Cruising through X last week a weird story caught my eye: it reported that The Food and Drug Administration’s top drug regulator, Dr. Tracy Beth Hoeg, was trying to hire a “friend” who wants the FDA to add warnings to antidepressants about “unproven pregnancy risks.” The story makes several claims that are bewildering and appear to be fabricated. I sent several questions to AP’s global health editor Jonathan Fahey, but he did not respond to repeated requests to explain the article’s puzzling errors.
AP reporter Matthew Perrone later blocked me on X. I’ve pasted my email to Fahey at the bottom of this article.
The person AP’s Matthew Perrone identifies as a “friend” of FDA’s Hoeg is Dr. Adam Urato, chief of maternal-fetal medicine at Metro West Medical Center in Massachusetts.
One passage in the AP story stood out to me:
Within the agency, Hoeg’s close relationship with Urato is viewed as a clear conflict of interest that, under normal FDA standards, would result in her recusing herself from any work on the petition. But Hoeg is actively working to speed up the agency’s review of her friend’s proposal, according to the people familiar with the situation.
I have never seen the term “friend” defined as a “conflict of interest” by any federal agency. Nor have I run across “friend” defined as a “conflict of interest” in the peer-reviewed scientific literature. It’s a conflict of interest that doesn’t seem to exist.
And I happen to know quite a bit about conflicts of interest in science, because I’m an expert on the matter.
While I was a Senate staffer, I wrote a law on conflicts of interest called the Physicians Payments Sunshine Act. The bill I wrote was later passed into law and you can now go look up doctors on the government’s Open Payments website to see who is giving them money. I’m sure AP reporters use this website all the time. During my time in the Senate, I also helped to reform conflicts of interest at the National Institutes of Health. This took thousands of hours, untold numbers of meetings, and years of work to complete.
When I left the Senate and joined the Safra Ethics Center at Harvard, I was celebrated as the “Father of Sunshine” for this work to reform conflicts of interest in medicine.
Confused by the AP’s confusing reporting, I contacted Health and Human Services (HHS) and FDA, sending them almost the exact same questions that I sent to AP’s Jonathan Fahey.
“Being a friend is not a violation of ethics or conflicts of interests’ laws,” wrote HHS spokesman Andrew Nixon, in an email. Several senior FDA officials told me that HHS doesn’t even have a legal definition for what a “friend” is and no government conflict of interest form asks people to identify who their friends are.
“It’s a hit piece from industry against Dr. Hoeg, who is doing an amazing job at the FDA,” said one FDA official.
Hoeg did not respond to requests for comment, but during a phone call, Urato told me the AP story was filled with fake facts. The FDA has not offered him a full-time job as AP reported, and if they did, he couldn’t take it as he has a full-time clinical practice with hundreds of patients. FDA has expressed interest in offering him a limited, part-time position as an “advisor,” but nothing has been formalized.
He’s known Hoeg for only a couple years, and met her once when he went to DC to testify in favor of a labelling change for antidepressants that warns pregnant women about the documented risks for fetuses.
“This whole thing is being made up, and it’s an absurdity,” Urato said. “I’m not close friends with her as we’ve only discussed work. But If I say I’m not friends with her, then it’s like saying I’m her enemy.”
Hellbound and Down 