In Washington, the Food and Drug Administration (FDA) has always relied on a panel of trusted experts for guidance. These experts are chosen carefully based on their experience and independence. However, recent actions suggest the agency is moving away from this practice.
FDA Commissioner, Dr. Marty Makary, has introduced ad hoc “expert panels” to discuss various topics such as antidepressants and menopause treatments. Critics, including former officials, are worried that these meetings may overlook essential federal guidelines about conflicts of interest and lack transparency.
Some observers argue these panels seem to favor unconventional opinions that align with certain personal agendas. Dr. Peter Lurie, a former FDA official, expressed concern that the panels aren’t representative of the general scientific community. He highlighted that the panels mainly feature voices with specific financial interests or controversial stances.
The panels began meetings in May, starting with a session discussing talc, a mineral found in some cosmetics and baby powder. This meeting was influenced by ongoing lawsuits alleging talc is linked to ovarian cancer, an assertion not backed by government studies.
In July, another panel focused on antidepressant safety during pregnancy. This meeting included experts tied to lawsuits claiming these drugs cause autism and birth defects. Despite a lack of scientific support for these claims, the panel concluded by calling for heightened warnings about the risks associated with these medications for mothers and their babies.
Interestingly, another panel examined estrogen drugs for menopause, urging the removal of specific warnings, particularly as most experts involved were either prescribers of these treatments or had ties to the pharmaceutical industry. This raised concerns among nearly 80 researchers who called for a more formal official advisory meeting.
FDA advisory panels generally operate under strict transparency rules that dictate how members are selected and mandate public participation. However, the recent meetings have not adhered to these principles. Critics feel the panels could serve more as platforms to endorse pre-existing opinions rather than gather unbiased data.
The recent discussions on antidepressants laid bare a range of unverified claims and theories, often highlighted by critics of pharmaceutical companies. Veteran participants voiced opinions against antidepressants, many of which stemmed from personal viewpoints rather than solid evidence.
Leading medical organizations criticized these meetings, calling them alarmingly unbalanced. While antidepressants do carry certain risks, experts argue that untreated depression poses more significant dangers during pregnancy.
In the context of menopause, last month’s panel included doctors who advocated for hormone therapies but had connections to drug manufacturers. They echoed sentiments expressed by Dr. Makary, who believes current warnings exaggerated the dangers of hormone replacement therapy.
The FDA maintains that these medications are only approved for treating specific menopause symptoms. Ongoing discussions on hormone therapy reflect a long-standing debate stemming from past studies that found serious health risks associated with certain hormone treatments. These debates remain contentious, particularly with calls from some experts to reconsider existing regulations.
As the FDA moves forward, it remains unclear if they will heed calls for more formal and transparent advisory meetings. Critics assert that true transparency would require a more balanced selection of experts free from potential conflicts of interest, highlighting a critical need for a more thoughtful approach to public health decisions.
