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Human Tissue Hearing. In response to congressional complaints about its monitoring of human tissue samples, the National Institutes of Health is planning steps to better account for where and how the samples are being used. A senior government researcher asserted his Fifth Amendment rights Wednesday and refused to testify before Congress about allegations that he profited […]
Human Tissue Hearing. In response to congressional complaints about its monitoring of human tissue samples, the National Institutes of Health is planning steps to better account for where and how the samples are being used.
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, 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.
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