In Practice

A Practicing Doctor's Views on Psychiatry and Contemporary Culture.

Peter D. Kramer is a psychiatrist and author. His books include Against Depression and Listening to Prozac. See full bio

June 11, 2008, Psychiatry

Drug Research: Is Sunshine Enough?

Research ethics: Sunshine and Pharma money

Senator Charles E. Grassley (R-Iowa) For a medical researcher, the failure to report income from drug companies is a serious ethical lapse.

No one knows how Harvard’s pending ethics review will turn out for Drs. Joseph Biederman, Thomas Spencer, and Timothy Wilens. They are the three psychiatrists spotlighted for possible conflicts of interest by Senator Chuck Grassley, of Iowa. According to the Congressional Record, Grassley had asked Harvard and the Massachusetts General Hospital for the doctors’ financial disclosure statements. On paper, it appeared that the researchers had received "a couple hundred thousand dollars" from the pharmaceutical industry. Then Harvard asked the doctors to review their records. After a second look, Grassley reports, “Dr. Biederman suddenly admitted to over $1.6 million dollars from the drug companies. And Dr. Spencer also admitted to over $1 million. Meanwhile, Dr. Wilens also reported over $1.6 million in payments from the drug companies.”

Grassley asked Big Pharma for the corresponding data. He says, “Based on reports from just a handful of drug companies, we know that even these millions do not account for all of the money. In a few cases, the doctors disclosed more money than the drug companies reported. But in most cases, the doctors reported less money. For instance, Eli Lilly has reported to me that they paid tens of thousands of dollars to Dr. Biederman that he still has not accounted for. And the same goes for Drs. Spencer and Wilens.” Grassley notes that in the meanwhile Biederman and Wilens were receiving National Institute of Health support to study a Lily drug, Stratera.

The New York Times has summarized some of the discrepancies, along with the doctors’ justifications, in a telling graphic. In five instances, involving two drug companies, Eli Lily and Johnson & Johnson, Biederman reported no income or amounts under ten thousand dollars when the industry reported payments over ten thousand. The most egregious example had Biederman reporting zero income from Johnson & Johnson (a figure he later amended to $3500), when the company said it had given him $58,169.

The ten-thousand-dollar threshold is important because National Institute of Health rules require reporting payments above that amount to universities, who will then require that they be disclosed to research subjects. According to the Times, in the period in question, “Harvard forbade professors from conducting clinical trials if they received payments over $10,000 from the company whose product was being studied.” So Harvard’s name may now be associated with research that should never have been undertaken.

As I say, Biederman and his colleagues have not formulated their defense. According to the Boston Globe, the doctors have denied violating conflict of interest rules. It is not hard to imagine differences of interpretation about categories of income, research expenses versus personal consulting fees. But if even a few of the charges were to stand, they would constitute a serious breach of trust between the doctors and their government, their research subjects, their universities, their colleagues, and the public.

My personal experience is with the last two audiences. Dr. Biederman’s research is of immense importance. The Times and other media focused on his work on childhood bipolar disorder, a diagnosis whose use has expanded enormously in recent years. As a doctor who works with late adolescents and adults, I have been more interested in Dr. Biederman’s studies of attention deficit disorder. He has been a great advocate of the diagnosis beyond school age. His research has shown that the condition responds best to medication, producing benefits in not only in the target disorder “but also self-esteem, cognition, and social and family function,” and that the treatments are relatively safe. I have been particularly impressed with his demonstration that stimulants are not gateway drugs; it is untreated ADHD, and not stimulant use, that leads to substance abuse.

Because these topics matter to me, I have attended Dr. Biederman’s lectures. His presentations are convincing. And when he speaks, Biederman makes no secret of his many ties to the pharmaceutical industry. In fact, I had a sense, as an audience member, that Biederman was proud of his affiliations to drug companies. His research shows that their products can offer help to people who may be floundering in life without knowing why.

Parenthetically, the talks I heard largely featured medications that are off patent, like Ritalin and the amphetamines. Of course, indirectly and substantially, more vigorous diagnosis and treatment of ADHD benefits Pharma. At least one of the events I attended was underwritten by a drug company. In other words, the potential sources of bias were right out there.

But where research is at issue, bias is a difficult consideration. Looking at the psychotherapy outcome literature, statisticians have shown that studies conducted by adherents of a given school are much more likely to find that school’s therapy effective. Once you control for researchers’ affiliations, differences between treatments tend to disappear; the most-studied interventions, cognitive-behavioral therapy and interpersonal therapy, look only as useful as uncodified, eclectic approaches. The issue is not open cheating but subtler forces that may be unapparent even to the scientists engaged in the research. It is not hard to imagine that cash on the barrelhead creates similar distortions, especially when the amounts run to a million dollars for each primary researcher. Using the psychotherapy research model, if you controlled for investigator bias, many results in the pharmacotherapy literature would fade.

I don’t know how much my view of Biederman’s work, or even of his general conclusions, has changed in light of the recent revelations. For one thing, as I have said, the charges have not been explored fully. For another, Biederman’s stance was always apparent.

But the dollar figures are sobering. I understand that we are a capitalist society and that scientists hope to be rewarded for their conceptual innovations. But we also, quite legitimately, trust the medical professions because we have an image of great research physicians who labor in the shadows, unrewarded, for the sake of their art and the good of humankind. That vision meshes poorly with evidence that drug companies put millions into the pockets of doctors who set the context for psychiatric treatment.

Clearly, Grassley is right that we need something like a “Sunshine Act” requiring Pharma to report all its payments to doctors. But the problem goes beyond transparency. In addition to bias, there is the question of credibility. Even when scientists’ results are accurate, who will believe them, when so much money changes hands? In the end, we simply cannot have researchers paid these sums, not for consulting, not for speaking, not for any reason other than direct full-time employment by drug companies. What good is research if it leads not to conviction about new discoveries but to suspicion about both the findings and the legitimacy of the profession as a whole?