DON REED HAS a favor to ask. His son Roman has been in a wheelchair ever since he was paralyzed in a football accident 10 years ago. Right now modern medicine offers no hope.
But some day, doctors and scientists have told the Reeds, there may be a way to help Roman. It involves microscopic human cells known as stem cells, which have an unusual ability to replicate and could theoretically replace any damaged or diseased tissue in the human body. Visiting a UC Irvine lab in March 2002, Don Reed even held a rat that had been paralyzed but was able to crawl after receiving an experimental stem-cell therapy.
The problem is, the Bush administration has refused to grant federal funding for most research on cells taken from human embryos, which are thought to hold the most potential. So thousands of desperate and infuriated families like the Reeds are intent on finding more money for that research. They say we could soon have a cure for juvenile diabetes, therapy for heart disease and Parkinson's, even possibly a way to undo spinal-cord injuries like Roman's _ if we would just dedicate a reasonable amount of funding.
That's why they're asking Californians to vote for Proposition 71, a November ballot measure that would direct $3 billion in state money to studying these particularly mutable cells.
"When I heard about it, I thought, I've just got to be involved," Reed told the Bay Guardian with sincere intensity. And when the campaign needed pieces of cardboard to lay petitions on, he cut boxes until his fingers blistered.
With even members of the Reagan family publicly criticizing President George W. Bush's stance, it's no surprise that almost the entire moderate-liberal segment of the state is rallying behind Prop. 71. An anti-Prop. 71 position has almost become synonymous with Christian conservatism. When the New York Times ran a story about Prop. 71 on Sept. 20, the paper only noted opposition from "the Roman Catholic Church, many evangelical Christians and moral conservatives."
But the Times didn't talk to Francine Coeytaux. She's neither Christian nor conservative and has no interest whatsoever in being associated with the religious right. Emphatically pro-choice, Coeytaux, who has a degree in public health, founded the Pacific Institute for Women's Health and has spent much of her career working to increase access to reproductive care, including abortion. She supports research on embryos and thinks the Bush administration's current restrictions are "outrageous."
She's also working to defeat Prop. 71. And she's joined by a growing number of pro-choice, pro-science, anti-Bush progressives who are struggling to deal with the fact that they are, for the moment at least, on the side of the Catholic Church.
The problem, the Pro-Choice Alliance Against Prop. 71 says, is that stem-cell research is bound up with some very tricky ethical and scientific issues the public knows little about _ among them, human cloning and genetic engineering.
Instead of involving the public in this effort, Prop. 71 would put just a few unelected people in charge of a newly created California Institute for Regenerative Medicine and the $3 billion it would allocate. They would largely be able to write their own rules _ and would even have broad discretion over what gets disclosed to the citizens of California.
Prop. 71 would earmark more money for this specific type of science than the UC system now spends on literally all of its research projects in a given year. The state legislative analyst estimates the measure, which would raise the money by selling bonds, would ultimately cost taxpayers a total of $6 billion.
Coeytaux questions whether it's wise to invest so much in a relatively narrow type of research. What if it never leads to workable medical therapies? Or what if they're prohibitively expensive anyway? There's no guarantee all this public money will lead to treatments most people will actually be able to afford.
"I think it is a bad law," Coeytaux told us. "If we let this institute be run by the people who will make the money off it, without the [research] guidelines we worked so hard to set up, how can anyone think there won't be abuses?"
Even thornier issues loom behind the good-government concerns. They start with the fact that Prop. 71 would fund embryo cloning _ which, Coeytaux knows from serving five years on California's Advisory Committee on Human Cloning, is the building block for human genetic engineering.
Although Prop. 71 specifically forbids bond money from being spent on human reproductive cloning _ the kind that would give us real-life genetic copies of other people _ the science is intertwined. After all, the placement of a single one of these cloned embryos in a woman's uterus could make the first human clone a reality _ before we've taken the time to consider the possible consequences or set up any safeguards. That could bring us a huge leap closer to the sort of genetic caste system depicted in Aldous Huxley's dystopian fable Brave New World.
It may sound far-fetched, but many respected scientists think we'll have to confront these issues sooner than we imagine. Some even predict society will ultimately be cleaved into two classes: those who have been bestowed with extraordinary advantages by geneticists, and those who are doomed to a life of drudgery by the inferiority of their natural DNA.
When that technology arrives, will we be ready? After all, how many of us were prepared for Dolly, the first cloned sheep, or that infamous glow-in-the-dark bunny?
Richard Hayes is a UC Berkeley Ph.D. who spent almost a decade on the national staff of the Sierra Club and now directs Oakland's Center for Genetics and Society, a nonprofit advocating responsible use of human genetic technology. He's deeply disturbed by the way the politics of stem-cell research is shaping up.
"Unfortunately, only two major constituencies are politically active on these issues: the religious conservatives, who want to outlaw all research using human embryos, and the biotech industry and research community, which resists even reasonable social oversight and control," Hayes told us. "If we want to avoid a future of free-market designer babies, we need a third voice on theses issues, allowing responsible medical research to proceed but drawing lines against a new, high-tech eugenics."
Hayes's nonprofit has analyzed Prop. 71 in detail, and he and a handful of other academics who study biotech are trying to spread word of their concerns. But they face the formidable problem of explaining a nuanced issue to an ill-informed yet opinionated public.
Some people may simply be intimidated by the scientific jargon, Hayes said. But if you can get past the fact that the terms are often unclear or overlapping, the concepts are hardly more complicated than the meiosis and mitosis you learned about in ninth-grade biology.
After a human egg is fertilized, it quickly begins to divide, into two cells, then four, then eight, and so on. Eventually, those cells take on different characteristics _ some turn into blood, or bone, or eyes, or lungs. But the very early cells, in that undifferentiated state, can still turn into any body part. Those are stem cells _ and some of them are found in the human body long after birth.
The least controversial form of stem-cell research is conducted on adult (also called multipotent) stem cells, which are typically taken from birth materials like the umbilical cord but can exist in parts of the body through adulthood. These cells have the potential to turn into several different types of cell, but their potential is more constrained than that of stem cells from embryos.
Researchers who work on embryonic stem cells are now focused on figuring out the "cues" that determine how these cells develop. They hope one day they'll be able to take a sick person's genetic material, put it into some stem cells, and then cue those cells to develop into healthy tissue of whatever sort is needed: new insulin-producing cells for a diabetic, fresh brain cells for someone with Parkinson's. In theory, the ability to replace a person's diseased or damaged cells with healthy cells that are a genetic match would eliminate the immune rejection problems that often accompany transplants.
But scientists admit it'll take many years to get to that point.
When embryonic stem-cell therapies have been used on laboratory mice, they've usually led to tumors. Therapies involving adult stem cells have, ironically, met with more success. But the consensus is that embryonic cells _ which were discovered in San Francisco in 1980, then first isolated in 1998 _ offer the greatest ultimate potential because they're effectively blank canvases.
Which is why scientists were so disappointed when Bush restricted such research in August 2001. Wanting to avoid conservative criticism for allowing embryos to be destroyed without completely shutting the door on this work, Bush announced funding could only be used for the study of embryonic stem-cell lines that had already been extracted from embryos. The compromise was seen as indicative of hostility to science and allegiance to the religious right, and it was little consolation for researchers who said the number and quality of those cell lines would prevent real advancement.
The scientific community was galvanized, and its frustration planted the seed for Prop. 71.
Whose health care?
The Yes on 71 campaign has lined up the support of a broad cross-section of California policy makers, from left-leaning Democratic leaders like state senate candidate Carole Migden to the California Chamber of Commerce and former secretary of state George Schultz. In part, that's because it's promoting the argument that this massive investment in stem-cell research will be a boon to the California economy. The campaign tosses around huge figures, saying, for instance, that the state could save $1 billion a year with treatments for chronic diseases like juvenile diabetes. In fact, it promises "$12.6 billion in new state revenues and health care cost savings _ and up to 22,000 new, good paying jobs for our state."
"It's a great opportunity for voters to help bring about cures for more than 70 debilitating diseases, which affect more than 128 million Americans," campaign spokesperson Fiona Hutton told us. "And to help our economy."
But some have their doubts.
First off, the expenditures are huge. Today the largest state-supported research program in the country _ the University of California's breast cancer program _ gets roughly $15 million a year. This one would get close to $300 million a year, and although the bonds are described as "tax-free," they will eventually have to be paid out of the General Fund and will tie up state money for decades.
Obviously, there's the potential that this initiative will wind up swamping _ or starving _ other research programs. But when we asked Hutton about that concern, she said it's "strange to hear our opposition ranting about breast cancer," because "this is the best bet for them."
When it comes to overall health costs, most analysts of the market say pricey new therapies, rather than lowering costs, often inflate them. And that's one of the concerns about Prop. 71 _ that any treatments that might come from it wouldn't be affordable.
Marcy Darnovsky, a social scientist who is Hayes's colleague at the Center for Genetics and Society, points out that, like in vitro fertilization, most stem-cell therapies would be highly personalized and involve the extraction and storage of human eggs, which cost a lot of money. "We wonder if it isn't going to be like IVF to the nth power, available only to people who can pay the many, many thousands of dollars," she told us.
"If it ever yields any treatments, it's going to be the most expensive form of health care," agreed medical sociologist Diane Beeson, a primary critic of the measure. And if things continue as they are, there's little reason to think insurance coverage would be enough to gain access to this kind of care.
In other words, Prop. 71 could move us closer to a double-tier system of health care in which the wealthy are able to repeatedly replace organs and body parts as the less prosperous simply die when disease gets them.
Another point of contention involves the sources for embryonic stem cells. These cells can be extracted from embryos left over from in vitro fertilization or can be created through the cloning of embryos. Many people are alarmed by that technology _ which involves replacing the nucleus of a human egg with one from another source and prompting the egg to develop into an embryo.
Though no U.S. scientist has so far been able to do this successfully, the fact that Prop. 71 funds such experimentation rouses the suspicion of Beeson and company. "Some companies have tried, but they haven't been successful yet," she said. "They realize it's going to take a long time _ I think that's why they want California taxpayer money to do this."
Judy Norsigian, who is best known for coauthoring the 1970 women's heath classic Our Bodies, Ourselves and still directs a Boston nonprofit by the same name, is highly concerned about the egg donation this technology requires. She argues that information about some of the drugs women have to take to enable egg extraction is too incomplete, and that the gaps in knowledge make real informed consent impossible.
"Media coverage of human embryo cloning research has largely focused on its therapeutic potential, neglecting the technology's dependence on the thousands, if not millions, of women who must undergo the substantial health risks associated with harvesting their eggs," Norsigian told a U.S. Senate committee in May 2002. "Of particular concern to us is the lack of adequate long-term safety data on the super-ovulating drugs that women have to take."
Thousands of women have reported serious side effects like irregular heartbeat, memory loss, joint pain, and suicidal depression after taking the drug Lupron, which isn't approved by the Food and Drug Administration for fertility purposes but is frequently used in that manner anyway.
Some members of the Pro-Choice Alliance Against Prop. 71 worry that the increased demand for ova will mean that new tactics will be used to recruit donors and that lower-income women in particular will suffer. Prop. 71 rules out paying women for eggs but allows the "reimbursement of expenses," which nowadays usually amounts to at least $5,000 for IVF purposes.
"It's outrageous they tell people women will be compensated for eggs," Hutton said. "It's expenses _ nobody is going to get any kind of compensation."
But Norsigian told us, "Until they have dealt with these problems, I don't see how you can argue for [Prop. 71]," noting that there's plenty to learn from preexisting IVF embryos.
Of course, this doesn't even touch on the bigger cloning debate.
Send in the clones
Glossy magazines already contain advertisements for the Microsort Gender Selection Process, which allows parents to determine, with 85 percent accuracy, the sex of their future baby. A Bay Area company is set to clone nine cats this year for consumers who want to replace their pets. And many scientists describe a future dominated by genetic castes, with intricately enhanced elites lording over unmodified servants. Take Princeton University's Lee M. Silver, who glowingly predicted in a 1997 book, "The GenRich class and the Natural class will become entirely separate species with as much romantic interest in each other as a current human would have for a chimpanzee."
The idea that we're getting close to actual human cloning may still seem preposterous, but the people drawing connections between Prop. 71 and that technology aren't fringe lunatics mouthing off about the hordes of little green men about to take over the state. They're largely academics who support scientific experimentation, even on embryos. They're simply convinced Prop. 71 would take us too far into territory that's complex both morally and biologically _ before we've had any sort of societal dialogue about the potential effects.
Darnovsky says it wasn't just opinions such as Silver's that spurred her interest in genetics; it was the lack of attention they attract. "So there are some weird scientists," she said. "What got me is, where are all the colleagues saying, 'shut up and go back to your mouse lab'?"
Supporters of Prop. 71 have tried to distance the measure from the technology of cloning, using "somatic cell nuclear transfer" instead of the more direct "embryo cloning" or "therapeutic cloning" in the language of the proposition itself, and even suing to prevent opponents from employing those terms elsewhere in the California ballot book. (They lost.)
Dr. Larry Goldstein, a medical researcher at UC San Diego who works with embryonic stem cells and supports Prop. 71, told us the pro-choice critique of 71 is "misinformed and unnecessarily fearful." The term embryo cloning, he said, is "designed by opponents of research to scare people. We're not talking about cloning people; we're talking about cloning cells. The real goal is the treatment and understanding of disease. They're taking advantage of people's general concern about cloning." But the fact remains that the product of this process, if placed in someone's uterus, could mature into a person, a cloned person.
A report put out last summer by the Hastings Center, the country's foremost think tank on bioethics, noted that while the destruction of embryos is common to stem-cell research discussions, "it is less widely known that ES [embryo stem] cells could also be crucially involved in the creation of embryos; ES cells could ultimately be used to create healthy children, and _ at least in principle _ to create genetically 'enhanced' children."
Darnovsky is concerned that few people understand that embryonic stem cells could therefore be "the raw material for designer babies. They're talking about engineering for therapies, why not for enhancement? We have no policies on those questions right now."
Even if you put aside the inherent potential for biological goofs and other moral arguments against cloning, it's hard to imagine how widespread cloning wouldn't bring with it attempts at the sort of genetic enhancement Darnovsky speaks of. She and others who are looking at these issues through a social-justice lens worry widespread genetic tinkering could make today's socioeconomic disparities look downright quaint. They ask you to imagine a world where wealthy families are able to commission incredibly attractive, frighteningly bright children who excel at everything they do. Ordinary families continue to breed "normal" kids, who of course stand little chance of competing with the souped-up "designer" children.
"There's nothing in this initiative to make sure that this technology won't be used for nontherapeutic purposes," sociologist Beeson said. "I don't think most people understand how far along we are in this biological revolution and how close we are to creating and manipulating human life in laboratories."
Goldstein disputes that this is what Prop. 71 is about, and he also makes a good case for proceeding. "There is no human technology that has not been misused. A wise society does not just ban new technology, it allows benevolent use _ like using it to cure disease _ while banning inappropriate use," he said. "There is the theoretical issue that 10, 20, 30 years down the road [we may confront human cloning]. But I'd argue that a society like ours could regulate it. In fact, we'd be in a better position to control this if we're also studying it. There is a role for human goodness here."
Others think the risks in Prop. 71 may outweigh the benefits.
"It seems to me," Darnovsky said, "that what stands between the glow-in-the-dark bunnies and the blond-haired, green-eyed babies is that it would be unthinkable to do that kind of experimentation on human beings." Of course, all it would take would be a scientist or lab that doesn't share that moral hesitation. California has a ban on reproductive cloning, but lacking a national ban, the embryo cloning technology developed here could easily be used in another state _ or another country _ to create human clones. As we've seen with nuclear proliferation, once a technology is developed, it's nearly impossible to keep it under wraps.
Even if this is the future of reproduction, most people would agree these issues are serious enough to warrant thorough discussion and at least some modicum of regulation. But experts say the United States has failed to craft policy to keep up with innovations in genetics and regenerative medicine.
Countries like the U.K. are perceived as being more permissive on stem-cell research, but they've also established government bodies to license and monitor all clinics and laboratories that store or use gametes or embryos. These agencies are designed so that full control doesn't rest with the researchers who might wish to explore their ethically contentious work unhindered.
"We need structures that protect overzealous scientists from temptations that might not be in the public interest," Beeson said.
If the United States is behind other parts of the world in the monitoring of genetics technology, then Prop. 71 may set us back even further.
The closest thing we have to the U.K.'s regulatory system is guidelines for informed consent and research on humans designed by the National Institutes for Health. Prop. 71 says the California Institute for Regenerative Medicine will follow those _ but only until it gets a chance to write its own.
"Those [guidelines] are really important because we know, in the past, about all the problems that can emerge with clinical trials," Coeytaux said.
Goldstein says that the NIH guidelines aren't comprehensive and that "the institute will need to develop stricter ones."
And like virtually everything in the proposition, the final call is left up to the institute, which is governed by a 29-member Independent Citizen's Oversight Committee.
That body would be charged with selecting the research programs and facility proposals to get public money, plus writing the rules governing ethics, research methods, and who owns patents.
Members, who would serve six-to-eight-year terms, would be appointed by elected officials from carefully delineated pools. However, a majority of committee members would come from research institutes, biotech companies, and disease advocacy groups.
"It's called the Independent Citizen's Oversight Committee, except it's not independent, and it's not full of citizens," said Tina Stevens, a San Francisco State University historian of bioethics who told us Prop. 71 has pushed her into an activist role for the first time.
Yes on 71's Hutton defends the design, saying the proposition's drafters wanted "the best and the brightest" and "people with the most knowledge of the research and bringing it to market."
She also said that Prop. 71 has "the most stringent guidelines that you could lace into an initiative" and argued that "what you do with an initiative is try to provide spirit and a framework."
Yet the proposition contains language that appears to exempt the institute from outside regulation. "The institute will develop its own scientific and medical standards," it says, "notwithstanding" several parts of the California Health and Safety Code "or any other current or future state laws or regulations."
"It's beyond description in terms of potential for abuse," bioethics attorney Debra Greenfield, who opposes the measure, told us. "The initiative says they do not have to live under existing and future California laws."
The ICOC would set salaries for institute employees, be exempt from civil service, and to top it all off, have a broad exemption concerning what meetings and records are open to the public, leading critics to charge that all institute business will be conducted with little or no public scrutiny.
"Every penny spent and every decision made will be made in public," Hutton insisted. When asked about the loophole written in, she said, "Look, you've got to have a way to discuss things that are pre-patent."
Members of the Pro-Choice Alliance suspect the drive to get the research done _ or worse, to get the money the research might lead to _ would taint the decisions made by these researchers, who, even if they work primarily for a university, typically also advise a biotech firm or two.
"We want to be clear that biotech stands to gain millions from this. That's not some comment on the rapaciousness of science; anyone could fall into exaggerating claims [when they want to pursue a certain type of work]. It's human nature," S.F. State's Stevens said. "That's why you need genuine oversight."
Stuart Newman, a professor of cell biology at New York Medical College and a strong advocate for scientists to consider the societal impacts of their work, says he thinks the whole proposition is largely motivated by the desire of biotech companies to patent technology having to do with human cells.
The initiative's passages about patents are nebulous: the institute will "balance the opportunity of the state of California to benefit from the patents, royalties, and licenses that result" with companies' intellectual-property concerns. That means biotech could prosper handsomely from this generous investment of taxpayer money _ while the state gets next to nothing.
It's not hard to find stories of researchers taking knowledge derived with government funds to biotech companies that then make millions off it. Take Mark Skolnik, who was working for the University of Utah when he identified the so-called breast cancer gene in 1994. He left to work for Myriad Genetics, which then offered the tests that screen for the gene for a couple thousand dollars a pop. Myriad patented not only the test but also the gene itself, and it can now even control what independent scientists do using that gene.
If it were your child ...
It's impossible not to feel compassion for people like Don Reed.
But Coeytaux thinks the Prop. 71 campaign is manipulating people's emotions. "One of the things I really resent about the pro-71 crowd is this 'If it were your child ...' " she told us. "I have one of those kids: my daughter is missing part of a chromosome."
But Coeytaux believes it'll be 30 or 40 years before her daughter might benefit from this research. "I do think we should be working on this for future generations," Coeytaux emphasized _ she just wants the scientists to be up-front about the realities.
And that's not exactly how the campaign is selling the measure. In one of the Yes on 71 TV spots, Dr. Jeff Bluestone of UC San Francisco says, "When a seven-year-old girl comes up to me, and she's scared, and she says, 'Will stem cells be an answer for me? Will they be a cure for me?' I'm absolutely confident in saying that, 'This will happen.' "
Practically any biologist will tell you that stem-cell research is worth exploring. But it may take much longer to develop therapies than Prop. 71's backers would have you believe.
"Scientists have been experimenting with stem cells since 1980," Newman told us, "and they still find it very difficult to cure or repair anything, even in mice."
The National Academy of Sciences' 2002 book Stem Cells and the Future of Regenerative Medicine states, "Because of a misunderstanding of the state of knowledge, there may be an unwarranted impression that widespread clinical application of new therapies is certain and imminent. In fact, stem cell research is in its infancy, and there are substantial gaps in knowledge that pose obstacles to the realization of new therapies from either adult or embryo-derived stem cells."
Norsigian said she thinks a lot of the well-meaning backers of Prop. 71 haven't looked at it closely. "A lot of people who support this now, if they knew the truth, they would feel differently," she said. "It's really unfortunate that the major critics have been the Catholic Church, because it's easy to discredit it. There are people with lots of deep reservations [about 71] who don't want to be associated with that. My response it that we can be articulate."
But the Yes on 71 campaign, started by a Silicon Valley developer whose child suffers from diabetes, has raked in more than $13 million in donations, many from high-profile people like Microsoft founder Bill Gates, actor Michael J. Fox, and New Jersey senator Jon Corzine. A chunk of the money comes from people who could benefit financially from advances in biotech, including Joseph S. Lacob and William K. Bowes Jr., venture capitalists who usually support Republican candidates and causes. But there's also plenty of money from unconnected donors who were likely swayed either by the heartstrings factor or the sense that this is another way to go after Bush _ or both.
In the mainstream media, the critiques of Prop. 71 almost always come from conservatives affiliated with groups like Focus on the Family, and the Prop. 71 campaign seems intent to group any other critics with them, despite huge political differences.
When asked about criticism from Beeson, Norsigian, and others, spokesperson Hutton told us, "I don't get why they're carrying the Catholic Church's water on this," then emphasized endorsements from pro-choice groups like the National Organization of Women and the Feminist Majority.
But members of the Pro-Choice Alliance Against Prop. 71, obviously pained when they're associated with religious conservatives, are holding their ground.
"I'm very strongly committed to women's right to an abortion," Beeson told us. "But I want people to see there are additional dangers within the realm of reproductive health."
Stevens acknowledged the difficulty of the task but struck a note of optimism: "Win or lose, Proposition 71 has the potential to put these issues before the public."
Yet with polls showing a strong lead for Prop. 71, and many anxious to brush aside any criticisms, you might say they don't have a prayer.
Research assistance by Laura M. Allen and Rachel Brahinsky. Read more about the arguments for and against this initiative on www.curesforcalifornia.com, www.allianceagainstprop71.org, and www.genetics-and-society.org.
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