Transparency in Health Safety and Product Safety
Public Citizen has worked for more than four decades to make sure there is clear transparency in the American health care system.
The first goal in good medicine is keeping the patient safe. That means having reasonable access to quality and unbiased information about all aspects of their health care.
Public Citizen battles a “corporate shield” loophole, which allows physicians and other health care providers to evade having medical malpractice payment reports, to increase transparency and accountability for patients.
Public Citizen works toward enhanced accountability in the medical field by physician accountability – analyzing trends in state disciplinary actions across the U.S. and pushing for greater disclosure of disciplinary actions taken against doctors and other health care workers.
Public Citizen report: Incomplete information in as many as 50,000 reports provided to the National Practitioner Data Bank, which serves as a national clearinghouse of transgressions by physicians and other health care providers that are critical to employment and credentialing decisions.
The Myocardial Ischemia and Transfusion (MINT) trial: A proposed trial that was expected to involve randomly assigning roughly that was expected to involve 3,500 heart attack patients throughout the U.S. and Canada to one of two experimental groups dictating when they received blood transfusions. Some were to be assigned to a “liberal” group where they would have been transfused at a higher level of red blood cell (RBC) counts, and some to a “restrictive” group where they would have been transfused at a lower RBC count. Researchers would then measure how many subjects died or had another heart attack within 30 days. Public Citizen called for the trial to be halted over serious ethical concerns, including unnecessary health risks and patient consent issues.
- Letter to the U.S. Department of Veterans Affairs (VA) (PDF): Dr. Michael Carome, director of Public Citizen’s Health Research Group, and Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, call on the VA’s Office of Research Oversight and the Office for Human Research Protections (OHRP) to immediately halt the the trial.
- Press Release: Public Citizen’s press release highlighting the call for the MINT trial to be halted.
- A list (PDF) of the researchers and institutions that provided letters of support for the MINT trial.
- The VA’s letter of acknowledgement (PDF) on August 15, 2017, received shortly after Public Citizen’s call.
- The MINT trial’s protocol (PDF).
- The MINT trial’s sample consent form (PDF).
The SUPPORT study: A trial that involved randomly assigning premature infants to one of two experimental groups. Researchers tried to keep blood oxygen levels in a high range for one group and a low range for the other. Parents were not informed that this experiment involved substantial risks for their babies, including increased risk of blindness, brain injury and death, depending on which group the babies were in.
Blog post: Dr. Michael Carome, director of Public Citizen’s Health Research Group, details how the editors of the prestigious New England Journal of Medicine (NEJM) sacrificed standards to defend the unethical clinical trial.
Statement: HHS’ response to Public Citizen’s finding of agency misconduct in SUPPORT study doesn’t add up.
Read testimony before HHS Panel on informed consent for human subjects research.
Report back from a press conference held outside HHS to demand HHS to stop ongoing unethical trials on premature infants.
Press Advisory: Press conference to highlight the need for HHS to strengthen the ethical standards by which human experiments are conducted.
Release: Public Citizen has learned of another, similar trial that also poses known risks to premature babies without fully informing the parents about those risks.
In the wake of controversy of the SUPPORT study, HHS hosts a meeting to look at what risks should be disclosed to participants in clinical trials.
Forty-five experts have declared that a federally funded trial involving premature infants used “seriously deficient” consent forms that violated requirements for clinical trials.
Letter to HHS: NIH should not censor one of its experts just because he might criticize ethical lapses in an increasingly high-profile study carried out on premature babies.
Release: 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.
Public Citizen report: new information about baby trial shows it was even more unethical than originally thought.
Public Citizen to secretary of HHS: suspend enrollment in baby trials and release the details of ongoing and earlier experiments.
Letter to the HHS secretary asking for a personally apologize to the parents of the HHS-funded experiment that exposed babies to risk of death and blindness without informing the parents.
Improved Patient Drug Information Program
Public Citizen petitioned the FDA to ban the distribution of dangerously misleading prescription drug information to the public by pharmacists arguing that drugs were misbranded when dispensed with inaccurate or misleading information. Read the comments, lawsuit and settlement that lead to an open discussion on the Improved Patient Drug Program:
Comments before the FDA’s Safety and Risk Management Advisory Committee regarding dangerous and misleading information on leaflets distributed with prescription drugs.
Lawsuit brought against HHS to request public comment on rules regarding patient information leaflets that are distributed with prescription drugs.
Statement on the settlement of a lawsuit that requested the U.S. Department of Health and Human Services to open discussions on the Improved Patient Drug Information Program to comments from the public.
Public Citizen urges the FDA to not remove a black box warning on Chantix, a smoking cessation drug, to become more transparent about the risks of the drug. The FDA removed the warning in December 2016. Public Citizen says with this move, the FDA made it less likely that doctors and patients will be aware of Chantix’s dangers.
Public Citizen petitions FDA for a black box warning on testosterone products to warn patients of cardiovascular risks.
Statement of Dr. Sidney Wolfe: FDA proposal to revise drug labeling regulations is welcome news and will improve drug safety.
Public Citizen report highlights the need to allow generic drug manufacturers to update labeling as they learn of new risks to protect patient safety.
Freedom of Information
Public Citizen files a Freedom of Information Act (FOIA) requesting the FDA to release all the comments about a proposal that would allow pharmaceutical companies to circumvent labeling rules and tell doctors that the medications’ risks are lower than they actually are.
Public Citizen petitioned the FDA to stop its longstanding practice of redacting portions of documents released to FOIA requesters without giving requesters an immediate right to appeal within the agency.
Conflict of Interest
It’s often hard to tell when drug companies pay doctors lavish speaking fees and when medical journal authors do work for drug companies. But these payments and relationships have the potential to influence what drugs doctors prescribe.
Clinical Trials Design
Federal officials agree with Public Citizen that a clinical study involving hundreds of kidney transplant patients who unwittingly participated violated federal rules for the protection of human research subjects.
A policy study of clinical trial registries and results database as evidence exists that pharmaceutical companies have suppressed unfavorable data.
Read about how Public Citizen went to court to enforce a Vermont law requiring drug companies to report the value and nature of gifts they give doctors and hospitals to the Vermont Attorney General.
Read our testimony before the Senate Special Committee on Aging in support of state laws requiring the disclosure of pharmaceutical company payments to physicians.
Congressional testimony on state laws requiring disclosure of pharmaceutical company payments to physicians.
Medical Safety vs. Corporate Profits
Public Citizen urges the U.S. Food and Drug Administration to limit dangerous off-label marketing practices used by the pharmaceutical and medical device industries.
Public Citizen and other groups sent a letter to lawmakers warning that a provision in the 2012 Food and Drug Administration Reform Act would block public access to potentially important health and safety information should be removed or substantially narrowed.
Read our 2002 comments on disclosure of conflicts of interest for participants in FDA advisory committee.
Read more about our work to protect patients by uncovering these conflicts of interest.
Drug Manufacturing and Approval Process
Keeping Dangerous Drugs Off the Market
Read our 2012 letter to the FDA addressing failures to disclose new drug application approval packages in a timely manner.
Our 2010 recommendations to the FDA on how the agency can alert the public to dangers and promote scientific innovation at the same time.
Our 2009 testimony before the FDA Transparency Task Force encouraging greater transparency.
When the FDA released documents related to its evaluation of the safety and effectiveness of the drug Bextra, it withheld key portions. Public Citizen sued the FDA and won.
Read our 2001 comments on the FDA’s proposed changes to disclosure of information from FDA Advisory Committee.
Public Citizen took the FDA to court to try to get information concerning pre-clinical and clinical studies for prescription drugs, in which clinical trials were discontinued because of death or serious injury.
In a letter Public Citizen called for a congressional investigation to find out who at the FDA knew about the status of a tamper-resistant hydrocodone product that had already been developed, when the FDA approved a dangerous, high-dose, non-tamper-resistant opioid known as Zohydro ER.
Compounding Drug Manufacturing
Read Public Citizen comments submitted to the Health Subcommittee of the House Energy and Commerce Committee regarding compounding pharmacy legislation.
Statement of Dr. Michael Carome: Draft proposal on pharmacy compounding would weaken existing laws governing drug manufacturing.
Release: Public Citizen fights against a law that would allow drug companies to remove labels containing clear, transparent drug information for the consumer.
Public Citizen to Congress: Proposed compounding pharmacy legislation would be a major step backward for U.S. drug safety, efficacy and accurate labeling.
Off-Label Use of Drugs
Public Citizen went to court to get information regarding records of off-label, unapproved uses of previously approved drugs and biologics.
Transparency in Product Safety
Public Citizen works to make sure Americans are protected from unsafe products and fights for clearer transparency regarding consumer product safety.
Consumer Product Safety Commission
Imagine a database accessible by anyone in the country and that contains a treasure trove of information about dangerous products that have harmed people. Such a database exists – it was created as part of the Consumer Product Safety Improvement Act of 2008. Public Citizen pushed hard to ensure that consumers can warn others about dangers – and that the government and manufacturers respond.
- Public Citizen praises the Consumer Product Safety Commission, which remains transparent in making sure that numerous products are safe for everyone, from infants to adults.
- Read our praise for the Consumer Product Safety Commission for voting to implement the Consumer Product Safety Information Database, which will allow people to share and access safety information about the products they own and are purchasing.
- Read our letter to the Secretary of the Consumer Product Safety Commission on the establishment of a consumer product safety information database.
- Read a statement we made before the Consumer Product Safety Commission on the establishment of a consumer product safety database.
- Read a coalition statement in support of a consumer product safety database.
Stalled Rulemaking Regarding Consumer Protections
Release: Calling out the Obama administration for stalling a crucial auto safety rule in an obscure White House office for a year and a half, where the public couldn’t see what was going on.
Public Citizen report: Public pays price as eight key food safety, financial, worker safety and environmental rules held up.
Deceptive Advertising and Marketing Practices
Public Citizen and allies file a complaint against Google, Disney’s Maker Studios and other companies who use unfair and deceptive practices to target marketing towards children.
Public Citizen and allies tell the Federal Trade Commission to end hidden ads on Instagram.
A company sued to keep a complaint about one of its products out of a database created by the Consumer Product Safety Commission (CPSC) and persuaded a district court judge to adjudicate the matter in secret, sealing documents pertaining to the case and permitting the company to use the pseudonym “Company Doe.” Public Citizen objected to the seal.
- Statement: Ergobaby exposed as the “company doe” that spend two and a half years in secret litigation to prevent a negative report about Ergobaby’s baby carrier from going into the Consumer Product Safety Commission’s online product safety database.
- Advisory: Public Has Right to Know Identity of ‘Company Doe,’ Access Court Records in Consumer Product Database Case, Public Citizen to Tell Federal Appellate Court.
- Release: Fourth Circuit: Injury to Corporate Reputation Not Enough to Justify Sealing Court Case.