INSTITUTE REPORT SAYS USABLE TREATMENTS ARE YEARS AWAY
San Jose Mercury News (California)
To the dismay of some advocates for the disabled and sick, a draft report issued Wednesday by California’s $3 billion stem-cell institute says the agency is unlikely to develop cures for diseases or other ailments any time soon.
The California Institute for Regenerative Medicine‘s proposed strategic plan, written by a group that included two Nobel scientists, methodically sets out a detailed blueprint for eventually turning stem cells into treatments for a variety of health problems.
But the plan — which must be approved by the institute’s board — cautions that stem-cell science remains in its infancy and that much of the agency’s time, energy and money will be consumed trying to understand the cells’ basic biology. Consequently, the plan concludes, the institute will still be doing early-stage studies on potential treatments by the time its money runs out in about 10 years.
Zach Hall, the institute’s president, said he and others who developed the plan were extremely careful about wording it so it set obtainable goals that didn’t unrealistically raise the public’s hopes.
“One of the points really is to try to educate people about what a long process it is to get any ‘therapeutic’ approved,” said Hall, who predicted it might take 15 years before the institute’s research results in a medical product.
Given the political sensitivity surrounding human embryonic stem cells, which are the institute’s main focus, he added, it is essential that the agency avoids rushing to commercialize a treatment that later turns out to be unsafe.
“That would set the whole field back,” he said.
The Foundation for Taxpayer and Consumer Rights, a Santa Monica-based group that has been critical of the institute in the past, said the agency’s plan “shows refreshing honesty” about how long it will take to make stem-cell treatments.
But others found the plan’s cautious approach disheartening.
“I consider this report’s estimate to err on the side of over-caution,” said Don Reed of Fremont, whose son was left a quadriplegic after he broke his neck in a college football game. “While it is right and proper for scientists to be careful,” said Reed, who attends many of the institute’s meetings, “I
take a more optimistic view. In 10 years, I expect my paralyzed son, Roman Reed, to be walking.”
That sentiment was echoed by 60-year-old Bill Franklin of Los Altos, who has suffered from Parkinson’s disease for 11 years.
“There’s no reason for things to take that long,” said Franklin, who worked to help pass Proposition 71, which created the stem-cell institute. “People with PD and other diseases, they want things to happen faster.”
Two lawsuits challenging the institute’s constitutionality have delayed the sale of bonds to finance the 2-year-old agency. Bolstered by a $150 million loan from Gov. Arnold Schwarzenegger, it has only recently begun seeking applications for its first research grants. Some patient advocates worry that the institute has fallen far behind some companies in developing stem-cell medicines.
StemCells of Palo Alto has begun a study in people to test the feasibility of transplanting fetal stem cells into human brains to correct a fatal disorder. Geron of Menlo Park claims it is close to seeking federal permission to test people with its stem-cell treatment for spinal injuries. And Advanced Cell Technology of Alameda intends to ask for approval next year to test people with its stem-cell treatment for an eye disorder called macular degeneration.
Hall said it has long been the institute’s plan to recruit businesses to pay the huge cost of doing late-stage studies of stem-cell treatments and putting such products on the market. He added that the institute may be able to speed up its research by piggybacking onto studies already begun by such firms.
But Hall said it’s unclear whether such corporate collaboration might speed up the development of stem-cell treatments. If it doesn’t, he added, the state will have to wait to see a share of any product revenue generated by its stem-cell grants, although California could begin receiving fees in a few years from businesses that license its research discoveries.
Jeff Sheehy, a member of the institute’s board who suffers from AIDS and was on the group that developed the plan, said no matter what progress companies make, it’s vital for the institute to proceed cautiously and methodically.
“There still is a lot of work that will need to be done to make these therapies widely available and safe,” he said. “This is a daunting scientific challenge.”
Joan Samuelson, a board member with Parkinson’s disease, agreed that the institute needs to be thorough. “But we also are in a rush,” she added. “That means every day we report to duty as if somebody is dying.”
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Contact Steve Johnson at [email protected] or (408) 920-5043.
