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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.

Conscious Choice cover

Now available in hardback and paperback as well as ebook!

 

From the press release: In this ground-breaking new history of early America, historian Robert Zimmerman not only exposes the lie behind The New York Times 1619 Project that falsely claims slavery is central to the history of the United States, he also provides profound lessons about the nature of human societies, lessons important for Americans today as well as for all future settlers on Mars and elsewhere in space.

 
Conscious Choice: The origins of slavery in America and why it matters today and for our future in outer space, is a riveting page-turning story that documents how slavery slowly became pervasive in the southern British colonies of North America, colonies founded by a people and culture that not only did not allow slavery but in every way were hostile to the practice.  
Conscious Choice does more however. In telling the tragic history of the Virginia colony and the rise of slavery there, Zimmerman lays out the proper path for creating healthy societies in places like the Moon and Mars.

 

“Zimmerman’s ground-breaking history provides every future generation the basic framework for establishing new societies on other worlds. We would be wise to heed what he says.” —Robert Zubrin, founder of founder of the Mars Society.

 

All editions are available at Amazon, Barnes & Noble, and all book vendors, with the ebook priced at $5.99 before discount. The ebook can also be purchased direct from my ebook publisher, ebookit, in which case you don't support the big tech companies and I get a bigger cut much sooner.

 

Autographed printed copies are also available at discount directly from me (hardback $24.95; paperback $14.95; Shipping cost for either: $5.00). Just email me at zimmerman @ nasw dot org.

3 comments

  • Daniel Peters

    “…. 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.

  • wayne

    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.

  • wayne

    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.

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