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.

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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