Wednesday, March 09, 2005

Stem Cell Agency Rebuts Critics in Capitol

Legislative hearings opened this afternoon into California's new stem cell agency with an emphasis on questions unanswered during its creation and a look at whether public dollars are being well spent.

Making his first public appearance since being named interim president of the California Institute for Regenerative Medicine, Zach Hall took on the critics of the agency. In remarks prepared for delivery, he defended its positions on issues ranging from conflicts of interest to medical ethics.

“We have made a strong beginning, but we have a daunting task before us – to build a new Institute from the ground up. Nevertheless, we are confident that we will be able to begin our first grant-making activities in a few months,” he said.

“Decisions made by the Institute must be transparent and must be perceived to be fair and objective judgments based on scientific merit, free of bias and conflict of interest. To achieve this end, we welcome public comment and strongly desire to forge a positive working relationship with the California Legislature,” he told lawmakers, who will consider later this spring legislation to tighten oversight of the stem cell agency.

Absent from the hearing was Robert Klein, the chairman of the Oversight Committee of the stem cell agency and previously its most visible defender.

State Sen. Deborah Ortiz, chairperson of the Senate Health Committee and author of the stem cell regulation bill, said in a statement, “Voters overwhelmingly approved Prop. 71 because of the promise it holds for finding new medical breakthroughs for debilitating and life-threatening diseases that affect millions of Americans.

“In approving this important research, voters also ponied up $3 billion to $6 billion of their hard-earned tax dollars. It is critical that Californians remain confident that their public dollars are well spent and the state receives a fair financial return on its generous investment – both in royalties and affordable access to therapies that are developed.”

A statement from her office pointedly noted that the hearing is dealing with critical issues not addressed entirely in Prop. 71.

They include adoption of “conflict-of-interest and economic disclosure requirements to ensure members of the governing committee and working groups that award research grants are not tainted by financial holdings or affiliations with any university or disease advocacy group; determining how much of the work by the governing and working groups should be conducted in a public forum; ensuring the state receives a fair financial return on its investment through royalties and/or access to medical remedies and products developed; and adopting strict patient protection regulations and bans on financial gain for donating eggs.”

Also appearing before the hearing, co-chaired by Assemblywoman Wilma Chan, D-Oakland, chairperson of the Assembly Health Committee, were an array of critics and watchdog groups with statements prepared in advance.

The Pro-Choice Alliance for Responsible Research, Our Bodies Ourselves, the Center for Genetics and Society, and Suzanne Parisian, M.D., a former chief medical officer for the FDA, urged stronger medical and ethical controls on the use of eggs from women.

“If researchers begin experimenting ...on a large scale, they will need eggs from many thousands of women. Payment to these women for their eggs, even if it is considered reimbursement, would create an economic inducement for women to put themselves at risk. This would be especially true for poor and young women,” said Marcy Darnovsky, associate director of the Center for Genetics and Society.

Terry Francke, general counsel for Californians Aware, urged open meetings for working groups of the agency. He rebutted contentions that they are similar to advisory groups of the National Academy of Sciences.

Francke said the stem cell groups are akin to state legislative committees and that closed sessions would be “utterly alien to California law on meetings of official bodies.”

The Greenlining Institute said the agency should be sure that minority groups receive stem cell agency business. Jorge Carralejo, a Greenlining board member, said the agency should set “goals” of 15 to 25 percent of contracts for small, minority-owned businesses, including professional services.

“No contracts of $1 million or more be awarded unless the business or institution, including universities, has a supplier diversity program and discloses its results by race and ethnicity,” he said in remarks prepared for the legislative committee.

Hall's remarks touched on all of the areas mentioned by agency critics. He said the Working Groups will conduct their sessions in private because “no scientist will offer frank reviews in an open meeting in which his or her remarks could be seen as public criticism of a colleague and peer.”


Hall also said, “The Institute is committed to creating comprehensive medical and ethical standards through a deliberative process that incorporates recommendations from many sources. No research grants will be funded until ethical and medical standards are in place.”

On diversity, he said, “The Institute is committed to creating comprehensive medical and ethical standards through a deliberative process that incorporates recommendations from many sources. No research grants will be funded until ethical and medical standards are in place.”

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