Great article in today's WSJ (need to be a subscriber to read, or just buy the damn hard copy) about a brewing scandal at Northwestern University involving a cardiothoracic surgeon, a cardiologist, the medical device industry, and the FDA. Essentially, the prominent CT surgeon, Dr. Patrick McCarthy, was implanting mitral valve prostheses into patients that had not been specifically approved by the FDA. Ultimately, the valve components were approved in retrospect, as happens often in medical technology. But the device was invented by Dr. McCarthy himself and he was working on compiling a series of patients for a case report eventually published in a major medical journal.
The controversey erupted when one of his valve patients developed complications and kept returning to the hospital with heart failure exacerbations. The patient's cardiologist, Dr. Nalini Rajamannan, did some investigating and was able to discover that the valve implanted in her patient had not been FDA approved at the time of surgery. So she enlists the help of an old college lawyer friend to represent the patient (who eventually had to have the device replaced in another surgery at the Ckeveland Clinic) in a malpractice lawsuit. Just to spice things up, and to quash any notion that Dr. Rajamannan is some selfless noble crusader who simply seeks justice for a wronged patient, her attorneys also submitted a list of demands to Northwestern University including such things as a multi-million dollar endowed professorship for herself, the firing of certain Northwestern empoyees, and the deposit of $1 million into her private retirement account!
Now beyond all the salaciousness and tabloid-esque personal enmity of such a story, a basic philosophical element of medical innovation is illuminated. At what point can we universally state that a new medical innovation has met the standards of rigorous testing and can safely substitute for previous modes of therapy? Laparoscopic surgery developed on the fly. No one knew how risky the surgery would be until enough patients (human guinea pigs?) had been accumulated in actual practice to determine statistical efficacy. New orthopedic components, although FDA approved, are routinely implanted into real live patients without knowing for sure that they will function as well as previous components. Laparoscopic for colorectal cancer was an experiment. No one knew if outcomes were going to be comparable with the open technique. Medicine demands testing the unknown, doubting previously held dogma.
Certainly it seems that the arrogant Dr McCarthy could have been more forthright about the fact he was implanting non-approved, but groundbreaking, rigorously tested valves into his patients. Communication and honesty have been proven over and over to be the foundation of the doctor/patient relationship and violation of this ethic is what leads to anger and malpractice suits. But when we allow patients to define themselves as victims of experimentation rather than as beneficiaries of novel medical innovations, then this country is bound to lose its place as the worldwide leader in biotech breakthroughs....