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

If you want to know the magnitude and concern of the problem facing the US Food and Drug Administration, where do you start?

An investigation conducted by the journal The BMJ in 2022 stated that FDA oversight of clinical trials, including the Covid-19 mRNA vaccines from Pfizer and Moderna, was “grossly inadequate”, ranging from failing to carry out adequate inspections to failing to alert scientific journals or the public if violation occurred. be marked.

In December, the results of an 18-month congressional investigation into the FDA’s actions, which were allegedly “fraught with irregularities” in approving Biogen’s expensive Alzheimer’s drug Aduhelm, were released. The report considers that the agency’s actions “raise serious concerns about deviations from FDA protocol” in “unusual collaborations” with drugmakers and suggests that the FDA “should take swift action to ensure that the review process for future Alzheimer’s disease treatments does not lead to a to the same doubts about the integrity of the FDA review.”

The efficacy of these drugs is still being debated and has not been approved in Europe.

But the problems here don’t just happen behind the pharmacy counter. In February, the FDA announced a voluntary recall from Global Pharma Healthcare of their Artificial Tear Lubricating Eye Drops “due to possible contamination.” In a confusing statement, the agency warned of a “risk of eye infection which could lead to blindness,” but also noted that there had been “deaths from bloodstream infections.” In the following weeks, another brand of eye drops was added to the list of products that potentially contained the product, and the death toll increased to “14 patients with vision loss, an additional 4 patients with enucleations (surgical removal of the eyeball), and 4 deaths.”

And as Peter Robison and Priyanka Pulla recently explained for Bloomberg, these drugs are drops that are “made in India and sold by two US distributors in boxes stamped with the drug inventory number issued by the Food and Drug Administration.”

There is more. In April, a research letter published in JAMA raised the issue of “Amounts of Melatonin and CBD in Melatonin Gum Sold in the US.” By examining 25 available brands of melatonin gum, the researchers found “nearly all products contained 10% more melatonin than advertised.” One product contains 347% more. The other drug contains nothing, but contains cannabidiol, also known as CBD, a drug derived from cannabis, another drug the FDA has pushed lawmakers to regulate.

“The regulatory framework for supplements is broken,” said study co-author Dr. Pieter Cohen told CNN at the time. “Manufacturers don’t obey the law, and the FDA doesn’t enforce the law. That means we have a lot of low-quality products out there.”

You 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? There’s no single, simple answer, but you can see the cracks more clearly in a few places.

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John Abramson, author of the new book “Sickening: How Big Pharma Broke American Health Care and How We Can Repair It,” traces the roots of this problem back decades. “In 1992, when an HIV drug that turned out to be effective got stuck in FDA hurdles, they didn’t have enough staff to get it done fast enough. Many people died, and this is a real crisis,” he explained. “The solution was for the Prescription Drug User Fee Agreement to be passed. The drug companies started paying a user fee that was due at the time of application for new drug approval. And now about 65% of the FDA’s budget for overseeing human products comes from drug and device companies. This comes with a timetable. strict regulations, and as I see it from the outside, there is a certain influence and obligation to the drug companies that comes from this agreement.”

Figures here vary — Forbes estimates the budget figure is 75%. But the question, as C. Michael White asked UConn Today in 2021, remains, “Why is the FDA partially funded by the companies it regulates?”

Another similar conflict of interest to which Abramson is concerned is what he calls a “revolving door between the FDA and the drug industry.” For example, he said, there is a former commissioner of the institution, Stephen Hahn. “He’s the one making decisions through the Trump presidency,” Abramson said. And then, “Five months after leaving government, Hahn is working in a high-ranking position at Flagship Pioneering, a private biotechnology investment company. They actually own most of Moderna. Hahn’s switch from the FDA to Flagship Pioneering is a perfect example of the revolving door that Flagship is likely to give Pioneering excellence along with its investment in new biotechnology products.”

But Arthur Caplan, PhD, of the NYU Grossman School of Medicine’s Department of Population Health, argues that consumer and patient demand has also led us down this path.

“The FDA is being told more and more often by Congress to speed up approval, to listen more to what I would call weaker evidence,” he said. “They’re trying to counter a movement that started with the Right to Try movement, which was basically saying, ‘We want to worry less about risk, less worry about safety, and more rights to access what we, as patients or patients. family, want to do it.'”

Caplan thinks, “The culture has changed so there’s a lot more emphasis on personal choice and autonomy. You see it all over our politics, but the FDA is also saying, ‘Stop trying to protect us. Your job is to let us get access to what we want, because we as citizens must have the right to take the risks we want to take in order to pursue the choices we want to take.'”

There is a certain regularity in the perspectives of Abramson and Caplan. Thirty years ago, public demand prompted major changes in drug development and the FDA. Now, this appears to be a factor in the current controversy and concern regarding his competence. And Arthur Caplan isn’t optimistic the situation will get any better.

“Back in the day the FDA’s job was to watch safety closely, to listen carefully to a panel of experts for their opinion, based on the best available evidence,” he said. “Now, the message being conveyed by politicians, from patient advocacy groups, even the general public is clear, ‘We don’t want paternalism; we want individual choice. We want freedom. We are less interested in what the experts tell us. I don’t think this has anything to do with the pharmaceutical industry, or the position that scientists take. I think,” says Caplan, “it has to do with a much larger cultural shift in America.”