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Stem cell policy vote due;

10-year spending strategy likely to get board approval.The Sacramento Bee (California)
In the fall of 2004, backers of Proposition 71 -- the state's $3 billion bond measure to support embryonic stem cell research -- suggested that cures for dozens of heretofore incurable ailments were within reach, if only taxpayers would offer up some cash.

The measure also was supposed to bring a monetary windfall for the state with lower health-care costs and royalties from new stem cell treatments.

Now, the reality of what that $3 billion might actually buy -- and when the goods can be expected -- is coming slowly into focus. Today, the 29-member governing board is expected to approve a 10-year strategy for spending the bond money.

It will also move closer to final approval a set of rules that will determine what royalties the state will get from sales of new stem cell treatments, as well as the cost to patients of drugs and therapies developed with the bond money.

The long-term plan framework -- first released in draft form in October -- foresees that researchers will take intermediate steps toward a variety of cures. But, a decade out, the plan anticipates that only one embryonic stem cell therapy -- such as a treatment for spinal cord injuries or a cure for Parkinson's disease -- is likely to be ready for large-scale clinical trials.

Availability of any therapies to the public likely will be years beyond that.

Watchdog groups say the plan offers a refreshingly sober contrast to the grand promises delivered during the Proposition 71 campaign.

"I think Californians deserve to have an honest assessment of what's going to be done with their money," said John Simpson, stem cell project director for the Santa Monica-based Foundation for Taxpayer and Consumer Rights. "That's happening now. And it may be sign that the scientists are in the ascendancy" in shaping the agency's agenda.

Of more concern, some observers say, is another item on today's agenda: the agency's proposed intellectual property rules, which have been shaped over the past year through public comment as well as by debate within the stem cell agency.

Among other things, the rules cover how the proceeds from stem cell inventions developed with the help of state money would be split among the state, research institutions and private companies. They also determine how companies bringing a treatment to market would set prices to comply with the requirement that cures be affordable to California residents, even those without insurance.

"This can seem esoteric. But it's going to determine, if profits come, who gets them and whether the stem cell research effort contributes to or helps reduce health care costs," said Jesse Reynolds, director of the Project on Biotechnology in the Public Interest at the Center for Genetics and Society in Oakland.

Although these rules wouldn't come into play for many years -- when stem therapies are actually ready for use -- the rules adopted now will set the framework for how those therapies are priced.

Simpson argues that the rules before the governing board today are too vague, and that the committee is missing an opportunity to establish a pro-patient pricing policy.

David Gollaher, president of the California Healthcare Institute, a La Jolla-based public policy research group for the biomedical industry, said the rules as proposed provide adequate pricing restrictions, without choking off the private sector's incentive to invest in new treatments.

"The critical aspect of any policy from our perspective is that it enable medicines to move from the research phase and to development and commercialization as quickly as possible," he said.

Even as the stem cell institute works out its bylaws, it has already begun granting money. It awarded $38 million in training grants for young researchers in April. Now, the agency is reviewing more than 300 applications for its first two phases of research grants, which will total as much as $104 million. The first awards for those grants are expected to be made in February.

The stem cell institute's work has been slowed -- and could still be blocked altogether -- by legal action brought by taxpayer and Christian groups soon after Proposition 71 passed. An Alameda County Superior Court judge found in favor of the state in April, but the ruling was appealed. An appellate court hearing is expected in January; a ruling there could then be appealed to the state Supreme Court.