While the government is busy backpedaling away from the idea that comparative effectiveness research should actually inform treatment decisions, some Stanford Med School researchers want to push ahead. In a New England Journal of Medicine article, the researchers ask why drug labels don't include information on how the meds compare with other treatments for the same conditions. And they want the FDA to change that.
Not only does pharma benefit from a drug-approval process that only requires them to test against placebo, drugmakers continue to reap the rewards after their drugs hit the market, because of a lack of head-to-head testing data. "Drug and device manufacturers benefit from an unacknowledged information gap that develops as more and more products are tested against placebo, but not each other," said Dr. Randall Stafford, a Stanford associate prof and lead author of the essay.
Stafford said that the public--and even doctors--sometimes think FDA approval of new meds means those new meds are better than the ones already on the market. Of course, that's not necessarily so. And with new treatments so much more costly than the growing band of generic options, that ignorance contributes to higher healthcare costs.
The researchers theorize that people might not be so eager for new meds if they knew the latest product's performance compared with the old. That's not something we expect drugmakers to line up behind--after all, new meds are their business. But it's food for thought.
- read the Stanford release
- check out the NEJM article