I saw this post by Jake Seliger, which went viral, “I am dying of squamous cell carcinoma, and the treatments that might save me are just out of reach.”
He describes what Alex Tabarrok in a 2015 post calls an “invisible graveyard,” due to the FDA being too cautious on potentially curative cancer treatments, “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.’”
Continuing:
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.
I hate to argue with someone dying of cancer (or has died in his case), but speaking of death, this “FDA is holding back cures” argument refuses to die. Think about it for a second: this would imply that the drugs that are not approved are more effective than the approved drugs. It implies that the drug pipeline is backwards or works in reverse: that drugs which are effective are rejected first, until eventually whittled down to the current line of treatments, all while the cures are being held back by the FDA. On the face of it, this makes no sense.
Such conspiratorial framing betrays a basic understanding of how cancer drugs are approved and the long odds. In the case of the author, his cancer was far too advanced for any trial to be effective, let alone curative. A clinal trial for a terminal cancer patient is a last resort and virtually never curative, nor prolongs life much.
Clinical trials are basically a last ditch effort so as to project the appearance of not losing hope or giving up, and testing drugs requires volunteers who have at that point exhausted their options. But no doctor is under the illusion that these trials are curative, as much hope patients and families may have riding on them.
Very occasionally, a drug shows promise and maybe extends life by a few months; the drug then advances to the next stage. When all the hurdles are cleared, it becomes part of the “standard modality of treatment” used on all patients. There is nothing being deliberately held back. No conspiracy to withhold treatments.
But the bar for FDA approval is surprisingly low; if anything, to many drugs are approved that maybe add months of life expectancy at significant cost, and not without serious side effects, assuming they even work as promised. One such example is NALIRIFOX, a recently FDA approved drug to treat stage-4 pancreatic cancer. Patients on NALIRIFOX lived a median of 11.1 months, which was 1.9 months longer than the control group.
Yes, this is considered the “state of the art” as far as treating pancreatic cancer, and was enough to earn it approval. If an extra 2 months is the bar that must be cleared for a drug to be approved, can you imagine the drugs that failed?
It’s more likely a drug is approved that doesn’t live up to its expectations, than wildly exceeds them, indicative of the great challenge in finding treatments. Many of the approved drugs are so underwhelming, that people can’t accept that this is the best “modern medical science” has to offer. People don’t see the hundreds or even thousands of cancer drugs that never get past the first stage–that not only fail to add any months of survival–but hasten death due to side effects. Doctors cannot bring themselves to saying “no”. To stop treatment is to be seen as giving up, even if the treatments do more harm than good.
Finally, a major factor is how poorly the “science media” communicates the realities of developing cancer treatments. A week does not go by without some breathless proclamation by the media that some “mouse therapy” holds a cure for cancer:
It logically follows, “If it works in mice, why can’t you just give it to people?” The media does an extremely terrible job putting these findings in their proper context. What’s rarely communicated by the media is that very few mouse studies ever lead to successful human trials–even in the earliest phases–let alone become an actual treatment.