Gland of Opportunity

Dr. William J. Catalona built an unrivaled repository of blood and tissue samples. Washington University wants to keep it. Now a judge will decide: Who owns the prostates?

Justice Armand Arabian concurred with the majority, but he was clearly torn. "Plaintiff has asked us to recognize and enforce a right to sell one's own body tissue for profit," Arabian wrote in a separate opinion. "He entreats us to regard the human vessel -- the single most venerated and protected subject in any civilized society -- as equal with the basest commercial commodity. He urges us to commingle the sacred with the profane. He asks much. Whether, as plaintiff urges, his cells should be treated as not, in my view, ours to decide. The question implicates choices which not only reflect, but which ultimately define our essence. A mark of wisdom for us as expositors of the law is the recognition that we cannot cure every ill, mediate every dispute, resolve every conundrum."

The U.S. Supreme Court declined to review the case, which is widely considered the compass that guides similar lawsuits across the nation.

More recently, families whose children are afflicted with Canavan disease, a deadly genetic disorder, settled a federal lawsuit against Miami Children's Hospital in Florida, which used donated tissue to find and patent the gene responsible for the disease. Researchers at the hospital subsequently created -- and licensed -- a screening test so that couples considering parenthood would know whether their offspring would be susceptible to the disorder. Families were angry that the hospital restricted access to the test to selected laboratories and physicians.

Mark Poutenis
Mark Poutenis

Exact terms of the settlement announced in September are confidential, but the parties say that the plaintiffs have agreed not to further challenge the hospital's ownership and licensing of the patent, and the hospital can still collect royalties from the test. Researchers, however, will be able to use the Canavan gene without a license from the hospital.

Researchers have prevailed over universities in at least two disputes over tissue banks, though neither case got far enough for a judge or jury to make a call.

In 1999 the University of Texas agreed to ship the world's largest breast-cancer tumor bank to Baylor University, which had successfully recruited Dr. Kent Osborne, a prominent breast-cancer specialist, and virtually his entire research team. While there was a disagreement over where the samples should be kept, the matter didn't result in a lawsuit.

"Initially they wanted to keep them," Osborne recalls. "There wouldn't have been anyone there who would have used them much, since the whole breast-cancer program, except for one or two people, were moving with me to Baylor. I think they would have liked to keep them just in the possibility that someone would have come along someday [and used them], and they initially verbalized resistance to moving them. But the National Institutes of Health intervened on our behalf."

Because the tumor bank had been established and maintained with government funds that came in the form of NIH grants, Osborne says, the NIH argued that the government owned the tumors and the tumors should move with the researchers and their ongoing federal grants.

A closer parallel to the dispute at Washington University may be found in a lawsuit brought against Texas Tech University by families of patients with Alzheimer's disease. The plaintiffs dropped the case in June, after the university shipped brain tissue and other donated specimens to the University of Georgia, where Shirley E. Poduslo, the repository's creator, had gone after leaving Texas Tech.

Floyd Holder, attorney for the families and Poduslo, says Texas Tech released the samples rather than risk public embarrassment. "What I did down here is I sued Texas Tech and said, 'By keeping these, you're violating a public trust,'" Holder recounts. "By being selfish and keeping them from my client, who went to the University of Georgia, what they're doing is forsaking their duty as trustee. I said, 'It's a breach of their duty, and the remedy is to appoint a new trustee.' And the judge said he jolly well would do it if he found they're not in a position to continue the trust."

Though the university argued that it should not be stripped of its trusteeship, Texas Tech moved many of the samples, rendering the lawsuit moot, Holder says.

Suzanna Martinez, spokeswoman for the Texas Tech University Health Sciences Center, says the school shipped the samples after receiving new consent forms from donors or their legal representatives authorizing the transfer. "The fight was more about Poduslo needing to get new consents, because those people never consented to take those wherever they wanted," Martinez says. "Once she received those new consents, that's why we allowed her to take them. Because then, legally, we could give them to her."

Holder says donors should decide who gets their tissues. "If the [donors] really want it, let's move them," the attorney says. "What's the point in fighting over it? What good does it do? There's only one common-sense thing to do. In the words of the immortal Rodney King: Can't we all get along?"

Apparently not.

Dr. Eric A. Klein, a prostate-cancer researcher at the Cleveland Clinic Foundation in Ohio, notes that consent forms used by researchers there and at Washington University state that samples will be used by researchers, or destroyed if a donor withdraws consent. Transferring jurisdiction isn't discussed. "Those are the only options," Klein says. "There's not an option up front for the patient to have the samples transferred elsewhere. This is just my opinion, now, but I don't think that a university or some other medical system could be compelled to do that if the only options that were presented to them in the consent form was: Either let us use them or they'll be destroyed."

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