Psychiatrists On the Take: the Focus of Government Investigations

The Boston Globe reports (below):

"a complaint unsealed last week in US District Court in Boston, prosecutors allege that New York-based Forest Laboratories Inc. illegally marketed the drugs Celexa and Lexapro for use in children by paying kickbacks, including lavish meals and cash payments disguised as grants and consulting fees, to induce doctors to prescribe the drugs. They also say the company misled doctors and the public by failing to disclose the results of a negative study."

The prosecutors’ complaint states that from 1999 to 2006, Dr. Jeffrey Bostic, director of school psychiatry at Mass General, gave more than 350 Forest-sponsored talks and presentations in 28 states, many of which addressed pediatric use of Celexa and Lexapro. According to the government complaint, the company paid Dr. Bostic more than $750,000 between 2000 and 2006 for his presentations.

Prosecutors said that: "Forest also paid Dr. Bostic to meet other physicians in their offices in order to ease their concerns about prescribing the drugs for off-label uses."
Dr. Bostic became Forest’s "star spokesman in the promotion of Celexa and Lexapro for pediatric use."  Indeed, an unnamed Forest sales representative is quoted saying, "Dr. Bostic is the man when it comes to child psych."

The Emory student newspaper, Emory Wheel, reports:

"The federal government may investigate former psychiatry chairman Charles B. Nemeroff’s consulting activities to gauge whether he fulfilled his required time commitments as chief investigator of multiple research grants from the National Institutes of Health (NIH)."

From 2003 to 2008, Nemeroff served as the primary investigator on a $3.9 million joint grant between Emory, the NIH and pharmaceutical giant GlaxoSmithKline (GSK). Sen. Grassley alleged that Nemeroff received more fees from GSK than the maximum amount allowed.

"The in-house investigation focused on documents from 2000 to 2006 provided by GSK, the largest single payer, and led to a Dec. 5 press release that said Nemeroff had received at least $800,000 in unreported outside income. Nemeroff stepped down as chairman in December but has continued in his teaching post; he is barred from participating in any sponsored research grants for the next two years at least."

"Based on information that was made public last fall, Grassley states in his letter that Nemeroff was a guest speaker who trained PsychNet doctors in the advocacy of GSK’s Paxil product. PsychNet is a program created by GSK to train doctors in promoting Paxil. According to public documents, Nemeroff served in this capacity in 2000."

University President James W. Wagner said:

" the real thrust of this [new investigation] was to question the conflict of commitment, which is something, very frankly, we need to look into.”

 "the University will look at whether Nemeroff was overcommitted in time to the University, the NIH and GSK."

“We have an ethical obligation, now that this matter has been brought, to understand the facts better, and we will, whether or not there is an investigation by the OIG.”

posted by Vera Hassner Sharav

THE BOSTON GLOBE
US cites Boston psychiatrist in case vs. drug firm complaint alleges kickbacks to MDs
By Liz Kowalczyk   March 6, 2009

Federal prosecutors say that a Massachusetts General Hospital psychiatrist became a "star spokesman" in helping a pharmaceutical company promote its drugs for treating depressed children, even though the medications were not approved for pediatric use by the US Food and Drug Administration.

In a complaint unsealed last week in US District Court in Boston, prosecutors allege that New York-based Forest Laboratories Inc. illegally marketed the drugs Celexa and Lexapro for use in children by paying kickbacks, including lavish meals and cash payments disguised as grants and consulting fees, to induce doctors to prescribe the drugs. They also say the company misled doctors and the public by failing to disclose the results of a negative study.

In the 34-page complaint, prosecutors said that from 1999 to 2006, Dr. Jeffrey Bostic, director of school psychiatry at the hospital, gave more than 350 Forest-sponsored talks and presentations in 28 states, many of which addressed pediatric use of Celexa and Lexapro.

"Forest also paid Dr. Bostic to meet other physicians in their offices in order to ease their concerns about prescribing" the drugs, the complaint said. Doctors are allowed to prescribe children drugs not approved by the FDA for pediatric use, a practice called "off label" use.

The government said that Bostic became "Forest’s star spokesman in the promotion of Celexa and Lexapro for pediatric use" and that the company paid him more than $750,000 between 2000 and 2006 for his presentations. The complaint quotes an unnamed Forest sales representative as saying, "Dr. Bostic is the man when it comes to child psych."

Bostic declined to be interviewed, but the hospital gave the Globe a statement describing him as a "highly regarded practitioner and educator in the field of psychiatry." The hospital said Bostic cooperated with the government, providing investigators with information about his speaking engagements.

"The United States complaint is brought against Forest Laboratories, not Dr. Bostic," the statement said. "The complaint consists of characterizations and allegations by the United States, not established facts. In those speaking engagements, Dr. Bostic talked to fellow physicians about the treatment of patients with various mental health conditions, not about one or two specific drugs."

On his Mass. General website on school psychiatry, Bostic outlines several treatments for depression in children and teenagers, including counseling and cognitive behavior therapy, as well as antidepressants. He mentions Lexapro and Celexa along with several other medications, and says, "There is no best medicine to treat depression."

Dr. Michael Jellinek, president of Newton-Wellesley Hospital and chief of child psychiatry at Mass. General, said he has known Bostic for years. "He has absolute integrity," Jellinek said. "I have seen no bias in terms of any choice of treatment or particular medication."

The allegations against Forest are part of a legal and political backlash against potential conflicts of interest in medicine, particularly in psychiatry. US Senator Charles E. Grassley, Republican of Iowa, has accused another Mass. General child psychiatrist, Dr. Joseph Biederman, of failing to tell Harvard Medical School until last March about most of the more than $1.5 million that the pharmaceutical industry paid him in consulting and speaking fees between 2000 and 2007. Biederman has said in statements and letters to the Globe that he has been conscientious about requirements that he disclose payments to his employers and that drug company money has not biased his research.

Harvard would not comment on whether Bostic disclosed his speaking fees, saying faculty disclosure forms are confidential.

In a statement, Forest said it "is committed to adhering to the highest ethical and legal standards, and off-label promotion and improper payments to medical providers have consistently been against Forest policy."

Liz Kowalczyk can be reached at kowalczyk@globe.com.  
© Copyright 2009 The New York Times Company
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EMORY WHEEL  U.S. to Probe Emory, Nemeroff
By Tiffany Han
3/07/2009

The federal government may investigate former psychiatry chairman Charles B. Nemeroff’s consulting activities to gauge whether he fulfilled his required time commitments as chief investigator of multiple research grants from the National Institutes of Health (NIH).

Sen. Charles Grassley (R-Iowa), the ranking Republican on the Senate Finance Committee, sent a letter to the inspector general of the U.S. Department of Health and Human Services (HHS), prodding him to investigate the conflict-of-commitment matter. The letter, made public on Feb. 24, also questioned whether Emory reported conflict-of-interest issues to the NIH in good faith.

When faculty apply for federal grants, which are a contract between the agency and the University, they request a salary amount in return for committing a percentage of their time to the research effort. Grassley charged in the letter that Nemeroff could not have fulfilled his commitments to the NIH “while, at the same time, spending hundreds of days on the road giving promotional talks for, among others, drug companies.” The NIH declined to comment.

The Office of the Inspector General (OIG) is prohibited by law from confirming or denying a possible investigation and cannot comment on cases that may be underway.

A spokesperson for Grassley’s office said the Feb. 24 letter was a form of public declaration that an investigation would be conducted. The spokesperson said Grassley’s office has been in discussions with the OIG since December.

Emory’s general counsel, Kent Alexander, said the University has not received word from the inspector general on whether any investigation would take place. He said the University was not aware of the Feb. 24 letter until a Wall Street Journal reporter contacted Emory about it earlier this week. Since then, Emory has begun taking a close look at past records relating to these new allegations, Kent said.

“We are taking all of this very seriously,” Alexander said. “Whether they pursue it or not, we’re certainly looking into it.”

Alexander said the University’s own review could take an unspecified amount of time, adding that “the important thing is to be thorough, accurate and fair.”

The University already conducted an internal investigation last fall after Grassley alleged that Nemeroff had misreported outside income and violated University and federal conflict-of-interest policies by exceeding limits set on outside consulting and speaking engagements. From 2003 to 2008, Nemeroff served as the primary investigator on a $3.9 million joint grant between Emory, the NIH and pharmaceutical giant GlaxoSmithKline (GSK). Grassley alleged that Nemeroff received more fees from GSK than the maximum amount allowed.

The in-house investigation focused on documents from 2000 to 2006 provided by GSK, the largest single payer, and led to a Dec. 5 press release that said Nemeroff had received at least $800,000 in unreported outside income. Nemeroff stepped down as chairman in December but has continued in his teaching post; he is barred from participating in any sponsored research grants for the next two years at least.

In a Dec. 22 statement, Grassley commended Emory’s “swift and sure-footed response” in dealing with the conflict-of-interest allegations, adding that the University has set an example for other research institutions to follow and for the NIH to “hold up as the kind of standard it expects from those receiving federal research dollars.”

But in the Feb. 24 letter, Grassley questions whether Nemeroff’s talks were “focused on substantive medical educational topics” that were not “product specific or promotional,” as the University had asserted in its Dec. 5 statement. University officials have said that a review of lecture slides and interviews with presentation attendees corroborated Nemeroff’s assertion that his conflicts of interest were purely financial and did not affect his research or judgment regarding patients.

Based on information that was made public last fall, Grassley states in his letter that Nemeroff was a guest speaker who trained PsychNet doctors in the advocacy of GSK’s Paxil product. PsychNet is a program created by GSK to train doctors in promoting Paxil. According to public documents, Nemeroff served in this capacity in 2000.

University President James W. Wagner said the “real thrust of this [new investigation] was to question the conflict of commitment, which is something, very frankly, we need to look into.” He said the University will look at whether Nemeroff was overcommitted in time to the University, the NIH and GSK.
“We have an ethical obligation, now that this matter has been brought, to understand the facts better, and we will, whether or not there is an investigation by the OIG,” Wagner said.

The inspector general, currently Daniel R. Levinson, leads investigations to ensure that federal programs under the HHS are run properly.

Don White, a spokesperson for the OIG, said that after any investigation, the office presents its findings but does not act on them. Any possible legal or administrative action would be brought by a legal office or the involved federal agency, he said. White said that while he cannot comment on whether an investigation is taking place, there is no timeline for a typical investigation.

— Contact Tiffany Han.

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