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 letter to the Food and Drugs 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]

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]

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]

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]

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]

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]

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]

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]

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]

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