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Senators launch campaign to amend stem cell program

by Paul EliasAssociated Press
March 16th, 2005

SACRAMENTO - Two state senators with opposite views on stem cell research forged an odd political alliance Wednesday when they introduced a proposed constitutional amendment to "reform" the new $3 billion California Institute for Regenerative Medicine, which is already facing two lawsuits seeking to put it out of business.

Sens. Deborah Ortiz, D-Sacramento, and George Runner, R-Lancaster, also introduced legislation banning for three years so-called "multiple egg donations" from women who voluntarily submit to hormone injections to "superovulate" in the name of research. If passed, that law would effectively prevent the agency from funding human cloning projects for medical research for three years.

Runner opposed Proposition 71, which passed in November and created the institute that is to dole out $3 billion in grants supporting human embryonic stem cell research. Ortiz, on the other hand, endorsed and campaigned for the initiative.

But Ortiz has grown increasingly concerned with some of the proposition's fine print that allows for key agency committees to conduct much of their work behind closed doors.

"There are some reasonable exceptions," said Ortiz, indicating the vetting of individual grant applications should be done in private, for instance. "But those exceptions ought not become the general rule."

The proposed proposition would also tighten the agency's conflict-of-interest policies and require that any medicine developed with agency funding be made affordable for all Californians and that all financial arrangements with pharmaceutical companies ensure that the state share in drug sales.

The two said the dramatic step of introducing a proposed constitutional amendment in the Legislature to be placed on the next California ballot, which needs two-thirds approval in both houses before being placed on the ballot, was necessary because Proposition 71, explicitly prohibits the Legislature from amending the initiative for three years. The proposition vested all the agency's decision-making power with a 29-member board appointed by Gov. Arnold Schwarzenegger and other elected officials.

"We believe there ought to be outside curbs," Runner said during a press conference at the Capitol Wednesday.

Ortiz and Runner insist they have widespread support in the Legislature and leaders of both houses said Wednesday they supported the legislation.

The duo also insist their action Wednesday wouldn't slow the agency's ability to issue its first grants, which it now hopes to do by October. However, the attorney general's office said the agency will be unable to sell bonds to a skittish market as long as the two lawsuits remain pending.

Interim president Zach Hall said Tuesday that he hoped for quick resolutions to the lawsuits, which allege the proposition illegally exempts agency members from conflict of interest laws and wrongfully places financial oversight of tax dollars in their hands.

Robert Klein and Ed Penhoet, the chair and vice chair of the committee that oversees the stem cell agency, said in a prepared statement released late Wednesday that nearly 60 percent of the California electorate supported Proposition 71.

"Their votes were not only an expression of hope, but also a vote of confidence that the Prop 71 initiative contains sufficient governance, oversight and accountability mechanisms to address the very same issues Sens. Ortiz and Runner discussed," the statement said. "The initiative anticipated and the institute is structured to provide significant conflict of interest regulations and medical and ethical standard, especially to protect women."

The legislation banning the multiple egg collection for three years needs a simple majority to pass, but Ortiz conceded it might run up against Proposition 71's prohibition against bills not viewed as "supplemental" to the initiative.

Nonetheless, she said the law is needed to protect the health of women who volunteer to take fertility drugs solely for research purposes.

Proposition 71 prohibits cloning to create babies but plans to fund human cloning projects designed to create stem cells. During a meeting with reporters Tuesday, Hall said cloning human embryos will give scientists better insight into how diseases begin and progress.

Those scientists vow to never remove the embryo from the petri dish and to destroy the creations after extracting the stem cells, according to the ballot language that forbids keeping experimental embryos longer than 12 days.

The basic idea is to take the genetic material - from the cell nucleus - from a patient's body and plop it into an unfertilized human egg. The implanted DNA then drives the egg to develop into an embryo.

To do that, California researchers will need eggs.

About 100,000 American women are injected annually with hormones to stimulate their ovaries to "superovulate" each year at fertility clinics in attempts to conceive babies. The process is arduous, and there's a 1-in-50 chance a patient will over-respond to the hormones, causing complications.

Ortiz, Runner and other critics of the practice said there may be long-term health consequences of fertility drugs and that a small percentage of women who go through the process may suffer adverse effects.

"The protection of women's health is not a Democratic or Republican issue," Runner said.

These issues weren't raised during last year's campaign, Ortiz said, and must be examined for the three years before conducting multiple egg donations.

The new legislative assault on Proposition 71 came on the same day that San Francisco, San Jose, Sacramento, San Diego and several other cities delivered bids that included free rent and other inducements to locate the agency's permanent headquarters in their cities.

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