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.