Wednesday, November 13, 2019

Changes Afoot in $5.5 billion California Stem Cell Initiative: Sponsor of the Measure Reacts to Suggestions and Questions

The proposed $5.5 billion California stem cell initiative is being altered in the wake of questions raised by some members of the governing board of the state stem cell agency, which is facing its financial demise unless the measure is approved by voters next fall.

In a phone conversation and email this evening, Robert Klein, sponsor of the initiative, said a "substantial amount of disinformation and misperceptions" exists concerning the measure. He said he was altering three key areas dealing with ethics and conflicts of interest, affordability and creation of a new scientific advisory board. 

Klein is the only person at this point who can modify his initiative. The state-imposed deadline is Monday at 5 p.m.  The governing board of the agency, known formally as the California Institute for Regenerative Medicine (CIRM), is scheduled to meet at 9 a.m. on Friday to consider the Klein initiative. This week's meeting was scheduled following a testy board discussion last week. 

Klein directed the writing of the 2004 initiative that created CIRM with $3 billion in state bond funding. Only $27 million is left, and it is earmarked for sickle cell research. Klein also directed the 2004 ballot campaign and was the agency's first chairman. 

Klein said he has received hundreds of comments about the proposed initiative, which makes sweeping changes in CIRM and the way it works. Klein's initial email about the changes in the measure is brief. The full text is  below. He said he would send more details about the changes later this evening and was open to more suggestions as they come in. (Update: As of 5:49 a.m. PST today Nov. 14, Klein had not delivered the details of his changes, which will be carried on the California Stem Cell Report when they are received.)

Here is Klein's email to the California Stem Cell Report.


"There is a substantial amount of disinformation and misperceptions being spread about the 2020 Initiative. I have addressed 3 areas of clarification below. Later today I intend to complete a more in-depth statement that covers a large number of points, which I will send to you upon completion. I hope the information below will provide a starting point for clarifying the understanding of a number of provisions.

"Amendments
"Although counsel assured me that the original wording in the 2020 initiative, as to any adoption of National Academy of Science standards for ethics or conflicts, was discretionary for the board, there will be posted on the Americans for Cures website, and distributed to CIRM, revised language that specifically states that the adoption of any part of the National Academy standards would be discretionary for the board. The requirements for open meetings to change any standards has not been modified. It remains in place.

"In addition, I have received helpful comments on the Accessibility and Affordability Working Group; and consequently, I have modified those sections to make it clear that the focus of this group is to work with designated experts on achieving early public and private insurance coverage for therapies derived from CIRM funded research. Please read the language in this section (sec. 7, 125290.75) which also provides more description of the expertise and experience qualifications of the Working Group members recruited outside of the CIRM board members on this Working Group.

"For clarity of purpose, the provision that addressed a potential advisory board, selected by the President and the Chair, has been revised and relabeled as a “task force” authorizing section, for specialized objectives. The membership of any task force has been restricted to California residents. These task forces will not have any function in evaluating grants, which must be reviewed and evaluated by the “Grants Working Group,” as clearly required by the Initiative.

"As additional comments are received, further modifications will be considered.

"Thank you."

Americans for Cures is a stem cell advocacy group that Klein founded and chairs. Here are links to the actual initiative and also to a summary prepared by the California Stem Cell Report. 
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