FDA ‘Black Box’ Lacks Transparency

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The Food and Drug Administration (FDA), the oldest “consumer protection agency” in our federal government, has lacked transparency for many years, writes New York neurologist Lawrence R. Huntoon, M.D., Ph.D., in the summer issue of the Journal of American Physicians and Surgeons. This deficiency “has adversely affected many aspects of science, medicine, public health, and safety.”

The FDA inspects clinical trial sites to ensure the safety of study participants and the quality and integrity of the data. These inspections occasionally reveal objectionable practices, such as failure to obtain informed consent, falsification of data, or violations in adverse event reporting. However, these reports have been largely hidden from public view, Dr. Huntoon writes.

More than half of the clinical drug trials that FDA relies on for drug approval remain unpublished years after approval. Studies yielding positive results are more likely to be published than those with negative results. This may falsely suggest that the new drugs are more efficacious and/or safer than the old drugs, according to literature that Dr. Huntoon cites.

The FDA often relies on overseas drug manufacturers, mainly in China and India, to self-monitor the quality of drugs produced and report any problems that are discovered. There have been substantial safety problems. People may have been taking the drugs years before they are recalled, Dr. Huntoon reports.

The FDA has uniform guidelines for acceptable clinical trials, but according to a 2014 study published in JAMA, many drugs are approved even though trials fail to adhere to these guidelines.

The information FDA provides to the public may contradict information provided by another government health agency, such as the Centers for Disease Control and Prevention (CDC), writes Dr. Huntoon. For example, warnings about the purported risks of using hydroxychloroquine to treat COVID-19 outside the hospital or clinical trial contradict information from the CDC and the American College of Cardiology.

Problems resulting from lack of transparency, Dr. Huntoon states, include incorporation of poor quality, fabricated, fraudulent data into publications, recommendations for “evidence-based care,” clinical guidelines, formularies, and standard-of-care declarations.

“FDA has a demonstrated history of being highly resistant to both internal and external efforts to improve transparency,” Dr. Huntoon concludes.

The Journal of American Physicians and Surgeons is published by the Association of American Physicians and Surgeons (AAPS), a national organization representing physicians in all specialties since 1943.

Read Full Article: https://jpands.org/vol25no2/huntoon.pdf