Could Medical Journals Assume The Role Of The FDA?

from the outside-perspectives dept

Yesterday, pharmaceutical maker GlaxoSmithKline got dinged after a study published in the New England Journal of Medicine found that patients on its popular diabetes drug, Avandia, were at an elevated risk for a heart attack. The company disputes the study's conclusion, but even if the drug stays on the market, it seems likely that patients will seek out competing drugs. What's interesting about the study is that it was conducted by a doctor who analyzed patient data that the company had posted to the internet. Unbeknown to him at the time he started his study, Glaxo had already discovered something similar, though it felt that the increased risk applied only to patients with pre-existing heart conditions. Coincidentally, a new law that's winding its way through Congress is likely to spur more of this "open source" drug safety research, as all companies will be required to post drug trial data on the web for others to chew over. The hope is that by allowing more third parties access to the data, the FDA's "broken" system for evaluating drugs can be fixed. While making more data public is usually a good thing, it's unlikely that this alone will prove to be a magic bullet. It's not hard to imagine trial lawyers and other motivated parties torturing the data so as to induce panic and lawsuits. On the other hand, the positive reputations of organizations like the New England Journal of Medicine could be put to good use if they play a more active role in informing the public about drug safety. Looking down the road, one could envision a system whereby it's the FDA's job to ensure that drug companies properly report safety and efficacy data, while third parties (think highly specialized versions of Consumer Reports) make judgments on a drug. Then, instead of having blanket pronouncements on whether a drug can be sold or not, it would be up to doctors to weigh all the risks and decide what's best for their patients on an individual basis.


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  1.  
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    Anonymous Coward, May 22nd, 2007 @ 3:55pm

    In Many Cases

    Could medical journals assume the role of the FDA? In many cases I certainly think they could do a much better job.

     

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    pharmD2B, May 22nd, 2007 @ 4:36pm

    "Then, instead of having blanket pronouncements on whether a drug can be sold or not, it would be up to doctors to weigh all the risks and decide what's best for their patients on an individual basis."

    That is a particularly scary thought.

    For every doctor that keeps up to date on the latest drug information there are 6 doctors that don't. Besides, doctors are not drug experts.

    Keeping a single entity such as the FDA makes the process of deciding where to look for necessary information much simpler. It also simplifies the recall and warning process.

    Let the medical journals run their studies and meta analyses and let the FDA have access to this information. In the cases where the FDA rules that a drug need not be recalled etc due to new evidence being presented at least the physicians and pharmacists that stay well informed will have the information at their disposal to make better judgments on the therapeutic choices for their patients.

     

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  3.  
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    RandomThoughts, May 22nd, 2007 @ 4:49pm

    Who dermines the level of risk? What happens when two good doctors disagree on something? That's the problem. The FDA is criticized for not looking at the trials close enough in some cases and taking too much time to approve drugs in others.

    The problem with using some kind of JAMA wiki is resource time constraints. You need good scientists looking at the results. Where does the money come from to staff that?

     

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  4.  
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    Urza, May 22nd, 2007 @ 5:15pm

    Hmmm...

    "Then, instead of having blanket pronouncements on whether a drug can be sold or not, it would be up to doctors to weigh all the risks and decide what's best for their patients on an individual basis."

    Hmm...so...if they won't be deciding if a drug can or cannot be sold, does that mean I'll be able to just go out and buy whatever drugs I want? Is it the FDA that makes things like LSD illegal? If so, I might like this idea :)

    Seriously though, who would decide things like what drugs would require a prescription in that case? The FDA isn't really just safe or unsafe...there are levels of safe and unsafe.

    As for the doctors not being able to decide - prescription drugs aren't safe for everyone. Doctors are already left with the decision of which drug is safe to give you. I highly doubt too much would change. Sure, the drug companies COULD sell pills that would kill you, but most doctors would figure that out and avoid them, and they wouldn't be very profitable.

     

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  5.  
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    Ferin, May 23rd, 2007 @ 6:45am

    My dad works at a major hospital with docotors who do heart transplants. (I would cite position/place, but I don't want to put him on the spot for me running my mouth)

    There were some ads runing recently from a lawfirm, saying that this one drug had been shown to increase risk of renal failure after heart procedures, and if you had had renal failure after having this drug, you would be entitled to compensation... blah, blah, blah.

    My dad got really pissed off by the ad, and explained to me that in most cases where the heart has serious problems, renal failure or damage is pretty much a given. (There's apparently a bunch of physiological reasons, but it went above my head pretty fast.)

    His whole point was, yes the drug could damage kidenys, if it was administered incorrectly, but in patients with kidenys that were already damaged from their heart trouble, using the drug to keep them alive/get them through surgery was basically a lesser of two evils.

    I guess my whole point is, this sounds like a decent idea to help deal with the FDA's short comings, but it does sound like it's opening the doors to some nasty and pointless lawsuits. Maybe what we should be doing is working on a new way for the FDA to work, instead of trying to put bandaids on, especially when they might just make things a lot worse.

     

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