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While the university contends that three scientists on the repository's gatekeeping committee evaluate proposals and decide who gets samples, Catalona is skeptical. His attorneys say he tried on several occasions to obtain samples by submitting written requests to Andriole, who had succeeded him as chief of urology. Responses, in the form of e-mails or notes, arrived after considerable delay, Piche says.
"If there is a committee, [Dr. Catalona] doesn't know who he's talking to," Piche says. "We actually think [Andriole] is the committee."
Andriole says he knows of no instance in which Catalona was denied access to samples he requested. He also says Catalona never waited very long before his requests were granted. "That's a very subjective thing," Andriole says. "Some people don't like to wait in line for five minutes at the bank."
Catalona's concerns go beyond asking permission and waiting for specimens. "These are samples that he's put together, and if you carve the best samples out and give them to somebody else, that interferes with what he's doing," Piche says.
While Andriole and Clayton say Catalona is welcome to use the tissue bank, as is any other researcher with a valid proposal, Piche says his client's work has been impeded by the dispute. "He, on a regular basis, gets requests to do extensions of his research with somebody else," Piche says. "All those kinds of things have been on hold."
The fight has also affected work at the National Cancer Institute in Maryland. The federal government's main cancer-research division returned 400 samples of frozen serum, a blood component, to Washington University after Catalona called federal researchers in June and told them they had no right to use the material.
Piche sees the return of the samples as evidence that the feds, who haven't officially weighed in on this fight, agree with his client. But Catalona may have more powerful friends than the federal government.
Five days before Catalona left Washington University for Northwestern, he sent new consent forms to every donor. The forms are brief and to the point: "Please release all my samples to Dr. Catalona at Northwestern University upon his request. I have entrusted these samples to Dr. Catalona to be used only at his direction and with his express consent for research projects." So far approximately 6,000 donors have signed the forms, according to Catalona.
Piche insists that his client isn't claiming ownership of the samples. Rather, Catalona is a trustee, and the university should honor the wishes of donors who signed new consent forms, Piche says.
Washington University officials contend Catalona improperly accessed patient lists when he mailed out the revised consent forms. Furthermore, the university claims, the tissues are no different from lab notebooks and other work products created with university funds. As far as the university is concerned, donors gave their tissue to the institution, not Catalona, and they gave up their rights when they signed original consent forms, which state: "By agreeing to participate in this study, you agree to waive any claim you might have to the body tissues that you donate." (The forms also say donors can withdraw their consent at any point, at which time their specimens will be destroyed.)
While Washington University says it spent hundreds of thousands of dollars to collect samples and maintain the repository, Catalona says government and private grants paid for the collection. As lead researcher for those grants, he contends the samples should be under his control.
It's a legal quagmire with few road maps. While blood and tissue donors elsewhere have sued after their specimens were used to produce valuable medical products, this may be the first time a court will decide who owns tissues before any profitable discovery has been made.
Courts have usually decided that blood and tissue donors have no right to share profits made possible by their specimens. There's no better example than John Moore, a Seattle man who sued his doctor and the University of California, which had patented cells produced from rare antibodies in his blood. The university, along with Moore's physician, sold the cell line to two biotech firms for $440,000, plus stock worth more than $3 million.
Moore had gone to UCLA for treatment of leukemia in 1976. He became suspicious that something more than his health was at stake when his doctor insisted that he return repeatedly to California for checkups that included taking samples of his blood, skin, bone marrow and sperm. The trips continued for seven years before Moore hired a lawyer, who discovered that big bucks were behind the exams the physician had said could be done only at UCLA. "Specifically, defendants were conducting research on Moore's cells and planned to benefit financially by exploiting the cells and their exclusive access to the cells by virtue of the ongoing physician-patient relationship," wrote the California Supreme Court in a 1990 ruling.
Moore claimed he should profit from discoveries that wouldn't have been possible without him. But a divided state supreme court ruled he had no property rights to cells that he'd surrendered. Otherwise, the court reasoned, research that could save lives might grind to a halt.
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