Stem Cell Snippets: Sherry Lansing to Stanford Freebies

Here are some links to interesting news, information or press releases related to California stem cell issues.

Sherry Lansing – CIRM Oversight Committee member Sherry Lansing, once a bigtime Hollywood executive, discusses her what makes her tick now. "I loved my job, but at a certain point it became repetitive. The highs weren't as high, and the lows weren't as low. So I asked myself: What is it that really gives me pleasure? The answer is giving back."

CIRM Overseer Flap – More from the Foundation for Taxpayer and Consumers Rights which is dogging the California attorney general concerning what is says is the illegal appointment of John Hein to the panel that reviews the financial operations of the California stem cell agency.

Stem Cell Bank –Joe Vanden Plas of the Wisconsin Technology Network reports: "The Madison-based National Stem Cell Bank has announced it will receive human embryonic stem cells from the University of California-San Francisco, giving it 13 of the 21 stem cell lines available on the federal registry."

Medical Freebies – In case you missed this, here is a link to the Los Angeles Times, which wrote: "They are common fixtures in many medical practices: free pens, mugs, stationery, stethoscopes and doctors' bags, all emblazoned with the logo of a new drug or a pharmaceutical firm. And those catered lunches staffers flock to? It may be courtesy of a major drug supplier. No more — at least for all staff and students at Stanford University's medical school, hospitals and clinics. Under a policy announced Tuesday, even free sticky notes violate ethics rules."

Open Access: Suber Rebuts

Open access advocate Peter Suber has challenged statements by Duane Roth and the fears of the UC Berkeley researchers concerning the move towards open access at CIRM. You can find his full comments here.

Open Access: Time to Catch the Wave

The drive for open access at the California stem cell agency moved forward last week with a presentation by University of California officials to the agency's Intellectual Property Task Force.

Following the Thursday session, Ed Penhoet, chair of the Task Force, said the group had heard "strong sentiment" for open access as described by the UC officials. But he noted that UC itself has not implemented open access policies even after three years of discussion. One UC official said he expected they may be approved next spring. Penhoet said CIRM will continue to work on the issue.

Open access means faster dissemination of research, more use of the information by other scholars and a reduction in cost to readers, according to the open access advocates.

Ben Crow, chair of the UC Academic Senate's committee on libraries, likened the impact of the Web and the Internet to the invention of printing, indicating that it was a force impossible to resist.

Francisco Prieto, a CIRM Oversight Committee member, said that sharing of research and transparency is a "bedrock principle" at CIRM. He said that open access is becoming "the standard" and that "perhaps we should push it."

John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights, said, "We're paying for it. We ought to be able to see it."

But Oversight Committee member Duane Roth said the marketplace seemed to be dealing with the issue of open access. He said he was "not sure CIRM should be doing something NIH isn't."

Because of the impact of open access, Roth also raised the specter of scientific journals changing from a subscription-based business model to the advertiser-based model that newspapers follow.

One faculty member from UC Berkeley noted that young researchers in his lab opposed open access policies because of the likelihood that they would limit their ability to have their research published in the top scientific journals. Publication in such journals is the key to securing good faculty positions, they said.

Coincidentally, a group of senior academic officials from around the country, including Barbara Horwitz, vice provost-academic personnel, at UC Davis, released a letter on Friday opposing federal open access legislation. Their letter contained a link to a Web site supporting the position of scientific journals.

Our comment: Fighting the Web is like trying to fight the tide. No information enterprise can resist it successfully. Newspapers, to their financial pain, have discovered that the hard way with significant loss of revenue. (However, their current sad state of economic affairs has more complex origins and was well underway prior to the widespread use of the Web.)

The choice before the scientific journals is whether to ride the wave of Web or to be smashed into the financial rocks trying to fight it. CIRM too really has no choice. It can only fiddle with the details.

As for the hiring practices at places like UC, changing realities will force some adjustments. Cheap sorting mechanisms such as counting the number of articles a scholar has published in a handful of journals are probably somewhat inappropriate any way. It is time to build a better model for finding good minds.

In addition to Crow, John Ober, director of policy, planning and outreach, Office of Scholarly Communication, University of California, and Lawrence Pitts, professor, Department of Neurological Surgery, UC San Francisco, and former chair of the UC Academic Senate appeared before IP Task Force.. The UC Berkeley faculty member that we mentioned got away before we could get his correct name. For more on open access and CIRM, see "fading print" and "call for open access."

Not Coming Up

We are holding off on our item on the open access discussions at CIRM despite our earlier promise to have something today. But here is the bottom line, IP Task Force Chairman Ed Penhoet said there was "strong support" for open access. More consideration of matter will come up in the future. The full item will be up by sometime tomorrow.

IP Policy for Business Moves on to Final Step

Call it the 25 percent conundrum. Or the payback puzzle.

That was one key issue facing the Intellectual Property Task Force of the California stem cell agency during its meeting Thursday on IP policy for grants to businesses.

Specifically, when do businesses have to come up with plans for access to CIRM-financed therapies, making them available to the uninsured and public agencies in California? (You folks out of state are out of luck.)

As originally proposed, businesses would have to come up with access plans when the agency's funding exceeded 25 percent of the invention. At that threshold, they would also have to provide therapies at the "federal Medicaid price" when the therapies were purchased with public funds.

The committee expressed concern about definitions of such terms as the Medicaid price and public funds, which are expected to be clarified in time for the Oct. 11 Oversight Committee meeting.

Task Force Chair Ed Penhoet introduced the topic of the 25 percent trigger by noting that some companies would find it onerous. Francisco Prieto of Sacramento, another Task Force member, said he "pulled the number out of my hat" when he originally suggested it.

John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights, said a percentage might be the wrong approach. He suggested tieing access plans to when a CIRM grant was made -- a "decisive point." After discussion about concepts other than a flat percentage including the idea of an "enabling amount" from San Francisco attorney Ken Taymor of MBV Law LLP, Penhoet indicated the staff would work on a percentage figure that varied, depending on when it was made in the process of the development of the therapy. Generally, the percentage would be larger at an earlier stage and grow smaller as the development cycle matured. What ultimately will be proposed will have to wait until closer to the Oversight Committee meeting.

Todd Gillenwater, vice president for public policy for the California Healthcare Institute, a biomedical industry association, said he was reserving a position on the percentage, pending completion of informal survey of some of the group's members.

Also up for clarification prior to the October meeting is language requiring the sharing of biomedical materials. Members of the Task Force were concerned about creating a burden on companies but also wanted to ensure the free flow of research. A representative of Applied Biosystems of Foster City, Ca., said he would like a provision that would allow companies to make a profit on research tools.

Most of the rest of the draft IP policy remained relatively unchanged.

Speaking to audience of 15 to 20 persons, Penhoet noted the difficulty in devising a commercial IP policy even after months of work and detailed testimony from a number of businesses. He indicated that the Task Force had plowed much new ground. Penhoet said there was a dearth of organized material on the questions before CIRM, declaring that his deputy, Mary Maxon, who performed virtually all of the research, had become the "world authority" on the subject.

The Task Force did not have a quorum for the discussion, and no vote was taken. But Penhoet was given an affirmative response when he asked the other members whether he had their permission to take the IP draft to the Oversight Committee. The meeting took place in CIRM's San Francisco headquarters. Four members of the 12-member group participated through a conference call connection. No media were present with the exception of the California Stem Cell Report.

(Editor's note: A slightly earlier version of this item contained an error in the 7th paragraph. It incorrectly stated that the variable percentage would be smaller initially instead of larger.)

Secrecy Broken on CIRM Grant Applicants

The secrecy surrounding the names of the scientists seeking $100 million in grants from the California stem cell aency has been breached by a nationally known researcher who works for one of the directors of CIRM itself.

One watchdog group says the breach is an attempt to manipulate the grant-making process. The California stem cell agency imposes the secrecy on names of scientists and institutions seeking grants to further what it believes is the public interest, to encourage the best science and to eliminate potential bias and conflicts of interest.

But, earlier this week, Hans Kierstead, a stem cell researcher who has been featured on the "60 Minutes" CBS TV program, told the Orange County Register that UC Irvine will be seeking more than $28 million out of the $100 million available. Reporter Gary Robbins said that UCI wanted to become "the West Coast mecca" of stem cell research.

Kierstead is an associate professor at the Reeve-Irvine Research Center at UC Irvine. The director of the center is Oswald Steward, who is also one of the 29 directors of the California stem cell agency. Also sitting on the Oversight Committee for CIRM is Susan Bryant, dean of the School of Biological Sciences at Irvine.

The Oversight Committee ultimately decides which scientists and insitutions receive grants. But Steward and Bryant would be barred from voting on a proposal from UC Irvine.

CIRM has declined to comment on the disclosure of the confidential information by Kierstead. We have asked UCI for comment, and will carry it if and when we receive. We also asked the Foundation for Taxpayer and Consumer Rights of Santa Monica, Ca., one of the CIRM watchdog groups, for a comment. John M. Simpson, stem cell project director for the group, replied:

"Reports from UC Irvine that the institution is seeking $26 million in Prop. 71 stem cell funds demonstrates an attempt to manipulate an award system shrouded in secrecy.

"In essence we've got one institution, which has two members on the stem cell oversight committee by the way, publicly staking out a claim on a quarter of the money to be awarded in the first round of research grants. UC Irvine has launched a campaign and is trying to build a bandwagon effect.

"The taxpayers who are putting up the $6 billion to fund stem cell research would be far better served if CIRM released the entire list of 350 who have expressed an intent to ask for money, how much each wants and with what institution they are affiliated.

"As it now stands CIRM will keep the big picture under wraps and institutions will leak information in dribs and drabs as it suits their own agendas. And as we have seen all too frequently in the last year, the UCs regularly act first in their own interests and not in those of Californians at large.

"Bottom line: It's the taxpayers money. We should learn directly from CIRM who wants it and why. And it should be available at one time, not piecemeal."

Earlier the California Stem Cell Report asked CIRM for names of the scientists and institutions, but was rebuffed by the agency. Here is part of its response:

"California law allows an agency to withhold certain information when the public interest in doing so outweighs the interest in disclosure. In this case, the public benefits more when the application pool for grants is as large and robust as possible, and the review process for those applications is as free of potential bias and conflicts of interest as possible.

"In light of the nature of the scientific profession, where reputation is the currency of the realm, ensuring confidentiality of applicants encourages the broadest range of research that may be funded, because applicants will not risk embarrassment or humiliation by being identified with a particular score or outcome if they are not funded. Novel or trend-setting research proposals are more likely to be submitted, and the public is thereby more likely to see the research and the field advance."

CIRM continued:

"Finally, confidentially ensures that the ICOC review process is conducted 'blind,' such that ICOC members are unaware of the identities of applicants, thus ensuring that conflicts of interest are avoided. Publicizing the names of the applicants would subvert this process and undermine the policies underlying it."

Given CIRM's inability to enforce confidentiality or secrecy, it would seem in its own best interest to level the playing field and minimize the ability of big players to exploit weaknesses in the system. One wonders about the reaction of a less well known stem cell scientist to the publicity move by Kierstead. Is that scientist going to have more or less confidence in the CIRM grant-making process? Is he or she going to be more or less likely to submit a grant? Will he or she be more or less inclined to play by rules that CIRM cannot enforce?

We encourage readers to weigh in with their comments, either anonymously or by name. Just click on the word "comment" below. The anonynomity is guaranteed through encryption. Not even we can see the names of anonymous posters.

Coming Up

Later today we will have a look at the outcome of Thursday's meeting of the Intellectual Property Task Force of the California stem cell agency, which discussed IP policy for grants to business. Also we will have an item on the debate over open access to research information at the agency.

But first will come a look at the breach in the secrecy surrounding the names of scientists and insitutions that have filed letters of intent to seek $100 million in grants from CIRM.

Open Access and Fading Print

Print is withering away in terms of sharing scientific research. At least that is one possible conclusion that could be drawn from information posted on the California stem cell agency's Web site.

The information comes in the form of background material supplied by advocates of open access who will appear at Thursday's discussion of the open access issue. For more on this, see "open access."

CIRM Defends Secrecy on Grant Letters of Intent

The California stem cell agency has responded to our query concerning the basis for keeping secret the names of scientists and institutions filing letters of intent in connection with $100 million in publicly funded grants. (See the "Sunshine" item below.)

Following the statement below from Dale Carlson, chief communiations officer for CIRM, we have a brief comment.

We also invite scientists who filed letters of intent to tell us whether they are willing to make their names and institutions part of the public record. Comments can be made anonymously by clicking on the word "comments" at the end of this item. If that device is used, I cannot see any information concerning the poster nor can other readers. You can also choose to comment under your own name.

Here is the statement from Carlson:

"This is another instance where we must balance competing claims on the public interest.

"California law allows an agency to withhold certain information when the public interest in doing so outweighs the interest in disclosure. In this case, the public benefits more when the application pool for grants is as large and robust as possible, and the review process for those applications is as free of potential bias and conflicts of interest as possible.

"In light of the nature of the scientific profession, where reputation is the currency of the realm, ensuring confidentiality of applicants encourages the broadest range of research that may be funded, because applicants will not risk embarrassment or humiliation by being identified with a particular score or outcome if they are not funded. Novel or trend-setting research proposals are more likely to be submitted, and the public is thereby more likely to see the research and the field advance. That's consistent with the Institute's mission – and the public's desire - to fund research that leads to cures, treatments, and therapies.

"Secondly, there are components of applications which may in fact contain information that is protected from disclosure by virtue of Health and Safety Code section 125290.30, subdivision (e)(2)(B), which exempts records that contain confidential intellectual property or work product of an applicant. There are also provisions in Prop 71 that address this issue and these materials. A letter of intent and subsequent application, as well as any ideas expressed therein, are the intellectual property of the applicant. Until we fund them, we have no right to share these documents with other people. We require our reviewers and others to sign confidentiality and non-disclosure statements in order to keep such information confidential. It would be totally contradictory to this policy (and maintaining the privacy of our applicants) to share this information (before its time - that is before funding) with anyone else. Our policy is consistent with the practices of other state and federal grant-making agencies, as well as the approach taken to the CIRM training grant applications.

"Finally, confidentially ensures that the ICOC review process is conducted 'blind,' such that ICOC members are unaware of the identities of applicants, thus ensuring that conflicts of interest are avoided. Publicizing the names of the applicants would subvert this process and undermine the policies underlying it."

Our comment: We are seeking only the names of the scientists and their insitutions – not the other information filed with the letters.

Again, what do you think about the secrecy issue, especially those of you who have filed letters of intent? Click on the word "comment" below to express your opinion.

CIRM Grant Program Stimulates More Comment

The Foundation for Taxpayer and Consumer Rights of Santa Monica, Ca., had this to say about the impressive show of interest in the $100 million in research grants being offered to California stem cell scientists.

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

"The huge response to CIRM’s request for stem cell research grant proposals clearly demonstrates keen interest in the field by California’s scientists. More important than that, though, it underscores once again the need for complete transparency in the award process.

"People will want to know exactly how a pool of 350 applicants is cut to 55 grantees.

"It also demonstrates again the need for the full public disclosure of the financial interests of the scientific advisors who will winnow down the applications and recommend who gets the taxpayers’ money."

We should add that the 29-member Oversight Committee will make the final decisions on the grants. But it is unlikely to reach down into hundreds of applicants and pull out one that was rejected. The recommendations by the review committee will be de facto decisions in all but a tiny fraction of cases, as was demonstrated in the earlier round of grants for training programs in 2005.

That said, it does not detract from truly impressive outpouring of letters of intents. As Zach Hall, president of CIRM, declared:

"We are quite excited about the strong response for our first research grants. It's clear that California scientists are eager to get started. The excellent response ensures that we will have a vigorous, high quality program of human embryonic stem cell research in California."

CFAC Says Applicant Secrecy is Bad Policy

As we mentioned in the item below, we queried the California First Amendment Coalition concerning CIRM's secrecy on the letters of intent.

Peter Scheer, executive director of the San Rafael, Ca., organization, said in an interview that CIRM's position may be legally defensible but is "bad policy." Without knowing who doesn't get a grant, he said the public does not have the "full picture." What is important, he said, is public confidence in the integrity of the grant process.

CFAC is a nonprofit organization dedicated to "advancing free speech and open-government rights."

Sunshine Needed on the Secret Names of Stem Cell Grant Applicants

Frothy rhetoric has surrounded the California stem cell agency since its inception, including predictions of a new California gold rush.

Today the rhetoric approached the reality – least in one regard. About 350 latter-day argonauts – stem cell scientists in this case -- have notified CIRM of their intentions to seek a chunk of the $100 million that the agency is going to be handing out in its first wave of research grants.

Who are these stem cell scientists? What institutions are involved? That is a secret legally protected by CIRM, even if the institutions seeking grants are other state financed entities such as the University of California. The information is "confidential," according to CIRM.

But this is also a case where CIRM's own rhetoric falls far short of reality. CIRM Chair Robert Klein has repeatedly extolled CIRM's policies as meeting the highest standards of openness and transparency. Yet it is hard to comprehend what public good is served by keeping the names of the scientists and their institutions secret. Would they have decided not to seek grants if their names were part of a public record? Highly unlikely.

The grant review process already has problems with excessive privacy. The scientists, for example, who review the grant requests do not have to disclose publicly their financial interests. Will they support grant requests from friendly colleagues? Will they protect their own interests by rejecting a grant from a scientist with a competing approach? Will they favor a grant that would aid a company in which they have some sort of interest, financial or otherwise? The public will not know. Perhaps CIRM will. The agency requires its reviewers to submit economic and other disclosures to the agency itself, but these again are secret documents.

We asked longtime observers of the CIRM scene, the Foundation for Taxpayer and Consumers Rights and the Center for Genetics and Society, if they had any comment on the secrecy involving the letters of intent. The California First Amendment Coalition was queried as well.

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

"Frankly, I don't understand what useful purpose is served by CIRM's penchant for secrecy. Much needed light would be shed on the entire process by saying who is thinking of applying for grants.

"And I don't understand why there would be any fear of embarrassing people who don't get an award. If you've got 350 applicants and are going to award at most 55 grants, that means you're funding less than 15 percent. There's nothing to be ashamed of in missing the cut when competition is that tough.

"Naming the applicants and their institutions has the added benefit of telling the public a lot about the hopes and aspirations of the faculty at California's universities. That's important stuff to know, if you're sending a kid off to college or thinking about it.

"In my personal life, I don't give money to people unless I know who they are, why they want it and what they plan to do with it. It shouldn't be any different with the taxpayers $3 billion.

"Bottom line: You want our money. Tell us who you are and ask for it in public."

According to an analysis of the state Public Record Act by the California attorney general's office, "...(A)ccess to information concerning the conduct of the public's business is a fundamental and necessary right for every person in the state."

The attorney general said that case law on the act has "emphasized that its primary purpose is to give the public an opportunity to monitor the functioning of their government. The greater and more unfettered the public official's power, the greater the public's interest in monitoring the governmental action."

Unfettered is a good word to describe CIRM, which is virtually alone among state agencies in its independence. Neither the governor nor the legislature, for example, can currently touch its budget or modify its decisions.

We believe CIRM has good intentions behind its disclosure policies. But in this case, good intentions are not enough.

More Tidbits on Eggan and the MacArthur...and a CIRM IP Note

Kevin Eggan thought it was a prank. His father, Larry, said he thought Kevin was too young for the award.

On the other hand, the elder Eggan said of the $500,000 MacArthur Foundation prize won by his son "we're hoping he takes us out to dinner," according to his hometown newspaper in Illinois, The Pantagraph.

The younger Eggan, who is a Harvard stem cell scientist and a member of the Standards Working Group of the California stem cell agency, said:

"I think the most important thing to me about this is the message that the MacArthur Foundation is sending. This points to the mainstream importance of embryonic stem cell research."

The announcement of the winners also contained an interesting sidelight on one of discussions at CIRM regarding intellectual property and providing access to therapies for the uninsured.

Some members of the CIRM IP Task Force bridle at such requirements, noting that some persons choose to go without health insurance.

One of the other MacArthur recipients, David Carroll, and his family have not had health insurance for some time. Carroll, of Warner, N.H., is a wetlands advocate whose most recent book is ``Self Portrait with Turtles: A memoir."

Reporter Gareth Cook wrote in the Boston Globe:

"Carroll has lived most of his life as a freelance writer and illustrator. He and his wife, who is also an artist, have raised three children and constantly struggled financially. For three decades, he said, he and his family have gone without health insurance."

UC Officials Call for Open Access to Taxpayer Financed Stem Cell Research

Around the world, public health scientists are struggling to gain access to research that will help them stave off a catastrophic outbreak of bird flu.

University libraries are rebelling against annual subscriptions to scientific journals that run upwards of $3,000 annually.

Patient advocate groups complain that scientists are not sharing their research, delaying the development of cures that can save lives.

It is all part of the backdrop of the debate over the innocuous sounding topic of open access, which will come before the Intellectual Property Task Force of the California stem cell agency this Thursday.

The informational presentation is tied into decisions that CIRM is making concerning who will have access to the research it finances, how the research will be distributed and how much the public (including scientists) will have to pay for it.

The subject is of great interest to more than one member of CIRM's Oversight Committee. But Jeff Sheehy pushed hard to have open access placed on the IP agenda this week.

After representatives of the University of California plumped for the issue at an IP Task Force meeting last month, Sheehy was emphatic. He said,

"This is really important for patients....An activist list serve that I'm on, they're looking at purchasing subscriptions so that people can get access to the data.

"We give up our bodies so people can study us....The state of California is paying for this research. And from a patient perspective, the idea that a study would be published with CIRM funding, having used California residents potentially as subjects of experiments, and we could not read those studies, we cannot access them is just unconscionable."

Appearing before the Task Force were John Ober, director of policy, planning and outreach, Office of Scholarly Communication, University of California, and Lawrence Pitts, professor, Department of Neurological Surgery, UC San Francisco, and former chair of the UC Academic Senate.

We queried Ober later for more on the issue. He cited a May 2005 letter by UC President Robert Dynes to Robert Klein, chair of the CIRM Oversight Committee, seeking an open access policy. The information provided by Dynes said an open access policy would achieve several important goals, including the following:

"Accelerate research progress and provide California’s public access without cost to a collection of published results of taxpayer ...funded research.

"Create a stable and permanent California-based archive of peer-reviewed research publications and source data to ensure the permanent preservation of these vital research findings.

"Secure a searchable collection of peer-reviewed research publications that (CIRM) and the ICOC can use to manage its research portfolio and measure scientific productivity and progress."

Perhaps the foremost advocate of open access is the Public Library of Science. See its open access section for even more on why it says "everything we publish is freely
available online for you to read, download, copy, distribute and use (with attribution) any way you wish."

CIRM Working Group Member Wins a MacArthur

Born in Normal, Ill., one of six children, he is a mountain climber who was freaked out by medical school. So he became one of the most skillful mouse cloners in the country, according to those who know.

He is Kevin Eggan, also a member of the Standards Working Group of the California stem cell agency. And today he became one of the winners, at age 32, of the MacArthur Foundation grants given each year to the quite bright.

Eggan's official occupation is principal investigator at the Harvard Stem Cell Institute.

He recently said:

"Doing a nuclear transplant is like playing the most difficult video game in the world. Imagine building your own Xbox before you play, and the game hardly works. It's like in Super Mario Brothers, where you have to do it over and over again until you master it."

As a MacArthur fellow, he will receive $500,000 over the next five years.

For more on Eggan, see the following stories: Mouse cloner, mountain climber and French cook and medical school refugee.

News Briefing Tomorrow on Stem Cell Issues

The Center for Genetics and Society is putting together a briefing tomorrow on stem cell issues and politics for editors and reporters across the country.

The conference call session, set for 10 a.m., will deal with exaggerations, stem cell technology, existing and proposed policies as well as shifting political alignments. Top officials from the nonprofit watchdog group will take part in the conference call, whose topic is the "politics of stem cell research in an election year."

The center supports embryonic stem cell research but has been critical of the California stem cell agency. It describes itself as an advocate of "responsible societal governance of the new human biotechnologies." In addition to its activities regarding CIRM, the center has also spoken out on stem cell issues elsewhere around the nation.

Richard Hayes and Marcy Darnovksy, executive directors of the group, recently authored the book, "Stem Cells and Public Policy."

For more details on tomorrow's conference call, email pshah@genetics-and-society.org.

Hundreds of Millions at Stake? Draft CIRM IP Policy for Business Now Available

The 37-page "deal" for businesses seeking grants from the California stem cell agency – at least the preliminary version of it – is now ready for some flinty-eyed dissection.

CIRM has posted the draft on its web site ahead of Thursday's meeting of its Intellectual Property Task Force in San Francisco.

The document grew out of the Aug. 29 meeting of the Task Force, chaired by Ed Penhoet. He says he wants to bring recommendations to the Oversight Committee Oct. 11 for its approval.

No one knows how much money could be at stake in connection with CIRM's plans for sharing the wealth with businesses, but it could be rather large. The agency itself could eventually give hundreds of millions of dollars to businesses to stimulate the development of stem cell therapies.

The IP proposals appear to be line with the principles offered on Aug. 29. The draft also attempts to clarify such terminology as the meaning of net revenue – important because the draft contains a 17 percent net revenue trigger on one revenue sharing feature.

The draft offered a little more detail on the "blockbuster" payments on successful commercial products. It proposed a payment equal to three times the original award(inflation adjusted) – paid back over five years – after revenues exceed $250 million.

Also clarified was the percentage of funding that would trigger a requirement that awardees provide a plan for access to CIRM-assisted therapies for uninsured Californians. The proposed figure is 25 percent of the funding of the invention or project. That would also kick in a requirement to provide the therapies to public agencies at the Medicaid price. However, some members of the Task Force say there is no such thing as the Medicaid price.

Oversight Committee member Duane Roth says California businesses need certainty in any proposal that requires financial commitments. They need to know "that this is the deal," he says.

Whether businesses on Thursday will make any counter offers on the deal is unknown. But only a handful were on board for the meeting last month.

A side note: Penhoet and the CIRM staff, especially Mary Maxon, well served the stem cell community, businesses and public by having the IP draft up on the web site last Friday. Also up was the transcript of Aug. 29 meeting. Early postings genuinely help all involved make intelligent and timely contributions to the discussion.

Love and Reed Mentioned in Massachusetts Political Coverage

The names of two members of the directors of the California stem cell agency have surfaced in coverage of the Massachusetts governor's race.

Ted Love and John Reed were mentioned in a story by reporter Dave Wedge of the Boston Herald that said that a company founded by the Democratic candidate, Chris Gabrieli, is "one of the world’s leading patent holders in stem cell research, raising questions about (his) denials that he stands to profit from his plan to fund the controversial science with tax dollars."

Wedge wrote:

"Isis Pharmaceuticals - a company in which Gabrieli owns $1.5 million in stock - ranks third in the country in stem cell patents. Gabrieli sat on the firm’s board of directors until February."


Wedge continued:
"The controversy came to a head (last week) when (Republican candidate Kerry) Healey launched an attack ad accusing Gabrieli of positioning himself to reap a financial windfall from his plan to invest $1 billion in taxpayer money in stem cell research.

 "The Herald also has learned that Gabrieli has ties to two biotech executives who have come under fire in California for sitting on an independent board that oversees that state’s $3 billion, taxpayer-funded stem cell research program. Gabrieli has called the California program a 'model' for his Bay State plan.

"Ten of the 29 executives on the California board have been criticized for their investments and interests in biotech companies, including Isis Pharmaceuticals director John Reed. The other with ties to Gabrieli is Ted Love, a board member of Predix Pharmaceuticals, a company that recently merged with Epix Pharmaceuticals, which is in Gabrieli’s investment portfolio."

'Desperate Companies, Delusional Researchers'

The Center for Genetics and Society, which is practically a next-door neighbor to Advanced Cell Technology, has published a critical assessment of the company in connection with the latest controversy involving ACT's new stem cell extraction method.

The piece also reviewed ACT's previous announcements of research that did not fully pan out, including details that we have not seen elsewhere.

The center wrote:

"What's been little remarked upon, however, is that this pattern of hyperbole has come to characterize both the field of stem cell research and the political debate about it. Miracle cures for myriad diseases are promised by proponents of work with embryonic stem cells. Early-stage research and even speculative applications of hypothetical research are promoted to garner public support and venture capital. Researchers in white lab coats pitching the potential of embryonic stem cells are identified only as research scientists, when in fact they are often also the financial beneficiaries of biotech corporations. Meanwhile, reasonable and minimal regulations are criticized as thwarting scientific progress.

"Given this climate of exaggerated expectations, it shouldn't be that surprising that desperate companies and delusional researchers regularly come along, and take advantage of the public's hopes and misperceptions in order to boost their stock prices or careers."

"In this case, the weak link was the media, on whom the public relies for accurate and critical reporting. Instead of reading the scientific paper closely—which would have revealed that the embryos were destroyed—most reporters took the press releases issued by ACT and Nature at face value. Given ACT's sketchy history of swindling, seasoned journalists should have known better."

As for the physical location of the center and ACT, CGS is in Oakland which is linked by an underwater tunnel and draw bridges to the island (Alameda) in San Francisco Bay that houses ACT.

CIRM's Financial Watchdogs Vote for Disclosure

Financial overseers of the California stem cell agency have decided not to seek an exemption from a state law that requires them to disclose their investments.

In a 4-1 vote, the Citizens Financial Accountability Oversight Committee decided to go along with the state's economic disclosure act that applies to most high level public officials, according to Garin Casaleggio, a spokesman for the state controller's office.

The only negative vote came from Myrtle Potter, a former executive in the biotech industry.

Prior to the meeting, the committee appeared to meet the qualifications for becoming the fourth state agency to be exempted from the disclosure law. The exemption provision was enacted only this year, which allowed the Commission on the Fair Administration of Justice, the Medication Errors Panel and the Alliance to Combat Trafficking and Slavery Task Force to be excused from normal financial disclosure.

The financial oversight committee held its first meeting ever last Thursday in San Francisco and reviewed the audit of CIRM by its contracted auditor as well as the controller's review of the audit. According to Casaleggio, the panel endorsed the recommendations in those audits, which CIRM has already basically implemented.

Democratic state Controller Steve Westly, chair of the panel, requested that CIRM "explore a streamlined grant process that would spur collaboration and innovation by requiring scientists to share research results," according to a press release. The release also said:

"Westly recommended the Institute’s Intellectual Property Committee review and report on the policies of research organizations that earmark a portion of research funding for grants that require annual disclosure of results."

Casaleggio told the California Stem Cell Report that the financial committee will receive a report from the controller's staff on CIRM's IP policy at its next meeting.

The committee indicated that it would meet again as soon as the second financial audit is available, perhaps in December. By that time, the state's auditor general may have completed its performance audit of the agency as well.

Casaleggio said about 40 persons attended the meeting, presumably including staff from both the controller's office and CIRM as well as a news crew from San Francisco TV station KGO, which was the only other news outlet beside this website to publish a report on the session.

For more on the disclosure exemption question, see "no time to weaken." See the item below for more on the ongoing dispute on one member's qualifications as well as the Political Muscle blog by Robert Salladay on the Los Angeles Times website.