Wow! Can I just say 'Wow?'
A medical journal has devoted an entire issue to problems with Infuse, a product sold by Medtronic that helps create bone and has been used on over 500,000 patients by more than 2300 surgeons. Infuse is one of Medtronic's most important products with sales of over $900 million last fiscal year.
The major takeaways from the latest issue of The Spine Journal?
- A review of the original 13 Medtronic-sponsored studies found that they reported 10 to 50 times fewer complications with Infuse than the data actually show.
- Many of the study authors had financial ties to Medtronic, with a median range of $12 to $16 million per study.
- Infuse proponents cite "less patient pain" to justify use of Infuse over traditional treatment; however, the severity of pain in this traditional treatment is overemphasized.
- Infuse can cause problems with nerves and the spinal cord.
This story is unprecedented for several reasons. Physicians tend to protect their own kind, and seldom lob bombs at their colleagues, for fear of ostracism. The main critic, Dr. Eugene Carragee of Stanford University, must know that he is not making friends with fellow surgeons by critiquing their research and pointing out the heaps of cash they are amassing from industry.
Further, as editor of a journal that is criticizing his own profession, he also takes a shot at medical journals themselves for publishing these garbage studies that downplayed risk to increase sales for Medtronic. In an accompanying editorial, he wrote:
It harms patients to have biased and corrupted research published. It harms patients to have unaccountable special interests permeate medical research. It harms patients when poor publication practices become business as usual.
Yet harm has been done. And that fact creates a basic moral obligation.
Who could disagree with that?
This story has the potential to go viral for the next few days, with coverage by The New York Times, Wall Street Journal, and the Milwaukee Journal-Sentinel, which has been leading the pack with coverage on the Infuse issue.
More importantly, this could be a critical turning point, when we see physicians finally break free from corrupt influence of industry and begin to put patients first and money second. Or maybe not.
Regardless, the war drums will not be calmed.
Last week, Senate Finance Committee Chairman Max Baucus (D-MT) and Sen. Charles Grassley (R-IA) sent a letter to Medtronic demanding a whole truckload of information on Infuse. It seems the senators have concerns that Medtronic-sponsored "science" is little more than a trojan horse designed to infiltrate the research community and plunder the federal healthcare programs.
Expect future skirmishes.
Paul Thacker is a POGO Investigator.
Image of B-52 bomber: Wikimedia Project. Trojan horse image via Wikimedia Commons.