On behalf of the editorial board and staff of TR, I want to extend my best wishes for the new year. I hope that you had a wonderful holiday season, that Santa was good to you, and that you are ready for 2009, rejuvenated and restored. Although it had its moments of exhilaration, 2008 was a rough year, full of disappointment and anxiety. Like a baby, a new year is very welcome.
While the challenges confronting the United States are great, I am nevertheless optimistic. With a new president and a strong determination to chart a better future, I predict genuine progress in solving problems that have long vexed our country. Near the top of the list, of course, is the current healthcare system, which is rife with inequity and inefficiency. How brave will Americans be in enacting change to our troubled system? Only time will tell.
The celebration of 2009’s arrival may have been more muted and restrained than those of the past. With the Dow Jones plunging, a recession deepening, and bonds offering returns of 0%, money is scarce. As 401K plans became 201Ks, a low-end bubbly from Costco sufficed as revelers in Times Square smooched and tooted their horns in an avalanche of confetti.
As anyone who follows the news knows, one of the main causes of our financial woes is a failure of regulation as Wall Street and banks ran wild with an anything-goes attitude, securitizing mortgages and collateralizing debt. (Which shows you what I know about economics—I thought that debt is electrophoresed.)
“Let’s regulate,” is the current cry as citizens seethe with the knowledge that, in the past year, their nest eggs have been boiled, scrambled, or fried.
The Regulation Solution
I agree with the drive for more regulation. I don’t want to see my retirement funds fall any further nor watch my university’s endowment vanish as the whizzes who once produced 20% returns were caught with their investment pants down—and I mean far down.
Regulation is a tough, grinding business. It requires lots of vigilance and legions of no-nonsense gumshoes and FBI types to scrutinize the books and ledgers. Given the shambles of the financial and mortgage industries, I would guess that the country will need tens (or hundreds?) of thousands of regulators to make sure that the treasury does not again fall asleep at the switch as the banks cook up new magic schemes to manufacture money from thin air.
In a spirit of patriotism … I have a modest proposal: I think that we should give the regulators watching over medicine (and that means you and me) over to the Treasury to watch over the financial system.
Where will these regulators come from? Regulators don’t grow on trees and finding good ones may be no mean feat. I worry that we may not have enough regulators around to keep the financial big boys on the straight and narrow.
In a spirit of patriotism to help our country reform, I have a modest proposal: I think that we should give the regulators watching over medicine (and that means you and me) over to the Treasury to watch over the financial system.
In the past decade, medicine has been different than other parts of the economy. Whereas deregulation fever took over the banks, in medicine, it was just the opposite as regulation fever sent our temperatures soaring. There are now rules governing just about everything. Soon, I am sure that we have a rule specifying the number of bathroom breaks a house office needs in 24 hours.
Consider a piece of news I heard on “The Rachel Maddow Show” on MSNBC. According to Maddow, the form required for a bank to get money from the Troubled Asset Relief Program (TARP) is just two pages long. Perhaps Maddow was exaggerating (she is on MSNBC after all) and other forms are needed. If the claim about the form is true, all I can say is “yikes” and I am going to put whatever money I have left under the mattress. It seems safer under there if that is how TARP will work.
I was struck by this story because, in my realm, regulations and red tape have proliferated like kudzu. Indeed, virtually everything I do has been subjected to increasing regulatory oversight and requires voluminous documentation with forms that are chock full of complex, confusing, and redundant questions. A recent protocol I submitted to use 200 mice was almost 50 pages long, and a request to collect a few more de-identified sera took two months of review and another gargantuan form.
CME is a thicket of regulation and miles of red tape. For every lecture I deliver, I complete a disclosure form that seems to ask about everything including the contents of my kids’ piggy banks. My PowerPoint presentation is then uploaded for the eyes of some grand inquisitor who will search for bias or recommendations of drugs for unapproved indications. (As you know, important parts of rheumatology therapy involve the off-label use of drugs. We are in a quandary here.)
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.