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Top News arrow Conflicts of Interest arrow NIMH Scientist Charged with Criminal Conflict of Interest
NIMH Scientist Charged with Criminal Conflict of Interest Print E-mail
Tuesday, 01 February 2011

CORRECTION: An Associated Press article about a federal criminal case accusing Dr. P. Trey Sunderland III of improperly accepting consulting fees from a drug maker, misstated the level of the charge against him. Dr. Sunderland was charged with "non-willful" criminal violation, a misdemeanor which carries a maximum one year prison term and $100,000 fine. It is NOT a felony, which is punishable by more than one year prison term.

Dr. Pearson "Trey" Sunderland III, Chief of Geriatric Psychiatry at the National Institute of Mental Health, pled guilty to criminal conflict of interest.

As reported by The Lost Angeles Times , the admission of a criminal violation by Dr. Sunderland came after years of denials and six months after he pleaded the Fifth Amendment, asserting his constitutional right against self-incrimination to a Congressional committee.The prosecution was the first of an NIH  scientist under federal conflict-of-interest laws in 14 years.

Dr. Sunderland faced up to a year in prison and a $100,000 fine for secretly contracting with Pfizer pharmaceuticals as a paid consultant for work that overlapped his duties as a full-time public servant. Dr. Sunderland was head of the Alzheimer's research unit at NIMH.  From 1998 to 2003, he received $285,000  in consulting fees from Pfizer pharmaceutical plus $15,000 in expenses.

The services Dr. Sunderland performed for the company included providing "access" to " a treasure trove of biological material"--namely, 3,200 tubes of spinal fluid samples costing the NIH (i.e., taxpayers) an estimated $6.4 million.

The spinal-fluid samples had been painfully collected from Alzheimer's patients at NIMH for the public good.  Thanks to Dr. Sunderland, Pfizer exploited these patients' painfully acquired tissues to refine and market Aricept, garnering billions in profit:  Aricept sales = $2 billion annually.

The details about Sunderland's secret deal that gave Pfizer access to much sought after samples of spinal fluid acquired for taxpayer-funded research were revealed in Congressional testimony by Dr. Susan Molchan, an NIH whistleblower.  (below) and CBS News.

The Los Angeles Times reported that "[Sunderland] also endorsed use of Aricept, Pfizer's drug for Alzheimer's, during a televised presentation at the NIH in 2003 [and] did not tell the audience about his affiliation with the company." And "on more than 80 occasions from 1999 to June 2004, Sunderland was paid by Pfizer for speaking appearances at conferences in the U.S. and overseas, documents show."

A plea agreement calls for Sunderland to submit to two years of probation, that he perform 400 hours of community service, and that he pay the government the $300,000 he received from Pfizer.

Some volunteers in the NIH study said the Sunderland punishment too lenient: Paul W. Lewis, a retired federal lawyer, who volunteered in the NIH research from 2001 to 2004, and who had provided tissue samples is quoted in The Los Angeles Times and The Institute for Science, Law & Technology (ISLAT)website stating:

"I don't consider this sentence to be much more than a slap on the wrist. I don't consider it much of a deterrent to people of his mind-set at NIH." 
He formally asked the NIH to return the samples he had provided for Alzheimer's research. He had allowed the spinal fluid to be drawn, he told the LAT, because his father had died of Alzheimer's and he wanted to help.

The US attorney Rod J. Rosenstein, who prosecuted the case, told reporters that Sunderland's actions were a breach of the public trust.

It is particularly galling that the nation's most prestigious academic institutions--including the NIH--turn a blind eye to the scientific, moral, and even criminal wrongdoing of their senior faculty.

After revelations of wrongdoing, in the midst of federal investigations, an article in NY Newsday quotes Dr. John Kane, a prominent psychiatrist who is the director of The Zucker Hillside Hospital / North Shore health system, stating:
"It is unfortunate that this is happening to such a fine man and an outstanding scientist....officials at North Shore have no qualms about the investigation into Sunderland's activities." "We are waiting for him,"
he said. 

Dr. Kane also defended "the importance of collaborations with industry. "We need to preserve the ability of scientists to interact with industry," he said.

The arrogance of the NIH director--who wouldn't say whether a criminal conviction would be cause for dismissal of a scientist-- led Congressman John Dingell to exclaim: "Will a criminal conviction for conflict of interest be enough to get someone fired from NIH?"  

UPDATE Dr. Sunderland's career in academic psychiatry does not appear to have sufferred after having pled guilty to criminal misdemeanor.

2008: Director of the Alzheimer Research Center at the Albert Einstein College of Medicine, New York

I am currently a member of many national organizations and was recently President of the Society of Biological Psychiatry besides serving on editorial boards for multiple scientific journals and as a regular reviewer for many others. From 1990-2000, I was Chair of the Institutional Review Board for the National Institutes of Health during a time of much change at the National Institute of Mental Health. I was also Chair of the Medical Advisory Board for the Washington, D.C. Alzheimer Association for many years, and I have published over 250 scientific papers in national and international journals. I am co-author of Aging and Mental Health with Robert N. Butler and Myrna Lewis.

Recently, I moved to the LIJ/Hillside/North Shore hospital system as the first recipient of the Litwin-Zucker Chair of Geriatric Psychiatry. I am currently the Director of the Litwin-Zucker Center for the Study of Memory Disorders and Alzheimer's disease along with the Scientific Director, Peter Davies, Ph.D., and my current studies focus on the longitudinal follow-up of older subjects and the use of biomarkers to help establish an early diagnosis of Alzheimer's disease. Early diagnostic strategies will employ genetic markers, structural and functional brain imaging, cognitive testing, blood tests and cerebrospinal fluid measures. It is hypothesized that these biomarkers will generate an early "fingerprint" of Alzheimer's disease. I am also interested in innovative treatment trials for early Alzheimer patients. The idea is that if the diagnosis can be made years before symptoms of memory disorder are evident, perhaps there are treatment strategies that might help delay or even prevent the first symptoms of this devastating illness. Together with the basic science of Dr. Peter Davies, we hope to quickly create a world-class research center within the LIJ/Hillside/North Shore hospital system.
See:  The Creativity Foundation, Copyright © 2008 - 2011

Alzheimer's research is a lucrative field for drug manufacturers and researchers who promote early screening / and interventions. However, it is a field that has, so far, developed absolutely nothing in the way of effective treatments that improve patients' lives.

 
Vera Hassner Sharav
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December 11, 2006: NIH Researcher Pleads Guilty over Secret Contract with Pfizer

Dr. Pearson “Trey” Sunderland.Dr. Pearson “Trey” Sunderland. [Source: CreativityFound (.org)]

Dr. Pearson “Trey” Sunderland III, a National Institute of Health (NIH) senior researcher on Alzheimer’s disease, pleads guilty to a federal charge that he committed a criminal conflict of interest. The charges stem from Sunderland’s contract with the pharmaceutical firm Pfizer as a paid consultant for work that overlapped his duties as a public servant. Sunderland is the first official in 14 years to be prosecuted for conflict of interest at NIH, an agency rocked in recent years by revelations of widespread financial ties to the drug industry.

According to the original court filing, in early 1998, “Sunderland initiated negotiations with Pfizer, the pharmaceutical giant, to be paid as a consultant for his work on the same project” that he headed for NIH, a research project into Alzheimer’s disease. In June 2006, Sunderland was revealed to have engaged in a secret contract with Pfizer to supply thousands of samples of spinal fluid collected from Alzheimer’s patients at taxpayer expense and slated to be used in NIH research. Sunderland turned those samples over to Pfizer, which in turn used them to refine and market its drug Aricept, a leading prescription drug for treating the disease (see June 14, 2006).

According to the original charging document filed with the court, in 1998 Sunderland approached Pfizer with a proposal that he be paid $25,000 a year for “consulting” with the firm, plus $2,500 every time he attended a one-day meeting with company representatives. Pfizer agreed. Later that same year, Sunderland set up another deal with Pfizer to be paid another $25,000 a year, according to prosecutors.

The House Energy and Commerce Committee received little cooperation from NIH—Sunderland himself invoked his Fifth Amendment right against self-incrimination when called to testify before the committee in June 2006—but subpoeaned 21 drug manufacturers known to have paid NIH researchers. Sunderland’s history of payments from Pfizer, which he did not reveal to the NIH as required by law, were some of those discovered. After that information was revealed in 2004, NIH director Elias Zerhouni requested that the inspector general of the Department of Health and Human Services investigate the matter. Government researchers found that 44 researchers, including Sunderland, had off-the-books relationships with drug and biotech companies; many of those researchers were reprimanded and/or took early retirement.

At the time of Sunderland’s contracts with Pfizer, NIH restrictions against public-private collaborations were far more lax than they are today. [Associated Press, 12/4/2006; Associated Press, 12/5/2006; Los Angeles Times, 12/5/2006; Washington Post, 12/5/2006]

'Public Trust Has Been Violated'
-

Congressman John Dingell (D-MI) asks, “Will a criminal conviction for conflict of interest be enough to get someone fired from NIH?”
Bart Stupak (D-MI) adds, “If the National Institutes of Health and Commissioned Corps fail to discipline Dr. Sunderland, even after criminal charges have been brought, we can only conclude that no one is being held accountable, the system is broken, and the public trust has been violated.” [Associated Press, 12/5/2006; Los Angeles Times, 12/5/2006] 
Committee member Tammy Baldwin (D-WI) says: “I found this story incredibly distressing because it is so important that people have confidence in the NIH. It is a pretty big move for people to donate human tissue to further scientific discovery. People have to have confidence that that decision… is treated with the utmost respect.” [Washington Post, 12/5/2006]

Guilty Plea Avoids Jail Time
- Sunderland pleads guilty to the charge under a plea agreement in which he admits to taking some $285,000 in “unauthorized” consulting fees from Pfizer as well as $15,000 in travel expense payments between 1998 and 2003. During the same period, he provided Pfizer with spinal-tap samples collected from hundreds of patients as part of a research collaboration approved by the NIH. He agrees to pay the government $300,000, perform 400 hours of community service, and serve two years’ probation. Sunderland faced up to a year in prison and a $100,000 fine, but avoided those penalties through his plea agreement.

After the hearing, US Attorney Rod Rosenstein tells reporters that Sunderland’s actions constitute a breach of the public trust. [Los Angeles Times, 12/5/2006; Washington Post, 12/5/2006] According to NIH spokesman Don Ralbovsky, Sunderland remains an employee, working as a “special assistant and senior adviser” in a division that gives out grants; Rabolvsky refuses to comment on whether Sunderland faces termination procedures. The branch of NIH that Sunderland once headed, the Geriatric Psychiatry Branch, no longer exists, according to Ralbovsky. [Washington Post, 12/5/2006] One media report says Sunderland is planning to retire. [Associated Press, 12/4/2006]

Sunderland will later become a doctor and director of the Alzheimer Research Center at the Albert Einstein College of Medicine in New York. [Lundbeck Institute, 12/11/2008]

Pfizer Denies Wrongdoing
-
For its part, Pfizer maintains that it broke no laws and breached no ethics, saying in a statement: “We believe our actions complied with applicable laws and ethical standards. We are not aware of any allegation that we violated any law or regulation.” [Los Angeles Times, 12/5/2006; Washington Post, 12/5/2006; Los Angeles Times, 12/11/2006]

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June 14, 2006: Whistleblower Says Government Made Secret Deal with Pfizer that Cost Taxpayers Millions

Dr. Susan Molchan testifies before Congress.Dr. Susan Molchan testifies before Congress. [Source: CBS News]Dr. Susan Molchan, a former clinical researcher for the National Institutes of Health (NIH), testifies before Congress that her supervisor at NIH made a secret deal with the pharmaceutical company Pfizer that involved human tissue samples supposedly collected for the public good, but were instead used for Pfizer’s own research and garnered the company millions in profit. [CBS News, 6/14/2006] Molchan testifies before the House Energy and Commerce Subcommittee on Oversight and Investigations [The Scientist, 6/14/2006] that a collection of unused spinal fluid samples, which CBS News describes as a "a treasure trove of biological material, many painfully given up by Alzheimer’s patients" disappeared without a trace from her laboratory freezer at NIH. The samples were slated to be used for NIH studies on Alzheimer’s disease. Molchan says she was told that some of the samples were lost due to freezer malfunctions, but, "nothing solid, nothing that made sense. I never got a handle on what happened to them." [CBS News, 6/14/2006]

Procuring the tissue samples alone cost the government $6.4 million, say committee staffers, who spent a year investigating the matter. "It would really be a shame if we find out that the National Institutes of Health has more control over its paper clips and trash cans than it has over its human tissue samples," says committee member Joe Barton (R-TX). [The Scientist, 6/14/2006] Molchan’s testimony, and other data gathered by Congressional investigators, prove that Molchan’s immediate supervisor, Dr. Trey Sunderland, a well-known psychiatric researcher, cut a secret deal with Pfizer at the same time Pfizer was launching and refining a new Alzheimer’s drug. "If individual scientists are making use of that tissue for their own personal gain, that’s something we need to know about it. It’s not the right thing," says House Energy subcommittee chairman Ed Whitfield (R-KY).

Sunderland provided Pfizer "access" to 3,200 tubes of spinal fluid, costing the NIH and, as a result, taxpayers, an estimated $6 million. In exchange, Sunderland reportedly received $285,000 in personal compensation. Pfizer’s drug Aricept is now the top-selling drug in the world for treating Alzheimer’s, generating $1.6 billion in sales in 2004. "The more tissue samples you can collect these days and extract genetic information about risk and benefit, that’s the future of drug development around the world," says Dr. Art Caplan, a bio-ethicist at the University of Pennsylvania.

The House committee finds that Pfizer itself broke no NIH rules or knew of any wrongdoing by Sunderland, who does not testify before Congress, instead invoking his Fifth Amendment right against self-incrimination. [CBS News, 6/14/2006] Sunderland himself received more than $600,000 in outside consulting and speaking fees from Pfizer from 1998 to 2004 without prior government disclosure or approval. A review by NIH’s Office of Management Assessment found that Sunderland "engaged in serious misconduct, in violation of HHS ethics rules and Federal law and regulation," the report stated. In December 2006, Sunderland will accept a plea bargain in regards to his accepting payments from Pfizer (see December 11, 2006). [The Scientist, 6/14/2006]

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 http://seattlepi.nwsource.com/health/1500AP_Research_Ethics.html

ASSOCIATED PRESS
Monday, December 4, 2006 . Last updated 11:25 p.m. PT
Government scientist faces ethics charge
By RITA BEAMISH

With a rare criminal case against a senior federal researcher, prosecutors
are sending a message to scientists on the government payroll: Making money
from companies on the side can land you in big trouble.

Dr. Trey Sunderland, a leading expert on Alzheimer's disease at the National
Institutes of Health, found that there was no wiggle room in his outside
work for a pharmaceutical company, even in a time when rules were far more
lax than today.
The U.S. attorney in Baltimore charged Sunderland with [CORRECTION]  "NON-WILLFUL" CRIMINAL
conflict of interest Monday for his private consulting with Pfizer Inc., that earned him
$285,000 and improperly overlapped his official duties.

Sunderland was researching early indicators of Alzheimer's both as an NIH
collaborator with Pfizer and a paid Pfizer consultant on work "directly
related" to his government job, according to the court papers filed with
U.S. District Court in Baltimore.

The scientist failed to obtain the proper approvals from his supervisors or
disclose the work to NIH as was required, the prosecutors said.
Last year, NIH banned such outside work for drug and biotechnology companies
following its own internal probe that was prompted by congressional
investigations and disclosures in the Los Angeles Times. The probes revealed
some researchers took advantage of a permissive environment which was
designed to encourage public-private collaborations that might speed disease
cures.

Lucrative moonlighting was still allowed during Sunderland's 1998-2003 deal
with Pfizer, but the prosecutors allege his consulting gave him a financial
interest in the work he did at taxpayer expense.

"This should put other federal officials on notice that you can't disregard
the rules," said Vera Sharav, president of the nonprofit Alliance for Human
Research Protection.
She and other critics contend that weak enforcement feeds conflicts even
when ethics rules are in place.

After NIH's internal investigation, most of the 44 researchers found to have
breached ethics rules got written or verbal reprimands or were permitted to
retire. An agency survey found that many scientists consider the new rules
so restrictive that they are considering leaving NIH.

The felony charge against Sunderland, with a maximum sentence of one year in
prison and a $100,000 fine, was contained in a criminal information rather
than indictment, a route that often precedes a plea deal.

Sunderland did not return a telephone message and his attorney, Robert Muse,
declined comment Monday. He remains on the government payroll although he asked to retire after House
investigators began unraveling his Pfizer financial ties two years ago.

Members of the House Energy and Commerce Committee which launched the probe
called Monday for Sunderland's dismissal from his post at the NIH's National
Institute of Mental Health. Otherwise, Rep. Bart Stupak, D-Mich., said in a
statement, "We can only conclude that no one is being held accountable, the
system is broken and the public trust has been violated."
"Will a criminal conviction for conflict of interest be enough to get
someone fired from NIH?" said Rep. John Dingell, D-Mich.

NIH officials declined to comment.
The court documents allege Sunderland participated as a government employee
"in a particular matter in which, to the defendant's knowledge, he had a
financial interest."

The conflict began in 1998 when Sunderland was making arrangements for NIH
to work with Pfizer on Alzheimer's research. At the same time, he began
negotiations to be a paid consultant on the same project, prosecutors
allege. Sunderland, 55, is to appear Friday for arraignment.

The case is believed to be the first conflict prosecution against a federal
scientist since 1992 when NIH researcher Prem Sarin was convicted of
embezzling a drug company payment to NIH that was intended to help with AIDS
research.
~~~~~~~~~~~~~

The Los Angeles Times

 

NIH researcher is ordered to forfeit Pfizer payments

 

The scientist, who pleaded guilty to conflict of interest, gets two years' probation and community service.
December 23, 2006|
David Willman

BALTIMORE — A federal judge on Friday spared a convicted National Institutes of Health researcher, Dr. P. Trey Sunderland III, any prison time but ordered him to hand over $300,000 in illicit payments he took from a major drug company.

U.S. District Judge J. Frederic Motz also sentenced Sunderland to two years of supervised probation and 400 hours of community service.

http://articles.latimes.com/images/pixel.gif"Obviously, this was unacceptable conduct," Motz said.

Sunderland had pleaded guilty Dec. 8 to a criminal conflict of interest related to his payments from Pfizer Inc. The sentence matched a plea agreement in November between prosecutors and Sunderland's lawyers.

Sunderland took Pfizer's money from 1998 to 2003 while he collaborated with the company in his official federal role as a researcher of Alzheimer's disease.

Under the government-Pfizer collaboration, Sunderland's NIH staff drew spinal fluid from hundreds of volunteers and turned over the samples to Pfizer. The drug company analyzed the samples for genetic clues that might help develop a treatment for Alzheimer's, a debilitating and fatal malady. NIH officials approved the scientific work.

But at the same time, Sunderland was collecting consulting fees from Pfizer related to the project and had not sought permission for such an arrangement, as required by NIH rules. He also did not report the income on his annual financial disclosure forms. At one point he told an internal ethics official that he had no interests outside the government.

NIH officials have said that if Sunderland had asked to moonlight for Pfizer, the request probably would have been denied because the activity overlapped with his official duties.

"It is illegal for any federal employee to make an official decision that directly affects their financial interest, unless they

Sunderland told Motz on Friday that he took "responsibility for these deeds." Glancing at prepared notes, Sunderland said that when he reconstructed in his mind the events that led to a criminal conviction, "I don't have an explanation."

"This process has humbled me in a way that I have never experienced before," he said. He added, his voice faltering, "This has been the most difficult thing I've ever had to do."

An assistant U.S. attorney who prosecuted the case, Martin J. Clarke, said that Sunderland's guilty plea, to one misdemeanor count, would serve as a "deterrent to future such conduct in the federal government."

Some volunteers in the government-Pfizer project said they considered Sunderland's punishment too lenient.

"I Don't consider this sentence to be much more than a slap on the wrist," said Paul W. Lewis, a retired federal lawyer who volunteered in the NIH research from 2001 to 2004.  "I don't consider it much of a deterrent to people of his mind-set at NIH."
In August, after learning of Sunderland's payments from Pfizer, Lewis formally asked the NIH to return his samples.  He had allowed the spinal fluid to be drawn, he said, because his father had died with Alzheimer's and he wanted to help."

http://articles.latimes.com/images/pixel.gif Sunderland's payments from Pfizer and other drug companies came to light after the Los Angeles Times reported in December 2003 that companies had made hundreds of payments of consulting fees and stock to senior NIH researchers. The reporting triggered a congressional inquiry.

Last year, the director of the NIH, Dr. Elias A. Zerhouni, announced that company consulting fees and stock payments would be banned.

Motz said he would allow Sunderland up to 18 months to pay the government the entire $300,000, with no interest charged.

Sunderland had told authorities before the sentencing that he intended to perform his community service with retired veterans at the U.S. Soldiers & Airmen Home in Washington.

Sunderland until earlier this year had headed the NIH's geriatric psychiatry branch. The unit is now disbanded, but as of Friday he remained on the federal payroll, the NIH said.

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THE LOS ANGELES TIMES
The Nation;  NIH scientist charged with conflict
By David Willman
December 5, 2006 Tuesday 
SECTION: MAIN NEWS; National Desk; Part A; Pg. 11

Federal prosecutors on Monday charged a senior scientist at the National Institutes of Health with conflict of inter-est for taking $285,000 in fees from a drug company that was involved with his government research.

Dr. P. Trey Sunderland III is the first official in 14 years to be prosecuted for conflict of interest at the NIH, an agency rocked in recent years by revelations of widespread financial ties to the drug industry. Sunderland accepted the fees from 1998 to 2003 from Pfizer Inc.  Sunderland, who has headed the NIH's geriatric psychiatry branch, is scheduled to appear Friday in a federal courtroom in Baltimore, according to the office of U.S. Atty. Rod J. Rosenstein.

Sunderland is expected to plead guilty to the single charge, said lawyers familiar with the case, who spoke on condition of anonymity because of confidentiality concerns. The scientist, 55, could get up to a year in prison and a $100,000 fine.

Sunderland's lawyer, Robert F. Muse, declined to comment Monday.
In an eight-page filing, prosecutors said Sunderland took money from Pfizer without getting the required advance permission from the NIH.
The services he performed for the company -- including providing hundreds of spinal-tap samples prized for poten-tial genetic cluesthat might help develop a treatment for Alzheimer's disease – were intertwined with his government duties.

And Sunderland failed to note his company fees and additional expense reimbursements on annual NIH financial reports.
Federal law prohibits officials from accepting outside compensation for their government duties.

In Sunderland's case, he spearheaded a "material transfer agreement" on behalf of the NIH, whereby his staff would collect andthen pass the spinal-tap samples to Pfizer. About the same time, in early 1998, "Sunderland initiated negotiations with Pfizer to be paid as a consultant for his work onthe same project," according to the criminal filing.

As a member of the U.S. Public Health Service Commissioned Corps-- the uniformed service led by the U.S. sur-geon general --Sunderland has been shielded from termination or other disciplinary measures by the NIH. His unusual status, and that of other similarly situated senior NIH researchers, has been criticized by members of Congress, who have questioned whether supervision is adequate. Sunderland appeared at a congressional hearing June 14 but did not testify, asserting his 5th Amendment right against self-incrimination. The hearing focused on the NIH response to the unauthorized drug company fees accepted by Sunderland and one of his research assistants.

The announcement of Sunderland's prosecution prompted some lawmakers to call for his firing. "If the National Institutes of Health and Commissioned Corps fail to discipline Dr. Sunderland, even after criminal charges have been brought, we can only conclude that no one is being held accountable ,the system is broken and the public trust has been violated," said Rep. Bart Stupak (D-Mich.). Rep. John D. Dingell (D-Mich.), who will take over in January as chairman of the House Energy and Commerce Committee, asked: "Will a criminal conviction for conflict of interest be enough to get someone fired from NIH?"

In Bethesda, Md., NIH spokesman Donald Ralbovsky said Monday that the agency would not comment on the charge against Sunderland "because it's a pending personnel matter." Sunderland's prosecution builds on events over the last several years: After the Los Angeles Times reported in De-cember 2003 that ranking NIH officials had received hundreds of company consulting payments, grants of stock or stock options, the House Energy and Commerce Committee asked the agency to disclose all such transactions over the previous five years. When the NIH did not promptly respond ,lawmakers acquired information from 21 drug companies.

The companies' responses identified scores of NIH researchers who were not previously known to have received certain payments. These included the fees Pfizer paid Sunderland. After examining the Sunderland case internally, NIH Director Elias A. Zerhouni requested nearly two years ago that the inspector general of the Department of Health and Human Services investigate it further.
The last NIH scientist to be prosecuted and convicted for a conflict of interest was an AIDS researcher, Prem S. Sarin. He was ordered in 1992 to repay a German pharmaceutical company $25,000 and was sentenced to two months of community service.

The NIH is composed of 27 research institutes and centers, and it operates the largest hospital in the nation for ex-periment medical research. The agency, whose budget last year was $28.5 billion, has some 18,000 employees, about 5,000 of whom lead or conduct research.

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Copyright 2006 Los Angeles Times All Rights Reserved

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http://www.washingtonpost.com/wp-dyn/content/article/2006/12/04/AR2006120401292_pf.html

The Washington Post
U.S. Criminal Charges Filed Against Scientist
Undisclosed Consulting Deals at Issue
By David A. Fahrenthold
Tuesday, December 5, 2006; B06

A top scientist at the National Institutes of Health whose alleged failure
to disclose consulting contracts with a drug company helped set off a probe
of possible ethical lapses by researchers was criminally charged yesterday
with violating federal conflict-of-interest rules.

Pearson "Trey" Sunderland III, 55, who was chief of the Geriatric Psychiatry
Branch of the National Institute of Mental Health, faces one misdemeanor
count that could bring a year in prison and a $100,000 fine, federal
prosecutors said. The charge was outlined yesterday in a document called a
"criminal information" -- a signal that Sunderland had waived the usual
grand jury indictment process, and that a plea agreement may be forthcoming.

In charging Sunderland, prosecutors alleged that he accepted $285,000 in
consulting fees and other payments from the Pfizer Inc. drug company between
1997 and 2004. Sunderland, who lives in Chevy Chase, failed to list these
payments on the required disclosure forms, prosecutors said.

At the time, Sunderland's department was working with Pfizer in research to
identify chemical warning signs of Alzheimer's disease. As part of the
research, Sunderland helped provide hundreds of government-owned tissue
samples for analysis.

In August 2005, a year after Sunderland's case came to light, NIH imposed
rules that bar employees from working for, or owning stock in, drug or
biotech companies. Sunderland's Washington attorney, Robert F. Muse, said yesterday he would
have no comment on the case.

In previous interviews, Muse had said that Sunderland had made no efforts to
conceal his outside work and that many NIH researchers had come to see the
disclosure forms as "basically a bureaucratic nuisance." Sunderland himself
invoked his Fifth Amendment right against self-incrimination when called to
testify before a House of Representatives subcommittee in June.

Don Ralbovsky, a spokesman for the Bethesda-based NIH, said that Sunderland
remains an employee and now works as a "special assistant and senior
adviser" in a division that gives out grants. He said he could not comment
on whether NIH is seeking to terminate him. The Geriatric Psychiatry Branch
no longer exists, Ralbovsky said.

Sunderland's first hearing is scheduled for Friday morning in U.S. District
Court in Baltimore.

Both the size of the payments and the transfer of human tissue made
Sunderland's one of the most infamous examples of apparently lax oversight
at the health institutes. Congressional investigators found that 44
researchers had off-the-books relationships with drug and biotech companies.

"I found this story incredibly distressing because it is so important that
people have confidence in the NIH," Rep. Tammy Baldwin (D-Wis.), who heard
testimony about Sunderland at a subcommittee hearing this summer, said
yesterday. "It is a pretty big move for people to donate human tissue to
further scientific discovery. People have to have confidence that that
decision . . . is treated with the utmost respect."

Charging documents filed yesterday by the Maryland U.S. attorney's office
say Sunderland's involvement with Pfizer began less than a year after he
became head of the branch in 1997.

The charging document provides this account:

In 1998, the institute, Pfizer and another company had agreed to work
together on a project to find "biomarkers" of Alzheimer's in samples of
cerebrospinal fluid provided by the government. Then, Sunderland signed his
own side agreement: He would be paid $25,000 a year for consulting with
Pfizer, plus a $2,500 fee every time he attended one-day meetings with the
company.

The same year, a similar arrangement was set up when NIMH and Pfizer agreed
to collaborate on a study of two "biomarkers" that were already believed to
help identify Alzheimer's cases. Sunderland made his own deal, again without
disclosing it to his bosses, to receive another $25,000 per year,
prosecutors alleged.

In total, prosecutors said, Sunderland was paid $285,000, plus travel
expenses. Though congressional investigators had previously said he had also
violated rules by transferring the tissue samples, Sunderland was not
charged with that yesterday.
~~~~~~~~~~~

 
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