Should Doctors Have a Financial Interest in Biomedical Products Research?

Should doctors be allowed to perform clinical trial research involving products if they have even an indirect financial stake in that product? It’s a question that is squarely before the FDA and an answer to which Minnesota-based Medtronic has a lot riding.

The product at issue dates back to 2002. At that time a group of FDA advisers met to decide whether or not to approve a powerful agent that promised to revolutionize back surgery. Even then one of the advisors raised initial concerns that some of the research in support of the product had been conducted by a doctor with a financial interest in the product. The rest of the advisors brushed off the concern and proceeded with approval.

Flash forward several years to complaints about the product, including widespread, unapproved use and adverse reactions in some patients that include life-threatening swelling in the neck from bone in unwanted locations and possibly fueling the growth of cancer cells or sparking adverse immune system reactions.

Now Medtronic is back before the FDA seeking approval of a similar product, and the agency and doctors have raised concerns about these adverse reactions and the ties many of the clinical researchers have to the product. It should go without saying that if a researcher stands to make a profit from the approval of a particular product they should not be involved in directing or conducting research in support of that product. But currently there is no hard and fast rule prohibiting such relationships. Given the change in focus by the FDA over the last year, that could change, and if it did, the Minneapolis Drug injury lawyers at Lord & Faris think that consumers would be much better off.