System for Approving New Medical Options Needs Improvement
Something Doesn’t Add Up
Not only did the team find that evidence for Infuse’s benefits over existing alternatives for most patients was questionable; they also discovered in a broad array of published research that risks of complications (including cancer, male sterility and other serious side effects) appeared to be 10 to 50 times higher than 13 industry-sponsored studies had shown. And they learned that authors of the early studies that found no complications had been paid between $1 million and $23 million annually by the company for consulting, royalties and other compensation. Carragee, MD ’82, estimates Medtronic has sold several billion dollars’ worth of Infuse for uses both approved and “off label.”
Without a rigorous, data-driven context, medicine’s expensive traditions and hunch-based treatments threaten to bankrupt us. “People say that we shouldn’t delay science; people are dying; we should get new treatments out there. I do not feel the pressure to do that until we have solid evidence,” Ioannidis asserts. “The resources many procedures draw are enormous.” And that leaves insufficient funds for the prevention plans and treatments we know actually work.
I have written about the problems with our health care research system several times. The existing system is in need of improvement and is made much worse by the general state of the broken health care system in the USA. Dr. John P.A. Ioannidis, the focus of the article, is doing fantastic work in this area.