Some Aussies Less Than Enthusiastic About CIRM Plan

While California stem cell directors heaped huzzahs on a proposed plan on how to spend billions on embryonic stem cell research, a different reaction came from half-a-world away.

BioEdge, a blog of the Australasian Bioethics Information website, carried a piece headlined "California Dreaming." It said, in part,

"Californian voters approved a $3 billion bond issue to finance the institute in 2004. With interest, the cost to the state will be about $6 billion. Now, it appears, that the Institute may have nothing to show for its efforts in cures or in royalties by the time it folds its tent and silently steals away. (The word royalties is not mentioned once in the entire (strategic plan)...."

Wisconsin Gives $1 Million to Thomson Firm, More Tidbits on WARF Patent Flap

The Cheeseheads have thrown down another stem cell gauntlet.

Here is the latest as reported by Kathleen Gallagher of the Milwuake Journal Sentinel:

"Stem cell pioneer James Thomson and two others have started a second company that aims to grow platelets and red blood cells from embryonic stem cells.
"The company, called Stem Cell Products Inc., believes it has a chance to be among the first in the world to bring an embryonic stem cell-related therapeutic to market."

Gallagher said that the state of Wisconsin has given $1 million in grants and loans to the firm, which was co-founded by University of Wisconsin-Madison researchers Igor Slukvin and Dong Chen and venture capital firm Tactics II Ventures.

Wisconsin-California relations also surfaced in a piece by Cathy Tran in The Scientist magazine. The article was a wrapup of the WARF patent flap. But it also had some interesting tidbits.

Tran wrote:

"(California stem cell scientist Jeanne) Loring said the first person to isolate human stem cells was Ariff Bongso at the National University of Singapore in 1994.

"That begs the question why, if the leap to cultivating human stem cells was an obvious one, it wasn't done sooner. Bongso told The Scientist that the scientific community seemed disinterested in the discovery, and so he did not pursue the research further.

"Loring said the first human embryonic stem cell line wasn't created until 1998 in part because the National Institutes of Health did not fund research on human embryos before 2001, which made it 'pretty close to impossible' for any U.S. academic lab to derive human embryonic stem cells. In addition, it was 'not easy to find an in vitro fertilization clinic that wanted to go to the trouble of providing embryos for this research.'

"Thomson, however, maintains that his discovery was far from obvious. 'In the early 1990s, when we started this work, it was not at all clear that the isolation of human embryonic stem cells was really possible, as other groups had tried and failed,' he told The Scientist in an email.

"One of the groups that tried and failed included researcher Michael West, CEO of Advanced Cell Technology and founder of Geron Corporation. 'From firsthand painful experience, [the techniques were] not obvious in the scientific community,' West told The Scientist. The challenge based on the discovery being obvious 'is easy in retrospect, but you really have to base it on real firsthand experiences of the people in those days.'"

CIRM Hires Finance Director

The California stem cell agency has hired University of California official Lorraine Hoffman as its chief finance and administrative officer, effective Nov. 1.

CIRM's press release, which is expected to be up on its site later today, said that Hoffman will be responsible for budgets, independent audits and human resources at the agency as well as assisting on facilities grants.

Hoffman is currently deputy to the senior vice president for business and finance for non-state capital development and facilities in the UC syste, office of the president.

CIRM to NIH: Forget You?

Optimistic Democrats and some stem cell scientists believe that this fall's elections are part of a trend that will trigger a veritable torrent of funding for embryonic stem cell research. But that amounts to little more than wishful thinking.

Certainly funding may increase somewhat if the political winds shift to a favorable direction, but there is no guarantee of that. Even with a president in 2009 who might support stem cell research, enormous federal budget deficits will continue to plague the country, and optional research is not likely to suddenly surmount that obstacle.

Moreover, California has embarked on a go-it-alone course that other states are emulating. California's position was reinforced in the draft of its strategic plan that will receive a full-blown hearing in Los Angeles on Tuesday and Wednesday. The actions by California and others are making the NIH – dare we say it – a tad irrelevant, at least in terms of embryonic stem cell research.

Writing in the blog of the American Journal of Bioethics,
James Fossett of the Rockefeller Institute’s Federalism Research Group noted that CIRM's plans include creation of "NIH-free zones." That will cost $250 million, compared to NIH funding currently of about $30 million annually for ESC research. Fossett wrote:

"While perhaps wasteful and inefficient in the short run, such expenditures ultimately mean that California can formulate its own policies around what goes on in those labs without having to care very much about what the feds do or don’t do. It also means that other states contemplating stem cell research programs funded with their own money are likely to look to Sacramento, rather than Washington, for guidance on how to manage conflict of interest, egg procurement, royalty income distribution, intellectual property and the other complex ethical and legal issues that surround this research."

He continued:

"The development of funding streams independent of Washington and dedicated research infrastructure free of federal funding restrictions means that if federal policy makers do decide to do something definitive on stem cell research, it may not have much effect on anything. Having spent the money on new facilities and done the political heavy lifting to get ethical and commercial agreements in place, states, companies and universities may well decide that they like things the way they’ve got them and they don’t need to pay attention to the feds."

Indirectly supporting Fossett's position was a Sept. 1 column in the Wall Street Journal by Sharon Begley. The piece focused on the impact of tight funding at NIH. The headline read: "A Smaller NIH Budget Means Fewer Scientists And 'Too-Safe' Studies."

Begley wrote that in 2004

"...Congress and the White House, calling for reduced budgets in the wake of tax cuts and a growing deficit, slammed on the brakes. Ever since then, NIH's budget has been flat or, adjusting for inflation, down. The chance that a scientist's work will be funded fell to 22% last year from 27% in 1995, and to less than 10% in some fields. Now the warnings are coming true: The plug is being pulled on promising research by scientists with solid track records.

"'When 27 percent of proposals were funded, it wasn't that hard to separate the top quarter, says molecular biologist Keith Yamamoto of the University of California, San Francisco. 'There was a natural cutoff,' he says. But at 10 percent 'the ability to distinguish a grant that deserves funding from one that does not vanishes. It becomes a crapshoot, with every grant in jeopardy.'"

The NIH and its enormous sway over research will not disappear any time soon. But it is an aging insitution, hobbled by its reliance on the good graces of the president and Congress, where a handful of truculent lawmakers can raise considerable mischief with its funding. CIRM does not share that weakness. Neither the California legislature or even the state's Terminator governor can fiddle with the agency's plans or restrict its budget.

An old cliché with considerable truth holds that pioneers are the ones with arrows in their backs. At the same time, pioneers snatch up the best land, the most favorable water rights and set the agenda for the latecomers. That favored position is where CIRM now finds itself.

CIRM to California: Lower Your Expectations

It was a message that could have been delivered by former Gov. Jerry Brown in his heyday.

Don't look for cures right around the corner. Science is hard and results are not guaranteed. Lower your expectations, as the former governor told Californians shortly after he was first elected. And it was a message that came through clearly in the California stem cell agency's draft of its strategic plan.

In the words of the Knight Science Journalism Tracker, the proposal "appears to be a rare case of prudence by public servants."

The plan was even heralded – sort of – in religious fundamentalist circles. A piece written by reporter Michael Foust in the Baptist Press said,

"In an announcement that some ethicists say should lead to a greater focus on adult stem cells, a much-celebrated California stem cell institute says any cures using embryonic stem cells likely are years away."

The strategic plan's theme of patience, at least as it was portrayed in the media, was somewhat different than the overheated rhetoric of the campaign for Prop. 71 two years ago.

A recent paper by Tamra Lysaght of the University of Sydney, published in the Australian journal Bioethical Inquiry, examined 99 news stories from the Prop. 71 campaign. Among her conclusions:

"Concerns regarding the hype surrounding the potential medical benefits of stem cell research and its implications for public expecations were notably absent from the public discouse prior to the passage of Prop. 71, though they were later noted by a number of scientific and institutional actors. The reasons for this phenomenom are unclear, but perhaps point to the reluctance on the part of the scientific and medical communities to openly question the value of this line of research or to critcize each other; fears about aligning with religious or other actors opposed to hESC research; or the influence of commercial, academic and media interests in framing and limiting crucial debate."

But even before the strategic plan emerged, CIRM officials talked of managing expectations and avoiding hype although the message was less than visible in the media.

The Center for Genetics and Society of Oakland, Ca., recently conducted a briefing on the politics of stem cell research for reporters and focused on the exaggeration question. Marcy Darnovsky, associate executive director of the center, said,

"Exaggeration is really one of the hallmarks of this issue. It’s pervasive on both sides of the debate, and each side’s hyperbole feeds the hyperbole of the other."

She continued:

"Just recently the Democratic Senate candidate from Missouri, who strongly supports the stem cell initiative (in that state), used the words "lifesaving," "cure," or "save [a life]" 22 times in a 732-word interview published by the Associated Press.

"Statements like these seriously degrade public understanding and distort political discourse. Perhaps more surprisingly, similar exaggerations have also become common in the world of science, in statements by scientists about stem cell research. It’s always been considered a matter of scientific integrity to refrain from making claims in the absence of clear evidence. But in the stem cell world, that principle is being regularly violated.

"One example: It’s common to hear that embryonic stem cell research will result in cures for Alzheimer’s disease, when in fact, unfortunately, the idea that stem cells have the potential to treat Alzheimer’s is far-fetched.

"Knowing this, Rick Weiss, the Washington Post’s science reporter, called a prominent stem cell and neurology researcher to ask why he and his colleagues weren’t correcting the misunderstanding. The scientist’s answer: 'To start with, people need a fairy tale... they need a story line that's relatively simple to understand.'"

CIRM has a difficult road. It must maintain the public's faith, which does require the delivery of easily understood messages with a vision of hope. But the controversy involving Advanced Cell Technology's report on stem cell extraction shows how nuances make a big difference. The $6 billion (including interest) that CIRM will cost taxpayers requires results. If something tangible and understandable is not forthcoming in a few years, it may erode public support for an endeavor that once gained 59 percent approval of the state's voters.

----------------------

Below you can find the verbatim statements made by Darnovsky and her colleague, Jesse Reynolds, at the Sept. 19 news briefing for editors and reporters. The statements are not currently available on the center's web site.

Text of Statements from CGS on Politics of Stem Cell Research

Here are the texts of remarks made by officials of the Center for Genetics and Society at a Sept. 19 briefing for reporters and editors on the politics of stem cell research. The statements are not currently available on the center's web site.

Remarks by Marcy Darnovsky , Associate Executive Director, Center for Genetics and Society


I’m going to talk first about several kinds of over-promising and distortion that are common in the stem cell debate. Then I’ll say a few words about some shifting political alignments and developments.

[Exaggerating cures]

Exaggeration is really one of the hallmarks of this issue. It’s pervasive on both sides of the debate, and each side’s hyperbole feeds the hyperbole of the other.

Opponents of embryonic stem cell research consistently overplay the current capabilities and the future potential of adult stem cells, and downplay what most scientists believe about the promise of embryonic stem cell research. Their major point is undeniable – that deriving stem cells from embryos necessarily destroys those embryos. But their objection is a minority position in the U.S., and one that’s being imposed on the majority.

The focus on embryos does another kind of disservice as well. The divide in our country over the moral status of human embryos, and over abortion rights, has overwhelmingly dominated the discussion of stem cell research, burying other important concerns. We need to look at this issue through a different lens.

Turning now to the situation among supporters of embryonic stem cell research: Far too many scientists, politicians, biotech entrepreneurs, and research advocates regularly exaggerate the likelihood and imminence of medical advances. The use of the word “cures” is routine – though as Jesse mentioned, the research is at an early stage, and right now there are no treatments or therapies based on embryonic stem cells, let alone cures.

Nonetheless, both the 2004 California ballot initiative and this year’s voter initiative in Missouri have the words “stem cell research and cures” in their titles, and the supporters of the Missouri initiative call themselves “The Missouri Coalition for Lifesaving Cures.”

And just recently the Democratic Senate candidate from Missouri, who strongly supports the stem cell initiative, used the words "lifesaving," "cure," or "save [a life]" 22 times in a 732-word interview published by the Associated Press.

Statements like these seriously degrade public understanding and distort political discourse. Perhaps more surprisingly, similar exaggerations have also become common in the world of science, in statements by scientists about stem cell research. It’s always been considered a matter of scientific integrity to refrain from making claims in the absence of clear evidence. But in the stem cell world, that principle is being regularly violated.

One example: It’s common to hear that embryonic stem cell research will result in cures for Alzheimer’s disease, when in fact, unfortunately, the idea that stem cells have the potential to treat Alzheimer’s is far-fetched.

Knowing this, Rick Weiss, the Washington Post’s science reporter, called a prominent stem cell and neurology researcher to ask why he and his colleagues weren’t correcting the misunderstanding. The scientist’s answer: "To start with, people need a fairy tale... they need a story line that's relatively simple to understand."

[Other distortions]

Other sorts of exaggerations and distortions are also rampant in the stem cell debate.

Opponents of embryonic stem cell research regularly blur the distinction between reproductive and research cloning. This can be seen as a logical extension of their position that an embryo is a full-fledged human being. But failing to acknowledge the difference between a cloned child and a cloned embryo certainly skews consideration of the issue.

Opponents of embryonic stem cell research often misrepresent concerns voiced by women’s health advocates and groups like the Center for Genetics and Society about issues such as procuring eggs for research. In Missouri, an anti-abortion rights group that opposes the initiative used our words to support their position, neglecting to mention that we support embryonic stem cell research

On the pro-embryonic stem cell research side, we’ve seen a clear pattern of overstating the economic benefits of allowing or funding research.

The coalition backing Missouri’s Amendment 2 is promoting a study that claims the initiative will "reduce state health care costs by billions." To the extent that it’s supported at all, this conclusion is based on savings that would be realized by curing a list of diseases that includes very unlikely candidates for stem cell research, such as stroke and Alzheimer's.

We saw similar hand-waving in the campaign for the California initiative – in fact, the economic studies were done by the same hired group.

[Why it matters]

Why do the exaggerations and over-promising matter?

First, they do real damage to public understanding, and to the possibility of a meaningful debate on a set of complicated issues.
Second, overblown claims can be very hurtful to those who suffer from debilitating diseases, cruelly raising hopes that are likely to be dashed.
Third, hype about stem cells has played a role in overheating the environment to the extent that we’re seeing fraud and embezzlement – as in the case of South Korean cloning researcher Hwang Woo Suk – and questionable claims like the announcement a few weeks ago by Advanced Cell Technology that seemed based more on their need to raise money through a stock spike than on any real advance.
And finally, hype is bad for science. It sets the stage for backlash or bad policy or both.


[Political alignments and developments]

I want to say just a few words about the political alignments on stem cell research. We’ve talked a fair amount on this call about the distortions caused by the political polarization on this issue. But in fact, there’s growing bipartisan support for stem cell research using embryos produced but not used for assisted reproduction. We’re seeing a growing realization that Americans can be religious and support embryonic stem cell research; that they can be liberal and support responsible regulation of stem cell and cloning research.

We’ve looked at opinion polling on this question. Stem cell research is even more subject to wording effects than many other issues. But our analysis of polls that provide balanced background statements shows clearly that

support for embryonic stem cell research has been growing,
significant uneasiness about the use of cloning techniques for stem cell research has persisted

Though some Democrats continue to use embryonic stem cell research as a wedge issue, the recent Congressional vote on extending federal funding showed that more and more conservatives are supporting it. There will eventually be a less restrictive federal funding policy, and it’s past time to shift the conversation to the question of how stem cell research will be conducted – what oversight and what rules of the road do we want to put in place.

This is particularly important when it comes to research cloning. An important piece of that story rests on the issue of women’s eggs for research. Here in California, the Center for Genetics and Society and several women’s health groups worked with a Democratic state senator on an eggs-for-research bill. It passed both the California Senate and House with near-unanimous votes, and is now sitting on the Governor’s desk awaiting his signature.

Let me wrap up with 3 points that we think are key:

First, the stem cell debate until now has focused so much on the status of embryos that some really important issues have been eclipsed
Second, the political polarization on embryonic stem cell research has created an atmosphere of hype, distortion, and as a result, public misunderstanding
Third, responsible oversight and enforceable regulation of stem cell research – the kind that are in place in many other countries with research efforts – are a high priority for the U.S. Putting a comprehensive policy in place will be a plus for everyone.

Remarks by Jesse Reynolds, Project Director- Biotechnology in the Public Interest, Center for Genetics and Society


These basics of science and policy can be complex, and key distinctions are easy to overlook. I’m sure you are familiar with much of this, but I want to try and get everyone on the same page.

The distinction between stem cells from adult body tissue and those from embryos has nearly monopolized the debate about stem cell research. But many people are not clear about a second distinction between two sources of embryonic stem cells. And its in describing these techniques where perhaps the most frequent mistakes in the coverage of stem cell research occur.

The first, which has been used to produce all currently existing embryonic stem cell lines, is to use embryos created but not used in fertility treatments.

The other is to use embryos created by the cloning process, called somatic cell nuclear transfer, to derive new stem cell lines with specific genetic compositions. This process of cloning for stem cells is sometimes called research cloning, therapeutic cloning, or just SCNT.

Cloning in stem cell research remains at an early, speculative stage. Although it has been receiving much attention, it is a tiny portion of stem cell research. Only a handful of labs in the world are working on such research cloning.

Research cloning brings up issues of concern beyond the moral status of the embryo.
First, is how to treat the women who may provide the eggs has been an issue of debate, particularly whether to pay them. Unlike “normal” stem cell research, many human eggs are needed for it. Egg extraction is a procedure with significant medical risk.
Second, treatments from cloning-based stem cell research are likely to be extremely expensive – and that they might therefore increase health inequities.
Third, the technique opens the door to unacceptable applications such as reproductive cloning.

Because “cloning” has a strong negative connotation, advocates and opponents for research cloning manipulate the language. The advocates just call it SCNT, imply that no embryo is created, and also imply that it is currently a critical part of stem cell research. The opponents will call it “human cloning,” in an effort to blur the distinction between cloning for stem cell research, and cloning for reproduction.

The distinction between research cloning and embryonic stem cell research in general is key to understanding and describing the scientific and political landscape. But this blurring between them has led to many outright inaccuracies in reporting. As an example, just last week, a columnist in a major Missouri newspaper wrote about a person whose cancer had been put into remission by a cloning-based stem cell treatment– when in fact stem cell lines have never been successfully derived from clonal embryos.

Moving on to policy, I’d like make a second key distinction – this one among what is allowed, what is regulated, and what is funded. I’ll start with federal policy.

There are no bans on stem cell research at the federal level, despite the rhetoric of some research advocates. Of course, laws that apply to medical research in general apply. Congress has supported a ban on research cloning, but the bill lacks votes to overcome a filibuster in the Senate.

There are also no regulations specific to stem cell research at the federal level. This is unlike other countries that have stem cell research programs, and despite widespread recognition among scientists that this work raises new oversight and regulatory concerns

The only national guidance is the area comes from the National Academies, a nongovernmental organization. It’s issued recommended guidelines for the conduct of stem cell research. These, for example, oppose paying women who provide eggs for research cloning. But these are not enforceable regulations, and some researchers have indicated that they will not necessarily follow them.

As you know, federal funding of human embryonic stem cell research has been restricted to the funding of work with lines created before August 2001. The recent bill that resulted in President Bush’s first veto, would have undone these restrictions. The passage and signing of this bill would have provided the opportunity to have discussions about federal oversight of this important research.

Moving on to the states: The lack of federal funding, and the accompanying lack of federal oversight, has resulted in an emerging patchwork of state laws and regulations. One state – South Dakota – bans the human embryonic stem cell research entirely. At least five other states ban research cloning. Research cloning is explicitly permitted in six states. Of course, when not cited in law, these practices are implicitly allowed.

Only two states are developing regulations for human embryonic stem cell research, California and Massachusetts. California will have two sets of regulations – one for state funded research, and another for any other source of funding.

Five states publicly fund stem cell research: California, Connecticut, New Jersey, Maryland, and Illinois. At $300 million per year for ten years, California’s program dwarfs the others. All these state funding programs except Maryland’s intend to fund research cloning.

Finally, I’d like to provide some details on Missouri, which is currently the site of the most prominent stem cell research debate. The Constitutional amendment before the voters would ensure that all stem cell research that’s legal at the federal level remains legal in the state. Because there are currently no laws specific to stem cell research in Missouri, the amendment would simply preserve the status quo.

It’s true that each year some conservative legislators introduce a ban on all cloning, including research cloning. But this ban is very unlikely to become law – it’s never even gotten out of committee in either house, and the governor has promised a veto. Moreover, research cloning is not even being done in Missouri. It is strange that the proponents of the proposed Amendment raised sixteen million dollars, as of the end of June, just to preserve the status quo. That is already more than has ever been spent on any race in the state.

The powerful emerging technologies of stem cell research are being developed largely without oversight. Some politicians talk of bans, and others advocate for protective constitutional amendments. But what’s missing is effective regulation to ensure that it is done right.

A Chockablock Stem Cell Agenda and Poetry

The folks at the California stem cell agency have been busy stuffing the agenda for next week's meetings of the Oversight Committee with weighty background papers on the topics up for debate.

The schedule is now chockablock with information, most of posted it on Wednesday, on everything from intellectual property to criteria for the first round of stem cell building grants.

We have been critical in the past of the lateness of postings of background material. This is a good step in the right direction. It helps the public and CIRM's special constituencies understand its activities and to respond in an intelligent, constructive and timely fashion.

If you need to rest your eyes from stem cell minutia, check out this ode to gin at the Internet Poetry Archive.

San Diego Stem Cell Researchers Enthused by CIRM Plan

Reporter Terri Somers of the San Diego Union Tribune has a more detailed story -- compared to her early report Wednesday -- on the CIRM draft plan in this morning's paper, including more reaction.

She wrote:

"San Diego-based stem cell scientists who will be applying for funding from the institute were enthusiastic after reading the proposal.

"'I think many of the five-year goals we are well on track for accomplishing, which probably means we'll be able to make the 10-year goals as well,' said Evan Snyder, a stem cell researcher at the Burnham Institute in La Jolla.

"'I also think there's a good appreciation (in the plan) for the fact that developing therapies depends on good fundamental knowledge of disease process and how cells work,' Snyder said.

"He and his Burnham Institute colleague Jeanne Loring said they were excited with a plan to provide about $182 million to interdisciplinary teams of scientists. Some of these teams will start out with a plan of addressing a specific disease.

In the early years, an important part of the institute's program will encourage scientist-initiated, curiosity-driven science relevant to the development of embryonic stem cell therapies. Limited federal funding for stem cell research makes the institute's funding of this what-if science imperative, the strategic plan states.

"Loring, one of many people interviewed by the committee drafting the plan, was enthusiastic to see that the funding included grants for scientists looking for many different ways to grow embryonic stem cell lines."

$3 Billion Not Enough?

Reporter Carl Hall of the San Francisco Chronicle wrote that the CIRM's draft strategic plan "suggests even $3 billion isn't enough to meet all the early expectations of stem cell research."

He said:

"The blueprint sets a strikingly modest tone for an effort ranked among the country's boldest research enterprises when state voters approved Prop. 71 in a hype-fueled 2004 election."

You can find his story here. The Sacramento Bee and Los Angeles Times do not appear to have written stories today on the plan.

The NY Times on CIRM's Proposed Spending Plan

Here is a link to the New York Times story by Nicholas Wade on the strategic plan proposed by the staff of the California stem cell agency.

An excerpt:

"Navigating between scientists who say that much basic research remains to be done and patients’ advocates who want the focus to be on new treatments, the institute says it will spend $823 million on basic stem cell research, $899 million on applied or preclinical research and $656 million on taking new treatments through clinical trials.

"A further $273 million is allocated for universities to construct “N.I.H-free” buildings, meaning laboratories in which none of the equipment has been bought with money from the National Institutes of Health. This is so researchers can be sure of not violating the rules that restrict federal money to research using government-approved stem cell lines."

CGS on the CIRM Plan

We queried the Center for Genetics and Society of Oakland, Ca., on their thoughts on CIRM's proposed strategic plan.

Here are the verbatim comments of Jesse Reynolds, project director, biotechnology accountability:

"First, the draft's assessment of the potential of embryonic stem cell
research is refreshingly honest. It cites as a ten year goal having a
single potential treatment at the proof of principle stage, and
describes the much-touted personalized stem cell lines as impractical.
This is in line with what most scientists will say, but is in sharp
contrast to the campaign language of Proposition 71. Voters would have
been better informed by this balanced assessment.

"Second, inadequate attention is given to the ethical, legal, and social
implications of CIRM's work. The human genome project set aside 3% of it
budget to this area. CIRM is overlooking a critical area by allocating
less than one percent to examining these implications.

"Finally, I am surprised at the small among of funds that is intended for
research into alternative sources of potent stem cells. If research in
this area leads to cell lines without destroying embryos or requiring
eggs, it would open up access to federal funds - worth hundreds of
millions of dollars. This seems to be a wise investment."

More Comment on CIRM's Strategic Plan

Patient advocate Don Reed has expanded a tad on his thoughts concerning CIRM's strategic plan.

Writing on his web site, stemcellbattles.com, he quoted a section that said,

“Given the time and expense of therapy development, it is unlikely that CIRM will be able to fully develop stem cell therapy for routine clinical use during the ten years of the plan.”

Then he remarked,

"I differ with that assessment with every fiber of my being."

Reed's comments can be found towards the end of the Oct. 4 item, which also has some interesting remarks on the recent round of stem cell meetings in California.

CIRM Posts Draft of Strategic Plan

The California stem cell agency's 194-page draft of its strategic plan has been posted on CIRM's web site, several hours after news stories with details of the report appeared. However, there is nothing on the CIRM's main web page at the time of this writing to indicate that this fundamentally important document is available to the public.

Interestingly, the cover has a quote from Roman Reed, son of patient advocate Don Reed, who expressed some reservations about the plan.

Roman is paralyzed with a spinal cord injury. It was he who came up with the motto of the agency: Turning stem cells into cures. That motto is on the cover of the plan.

A Quick Look At Who is Covering CIRM's Plan Today

As of the time of this posting, neither the San Francisco Chronicle (the hometown paper for the California stem cell agency), the Los Angeles Times (the state's largest paper), The Sacramento Bee nor the Orange County Register appear to have posted stories online concerning CIRM's strategic plan. The San Jose Mercury News and the San Diego Union Tribune both have stories online. The San Diego paper performed a nice public service, posting the executive summary online. As of this writing, the plan was not available on CIRM's web site. For links see items below.

Some Unhappy with CIRM's Strategic Plan

Reporter Steve Johnson of the San Jose Mercury News also moved quickly on the CIRM strategic plan, reporting in the lead of his story that the proposal dismayed some advocates of the sick and disabled.

Here are some excerpts:

"Zach Hall, the institute's president, said he and others who developed the plan were extremely careful about wording it so it set obtainable goals that didn't unrealistically raise the public's hopes.

"'One of the points really is to try to educate people about what a long process it is to get any `therapeutic' approved,' said Hall, who predicted it might take 15 years before the institute's research results in a medical product."

Johnson continued:

"But others found the plan's cautious approach disheartening.

"'I consider this report's estimate to err on the side of over-caution,' said Don Reed of Fremont, whose son was left a quadriplegic after he broke his neck in a college football game. "While it is right and proper for scientists to be careful,' said Reed, who attends many of the institute's meetings, "I take a more optimistic view. In 10 years, I expect my paralyzed son, Roman Reed, to be walking.'

"That sentiment was echoed by 60-year-old Bill Franklin of Los Altos, who has suffered from Parkinson's disease for 11 years.

"'There's no reason for things to take that long,' said Franklin, who worked to help pass Proposition 71, which created the stem-cell institute. 'People with PD and other diseases, they want things to happen faster.'"

Johnson also had comments from two CIRM Oversight Committee members:

"Jeff Sheehy, a member of the institute's board who suffers from AIDS and participated in the group that developed the plan, said no matter what progress companies make, it's vital for the institute to proceed cautiously and methodically.

"'There still is a lot of work that will need to be done to make these therapies widely available and safe,' he said. 'This is a daunting scientific challenge.'

"Joan Samuelson, a board member with Parkinson's disease, agreed that the institute needs to be thorough. 'But we also are in a rush,'' she added. 'That means every day we report to duty as if somebody is dying.'"

More Details on CIRM's Strategic Plan

Reporter Terri Somers of the San Diego Union Tribune moved quickly and was probably first on the Web with substantial details of the strategic plan drafted by CIRM staffers. It has been reviewed along the way by the Oversight Committee but final approval is not slated until December.

Here are excerpts from her story. The executive summary can be found on the newspaper's web site (see item below) and not on the CIRM web site at the time of this writing.

"The institute has already announced that it will be seeking applications for grants intended to “jump-start” human embryonic stem cell research in California. Under the plan, $135.3 million would be spent on the jump start initiative.
"An additional $148.5 million would be earmarked for annual innovation grants, and $75.3 million would fund work in the basic biology of stem cells.
"The plan also directs money toward science that is directed at a specific mission, such as the investigation of better methods of generating specific types of stem cell lines, such as those that can be used as models of diseases, or using stem cell to create copies of tissues and organs that can be used in the lab to test new therapies for various diseases.
"More than $60 million would be directed to scientists who are researching ways to create stem cells that would not create a toxic response from a patient's immune system if used in a therapy.
"About $451 million would be given to researchers in academia and biotech companies for early-stage clinical testing of promising therapies. and $108 million would be directed to academia and industry for core services such as accredited manufacturing facilities.
"The plan also calls for innovative funding techniques.
"For instance, about $122 million will be directed toward disease teams.
"These teams would include scientists who will work together over a number of years to develop a therapy. The work would have to follow a careful, detailed and plausible strategy with defined milestones for bringing the therapy to clinic.
"The plans calls for $60 million to be spent on interdisciplinary research teams working on a specific scientific goal.
"Recognizing that stem cell research will influence society in ways other than new therapies, the committee will sponsor empirical research and conference that take a more theoretical approach to dealing with moral issues. For that purpose, $25.5 million has been budgeted.
"The institute will also spend $2.3 million for outside experts to assess the economic impact of stem cell research in California, and $10 million for public outreach programs that include a web portal and educational workshops."

Executive Summary of CIRM Strategic Plan Draft

Here is a link to the executive summary of the draft strategic plan of the California stem cell agency. It is on the San Diego Union Tribune's web site and was not available on the CIRM web site at the time of this posting. See this location for the summary.

CIRM's Draft Plan Calls for $463 Million to Push Stem Cells into Clinics

The California stem cell agency today released the long awaited draft of its strategic plan and called for spending $463 million for research aimed at bridging the gap from basic stem cell discoveries to treatment in the clinic.

That was the single largest amount specifically delineated by the plan, according to the Foundation for Taxpayer and Consumers Rights, which posted a press release on the plan even before the plan was available on CIRM's own web site.

The foundation said $451 million was recommended for clinical trials, with costs shared with industry.

John M. Simpson, stem cell project director for the foundation, said:

"During the Proposition 71 campaign, proponents implied that miraculous cures were just around the corner. This plan acknowledges just how difficult the task ahead is and is a welcome change from the hype that has all too often been associated with stem cell research. Californians are entitled to an honest assessment of the prospects for research they are funding."

The draft will be discussed at the Oversight Committee meetings in Los Angeles later this month. Final approval is scheduled for December.

We will have more on this later today when the plan becomes publicly available.

(Editor's note: An earlier version of this said $423 million was recommended for bridging the gap between the lab and clinic.)

Feds Say 'Substantial Question' Exists on WARF Patents

The federal government will review Wisconsin's claims to patents on embryonic stem cells in a move that will probably take a few years to play out.

The agency agreed that "substantial questions" exist involving the patents.

Reporter Andrew Pollack of the New York Times wrote:

"Re-examinations brought about by a third party, as this one was, result in all the patent claims being canceled 12 percent of the time, said Brigid Quinn, a spokeswoman for the patent office. In another 59 percent of cases, smaller changes are made. Ms. Quinn said the patent office receives 400 to 500 requests for re-examinations each year and grants 90 percent of them.

"The Wisconsin Alumni Research Foundation, or WARF, a patent licensing organization affiliated with the university, provides academic researchers with free licenses and charges them $500 for cells. Companies are charged $75,000 to $400,000, depending on their size and the terms of the license. One company, the Geron Corporation, has exclusive commercial rights to heart, nerve and pancreatic cells derived from the embryonic stem cells."

Reporter Kathleen Gallagher of the Milwaukee Journal Sentinel quoted John M. Simpson of the Foundation of Taxpayer and Consumers Rights of Santa Monica, Ca., one of the two nonprofit groups challenging the patents, as saying his organization was not motivated by regional jealousy. Gallagher wrote:

"'If California had these patents with these claims, we'd be trying to challenge them,' said Simpson, who was born in Madison and whose mother worked in a research lab on the UW-Madison campus."

Here are links to other news stories and press releases: The AP(which appeared overseas), Terri Somers of the San Diego Union Tribune, Jim Downing of The Sacramento Bee, Bernadette Tansey of the San Francisco Chronicle, David Wahlberg of the Wisconsin State Journal, Rob Waters of Bloomberg, Foundation for Taxpayer and Consumer Rights press release.

Rules Approved for Millions in Lab Grants

After hearing statements that new lab space is running from $500 to $800 a square foot, a panel of the California stem cell agency Monday approved procedures to move quickly on laboratory grants to be awarded early next year.

The Facilities Working Group, in only its second meeting ever, approved criteria and bylaws that will go before the Oversight Committee for approval Oct. 11.

That will set the stage for a round of millions in grants for small-scale renovations of labs so that they can perform embryonic stem cell research.

Only a few changes were made in the selection process and criteria posted earlier on CIRM's web site. Added to the criteria were consideration of how soon a project can be operational and the record of the grant applicant in terms of staying on budget and completing projects on time. The exact language will be worked out and posted on the CIRM web site, probably on Wednesday.

The panel amended the bylaws to ensure that alternate members of the facilities group could vote on grants. The working group also indicated it would insert language to bar group members from discussing specific grant applications with the applicants once the proposals were submitted.

The group discussed a provision in the bylaws concerning the requirement of matching funds from applicants, giving preference to applicants with higher matching amounts. The issue involved whether applicants could get credit for money spent on the project prior to the grant. Just how that is all worked out will probably have to wait for the Oversight Committee meeting.

The agency is considering making as many as 15 grants, possibly up to $2 million per year. The current plan is to seek applications later this month with approval in March or April.

The agency can make about $300 million in facilities grants. Criteria for larger projects will be developed next year.