If you think prescription drugs are getting more dangerous, you are right. Once upon a time if a drug were linked to dangerous side effects or deaths, it would simply not be approved. End of story. Now, the risks are transferred to the patient in the form of detailed warnings on the label and TV commercials.
This provides a false sense of security. Most patients still believe a doctor would not prescribe a drug if it weren't safe and doctors still believe the FDA would not approve a drug it weren't safe. In many case, both have barely noticed the take-at-your-own-risk status of many prescription drugs which once would not have been approved.
Recent examples of drugs that once would not have been approved include the aggressively promoted blood thinners Xarelto and Pradaxa which are linked to uncontrollable bleeding and deaths since there is no drug to arrest bleeding. The FDA received 15,043 reports of serious injury or death linked to Xarelto in one year alone.
Then there's fluoroquinolone antibiotics. Fluoroquinolones are among the best-selling drug classes but are linked to tendinitis and tendon ruptures, liver injury, heart problems and mental effects like confusion, hallucinations and psychosis. The Journal of the American Medical Association reported that of 4,384 patients diagnosed with retinal detachment, 445 (10 percent) were exposed to a fluoroquinolone in the year before diagnosis. Fluoroquinolones are a "major risk factor for development of community and hospital acquired C. difficile infection," reports the Duke Antimicrobial Stewardship Outreach Network (Dason), the dreaded and tenacious intestinal microbe. Last year because of serious side effects, some permanent, the FDA said fluoroquinolones should only be used as a last resort.
Why are such dangerous drugs being waved through? The FDA was always Pharma friendly because of cronyism, the revolving door and huge fees drug makers pay for quicker approvals but it has become more so.
When Robert Califf was confirmed in 2016 as FDA Commissioner despite 23 financial links to Pharma and cheerleading for Vioxx and Xarelto, many felt the industry taint at the FDA could not get worse. Little did they know Trump would pick venture capitalist Scott Gottlieb to be FDA Commissioner----a person so enmeshed with Pharma profits and conflicts of interest, his appointment would once have been inconceivable.
"From 2013 to 2015, for example, Dr. Gottlieb received more than $150,000 to advise Vertex Pharmaceuticals, a company whose two approved drugs are seen as breakthrough treatments for cystic fibrosis but carry list prices of more than $250,000 a year," wrote the New York Times when he was picked. "He's the acting chief executive of Cell Biotherapy, an early-stage cancer biotech firm that he helped found. He has served for years as a consultant to pharmaceutical giants like GlaxoSmithKline and Bristol-Myers Squibb and is paid by other companies for his expertise."
Gottlieb has also held seats on the corporate boards of Tolero Pharmaceuticals and MedAvante, which assists pharmaceutical companies with clinical trials, the Times noted.
Of course it is not just the FDA that now belongs to industry under Trump. The new head of the Department of Health and Human Services, Alex Michael Azar II, is a former Pharma executive and lobbyist. Think about that.
With the foxes guarding the henhouses, is it any wonder drugs are becoming more expensive and dangerous?
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