The one-year anniversary of my total glossectomy
jakeseliger.com
jakeseliger.com
I've been "reading the Internet" since the late '90s with sites like /., and, when I got diagnosed with the death sentence sentence—recurrent and metastatic head and neck cancer—I began looking into clinical trials, and I realized that I'd never read any good descriptions of what clinical trials are like from the patient's perspective.
So my wife and I decided that the thing that we needed to exist in the world didn't exist, and thus we made it. When my wife and I started writing in earnest about the clinical-trial process in particular ("Please be dying, but not too quickly" is the most comprehensive: https://bessstillman.substack.com/p/please-be-dying-but-not-...), I kept expecting someone to leave a comment or send an email saying: "Hey buddy, this has already been done, check it out here: _______." But that comment or email never came. Probably someone else's comprehensive essay and guide exists somewhere, given how big the Internet is, but I've never seen it.
Without having had this kind of experience, I think it's difficult to understand just how difficult and not-user-friendly the clinical-trial process is. If we can help move the needle on that, we might dramatically reduce the number of people who are in a position like mine. Personalized cancer vaccines are so close: https://jakeseliger.com/2024/04/12/moderna-mrna-4157-v90-new..., and I don't understand why the FDA hasn't approved Moderna's mRNA-4157 yet, apart from bureaucratic inertia and indifference to human suffering.
I hope no one who has read our work has to go through a version of what I've been through, or has friends or family who must, but, statistically, given that a couple hundred thousand people have seen it, someone will. And it is better to be equipped with some sense of what to do and how to do it, than to have to try to figure it from scratch. I've wound up emailing guidance to a lot of people about head and neck cancers, and clinical trials.
It just gets weird with the overbroad supreme court decisions that are like: "well, stuff that only happens in a single state but that might be used for interstate commerce or somehow impact interstate commerce indirectly" is also covered. [1][2]
Both very in character for what FDA does.
If they delay drugs they are bureaucratic and indifferent. Filling graveyards, as said.
If they release drugs too fast/unproven then they open the gates to scammers, unethical companies trying to sneak ineffective products they spent too much on, ect. Basically the whole reason the FDA was formed would be in question. Then it sounds self serving but the people in charge will start to ask why do we even have the FDA? Which will drain funding then eventually set us back to the reason the FDA had to be invented in the first place. Snake oil salesmen will run rampant and we will need an agency to prevent dying desperate people being taken advantage of for whatever remaining money they have.
Drug development takes 12 years [1] and costs >$2B (on average) because the FDA requires >99.99% confidence that pharmaceutical companies are not selling quack cures. Do we need that level of confidence? Especially for cancer, is that degree of confidence warranted? Is the process efficient? I think that it would be absurd to even argue these points.
There's legitimate fear of quack medicine and scammers -- and then there's whatever the FDA is gripped by, which seems to me a lot like insanity.
[1] - https://pharmanewsintel.com/features/understanding-us-food-a...
I don’t believe the FDA has any such quantitative constraint on approvals. The guidelines are strict, but each is evaluated individually.
There’s no such quota for how many drugs are approved, how many people can die, to say this is the FDAs position is not true.
Is something more desperately needed and deserved by people who re suffering? Of course yes, things should be better.
I’m just saying of the many important problems that need to be solved, the FDA having life death limits is not one of them.
The FDA's position is that it's better for 10,000 patients to die of neglect than have 1 patient die of quackery
In the end, they've killed an awful lot of people via inaction, lack of urgency, lack of efficiency. But that's okay, because killing people via inaction is not quackery, after all. Better a million die of neglect than another thalidomide, the FDA would say.
All the people on here with advanced degrees got them to kill orphans with drones right? Just like all the doctors they are accusing of killing people went to med school so they could kill people indirectly though policy.
The entire reason the FDA exists is that there is only a tiny sliver of people that can offer any real medical help to a dying person. Yet there are endless streams of con artists that will enthusiastically take the money of a desperate dying person because its easy. Shut off brain forgets that.
Based on my experience the actual solution is greatly expanding the FDA to allow them to be able to handle the highly increased flow of new research and create a central point for dying patients to find and get in programs. Right now they don't have the resources and have to rely on strict bureaucracy. Again the idea that the overwhelming majority of doctors would not jump at the chance to save people rather than put them in the ground slower is absurd.
The FDA needs overhauled so start contacting your senators is pretty much all we can do.
The FDA's job isn't to hold your hand and get you into scientific research studies.
The FDA mandates certain steps -- the collection of certain data -- before it allows drugs to be marketed. Phase 1 is a safety study, Phase 2 is an efficacy study, and Phase 3 is a broader efficacy study. It is on the companies to collect this data; the FDA merely reviews it. (And then reddit-votes on which drugs to approve, with results that are sometimes funny, sometimes nakedly unethical e.g. flibanserin, and sometimes just ridiculous e.g. aducanumab.)
Having more FDA employees would not speed-up the process by much, as the data collection itself is the arduous bit, nor would it reduce expenses at all.
The best possible thing to do would be to simply get rid of Phases 2 & 3. That's how they did things until the early 1960s -- and, lest we forget, the 40s-60s were known as "the Golden Age" of drug development. Instead of increasingly onerous and expensive trials, allow drugs to be marketed once they're proven safe, and subject them to mandatory postmarketing surveillance.
Besides, that hard-won efficacy data is often interpreted (by the FDA!) in subjective and bizarre ways, so its value is not awfully high. It's not worth the price society is paying for it.
If/when someone dies of something FDA approved, it becomes a big scandal. Heads might roll, funding constrained.
If 10,000 people die from something that an unapproved treatment could cure, it's not news at all. People have always been from that.
FDA, like any organization, responds to incentives and does what's best for it.
I’ve had a partial glossectomy for the same PD-L1 negative cancer and have been reading your posts since before I was metastatic recurrent. I think about you relatively often. (I might have even seen you at UCSF a ~couple months ago, but I didn’t want to awkwardly ask if you were the guy from the internet.)
I admire your strength.
I wish the best for you and your wife.
I feel like it's similar to your strength. From your writing I gather you've had more than your share of bad days, emotionally, during this ordeal. But you're still here, still writing, still posting here, talking to random strangers on the internet. And you and your wife's drive to document all this so others can better navigate the clinical trial process in the future... yeah, absolutely, this is strength, and a lot of it, even if you don't feel strong.
Anyhow, for what it's worth, know that there are random people on the internet who follow your story from afar, and that we're rooting for you.
See also, in the not-so-helpful department: "you're so lucky [to not be dead yet]" when luck would've not been being so close to death in the first place.
I also don't really understand how it's supposed to be inspirational but I wish you the best and hope you make it through to the other side to the full recovery phase.
Yep - that's called a "patient advocate". I learned about it when I was in my teens, and went with my grandfather to the VA hospital on a regular basis.
Multiple times I had to remind the healthcare providers that he had long-standing kidney issues, that contrasting agents had caused immediate and significant reductions in kidney function in the past, and that as a result we should consider why such tests were ordered and what benefit the results would provide.
I 100% believe they would have unintentionally killed him years early if I hadn't been there to question them and push back.
I had a coworker that had the same thing. Watching him deal with it was difficult.
Oh man, I hope he or she was okay. This is terrible. In most people in whom squamous cell carcinoma of the tongue gets caught early, it's curable. I'm in the group in whom it's caught relatively early, but the initial surgery and radiotherapy isn't enough.
Regarding attitude, I figure that there is much I can't control, but attitude is one I can. WWMAD? (Would would Marcus Aurelius Do?): https://jakeseliger.com/2023/09/18/stoic-philosophy-finding-...:
You’ll see stoic ideas threaded through the essays my wife and I have been writing about my fatal cancer diagnosis: “Every day I’m trying to make a good and generative day, and I remind myself that there are many things I can’t control, but, as both Frankl and the Stoics emphasize, I can control my attitude.”
One way to see the virtues of this attitude is by process of elimination: What’s the alternative? Wallowing in bad days in which I accomplish and achieve nothing important? Getting angry about things I can’t control, and things that will remain the same whether I’m angry about them or not? Lamenting that which cannot be, and will not be no matter how much I wish it so? Nothing will bring my tongue back. Bemoaning my fate will not avert it (though I’m also not passively accepting fate: as described below, I appear to be in a clinical trial for a novel, promising drug that targets squamous cell carcinoma of the tongue). The likelihood of another decade of life is not literally 0.0, but it’s under one percent and would require a series of near-miracles via clinical trials.
I won't go into details about what he went through. Not fun.
I sincerely wish you the best. I live on Long Island, and have been watching folks battling cancer, constantly, since 1990 (when I moved here).
Indeed, those who confront suffering with courage encourage the rest of us.
To be clear, I'm not really talking about this story in particular, but the way people discuss other people in really bad situations. It seems like almost any reaction that isn't "lie there motionless" gets called "courageous".
I guess it feels more like a pep talk than an evaluation.
Some people also go into denial about what's happening, and denial can be fatal. This is not quite 100% on point, but my wife wrote a story about meeting a patient whose large mass on the side of her neck had not been there for just a couple days: https://bessstillman.substack.com/p/just-because-you-wont-se...: "Per triage, my patient’s symptoms started yesterday and she’s worried that the swelling might be an infection or maybe a pulled muscle, but the moment I walk into the room I know that I’m going to ruin her life."
Some attempt to take the hedonic path that would not, I think, be very satisfying, and yet they pursue it (heedlessly spending down cash on trinkets, the non-prescribed drugs you might imagine, Vegas, etc.). This is distinct from someone who decides: "I've always wanted to visit Tokyo and now I'm finally going to do it."
I think it's good to try and lead and positive, generative life, even when what is left of that life is limited, and when what "positive, generative" means will vary widely by person.
There’s a lot of dark places people can go and choose to stay when they experience tragedy. Drugs, alcohol abuse, suicide, wallowing in misery etc. Perhaps you’ve never experienced tragedy, or been tempted by these dark reactions but for many they are all too familiar and it takes enormous courage to combat them. Seeing examples of others who are suffering reacting positively is greatly encouraging.
Sometimes I feel really sad that the bus factor of some treatment is 1, and double sad when that one is me. No one should have delayed care just because I need my vacation, or my day off.
Kudos to the surgeon who trusted his instincts and suggested a surgical biopsy, sometimes patients get so happy with dubious results that we feel like we're removing their happiness, or that we're secretly hoping for the worst.
I hope that you're going through this with peace of mind.
Hang in there