Big Troubles at Mass General

The blogosphere is buzzing with the Sunday New York Times article by Gardiner Harris and Benedict Carey in which we learn that three child psychiatrists at MGH did not report most of the payments they received from drug companies on conflict of interest disclosures.

I have been reading the pertinent documents in the Congressional Record in order to figure out whether these three psychiatrists, all of whom I know from my training days at MGH, behaved very badly or just a little badly. All three are highly intelligent and committed researchers. During my residency days, I received a few lectures from Dr. Wilens, and he is a good, solid person. I didn’t have as much contact with Dr. Biederman or Dr. Spencer.

The issue at hand is a little complicated, but here’s my understanding. Whenever a researcher is awarded money from the NIH (National Institutes of Health) to conduct research, the employing institution (in this case, Harvard) must obtain detailed conflict of interest disclosures from these researchers. After all, this is public money, and the NIH wants to make sure that our hard-earned tax dollars are being spent responsibly. There are two big rules that are relevant to this controversy. Rule One is that researchers cannot accept more than $20,000 in payments from a drug company whose drug they are funded by NIH to research. Rule Two is that they must disclose any payments of $10,000 or more that they have received from any drug company.

The most serious of Senator Grassley’s allegations (Grassley being the ranking member of the Senate Finance Committee) is that all three doctors broke Rule One. They all conducted NIH-funded studies of Eli Lilly’s Strattera (atomoxetine) for ADHD during years that they also received payments from Lilly—payments that exceeded the maximal payments permitted. If this is true, it represents a pretty significant breach in the integrity of the NIH funding process.

The other allegation is that the doctors chose to reveal only a fraction of all the money they actually received from drug companies. When Grassley and his aides looked over each doctor’s yearly disclosures, it appeared that they received no more than a combined few hundred thousand dollars over a seven year period. However, when the doctors were asked to look back over their financial records for the Senate Finance Committee, they suddenly discovered quite a few overlooked checks, to the tune of $1.6 million each for both Biederman and Wilens, and $1 million for Spencer.

I am inclined to give them the benefit of the doubt on this issue. I don’t think they hid these payments out of greed, sneakiness, or the thrill of getting away with something. They probably simply didn’t believe these earnings were relevant to the NIH funding they received. If you look at the charts detailing each doctor’s income in the Congressional Record, you can get a sense of why this might have occurred. Many of the large payments were not from drug companies directly but from third party medical education companies, with vague and uninformative names such as “Phase 5,” “MedLearning,” “Strategic Implications,” and “Primedia.”

For example, in 2005, Dr. Wilens received only $9500 directly from Eli Lilly, but $70,000 from “Promedix,” and $37,750 from “Advanced Health Media.” A little googling reveals that Promedix is a division of Advanced Health Media, which in turn is a company that does “speaker program management.” So Wilens received a total of $107,750 for speaking programs, but the disclosure does not allow us to track things any more specifically. Who was he speaking for? Was this CME or promotional? How did this relate to his NIH funded research?

I’m willing to bet that most of this money came from Shire, because I have seen Wilens, Biederman, and Spencer headlining many Shire-supported CME programs on ADHD. (See here for some background).

So the psychology of non-disclosure may have gone something like this: “I’m doing NIH-funded research on an Eli Lilly drug, so I’d better be scrupulous about disclosing payments from Lilly. But the marketing work I’m doing for Shire is not relevant to my NIH research, and it’s indirect CME money anyway, so I won’t disclose that.”

A little sleazy? Maybe. Malevolent? I don’t think so.

The big lesson here is that Congress must pass the Physician Payment Sunshine Act, because we will never be able to grasp the extent of the complex financial relationships between companies and thought leaders without this legislation.