I am dying of squamous cell carcinoma, and the treatments that might save me are just out of reach

July 22, 2023 By in Books 70 Comments

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 the simple answer is: “I don’t know.” 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 one answer. Maybe in the future others won’t have to go through what I’m going through.

Jake Seliger, possible figurehead for the invisible graveyard of men and women killed by the FDA's slowness
The author on July 22, 2023, when he is, or was, still alive.

70 responses

    • The right-to-try regime is a patchwork of state and federal laws that scream “liability” to drug companies. So it’s rare that patients can actually access experimental medicines under that regime because drug companies don’t want to take the risk. A proper right-to-try system would involve severely limiting FDA’s power to control market access.

      Like

      Reply

      • Section 2 of the federal Right To Try Act of 2018 explicitly says that “no liability …. shall lie against the manufacturer or sponsor, prescriber or dispenser, or other individual entity” regarding an unapproved drug administered under the Act, other than for “reckless or willful misconduct, gross negligence, or intentional tort under any applicable State law.” So I’m pretty sure you’re wrong.

        Like

      • This is not accurate.

        Jake- Please feel free to reach out if you have questions, would like information, or want to be connected to companies that are currently using the Right to Try federal and companies that may be preparing to use the Right to Try for Individualized Treatments which is now law in both Arizona and Nevada.

        Naomi Lopez
        Vice President of Healthcare Policy
        Goldwater Institute
        602.462.5000

        Liked by 1 person

  4. This is almost too tragic to read and think about, but it is so important that we must all make this so much of a bigger priority than it currently is. Bless you and your loved ones, and everything you have and are and I pray for you and your family to find peace.

    Liked by 1 person

    Reply

  5. This is almost too tragic to read and think about, but it is so important that we must all make this so much of a bigger priority than it currently is. Bless you and your loved ones, and everything you have and are and I pray for you and your family to find peace.

    Liked by 1 person

    Reply

  7. Hey, feel free to ignore or delete this, I know that most tech people are highly adverse to this message and you’ll possibly even think this is ‘predatory’ and in bad taste, but you know what? I’m going with my right to try because as you say time is running down. I dont know you or where you stand on this issue but I’m also ‘in tech’, I saw this on hackernews just now, and I’m a theist who puts his faith in one man who said our energy carries on after this shell we call a body dies, and if we trust him he’ll be there for us on the other side. I don’t often call myself a Christian because I dont follow a ‘church’ institution but I believe Jesus when he said he came to earth so that all who believed he was here to take away sin and the eternal effects of death and put their trust in him would live again.. I kinda see it as having my HDD powered down, and knowing it will be plugged in again in the future. IDK if any of this resonates but honestly what do you have to lose? there’s no dignity in dying, all ego and theories get set aside, who cares what other people think, I’m just saying there’s one guy who’s offering an eternity after this one and it costs nothing but to ask him to save you before you go. Good luck friend.

    Liked by 1 person

    Reply

    • Timothy – I think this was very well worded and very brave of you. This article must have touched your heart as it did mine. There is another book called ‘Proof of Heaven’ written by a neuroscientist that touched me also. Listen to Jesus and not those that try to benefit from him. I am currently undergoing treatments for the second time for an aggressive form of sarcoma and my fate is ultimately the same as yours Mr. Selinger. God be with you.

      Liked by 1 person

      Reply

  9. Hi, I’m sorry this cancer has happened to you. It sucks. Hopefully your message will live on and help change the future for others. They thank you.

    Like

    Reply

  10. Pingback: I am dying of squamous cell carcinoma, and potential treatments are out of reach – Veritas Reporters

  11. I agree with you.

    People need more agency. The presumption that the nanny state always knows best is wrong, and had we had it before, we wouldn’t have had half the basic treatments we have today.

    I hope you enjoy your last days here.

    Like

    Reply

  12. Are similar treatments possibly available in other countries? Latin America ex Mexico comes to mind since there’s a high rate of this sort of cancer there.

    Like

    Reply

  13. Pingback: I’m loss of life of squamous cell carcinoma, and doable therapies are out of attain – TOP Show HN

  14. Pingback: I am dying of squamous cell carcinoma, and potential treatments are out of reach by theoldlove - HackTech

  16. Very sorry to hear this. Thank you for your work with this blog, watch I’ve found to be a source of unconventional wisdom and thought provocation for what must be over a decade now. I’ve not spoken much, but your words and links have been very valuable to me.

    Thank you from my corner of meatspace and the Internet, and know that you will be missed. In the meantime, my prayers are with you and yours, for both peace and healing.

    Liked by 1 person

    Reply

  17. Go to YouTube and search for “Dr. Thomas Seyfried”. He is a brilliant cancer researcher at Boston College. He has researched cancer metabolism for decades. His approach may seem radical, but has lots of evidence to support it. I have seen many people helped by his approach. Contact him, he can give you the information you need to find a possible way to treat your cancer.

    Here is one interview Dr. Seyfried had with Dr. Sanjay Juneja, a triple board-certified Hematologist & Medical Oncologist serving as Chief of Oncology Service at Baton Rouge General Hospital: https://www.youtube.com/watch?v=qa3j40c8iAo

    More about Dr Juneja:
    Dr. Sanjay Juneja is a triple board-certified Hematologist & Medical Oncologist serving as Chief of Oncology Service at Baton Rouge General Hospital, a social & news media personality known as the ‘TheOncDoc’ with over half a million followers, and one of fifteen social media doctors participating in the Healthcare Leaders in Social Media Round Table Series for the White House.

    He has been featured by The Washington Post as well as dozens of national podcasts and regional news channels (PBS, CBS, NBC, NPR), and has given keynote speeches and partnered with American Cancer Society, BeTheMatch, Leukemia & Lymphoma Society, Harvard University, Louisiana Department of Health and several others.

    Like

    Reply

  18. i’ve read and enjoyed your comments for years; I hope you somehow take solace in that you and your writings have been enjoyed by strangers across the world.

    Liked by 1 person

    Reply

  19. Pingback: I am dying of squamous cell carcinoma, and potential treatments are out of reach – Latest-News-Events

  20. You can see if any of these are available in India. Most of the drug companies operate there and there are many trials going on there. Try contacting HCG Pinnacle, Bangalore. I’ve been in similar situation with my mom and explored the possibility.

    Like

    Reply

  21. Maybe you can bypass FDA and directly reach out to various cancer drug companies (that you trust), possibly even to those that are not in your country. You offer yourself as a test patient and you promise to sign paperwork whereby you and your spouse/family completely indemnify company from any consequences. Also anything that strengthens immune system could help. In worst case, I hope you find peace.

    Liked by 1 person

    Reply

  23. Pingback: New best story on Hacker News: I am dying of squamous cell carcinoma, and potential treatments are out of reach – Cassinni

  24. This is may be an option. It’s honestly not that complex. You can hack this together with a basic college lab worth of tech and a reasonable amount of capital. If you have nothing to lose.

    Engineered skin bacteria induce antitumor T cell
    responses against melanoma

    Like

    Reply

    • First of all, I am really sorry this is your situation. It is not just.

      Have you looked into repurposed drugs against cancer? Many old off patent drugs like Metformin have known/likely anti cancer properties but are not interesting candidates for expensive trials because they can’t be patented anymore. They are not a miracle cure but taken together to target the cancer from all possible avenues (similar to how you treat HIV) this approach seems quite promising to me. Two books have recently been published on this topic. The repurposed drugs revolution by Justus Hope and the monograph “Cancer Care” by Paul Marik (h-Index > 100). The latter can be downloaded for free, no registration is required.

      I’ll pray for you.

      Like

      Reply

  26. Sorry to hear the news. Your blog has been one of the best around — always a stimulating read for other writers and bloggers. I’ll be revisiting your archives over the next few weeks and encourage others to do so — lots of fascinating discussions and thoughts. Good luck with your illness.

    Robert Nagle, Personville Press

    Liked by 1 person

    Reply

  27. It’s not too late for cryonics. You can have your body or head put in liquid nitrogen by one of America’s cryonics providers (Alcor or the Cryonics Institute) and when a cure to being vitrified is found and a cure to your cancer is made legal, the future could wake you up. It’s a chance.

    Like

    Reply

  28. Thank you for sharing your story, I came across it on Twitter. I was unaware of this right to try issue, so you’re vulnerable article is increasing awareness. I made a donation to the Mayo clinical trials as you suggested, in your honor. You are continuing to help people even in these tragic times, which is a testament to your character. I hesitated to write that I wish you well as a sign off, but I do, I wish you well.

    Liked by 1 person

    Reply

  29. I had the same thing my friend, but mine didn’t spread for some reason…they got it all with radiation and chemo after the surgery…I was just waiting to hear it spread but it didn’t. I hope this article pushes things forward. You die the right thing to write it.

    Liked by 1 person

    Reply

  30. Pingback: I’m death of squamous cell carcinoma, and doable remedies are out of reach – TOP HACKER™

  32. Note that Montana just passed the strongest “Right To Try” bill in the USA.

    Unfortunately, as someone already pointed out, most drug companies are loathe to do “right to try” in any circumstances, even in states with such laws, because of the potential liability. Also, they are flat-out scared of retaliation by the FDA. Yes, retaliation.

    Like

    Reply

  33. My wife is stage 4 melanoma. Out of options.. We recently looked at this trial which is also for scc. It’s an intratimoral oncolytic agent injection combined with immunotherapy. It’s turned out not to be for her but it had some very promising results on pre-treated patients so we jumped on when I saw it. I’m not sure currently recruiting but the sponsor has an expanded access link on their website. Mayo phoenix one of the trial locations so I assume it’s been considered. Good luck. It completely sucks. ClinicalTrials.gov Identifier: NCT03767348

    Like

    Reply

  34. For anyone interested in a more rigorous analysis of this: https://www.sciencedirect.com/science/article/abs/pii/S0304407618302380

    > Implicit in the drug-approval process is a host of decisions—target patient population, control group, primary endpoint, sample size, follow-up period, etc.—all of which determine the trade-off between Type I and Type II error. We explore the application of Bayesian decision analysis (BDA) to minimize the expected cost of drug approval, where the relative costs of the two types of errors are calibrated using U.S. Burden of Disease Study 2010 data. The results for conventional fixed-sample randomized clinical-trial designs suggest that for terminal illnesses with no existing therapies such as pancreatic cancer, the standard threshold of 2.5% is substantially more conservative than the BDA-optimal threshold of 23.9% to 27.8%. For relatively less deadly conditions such as prostate cancer, 2.5% is more risk-tolerant or aggressive than the BDA-optimal threshold of 1.2% to 1.5%. We compute BDA-optimal sizes for 25 of the most lethal diseases and show how a BDA-informed approval process can incorporate all stakeholders’ views in a systematic, transparent, internally consistent, and repeatable manner.

    Like

    Reply

  35. Pingback: How do we evaluate our lives, at the end? What counts, what matters? « The Story's Story

  36. Pingback: How attain we evaluation our lives, on the halt? What counts, what issues? – TOP Show HN

  37. “A Dysbiotic Microbiome Promotes Head and Neck Squamous Cell Carcinoma”
    doi: 10.1038/s41388-021-02137-1 (published 2022 Jan)

    The FDA just shut down openBiome who would have provided a safe and tested means of accessing verified human FMT sources. Not because they didn’t work, but because they would have competed with big pharma.

    Liked by 1 person

    Reply

  39. I am a 24/7 caregiver for a loved one with glioblastoma: my heart breaks for you, for him, and for all of the nameless others who are in this awful predicament. Jake, have you heard of the Promising Pathway Act? I think it’s our best shot to change the current drug approval regime. Here is a letter to email your elected officials, provided by one of the best glioblastoma activists in the world: https://virtualtrials.org/activism.cfm

    Liked by 1 person

    Reply

  41. I had a squamous cell carcinoma on my tongue that was removed in 2016. Starting before the surgery, I used several natural substances and two off-label pharmaceuticals. Cimetidine reduces metastasis by inhibiting attachment of circulating tumor cells to the endothelium and reduces the recruitment of regulator T-cells in tumors that help the tumors hide from the immune system. I also used mebendazole (Vermox), an anti-worm drug that visibly shrank the tumor in the weeks before surgery. It’s not well understood how it works. Mebendazole requires a prescription and is very expensive in the US, but is over the counter in Europe. A related drug, fenbendazole, appears to be at least as effective and can be bought reasonably on Amazon or in farm supply stores without a prescription. It has passed phase I trials in humans, so it’s fairly safe to use. One should only use Merck brand as only Merck produces regulated fenbendazole so you know what you’re getting.

    Joe Tippens of Oklahoma City found he had stage 4 lung cancer around the time when I found my tumor and still uses fenbendazole to stay alive. You can read about his experience on his site at http://mycancerstory.rocks . There are no guarantees, but at this point I believe that it’s worth trying even long shots, such as Joe Tippens’ protocol, which is explained on his site. (And I expect that the chances of slowing or stopping oral squamous cell carcinomas by these means are pretty good.)

    Like

    Reply

  42. Pingback: I am dying of squamous cell carcinoma, and the treatments that might save me are just out of reach

  44. This is SUCH a YOU story to write 😊🙏🙌✨👏 and it’s so bad ass to share your story with a light on what could help others if not you. 🙏❤️‍🔥 You’re such a light to this world: why would they not let you try something you want to try when the view is totally bleak anyway?! We need people to be less protective where it’s obvious to not be protective and allow you and others to bodily autonomy. 💖 I support your ask! I wish I could personally rush MRNA treatment to you! And I support you! Your perspective is so on point. And I’m infuriated at the system for holding you back, for losing me my friend when you could try something and may be be lost anyway, or may be heal. Find new happiness. You deserve better! Love you, man. 🙏

    Liked by 1 person

    Reply

  45. Pingback:  What it’s like to be married to a dying man « The Story's Story

  46. While I am often not in agreements with the contents of the links you provided here, your website has been a great source of my knowledge and reading for five-seven years, even since I stumbled on it. I have recently suffered severely from a shortage of a prescription drug, though my consequence is a tea storm compared to yours. I can only wish you the best of lucks and hoped that you lived through this.

    If you don’t mind another nerd disagreement. Despite that I am a cynic, and I think the FDA and most government agencies are just doing their jobs in their best capabilities more than their interests. I worked in the private sector as cogs in some of the biggest conglomerates in the world. Internal regulations are more serious, roadblocked progress than any government regulations. For government regulations, people often forget about its existence or adjusted, until they need a scapegoat.

    I think government agencies and works are much more important or consequential to the lives of the public than the private sector. However, it lacked the capability to find talented people, as people rather work for money in the private sector. The FDA, IRS, and others, are slow, because they don’t have enough staffs or talents, to regulate the massive private sector, rethink their failing initiatives, having to answer to clueless congress, with extra useless regulations, or changes, promoted by thinktanks, and lobby groups.

    We suffered the consequences of failing public sector. It became the false hope and scapegoat. When things are running well, no one think of it. When consequences are tragic, they are the cause of blame. When realistically, there are so many bad decisions from different actors that cause those tragedies. A kafkaesque mess. The right to take potential life-saving drugs when death is a certainty, should be at the individual, not placed upon the bureacracy.

    Like

    Reply

  48. May you find the wisdom to spend every moment left to you in the way that provides the maximum joy, happiness, fulfillment and goodness for you and this world. And, may you have way more than you expect.

    Liked by 1 person

    Reply

  49. Mo and I were shocked to hear of this from Bess. I have no wisdom for you, I’m sorry. I cannot even come up with proper words to send your way, other than you are in our thoughts and this is heartbreaking to hear.

    Liked by 1 person

    Reply

  50. Pingback: Sunday assorted links - Marginal REVOLUTION

  51. Pingback: A blogger prepares to say goodbye — Links, Links, Links | Idiotprogrammer: Texas Literary Blog

  52. Pingback: If you’re involved in drug development and have first-hand knowledge of the FDA’s torpor, get in touch « The Story's Story

  54. Pingback: When you occur to’ve first-hand knowledge of the FDA’s torpor, procure fervent – TOP HACKER™

  55. Pingback: If that you just may perchance rep first-hand files of the FDA’s torpor, derive in contact – TOP Show HN

  56. Pingback: If you have first-hand knowledge of the FDA’s torpor, get in touch – Veritas Reporters

  57. Pingback: Have to you are going to please in first-hand files of the FDA’s torpor, gain alive to – TOP Show HN

Leave a Reply