Harvard Psychiatrists Disciplined for Conflicts of Interest

Alliance for Human Research Protection – July 21, 2011

by Vera Sherav

Psychiatrist Joseph Biederman was funded millions by Pharma while promoting child "bipolar" disorder

The primary promoters–inventors, one might say– of diagnosing children with “bipolar” disorder, who for over a decade, aggressively promoted the biopolar diagnosis and use of antipsychotics in children, were disciplined by Harvard University and its affiliated Massachusetts General Hospital.

An investigation, prompted by Sen. Charles Grassely, was conducted by Harvard University-affiliated Massachusetts General Hospital. It concluded (earlier this month) that psychiatrist Joseph Biederman and two of his proteges, Thomas Spencer and Timothy Wilens -each of who failed to disclose millions of dollars they had each received from the makers of antipsychotics, the drugs they promoted for the treatment of bipolar in children–had indeed violated the University’s/ and hospital’s conflict of interest reporting  standards.

The three wrote a mea culpa letter stating “we want to offer our sincere apologies…” acknowledging “our mistakes…”

However, no mention was made anywhere about the profound consequences of these psychiatritsts’ commercially-driven clinical recommendations. No mention about the corruption of the scientific literature, about clinical practice that deviated from the Hippocratic Oath, “First, do no harm,” nor was any mention made about the harm suffered by children whose doctors were misled about the safety and efficacy of highly toxic drugs.

Child psychiatrists and pediatricians throughout the US were guided by these exceedingly influential Harvard psychiatrists.

As Sen. Chuck Grassley noted in 2008 in the Congressional Record, “they are some of the top psychiatrists in the country, and their research is some of the most important in the field. {But] They have also taken millions of dollars from the drug companies.”

The companies that paid them millions include: Eli Lilly, Johnson & Johnson, Pfizer, GlaxoSmithKline and Bristol-Myers Squibb.

The Senator brought public attention–and to Harvard University administrators’ attention–the financial conflicts of interest, “Out of concern about the relationship between this money and their research.”

Indeed, documents uncovered during litigation confirmed that the research was scientifically corrupt and commercially-driven. The New York Times reported that Dr. Biederman promised Johnson a& Johnson that a study (yet to be conducted) in preschool children who would be given the company’s antipsychotic, Risperdal (risperidone) “will support the safety and effectiveness of Risperdal in this age group.”

“The psychiatrist, Dr. Joseph Biederman, outlined plans to test Johnson & Johnson’s drugs in presentations to company executives. One slide referred to a proposed trial in preschool children of risperidone, an antipsychotic drug made by the drug company. The trial, the slide stated, “will support the safety and effectiveness of risperidone in this age group.”

Dr. Biederman was the lead author of a trial published last year concluding that treatment with risperidone improved symptoms of attention deficit and hyperactivity disorder in bipolar children.”

Another of Biederman’s Harvard ignoble disciples was Jeff Bostic, who is also at Massachusetts General Hospital. He was named in a 2009 lawsuit joined by the US Department of Justice alleging Forest Laboratories promoted its antidepressants for pediatric use without FDA approval and paid kickbacks to docs to encourage prescriptions. He received $750,000 in payments for giving talks on using these drugs in children.

Strangely, the National Institute for Mental Health, which had awarded thse psychiatrists millions of dollars at taxpayers expense. It appears that NIMH officials did not see fit to even conduct an investigation into the corruption of science and violation of federal regulations. This demonstrates a lack of professional and moral integrity at the NIMH whose administrators think nothing about the misappropriation of public money for commercially-driven, junk research.

http://www.ahrp.org/cms/content/view/828/9/

Backstory from Pharmalot:

Pharmalot

Harvard Docs Disciplined For Conflicts Of Interest

By Ed Silverman // July 2nd, 2011 // 9:03 am

Three years after they were fingered in a US Senate probe into the interplay between academics who receive grant money from both pharma and the National Institutes of Health, three prominent psychiatrists from Harvard Medical School and Massachusetts General Hospital have been sanctioned for violating conflict of interest rules and failing to report the extent of their payments.

In a mea culpa addressed to their colleagues, Joseph Biederman, Thomas Spencer and Timothy Wilens wrote that “we want to offer our sincere apologies to HMS and MGH communities…We always believed we were complying in good faith with the institutional polices and our mistakes were honest ones. We now recognize that we should have devoted more time and attention to the detailed requirements of these policies and to their underlying objectives.”

And what is their punishment? They must refrain from “all industry-sponsored outside activities” for one year; for two years after the ban ends, they must obtain permission from the med school and the hospital before engaging in any of these activities and they must report back afterward; they must undergo certain training and they face delays before being considered for promotion or advancement (you can read their letter here).

The hospital had this to say: “A committee at Massachusetts General Hospital that has been looking into conflict-of-interest questions involving three MGH child psychiatrists has completed its review. Appropriate remedial actions have been taken by the hospital to address specific issues (read the statement). And a Harvard Med School spokesman sent us this: “We confirm that the review of their compliance with the Harvard Medical School Policy on Conflicts of Interest and Commitment has concluded, and appropriate actions have been taken.” He added that the conflicts policy was revised last year.

The sanctions result from a long-standing controversy over the explosive use of antipsychotics in children. Biederman, in particular (see photo), had been one of the most influential researchers in child psychiatry. Although his studies were small and often financed by drugmakers, his work helped fuel a 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder.

For more than a decade, Biederman and his colleagues aggressively promoted the diagnosis and use of antipsychotics to treat childhood bipolar disorder, a problem that once was largely believed to be confined to adults. But the docs maintained this was underdiagnosed in kids and the meds could be used for treatment, even though they had not been approved for most pediatric use at the time. Meanwhile, the relationships with drugmakers were never properly disclosed (back story).

And for years, payments they received from drugmakers were not thoroughly reported to university officials. Yet, millions of dollars in NIH grants, which were administered by the hospital, were awarded to the docs at the same time they were receiving money from various drugmakers that make and sell antipsychotics and antidepressants. Which ones? Eli Lilly, Johnson & Johnson, Pfizer, GlaxoSmithKline and Bristol-Myers Squibb.

At one point, Biederman pushed J&J to fund a research center at MassGen that would focus on the use of its Risperdal antipsychotic in children, well before the med was approved for pediatric use. He was then placed in charge of the institute and began a study of 40 children between 4 and 6 years old who were given Risperdal and Lilly’s Zyprexa, another antipsychotic. At the time, Harvard and MGH rules forbid researchers from running trials with drugmakers if they receive more than $10,000 from a company that makes the drug (back story).

But in June 2008, US Senator Chuck Grassley made a far-reaching statement before Congress that pulled the curtain back on the money involved. The statement is memorialized in the Congressional Record. Referring to the three docs, he said “they are some of the top psychiatrists in the country, and their research is some of the most important in the field. They have also taken millions of dollars from the drug companies.”

“Out of concern about the relationship between this money and their research, I asked Harvard and Mass General Hospital last October to send me the conflict of interest forms that these doctors had submitted to their institutions. Universities often require faculty to fill these forms out so that we can know if the doctors have a conflict of interest. The forms I received were from the year 2000 to the present. Basically, these forms were a mess. My staff had a hard time figuring out which companies the doctors were consulting for and how much money they were making.”

How much were they making? At first, maybe a couple of hundred thousand dollars combined. But at his behest, the med school and hospital asked the docs to take a second look. “And this is when things got interesting. 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.

“The question you might ask is: Why weren’t Harvard and Mass General watching over these doctors? The answer is simple: They trusted these physicians to honestly report this money.” And as Grassley then noted, there was still more money that went unreported (to read the Congressional record, click here and then check the box for 2008 and type in the name ‘Biederman’ in the search box. Then click on ‘payments to physicians’ to read the complete statement and the chart showing payments to each doc).

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