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Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, says he's never heard of a case like the one between Catalona and Washington University. He says he doubts the original consent forms give legal custody to the doctor. "Normally, a doctor can't handle them," Caplan says. "You've got to give them to the school. The doctor can say, 'I'm going to use them,' or, 'I'm going to have exclusive control over them,' or whatever. It's very hard for someone to donate tissues to an individual doctor."
Legalities aside, Caplan says the focus should be on ethics.
"Ethically, I'd like to see them honor these requests," Caplan says. "People make these gifts -- and they are gifts -- and certainly you can say, 'I made the gift contingent on the fact that this doctor's going to work with these tissues. I know that Wash. U. has control, but I really gave them because I like this doctor. If he's moving and he wants them, he should have them.' I think, ethically, the school should honor that, if they want to keep getting people to give tissues to them.
"Normally, when pushed, a school would probably say, 'OK, take it,'" Caplan adds. "I'm suspicious that there's something unique or valuable here that they're fighting over."
Even run-of-the-mill tissue is worth a lot of money. While it's illegal under federal law to sell human body parts for transplant purposes, tissue, eyes, limbs, hearts and almost anything else may be bought or sold if the goal is research.
In its lawsuit against Catalona, Washington University says it would take well over $1 million and several years to replace the prostate-tissue repository. And a formerly rarefied field is now crowded, owing to advances in genetic research that have created a huge market for all sorts of tissue and body parts that once were thrown away. Private companies that collect tissue for research have cut deals with hospitals for surgical leftovers, sometimes paying cash, sometimes offering free access to their collections in return for specimens. One such company is Massachusetts-based Ardais Corp. According to a 2002 story in the Boston Business Journal, Ardais, which was founded in 1999, spent $40 million compiling a bank with tissues from at least four medical centers and is making a profit.
"The tissue samples in and of themselves have value, even without a gene discovery," notes Laurie Rosenow, a Chicago attorney who recently helped negotiate the Canavan disease settlement on behalf of plaintiffs. "It's really expensive to get the tissue. A researcher can go online and see what's available. There are catalogs where, for money, you can say, 'I need 10,000 samples of such-and-such cell line.'"
In its lawsuit, Washington University claims that it is the "true and legal owner" of the tissues and can use or transfer them without asking anyone's permission. In his counterclaim, Catalona says donors have the right to know that Washington University might sell their tissues.
That, Clayton vows, isn't an option. "We will not sell these samples to anyone," the medical school spokesman says. "That just won't happen."
But there are other ways to realize profits from the samples. Universities, hospitals, drug companies and biotech firms have patented scores of genes, proteins, amino acids and assorted molecules with links to prostate disorders. (The U.S. government, holder of patent number 5,489,525, controls the rights to an antibody that can signal prostate cancer.) Typically, these substances can be scrutinized to help detect cancer, according to claims filed with the U.S. Patent and Trademark Office. Once a patent is secured, researchers may be required to pay royalties to patent holders for studying genes and other substances found within the human body.
"If they've got a patent on a chunk of DNA, anyone who wants to use it, to do research on it -- to do anything, basically -- has to get permission from the patent holder," explains Tim Holbrook, an assistant professor of law who specializes in patent issues at Chicago-Kent College of Law in Chicago. "Most likely that requires a license, so they'll charge some sort of fee for it."
Washington University holds just one patent directly related to prostates, according to patent-office databases, and that's for a genetically modified mouse that generates prostate tumors similar to those in humans. But the university possesses 417 other patents, including dozens for proteins, genes and DNA sequences. One is for mammaglobin, a protein associated with breast cancer that could prove useful as a marker for the disease. The university exclusively licensed the patent to Corixa, a biotech firm that hopes to create a cancer vaccine based on mammaglobin, according to a 2000 report by the company to the U.S. Securities and Exchange Commission. The company typically pays universities in cash or shares of stock for exclusive licenses and also covers research costs, according to the report.
Another Washington University patent is for proteins that may be useful in fighting a variety of infections, including HIV. Yet another is a protein-based test to determine a person's chances of contracting Alzheimer's disease. In most cases, the university's medical school, which collected nearly $330 million in federal grants in the fiscal year ending June 30, doesn't have to dig into its own pocket to pay for these discoveries. And research is a growing business for the medical school, which received less than $130 million in government grants a decade ago. Between government and private grants, the medical school has estimated it will soon be bringing in a half-billion dollars annually in research money.
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