Medical Device Mongering, a Variant of Disease Mongering

In a recent note, I discussed disease mongering, another name for medicalization of conditions such as fibromyalgia (see: Disease Mongering (i.e., Medicalization) by Pharmaceutical Companies). According to the Wikipedia, medicalization refers to the process whereby certain conditions are defined as diseases and then come under the purview of doctors and other health professionals for treatment. The process of medicalization typically involves changes in social attitudes and terminology relating to certain conditions and usually accompanies, or is driven by, the availability of treatment. In response to my note, Dr. Brian Jackson submitted a very interesting comment which I reproduce below with boldface emphasis mine. This is the second of his recent comments that I have elevated to the level of a note. Keep them coming, Brian.

One more angle you didn't mention -- article placement in mainstream media by device companies. Typical scenario is that a device company is trying to push a new, technologically sexy product. They partner with a hospital/clinic/surgeon who sees an opportunity to promote themselves as cutting edge by offering this new device/procedure. They jointly pitch a story to a local science/medical writer, who doesn't have the background to critically assess the details, but who appreciates the material which is easy to package up into a news story. I saw this recently with a spinal fusion device being promoted by orthopedists...together with the device manufacturer. The story implied, for example, that spinal fusion is beneficial in most people with chronic back pain.

Some of the stories behind medical device mongering, which I describe here as a variant of disease mongering, are even more insidious than Brian describes. A not unusual scenario is that an orthopedic surgeon invents a spinal fusion device and then receives patent royalties or ownership in the company that manufactures it. Under such a scenario, the surgeon has a strong financial incentive to use the device in his practice. As Brian relates above, the device may also be promoted in the lay press, often with little attention being paid to the strict clinical criteria for its use. Patients with back pain who are desperate for relief may seize on the device as a cure-all for their ailment.

The rules regulating the use of medical devices by the FDA are different than those for drugs and the bar is not set high for proof of efficacy as opposed to the need to demonstrate its safety. In the case of back pain, for example, the clinical indications for the implantation of a spinal prosthetic device may be highly subjective as opposed to the use of a chemotherapeutic agent in the case of cancer treatment. In fact, the physician's judgment may be colored by the fact that he or she is deriving financial gain from the procedure beyond the professional fee. Although full disclosure of these financial connections to a patient are certainly warranted in such a case, I am not convinced that this is the perfect solution to the problem.