"Will a criminal conviction for conflict of interest be enough to get someone fired from NIH?"  

The Associated Press, The Los Angeles Times, and The Washington Post report that "Dr. Trey
Sunderland, a leading expert on Alzheimer's disease at the National Institute of Mental Health"
is charged with criminal felony for contracting with Pfizer as a  paid consultant for work that
overlapped his duties as a public servant.

AP reports that: "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."

David Willman, of the LAT, whose original investigative report uncovered
the concealed conflicts of interest at the NIH, reminds readers that NIH had refused to
cooperate with lawmakers, so the House Energy and Commerce Committee requested
the information from 21 drug manufacturers whose  "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 DHHS  investigate it further.

What is particularly galling is that public servants who serve industry's interest while collecting
taxpayer salaries--officials who betray the public trust-- remain on the public payroll.
As Congressman john Dingell put it: "Will a criminal conviction for conflict
of interest be enough to get someone fired from NIH?"  

Contact: Vera Hassner Sharav
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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 felony 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
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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http://www.washingtonpost.com/wp-dyn/content/article/2006/12/04/AR2006120401292_pf.html

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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