| New England Journal of Medicine article on latest collagenase trials |
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09/03/2009 23:44
moondanc 
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09/03/2009 23:44
moondanc
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New England Journal of Medicine article on latest collagenase trials
The current Volume 361:968-979 September 3, 2009 Number 10 of the NEJM has an article on the latest trials. Below is a link to the abstract.
http://nejm.highwire.org/cgi/content/abstract/361/10/968
A 21 day free trial to the journal is available here:
http://nejm.highwire.org/cgi/content/full/361/10/968
Authors of the study are:
Lawrence C. Hurst, M.D., Marie A. Badalamente, Ph.D., Vincent R. Hentz, M.D., Robert N. Hotchkiss, M.D., F. Thomas D. Kaplan, M.D., Roy A. Meals, M.D., Theodore M. Smith, Ph.D., John Rodzvilla, M.D.
This is what really jumped out at me:
"Dr. Hurst reports receiving consulting and advisory-board fees and grant support from Auxilium Pharmaceuticals and grant support from BioSpecifics Technologies (and may receive royalty fees pending Food and Drug Administration [FDA] approval); Dr. Badalamente, receiving consulting and advisory-board fees from Auxilium Pharmaceuticals and grant support from BioSpecifics Technologies (and may receive royalty fees pending FDA approval); Dr. Kaplan, receiving consulting and advisory-board fees from Auxilium Pharmaceuticals; Drs. Rodzvilla and Smith, being employees of and holding stock options with Auxilium Pharmaceuticals; and Drs. Meals, Hentz, and Hotchkiss, receiving consulting fees from Auxilium Pharmaceuticals"
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09/04/2009 15:25
Mike Snot registered
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09/04/2009 15:25
Mike Snot registered
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Re: New England Journal of Medicine article on latest collagenase trials
Objective, no?
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09/04/2009 20:50
juratenot registered
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09/04/2009 20:50
juratenot registered
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Re: New England Journal of Medicine article on latest collagenase trials
They now require the authors to list all such affiliations and conflicts of interest.
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09/04/2009 20:56
juratenot registered
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09/04/2009 20:56
juratenot registered
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Re: New England Journal of Medicine article on latest collagenase trials
It looks like a good study. A "prospective, randomized, double-blind, placebo-controlled, multicenter trial"; that's the gold standard.
There was a frequency of 1% serious adverse events: 2 tendon ruptures and one person who developed "complex regional pain syndrome" (don't know what it is, but I don't want it). Otherwise the collagenase improved function.
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09/04/2009 22:22
jimh 
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09/04/2009 22:22
jimh
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Re: New England Journal of Medicine article on latest collagenase trials
I'm not necessarily alarmed by all the "consultant" money being paid. Some of these MDs have been working on this treatent for over 10 years now and they expect to make some money from it. That's how our system works. And we hope that since the study appears in NEJM that means it's been appropriately peer-reviewed.
Edited 09/16/09 20:27
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09/06/2009 21:32
MissMyGuitars 
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09/06/2009 21:32
MissMyGuitars
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Re: New England Journal of Medicine article on latest collagenase trials
Please do not lead people to believe that these types of affiliations necessarily have impact on the quality of the data. This is nothing more than a conspiracy theory.
Two things to remember here. One, like it or not, this is simply the way things get done these days. It is common (and good) practice for manufacturers of any product to seek, and pay for if necessary, expert third party testing. And two, unlike the activist or otherwise biased web sites or printed propaganda I come across on a routine basis, articles published in the New England Journal of Medicine have been vetted through a peer review process. Every physician on the peer review board would have to be on the take for these supposed doctor/drug company conspiracies to actually work..... not likely.
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09/15/2009 23:22
moondanc
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09/15/2009 23:22
moondanc
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Re: New England Journal of Medicine article on latest collagenase trials
Quote:
I'm not necessarily alarmed by all the "consultant" money being paid. Some of these MDs have been working on this treamtent for over 10 years now and they expect to make some money from it. That's how our system works. And we hope that since the study appears in NEJM that means it's been appropriately peer-reviewed.
Hi jimh and others who responded,
I was going to let this go but upon more thought just have to comment. I don't have any problem with MDs being paid-- in stock options, royalties, cash, etc. for the work they've been doing on this drug. What I DO object to is these same docs being some of the primary docs running the FDA trials--it's a conflict of interest or surely gives the appearance of one. There are plenty of hand surgeons and universites in the US other than these 8-10 docs who could be running the trials. I'm not sure how many trial sites there were to get the 308 patients-- I do know some of the docs weren't connected to Auxilium.
Peer review--yes, it is necessary but it's only as good as the data presented and there have been several cases over the past years-- one in particular at UCSF-- where the pharmaceutical company running the trials sought to muzzle/stop the researchers from presenting the adverse data. In fact, I believe in that case the researchers had signed contracts promising not to reveal any data to the public. If there was/is bias on the part of researchers and/or if they are not following trial guidelines, this generally is not avaialbe to their peers who are doing the review and that's why it's much better to avoid even an appearance of conflict of interest.
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