FDA's Makary stacks the deck with conflicted "expert panels"
Promoting "listening sessions" that don't listen to disparate voices
Last month, FDA commissioner Marty Makary, MD, led a panel on menopause replacement therapy that didn’t sit well with many women’s health experts. It sat well with some - those who were handpicked and invited by Makary to sing the same tune in rhythm with what Makary wanted to hear. And it undoubtedly sat well with those who agreed with the handpicked huddle.
This month - in what seems like it will be a continuing pattern by Makary - he led another “expert panel” on selective serotonin uptake inhibitors (SSRIs) - a type of antidepressant used during pregnancy.
As I did when I wrote about the menopause panel, I’m not going to dig into the evidence; there are people who have done that better than I could. I’m going to focus again, as I did with the menopause panel, on how this “show” was managed, and what some of those who weren’t invited had to say afterwards.
FDA Senior Advisor for Clinical Sciences Tracy Beth Hoeg MD, PhD, gave the introduction, “very excited” about the panel of “world-renowned experts.” And, “to start off the show” as she put it, she introduced Dr. Makary, who said:
We are here to listen to all of you. We want this to be a robust discussion where you feel unfiltered and uninhibited to share your scientific opinions.
There were a lot of viewpoints that weren’t represented in the panel and, so, were not listened to at this event. So there was some filtering that took place because the “unfiltered, uninhibited” opinions were selected to be of one mind. Indeed, it didn’t feel like a scientific session. It felt like “a show” - more like a barbershop quartet in perfect harmony. Because there wasn’t an exchange of competing scientific opinions.
Journalist Merrill Goozner wrote under this headline:
Excerpts:
This wasn’t an advisory committee. It was a presentation committee, where each of the panelists made five- to seven-minute presentations with no one from the public allowed to speak or ask questions.
The 10-person roster, seven of whom were men, was larded with critics who have spent their careers attacking the science behind anti-depressants and questioning their use, both in pregnancy and in general psychiatry. …
At the outset of the hearing, Høeg asked each of the ten panelists making presentations to declare their conflicts of interest. None did. One said he had no conflicts. The rest ignored the request and never addressed the issue, even though three of the panelists had jointly issued a paper in 2019 disclosing they worked as consultants in anti-SSRI litigation. That paper suggested SSRI use during pregnancy leads to genetic “malformations,” a claim refuted by other studies.
Lizzy Lawrence of Stat News reported: “9 out of 10 panelists have either been paid witnesses in litigation involving antidepressants, run media platforms rooted in SSRI skepticism, or have published research pointing to the drugs’ potential risks in developing babies. Many share the views of health secretary Robert F. Kennedy Jr., who has called SSRIs harder to quit than heroin and has falsely linked them to mass shootings.”
NPR reported under this headline:
Excerpt:
Opening the panel discussion on FDA on July 21, FDA Commissioner Marty Makary said that SSRIs have been "implicated" by studies to be involved in a range of health effects, including pulmonary hypertension and cardiac defects in babies. Then a majority of the panelists, including psychiatrists, psychologists and a social work professor, cited studies they said illustrate serious health risks, like miscarriage and autism.
Several groups of healthcare providers, including the American College of Obstetricians and Gynecologists (ACOG) and the National Curriculum for Reproductive Psychiatry have spoken out against many of the claims made by the panel, saying that it misrepresented evidence and spread misinformation.
Here’s an excerpt from ACOG’s statement afterwards:
Today’s FDA panel on SSRIs and pregnancy was alarmingly unbalanced and did not adequately acknowledge the harms of untreated perinatal mood disorders in pregnancy. On a panel of 10 experts, only one spoke to the importance of SSRIs in pregnancy as a critical tool, among others, in preventing the potentially devastating effects of anxiety and depression when left untreated during pregnancy.
Robust evidence has shown that SSRIs are safe in pregnancy and that most do not increase the risk of birth defects. However, untreated depression in pregnancy can put our patients at risk for substance use, preterm birth, preeclampsia, limited engagement in medical care and self-care, low birth weight, impaired attachment with their infant, and even suicide. Data also show that discontinuing SSRIs due to pregnancy or lactation can carry risks. Patients need access to evidence-based, compassionate treatment options so that they can continue their paths to parenthood in sound physical and mental health.
The National Curriculum in Reproductive Psychiatry (NCRP) said:
We are deeply concerned that the panel included speakers who presented misleading or stigmatizing information about psychiatric treatment during pregnancy, undermined the scientific consensus, and failed to appropriately center the well-being of pregnant individuals.
NCRP’s statement included a long section on misrepresentation of evidence and ideological bias.
The Society for Maternal-Fetal Medicine (SMFM) said:
As experts in high-risk pregnancies, the Society for Maternal-Fetal Medicine (SMFM) and its members are alarmed by the unsubstantiated and inaccurate claims made by FDA panelists concerning maternal depression and the use of SSRI antidepressants during pregnancy.
Journalist Goozner concluded his article on the panel event this way:
How sad. Makary and his boss, Robert F. Kennedy Jr., came into office declaring they’d adhere to full transparency in their dealings with the public. They also promised to eliminate conflicts of interest from the committees advising the Health and Human Service Department’s various sub-agencies. What we’re getting instead is a complete lack of transparency and committee members that may not have ties to industry but are ideologically biased with financial ties to other parties with a stake in the agency’s decisions.
Makary has referred to these events as “listening sessions.” But they’re really telling sessions. The voices of ACOG, NCRP, SMFM and others were not heard much less listened to in this “show.” A lot of the talk about transparency by the new leaders of US federal health agencies feels like empty, feel-good rhetoric. True “listening sessions” would invite and openly engage differing opinions with participation from the audience as well - something that has not happened in these shows so far. Instead, Makary knows exactly what he wants to hear and he gets it delivered to him, in an event that is highly promoted and posted on YouTube. He’s stacking the deck, and losing public trust in the process.
It’s time for more listening - from disparate parties- and fewer barber shop quartet tunes that fall flat in handpicked harmony.
Gary, maybe Makary has it right. It's so much easier to get stuff done when you're surrounded by reliable supporters. Debate, dialogue and viewpoint diversity - so overrated!