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 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In general, Public Citizen strongly supports the policies proposed in the draft guidance document.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]

The House of Representatives’ passage of S. 204, the Senate’s seriously flawed False Hope legislation, opens the gate to a dangerous, uncharted pathway for accessing experimental medications that have not been shown to be safe or effective. The bill passed today will expose vulnerable patients to risks of serious harm, including dying earlier and more painfully than they otherwise would have, without appropriate safeguards.

[Created on 5/22/2018]

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 INSYS Development Company’s new drug application for buprenorphine sublingual spray for the treatment of moderate-to-severe acute pain where the use of an opioid analgesic is appropriate because the risks of the drug outweigh the benefits.

[Created on 5/22/2018]

Public Citizen urged members of the U.S. House of Representatives to oppose S. 204, the version of “False Hope” legislation that was passed by the Senate in August 2017. Importantly, although H.R. 5247 — the House of Representatives-passed version of this legislation — has significant flaws that would endanger patients, it nevertheless would provide substantially stronger safeguards for patients who would receive investigational drugs under the Right-to-Try pathway than those provided by S. 204.

[Created on 5/21/2018]

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