Washington, Aug 18 (AP) — Traditionally, the Food and Drug Administration (FDA) relies on a roster of expert advisers who are rigorously vetted for independence and expertise when outside guidance is needed. However, the agency isn't always consulting this trusted group recently.
FDA Commissioner Marty Makary has initiated a series of ad hoc “expert panels” to tackle subjects like antidepressants and menopause drugs, enlisting physicians and researchers who often present contrarian views and have financial interests in these topics.
There is concern among former agency officials that these meetings may bypass federal rules governing conflicts of interest and transparency while promoting views aligned with Health Secretary Robert F. Kennedy Jr.
"These meetings provide an opportunity to advance RFK's particular concerns — like talc, antidepressants, and fluoride — through handpicked participants,” commented Dr. Peter Lurie, a former FDA official and current president of the Centre for Science in the Public Interest. “No one would regard these panels as reflecting general scientific consensus on these topics.”
A spokesperson for Kennedy did not respond to detailed questions about these panels, stating instead that they aim to apply “rigorous, evidence-based standards to ingredient safety and modernize regulatory oversight.”
In May, an inaugural meeting centered on talc, a soft mineral used in cosmetics and baby powder, echoed numerous lawsuits claiming its link to ovarian cancer, despite federal studies finding no cancer connection.
July witnessed a meeting about the safety of antidepressants during pregnancy, where experts claimed the drugs cause autism and birth defects—claims not supported by scientific evidence. The meeting concluded with a majority calling for new warnings about antidepressant use by expecting mothers.
A separate meeting on menopause estrogen-based drugs saw experts favor the removal of longstanding warnings, with many involved having connections to the pharmaceutical industry.
Nearly 80 researchers have formally objected to the “hormone proponents” meeting and requested an official advisory committee session.
FDA's official advisory panels operate under stringent transparency requirements, including public disclosure and opportunities for public comments. Meetings typically conclude with FDA scientists sharing a detailed memo of their recommendations. The recent ad hoc sessions have not followed such protocols.
There is legal concern that the FDA could face challenges if it bases regulatory actions on information from these informal panels.
Genevieve Kanter, health policy specialist at the University of Southern California, suggested, “These panels appear to be aimed at legitimizing preset opinions,” noting that such information might be used in legal disputes as credible expert consensus.
Kennedy, a critical voice against pharmaceutical companies, has historically targeted antidepressants, even alleging they might contribute to school shootings without evidence.
The FDA session aired unverified claims connecting these drugs to autism, supported by experts who had previously testified in lawsuits against pharmaceutical firms. Psychiatric experts argue that the documented risks are minimal compared to the known consequences of untreated maternal depression, which include pregnancy complications and even suicide.
Moreover, FDA has not clearly disclosed its selection process for panelists, and the menopause hormone meeting seemingly reflected pre-established stances, consistent with Makary's view that current warnings exaggerate risks of hormone therapies.
Makary has praised hormone replacement therapies as "modern-day miracles,” despite FDA and other authorities advising against their use for preventing chronic conditions.
There is ongoing debate about a significant study stopped 20 years ago that linked hormone use to severe health risks. Even so, some doctors argue that warnings are overemphasized, especially for low-dose products.
The FDA's next steps remain uncertain, whether adopting changes or convening an official advisory meeting. Critics argue that Kennedy's commitment to "radical transparency" demands balanced panels free of conflicts.
"Real transparency would entail forming balanced expert panels, rigorously screened for conflicts of interest while welcoming public participation,” Lurie pointed out. “This approach starkly contrasts with the current process.” (AP) SCY SCY
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