From fatal eyedrops to mislabeled melatonin, why the FDA is failing the public

If you want to know just how big and worrisome the U.S. Food and Drug Administration problem is, where do you start?

In a 2022 study by the same journal, the BMJ said FDA oversight of clinical trials involving Pfizer and Moderna’s mRNA COVID-19 vaccines “It’s totally inadequate” From not conducting enough tests to failing to alert scientific journals and the public when violations were reported.

December results are 18-month congressional inquiry He criticized the FDA’s allegedly “fraudulent” actions in approving the launch of Biogen’s expensive Alzheimer’s drug Aduhelm. The report assessed that the agency’s actions “raise serious concerns about FDA’s protocol violations.” “Extraordinary collaboration” In consultation with the drug company, the FDA “must act expeditiously to ensure that the process of reviewing future Alzheimer’s treatments does not raise similar doubts about the integrity of FDA’s review.”

of The effectiveness of the drug is still debated,and it is Not approved in Europe.

But the problem here isn’t limited to behind the pharmacy counter. In February, the FDA announced a voluntary recall of Global Pharma Healthcare’s artificial tear lubricant eye drops.due to possible contaminationIn a misleadingly worded statement, officials warned of “the risk of eye infections that can lead to blindness,” but also noted that there have been “deaths from bloodstream infections.” Added to the list of products that may have been contained, the victims were “14 patients with blindness, 4 patients with enucleation (surgical removal), and 4 dead. ”

And, as Peter Robison and Priyanka Pura recently explained on Bloomberg, these were drops “manufactured in India and sold by two US distributors in stamped boxes.” Combined with the Drug Inventory Number issued by the Food and Drug Administration. ”

We have others, too. A research letter published in JAMA in April stated, “Amount of melatonin and CBD in melatonin gummies sold in the US.“In a survey of 25 brands of readily available melatoning oils, researchers found that ‘nearly all products’ It contained 10% more melatonin than advertisedOne product contained over 347%. Another product contained none, but he, a cannabis-derived drug, contained cannabidiol, also known as CBD, which is yet another FDA-approved drug. Legislators forced to regulate.

”The regulatory framework for supplements is broken‘, study co-author Dr. Peter Cohen told CNN at the time. “Manufacturers aren’t following the law, and the FDA isn’t enforcing the law. So there’s a lot of low-quality products out there.”

I understand. how did we get here Why does the system that is supposed to protect us from unsafe prescription and over-the-counter drugs seem so broken? I can confirm.

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Dr. John Abramson, author of the recent bookFeeling sick: How Big Pharma ruined America’s healthcare and how we can fix it“In 1992, when what proved to be an effective HIV drug hit the FDA’s bottleneck, the agency didn’t have enough staff to handle it quickly. was,” he explains. “The solution was that the Prescription Drug License Agreement was passed. 100% are coming from pharma and medical device companies, which comes with a tight schedule and, as can be seen from the outside, the deal creates a certain amount of leverage and obligations to the pharma companies.”

The numbers here vary – Forbes announces its budget amount as high as 75%. But questions remain, as C. Michael White asked at his UConn Today in 2021. ”Why does the FDA get some of its funding from regulated companies?? ”

Another similar conflict of interest that worries Abramson is what he calls “the revolving door between the FDA and the pharmaceutical industry.” For example, he says, there is the former head of the agency, Stephen Hahn. “He was in control throughout Trump’s presidency,” Abramson said. And, “Five months after leaving government, Hahn went on to work in senior positions at Flagship Pioneering, a biotechnology private investment firm. Hahn’s transition from the FDA to Flagship Pioneering is a perfect example of this.” This revolving door will help Flagship Pioneering to invest in new biotech products. could become ”

but Dr. Arthur KaplanNew York University Grossman School of Medicine Department of Population Health believes that consumer and patient demands have also led us down this path.

“The FDA is increasingly being told by Congress to listen more to what I call weaker evidence to speed up approval,” he says. “They are trying to swim upstream against the movement that started with the war. Transfer of right to tryThis is basically, “We want to worry less about risk, worry less about safety, and have more access to what we want as patients or their families.”

“We’ve seen a culture change that places more emphasis on individual choice and autonomy,” Caplan said. Please stop trying to protect us. We have access to what we want. Because we, the people, should have the right to take risks in order to pursue the choices we want to pursue. ”

There is a certain circularity in the perspectives of Abramson and Kaplan. Thirty years ago, public demand caused major changes in drug development and the FDA. Now that seems to be a factor in the current controversy and concern over its capabilities. And Arthur Kaplan isn’t optimistic that things will get any better.

“It used to be that the FDA’s job was to closely monitor safety and listen intently to expert panels based on the best available evidence,” he says. “Now the message is clear from politicians, patient advocacy groups and even the general public: ‘We don’t want paternalism. We want individual choice. We want freedom. We want freedom.’ I’m not very interested in what the experts say. I think it’s about social change,” says Caplan.