Drug company link could hit biobank plans.
Revelations about the unauthorized transfer of tissue samples by a US neuroscientist are adding to the challenges faced by researchers who are attempting to set up biobanks — stores of human tissues that can be used to probe the causes of disease.
The latest problems stem from the case of Trey Sunderland, chief of the Geriatric Psychiatry Branch of the National Institute for Mental Health. He is accused of shipping more than 3,000 samples of human spinal fluid to the drug company Pfizer without approval from his employers.
A subcommittee of the US House Committee on Energy and Commerce, which is investigating the shipments, said on 13 June that Sunderland received $285,000 for the samples. This was part of more than $600,000 he received from the company between 1998 and 2004.
Sunderland invoked his right not to testify against himself at a 14 June hearing. His lawyer did not return phone calls seeking comment.
The allegations, which surfaced after a tip-off from a whistleblower in April last year, angered lawmakers. “What we have learned from this investigation is that the National Institutes of Health (NIH) lacks adequate controls for human tissue samples, human subject protection, and the scientific conduct of many of its senior employees,” says committee member John Dingell (Democrat, Michigan).
Such criticism worries researchers, because scientists are starting to use stored banks of tissue to link genetic, medical and personal health data. Iceland, Estonia and the United Kingdom are already developing national databases, and the United States is considering setting up a biobank containing information on hundreds of thousands of Americans (see Nature 429, 475–477; 2004). The NIH has already announced two specific projects linking genetic and environmental information on patients with conditions such as Alzheimer's disease.
Ethicists and scientists fear that reports of lax policies and misconduct will hurt such initiatives. “If there is a perception that the researcher is using the samples to line his or her pockets on the side, you're going to lose public support,” says Arthur Caplan, an ethicist at the University of Pennsylvania in Philadelphia. “There is nothing more corrosive to altruism than people making money off research.”
Scandals elsewhere have already had similar effects. In Britain, for example, scientists reported a drop in the donation of organs for research after a pathologist at Alder Hey Hospital in Liverpool was revealed to have illegally removed organs from the bodies of children on which he had conducted post-mortems (see Nature 409, 655; 200110.1038/35055696). The incident led to new human-tissue legislation in 2004 and the creation of the Human Tissue Authority, tasked with overseeing the handling of such samples.
In Sunderland's case, a lack of oversight is giving particular cause for concern. “A lot of this stuff was collected with pretty vague consent and rules,” says Caplan. “It's an issue and it's going to pop up again.” Michael Gottesman, NIH deputy director for intramural research, says the agency will clarify its policies on the storage and shipment of tissue samples and develop an electronic database for tracking patient samples in all of its 27 branches.
Such measures could help to restore confidence among potential donors. But biobank officials will have to tackle other issues if the initiatives are to succeed, such as questions about who ‘owns’ the information stored in tissue repositories. In April, for example, a US federal judge had to intervene in a dispute between patients, a researcher and the University of Washington in St Louis over a valuable tissue repository housed at the university (see Nature 440, 1102–1103; 2006).
There are also concerns about how investigators protect the privacy of patients who donate tissue, and how they give consent for future studies on these tissues. National laws differ on such matters, although several efforts are under way to devise uniform rules. “There's a real movement for harmonization across international barriers,” says Mark Sobel, executive officer of the American Society for Investigative Pathology. “I think by 2007 or 2008, we're really going to see some global acceptance for it.”