Beyond research protocols and CME, there is regulation about accreditation, certification, compliance, concordance, and a myriad of other things. Furthermore, once it starts, regulation is hard to stop and the ranks of the regulators grow. Face it, I am now a regulator, conscripted or deputized or whatever into the ranks of regulators overseeing medicine. Because of my service on the IRB and research committees, I have become a foot soldier in the regulatory army.
(Trust me, regulation in medicine seems neither rational nor fair. While rules prescribe the number of pens a drug company can dispense as giveaways, the regulation of drug pricing remains off limits. Furthermore, our society thus far is totally unable to enact the one regulation in medicine that makes sense: Every person in this country should have insurance for healthcare).
A Year of Conscientious Regulation?
Like most medical professionals, I am mindful that we are in a high-stakes business and I take my job seriously. In my committee work, I request many changes in protocols and I want informed consent documents to be better. I want words like “frailty” or “disability” defined in more sensitive and less alarming ways, and I want the side-effect list to be more comprehensive. I am earning my spurs as a regulator, and I suspect that I am becoming a pain in the gluteus maximus.
In the transfer of regulators from medicine to the Treasury Department, we could lend them for a while or donate them in perpetuity. Either way is fine, as long as the form to receive a billion dollars of bailout money is at least as long as the form required for drawing two teaspoons of blood from a vein that, as we have informed subjects countless times, can get bruised or infected.
I think that it is time to restore the values in this country and apply regulatory oversight in a constructive and thoughtful way.
Let 2009 be a new beginning. Let the regulators who make sure that researchers handle mice properly also make sure the banks handle the hard-earned money of Americans properly. And, let the regulators make it hard for the Bernie Madoffs of the world do their mischief, rather than making it hard for doctors and researchers to do their good.
Dr. Pisetsky is physician editor of The Rheumatologist and professor of medicine and immunology at Duke University Medical Center in Durham, N.C.