New book chronicles ‘unholy birth’ for FDA

Decades ago, people could promote dangerous patented drugs and promised benefits — even when their concoctions could have disastrous consequences.

Then several tragedies occurred, killing and maiming children and adults in the name of health. Subsequently, the United States created the Food and Drug Administration, the federal agency that today oversees and regulates prescription drugs, medical devices, and other products.

Mikkael A. Sekeres, an oncologist and former chair of the Food and Drug Administration’s Oncology Drugs Advisory Committee, wrote in his new book, “Drugs and the Food and Drug Administration: Safety, Efficacy, and Public Trust,” it was an “unholy birth.”

After its difficult beginnings, Sekers says, developing the agency into a trusted organization has been difficult. Sekeres’ book chronicles the FDA’s turbulent early years as well as more current challenges, including showing how public health safeguards have been tested by a modern breast cancer drug.

Early “remedies,” known by names such as Benjamin Brandreth and Perona’s vegetable pills, can range from ineffective to fatal. It would take the advocacy of concerned patients and parents, the work of troubled journalists, and tragic drug fraud, including child deaths from tetanus-contaminated smallpox and diphtheria vaccines at the turn of the 20th century, to launch the Food and Drug Administration.

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Sekeres writes about everything from the FDA’s painstaking 1937 search for remaining bottles of a killer elixir with antifreeze to the agency’s 1962 claim that the drugs were both safe and effective for market in the United States.

He weaves in his experiences evaluating whether the U.S. Food and Drug Administration should allow the sale of Avastin, a drug approved to treat breast cancer in the face of data showing it does not prolong or improve patients’ quality of life. In 2011, the Food and Drug Administration withdrew approval for this use of the drug, and Sekeres paints a vivid picture of the process that he says has tested FDA strength.

It’s the doctor’s view on the products that fill our medicine cabinets, but Sekeres includes patients in the mix, too. An audience that, in his words, “revolts, protests loudly enough to be heard, to provoke change” is the real driver of this engaging book—and a reminder of who the sometimes “deliberate and insanely slow” agency must serve.

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from San Jose News Bulletin https://sjnewsbulletin.com/new-book-chronicles-unholy-birth-for-fda/