Consumer Watchdog Welcomes Changes at Stem Cell Agency

Consumer Watchdog's John M. Simpson today welcomed the response by CIRM 

Chairman J.T. Thomas to address the recommendations for sweeping changes at the California stem cell agency. 

Writing on his blog, Simpson, a longtime observer of the agency, said, 

"It looks like the message is finally getting through to California's stem cell agency board....
"Part of what is driving the new approach is the realization that CIRM will need to find a new source of funding -- possibly going back to the voters -- if it is to continue.  As Thomas told the board today, "If we don't have credibility, we won't have a chance of sustaining the agency."

UC Davis Stem Cell Researcher: 'Ivory Tower' IOM Recommendations Harmful to California Stem Cell Agency

The $3 billion California stem cell agency has funded in the neighborhood of 500 to 600 scientists and institutions, reviving and starting careers and stimulating construction of $1 billion in new research labs around the state.

None of those recipients, as far as we know, has come forward to comment publicly on the sweeping recommendations by Institute of Medicine for changes at the agency. Until today, that is.

UC Davis researcher Paul Knoepfler, who may be the only stem cell scientist in the United States with a stem cell blog, weighed in with his thoughts today, which do not align with those of the blue-ribbon IOM panel.

“Harmful” is one word that Knoepfler, who is a stem cell agency grant recipient,  used to describe the recommendations. He predicted “extremely negative repercussions” that “would actually make CIRM less effective and less responsive to patients and California citizens.”

He wrote that the IOM report, which will come before stem cell agency governing board next week “...seems more like an ivory tower intellectual exercise than an operative, realistic guide to a dynamic agency that must operate in the real world.”

He defended the CIRM governing board, which came under fire from the IOM for conflicts of interest. Institutions linked to board members have received about 90 percent of the $1.7 billion that the board has awarded, according to compilations by the California Stem Cell Report. The IOM said,

“Far too many board mem­bers represent organizations that receive CIRM funding or benefit from that funding. These com­peting personal and professional interests com­promise the perceived independence of the ICOC, introduce potential bias into the board’s decision making, and threaten to undermine confidence in the board."

Knoepfler said,

“(The) IOM itself admits there is no evidence that any conflicts of interest have ever guided (the agency's governing board) decisions. Not one example.”

Knoepfler also wrote,

“Interestingly, highlighting the extremely sensitive nature of this issue, while I’ve been talking with many bigwigs about this, at this point no one is wiling to go on the record with an opinion about it except one courageous soul, Don Reed (see his piece here).”

There is a reason for that. The IOM is the most prestigious organization of its sort. Its studies are described as the gold standard. And it has a rareified membership that many scientists seek to join. So few are ready to give the organization a smack on the nose. Likewise, California researchers are loath to publicly criticize the stem cell agency because it holds the strings to the purse that finances their careers.

California scientists, however, should be asking themselves a bottom-line question. Do they want to see the stem cell agency continue for another 10 to 20 years? Under the best of circumstances, that may be unlikely given the other pressing needs that the state faces. But if CIRM directors do not forthrightly address the recommendations of the IOM panel, the fate of the stem cell agency is exceedingly uncertain.

Patient Advocate Says IOM Recommendations Would 'Destroy' California Stem Cell Agency

California's “beloved,” $3 billion stem cell research program should not be altered despite recommendations from the most prestigious scientific organization of its kind. So says longtime patient advocate Don Reed of Fremont, Ca.

Reed says the recommendations by the Institute of Medicine (IOM) are a “threat” that would “destroy” an agency that “is like nothing else on earth.” Reed is urging other patient advocates to turn out at next week's critical meeting of the stem cell agency's board and lobby against alterations in how it does business.

Reed and CIRM's Amy Adams
World Stem Cell Summit photo

Reed is a fixture in stem cell circles nationally and in California and has been a regular at the stem cell agency's public meetings since 2004. He is also vice president of Americans for Cures, a private stem cell lobbying group created by Robert Klein when he was chairman of the stem cell agency,  formally known as the California Institute for Regenerative Medicine(CIRM).

Reed has written twice about the IOM report on his blog with duplicate publication on the Huffington Post. Yesterday, he said IOM “defies” the voters' will when they created the stem cell agency in 2004. On Dec. 19, he said the $700,000, 17-month study was “staggeringly misguided.” He wrote,

“If its recommendations were enacted, they would silence stem cell patient advocate involvement, eliminate public debate on funding proposals, and delegate the real decisions to secret proceedings by an out-of-state-controlled board.”

Reed described the stem cell agency as “fantastic” and wrote,

“So why mess with it, in such a brutal and insulting manner?”

This writer has known Reed since the early days of the stem cell agency and respects him. But in this case he has many of his facts wrong. To mention just a few key points: Patient advocates would not be silenced; their role would be changed. Public comment would not be eliminated. Scientists could still appeal negative decisions by reviewers to the full board if they so choose, although the “extraordinary petition” process would be eliminated. The voters' will would not be defied; they provided for a mechanism for making changes in the stem cell program.

While Bob Klein has not been heard from publicly on the IOM report, some of Reed's comments reflect Klein's past positions against altering the agency. Klein, an attorney and real estate investment banker, might well be considered the father of the agency. He directed the writing of the 10,000-word measure, Prop. 71, that created the program and wrote much of ballot initiative himself. The initiative contained a detailed description of the qualifications for the chairman, which fit only one person in California. It was no surprise when he won the post.

In years past, Klein has been extraordinarily protective of the ballot measure, at one point boxing in the board on earlier proposals for changes that he disliked and that the IOM report now echoes.

In 2010, he was the prime advocate for commissioning the IOM report which he expected to serve as the basis for continued funding of the agency. It will run out of cash for new grants in 2017.

To keep the money rolling in, Klein said the IOM report would constitute a “gold standard” that would generate increased enthusiasm for the research.

According to the transcript of the Aug.18, 2010, governing board meeting, Klein declared,

“(We will) never convince the people that are adamant against us. But for the public and for the constituent groups that are reasoned and prepared to look at evidence, this is a very important validation that they can look to to separate out what is a false claim from real performance.”

Also writing yesterday about the IOM study was Bradley Fikes of the San Diego U-T, the dominant daily newspaper in that area.

He summarized Reed's latest item as well as this on the California Stem Cell Report yesterday. Fikes plans to file his own story within the next few days.

Feel free to file your own comments by clicking on the word “comment” below or with the stem cell agency at info@cirm.ca.gov. Anonymous comments are permitted on this blog.

Nature Biotechnology: California Stem Cell Agency Receives 'Stinging Rebuke'

The headline this week in Nature Biotechnology read: “IOM smacks down California Institute of Regenerative Medicine.”

The story by Senior Editor Laura DeFrancesco said that the $3 billion California stem cell agency “received a stinging rebuke of much of the way it has been carrying out its business by a group of independent reviewers.”

At the same time, DeFranesco wrote that the blue-ribbon, Institute of Medicine panel “praised the courage and vision of the individuals who spearheaded the program as well as those toiling in the CIRM office in San Francisco.”

The Nature Biotechnology piece covered familiar ground for many readers, summarizing the IOM's sweepingrecommendations last month, including those dealing with the built-in conflicts of interest on the agency's 29-member governing board.

DeFrancesco wrote that is unclear whether the agency will move to adopt any of the recommendations from the panel, many of which have been rejected in the past.

Some members of the CIRM governing board last month bristled at some of the recommendations. The board is scheduled to discuss the IOM report, for which it paid $700,000, at a public meeting Jan. 23 in Berkeley. Patient advocates are already organizing a turn-out to lobby against some recommendations.  

San Diego Newspaper Calls for Major Changes at California Stem Cell Agency

The San Diego U-T today ran an editorial that was headlined “Stem cell research institute must fix itself.”

The editorial was written in response to findings by the Institute of Medicine that the $3 billion California stem cell should make sweeping changes to deal with issues ranging from conflicts of interest to management structure.

The San Diego U-T editorial came as part of a unanimous reaction so far from California newspapers.

The San Diego paper said,

“We hope we are wrong in thinking that, given the number of times the same criticisms of CIRM have come up over the past seven years, the agency doesn’t really take them seriously.

“If that is the agency’s attitude, it could well be a fatal error. CIRM has enough money remaining from the original $3 billion to continue awarding research grants for another four years. But it will either have to go back to California voters in 2014 or 2016 for another bond issue to continue its operations or find a different source of funding.

“Whichever CIRM decides, whoever is asked to foot the bill, either taxpayers or the private sector will demand transparency and accountability. We hope CIRM can demonstrate it.”

Boxing in the California Stem Cell Board

Robert Klein is much admired for his prodigious efforts on behalf of stem cell research, including his service as the first chairman of the $3 billion California stem cell agency.

Klein was adept at many tasks, such as directing the ballot campaign that resulted in passage of Proposition 71 in 2004 and creation of of the agency. One of Klein's less publicly recognized skills was putting the governing board of the agency in a box from time to time.

The 29 members of that board could well be headed for another box – this time in connection with their position on the Institute of Medicine's sweeping recommendations for major changes at the stem cell agency.

Here is how that could work based on a similar situation in 2009 involving Klein and the Little Hoover Commission, the state's good government agency.

Klein did not welcome the inquiry by the commission, which was requested by state lawmakers who had butted heads with Klein. He knew that the commission would come up with recommendations that he would find odious.

So even before the Hoover report was released in its final form, Klein had the board's outside counsel, James Harrison, prepare a legal memo on a draft version of the study. Harrison's memo said many of the most far-reaching recommendations of the commission would require a vote of the people – a more costly and unlikely proposition than a vote of the legislature.

Harrison's memo was dated June 23, 2009. The commission report was released June 26, 2009. On June 30, 2009, Klein warned directors in an email that support of some of the proposals would violate their oath of office. The first time a subcommittee of directors had to a chance to react publicly came on July 16, 2009. The full board did not have the Hoover report on its agenda until Aug. 6, 2009. By that time, they were thoroughly boxed in.

Their choices were minimal, even if they disagreed with Klein. To do anything other than go along with him would mean rejection of a 10-page legal opinion from Harrison, which could be interpreted as no-confidence vote on Harrison and possibly Klein. Board members were not interested in losing Harrison, who has been valuable asset to the board since day one. Overthrowing Klein was even less likely in 2009.

Harrison is currently revisiting his 2009 memo in the wake of the Institute of Medicine recommendations, which echo some of the major Hoover proposals. The board has also scheduled a workshop for Jan. 23 that will discuss the IOM proposals.

If Harrison produces another legal memo that is as explicit as the 2009 document, CIRM directors will have few choices.  The best procedure may well be for Harrison to continue his work on the memo until after the Jan. 23 meeting. Directors could then decide on initial steps in connection with the IOM recommendations and ask Harrison how they can proceed legally, although the task is really more of a political challenge than a legal one.

Directors paid $700,000 for the IOM's evaluation and advice. It is a prestigious body with virtually no critics in the scientific community. It would be odd, to say the least, for CIRM directors to now reject major recommendations from the blue-ribbon panel only because the proposals might require a statewide vote. The response is likely to be from some: Well, stem cell directors, let's have a statewide vote, and we expect you to support the IOM changes if you plan to seek additional state funding. 

Placing another stem cell measure on the ballot -- with or without related additional funding for the agency -- would bring into play a host of issues, including possible elimination of the agency. Not to mention disturbing existing stakeholder relationships and raising uncertainty in the scientific and biotech business communities. 

Directors believe the agency has made a major contribution both to California and to science. So does the IOM. The directors need to move forward on the IOM recommendations if they are to continue their research efforts beyond 2017, when cash for new grants runs out.  And putting the board in a box is not the best way to give them the room they need to maneuver. 

California Editorial Unamity: Stem Cell Agency Needs Revamp

With the addition of another editorial this week, reaction among California newspapers so far has been unanimous that the $3 billion California stem cell agency should heed the sweeping recommendations of the prestigious Institute of Medicine.

The Riverside Press-Enterprise added its voice yesterday, declaring,

“Good intentions do not justify poor practice.”

Like others, the newspaper said that the agency “needs to revamp its governance structure to avoid potential conflicts of interest and boost public confidence in the agency.”

The Riverside paper focused on the conflicts of interest at the organization, which has seen about 90 percent of its funding go to institutions with ties to directors, but also supported other recommendations, including elimination of the dual executive arrangement at the research effort. 

The editorial said,

“An agency spending Californians’ money has no business being cavalier about good government practice and ethical safeguards — no matter how promising the potential therapies might be. The stem-cell institute is not a private fiefdom, but a taxpayer-supported undertaking. Yet many on the stem-cell institute’s board objected this month to the report’s recommendations.

“The agency also said that Prop. 71’s provisions mean that enacting many of the proposed fixes would require either a supermajority vote of the Legislature or another ballot measure. That prospect should warn Californians about the dangers of voting for complex, costly, politically driven initiatives that have little to do with fundamental state duties.

“Still, the stem-cell agency cannot just sit on these recommendations without damaging its credibility. The search for medical breakthroughs does not justify ignoring vital safeguards for spending taxpayer dollars.”

For a look at other editorials, see here and here.

Southern California Newspaper Tackles Stem Cell Agency and UC Irvine Grants

The Orange County Register today zeroed in on the $3 billion California stem cell agency and its relationship to the local University of California campus in the wake of sweeping recommendations for changes at the eight-year-old agency.

The article by Melody Petersen was headlined “Ties to stem cell board lucrative.”

Petersen began her article with story of the $20 million award to StemCells, Inc., earlier this year and the firm's partnership with Frank LaFerla of UC Irvine, which is located in Orange County.

The award was rejected twice by reviewers at the stem cell agency but the governing board of the agency (CIRM) approved it on a 7-5 vote in September following lobbying on behalf of the company by the board's former chairman, Robert Klein, and others.

Petersen said the award was not the first time that questions have been raised about stem cell agency grants. She said that the 17-month study by the prestigious Institute of Medicine (IOM) and some of its findings, particularly those dealing with conflicts of interest, echoed criticisms that have been raised for years.

She wrote,

“Repeated independent reviews of the agency, including one by the (IOM) released this month, have found that its board is rife with conflicts of interest. In fact, of the $1.7 billion that the agency has awarded so far, about 90 percent has gone to research institutions with ties to people sitting on the board, according to an analysis by David Jensen at the California Stem Cell Report, which closely follows the agency's operations.

While the agency has yet to produce a cure, Petersen said,

“What's clear already is that the money has transformed stem cell research in California and poured hundreds of millions of dollars into the state's universities, including UC Irvine.”

She noted that the CIRM governing board is dominated by members from the UC system, including two professors at UC Irvine.

Peterson continued,

“Before Proposition 71 (the measure that created the agency) passed, UC Irvine had less than ten stem cell scientists, who received about $1.5 million in funding each year. Now, after receiving $100 million in grants from the state agency, the university has sixty scientists working to advance stem cell research and teaching. It touts itself as one of the top stem cell research centers in the world. In 2010, it opened an $80 million four-story stem cell research center with the agency picking up $27 million of the cost.

“As UC Irvine has won increasing amounts of taxpayer money, its two professors who sit on the agency's board have risen in status on campus.

Susan Bryant
UC Irvine photo

“Professor Susan Bryant, an expert in regenerative medicine, was dean of the School of Biological Sciences when she was named to the agency's board in 2004. She was then promoted to vice-chancellor of research. In July, she was named the university's interim executive vice-chancellor and provost, its second most powerful administrator.

“When Professor Oswald Steward, a stem cell scientist, joined the agency's board in 2004, he was director of UCI's Reeve-Irvine Research Center for Spinal Injury. Since then, the scientists working in his center have received millions of dollars in grants from the agency. In May, the university rewarded Steward with an additional title: senior associate dean of research for the School of Medicine.”

“The two professors are prohibited from receiving any agency funds for their own scientific work. But so much money has been funneled into the stem cell field in California that it can be difficult to show their continued scientific efforts are not somehow benefiting. For example, Bryant co-authored a scientific article in 2009 with nine other scientists about the genetics of salamanders, which can regenerate limbs. In the report, the group recognized the state agency for partially funding their work. Bryant said that the money was received by another scientist in the group who was not employed by UC Irvine. She said the state agency has never given a grant for research involving salamanders. 'I have never-ever benefited from CIRM funding,' Bryant said using the agency's acronym.

Os Steward
UC Irvine photo

“Steward said he stopped his stem cell research when he joined the board in 2004. His board position, he said, 'has prevented me from taking on lines of research I otherwise would do.'

“Tom Vasich, a campus spokesperson, said Bryant and Stewart's positions on the agency's board played no part in their promotions and success at the school.”

Petersen additionally reported that Steward and Bryant are not allowed to vote on grants to UC Irvine.

Petersen pointed out that the University of California has 16 members on the 29-member board. One of those is the chairwoman of the UC Regents, Sherry Lansing. Petersen also noted that three of the UC officials, including Steward, hold seats on the board as patient advocates.

Petersen is a recent addition to the Register's staff, joining it in November as an investigative reporter. She worked as a business reporter for the New York Times and authored  "Our Daily Meds," a book about the pharmaceutical industry. She shared in the top award in newspaper financial journalism when she was at the San Jose Mercury News.  

Two More Editorials: The California Stem Cell Agency Should Heed IOM Recommendations for Reform

Two other major California newspapers today said the $3 billion California stem cell agency needs to “clean up its act” if it wants to be successful in continuing its efforts at turning stem cells into cures.

The editorials appeared in the Los Angeles Times, the state's largest circulation newspaper at more than 700,000, and the San Jose Mercury News in California's Silicon Valley. The Mercury News has a reported circulation of nearly 600,000, although that figure includes other Bay Area newspaper owned by the same chain.

Both editorials focused on the 17-month evaluation of the agency by the prestigious Institute of Medicine (IOM) as did earlier editorials in The Sacramento Bee and the San Francisco Chronicle. The IOM recommended sweeping reforms at the agency that would alter its structure and target conflicts of interest. 

The Times said,

“The $700,000 spent on the study...will be wasted if the institute's oversight board fails to heed the (IOM) committee's criticisms, which echo the findings of the Little Hoover Commission and other groups over the years.”

The editorial continued,

“The 29-member board is made up almost entirely of representatives of advocacy groups and research institutions that have a direct interest in how the money is spent.”

The Times cited the California Stem Cell Report's calculations that about 90 percent of the $1.7 billion awarded by CIRM has gone to institutions linked to current and former members of its governing board. 

The Times noted an award to a Northern California firm that has stirred some criticism. The editorial said,

“The board also overrode the advice of its scientific advisors — twice on a single application when it considered a grant for a well-connected company, StemCells Inc. based in Newark, Calif. The board granted the company $20 million after Robert Klein, the driving force behind the passage of Proposition 71, which created and funded the agency in 2004, and its former head, lobbied so intensively for the company that one board member described it as 'arm-twisting.'"

The Times concluded,

“The agency has used more than half of its funding and one day will almost certainly want to ask taxpayers for more. It should remember that voters will look for evidence of public accountability as well as respected research.”

The San Jose paper sounded a similar note about the agency. Its editorial said,

“(I)f it wants to survive...it should heed the Institute of Medicine's advice to eliminate conflicts of interest on its board -- and do it before awarding the remaining $1.2 billion of the $3 billion voters approved for stem cell research.”

But the paper said the stem cell agency should not be provided any more state funding.

“Long-term funding was never the intent when Proposition 71 passed in 2004. It was supposed to kick-start research at a time when federal funding was blocked and to establish California as a major player in the rapidly advancing medical field. 

“The agency could continue to bring value to the state as an advocate and funder of research, but only if it can attract private donors, partners and investors. For that to happen, it will need a board that passes the ethics test, with more independent experts and industry executives free of conflicts. 

“At the outset, stem cell advocates took immense pride in structuring the agency to keep it relatively free of legislative interference despite the use of public money. Politicians kept their hands off, which was good. But the agency created its own inappropriate influences in the way it constituted its board. Now it needs to clean up its act.“

Meager Coverage of Yesterday's Bristling IOM-CIRM Meeting

Mainstream news coverage today was skimpy, to put it mildly, of the testy session yesterday involving the governing board of the California stem cell agency and representatives of the prestigious Institute of Medicine(IOM).

Only two pieces appeared, one in the San Diego U-T and another on the web site of the Los Angeles Times. Both discussed what the Michael Hiltzik of the Times column called “overt hostility” on the part of several board members (see yesterday's item here). Bradley Fikes of the San Diego paper said the patient advocates on the board “strongly criticized” the IOM report on the grounds that it “unfairly suggests that they have a conflict of interest.”

One of the recommendations of the IOM is that the agency develop ways to manage personal conflicts of interest dealing with patient advocates and others at the agency.

Fikes wrote,

"'I'm a colon cancer survivor,' said Art Torres, vice chairman of the oversight committee, and a patient advocate designate. 'Does having colon cancer make me biased?'
“Jeff Sheehy, another patient advocate designate, protested what he called a 'defenestration' of patient advocates, whose interests often span multiple diseases.”

Ron Leuty of the San Francisco Business Times skipped the IOM matter and wrote about the awarding of $36 million in grants. However, a list of the most popular stories on the Business Times web site, ranked as No. 5 Leuty's story last week on the IOM study, just below an article about Stanford's $111 million concert hall.

Fikes also had a piece on ViaCyte, which is in his area, receiving another $3 million from CIRM.

LA Times: On the California Stem Cell Agency and Wasting $700,000

The headline on the Los Angeles Times web site this afternoon read,

"Is California's stem cell program preparing to waste $700,000?"

The question was raised by Pulitzer Prize-winning columnist Michael Hiltzik, whowas commenting on the presentation today by the prestigious Institute of Medicine's (IOM) on its sweeping recommendations for changes at the state stem cell agency. 

Hiltzik wrote, 

"If you're betting that the California stem cell agency will spurn key recommendations of a blue-ribbon review panel that criticized its leadership and management structures, you might want to double that bet. Several board members showed overt hostility to the panel's recommendations during a public meeting today."

Harold Shapiro, chairman of the IOM panel and former president of Princeton University, delivered the briefing. The group's study took 17 months and cost the stem cell agency $700,000.

Hiltzik's piece summarized the IOM proposals, which echoed many criticisms that have been aired for years in California.  Hiltzik wrote, 

"CIRM Chairman Jonathan Thomas glided over those issues when he introduced Shapiro. Thomas observed that the Institute of Medicine report included many statements "validating CIRM, its process, what it was able to achieve," which is a bit like launching the investigation of a plane crash by focusing on all the planes that land safely every day. Thomas did mention that the Institute of Medicine had made numerous recommendation about how to "take something which is already a great experience and improve it even further." 

"Shapiro got only a few minutes into his presentation before board members started interrupting him with objections to the Institute of Medicine's recommendation for a majority of independent members."

Hiltzik concluded, 

"Thomas promised to stage a public workshop on the Institute of Medicine report soon and to subject them to 'lengthy discussion.' 

"Does that sound as if the board will be taking seriously the advice that it change the way it does business? Stay tuned, but don't hold your breath."

Constitutional Questions Raised on Sweeping Changes at the California Stem Cell Agency

The outside counsel to the governing board of the California stem cell agency is preparing an opinion on whether some of the major changes recommended by the blue-ribbon Institute of Medicine(IOM) study might require a vote of the people.

More than three years ago, the same issue was raised  and used by the agency to resist unwanted changes.

Kevin McCormack, agency spokesman, said today that James Harrison of Remcho Johansen & Purcell of San Leandro will perform the analysis. Harrison has been counsel to the CIRM board since its inception. He also wrote part of Proposition 71, which created the stem cell agency in 2004.

Harrison's analysis was disclosed after CIRM Director Sherry Lansing, who is also chairwoman of the University of California Board of Regents, said this morning that the board's "hands are tied" concerning some of the IOM proposals because they could require a vote of the people. Other members of the board bristled at the IOM recommendations.

In 2009, Harrison tackled a similar task in connection with related, proposed structural changes at the $3 billion stem cell research effort. In reaction to proposals by the Little Hoover Commission, the state's good government agency, Harrison said,

“The Little Hoover Commission’s proposals would effect drastic and disruptive changes to CIRM’s governance and operating systems. Such changes run counter to the voters’ intent, and do not further Proposition 71’s purposes.”

The California Stem Cell Report wrote at the time, 

"The 10-page legal memo hung most of its arguments on a provision in Prop. 71 that states that it can only be amended by the legislature if the changes 'enhance the ability of the institute to further the purposes of the grant and loan programs.'
"Harrison's memo said the Hoover proposals (in question) could only be enacted through another ballot measure...."

The Little Hoover proposals dealt with the structure of the board and the conflicting responsibilities of the president and the chairman. The IOM has recommended major changes in both areas and approvingly cited the Hoover study .

Harrison's analysis will also delineate which IOM recommendations can be implemented by board action and which will require legislative approval.

The IOM report, which cost the stem cell agency $700,000, recommended a host of changes that critics for years have said are needed. But the 17-month study also went beyond what the critics had proposed. The IOM said that the 29-member governing board should be stripped of power to approve individual grants. Instead, the board would be limited to voting for or against a slate of applications.

The IOM also proposed far-reaching changes to remove conflict of interest problems, clean up a troubling dual-executive arrangement and fundamentally change the nature of the governing board. The recommendations would greatly strengthen the role of the agency's president, significantly alter the role of patient advocates on the governing board and engage the biotech industry more vigorously.

CIRM's governing board and its first chairman, Robert Klein, an attorney who directed the writing of the stem cell initiative and wrote parts of it, have mightily resisted related proposals. In 2009, Klein even warned of lawsuits if legislative action were initiated for reforms (see here and here). 

In an editorial today, The Sacramento Bee said changes are long overdue at the agency. The Bee said CIRM has "been consumed by a siege mentality that has prevented any real introspection.”  In another editorial earlier this week, the San Francisco Chronicle said that prompt and major changes are needed at the agency.

Many of the more significant recommendations clearly require either a rare, super, supermajority vote of the legislature (70 percent) and the signature of the governor or another ballot initiative, which is very unlikely. Achieving the 70 percent vote is exceedingly difficult except on the most noncontroversial matters before the legislature. The requirement permits only 13 members of the 40-member Senate to block any CIRM legislation, giving minority viewpoints extraordinary power over the content of any CIRM legislation.

(See here for a list of IOM recommendations that would likely require legislative action.)

Some California Stem Cell Board Members Bristle at IOM Recommendations

Some directors of the $3 billion California stem cell agency today sharply challenged recommendations by the Institute of Medicine(IOM) concerning conflicts of interest and the role of patient advocates on the governing board.

Much  of the criticism came from the 10 patient advocate members on the board, whose roles would be significantly altered  under the IOM recommendations. Jeff Sheehy, a patient advocate for HIV/AIDs and vice chairman of the agency's grant review group, said he saw no evidence in the IOM report for its recommendations regarding patient advocates. He said,

 "If you had some here, I would be more comfortable." 

He continued,

"We are not all powerful. We are a minority on the (29-member) board." 

Jonathan Shestack, another patient/adovcate director, said the IOM's conclusions on "conflicts of interest could not possibly be more incorrect than they are." He said,

"Advocates are here to advocate."

Harold Shapiro, chairman of the IOM study, said, "We are not against patient advocates." He said that the IOM supports advocates and that its recommendations could increase the role of patient advocates, albeit in a different manner.

Shapiro added that conflicts of interest do not necessary bar participation by board members. He said, however, they must be disclosed and managed.

Director Robert Price of UC Berkeley said,

 "We have gone to great lengths to manage conflicts of interest."

The IOM recommended that all board members be removed from the grant review process, which would be turned over to the CIRM president. The board would only vote on a slate of applications, not individual grants. More disclosure would be required of personal conflicts of interest, including health matters, that the board said research has shown can create bias.

 The IOM report said,

 “Far too many board mem­bers represent organizations that receive CIRM funding or benefit from that funding. These com­peting personal and professional interests com­promise the perceived independence of the ICOC(the CIRM governing board), introduce potential bias into the board’s decision making, and threaten to undermine confidence in the board.”

More than 90 percent of the $1.7 billion that the CIRM board has awarded has gone to institutions that are represented on the CIRM governing board.

J.T. Thomas, chairman of the CIRM board, said that the agency takes the recommendations "very seriously" and that they would discussed further at a board workshop in early January. The workshop is scheduled to be public but the date and location has not been announced. Thomas said the recommendations will receive "lengthy discussion" thereafter and review by appropriate subcommittees of directors.

No one from the public commented during the roughly 90 minute discussion.  Eighteen out of 29 board members were present at the beginning of today's meeting.

Sacramento Bee and IOM: Restructuring Needed at California Stem Cell Agency

The Sacramento Bee today praised the Institute of Medicine (IOM) recommendations for wide-ranging changes at the $3 billion California stem cell agency.

The newspaper's editorial and an earlier one in the San Francisco Chronicle come as the IOM formally presents its findings this morning to CIRM directors, some of whom would likely lose their seats if the recommendations are implemented.

The Bee said that for years “numerous outside critics” have recommended similar changes at the state agency to avoid conflicts of interest and possible misuse of public funds. The Bee wrote,

“Instead of listening, leaders of this institute(CIRM) – a poster child of how ballot initiatives can be manipulated to create quasi-public institutions with little public oversight – have been consumed by a siege mentality that has prevented any real introspection.”

The Bee noted that about 90 percent of the $1.7 billion handed out by the eight-year-old agency has gone to institutions connected to members of the 29-member governing board. One of the IOM recommendations would bar the board from voting on individual grant applications. Instead, the applications would be voted on as a block.

The Bee continued,

“It is to CIRM's credit that it solicited the Institute of Medicine report last year. Although some taxpayers may blanch at the report's $700,000 price tag, it will be worth the cost if it leads to a restructuring of how CIRM operates. 

“Of course, if it fails in that task, it will only affirm the view of many voters that they should never again endorse a California research initiative, especially one like Prop. 71 that lacks proper controls and accountability over taxpayer dollars.”

IOM Report: Chronicle Says Prompt and Major Changes Needed at Stem Cell Agency

The San Francisco Chronicle today said the $3 billion California stem cell agency needs to make major changes “to avoid conflicts of interest and retain its credibility with the public, and it needs to do so sooner rather than later.”

In an editorial that came in response to the sweeping recommendations of the Institute of Medicine last week, the Chronicle declared,

“The California Institute for Regenerative Medicine (CIRM), the stem cell funding agency that state voters approved in 2004, has been an 'innovative initiative' that's strengthened California's biotechnology industry and furthered the cause of basic stem cell research, according to a new independent review by the Institute of Medicine (IOM). But the agency needs to make some major structural changes in order to avoid conflicts of interest and retain its credibility with the public, and it needs to do so sooner rather than later.”

The editorial continued,

“The institute also needs to respond to the criticisms in the report, and to do so as quickly as possible. In particular, the institute needs to reform its management if it's to continue its mission after state funding runs out, as it appears the institute's chairman would like to do. Its governing board is too involved in day-to-day management. Nearly all the 29 members of that same board are on the payroll of institutions that have won grants - a serious conflict of interest.”

The Chronicle editorial was the first that we have seen on the subject, but additional comments from individuals have come the way of the California Stem Cell Report.

In an email, Tom Hall, a retired history professor in Berkeley, said,

“At the risk of being too cynical, it seems to me that those who expect the agency to implement the proposals are being more than a bit naïve. The proposals amount to asking people to commit suicide. Those presently involved have too much self-interest at stake to voluntarily drop out. Some kind of pressure will have to be applied.”

Hall referred to IOM recommendations that the 29-member CIRM governing board be barred from voting on individual grant applications and its members be removed from the grant review process. The IOM also said that the majority on the board should consist of “independent” members, which would likely mean that some current board members would lose their seats.

Another email from a person with close knowledge of the stem cell agency, but who must remain anonymous, said,

“I worry that CIRM (governing board) will once again circle the wagons and construct elaborate excuses for inaction and preserving the status quo. It's really terrible because you could make incredible advances if only the energy and dollars were directed properly.”

The Sacramento Bee ran a related editorial yesterday that called for “putting the brakes” on "the initiative machine," which was the process used to create the stem cell agency in 2004. The Bee said that initiatives are “driven by special interests and buttressed by a business network of signature gatherers, legal services and campaign consulting.”

The stem cell initiative, Proposition 71, also has become a two-edged sword for the agency, locking in management minutia and making it nearly impossible to make needed changes, such as those recommended last week by the blue-ribbon Institute of Medicine panel.

Among other things, The Bee indicates that it would support “a sunset of 10 to 15 years for laws passed by voters – or automatically putting such laws back on the ballot for voters to reject or affirm.”

The Bee has yet to editorialize directly on the IOM report.

IOM Proposals for Overhaul at CIRM Win High Marks

The Institute of Medicine's recommendations for major changes at the California stem cell agency today received generally high marks from independent observers and critics.

Many of the proposals echoed suggestions from California's Little Hoover Commission, the state's good government agency. Asked for comment, Stuart Drown, the commission's executive director, said,

“The institute’s recommendations for much-needed changes to CIRM’s governance structure to provide greater efficiency, clarity and accountability reinforce the recommendations the Little Hoover Commission made in 2009."

He continued,

“Then and now, the Commission’s recommendations are aimed at improving CIRM’s ability to meet its goals for the good of all who can benefit from stem cell research, and to ensure that California taxpayers’ dollars are put to their most efficient use to that end.”

The California Stem Cell Report also asked the agency's first president, Zach Hall, for his thoughts. Here is the full text of what Hall, who was one of the peer reviewers on the IOM study, had to say,

“The IOM Committee and its staff have done an impressive job.  The report recognizes the scientific value and achievements of the CIRM and, at the same time, makes cogent recommendations that, if taken seriously, will further improve the quality and the public credibility of the Institute. The committee and staff deserve the thanks of the scientific community and all California citizens for their careful and thoughtful work.” 

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., said,

“It's long past time to make the changes the report calls for, but given the spin the agency put on its response -- saying the report praises the 'agency as a bold innovation' -- shows it's business as usual. This sort of behavior will only ensure that CIRM doesn't get another round of public funding,” 

Marcy Darnovsky, associate executive director of the Center for Genetics and Society of Berkeley, Ca., welcomed the recommendations. But she said,

“Given the agency’s shortcomings and the state’s budgetary problems, it would be wrong to ask Californians to give it more public money. If the agency acquires new funds from industry sources or venture firms, it must recognize that it has ongoing obligations to the people of California.” 

She continued,

 “CIRM has not responded in a meaningful way to many previous public interest suggestions or to independent reviews, including the one in 2009 by the state’s Little Hoover Commission. We hope the agency will not continue that pattern.” 

The California Stem Cell Report also queried most of the 10 patient advocates on the agency's governing board for comment. Their roles could be altered in a major way by the IOM recommendations. None of the advocates have yet responded.

(The full text or nearly full text of all the above comments is available here.)