The Washington PostDemocracy Dies in Darkness

New book recounts the FDA’s ‘unholy birth’

Mikkael A. Sekeres, an oncologist and a former FDA Oncologic Drugs Advisory Committee chairman, wrote “Drugs and the FDA: Safety, Efficacy and the Public’s Trust.” (Sylvester Comprehensive Cancer Center)

Decades ago, people could hawk dangerous patent medicines and promise benefits — even when their concoctions might have catastrophic consequences.

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

It was an “unholy birth,” writes Mikkael A. Sekeres, an oncologist and a former FDA Oncologic Drugs Advisory Committee chairman, in his new book, “Drugs and the FDA: Safety, Efficacy and the Public’s Trust.”

After its rough beginnings, Sekeres says, the agency’s development into a trusted institution was rocky. Sekeres’s book recounts the FDA’s tumultuous early years as well as more current challenges, including showing how its public health safeguards were tested by a modern-day breast cancer drug.

Early “treatments,” known by names like Benjamin Brandreth’s Vegetable Pills and Peruna, could range from ineffective to deadly. It would take the advocacy of concerned patients and parents, the work of muckraking journalists, and a tragic drug adulterations, including children’s deaths from tetanus-tainted smallpox and diphtheria vaccines at the turn of the 20th century, to launch the FDA.

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Sekeres writes about everything from the FDA’s painstaking 1937 search for remaining bottles of a deadly elixir with antifreeze in it to the agency’s 1962 demand that drugs be both safe and effective to be marketed in the United States.

He weaves in his experiences evaluating whether the FDA should allow the sale of Avastin, a drug approved to treat breast cancer in the face of data that showed it didn’t prolong or improve the quality of patients’ lives. In 2011, the FDA withdrew approval for that use of the drug, and Sekeres paints a vivid picture of a process he says tested the FDA’s mettle.

It’s a physician’s-eye-view on the products that fill our medicine cabinets, but Sekeres includes patients in the mix, too. A public that, in his words, “revolts, protesting loudly enough to be heard, to provoke change” is the true driver of this engaging book — and a reminder of who the complex, sometimes “maddeningly deliberate and slow” agency should ultimately serve.

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