NIH Plans to Improve Monitoring of Human Tissue Samples

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.

The samples are increasingly used to make medical discoveries that improve patient care, but investigators with the House Energy and Commerce Committee say a researcher shared thousands of tissue samples with drug maker Pfizer Inc. and appears to have netted at least $285,000 from work associated with that transfer.

Lawmakers on the committee have been highly critical of the arrangement and held two days of hearings that were continuing Wednesday.

"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.

An agency 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.

"We agree we need to improve the tracking of tissue samples," Burklow said. "We are in the process of determining the best way of doing that now."

The committee's investigation focuses on Dr. Trey Sunderland, chief of the geriatric psychiatry branch at the National Institute of Mental Health and an expert on Alzheimer's disease.

His 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 without taking leave. There has been no resolution of that referral.

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.

Sunderland's attorney, Robert 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.

The committee said Sunderland was not authorized to transfer the tissue under the agreement.

But Muse said the agreement permitted spinal tap fluids to go to Pfizer.

"It didn't compromise any research activities. Other groups received this, and sharing it was viewed as a benefit to research being done at NIH. That's why they permitted it."

NIH officials will testify on Wednesday before the Energy and Commerce subcommittee, and Sunderland has also been called to testify.