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