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Harvard Psychiatrists Disciplined for Conflicts of Interest

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Harvard Psychiatrists Disciplined for Conflicts of Interest Print E-mail
Thursday, 21 July 2011
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 g”uided 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 lawsuitjoined 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.

Vera Sharav

 

jos._biederman.jpg

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).

doctorsandmoney11And 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 hereand 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).

pic thx to jerome kassirer

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Written by dawneworswick

July 22, 2011 at 12:37 am

Posted in Uncategorized

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