CIRM's Court Date Draws Coverage

The Valentine Day hearing on the appeal in the California stem cell lawsuit drew two stories today, one in Dow Jones' MarketWatch and the other in the Los Angeles Daily Journal.

Anne Marie Ruff wrote the Daily Journal piece, a fairly lengthy overview of the legal machinations. She quoted yours truly as saying, "California courts are loath to tell voters that they have no business ruling themselves, which is what the initiative process is all about.”

Carolyn Pritchard wrote a shorter piece on Market Watch, covering similar ground. Pritchard linked to a video of an interview with CIRM Chairman Robert Klein. Neither article carried material that would be surprising to readers of this blog.

Sacramento Bee: CIRM Grants 'Needlessly Shrouded'

The Sacramento Bee today endorsed sunshine at the California stem cell agency.

In an editorial headlined "grant process is needlessly shrouded," the newspaper called for legislative changes to open up CIRM. Here is an excerpt:

"Scientists from outside states do much of this review work, and are not required to publicly disclose their potential conflicts of interest. Undoubtedly, some of those scientists have outside consulting work, or personal relationships with researchers seeking funding, that could affect their grant decisions. Yet under the institute's shrouded procedures, it is impossible for anyone -- including researchers applying for grants -- to be assured that grant reviewers are recusing themselves at the proper times.

This lack of public disclosure is the single most glaring problem with the Institute for Regenerative Medicine. While it is momentous that California is now on the leading edge of financing embryonic stem cell research, the institute still hasn't adopted a transparent procedure for policing potential conflicts. Lawmakers, in this session of the Legislature, need to correct that."

The Bee editorial had received two comments from readers as of this morning. Both were generally opposed to ESC research. One asked, "Can we do a recall on ballot initiatives."

We want to assure curious minds that The Bee editorial and our item below, "CIRM Money Machine," only coincidentally appeared within less than 24 hours of each other. No collusion existed. But being a skeptic ourselves, we know that the denial will do no good.

What Do You Think?

Should CIRM continue its policy of secrecy concerning grant applications and the economic interests of those who make de facto decisions on scientists and institutions that should receive tens of millions of dollars of public funds? Let us know by using the comments function below. Just click on the word "comments" and you can leave a note – included an anonymous one that encrypts your identity. See the item below for a discussion of the topic.

The CIRM Money Machine and Potential Scandal

Giving away millions is not always easy.

Eighteen months ago, the talk included references to rubber stamps, "re-reviewing" not to mention honesty and legality.

The scene was Sacramento, Sept. 9, 2005, when the Oversight Committee of the California stem cell agency awarded its first-ever grants, which went for training programs for stem cell scholars at California schools.

The 29-member panel was whipping through the list of soon-to-be recipients when they ran out of applicants with really high scores. It was then that discussion surfaced about whether the board was merely rubber-stamping decisions of its grant reviewers or doing something more.

And it was then that Philip Pizzo, dean of the Stanford School of Medicine, said,

"In a sense our job was to really choose or approve the people who are going to be reviewers, and by way of delegated authority, we're asking them to make recommendations which are really decisions because we don't have all the data."

Pizzo's comment and similar ones by other CIRM overseeers 18 months ago are critical to understanding questions of conflicts-of-interest, openness and transparency at the grant review level. CIRM has imposed a lid of secrecy on virtually all of the doings of the grant review group. Not even the Oversight Committee members, for example, are supposed to know the names of the institutions seeking grants, although it was relatively straight forward to identify a goodly number of the applicants in 2005 based on the bowdlerized information available then. You just needed to be conversant with California institutions involved in stem cell research.

CIRM conceals the names of the applicants lest it embarrass the losers. CIRM says that encourages good science by encouraging potentially rewarding but risky ventures – ones that the authors might not want to vet in public. Moreover, CIRM says the Oversight Committee actually makes the grant decisions – not the grant review committee. Thus such matters as the economic interests of the grant reviewers and their closed-door meetings to give away tens of millions of public dollars are not really important in terms of openness and transparency.

Eighteen months ago, the Oversight Committee only turned down a couple of grant applications that were recommended by the grant review group(the number is not entirely clear from the transcript of the session). The Oversight group is not likely to reject any significant number of recommendations this Friday for SEED grants. If it does, it soon will not have anybody willing to serve on the grant review committee. Moreover, the CIRM directors simply do not have enough information to perform any sort of significant second-guessing of its hard-working reviewers, all of whom are from out-of-state.

CIRM Chairman Robert Klein, in 2005, bridled at Pizzo's remark that reviewers were actually making decisions, which Pizzo conceded was an impolitic choice of words although they clearly reflected the sentiment of a number of committee members. Klein commented again later when Gerald Levey, dean of the UCLA medical school, said, "What is the purpose of discussing everything on an individual basis? Why don't we just vote en bloc? We're just going through this on an individual basis, but it has no meaning."

Klein, who is an attorney, replied,

"We have to go through this on an individual basis because of the laws of the state of California. And to observe the very high standard of conflicts adopted by this board, we have to make sure we have roll call votes on every application. That is the challenge and it is a new process for California as well as a nation."

It IS a challenging and new process, one that does not have to follow the well-trod but not necessarily applicable procedures of older institutions that are fundamentally different than CIRM. The NIH is often cited as a precedent for CIRM's secrecy on grants. But the NIH can easily be controlled by Congress and the President. CIRM is virtually immune from control by the California Legislature and governor.

The California stem cell agency should rethink its policies on financial disclosure and transparency. Opening the doors will help to protect the agency from the suspicions that will certainly surface as the CIRM money machine begins to hand out hundreds of millions of dollars. Not to mention helping to prevent an outright scandal that would be relished by opponents of embryonic stem cell research.

Stem Cell Snippets: Court Appeals, Cheerleading,UC Davis Plans, Pera and Kuehl

Stem Cell Lawsuit Appeal – The time has changed on the oral arguments on Feb. 14 in the appeal of the verdict in the CIRM lawsuit trial. It is now set for 2 p.m.

World's Oldest Cheerleader? – Relentless patient advocate Don Reed says next Friday (when CIRM makes its first research grants) is an "unbreakable date" in San Francisco (actually Burlingame, which is near the airport). In his effort to generate favorable news coverage, he wrote a piece on "StemBlog," which is part of the Stem Cell Action Network. Reed said this about the expected grant announcements, "Worst Scenario: the opposition shows up in full force, which they will– and in support? Old white-haired Don is there by himself, the world’s oldest cheerleader. Best Scenario: a ton of people smiling, including some friends driving wheelchairs, joined in the celebration of a truly historic day, when in the face of seemingly insurmountable odds, a great state led a great nation into a new age."

Losing the Stem Cell Race – The Washington Post and the Sacramento Bee carried an op-ed piece that suggested state efforts to pump up stem cell research are not enough. According to Joseph Fuller and Brock Reeve, the reasons include: "The entry of individual states into the breach left by the federal government has helped drive research activity. But it has also created a patchwork of regulations and funding levels that constrains research collaboration. Expensive and restrictive enabling patents, political controversy and the absence of federal research money, coupled with a long time to market, have made venture capitalists reluctant to invest. In 2005, just over $100 million in venture capital went to stem cell ventures, compared with $500 million in biotech ventures at an equivalent stage."

UC Davis Stem Cell Plans – The campus newspaper at UC Davis has a rundown on $75 million in stem cell research building plans on the campus. Written by Allie Shilin, the piece says: "The newest addition to the center is a 5,160-square-foot Good Manufacturing Practice laboratory to be housed in a 100,000-square-foot renovated portion of the UC Davis Medical Center on Stockton Boulevard in Sacramento."

Reijo Pera – The co-director of the UC San Francisco ESC research center is leaving to join Stanford as director of "human embryonic stem cell research and education for the Stanford Institute for Stem Cell Biology and Regenerative Medicine."

Kuehl's CIRM Legislation – Jesse Reynolds of the Center for Genetics and Society is "encouraged" by State Sen. Sheila Kuehl's proposal to make changes at the California stem cell agency. He writes on Biopolitical Times that her ideas are worthy of support.

Not Enough Info on Egg Donation Risks, Critic Says

The Pro-Choice Alliance for Responsible Research said today that this week's Institute of Medicine report on the risks of egg donations shows "how little scientific data exists about the health risks of egg retrieval."

Susan Berke Fogel, coordinator of the group, made the comment in connection with the document that resulted from last year's conference prompted by the California stem cell agency. She said in a statement:

"By suggesting that researchers must have thousands of women’s eggs now, despite the critical absence of safety data, the report does women a great disservice. A more responsible conclusion would be to call for:
1. Research endeavors that do not require egg extraction procedures solely for research purposes; and
2. Research that will better define the risks of multiple egg extraction, so that meaningful informed consent will be possible. This will serve not only women who may want to donate eggs for research, but women who now undergo these procedures as part of infertility treatments."

The full text of the statement can be found below. It did not appear elsewhere on Web at the time of this posting.

Text of Fogel Statement

Here is the text of the statement by Susan Berke Fogel, coordinator of the Pro-Choice Alliance for Responsible Research, on the IOM report on the risks of egg donations. Fogel's statement could not be found elsewhere on the Internet at the time of this posting.

"The Institute of Medicine has released a new report of its assessment of the health risks for women who may be asked to provide their eggs for embryonic stem cell research. The report documents how little scientific data exists about the health risks of egg retrieval, and as a reviewer of the report, I believe it misses an important opportunity to lead the way by requiring critically important safety evidence before we ask women to take potentially serious unknown risks with their health.

"There are many paths of investigation in embryonic stem cell research that can move forward while this safety data are being gathered. Scientists can use embryos initially created for in vitro fertilization, but not ultimately used for this purpose and thus available to researchers with the donor’s consent. They can also use stem cells found in amniotic fluid. Even somatic cell nuclear transfer is possible using eggs that do not fertilize during in vitro fertilization.

"Much attention has been given to the known risks of ovarian hyperstimulation that can result from drugs used to stimulate the ovaries to produce multiple eggs. But the risks of drugs used to suppress the ovaries before such controlled hyperstimulation have been much less studied, and the drug most commonly used for this purpose – leuprolide acetate (Lupron) – has never been approved by the FDA for this purpose. We know from the anecdotal reports of hundreds of women harmed by Lupron that such research is essential to establishing an adequate picture of the risks involved. Moreover, the recent drop in breast cancer rates and its link to a decline in hormone replacement therapy (HRT) is a timely reminder of how little is known about the long term effects of large doses of hormones.

"The IOM report accurately states, 'one of the most striking facts about in vitro fertilization is just how little is known with certainty about the long-term health outcomes for the women who undergo the procedure.' It goes on to acknowledge that even 'that limited knowledge is not directly applicable to the safety of ooctye donation for research.' The report then rightfully suggests the need to collect good data, engage in long-term studies, and reduce risks to women.

"Unfortunately, the IOM report elevates SCNT over other avenues of research in the development of future stem cell therapies. By suggesting that researchers must have thousands of women’s eggs now, despite the critical absence of safety data, the report does women a great disservice. A more responsible conclusion would be to call for:

"1. Research endeavors that do not require egg extraction procedures solely for research purposes; and
"2. Research that will better define the risks of multiple egg extraction, so that meaningful informed consent will be possible. This will serve not only women who may want to donate eggs for research, but women who now undergo these procedures as part of infertility treatments.

"Much scientific progress can be made by pursuing avenues of embryonic stem cell research that do not require women to sacrifice their health and well-being while important safety data are being gathered. The decision of whether to proceed with egg procurement for research should be based on adequate scientific evidence. It is premature to ask women to put their health on the line.

"The Pro-Choice Alliance for Responsible Research is a coalition of reproductive health and justice advocates, bio-ethicists, academics, and researchers working to ensure safety, accountability, and transparency in bio-technology from a women's rights perspective."

ESC Research: Doing Well vs. Doing Good

Is embryonic stem cell research an economic boon or boondoggle for California? Or for other states as well?

Writer David Hamilton, formerly of the Wall Street Journal, discussed the subject this week on Slate. Here are excerpts of what he had to say:

"If medical treatments can be derived from stem-cell research, they are at least a decade or two away, if history is any guide. Even then, new therapies envisioned by supporters, such as diabetes treatments that regenerate insulin-producing islet cells, might add to government health-care costs instead of curbing them. The Baker-Deal report (from the 2004 Prop. 71 campaign) figured that stem-cell therapies could save California at least $3.4 billion in health-care costs over the next three decades by assuming the therapies would reduce state spending on six major medical conditions by 1 percent to 2 percent. While the authors cast that as a 'conservative' estimate, they don't even model the possibility that costs might rise instead. Recent medical advances haven't appreciably slowed growth in overall U.S. health-care spending, which continues to rise far faster than inflation.

"Ideally, of course, stem-cell therapies would start a trend in the opposite direction by reducing or eliminating the need for expensive and often lifelong medical care. For that to happen, though, the new treatments would need to largely replace existing ones at a reasonable price, and then doctors would have to use them sparingly—for instance, only on the patients most likely to benefit. None of these assumptions is a particularly good bet under the current U.S. health-care system, in which new treatments are often simply added to older ones, and where insurers so far have tended to pay top dollar for incremental medical advances."

Hamilton continued:

"What about the potential of stem-cell research to spur economic development—can a state that sponsors stem-cell research hope to attract cool scientists who will then draw others, plus a coterie of entrepreneurs and venture capitalists? Biotech companies do tend to cluster in places like San Francisco and Boston, but their overall impact on regional economies tends to be limited. While they often pay high salaries, the vast majority of these companies are tiny, unprofitable startups with fewer than 100 employees. They frequently collapse well before they earn a dollar in sales. Even successful biotech ventures are often bought out by distant drug companies, which sometimes shut down the acquired company while transferring its research activities and any products elsewhere. On top of all that, big states like California and New York are going to wind up competing for some of the very same scientists, VCs, and entrepreneurs, further shrinking the rewards.

"Why did Baker and Deal see dollar signs? The $200,000 stem-cell supporters paid to Deal's firm, the Analysis Group, for campaign consulting might have something to do with it. In an interview, Baker said he didn't think of the report as advocacy but added that 'we knew we were working for people who wanted to pass this thing.' And while he still believes the economic benefits of stem-cell research could be 'quite large,' Baker also describes the report as merely 'one possible version of how things might happen.'"

Hamilton's bottom line:

"None of this means that stem-cell research doesn't deserve government funding. Stem-cell science, after all, remains in its infancy. Nearly a decade after the discovery of embryonic stem cells in humans, scientists still don't know exactly how they work, how to assure their purity, or what unexpected side effects they might have when transplanted into the human body."

Since the Bush administration refuses to support ESC research, Hamilton, concluded "the states are right to ante up where the federal government has failed to. They just shouldn't expect to do well while they're doing good."

Hamilton's piece does not deal with a related reason for the economic argument for ESC research. Creating a dream of riches is an attempt -- generally successful, we might add -- to shift the terms of the debate. It is a no-win proposition if ESC research backers find themselves locked into a discussion of whether they are killing babies.

Media Unexcited by SEED Grant Scores

Tuesday's announcement of the scores on the first-ever research grants to be awarded by the California stem cell agency received virtually no media attention.

A brief note popped in the East Bay Business Times, which is all that surfaced in what one might call mainstream media. But a biotech blog called PIMM published an item and included the scientific ranking of all the proposals. Attila Csordás, posting on PIMM, recommended reading the "WEAKNESSES" (their capitalization) section of the reviews of the grant proposals.

One web site aimed at the big money boys (venture capitalists) also carried a note on the announcement. VentureDeal unfortunately made an error in its item, saying that CIRM was "created by a $300 million general bond" instead of noting that CIRM has authorization for $3 billion in bond funding. (Actually similar errors are not uncommon in reports that we have read over the last two years.) The information on the grant proposals obviously would be useful to investors in the stem cell arena. It gives a quick overview of a number of new areas that some scientists believe are worth exploring including an evaluation of their public value (meaning to California – not as a public company).

Look for the mainline media to hit the actual grant awards next week pretty hard. It is a simple event to cover and will have considerable appeal to television with visuals and interviews with persons who could benefit from stem cell therapy. Freshness of the Congressional debate over stem cell research also will help drive the coverage. Stories will be dominated by numbers and names: How much and which institutions and individuals will be wallowing (sort of) in cash, thanks to a vote of the people more than two years ago.

SEED Grant Recommendations Available

The scored recommendations for funding of SEED stem cell research grants by the California stem cell agency are now available on CIRM's web site.

The posting lists the titles of all the applications, their score, recommendation for funding along with a "public benefit" and "public review report" and a summary of the CIRM working group's review. The public benefit report was prepared by the applicant.

Names of the applicants remain secret.

The Oversight Committee will make the awards next week.

Warm-up for a Big Money Week

You could call it the CIRM Round – the wave of meetings surrounding each session of the California stem cell agency's Oversight Committee.

But in this case it is a mini-wave, given the committee's busy, two-day agenda – freshly posted on the Web -- during which it is expected to award its first research grants. Ahead of that is a meeting of the legislative subcommittee Feb. 12. The presidential search subcommittee met last month.

In addition to consideration next week of the recommendations on $24 million in SEED research grants, the Oversight Committee will take up a report (not yet online) from the search group. Overseers are scheduled to consider recommendations from the legislative panel involving federal stem cell legislation. Legislative matters at the state level involve two umbilical cord blood bills (AB34 and AB40) and possibly proposed legislation by Sen. Sheila Kuehl, D-Santa Monica, chair of the State Senate Health Committee.

That proposal is not specifically listed on the agenda, but should be discussed if the stem cell directors want to move off their reactive legislative posture.

Also on tap are federal rules (OMB Circular A-21) having to with determining costs on grants. It is not clear why this is on the agenda based on the online material, but it is likely to involve issues of separation of federal and state grant money, since federal grants must be isolated from non-approved stem cell lines.

Remote locations for the legislative subcommittee are available to the public in California in Palo Alto, Chico, Sacramento, La Jolla and San Francisco as well as Maui in Hawaii. No remote locations are available for the Oversight Committee meeting Feb. 15-16 in Burlingame.

Twenty-five Secret Applicants for $48.5 Million in Public Funds

On the surface, the odds look pretty good in CIRM's $48.5 million grant program for "shared" stem cell labs.

The institute plans to hand out as many as 15 grants, and only 25 institutions have filed letters of intent. Of course, their names are secret by order of CIRM, even though every major University of California campus is certain to have filed. Include Stanford, USC, the Burnham and Salk Institutes, etc., and it is not hard to come up with something close to 25 non-profit and academic institutions. That number may shrink by the deadline for formal applications.

The reason for the secrecy is concern that losing institutions would be embarrassed. Nonsense, we say. Moreover, this is public money that is being given away, and it should not be done behind closed doors any more than absolutely necessary.

According to CIRM's press release, the institutions must provide a 20 percent match of the total cost for renovation and equipment.

CIRM also said,

"The Shared Research Laboratory Grant Program will fund dedicated laboratory space for the culture of human embryonic stem cells (hESCs), particularly those that fall outside federal guidelines. (Current federal policy prohibits research involving hESCs isolated after August 2001 from being conducted in laboratories constructed with any federal funding.) CIRM’s grants will support the development of core laboratories to be used by multiple investigators and shared by multiple institutions, and provide an environment for scientific research on hESCs under CIRM’s medical and ethical standards."

The grants are expected to be awarded this June.

Do you think the names of the applicants should be secret? You can respond by using the "comments" function below. Anonymous comments are permitted.

Thal Dies in Small Plane Crash

Leon Thal, a member of CIRM's Oversight Committee and a brilliant San Diego neuroscientist, died during the weekend when his small plane crashed in the Southern California mountains.

Thal, a longtime and skilled pilot, was the only person aboard when the plane went down Saturday night, according to a story in the San Diego Union-Tribune by Cheryl Clark and Sandra Dibble.

Thal, 62, was chairman of the neurosciences department at UC San Diego and had served as one of the 29-directors of CIRM since its inception two years ago. The San Diego newspaper wrote that Thal

"was one of the world's leading experts in the development of new therapies for Alzheimer's. He directed the Alzheimer's Disease Cooperative Study, a consortium of more than 70 research centers in the United States and Canada that investigates experimental therapies. He also managed UCSD's Shiley-Marcos Alzheimer's Disease Research Center.

"Thal oversaw more than $100 million in federal research grants and was a collaborator on many others. He and his department had received millions of dollars in research funds over the past 30 years."

In 2004, Thal shared the $100,000 Potamkin Prize, one of the highest honors in neurosciences.

The San Diego paper quoted Henry Powell, a professor of pathology and chairman of the UC San Diego Senate academic senate, as saying of Thal:

"He was a skillful manager of strong-minded people, charming and diplomatic as well as visionary and persuasive."

Thal was appointed to the CIRM board by the governor.

Magnus: Do We Need More Guidelines?

"Too little, too late." That's what Stanford ethicist David Magnus has to say about the recommendations released last week concerning embryonic stem cell research.

The proposals came from the International Society for Stem Research. But Magnus asked, "Do we really need another set of guidelines."

Writing in the San Jose Mercury News, he said:

"The ISSCR group missed a real opportunity to address many new challenges that stem-cell researchers and oversight committees face -- challenges that have had little attention.

"All of the guidelines to date focus on bench research. But Menlo Park biotech company Geron has already announced that it intends to start clinical trials using differentiated embryonic stem cells for patients with acute spinal cord injury. Yet we have almost no guidance on how oversight committees should evaluate these trials or what should go into informed consent forms. Astonishingly, neither the NAS nor ISSCR has said anything about the right of subjects who may oppose stem-cell research to know that the cells placed in their bodies for research come from embryonic stem cells."

Magnus also said that the "one really novel stand" from the group concerned payment for eggs for research. He continued:

"The ISSCR group says local oversight committees should determine the appropriate policy: no payment, reimbursement of direct expenses, or substantial compensation for time and suffering. The problem with this recommendation is that it seems to fly in the face of virtually every law in place. The NAS guidelines call for a prohibition on payment of egg donors beyond direct expenses. Proposition 71 has a similar ban in place. Many other states and countries have made it unlawful to pay women more than a token amount or to pay anything beyond their direct expenses.

"Many researchers are worried that they will have a difficult time getting access to the eggs they need. But offering standards that cannot be followed by any of the major players in stem-cell research is a recipe for irrelevance."

The recommendations have been praised by John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, who said:

"We are pleased the international guidelines stress public benefit and we will continue to insist that California's regulations provide affordable access to any discoveries or cures resulting from research funded by the state program. Too often stem cell advocates have hyped the immediate benefit of stem cell research. I'm delighted to see the call for realism. The Scientific Strategic Plan for the California Institute For Regenerative Medicine already reflects that realistic approach."

Reporter Terri Somers of the San Diego Union-Tribune quoted Larry Goldstein, an ESC researcher at UC San Diego and a member of ISSCR task force, as saying.

“Realizing that stem cell research is an international community, we have to be able to share cells and our scientific methods across borders with some confidence that we have been doing our work to some agreed-upon ethical standards.”

Stem Cell Counsel Owed $110,000

The outside counsel for the California stem cell agency might be having second thoughts about its political connections.

Remcho, Johansen & Purcell of San Leandro, Ca., is owed $111,000 by the political campaign of former Lt. Gov. Carlos Bustamante, according to a story by Sacramento Bee reporter Shane Goldmacher.

Bustmante's campaign owes $390,000, and the largest component of that is Remcho. Bustamante says he hopes to pay it off, but former politicians who are out of office and don't plan to hold office have a hard time raising cash.

Ironically, the second largest debt, $109,000, is to the Bonner Group, a fund-raising firm, which obviously did not raise enough cash to keep the campaign out of debt.

One also might wonder what a law firm did for a political campaign that costs $111,000. Campaigns do need some legal advice but that is 370 hours at $300 an hour. The Bee said Remcho had no comment on the unpaid bills.

The Pluripotent Presidential Candidate

From PajamasMedia, quoting political consultant Dick Morris:

"Obama is like a stem cell. He can become any part of the body he wants to be."

"He can become the new Democrat that Hillary wanted to be and that Bill Clinton was when he won the nomination."

Comments Update

We are again encouraging all who feel the need or who are inspired to comment on items on this report or on the comments of others. We have improved our "comment" function, enabling a "moderator" provision. We will examine each comment before it actually appears. This will avoid spam type comments and "flaming." The note on the comment pop-up, however, uses the word "approval." Google, which hosts this site, does not allow us to change that word. However, our function is to moderate -- not to endorse or approve of or disapprove of what you have to say. Your comments are yours and yours alone. The "approval" relates to spam and flames. Anonymous encrypted comments are still permitted. And we expect to publish the thoughts of many who disagree with positions of the California Stem Cell Report.

Promoting California's Stem Cell Giveaway

Stem cell advocate Don Reed is beating the publicity drum for the Big Event this month, and it is not the Super Bowl.

Reed, who has a keen sense of PR, is pitching Feb. 16 as an "unbreakable date" in San Francisco. On Jan. 31, he wrote on his blog, stemcellbattles.com:

"There will be lots of reporters… If our friends are not there, who will they talk to?

Hint: the opposition will definitely be there…"

The date is when the CIRM Oversight Committee is expected to conclude its decisions on the first wave of more than $100 million in research grants to be dished out this year.

Reed is well-connected in the patient advocate community. He knows that TV cameras cannot resist sympathetic interviews with persons afflicted diseases or other problems that could be treated with future stem cell therapies. And the TV audience is likely to be much more sympathetic to their concerns than those opposed to ESC research on theological grounds.

Perhaps state Sen. Sheila Kuehl, D-Santa Monica, is also considering being on the scene, which could be an excellent venue to promote her legislation concerning the stem cell agency. TV rarely covers the agency, and it is not likely to become excited about a legislative story unless it becomes truly extraordinary.

Legislators Target California Stem Cell Agency

The California stem cell agency may have believed its difficulties with the California legislature had vanished, but no such luck.

A bipartisan attempt is underway to change the composition of CIRM's Oversight Committee and dictate some terms of its intellectual property policies, among other things. The effort must be bipartisan because a colossal majority of 70 percent of both houses is required to pass a bill affecting CIRM. The governor's signature is required as well.

Reporter Malcom Maclachlan of the Capitol Weekly was the first to break the news about the latest effort to assert legislative influence over CIRM. He said Sen. Sheila Kuehl, D-Santa Monica, and Sen. George Runner, R-Antelope Valley, will author the legislation. Kuehl is the chair of the Senate Health Committee, replacing Deborah Ortiz, who stem cell Chairman Robert Klein once denounced as an "ongoing threat." Ortiz left the legislature because of term limits. Runner is a Republican leader in the Senate, serving as its GOP caucus chair.

Maclachlan wrote that legislation now being drafted would require that two "public interest" representatives be appointed to the 29-member CIRM Oversight Committee. That presumably would mean that two persons now on the board could lose their seats, since the measure does not provide for increasing the size of the committee.

The legislation also "would allow the ICOC to negotiate royalties of 2 percent to 5 percent on any treatments developed via grants to for-profit entities; there would be no cap on the royalties the state could receive."

Maclachan, who has produced a number of stories on the stem cell agency, continued:

"The bill would also force for-profit entities to offer these treatments to the state at the Medicaid prices, rather than the current requirement that they be offered in line with weaker standards under the California Prescription Drug Discount Program. Finally, it would widen the definitions of what state agencies would be eligible for the discounts. Current CIRM regulations limit this to the state discount drug program, while the legislation would open it to any state agency, including prisons and county indigent health-care programs."

Maclachan quoted Dale Carlson, spokesman for CIRM, as saying the agency would have no comment until it had an opportunity to review the bill.

Carlson also said:

"We have benefited greatly from the Legislature's advice and counsel in years past, and we look forward to a continuing cooperative partnership. We are interested in any and all ideas that can bring stem-cell treatments and therapies to fruition."

Winning passage of the legislation would be a remarkable achievement. No other legislation requires 70 percent approval – not even the state budget or tax increases. Negative votes from only 13 senators can kill the bill. But the measure will certainly provide a forum for lawmakers and others to make their voices heard at more length than the three minutes allowed for each public comment at CIRM meetings.

For more on the reasoning behind the legislation see the item below.

Rationale Behind Kuehl's Stem Cell Legislation

The new chair of the California State Senate Health Committee will "push the CIRM to live up to its promises," including insuring that all Californians will have access to any therapies developed as the result of state-funded stem cell research.

So says the January newsletter put out by Sen. Sheila Kuehl, D-Santa Monica. The newsletter carried a piece by Peter Hansel, staff director of the Senate Health Committee, that discussed the California stem cell agency at some length, including needed changes. Hansel, it should be noted, also served as a Health Committee analyst when it was chaired by Sen. Deborah Ortiz, who is now out of office.

Hansel wrote that Kuehl disagrees with arguments that CIRM should should go easy in terms of royalty requirements and affordable access to cures and therapies. He noted that CIRM has adopted some IP rules that respond to legislative concerns. Hansel continued:

"However, regulations governing the pricing of stem cell therapies in California run counter to assurances given to the Legislature. While at first proposing that grantees and licensees sell such therapies to publicly funded programs at the federal Medicaid price, the CIRM has recently reduced that to a requirement to sell at the same prices they offer them to the state’s new California Prescription Drug Discount Program, a significantly less favorable price. Similarly, the regulations for grants and loans to commercial entities propose to cap the amount of revenues coming back to the state associated with most products developed with Prop. 71 funds, as opposed to giving the state an open-ended return commensurate with its investment. By contrast, New Jersey, which also allows commercial entities to receive grants under its stem cell research program, requires such grantees to share a percentage of revenues—one percent—on an open-ended basis from licensing or commercialization of inventions (two other states that fund stem cell research, Illinois and Connecticut, do not allow for-profit entities to receive funding while another two, Maryland and Illinois have yet to develop policies for grants to for-profits). Capping returns from joint research ventures also appears to run counter to the practices of most universities who co-fund research with commercial entities and the venture capital industry.

"In addition, recent changes require grantees to grant exclusive licenses for inventions they develop to entities that agree to have plans at the time of commercialization to provide access to resultant therapies and diagnostics for uninsured patients, consistent with 'industry standards,' The current industry standard, the patient assistance programs that have been developed by the major drug companies, have been shown to be woefully inadequate in encouraging access to free or reduced price drugs for uninsured persons. Thus, it is incumbent on the CIRM to develop a more meaningful standard than this."

calif legislation, IP, affordability, access, skuehl, phansel