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THE NATION

NIH Seeks Outside Inquiry of Scientist

Agency ethics officials target an Alzheimer's researcher who accepted
more than $500,000 from a drug company and did not report it.

By David Willman
Times Staff Writer

January 28, 2005

WASHINGTON - Ethics specialists at the National Institutes of Health
have requested an outside investigation of an Alzheimer's disease
researcher who accepted more than $500,000 from a drug company without
seeking permission or reporting the income to the agency as required,
according to government officials familiar with the matter.

In response, the investigations unit of the inspector general's office
at the Department of Health and Human Services has opened an inquiry
into the researcher, Dr. P. Trey Sunderland III, the officials said.

Among the circumstances being investigated is whether Sunderland's
conduct violated federal conflict-of-interest law, they said.

The inspector general's office is empowered to subpoena documents and
to question witnesses. It also may refer a matter for criminal
prosecution to a local U.S. attorney's office or to the Justice
Department.

Based on interviews and public records, the Los Angeles Times reported
last month that Sunderland's paid services for Pfizer Inc. often
overlapped with his government role. For instance, at the same time
that Sunderland accepted consulting and speaking fees from Pfizer, he
led a study of Alzheimer's patients in which the company collaborated.

In the spring of 1998, Sunderland's NIH staff began providing the
company with samples of spinal fluid that the government employees
collected from elderly patients who had visited the agency's research
hospital in Bethesda, Md. The research collaboration with Pfizer
spanned about five years.

Sunderland, 53, has focused at the NIH on finding ways to detect
Alzheimer's disease before a patient develops pronounced symptoms. And
Pfizer, along with a corporate partner, Eisai Inc., stands to gain
billions of dollars in sales from the early-stage treatment of
Alzheimer's.

The Times article last month reported that Sunderland also was a paid
consultant to Eisai in recent years, according to information recently
provided to the NIH by his attorney. The two companies jointly market a
drug called Aricept, which is approved for treating the symptoms of
mild to moderate Alzheimer's. The once-a-day pill generated worldwide
sales of $1.6 billion in 2003, making it the top-selling Alzheimer's
drug.

Sunderland endorsed the use of Aricept during a televised presentation
at the NIH in September 2003. Viewers of the event, broadcast by
C-SPAN, had no way of knowing about Sunderland's affiliation with
Pfizer or with Eisai.

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.

Investigators are now examining whether Sunderland used vacation hours
for all of his private appearances or whether he spoke for Pfizer while
on government time, according to officials familiar with the inspector
general's probe.

Sunderland's attorney, Robert F. Muse, declined to comment for this
article. In a letter last month to the director of the NIH ethics
office, Muse said Sunderland had not tried to hide his dealings with
Pfizer or other companies.

"Dr. Sunderland has committed no unethical acts," Muse wrote. "His
failures have been in the context of not keeping and filing proper
paperwork."

Throughout the NIH, Muse wrote, the monitoring of financial
relationships between the government scientists and their outside
employers has been characterized by "indifference, lack of enforcement
and administrative shortcomings."

Internal NIH e-mails show that Sunderland was aware of agency
conflict-of-interest rules that could ban him from taking consulting
fees from a company, like Pfizer, that maintained a formal research
agreement with the NIH.

In e-mail exchanges in March 1999 that had not previously been made
public, an NIH ethics officer, Olga Boikess, asked Sunderland about a
lecture that he had delivered at a psychiatric conference. On March 23,
1999, Sunderland replied:

"I can tell you that I have no CRADAs or MTAs with any European
pharmaceutical company, so there should be no possible conflict of
interest."

CRADA is shorthand for "cooperative research and development
agreement." An MTA is a material transfer agreement, an arrangement to
exchange proprietary material or information.

In 1998, Sunderland's NIH staff had begun providing Pfizer with samples
of the spinal fluids under terms of a material transfer agreement.
Pfizer pledged to provide analyses of the samples.

Starting that year, and continuing through 2003, Pfizer paid Sunderland
consulting and speaking fees totaling $508,050, records reviewed by The
Times show. Related documents describe how Sunderland received fees
from Pfizer as recently as June 3, 2004.

The NIH over the last decade has allowed employees who seek advance
approval to enter into a wide variety of paid positions with
pharmaceutical and biotechnology companies. However, NIH policies have
consistently forbidden its scientists from accepting income from a
company that is collaborating with their government laboratory.

Ethics specialists under the director of the NIH, Dr. Elias A.
Zerhouni, requested the inspector general's investigation of
Sunderland, according to the officials familiar with the matter, who
spoke on condition of anonymity. A deputy NIH director assigned by
Zerhouni to oversee ethics matters, Dr. Raynard S. Kington, has said
that he is not at liberty to discuss the specifics of any internal
review or investigation.

However, an in-house newsletter at the NIH this month, paraphrasing
Kington, said agency officials were "investigating every case that has
come to light of inappropriate outside activities at NIH." The
newsletter quoted Kington as saying that "fairly soon, we'll enter the
penalty phase of these investigations.... Some employees have
substantially violated rules and regulations."

It has been nearly 13 years since an NIH scientist was prosecuted and
convicted for an offense related to a conflict of interest. The
scientist, Prem S. Sarin, repaid $25,000 to a German pharmaceutical
company involved with AIDS research. A federal judge also sentenced him
to two months of community service. He had faced a maximum sentence of
about 20 years in federal prison, said his lawyer, W. Neil Eggleston.

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Copyright 2005 Los Angeles Times

I did not see anything that prevents a scientist from the "revolving door
scam" in which private sector scientist leave their job and go to work for
the government and then after working long enough to gain career status
(three years, I belive) go back to the private sector.  After a short time,
with the private sector they can then go back to work for the government.
This can happen over and over again.  It has happened at the FDA and my
guess is that it has / is happening at NIH.  Sort of like the fox having a
key to the hen house with unlimited visiting authority.

BTW, the NIH principal investigator for the Statin Study, Dr. Golomb,
accepts absolutely
nothing from the pharm cos - not even the statins for the study.  There are
ethical NIH investigators.

Now that the NIH is changing their ethics policy, there will be more.