Background: Weighing a constitutional amendment to support stem cell research
California voters—through Proposition 71—will decide whether to endorse human embryonic stem cell research with a constitutional amendment and a major financial commitment over the next decade. With religious and ethical overtones, big money at stake, and many lives potentially in the balance, the controversy over Proposition 71 is a heated one. The moral status of human embryos (which are no longer viable after the cells have been collected) is a significant part of the debate; but other issues are prominent in the discussion as well. Besides the ethical considerations, voters are being asked to weigh the following:
- Should the state seek to become a leader in this field?
- What will it cost and is this the best way to spend the money?
- What will the benefits be, and who will receive them?
- Is a constitutional amendment the right vehicle?
The backers of Prop. 71 argue that the federal government is failing to capitalize on this crucial avenue of research. They want California to step into the breech and serve as a sort of experimental laboratory—invoking the vision famously laid out by Justice Louis Brandeis in his 1932 dissent in New State Ice Co v. Liebman:
“It is one of the happy incidents of the federal system that a single courageous state may, if its citizens choose, serve as a laboratory; and try novel and economic experiments without risk to the rest of the country.”
Prop. 71 proponents argue that a constitutional amendment—more difficult to repeal than a statute created by initiative—would help insulate ongoing human embryonic stem cell research, which most predict will take many years to yield clinically useful results, from the shifting tides of political power.
Proponents are turning to the state because of what they maintain is inadequate federal support. In 2003, the budget of the National Institutes of Health, which issues most federal biotechnology funding, was more than $27 billion, while grants for human embryonic stem cell research totaled only $24.8 million. (In contrast, adult stem cell research garnered approximately $300 million in federal funding.)
Because California is home to more than half of the country’s biotechnology companies, research institutes, and commercial firms, supporters say the state is uniquely suited to take advantage of research opportunities that the federal government is failing to exploit fully. Proponents hope that Prop. 71 funding is enough to build 12 to 15 new stem cell research centers over the next decade. If the referendum passes, California’s taxpayers’ support of human embryonic stem cell research could be more than tenfold the amount provided by the federal government.
Opponents have powerful arguments of their own. They maintain the measure is far too expensive, especially in light of current budget pressures and the limited health care access facing many residents. They say the oversight proposed for the program is too lax. And finally, they maintain that embryonic stem cell research is too speculative and risky to warrant a change in the state’s constitution, and that such constitutional protections will only tie the state’s hands when deciding on funding priorities in the future.
A national hot-button issue resurfaces
The issue made front-page headlines in the summer of 2001, when President Bush announced his policy to permit certain stem cell research with federal funds. It resurfaced in 2004 in the wake of former President Ronald Reagan’s death from Alzheimer’s disease. Nancy Reagan, who had been a forceful behind-the-scenes advocate for stem cell research, began to voice her support in public a few weeks before her husband’s death. She echoed noted celebrities and disease advocates Michael J. Fox and Christopher Reeve.
On July 27, Ron Reagan addressed the Democratic National Convention in Boston. He said embryonic stem cell research is “above politics” and urged a federal effort with the focus and scope of an Apollo project to capitalize on the promise of stem cell research. He predicted new therapies would be available within ten years if sufficient resources are invested.
The stem cell issue continued to gain traction throughout the summer, frequently addressed in the Presidential campaign by the candidates and their surrogates. On August 9, 2004, the third anniversary of the Bush Administration policy on embryonic stem cell research (see below), First Lady Laura Bush said that “embryonic stem cell research is very preliminary and the implication that cures for Alzheimer’s are around the corner is just not right.” Governor Schwarzenegger has been supportive of stem cell research, but is considering opposing Prop. 71, a measure he believes is too costly.
The few polls aimed at gauging national public opinion have revealed significant majorities in favor of embryonic stem cell research. A survey released in August by the University of Pennsylvania National Annenberg Election Survey analyzed American adults’ support for federal funding of embryonic stem cell research: 64 percent favored it; 28 percent were opposed. Generally, support is highest among white, pro-choice, liberal, nonreligious democrats; it’s weakest among conservative republicans and blacks. Most poll respondents indicated that their religion beliefs have the greatest influence on their view of stem cell research. There is no known formal opposition to adult stem cell research.
But California’s Prop. 71 is much more closely contested. A Field poll released August 15 found that 45% would vote for Prop. 71 while 42% oppose it. The poll has a margin of error of 4.5%. It revealed a sharp division along party lines. Only 31% of Republicans support the measure (59% oppose it). Almost the reverse is true of Democrats: 57% are for the measure and 27% are opposed. (See PollWatch for updated information.)
A majority, but not all, of the medical and scientific communities support embryonic stem cell research. A comprehensive list of such support may be found at http://rs192.securehostserver.com/~curesfor/coalition.php.
The policy background
Debates about embryo research stretch back to the early 1970s and the beginnings of research into in vitro fertilization (IVF). In 1996, the U.S. Congress adopted language, renewed annually, stating that federal funds may not be used in research involving the destruction of human embryos.
But the questions took on new urgency, and the current stem cell controversy began, when two teams of American researchers reported in 1998 on methods of deriving cell lines (or preparations) with cells taken from the inner cell mass of very early embryos. (See a timeline of pre-election prop. 71 events.) On August 9, 2001, President Bush announced a compromise designed to allow federally funded stem cell research to proceed, while taking account of concerns regarding the moral status of the embryo. The administration policy allows the use of federal funds for research conducted on certain pre-existing stem cell lines, but will not fund or support any lines created after the date of the announcement.
To qualify for funding, the pre-existing stem cell lines had to be derived from excess embryos created solely for reproductive purposes. They also had to be made available with the knowledge and informed consent of the donors and without any financial inducements for the donors.
The August 2001 policy did little to quiet the debate. In announcing the policy, President Bush said, “more than 60 genetically diverse cell lines” already existed and hence would be eligible for federal funding. The NIH later issued a clarification, explaining that 78 lines were known to be eligible for funding, after a worldwide review of lines held by universities, private companies, and other research groups.
But it soon became apparent there was a considerable gap between eligible stem cell lines and available stem cell lines. The process of turning the originally extracted stem cells into a preparation available to other researchers involves elaborate steps of growth, characterization, quality control and assurance, development, and distribution. Making the lines available to federal researchers also involves settling issues of ownership, payment, and intellectual property.
The upshot is that as of this August, 21 lines had been made available to federal researchers. More than 400 shipments of preparations from these eligible lines have been made to researchers, according to an HHS press release. The number of eligible cell lines is expected to grow with time (the NIH has made “infrastructure awards” totaling just over $6 million to a number of institutions to make their eligible stem cell lines truly available). It is unclear how many of the 78 lines will one day become available. In July, the NIH announced the establishment of a bank of stem cells to house available lines.
Research advocates reacted swiftly. “Creating a bank to house stem cell lines created before August 2001 does nothing to increase the wholly inadequate supply of stem cell lines for research,” says Dan Perry, president of the Coalition for the Advancement of Medical Research (CAMR), an umbrella group representing 76 disease advocacy organizations favoring stem cell research. The federal government “must allow American scientists to create and utilize the best stem cell lines available. Otherwise, American science will continue to fall behind and American patients will continue to suffer,” Perry says.
Announcing the creation of a bank for NIH stem cell lines is “a bit like giving a new paint job to a car without an engine. It’s still not going to take you where you need to go,” says Sean Tipton, vice president for communications of the Washington-based CAMR.
Although scientists and advocates, chafing under the federal limits, have urged President Bush to relax the strictures, he has thus far refused to reconsider his 2001 policy. “The President’s policy rests on this significant principle—no taxpayer funding for embryo destruction—not an assumption regarding the number of stem cell lines. Even as the science develops, this principle does not change,” according to HHS Secretary Tommy Thompson. “Neither unexpected scientific breakthroughs nor unanticipated research problems would cause the President to reverse this policy.”
Pressure for President Bush to reconsider his policy on stem cell research has come from many quarters. In April of this year, 206 members of the U.S. House of Representatives wrote a letter urging him to reconsider. On June 4, the Senate followed suit, with a letter from 58 senators (including 15 Republicans) urging him to “expand the current policy regarding embryonic stem cell research” and consider other resources, including “more than 400,000 IVF embryos, which are currently frozen and will likely be destroyed if not donated, with the informed consent of the couple, for research.” Democratic presidential candidate John Kerry has vowed that, if elected, he would reverse the restrictions on embryonic stem cell research, believing the federal government should not “sacrifice science for ideology.”
While the administration policy limits the number of eligible stem cell lines to be funded with federal dollars, it does not a set a limit on federal funds, nor does it prohibit states or private firms from using other stem cell lines for research. New Jersey has created a stem cell research institute with a combination of private and public funds; some other states are also exploring how to attract biotechnology research ventures. Harvard University has created a stem cell bank as a repository for 17 cell lines it owns to be studied with private funding.
Supporters of Prop. 71 and their arguments
Although former governor Gray Davis signed legislation (SB 253), effective January 1, 2003, that supports all types of stem cell research, California has yet to back this up with any substantial funding. Last year, Governor Schwarzenegger’s administration initially attempted to repeal the law because of its cost (it authorized $220,000 plus the salaries of two state employees to develop guidelines for stem cell research, but the funds have not been spent). Advocates of embryonic stem cell research in California considered the level of state support tepid, and went back to the drawing board. Prop. 71 is the result.
The financial support for the measure has come mostly from disease advocacy organizations, venture capital firms, and individuals whose families have been affected by diseases such as diabetes, Parkinson’s, and Alzheimer’s. (See MoneyWatch for more information.)
The proposition’s main sponsor is the California Stem Cell Research and Cures Initiative (CSCRCI), a group that says it plans to spend up to $20 million to advocate in favor of Proposition 71. (By August 1, it had reported spending approximately $7 million, compared to about $50,000 raised by opponents). The group’s Web site lists numerous supporters, including celebrities, scientists, and patient advocacy organizations, as well as church coalitions and business groups, such as the Los Angeles Chamber of Commerce. The arguments in favor of Prop. 71 crystallize around two main issues:
The promise of science. The idea that these embryonic cells could be grown into a vast array of specific cells, tissues, and organs means the potential medical payoff from such research is huge, say proponents. The materials accompanying the proposition identify many diseases that could eventually be ameliorated or potentially cured: cancer, diabetes, heart disease, Alzheimer’s, Parkinson’s, spinal cord injuries, blindness, Lou Gehrig’s disease, HIV/AIDS, mental health disorders, multiple sclerosis, and Huntington’s disease.
“About half of California’s families have a child or adult who has suffered or will suffer from a serious…condition that could potentially be treated with stem cell therapies,” according to Prop. 71 literature. Similar materials cite 100 million to 125 million potential beneficiaries.
However, advocacy literature is typically silent on any time frame for such breakthroughs, although some materials give a nod to the notion of basic research laying the groundwork for eventual applications in humans. Scientists tend to shy away from predictions about the time it might take for a scientific breakthrough to travel from the research bench to the patient’s bedside—knowing that it could be a trip with many twists and turns, not to mention the regulatory pitfalls.
Nevertheless, enthusiasm for human embryonic stem cell research is palpable in scientific quarters. The CSCRCI Web sites boast endorsements from 21 Nobel Prize winners. The list includes some of California’s most prominent scientists: David Baltimore (Cal Tech), Paul Berg (Stanford), J. Michael Bishop (UCSF), Paul Boyer (UCLA), and Stanley Prusiner (UCSF).
Economic impacts. Proponents of Prop. 71 stress that as a bond measure it will not increase taxes. Pouring an average of $295 million per year over the next decade into stem cell research at California universities, medical schools, and research facilities will create jobs and put the state on the road to finding cures, they say. “The state will also have the opportunity to share in royalties, patents, and licenses resulting from the research—generating additional new state revenue for decades to come,” according to the CSCRCI.
Proponents also argue that Californians stand to benefit if health care costs drop because stem cell research leads to treatments and cures for leading killers. If the initiative “leads to cures that reduce our health care costs by only 1 percent, it will pay for itself,” says the CSCRCI Web site, which goes on to speculate that the potential for savings could be far greater—on the order of “tens of billions of dollars in the decades ahead.”
Proponents stress the referendum’s oversight and audit requirements, and point out that the referendum addresses informed consent and human subjects’ protections.
Opponents of Prop. 71 and their misgivings
Opponents of Prop. 71 have raised less money and have a lower profile than its backers, but they nonetheless articulate a series of pointed objections to the measure on fiscal, political, scientific, and moral grounds.
Hype and speculation. Opponents say the benefits promised from stem cell research are highly remote. “It is utter speculation that we will be able to take these precursor cells and make them dance to our tune,” says H. Rex Greene, MD, an oncologist and director of the Dorothy E. Schneider Cancer Center in San Mateo. Proponents “really haven’t made any good scientific arguments to show that $3 billion of taxpayer money is going to deliver anything of therapeutic value. They wrap themselves in the cloak of stem cells, but all of the advances to date have been with adult stem cells.”
In general, opponents of embryonic stem cell research complain about overblown claims and hype made by scientists and disease advocacy organizations. They say advocates are raising false hopes and doing patients and their families a disservice by lumping together all the many diseases that might benefit from embryonic stem cell research. (In fact, scientists have acknowledged that Alzheimer’s disease is unlikely to benefit from stem cell research in the near term, given that it is a complex whole-brain disorder.)
Financial and “good government” issues. Many of the arguments combine objections to the large outlay of money with a reluctance to change the constitution for a relatively narrow interest. A constitutional amendment, opponents say, not only is difficult to repeal, but it limits the state’s flexibility if emergencies arise and spending priorities change.
The amount of money dedicated to what he calls “just one narrow type of research,” troubles Dr. Greene. “Is this a legitimate priority for the state of California, when it can’t even balance its budget? With a health care system so underfunded…that our main agency for taking care of the mentally ill is the jail, do we really need to spend $3 billion on stem cell research?”
Opponents of Prop. 71, including State Senator Tom McClintock, further argue that Prop. 71 will lead to cuts in health, education, and police and fire services, which they say are more vital to Californians than stem cell research.
The California Catholic Conference has raised objections to the measure. Although the group has moral misgivings regarding embryonic stem cell research—“we object to the killing of embryos to harvest stem cells for research” —its spokesperson, Carol Hogan, chooses instead to focus on the fiscal aspects. “California just cannot afford to go further into debt to support this controversial research,” she says.
A group known as Doctors, Patients & Taxpayers for Fiscal Responsibility (DPTFR) calls Prop. 71 a “raid on the treasury” and a “shameless attempt by a small group of venture capitalists and pharmaceutical companies to force California taxpayers to pay for their research and development costs.” Spokespersons for DPTFR say Prop. 71 is really more for the benefit of scientists than patients and is “written by the very people who will profit from the spending.” Indeed some opponents say Prop. 71 is tantamount to corporate welfare, allowing corporations to make millions with little or no risk.
Other observers express skepticism about claims that the bond borrowing would be offset by savings in health care costs or royalties from new discoveries. The proponents’ “claim that it is going to pay for itself is ludicrous,” says Wesley J. Smith, a nationally known bioethicist who is a Senior Fellow at The Discovery Institute and a consultant to the Oakland-based Center for Bioethics and Culture. “If it were going to pay for itself, you would have to beat private investors off with a stick.” Smith maintains that Prop. 71 is a special interest gambit like any other, even if it involves medical research and the promise of cures. “What you have here is really just a special interest money grab,” he says. “No wonder. Even people who might be skeptical about special interests suspend their skepticism when the message is: We need the money for cures.”
Ethical considerations. Many opponents of embryonic stem cell research consider embryos to be human life, which they regard as beginning at the moment of conception. Thus, opponents of embryonic stem cell research consider the intentional destruction of embryos tantamount to murder.
Many also fear that government funded support for embryonic stem cell research will increase the likelihood for both funding support and continued legalization for both abortion and cloning.
Wesley Smith stresses his belief that the measure would put California on a slippery slope to cloning for human reproduction. Proponents “want to create a kind of a mini state with a constitutional protection for a specific type of research,” he says. This is an abuse of the process.”
Critics of Prop. 71 say that by resorting to the initiative process, powerful interests have end-run the typical hearing process that would offer a chance to examine the complex issues regarding consent, ownership, and the moral status of the embryo. Dr. Greene points to the language in Prop. 71 that informed consent and human subjects’ regulations “shall be generally based...with modifications to adapt to the mission and the objectives of the Institute.” He says the language undercuts any ethical accountability. “Ethically speaking, this will mean the foxes are guarding the chicken coop.”
“This is about the moral status of the embryo,” adds Dr. Greene. “Are the embryos property or progeny? It has yet to be worked out.”
Jeff Stryker did the reporting and writing for this article.
