Fatal clinical drug trial failed because company did not review all data
The company that conducted a fatal French clinical drug trial that killed one and left four permanently damaged has revealed that it did not review all the available data before administering increased dosages to patients.
Not only is it astonishing that they failed to use all the available data, it is even more amazing that the company itself admits to this.
As I noted when this story first broke in February, this is a big deal, and should get major coverage by news organizations.
…it is disturbing that a research company could be so cavalier about the lives of the human beings it is using as test subjects.
This story also illustrates indirectly the significant decline in the state of today’s modern mainstream press as well as the greater interests of the general public. This is a major science story. For a clinical drug study to kill one of its test subjects is a big deal. Yet I am certain that this will get no coverage in any cable news outlet. (If anyone see a video story about this, please let me know.) The written news outlets on the web will likely do a story, but it will not give it wide exposure.
As far as I can tell, this story got no coverage in the press then, and I expect none now. A dark age is surely coming.
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In 2020 when the world panicked over COVID I wrote that the panic was unnecessary, that the virus was apparently simply a variation of the flu, that masks were not simply pointless but if worn incorrectly were a health threat, that the lockdowns were a disaster and did nothing to stop the spread of COVID. Only in the past year have some of our so-called experts in the health field have begun to recognize these facts.
Your help allows me to do this kind of intelligent analysis. I take no advertising or sponsors, so my reporting isn't influenced by donations by established space or drug companies. Instead, I rely entirely on donations and subscriptions from my readers, which gives me the freedom to write what I think, unencumbered by outside influences.
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The company that conducted a fatal French clinical drug trial that killed one and left four permanently damaged has revealed that it did not review all the available data before administering increased dosages to patients.
Not only is it astonishing that they failed to use all the available data, it is even more amazing that the company itself admits to this.
As I noted when this story first broke in February, this is a big deal, and should get major coverage by news organizations.
…it is disturbing that a research company could be so cavalier about the lives of the human beings it is using as test subjects.
This story also illustrates indirectly the significant decline in the state of today’s modern mainstream press as well as the greater interests of the general public. This is a major science story. For a clinical drug study to kill one of its test subjects is a big deal. Yet I am certain that this will get no coverage in any cable news outlet. (If anyone see a video story about this, please let me know.) The written news outlets on the web will likely do a story, but it will not give it wide exposure.
As far as I can tell, this story got no coverage in the press then, and I expect none now. A dark age is surely coming.
Readers!
Please consider supporting my work here at Behind the Black. Your support allows me the freedom and ability to analyze objectively the ongoing renaissance in space, as well as the cultural changes -- for good or ill -- that are happening across America. Fourteen years ago I wrote that SLS and Orion were a bad ideas, a waste of money, would be years behind schedule, and better replaced by commercial private enterprise. Only now does it appear that Washington might finally recognize this reality.
In 2020 when the world panicked over COVID I wrote that the panic was unnecessary, that the virus was apparently simply a variation of the flu, that masks were not simply pointless but if worn incorrectly were a health threat, that the lockdowns were a disaster and did nothing to stop the spread of COVID. Only in the past year have some of our so-called experts in the health field have begun to recognize these facts.
Your help allows me to do this kind of intelligent analysis. I take no advertising or sponsors, so my reporting isn't influenced by donations by established space or drug companies. Instead, I rely entirely on donations and subscriptions from my readers, which gives me the freedom to write what I think, unencumbered by outside influences.
You can support me either by giving a one-time contribution or a regular subscription. There are four ways of doing so:
1. Zelle: This is the only internet method that charges no fees. All you have to do is use the Zelle link at your internet bank and give my name and email address (zimmerman at nasw dot org). What you donate is what I get.
2. Patreon: Go to my website there and pick one of five monthly subscription amounts, or by making a one-time donation.
3. A Paypal Donation or subscription:
4. Donate by check, payable to Robert Zimmerman and mailed to
Behind The Black
c/o Robert Zimmerman
P.O.Box 1262
Cortaro, AZ 85652
You can also support me by buying one of my books, as noted in the boxes interspersed throughout the webpage or shown in the menu above.
“…. will get no coverage in any cable news outlet.”
Has anyone watched a “cable news outlet” recently? They get a large fraction of their income from Pharmaceutical companies. They are NOT about to bite the hand that feeds them.
Mr. Z– absolutely correct.
I only play a Pharmacologist on the Interweb, but I have participated in drug-studies, and one of those was for a psychoactive substance. (a timed-release Xanax formulation) But, only familiar with Protocols we use here in the USA, and what anecdotally happened in my case. (Not directly comparable, as Xanax was already marketed & 50 million people had already taken it.)
–It was a “metabolism/clearance” study & I had to physically stay 24/7 at the Facility whilst they dosed me up. Knew instantly I was in the active-substance arm, and they drew my blood every 4 hours for 2 straight days plus psychological testing every 8 hours. Prior to that, had extensive blood-work, physical-screening, CT & MRI, etc., and a lengthy informed-consent session with the Investigator, & they wouldn’t proceed with anyone, if we tested positive for any other substances we weren’t supposed to be taking, smoking, or drinking.
Killing test-subjects at that phase of the French study, is a huge deal.
Toxicity-screening at Phase 1 and 2, is designed to prevent these type of blunders. And the dose escalation Arm protocol, “sounds faulty to me,” but I am lacking in specifics.
I can’t read French, but the report is here:
http://social-sante.gouv.fr/IMG/pdf/fevrier_2016_-_note_etape_-_accident_essai_clinique.pdf
Not a yuge fan of Wiki, but they have a rather complete rundown of BIA10-274, which includes stuff from the French report:
https://en.wikipedia.org/wiki/BIA_10-2474
(Haven’t taken it all in yet.)
It is interesting to note– the drug utilizes the “edoncannibinoid” system in the body. -Think “cannabinoid” as in, from the “THC derivative,” Family, although that specific molecule is not present in raw Maryjane, our bodies/brains do have an innate “system” which modulates those type-of-molecules. There is an extensive body of research on that system, although it is very poorly understood in most regards.]
tangentially, but related on the margins;
Extensive screening of cannabinoid analogs was conducted in the late 70’s/early 80’s [there were literally 10’s of thousands of these analogs developed]– they were trying to find a THC analog without any overt psychoactive effects, but that targeted things such as pain, glaucoma, Parkinson’s, etc., and the substrates for what is believed to be a causation mechanism for major Thought Disorders.
Daniel Peters– I stopped watching cable/network “news” in large measure (90%+/-) last winter & I’m going 100% off “news,” as of January 1st, 2017.
The day-by-day minutia and endless contrived/manufactured “conflict,” and pure lies, was driving me insane.
Highly suggest C-span, if you have the time.
(I’m not a special pleader for Big Pharma and/but–my daughter works in R&D for one of the top 5. They don’t care what network their adverts appear on, as long as it hits their target demographic. Increasingly, they are not allowed to market to Doctors, so they stepped up marketing to people, who then pressure their Doctors for all these name-brand lifestyle drugs. If people had to actually pay market-prices for their meds, they’d be a lot pickier on non-essential meds.)
The Pharmaceutical business is controlled to death. When you are that heavily regulated, the Government is your Partner.
Mr. Z; my daughter & son-in-law, both actual Pharmacologists, will be visiting for the next week. I’ll quiz them on the whole BIA10-274 affair and general protocols, for any tidbits of interest.
I wish I could read French, ‘cuz I’m leery of Wikipedia, but it appears someone disregarded vital factoids in the preliminary data, and the Administrators then signed off on everything nonetheless. Determining who is “responsible” is going to be a protracted mess.