Harvard Researchers and a Broken System

The New York Times reported yesterday on a Senator Grassley’s revelations into unreported income by some big names amongst researchers. I don’t get how Harvard renowned researchers could be so blasé about failing to report millions of dollars in income from pharmaceutical companies.

The researchers — Drs. Joseph Biederman, Timothy Wilens, and Thomas J. Spencer — failed to report millions of dollars to their university, as required by Harvard’s rules regarding conflicts of interest. The time period under investigation by Senator Charles E. Grassley was from 2000 to 2007, and two of the researchers– Wilens and Biederman — both failed to report $1.6 million in earnings from pharma, or about $225,000 a year.

This is not chump change to anyone. There’s no way you could simply forget to report such a sum year after year. All the researchers had to say for themselves was “Hey, we thought we were complying with all disclosure rules.”

Really? Is that the best they can muster for an excuse?

These are world-famous, NIH grant-getting researchers at Harvard University — one of the most prestigious universities in the world. They’ve overseen dozens of large-scale clinical trials, with budgets in the millions and staffing in the dozens. These aren’t some absent-minded professors in some backwater university. These are powerful, policy-making men. In fact, one of them — Biederman — has basically legitimized medicating kids as young as 3 or 4 for “bipolar disorder.”

And their excuse amounts to, “Sorry, we thought we had complied with all the rules.”

Their own university wouldn’t let a prospective student enroll who simply forgot to fill out a part of their college application. The student wouldn’t be able to just show up one day and say, “Oh, sorry about that, I thought I had filled it all out. My bad. Let me in anyway.”

This is either an example of gross negligence on the part of the researchers, in being able to maintain simple income reporting paperwork (which, one would think, one would have down to somewhat of a science if one is going to accept such large, continuous chunks of money from companies). Or, it’s something worse — a possible poor attempt to cover up one’s actual payments assuming that since there was no oversight or coordination with the pharmaceutical companies themselves, the university would never be the wiser.

In any case, it shows that (1) at least one prestigious university’s conflict of interest reporting procedures are deeply flawed and virtually useless; (2) even the biggest and brightest research stars are apparently confounded by their own university’s conflict of interest policies; and (3) abuses like this will continue as long as oversight is minimal and rarely enforced. It apparently takes the interest of a U.S. Senator to conduct the minimal oversight one would expect the university itself to be doing:

Mr. Grassley said these discrepancies demonstrated profound flaws in the oversight of researchers’ financial conflicts and the need for a national registry. But the disclosures may also cloud the work of one of the most prominent group of child psychiatrists in the world.

But at the article points out, it also calls into question some of the studies published under the researchers’ names, given prior flaws found in peer-reviewed studies funded by pharmaceutical companies:

In the past decade, Dr. Biederman and his colleagues have promoted the aggressive diagnosis and drug treatment of childhood bipolar disorder, a mood problem once thought confined to adults. They have maintained that the disorder was underdiagnosed in children and could be treated with antipsychotic drugs, medications invented to treat schizophrenia.

I am deeply disappointed in Harvard University’s lack of oversight into its own researchers, and the researchers’ own apparent lack of judgment in not reporting such huge amounts of income. Something is seriously broken here — either with the incentives given to researchers, how researchers track their own time and money, how pharmaceutical research is carried out, or how universities require conflicts of interest and such income to be reported. Or all of the above. Whatever the case, it’s nothing something that will be easily or readily fixed without changes in the rules and better oversight by those responsible.

Read the full article: Researchers Fail to Reveal Full Drug Pay