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CASE STUDY | DR. P. TREY SUNDERLAND III
$508,050 From Pfizer, but No 'Outside Positions to Note

By David Willman
Times Staff Writer

December 22, 2004

BETHESDA, Md. — While reviewing financial disclosure reports from
scientists at the National Institutes of Health, ethics officer Olga
Boikess noticed that Dr. P. Trey Sunderland III had not declared any
jobs with industry.

In an e-mail sent in March 2000, Boikess told Sunderland: "You did not
list any outside positions."

Sunderland, a leading NIH psychiatric researcher, replied: "I do not
have any outside positions to note."

In fact, Sunderland had been paid $77,000 in consulting and speaking
fees the previous year by Pfizer Inc., now the world's biggest drug
company, according to company documents. Between 1998 and 2003, Pfizer
paid him $508,050. He did not seek approval to work for Pfizer, and he
did not report any of the income to the NIH, as required by agency
rules.

Pfizer's payments to Sunderland and his failure to follow the NIH's
reporting requirements were described at a congressional subcommittee
hearing in June.

Subsequent interviews and government and company documents examined by
the Los Angeles Times — including the e-mail exchange with the ethics
officer — show that Sunderland's paid efforts for Pfizer often
overlapped with his NIH role.

Sunderland took the fees from Pfizer at the same time that he led an
NIH study of Alzheimer's patients in which the company collaborated.

He also endorsed use of Aricept, Pfizer's drug for Alzheimer's, during
a televised presentation at the NIH in 2003. Sunderland did not tell
the audience about his affiliation with the company.

Sunderland, 53, is one of the nation's leading researchers on
Alzheimer's, the malady that causes dementia in approximately 10% of
people over age 65.

He joined the NIH in 1982 after earning an undergraduate degree at
Harvard University and a medical degree at George Washington
University. As chief of the geriatric psychiatry branch at the
agency's National Institute of Mental Health, he has focused on
finding ways to detect the disease before a patient develops
pronounced symptoms.

Pfizer, along with a corporate partner, Eisai Inc. of Japan, stands to
gain billions of dollars in sales from early stage treatment of
Alzheimer's. The companies jointly market 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 last year,
making it the top-selling Alzheimer's drug.

Sunderland also consulted for Eisai from 1999 to 2003, according to
information newly provided to the NIH by Sunderland's attorney.
Sunderland's income from Eisai was not reflected in documents that the
NIH turned over to Congress this year.

Government and company documents show that Sunderland teamed up with
Pfizer in both his government and his private roles beginning in 1998.
He worked for the company as a paid consultant — and at the same time
led his NIH laboratory in an official research collaboration with
Pfizer.

While the NIH allows many forms of moonlighting, the agency forbids
its scientists from accepting income from a company that is
collaborating with their government laboratory.

The policy seeks to protect the independence of the labs and is
consistent with federal law, which prohibits employees from being paid
by an outside party for performing government work.

The results of the NIH-Pfizer collaboration, announced in April 2003,
underscored the promise of early detection of Alzheimer's. An NIH news
release quoted Sunderland, who said such diagnoses "could point to new
possibilities for preventive" drugs.

The news release did not mention that Sunderland was a paid consultant
to Pfizer.

Investigators at the NIH director's office are assessing whether to
refer Sunderland's conduct to the inspector general at the Department
of Health and Human Services, documents show.

Sunderland declined to answer questions submitted to him for this
article.

Sunderland's attorney, Robert F. Muse, said in recent letters to the
NIH that his client had not intentionally ignored any rules.

"Dr. Sunderland deeply regrets that he did not pay more attention to
the forms that are now the subject of this review," Muse wrote. "But
this lack of attention to outside activity reporting does not justify
an inference that he was hiding his outside activities or that a
conflict of interest existed."

Sunderland began his research of Alzheimer's in the early 1980s by
studying elderly patients who were recruited to the NIH Clinical
Center, the world's largest facility for experimental medical
treatment.

Several times a year, the patients returned to have their spinal
columns tapped for samples of fluid. Sunderland and his staff would
examine the samples for biological "markers" that might provide clues
for selecting new treatments. By the late 1990s, Sunderland had
collected samples from about 600 spinal taps.

In spring 1998, Pfizer joined the NIH in a formal research
collaboration. The "material transfer agreement" called for
Sunderland's staff to provide samples of the spinal fluid to Pfizer.
The company in turn would share its analyses of the materials with the
NIH.

Sunderland already was on Pfizer's payroll as a consultant, according
to company and government records.

Within months, the company assigned Sunderland research that even more
directly overlapped his government responsibilities. He was "to assist
Pfizer in its program to study known markers of Alzheimer's disease,"
the records show.

Sunderland has repeatedly encouraged the use of Aricept and other
drugs in its chemical class. At a number of points, he did not
acknowledge his role with Pfizer, records show.

In 1998, he wrote two medical journal articles praising Aricept, which
Pfizer and Eisai had just begun marketing to doctors in the U.S.

In one article, Sunderland wrote that Pfizer's drug "appears to be
less toxic and better tolerated" than a competing medication. Using
either Aricept or tacrine, he wrote, "provides modest significant
symptomatic improvement in patients with mild to moderate Alzheimer's
disease."

Neither article disclosed to its physician readers that Sunderland was
a paid consultant to Pfizer. Sunderland's attorney has told the NIH
that his client often acknowledged his affiliation with Pfizer when
addressing physicians.

On April 15, 1999, Sunderland and one of Pfizer's chief researchers
spoke together at an NIH conference, where an array of researchers,
industry executives and federal regulators came to discuss new ways to
develop drugs.

Sunderland's counterpart from Pfizer underscored the special value to
the company of gaining access to the extensive spinal samples drawn at
the NIH.

"I want to emphasize," said B. Michael Silber, Pfizer's director of
genetics research, "that the beauty of what we're able to do as a
partnership has really evolved because of Dr. Sunderland's ability to
attract the kinds of patients to be followed in [long-term] studies …
and who are granting us the permission to be able to take samples from
them."

Silber called the then-ongoing project with the NIH "a very exciting
collaboration" that, if successful, would help Pfizer to decide which
drugs to push toward "expedited review and approval."

Sunderland did not tell the crowd that he was a paid consultant to
Pfizer.

From 2001 to February of this year, Pfizer also paid consulting fees
totaling about $64,500 to one of Sunderland's NIH staff,
biostatistician Karen T. Putnam. Her attorney, David Schertler, said
that based on a conversation with Sunderland, Putnam chose not to seek
approval from the NIH to consult for Pfizer.

During recent questioning by NIH investigators, Sunderland said that
he did not recall advising Putnam, according to a summary of the
interview.

Sunderland was often on the road for Pfizer. From 1999 to June of this
year, he appeared as a speaker for Pfizer at more than 80 domestic and
international gatherings of doctors, documents show.

In July 2003, Sunderland also was coauthor of a report that urged the
government and insurers to pay for more prescriptions for seniors with
mood disorders, including Alzheimer's. Three coauthors of the report,
published in Archives of General Psychiatry, listed their financial
ties to Pfizer. Sunderland did not.

Pfizer and nine other drug companies helped pay for preparation of the
report.

On Sept. 16, 2003, Sunderland delivered a public lecture at the NIH,
"Alzheimer's Disease: Advances and Hope," during which he summarized
his long-term work with the spinal fluids. The session was broadcast
several times by C-SPAN.

A member of the audience asked Sunderland if he would object to a
patient taking Aricept in combination with vitamin E "as an attempt at
preventing or delaying possible onset of Alzheimer's."

Sunderland replied: "The quick answer is no. I have no problem with
it." In fact, he said, "we're advocating" use of multiple medications
simultaneously.

Again, Sunderland did not tell the audience about his paid role with
Pfizer.

Sunderland also did not note that his comment on using Aricept for
prevention exceeded the purpose for which the Food and Drug
Administration approved the drug: treating symptoms of mild to
moderate Alzheimer's.

Aricept and other drugs in its chemical class increase levels in the
brain of a chemical that nerves use to communicate with one another.
The drugs have not been proven to prevent or slow or halt the advance
of Alzheimer's. On the other hand, doctors are permitted to prescribe
drugs for any medical purpose they deem appropriate.

Dr. Russell Katz, who supervises the FDA's reviews of drugs for
Alzheimer's, said in an agency newsletter last year that the compounds
in Aricept's chemical class had "an effect on symptoms." But Katz
added that the FDA had "no evidence that they have any effect on the
underlying progression of the disease. During treatment, as far as we
know, the nerve cells are still dying."

And there are side effects: At least 10% of patients who took Aricept
in clinical trials suffered nausea or diarrhea — about double the
rates of those given a placebo pill, according to Pfizer's data.

Muse, Sunderland's attorney, told the NIH in a letter this month that
his client had not encouraged use of any Pfizer product "in an
unbalanced way." Muse also has presented materials to NIH
investigators showing times when his client acknowledged his ties to
Pfizer and other drug companies at formal presentations to physicians.

"Several NIH administrators," Muse said in a letter to the agency on
Aug. 31, also had known about Sunderland's role with Pfizer.

"Trey Sunderland has brought honor and distinction to the National
Institutes of Health," Muse wrote. "His reputation with colleagues
throughout the profession has been sterling. His leading role in the
effort to tackle Alzheimer's disease is well recognized both
nationally and internationally. His groundbreaking scientific work —
and his effective communication of that work in a language that
nonscientists can understand — represent the best that the NIH has to
offer."

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