Fda顧問利益衝突可能性浮上檯面

Report details possible conflict of interest issues for FDA advisors July 6, 2018 by Bob Yirka, Medical Xpress Charles Piller, a contributing correspondent for the journal Science, has published a Feature piece in the journal detailing what he describes as possible conflicts of interest issues by people who serve as advisors to the FDA. In his report, he offers examples of what he describes as possible conflicts of interest. He also suggests the FDA might want to review its rules regarding what advisors can and cannot do after they have served in an advisory role for the agency. The Food and Drug Agency is tasked with providing a safeguard for the public. Food and drugs proposed by business entities are reviewed by teams at the agency and must win a seal of approval before they are allowed to sell a product to the public. As part of this process, the FDA calls in expert advisors to offer testimony or advice on given products, such as new drugs. In his report, Piller focuses on people who worked as advisors for the FDA who later received what could be perceived as compensation from those they have reviewed, for their efforts. He and associate Jia You looked at publicly available data concerning 107 doctor advisors and found that 40 of them received benefits such as payment for hotels or research grants. More than half of them, he notes, received over $100,000 in such "gifts," and seven of them got more than $1 million worth. And none of the payments were reported by the FDA. One doctor in particular, he notes, received $1.9 million from a pharmaceutical company after one of its drugs was approved by a panel on which that doctor had been an advisor. In a related segment, Piller notes that it is not just advisors who might be engaging in questionable activities. He notes that one former director for the agency who was once involved in reviewing drugs now operates a consulting business that offers advice to pharmaceutical companies on how to get their drugs approved.Piller sums up his paper by suggesting that it might be time for the FDA to shore up its non-compete contracts for both advisors and employees—doing so, he notes would eliminate the possibility of such people making decisions that are in their own best interests rather than those of the public.

More information: Charles Piller. Hidden conflicts?, Science (2018). DOI: 10.1126/science.361.6397.16 Summary An investigative report uncovers little recognized and unpoliced potential conflicts of interest among those who serve on FDA advisory panels that review drugs. Some members of such panels are later receiving significant payments from either the makers of drugs they previously reviewed, or from competitors. This is happening despite the FDA's established system to identify possible financial conflicts of interest among those recruited for the drug advisory panels. The investigation analyzed records on the federal Open Payments website between 2013 and 2016. Of 107 physician advisors who voted on FDA advisory committees during this time, 26 later took more than $100,000 from the makers of drugs, or from competing firms. in post-hoc earnings or research support. Even though these payments might not be truly "quid-pro-quo," according to Vinay Prasad, an oncologist who also studies financial conflicts that exist in drug approvals, those asked to weigh in stand to gain tremendously in their further professional careers. "It's in their best interest to play nice with the companies." FDA may also have missed or judged insignificant financial ties physicians had before their service on the drug approval advisory panels.