Posts Tagged ‘Emory University’

Grassley Wants Website Disclosing Conflicts of Interest—Letter Cites Harvard Psychiatrists Failure To Report Nearly $1 Million

Friday, August 5th, 2011

 In a letter to OMB [ Office of Management and Budget]  Sen. Chuck Grassley warned the administration not to back off from a proposed rule that would create a website to disclose medical researchers’ conflicts of interest. “I am troubled that taxpayers cannot learn about the outside income of the researchers whom the taxpayers are funding, and this flies in the face of President Obama’s call for more transparency in the government. The public’s business should be public. The consequences of a lack of transparency include doctors’ possibly using taxpayer-funded grants to leverage their own financial interests, to the detriment of consumers.” Grassley said he’s worked tirelessly “to shine light on these relationships, including with the help of Sen. Kohl in securing the passage of the Physician Payment Sunshine Act of 2009.” Read the letter here: http://1.usa.gov/r0OLYG

 

The Honorable Jacob J. Lew
Director
Office of Management and Budget
Eisenhower Executive Office Building
1650 Pennsylvania Avenue, NW
Washington, DC 20503

Dear Director Lew:
I write to you today regarding public disclosure of financial relationships between physicians and the drug, device and biologic industries. For the past three years I have worked to shine light on these relationships, including with the help of Senator Kohl in securing the passage of the Physician Payment Sunshine Act of 2009 (PPSA).

Before the passage of PPSA, in summer of 2008, I began releasing the results of my oversight work that demonstrated that universities are not and have not managed their professors’ financial conflicts of interest and that change is needed at the National Institutes of Health (NIH). Specifically, I found:

The Chair of the Psychiatry Department at Emory University failed to report hundreds of thousands of dollars in payments from a pharmaceutical company while researching that same company’s drugs with an NIH grant. The Health and Human Services Office of the Inspector General (HHS OIG) is now investigating the matter.

The Chair of the Psychiatry Department at Stanford University received an NIH grant to study a drug while partially owning a company that was seeking FDA approval of said drug. He was later removed from the grant.

Three psychiatrists at Harvard University failed to report almost a million dollars each in outside income while heading up several NIH grants. Harvard released a report on the matter, and a briefing has been scheduled with my office.
I am concerned about recent reports that the Office of Management and Budget (OMB) may be attempting to weaken conflicts of interest rules proposed in May 2010 by the Department of Health and Human Services (HHS).

According to an article in Nature, OMB has removed the requirement for a publicly available website that would publish the conflicts of interests of researchers funded by taxpayers.1 I am troubled that taxpayers cannot learn about the outside income of the researchers whom the taxpayers are funding, and this flies in the face of President Obama’s call for more transparency in the government. The public’s business should be public. The consequences of a lack of transparency include doctors’ possibly using taxpayer-funded grants to leverage their own financial interests, to the detriment of consumers. Transparency is a backstop against such practices. I urge OMB to follow through and approve a rule that includes a publicly available website. OMB is the final arbiter of this decision. Any weakening of publicly available information requires careful scrutiny.

In order to understand why OMB appears to have concluded that weakening the HHS proposed conflict of interest rule is appropriate, I would appreciate your response to the following requests for documents:

1) Please provide all records relating to communications, including emails, with OMB staff regarding the Department of Health and Human Services’ proposed conflicts of interest rule from May 1, 2010, to the present.

2) Please provide all records, including calendar entries, relating to meetings with Administrator Cass Sunstein, OMB Office of Information and Regulatory Affairs, from May 1, 2010, to the present.

I request that OMB respond to my request by no later than August 25, 2011. Thank you for your attention to this important matter.

Sincerely,
Charles E. Grassley
Ranking Member
See the letter here: http://1.usa.gov/r0OLYG

 

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DSM Panel Members Still Getting Pharma Funds

Friday, May 21st, 2010

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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University of Miami under fire for hiring psychiatrist who took millions in Pharma funds and was “pharma pimping for Paxil”

Friday, November 6th, 2009

John Dorschner
The Miami Herald
November 6, 2009

Charles Nemeroff, an Atlanta psychiatrist who was the subject of a Senate investigation concerning huge sums he received from drug companies, has been named chairman of the psychiatry department at the University of Miami.

Last year Nemeroff, as the top psychiatrist at Emory University, was the focus of an investigation by Sen. Charles Grassley, R-Iowa, who said he was concerned about the millions the psychiatrist received from drug companies while conducting supposedly unbiased research for the National Institutes of Health on drugs made by the companies he was receiving money from.

On Thursday, Pascal Goldschmidt, dean of UM medical school, called Nemeroff “an exceptional psychiatrist and an exceptional scientist who has one issue in which he recognizes he made a mistake,” in not telling Emory how much he was getting from drug makers.

Goldschmidt said he had read investigative reports from Emory about Nemeroff’s activities and Emory found nothing to indicate that payments the psychiatrist received had in any way influenced his research results.

Elsewhere, opinions are divided.

The former head of psychiatry at Duke University told The Miami Herald Thursday that Nemeroff was “economical with the truth” and his work can’t be trusted, while the leader of the Columbia University psychiatry program said Nemeroff was a top-flight scientist and he had never seen any bias in his work.

Read entire article: http://www.miamiherald.com/business/story/1319569.html

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Say what? Psychiatrist Charles Nemeroff who failed to report $1.2 mil in Pharma deals lands psych chairmanship at University

Thursday, November 5th, 2009

John Dorschner
The Miami Herald
November 5, 2009

Charles Nemeroff, an Atlanta psychiatrist who was the subject of a Senate investigation concerning huge sums he received from drug companies, is being named chair of the psychiatry department at the University of Miami medical school.

Last year Nemeroff, as chair of the Department of Psychiatry at Emory University, was the intense focus of an investigation by Sen. Charles Grassley, R-Iowa, who said he was concerned about the money the psychiatrist received from drug companies while conducting supposedly unbiased research for the National Institutes of Health on drugs made by the companies he was receiving money from.

On Thursday, Pascal Goldschmidt, dean of UM medical school, called Nemeroff “an extraordinary psychiatrist and scientist. . . . He got into serious trouble on disclosure on conflict of interest.”

Goldschmidt said he had read investigative reports from Emory about Nemeroff’s activities and found nothing to indicate that payments the psychiatrist received had in any way influenced his research results.

In a telephone interview at mid-day Thursday, Nemeroff, 60, told The Miami Herald he was excited to be coming to Miami. “I think it’s going to be a top-10 school.”

A front-page report by The New York Times in October 2008 said that congressional investigators found Nemeroff — “one of the nation’s most influential psychiatrists” — had received $2.8 million in consulting deals with drug makers over seven years and failed to report at least $1.2 million of that to Emery University.

Read entire article: http://www.miamiherald.com/news/breaking-news/story/1318257.html

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Psychiatrist exposed in Grassley investigation resigns after failing to report hundreds of thousands in Pharma funds

Monday, November 2nd, 2009

Bob Grant
TheScientist.com
November 2, 2009

The Emory University psychiatry researcher who failed to report hundreds of thousands of dollars in pharmaceutical company payouts while receiving millions of dollars in funding from the National Institutes of Health to study the company’s anti-depressant drugs is leaving the university, according to the Atlanta Journal Constitution.

Charles Nemeroff,  a renowned depression researcher, failed to disclose to Emory approximately $800,000 in payments he received from drug maker GlaxoSmithKline (GSK) while he was the principal investigator (PI) on a multi-million dollar grant from the NIH to study five GSK antidepressants. Amid an investigation conducted by Emory, Nemeroff stepped down from his position as chairman of the psychiatry department last October. Later that month, the psychiatrist stepped down as PI from the $9.3 million NIH grant as the Senate probed his failure to disclose income from GSK, and the NIH froze funding on the five-year grant.

Read entire article: http://www.the-scientist.com/blog/display/56127/

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