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    Wednesday, February 14, 2007

    Twisted Findings: The FDA is warning us about the new Rotavirus vaccine:

    The government warned on Tuesday of potentially life-threatening twisting of the intestines in infants vaccinated against a virus that is the leading cause of early childhood diarrhea.

    The condition, called intussusception, is the same that led to the withdrawal of the first rotavirus vaccine eight years ago.

    The Food and Drug Administration said it was unknown whether the recently approved vaccine, called RotaTeq, caused the 28 new cases. The condition also can occur spontaneously. Indeed, the reports don't exceed the numbers expected to occur naturally each year _ the so-called background rate, the FDA said.

    I've been reluctant to use the RotaTeq vaccine because of just this possibility. Not that I thought it would cause more intussusceptions (the preliminary studies showed that the indicence of this particular side effect was no different than spontaneous cases), but because the FDA was likely to issue a warning such as this. In the public's eye (and the eye of the plaintiff's bar), a warning from a government agency says that there's a problem, not that there "might" be a problem. When the Weather Service issues a tornado or flood or winter storm warning means the tornado, flood, or winter storm is happening now - not that it might happen. Maybe the FDA should initiate a "watch" category, just like the weather service, instead of making everything a warning.

    But one suspects that the real goal of the FDA's warnings against harms that have not occurred is to prove to the public that they aren't in bed with the pharmaceutical companies. We now have big black box warnings on anti-depressants that warn not against an actual increase of suicide with their use, but a slight increase in thoughts of suicide. But the RotaTeq warning is an even more egregious example of baseless warnings. If intussusception is happening in vaccinated children at the same rate that it's happening in unvaccinated children, then what's the beef?

    More thoughts on the FDA's risk aversion.

    posted by Sydney on 2/14/2007 11:35:00 AM 1 comments


    Part of the issue here is the recent problems with a number of drugs and the governments response to these situations. In today's WSJ we find under Vaccine Draws FDA Warning the following information:

    Michelle Goveia, medical director of pediatric medical affairs at Merck, said the company continues to believe that the vaccine should be administered to all children.


    Some analysts have forecast that the vaccine could reach $500 million in sales by 2009.

    Given Merck's problems with Vioxx one has to question their veracity.

    Directly below the above article we find an article titled Witness Testifies Drug Maker Knew About Concers Over Ketec Study with the following quotes:

    A former employee of the Sanofi-Aventis SA contractor that oversaw a clinical trial of the antibiotic Ketek told Congress the drug maker knew there was evidence of a problem with the study before regulators discovered fraud.


    Rep. Bart Stupak, another Michigan Democrat and chairman of its investigations subcommittee, said the FDA's interactions with the drug industry had become "incestuous."

    The excesses of the past are causing an increased scrutiny of the drug industry. As the drug industry has, in the past few years, placed all of it's bets on just a few drugs the need to create, not only a blockbuster product, but the surrounding buzz has caused some to engage in data manipulation.

    Until there is more transparency in drug trials, along with clearer data reporting, people will question every adverse reaction to every new drug, especially one that treats a condition not normally fatal in this country.

    Steve Lucas

    By Anonymous Anonymous, at 2:56 PM  

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