FDA is likely killing man with squamous cell carcinoma

FDA is likely killing man with squamous cell carcinoma
FDA (Image: Wikimedia)

Jake Selliger describes how he is “dying of squamous cell carcinoma, and the treatments that might save [him] are just out of reach,” due to the FDA, which routinely takes many years to approve life-saving medical treatments.

“The FDA is responsible for more deaths on an annual basis than any other government agency. Here’s one of its victims,” notes Paul Matzko of the Cato Institute. Researchers are “curing multiple cancers right now,” yet “the FDA is acting like it’s business as usual” and dragging its feet on approving cures. Selliger’s impending demise shows how the “FDA is much more” harmful “than your political opponents you think you hate,” argues Richard Hanania of the University of Texas.

Selliger describes how he will soon die because of the FDA’s delays in approving advances in cancer treatments:

Professor Alex Tabarrok writes about how “when the FDA fails to approve a good drug, people die but the bodies are buried in an invisible graveyard.” I’d like to make that graveyard a little bit more visible because I’m going to be buried in it, in a few weeks or months. A squamous cell carcinoma tumor appeared on my tongue last September; the surgery for it occurred in October, followed by radiation in December – January, but the tumor reappeared at the base of my tongue in April. A massive surgery on May 25 appeared to produce “clean margins” (that is, no tumor cells remained where the surgeon operated), albeit at huge cost: I have no tongue any more, just a “flap” of muscle where it used to be, and no ability to swallow solid foods ever again. Monday I’m starting chemotherapy, but that’s almost certainly going to fail, because a CT scan shows four to six new gross tumors, four in my neck and two, possibly, in my lungs.

So what might help me? MRNA tumor vaccines. Head and neck squamous cell carcinomas (HNSCC) are notoriously treatment resistant, and mRNA vaccines have shown huge promise. Why aren’t they happening faster? Because the FDA is slow. There are some trials underway (here is one from Moderna; here is another), and, although I’m trying to enroll, I may be too late, since my cancer moves so aggressively. The FDA was loathe to approve initial mRNA human trials, even when those trials would have been full of people like me: those who are facing death sentences anyway.

Here is one story, from “Why the FDA Has an Incentive to Delay the Introduction of New Drugs:”

“In the early 1980s, when I headed the team at the FDA that was reviewing the NDA for recombinant human insulin, . . . we were ready to recommend approval a mere four months after the application was submitted (at a time when the average time for NDA review was more than two and a half years). With quintessential bureaucratic reasoning, my supervisor refused to sign off on the approval—even though he agreed that the data provided compelling evidence of the drug’s safety and effectiveness. ‘If anything goes wrong,’ he argued, ‘think how bad it will look that we approved the drug so quickly.'”

The problem is that delaying mRNA cancer vaccines kills people like me.

We need to have a much stronger “right to try” presumption: “When Dying Patients Want Unproven Drugs,” we should let those patients try. I have weeks to months left; let’s try whatever there is to try, and advance medicine along the way. The “right to try” is part of fundamental freedom—and this is particularly true for palliative-stage patients without a route to a cure anyway. They are risking essentially nothing.

When I am dead and buried at least those who I love and who love me will know the FDA protected me and millions of others like me from ourselves. Thanks, FDA. But the dead do not vote and do not agitate for change, so the system is likely to grind on.

FDA employees commonly take years to approve life-saving drugs. That results in the deaths of hundreds of thousands of people who could have been saved by earlier approval of those drugs. For example, at least a hundred thousand people died waiting for the FDA to approve beta blockers. One of the FDA officials involved in delaying their approval was John Nestor. Nestor was notorious for following rules in ways designed to frustrate and inconvenience other people. As the Journal of American Physicians and Surgeons notes:

Nestor had the unique habit of getting into the leftmost lane [on the highway] with his cruise control set at 55 mph, the posted speed limit. He would drive at this speed regardless of what came up behind him. Cars would zoom up close to his rear bumper; drivers would flash their lights and blast their horns,some swerving around him on the right while giving him the finger—none of this fazed Nestor in the least. As he explained it, 55 mph was the law, and he had a right to drive in whichever lane he chose: “Why should I inconvenience myself for someone who wants to speed?”

Nestor followed this rigid mindset in his work at the FDA. He was very good at using agency red tape, and minor risks or side effects of drugs, as an excuse to avoid approving life-saving drugs.

The FDA didn’t approve a home test for HIV until 24 years after it first received an application. According to an FDA advisory committee, the test “holds the potential to prevent the transmission of more than 4,000 new HIV infections in its first year of use alone.” That means thousands of people likely got infected with AIDS as a result of the delay in approving it. As Roger Parloff of Fortune notes, the FDA’s delay in approving the home HIV test is a “scandal.” It likely caused the deaths of thousands of people, given the mortality rate from AIDS.  It may also have caused billions of dollars in additional costs for taxpayers, given that AIDS is a costly and debilitating disease to treat, resulting in treatment costs of perhaps $600,000 per AIDS sufferer.

In light of the countless people killed by the FDA’s deadly delays in approving life-saving drugs and medical devices, drugs and devices should not have to be approved by the FDA before they can be sold. Instead, the FDA should only be able to remove drugs and devices from the market once it has evidence that they should be banned based on their ineffectiveness or dangerousness. The FDA should also be allowed to place warning labels on drugs and devices based on their risks, even when the quantum of evidence is not sufficient to prove the need for a ban. Originally, the FDA did not have premarket approval powers, even when it had enforcement authority to take action against quackery and unsafe drugs and devices.

Hans Bader

Hans Bader

Hans Bader practices law in Washington, D.C. After studying economics and history at the University of Virginia and law at Harvard, he practiced civil-rights, international-trade, and constitutional law. He also once worked in the Education Department. Hans writes for CNSNews.com and has appeared on C-SPAN’s “Washington Journal.” Contact him at hfb138@yahoo.com


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