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 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]

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 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]

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]

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]

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]

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]

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]

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]

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]