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 petitioned the Food and Drug Administration (FDA) to ban the sale of olmesartan medoxomil – an angiotensin II receptor blocker (ARB) found in the widely prescribed hypertension medications marketed under the brand names Azor, Benicar, Benicar HCT and Tribenzor, as well as in other generic versions – because it can cause a severe gastrointestinal disorder that leads to severe and chronic diarrhea, vomiting, abdominal pain and weight loss.
Public Citizen calls on the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) to follow the example of Sweden’s Medical Products Agency and require the immediate removal of hydroxyethyl starch (HES) solutions from the market in Europe because the solutions cause kidney failure, bleeding, and death and there are safer alternatives available. Recent drug utilization studies in 10 European Union countries indicate the futility of the PRAC’s 2013 decision to restrict the use of HES products in Europe.
Public Citizen urged the Food and Drug Administration (FDA) to issue expanded guidance that includes a discussion of the types of clinical investigations for which the agency might consider an institutional review board’s (IRB’s) waiver of informed consent to be appropriate from both an ethical and regulatory perspective.
In a post to Yale University’s CRITical Thinking blog, we discuss key features of a pro-patient, pro-public health agenda for the regulation of medical products. The blog post is derived from a presentation made at the June 2017 international conference hosted by the Yale Collaboration for Research Integrity and Transparency (CRIT) titled “Ensuring Safety, Efficacy, and Access to Medical Products in the Age of Global Deregulation.”
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Medical Imaging Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA adopt the approach of the European Medicines Agency and ban and restrict linear gadolinium-based contrast agents used in MRIs because they can remain deposited in the brain for months or even years and, with certain exceptions, offer no unique benefits over potentially safer, more widely used macrocyclic gadolinium-based products.
Public Citizen and 16 other groups sent a letter to members of the U.S. House of Representatives urging them to oppose S. 204, which is deceptively titled the “Right to Try Act of 2017” but should instead be called the “False Hope Act of 2017.” The legislation, as amended and passed by the U.S. Senate on August 3, 2017, would put countless patients at risk by undermining important FDA safety rules related to the use and oversight of unapproved, experimental medications.
Public Citizen submitted comments strongly urging the Occupational Safety and Health Administration (OSHA) not to: 1) finalize its proposal to rescind, for construction and shipyard workers, all ancillary provisions from its final 2017 beryllium rule; 2) delay for one year the deadline for compliance by construction and shipyard employers with the final beryllium standard; or 3) abdicate its duty to protect workers by refusing to enforce the final beryllium rule for construction and shipyard workers while this latest proposal is pending.
Public Citizen and 17 other groups sent a letter to members of Congress urging them to oppose legislation that would most appropriately each be titled the “False Hope Act of 2017.” The legislation would put countless patients at risk by dramatically undermining the FDA’s role in ensuring that medical products are safe and effective before they become widely used.
Public Citizen calls on the Office for Human Research Protections (OHRP) and the Department of Veterans Affairs (VA) Office of Research Oversight to immediately suspend the National Institutes of Health-funded Myocardial Ischemia and Transfusion (MINT) trial that is expected to involve 3,500 heart attack patients throughout the U.S. and Canada because of potentially serious ethical and regulatory violations.
In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees, Public Citizen urges the FDA to reject Intellipharmaceutics’ new version of oxycodone because, contrary to agency guidelines, the company has not conducted any human abuse potential studies of the drug to support a labeling claim that the drug deters intravenous abuse.