The New York Times Questions Prodisc, Surgeons, Hospitals, Industry and FDA
BY DAVID KRESSEL, JANUARY 30, 2008
In the January 30th issue of the New York Times, healthcare reporter Reed Abelson takes a critical look at spine surgery, and in particular a novel device called Prodisc in an article titled "Financial Ties Are Cited as Issue in Spine Study." In simple terms, she suggests that the FDA approval of the device was the result of clinical trial investigators having financial interests in the product's success and that Prodisc is a bad product.
We disagree with many of Ms. Abelson's implications and conclusions.
- Industry and surgeons drive innovation in medicine. Without the combination of capital and engineering from companies with clinical knowledge from surgeons, new products will never develop beyond drawings on napkins. The goal of regulation cannot be to separate industry and doctors, but to assure full disclosure of relationships between doctors and companies in cases where there is the potential for or appearance conflict of interest.
- Safeguards of this sort are in place at the FDA and at most hospitals. As noted in the article, Hospital for Special Surgery stated their patients were informed of the hospital's involvement with Spine Solutions, the company that developed Prodisc and was acquired by Synthes. Society can't punish doctors and institutions for following the rules, by after the fact changing the rules. Parties that don't follow the rules are always subject to punishment and prosecution. We hope Synthes and the surgeons involved in the trial properly disclosed their financial interests to the FDA, and with the exception of the one surgeon mentioned, there is no proof to suggest anyone didn't.
- Ms. Abelson pulls anecdotes to imply Prodisc is a bad product. That kind of reporting is a 10x exaggeration of the flaws she is trying to point out in her article. No surgery has a 100% success rate.
- As for the broad statement Abelson makes, that spinal fusion doesn't benefit patients, a metadata analysis presented to CMS in 2006 confirmed fusion's ability to reduce pain in the short and long term, and the $21 million SPORT trial published in 2007 confirmed that spinal surgery is better than no surgical approaches in reducing pain and restoring functionality for patients.
