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) Endocrinologic and Metabolic Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject Sanofi’s new drug application for sotagliflozin for treatment of type 1 diabetes because the drug offers minimal benefits that do not outweigh the significantly increased risk of life-threatening diabetic ketoacidosis.

[Created on 1/17/2019]

In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Bone, Reproductive and Urologic Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject Amgen’s new drug application for romosozumab for treatment of osteoporosis in postmenopausal women at high risk for fracture because of clinical trial data linking the drug to an increased risk of serious adverse cardiovascular events.

[Created on 1/16/2019]

In testimony before a joint meeting of the Food and Drug Administration’s Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee, Public Citizen urged the committees to recommend that the FDA immediately remove from the market the widely used gout medication febuxostat because it poses unique, serious risks – include the risk of dying from cardiovascular disease – but offers no unique benefit. Public Citizen had requested such action in a citizen petition submitted to the agency on June 21, 2018.

[Created on 1/11/2019]

A groundbreaking study published by Public Citizen in the journal Public Health Nursing showed that state nursing boards are failing to protect patients from nurses who engage in sexual misconduct. According to the study, only 882 U.S. registered licensed practical or vocational nurses have been reported to the National Practitioner Data Bank over 14 years (from 2003 through 2016) because of such misconduct.

[Created on 12/17/2018]

The FDA’s withdrawal of its proposed rule that would have allowed generic drug makers to immediately update safety labels to describe new risks to consumers without prior agency approval represents a flagrant disregard for public health and common sense because it continues to immunize generic manufacturers from any liability if patients are injured or killed by a generic medication, even when warnings about serious risks known to the companies are missing from the labels.

[Created on 12/13/2018]

In a letter to Dr. Scott Gottlieb, the Food and Drug Administration (FDA) Commissioner, Public Citizen and the chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee explain how the Commissioner misled the public regarding potential “unique” benefits of Dsuvia, a controversial, highly potent opioid pain relief medication.

[Created on 12/11/2018]

Public Citizen, in general, supports the Food and Drug Administration’s (FDA’s) draft guidance for industry “Insanitary Conditions at Compounding Facilities (Revision 1).” The numerous detailed examples of insanitary conditions provided in the draft guidance should assist compounding facilities in identifying and remediating insanitary conditions. However, Public Citizen strongly objects to the FDA’s addition of a statement indicating that for physician compounding or repackaging of drug products, the agency does not intend to enforce legal requirements that prohibit the preparation, packing, and holding of drugs under insanitary conditions.

[Created on 11/26/2018]

In a joint op-ed, Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, and Dr. Raeford Brown, chair of the Food and Drug Administration’s (FDA’s) Anesthetic and Analgesic Drug Products Advisory Committee, are highly critical of the FDA’s reckless decision to approve sufentanil sublingual tablets, a new opioid that will be sold under the brand name Dsuvia.

[Created on 11/16/2018]

In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject new drug application submitted by SpecGx for an immediate-release oral tablet formulation of oxycodone that is intended to be abuse-deterrent for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

[Created on 11/14/2018]

Public Citizen sent a letter to the Florida Attorney General requesting an investigation of the use of falsified scientific citations in the advertisement and promotion of an illegal heart-toxic drug for treatment of cancer by Utopia Wellness, a Florida-based medical center. The medical’s website materials misleadingly claim that cesium chloride is safe and effective for treating cancer but offers no evidence from well-controlled clinical tests to support its claims.

[Created on 11/7/2018]

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