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.

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Public Citizen, joined by two academic physicians, urged the Food and Drug Administration (FDA) to revised its draft guidance on the assessment of pressor effects of drugs to specify, among other things, the following: (a) a time interval that distinguishes short-term drug use from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]

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]

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]

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]

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]

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