Essentially two answers were given in the article, neither satisfactory. First, it was admitted that when the current laws were written, device makers were simply not on anyone's radar screen. Second, many medical device companies are based in Minnesota and have a lot of political clout.
The question, "Are devices just like drugs or not?" keeps popping up and so I am going to restate the case without offering a definitive answer--and invite comments from you readers.
I can think of two ways in which the device industry differs in some basic way from the pharmaceutical industry. Please bear a couple of things in mind as I explain these two things. I am, by training and experience, a family physician. We family docs are not big-time device users. So I am left at a disadvantage in talking about this topic compared to surgeons, cardiologists, and other specialists whose bread and butter involves medical devices. Also please bear in mind that the end result of all this talk is supposed to be the benefit of the patient. We are not trying to rein in pharmaceutical industry influence, and get greedy docs to clean up their act, simply so we can all get gold stars in the teacher's grade book. We are trying to reform this system because of our conviction that at present, it is not serving the patient.
So, my nominations for how devices are legitimately different from drugs and so may mandate a somewhat different regulatory approach:
- Several academic medical center policies that basically ban drug reps outright do not ban device reps, and I think that is justifiable. I don't need a drug rep on site to show me how the patient is supposed to swallow a capsule. Virtually all the information that I need to know about how to prescribe a drug could be provided to me in writing. For many devices this is not true. The company rep may be in fact a skilled engineer. Many devices need fine adjustments to work properly and the company staff may know much more about how to make these adjustments than anyone else in the hospital. And the adjustments may well require a hands-on demonstration if the physicians and nurses are to become adequately skilled at using the device.
- Just as device reps have knowledge that physicians really need to take good care of patients, some physicians have knowledge that device manufacturers truly need to design the next generation of devices. In today's world, I doubt that a single drug is ever discovered or developed as a result of a practitioner calling up the drug company and saying, "I sure wish I had a drug that I could give my diabetic patients who have foot pain." The company's in-house scientists know far better than any practitioner what classes of molecules are out there that could become new drugs, and what bodily functions those molecules affect. But I assume that many medical devices are developed because, say,. an orthopedic surgeon calls up the company and says, "This artificial hip that you make is pretty good but I find it a bit awkward to apply the cement. Now, it dawned on me that if you modified the surface where the prosthesis attaches to the femur, the cement would go on a lot easier and you could have a much more secure attachment." (Or however they attach the danged thing--I have no clue.) So there is much more room for legitimate consulting between the company and a group of medical specialists in the device than in the drug case.
I would invite the executives of the device companies, if they want transparency and reform as much as some of them have said in Minnesota, to help legislators and regulators decide which payments are which. I also propose that medical professionalism remains an important part of the equation here because it is often the case that if there is a difference, the physician who gets the fee knows it--though the ability of physicians to go into rationalization-and-denial mode when their gravy train is interrupted is probably just as great on the device as on the drug side. Meanwhile I invite readers to comment at will.