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.

Klein Lobbying Group Employee Organizing pro-CIRM Turnout for Hoover Inquiry

Patient advocate Don Reed is attempting to drum up a CIRM-sympathetic turnout at next Thursday's Little Hoover Commission hearing into the California stem cell agency.

Writing on his blog, Reed also acknowledged he is on the payroll of the private lobbying group of CIRM Chairman Robert Klein, Americans for Cures. Reed, who is a vice president of the group, said he receives a "small stipend." Reed regularly speaks on issues before the CIRM board of directors during their meetings.

As far as the Hoover Commission inquiry is concerned, Reed said,

"Personally, I am a little worried about making changes in something good. That is like going into the hospital for open heart surgery—when there is nothing wrong with you."

Reed also looked askance at the appearance of John M. Simpson of Consumer Watchdog and Jesse Reynolds of the Center for Genetics and Society as witnesses next week. Reed said,

"...I object to the choice of two critics as representing the entire consumer population of California. It is my understanding both men are paid lobbyists. (There is nothing wrong with that; they could make a similar comment about me.  I work for a group called Americans for Cures Foundation, which supports stem cell research, and receive a small stipend from that organization.) But to choose such vocal critics without a balance is to ignore the 59.2% of California which voted in favor of Proposition 71."

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.

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.

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)

California Stem Cell Chief Says He Was Unaware of Personal Attack on Lawmaker

Robert Klein, chairman of the $3 billion California stem cell agency, today said he was "completely unaware" of the personal attack on a California state lawmaker by his lobbying group, Americans for Cures.

Klein, who is president of Americans for Cures, said he had "great personal respect" for Sen. Sheila Kuehl, D-Santa Monica, the object of the attack. Kuehl, a respected California lawmaker and chair of the state Senate Health Committee, drew the ire of Americans for Cures because of her legislation aimed at ensuring affordable access to taxpayer-financed stem cell therapies.

In a statement to the California Stem Cell Report, Klein praised Kuehl's "intellectual strength" and leadership. Here is the text of what Klein sent the California Stem Cell Report:

"Dear David,

"Theoretically, I have been on vacation since Tuesday morning, July 8th, but I gave up my vacation last night and came back to CIRM to deal with misinformation regarding my personal position on SB 1565. As I stated at the Controller’s financial oversight committee meeting on Monday, July 7th, I have great personal respect for Senator Kuehl, including most recently her leadership on the effort to create universal healthcare coverage. On Monday, I made it clear that I have deep respect for her intellectual strength in the healthcare area, and that the ICOC’s position is a substantive policy disagreement. The ICOC has taken the position that the complexity of the stem cell therapy area may not permit simple pricing formulas and the agency needs discretion in adapting to the 70 areas of possible stem cell therapies for chronic disease and injury. I also emphasized on Monday that the ICOC is committed to the same goals as Senator Kuehl in obtaining the lowest possible price for state and local government public providers in California.

"The language in the bill addressing embryonic stem cell research, I think, is being interpreted very differently by the ICOC and Senator Kuehl. We are very concerned about the message this type of an amendment would send within California and nationally, and we do not believe that the message would be consistent with the best scientific and medical knowledge at this time.

"As always, I am happy to discuss this with you further. I wanted to make sure you knew right away that I was completely unaware of the blog entry. I have requested that the Daily Kos entry associated with Americans for Cures be deleted from the site because it did not receive clearance from senior members of the organization, and it did not properly reflect the organization’s views on Senator Kuehl.

"Bob Klein"

Klein's Lobbying Group Apologizes for Blistering Attack on Kuehl

The lobbying group controlled by Robert Klein, chairman of the California stem cell agency, today apologized to state Sen. Sheila Kuehl for the personal attack on her that it published on the influential national political blog, the Daily Kos.

The co-executive directors of Americans for Cures, Amy Daly and Constance McKee, said the language in the item, which included such terms as "dumb," "craven" and "ignorant," was inappropriate. Daly said the item had been removed from the Daily Kos.

Here is the text of their apology, which they asked the California Stem Cell Report to run.

"To all who have read the Americans for Cures diary posted on DailyKos regarding SB 1565:

"We write to offer a formal apology to Senator Kuehl and her supporters. This posting did not go through our normal review clearances. The choice of language was inappropriate and did not reflect the respect that senior members of the organization have for Senator Kuehl.

"We have always appreciated her efforts and were disappointed that her single payer plan was not implemented. She has historically been a great health care advocate for the people of California. This is why it has been so frustrating to us that she is working with Senator Runner – who is strongly anti-embryonic stem cell research – to implement a bill that could frustrate efforts to get stem cell therapies to patients.

"We were wrong in our characterization of her. We have been working hard to educate everyone about the perils of this bill. No one is questioning it precisely because Senator Kuehl has been such an effective advocate. Our frustrations prevented us from using good judgment in our post, and we apologize profusely for our insensitive and unwarranted remarks.

"It should be noted that Bob Klein was completely unaware of our actions on this. We have not spoken to him or met with him in well over two weeks. I’m certain that he is as disappointed in our judgment as you, and we, are.

"Please forgive us and please put the blame for this where it belongs – on Americans for Cures Foundation staff involved in this individual posting – not on Bob Klein. Americans for Cures Foundation has learned from this experience and will re-institute the tight control it has historically had over its postings.

"Sincerely,

"Amy Daly & Constance McKee"

Consumer Watchdog Says Klein Should Resign Because of Personal Attack on Lawmaker

The Consumer Watchdog organization today called for the resignation of Robert Klein as chairman of the $3 billion California stem cell agency after his private lobbying group called a respected state senator "dumb" and "craven."

John M. Simpson, stem cell project director for Consumer Watchdog, a nonprofit Santa Monica, Ca., organization, said the attack was an inappropriate "over-the-top, hysterical call to battle."

Writing on the group's blog, Simpson referred to the Internet posting Thursday by Americans for Cures, Klein's stem cell lobbying group, on the Daily Kos, a widely read and influential political blog.

Americans for Cures targeted Sen. Sheila Kuehl, D-Santa Monica, and her legislation – SB 1565 – which is designed to ensure affordable access to any therapies that result from taxpayer-financed stem therapies. Simpson wrote:

"One can oppose the bill without launching personal attacks and suggesting the sky is falling. For the most part, the board members and agency's staff have followed that policy. But Klein insists on wearing two hats: ICOC(CIRM's board of directors) chairman and president of his advocacy group.

"The positions are incompatible. Since Klein refuses to give up the advocacy role, he must step down from his public position as head of a state agency. Failure to do so undermines the stem cell agency's credibility and ability to do its vital work."

Simpson summarized the legislation:

"It puts in statute regulations CIRM itself developed governing access to drugs by the uninsured; it lowers the vote of the scientific working group necessary to recommend funding non-embryonic stem cell research from a two-thirds majority to a simple majority; and it asks the state's non-partisan Little Hoover Commission to study the governance structure of the agency."

Kuehl's aides have been working with CIRM staffers to deal with the agency's official objections. Earlier this week, Kuehl amended her measure to deal with CIRM concerns. But Klein's lobbying group says the bill is unacceptable in "any form."

We have asked CIRM and Kuehl's office if they have any comment on the posting by the Klein group. We have not received a response, but will carry their comments should they make any.

Klein's Group Says Kuehl is Ignorant or Mindless or Craven and Dumb

Using the influential national political blog, the "Daily Kos," the private lobbying group of the chairman of California's $3 billion stem cell agency today filed a sharp, personal attack on a Democratic state legislator who is seeking to ensure the affordability of stem cell therapies financed by taxpayers.

Americans for Cures, whose president is Robert Klein and who also serves as chairman of CIRM, wrote an item for Daily Kos which took on highly respected California state Sen. Sheila Kuehl(see photo), D-Santa Monica, co-author of SB 1565, the affordability legislation in question. The Daily Kos is one of the more widely read political blogs in the nation. According to its web counter, it had 899,000 page views today.

The Daily Kos piece, which did not identify the specific author of the article but only attributed it to Klein's group, said,

"Either Kuehl is ignorant on the science, or mindlessly buying into Republican and anti-cures messaging from the Catholic Church, or playing dumb in a craven attempt to get Republican votes to back her legacy as defender of the poor."

Kuehl heads the Senate Health Committee and has been a leader on a variety of issues, including universal health care. A graduate of the Harvard Law School, she has been cited by Capitol insiders as one of the more intelligent lawmakers in Sacramento.

Late last month, at a meeting chaired by Klein, CIRM directors formally opposed SB 1565 but indicated that they wanted to continue to work with Kuehl to resolve differences. Klein's lobbying group, however, was unbending. It referred to "legislative dirty tricks." It called Kuehl's legislation "a thinly veiled ploy to stop embryonic stem cell research in California." Klein's group said,

"California is an example of what we’re seeing all across America.  Anti-cures forces are stepping up state-based legislative dirty tricks to pass 'personhood' laws that would discourage or criminalize stem-cell research.  If this sounds like the pro-life strategy that successfully undercut federal support for reproductive rights, you’re connecting the dots.  Anti-cures legislation is popping up all over America right now, in anticipation of a loosening of restrictions on hESC in January 2009."

Klein's group said,

"We speak for advocates whom Kuehl claims to represent. Our focus is on cures, not legacy.  We understand that private capital will lead science to the marketplace."

Klein's group declared,

"SB 1565 should not be passed in any form."

Klein's Lobbying Group Waging Cyberspace, Patient-Advocate Battle Against SB 1565

The private stem cell lobbying group controlled by Robert Klein, who is also chairman of the state of California's $3 billion stem cell agency, has launched a major campaign to kill legislation aimed at ensuring affordable access to therapies financed by the agency.

The group is Americans for Cures, which denies that it engages in lobbying. Klein (see photo) is its president, a very unusual position for a top government official. Americans for Cures shares the same address as Klein's real estate investment banking firm in Palo Alto, Ca.

Via the Internet, the group is marshalling patient advocates and stem cell research backers to write, phone, email and personally appear in Sacramento to defeat the legislation. Sample scripts are provided along with names, phone numbers and email addresses of lawmakers.

Its email message to supporters says:

"We need you to take a few minutes to help save the California Institute for Regenerative Medicine and embryonic stem cell research in California.  This is under siege right now in the state legislature."

Americans for Cures is targeting SB 1565 by Sens. Sheila Kuehl, D-Santa Monica, and George Runner, R-Antelope Valley. It sailed easily through the Senate and comes before the Assembly Appropriations Committee on July 16. No state lawmaker has voted against it.

Assuming the bill clears the committee next week, it then faces Assembly floor action and would return to the Senate for concurrence in Assembly amendments before going to the governor for his signature, which is by no means assured.

Also linked to the Americans for Cures effort is patient advocate Don Reed of Hayward, Ca., who is vice president of the group. Reed has appeared personally in the Capitol to oppose the bill, but says he is doing so as a private individual. Reed is also one of the most regular attendees at CIRM's public meetings, testifying on almost every occasion.

Reed wrote recently on his blog, stemcellbattles.com, that passage of the bill is a retirement "gift" by lawmakers to Kuehl, who is barred from running again for legislative office because of term limits. Reed said that personally he regards passage of the measure as akin to "getting an arm chopped off in a sword battle."

Klein's private political activities and lobbying efforts fouled relations with the legislature as early as 2005. At one point, CIRM directors moved the agency's legislative unit out from under Klein's control. Relationships improved, but Klein now has a firm grasp on the agency's dealings with lawmakers.

Activities of Klein's group have also lead to public confusion about its relationship to the official state agency. At one point in 2007, Americans for Cures (then operating with a different name) called a news conference for CIRM. The agency staff did not learn about the news conference until it was disclosed on the California Stem Cell Report. This week, Wesley J. Smith, a lawyer, author and foe of hESC research, incorrectly attributed language from Americans for Cures to CIRM. He said CIRM is "is wailing and gnashing its teeth that the very existence of the CIRM is threatened." His error has been picked up by at least one other web site(a religiously oriented foe) and probably more.

CIRM has never officially commented substantively on Klein's lobbying group, and Klein does not see the activity as a conflict with his government duties. Nonetheless, the priorities of Americans for Cures are not necessarily the same as those of a government agency, whose first responsibility is to the public – not industry, not patient advocates and not researchers.

(The item below contains the text of the email being sent out to drum up opposition to Kuehl's bill. The copy was sent to us by an interested party who must remain anonymous.)

(Editor's note: An earlier version of this item indicated that Smith's opposition to hESC research is religiously based. He says he "does not argue from religion or get into it."

Text of Americans for Cures Email and Links to Its Position

Here is a partial text of the email message from the Americans for Cures campaign against SB 1565, minus much of its html coding.

Here also are links to Cures' one-page analysis of the bill and its full analysis, its home page pitch on SB 1565 and other material.

Subject: Action Alert: Last Chance to Stop Restrictions on Research

We need you to take a few minutes to help save the California Institute for Regenerative Medicine and embryonic stem cell research in California.  This is under siege right now in the state legislature.  A few weeks ago, we failed to stop Senate Bill 1565 (Kuehl-Runner).  The bill was passed by the Senate, and has now also passed through two Assembly Committees: Health and Judiciary. The final step before a floor vote is a hearing in the Assembly Appropriations Committee (contact information below). We need you to act now and ask for a NO vote on SB 1565. Here's how:
1.Please call the Appropriations Committee at (916) 319-2081 and fax the Committee at (916) 319-2181.
2.Please email us to add your name to our listof those who oppose SB 1565.
3.Please call/fax/write as many of the Committee Members as you can.
4.Please call/fax/write your own Assembly Member. (To find your Assembly Member or State Senator, please click here and enter your address.)
5.Please see below for a script/sample email.

The Appropriations Committee will hear the bill on July 16, and so we need your help right now. If you live near Sacramento, please consider joining us in person to stand up for this research. (Let us know if you can be there we'll keep you updated on time and place.)

Over seven million voters expressed a desire to fund embryonic stem cell research when they passed Proposition 71. SB 1565 would remove the built-in preference for embryonic stem cell research - directly contradicting the will of Californians.

We passionately support the goal of healthcare that is accessible and affordable to all Californians. However, this bill will discourage private industry from developing therapies and cures. Currently, the law allows the California Institute of Regenerative Medicine (CIRM) to provide companies with additional incentives to develop therapies for "orphan" diseases such as cystic fibrosis and Lou Gehrig's disease. SB 1565 will eliminate these incentives, making it financially unfeasible for companies to pursue therapies for rare diseases. SB 1565 abandons these patients and their families.  
  
If SB 1565 passes, entrepreneurs and private capital will likely remain on the sidelines in the fight for cures. That means a delay in developing cures and therapies; even worse, therapies for some conditions may never be developed.  
  
Opposing SB 1565 keeps therapy development on the fastest track for cures.  
Opposing SB 1565 is the best vote for taxpayers because new therapies can reduce direct and indirect economic costs.  
Opposing SB 1565 is the best vote for families and patients who suffer every day from devastating chronic conditions.  

We must accelerate investment in CIRM technologies for the benefit of everyone. And that is why we need you to call now.
 
1.Please call the Appropriations Committee at (916) 319-2081 and fax the Committee at (916) 319-2181.
2.Please email us to add your name to our list of those who oppose SB 1565.
3.Please call/fax/write as many of the Committee Members as you can.
4.Please call/fax/write your own Assembly Member. (To find your Assembly Member or State Senator,  please click here and enter your address.)
5.Ask your friends and family to do the same.
6.After you have done your best to stop SB1565, please let us know what you were able to accomplish. (inform@americansforcures.org)

Thank you for being on the frontlines in the fight for cures.
  

Warm regards,
Amy & Constance
  

For a full analysis of the bill and its negative impacts, please click here .
  

Sample Script/Email:
 

Hello, my name is ______________, and I live in ____, CA.  I am calling/writing to urge Assembly Member __________ to oppose Senate Bill 1565 in the Appropriations Committee and on the floor.  SB 1565 will remove CIRM's funding preference for embryonic stem cell research and will delay the development of emerging medical treatments that have the potential to help millions of Californians and people around the globe.  SB 1565 will price-fix technologies not yet in existence. It will discourage investment in vital stem cell research and cures.  We must stay on track to develop these lifesaving treatments, and for that, I am asking for your NO vote on SB 1565.  Thank you.  
  


Assembly Committee on Appropriations
      
  Committee Members   District   Phone   Fax   E-mail   
  
  Mark Leno - Chair     Dem-13   (916) 319-2013   (916) 319-2113     Assemblymember.leno@assembly.ca.gov   
  
  Mimi Walters - Vice Chair     Rep-73   916) 319-2073   (916) 319-2173     Assemblymember.walters@assembly.ca.gov   
  
  Anna M. Caballero     Dem-28   (916) 319-2028   (916) 319-2128     Assemblymember.Caballero@assembly.ca.gov   
  
  Mike Davis     Dem-48   (916) 319-2048   (916) 319-2148     Assemblymember.Davis@assembly.ca.gov    
  
  Mark DeSaulnier     Dem-11   (916) 319-2011   (916) 319-2111     Assemblymember.DeSaulnier@assembly.ca.gov   
  
  Bill Emmerson     Rep-63   (916) 319-2063   (916)319-2163   Assemblymember.emmerson@assembly.ca.gov   
  
  Warren T. Furutani     Dem-55   (916) 319-2055   (916) 319-2155     Assemblymember.Furutani@assembly.ca.gov   
  
  Jared Huffman     Dem-6   (916) 319-2006   (916) 319-2106     Assemblymember.Huffman@assembly.ca.gov   
  
  Betty Karnette     Dem-54   (916) 319-2054   (916) 319-2154   Assemblymember.Karnette@assembly.ca.gov   
  
  Paul Krekorian     Dem-43   (916) 319-2043   (916) 319-2143   Assemblymember.Krekorian@assembly.ca.gov   
  
  Doug La Malfa     Rep-2   (916) 319-2002   (916) 319-2102     Assemblymember.lamalfa@assembly.ca.gov   
  
  Ted W. Lieu     Dem-53   (916) 319-2053   (916) 319-2153     Assemblymember.Lieu@assembly.ca.gov   
  
  Fiona Ma     Dem-12   (916) 319-2012   (916) 319-2112   Assemblymember.Ma@assembly.ca.gov   
  
  Alan Nakanishi     Rep-10   (916) 319-2010   (916) 319-2110   Assemblymember.nakanishi@assembly.ca.gov   
  
  Pedro Nava     Dem-35   (916) 319-2035   (916) 319-2135     Assemblymember.nava@assembly.ca.gov   
  
  Sharon Runner     Rep-36   (916) 319-2036   (916) 319-2136     Assemblywoman.Runner@assembly.ca.gov   
  
  Jose Solorio     Dem-69   (916) 319-2069   (916) 319-2169   Assemblymember.solorio@assembly.ca.gov     


 
       
  Authors   District   Phone   Fax   E-mail   
  Senator Sheila Kuehl     Dem-23   (916) 651-4023   (916) 324-4823   senator.kuehl@sen.ca.gov   
  Senator George Runner     Rep-17   (916) 651-4017   (916) 445-4662   Via website: http://cssrc.us/web/17/contact_us.aspxhttp://cssrc.us/web/17/contact_us.aspx

Klein's Lobbying Group Opposes Affordable Access Bill

The private stem cell lobbying group run by Robert Klein, who also serves as chairman of the $3 billion state stem cell agency, is formally opposing legislation aimed at ensuring that state-financed therapies are affordable and accessible to Californians.

The opposition of Americans for Cures was noted today in the legislative staff analysis of SB1565 by Sen. Sheila Kuehl, D-Santa Monica, and Sen. George Runner, R-Antelope Valley.

The legislation cleared the Assembly Judiciary Committee today on a unanimous vote. No lawmaker has voted against the proposal in either house. It now goes to the Assembly Appropriations Committee and from there to the Assembly floor. It has already passed the state Senate.

The staff analysis said that Klein's group, Americans for Cures,

"...believe that access and affordability are best addressed by creating larger pools of affordable healthcare insurance, and that policies should accelerate cures, rather than discourage them. It is important to note that the intellectual property provisions in this bill that the opposition contend will create disincentives to commercialize drugs and therapies are very similar to the current and proposed regulations promulgated by the ICOC."

Klein is president of Americans for Cures, which shares the same address as his real estate investment banking firm in Palo Alto, Ca. It is extremely unusual for the head of a state government agency to also lead an advocacy group whose interests are in the same arena as the agency's. Americans for Cures has denied that it is a lobbying group, although it attempts to influence legislation and government decision-makers.

Klein told the Legislative Subcommittee of CIRM's board of directors last week that patient advocacy groups nationwide would be lobbying California legislators on SB1565. It is our recollection that he did not mention the role of his own group, which has nationwide ties with advocacy groups.

The staff analysis also added more information about an independent state body, the Little Hoover Commission, that would be requested under the bill to examine CIRM with an eye to coming up with recommendations, particularly in relationship to the built-in conflicts of interest on its board. The analysis said,

"The Little Hoover Commission is uniquely positioned to review conflicts and make recommendations for improved governance.

"An independent state oversight agency established in 1962, the Little Hoover Commission's role differs in three distinct ways from other state and private-sector bodies that analyze state programs. Unlike fiscal or performance audits, the Little Hoover Commission's studies look beyond whether programs comply with existing requirements, instead exploring how programs could and should function in today's world. The Little Hoover Commission produces reports that serve as a factual basis for crafting effective reform legislation and follows through with legislation or administrative changes to implement its recommendations.

"In addition to the public hearings the Little Hoover Commission holds to develop findings and recommendations, hearings are held and progress reports are issued in the years following the initial report until the Little Hoover Commission's recommendations have been enacted or its concerns have been addressed. These processes uniquely position the Little Hoover Commission to review possible conflicts and make recommendations for improved governance of CIRM and the ICOC, thus helping ensure better accountability to Californians for their $6 billion investment."

At its meeting Thursday and Friday, the board of directors of CIRM is expected to formally oppose SB1565.

Growing an Arm, a Leg and an Ear

Some of you may have wondered about the "Veterans for Cures" effort by Robert Klein's private advocacy group mentioned in the item below.

Here is what it is likely linked to – a $250 million military effort to grow body parts or at least the thinking behind it.

U.S. Army Surgeon General Lt. Gen. Eric Schoomaker (see Defense Department photo above) earlier this month told reporters about how researchers are growing a new ear for a Marine, using stem cells from his own body. Reporter Lisa Burgess of Stars and Stripes reported that the Schoomaker said,

"It's like baking a cake."

So far none of the military cash is slated to go to California, but that could change as researchers here see the potential for grant funding.

Here is another piece on the Defense Department program on a blog by a Belgium consulting firm, Pantopicon.

Klein's Private Group Plans Expanded National Stem Cell Push

Americans for Cures, the private stem cell activist group tied to the chairman of California's governmental stem cell agency, is embarking on a new, 50-state strategy to beef up efforts to "pass pro-cures legislation and defeat anti-cures legislation."

The advocacy group, which says that it does not perform lobbying, says it is setting up affiliates in each state and wants to hear from persons who want to help out (write inform@americansforcures.org).

Complete details for the national effort are being worked out, but Americans for Cures plans to create a Web page for each state affiliate (here is a sample) along with a rundown on the status of research and that state's laws. The affiliate would be "a single point of contact in each state, and may be one person or a group. That point will be the ‘network hub' for stem cell advocacy, to keep us informed, and to organize in the affiliate state," the co-directors of the group, Amy Daly and Constance McKee, said in an email to their supporters.

The group is also planning a "Students for Cures" group and a "Veterans for Cures" group.

The chairman of CIRM, Robert Klein, is also president of Americans for Cures, which operates out of the offices of his real estate investment banking firm. It is unusual for a top state official to lead a group that solicits possibly tax-deductible contributions and attempts to influence government policy and legislation in the same area as his agency. More than one critic has called on him to resign from one of the posts.

(On a slightly different subject, Americans for Cures' new website has some videos involving persons with a variety of ailments. We watched the Alzheimers segment. It was quite powerful.)

Klein Group Says It Does Not Lobby

The American for Cures Foundation, whose president, Robert Klein, is chairman of the $3 billion California stem cell agency, has taken issue with our description of it as a lobbying group.

Amy Daly, executive director of the group, says that it does not lobby and that the California Stem Cell Report is reporting inaccurately.

She sent along the following from co-executive director Constance McKee:

"At your(Daly's) request, I have carried out additional research on Mr. Jensen’s 'definition' that would include our work as a lobbying firm. We do not make representations directly to Congress or its committees, nor do we ask for or accept any fees on behalf of others to do so. We educate individuals as to science and issues, and suggest how they themselves can advocate for stem cell research..... I could find no legal or tax definition under which our activities could be accurately described as 'lobbying.'

"You might be interested in the Supreme Court’s narrow definition of lobbying. Clearly that is not what we do.

"'The U.S. Supreme Court has rejected congressional efforts to regulate grassroots communications as a form of 'lobbying,' on constitutional grounds. In 1953, in a suit involving a congressional resolution authorizing a committee to investigate 'all lobbying activities intended to influence, encourage, promote, or retard legislation,' the Supreme Court narrowly construed 'lobbying activities' to mean only 'direct' lobbying (which the Court described as 'representations made directly to the Congress, its members, or its committees'), and rejected a broader interpretation of 'lobbying' out of First Amendment concerns. [United States v. Rumely, 345 U.S. 41 (1953).]"

Americans for Cures is obviously relying on a narrow legal definition of the word lobbying. However, lobbying has broader meaning. Merriam Webster's Third Unabridged Dictionary notes that lobbying includes conducting "activities (as engaging in personal contacts or the dissemination of information) with the objective of influencing public officials."

The legal definition of lobbying is of great importance to Americans for Cures. Too much lobbying could lead to a loss of its nonprofit status, according to the Nonprofitexpert.com web site.

Nonetheless Americans for Cures makes it clear on its web site that its goals include influencing public policy, declaring that it seeks to help "encourage" decision-makers to fund stem cell research. Indeed, Daly appeared briefly before the CIRM Oversight Committee in January and addressed the question of how the committee should proceed in handling an attempt to overturn a negative decision on a grant application. The group's recent conference in San Francisco promised attendees that they would be taught how "key federal and state programs are funded, and what they can do to make their voices heard," including "specific actions" that advocates "can take to accelerate research and cures."

Some people thing that lobbying is pernicious. We do not. The problems with lobbying result from poor ethical practices, abuses related to power and money and the failure to consider all points of view. Citizens, businesses, nonprofit organizations and other groups can and should be deeply involved in the governmental process. The voices of all are needed in order to formulate the best laws, regulations and policies.

How Many Hats for Klein?

The Center for Genetics and Society is tackling Robert Klein and his "incompatible" roles as head of a $3 billion, state-of-California stem cell enterprise and his leadership of a private group that attempts to influence politicians and government leaders concerning stem cell research.

The conflicting roles are not new. They have existed since 2004 but have attracted almost no attention in the mainstream media. Klein (see photo) is both chairman of the California Institute for Regenerative Medicine (the state group) and president of Americans for Cures, which is headquartered in the office of his real estate investment business.

Writing on Biopolitical Times, the blog for the center, Jesse Reynolds, who has followed CIRM since its birth, says:

"Imagine the response if the appointed head of California’s Department of Transportation was also the leader of a highway-building advocacy group that issued statements praising the department head, attacked his or her political opponents, raised funds for allies, spread misinformation about the benefits of highways, and compiled arguments against mass transit and bicycling."

Reynold also writes:

"Not only is (Klein) juggling two incompatible roles - stem cell booster and public servant - but under his guidance, his advocacy organization has attacked his political opponents, praised his own work, and spread misleading information. "

Reynolds continues:

"After the ballot measure passed in November 2004, Klein tried to wear both hats, those of booster and of public servant. The initiative campaign transformed into the advocacy group California Research and Cures Coalition, which remained headed by Klein and operated out of his business office in Palo Alto. In response to public criticism, he quickly resigned from the organization.

"But Klein couldn't resist politicking for his cause. In 2006, a new group appeared, Americans for Stem Cell Therapies and Cures, with Klein again at the helm. Its first action was to issue a public letter smearing Sen. Deborah Ortiz (D-Sacramento) on the eve of her primary election for Secretary of State. She had been the most vocal supporter of the stem cell initiative in the state house, but was now backing legislation to reform the agency. As a taxable lobbying group, Klein's outfit raised also raised money for his political allies in the fall 2006 general election.

"Now, Americans for Stem Cell Therapies has assumed the mantle of both the California Research and Cures Coalition and Americans for Stem Cell Therapies and Cures. Two months ago, it issued a press release backing one of Klein's pet projects at the CIRM. What's more, it is extensively downplaying the potential of a new alternative to the use of embryos in stem cell research - an alternative whose ascendance would call into question the relevancy of CIRM and its use of taxpayer dollars during a time of budget crunching."

Learning How to Tell the Stem Cell Story

The private lobbying group of the chairman of the California stem cell agency is holding a two-day session this Saturday and Sunday in San Francisco and promises to help advocates learn more about how to make their voices heard.

The group is the Americans for Cures Foundation, whose president is Robert Klein, who also serves as chair of the $3 billion state of California Institute for Regenerative Medicine. It is unusual for the head of a state agency to also have his own advocacy group in the same field, as we have noted previously.

Klein and Alan Trounson, president of CIRM, are both scheduled to speak along with a number of scientists as well as advocacy experts.

The session is reasonably priced -- $100 for both days, If that is too much, it's a good bet that a call to the group could lead to assistance.

The agenda is heavily loaded towards hands-on advocacy and selling the message. We suspect it would be a good value for those who want to learn more about telling the stem cell story.

We should also note that Klein's group has a redesigned and much improved web site, which is worth checking out.

CIRM Legislation Hearing Scheduled for Early April

The latest legislation to target the California stem cell agency is set for its first hearing April 2 in Sacramento before the Senate Health Committee.

The bill is aimed at ensuring affordable access to stem cell therapies financed by public funds in California. It would also require a study of the agency with an eye to correcting some of the difficulties it has had with such problems as conflicts of interest.

The lead author on the measure, SB1565, is Sen. Sheila Kuehl, D-Santa Monica, who is chair of the Health Committee. She is not expected to have difficulty in winning approval of her bill and sending it to the Judiciary Committee.

CIRM has not taken a position on the measure, but has opposed similar efforts in the past. Last month, one stem cell activist, Don Reed, opposed the measure, calling it "another distraction, another delay." Reed also said that CIRM is "squeaky clean" although one of its directors. John Reed (no relation to Don Reed), is under investigation by the state for violating CIRM's conflict-of-interest rules. Five other directors also violated conflict policies last year by writing letters on behalf of grant applicants.

Don Reed is vice president for public policy for Americans for Cures Foundation, which is the private, nonprofit stem cell lobbying group run by CIRM Chairman Robert Klein. It was Klein, an attorney, who advised John Reed to lobby CIRM staff on behalf of a grant to his institution.

The Bee Calls for Klein Resignation If He Continues to Lobby on Land Deal

The Sacramento Bee said today that California stem cell Chairman Robert Klein should resign from his post at the $3 billion state institute if he continues to lobby on behalf of a controversial Northern California deal that would swap favorable land use decisions for a private stem cell research facility.

The editorial noted that Klein's stem lobbying group, Americans for Stem Cell Therapies and Cures, earlier this spring received $125,000 from the Angelo Tsakopolous' land development company, which is seeking to convert farmland to commercial development. In return, a $200 millon stem cell nonprofit institute would be created at the location. The more than 2,000 acres is located on Interstate 80 between Sacramento and UC Davis.

The Bee wrote in an editorial:

"Klein says there's no connection between his efforts to retire campaign debt (owed by his lobbying group) and his support for the Yolo project, but it nonetheless creates an appearance of paycheck politics. If Klein wants to continue to promote the Yolo project or any project that could overlap with his duties as a state official, he needs to resign from CIRM. The sooner the better."

The newspaper said that Klein makes a "compelling case" for the type of research facility that would be built at the site by a nonprofit institute that would be headed by Klein. The Bee wrote,

"But if the case is strong, the multiple hats that Klein is wearing with this project are troublesome....He is cagey when asked if he would also continue to chair CIRM. There's the potential that the industries and researchers who would be part of this Yolo research center would also seek funding from the California institute, which would put Klein in a serious conflict of interest."

Yolo Stem Cell Proposal Attracts More Attention

A "farmland war," "unethical" – two of the descriptions emerging today in a fresh story about the Northern California land development/stem cell research project involving the head of the state's $3 billion stem cell agency.

CIRM Chair Robert Klein and Angelo Tsakopolous, a Sacramento area land developer, are lobbying for a proposed 2,800-acre land deal near the capital that would also create a stem cell research center with a projected endowment of $200 million. Earlier this spring, Klein's private lobbying organization received a $125,000 contribution from Tsakopolous' company. Klein would chair the proposed nonprofit.

In a story written by reporter Ralph Brave, the Sacramento News & Review today painted a bucolic picture of the development's location, which is hard on a very busy freeway just west of Sacramento. Brave wrote:

"This acreage has become the latest battleground in the ongoing war over the fate of Yolo County’s distinctive dedication to preserving farmland and open space. Although it’s just commenced, this particular battle’s mix of the area’s most powerful real-estate magnate, the head of the state’s stem-cell oversight committee, the re-evaluation of Yolo County’s General Plan governing development, and next year’s elections promises a prolonged, intense struggle that could determine much about the county’s and the region’s future."

The election issue involves at least the chair of the Yolo supervisors, a locally elected official who is seeking a seat in the California legislature. The dispute was characterized as a "farmland war" in a caption on a photo of a portion of the site.

Brave continued:

"Environmental attorney James Pachl told SN&R that Tsakopoulos’ 'proposal is an attempt to bribe the supervisors by offering to contribute to a fashionable charity in exchange for approval of AKT’s development project(AKT is Tsakopolous' company). Perhaps legal, but too unethical for most public officials to consider. The AKT property is valuable farmland, wildlife habitat and open space that should continue to be farmed.' A supporter of stem-cell research, Pachl expressed concern that 'the proposal will create a local political firestorm that will likely stop the project and damage the credibility of stem-cell researchers.'"

The newspaper also brought into its coverage another CIRM official, Claire Pomeroy, a member of the Oversight Committee and dean of the UC Davis School of Medicine.

Brave wrote that attendees at one dinner promoting the project included two Yolo supervisors, Klein and Pomeroy.

Brave said Pomeroy later told him that "it would not be 'appropriate to involve myself in land-use decisions.'"

Last Saturday, reporter Luke Gianni of the Woodland Daily Democrat quoted Pomeroy as saying,

"The concept of a research center for stem cells is a good one and something I support. A new research park in this region, in addition to the stem cell facilities we're currently building in Sacramento, could help complement the promising work our scientists are now doing in regenerative medicine."

Brave's story contained more details on financing the stem cell research facility, provided by Amy Daly, executive director of the Klein lobbying group, Americans for Stem Cell Therapies and Cures.

"Upon approval for residential and commercial development for some portion of the Tsakopoulos 2,800-acre property, 200 acres would be donated to a new nonprofit called Bridge to Cures. One hundred of those acres would be taken to a bank and used as collateral for a loan to finance the building of the research center and its labs. Part of the profits from the residential and commercial development would go into an endowment, to be used as loans, grants and other financing for biotech companies to advance stem cell and other biomedical discoveries into clinical applications."

Daly said the center's labs would be leased to for-profit companies. Earlier, she told the California Stem Cell Report that Klein would chair Bridge To Cures.

Size of the endowment has ranged from $50 to $400 million, depending on the size of the development that might be approved.

To see all the items on this subject, click on the label "yolo" below.