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 cases, both have barely noticed the take-at-your-own-risk status of many prescription drugs which once would not have been approved.

The parade of injected biologic drugs that currently dominate the advertising "space,"–– Humira, Dupixent and Stelara––would once not have been approved because of their serious side effects like immunosuppression in light of the minor conditions they address. Some suggest the wide swath of citizens taking advertised biologics explained the US' Covid dramatic toll compared to countries with populations not on immunosuppressing drugs.  

As early as 2004, the FDA's David Graham, Associate Director of the Food and Drug Administration's Office of Drug Safety, highlighted the dangerous drugs being waved through. "I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless," he said. While he was at FDA, dangerous drugs like Trovan, Lotronex, Baycol, Seldane, and Propulsid were removed or restricted.

The blood thinners Xarelto and Pradaxa, highly promoted ten years ago, once would not have been approved because of their links to uncontrollable bleeding and deaths. In 2017, the FDA had received 15,043 reports of serious injury or death linked to Xarelto in just one year.

Then there's fluoroquinolone antibiotics. Fluoroquinolones were among the best-selling drug classes despite their links 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. After revelations of serious side effects, some permanent, the FDA finally said fluoroquinolones should only be used as a last resort.

CONFLICTS OF INTEREST

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.

Former FDA commissioners Robert Califf and Scott Gottlieb were poster children for conflicts of interest (COI). Califf had 23 financial links to Pharma when approved for the post by Joe Biden in 2021 after his previous service under Obama. He admitted and defended his close collaboration with drugmakers and unabashedly cheer led for Vioxx and Xarelto.

Venture capitalist Scott Gottlieb's COIs, commissioner from 2017 to 2019, almost sounded like a satire.

“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 had also held seats on the corporate boards of Tolero Pharmaceuticals and MedAvante, which assists pharmaceutical companies with clinical trials, the Times noted.

And the COIs are not just at FDA. Alex Michael Azar II, who headed the Department of Health and Human Services (HHS) from 2018 to 2021, was actually a former Pharma executive and lobbyist! No divided loyalties there.

In addition to extirpating Pharma funded government officials how can the proliferation of dangerous prescription drugs be stopped? A good start is to ban direct-to-consumer drug ads, Pharma's primary route of dissemination.