Alberta Innovates- Health Solutions

A recent magazine article forecasts that "genes will be considered the intellectual property of the (chemical, pharmaceutical, or biotechnology) firm that registers them first, even though they exist in nature." It's an ominous prediction that has already borne fruit. Nearly 100 U.S. patents on animals have been issued, according to published reports. As science and commerce merge, ethical and moral implications are arising over how human genetic material is to be treated-both under the microscope and under the law.

American John Moore's cancer-ridden spleen has become "the poster child for the issue of commercialization of human genetics," says Stanford law professor Hank Greely. The health law and policy specialist has closely studied the legendary case that saw Mr. Moore's physician, Dr. David Golde, patent and allegedly profit from a cell line taken from his patient without his apparent knowledge or consent.

As Professor Greely, a panelist at the recent Commercialization of Genetic Research conference. tells it, Dr. Golde had diagnosed Mr. Moore as having a rare form of cancer called hairy cell leukemia. In 1976, a splenectomy was the normal treatment for this disease. Dr. Golde removed Mr. Moore's enormous, 22 pound spleen-a normal spleen weighs about a half pound.

Through research which he conducted over the next six years, Dr. Golde discovered that Mr. Moore's spleen exhibited some unusual qualities that he thought could be used to develop a cancer treatment. A cell line he created from it was patented in 1984. Later that same year, Mr. Moore filed a lawsuit against his doctor. After a seven-year legal battle, he walked away with a small financial settlement.

In numerous interviews, Mr. Moore has likened the experience of being patented to "rape." Professor Greely suggests that Mr. Moore was an unfortunate victim of the time. "Now we need to go back mentally to 1976, an era when our institutional review boards, medical ethics boards, and regulation of human subjects research were in their infancy. There was no written consent saying that Moore understood and recognized and signed away that he was participating in human subjects research," Professor Greely says. "That was not unusual, that was the norm in 1976."

Nearly 25 years later, the situation pertaining to human subject research has changed-to a degree. There is now a certain amount of regulation in place in the United States to prevent anomalies such as the case of John Moore's spleen from happening again, Professor Greely says.

In Canada, the country's three main research bodies have just released a new ethics policy, to be implemented by September 1999, which outlines information to be included in patient consent forms, and patient rights regarding clinical trials.

Dr. Hank Greely is a Professor of Law, and Professor, by courtesy, of Genetics at Stanford University specializing in health law and policy.

MRC ethics website: http://www.mrc.gc.ca/ethics/english/index.htm