Drugs

Probe 2 ‘Unethical’ Minnesota Tests: Public Citizen

Public Citizen says FDA and the HHS Office for Human Research Protections (OHRP) should immediately investigate two prospective clinical trials in Minnesota that involved testing the general anesthetic ketamine and powerful sedatives on patients without their consent. The advocacy group was joined by 64 doctors, bioethicists, and academics in the call for FDA/OHRP action, according to a Public Citizen news release (contains link to letter to FDA and OHRP).

The group says that researchers at Hennepin County Medical Center failed to obtain consent from test subjects for high-risk clinical trials involving testing the safety and effectiveness of the ketamine compound compared with other potent sedative drugs for managing pre-hospital agitation. The drugs were injected into the subjects by Hennepin County emergency medical system paramedics, Public Citizen says.

The trials were first reported by the Minneapolis Star Tribune and described in the journal Clinical Toxicology. “The use of ketamine in particular made these experiments high-risk,” says Public Citizen Health Research Group director Michael Carome. “Ketamine can cause severe airway obstruction, interfering with breathing.”

The hospital has aggressively defended the trials, Public Citizen says, and has misrepresented them as “observational studies.”

Carome says the “regulatory and ethical lapses in the oversight and conduct of these trials reflect colossal failures of the Hennepin County Medical Center’s human subjects protection program. The failures extended from the researchers to the institutional review board that approved the trials to senior institutional officials. FDA and OHRP must promptly find out whether there are other trials ongoing at this medical center with similar lapses.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome