Associated Press Cannot Explain Bewildering Reporting on FDA’s Tracy Hoeg and Antidepressant Risks

AP global health editor Jonathan Fahey did not respond to repeated requests to defend journalistic errors that dismissed peer reviewed studies.

8 minute read

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.”

In his practice, Urato treats depressed women who are on antidepressants and always advises them of the research that has found risks for these drugs to developing fetuses. To ensure all women are warned, he has started a petition that asks the FDA to place a formal warning on the label for antidepressants. READ PETITION HERE.

“There’s 12 MRI studies in humans that show brain alterations found in offspring who were exposed in utero to antidepressants, and the corporate media has ignored this,” Urato says.

The AP falsely states in their story that Urato is making up “unproven pregnancy risks” but Nature Communications published a peer-reviewed study last May that found these exact risks that AP denies. The children of pregnant mothers on antidepressants later exhibited higher anxiety and depression symptoms than unexposed kids. Kids exposed to antidepressants while in utero were also found to have different brain activity when shown photos of fearful faces.

“These findings have potential implications for the clinical use of [antidepressants] during human pregnancy and for designing interventions that protect fetal brain development,” the authors concluded. The study appears in Urato’s petition along with dozens of other peer-reviewed studies.

“What a woman should do varies from patient to patient,” Urato told me. “But the first thing is to inform them. We know that cancer drugs are toxic, but we don’t ignore that and hide it from patients for fear they won’t get treated for cancer.”

Urato says he doesn’t know if the FDA will act on his petition, despite the evidence. “What the FDA will do with that, I don’t know.” However, Urato has had success with a prior FDA petition.

Urato partnered with Public Citizen in 2019 to petition the FDA to withdraw the drug Makena, because it had been approved to stop premature births without adequate data showing it helped pregnant women. The FDA later agreed with the petition and withdrew Makena from the market in 2023.

Oddly enough, AP’s Matthew Perrone covered Urato’s success at getting the FDA to remove Makena from the market, which you can read here: “FDA forces unproven premature birth drug Makena off market.”

“This is all a distraction,” Urato told me. “It’s so stupid. Of course we need to warn women.”

FULL DISCLOSURE: While working in the Senate, I was invited to give the keynote address at a conference on conflicts of interest in medicine and research hosted at Tufts University. Administrators later withdrew my invitation, causing one of the organizers to resign and creating a minor scandal that made news in the Boston Globe.

“It’s too bad a reform perspective has been removed from the program,” the Senate Committee’s spokeswoman told the Globe.

Some days later, I got a call from a physician who said Tufts organizers chose him to give the keynote speech in my place. I remember him being irate that Tufts had silenced me. He told me he wanted to know exactly what I was going to say, as he was going to give my exact same talk. He then took notes as I explained my speech. I may have also sent him my slide deck, but I can’t remember as this conversation took place in 2009.

I do remember laughing during the conversation at the thought that Tufts administrators were going to hear exactly what I was going to say, although it was coming from the mouth of someone they deemed more acceptable.

When I called Urato for this story, I thought it was the first time we had ever communicated. However, he reminded me during our conversation that he was the physician who called me all those years back, angry that Tufts had cancelled my keynote address. And he was the person who gave my talk at Tufts about the importance of conflicts of interest in medicine. Urato sent me this article in the Tufts newspaper to show this was the case.

I have no clue if AP or other reporters believe this makes Urato and I “friends” but feel free to discuss in the comments below.

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Below is the email I sent to AP asking them to explain their bewildering article.

Hello Jonathan,

I’m working on a story about this AP article that claims FDA’s Tracy Hoeg is bringing a “friend” to FDA and that this is an FDA conflict of interest. That story is here https://apnews.com/article/hoeg-urato-fda-drugs-antidepressants-pregnancy-warnings-a2a48cd2285f5b33aef2d390b5b60d0c

While I was a Senate staffer, I wrote a law on COI called the Physicians Payments Sunshine Act that many reporters now use through the government’s Open Payments website. I also helped to reform NIH COI regs. I also wrote an award winning series for the BMJ on FDA COVID vaccine approvals by digging through FDA COI disclosures.

The AP alleges in this passage, which I’ve put in italics:

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 COI for any federal agency. Nor have I run across this claim in the peer-reviewed literature. I also don’t know what “friend” means as I spoke to Adam Urato and he said he’s met Hoeg only a few times and it was only over professional matters.

Senior FDA officials have contacted me and explained that the FDA General Counsel has no legal definition of “friend” and no record of “friend” appearing in any COI policies. I have a couple questions, please.

1. Can you provide me with any evidence FDA/HHS has a legal definition for the term “friend”?

2. Can you provide me with an FDA/HHS policy that lists the term “friend” as a conflict of interest, as AP reports?

3. AP states that Urato wants FDA to add new warnings to antidepressants about “unproven pregnancy risks.” Nature communications published a study about the pregnancy risks to fetuses and SSRI use last May. Can you explain to readers why AP thinks this study is false? Has it been retracted? This is one of many studies showing effects to fetuses from SSRI use.

Again, we need a response by COB today.

Thank you for your time,

Paul