George Ebers’ views on MS clinical trials

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George Ebers’ views on MS clinical trials

Postby Direct-MS » Mon Nov 01, 2010 3:07 pm

George Ebers is perhaps the #1 MS researcher in the world and is a professor at Oxford in England. Notably he is also one of the few MS researchers who is not compromised by major financial ties to the MS drug companies. He recently expressed his well supported views on, why the clinical trials of the MS drugs are basically worthless, in an abstract for his presentation at a neurology conference in Barcelona. He writes

"Clinical trials of multiple sclerosis have been uniform in utilising invalidated outcome measures. This has occurred to a degree to which it is difficult to find parallels in medicine in general.We have recently evaluated the outcomes which have been used for evaluating past trials leading to drug approval and current trials. It is not a pretty sight.

It is quite clear from natural history studies that relapses have very little if anything to do with long term outcome. Similarly, MRI measures have been thoroughly evaluated within large datasets and found to be similarly non-predictive for meaningful outcomes. The measures of disability used in trials certainly don’t measure unremitting disability as investigators and their industry supporters have claimed.

The widespread embracing of dubious and poorly validated outcomes by some MS investigators, often in contexts where there are egregious conflicts of interest, threaten academic credibility not to mention long term professional autonomy."
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Postby Squeakycat » Tue Nov 02, 2010 6:10 am

Is there a citation for this abstract or the full paper?
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Postby Direct-MS » Tue Nov 02, 2010 11:53 am

It is available on the website of the "Controversies in Neurology" Conference in Barcelona. http://comtecmed.com/cony/2010/scientific_prog.aspx
While you are there check out the Zamboni (for CCSVI) and Stuve (against CCSVI) abstracts as well as some other useful ones
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Postby HappyPoet » Tue Nov 02, 2010 2:02 pm

Hello Dr. Embry,

Thank you very much for posting George Ebers' abstract. I stopped believing in "MS" DMD clinical trial results when I learned that the data the FDA relies upon in its determinations is self-reported data and that executives of Biogen/Elan, makers of Tysabri, had been caught participating in insider-trading regarding Tysabri, which just so happened to be the DMD I had been taking until the FDA pulled it off the market due to PML:

Former Biogen Executive Settles Insider-Trading Charges
"by John Hechinger, Wall Street Journal, January 12th, 2006
http://www.corpwatch.org/article.php?id=13094

"The former general counsel of Biogen Idec Inc. settled securities-fraud and insider-trading charges, agreeing to pay more than $3 million related to his sale of company shares on the day the biotech company learned that a patient taking its new multiple sclerosis drug was sick with a deadly infection."

On a different topic, the book, Your Inner Fish, by Neil Shubin is required reading in my daughter's high school AP Biology class. When I saw your name in the first chapter, I was happily surprised and couldn't wait to tell my daughter about you, your son, and your wonderful foundation, DIRECT-MS.

Mr. Shubin talks about one important way in which fish and humans differ which relates to CCSVI. To look left or right, fish must turn their entire body left or right, whereas humans can turn their head left or right without turning their whole body, thanks to the evolution of the neck!

Btw, DIRECT-MS on Facebook, is terrific.
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Postby Direct-MS » Tue Nov 02, 2010 2:32 pm

Thanks for the link. I always wondered what happened to those crooks at Biogen. My 2005 article on the Tysabri crooked dealings is at http://www.direct-ms.org/magazines.html#tysabri
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Postby HappyPoet » Sun Nov 07, 2010 9:47 am

Dr. Embry, thank you for the link to your article. What galls me about Biogen's "general counsel" is that, as a lawyer, he certainly knew that his actions were not only immoral and unethical but also ILLEGAL. Love your word choice -- crooks!

:)
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