Drugs

Lawyers Discuss FDA Bias Concern on Chantix Study

A briefing document prepared for a joint advisory committee meeting that voted 10-9 to recommend removal of a Boxed Warning for Pfizer’s Chantix relating to potential psychiatric risks, including suicide and suicidal ideation, raised CDER medical reviewer concerns that data from a company post-marketing study were biased depending on how money the company gave the investigators. Three Hogan Lovells attorneys write in an online blog post that the study results appeared to show that the drug did not significantly increase the incidence of suicide and suicidal thoughts.

“FDA suggested that money given to investigators from Pfizer may have influenced the study results,” the post says. “According to the briefing document, in sites where investigators received $25,000 or more in speaking and consulting fees from the company, only 1.8% of patients who had already been diagnosed with a psychiatric disorder were reported to have side effects, such as anxiety, agitation, hostility, or suicidal thoughts, during the trial. On the other hand, at locations where physician/investigators received less money or no payments at all from Pfizer, 6.4% of patients were reported to experience such side-effects.”

The attorneys say that the agency’s briefing document message was essentially clear — the study results may not be trustworthy given how the data were collected and analyzed, and due to conflicts of interest related to payments to investigators. “This briefing document is the first time we are aware of agency disclosure of concerns about bias from industry payments to clinical investigators,” they write. “We will be watching closely for other indicators of concern by the agency regarding such payments…. Given that reviewers have expressed concerns about the data used to support the removal, this regulatory decision will be particularly interesting and one that could influence conflicts of interest disclosure policy going forward.”

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