June 14

Chief NIH Geriatric Psychiatrist Takes the Fifth Refusing toTestify about Tissues Sent to Pfizer

The House Energy and Commerce investigative report is an indictment of the NIH and its lack of any safeguards to protect the integrity of its scientific research. See the complete report on Dr. Sunderland who refused  to testify "about allegations that he profited from sharing human tissue samples with a drug company."  http://energycommerce.house.gov/108/home/staff%20report.pdf

Dr. Sunderland is accused of "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…[and that he] failed to tell agency officials about  his arrangement with the drug giant Pfizer Inc., [as well as another company] as required by federal rules."  

David Willman, Pulitzer Prize winner, of The Los Angeles Times-whose investigative series (2003) uncovered the unseemly culture of corruption at NIH–reports (below) that  an investigation by the House Energy and Commerce Committee concluded that Dr. Sunderland had pocketed more than $600,000 in fees from Pfizer Inc. "while providing the drug company with thousands of samples of spinal fluid drawn from patients who were studied for his government work."  

"The Committee staff estimated that, assuming a cost of $12,000 per research patient, it cost the government $6.45 million to collect the samples that Sunderland shipped to Pfizer."

Pleading the Fifth amendment harks back to the Senate Kefauver hearings on organized crime See: http://history.acusd.edu/gen/filmnotes/kefauver.html

The difference is Dr. Sunderland is a commissioned official of the Public Health Corps and the highest ranking-The Washington Post refers to him as "world renowned"-Alzheimer’s expert.

The culture of entitlement exhibited by NIH’s highest paid staff is a reflection of the arrogance and corruption currently permeating medical research. Industry’s influence-has reduced scientists to be lackeys of the drug industry-their services for sale to the highest bidder. These arrangements have tainted the very integrity of science-its  products and literature; it has undermined the trust between physicians and patient; has undermined the safety of patients in clinical trials, and debased medical practice whose  clinical practice guidelines are informed by fraudulent claims, not science.
See:  The National Institutes of Health: Public Servant or Private Marketer? LAT, December 2004

See also, LAT article, January 2005: https://ahrp.org/infomail/05/01/31.php

Oddly, The New York Times has not seen fit to waste ink on the corruption at the nation’s premier medical research institutes.

Contact: Vera Hassner Sharav
veracare@ahrp.org <mailto:veracare@ahrp.org>  
Associated Press
Researcher Mum in Human Tissue Hearing
By KEVIN FREKING , 06.14.2006, 01:53 PM

A senior government researcher asserted his Fifth Amendment rights Wednesday and refused to testify before Congress about allegations that he profited from sharing human tissue samples with a drug company.

"I respectfully decline to answer this question and any other questions based on my constitutional rights," Alzheimer’s disease expert Dr. Trey Sunderland said in response to the first question from members of a House subcommittee.

At the same hearing, the director of the National Institute of Mental Health told lawmakers he had recommended that Sunderland be fired.

Investigators with the House Energy and Commerce Committee say Sunderland shared thousands of human tissue samples with drug maker Pfizer Inc. and appears to have netted at least $285,000 from work associated with that transfer.

Lawmakers complained to the National Institutes of Health about its monitoring of tissue samples, which are increasingly used to make medical discoveries that improve patient care. NIH officials said they were planning steps to better account for where and how the samples are being used.

"Federal laws and policies do not permit NIH scientists to profit personally from their jobs and their patients by providing irreplaceable government assets," said Rep. Ed Whitfield, R-Ky, chairman of Energy and Commerce’s oversight and investigation subcommittee.

On the hearing’s second day, Sunderland was sworn in and then cited his right to avoid risking self-incrimination. A former colleague of his, Karen Putnam, did the same.

In a brief interview following the hearing, Sunderland said he submitted his resignation on Nov. 8, 2004, and has waited to leave since then.

"I really want to get through this and move on," Sunderland said. His attorney, Robert Muse, added: "NIH has held him captive."

Muse previously has said the scientist, who is chief of the geriatric psychiatry branch at the National Institute of Mental Health, followed NIH rules and took no money for providing the samples.

The director of the mental health institute, Dr. Thomas Insel, said he would have fired Sunderland but he did not have the authority because the scientist, though tasked to the institute, was employed by the public health Commissioned Corps.

Insel said he had recommended to the Commissioned Corps in November 2005 that Sunderland be terminated.

Earlier, an NIH spokesman, John Burklow, said the "specific consulting arrangements in question, had they been known to NIH, would not have been approved" under ethics regulations. He said collaborations among scientists that involve human tissue samples are common and essential, but there are
rules to protect the samples and to ensure there is consent about the use of the samples.

Sunderland’s outside work has prompted scrutiny from committee investigators before. About two years ago, the committee said Sunderland had received $517,000 since 1999 in consulting fees or expense reimbursements from Pfizer and that there was no record that he received prior approval for those activities or disclosed it in his financial report filings.

The NIH reviewed the case and tightened its rules for outside work arrangements. It also referred an allegation to Health and Human Services’ inspector general that Sunderland may have conducted outside activities during government work hours. There has been no resolution of that referral.

At the NIH, Insel said, it "is not good enough to be clean. It has to be Camelot. There can be no question of conflict of interest."

In the meantime, congressional investigators continued to probe Sunderland’s work with Pfizer on an Alzheimer’s drug. They concluded there were "reasonable grounds" to believe $285,000 of the $517,000 he received from Pfizer was for work derived from giving the drug company access to spinal
fluid samples and plasma samples.

Muse said his client "didn’t receive a dime for providing anything to Pfizer. He received fees for consulting as well as for lectures. These were known to NIH and they were permitted under NIH rules."

The transfer of spinal fluid samples was done under a 1998 material transfer agreement, or MTA, between the National Institute of Mental Health and Pfizer.

"We sought a partner who had knowledge, experience and access to samples that would make this project possible," former Pfizer employee David Friedman testified of the work on pinpointing proteins in the samples that could signal the advent of Alzheimer’s. He added that payments to Sunderland
were not in exchange for the samples.

Copyright 2006 Associated Press. All rights reserved.

NIH Researcher Gave Samples to Pfizer, Pocketed $600,000
By David Willman, Times Staff Writer
June 14, 2006

WASHINGTON – A senior Alzheimer’s disease researcher at the National Institutes of Health pocketed more than $600,000 in fees from Pfizer Inc. while providing the drug company with thousands of samples of spinal fluid drawn from patients who were studied for his government work, congressional investigators said in a report made public Tuesday.

The new details about the conduct of the scientist, Dr. P. Trey Sunderland III, drew bipartisan criticism from members of an investigative panel of the House Energy and Commerce Committee.

The House members said Sunderland’s conduct raised broad questions about how the NIH accounted for materials harvested from patients – materials that hold promise for finding cures or ways to better diagnose serious diseases.

Lax record-keeping regarding samples of human tissue leaves NIH laboratories "vulnerable to the risks of theft and abuse," said the committee chairman,
Rep. Joe L. Barton (R-Texas). "It would really be a shame if we find out that the National Institutes of Health has more control over its paper clips and trash cans than it has over its human tissue samples."

The committee’s senior Democrat, Rep. John D. Dingell of Michigan, said: "NIH lacks adequate controls for human tissue samples, human subject protection and the scientific conduct of many of its senior employees. Accountability must be restored to NIH’s own research programs."

Documents presented at a panel hearing Tuesday showed that from 1996 to 2004, Sunderland accepted consulting, speaking and advisory fees from Pfizer totaling about $612,000. The committee staff found that nearly half of the money, $285,000, was for his consulting related to the search for scientific clues in 3,245 samples taken from 538 patients who participated as volunteers at the NIH.

The committee staff estimated that, assuming a cost of $12,000 per research patient, it cost the government $6.45 million to collect the samples that
Sunderland shipped to Pfizer.

An attorney for Sunderland, Robert F. Muse, said Tuesday that his client "did not conceal his relationship with Pfizer." However, the committee staff noted that Sunderland did not obtain required written authorization from the NIH before he entered into paid arrangements with Pfizer and other drug companies.
The Los Angeles Times reported in January 2005 that, based on an internal review at the NIH, officials had referred Sunderland’s conduct for investigation by the inspector general of the U.S. Department of Health and Human Services.

The NIH last year banned all employees from accepting consulting fees or stock options from pharmaceutical and biotechnology companies.

A spokesman for the NIH, John Burklow, said Tuesday that officials could not discuss the Sunderland case because "it remains under investigation." But
Burklow said that even under the NIH’s earlier, more permissive ethics rules, federal employees were prohibited from outside arrangements that overlapped with their government work.

"It is important to note that the specific consulting arrangements in question, had they been known to NIH, would not have been approved under the present or previous ethics regulations," Burklow said, adding: "We share the committee’s concerns in regard to the ethical management of human tissue
samples and the development of rigorous and uniform policies to protect the public’s trust and interests."

Serious Misconduct’ by NIH Expert Found
Scientist Did Not Report Sending Tissues to Drug Firm and Getting Paid, Report Says
By Rick Weiss <http://projects.washingtonpost.com/staff/email/rick+weiss/>
Washington Post Staff Writer
Wednesday, June 14, 2006; Page A06

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.
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