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 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]

Public Citizen is deeply concerned that once the Food and Drug (FDA) finalizes the proposed rule, clinical investigators inappropriately will seek, and IRBs inappropriately will grant, waivers of informed consent for clinical investigations that involve greater than minimal risk to the subjects.

[Created on 2/13/2019]

In testimony before the Food and Drug Administration’s (FDA’s) Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee, Public Citizen urged the FDA to reject the premarket approval applications for the three mesh products for transvaginal repair of pelvic organ prolapse (POP) that are still on the market because these devices offer no clinically significant benefits in comparison with non-mesh repair of POP and have high rates of serious complications. Surgical mesh for transvaginal POP repair is a quintessential example of the fundamental deficiencies in the FDA’s oversight of medical devices, particularly those that are permanently implanted.

[Created on 2/12/2019]

The arrest of a male nurse for the sexual assault of an incapacitated female patient in Arizona underscores what Public Citizen found in a groundbreaking study last month: State nursing boards are failing to protect patients from nurses who engage in sexual misconduct.

[Created on 1/23/2019]

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]

Pages