Majority of doctors who oversee FDA drug approval receive payments from companies they monitor, report shows

Strict guidelines for conflicts of interest prior to drug approval, but lax rules afterwards

Clark Mindock
New York
Thursday 05 July 2018 19:36 BST
The study found that physicians often receive financial support from the drug companies after they oversee their drug approval
The study found that physicians often receive financial support from the drug companies after they oversee their drug approval (Reuters)

Independent advisers tasked with reviewing drugs for the US Food and Drug Administration (FDA) sometimes receive massive financial support from the very companies they are tasked with overseeing, in spite of strict conflict of interest rules intended to cut down on that potential influence, a new investigation by Science magazine has found.

The financial support can include direct payments to the researchers, or indirect support through research funding from major pharmaceutical companies and their competitors hoping to bring a new drug market.

The magazine’s investigation found that this support was doled out after the drugs were approved, thus avoiding the types of disclosures that would have raised questions by the FDA during the drug approval process.

The analysis of payments, made public through disclosures in scientific publications,found that, of 107 physicians who advised the FDA on 28 drugs that were approved between 2008 and 2014, the majority of them later received financial support — including direct payments for consulting, reimbursements for travel expenses, or other support for research — from the companies whose drugs they voted on.

That includes seven physicians who received over $1m (£750,000) in such financial support from the companies, 19 who received between $100,000 (£76,500) and $1m, 14 who received between $10,000 (£7,500) and $100,000, and another 26 who received between $1,000 (£756) and $10,000 in financial support. Forty-one physicians or advisers received no payments or financial support from the companies they voted on.

One of those physicians identified in Science Magazine’s report is Jonathan Halperin, a cardiologist with Mount Sinai in New York. Mr Halperin, who received at least $2.1m (£1.59m) in financial support from pharmaceutical companies like AstraZeneca, disputed the notion that after-the-fact payments for consulting or in support of research influenced his decision making process.

Mr Halperin further noted that he did not receive direct benefits from the $1.9m (£1.44m) AstraZeneca provided to Duke University, where he chairs a data monitoring committee for pharmaceutical research. But, he indicated that the relationships like his with pharmaceutical companies and those tasked with overseeing the FDA’s drug approval process may be the price to pay for expertise.

“It’s probably better to have someone who has some experience in “the specialised topics considered] than a bunch of un-conflicted high school students,” Mr Halperin told the magazine.

He did indicate that he shares concerns that expectations of future rewards could promote bias.

“I share [the] concern that this could lead to people acting in ways that you would not want them to do,” Mr Halperin said. “We don’t want incentives that are not serving the public interest. In my case, it’s the patient’s interest”.

Mr Halperin was not immediately available to respond to questions regarding his role and his ideas about these perceived after-the-fact conflicts when The Independent contacted his office for comment and clarification.

The FDA told The Independent that it does not generally comment on specific reports or articles, and did not respond to specific follow-up questions regarding the FDA’s policies regarding after-the-fact financial compensation, and what concerns those might raise.

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