An investigation by the US Senate has revealed that Medtronic paid doctors to endorse their new spine fusion product, Infuse.
The investigation found that several positive articles and reviews of the product were written and edited with input from Medtronic employees. Additionally, the doctors attached to the studies were paid millions of dollars to endorse and downplay the risks associated with the product.
According to the report, there were total of 11 papers published from 2002 to 2009 involved in the case. While this type of “ghostwriting” is not illegal, it’s seen by many as a violation of integrity.
Dr. Silverman Comments
Infuse, by Medtronic, is a good product from a good company, but it isn’t the panacea to all fusion and nonunion problems. Good medicine and surgical skill trumps the magic bone growing paste every time.
The basic science behind this product is sound and well respected. It all began in the 1970s with the famous Dr. Marshall Urist who first identified Bone Morphogenic Protein. In his landmark study, he implanted this substance in muscle, and to everyone’s amazement bone formed. However, bone healing and bone formation are different and the random application of such proteins that direct bone formation are only part of the treatment needed to make bone heal.
All scientific articles have some bias. Even a double blinded, random controlled study will be tainted by the beliefs of the writer in interpretation. But what happened with Infuse crossed a red line. The doctors working with Medtronic signed their names to marketing literature rather than scientific literature. How we react to this will influence how the public feels about doctors. If this is handled wrongly, we will lose complete trust in doctors and the system of treatment will collapse.
Instead of congressional investigation, this needs to be handled by state medical officials and the American Board of Orthopaedic Surgery. This is an ethical violation and should be dealt with accordingly. I expect it will also provide many lawsuits and possibly criminal action. However, we physicians need to effectively police our own.
Source article:
Medscape