'Serious Misconduct' by NIH Expert Found
Scientist Did Not Report Sending Tissues to Drug Firm and Getting Paid, Report Says
By Rick Weiss, Washington Post Staff Writer
Wednesday, June 14, 2006; A06

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A world-renowned Alzheimer's disease researcher at the National Institutes of Health took advantage of the agency's lax oversight by improperly forwarding valuable tissue specimens to a pharmaceutical company and then accepting hundreds of thousands of dollars in consulting fees from it, according to congressional investigators.

Trey Sunderland, chief of the geriatric psychiatry branch at the National Institute of Mental Health, failed to tell agency officials about his arrangement with the drug giant Pfizer Inc., as required by federal rules, the investigators concluded in a 27-page preliminary report released yesterday.

Sunderland also did not properly disclose arrangements with another company, said the report, which found no wrongdoing by the drug companies. And though the NIH has not released the findings of its own investigation, the House report said the agency has concluded that Sunderland committed "serious misconduct, in violation of HHS ethics rules and federal law and regulation."

"I wish we were holding this hearing to congratulate him on some great discovery," said Rep. Joe Barton (R-Tex.), chairman of the Committee on Energy and Commerce, at a hearing yesterday of the oversight and investigations subcommittee. "Instead, we're going to have to discuss how he used his position to use NIH spinal fluid samples to further his own undisclosed personal consulting."

Sunderland, who has been subpoenaed to testify at a follow-up hearing today, has conceded that some disclosures were not properly filed -- in part, he has said, because of paperwork errors by office staff members.

"There was no effort to conceal this in any way," Sunderland's Washington attorney, Robert F. Muse, said yesterday, adding that "his failure to file was not unusual."

Until the NIH recently strengthened its conflict-of-interest rules, Muse said, many NIH doctors saw the requirements to disclose outside consulting as "basically a bureaucratic nuisance." They let their superiors know what they were up to through other channels, Muse said.

Several researchers linked to such failings have avoided closer scrutiny by leaving the NIH in the past two years. But Sunderland's request to retire has been denied -- an option the agency had because, unlike most NIH scientists, he is part of the commissioned corps, one of the nation's seven uniformed services.

Muse said that the denial is evidence that he is being made a scapegoat.

The congressional report builds on findings of conflict of interest among NIH researchers in 2004 and 2005, which led Director Elias A. Zerhouni to institute restrictions last year on drug company consulting and other outside activities by NIH employees.

The new focus is on blood and other tissue samples collected by NIH scientists for clinical research, and on the NIH's alleged lack of an inventory system or clear policies to ensure that those federally owned samples are used only for the purposes for which they were donated.

"It's important to remember that each of these samples originated in a person . . . that chose to make a gift so research could progress," Rep. Tammy Baldwin (D-Wis.) said at yesterday's hearing. "What is most shocking to me is the carelessness in the way in which some at NIH seem to be treating such a precious commodity."

At the heart of the investigation is Sunderland's use of spinal fluid collected in the early 1990s by an NIMH scientist, Susan Molchan, who later left the institute. When Molchan -- who once filed sex discrimination charges against Sunderland that were unsuccessful -- sought to resume her research in a different lab in 2004, she learned that many of her 10- to 15-year-old samples, which she hoped to retrieve, were no longer in the NIMH's freezers.

Acting on a complaint from her, House investigators found that Sunderland had sent thousands of specimens -- including some of Molchan's -- to Pfizer under an agreement not approved by NIH officials. Pfizer used the samples in its search for biological markers of Alzheimer's progression, which could have led to a potentially lucrative test. Sunderland ultimately received at least $285,000 in consulting fees for work relating to the specimens, investigators said, as well as more than $300,000 for giving talks and other activities.

"In sum, the records and interviews conducted in this investigation raise serious questions of misconduct in connection with, and inadequate oversight and control over, human tissue samples" at the NIH, the report concluded.

NIH spokesman John Burklow said the agency is "evaluating the process of material transfer out of NIH and will be clarifying current rules." Under the clarifications, he said, "all transfers of human samples will require an appropriate agreement signed off by a senior official."

The NIH's Office of Human Subjects Research in January also revised its guidance on the use of stored tissue samples. The new language requires careful tracking of all specimens and documentation of their fate.

© 2006 The Washington Post Company

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

NIH Under Fire: Longtime Favorite of Congress - Wash Post / WSJ
Sun, 27 Jun 2004

Under fire from Congress with evidence of NIH staff engaging in secret outside contracts and consultancies, NIH Director, Dr. Elias Zerhouni, turned a corner. He acknowledged the problem at a hearing (June 22) of the House oversight subcommittee of the Energy and Commerce Committee, and issued a series of reforms to bring NIH researchers in line with government guidelines on outside activities and remuneration. His predecessor, Dr. Harold Varmus, had waived conflicts of interest guidelines, apparently believing that scientists have special entitlements and are less given to greed and temptation than other mortals.

The Congressional probe was prompted by an investigative report by David Willman of the Los Angeles Times (December 7, 2003), who uncovered conflicts of interest of unprecedented magnitude among 94% of the highest paid scientist at institutes of the NIH. The article also uncovered abuse of patients in clinical trials.

The Washington Post reports about an example uncovered by the House subcommittee investigation of a high NIH official who received secret fees: "drug giant Pfizer Inc. reported that Trey Sunderland, a researcher at the National Institute of Mental Health, was paid $517,000 in fees, honoraria and expense reimbursements related to consulting arrangements with the company over the past five years. Greenwood said the information was not on Sunderland's financial disclosure reports as required by federal ethics rules. An NIH official said Sunderland was traveling abroad and could not be contacted."

Given the scope of the violations throughout NIH, it is doubtful that Trey Sunderland is the only official at the NIMH who was involved in secret financial deals with pharmaceutical companies. The Alliance for Human Research Protection (AHRP) is concerned about recent revelations involving concealed evidence of attempted suicides by teens in antidepressant drug trials, and the role of NIMH in that concealment. AHRP has twice submitted written letters of concern to Dr. Thomas Insel, director of the NIMH (copies to Dr. Zerhouni) questioning NIMH's role in the concealment of adverse clinical trial data (April 30 and on June 23, 2004).

AHRP discovered in FDA documents that at least two teenagers enrolled in an NIMH-sponsored Prozac trial, attempted suicide. The published report of that trial failed to disclose any suicide attempts. Additionally, AHRP discovered in FDA's medical review, that this taxpayer funded trial was "part of (Eli Lilly's) pediatric development program for fluoxetine" to gain FDA approval for children. See: Food and Drug Administration (FDA). Center for Drug Evaluation and Research (CDER). June 25, 2001. Application number 18-936/SE5-064. Medical Review by Andrew Mosholder, MD. Posted on FDA's website Sept. 25, 2003: http://www.fda.gov/cder/approval/index.htm

We believe these revelations suggest the need for a thorough investigation of NIMH officials' financial ties to drug companies--and the agency's possible misappropriation of public funds. The Wall Street Journal reports that lobbyists from academia and elsewhere sense the chilly new atmosphere toward NIH. There is "NIH fatigue" on Capitol Hill, one lobbyist says, and "lots of pushback" from once-friendly members of Congress and their staffs."

Oddly, The New York Times has not seen fit to report about the corrupt practices that have tainted NIH's credibility. Yet, the Times does report on its front page about the pervasive corrupting influence of the pharmaceutical industry on individual physicians who accept $10,000 kick-backs. See: As Doctors Write Prescriptions, Drug Company Writes a Check, By Gardiner Harris http://www.nytimes.com/2004/06/27/business/27DRUG.final.html?hp

The most damaging corrupting influence of the pharmaceutical industry on the culture of medicine and the safety of prescription drugs, is its influence on science and scientists at elite medical research institutions. If scientists at prestigious institutions get away with concealed financial deals with companies whose products they proclaim to be "safe and effective" by reporting partial data, why would anyone expect ordinary physicians who are under pressure from HMOs to be less susceptible to pharmaceutical company bribes and kickbacks?

Contact: Vera Hassner Sharav
Tel: 212-595-8974

Washington Post
NIH Scientists Broke Rules, Panel Says
Deals With Companies Went Unreported, Probe of Potential Conflicts of Interest Finds
By Rick Weiss, Wednesday, June 23, 2004; Page A19

Researchers at the National Institutes of Health violated federal rules by engaging in lucrative collaborations with pharmaceutical and biotechnology companies and not reporting those arrangements to ethics officials as required, according to documents released yesterday as part of an escalating congressional investigation into conflicts of interest at the agency.

The House oversight subcommittee had already identified several instances in which scientists engaged in outside activities that posed at least the appearance of a conflict of interest. But in those cases the arrangements had been approved by top legal and ethics officials. Now, NIH officials said, disciplinary actions may be needed.

Testimony yesterday also provided evidence that Lance A. Liotta, a researcher at the National Cancer Institute, continued to receive thousands of dollars in compensation from one such business arrangement through May, despite his testimony under oath last month that he had suspended the collaboration months before.

The subcommittee said Liotta and others used their government computer systems to exchange e-mails relating to their private consultancies, supporting some lawmakers' contention that some government scientists have been illegally using federal resources for personal gain.

It remains to be seen how many of the subcommittee's allegations will stand up to closer scrutiny as bona fide breaches of ethics rules. Many details of the cases were still missing as of yesterday, and key individuals could not be reached to comment after the hard-hitting six-hour hearing came to a close.

But having learned of some of the new findings late last week, NIH Director Elias A. Zerhouni came before the subcommittee yesterday with proposed revisions to NIH ethics rules more severe than those he had recommended a month earlier. "I have reached the conclusion that drastic changes are needed," he said.

The new allegations emerged as part of the panel's expanding investigation into government employees' consulting deals with private companies. Although House members began by focusing on NIH, where top scientists' spare time is in great demand by drug companies wishing to capitalize on their expertise, they widened their probe last week to include 15 other federal agencies. In letters sent to agency heads, the subcommittee chairman, James C. Greenwood (R-Pa.), and House Energy and Commerce Committee Chairman Joe Barton (R-Tex.) asked that records of all such collaborations be provided to them by July 2.

Yesterday's surprise disclosure that many NIH scientists may be engaging in outside deals without the required agency reviews and approvals grew from inquiries Greenwood made to 20 pharmaceutical companies. Given the lack of a centralized NIH database of all agency scientists' outside collaborations, Greenwood went directly to the companies, asking them to reveal all the arrangements they had. Of the 264 arrangements the companies reported, Greenwood said, "about 100" were apparently unknown to NIH officials. That sampling has Congress wondering, "What else is out there?," said Rep. John D. Dingell (D-Mich.).

In one example detailed by Greenwood, drug giant Pfizer Inc. reported that Trey Sunderland, a researcher at the National Institute of Mental Health, was paid $517,000 in fees, honoraria and expense reimbursements related to consulting arrangements with the company over the past five years. Greenwood said the information was not on Sunderland's financial disclosure reports as required by federal ethics rules.

An NIH official said Sunderland was traveling abroad and could not be contacted. In another highlighted arrangement, Alan Moshell of the National Institute of Arthritis and Musculoskeletal and Skin Diseases was retained as an expert witness in several private product-liability lawsuits involving the drug Accutane at a rate of $600 per hour -- and did so without required agency permission -- Greenwood said. Those arrangements were described by Health and Human Services general counsel Alex M. Azar II as particularly worrisome as Moshell allegedly testified in those trials to the inadequacy of the government's own warning label on the drug.

Moshell did not respond to calls and an e-mail late yesterday. The subcommittee also provided new details regarding an alleged conflict of interest outlined in a May hearing, in which cancer researcher Liotta and an FDA scientist became paid consultants for a California biotechnology company that is in competition with a Bethesda company with which the two scientists and the Cancer Institute were already collaborating. Liotta testified last month that by March of this year he had suspended the California arrangement, pending a fresh ethics review by agency officials who initially approved the deal but later expressed regret at having done so.

Yesterday, Greenwood flashed on a giant screen copies of several canceled checks from the company -- Biospect Inc. of South San Francisco, recently renamed Predicant Biosciences -- made out to Liotta. The latest check, for $3,125, was dated May 1. Greenwood also showed evidence supplied by the company that it had paid Liotta a total of $70,000, significantly more than the approximately $49,000 that Liotta reported to ethics officials.

A cancer institute spokesman said yesterday that Liotta had an appointment and would not be able to respond to media queries.

Zerhouni has already imposed new tiers of ethics review for all proposed outside consulting arrangements by NIH employees and greater public disclosure of approved arrangements. Yesterday, he proposed additional restrictions, including some that could be accomplished internally and others that may require new legislation.

Among them: a ban on ownership of drug company or biotech stocks by some key employees, and restricted stock ownership for all other employees; no membership on corporate boards; creation of a centralized registry of all outside arrangements and a public list of the awards that employees may receive; and prohibition of all paid consulting or speaking engagements at institutions that receive NIH funding.

The Wall Street Journal
Bernard Wysocki Jr., National Institutes of Health Is Under Fire;
Longtime Favorite of Congress Grapples With Slim Funding Increases, Conflicts Inquiry
Wall Street Journal, Jun 22, 2004 p. A.4

Washington -- THE NATIONAL INSTITUTES of Health, long a sacred cow in Washington, is coming under fire from the very Congress that once showered it with funds. After doubling its annual budget to $28 billion in the past five years, Congress has given NIH tiny increases this year, as large fiscal deficits force budget tightening. Meanwhile, lawmakers are pressing agency officials to explain how they spend all the money -- and why there isn't more bang for these bucks.

More ominously for the agency, congressional investigators have launched a high-profile probe into the outside activities of NIH scientists, many of whom already enjoy special exemptions from civil- service salaries and command salaries of as much as $200,000 a year. The congressional probe is delving into potential conflicts of interest within NIH, following disclosures that scores of NIH scientists enjoy lucrative consulting relationships, often with pharmaceutical and biotechnology companies.

A House subcommittee will hold the third in a series of hearings on these sometimes-lucrative outside activities today. Lawmakers are expected to make public a list of 122 awards and prizes given to NIH scientists and administrators since 1999, totaling about $575,000. In 34 cases, the House documents show, the money came from universities and other institutions that get NIH grants, creating at least the appearance of impropriety in some cases, House investigators say.

It is an unusual battering for NIH, whose 27 component institutes and centers have long been admired as the crown jewel of America's biomedical research effort. Several steps taken by Elias Zerhouni, the director of NIH since 2002, to put some restrictions on outside activities have failed to mollify lawmakers.

"When people get awards from a grantee, there's at least the appearance of conflict of interest," says Rep. Jim Greenwood (R., Pa.) chairman of the House subcommittee. He said Dr. Zerhouni is expected to come before the panel today and make proposals covering awards and outside consulting. "In the main, they are pretty darn good."

Some committee members have openly scoffed at the recommendations of a blue-ribbon commission appointed by the 53-year-old NIH director. This clearly caught Dr. Zerhouni, a former senior administrator at Johns Hopkins University in Baltimore, off guard, since he believes the blue-ribbon panel recommended "draconian" steps, including limiting the size of consulting fees from industry and banning outside consulting activity by high-ranking NIH officials.

NIH is in the spotlight for more than the conflict-of-interest investigations. The huge increase in funding has prompted legislators to demand high-profile results against diseases. The impatience crops up repeatedly, as members of Congress often emphasize to NIH officials that its vast research should ultimately translate into treatment for diseases.

Further denting its image, lawmakers are using the NIH as a springboard into a wider investigation of ethics in government. Friday, the House Energy and Commerce Committee expanded the conflict- of-interest inquiry beyond NIH to 15 federal agencies. "Our goal is to learn whether the practices we have uncovered at NIH also exist in other agencies," Rep. Joe Barton (R., Texas) the committee chairman, said Friday. Dr. Zerhouni in a recent interview said he had grave misgivings about a complete ban on outside activities, particularly on payments for writing and speaking. "If that's under attack," he said, "then we have a real issue."

The NIH guidelines on outside activities were loosened by Dr. Zerhouni's predecessor, Harold Varmus, in 1995, when, Dr. Varmus says, NIH was having trouble recruiting top private-sector talent. Dr. Varmus, now president of Memorial Sloan-Kettering Cancer Center in New York, says a new NIH vaccine center couldn't have recruited 10 top scientists recently without the enticements of high pay and outside income.

Gary Nabel, director of the vaccine center, says 80% of these critical subordinates do outside speaking and writing, and about half do outside industry consulting for pay. Dr. Nabel himself has consulted on gene therapy in cardiovascular disease. It is an area of expertise that he says doesn't conflict with his current job, which is to oversee development of vaccines for the AIDS, Ebola and other viruses. Dr. Nabel says he hasn't had any turnover among the top people recruited over the past five years. However, he says, if a ban on all outside activity is imposed, "the most talented people" would be tempted to leave NIH.

Several members of the House subcommittee investigating NIH remain skeptical. Rep. Diana DeGette (D., Colo.), has repeatedly questioned Dr. Zerhouni about the need for outside compensation by scientists in the civil service. She says she understands why interaction is important but doesn't see the need for extra pay. While she hasn't made up her mind on the issue for NIH scientists, Rep. DeGette says, "I think it's very difficult to enforce conflict-of-interest rules without an outright ban."

One target of the probe by Congress is Richard Klausner, former director of the National Cancer Institute. In 2002, shortly after he stepped down, the cancer institute awarded a $40 million contract to Harvard University for drug-discovery research. The lead scientist at Harvard later formed a private company, made Dr. Klausner an officer and awarded him stock in the enterprise. Dr. Klausner says he didn't have any role in awarding the Harvard contract and joined with the private company only after leaving government service. Currently, Dr. Klausner is a senior official at the Bill & Melinda Gates Foundation, which funds infectious-disease research.

In a separate case, several members of Congress lashed into two officials, one of NIH, the other of the Food and Drug Administration, who worked together in their official capacities with one biotech company while moonlighting for a competitor. Both officials stopped the moonlighting, after protests. More witnesses are expected to come before the House panel this morning.

The agency's growing budget has brought it a different kind of scrutiny. Some legislators see it as never satisfied. Sen. Pete Domenici (R., N.M.) raised eyebrows this spring when he said NIH has "turned into pigs." A recent study by the Rand Corp., the California think tank, found that nearly half of the federal research and development budget is going to medical schools.

Lobbyists from academia and elsewhere sense the chilly new atmosphere toward NIH. There is "NIH fatigue" on Capitol Hill, one lobbyist says, and "lots of pushback" from once-friendly members of Congress and their staffs.

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