Sunday, September 20, 2009

Nature on Grassley and Sunshine; How High Up the Food Chain?

A news article and an editorial in the British journal Nature offer a number of comment-worthy points. The editorial is open access:

The editorial speaks in praise of the Grassley-Kohl Physician Payment Sunshine Act and notes that it now stands a good chance of passing as part of any health reform bill that moves through Congress this year. (It was incorporated into the Baucus markup for the Senate Finance Committee last week.)

The news analysis by Meredith Wadman is primarily a profile of Paul Thacker, Grassley's principal staff investigator who's behind many of the most significant coups that the Iowa Republican has pulled off in the last few years, expopsing major academic physicians for serious underreporting of funding received from industry either to the NIH, to their home universities, or both.

The article spends a fair amount of time discussing the downfall of Emory University former Chair of Psychiatry, Charles Nemeroff, whose many escapades we have followed closely in this blog. Dr. Nemeroff apparently gave Wadman his first statement to the press after being disciplined by Emory: "I made mistakes in the area of conflict of interest for which I am sorry and remorseful. However, the mistakes I made were honest mistakes... in my view at the time, in keeping with my understanding of the current Emory policies.... I also plan to use my recent experience to help others avoid problems with conflict of interest from the lessons I have so painfully learned."

There are a couple of undercurrents in the Wadman article and also in the editorial that require some critical comment. Wadman quotes Joseph Cubells, a neurogeneticist at Emory, in defense of Nemeroff. Cubells objects that the case against Nemeroff is hardly as black and white as the media have made it out; and he also praises Nemeroff for "intellectual honesty," especially for including a psychotherapy-only comparison group in a major NIH study of depression that was temporarily halted because of the COI issues.

I concur with Cubells that comparing antidepressants to psychotherapy only is generally not a move designed to win friends among the drug industry, as long as the trial sets up a truly level playing field. However, his portrayal of Nemeroff as basically an honest guy who got tangled up in a complex set of morally confusing circumstances is not the impression that I get from some of my psychiatrist colleagues, who are quick to point to Nemeroff's national reputation within their field. The fact that he was commonly referred to by the nickname "boss of bosses" suggests that traits besides intellectual honesty were prominent in his character. If today he is truly repentent I give the man full credit.

The other important undercurrent in both the Wadman article and the editorial is the reminder that people like Nemeroff were (at least till recently) avidly recruited by academia because they promised to do just what their own bosses wanted--drive the gravy train of lucrative industry-funded research contracts straight through the university's front gate. If Emory treated their problem child with kid gloves for many years, it was clearly due to the ease with which he could have picked up his whole operation and moved to another university that would have been all too glad to welcome him and his Pharma bucks. As Wadman notes, at times, research grants from NIH and its daughter, the National Institute of Mental Health, specified that recipients should link up with industry to be sure that new discoveries were quickly brought to market to help patients faster.

That comment does, to my mind, offer something of a defense for at least a number of the academic docs now being pilloried for their COIs. The basic question is always the same--when there is bad behavior within an organization, how high up the food chain do you assign responsibility? Were the faculty who took all the industry cash the bad guys, or are they in effect taking the fall for their higher-up administrators who encouraged and abetted them?

Let's be blunt. Today, academic medical centers have got religion and are falling over each other to implement tough new COI policies. All of these COI policies are aimed at individual faculty. Supposedly if the faculty member brings in mucho Pharma research grants, he's golden. But if that same faculty member starts to line his own pockets with speaker's fees, consulting fees, and stock options, that spells trouble.

Now let's turn this around from the Big Pharma perspective. Two "key opinion leaders" from academic medical centers approach you for research funding. One of them says, "By the way, just so there's no confusion later on, I am very happy to perform legitimate scientific research for your firm. But I have strong views on individual COI and would prefer not to take any money for any other activities, such as your speakers' bureau and for consulting." The other doc is clearly ready to jump into bed with them for as high stakes as he can play.

With whom will the company rather do business with-- Goody Two Shoes? Or the doc who's made it clear that he's for sale? So who's most likely to land the really big research grant? And later on, who's more likely to be hobnobbing with the upper echelons of the drug firm, to be sure that he gets first dibs on the next big grant, and the next?

In short, by asking their top faculty to be squeaky clean on individual COI, but to be sure to keep the big Pharma money flowing onto campus, academic medical centers are sending their faculty a decidedly mixed message.

All of which is why, as I wrote in HOOKED, the really important COI policies are for institutional and not individual COI.

Wadman M. The senator's sleuth. Nature 461:330-34, 12 Sept. 2009.


JPB said...

Perhaps the institutional COI's are are dramatic but the COI's of the individual doctor also have a tremendous impact on the the practice of medicine and on the patient (who thinks that s/he is getting unbiased advice).

Anonymous said...

So Paul Thacker is Charles Grassley's ghost writer?

Anonymous said...

What is just as interesting is what isn't in the bill and what Sen. Grassley is NOT investigating.

At best it is naive to assume that pharmaceutical companies are the only companies with a huge financial stake in health and medical research and health care - enter insurance companies.

More than one Attorney General's office has investigated disability insurance conglomerates inappropriate classification of patients as having mental health disorders. Why would they do that? Because UnumProvident and others only pay a total of two years of disability for patients thus classified instead of a lifetime of disability payments. Can you say billions of dollars at stake?

Curious as to why Grassley ignores academics and doctors with ties to insurance companies. I wonder why?