If you find this piece worthwhile, consider the Go Fund Me that’s funding ongoing cancer care.
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.” (41)
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.
In computer science there is a convention in which one’s first program prints “Hello, world.” Now it is my turn to write “Goodbye, world.” I’m crying as I write this and am sorry to have to go so soon. I have to give back the gift, though with great sadness.
Here is more about the FDA being slow and bureaucratic.
EDIT: Thank you for all the comments and emails. Many of you have asked what you can do to help, and one possible answer is to consider the Go Fund Me that’s funding ongoing care. Apart from that, I’m being treated at the Mayo Clinic Phoenix, and they have a system set up for donations to support clinical trials, so maybe that is another answer; I hope that, in the future, others won’t have to go through what I’m going through.
You may like some of the other essays I’ve written, like “I know what happens to me after I die, but what about those left behind?“, or that Bess has written, like “How much suffering is too much?”
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