Biology Reference
In-Depth Information
Just before leaving for Africa, I was invited to speak to the Michigan Cardiothoracic
Society Meeting on quality of care and minimally invasive valve surgery. I looked forward to
this because the Michigan Society had been working on something they called Phase of Care
Mortality Analysis (POCMA). Furthermore, I am very concerned that the drive for minimally
invasive surgery does not result in declining quality and rather that, if possible, quality
improves. The American patient clearly wants more and more-less invasive procedures,
although from a medical point of view this may carry more risk and adverse
events/complications. Medicine, in its drive for “more- less” invasive procedures, needs to be
careful that more mediocre outcomes are not delivered. Over the last century there been a
number of products adopted for the sake of efficiency and ease of use at the cost of quality. For
example, microwave ovens instead of barbecue, ballpoint pens instead of ink calligraphy type
pens, CD instead of LPs, MP4 instead of DVD audio or SACD, digital pictures including smart
phones instead of analog, LCD instead of plasma screens, iPad or smart phones instead of PCs,
E-readers instead of topics, and other so called disruptive technologies. This movement also
applies to medical devices (PCI instead of coronary bypass, endovascular stents instead of
open graft replacements, maybe trans catheter valves displacing leaflets instead of open or
minimally invasive replacements) and treatments. The ethics of animal and humans research to
approve new medical devices is a lengthy discussion in itself, but on the whole the FDA has
successfully balanced competing groups in the approval of new devices. A challenge is the
difficulty of first trying out in man new devices for the first time, after appropriate research.
That is very difficult to do now in the USA except for a device personally made by a surgeon.
Much has been written also about conflicts of interest, particularly financial. If a surgeon or
physician has developed a new treatment, it would seem reasonable that person should not be
involved in research studies (“randomized trials”) to evaluate the affectivity and approval of
the treatment since the potential conflicts are too great. On the other hand, when a new
treatment is tried for feasibility in humans, the person most concerned about absolute safety is
the person who has the passion for the success of the treatment, as long as there is not a
financial incentive. Furthermore, the harsh conflict of interest (COI) policies that essentially
prevent unbiased physicians being involved in research for IRB approved studies that are fully
vetted are also detrimental to patient care. For example, there is the issue of who will pay the
travel expenses for physicians to attend executive meetings for planning large research studies.
The physicians should not, and will not unless there is some hidden benefit, nor should their
institutions. As a result, the quality of the study and patient care suffers because the best
experts, assuming they are not paid or remunerated other than for travel expenses, will not
participate. Altruism only goes so far and being away from their home institutions, is a
considerable loss in productivity, never mind their own reimbursement if they are in a private
practice scenario. Why should they lend their expertise at their own expense? This is a very
unfortunate idea that borders on being unethical since patients will not, in the end, be given the
best care. On the other hand, most COI policies have targeted physicians and not hospitals,
institutions or universities. Thus, well known universities have strict COI policies but do not
address the conflicts that institutions have with bringing to market their own products. The
situation is even more complex if one looks not just at financial COI but also, within a “gift
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