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.
READER COMMENTS
steve
Feb 15 2025 at 1:51pm
I think in the ideal, you would eliminate financial conflicts of interest. In the ideal, you would also eliminate all other unfair bias. If you work in medicine long enough you realize that some people are biased against some therapies without a rational basis. Maybe they had a bad outcome early in their practice with a given therapy so they just wont look at or listen to evidence without bias for that therapy or something they consider similar ever again. However, we dont live in the kind of world. What we can try to do is make sure that when there are financial conflicts they are made apparent (as well as other biases).
It also makes sense just from a pragmatic POV to have drug company reps involved. They will know the details of the studies better than anyone so rather than having to delay meetings to ask for more details you can ask the people present. By and large the people on the committees have other full time jobs so if they make the time commitment we should make an effort to move things along efficiently.
Steve
Craig
Feb 15 2025 at 2:20pm
“I think in the ideal, you would eliminate financial conflicts of interest.”
I agree and I don’t think that what is being complained about are FDA employees having stock options in Moderna. Those employees do have to make financial disclosures of course, but rather I think what is at issue is more along the lines of ‘regulatory capture’ where the regulators are hoping to retire or move someday into a plum private sector position.
Alan Goldhammer
Feb 15 2025 at 6:42pm
“I agree and I don’t think that what is being complained about are FDA employees having stock options in Moderna.” (for some reason I cannot use the quote functions from Microsoft Edge; they don’t show up even though the HTML code is correct)
FDA employees are not permitted to hold stock in any company subject to regulation. I had a good friend who retired from a large pharma company and had to divest all of his stock when he went to FDA to work as a special assistant.
Alan Goldhammer
Feb 15 2025 at 6:39pm
Something I know a fair amount about as David and Charley both know. I was a part of the pharma industry team that negotiated the first user fee act that added resources to the FDA from industry paid fees. I was also involved in the first four reauthorizations of the Act. It allowed the FDA to hire more reviewers and improve the IT infrastructure. We were accused at the time by “buying off the FDA.” Nothing could be further from the truth. We only wanted performance goals that would be reported out every year. I give a lot of credit to then FDA Commissioner, David Kessler, who recognized that the Agency was having difficulty in getting work done in a timely manner.
Regarding advisory committees, I don’t think there is a shortage of experts for FDA to draw upon. I have always been one who supports transparency rather than outright prohibitions. As long as the FDA has a broad group of experts, which they always do, the presence of one or two who have appropriately communicated that they may have a conflict I don’t see an issue. One of the worst FDA decisions of all time came with the approval of Adulhelm for Alheimer’s Disease against the advice of the AC. The drug did not work and was withdrawn from the market leaving FDA and those who supported the approval with egg on their face.
Billy Kaubashine
Feb 16 2025 at 11:28am
Full and adequate disclosure rules would do much to eliminate the harmful effects of conflicts of interest without excluding helpful and knowledgeable input from those who know the most and deserve to profit from it.
Same goes for politicians. Don’t ban Legislator “X” from owning stock…….Make Legislator “X” (and her family members) promptly disclose all investments.
David Henderson
Feb 16 2025 at 11:36am
I agree.
Peter
Feb 16 2025 at 1:29pm
I don’t know if I agree here. Approving authorities, panels in this case, don’t need industry knowledge, they simply need to be staffed by diligent intelligent open minded individuals acting in good faith which alas, they generally aren’t. It’s on the presenter to present the material in a way that they can understand it and I’d go as far as to say it should be in plain English at a level a completely unaffiliated zero knowledge high school student could follow.
The problem isn’t a lack of insiders with expert knowledge that don’t have industry ties as the article suggests but an odd belief that approving panels should be made up of those sort of people at all.
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