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Is the Vaccine Shield a Model for Limited FDA Preemption
The WSJ has an interesting article today about the limits on lawsuits in the arena of certain vaccines. It may require subscription to access, but it can be found here:
http://online.wsj.com/article/SB123535050056344903.html
There are also summaries at various blogs, including Fierce Biotech:
http://www.fiercebiotech.com/story/booming-biz-raises-questions-about-vax-legal-shield/2009-02-23
What is unique about the vaccine law is that the shield is quite limited. If individual plaintiffs are turned down by the "vaccine court," or are otherwise not happy with the verdict, they are still free to file suit privately.
Might this be a model for limited preemption in the wider drug arena? Probably not, in that it would require an enormous "drug court"--or many--to field all the potential claims. Still, according to the article, Henry Waxman has been a key supporter of the current regime re: vaccines and, overall, it seems to have worked reasonably well.
What do you think?
Showing posts with label Vaccine. Show all posts
Showing posts with label Vaccine. Show all posts
Monday, February 23, 2009
Thursday, February 12, 2009
FUDGING DATA ON AUTISM-VACCINES?/WHO'S ZOOMIN' WHOM?
Further update - read the links provided by our commenters below. The story gets curioser and curioser. (I have no idea why some links just works and others have to be pasted into browser. Our crack tech dept., which just got a new corner office (albeit in the basement) may know.
I do hope you are enjoying the new, wide-bodied PharmaLittle. An achievement that brought the Tech. Dept. plumbing and a hot plate.
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Related to the story below, many of you will know the wider story of today's vaccine court decision rejecting claims of plaintiffs for autism linked to vaccines (solely). The story is in the NYT
http://www.nytimes.com/2009/02/13/health/13vaccine.html?_r=1&partner=rss&emc=rss
Father of Autism-Vaccine Link Accused of Fudging Data
I am pasting in this summary just as Nathan contributed it to us. Thanks, Nathan!
It is probably accurate that we more often think of "fudging" done in the interest of market share than in the interest of academic egos or other self-interests (being on the take from plaintiff's' lawyers). If we do, we are in tune with surveys of public opinion more generally.
Speaking for myself, anyway, I have said more than once that I thought the overall level of integrity in pharma was at least as high as in academia, probably higher. The difference has more to do with the consequences when things go ethically south, although that also cuts in both directions.
Whatever the truth finally turns out to be in this case, it is a good reminder that no one has a corner on virtue--or the lack thereof.
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Here's a story for you. It appears that the researcher who originally postulated a link between the MMR vaccine and autism may have fudged his numbers a bit. It goes to show you that there are influences on researchers from all directions - not just the ones we tend to think about on this site.
http://www.medpagetoday.com/Pediatrics/Autism/12850
Here's a quote:LONDON, Feb. 11 -- The British researcher who first linked childhood vaccines to autism has been accused of falsifying data in a 1998 study published in The Lancet. The Times of London reported Sunday that Andrew Wakefield, M.D., apparently altered clinical findings on eight of 12 children whose cases were the basis for the study. The allegations follow disclosures in 2004 that Dr. Wakefield's research was partially, and secretly, funded by plaintiffs' lawyers in suits against vaccine makers, and that he had cut procedural corners in the research.
I do hope you are enjoying the new, wide-bodied PharmaLittle. An achievement that brought the Tech. Dept. plumbing and a hot plate.
***********************************************************
Related to the story below, many of you will know the wider story of today's vaccine court decision rejecting claims of plaintiffs for autism linked to vaccines (solely). The story is in the NYT
http://www.nytimes.com/2009/02/13/health/13vaccine.html?_r=1&partner=rss&emc=rss
Father of Autism-Vaccine Link Accused of Fudging Data
I am pasting in this summary just as Nathan contributed it to us. Thanks, Nathan!
It is probably accurate that we more often think of "fudging" done in the interest of market share than in the interest of academic egos or other self-interests (being on the take from plaintiff's' lawyers). If we do, we are in tune with surveys of public opinion more generally.
Speaking for myself, anyway, I have said more than once that I thought the overall level of integrity in pharma was at least as high as in academia, probably higher. The difference has more to do with the consequences when things go ethically south, although that also cuts in both directions.
Whatever the truth finally turns out to be in this case, it is a good reminder that no one has a corner on virtue--or the lack thereof.
*********************************************************************
Here's a story for you. It appears that the researcher who originally postulated a link between the MMR vaccine and autism may have fudged his numbers a bit. It goes to show you that there are influences on researchers from all directions - not just the ones we tend to think about on this site.
http://www.medpagetoday.com/Pediatrics/Autism/12850
Here's a quote:LONDON, Feb. 11 -- The British researcher who first linked childhood vaccines to autism has been accused of falsifying data in a 1998 study published in The Lancet. The Times of London reported Sunday that Andrew Wakefield, M.D., apparently altered clinical findings on eight of 12 children whose cases were the basis for the study. The allegations follow disclosures in 2004 that Dr. Wakefield's research was partially, and secretly, funded by plaintiffs' lawyers in suits against vaccine makers, and that he had cut procedural corners in the research.
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