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FDA approved drugs may become riskier

FDA approved drugs may become riskier

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The FDA rejected this dangerous drug

Since the birth defect tragedies of thalidomide fifty years ago, the FDA has been passionately committed to only approving drugs that are safe and effective. Frances Kathleen Oldham Kelsey, an FDA drug reviewer, refused to approve the anti-nausea drug even though it was approved and in wide use elsewhere.

Now those safeguards are slipping away for two reasons. President Trump has promised to speed FDA drug approvals and “off-label marketing” on the part of drug makers is increasingly called "speech" and legal. 

Speedy or expedited approvals are correlated with more risky drugs. Vioxx, Bextra, Baycol, Trovan, Meridia, Seldane, Hismanal, Darvon, Raxar, Redux and at least 11 drugs have been withdrawn after wide user showed them unsafe; some had expedited approvals.

“Off-label marketing” is claims of benefit by drug makers not established by the FDA and/or downplaying or hiding of safety risks that have been established or might exist. It allows drug companies to bring their sales pitch directly to doctors and patients long before safety and effectiveness have been established and raises the question—why have any FDA? Almost all major drug companies have settled off-label promotion charges under the False Claims Act.

In 2015, U.S. District Judge Paul A. Engelmayer ruled that the First Amendment allows a drug company to "engage in truthful and non-misleading speech promoting the off-label use" of drugs and that the FDA cannot bar such "speech." Recently both the FDA and Amarin Pharma, Inc., manufacturer of the cardiovascular drug Amarin behind the ruling, agreed to stand by the speech decision.

Drug makers are not alone in promoting off-label marketing “speech” not verified by the FDA. In 2014, the FDA itself issued a draft guidance that according to Public Citizen gives “drug companies free rein (the FDA “will not object”) to tell doctors that a medication is less dangerous than the FDA has concluded and is stated on the approved labeling.”

The poster child for off-label marketing might be Pfizer's Neurontin, approved only for "adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults with epilepsy" but aggressively marketed for chronic pain, bipolar disorders, and other psychiatric conditions.

Another off-label marketing scheme centered around Evista, a selective estrogen receptor modulator. Eli Lilly, its manufacture, noted fewer breast cancer cases in an Evista trial and wanted to market if for prevention of breast cancer for which it was not approved and despite American Society of Clinical Oncology doctors advising Lilly the anticancer marketing claims were an egregious stretch and that Evista's high risk of stroke negated any anticancer benefits.

Eventually Evista did receive approval to reduce the “risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer” but the caution was also justified. Its label warned about "Serious and life-threatening side effects," “death due to stroke," and that the drug doesn’t “completely prevent breast cancer."

Nonetheless, Scott Gottlieb, named FDA Deputy Commissioner for medical and scientific affairs in 2005, wrote a scathing oped to the Wall Street Journal claiming that Lilly’s off-label marketing and guilty plea turned out to be a “public service.”

The appointment of Gottlieb, a Wall Street insider known for recommending hot medical stocks and often having to recuse himself when Deputy Commissioner for his stock holdings, was assailed by former FDA Commissioner Donald Kennedy and Jerome Kassirer, former editor of The New England Journal of Medicine at the time. Now, Gottlieb is reportedly on Trump’s short list to head the FDA despite his strong links to the drug industry.

Over 50 years ago, the company that made thalidomide complained to the FDA that Kathleen Oldham Kelsey, who rejected the drug, was a petty bureaucrat. What if thalidomide had been granted a speedy approval and off-label marketing about it allowed? 

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