The politics of science

Senator Deborah Ortiz wants to establish California as the leader in the therapeutically promising field of embryonic stem cell research. In doing so, the Sacramento Democrat sets out on a collision course with President George Bush and much of Congress, a decision she says is “a question of good policy, not politics.”

The opening volley in this developing battle came last week when the Senate Committee on Health and Human Services, which Ortiz chairs, approved a package of legislation regarding human cloning, embryonic tissue and stem cell research. This included the use of the controversial technique of creating embryos through non-reproductive cloning, only to destroy them in order to retrieve embryonic stem cells for research into medical therapies.

If the bills continue to gather the necessary legislative approvals over the coming months, their major scientific implications could be coupled with potentially explosive political considerations that could affect the governor’s race and perhaps even spawn a constitutional struggle over states’ rights.

But at its nucleus, this issue is the latest balancing act between medical hope and moral vertigo as humans assume ever-increasing powers over the earliest stages of reproduction.

Bill allows cloning
Passing out of the committee with a 7 to 1 vote, Senate Bill 1272 by Ortiz explicitly creates a state policy to permit embryonic stem cell research, in which the foundational cells for all the various tissues and organs in the human body are “harvested” from a two-week-old human embryo and are then directed to develop into a particular type of cell for cultivation into repair tissue.

The bill also specifically cites “somatic nuclear cell transplantation” among the research techniques to be permitted, a scientific phrase for cloning. It would make California the first state in the nation to make non-reproductive cloning a procedure explicitly allowed by state law. The legislation also for the first time sets up a regulatory framework for embryo research covering the private as well as the public sector. SB 1272 declares that no research could be carried out on an embryo in which the “primitive streak” has appeared, which is the very earliest indication of a neurological system and tends to show up after 14 days or so. The law also requires approval for all such research by a scientific ethics review board, and informed consent from anyone whose embryos are donated toward the research.

Ortiz’s bill is aimed directly at countering federal legislation passed by the House of Representatives last year outlawing human cloning, including non-reproductive research cloning. The measure has been endorsed by President Bush and is due to be taken up for a vote by the U.S. Senate in April. If enacted, anyone engaging in research cloning or any doctor prescribing therapies developed overseas which utilized research cloning, would be subject to criminal penalties of 10 years in prison and a $1 million fine.

Senator Dianne Feinstein has an alternative bill, which would prohibit reproductive human cloning, but permits research cloning. At the state Senate hearing last week, the Health Committee passed a resolution by Senator Ortiz calling on Congress and the president to reject the more restrictive bill and adopt the Feinstein approach.

The state Senate panel itself adopted this approach by also passing legislation by Senator Dede Alpert (D-San Diego) that extends a ban on reproductive cloning in California, a law originally authored by former Sacramento-area state Senator Patrick Johnston and enacted in the wake of the cloning of Dolly the sheep in 1997. The Johnston law expires at the end of this year. The new ban would have no sunset date.

Why is the cloning issue so closely tied to stem cell research? Scientists claim great promise in using embryos that have been cloned with the DNA of a particular patient, so that the resulting repair tissue or organ is a perfect genetic match for the patient, potentially overcoming rejection by the immune system.

Yet that science creates some complicated politics, wedding pro-life concerns about harvesting embryos with popular fears that human cloning efforts will reinvigorate the dark world of eugenics and the creation of genetically engineered “designer babies.” But to the scientists who work in this field, it’s about fighting disease.

Researchers believe that stem cell research offers the brightest hope for a new era of “regenerative medicine,” in which the damaged tissues of those suffering from chronic conditions—like heart disease, diabetes and spinal cord injury—can receive implants or grafts of healthy tissue.

Complicated politics
The hearing on the Ortiz bill had its share of strange bedfellows and new political divisions that have come to typify the emerging politics surrounding biotechnology. Sitting together in the hearing room’s front row were Stanford Nobel Laureate scientist Paul Berg, a renowned researcher in the genetics of cancer, and Hollywood producer Jerry Zucker (of Airplane! fame), who has an adolescent daughter with juvenile diabetes. Berg and Zucker are working as a team in both the state and national capitals to block prohibition of non-reproductive cloning for stem cell research.

As expected, pro-life groups opposed the Ortiz bill, but split on the Alpert bill banning reproductive cloning, which involves the implantation of the embryo clone in a woman’s uterus.

While the Committee on Moral Concerns supported the ban, other pro-life groups, including a prominent Catholic group, opposed it on the grounds that once an embryo has been created, cloned or not, it should be allowed to come to birth. This split was reflected in the committee vote, where pro-life Senator Jim Battin (R-La Quinta) voted for the reproductive cloning ban while pro-life Senator Ray Haynes (R-Riverside) voted against it.

California’s most vocal advocate of reproductive cloning, Mark Eibert, also appeared at the hearing to argue against the Alpert bill, though on the grounds that cloning is a reproductive technology which should eventually be available as an option for infertile couples. Accompanying him was University of Alabama medical ethicist Gregory Pence, an advocate of both cloning and genetically engineered children.

In his written statement, Pence argued that, “A child created through reproductive cloning would be a delayed twin, nothing more. Once one accepts the idea that twins are normal in nature, and that there is nothing wrong with what already occurs in nature, the initial ‘yuk’ factor is overcome.”

A new organization from the Bay Area, the Center for Genetics and Society, passed out a letter it had sent to Congress the day before calling for a ban on reproductive cloning and a moratorium on non-reproductive cloning. Signed by a hundred individuals generally identified as progressive—including former Senator Tom Hayden, former Clinton cabinet member Henry Cisneros, environmental writer Bill McKibben and reproductive rights advocate Judy Norsigian—the letter endorsed this “middle ground” because they fear that the creation of cloned embryos for research purposes would “increase the risk that a human clone would be born and would further open the door to eugenic procedures,” in which the embryos are engineered for desired genetic traits.

Members of the group have also expressed concern over the potential for exploitation of impoverished women in the U.S. and abroad to secure their eggs for use in therapeutic cloning. Other members have questioned whether the regulatory scheme outlined in the Ortiz bill is adequate in protecting against abuses. Asked about these and other concerns, Ortiz replied that the bill in its current form represented the beginning of the process for making this law.

Promising technology
The bill’s passage comes in the wake of a dramatic half-day “Informational Hearing” held by Ortiz at Stanford University on March 8 in which research scientists, clinicians and patients marshaled their evidence and arguments for aggressively pursuing the therapies and cures that could emerge from embryonic stem cell research.

Professor Hans Weirstead of UC Irvine showed a video in which a mouse with a partial spinal cord injury was able to regain bladder and bowel control and most of its ability to walk just eight weeks after treatment with new neurological tissue derived from embryonic stem cells.

Weirstead and others argued that embryonic stem cells show properties that alternative cell treatments do not, such as their abilities to grow rapidly and, once implanted, to migrate into the healthy tissue surrounding an injury or disease site so that the stem cell graft takes hold and is integrated into the body’s functioning.

At the same Stanford hearing, Dr. Irving Weissman, chair of a National Academy of Science’s panel on stem cells, said that embryonic stem cells also offered “the broadest window of research you could imagine,” for “virtually any common disease for which we inherit a risk.” By culturing the embryonic stem cells in a lab, the scientist said, one could identify the earliest genetic mutations of any inheritable disease risk.

Proponents of the research have not held back in their war of words against their opponents. Stanford’s Berg has called them “the terrorists of today’s biotechnology.” Weissman wanted the moral burden placed on the opponents: “Those who would ban such research must take responsibility for those future patients whose lives could have been saved or altered by such [embryonic stem cell-derived] treatments.”

Meanwhile, opponents have been making their case directly to the people, launching radio and television ads in the states of undecided members of Congress warning that scientists want to create “experimental embryo farms” and “embryo hatcheries.” Biotechnology activist Jeremy Rifkin, who shares the concern over use of cloned embryos for genetic selection and design, claimed that this technology will create “the ultimate shopping experience.”

Tough timing
Patient groups and individual patients have become heavily involved in the debate. Susan Rotchy, a young mother who suffered paralysis in 1995 after an automobile accident, warned the panelists and attendees at the March 8 hearing, “One way or another you will all be affected by this. Maybe not now. Maybe from a cancer 20 years from now. And you will be wishing, ‘Why didn’t I do something about this?’ Don’t be wishing. Do something now.”

Ortiz believes that so many like Rotchy are “suffering things like that, with their lives and their futures disrupted, that in this debate their story has to be told again and again.” She is optimistic about passage of her bill through the Senate and views the Assembly as generally supportive.

If her reading of the Legislature is correct, it could set up a political time bomb for Governor Gray Davis, in which he will have to make a decision on the bill five weeks before the November election. Political experts are divided over how this issue might play out politically in such a short time frame.

Senator Ortiz herself is so committed to the issue that she has been actively exploring with some of the state’s top health law attorneys whether California could find constitutional grounds to proceed with the research in the face of a federal ban.

Asked how it felt to be taking on the president and perhaps Congress, Ortiz replied, “We legislators are only here for a short time. We need to do everything we can while we’re here to address and alleviate the suffering.”