Saturday, July 25, 2009

Carlat's Take on ACRE: Some Ruminations

Returning to the last post but one, I offer some further ruminations on the ACRE group based on Danny Carlat's blog posting, with his rather detailed set of reports and reflections on ACRE's inaugural meeting.

Perhaps easy to miss in Danny's run-down is a possible positive role for ACRE, if you happen to look at them from the vantage point of us "Pharmascolds" who believe that conflicts of interest are a serious matter at the medicine-Pharma interface. Let me reflect first on why a positive role may be possible, and then describe what it would be. (I trust from previous posts that it's very clear what their negative role is--to continue to rationalize the status quo in which physicians line their pockets with Pharma money and continue to trash professionalism and public trust in medicine and medical science.)

Danny offered us a personal glimpse of Dr. Tom Stossel, ACRE's chief mover and shaker. From a distance he's an in-your-face blowhard with nothing to offer in a serious debate over COI except soundbytes. Danny insists that up close and personal, he's really a pretty nice guy, and the positions he argues for are much more moderate than his public persona would suggest.

That bit caught my attention because I was tempted to say the same thing about my colleague here at the University of Texas Medical Branch, Avi Markowitz. Danny does not know him and described him as one of the more extreme, take-no-prisoners speakers at the ACRE meeting--and also the one who has the longest list of financial relationships with Pharma. I do know him a bit and would describe him in the same way as Danny describes Stossel--when you get him aside and talk one on one, he is quite reasonable about most of the issues.

So these glimpses of the real people behind all the anger and angst that Danny described at the ACRE meeting raise the question of when they are all done with their hissy fit, can they contribute? And Danny sort of hinted at how that could happen.

I have for all of my professional-academic career been a great believer in Epstein's Law: If you think the problem is bad now, just wait till you've solved it. If we ever have truly meaningful health reform in the US, it will without doubt lead to major problems. Now, I personally would much prefer to discover and then to deal with those new problems, than to keep on dealing with 45 million uninsured, 75 million underinsured, and the incredible, crazy bureaucracy of the present-day nonsystem. But I'd be an utter fool if I claimed that the new, reformed system would be problem-free and would work like a charm from the get-go.

Now the same must be true of the new relationship that we Pharmascolds would like to see created between the pharmaceutical industry and the medical profession. I personally welcome a world in which no patient will ever have to wonder whether their doctor prescribed a certain drug for them because the drug rep gave her a neat pen or took him out for a nie dinner--or whether an academic physician in the pay of the drug company helped to cook the books when the research trial was being done. But for sure that new world will have its own set of problems and we will have to deal with them.

To any Pharmascold who has followed this debate for any period of time, ACRE's claim--that the pendulum has now swung too far in the direction of those imposing tight COI restrictions, and the crazy and useless restrictions are seriously hampering the progress of medical science--is simply a hoot. Period. But even if so far, the pendulum has come nowhere near a swing to the opposite side, it is nevertheless true that in the past couple of years, particularly, the pendulum has shifted noticeably in that direction. And so, if present trends continue, in another couple of years, perhaps, there might be a serious danger of overreaction and excess in the way we deal with COI.

My case study, to date, is the somewhat clumsy but well-intentioned effort at NIH to impose strict COI guidelines in the face of news reports that senior NIH officials had for years been flaunting the existing rules and pocketing, in some cases, six figures' worth of drug company consulting fees in ways that directly conflicted with their NIH research. At one point, the new draft NIH rules said that if you were a scientist there, your secretary could not own stock in a drug company. I agree--give me a break. Both NIH employees who seriously agreed with the intent of the new rules but thought them overkill, as well as many employees looking for a handy stick to beat the new rules with, pounced on this particular provision. So I agree--the next time a Pharmascold comes up with a rule as wild as that one, somebody needs to call a time-out.

If a group like ACRE would grant the fundamental premise, that today and in the past, COI is a serious problem, and the way Pharma has spent its money on medical science has threatened to undermine rather than to advance that science, then we could imagine them serving a very useful watchdog function in the future, reining in the inevitable excesses of us do-gooders. But at present, that appears to be a very big if.


Anonymous said...

Perhaps a 'pharmascold' like Dr. Caralat should be more aware of patient confidentiality. He stated that two of the three female ARCE speakers were (his?)patients.

Howard Brody said...

I agree with "Anonymous" that had Dr. Carlat identified some of the speakers at ACRE as HIS OWN patients, that would be a serious breach of confidentiality. The actual passage in his blog that Anonymous appears to be referring to is:

For the most part, what unreeled over the next 6 hours was an endless succession of smart, accomplished, and furious men (actually, there were three women—two of whom were patients).

I took this to mean that the two women speakers represented the patient's point of view or patients' advocacy organizations. I certainly did not interpret this to mean that they were HIS patients.

Daniel Carlat said...

To both Howard and anonymous,

Indeed, these were not my patients. One was Amy Farber, CEO of LAM Treatment Alliance who is afflicted with lymphangioleiomyomatosis, a rare and fatal disease. The other was Tracy Olson, a patient with multiple sclerosis. Both women spoke in the section of the program called "Value of Collaboration to Patients."