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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Despite promises to cut back on Pharma funds, 56% of DSM V panel members have reported industry ties— Zero improvement over the percent of DSM-IV members.

By CCHR International
May 21, 2010

Due to Senate investigations into the American Psychiatric Association, psychiatrists have promised to cut back on their conflicts of interest (pharma funds), but of the current DSM task force members, those who will be deciding on the holy grail of psychiatric disorders (DSM) and what constitutes a “mental illness” are still heavily funded by Pharma. In fact, there is no improvement over cutting down the number of panel members who are getting paid by industry over the last DSM revision in 1994. It was 56% then and its 56% now. So much for psychiatry’s promises…

Former APA president Nada Stotland stated: “We are in the midst of a revolution caused by public and legislative concern about the influence of the for-profit sector….” [Emphasis added] Part of that public pressure for the APA to disclose its conflicts of interest with pharmaceutical companies was driven by Lisa Cosgrove Ph.D. et al’s study of DSM-IV and DSM-IV-TR committee members, which found that of the 170 members, 56% had one or more financial associations with companies in the pharmaceutical industry.  Pharma’s psychotropic drug profits have soared commensurately with the increased numbers of disorders voted into the DSM.

• Of the 137 DSM-V panel members who have posted disclosure statements, 56% have reported industry ties—no improvement over the percent of DSM-IV members.

• Writing in Psychiatric Times (March 6, 2010), Cosgrove and Harold J. Bursztajn, MD, stated: “Although the APA recently announced that it would phase out the visibly industry-supported educational programs, the organization has remained curiously silent about acknowledging and monitoring industry funding of the 2 philanthropic arms of the APA—the American Psychiatric Foundation (APF) and the American Psychiatric Institute for Research and Education (APIRE).”

• APF’s 15-member board of directors includes 4 high-level executives from pharmaceutical companies that either manufacture drugs recommended by APA (i.e.; in APA’s Clinical Practice Guidelines [CPG]) or have products in development targeted for mental disorders.

• Other board members include 2 more with industry ties and a senior vice president at one of the largest public relations agencies in the world, whose clients include 6 drug companies.

• APF’s corporate advisory council comprises pharmaceutical companies that contribute significant funding to APF and manufacture drugs recommended in the APA’s CPG; 6 of the companies give $40,000 “and above” per year.

• APIRE, like APF, does not require disclosure of financial conflicts of interests, yet 9 of 16 of its board members have industry ties.

• At least a quarter of the presenters at this year’s APA congress have significant pharmaceutical company ties.

The APA should sever all ties to pharmaceutical company interests. The US Senate Finance Committee has investigated at least a dozen APA psychiatrists over their undisclosed financial ties to drug companies, including:

Investigated - Alan Schatzberg, APA President: Owned $6 million equity in and as co-founder of drug developer Corcept Therapeutics while principle investigator in an NIH-funded, Stanford-based study of Corcept’s drug mifepristone. Schatzberg initiated the patent application on mifepristone to “treat psychotic depression” in 1997. In 2008, after months of Congressional scrutiny, Schatzberg stepped down from his position as principal investigator in the study.


Investigated – Joseph Biederman: Chief of the Program in Pediatric Psychopharmacology, Massachusetts General Hospital, he earned $1.6 million in consulting fees from drug makers between 2000 and 2007, most of which was not disclosed to Harvard University officials. In March 2009, court documents showed Biederman promised Johnson & Johnson in advance that his studies of their antipsychotic Risperidone would prove effective when used on preschool age children.


Investigated - Melissa DelBello: Research psychiatrist, University of Cincinnati failed to disclose all her Pharma earnings. In 2002, she was the lead author of a study that reported patients benefited from Seroquel by AstraZeneca, which paid her $180,000. She disclosed receiving $100,000 from the company between 2005 and 2007, but federal investigators discovered it was more than double that—$238,000.


Investigated - Frederick Goodwin: Former NIMH director, Goodwin earned at least $1.3 million between 2000 and 2007 for marketing lectures to physicians on behalf of drug makers, which he did not reveal to the producers of “The Infinite Mind” that he hosted on the National Public Radio during its 10-year run. NPR removed the program.


Investigated - Charles Nemeroff: Perhaps the most egregious case exposed was that of Dr. Nemeroff, chair of Emory University’s department of psychiatry and, along with Schatzberg, coeditor of the influential Textbook of Psychopharmacology. He received more than $960,000 from GSK, but reported to Emory $35,000.  He earned a further $2.8 million from various drug makers but failed to report at least $1.2 million. Nemeroff resigned his position at Emory in 2008.


Investigated - Martin Keller: Professor of Psychiatry at Brown University. His (and others’) Study 329 (ghostwritten by a GSK rep.) on Paxil use in children allegedly misrepresented data and suppressed information linking Paxil to suicidal tendencies. Keller didn’t disclose the full extent of his financial ties with companies to medical journals that published his research. In another matter, following a criminal investigation, Brown University returned $300,170 to the state of Massachusetts for research Keller’s department never performed. Keller stepped down as chair of psychiatry at Brown.


Investigated - Augustus John Rush: Former Vice-Chairman of the Dept. of Clinical Sciences at the University of Texas Southwestern Medical Center. He reported only $3,000 of the nearly $18,000 that Eli Lilly paid him in 2001.  Between 2000 and 2007, he failed to report another $12,000 from various drug companies.


Investigated - Karen Wagner: Professor, University of Texas Medical Branch failed to disclose more than $160,000 in payments from GSK, reporting only $18,000. Wagner worked on NIH-funded studies on the use of Paxil to treat teen depression and was a co-researcher on Study 329 (see Keller), for which she was paid more than $18,000. In 2002, Eli Lily paid her over $11,000, which was not disclosed.


Investigated – Thomas Spencer: Assistant Director of the Pediatric Psychopharmacology Unit at Massachusetts General Hospital and Associate Professor of Psychiatry, Harvard Medical School, reportedly failed to disclose at least $1 million in earnings from drug companies between 2000 and 2007.


Investigated - Timothy Wilens: Associate Professor of Psychiatry at Harvard Medical School allegedly failed to report he had earned at least $1.6 million from drug makers.

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Also see: DSM Panel Members Still Getting Pharma Funds

By CCHR International
May 21, 2010

NEW ORLEANS – As psychiatrists from around the world flood the area this weekend to take part in the Annual Meeting of the American Psychiatric Association (APA), psychiatric watchdog Citizens Commission on Human Rights (CCHR) is demanding that the APA sever all ties to pharmaceutical company interests and that psychiatrists stop killing children with harmful drugs.

The APA is expected to release its guidelines to reduce pharmaceutical industry ties at its convention, but it is likely to be self-serving and occurred only after public and legislative pressure forced the issue.

The US Senate Finance Committee has investigated at least 16 APA psychiatrists over their undisclosed financial ties to drug companies, including the APA’s own President, Alan Schatzberg who has stepped down as principal investigator of a National Institute of Health (NIH) funded study after months of Congressional scrutiny into his ties to the drug he was studying.  He was found to have actually initiated the patent application of the drug he was studying to “treat psychotic depression.”

Other notable APA members under scrutiny by the Senate Finance Committee and scheduled to present in New Orleans are Thomas Spencer, Assistant Director of the Pediatric Psychopharmacology Unit at Massachusetts General Hospital and Dr. Joseph Biederman, Chief of the Program in Pediatric Psychopharmacology, Massachusetts General Hospital.

Dr. Spencer reportedly failed to disclose at least $1 million in earnings from drug companies between 2000 and 2007. Dr. Biederman earned $1.6 million in consulting fees from drug makers during the same period, most of which was not disclosed to Harvard University officials. In March 2009, court documents showed Biederman promised Johnson & Johnson in advance that his studies of their antipsychotic risperidone (Risperdal) would prove effective when used on preschool age children. Risperdal has been linked to potentially life-threatening diabetes and Neuroleptic Malignant Syndrome.  The FDA database from 2000 to 2004 found at least 45 deaths in children under 18 with newer antipsychotics and 1,328 reports of other serious side effects, some life-threatening.

Former APA president Nada Stotland stated: “We are in the midst of a revolution caused by public and legislative concern about the influence of the for-profit sector….” [Emphasis added].  Part of that public pressure for the APA to disclose its conflicts of interest with pharmaceutical companies was driven by Lisa Cosgrove Ph.D. et al’s study of DSM-IV and DSM-IV-TR committee members, which found that of the 170 members, 56% had one or more financial associations with companies in the pharmaceutical industry.  Pharma’s psychotropic drug profits have soared commensurately with the increased numbers of disorders voted into the DSM.

While APA leaders and members profit from their industry connections to the drugs they are promoting; children are being killed by these same drugs.

Also see:  Meet the Psychiatrist Pushing For A Brave New World of Pre-Drugging Kids—Patrick McGorry

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TransWorldNews
By Janne Larsson
March 5, 2010

The companies producing methylphenidate products (like Ritalin and Concerta) are normally competitors, marketing ADHD as a disease and the narcotic drugs as its solution. But when they are threatened with marketing restrictions they have a common interest.

If more scientific long-term studies would be done showing the harmful effects of the drugs it could lead to withdrawal from the market of this class of drugs. Therefore Big Pharma has to stop all such studies not written and controlled by themselves. The only studies they support are those conducted by paid researchers like psychiatry professors Joseph Biederman, Timothy Wilens and Thomas Spencer, where the outcome is known already from the beginning.

The European Commission has 27 May 2009, after a long review by the European Medicines Agency (EMEA), decided to issue warnings about methylphenidate drugs. The Commission has also decided that a number of long-term studies of good quality should be done to investigate different harmful effects of these drugs.

So for example the manufacturers were ordered to submit data how they could do long-term studies of psychiatric adverse effects (e.g. depression, hostility and psychotic reactions) and of cognitive effects (effects on learning, intellectual function) of the drugs. The answer from the pharmaceutical companies was a confidential report Feasibility Assessment of a Study of Long-term Effects of Methylphenidate on Cognition and Psychiatric Outcomes written 30 October 2009 – now made public by a Swedish court.

Read entire article:  http://www.transworldnews.com/NewsStory.aspx?StoryID=244733

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