Drugs

‘Dangerous, Unethical’ Tests at Minn. Medical Center: Public Citizen

FDA inspected a Minnesota medical center and found violations that “subjected unwitting patients to dangerous and unethical human testing,” according to documents obtained by Public Citizen under the Freedom of Information Act (FOIA). Researchers at Hennepin County Medical Center “failed to obtain consent from test subjects for high-risk clinical trials that involved testing the safety and effectiveness of ketamine compared with other potent sedative medications for management of pre-hospital agitation,” the group said. The medications were injected into the subjects by Hennepin County emergency medical system paramedics.

The agency inspected the medical center’s institutional review board in August and evaluated records related to the IRB’s review and approval of the ketamine research and at least two other studies. “In a July 25 letter (PDF), Public Citizen and 64 doctors, bioethicists and academics requested that the FDA and the Office for Human Research Protections (OHRP) investigate the medical center,” Public Citizen says.

The advocacy group recently received the initial FDA inspection results in a response to a FOIA request, which revealed that “the Hennepin center’s IRB approved the research without ensuring that the FDA’s requirements for obtaining informed consent of the subjects and for providing adequate safeguards to protect the rights and welfare of vulnerable subjects were satisfied.”

Public Citizen, joined by two bioethicists at the University Minnesota, sent a follow-up letter (PDF) today to agency and OHRP that highlighted the key observations made by FDA inspectors. It said the medical center is “clearly incapable of protecting human subjects” and called for a suspension of research at the facility.

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