Stem Cell Affordability Legislation Introduced in State Senate

Legislation aimed at ensuring affordable access by Californians to therapies developed as a result of taxpayer-funded stem cell research is once again before California lawmakers.

This year's measure is SB343 by Sen. Elaine Alquist, D-San Jose, and is now before the Senate Health Committee, which she chairs. (Alquist is at left with a friend who is now in the White House.)

A somewhat different version of the bill was vetoed by Gov. Arnold Schwarzenegger last year after it was opposed by the California stem cell agency. However, last year's legislation, SB1565, won approval of both houses by enormous margins, 37-1 in the Senate and 64-7 in the Assembly.

Enormous margins are required to enact any legislation affecting CIRM because Prop. 71 specified that 70 percent approval of both houses is necessary to enact even the tiniest changes in the law, such as removing the requirement that the chair of the agency is responsible for the CIRM annual report. The unprecedented, super, supermajority requirement does not exist for any other California legislation, including enactment of a budget or imposition of taxes.

Alquist's bill has been changed somewhat from SB1565 to permit a waiver of the affordability requirement in some unusual cases. One of CIRM's objections last year was that SB1565 was inflexible.

The CIRM directors' Legislative Subcommittee will consider its position on SB343 at a meeting March 31. Teleconference locations where the public can participate include San Francisco (two sites), Healdsburg, Washington, D.C., Menlo Park, Palo Alto, Calistoga, Elk Grove and La Jolla. Specific addresses can be found on the agenda.

Also up for consideration on March 31 is SB471 by Sen. Gloria Romero, D-East Los Angeles. The measure states that all education policy makers in the state, including those involved with kindergarten through the 12^th grade, should collaborate with CIRM to advance its educational initiatives. Those include an upcoming CIRM program on stem cell science and regenerative medicine.

Alquist's bill has been referred to her Health Committee. Romero's has not yet been assigned to a committee for hearing.

Biotech Courtier, the People's Will and 'Money Talks'

Gov. Schwarzenegger's veto of this year's CIRM legislation was deeply buried by most news outlets, if they carried anything at all. But his action triggered a fiery op-ed piece by J. Wesley Smith in the San Francisco Chronicle.

Writing on Oct. 2, Smith, senior fellow in human rights and bioethics at the Discovery Institute, asked,

"What is it about embryonic stem cell research that turns politicians into courtiers? "

He said government leaders are more than ready to denounce the "get-rich, money-talks ethos" of Big Pharma, but "trip over each other to grant (biotech) policy agendas carte blanche."

Smith was talking about SB1565, legislation by state Sen. Sheila Kuehl, D-Santa Monica, which was aimed at providing affordable access to CIRM-financed therapies. The measure was opposed by the biotech industry and CIRM.

Smith said the governor claimed "incongruously that it 'does nothing to advance the will of over 7 million voters,' when precisely the opposite - assuring access for the poor to CIRM-facilitated treatments - was clearly part of the package voters thought they bought when passing Proposition 71."

Smith continued,

"Given the governor's constant harping about the crucial importance of bipartisanship, the veto is ironic. Talk about a bipartisan measure! SB1565 passed the Senate unanimously and by an overwhelming 64-7 in the Assembly. Other than naming freeways after dead luminaries, it is rare to find such agreement in the ideologically divided California Legislature.

"In backing the CIRM's fiscal profligacy and giving the back of his hand to the poor and the ill through his veto, Schwarzenegger made a joke of his reputation as a fiscal conservative and bipartisan consensus builder. How sad that the once mighty Arnold, who came to Sacramento vowing to smash boxes, has instead assumed the role of a mere industry retainer."

Jerry Steele, an advocate of adult stem cell therapy writing on the TheraVitae blog, also was critical of the veto. He said,

"The CIRM has been mired in many controversies on where the money has been distributed and is deathly quiet on the issue of when it is going to produce any cure."

Steele asked if California has received a return on its investment,

"Well, even the staunchest supporter of the CIRM would be hard pressed to come up with any successful results- I tried Google and the most I could come up with was a few semi-famous scientists have migrated to California to live off the taxpayer."

Geron, a Menlo Park, Ca., stem cell company, had a different view, although it was very brief. In what amounted to a one sentence news release, the firm said it supported the veto because the legislation ran "counter" to Prop. 71.

Don Reed, patient advocate and a vice president of the private stem cell lobbying group belonging to CIRM Chairman Robert Klein, gave a cyberspace sigh of relief on his blog. But he noted that the Little Hoover Commission, a bipartisan good-government state agency, will be looking into CIRM.

Reed vowed,

"If the Little Hoover Commission develops a new law or initiative against us, I will let you know about it early, so we can protect California’s great gift to the world."

Unsaid was the implication that any proposed change in CIRM's operations would be an attack.

Arnold Nixes CIRM Legislation

Despite overwhelming bipartisan legislative support, California Gov. Arnold Schwarzenegger has vetoed legislation aimed at ensuring affordable access to stem cell therapies as the result of taxpayer-funded research.

His veto message said:

"This bill (SB1565)undermines the express intent of Proposition 71 in two ways: it eliminates the priority for funding human embryonic stem cell research and it places an unnecessary restriction on the Independent Citizens’ Oversight Committee authority to adopt intellectual property regulations that balance patient need and essential medical research.

"More than seven million voters were very clear when they passed Proposition 71 in 2004. They wanted to fund embryonic stem cell research that the federal government wouldn’t. They also wanted to make sure that California receives a return for its historic investment in medical research. Both of those important goals are already being accomplished.

"This bill does nothing to advance the will of over seven million voters. For this reason, I am unable to sign this bill."

Only a handful of lawmakers voted against the bill, which required 70 percent approval of both houses of the Legislature.

Advocate Reed Says No Need for Independent Look at CIRM

On Sept. 5, 2008, we carried an item dealing with a proposal for an examination of the California Institute for Regenerative Medicine by a bipartisan state department charged with improving government operations.

We said that corporations pay hundreds of thousands of dollars or more for independent assessments of their operations and that CIRM should welcome the opportunity to have a similar study performed for free. The springboard for our comments was an item written by patient advocate Don Reed on his blog, stemcellbattles.com. Reed has responded to our item. Here is what he sent us.

"Several days ago David Jensen printed a thoughtful article inquiring why I was encouraging people to write to Governor Arnold Schwarzenegger ( State Capitol Building, Sacramento, CA 95814), urging him to veto Senate Bill 1565.
 
"The reason is simple. If people like our stem cell program as it is (I do), they should defend it. The Governor will be deciding in the next few days whether to accept SB 1565, or veto it.  This is the only chance we have of preventing SB 1565 from becoming law.
 
"SB 1565 could completely restructure California’s stem cell research program, as well as removing our state’s official preference for embryonic stem cell research.
 
"The article criticized advocates like myself who are allegedly “blind to blemishes… (and who) regard any evaluation or analysis of the effort as destructive.”
 
"I don't see it that way. As someone who attends and participates in most of the meetings of the stem cell program, I see a constant and vigorous process of adjustment and correction.  The CIRM has had (by my count) four in-depth official audits; the California Court system has examined our (California’s) structure.  Evaluation and analysis is ongoing, and the public is involved in every step of the way. That’s good; it’s democratic; it’s necessary.
 
"What I do object to is throwing out something magnificent after the decision has been made.  California fought for our stem cell program, debated over it, and voted.
 
"Why did we have to use the initiative process?
 
"Practicality!
 
"I fought for three years trying to pass the Roman Reed Spinal Cord Injury Research Act—and California ended up with only $1.5 million a year for that program. It is a good program, spending $12 million, but bringing in more than $50 million dollars in matching grants, new money for the economy—but it is so little, compared to the need.
 
"As a grass roots organizer I helped with Senator Deborah Ortiz’s groundbreaking legislation. She did a terrific job, gaining permission for the (then) controversial new medical procedure. To me, she will always be the Mother of California stem cell research. But those bills came with no money. It took a real fight to get a lousy hundred thousand bucks to run a committee, and no research money whatsoever.
 
"I remember a group of advocates meeting with Senator Barbara Boxer, a true friend of research, and she told us: “What you need is billions of dollars, and we can’t get that for you in Sacramento.” 
 
"So Sacramento couldn’t raise the money to fund the research. Washington dropped the ball for political reasons.
 
"But California came through.
 
"Embryonic stem cell research offers hope for cure not only for my paralyzed son, but also for Sarah Palin’s boy who has Down’s Syndrome, and for millions more who suffer with incurable illness or injury.  
 
"SB 1565 would remove California’s official preference for embryonic stem cell research, which was the reason we passed the program in the first place. Unfortunately the new Republican platform calls a complete ban on embryonic stem cell research, both public and private, criminalizing it completely. SB 1565 is co-authored by Senator George Runner, a long-time opponent of embryonic stem cell research, and if that bill passes, it could provide ammunition to the opponents of the research.
 
"And the program itself? The California structure--with decisions made by patient advocates and experts-- was designed specifically to keep the focus on the quest for cure. No one wanted it to become a self-serving bureaucracy, rambling around in search of reasons to justify its existence, making endless speeches and not actually doing a lot.
 
"We wanted intelligent action, and we got it.
 
"So of course we are going to defend it. Can someone point me to a better program, anywhere in the world?
 
"If so, let me know. In the meantime, I think we should protect what we won.
 
"Anybody that cares about stem cell research should write Governor Schwarzenegger today. (tip: on the outside of the envelope, put VETO S.B. 1565, that helps them."

A Partial Case for a Deep Outside Look at CIRM

California patient advocate Don Reed has embarked on a letter-writing campaign to have the governor of the state veto legislation aimed at ensuring affordable access to taxpayer-financed stem cell therapies.

Of course, Reed, a longtime and effective advocate for stem cell research, does not see the legislation that way. In an appeal on his blog to the patient advocate community, he warns that SB1565 "intends to restructure" the board of directors of the $3 billion California stem cell research effort. With all due respect to Reed, he has overstated the case in a way that does not necessarily well-serve the best interests of the California Institute for Regenerative Medicine.

His assertion is based on the measure's request for a study of CIRM by the state's bipartisan Little Hoover Commission. Even if the commission performs the study and recommends structural changes, their enactment is remote. They would have surmount a huge barrier, including possible alterations in the state Constitution. That would require a two-thirds vote in both house of the legislature and a vote of the people.

Reed's latest outpouring against the legislation embodies in some ways the deep-seated concerns among some stem cell advocates that somehow CIRM could be thwarted. Many supporters of the state research effort are wary of any public scrutiny of the agency. They are blind to blemishes. They regard any evaluation or analysis of the effort as destructive. The true believers also sometimes seem to be bent on funding hESC research regardless of whether the state of California benefits significantly from the expenditure of $6 billion in public funds, including interest.

Prop. 71 created the California Institute for Regenerative Medicine. The ballot measure was not hammered out in a public process. It was written behind closed doors with no public input. It was put before the people because someone ponied up $1 million-plus to gather the necessary signatures to place it on the ballot. The initiative placed representatives of the beneficiaries of the $3 billion in grants in control of the rules for giving away the money, a built-in conflict-of-interest that naturally raises concerns. Prop. 71 also created difficulties that have repeatedly hampered CIRM's operations, including an unusual quorum arrangement that forced directors last month to fill out their panel by picking a member from the audience. All of which is legal under Prop. 71. And then there is the dual executive arrangement that helped to create unhealthy management tension early on.

All public agencies need and deserve outside scrutiny. It is one of the basic principles of American government and is embodied in the concept of checks and balances amid the three branches of government. CIRM operates largely without those checks. For all practical purposes, it is free from fiddling by the executive or legislative branches of California government.

CIRM is an extraordinary experiment, unprecedented in California history. Some believe it could serve as a model for successfully tackling other difficult social problems. It is important that it be successful, fulfilling its mission efficiently and in a manner that recognizes its first responsibility is to the public – not the scientific community, not patient advocates and not industry. They are all exceedingly important constituencies, but CIRM is first a public endeavor. If CIRM is perceived to be under the control of those groups, its credibility will be damaged. Public trust can be mercurial. It can easily vanish overnight, and the whole field of hESC research can become besmirched.

Corporations regularly pay hundreds of thousands of dollars – if not millions – to outside consultants to analyze and critique their operations as they strive to remain efficient and competitive. The Little Hoover Commission will basically do the same job for free for the California Institute for Regenerative Medicine. CIRM should welcome the commission and use the opportunity to build support for making some of the difficult changes that could make it more successful in its mission.

California Lawmakers Make Stem Cell History

Another first has been scored in the brief history of California's unique and unprecedented, $3 billion stem cell research effort.

For the first time, California lawmakers have passed legislation that would affect the California Institute of Regenerative Medicine, a tiny state agency that functions largely outside of the control of both the governor and the state Legislature. CIRM was deliberately created that way through an initiative measure passed by voters in 2004. No lawmakers or other elected officials had a say in its contents.

The complex proposal, Prop. 71, set an extremely high bar against tinkering in its operations by the legislature. The ballot measure required a 70 percent vote of both houses to pass legislation that would affect CIRM – a super, supermajority vote that does not exist for any other bill. Even the state budget requires only a two-thirds vote. That hurdle has been so difficult to clear that California is now deadlocked in a record-setting, two-month long budget crisis.

Nonetheless, lawmakers last week sent to Gov. Arnold Schwarzenegger a bill – SB1565 – by Sens. Sheila Kuehl(see photo), D-Santa Monica, and George Runner, R-Antelope Valley, designed to ensure affordable access to stem cell therapies developed as a result of state funding. The bill was opposed by CIRM, industry and some patient advocates. They complained about its lack of flexibility, economic impediments and a change that would make it easier to fund research that was not based on human embryonic stem cells.

Kuehl said the bill is needed because Prop. 71 "lacks any provisions" to ensure that poor and uninsured Californians will be able to receive state-funded therapies at "the best available prices." She is joined by a raft of supporters included health access groups, retired persons, nurses and others.

The governor has until Sept. 30 to act on the bill. Otherwise it will go into effect without his signature. He could veto it. An override of the veto would seem remote even though the bill passed overwhelmingly. No negative votes were recorded until the measure hit the Assembly and then only a handful. It finally went to the governor after the Senate on Aug. 29 concurred, 37-1, in Assembly amendments.

Schwarzenegger has been a good friend of the stem cell agency and has garnered considerable favorable publicity touting it as a model for a way to get things done. Our bet is that he will veto the bill, but we could be wrong.

(Editor's note: The governor has pledged to veto any bill that comes his way until the budget crisis is resolved. However, he has breached that promise several times already. But his pledge could be good political cover for a veto if he chooses to use it. That also assumes no budget will be in place by Sept. 30.)

SB1565: CIRM Hopes Now Rest with Arnold

The California stem cell agency will be looking to Gov. Arnold Schwarzenegger to gallop to its rescue and veto legislation aimed at ensuring affordable access to state-financed stem cell therapies.

The bill cleared the Assembly on Monday, 64-7, and now is only one step away from hitting the governor's desk. It will only take Senate concurrence in Assembly amendments to send the measure, SB1565 by Sens. Sheila Kuehl, D-Santa Monica, and George Runner, R-Antelope Valley, to the governor.

So far the governor has not taken a position on the legislation, although he has been a friend indeed to the stem cell research program. A couple of years ago when CIRM was in financial straits, he loaned it $150 million, which has since been repaid with the state bond funds that finance CIRM's efforts. On more than one occasion, he has cited CIRM as evidence of doing good, both economically and scientifically.

CIRM and industry groups object to Kuehl's bill because it would lock into state law requirements that the agency contends would hamstring it in connection with negotiations with biotech companies. CIRM also objects to a provision that would lower a barrier to the funding of non-embryonic stem cell research.

Reporter Ron Leuty of the San Francisco Business Times wrote about the provision last month, noting that it was inserted at the request of the conservative Runner, who opposes to human embryonic stem cell research.

Leuty quoted Jeff Sheehy, a member of the CIRM board of directors, as saying,

"We may be handing a political victory to people opposed to human embryonic stem cell research that hasn’t been earned and that isn’t supported by the science."

The issue, however, is of little notice in the Capitol, where lawmakers and the governor are embroiled in a nearly two-month stalemate that has become the California budget crisis. The governor has ordered the layoff of 10,000 state employees and seeks to cut the pay of 200,000 state employees to the federal minimum hourly wage of $6.55 until a budget is passed. The spending measure is being blocked by Republicans, who can do so because it requires a two-thirds vote.

One could speculate that the CIRM legislation could get caught in that battle. Schwarzenegger needs some Republican votes for a budget. Perhaps he could generate a couple by signing the legislation, arguing that he is acting to support stem cell research that does not destroy human life.

The possibility may be remote but stranger things have been done under the dome. And lawmakers and the governor are desperate to find a solution to the budget crisis.

CIRM Should Say No to Mullin Tresspass Bill

Directors of the California stem cell agency this week are scheduled to discuss legislation aimed at dealing somewhat with the recent upsurge in attacks on California researchers, including at least one of its grantees.

On the agenda for either tomorrow or Wednesday is AB2296 by Assemblyman Gene Mullin, D-San Mateo. It has already passed the Assembly and is now in the Senate Public Safety Committee in a heavily amended form.

It now states in part:

"Any person who enters the residential real property of an academic researcher for the purpose of chilling or interfering with the researcher's academic freedom is guilty of trespass, a misdemeanor."

The bill totals about 600 words. The legislative staff analysis is about 5,600 words, reflecting the complexities of the issues involved. (CIRM has linked on its agenda to an earlier analysis.)

While we are adamantly opposed to the domestic terrorism that has targeted researchers in this country, we cannot support the Mullin bill. Nor should CIRM.

The legislation is vague and raises major constitutional issues regarding freedom of speech. Existing law already provides a wide array of tools dealing with trespass, as the legislative analysis points out. The measure is certain to be challenged by such enterprises as the ACLU. Who knows what "chilling" a researcher's academic freedom means? And one wonders exactly why persons engaged in labor union activities are specifically exempted from the terms of the proposed law.

Instead of endorsing the bill, CIRM directors should add $50,000 to the reward in the firebombing case at UC Santa Cruz, which occurred at the home of CIRM-funded research David Feldheim. That would bring the total to $100,000. CIRM should also issue a strong condemnation of the terrorist actions and make it clear that there is no tolerance for those misguided souls who think they protect mice by endangering children and adults.

Patient Advocate Reed's Relentless Effort Against SB1565

Patient advocate Don Reed sent along the following concerning legislation aimed at ensuring affordable access to taxpayer-financed stem cell therapies in California.

He focuses on another element of the bill, which changes voting requirements on research that is not directly related to human embryonic stem cell inquiries.

Reed, vice president of Americans for Cures, has been campaigning vigorously against the bill, SB1565 by Sens. Sheila Kuehl, D-Santa Monica, and George Runner, R-Antelope Valley. Many of Reed's efforts surface on the Internet at his blog, stemcellbattles.com. Among other things, Reed is drumming up a letter-writing campaign (better than emails, he says) against the bill.

We checked into his blog recently and saw his account of the hearing last month on SB1565 in the Assembly Appropriations Committee. He noted that CIRM Chairman Robert Klein testified against the measure. It was Klein's first public appearance as chairman of CIRM before a legislative committee. Klein refused to appear before a committee in 2005 and instead launched a national effort among patient advocate groups against those proceedings, triggering a certain amount of unhappiness among some state lawmakers.

The Americans for Cures lobbying group was created by Klein and operates out of the same Palo Alto, Ca., address as his real estate investment banking firm. SB1565 is now on the Assembly floor. If it passes as expected, it will go to the Senate for concurrence in Assembly amendments and then to the governor.

Here is Reed's letter:

"SB 1565 UNCONSTITUTIONAL? Open Letter to the California Assembly and Senate

"Dear Senators and Assembly members:
 
"As the father of a paralyzed young man, (Roman Reed, who inspired the Roman Reed Spinal Cord Injury Research Act, source of America's first state-funded embryonic stem cell research) I strongly oppose Senate Bill 1565 (Kuehl,Runner).
 
"Please be aware that the bill has changed since you first saw it. The bill now contains a poison pill amendment, offered by Senator George Runner, a known opponent of the California stem cell research program. The Runner amendment not only defies the will of the voters, but may violate the California Constitution.
 
"First, here is our stem cell program’s current law, which was enacted by the electorate, and written into the California State Constitution:
 
"'(C) … a high priority shall be placed on funding pluripotent stem cell and progenitor cell research that cannot, or is unlikely to, receive timely or sufficient federal funding…Other research categories…shall not be funded by the institute.'
--Article XXXV of the California Constitution: Section 5, Chapter 3. California Stem Cell Research and Cures Bond Act, Article 1. 125290.60.
 
"As you know, our stem cell program may only be amended  to '…enhance the ability of the institute to further the purposes of…the measure…'—Section 8, Amendments.  
 
"And Senator Runner’s amendment, recently added to SB 1565?
 
"'(D) “Notwithstanding paragraph (C), any other scientific and medical research and technologies and/or any stem cell research proposal not actually funded by the institute under subparagraph (C) may be funded by the institute...'
 
"This turns our program upside down! Proposition 71 was enacted by the voters to give priority to forms of stem cell research not likely to be funded by the federal government.  The Runner amendment removes that priority, and would instead allow precious research dollars to be spent on 'any other scientific and medical technologies'.  That could be almost anything; a bedpan is a piece of medical technology.
 
"How can such a complete reversal be said to “further the purposes” of our stem cell program? Such seeming violations of the Constitution are almost certain to invite legal actions; have we not had enough lawsuits, enough delays?
 
"The original intention of SB 1565, to guarantee access of stem cell therapies to the uninsured, has already been achieved, and without the need for this bill. Bill author Senator Sheila Kuehl, a highly respected legislator, has publicly stated that she and CIRM (California Institute for Regenerative Medicine) are 'on the same page' regarding how low-income residents could receive benefits from CIRM-developed products.
 
"But the Runner amendment could gut the California stem cell program.
 
"Those who know, oppose. SB 1565 is opposed by the Coalition for the Advancement of Medical Research, which is a board of more than 80 medical, educational, and disease advocacy groups: as well as every other stem cell research support group which has taken a position on the issue.
 
"On behalf of every California family with a loved one suffering from chronic disease or disability, I urge your 'NO' vote on Senate Bill 1565, when it comes before you for concurrence.
 
"Thank you.
 
"Don C. Reed
Co-chair, Californians for Cures
Sponsor, Roman Reed Spinal Cord Injury Research Act
Vice President, Public Policy, Americans for Cures"

Klein Confirms Resignation, Lobbying Connections Remain

The chairman of the California stem cell agency has personally confirmed that he has resigned as head of his personal stem cell lobbying group, Americans for Cures, which has been nearly silent on the subject since July 14.

Robert Klein's exit as president of the group came after it excoriated an influential California lawmaker on a widely read political blog, the Daily Kos.

Second-hand reports surfaced (the first on July 14) that he was resigning as president of the group, which shares the same address as his real estate investment firm as well as the same fax number.

Since then, Americans for Cures has not responded to repeated requests asking for confirmation of Klein's departure. Nor did Klein tell state Sen. Sheila Kuehl, object of the attack, that he was resigning, as he had said he would.

But Robert M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., encountered Klein last week at the meeting of the CIRM Standards Working Group. Simpson said,

"I asked Klein what his status with the group was when I saw him on Friday. He said that he had resigned the night he learned about the Kos article and came back from vacation.

"I told him that his name was still on the website. He said he'd call them to have it removed."

Since then, the reference to Klein as president has been removed from the website by Americans for Cures, along with a list of all its directors.

On July 24, we wrote about Klein's failure to announce his resignation, commenting that the initial, second-hand reports may have amounted to some sort of trial balloon that Klein hoped would trigger calls for him to remain as head of Americans for Cures.

Don Gibbons, chief communications officer for CIRM, today volunteered the following reaction to our trial balloon comment,

"The Americans for Cures web site has been corrected regarding the president. That theory you put forth on the issue goes beyond speculative paranoia."

With his resignation, Klein has recognized that his connections with Americans for Cures are not compatible with his role as a public servant and chairman of an agency that is giving away $3 billion of California taxpayer's money.

Klein's resignation, however, is less than a half-measure and does not even well serve his own best interests. If it is an attempt to distance himself from the organization, it falls far short. If he continues to serve on the board of directors of the lobbying group, if the group continues to share Klein's office fax number and address, if he continues to control hiring and policy and generate financing for the group, Klein remains accountable for whatever the group does. Particularly for any actions that do not coincide with the best interests of the people of California or CIRM.

Klein volunteered for his role at CIRM and has not been paid for his work for nearly three years, which is all to his credit. Would that more California businessmen and women donate their time and energy to help solve some of society's difficult problems.

But when Klein accepted his job as a public servant, other activities became incompatible. One of those is directing a lobbying group that operates in the same area as CIRM.

As we reported earlier, Klein's dual roles represent an inherent conflict of interest. It is as if a high level executive with the California Medical Association also served on the state Medical Board. It is impossible to know whether their official actions represent their own views or the views of the special interest group.

CIRM Mulls Kuehl Legislation Once Again, Supplier Proposal Also on Table

A directors subcommittee of the California stem cell agency will discuss on Thursday their opposition to legislation aimed at ensuring affordable access to state-financed stem cell therapies.

The bill is only two steps away from being sent to the governor's desk. No lawmaker has voted against the measure, SB 1565 by state Sens. Sheila Kuehl, D-Santa Monica, and George Runner, R-Antelope Valley. It is now on the the Assembly floor. If it wins approval as expected, it will go to the Senate for concurrence in Assembly amendments and then to the governor.

CIRM has officially opposed the measure, and it is not clear what its Legislative Subcommittee might do at the Thursday afternoon meeting, short of renewing the agency's opposition. Interested parties can participate or listen in on the meeting at public teleconference locations throughout the state, including San Francisco, Elk Grove, Irvine, Healdsburg, Sacramento and Palo Alto.

The meeting comes as BioRegion News is carrying a lengthy look at the bill, its support and opposition. Written by Alex Philippidis, the piece quotes Kuehl as saying regarding CIRM,

"They don’t intend to remove their opposition. They simply want more, and more, and more amendments, because they want the bill to go away. But the bill is not going away."

Also up for discussion at the Thursday meeting is the California supplier bill, AB 2381 by Assemblyman Gene Mullin, D-San Mateo. That bill would define California supplier for the purposes of providing a preference to such businesses as required by Prop. 71.

Currently the bill is in the Senate Appropriations Committee and is scheduled for a hearing Aug. 4. CIRM is also proceeding with its own regulatory definition of California supplier. The legislation has been the subject of considerable negotiation. Movement by CIRM may well come at the Thursday meeting. Here is a link to the latest amended version of the bill, although it may not reflect more current drafts that are not available on the Internet.

Stem Cell Affordability Bill Marches Towards Schwarzenegger

Legislation aimed at ensuring affordable access to any therapies developed as the result of California's $3 billion stem cell research program today easily cleared its final committee hurdle and appears likely to wind up on the desk of Gov. Arnold Schwarzenegger.

The measure (SB 1565) by Sens. Sheila Kuehl, D-Santa Monica, and George Runner, R-Antelope Valley, was sent to the Assembly floor by the Assembly Appropriations Committee. Presuming it wins Assembly approval, it will go back to the Senate for concurrence in Assembly amendments. No lawmaker has voted against the bill, nor did any today although the final official vote is not yet available.

The bill has faced sometimes vitriolic opposition, particularly from the private lobbying group of the chairman of the state's stem cell research effort, Robert Klein. Americans for Cures lambasted Kuehl as "ignorant" and "craven" in a posting on the Daily Kos, a political blog with about 1 million page views a day.

Americans for Cures, which operates out of the same address as Klein's real estate investment banking firm, later apologized and asked that the offending item be removed. Klein said he did not know about the item. He is reportedly resigning as president of Americans for Cures, but it is not clear whether he will sever all ties or whether the organization will move from his offices.

Klein's connection to the lobbying group, which is an offshoot of the Prop. 71 campaign organization, has long triggered criticism because of concerns about conflicting interests.

One commentator, who must remain anonymous, told the California Stem Cell Report today:

"I would say it's an inherent conflict to be an officer of any kind of 'Cures,' while being on the ICOC (the board of directors of the stem cell agency). It would be like a physician who is a high level officer in the California Medical Association being on the (state) Medical Board. One would never know whether their official actions represented their own views or the views of the CMA."

Americans for Cures has not yet confirmed that Klein is resigning. (Shortly after this item was posted, we saw a report on the Niche stem cell blog of Nature magazine saying that Americans said Klein has resigned but will remain on the lobbying group's board, which probably means that it will continue to be housed at Klein's offices.)

The next lobbying target for CIRM and the stem cell activists is the governor, who can veto the legislation and who has been more than receptive towards the stem cell agency's efforts.

Here is a link to the latest legislative staff analysis of the bill.

CGS Says CIRM Legislation is 'Gentle'

The Center for Genetics and Society says the stem cell measure now before the California legislature would only "gently alter" affairs at the state's $3 billion stem cell research effort.

The group's comments came as as more activity surfaced concerning the measure, SB 1565, which comes before the Assembly Appropriations Committee today. It has sailed through the legislature without a dissenting vote despite fierce – sometimes scathing – opposition from stem cell advocates.

Commenting on the center's blog, Biopolitical Times, Jesse Reynolds said that CIRM's board of directors is engaging in "histrionics" and opposes the measure even though it would give them more flexibility.

Reynolds, who wrote presciently nearly four years ago about some of the problems that have surfaced at CIRM, commented Tuesday that the agency

"... can fund any biomedical research if a two-thirds supermajority of its grants review working group approves. The current Senate bill would lower that bar to a simple majority.

"This would not restrict the CIRM in any way. If anything, the bill simply gives the CIRM more flexibility. Considering that the grants working group generally operates by consensus, that the governing board must approve all grants, and that the CIRM currently generously supports non-embryonic stem cell research, the amendment would have zero practical impact.

"Nevertheless, the board worked itself into histrionics over any concession to the development of alternatives."

Reynolds' "gently alter" remark appeared in a related posting that said that Klein's apparent resignation as president of his lobbying group, Americans for Cures, was long overdue. A CIRM spokesman said on Monday that Klein had resigned, but deferred any further comment to Americans for Cures. That group has not responded to repeated requests for confirmation of the Klein resignation.

Reynolds' postings came as patient advocate Don Reed, vice president of Americans for Cures (the private lobbying group of CIRM Chairman Robert Klein), wrote on the influential Daily Kos political blog about the measure. He urged readers to lobby against the bill and send "hard copy" letters to the governor, asking him to veto the proposal.

Also, James Kovach, president of the Buck Institute in Novato, Ca., sent a letter to a member of the Assembly Appropriations Committee, declaring the organization's opposition to the Kuehl bill. He said it would disrupt embryonic stem cell research. The full text of the letter follows in a separate item below.

Text of Buck Institute Letter on SB 1565

Here is the text of a July 15 letter to Assemblyman Jared Huffman, a member of the Assembly Appropriations Committee, from the Buck Institute, opposing legislation aimed at ensuring affordable access to state-financed stem cell therapies.

Dear Assemblyman Huffman,
 
Thank you for the opportunity to comment on SB 1565.  We understand that SB 1565 will be heard before the Appropriations Committee on Wednesday, July 16th, at the Sacramento Capitol. As this will be the last full committee hearing on SB 1565, before it goes to the Assembly floor, on behalf of the Buck Institute I would like to provide you with our view of this proposed bill.
 
We strongly oppose SB 1565.  Our reading of the proposed changes led us to conclude that the changes are unnecessary and, if adopted, would likely have several negative consequences.  Our primary objections are set forth below:
 
The scientific review committees are represented by specialists in stem cell research.   They are already tasked with reviewing many excellent applications for funding of research in the stem cell arena.  It is important work done on often grueling schedules and any requests to evaluate “vitally important research” not associated with stem cell and/or stem cell related work will distract their attention from the work they were specifically chosen to perform.  We believe the purpose of Proposition 71 will be altered by the amendment and moreover, alter the mission of the scientific review committees.
 We believe the proposed amendment will disrupt the conduct of human embryonic stem cell research as set forth in Proposition 71, the Constitution of the State of California and the will of a majority of the voters in California.  If passed, the proposed amendment would alter the will of the people without their consent. 
The potential change in the direction of stem cell research funding would come at a crucial juncture in the development of the CIRM.  The development of the CIRM has been guided by the principles embodied in Proposition 71 and is just beginning to apply its full attention to stem cell research funding rather than the startup activities and infrastructure development of the largest and singularly unique enterprise of its kind.
The CIRM has been under virtually constant scrutiny from its inception.  Our experiences with the CIRM and its staff have not always turned out as we had hoped but we have never had reason to question the CIRM’s dedication to fulfillment of the intentions of Proposition 71.  We see no benefit in adding more layers of scrutiny to an already transparent organization. 
The fair pricing sections proposed by SB 1565 are redundant to administrative procedures that we have seen first hand to be working to ensure that all Californians benefit from therapies developed by Proposition 71.
 
With the above in our thoughts, we ask that you oppose the passage of SB 1565.
 
For the sake of completeness, I have attached a cogent editorial written by a colleague, Don Reed.   http://www.dailykos.com/story/2008/7/15/111757/794?new=true
 
Please feel free to contact me with any questions or desire any clarification of our position on SB1565.
 
Jim
 
Jim Kovach, M.D., J.D.
President & COO
Buck Institute for Age Research

Latest Version of SB 1565

Here is a link to the full text of the latest, amended version of legislation, SB 1565, which is aimed at ensuring affordable access to therapies financed by California's $3 billion stem cell agency.

It is the measure that triggered flap that has led to the resignation of Robert Klein, chairman of the agency, as president of his own stem cell lobbying group.

The bill comes before the Assembly Appropriations Committee Wednesday.

Klein Resigns as Head of Stem Cell Lobbying Group

In the wake of a flap over a personal attack on a leading California lawmaker, Robert Klein, chairman of the California stem cell agency, has resigned as president of the stem cell lobbying group that posted the offending item on the Internet.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., today reported Klein's resignation on the Watchdog group's blog. Klein's action came after Simpson called for Klein (see photo) to resign either as president of Americans for Cures, Klein's lobbying group, or as chairman of the $3 billion state agency.

Simpson wrote,

"Don Gibbons, communications director for the California Institute for Regenerative Medicine, called this afternoon to tell me that Klein had stepped down from Americans for Cures. His phone call came after my posting the view today that holding both the state position and the advocacy position was untenable and the situation was a train wreck waiting to happen.

"In fact, Gibbons said, Klein quit the presidency on Friday, but didn't issue any public statement about it until he personally told Sen. Kuehl what he had done."

Sen. Sheila Kuehl, D-Santa Monica, is the lead author of legislation aimed at ensuring affordable access to any therapies developed as the result of CIRM-financed research.

Kuehl's office told the California Stem Cell Report that the senator and Klein were scheduled to talk on Tuesday. Americans for Cures has not responded to inquiries concerning Klein's resignation.

Coming Stem Cell Train Wreck?

The combination of Robert Klein as head of a state agency giving away $3 billion for stem cell research and presiding as well over a personal, stem cell lobbying group is a "train wreck waiting to happen," according to the Consumer Watchdog group.

John M. Simpson, stem cell project director for the Santa Monica, Ca., organization, said he welcomed Klein's apology for the "unseemly" attack on state Sen. Sheila Kuehl, lead author of legislation opposed by both the stem cell agency and Klein's group.

Simpson wrote on his organization's blog:

"The apologies are welcome.  However, so long as Klein remains chairman of the state stem cell agency, the California Institute for Regenerative Medicine, and president of the advocacy group, Americans for Cures, the situation remains a train wreck waiting to happen."

Simpson continued:

"Insisting on wearing both hats in untenable.  It damages the credibility of both CIRM and Americans for Cures. Klein needs to realize his dual roles seriously undermine the dedicated staff of both organizations."

Patient Advocate Reed Praises Kuehl, Says Sometimes People Go Too Far

Patient advocate Don Reed, who has probably attended more meetings of the California stem cell agency than any of its directors or even its staffers, reacted this weekend to the blistering attack on the author of legislation he fervently opposes.

Reed (see photo) is vice president of Americans for Cures, which fired off the personal comments on the national and influential political blog, Daily Kos. While Reed said that he is proud of the group, he added:

"Sometimes in the heat of battle, people go too far with hurtful words."

Here is the text of what he sent the California Stem Cell Report.

"A negatively slanted editorial on Senate Bill 1565 (Kuehl, Runner) was recently printed in the weblog Daily Kos. It was written by some of the staff at Americans for Cures, a group with which I am proud to be associated. They are my friends and co-workers.

"But I want it clearly understood I had no part in the writing of that particular article.

"I have not yet been able to read the entire piece, just bits and pieces of it. But as the co-directors of our group have publicly apologized for it, apparently it went over the edge. Sometimes in the heat of battle, people go too far with hurtful words. I have stuck my own foot in my mouth too many times to criticize anyone.

"I do strongly oppose SB 1565. Anyone wanting my opinions need only go to my website, www.stemcellbattles.com, or just Google me. My writing is signed, either with my name, Don C. Reed, or as Diverdonreed, for blogs which require a pseudonym.

"But my differences with Senator Sheila Kuehl are professional, not personal. She has earned the right to be treated with affection and respect.

"Ironically, last week I had a very positive conversation with Senator Sheila Kuehl’s legislative aides, Lark Park and Peter Hansel. We argued about the bill, of course. To me the bill is a serious mistake: a threat to the California stem cell program.

"I had two reasons for the visit.

"One reason was of course to see if there were any loopholes possible, especially in the price-control part of the bill. Ms. Park and Peter Hansel said the Senator had offered to make a change. The stem cell board may or may not agree that the answer is enough to gain their support, but it was a genuine attempt, a serious proposal. (Other serious objections remain, and I am still in opposition to the bill.)

"But there was a second reason for the visit, a personal one, something I had hoped to tell the Senator herself, but that was a long shot at budget crisis time.The Senator is “termed out”, that California mistake of a law that says lobbyists may remain in Sacramento forever, but the people’s representatives can only stay a while.

"But her efforts on behalf of all Californians will live on after her term in office. It is to be hoped she will continue her work to bring decent and affordable healthcare to everyone, perhaps on a national or international level. I would love to see her be U.N. Ambassador for international health programs, or a similar position.

"Sheila Kuehl is an exemplary human being. She makes the world a brighter place."

(After Reed sent us this item, we sent him a copy of the piece on Daily Kos, which has removed the item. If you would like to receive a copy of it, please email a request to us at djensen@californiastemcellreport.com)

Stem Cell Affordability Legislation Changed to Meet CIRM Objections

The California lawmakers behind legislation to ensure affordable access to taxpayer-financed stem cell therapies moved last week to ease the concerns of the state's $3 billion stem cell research agency.

The changes were made prior to a scathing, national Internet attack on the bill's lead author by the private lobbying group run by Robert Klein, who also serves as chairman of the state stem cell agency. One consumer advocate has called for Klein's resignation in the wake of the assault by Americans for Cures, the Klein organization. The group used such terms as "ignorant," "dumb" and "craven" in connection with Sen. Sheila Kuehl, D-Santa Monica.

Late Friday, Klein's group apologized. Klein told the California Stem Cell Report he was unaware of the Internet attack by his group and said he had "great personal respect" for Kuehl. Our understanding is that he intends to personally apologize to Kuehl.

CIRM last month officially opposed Kuehl's bill, SB 1565, on the grounds that it would discourage biotech firms from developing therapies and limit the agency's flexibility to negotiate affordability issues, among other things.

In response, Sens. Kuehl and George Runner, R-Antelope Valley, made changes that appear to go a long ways in dealing with the objections. But in a letter Thursday to Kuehl, Klein expressed the agency's continued opposition. The letter, dated the same day as the Internet attack on Kuehl, was also signed by CIRM President Alan Trounson and Ed Penhoet, vice chairman of the CIRM board of directors.

Below are key sections of the latest amendments to the measure, as provided by Kuehl's office. The actual bill, however, will not be available online via the Legislature’s website until Tuesday. The measure comes up for a hearing in the Assembly Appropriations Committee on Wednesday. The full text of CIRM's letter to Kuehl follows in a separate item.

Here are the amendments in SB 1565.

"Any plan subject to subdivision (a) shall include a requirement that each grantee and any licensee of the grantee that sells drugs that are, in whole or in part, the result of research funded by CIRM shall provide those drugs to publicly funded programs in California at one of the three benchmark prices in the California Discount Prescription Drug Program."

"Notwithstanding subdivision (c), the ICOC may waive the requirement that grantees and licensees of the grantee provide drugs that are, in whole or in part, the result of research funded by CIRM at one of the three benchmark prices in the California Discount Prescription Drug Program (Division 112 (commencing with Section 130500)), as it exists on January 1, 2008, only when the following conditions are met:
"(1) Either of the following conditions is met:
"(A) The drug shall be used for the diagnosis, cure, mitigation, or prevention of a rare disease or condition, as recognized by the federal Food and Drug Administration under Section 360bb of Title 21 of the United States Code, by individuals who would not otherwise have access to the drug through private insurance or public programs, the number of individuals who will have increased access to the drug represent a significant proportion of the individuals in California who have that rare disease or condition, and the ICOC has made a determination that, in the absence of the waiver, development of the drug will be impeded.
"(B) The grantee commits, in writing, to provide expanded access to a drug under its access plan to a class of patients who would not otherwise receive access to the drug, including working uninsured individuals who do not qualify for any public program or private health plan or policy that provides coverage of the drug, and the ICOC has made a determination, before granting a waiver and based on the number of individuals who will have access to the drug and the likely costs of the drug, that the waiver will provide significant benefits that equal or exceed the benefits that would otherwise accrue to the state through the pricing requirements set forth in subdivision (c).
"(2) The ICOC has conducted a public hearing prior to adopting any waiver pursuant to this subdivision. The ICOC shall provide findings and declarations and documentation to the Legislature substantiating the need for, and benefits of, a waiver adopted pursuant to this subdivision at least 30 days prior to the public hearing and shall post these documents on its Internet Web site at the time of submission to the Legislature and provide notice to the public that these documents have been posted."

CIRM Letter Opposing Kuehl Legislation

Here is the text of the CIRM letter stating the agency's continued opposition to SB 1565.


SB 1565: OPPOSE UNLESS AMENDED

July 10, 2008

Dear Senator Kuehl:

Thank you for the opportunity to comment upon the potential amendments to Senate Bill No. 1565. While the Independent Citizens’ Oversight Committee (the “ICOC”), the governing board of the California Institute for Regenerative Medicine (“CIRM”), has taken a position in opposition to the bill on the grounds that is it premature and unnecessary, we appreciate your willingness to engage in a dialogue regarding the potential amendments.

Section 1 of the bill, which would remove the two-thirds vote requirement for funding “vital research opportunities” was added in early June and it has caused a powerful reaction of unanimous opposition from CIRM’s governing board. Proposed subparagraph (E) makes clear that the goal of Section 1 is to eliminate the priority that Proposition 71 places on human embryonic stem cell research. As long as Section 1 remains in the bill, we must strongly oppose SB 1565.

At a time when opponents of stem cell research are arguing that recent developments obviate the need for human embryonic stem cell research, a position we believe to be incorrect, the proposed amendment to Proposition 71 would send the wrong message to Californians and to the nation at large. It would also thwart the will of the more than seven million Californians who voted for Proposition 71 in order to address the federal funding gap for human embryonic stem cell research, a gap that continues to exist to this day. By removing the two-thirds vote requirement, the amendment would undermine the very purpose of Proposition 71 – to provide a priority for funding human embryonic stem cell research. Finally, eliminating the two-thirds vote requirement would be inconsistent with the requirement that Proposition 71 may only be amended to further its purposes. For all of these reasons, which are discussed in greater detail in the attached addendum, we are strongly opposed to the removal of the two-thirds vote requirement.

With respect to Section 2 of SB 1565, we share your view that California state and local government purchasers should have access, at the lowest possible price, to the therapies and drugs derived from CIRM-funded research. Indeed, our regulations include provisions very similar to those set forth in SB1565. Given the complexities of our healthcare system and the uncertainty regarding the types of therapies and drugs that will be developed as a result of CIRM-funded research, we must retain the flexibility to address issues specific to particular diseases and particular therapies. We appreciate your offer of alternative language, including a waiver process. However, we offer our suggestions below in an effort to reduce the risk of unintended consequences. If you are willing to remove the amendment to the two-thirds vote requirement and to accept our proposed amendments, we would be willing to consider taking a “neutral” position on the bill.

Proposed Addition of Subdivision (e)

We believe it would be preferable to give CIRM greater discretion to establish a waiver mechanism pursuant to the Administrative Procedure Act. The addendum to this letter addresses this issue in more depth. This would permit CIRM to assess changes in medical technology and in the health care sector prior to defining the scope and contours of the waiver and it would provide an opportunity for the Legislature and the public to comment upon the proposed waiver mechanism before it is adopted. Therefore, rather than trying to anticipate the circumstances pursuant to which a waiver may be justified, we recommend replacing subdivision (e) with the following language:

(e) Notwithstanding subdivision (c), CIRM may waive the requirement for grantees, and licensees of the grantee, to sell drugs that are, in whole or in part, the result of research funded by CIRM, at one of the three benchmark prices in CalRx, based on a finding that a waiver is necessary to protect the health of Californians whose lives or quality of life is at risk. CIRM shall adopt a regulation or regulations pursuant to the Administrative Procedure Act to implement the waiver provided in this subdivision after notifying the Legislature and conducting a public hearing.

Proposed Amendments to Subdivision (c)(1)

Your proposed amendments to subdivision (c)(1) clarify what we understand to be the original intent of SB 1565. We believe that further refinements, however, may sharpen the expression of the Legislature’s intent. For example, we understand that you intend SB 1565 to apply only to therapies or drugs purchased in California by California state or local government funded programs. The current language, however, would appear also to apply to federally funded programs, including programs funded and administered entirely by the federal government without regard to need. Similarly, we are concerned by the provision that specifies that CalRx, as it exists on January 1, 2008, shall apply regardless of any subsequent changes in the law. While we share your concern about the unintended consequences that could flow from designating a successor program, we believe these concerns could be addressed by incorporating a successor program only if it covers CIRM stem cell-derived therapies or drugs. We therefore propose the following changes to subdivision (c)(1):

(c)(1) Any plan subject to subdivision (a) shall include a requirement that each grantee and any licensee of the grantee that sells drugs that are, in whole or in part, the result of research funded by CIRM shall sell those drugs in California to publicly California state and local government funded programs in California at one of the three benchmark prices in the California Discount Prescription Drug Program (Division 112 (commencing with Section 130500)), as it exists on January 1, 2008, or a successor program to the extent that the program applies to California Institute for Regenerative stem cellderived therapies and drugs.

Conclusion
CIRM is committed to working with the Legislature to address the important issues raised by SB 1565 and to ensure that Californians have access to therapies and drugs derived from CIRM-funded research. Placing these provisions in statute, however, may hinder our efforts rather than help, because we cannot anticipate all of the challenges we will face in the future.

We recognize that the Legislature could amend the law in the future through urgency legislation, but we are concerned about the potential political opposition to changes that may be required to ensure that Californians have access to a therapy derived from human embryonic stem cells. Given the 70 percent vote requirement in Proposition 71, such opposition could prevent the Legislature from passing an amendment that is essential to ensure access. CIRM’s ability to amend its regulations pursuant to the Administrative Procedure Act, on an emergency basis if necessary, does not pose the same risk.

While well-intentioned, SB 1565 is premature and unnecessary. Nonetheless, if you are willing to amend the bill to remove Section 1 and provide for a waiver directive regarding the public pricing policy as described above, we are prepared to recommend a neutral position to the ICOC.

We appreciate your support of CIRM and your willingness to work with us to address these critical issues.

Sincerely,
Robert N. Klein, Chairman, ICOC
Alan O. Trounson, President
Edward E. Penhoet
Vice –Chairman, ICOC