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.

Although Public Citizen welcomes this long-overdue action, this ban comes too late for the thousands of women who have been irreparably harmed by these devices, long after the FDA knew the devices had “not demonstrated a reasonable assurance of safety.”

[Created on 4/16/2019]

Public Citizen petitioned the Food and Drug Administration (FDA) to add a black-box warning to the product labeling for the osteoporosis drug, Prolia (denosumab), to alert doctors and patients about the risk of vertebral fractures associated with cessation of the drug and need for alternative osteoporosis treatment after stopping the drug.

[Created on 4/16/2019]

Public Citizen urged the Food and Drug Administration (FDA) not to approve the do novo premarket application for the neuroAD Therapy System from Neuronix as an adjunctive treatment of mild-to-moderate Alzheimer’s Dementia because the data from the clinical trials demonstrated that the device does not offer any clinically meaningful benefits.

[Created on 4/9/2019]

Scott Gottlieb, Food and Drug Administration (FDA) commissioner, today testified about opioids at a hearing of the U.S. Senate Appropriations Committee’s Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies. His testimony included several misleading statements and omissions.

[Created on 3/28/2019]

In testimony before the Food and Drug Administration’s (FDA’s) General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee, Public Citizen highlighted the serious health problems linked to breast implants and the inadequate regulation of these and other permanently implanted medical devices over the past several decades. The history of breast implants reminds us why much more extensive mandatory pre-approval testing of permanently implanted devices, like breast implants, is necessary; otherwise, patients are serving as unwitting guinea pigs.

[Created on 3/26/2019]

Public Citizen petitioned the Food and Drug Administration (FDA) to immediately impose a moratorium on approval of all new drug applications for new opioids or new opioid formulations, not to be lifted until the FDA has implemented the elements recommended by the National Academies of Sciences, Engineering, and Medicine for inclusion in a currently non-existent opioid regulatory framework that is intended to prevent a continuation of dangerous past regulatory errors that clearly have contributed to the current deadly opioid crisis in the U.S.

[Created on 3/21/2019]

Public Citizen strongly urged the Food and Drug Administration (FDA) not to approve the new drug application (NDA) for sotagliflozin (ZYNQUISTA) for use as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes because the data from the phase 3 clinical trials presented in the NDA show that the drug causes an unacceptable eight-fold increased risk of life-threatening diabetic ketoacidosis in subjects with type 1 diabetes given the drug, compared with those given a placebo.

[Created on 3/11/2019]

Scott Gottlieb was entangled in an unprecedented web of Big Pharma ties when he was nominated in 2017 to be FDA commissioner. Not surprisingly, his tenure as commissioner was marked by regulatory decision making regarding medications and medical devices that tilted further in favor of industry's financial interests rather than the interests of public health.

[Created on 3/5/2019]

Public Citizen strongly urged the Food and Drug Administration (FDA) not to approve the new drug application (NDA) for the drug-device combination of esketamine (SPRAVATO) for intranasal administration for the treatment of treatment-resistant depression because the data from the clinical trials presented in the NDA failed to provide substantial evidence that the drug is effective for its proposed indication for use and there is clear evidence that the drug has serious risks of harm.

[Created on 2/27/2019]

Public Citizen strongly urged Maryland Senate’s Education, Health, and Environmental Affairs Committee to soundly reject Senate Bill 372 because it would (a) seriously compromise patient access to nearly half of the information about important disciplinary actions taken by the Maryland Board of Physicians against physicians who may have been found to have engaged in serious misconduct, (b) make it more difficult for the Board to investigate and discipline physicians under certain circumstances, and (c) ultimately, undermine patient safety protections in Maryland.

[Created on 2/22/2019]

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