By JOHN M. BRODER – New York Times
LOS ANGELES, Nov. 26 – As California moves to begin a lushly financed program of embryonic stem cell research, medical ethicists and other skeptics are concerned that the $3 billion that state voters approved for the endeavor could become a bonanza for private profiteers.
Critics say the ballot measure that passed by a wide margin on Nov. 2 contains inadequate safeguards to ensure public oversight of the financial allocations and guarantee public benefit from any medical breakthroughs. They also worry that the promise of stem cell studies has been oversold to the public and say the money might better be directed to more mature medical technologies.
Even those who support human embryonic stem cell research voice concern that the program will be captured by advocates for research into certain diseases or narrow lines of inquiry, and that the public will have little say in how the money is spent.
Lt. Gov. Cruz Bustamante, a supporter of the ballot proposition, recently said that he expected California to become a magnet for stem cell researchers pushing the edge of medical science.
“It’s this century’s gold rush,” Mr. Bustamante said at a ceremony at the University of California, Berkeley, on Nov. 16, as he appointed the university’s chancellor, Dr. Robert J. Birgeneau, to the 29-member panel that will oversee the research project.
That is exactly what some critics fear.
“There’s a lot more truth there than he intended,” said Wayne C. Johnson, who ran the unsuccessful campaign to defeat the ballot measure. “Three billion dollars is a lot of money, and there’s a potential for a lot of people to get very, very wealthy without accomplishing any public good.”
Sponsors of the measure respond that it was carefully drawn to eliminate potential conflicts of interest, although they acknowledge that many of the rules governing its conduct have not been written. The initiative creates the California Institute for Regenerative Medicine, which will dole out roughly $300 million a year for 10 years in grants and loans to public and private entities pursuing stem cell studies. Final authority rests with the oversight panel, which will include representatives from most of the state’s major medical schools, members of nonprofit research institutes, executives of commercial Biotechnology firms and public members who are advocates for research in a range of diseases.
The idea, said Robert N. Klein II, the Palo Alto real estate magnate who organized the ballot campaign, is to provide a variety of voices to prevent the fund from being hijacked by private interests seeking a windfall of public money.
Mr. Klein said that no member of the oversight committee was allowed to vote on a potential grant to his or her institution, and that those receiving grants from the California institute must follow National Institutes of Health rules for publishing and sharing data. He also said a group of outside experts, with no financial stake in the program, would be formed to ensure that grants were made equitably and ethically and based on the most promising science.
“They will be dedicated to making sure that money is spent wisely and accounted for thoroughly,” Mr. Klein said.
Critics note that as research progresses the state may be confronted with conflicts over patent rights for research techniques and potential treatments. Some patents in the field are already held by the University of Wisconsin, a pioneer in stem cell studies, and Geron, the leading private company involved in embryonic stem cells.
Mr. Klein acknowledged such potential problems, but he said he hoped they would be resolved quickly and in the public’s favor. He also said that the greatest financial boon to California would not be in licensing fees or royalties, but in savings on the state’s huge health care expenses.
He said the $3 billion bond would pay for itself many times over if research led to even marginal improvement in therapies for a few of the 70 diseases for which stem cell studies show promise.
Embryonic stem cells are formed during the first few days of the development of the human embryo and give rise to the specialized cells of various body tissues, including heart, kidney and brain cells. They are a valuable research tool for studying the development of human tissues and may hold the key to developing medicines and therapies to treat a variety of diseases and conditions, including Alzheimer’s, Parkinson’s, diabetes and spinal cord injuries.
Research in the field is still in its infancy and is controversial because extraction of stem cells involves the destruction of human embryos. President Bush, in one of his first official acts in 2001, limited federal financing for embryonic stem cell studies to a handful of existing colonies, or lines. Many scientists and advocates for disease research contend that the restrictions are stifling a promising avenue of science that could bring treatment or cures to millions of Americans. Some of them united to place the stem cell initiative on the California ballot, backed by more than $25 million from venture capitalists, wealthy individuals and disease advocacy groups.
California voters approved the measure by 59 percent to 41 percent. Opponents spent barely $400,000.
Leaving aside the continuing controversy over the morality of this research, matters of business and governmental ethics remain.
The syndicated columnist Charles Krauthammer, a member of the President’s Council on Bioethics, supports some types of stem cell research but says the California initiative goes too far.
“This is an unbelievable rip-off by people with an interest in the business of stem cells,” said Mr. Krauthammer, who suffered a crippling spinal cord injury when he was young. “This is a huge grant from the people of California to a very specific biotech business, and it’s only because of stem cells’ notoriety that it’s this and not something else. If taxpayers were to spend $3 billion, the logical thing would be to devote the money to the most promising areas of research, but that was never discussed because of the sexiness of stem cells. The oversight provisions are abysmal and it’s basically a slush fund.”
Miriam Piven Cotler, a medical ethicist at California State University, Northridge, says she supports the research but has concerns about how the process will be conducted.
“We have committed an elaborate public mechanism to this research,” Dr. Cotler said. “Who safeguards it? What interests will be represented, how public will their deliberations be and how much power will they have?”
The initiative goes only part of the way to addressing her worries, Dr. Cotler said, adding: “I knew it was a compromise when I voted for it. I hope it will play out correctly.”
Marye Anne Fox, chancellor of the University of California, San Diego, which stands to reap large benefits from the new program, said the large amount of money unencumbered by federal restrictions presented a “grand challenge” for California research institutions and medical science generally.
Dr. Fox said she expected the program to provide money for state-of-the-art research facilities, at least one of which she hopes will be built in the San Diego area to take advantage of the existing concentration of nonprofit research institutes and private biotechnology companies there. The Burnham Institute and the Salk Institute for Biological Studies are neighbors of her university’s campus, and both are represented on the 29-member panel overseeing the state stem cell initiative.
But Dr. Fox said it was important that an outside review panel with no vested interest in the grant-making process be empowered to assure that proposals were subject to scientific peer review and awarded on the basis of merit, not insider connections.
“It’s a tremendous opportunity,” she said. “We are going to see an investment of a state that focuses on questions that are not funded at the federal level, apparently for political reasons.”