Tuesday, February 28, 2017

Will FDA obey Trump, take step backward?

Researcher warns of using under-tested drugs, cites futile treatment on his father 

Dr. Cary Gross
Can some cancer treatments do more harm than good?

Absolutely, indicates Cary Gross, professor of medicine and cancer researcher at the Yale University School of Medicine, in a recent article in The Washington Post.

Gross cites the case of his own 80-year-old father, who'd been treated for Hodgkin's disease and couldn't walk because of weakness when his oncologist suggested a new, expensive, risky drug that was covered by insurance.

The oncologist was afraid chemo might do more harm than good but believed the "targeted therapy" treatment that used antibodies to kill only cancer cells would work.

Although the tumors shrunk at first, and Gross' father regained some strength, he experienced mild pain in his feet after a few months, followed by more severe shooting pains through his legs. Those side effects, Gross wrote in his article, again prevented him from walking and kept him bed-bound.

He subsequently died.

"The Food and Drug Administration had approved the treatment based only on a small study of about 100 patients, one-third of whom demonstrated complete remission," Gross reported.

"Although side effects were rare, the average age of patients in the study was 31. This is typical of cancer-treatment studies, which most often test new drugs in younger and healthier people — not older people with lots of medical conditions."

Gross expresses fear that "unfortunately, our government's commitment to evaluating new drugs is about to take a step backward. At a recent meeting with pharmaceutical company executives, President Trump announced he would be cutting regulations 'at a level nobody's ever seen before.'"

The FDA, he contends, "shouldn't shy away from requiring thorough evaluation of new drugs. The same level of enthusiasm and funding that goes into developing new treatments should be invested in testing whether they are safe and effective in patients outside of the initial small trials. Under-tested drugs with unclear safety profiles and efficacy should not be given to broad swaths of the population."

Other illustrations of clinic trials and their aftermath can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a VitalityPress book I, Woody Weingarten, aimed at male caregivers.

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