprotamase (Sollpura).
[Created on 1/28/2011]

Testimony on Classification of Automatic External Defibrillators (HRG Publication #1929)
In the interest of protecting public health and promoting innovation, it is imperative that FDA reject industry wishes and instead maintain the class III categorization of AEDs and require AED manufacturers to submit PMA applications.
[Created on 1/25/2011]

Statement: FDA Dodges Responsibility Regarding Medical Device Approval, Defers to IOM (HRG Publication #1928)
By deferring several important, previously proposed Food and Drug Administration (FDA) actions to a future report by the Institute of Medicine (IOM) – often because the device industry did not agree with these proposals when first issued by the FDA in August 2010 – the FDA is not being forceful enough about improving the safety and effectiveness of new devices.
[Created on 1/19/2011]

Statement: FDA’s Response to Preventable Acetaminophen Toxicity Problem is Dangerously Inadequate (HRG Publication #1927)
The measures announced today by the Food and Drug Administration (FDA) concerning acetaminophen in prescription drug products are certainly a step forward, but they entirely fail to address the greater issue of over-the-counter (OTC) use of this drug and to implement strong recommendations made by three FDA advisory committees in June 2009 about this problem.
[Created on 1/13/2011]

Testimony on Liprotamase (HRG Publication #1926)
Liprotamase, a new drug proposed to treat patients with cystic fibrosis who have problems digesting food should not be approved by the Food and Drug Administration (FDA), and further trials to determine the effectiveness of liprotamase would be unethical.
[Created on 1/12/2011]

Statement: Until Mental Health Services Are Improved, Tucson-Like Mass Murders Will Not End (HRG Publication #1925)
Until serious attention, at a national and state level, is directed at providing much better care for the seriously mentally ill and controlling the proliferation of guns, there will be many more Tucsons.
[Created on 1/11/2011]

2010

Rapidly Increasing Criminal and Civil Monetary Penalties Against the Pharmaceutical Industry: 1991 to 2010 (HRG Publication #1924)
Over the past two decades, especially during the past 10 years, there has been a marked increase in both the number of government settlements with pharmaceutical companies and the size of the accompanying financial penalties.
[Created on 12/16/2010]

Statement: FDA Must Not Approve Another Dangerous Weight Loss Drug (HRG Publication #1923)
An advisory committee for the Food and Drug Administration (FDA) will weigh approval of the new weight loss drug combination bupropion and naltrexone (Contrave) today – and the agency must reject it.
[Created on 12/7/2010]

Testimony on Bupropion and Naltrexone (Contrave) Safety (HRG Publication #1922)
The new weight loss drug combination bupropion and naltrexone (Contrave) causes serious adverse events and should not be approved.
[Created on 12/7/2010]

Position Statement: Delayed FDA Removal of Painkiller Propoxyphene (Darvon, Darvocet) From U.S. Market Has Cost More Than 1,000 U.S. Lives (HRG Publication #1921)
The announcement by the U.S. Food and Drug Administration (FDA) that propoxyphene-containing products are finally going to be taken off the market – because of dangers previously known and acted upon, with bans announced in the UK almost six years ago, and in Europe, almost 1½ years ago – is a serious indictment of the FDA’s long-lasting unwillingness to protect people in this country from a deadly but barely effective painkiller.
[Created on 11/19/2010]

Testimony to IOM Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs (HRG Publication #1920A)
Dr. Wolfe testified to the Institute of Medicine (IOM) Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs.
[Created on 11/9/2010]

Position Statement: FDA’s Decision to Pull Diet Pill Meridia Commendable, But Took Too Long for Drug’s Victims (HRG Publication #1920)
The FDA’s decision today to ask pharmaceutical maker Abbott to withdraw the drug is commendable, but dangerously too late for all of the victims of its unacceptable risks.
[Created on 10/8/2010]

Comments on FDA 510(k) Medical Devices Working Group Preliminary Report and Recommendations (HRG Publication #1919)
The 510(k) premarket approval process has failed to keep dangerous and ineffective medical devices from the market as we have documented in a recent PLOS article reviewing the FDA device approval process.
[Created on 10/4/2010]

Testimony on Sibutramine (Meridia) Safety (HRG Publication #1918)
Sidney Wolfe, M.D. reviews the history of Sibutramine (Meridia) and encourages the FDA to ban the unsafe medication.
[Created on 9/15/2010]

Petition to Reduce Medical Resident Work Hours (HRG Publication #1917)
Public Citizen petitions the Occupational Safety and Health Administration (OSHA) to implement regulations for the work hours of resident physicians and subspecialty resident physicians, (i.e., medical and surgical fellows), building from the recommendations made by the Institute of Medicine in its 2009 Report, Resident Duty Hours: Enhancing Sleep, Supervision, and Safety.
[Created on 9/2/2010]

Position Statement: Study Reinforces Long-Known Dangers of Weight-Loss Drug Meridia (HRG Publication #1917A)
It is no surprise that a study published today in the New England Journal of Medicine shows that the weight loss drug Meridia increases the risk of strokes and heart attacks.
[Created on 9/1/2010]

FDA’s Partial Hold on Unethical Diabetes Drug Trial Does Not Do Enough to Protect Patients (HRG Publication #1916)
The Food and Drug Administration (FDA) has gone only half-way in stopping the unethical TIDE study by halting the recruitment of any new patients. To allow the experiment to continue at all is a major breach in the FDA’s obligation to protect people in clinical trials.
[Created on 7/21/2010]

Comments on FDA Transparency (HRG Publication #1915)
These comments focus on how the FDA should implement stronger requirements concerning pre-approval data disclosure, data disclosure for abandoned, withdrawn or denied marketing applications, more consistent post-approval review disclosure, and better affirmative disclosure practices as a way of reducing the backlog in processing Freedom of Information Act (FOIA) requests.
[Created on 7/20/2010]

Testimony on Phentermine and Topiramate (Qnexa) (HRG Publication #1914)
Sidney Wolfe, M.D. and Charles Preston, M.D., M.P.H, urge the FDA to not approve phentermine and topiramate (Qnexa) because the diet drug is unsafe.
[Created on 7/15/2010]

Testimony on Rosiglitazone (Avandia) Safety (HRG Publication #1913)
Dr. Sidney Wolfe, M.D. and David Juurlink, M.D. Ph.D, FRCPC urge the FDA to withdraw the unsafe diabetes medication rosiglitazone (Avandia).
[Created on 7/14/2010]

Article in PLoS Medicine on Breakdown of U.S. Review Process (HRG Publication #1912)
The number and complexity of medical devices have increased over the past several decades. A series of recent safety issues have raised public awareness about shortcomings in the Food and Drug Administration’s (FDA) regulation of medical devices.
[Created on 7/13/2010]

Letter on Regulation of Direct-to-Consumer Marketing (HRG Publication #1910)
Public Citizen suggests that whether a particular advertisement presents risks in a “clear, convincing and neutral” manner should be determined by techniques similar to those used to determine consumer comprehension of benefits.
[Created on 6/28/2010]

Article in BMC Medicine on Public Support of Reducing Resident Physician Work Hours (HRG Publication #1909)
Americans overwhelmingly disapprove of shifts lasting longer than 24 hours, which are currently required by teaching hospitals. This is according to new findings published in today’s edition of the online journal BMC Medicine — the first systematic study of public perceptions of resident work hours. Public Citizen contributed to the research and urges a reduction of medical resident work hours.
[Created on 6/1/2010]

Letter Urging FDA to Halt Rosiglitazone (Avandia) Trial (HRG Publication #1908)
Dr. Wolfe urges the FDA to stop the unethical Thiazolidinedione Intervention in Vitamin D Evaluation (TIDE) trial.
[Created on 5/11/2010]

Testimony on Rosiglitazone (Avandia) (HRG Publication #1907)
Dr. Wolfe explains why the TIDE study must be stopped and why Avandia should be banned.
[Created on 4/28/2010]

Guide to Avoiding Unnecessary Cesareans in New York (HRG Publication #1906)
More than 33,000 cesarean sections in New York in 2007 may have been unnecessary. Read our recommendations on how women, hospitals and medical centers can avoid these unnecessary operations.
[Created on 4/21/2010]

Ranking of State Medical Boards’ Disciplinary Actions: 2007-2009 (HRG Publication #1905)
Every year, we evaluate how well each state medical board is protecting the public by disciplining doctors. This year, Minnesota disciplined the fewest doctors and Alaska disciplined the most doctors.
[Created on 4/5/2010]

Testimony on the Cancer Risk of Calcineurin Inhibitor Skin Medications Tacrolimus (Protopic) and Pimecrolimus (Elidel) (HRG Publication #1904)
Sidney Wolfe, M.D. testified about the lymphoma risk posed to children by the ezcema medications tacrolinus (Protopic) and pimecrolimus (Elidel).
[Created on 3/22/2010]

Letter to FDA Praising Food Safety Cautiousness, Attacking Drug Safety Recklessness (HRG Publication #1903)
In contrast to becoming more active and cautious in enhancing food safety by removing potentially dangerous products before they have caused harm, several FDA decisions in the past year regarding prescription drugs can only be described as reckless.
[Created on 3/8/2010]

Article in Health Matrix: Survey of State Medical and Osteopathy Board Disciplinary Web Sites in 2006 (HRG Publication #1902)
We sought to describe doctor disciplinary information provided on the web sites of state medical and osteopathic boards. Information collected included state board, hospital and federal government actions, as well as malpractice judgments and settlements and conviction information.
[Created on 2/22/2009]

Open Letter to Executive Director of the Accreditation Council of Graduate Medical Education (ACGME) (HRG Publication #1901)
We encourage the ACGME to adopt the IOM’s resident work hour limit recommendations.
[Created on 2/4/2010]

Petition to Ban Fibromyalgia Drug Milnacipran (Savella) (HRG Publication #1900)
Milnacipran (Savella) has highly questionable clinical efficacy and has been associated with a large number of potentially serious adverse reactions including hypertension, increased heart rate and an increased incidence of suicidal ideation.
[Created on 1/19/2010]

2009

Testimony: Issues in Clinical Trials of New Drugs for Community-Acquired Bacterial Pneumonia (HRG Publication #1899)
The draft guidance under discussion clarifies several important issues regarding the appropriate design and conduct of noninferiority (NI) trials for community-acquired bacterial pneumonia (CABP).
[Created on 12/10/2009]

Petition to Ban Sibutramine (Meridia) (HRG Publication #1898)
This purpose of this letter is to re-petition the FDA to immediately ban the weight loss drug, sibutramine (Meridia & Abbott in the U.S.).
[Created on 12/2/2009]

Article in JLME: DTC Advertising Harms Patients and Should Be Tightly Regulated (HRG Publication #1897)
In an article published in the Journal of Law Medicine & Ethics, Health Research Group Deputy Director Peter Lurie evaluates direct-to-consumer (DTC) advertising and finds that the harms of DTC advertising outweigh the benefits.
[Created on 11/23/2009]

Petition Asking FDA to Reconsider Banning Propoxyphene (Darvon) (HRG Publication #1896)
This petition asks the FDA to reconsider granting our petition to ban Propoxyphene (Darvon).
[Created on 11/23/2009]

Letter Requesting That Medicare Deny Reimbursement for Transcranial Magnetic Stimulation (HRG Publication #1895)
Public Citizen asks the Center for Medicare & Medicaid Servces to deny reimbursement for TMS because the treatment has not been proved to be effective.
[Created on 11/11/2009]

Comments on FDA Draft Guidance on Postmarketing Studies and Clinical Trials (HRG Publication #1894)
Public Citizen has reviewed the draft guidance in detail and supports its purpose and approach.
[Created on 10/13/2009]

Letter Published in Biological Psychiatry: Transcranial Magnetic Stimulation Not Proven Effective (HRG Publication #1893)
Peter Lurie, M.D., M.P.H., and Eunice Yu disagree with the Reardon’s conclusion that TMS is “safe and effective in the treatment of major depression.”
[Created on 10/1/2009]

Request for a Negative National Coverage Decision for the Menaflex Collagen Scaffold Surgical Mesh for Patients With Knee Meniscus Damage (HRG Publication #1892)
We are writing to request that the Center for Medicare & Medicaid Services (CMS) issue a National Coverage Determination (NCD) that would deny Medicare reimbursement for ReGen Biologics’ Menaflex Collagen Scaffold (MCS).
[Created on 9/25/2009]

FDA Internal Review Slams Knee Device’s Approval Process (HRG Publication #1891)
Statement by Peter Lurie, M.D., M.P.H.
[Created on 9/24/2009]

Public Comments on Resident Work Hours (HRG Publication #1890)
Peter Lurie, M.D., M.P.H. and Hillary Peabody, M.P.H. testify before the Medicare Payments Advisory Commission, encouraging the Accreditation Council on Graduate Medical Education (ACGME) to implement the IOM’s recent recommendations on resident work hours.
[Created on 9/18/2009]

Hearing Highlights Dysfunction of U.S. Health Care System, Points to Need for ‘Medicare for All’ (HRG Publication #1889)
All the problems with the U.S. Health care system could be reduced or even eliminated if there was only a ‘Medicare-for-all’ system, also known as single-payer, for health care in this country.
[Created on 9/16/2009]

Letter Urging Secretary Sebelius to Provide Hospitals and Nursing Homes With Disciplinary Data on Nurses and Other Allied Health Professionals (HRG Publication #1888)
This letter urges Secretary Sebelius to immediately implement Section 1921 of the Social Security Act. This would significantly reduce the chances that patients will be injured or killed by any of the more than 100,000 non-physician health professionals (e.g., nurses, pharmacists, physician assistants) and other health workers with disciplinary records who may be employed in hospitals or nursing homes.
[Created on 8/25/2009

Have the Courage to Say Health Care Is a Right, Not a Privilege (HRG Publication #1887)
Statement by Sidney Wolfe, M.D.
[Created on 7/30/2009]

Life-Threatening Liver Toxicity of Avandia Shown in New Public Citizen Research Published in Peer-Reviewed Medical Journal (HRG Publication #1886A)
New research by Public Citizen published today in a peer-reviewed medical journal reinforces the case that the diabetes drug Avandia can cause death from liver failure and should be banned immediately by the Food and Drug Administration (FDA).
[Created on 7/22/2009]

Public Citizen’s Response to FDA Draft Guidance on Conduct of Clinical Trials in Community-Acquired Bacterial Pneumonia (HRG Publication #1886)
The Food and Drug Administration’s recent draft guidance on community-acquired bacterial pneumonia (CABP) is significant step forward from the previous draft guidance, issued in 1998. However, it includes recommendations that contradict established principles of rigorous clinical trial conduct, as defined in the International Conference on Harmonization documents E-9 and E-10, and a number of issues are left unaddressed.
[Created on 6/29/2009]

Dr. Sidney Wolfe’s Testimony Before Subcommittee on Health at Hearing on Health Insurance (HRG Publication #1885)
Sidney Wolfe, M.D., testifies about the need for a single-payer health insurance plan.
[Created on 6/24/2009]

Testimony of Peter Lurie, M.D., M.P.H. and Hillary Peabody, M.P.H. Before the FDA Transparency Task Force (HRG Publication #1883)
Dr. Lurie and Hillary Peabody testify that pre-approval documents should be made available to the public, the FDA’s Freedom of Information Act (FOIA) processes should be made more efficient and consistent, and the FDA should expedite the production of standardized drug information for patients.
[Created on 6/24/2009]

Testimony of Peter Lurie, M.D., M.P.H. and Jonas Hines on Medical Device Regulations (HRG Publication #1882)
Testimony by Peter Lurie, M.D., M.P.H. and Jonas Hines before the Subcommittee on Health Committee on Energy and Commerce, United States House of Representatives.
[Created on 6/18/2009]

Letter in Neuropsychopharmacology: Post Hoc Analysis Does Not Establish Effectiveness of rTMS for Depression (HRG Publication #1881)
Peter Lurie, M.D., M.P.H., Sidney Wolfe M.D. and Jonas Hines find fault with the analysis of the effectiveness of repetitive transcranial magnetic stimulation for treating depression.
[Created on 6/15/2009]

Letter to the Editor of the Washington Post Regarding the Coverage of the Recent Congressional Hearing on Single-Payer (HRG Publication #1880)
James Floyd M.D. describes Dana Milbank’s recent column in the Washington Post on the recent hearing on single-payer health care as polemical.
[Created on 6/15/2009]

Public Pressure Helps End Silence on Single-Payer in Congress (HRG Publication #1879)
Statement by James Floyd, M.D.
[Created on 6/11/2009]

Critique of New Antiarrhythmic Drug Dronedarone Published in the New England Journal of Medicine (HRG Publication #1878)
James Floyd M.D. criticizes the new antiarrhythmic drug dronedarone.
[Created on 6/9/2009]

Prasugrel STEMI Subgroup Analysis Published in the Lancet (HRG Publication #1877)
Letter in The Lancet faults subgroup analysis of TRITON-TIMI 38 trial comparing prasugrel with clopidogrel.
[Created on 6/3/2009]

Letter Urging the FDA to Halt its Review of Prasugrel (HRG Publication #1876)
Dr. Serebruany, Dr. Floyd and Dr. Wolfe encourage the FDA to stop its review of prasugrel until a new Phrase 3 study can be conducted with appropriate lower doses of prasugrel and properly defined outcomes.
[Created on 6/2/2009]

Testimony of James Floyd, M.D. at Meeting of Anti-Infective Drugs Advisory Committee on Cethromycin for the Treatment of Community-Acquired Bacterial Pneumonia (HRG Publication #1875)
James Floyd, M.D. testifies about the design flaws in the studies conducted on cethromycin for the Treatment of community-acquired bacterial pneumonia.
[Created on 6/2/2009]

Letter to Secretary Sebelius About National Practitioner Data Bank Deficiency (HRG Publication #1874)
Alan Levine and Dr. Sidney Wolfe present Secretary of Health and Human Services Kathleen Sebelius with a report on the deficiencies of the National Practitioner Data Bank, and urge the Secretary to meet to discuss specific recommendations for improvement.
[Created on 5/27/2009]

Hospitals Drop the Ball on Physician Oversight (HRG Publication #1873)
Lack of detection and widespread under-reporting to the National Practitioner Data Bank raise serious questions about hospital peer review.
[Created on 5/27/2009]

Testimony Before the FDA Concerning the Premarket Approval Application for Confluent’s DuraSeal Xact Sealant System for Spinal Use (HRG Publication #1872)
Dr. Lurie and Jonas Hines testify before the Neurological Devices Panel of the Medical Devices Advisory Committee, Center for Devices and Radiological Health, Food and Drug Administration, on how Confluent’s DuraSeal Xact Sealant System for Spinal Use should not be approved.
[Created on 5/14/2009]

Petition to the FDA Requesting Enhanced Warnings for Amitiza (Lubiprostone) (HRG Publication #1871)
Public Citizen petitions the Food and Drug Administration (FDA) to add a black box warning regarding the risk of abortion to the Amitzia product label, change the drug’s pregnancy category from C to X, contraindicate nursing while taking the drug, require the distribution of an FDA-approved Medication Guide for all patients, and mandate a “Dear Doctor” letter.
[Created on 5/5/2009]

Statement of Dr. Peter Lurie on FDA Granting Public Citizen’s Petition That Sought to Warn Patients and Doctors About the Dangers of Botulinum Toxin (HRG Publication #1870)
Statement by Peter Lurie, M.D., M.P.H.
[Created on 4/30/2009]

Testimony at Congressional Forum: An Examination of U.S. Health Insurance (HRG Publication #1869)
Annette B. Ramírez de Arellano, DrPH testifies about the state of U.S. Health Insurance.
[Created on 4/22/2009]

Public Citizen’s Health Research Group Ranking of the Rate of State Medical Boards’ Serious Disciplinary Actions, 2006-2008 (HRG Publication #1868)
Public Citizen uses data from the Federation of State Medical Boards to analyze the rates of serious disciplinary actions taken by state medical boards from 2005 to 2007.
[Created on 4/20/2009]

Letter to FDA Urging Rejection of Antipsychotic Drug Sertindole Because of Sudden Cardiac Death (HRG Publication #1867)
Letter from Dr. Sidney Wolfe and Dr. James Floyd recommending that the FDA not approve the dangerous antipsychotic Sertindole.
[Created on 4/9/2009]

Letter urging FDA to Reject Use of Seroquel in Depression (HRG Publication #1866)
Dr. Sidney Wolfe and Dr. James Floyd advise the FDA to not approve Seroquel for use in Major Depressive Disorder and Generalized Anxiety Disorder.
[Created on 4/9/2009]

Letter in JAMA: The Role of Tax Reform in Health Care Reform (HRG Publication #1865)
Letter in response to a 2008 Journal of the American Medical Association article by Drs. Sessions and Lee that advocates for health care reform in the form of a regressive value-added tax to finance vouchers for private health insurance.
[Created on 3/25/2009]

Letter to the Editor in The Washington Post Re: President Obama’s Effort to Reform Health Care (HRG Publication #1864)
Dr. James Floyd criticizes President Obama’s efforts to incrementally reform U.S. health care and advocates a single-payer health care system.
[Created on 3/17/2009]

Letter to FDA Commissioner About Defective Welch Allyn AEDs (HRG Publication #1863)
Public Citizen questions FDA Commissioner why a defective life-saving device continues to be marketed.
[Created on 3/13/2009]

Letter to FDA Commissioner Condemning Delayed Recall of Defective Intravenous Infusion Pumps (HRG Publication #1862)
Public Citizen criticizes the FDA for its delayed recall of a defective intravenous infusion pump that has been known for years to malfunction.
[Created on 3/12/2009]

Statement of Dr. Sidney Wolfe on the Recall of Shiley 3.0 PED Tracheostomy Tube (HRG Publication #1861)
Dr. Sidney Wolfe speaks out against the unnecessary delay by the FDA in notifying the public of this public health threat.
[Created on 3/10/2009]

Statement of Dr. Peter Lurie on Approval of SyntheMed’s REPEL-CV Bioresorbable Adhesion Barrier (HRG Publication #1860)
Peter Lurie, M.D., M.P.H., makes a statement against FDA’s approval of SyntheMed’s REPEL-CV medical device because it has not been shown to be safe or effective.
[Created on 3/9/2009]

Statement of Dr. Peter Lurie on Wall Street Journal Story Regarding Approval of ReGen Biologics’ Menaflex Collagen Scaffold Medical Device (HRG Publication #1859)
Dr. Lurie comments on an article published in the Wall Street Journal that revealed that ReGen Biologics manipulated an FDA advisory committee in order to gain FDA-approval of a medical device that does not have any discernable clinical benefit.
[Created on 3/6/2009]

Letter to the American Medical Association Supporting Ban on Commercial Support of Continuing Medical Education (HRG Publication #1858)
The Health Research Group calls for the American Medical Association to adopt a policy that would completely eliminate commercial support for physicians’ continuing medical education.
[Created on 2/23/2009]

Letter to FDA About Safety Concerns with Prasugrel Hydrochloride and Removal of Dr. Sanjay Kaul from Cardiovascular and Renal Drugs Advisory Committee Meeting (HRG Publication #1857)
Public Citizen researchers present safety and efficacy data about prasugrel hydrochloride, and recommend labeling to effectively communicate the drug’s risks (including hemorrhage and cancer) to consumers. The group also urges the removal of Dr. Sanjay Kaul from the Cardiovascular and Renal Drugs Advisory Committee meeting.
[Created on 2/19/2009]

Testimony of Sidney Wolfe Before Food and Drug Administration Advisory Committee on Propoxyphene (Darvon) (HRG Publication #1856)
Dr. Wolfe testifies before the Food and Drug Administration and advocates for a two-year phased withdrawal of these products.
[Created on 1/29/2009]

Statement of James Floyd on Public Citizen Joining Leadership Conference for Guaranteed Health Care in Support of Single Payer National Health Insurance Program (HRG Publication #1855)
Public Citizen researcher James Floyd, M.D., endorses a single payer health insurance program in the U.S. as the best solution the health care crisis in this country.
[Created on 1/28/2009]

Statement of Peter Lurie on Government Accountability Office Report on Medical Device Approval Standards (HRG Publication #1854)
Dr. Lurie comments on a Government Accountability Office report that shows the Food and Drug Administration routinely approves medical devices using lax testing standards, and points to the deficiencies of the 510(k) approval process for medical devices.
[Created on 1/15/2009]