Continuing my blogging post-conference for the American Society of Law, Medicine and Ethics, "Conflicts of Interest in the Practice of Medicine" (see previous post for link), two tidbits on the medical device industry. Two speakers addressed this topic, Dr. Rita Redberg, UCSF cardiologist and editor of Archives of Internal Medicine with its splendid "Less is More" feature, and Kelly Dineen, JD, St. Louis U law school. (Dr. Redberg was co-author of the excellent New England Journal commentary on the recent IOM report on FDA regulation of medical devices: http://brodyhooked.blogspot.com/2011/08/more-on-iom-report-on-fda-scrutiny-of.html.) I'm reporting my own impressions based on what they said, so don't blame them for what follows.
First, there was much discussion at the conference of the recent New York Times expose of the role of venture capitalists in lobbying against stricter FDA regs on devices, which is what the IOM recommended:
The general comment was that it is notable how the device industry, and the venture capitalists that seek to profit off devices, have really taken the gloves off and come out swinging against the IOM and the scientific community generally. Dr. Redberg reported testifying on Capitol Hill and encountering Congressional committees that had been captivated by a device-industry-funded report that slammed "unnecessary" government regulation and threatened job losses of the FDA tightened its rules, and did not want to address patient safety or effectiveness at all. Apparently all patient concerns must give way before the almighty dollar.
Second, Ms. Dineen described in some detail the role of medical device reps in one area of medicine, neurosurgeons who specialize in implanting devices that give electrical signals to nerves (neuromodulation) for a variety of conditions. I have previously been fairly sympathetic to the difference between device reps and drug reps, based on the argument that devices need hands-on technical expertise that sometimes requires trained company reps to be in the operating room or at the bedside to advise the doc on how best to adjust the device. Ms. Dineen revealed an important qualifier I had not been aware of.
As I took her point, implanted neuromodulation device reps are functioning as basically unpaid labor for the neurosurgeons--a substantial company-funded subsidy for their practices. With device reps being ubiquitous, surgeons can turn to them for all the technical parts of the device, leaving their own role simply that of making the incision and sticking the device in. How the device is programmed to do its work, and what to do if something goes wrong later, can all be delegated to the company rep, who's more than eager to oblige, in exchange for the neurosurgeon's devotion to that company and its expensive products. In everyday practice the neurosurgeon can even "supervise" what the rep does (often from a considerable distance) and then proceed to bill hundreds of bucks for the visit. Now, the surgeons could take a course and learn how to do this programming function for themselves; or they could hire their own technicians to become part of their office and OR staff and do it for them. But why spend that time or money when the device company is eager to supply the reps for free?
End results: patients are cared for by staff who have the company's rather than the patient's interests at heart; neurosurgeons make more money for less work; and the device gravy train keeps rolling. Must keep those venture capitalists happy, after all.
The take-home message is that once again in medical devices, things are not as they seem. The "need "for hands-on assistance with the device, that justifies reps running free range through the hospital and clinic, may be more manufactured than real.