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    Home»Economy»Are Conflicts of Interest at the FDA a Big Problem?
    Economy

    Are Conflicts of Interest at the FDA a Big Problem?

    Press RoomBy Press RoomFebruary 15, 2025No Comments4 Mins Read
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    I caught a little snippet on Fox News Channel in the last day or two of RFK, Jr. in the White House after he was confirmed as secretary of the Department of Health and Human Services (HHS.) I was already nervous about him. When I hear someone who is used to advocating government coercion say that he wants to “make America health again,” I worry that he wants to regulate what various food producers can put in our food.

    When I saw that recent snippet, I got nervous for another reason. In those few seconds he spoke, he said he would go after conflicts of interest at the FDA (Food and Drug Administration), the CDC (Centers for Disease Control), and the NIH (National Institutes of Health.)

    As someone who believes that incentives matter, you might think that I would favor going after conflicts of interest. I don’t know enough about the CDC and the NIH, but in the case of the FDA, I don’t favor doing so. I start with the assumption that incentives matter, but I also believe in looking at the evidence. Co-author Charley Hooper, who follows the FDA closely, and I wrote a piece over 15 years ago in which we wrote about the problems with excluding from the FDA’s drug panels people who had conflicts of interest. The basic problem is that you might not get enough people who know much about the drug being considered.

    I reposted our article at my Substack. It’s titled “Swing Vote at the FDA.”

    We lead as follows:

    In Kevin Costner’s new comedy Swing Vote, the presidential election comes down to a single voter. The premise is absurd. But we don’t need to go to the movies to see absurd plots in which big decisions hinge on one voter. The U.S. Congress, via the Food and Drug Administration, has created its own. Except this time, it’s a tragedy.

    Congress requires the FDA to severely limit independent experts from participating in FDA advisory committees if they have ties to industry. But the FDA has run into an intriguing problem with one rare disease, infantile spasm—a devastating form of epilepsy that strikes about 8,500 U.S. infants in the first year of life. When the FDA excluded all those with a “conflict of interest,” it ended up with only one available committee member.

    Later in the piece, we give our evidence and, surprisingly, it comes from a Naderite organization. We write:

    Thankfully, the hypothesis that having worked for a drug company makes an expert corrupt can be tested. In fact, this hypothesis has been tested—and rejected. Moreover, it was rejected by a study done by five researchers, four of whom were employees of the Naderite Public Citizen’s Health Research Group.

    In 2006, Sidney Wolfe and three of his fellow employees, along with one other author, published an article in the Journal of the American Medical Association that draws on 221 meetings of FDA advisory committees, including 76 product-specific meetings that involved yes or no votes on individual drugs.

    Their findings? None of the 76 voting outcomes would have changed had voters with conflicts of interest been excluded. [italics added] The authors also found that those with conflicts were no more likely to vote for “their” company’s drug than those without conflicts. Indeed, those with a conflict were actually more likely than those without to vote for drugs that would compete with “their” company’s product. That didn’t stop Wolfe and his co-authors from concluding, “Ideally, all panels of scientific experts advising a federal decision-making body would be free to financial conflicts of interest with the affected companies.” Their own findings, though, belie that conclusion.

    Read the whole thing, which is not long.



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