Saturday, October 28, 2006

Missing: Arnold's Promised $150 Million Stem Cell Loan

Last July, in the heat of the national debate about stem cell research, Gov. Arnold Schwarzenegger made headlines by promising $150 million to bail out the fiscally strapped California stem cell agency.

Today, more than three months later, the agency has not seen one dime of the promised loan despite the governor's July 21 statement that CIRM "need(s) the money now." Schwarzenegger said that it was "critical we take action" and that money should begin flowing "as soon possible."

The California Stem Cell Report queried both the governor's office and CIRM concerning Schwarzenegger's failure to provide the money. The governor's office has not responded to our request on Friday about what has blocked the cash. CIRM also has been less than informative.

Dale Carlson, spokesman for the agency, said that the State Department of Finance "needs to review the loan documents which are still being written," but declined to elaborate.

Unexplained was whether there is some problem with making the loan to CIRM, which one would think would be a fairly routine procedure that could be executed in less than three months. Unexplained also was the exact nature of the loan mechanism, which was not discussed in news reports at the time of the governor's announcement.

Anne Sheehan, an aide to the governor, told the CIRM Oversight Committee at the beginning of August that the loan amounted to "uncharted waters" for the state but that she expected action on it by the middle of August.

Since Schwarzenegger's politically exquisite timing of the loan announcement, which received worldwide attention, he has been involved in a re-election campaign in which he has built a commanding lead over his Democratic opponent, state Treasurer Phil Angelides. Perhaps the campaign has distracted Schwarzenegger's office from fulfilling the loan promise.

California stem cell Chairman Robert Klein alluded to the pressures of the campaign at a meeting of the CIRM Oversight Committee earlier this month. He indicated that the elections had made it difficult to hold a meeting of the CIRM Finance Committee, a special body created by Prop. 71, to approve issuance of CIRM bonds.

However, neither CIRM nor the governor's office explained if or why the Finance Committee would be involved in a loan between two state entities. Klein indicated that the Finance Committee, at its next meeting, would review more requests for bond anticipation notes, which are expected to be issued to private contributors to CIRM.

A July 20 press release by CIRM cited a section of Prop. 71 that appears to allow the state director of finance to provide funding to CIRM from the state's general fund if it is within the amount of unsold bonds authorized by the Finance Committee. That group has already approved $200 million in bonds, which have not been sold, so it would appear giving CIRM the $150 million is a simple ministerial act, but maybe not.

Klein said he hoped the Finance Committee could meet very soon after the fall elections, which will come a week from Tuesday.

The stem cell agency has been strapped for funds because of lawsuits that have blocked the issuance of state bonds that would fund it. It has operated, for the most part, on the basis of private contributions and loans since it began operations in late 2004. CIRM did not respond to a question from the California Stem Cell Report about whether the failure to provide the loan has created any financial difficulties at the agency. Sphere: Related Content

Welcome to The Biopolitical Times

The Center for Genetics and Society has entered the blogosphere with a site called The Biopolitical Times. Initial topics are heavily tilted to the current relationship between vote-crazed politicians and their attempts to exploit embryonic stem cell research.

An excerpt from an item by Marcy Darnovsky:
"We’ve moved on from Fox and counter-Fox, wherein Rush Limbaugh demonstrates that “big idiot” is far too kind. Now we have top-level Democrats demonstrating their skill in cheap emotional blackmail. The take-home sentiment of a new ad by Majority Action, a Democratic 527, is that the Stem Cell Saviors will cure us all. And anyone who doubts that may as well have the blood of that sweet little six-year-old on their hands. This ad should be as embarrassing to those of us who support embryonic stem cell research as Limbaugh’s antics should be to its opponents."
The center, which has actively tracked the California stem cell agency, is inviting comments, private or public, on the site. Sphere: Related Content

Thursday, October 26, 2006

Stem Cell Snippets: Warehouses, Fox Ad and Pombo

Here links to some stories related to California stem cell issues:

UC Davis – A warehouse in Sacramento is being converted into a $75 million stem cell research center by UC Davis. Reporter Jim Downing of The Sacramento Bee wrote:
"The new director of the Davis program, Jan Nolta, starts work Nov. 1. Nolta, who grew up in Willows, was recruited from Washington University in St. Louis along with longtime collaborator Gerhard Bauer, an Austrian native who is an an expert in the design and management of ultra-clean laboratories. Nolta and Bauer were at the UC Davis Medical Center on Wednesday as U.S. Rep. Doris Matsui, D-Sacramento, toured the laboratories of Mark Zern, an organ transplant expert whose research team is studying ways to use embryonic stem cells to regenerate the liver."
Michael Fox – His stem cell TV ad rivals the nuclear destruction commercial in the 1964 presidential race in terms of free air time, according to one longtime observer at the Poynter Institute, a newspaper think tank.

Pombo – Stem cell research rose to a higher level of visibility in a Central Valley congressional race in California. Reporter Lisa Vorderbrueggen of the Contra Costa Times wrote the story concerning incumbent Republican Richard Pombo and Democrat Jerry McNerney. Sphere: Related Content

Arlington Speaks on CIRM's Orphan Software

The head of the Arlington Group, the defunct grant review software firm used by the California stem cell agency, says that CIRM has not acquired the copyright or intellectual property rights to the program used by the agency and other major grant providers.

Earlier, we reported that the San Diego Union-Tribune quoted CIRM President Zach Hall as saying that the agency owned the computer codes involving the grant review program. (See item below.)

In response to an inquiry from the California Stem Cell Report, Mary Taylor, CEO and founder of Arlington, provided the following statement that we are carrying verbatim:

"CIRM acquired the rights to the Easygrants software source code to use, modify, or have modified for them for their business purposes.

"They did not acquire the intellectual property, distribution rights, copyright, etc. Second, Arlington Group delivered to CIRM all of the work that had been done to date on their system, including significant documentation of requirements for the system configuration, as well as the initial development work. With this in hand, when they begin working with the new development group, they can hit the ground running.

"Finally, with this transaction, CIRM is saving the state money on license fees for 2007 and forward. So while it was an unexpected challenge, worst of all for AG, CIRM has taken the steps needed to ensure their success and be good stewards of the state's money."

Why is all this important? Orphaned software can be a disaster. Often it is poorly documented internally, without explanations of how the code was constructed and works. When glitches occur, that makes it extremely difficult to maintain by the purchasers. That can mean that information is lost and cannot be compiled properly. Hopefully that is not the case here. Sphere: Related Content

Wednesday, October 25, 2006

Death of CIRM Software Firm Only a 'Hiccup'

The California stem cell agency, which faces an enormous task in reviewing a flood of grant applications, is minimizing the impact of the demise of the company that produced the software for evaluating and coordinating the applications.

Reporter Terri Somers of the San Diego Union-Tribune wrote that the Arlington Group of McLean, Va., suddenly went "belly up," leaving CIRM in a digital lurch.

But, she also wrote, CIRM President Zach Hall said that CIRM now owns the computer codes behind the Arlington program. Somers continued:
"There was no warning that Arlington was about to go out of business, Hall said. Apparently an investor withdrew his money unexpectedly, causing the company to fold, he said.

"Before that happened, the institute had paid $108,000 to Arlington, Hall said.

"The institute has since contracted with a new company, composed of former Arlington employees, to build the system at a cost equal to what it was to have paid the defunct company, Hall said."
The original eight-year contract called for payment of $233,474 in the first year.

Somers reported:
"'This has been a hiccup for us in terms of time schedule,' Hall said. 'But it's not a major issue.'"
Dale Carlson, spokesman for CIRM, today told the California Stem Cell Report,
"We got the source code, which will be helpful to us going forward. We've got their senior developers ready to work with us. It isn't delaying the review of the grants. It isn't costing us any more money. And we're talking with Arlington's major customers about an ongoing network to support the platform."
Those customers include the Bill & Melinda Gates Foundation, David and Lucile Packard Foundation and the Howard Hughes Medical Institute.

(Editor's note: A slightly earlier version of this item did not include the last two paragraphs.) Sphere: Related Content

The $25 Million Bioethicists' Dog

The blog at the American Journal of Bioethics has addressed the issue of big money and "the butcher's avarice" in the stem cell wars being fought across the country in this fall's election.

Specifically Jim Fossett, director of health and Medicaid studies at the Rockefeller Institute, wrote on Oct. 21 about the Missouri tussle and noted how California led the way. He also had this to say:
"There are huge amounts of money at stake in the embryonic stem cell research debate, and much of the political and financial support for such initiatives is coming from parties that expect to get something out of them—large research grants, potentially lucrative patents and commercial opportunities, scientific prestige, political credit and campaign contributions, tax revenue and jobs. Bioethicists also have a dog in this fight — CIRM’s draft strategic plan earmarks $25 million to examine the social, ethical, etc. implications of stem cell research, and there have been complaints from some quarters that this isn’t enough. By the rules that govern politics and the markets, this is absolutely ok. The right to petition the government for a redress of grievances is enshrined in the Constitution, and capitalism relies on rewards to those who provide society with useful things. The desire for money and status is perfectly compatible with, and is frequently accompanied by, a deeply felt desire to do good and heal the sick. Those who find the scramble for money distasteful might usefully contemplate Adam Smith—'It is not by the butcher’s altruism, but by his avarice, that we may expect to receive our dinner.'"
Sphere: Related Content

Klein Helps Aussies in Stem Cell Fray

California stem cell Chairman Robert Klein recently sang a stem cell tune that was "music" to some Australian ears. So says reporter Leigh Dayton in a story in The Australian.

Australia is caught up in a bit of controversy over stem cell research, and Klein visited there to support the forces of embryonic stem cell research.

Dayton wrote:
"'Mr Klein generously offered to visit Australia to help us in the current legislative climate," (Stephen) Livesey (CEO of the Australian Stem Cell Center) says. 'He provided the Australian stem cell science community with advice on how to engage the public, patients and politicians on the complex topic of stem cell research.'"
Klein's stem cell drum beating had a familiar sound to those who have heard him speak in California, but wa swelcomed down under.

Dayton reported:
"Clearly, Klein's words are music to the ears of Australian scientists and patient advocacy groups pushing to change the nation's embryo research and anti-cloning legislation."
The Australian account said Klein was "a guest" of the Australian Stem Cell Center last week, but did not specifically make clear who funded his trip. CIRM says it did not pay for his trip. Sphere: Related Content

Stem Cell Snippets: Conflicts, WARF and Politics

Here are links to items of interest related to California stem cell matters.

Conflicts of Interest – Maryland is wrestling with the same conflict-of-interest questions that dog the California stem cell agency. Erin Bryant of Capital News Service wrote that legislation creating the Maryland stem commission built in the conflicts and does not spell out whether commission members are allowed to vote on applications from their own institutions. One member of the group thinks they should.


WARF – Longtime WARF stalwart Beth Donley is leaving that organization. Donley, the foundation's general counsel, had worked for the organization for eight years. Only six weeks ago she too control of its WiCell affiliate. Donley said she wants to move on to the "next level" – the private sector. That could be translated as higher compensation. It does seem odd that she is leaving so soon after her appointment to the WiCell position. Here is a link to Joe Vanden Plas' story on the Wisconsin Technology Network.


NEJM – The New England Journal of Medicine has a couple of pieces on the politics of stem cells and the flap over the ACT stem cell extraction announcement. Nothing new in the ACT item, but it is a straight-forward delineation of what occurred as compared to the somewhat muddled accounts elsewhere. Likewise with the politics piece. Sphere: Related Content

Friday, October 20, 2006

Who is John Reed?

The 29 men and women who direct the California stem cell agency labor largely in public anonymity. While they oversee the expenditure of $6 billion in public funds, what makes them tick is really not known by the folks whose interests they represent.

Now comes a piece by Terri Somers of the San Diego Union-Tribune concerning John Reed, one of the members of CIRM's Oversight Committee and chief executive of the Burnham Institute in La Jolla, Ca.

So who is Reed? An accomplished scientist and triathlete who rises at 3 a.m. and who "exudes the wholesome earnestness of a patriarch in a 1950s black and white sitcom." He also sings rock at company soirees.

Somers, however, devotes most of her piece to Reed's professional accomplishments. An excerpt:
"Since delving into apoptosis, Reed has written more than 550 peer-reviewed scientific articles and 50 book chapters. He has the distinction of having published more papers on programmed cell death during the past decade than any other scientist worldwide, according to the Institute for Scientific Information. He was also recognized by the Institute for Scientific Information as the world's most cited scientist in all areas of research from 1997 to 1999."
We confess to a fondness for profiles about people such as Reed -- people who actually do the job, provide the leadership and set the tone of enterprises. But good profiles are rare in the media. It is difficult to create a three-dimensional portrait of an individual in the amount of time provided by most newspapers or media outlets. Not all reporters have the skills to crawl inside, so to speak, another person's personality. Perhaps the most difficult part of reporting a profile is to find persons who know the subject of the profile well and who are willing to comment critically and publicly about him or her. After all, none of us are perfect, and to be complete a profile should reflect at least some of that imperfection.

That said, we would like to see more profiles, regardless of their limitations. Sphere: Related Content

Stem Cell Snippets: Rentals to DNA

Here are links to some interesting items related to stem cell issues.

Sharing – One of the goals of the upcoming rounds of lab grants by the California stem cell agency is to increase the sharing of CIRM-funded facilities with other nearby scientists not so fortunate as to have access to the costly gear needed for research. The topic has not received much media attention but its importance was highlighted in an article by Bernadette Tansey of the San Francisco Chronicle. "Microscope for hire" was the headline. In this case, the article discusses UC San Francisco's plans to rent out their tools, six new microscope worth $2 million.

Diver Don – Ubiquitous stem cell advocate Don Reed popped up in the lead of a story by Jason Gertzen in the Kansas City Star looking at the Missouri stem cell measure, which is on the November ballot. The piece used Reed, a former professional scuba diver, as an example of the folks who hope for cures. Reed, meanwhile, is exhorting -- via his website, stemcellbattles.com – the millions of folks with disabilities throughout the country to vote for their best interests in the November election.

Tell-All –-J. Craig Venter is baring all, according to reporter Antonio Regalado of the Wall Street Journal. Venter is just about ready to release his DNA to the world. Venter, you may recall, was the gent best known for his efforts to be the first to decipher the full sequence of the human genome. An interesting piece about a controversial scientist. Here is a link to a free version of the story. Sphere: Related Content

Monday, October 16, 2006

Setting Sail Again – Sort Of

The California Stem Cell Report is leaving the Old Country Tuesday and returning to its home port in Romantic Old Mexico. We have concluded an excellent visit to California, playing with grandchildren and family and now are flying back to ready Hopalong, our sailboat and only home, for a winter's cruising along the west coast of Mexico. Hopalong has been resting at a berth near Guaymas, but we will haul her onto dry land to pull one of her masts to make repairs. The work schedule means that we may not be filing items as often as we have over the past weeks.

Meantime, keep reading the report, send along your comments and tips and whatever else you think may be of interest. We can be reached at djensen@californiastemcellreport.com or you can post a comment by clicking on the word "comments" that appears after each item. Sphere: Related Content

SEED Grant Hopefuls Total 232; Names Remain Secret

A whopping 232 applications competing for $24 million in grants has deluged the California stem cell agency – a figure that CIRM today said demonstrated "the keen interest in the field and the pent up demand for funding for human embryonic stem cell research."

Names of not only the scientists but also their institutions, many of them likely state-funded schools, are secret by the decision of CIRM. However, nothing prevents the applicants themselves from disclosing the fact that they have applied for state funding, and some are expected to do so.

Failure to disclose the names of persons and institutions seeking state funds is poor governmental policy and hardly complies with CIRM's oft repeated pledge for the highest standards of transparency and openness.

John M. Simpson, stem cell project director for the Foundation of Taxpayer and Consumers Rights of Santa Monica, Ca., said:
"The stem cell institute missed another opportunity to operate transparently and build the public’s trust when it announced today that it received 232 applications for 30 SEED research grants from researchers affiliated with 36 nonprofit institutions.

"Californians have a tremendous interest in knowing how this pool is cut to 30 grantees. All would be better served if the names of the applicants and their institutions were released. If you want our money, tell us who you are.

“There’s no need to worry about embarrassing somebody because they don’t get a grant. CIRM is planning to fund only 12.9 percent of the applicants. Missing this cut is no big deal. Scientists need to develop thicker skins if they want to use public money for their work and CIRM needs to let the sun shine in."
(You can read more on this subject at "sunshine needed," "bad policy," "secrecy broken" and "CIRM defends.")

In a CIRM press release, Arlene Chiu, CIRM director of scientific programs, said, "We’re delighted that there is such strong competition for our inaugural research initiative, and that the applicants are considering such a broad range of approaches. It bodes well for the future of our program."

The grants are expected to be awarded in January – the first research funded by the agency since it was created in 2004. Review of the applications, a prodiguous task, is scheduled for late November. (See item below.) Sphere: Related Content

Sunday, October 15, 2006

SEED Grant Applications Pour Into CIRM

The California stem cell agency was flooded last Friday with applications for the $24 million SEED grant program but the exact number is not expected to be released until Monday.

Initially, 301 letters of intent were filed for about 30 SEED grants with 78 letters for the $80 million comprehensive grant program. Roughly 40 California institutions were represented. The names of those filing letters of intent and applications for public funding are secret. Only those winning grants will be identified by CIRM.

Nearly overwhelmed by the numbers, CIRM earlier asked institutions to certify that letters of intent were filed by "principal investigators." Dale Carlson, a spokesman for CIRM, said "only five or six" letters were eliminated as a result of the certification process.

On Oct. 1, we reported concerns that the certification effort was unfair and penalized younger scientists. (See "whittling down the researchers.") That issue came up indirectly during last week's meetings of the Oversight Committee.

Chairman Robert Klein noted that one of the goals of the agency is to expand the number of stem cell researchers. He asked CIRM President Zach Hall whether a future round of grants would be proposed to advance that effort.

John Reed, a member of the Oversight Committee and president of the Burnham Institute, also indicated that younger researchers ought to be encouraged.

Hall responded that the SEED grant program was not meant for staff scientists or post-doctoral applicants. He indicated that a grant program aimed at younger scientists could be worthwhile sometime in the future.

To help deal with the imposing number of grants, the Oversight Committee last week added 18 alternate members to the grants working group in addition to the existing 16 alternates. Fifteen scientists sit as regular members of the group.

Just how the review process will work is not entirely clear. The California Stem Cell Report plans to post an item in the near future dealing with the mechanics of how the reviewers will go through the grants.

The agency has scheduled Nov. 28-30 for review of the SEED grant applications by the Grants Working Group. Applications for comprehensive grants are due Nov. 13 and scheduled to be reviewed Jan. 8-10. Sphere: Related Content

Doggie Bag Tidbits from the CIRM Meeting

Here are some leftovers from last week's meeting of the Oversight Committee of the California stem cell agency.

Need for Speed – Each year's delay in issuing bonds costs the agency about $84 million because inflation diminishes the value of the $3 billion authorized two years ago, said Chairman Robert Klein. President Zach Hall also said the agency is moving fast to hire a scientific review officer, a senior facilities officer and a grants technical assistant.

Intellectual Property – Discussion was deferred on the policy on intellectual property for businesses, including open access on scholarly publications involving CIRM-funded research. Time ran short at the Wednesday session so IP was taken off the agenda.

Eggs – About 300 persons viewed the egg risk conference online compared to the 90 who attended the actual session, according to Hall. The agency will issue a report on the conference near the end of the year.

UK/California stem cell summit -– Sixteen California scientists and 16 UK scientists will meet in Great Britain on Nov. 13-14 to discuss stem cell matters. Hall will be attending and will check out the stem cell bank in Merrie Olde England. Sphere: Related Content

Stem Cell Snippets: UC Irvine, Loring and Windows of Opportunity

Here are some links to stories of interest related to California stem cell matters

UCIThomas Yuen, chairman and CEO of Prime Cell Therapeutics of Irvine, Ca., has donated $1 million for embryonic stem cell research at UC Irvine, according to a piece by reporter Gary Robbins of the Orange Country Register. Prime Cell is a privately held stem cell engineering firm currently involved with adult stem cells, according to its web site. Robbins said Yuen, 54, has kidney disease and quoted him as saying, "My illness exposes me to a lot of people who are sick and suffering. And I believe stem-cell work holds the promise of treating a multitude of age-related and chronic diseases."


WARF
– Reporter David Wahlberg of the Wisconsin State Journal takes a crack at the WARF patent dispute. An excerpt from his balanced article: "WARF's stance, that Thomson's work is worthy of patents, 'is like saying that just because heating in water works for cooking a chicken egg, it's novel to consider using heating in water to cook a duck egg,' said Jeanne Loring, a stem-cell researcher at the Burnham Institute for Medical Research in California."


Out FrontHartford Courant columnist Dan Haar writes: "The federal ban (on ESC research)has created a window of opportunity for Connecticut, California, Illinois, New Jersey, and perhaps a few other states that have had the foresight to front their own cash. 'When the ban goes away, there are only going to be a few places in the country that already have this,' said Marc Lalande, a UConn geneticist and associate dean who heads the university's stem cell working group. 'We are going to have a leg up. We will be able to compete successfully for federal funding.'"

Strategic Plan – The Red Herring web site posted a piece on CIRM's strategic plan, saying "for the most part" it received an "informal endorsement." Sphere: Related Content

Friday, October 13, 2006

Stem Cell Snippets: From WARF to Researcher Conflicts

Here are some tidbits and links to some interesting news items, press releases or other material concerning California stem call issues.

WARF -- "The recent out-of-state challenges, including one from California, to stem cell patents held by the Wisconsin Alumni Research Foundation (WARF) lack merit and underscore the need for serious patent reform in the United States," says patent attorney Grady Frenchick. In a piece on the Wisconsin Technology Network, he says the challenges are politically motivated. .

Bonds -- CIRM has no plans to sell $1 billion in general obligation debt next year even if it overcomes court challenges, Reuters reports.

Attorney General's Race -– Patient activist Karen Miner pens piece endorsing Jerry Brown for California attorney general, saying his opponent is anti-stem cell research.

Salaries – In response to a request from the California Stem Cell Report, CIRM released the following salaries for the latest hires at CIRM: Lorraine Hoffman, chief finance and administrative officer, $190,000, and Marcia Davey, interim financial officer, $142,000.

Disclosure -– Ivan Oransky, deputy editor of The Scientist, writes in the Boston Globe on the need for more disclosure from scientists. "A survey published in the Journal of Law, Medicine, and Ethics of clinical researchers' attitudes on conflicts of interest included this mind-boggling response: 'Let's say . . . we do a dozen studies for [Company X] . . . and it is a $2 billion company. . . Let's say that I owned a lot of stock in [Company X]. I mean, the application of a new drug to the company, let alone our ability to participate in that drug, would not affect that one iota. So, as far as I am concerned, conflict of interest is overblown.' Message received: Researchers know best. Please stop bothering us with these silly rules and your sensationalist investigations." Sphere: Related Content

Thursday, October 12, 2006

Stem Cell News Coverage: Spending, Geography and Planning

News coverge of the meetings of the California stem cell agency was a bit light this week with only the San Francisco Chronicle, the San Diego Union-Tribune and Bloomberg carrying stories.

However, we may see something later from the Los Angeles Times and New York Times, both of which had reporters at the Tuesday meeting.

Terri Somers of the San Diego paper focused on the question of geography as a criteria for selection of research facilities (see item below). She wrote:
"The (Oversight Committee) has shown geographic biases before.

"(Committee member Duane) Roth recalled that the vote on the location of the institute's headquarters – whether in San Diego or San Francisco – was ultimately decided by a vote in which the majority of board members selected what was geographically convenient for them.

"Roth suggested that if geography would be a big factor, applicants should compete for grants regionally."
Carl Hall of the Chronicle discussed the agency's spending plans for 2007 (a revised budget for the agency is expected to be formally presented in December.) Hall wrote:
"California stem cell policymakers revealed a rough outline of what could be a $500 million attempt in 2007 to push the state's stalled experiment in stem cell research into a new phase of productive grant making."
He reported that stem cell chairman Robert Klein says he expects facilities grant to "almost certainly by matched 2 to 1 by institutions and private donors." The committee, however, has not yet set a matching criteria that exceeds 20 percent.

Rob Waters of Bloomberg wrote about the draft of the agency's strategic plan.
"The agency's motto, 'turning stem cells into cures' was on the report's cover. The message inside was more nuanced: While the agency seeks to accelerate research, the report said 'it will take time, perhaps decades' to get proven treatments. The statement drew support from scientists, concern from those afflicted by diseases that may be helped by stem cell therapy.

"'I think some people will look at this plan and say the goals are too modest,' said Leon Thal, a University of California-San Diego neuroscientist and member of the agency's governing board. "'I disagree. I think they're realistic.'"
Sphere: Related Content

Wednesday, October 11, 2006

Conflicts of Interest: From Press Releases to Matching Funds

For those of you who may have forgotten -- at least 14 members of the 29-member Oversight Committee come from institutions that could benefit from the roughly $300 million in proposed grants from CIRM to build research facilities. The committee will decide which instititions receive the cash and under what terms. Members, however, are forbidden from voting on grant applications from their own institutions.

Those built-in conflicts of interests at the California Institute for Regenerative Medicine surfaced today during a discussion concerning the grants and the process of issuing press releases about CIRM-funded research.

Just what should CIRM require from medical schools and other institutions that receive grants for multimillion dollar laboratories? The law requires that applicants must secure matching funds from other sources that equal at least 20 percent of the award. But how that credit is calculated is yet to be determined. Applications will not be submitted for many months, and fundraising is already underway. So the issue of what expenditures made now or even earlier can be counted as matching funds is not an insignificant matter for the deans of the medical schools and others who are raising the cash.

Also up for debate was a provision that would favor grants to institutions that propose a higher matching percentage.

Given their responsibilities to the institutions they work for, some of the deans wanted to be sure their fundraising efforts and money for initial building plans would not be wasted. Some also noted that an early clarification of the issue would mean meaning speedier construction, a goal that CIRM advocates.

Brian Henderson, CIRM Oversight Committee member and dean of the USC School of Medicine, said favoring institutions offering higher matching funds could lead to a "ridiculous escalation" in which schools try to outbid each other. David Baltimore, CIRM Oversight Committee member and president of Caltech, noted that a bidding war disadvantages "poorer" institutions. He favored a straight percentage.

Also disturbing some directors of the agency were grant criteria that would consider the geographic location of applicants within California with an eye to assuring that facilities are available to researchers throughout the state.

Baltimore said the board is "too conflicted" to consider geography. But Henderson said, "Reasonable geographic distribution is a laudable goal." Gerald Levey, an Oversight Committee member and dean of the School of Medicine at UCLA, opposed the use of geography as did Oswald Steward, chair of the Reeve-Irvine Research Center at UC Irvine.

The press release issue can be crystalized in the following manner: Should recipients of $10 million grants, or for that matter any size, be required to "coordinate" with CIRM press releases on the results of the taxpayer-funded research.

Baltimore, who brought up the proposed requirement, said it "was an inappropriate transgression of the independence of (our) institutions." It was a sentiment heatedly defended by others at various institutions.

However, Jeff Sheehy, Oversight Committee member and deputy director for communications at the UCSF AIDS Research Instititute, said coordination on press releases was not an onerous requirement and would help protect CIRM. Ultimately he dropped his opposition to removing the language, declaring that the board was wasting time on the matter in extended debate.

Our point – for now -- about these discussions is not which position prevailed. What is important is that the directors of the $6 billion California stem cell agency are setting the terms of contracts that could benefit their institutions.

The directors are not in a good place. When a director votes, one can imagine him or her thinking: Whose interests do I serve? My employer's? The person who appointed me? The groups I am supposed to represent? CIRM's interests? Or the people of California?

Some of these issues are found in other segments of state government but rarely to the degree they are found on the Oversight Committee of the California stem cell agency. And it is all legal, courtesy of California voters, who created this situation in 2004 when they approved Prop. 71. Nonetheless, for those affected by CIRM and who follow its activities, understanding the conflicts and how they can affect multimillion dollar decisions is an imperative.

By the way, the matching fund issue comes up again at the Oversight Committee meeting in December. The geographic criteria was retained on a 15-10 vote. And grant recipients can ignore any coordination efforts on press releases. The offending press release language, which has been around for months, was removed, triggering another delay in official adoption of the regulations.

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We encourage comments on this and other items on the California Stem Cell Report. You can post them directly by clicking on the word "comments" below. If you so desire, your comments can be published anonymously, courtesy of Google, which hosts this blog, and makes it impossible for even us to determine the identity of the poster. Sphere: Related Content

Coming Up Tonight

Sometime in the next few hours we will post an item on today's meeting of the Oversight Committee of the California stem cell agency. It will look at the institutional but legal conflicts of interests that many of the members of the committee have. Sphere: Related Content

Tuesday, October 10, 2006

Few Complaints Voiced on CIRM Strategic Plan

The California stem cell agency's proposed plan for spending $3 billion on stem cell research received its first real screening tonight, and the audience seemed nearly enamored with the effort.

A few minor questions were raised along with some remarks that could be construed as slightly critical, but generally the comments were along the lines of "extraordinary work product" and "outstanding document."

The screening of the plan occurred at a meeting of the CIRM Oversight Committee, a few miles from Hollywood at the Luxe Hotel on Sunset Boulevard. The proposal comes up for consideration again at another meeting of the committee on Wednesday.

CIRM President Zach Hall walked the audience – the 29-member Oversight Committee – through the document that he and his staff have been working on for about a year. He noted that is a "living plan" and subject to change by the committee, which is not expected to give it a final nod until December. Even then, he proposed that it be reviewed regularly and altered to meet changing needs and opportunities.

While the document contains specific figures, Hall said those are not "immutable" and were intended to be approximate. Final approval of grants is also in the hands of the board – not the CIRM staff.

Hall did highlight one aspect of the plan's special programs – collaborative research and disease teams that would cross multiple institutions and disciplines. They would be tightly focused and managed and encouraged to have a professional manager to push the project along. The plan envisioned $122 million for the disease team program and $60 million for the research team effort. (See page 87 of the plan.)

Oversight Committee member Claire Pomeroy, dean of the UC Davis School of Medicine, and others asked for insertion of language specifically discussing the funding of embryonic stem cell vs. adult stem cell research and human vs. nonhuman research.

Ted Love, another Oversight Committee member and president of Nuvelo, said safety should be an "extraordinary priority" of the plan. "Nothing creates a crisis like safety," he said, referring to public alarm that occurs when human experiments go awry.

Other board members emphasized the need for a top notch public education and communications effort. Committee member Joan Samuelson, president of the Parkinson's Action Network, said that the agency can "succeed only if they (the public) are with us." The plan suggests spending $4.5 million for "public outreach." (See page 105.)

John M. Simpson, stem cell project director for the Foundation of Taxpayer and Consumers Rights and often a critic of the agency, praised the plan's realism and outreach. But he reminded the board,
"At the end of the day the best scientific plan is meaningless unless there are guarantees for affordable access to cures and treatments."
While plaudits were handed out liberally during the evening meeting, the biggest round of applause came following testimony from another member of the public, Roman Reed, who is paralyzed as the result of a football accident.

He said he had told his young son that one day they would walk side by side.

And then Reed told the CIRM board,
"I believe that one day you will make my promise to my son come true."
Sphere: Related Content

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)...."
Sphere: Related Content

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.'"
Sphere: Related Content

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. Sphere: Related Content

Monday, October 09, 2006

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. Sphere: Related Content

Friday, October 06, 2006

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. Sphere: Related Content

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. Sphere: Related Content

Thursday, October 05, 2006

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. Sphere: Related Content

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."
Sphere: Related Content

$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. Sphere: Related Content

Wednesday, October 04, 2006

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."
Sphere: Related Content

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." Sphere: Related Content

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. Sphere: Related Content

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. Sphere: Related Content

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. Sphere: Related Content

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.'"
Sphere: Related Content

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."
Sphere: Related Content

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. Sphere: Related Content

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.) Sphere: Related Content

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. Sphere: Related Content

Tuesday, October 03, 2006

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. Sphere: Related Content

Read All About It! At Least Some Of It

The agenda for the Oct. 10 and 11 meetings of the Oversight Committee for the California stem cell agency is now available on CIRM's web site with the draft of the strategic plan expected on Wednesday.

As usual, the sessions are fully packed. Much of the background material is not yet available, but the agency seems to be doing a better job of posting the material earlier.

We make that comment after being obliquely chastized on Monday by one CIRM staffer for failing to note when the agency improves its performance. Point taken.

Scheduled to be posted on the CIRM web site on Wednesday is a rather hefty document – the draft of the strategic plan for the agency. We are told it is in the range of 90 to 100 pages, so plan on curling up in the front of the fire for a good read.

If you want to influence CIRM's spending plans, now is the time to weigh in. The plan comes up for discussion at the meetings next week. It is scheduled to be approved at the Oversight Committee in December. Sphere: Related Content

Sunday, October 01, 2006

Whittling Down the Researchers: The 'Unhappy' Result of Stem Cell Enthusiasm

The California stem cell agency faces a nearly overwhelming task in the wake of notices from about 350 scientists, saying they intend to apply for about $100 million in grants over the next few months.

The agency has already moved to whittle down the number of potential applicants by requiring the institutions involved to certify that the letters of intent were filed by principal investigators. One veteran stem cell scientist, who is not affected by the certification call, said the requirement has left "fair numbers of angry and anxious people."

The certification will elminate some, perhaps many applications from less senior scientists, despite CIRM's intention to encourage younger researchers.

The requirement for a letter of certification was not mentioned in the initial instructions for the letters of intent. The certification form that was posted on CIRM's web site was created on Sept. 19, four days after the deadline for the letters of intent.

In response to a series of questions from the California Stem Cell Report, Dale Carlson, chief communications officer for CIRM, said,
"The certification form was promulgated after the LOIs(letters of intent) came in, to clarify the qualifications necessary to apply for either grant (PI must be an independent investigator, full-time, on-site, etc.). It may eliminate some full applications from some who filed LOIs but aren't qualified for grants. It's common to require written confirmation of portions of a grant application. I haven't heard of any complaints."
However, it is clear that some folks are disappointed and feel as if the rules were changed in the middle of the game.

The scientist who discussed this issue with the California Stem Cell Report asked not to be named for a number of reasons. We understand that position. For us, it is enough to say that CIRM plays a vast role in the funding of research, and no prospective applicants are likely to want to appear to be grousing about its conduct. Anonymity of sources, however, always raises a flag. In this case, the individual we spoke with is well respected in the field and has had considerable experience with grant reviews, conducting them for the NIH.

Here is what we learned during our discussions, which dealt primarily with the SEED grants, which attracted 280 scientists. CIRM says the grants, which are scheduled to be voted on by the Oversight Committee in February, are aimed at bringing in "new ideas and new investigators."

Many of the scientists who filed letters of intent will be disappointed, we were told. Many aren't qualified under the terms of the certification. A good part of the problem is the classification of reseach scientists at many institutions as non-faculty. Instead they carry titles such as research professional or staff scientist. The letter of certification asks institutions to certify that an applicant holds a "faculty-level position," among other things.

The fundamental problem is the size of the potential applicant pool. The scientist compared it to an NIH experience in which the number of applications was far smaller but the number of reviewers much, much larger. Even if the number of CIRM grant applications is reduced by half, it is still too large for the 15 scientific grant reviewers.

We asked CIRM about the workload, assuming ultimately 200 applications with about two hours spent on each grant by each of CIRM's scientific reviewers. By law, as we understand it, each reviewer in the CIRM grants program must examine each application. That amounts to 400 hours or 10 "normal" work weeks for each scientist, who already has a full plate with his or her own work. Is that a reasonable estimate, we asked CIRM last Monday. If not what is? We have not yet had a response on that matter and others, such as whether it is fair to impose what appears to be a requirement that was not laid out in the original request for letters. We have indications that a response may be coming at some point. We will carry it when it arrives.

The scientist we talked to did not have a solution to the workload issue or how to fairly screen out some of those who filed letters of intent. But it is clear that fixing the number of reviewers in state law is a limiting factor, to put it mildly. It would be useful to be able to revise such minutia without going to a vote of the people, which is what is currently required for a change.

CIRM reviewers are all from out-of-state and cannot apply for CIRM grants. Although reviewers can learn from the reviewing process, our scientist said that it is a "great burden" to be a grant reviewer, either for CIRM or the NIH. Most do it out of an "irrational sense of altruism."

Let us know about what you think about this issue. Click on the word "comments" below to express your opinion. It can be done anonymously. Google, which hosts this blog, has set up anonymous comments in such a fashion that not even we can determine the names of those who use the "anonymous" feature.

Here is a link to the certification form and the application instructions. Sphere: Related Content