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STEM CELL CONTROVERSIES CONTINUE TO GROW

Genetic Crossroads
May 31st, 2005

Recent developments in Washington DC, South Korea, and California have rocked the political and scientific worlds that now revolve around stem cell research. Taken together, the news raises hope that debate about embryonic stem cells will now shift to the serious societal issues that are unrelated to the status of embryos, and that the research can go forward with responsible oversight. But it also raises concerns that undue haste and insufficient attention could undermine both important social and ethical values, and the scientific effort itself.

The House of Representatives voted 238 to 194 to allow stem cell research with unused embryos in IVF clinics, an indication that a break in the long-standing political gridlock on embryonic stem cell research may be forthcoming. But President Bush immediately vowed to veto the bill, and posed for above-the-fold photos with an infant conceived from a frozen IVF embryo, reinforcing false assumptions that the status of embryos is the sole ethical issue in question.

Researchers in South Korea announced a more efficient method of producing stem cells from embryos produced by research cloning. The new techniques may assist research efforts, but heighten the urgency of regulation to prevent eugenic applications of this gateway technology. Commenting on their work in the same issue of Science magazine, two Stanford University scholars who support embryonic stem cell research raised concerns about women who will provide eggs for such research, and about widespread "therapeutic misperceptions."

A committee of the US National Academies issued long-awaited guidelines on embryonic stem cell research. The guidelines and the effort represent an acknowledgment of the urgent need for effective oversight, but fail to call for enforceable regulations and are inadequate in other ways.

The leadership of California's $3-billion stem cell institute adamantly resisted a reform bill authored by a state senator who was formerly a strong supporter, despite her agreement to seriously weaken the legislation. Three of the state's largest newspapers came out in support of the legislative reforms and criticized the institute's rebuff, with the Sacramento Bee's editorial page calling Robert Klein a "stem cell czar" and a "rogue operator."


Federal bill to expand funding for embryonic stem cell research

The US House of Representatives passed legislation that would largely remove the restrictions on federal funding of embryonic stem cell research put in place by President Bush in August 2001. The Stem Cell Research Enhancement Act would allow the federal government to fund stem cell research using embryos produced but unneeded for assisted reproduction. The bill would not allow federal funding of research using the technique known as research cloning or somatic cell nuclear transfer.

From the perspective of those who support embryonic stem cell research but advocate rigorous oversight of it, the bill is a step in the right direction. By attempting to focus where there is widespread agreement, it could help overcome the stalemate in
Washington.

Unfortunately, however, the bill does not provide protections against an important conflict-of-interest potential in the assisted reproduction industry. Though it prohibits payments for embryos, it could actually encourage IVF practitioners to retrieve greater numbers of eggs from women than they otherwise would, in order to produce more "leftover" embryos for stem cell research.

Although the bill is expected to pass the Senate, President Bush has promised a veto. In the face of defections among Republican legislators and opinion polls showing growing support for stem cell research using existing embryos, Bush argued that "there is no such thing as a spare embryo," thus furthering the polarization that obstructs the development of responsible policies regarding health disparities, protection of research subjects and egg providers, and oversight of gateway technologies.

CGS press release: "New Cloning Study and Federal Stem Cell Bill Highlight Need for Strong Biotechnology Oversight" (May 20)

National Academies guidelines for embryonic stem cell research

A special committee of the US National Academies released guidelines for human embryonic stem cell research amid fanfare in the scientific and popular media. While it is encouraging that scientists recognize the importance of the broader challenges posed by this research, the committee has failed to propose an effective policy structure. Instead, the voluntary guidelines leave each local institution free to adopt or reject pieces as they see fit. The report specifically declines recommending the adoption of binding national regulations, though that is the approach being taken in countries including the UK, Canada, Singapore, and South Korea.

The guidelines recommend that each institution conducting human embryonic stem cell research establish a local "embryonic stem cell research oversight" (ESCRO) committee. But these committees are likely to have close relationships with the scientists they are expected to regulate.

The guidelines recommend prohibiting three research activities, but qualify each recommendation with the stock loophole phrase "at this time." The suggested prohibitions are on inserting human embryonic stem cells into primate or human blastocysts, breeding human-animal chimeras, and allowing research embryos to develop beyond 14 days. The guidelines fail to address the problematic prospect of gene transfer into stem cells, which could open the technical door to inheritable human genetic modification.

CGS press release: "Comments on the National Academies Report, Guidelines for Human Embryonic Stem Cell Research" (April 26)

"Stem cell guidelines get mixed reception: Critics say voluntary rules are too lax," by Edie Lau, Sacramento Bee (April 27)

Research cloning developments

As reported in headlines around the world, a research team led by Woo Suk Hwang of South Korea announced the use of somatic cell nuclear transfer to derive genetically matching stem cell lines from eleven patients, and procedures that reduced the average number of eggs required for each line to less than twenty.

The increased efficiency means that research cloning could expose fewer women to intrusive and dangerous egg extraction procedures, but it does not eliminate the problem. As observers close to the biomedical world acknowledge, thousands of human eggs will still be needed for research. If any therapies are successfully developed, even more eggs will be required, putting women at risk and increasing costs of the treatments to the point where they may be inaccessible to most people. And the more widespread the production of cloned embryos becomes, the more urgent the need both for effective oversight measures to prevent their misuse, and for laws against reproductive cloning.

Much less widely noted than the research cloning development was a cautionary comment on it published in the same issue of Science by Stanford University bioethicists Mildred Cho and David Magnus. Among other concerns, Cho and Magnus point to the "major challenge" of procuring eggs without exposing women to serious risks, including death, that may not be justifiable within existing bioethical categories. They also caution against "misconception of therapeutic use," pointing to the "large gap between research and therapy…particularly in frontier areas of research where therapeutic impact in humans is unproven."

"Issues in Oocyte Donation for Stem Cell Research," by David Magnus and Mildred K. Cho, Science, (May 19) [PDF]

Opinion: "Eggs Over Easy? False Dawn for Stem Cell Cures," Michael Cook, BioEdge,
(May 25)

The California Institute for Regenerative Medicine: An update

The leaders of California's $3-billion stem cell research funding program, the Institute for Regenerative Medicine (CIRM), continue to resist legislative oversight of its activities - even as the proposed reforms are repeatedly weakened at their behest.

Increasingly, critics and supporters alike are criticizing CIRM's unwillingness to behave as a public agency responsible to the public interest. The editorial pages of California newspapers have called Robert Klein, the controversial chair of the CIRM's governing board, a "rogue operator" (Sacramento Bee, May 22) who has turned the agency into his "personal fiefdom" (Los Angeles City Beat, March 24), and have lambasted CIRM's leaders for "engaging in inexcusable rhetoric" (Los Angeles Times, May 26).

The CIRM's governing board, the Independent Citizens' Oversight Committee (ICOC), voted unanimously on May 23 to oppose one of the reform bills introduced by Sen. Deborah Ortiz (D-Sacramento) that has now passed unanimously out of two powerful legislative committees. Newspaper editorial boards that supported Proposition 71 are lining up to back Sen. Ortiz's reform bill, known as SCA 13, which would come before California voters in the next general election.

Nonetheless, some ICOC members have pulled out the rhetorical stops, asserting that the reform would "cripple" stem cell research and cause "extra suffering and deaths."

Unfortunately, after a May 25 meeting with Klein, Sen. Ortiz weakened some of SCA 13's key provisions, almost to the point of gutting the measure. Now, instead of mandating that the CIRM implement conflict of interest provisions equal to those of the National Institutes of Health, SCA 13 specifies weak requirements. For example, members of the three powerful advisory groups would not disclose their personal financial interests to the public. Instead, they will report conflicts to the CIRM itself, and the state auditor would evaluate these annually. This would not reassure the public that those who recommend how billions of dollars are spent, and develop critical research standards, are free of financial entanglements.

This is all the more critical because the ICOC is itself marred by conflicts of interest. Research by the Center for Genetics and Society has revealed that seven ICOC members have significant business connections with companies connected to stem cell research, including substantial equity investments and board memberships that may pose personal financial conflicts of interest. Such personal interests in stem cell research are just part of the problem. All investments by board members in biomedical companies raise concerns, as the CIRM is permitted to fund any biomedical research.

A lawsuit challenging the constitutionality of the stem cell research program is currently preventing the issuance of the bonds to fund the CIRM's research grants. In the meantime, ICOC Chairman Robert Klein has proposed raising $100 million from private "philanthropic sources" - groups that are likely to have preferences about how the money is spent.

If the stem cell project stumbles due to conflicts of interest, or even a loss of public trust, any potential therapies could be delayed for years. The overheated promises now common for stem cell research has caused observers to recall the promises made 15 years ago for another line of biomedical research, "gene therapy," which has yet to recover from the death of research subject Jesse Gelsinger in a 1999 clinical trial that was one of many marked by conflicts of interest and other serious lapses. In the long run, the potential for stem cell research is better served by proceeding wisely, not rapidly.

CGS press release: "Center for Genetics and Society reveals 7 of 29 on stem cell board may have personal conflicts of interest" (April 6)

"Celling out: The directors of stem cell institute have direct ties to biotech," San Francisco Bay Guardian (April 6)

"Stem cell panel facing allegations of conflict," Terri Somers, San Diego Union Tribune (April 7)

Opinion: "Stem Cell Agency on Errant Fast Track," Michael Hiltzik, Los Angeles Times (May 16)

"Stem Cell Dispute Heats Up," Rone Tempest, Los Angeles Times (May 24)

Editorial: "Stem Cell Research Accountability," Los Angeles Times (May 26)

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