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 testified against the additional approval of liraglutide (Victoza) for reducing cardiovascular risk in diabetes patients because the clinical trial to support such approval failed to show any benefit in the 2,500 American subjects in the trial. The study only showed a significant benefit in non-U.S. subjects.
Public Citizen requests that the Office for Human Research Protections (OHRP) immediately expand its ongoing compliance oversight investigation of the Surfactant Positive Airway Pressure and Pulse Oximetry Trial in Extremely Low Birth Weight Infants (SUPPORT) trial to evaluate newly uncovered information — recently obtained by Public Citizen under the Freedom of Information Act — that reveals additional major ethical lapses and failures to materially comply with key requirements of federal regulations for the protection of human subjects.
Public Citizen today applauded the U.S. Food and Drug Administration (FDA) for urging Endo to take Opana ER off the market, while criticizing the fact that the FDA approved it and blasting Endo Pharmaceuticals’ defiant response to the request.
Public Citizen and 12 other groups sent a letter to members of U.S. House of Representatives’ Energy and Commerce Committee urging them to oppose two bills that would significantly expand marketing for unapproved uses of drugs and medical devices that have been approved or cleared by the FDA for at least one use. The legislation would undermine regulatory standards for ensuring that drugs and medical devices are safe and effective for each marketed use.
Public Citizen published an article on Other98.com that outlines the true causes for high drug prices in the U.S. and makes the case for why consumers should rally behind the recently introduced Affordable Meds Act to rein in monopoly abuses by Big Pharma and make medicines affordable.
In a letter to the editor of The Hill, Public Citizen criticized a recent op-ed (“Beryllium broadside: Obama’s last-minute rule-making will cost jobs”) for unfairly decrying the U.S. Occupational Safety and Health Administration’s (OSHA’s) efforts to protect workers from exposure to beryllium in the workplace.
In comments to the Food and Drug Administration (FDA) on manufacturer communications regarding unapproved uses of approved or cleared medical products, Public Citizen discusses the risks to patients when manufacturers promote their products for unapproved uses and the unreliability of journal articles as a basis for physicians’ decisionmaking. We also explain that the First Amendment does not support the industry call for relaxation of the restrictions on promoting products for uses that the FDA has not approved as safe and effective for patients.
Public Citizen expressed serious concern regarding the Food and Drug Administration’s (FDA’s) failure to provide timely notice in the Federal Register of the April 13, 2017, meeting of the Antimicrobial Drugs Advisory Committee in accordance with the requirements of the agency’s own regulations. In the event that the agency fails to provide timely notice of advisory committee meetings in accordance with all regulatory requirements with respect to future advisory committee meetings, we will pursue available legal avenues to ensure compliance.
Dr. Gottlieb’s appointment as FDA Commissioner would further accelerate a decades-long trend in which agency leadership too often makes decisions that are aligned more with the interests of industry than those of patients. We urge other senators to oppose Dr. Gottlieb’s nomination. The Senate should demand a nominee who is better suited to protect public health, rather than a venture capitalist who is ridden with conflicts of interest.
In testimony before a joint meeting of the Food and Drug Administration’s Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees, Public Citizen concludes that the risks of reformulated Opana ER (extended release oxymorphone) outweigh its benefits and recommends that the drug be withdrawn from the market.