After years of unrestrained pharmaceutical influence, the federal Food and Drug Administration has completely lost its way. Scientists, educators, industry and political insiders have documented, over and over again, how the agency has lost its independence and mission in the past decade. Critics charge that the FDA treats the pharmaceutical industry as its client, rather the public and public health.
President Obama didn’t help the problem when he appointed Robert M. Califf to head the agency. Called a “big pharma mega-lobbyist” and the “ultimate industry insider,” he received millions in funding and salary support from Eli Lilly, Merck, Novartis and other drug companies. Worse, Califf was a board member and consultant for a company whose sole purpose is to help pharmaceutical companies evade and manipulate FDA regulations.
So a perfect choice for the job. Between 2009 and 2011, prescription drug, biotechnology and medical device companies spent more than $700 million lobbying Congress and the Obama administration. That’s certainly enough to guarantee one of their own received the job.
With such a conflict of interest, U.S. citizens, or consumers, as we are more often labeled, cannot rely on the FDA’s decisions, which is frightening, given that the FDA supposed to protect us, the would-be medicine takers.
So leave it to our nation’s unofficial, trustworthy consumer watchdog, the magazine Consumer Reports, (which hires its own independent drug safety experts to conduct the tests) to warn us clearly and unequivocally to stay away from the highly advertised, new drug called Belsomra to treat insomnia. The top three reasons: It’s expensive ($70 for seven pills), barely works and poses serious safety concerns. Next-day problems after taking the drug included driving accidents, traffic tickets, hallucinations or sleep paralysis — a feeling that you can’t move or talk while falling asleep or awakening.
“The FDA has set a disturbing precedent by approving an untested dose of a drug. For a deadly cancer with limited treatment this gamble might make sense, but not for a condition like insomnia and where Belsomra doesn’t appear to work any better, or more safely, than available treatments,” said Dr. Lisa M. Schwartz at the Geisel School of Medicine at Dartmouth, one of the experts hired by Consumer Reports.
The magazine’s medical advisers say that a sleeping pill is usually not the best treatment for insomnia. Instead, cognitive behavioral therapy, which involves talking to a therapist to learn a new set of behaviors regarding sleep, is as effective as sleeping pills, and has been shown to help up to 80 percent of chronic insomnia sufferers. Studies have found that relaxation training, setting and sticking to consistent bedtimes and wake-up times, regular exercise, quitting smoking, cutting back on caffeine and alcohol in the afternoon and evening, keeping your bedroom quiet and dark, and not watching TV or using smartphones in bed can help relieve insomnia.
Americans deserve a real public health agency again; lobbyists are definitely contraindicated.
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