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    Friday, May 12, 2006

    Politicizing Science: If the FDA and the Department of Health and Human Services were to go to a pharmaceutical company and advise them on how to get their drug approved in the United States in order to satisfy the objectives of an influential campaign donor to the sitting President, wouldn't that be a politicization of the drug approval process to a profound and crass degree? Why, yes, it would. But, apparently, it has happened:

    [A big drug company] had historically refused to permit [a subdivision of the big drug company] to seek marketing approval for [a desired drug]... in the United States.

    Both [FDA] and I (HHS) have taken steps to persuade [the subdivision] and [the big drug company] to change their positions. In February, [we] met with ... the President of [the subdivision], to discuss the availability of [the desired drug] in the United States for research and marketing. In March I wrote to....[the] President of the Board of [the big drug company], to ask him to permit [the subdivision] to begin any necessary testing of [the desired drug] in the United States in Preparion for filing a new drug application with the FDA.....

    ....FDA arranged a meeting between [the subdivision] and [a U.S. non-profit research group]. The meeting's purpose was to facilitate an agreement between those parties to work together to test [the drug] and file a new drug application for the drug. The [research group] was identified as the most likely group to work with [the subdivision] because of an existing contract between these two parties that required [the subdivision] to give [the research group] sufficient amounts of the drug for the [research group] to conduct clinical trials. The contract also appeared to require [the subdivision] to license the drug to [the research group] if [ the drug company] was unwilling to sell the drug in the United States.


    Sounds like the FDA and the HHS are more interested in getting said drug to market than making sure it's safe. That seems an extraordinary role for both agencies, does it not?

    The year was 1993. The drug, RU-486. Today, it was revealed that a seventh woman died after using the much desired drug.
     

    posted by Sydney on 5/12/2006 09:08:00 PM 10 comments

    10 Comments:

    Life news certainly can not be viewed as objective medical reporting. I do not pretend to understand the medical issues but at a minimum I would assume there is some risk benefit analysis re: complications from the drug vis a vis pregnancy to term and other forms of abortion or birth control. Also, there seems to be substantial evidence of practioners not following the manufacturers advice. Does not sound like a good idea in most cases.

    By Anonymous Frank, at 1:18 PM  

    According to this article, the same infection that occurred after taking RU-486 happened in several cases after miscarriage or natural birth.
    It seems that author of this blog is so much against this particular drug that she is loosing objectivity. Do you have any data that shows that taking this drug as directed is riskier than having an abortion? That it is riskier than natural birth?

    By Anonymous Anonymous, at 7:17 PM  

    Pregnancy carries risk for a woman. If she has the child, miscarries, or aborts it. There is no perfect solution just like there is no perfect birth control except abstinance to date. Being a woman you accept the risk and move on. Hell, tampons can kill you (TSS). Just because a car can kill you, you don't see people giving up driving. I agree with annoymous's statements.

    By Anonymous Dara, at 10:07 PM  

    Doesn't have to be RU-486, could be anything. I don't think the point was to stir up a political debate about abortion - rather the concern is about the propriety of politics intruding on scientific decisions.

    Surely people remember the HIV-screen scandal in France ? Or the Soviet practice of declaring enemies of the state to be mentally ill? It's probably more common that anyone would want to believe. Here's somehting from today's news:

    http://www.timesonline.co.uk/article/0,,6-2176383,00.html

    "Oh, brave new world that hath such creatures in't"

    John Fembup

    By Anonymous Anonymous, at 11:26 AM  

    Interesting article in the Times--I do agree with its editorial slant--access to healthcare should not be dependent or in any wat related to personal politics. Offending one's sensibilities is not the same as physical assaults or the threat of physical assaults. Thanks Again Frank

    By Anonymous Frank, at 3:39 PM  

    Doesn't have to be RU-486, could be anything. I don't think the point was to stir up a political debate about abortion - rather the concern is about the propriety of politics intruding on scientific decisions.
    This is not the first post on RU-486 on this blog. The rate of side effects for RU-486 is pretty low; and it's been safely used for many years in Europe before allowed in the US.
    If we are talking about politics and science there are better examples than RU-486. Plan B comes to mind as well as the recent FDA declaration about medical marijuana.

    By Anonymous diora, at 9:33 PM  

    Is is true, as was stated at another blog, that in several of these instances the patient was applying the medicine vaginally, rather than taking it orally?

    By Anonymous Anonymous, at 5:13 PM  

    I believe that what was being used vaginally was misoprostol. The RU would be to kill the embryo, and the misoprostol is to bring on contractions to get rid of it. It's a pretty common off-label use for that drug, which I believe is primarily for ulcers(?).

    Having been given the misoprostol for a missed miscarriage, I can state that in my experience, a D&C is far less painful, quicker, and less emotionally traumatic. I do wonder how much the misoprostol contributed to those women/girls' deaths.

    By Blogger LibraryGryffon, at 2:49 PM  

    OK, having just read the article, it says that the only drug this woman had used was the misoprostol. So my concerns about it are valid.

    I had understood, perhaps incorrectly, that the term "RU-486" refered only to the other drug, mifepristone, but that they (mifepristone and misoprostol) were often used in tandem.

    By Blogger LibraryGryffon, at 2:53 PM  

    On July 15 you complained about "junk science" blaming thimersol for autism. Isn't your claim that RU-486 is causally responsible for particular deaths using the same logic as the junksters? Where are your comparison groups for estimates of risk with alternate methods or the risks associated with no method at all?

    By Anonymous Anonymous, at 6:31 PM  

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