But that was about as far as it went.
Here are links to some of the stories this morning on the stem cell agency, the proposed constitutional amendment and other proposals. We are also carrying on this blog the joint press release from the two California senators, the statement from Robert Klein and Ed Penhoet and the statement from the Center on Genetics and Society because not all of them are available on their various web sites at the time of this writing.
See the CIRM statement and the one from Genetics and Society for their "welcoming" comments.
Megan Garvey, Los Angeles Times; Carl Hall, San Francisco Chronicle; Bill Ainsworth, San Diego Union Tribune.
SENATORS ORTIZ AND RUNNER
INTRODUCE LEGISLATIVE PACKAGE TO
PROTECT PUBLIC’S INVESTMENT IN STEM CELL RESEARCH
SACRAMENTO – Senator Deborah Ortiz (D-Sacramento) and Senator George Runner (R-Antelope Valley) today announced they will introduce two bills and a Senate Constitutional Amendment to ensure public accountability in the implementation of Proposition 71, the stem-cell research initiative approved by voters in November.
“To maintain the public’s confidence, the integrity of this important research and California’s significant financial investment, we must make sure meetings are open to public scrutiny, strict conflict-of-interest and economic disclosure standards are developed, patients’ rights are protected and the state receives a fair financial return on its generous investment,” Ortiz said.
“The voters of California did not vote for Proposition 71 so that biomedical companies get a windfall of billions of tax dollars with little or no accountability,” Runner said. “It’s critical that we establish the highest ethical conflict of interest standards, true operating transparency, and a direct benefit to Californians from their $6 billion investment.”
Proposition 71, the California Stem Cell Research and Cures Act, provides $3 billion in general obligation bonds to fund stem cell research and research facilities in California. The act established the California Institute for Regenerative Medicine, led by the Independent Citizen’s Oversight Committee (ICOC), to award grants and loans for stem cell research and research facilities.
Under the Ortiz-Runner constitutional amendment, employees of the Institute, the ICOC and members of the working or advisory groups will be subject to conflict-of-interest and financial disclosure requirements similar to those that govern California public officials and individuals serving or employed by the National Institute of Health. The legislation also will require that all meetings and records are subject to state open meeting and public record laws.
The measure will include strict guidelines to ensure clinical treatments, products or services resulting from the biomedical research are made available to California citizens and public health programs at affordable
costs. It also will require that all financial arrangements ensure the state recoups legal and administrative costs and a share of royalties or licensing revenues derived from the development of clinical treatments, products or services.
Ortiz and Runner also will jointly author legislation to provide for a three-year moratorium on multiple donations of eggs solely for research purposes. That bill will expressly prohibit payment in excess of reimbursement and require providers of fertility treatment services to give patients timely and appropriate information so they may make informed choices regarding the disposition of any human eggs remaining after fertility treatment. Fertility treatment providers also will be required to provide standard disclosures of medical risks, developed by the Department of Health Services, to women considering undergoing fertility treatment.
A second bill will require the State Auditor to conduct periodic financial and program audits of the ICOC and the Institute.
Because of provisions in Proposition 71, the Legislature may only make changes “in furtherance of” the initiative by receiving approval from voters. Legislative constitutional amendments require two-thirds majority approval from both the Assembly and the Senate to qualify for the ballot.
The Senators believe the provisions dealing with egg donations, patient protections and audits are “supplemental to” Proposition 71, and can be enacted by a simple majority vote of the Legislature.
“These measures will uphold our promise to the public that Proposition 71 is implemented in an open, thoughtful and deliberative manner,” Ortiz said. “We owe this public accountability to millions of Americans afflicted by conditions that may some day be cured through stem cell research, and to the taxpayers of California who are funding this critical research.”
# # #
Statement by Robert Klein, Chair
Ed Penhoet, Vice Chair
Independent Citizens’ Oversight Committee
For the California Institute for Regenerative Medicine
Regarding the News Conference Today in Sacramento by
State Senators Deborah Ortiz and George Runner
Wednesday, March 16, 2005
Emeryville, CA – Robert Klein and Ed Penhoet, Chair and Vice Chair, respectively, of the Independent Citizens’Oversight Committee for the California Institute for Regenerative Medicine, made the following statement regarding today’s news conference in Sacramento by State Senators Deborah Ortiz and George Runner:
“First of all, we want to acknowledge and express our appreciation to Senator Ortiz for her leadership in the area of stem cell research in Sacramento and throughout the State of California.
Senator Ortiz and the California Institute for Regenerative Medicine share the same goal: to support stem cell research and to ensure that California leads the way for finding cures for people with disease, illness and injury.
60 % of California voters cast their ballots last Fall, and more than 70 patient and disease advocacy groups, and medical, research and scientific organizations affirmed their hope in the promise of stem cell cures. 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 Senators Ortiz and Runner discussed today.
The initiative anticipated and the Institute is structured to provide significant conflict of interest regulations AND medical and ethical standards, especially those that protect women, based upon recognized and respected standards adopted by the National Institutes of Health. Those regulations and standards are in process of being developed by the Institute’s governing board, the ICOC, its subcommittees and working groups. The public and all interested parties have been, will be – and should be – active participants in this process. In addition, the National Academies of Sciences and Medicine are currently in the process of developing model medical and ethical standards for stem cell research – specifically to meet California’s timeline -- which are due public in April and shall be taken into full consideration by the Institute and the public in the coming months. And, it is important to note, that there are federal regulations already in place that will apply to future research conducted with Prop 71 grants to ensure the appropriate protections for all patients.
In the short few months that this Institute has been in place, we have made significant progress towards setting appropriate and necessary conflict of interest rules for staff. The ICOC is committed to adopting stringent conflict of interest policies and medical and ethical standards – with input from the public. In fact, we have now held 13 open public meetings in just 13 weeks.
We welcome Senator Ortiz, Senator Runner and their colleagues’ participation in this ongoing process, and we look forward to collaborating together with members of the Legislature and the public in this important endeavor.
At the time same time, the voters of California sent a clear message: they entrusted the Institute’s governing board, which is comprised of 29 prominent Californians -- leaders in academia, science, medicine, research, patient advocacy and business -- to move forward with the work ahead. This Board is dedicated to addressing all and more of the issues addressed by Senators Ortiz and Runner today.”
# # #
Critics of Proposition 71 Welcome Reform ProposalCenter for Genetics and Society, Pro-Choice Alliance for Responsible Research support proposal by Sens. Ortiz and Runner
SACRAMENTO – Public interest critics of California’s new stem cell institute, which was created by Proposition 71, welcomed a reform proposal announced today by Senators Deborah Ortiz and George Runner.
“The voters of California passed Proposition 71 based on promises of widely available cures, high ethical standards, and public accountability. They did not vote for throwing out laws that prevent secret meetings and guard against conflicts of interest,” said Marcy Darnovsky, associate executive director of the Center for Genetics and Society.
“We’re glad to see the Senators stepping up to protect Californians, who are the investors in this multi-billion dollar experiment.”
The Center for Genetics and Society and the Pro-choice Alliance for Responsible Research – who both support embryonic stem cell research but were prominent critics of Proposition 71 both before and after the recent campaign – expressed their support and optimism for the proposal’s passage.
“The Ortiz-Runner proposal will bring the public accountability and openness that the authors of Proposition 71 deliberately left out,” added Susan Berke Fogel, director of the Pro-Choice Alliance for Responsible Research. A moratorium on multiple egg extraction is critical to protect women’s health, as long-term effects of the drugs used are yet not known.”
The legislators’ announcement follows last week’s joint informational hearing on implementation of Proposition 71, chaired by Senator Ortiz and Assemblymember Wilma Chan. The hearing addressed many of the issues that have been raised by public interest critics, including conflicts of interest, open meetings, egg extraction, diversity in employment and hiring, health disparities, and financial returns to California.
“I hope that the leadership of the Institute realizes that this proposal will strengthen – not hinder – their work,” said Jesse Reynolds, program director at the Center for Genetics and Society. “The Institute must retain the confidence of the voters to be effective.”For more information, see http://www.genetics-and-society.org/policies/california/ .
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