Policy expands embryonic stem cell research

California law allows therapeutic cloning but disallows cloning technology for reproductive purposes.

By Andis Robeznieks, amednews staff. Oct. 14, 2002.

Although leading researchers downplayed a new California law promoting embryonic stem cell research as merely symbolic, it was a bit of symbolism they appreciated nevertheless.

"We certainly appreciate the intent," said Thomas B. Okarma, MD, PhD, president of Geron Corp., a biopharmaceutical company headquartered in Menlo Park, Calif. "But it's not clear whether it will translate into funding, or programs, or real work."

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While funding is still uncertain, the law does make clear that California is a place where human embryonic stem cell research is allowed and supported. The law follows the current federal policy of using stem cells from embryos created but no longer needed for reproductive purposes; it goes beyond federal policy by allowing use of embryos created from somatic cell nuclear transplantation -- also known as therapeutic cloning.

The law requires that individuals receiving fertility treatment be provided with information on donating unused embryos for research, and it outlaws the use of cloning technology for reproductive purposes.

Until more funding becomes available, researchers don't see any immediate impact on the practice of medicine; but they see the research paying huge dividends in years to come.

"It's not going to happen in the next five years," said Irving Weissman, MD, Stanford University professor of cancer biology. "There may be no short-term impact at all, but down the line I believe this research will lead to drug therapies and cell therapies we cannot even imagine."

California's biomedical industry includes 2,500 companies with 225,000 employees.

For example, instead of just using the existing stem cell lines approved by the Bush administration, Dr. Weissman said California's law would allow new stem cells to be created from cancer cells. From that, he said, scientists may be able to learn how leukemia develops and grows from its precursors.

"I think, overall, this is very forward," said Dr. Weissman, who was selected as the 2002 California Scientist of the Year by the California Science Center. "It puts California at a competitive advantage over every other state, and so the research institutions should benefit."

The language of the law itself notes how important the biomedical industry is to the economy. The 2,500 companies that make up the state's biomedical industry employ 225,000 people, pay $12.8 billion annually in wages and salaries, invest more than $2.1 billion in research and report $7.8 billion in worldwide revenue.

The law also states that these figures "would be significantly diminished by limitations imposed on stem cell research."

Brain drain still a possibility

Much has also been made of a potential "brain drain," as other nations seek to recruit American stem cell researchers by offering a scientific climate with much fewer restrictions than the United States.

So far, there has only been one highly publicized instance of this, when Roger Pederson, PhD, left the University of California, San Francisco, to go to the University of Cambridge in England last year.

$7.8 billion in worldwide revenue is reported annually by California's biomedical industry.

Dr. Okarma said the United States may still lose more stem cell scientists because of the political climate.

"I think the threat is broad and real -- but it is indirect," he said. "There's no question that the politicization of this work has cast a pall on the research. As a result, young investigators are reluctant to get into the field."

Eventually, Dr. Okarma believes, the chill will go beyond investigators and translate into economic loss.

"The same uncertainty that turns off a university investigator, turns off a portfolio manager," he said.

Bertram Lubin, MD, the senior vice president for research at Children's Hospital & Research Institute at Oakland, noted that institutions will have to take care to make sure any state money they accept for embryonic stem cell research doesn't conflict with federally funded projects they may be undertaking.

"We don't want to jeopardize our [National Institutes of Health] funding, so everyone is going to tread lightly on this for a while," Dr. Lubin said, adding that -- until the state comes through with money -- most people will have to play by the federal rules.

California law would allow new stem cells to be created from cancer cells.

"It comes down to: Where are you going to get the resources to do the work?" he said, adding that California's state budget crisis does not offer much room for optimism.

Dr. Weissman, however, said he thought the state just needed to set new priorities.

"The state is always out of money," he said. " But it's always allocating money and reallocating money. This is an investment in universities. Getting the best and brightest to do research in your state brings a lot of overhead and the best students."

Dr. Lubin said the most important thing the state law might accomplish is change at the federal level. "California may push the federal government to change its policies," he said.

Although Dr. Okarma called the new California law "a breath of fresh air," he predicted true political change will not occur until the research starts showing tangible results in humans.

"It will turn around when the first paralyzed person gets movement in their feet, and when the first diabetic can throw away their insulin," he said. "If we're only half right [about the promise of stem cell therapies], this is going to change the way medicine is practiced."