Every year, dozens of reports are issued on the performance of California state agencies and commissions. Most of them are promptly noted, filed away and their recommendations ignored. Contrary to this norm, the California Institute for Regenerative Medicine requested a report on its progress from the prestigious national Institute of Medicine.
CIRM, which was created when voters approved Proposition 71 in 2004, responded by making dramatic changes in its policies and procedures. Yet that is not the impression left by The Bee's news story on our response to the IOM report ("Analyst: Stem cell agency reforms fall short," Feb. 1.)
Rather than ignore this report and take a defensive posture, the agency's oversight board did as The Bee's editorial board recommended in December when the IOM report was first released. At that time, the editorial board said we should take "a hard look at CIRM's internal structure and revamp it to avoid conflicts of interest."
Of course Dr. Harold Shapiro, lead author of the report, wishes that all of his recommendations had been adopted, but our oversight board made up of some of the most prominent leaders in science and medicine in California, dedicated patient advocates and leaders of the state's biotech industry had a responsibility to analyze and respond to this report according to its own best judgment. The way The Bee's story was structured left the impression that the IOM committee and its chair, Dr. Shapiro, were bitterly disappointed in our response, but in fact his own words give a very different picture.
In a letter sent to CIRM by Dr. Shapiro after seeing our proposal, he said: "The proposals you shared with me represent a very thoughtful and significant response to our recommendations and will, I believe, serve the long term interests of the citizens of California and the field of regenerative medicine. In particular these proposals take a significant step towards dealing with financial conflicts of interest, enhancing the credibility and integrity of the scientific review process, increasing the role of industry representatives, further clarifying the roles of the President and Board Chair, and establish the Scientific Advisory Board as the IOM Committee recommended."
At its last meeting, the board voted to:
Remove even the appearance of conflict of interest from its decisions, by stripping the representatives of institutions which might receive grant funding from their right to vote on any grants. (It should be noted that these institutional members, a minority of the board, have never had the right to vote on or discuss any grants going to their own institutions.)
Move the programmatic review of grant applications, a process used to balance our research portfolio, from the private grant review meeting to the public meetings of the board.
Reform the process for applicant appeals of recommendations of our scientific grants review group, giving more responsibility to CIRM's science staff to evaluate the facts behind an appeal before it is brought to the board.
The responsibilities of the president and the chair will be clearly defined.
Accelerate the pace of industry involvement with CIRM, something that has already begun in the last two years.
Create a scientific advisory board to provide counsel on such issues as funding priorities and portfolio strategy.
A great deal has been written by The Bee and others about the structure of CIRM's board and its governance. Some of the criticisms may be valid but there is little question that the results speak for themselves. We have made California the world's leader in stem cell research with unprecedented speed.
The IOM report itself cited CIRM for having "substantially enhanced California's position as one of the key international hubs of activity in regenerative medicine" through the research we have funded and the international collaborations we have established. Starting from nothing, as a brand new state agency, we have certainly made our share of mistakes, but we have also been an engine of development, a bright spot in our state's economy during a very difficult time.
Critics have cited the fact that most of the research funded by CIRM has been done at those institutions represented on the board but where else would that work have been done?
As The Bee noted, by passing Proposition 71 in 2004 with almost 60 percent of the electorate voting in favor "Californians embraced the idea of turning the Golden State into a hub for embryonic stem cell research." They have gotten what they voted for, and then some, as the IOM report also made clear.
When Proposition 71 was submitted to the voters, there was a real possibility that California and the entire U.S. would be left behind by one of the most dramatic advances in science and medicine in generations. The potential of regenerative medicine is nothing less than the possibility of taking some of the chronic diseases that have been a scourge of mankind for centuries and reversing them. Rather than being left behind, California chose to become what CIRM has helped to create: the Mecca for stem cell research, the place where scientists from around the world want to come.