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Judge sides with Wash. U. in suit over lab samples

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Washington University will get to keep the samples as a result of the ruling (UPI file photo/Bill Greenblatt)

By AP/KWMU

St. Louis, MO – A federal judge in St. Louis ruled last week that research samples belong to Washington University and not the researcher who wanted to take them with him when he moved to Chicago, a case that has national implications.

Research participants, including the former patients of Doctor William Catalona, had claimed ownership of prostate cancer and blood samples they donated for research at Washington University. They wanted their specimens to follow the prostate surgeon when he left St. Louis for Northwestern University in Chicago.

But Judge Stephen Limbaugh ruled that Washington University owns the vast collection of research specimens, saying if left unregulated, "the biological materials would become nothing more than chattel going to the highest bidder."

"Selling excised tissue or DNA on E-Bay would become as commonplace as selling your old television on E-Bay."

An appeal is planned. Dr. Catalona, a renowned prostate cancer researcher, and his colleagues have collected the samples since the late 1980s.

The collection, which is among the largest in the nation, is kept in 20 liquid-nitrogen freezers at Washington University. It includes more than 270,000 blood and tissue samples from 30,000-plus donors and has been used for groundbreaking work.

Catalona used it to show that PSA was a first-line screening test for prostate cancer, which he reported in the New England Journal of Medicine in 1991.

Catalona worked at Washington University from 1976 to February 2003, when he left over what he viewed as restricted access to the very samples he had collected. A year earlier, the university had established a peer-review mechanism to determine who could use the samples. Catalona said he eventually was able to use samples but always after a delay.

When Catalona decided to resign to accept a post at Northwestern University, he announced his move and plans to continue research in Chicago to 10,000 of his former patients. He gave them the opportunity to have their biological materials transferred to his care and research at Northwestern.

About 6,000 donors signed forms indicating they wanted to transfer their specimens. A few weeks later, Washington University filed suit in federal court, wanting to settle the ownership issue. Research on the specimens was effectively halted while the lawsuit played out for three years.

Limbaugh cited two earlier cases in which courts found that donors do not own tissue they donate. He also expressed concerns for the "great potential for prejudicial influences into medical research," if donors could redirect their samples for their own reasons.

The St. Louis case is the first involving a university, tissue donors and a researcher asserting that donors have the right to reclaim their tissue and send it to him, university spokesman Don Clayton said.

Washington University said it was pleased with the ruling, which the school noted allows it to make the specimens available to researchers, including Catalona. "We are looking forward to resuming research with these samples that is consistent with the expectations under which the donations were made, that is, to make discoveries about how cancer develops and can be treated," Clayton said in an e-mail Monday.

Catalona, who plans to appeal, said he regrets that Limbaugh made it "a fairly narrow case of property law," when a higher issue, "patient autonomy" and the need to respect the wishes of research subjects, is at stake. He said he is not willing to concede that Washington University unconditionally owns the samples.

Dr. David Korn, senior vice president of the Association of American Medical Colleges, which had filed a "friend of the court" brief in the case, praised the ruling, saying any other decision would have hurt medical research. A tissue sample collection is like a great research library, he said.

"If, at any time, book donors or their heirs could walk into the library and take out volumes, it would be awfully hard to maintain a library of any scholarship value," he said.

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