The title says it: if you’re involved in drug or medical development and have experienced the FDA’s torpor, or vengeance, consider getting in touch; anonymously is fine. I want to make explicit something a few people caught in “I am dying of squamous cell carcinoma, and the treatments that might save me are just out of reach:” many of the people with first-hand knowledge of the costs of the FDA’s slowness don’t want to speak out about it, even anonymously. They’re justifiably worried about their lives and careers, as well as what appears to be the FDA’s penchant for punishing companies or individuals who criticize or want to reform it. So the people who know most about the problem are incentivized not to speak up about it, kind of like the way mafioso were discouraged from discussing what they knew for fear of retribution. Some of them will talk about their experiences and knowledge over beer or coffee, but they won’t go further than that.
There are reform efforts and at least three serious people I now know of who are working on books about the invisible graveyard that I’m likely to join soon—and perhaps become a mascot for: a million deaths are a statistic but one is a tragedy, as they say. If the life and death of one man can stand for the millions who have died, maybe people will pay more attention. So if you have any direct experience that you’re willing to share, including anonymously, consider doing your bit for reform.
Some of that experience might include:
* General FDA slowness and lack of responsiveness.
* The sense of vendetta—that criticizing the FDA in public, especially over specific decisions, will lead to retribution later.
* Patients who wish to try drugs but can’t.
* Scientists, doctors, or companies that deliberately slow down what they’re doing.
* Whatever else I might be missing.
Many observers are aware of these problems but also the extent to which many people with rich specifics are reluctant to share those specifics, for good reason. I will respect anonymity and am aware of people working on projects designed to help FDA reform—and, hopefully, to save the lives of people like me, who are suffering from maladies that are likely curable with existing technologies, if the FDA made those technologies legal to consistently test and try, and if the FDA worked harder to make the existing trial process faster, easier, and more transparent.
The FDA situation is a specific example of the country’s love of process and bureaucracy, rather than a love of effectiveness and success. We’re suffering from huge bureaucratic drag in doing anything; we see the same general problem recur in building out subways or other forms of transportation infrastructure, in building new electricity transmission lines, in permitting new electrical generating capacity, in building new housing, in the Nuclear Regulatory Commission (NRC), and in the FDA. Works in Progress is a good publication covering these kinds of issues. We’re stuck with the sclerotic processes implemented in the ’70s instead of the dynamic, transparent, and far faster processes we should have today. We’re all suffering the results, some of us more acutely (like yours truly, who is doing for lack of large-scale, deployed, and debugged customized vaccine technology) and some of us less directly.
Anything that is small enough to build in a factory and ship via container is cheap and abundant; anything that requires opaque regulatory approvals or that goes into the body is expensive and tragically scarce. Ezra Klein and Derek Thompson are writing a book presently titled Abundance: What Progress Takes, which is about this subject and which I’d write about if I were likely to last until April 2024.
Practitioners on the ground, like doctors, see the deaths of their patients. The FDA is more concerned about political issues. There’s nothing like watching people die to alter your risk tolerance.
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Thank you for sharing your story with the world and potentially saving future lives. I was wondering if you had looked into the traditional usage of turkey tail fungi to treat/shrink tumors? I’ve seen a few references in medical journals but not as well studied as it probably should be.Take care,Mike
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It is quite incredible we live in a world where so-called right-to-try is illegal in many states. Perhaps there is a grand conspiracy more than the FDA dragging their feet. It’s interesting to observe the sudden interest in murder-by-doctor (“physician assisted suicide”) but no interest in improving the drug pipeline. Fact of the matter is they want us dead. Pro-abortion, pro-suicide government bodies have no interest in saving their own citizenry. There’s plenty of will participants 100 miles from the border. It is no mystery why America is crumbling by every social, economic, and political measure.
Is the FDA responsible? Unlikely, given that the FDA is defacto controlled by private interests in the pharmaceutical industry. There’s no mystery why Pfizer became the drug of choice for “vaccination”. Under this assumption you’d think the FDA would be more than happy to inject you with whatever you can pay for.
Look further up the food chain and you realize that the monied interests would prefer all of us dead. It’s soylent green. I’m sorry to hear you are a victim of this machine. My condolences to you and your’s.
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https://www.biospace.com/article/fda-blocks-mesoblast-cell-therapy-again-asks-for-more-data/
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Please accept my heartfelt, deeply troubled appreciation for this, Mr Seliger. I find your clarion word charged with urgent importance. Albeit begging your pardon kindly. Not to confuse my 100% heartfelt solidarity with – agreement per se (alas). Beacon of hope that your message would be. If it only could – alas.
You didn’t meant for your crucial perspective to glare as yet another signpost of our unsinkable luxury liner nation’s doomed outlook. And to the best of my knowledge, information and understanding not all hope is lost. If I don’t see you in this life again Mr Seliger, I hope to see you in the next. Like Jimi said – “don’t be late.”
Looking into the FDA: to my considerable dismay I find it has no regulatory oversight agency. Closest thing to authority over it? Its duly constituting body the US Congress. Can the Senate or the House find its rear end with its own two hands? How about these current legislative Keystone Cop hearings into the oldest moldiest ‘alien bodies’ hearsay ever to be repeated, decade after decade, as many times as it takes -until it becomes true?
The whole truth proves much worse than the “only half” you tell; bad enough alone. But I must quote the testament of Dr Henry Wall, Jr (from his 2012 book) who figured out his father’s fate at the hands of the (shadow Charles Mansons) FDA – only by extraordinary one-man effort (finding a trail of buried clues):
https://archive.is/fHc3k#selection-853.110-857.591
The FDA has been gleefully off leash and running wild to do as it damn well pleases for over a half century. It isn’t about to be reined in. This network operation from hell has its tracks well covered, the better that none of us should be able to find out a thing (Dr Henry Wall, Jr – his book FROM HEALING TO HELL):
https://archive.is/fHc3k#selection-757.99-757.384
Most of what has been done to people can never be discovered from only 130 boxes. And the 5 alarm reality of this situation (specific to the FDA and shadow accomplices) proves to be nothing amenable to ‘reform’ – taking into account all 3 things – the truth, the WHOLE truth – and not a thing but.
Red alert bad news for vain hopes. One might as well appeal to a 3rd Reich’s ‘humanity improvement committee’ to ‘improve’ their operations at Dacchau (so they’ll be less inhumane).
In ‘buried’ history written out of ‘the books’ – including records treacherously destroyed, documents shredded etc) the FDA with NIMH accomplices has been digging not one but two mass graves.
And with the one of those two that you, Mr Seliger, unhappily expect to be joining – in the event that you get to heaven before we do, maybe bore a hole and pull me through.
The FDA as you can attest all too solemnly is slamming brakes on medicines and treatments urgently needed for serious even life-threatening conditions.
That’s the 180 degree opposite of its push for silk purse ‘medicines’ from sows ear mind destroying substances.
The FDA’s 1966 ‘Psychotomimetic Advisory Committee’ push ploy (as ratted out by Dr Wall) has been ‘refreshed’ – meet its Summer 2023 reincarnation today – FDA’s brave new “Recommendations Aim to Inform Psychedelic Drug Development”
“Inform” – the FDA’s horses know the way to carry this slay (there are ways of getting things done)
http://www.fda.gov/news-events/press-announcements/fda-issues-first-draft-guidance-clinical-trials-psychedelic-drugs
They might be doing as little as possible – nothing at ‘best’ – to develop drugs urgently need for serious illnesses (“it seems like the least we can do”).
But while plenty of nothing is being done that urgently needs doing – it’s not like the FDA is doing nothing.
And in dealing with any federal dictatorship or non-federal underworld, I would call for the accurate term to be used (minus any 1938 “Sympathy For The Munich” diplomacy) pulling no punches when it comes to strong-arming manipulation’s classic tactics of INTIMIDATION (please):
You score 100% accuracy with the 1920s Chicagoland analogy to this noxious FDA (and NIMH) subterfuge. The only thing that escapes are the ramifications. There is not a basis for ‘reform’ of some things. The much darker writing on the wall thus escapes – at the last moment precisely when the bad guy gets away.
But we are only human. It is our nature to always try holding out hope whether there is any or not in reality, even to our own detriment. Rather than realize as Churchill did all alone at first in 1938 the far grimmer fact of a matter.
Tyranny is what it is. Even when it dresses in fleece to go forth smiling in all faces on the outside (where it shows) – doggedly keeping its salivating appetite hidden inwardly (where it don’t).
Brian Akers, PhD (cf USA Wire Nov 17, 2022)
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