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Stem-Cell Guidelines Set: BOARD AGREES TO GIVE CALIFORNIA 25% OF REVENUE

Posted on: Saturday, 11 February 2006, 15:00 CST

By Steve Johnson, San Jose Mercury News, Calif.

Feb. 11--The board overseeing California's $3 billion stem-cell research initiative agreed Friday to give the state 25 percent of all revenue generated from any therapies it develops.

The board also set preliminary ground rules to provide good treatment to women who donate eggs for the studies.

One of the more difficult issues facing the stem-cell institute, created by Proposition 71 in 2004, is how to repay the state if its stem-cell grants result in valuable commercial products.

Some board members had feared sharing any revenue with the state might discourage scientists and companies from getting involved in the program. They also worried it might hinder the state's ability to sell tax-exempt bonds to finance the institute. But the group decided giving the state a 25 percent royalty on any revenue exceeding $500,000 was reasonable.

"This was a compromise," said Ed Penhoet, the board's vice chairman and president of the Gordon & Betty Moore Foundation. "There is probably nobody completely happy."

Research on stem cells, which can grow into organs and other tissues, has the potential to lead to treatments for everything from brain disorders and spinal-cord injuries to such major diseases as diabetes and Parkinson's disease. But stem-cell research is controversial in large part because some of the most promising stem cells are derived from embryos.

The revenue-sharing guidelines were part of a general policy adopted by the board sorting out who should benefit from products developed from the research.

The policy applies only to research done by universities and other non-profit institutions, however. The board plans to begin drafting a separate policy soon for businesses that receive its stem-cell grants.

The policy also requires that any drugs or other products developed from the grants be made available to Californians at prices set by the federal Medicare program, to avoid price gouging.

In addition, researchers who get institute money must freely share their discoveries with other scientists and have easy-to-understand summaries of their work posted on the institute's Web site, www.cirm.ca

.gov.

Although the rules governing egg donations for stem-cell studies are preliminary and subject to further public comment, they were widely praised by board members and others at the group's meeting Friday at Stanford University.

The safeguards for egg donors are more rigorous than those set by the National Academies of Science and some other states, said Dr. Bernard Lo, who heads the medical ethics program at the University of California-San Francisco and helped draft the regulations.

Lo said it was essential to have strong ethical guidelines because of recent revelations that many egg donors for South Korean stem-cell studies were hospitalized and may have been coerced into participating.

The board's rules spell out a number of steps to ensure that women understand what will be done with their eggs and the potential health risks to them, which can include painful bleeding and infections. The rules also require researchers to pay any medical bills the women incur as a result of donating eggs.

Two lawsuits filed by taxpayer and anti-abortion groups, which claim the stem-cell program is unconstitutional, are holding up the sale of bonds to finance the program, delaying the research effort.

Contact Steve Johnson at sjohnson@mercurynews.com or (408) 920-5043.

-----

Copyright (c) 2006, San Jose Mercury News, Calif.

Distributed by Knight Ridder/Tribune Business News.

For information on republishing this content, contact us at (800) 661-2511 (U.S.), (213) 237-4914 (worldwide), fax (213) 237-6515, or e-mail reprints@krtinfo.com.


Source: San Jose Mercury News

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