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....
nice article -- use the google backdoor to read wsj articles (google the title of the article, the full text is linked in google).
The article is interesting. Unfortunately it brings up issues that may erode public trust in physicians—a prominent arrogant surgeon implanting unproven devices without specific consent to do so, a greedy cardiologist looking to get financial and professional advancement for calling him on it, and a worried university that wants to cover its behind.
I know nothing more about this case other than what the WSJ writes about, but it seems that this case doesn’t necessarily threaten advancement in biotechnology. There is nothing unethical about trying unproven treatments on patients (or taking treatments proven in one situation and applying them in another), as long as patients are made aware and consent, and if don’t consent, can opt for standard management. It seems that the surgeon’s mistake was to not adequately inform the patient (or at least not inform her in a manner that she won’t deny she ever knew). I agree that we benefit from experimentation/innovation, but the patient has to know and consent when there is deviation from the standard of care.
This business of the lawyer representing both the patient and the cardiologist doesn’t seem right either (not to mention the cardiologist’s perception that she somehow deserves compensation/protection for all this.) I don’t like to conjecture, but is seems like the cardiologist stumbled unto some probable unethical behavior by the surgeon and she decided to use the patient and this case for personal advancement (why else would a physician share a lawyer with a plaintiff/patient in a malpractice case?) I say that the surgeon’s behavior was probably unethical because the university and device company were also involved in, aware of, and consented to what the surgeon was doing, it is not clear that what he did was illegal, nor that what he did was any different than what is being done at university hospitals today. It also wasn’t like he was doing something completely different or novel, just a variation. In the end, the surgeon should have told the patient she was also a subject.
Buckeye, I forgot to ask if the IRB had any oversight of the use of the non approved technology?
Dear Buckeye Surgeon:
I believe that you are wrong in assuming that Dr. Rajamannan is neither heroic nor selfless. I believe she is. Why? Because I have read the posts on heart.org. When she questioned the integrity of Dr. McCarthy, Northwestern stopped her from practicing medicine at the hospital. Therefore likely she had to get a lawyer to fight her case to reinstate her clinical duties. Also reading the profiles of the professors at Northwestern, she appears to be their top researcher. Please check out all the details.
From a Concerned Citizen for the welfare of patients
The Myxo device never got an FDA approval. The device is now called the D'etiologix, new name and new indication.
Therefore, the device implanted in the patients is still considered experimental.
Experimental device without informed consent means human experimentation- goes against the Nuremberg laws and the Common Rule.
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