Thursday, July 31, 2008

CIRM Website Improves; More Info on Where The Money Goes

The California stem cell agency is slowly beefing up and improving its web site, posting additional information that is helpful to folks seeking to know more about how $3 billion in taxpayer funds are being spent.

One of the features added to the site recently is a list of all 206 grants (worth $554 million), their subject areas, institutions and the names of the principal investigators with links to the summary of the proposal by reviewers.

CIRM has also posted a ranking of institutions by the dollar value of CIRM grants that they have received. That list includes the type of grants awarded to each institution and the total dollars in each grant round.

Much, if not all, of this information was previously available on the CIRM website. But it took a lot of digging to ferret it out. The material is basic information, but it takes considerable work and care to compile it in a readily accessible format, not to mention updating it as warranted. And as we mentioned earlier, CIRM has also begun an "alert" service that provides automatic email notification to interested persons about a variety of events and information.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., recently singled out the list of all 206 grants for praise, calling the summary "user friendly and handy."

Don Gibbons
is the chief communications officer for CIRM and oversees the content on the website. He is to be commended for pulling all this together. It is a valuable resource for the public and interested parties. We look forward to other features that he may add to the web site.

You can sign up for the CIRM alerts by going to its home page and clicking on the sign-up button. Sphere: Related Content

Wednesday, July 30, 2008

The Associated Press Digs Into Eggs, Money and Stem Cell Research

The Human Egg Debate just racheted up a notch.

Generally confined to scientific journals and websites like the California Stem Cell Report, the issue of scientists paying for eggs for human embryonic stem cell research today clattered onto a broader stage in a thorough-going piece by The Associated Press. The international news service distributes its stories to virtually every newspaper, radio and television station in the country.

Marcus Wohlsen wrote the article out of San Francisco. It began,
"Facing a human egg shortage they say is preventing medical breakthroughs, scientists and biotech entrepreneurs are pushing the country's top funders of stem cell research to rethink rules that prohibit paying women for eggs."
The California stem cell agency was mentioned in the second paragraph. Stemagen, a San Diego stem cell firm, was mentioned in the sixth. Alan Trounson, CIRM's president, Harvard's Kevin Eggan, Cascade LifeSciences, also of San Diego, and the Center for Genetics and Society of Oakland, Ca., were all included.

Sam Wood
(pictured), chief executive of Stemagen, said that bans on payments for eggs have kept researchers from making advances that could save lives.

He was quoted as saying,
"You need to have enough eggs to make this thing work, and when you have enough eggs it does work."

"If these guidelines weren't in place, we'd already have many (stem cell) lines and be much closer to a treatment for devastating illnesses for which these are so well suited."
The AP story continued:
"As the country's largest funder of stem cell research by far, California's policy sets the pace for biotech firms and academic researchers nationwide. National guidelines advising against egg payments were developed to ensure any innovations would remain eligible for California funds; any changes to the state's policy would likely have an immediate ripple effect.

"California could also face increasing competition for business and scientific talent as New York prepares guidelines for its own $600 million stem cell research program. A draft report released by the New York program's planning committee said the state may allow payment for eggs."
But Wohlsen quoted Marcy Darnvosky of the Center for Genetics and Society as saying,
"Do we really want to put women at risk to provide raw materials for research a lot of scientists say really isn't the way to go?"
The references to Cascade, Trounson and Eggan all were to events chronicled earlier on the California Stem Cell Report, including the June meeting of CIRM's directors and the February meeting of the CIRM Standards Working Group.

The AP story pulled all of it together for general readers across the nation and perhaps abroad. Wohlsen's article will also attract the attention of editors around the country who may well commission locally written pieces and possibly editorials. It might even trigger a television news story or two. Sphere: Related Content

Fresh Comment

Don Thornton has filed a comment on the correction item below. Sphere: Related Content

Tuesday, July 29, 2008

Correction

The "Klein Confirms Resignation" item incorrectly identified John M. Simpson as Robert Simpson.

This is not the first time I have had made that mistake. The reasons go back to the early 1970s when I covered the California State Capitol for United Press International. Ronald Reagan was then governor. But he was not the only fixture under the dome. An elderly gentleman by the name of Robert Simpson also prowled the hallowed halls of state government. He was upset about some quite legitimate issue involving him personally, and the state system that did it to him. Unfortunately, the details are lost to memory. Even Google can't turn them up.

Robert Simpson meandered about the Capitol with his walker on nearly a daily basis, carrying hand-lettered signs with red characters proclaiming his grievances. His most memorable slogan was: "Reagan is a bastard!" It came at a time when such a public denunciation was still shocking. From time to time, Simpson was arrested by state police or Reagan's security forces and carted off to the local hoosegow. Undeterred he would pop up the next day invigorated by the experience.

I interviewed Robert Simpson on several occasions. His dentures did not fit well, and his enunciation was poor. Sometimes, spittle would fly and land on those nearby. The stories I wrote about him did little to solve his problems with the state of California. He was banging futilely against the state's bureaucracy. However, he relished the fight and the attention.

A couple of years later, a new reporter arrived in the Sacramento UPI bureau. (I taught him everything he knows.) Appropriately, he re-discovered Simpson and wrote about him again, pushing those stories into national prominence. Mr. Simpson, as we called him, delighted once more in the attention but his disputes were never settled to his satisfaction.

My recollection is that Mr. Simpson's health, never the best, declined. Members of his family came from out of town to assist. His obituaries were fulsome and replete with fond references to Mr. Simpson's good humor, despite his belief that he was never treated fairly by the state of California and the governor who portrayed so many amiable characters on the silver screen.

And that is why my fingers – to this day -- sometimes type in Robert Simpson's name instead that of John M. Simpson. Sphere: Related Content

CIRM Revising Rules on Pre-2006 Cell Lines

The CIRM Standards Working Group had a plateful last week, dealing with the question of whether it can finance human embryonic stem cell research involving cell lines that were derived prior to CIRM regulations.

The short answer is provided by John M. Simpson, stem cell project director of the Consumer Watchdog group, who attended the meeting. He wrote on his group's blog:

"A stem cell line may be deemed acceptably derived before November 2006 if the following criteria are met:

"Informed consent from woman or couple in IVF (and no indication that original donor would not consent for research).

"Approval of the donation protocol by an Institutional Review Board.

"Compliance with prevailing ethical and legal standards in place at the time of derivation in the jurisdiction where the derivation was carried out.

"The process to determine if the criteria had been met would begin with a request to CIRM. The staff would review the request and make a recommendation to the oversight board, the Independent Citizens Oversight Committee.  The review would have to include consideration of the scientific significance of the stem cell line.  The ICOC would consider the request in a public meeting after publicly posting it."

The Standards Working Group did not have a quorum so its "plan" will go to directors, presumably at their August meeting, as representing the "sense of the group" but without a formal recommendation. Such a practice is commonplace with CIRM since it has perennial problems with securing quorums at meetings.

If you see problems with the CIRM proposal or support it, now is the time to send something along to the agency. Sphere: Related Content

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. Sphere: Related Content

Monday, July 28, 2008

CIRM Confirms Departure of General Counsel

The California stem cell agency today confirmed that Tamar Pachter is leaving her post (see item below) as general counsel of the $3 billion enterprise.

Her Aug. 15 departure pretty much finishes off the senior management team assembled by former President Zach Hall, who retired in the spring of 2007. The top senior executives now in place were brought in after Hall left and after Chairman Robert Klein recruited Alan Trounson as president.

Under Klein's leadership, CIRM has also been reorganized to shift more staff and responsibility to the chairman's office, undoing directors' changes in 2007 that stripped Klein's office of six positions.

Klein and Hall butted heads more than once, mostly in private, but in public put the best face on their relationship. Conflicts emerged partly because of the overlapping roles provided for president and chairman in Prop. 71. Under normal state and business practices those roles could be clarified by an organization's board of directors, but Prop. 71 locks them into state law, making them virtually impossible to change. The differences between the men, however, went beyond the CIRM structure, reflecting their divergent personalities, professional background and philosophies.

In response to a query from the California Stem Cell Report, Don Gibbons, chief communications officer for CIRM, confirmed Pachter's resignation. He said she would return to the state Department of Justice, where she served as a deputy attorney general. It was in that position that she argued and won the case that threatened to put CIRM out of business. Sphere: Related Content

CIRM's Chief Counsel Quits

The attorney who successfully defended the California stem cell agency against challenges to its existence has resigned as CIRM general counsel after only 16 months on the job, according to a well-informed source.

One longtime observer of CIRM affairs characterized the reported resignation of Tamar Pachter(pictured) as a "troubling development" that reflects poorly on CIRM Chairman Robert Klein.

Pachter could not be reached for comment on her decision to leave her $225,000-a-year post. CIRM has not responded to our queries on her resignation.

Pachter is at least the 17th employee to leave CIRM since it began work in 2005. The agency has only slightly more than 30 employees with plans to reach 39 by the end of this fiscal year.

Only last December Pachter received a 41 percent pay increase, up from the $160,000 that she was hired at in March 2007.

Rumblings have surfaced, however, that Pachter was not happy. One likely issue is the fragmented legal approach at CIRM. Typically a general counsel oversees all the legal operations of a state agency or business. However, that was clearly not the case at CIRM.

The agency has retained outside counsel, Remcho, Johansen & Purcell of San Leandro, Ca., since 2005 at a cost exceeding $1 million. CIRM has at least three other attorneys, not including Pachter and Chairman Klein, who wrote much of Prop. 71, the ballot measure that created the agency. None of those attorneys reported to Pachter, according to CIRM's organizational chart. Instead they come under Klein.

CIRM plans to hire two more attorneys this year. Neither of them is linked directly to the general counsel's office. CIRM also has received legal assistance from the state Department of Justice.

Frequently Pachter and James Harrison, Remcho's main CIRM representative, would attend the same CIRM public meetings. Often, Klein deferred to Harrison at those sessions. The Harrison/Remcho contract is due to be renewed on Wednesday for $450,000 for 2008-09 at rates up to $350 an hour.

We asked John M. Simpson, stem cell project director for the Consumer Watchdog group of Santa Monica, Ca., for his thoughts on Pachter's departure. Simpson recently commented on how CIRM's top management seems to be an "old boys' club."

Simpson said,
"If Tamar Pachter has resigned, it is a troubling development. CIRM has been plagued with high turnover and much of the blame for this rests with the management style of Chairman Bob Klein. The agency has lurched too frequently in different directions; what's needed is a steady hand at the helm that allows the routine to become routine."
When Pachter was hired out of a pool of nearly 100 applicants, CIRM hailed her "impeccable legal credentials" and described her as a "superb litigator." Sphere: Related Content

Thursday, July 24, 2008

Bee 'Flabbergasted' by Klein's Actions

The Sacramento Bee has not been pleased with Robert Klein virtually since he became chairman of the $3 billion California stem cell agency more than three years ago.

Earlier this week, the newspaper fired off another editorial lambasting Klein, this time accusing of him of misusing his office.

The case in point involves Klein's personal stem cell lobbying group, Americans for Cures, which recently publicly excoriated an offending state legislator in a posting on a widely read, national political blog.

The Bee wrote,
"Through his connections with the governor and other state leaders, Klein effectively directs who is appointed to the institute's 29-member oversight board, which includes university deans dependent on research funds that Klein controls.

"That should be enough power for any one public official. But not for Klein.

"Up until last week, Klein also served as president of Americans for Cures, an advocacy group that works out of offices he owns in Palo Alto. That linkage provides Klein with a nongovernmental agent with which to go after his opponents and further his institutional power."
The Bee continued:
"Government officials shouldn't be affiliated with special interest groups that lobby on issues that affect their agencies. After three years, it remains flabbergasting that Klein doesn't recognize that conflict and the injury it causes to the state's stem cell program. Even more curious is why the institute's 'oversight' board continues to condone it."
The Bee's editorial was written before the disclosure that Klein plans to spend 88 days traveling out of state this fiscal year at taxpayer expense. We are certain that the newspaper would have been even more exercised if that had been known at the time the editorial was written.

As far as Klein's reported resignation as president of Americans for Cures, so far no official announcement has been forthcoming. One report had it that the resignation would be announced after he told Sen. Sheila Kuehl, the object of his group's ire, about it. But her office said that Klein did not mention resigning in their conversation following the offending Internet post.

The delay in announcing his resignation may indicate that the earlier resignation reports amounted to something of a trial balloon effort by Klein in which Klein expected supporters to rally around him. Meanwhile, he is still listed as president on the Americans for Cures website. Sphere: Related Content

Lockyer Names Quint to CIRM Directorate

The California stem cell agency has a new member on its board of directors, a cardiologist from San Jose who once treated former state lawmaker John Vasconcellos.

The new member of the CIRM Oversight Committee is Robert Quint, who was appointed to the post by state Treasurer Bill Lockyer.

A spokesman for Lockyer said Vasconcellos had recommended Quint. "We were highly impressed with Quint's resume, and the man himself, and Lockyer decided he was the person for the job." the spokesman said. Lockyer and Vasconcellos, both Democrats, served in the state legislature together.

Quint replaces Janet Wright, also a cardiologist, on the 29-member board. Wright left earlier this year to take a job in Washington, D.C., with the American College of Cardiology.

Quint has operated his own cardiology practice in San Jose since 1980. Lockyer's office said,
"He has helped develop pioneering diagnostic and treatment techniques for arteriosclerotic heart disease, including coronary angiography and angioplasty."
We asked Lockyer's office whether Quint had been recommended by CIRM Chairman Robert Klein. Spokesman Tom Dresslar replied,
"Former state legislator John Vasconcellos did.  He and Lockyer go way back."
One vacancy remains on the CIRM board of directors. Sphere: Related Content

Wednesday, July 23, 2008

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. Sphere: Related Content

Fresh Comments

Larry Ebert has posted a comment on the "group-think" item. "Anonymous" has filed a comment on the "WARF whacked" item. Sphere: Related Content

Tuesday, July 22, 2008

The Perils of Group-Think at CIRM

Is the California stem cell agency dominated by an Old Boys Club that is shy on experience in running a grant program totalling a half-billion dollars?

John M. Simpson
, stem cell project director of Consumer Watchdog of Santa Monica, Ca., thinks so.

Simpson, who describes himself as a "fat, old white guy," says he doesn't have anything against such persons. But he warns about the perils of group-think when the top execs are cut from the same general mold.

Only one woman and no minorities hold top management positions at CIRM, which Simpson lists as chairman, vice chairman, president, vice president, chief scientific officer and chief communications officer.

Writing on his organization's blog, Simpson sees the hiring of John A. Robson of McGill as part of the influence of CIRM's old boys. Simpson cites the role of Richard Murphy, former CIRM director, former interim president and ongoing consultant, in recruiting Robson. Murphy also once worked at McGill.

Simpson also notes that former CIRM acting president Lori Hoffman had a falling out with Chairman Robert Klein last year and was "pushed out."

Simpson writes that with Zach Hall as president and Arlene Chiu as chief scientific officer, CIRM "had extensive experience on the grant-making and management side of the equation by virtue of their time at the National Institutes of Health. They knew something about holding grantees accountable."

Simpson continues,
"The Old Boys Club members' experience has been on the grant-receiving side -- and most of that in academia.  Certainly some of the top executives at an agency charged with handing out $3 billion in scientific grants should have experience on the grant-making side. It's almost as if the henhouse is being taken over by the foxes."
Simpson concludes:
"I fear the Old Boys Club is letting visions of playing on the international stage distract them from what is really CIRM's charge: Funding vital research and finding cures in California.  The real danger of a having a management team that looks alike is that team members will think alike. Nobody will stand up and say, 'Wait a minute; just what are we doing here and why?'"
Sphere: Related Content

Fresh Comment

Marcy Darnovsky of the Center for Genetics and Society in Oakland, Ca., has filed a comment on the "no egg shortage" item. Sphere: Related Content

Monday, July 21, 2008

Fresh Comments

Larry Ebert has posted a comment on "WARF Whacked Again."

Angsuman Chakraborty
has posted a comment on "Stem Cell Globe-Trotting." Sphere: Related Content

A Re-Look at Friday's Egg Meeting

The California stem cell agency has taken issue with the way we have framed this coming Friday's meeting dealing with human eggs.

It is not really about availability, cost and prices, says CIRM. But rather about stem cell lines and embryos created through IVF treatments and their possible use in CIRM-financed research.

Geoff Lomax, senior officer for the Standards Working Group, said,
"You have got this one completely wrong and framed the meeting in a sensational and inflammatory way which does a disservice to thoughtful policy deliberations."
Lomax prepared the briefing paper – called "Use of Embryos Created for Reproductive Purposes with Paid Gametes" – for use at the Standards meeting later this week.

When we read it, we took a broader perspective, one that concerned the general availability of eggs for research and the economics behind their apparent scarcity.

But first CIRM must deal with the information Lomax presents in his background material as well that which will be brought to the table by others.

He wrote:
"Nationally, the CIRM policy deviates from other jurisdictions that have developed policies to advance stem cell research. This deviation has raised concerns over the ability of CIRM researchers to utilize materials derived under other jurisdictional policies or the National Academies Guidelines."
The issue of the use of human eggs is freighted with emotional and political baggage, plenty of which will surface eventually. But meantime, Lomax is trying to lay the groundwork for a straightforward consideration of practical issues that need attention sooner rather than later. Sphere: Related Content

San Diego Researchers Say No Shortage of Human Eggs

Jeff Sheehy, a member of the board of directors of the California stem cell agency, has brought to the human egg debate a new entry that appears to fly in the face of assertions that scientists cannot get enough eggs for their human embryonic stem cell research.

His comments and information come as the CIRM Standards Working Group plans to dig into the topic again this Friday during a public hearing in Los Angeles. The issue of egg availability, however, goes well beyond California, reaching out to such places as the United Kingdom, where discounted IVF services are being offered to generate eggs for research.

Sheehy, also a member of the Standards Working Group, pointed to work being done by Cascade LifeSciences in San Diego and others to show that the egg shortage concerns of CIRM President Alan Trounson and Harvard's Kevin Eggan may be overstated.

Sheehy's starting point is a letter for reconsideration of Cascade's rejected application for a CIRM grant. Cascade's letter, which can be found here on the California Stem Cell Report, stated that the firm was collaborating with David Smotrich of the La Jolla IVF clinic to obtain eggs. Cascade said that the clinic had a "list of young and healthy volunteers who desire to donate oocytes specifically for this SCNT project. All these donors were pre-tested and demonstrated a high oocyte production (20-25 oocytes per cycle) in response to homornal stimulation."

Last week Sheehy queried Ken Woolcott, who wrote the reconsideration request, about the availability of eggs, which Sheehy recalled as being 100 a year. Sheehy also asked whether they were obtained under circumstances that would make them available for use by CIRM grantees i.e. proper consent, no payment outside of CIRM policy, etc.

In response, Woolcott, Cascade's chief business officer, emailed Sheehy that he checked with Cascade's primary investigator, Dr. Sophia Khaldoyanidi, as well as Smotrich, head of the collaborating La Jolla IVF clinic. Woolcott replied,
"Dr. Smotrich confirmed that the oocyte donors are only reimbursed for their time and medical care expenses.   These donors are not IVF patients that receive discounts or are paid for their eggs.  They tend to be donors that desire to enhance medical research in the Stem Cell  area, are younger and have a track record of high oocyte quality and productivity. 

"I believe that this is consistent with the draft guidelines prepared by CIRM and is consistent with the law in California.    More importantly, any work in this area would be subject to IRB approval."
Sheehy said that Woolcott's information is "very important" if it "confirms that at least one investigator in California is able to obtain sufficient oocytes to conduct research within the confines of CIRM's ethical standards and the provisions of Prop. 71 and SB 1260(the law that deals with non-CIRM funded hESC research)."

But the devil may well be in the details. In this case, does the La Jolla clinic's definition of reimbursement for "time and medical care expenses" match that of CIRM's? Sphere: Related Content

Friday, July 18, 2008

A Critical Look at CIRM's Stem Cell Globe-Trotting

The Consumer Watchdog group is taking a dim view of the travel plans of the top executives of the California stem cell agency, describing as "bafflegab" the justification for spending much of the $558,000 in what CIRM describes as its "other travel" budget.

John M. Simpson
, stem cell project director for the non-profit advocacy group, made his comments on his organization's blog. They were based on previously undisclosed documents that he requested from CIRM.

Among other things, the CIRM documents showed that its chairman, Bob Klein(pictured), is scheduled to be outside of California for 88 days at state expense in 2008-09. That does not include his travel within California, such as his trip today to Santa Barbara.

Chief Science Office Marie Csete will be out of California 75 days, CIRM President Alan Trounson 68 days, Chief Communications Officer Don Gibbons 32 days. All of which amounts to a 287 percent increase (in terms of dollars) in "other travel" by CIRM officials.

China, Japan, the United Arab Emirates, Israel, the United Kingdom, Sweden, The Netherlands, France, Korea, Australia, Italy, South Africa and Canada are among the destinations.

To a CIRM travel justification that said in part that some of the trips were necessary "in order to have an integrated picture of state of the art and forward-looking research agendas," Simpson retorted, "bafflegab."

He continued,
"After crunching the numbers I checked with some scientists.  All agreed there is a need for the hard-working science staff to attend some conferences to stay abreast of the latest developments. Perhaps one or two a year, suggested one.

"Another scientist reported traveling 4-5 days a month to to give seminars, attend meetings and review grants and then said about CIRM's travel plans:

"'Is the travel necessary? No.  Useful for CIRM? Probably not very much.  Good for Bob and Alan?  Absolutely.'

"Voters passed Proposition 71 because they wanted to pay for vital stem cell research in California that the federal government would not fund.  They did not intend to send Bob Klein around the world as a stem cell research advocate."
Still undisclosed, as far as we can tell, are travel expenses that are not classified as "other travel."

Simpson has posted the documents in question on his website. Links to them are contained in his blog. Sphere: Related Content

CIRM Reviews the Business of Human Eggs

One week from today, the California stem cell agency is going to dig into the hot topic of human eggs – how many can scientists can get and their cost.

To its credit, the agency has posted background material on the subject well in advance of the July 25 meeting of its Standards Working Group in Los Angeles. Providing the material early is a refreshing change from CIRM's recent dilatory practices. The agency is to be commended.

The egg meeting comes in the wake of complaints earlier this year by researchers and CIRM President Alan Trounson that human eggs were not to be had in sufficient quantities for research. Kevin Eggan(pictured) of Harvard, a member of the Standards group, said that he and his colleagues had spent $100,000 advertising for human egg donors with little success.

The problem is that California and other states bar compensation for eggs for research. But handsome payments -- $15,000 and even more -- are made by IVF clinics for the same egg donation process. So most women take the cash.

Eggan made his comments last February. The ensuing discussion set in motion a review of CIRM policies dealing with compensation of donors. The issue also came up briefly last month at the meeting of the CIRM board of directors.

Trounson said scientists are having a "terrible time" securing eggs. He declared,
"It's all because there's no partnershipping arrangements or because they're using very few oocyte material. They're now trying to use cattle eggs, other species. They're floundering."
CIRM has prepared a draft briefing paper dealing with the egg issue. The agency has not completed all of its work on the subject, but it is surveying funding institutions, interviewing scientists and others and determining whether specific cell lines are not being used by CIRM grantees.

The briefing paper lists the following policy questions.
"Should CIRM funded researchers be able to use 'outside' hESC lines if they are derived from IVF-embryos created with paid gametes?

"Should CIRM funded researchers be able to utilize hESC lines derived from IVF-embryos created with paid gametes under an 'authorized authority'?

"Should CIRM funded researchers be be able to utilize IVF-embryos created with
paid gametes to derive new lines?"
Also prepared for next week's meeting is a briefing paper on uses of cell lines derived prior to CIRM regulations. Sphere: Related Content

WARF Whacked Again

The latest chapter in the WARF stem cell patent saga opened today with the filing of an appeal by two consumer groups and a statement from California researcher Jeanne Loring of the Scripps Institute. She said,
"It's not just scientists that are affected by the patents. Patients and their families know that WARF’s iron-fisted control of stem cells is slowing life-saving research."
Consumer Watchdog of Santa Monica, Ca., and the Public Patent Foundation in New York City announced the filing of the appeal. The issue is not likely to be resolved for years, although John M. Simpson of Consumer Watchdog said WARF has already relaxed its licensing requirements in the wake of the patent challenge.

Simpson said,
"WARF executives were acting like arrogant bullies blinded by dollar signs. Our challenge has engendered a more co-operative stance towards the stem cell research community on their part."
Sphere: Related Content

Thursday, July 17, 2008

Kindling the Flame in Goleta: Thomson, Klein Part of Gaucho Show

California's Robert Klein will share the stage with Wisconsin's Jamie Thomson Friday at the University of California, Santa Barbara, which has lured the renown researcher to its seaside campus with a $1 million package, including a new lab.

Klein, of course, is both the chairman of California's $3 billion stem cell agency and still officially president of his own private stem cell lobbying group, Americans for Cures. (No announcement has been forthcoming from the group confirming his reported resignation in the wake of its vitriolic attack on an influential state legislator.)

Klein and Thomson (pictured) will appear as part of a town hall event to discuss the state of stem cell research. The roundtable will also feature Congresswoman Lois Capps, a former nursing instructor, Gaucho (as UCSB denizens are known) alum and Wisconsin native.

CIRM has had a huge impact in California stem cell circles in the last 3 ½ years, but UC Santa Barbara might well be a poster child for what the agency has achieved.

Human embryonic stem cell research hardly existed on the campus (pictured) prior to 2005, the first full year for the California's research effort. But with a strong push from professor Dennis Clegg, now co-director of the UCSB Center for Stem Cell Biology and Engineering, the school scored in the first round of grants approved by CIRM. Today it has $6.7 million in stem cell research and lab construction funds from the California stem cell agency and another $3 million from one of the founders of Amgen. And it succeeded in drawing Thomson into the state on a part-time basis.

Thomson, whose lab is located in the UCSB California NanoSystems Institute, says,
"I am attracted by UCSB's strengths in materials science, instrumentation, and by the availability of marine model organisms for comparative studies."
Of course, UCSB's $6.7 million in CIRM funding is eclipsed by the $91 million given by CIRM to Stanford and the $69 million to UC San Francisco. But those campuses can generate buckets of money even without the state cash.

The Santa Barbara university has this to say about its fledgling stem cell effort:
"UCSB is well positioned to make unique, significant contributions in stem cell research, with extraordinary enabling technologies in biomaterials, systems biology, nanotechnology, micro-processing and bioengineering, all of which are synergistic with fundamental biomedical research efforts. Our approaches are uniquely distinct from those at California medical schools, with our emphasis on basic biological questions and engineering challenges related to stem cell research."
What CIRM has done is kindle a flame in Goleta (the actual location of UCSB). The hope is that the UCSB effort will grow and prosper, bringing new initiatives and insights into development of possible stem therapies. Sphere: Related Content

Wednesday, July 16, 2008

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. Sphere: Related Content

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. Sphere: Related Content

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

Sphere: Related Content

The Media Mustard and Meaning of Klein-Kuehl Flap

The Klein-Kos-Kuehl Affair has drawn no attention in the mainstream media and almost none on the Internet – surprising to some deeply involved in the California stem cell scene.

Especially given the history of high profile verbal snafus that have publicly plagued scores and scores of public figures. In a totally different context than stem cell research, the Klein flap recalls presidential aspirants who have been given serious media fits as the result of misguided rhetoric, either from themselves or associates. One only has to look at the Obama-Clinton race to see major political figures wrestling with verbal gaffes.

But the reality is that the comments from Robert Klein's lobbying group, Americans for Cures, concerning an influential state lawmaker's intelligence, knowledge and political fortitude are not even close to making the front page of any newspaper. They may be outrageous, an incredible display of bad judgment and reflect poorly on California's $3 billion stem cell research program, but they do not cut the media mustard.

We cannot find even a single story on the comments in any newspaper in California, much less a current story dealing with the underlying conflicts of interest posed by Klein's dual roles as head of a stem cell lobbying organization and chairman of the leading source worldwide of funding for human embryonic stem cell research. Only two Internet sites that we know of have picked up on the matter, The Niche stem cell blog of Nature magazine and Larry Ebert's IPBiz blog. Monya Baker of Niche largely provided a neutral summary of the events. Ebert made reference to what he called ongoing bungling at CIRM.

We asked one mainstream media reporter about the reasons for the lack of coverage, promising anonymity to guarantee candor. The response:

"It was an easy call that it was not as important as the many other stories on my plate. You know how it goes: Mainstream media has to deal with many more topics than most blogs, including the California Stem Cell Report. For instance, Dave Jensen doesn't have to worry about sharing space on his blog with stories on the price of oil, or failing banks, or city council meetings and murder trials. Blogs also are not expected to meet the same journalistic standards as newspapers, which means they can run items with one source and lots of opinion. And they can touch on the same topic in many different posts, giving incremental developments.

"Meanwhile, newspapers try get several sources and views into one story. We are also dealing with budgetary, staffing and news hole cuts. That means reporters in mainstream media are covering much, much more than just CIRM and stem cells. (CIRM is just one small piece of my very broad and complicated beat.) All that means that I must be much more selective in what I write about."
We also asked John M. Simpson, stem cell project director of Consumer Watchdog, for his views on the media coverage. Simpson had a long career as a newspaper editor prior to holding his current position. He said,
"The news business is in a terrible state. Newsroom staffs have been slashed. Every news organization is trying to do more with less and that's simply impossible.

"Complex ongoing stories, like CIRM and its governance structure, get short shrift in the face of the current crisis in journalism.

"Until somebody figures out a new viable financial model to support quality journalism, we going to see less and less coverage of issues like this. I don't want to sound hysterical, but I think good democratic government is seriously threatened by the sorry state of the mainstream media."
With 30 years experience in journalism, we do not disagree with either our anonymous reporter or Simpson. But we can also add that coverage of state agencies has traditionally been given short shrift in California. It is easier to cover the governor, political activities and only the highest profile legislative issues.

CIRM is off the current agenda for the mainstream media. Does that mean that the issues or specifics involved in the Klein-Kos-Kuehl affair are not important? Far from it. The posting by Americans for Cures was destructive of CIRM's goals. Ironically, the action increased the likelihood that the bill will pass. The vitriol demonstrated indirectly that CIRM is not to be trusted in sensitive dealings. It showcased once again flaws in Klein's leadership that surfaced as long ago as 2005. And it highlighted one of the conflicts that pervade CIRM's board of directors.

The California stem cell experiment is a remarkable endeavor. It has achieved much. But much more remains to be done. CIRM directors should look to finding ways to foster cooperation – not only with the international stem cell community – but here in California, where the home fires are now in need of some renewed and careful tending. Sphere: Related Content

Tuesday, July 15, 2008

Fresh Comments

Jesse Reynolds of the Center for Genetics and Society, who has followed California stem cell affairs since prior to the passage of Prop. 71, has posted comments on the "Klein Resigns" and "CIRM Letter" items. Sphere: Related Content

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. Sphere: Related Content

Monday, July 14, 2008

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. Sphere: Related Content

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."
Sphere: Related Content

Sunday, July 13, 2008

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) Sphere: Related Content

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."

Sphere: Related Content

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
Sphere: Related Content

Friday, July 11, 2008

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"
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Consumer Watchdog: Despite Apology, Klein Still Should Still Resign

The Consumer Watchdog group today said it is not withdrawing its call for the resignation of Robert Klein as chairman of California's $3 billion stem cell agency, despite an apology from his lobbying group for its personal attack on a Democratic state legislator.

John M. Simpson, stem cell project director of Consumer Watchdog of Santa Monica, Ca., said the co-executive directors of Klein's lobbying organization, Americans for Cures, "are taking the blame" for the posting on an influential national political blog, Daily Kos. Simpson said on his group's blog,
"What this incident underscores is how inappropriate it is for Klein to hold  positions as chairman of the California stem cell agency and president of a stem cell advocacy group simultaneously.  If he wants to be an advocate -- and he can indeed be effective as the passage of Proposition 71 demonstrates -- he must step down from his position as chairman of the stem cell board.

"The welcomed staff apology does not change the fundamental confict Klein faces by insisting on holding both positions."
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Stalled

Our promised items on changes to SB 1565 have been stalled because of events related to Americans for Cures and their posting on Sheila Kuehl. We will carry the amendments and the CIRM opposition letter during the weekend. Sphere: Related Content

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"
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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. Sphere: Related Content