CIRM Panel Sets Lab Criteria, Nitty Gritty Still Pending

Much work remains to be done on the details for the criteria for $220 million in stem cell research lab grants to California universities and research institutions, but “great progress” was achieved earlier this week, according to one long longtime observer.

John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, said the lengthy session “accomplished a lot.” He wrote in an email that the

"CIRM staff needs to fill in major details with draft language now that broad policy objectives have been set. It was a long meeting, but a necessary one if the public is to have faith in the mechanism of doling out $220 million in building grants."

Simpson, who was a newspaper editor for many years prior to his current position, offered this account of this week's events.

The Facilities Working Group during a marathon seven-hour meeting Thursday unanimously decided to require that the 20 percent matching requirement necessary under Prop. 71 to receive a facilities grant be made in cash.

The eight FWG members present also agreed to refer to amounts contributed to a project beyond the 20 percent threshold as "leverage."

The panel selected five criteria to use in making the awards and the points
that would be awarded to each of the criteria. Assuming that an applicant
could receive 100 points, the criteria and and possible value are:

--Urgency (20 points)
--Value (25 points)
-- Leverage (25 points)
--Functionality (15 points)
-- Shared resources (15 points)

The members considered the possibility of using a scale with more total
points as long as the ratio among the criteria remained the same and
suggested CIRM staff give that further thought.

All agreed that if CIRM is to maximize its impact on stem cell research
facilities across California, it will be necessary to encourage institutions
to bring as much "leverage", that is cash, to building projects as possible.

"We'll have to get substantial cash leverage," said Bob Klein, ICOC
chairman.

All of the procedures and criteria developed by the FWG for the proposed
$220 million in facilities grants must be approved by the ICOC.

The FWG also voted to recommend that grant recipients be required to use
buildings financed with CIRM money for regenerative medicine for a definite
period of time, perhaps 10 or 20 years. They decided to leave the exact time
requirement to be determined by the ICOC.

The panel also developed definitions for each of the criteria. The next step
is for the CIRM staff to propose draft language for standards to evaluate
each of the criteria. The proposals will be discussed at a meeting of
"interested parties" (representatives of institutions likely to seek money)
on July 25.

The FWG will is expected to meet July 30 to complete its recommendations so
they can be forwarded to the ICOC for its August meeting.

Arlene Chiu, acting chief scientific officer, outlined a proposal to consider a two-step process to review the facilities grants. They would be reviewed first by the Scientific Working Group for scientific merit and then be forwarded to the ICOC. After ICOC review, the proposals would go to the
Facilities Working Group for review and recommendation to the ICOC.

The FWG did not act on that proposal because by that point in the meeting it
was short of a quorum, Joan Samuelson and Stuart Laff, having departed around 6 pm. The consensus appeared to be that the staff recommendation made sense.

Other committee members attending were: David Lichtenger, chairman; Klein; Edward Kashian; David Serano Sewell; Janet Wright and Jeff Sheehy. Around 20 people, mostly representatives of institution seeking money, attended.

(Editor's note: An earlier version of this item did not include Janet Wright as one of the committee members attending the Facilities Group meeing.)

The Bee Calls for Klein Resignation If He Continues to Lobby on Land Deal

The Sacramento Bee said today that California stem cell Chairman Robert Klein should resign from his post at the $3 billion state institute if he continues to lobby on behalf of a controversial Northern California deal that would swap favorable land use decisions for a private stem cell research facility.

The editorial noted that Klein's stem lobbying group, Americans for Stem Cell Therapies and Cures, earlier this spring received $125,000 from the Angelo Tsakopolous' land development company, which is seeking to convert farmland to commercial development. In return, a $200 millon stem cell nonprofit institute would be created at the location. The more than 2,000 acres is located on Interstate 80 between Sacramento and UC Davis.

The Bee wrote in an editorial:

"Klein says there's no connection between his efforts to retire campaign debt (owed by his lobbying group) and his support for the Yolo project, but it nonetheless creates an appearance of paycheck politics. If Klein wants to continue to promote the Yolo project or any project that could overlap with his duties as a state official, he needs to resign from CIRM. The sooner the better."

The newspaper said that Klein makes a "compelling case" for the type of research facility that would be built at the site by a nonprofit institute that would be headed by Klein. The Bee wrote,

"But if the case is strong, the multiple hats that Klein is wearing with this project are troublesome....He is cagey when asked if he would also continue to chair CIRM. There's the potential that the industries and researchers who would be part of this Yolo research center would also seek funding from the California institute, which would put Klein in a serious conflict of interest."

Fresh Comment

Jesse Reynolds of the Center for Genetics and Society makes an interesting point in a comment on the Lansing item below. He notes that Jeff Sheehy, who serves as a patient advocate and is on the Facilities Group, is employed by UC San Francisco.

Sherry Lansing Resigns from Lab Grant Group; Conflicts of Interest Cited

University of California Regent Sherry Lansing today resigned from the group that is setting criteria for the California stem cell agency's $220 million lab grant program. 

California stem cell Chairman Robert Klein announced Lansing's resignation at the beginning of the meeting of the Facilities Working Group. 

He said Lansing, who is in Portugal, was leaving the group because she "wants things to go forward and because she sees possible conflicts with her role as a UC regent and the working group's work," according to John M. Simpson, of the Foundation for Taxpayer and Consumers Rights. 

Simpson is attending the meeting in the San Francisco area this afternoon. A number of UC campuses are expected to seek building funds under the program. The facilities group makes funding criteria recommendations to the full Oversight Committee, on which Lansing also has a seat. 

That committee will make the final decision on the rules for receiving the grants. Many of its members are employed by or have links to institutions that are likely to apply for funds. 

With the resignation of Lansing, none of those institutions have seats on the 10-member facilities group. The only members of the Oversight Committee now on the panel are five patient advocates. The other members come from the private sector or, in one case, the state Department of Corrections.

More On the Presidential Search, Plus Lab Grants and ICOC Vacancies

John M. Simpson, stem cell project director of the Foundation for Taxpayer and Consumers Rights, offered the following observations on today's CIRM events, including this afternoon's meeting on the criteria for $220 million in lab construction grants and vacancies on the Oversight Committee.

Simpson, who has followed the agency closely for about two years, was present for this morning's meeting of the Oversight Committee concerning its attempts to find a new president. Simpson said in an email:

"'Steady progress' is being made toward selecting a president and chief executive of CIRM, Robert Klein, ICOC chairman, said this morning after an early morning executive session of the board. He declined, however,...to be specific about a time table to complete the selection. He said selecting the right candidate was the most important issue, not the schedule."

Simpson said board went into executive session about 7:15 a.m. Klein predicted a 15 to 30 minute meeting.

Simpson continued:

"The board resumed public session at approximately 8:15 am with Klein commenting that he should have offered a more realistic prediction of the length of the meeting given the board's proclivity for full discussion of
issues.

"'There were a lot of thoughtful comments,' Klein said."

Simpson said that he complained to the Oversight Committee about the failure of the Facilities Working Group to post background documents on the lab grant criteria well in advance of this afternoon's critical meeting. Simpson said the documents were vital to understanding the largest grant package CIRM has offered so far. He said he wanted to the full board to be aware of the situation.

Concerning the vacancies on the board, Simpson said,

"After the meeting in conversation with Tamar Pachter, General Counsel, and James Harrison, outside counsel, it emerged that both David Baltimore, former president of Caltech and Richard Murphy, former president of the Salk Institute, have resigned from the board. They had their ICOC positions by virtue of their jobs before recently retiring.

"With the vacancy created by the death ofLeon Thal, the ICOC has 26 members instead of the full compliment of 29. This means that a quorum -- something the board frequently has had difficulty mustering -- is now 17 members rather than 18."

The CIRM quorum requirement is large and is written into state law by Prop. 71. It cannot be changed by the Oversight Committee, only by an unlikely revision in the law. In contrast, other government entities often need only a simple majority of their members to take legal action. Large quorum requirements mean that a minority on a board can block action simply by not being present at a meeting.

CIRM Directors Still Looking for New President

Directors of the California stem cell agency this morning met again behind closed doors to discuss candidates to head the $3 billion research effort but adjourned without announcing a decision.

The search is now into its seven month. CIRM's first president, Zach Hall, announced his plans to leave early last December. The agency has been without a permanent president since the beginning of May, when Hall departed.

The Oversight Committee could have acted this morning. The matter of presidential compensation and candidates was properly noticed on its agenda. But virtually the entire teleconference meeting, which included a link to one director in Portugal, was in executive session, and no announcements were made during the public segment.

John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, asked during the public portion whether a new president would be named prior to the directors meeting in August.

Chair Robert Klein replied that artificial timelines could not be imposed and and that the search must focus on finding a president with the right scientific vision for the agency, according to CIRM officials. Previously the Oversight Committee had expected to fill the position in June.

Klein may call another presidential meeting within the next 10 or 15 days.

Stem Cell Snippets: Pachter, Kessler and Google

CIRM General Counsel – Jessica Jones has a brief Q&A on law.com with CIRM's new general counsel, Tamar Pachter. Among other things, Pachter was asked what is like working for a controversial agency. Her reply, "Is there a state agency that isn't controversial (laughs). It really doesn't affect my work all that much."

Egg Concerns – Anna Salleh for ABC Online reports concern in Australia about international trafficking in human eggs for stem cell research. Catherine Waldby of the University of Sydney is quoted as saying there are already problems in eastern Europe. Waldby's research is to be published in the New Genetics and Society Journal.


Kessler and Google Health Committee – CIRM Oversight Committee member David Kessler has been named to Google's Health Advisory Council. Kessler is also dean of the UC San Francisco medical school. The Google council is aimed at understanding health issues and providing "feedback on product ideas and development." Sergey Brin, co-founder of Google, contributed at least $100,000 to the Prop.71 campaign.

Poultry and CIRM's Oversight Committee

The California stem cell agency has two lame ducks on its board and another vacancy that has remained unfilled as the result of gubernatorial inaction since last February.

The vacancy on the Oversight Committee is the seat formerly held by Leon Thal, who died in a plane crash on Feb. 3.

Thal was appointed to the board by Gov. Arnold Schwarzenegger. State law requires him to fill the vacancy within 30 days. We asked the governor's office today when the post would be filled. Sabrina Lockhart, a spokeswoman, replied:

"Gov. Schwarzenegger is proud of California's leadership in stem cell research - which has placed our state on the cutting-edge of this potentially life-saving science. Because stem cell research is such an important priority for the Governor, he will fill the vacancy as soon as he finds an ideal candidate to fill the position."

It is not uncommon for governors to flout deadlines such as the one created by Prop. 71 for filling vacancies.

The lame ducks on the board are David Baltimore, former president of Caltech, and Richard Murphy, who retired earlier this month from his position as head of the Salk Institute.

Both hold their seats on the 29-member Oversight Committee as the result of their former professional positions. Both are expected to continue to serve at least for some time, which appears to be permissible under Prop. 71.

More Fresh Comments

Anonymous weighs in with more on the "cronyism" business related to the "90 Percent" item below. We have posted an answer to the question of why only 27 biographical sketches are found on the CIRM website for the 29-member Oversight Committee.

Fresh Comments

An anonymous comment has been posted on the "90 percent" item below, which raises a question about the significance of the item. We have posted a reply. "Faye" also had a comment about the terms of Oversight Committee members and whether they can be rotated out. We have posted additional information in response to her query. You can find all of this by going to the "90 percent" item and looking at comments at the end of the item.

New Lab Proposal Info Now Available

The California stem cell agency this afternoon posted 58 Power Point slides for the meeting of the Facilities Working Group Thursday afternoon. The slides summarize comments made at four earlier hearings, identify some questions that should be answered at this week's session and outline steps to be taken before the proposal is presented to the Oversight Committee Aug. 8 in San Francisco for approval.

While obviously sketchy, they are useful -- in fact mandatory reading -- for anyone interested in the subject of giving away $220 million for construction of new stem cell research labs in California.

Five-hour Research Lab Meeting: A Mockery?

The California stem cell agency Thursday afternoon is going to attempt to set criteria in five hours for handing out $220 million in research lab grants in a process that one watchdog likens to a "public relations sham."

No proposed criteria will be available prior to the public meeting. They may not be available at the beginning of the meeting either. Instead, the only advance, online offerings are likely to be marginally useful, Power Point presentations that will summarize issues and suggestions presented during previous four public sessions of the Facilities Working Group.

John M. Simpson, stem cell project director for the Foundation of Taxpayer and Consumer Rights, Monday said in an email to California stem cell Chairman Robert Klein,

"This facilities RFA is one of the most important and potentially contentious RFAs that CIRM will issue. It's supposed to be based on the input of four public hearings held around the state.

"The ICOC is to be commended for authorizing those hearings to gather public input about the policies.

"However, not making a draft of the policies to be discussed available with ample time for review by the public so they can make intelligent comments at the meeting makes a mockery of the entire process. It forces one to conclude that there was no real interest in meaningful public input and that your process was nothing more than a public relations sham."

Simpson added that not having the information in advance also makes it difficult for members of the working group to take intelligent action.

The only documents available online until late Monday afternoon were two facilities group transcripts from May 31 and June 4. Transcripts from hearings June 11 and June 19 were not available until Simpson called -- in his email to Klein -- for them to be posted forthwith.

The failure to post important material well in advance harkens back to earlier days of CIRM, when even members of its Oversight Committee complained publicly about not getting background material in advance. Some of that can be chalked up to growing pains.

But problem is obviously continuing. It has been compounded by not allowing enough time at meetings -- called by Klein or other committee chairs -- to cover all the necessary ground. In this case, for example, 11 persons sit on the Facilities Working Group. If each took only 10 minutes asking questions or making comments, that would consume nearly two hours. Then there is a staff presentation, questions and comments from representatives of California universities and institutions as well as from the general public. All with no draft criteria to actually read and study ahead of time.

Encumbering the process of handing out research lab grants fits with what one might call a modified stonewall strategy. CIRM does not have to make grants for lab construction. If it did not, CIRM would would have more money for research, which seems to be a priority of patient advocates on the Oversight Committee. On the other hand, executives from institutions represented on the committee could understandably take a different view although grants for their researchers are certainly important to them.

Whatever the case, the facilities group's hearings on the research lab criteria have been one of CIRM's more heavily attended series of events – mainly by folks from universities and nonprofit institutions.

It is a disservice to them, the public and CIRM itself not to provide a better opportunity for comment as well as thoughtful consideration by the working group.

Conflicts at CIRM: The 90 Percent Test

About ninety percent of the $209 million handed out so far by the California stem cell agency has gone to institutions that have "representatives" on the board that approves the funding.

The grants have gone for training new stem cell scientists, funding research and remodeling laboratories.

The group that approves the money is the 29-member Oversight Committee. Fourteen members of that committee have close links to the institutions that have received about $190 million in grants.

None of this is illegal but it illuminates the nature of the built-in conflicts of interest on the board. Prop. 71 created the situation. Nearly all the institutions in California that could be suitable recipients of stem cell research have some sort of representation on the decision-making board. The measure spelled out, for example, that five executive officers from University of California medical schools have seats on the board. It also stipulated that four executive officers from California research institutions sit on the Oversight Committee. The group would be hard pressed to come up with a long list of other institutions that would make suitable candidates for hefty stem cell funding.

Members of the Oversight Committee are barred from voting on grants to their institutions, and CIRM goes to considerable lengths to make sure that does not happen. However, all members of the committee can vote on the rules and standards for making the grants. And this week, a working group of CIRM is scheduled to devise rules for $220 million in grants for major labs at California institutions. Those standards will help establish, among other things, whether the money will be accessible to smaller institutions and spread geographically around the state or even whether that is a good idea.

While some have deplored the conflicts on the board, the situation is not likely to change soon. Prop. 71 can only be modified by another vote of the people or by a super, supermajority vote in the legislature and approval of the governor.

In the absence of a change, the Oversight Committee's structure and actions make it even clearer that CIRM should operate with a maximum of disclosure and openness, something the committee sometimes feels uncomfortable with.

Here are the names of the members of the Oversight Committee with links to institutions that have received grants and the size of the grants. Some members directly represent their institutions, such as the deans. Others, such as Sherry Lansing, have close links to an institution but serve as the result of some other designation. Lansing is a University of California regent, but serves on the board as a patient advocate.

David Baltimore, president emeritus Caltech, $2 million; Robert Birgeneau, chancellor UC Berkeley, $5.5 million; David Brenner, dean UC San Diego medical school, $17.7 million; Susan V. Bryant, dean School of Biological Science UC Irvine, $17.5 million; Michael A. Friedman, president City of Hope, $357,978; Brian E. Henderson, dean USC medical school, $9 million; David A. Kessler, dean UC San Francisco medical school, $30 million; Sherry Lansing, UC regent, 10 UC campuses have received grants; Gerald S. Levey, dean UCLA medical school, $15.8 million; Richard A. Murphy, president Salk Institute, $8.9 million; Philip Pizzo, dean Stanford medical school, $31 million; Claire Pomeroy, dean UC Davis medical school, $11 million; John C. Reed, president Burnham Institute, $17 million, and Oswald Steward, chair of the Reeve, Irvine Research Center, UC Irvine, as noted under Bryant, the campus has received $17. 5 million.

The amounts could be larger, for example, if we included the $8 million in grants to Children's Hospital of Los Angeles, which has close ties with USC. Or the $10 million to the Gladstone Institute, which has ties to UC San Francisco.

Short biographies of members of the Oversight Committee can be found here. More specifics on the size and nature of the grants can be found here(see the list at the end of the press release.

UC Davis Tightens Rules on Industry Influence

Efforts to control the influence of the medical industry in academia received more support recently at the UC Davis medical school, whose dean sits on the Oversight Committee for the $3 billion California stem cell agency.

Reporter Dorsey Griffith of The Sacramento Bee wrote earlier this week:

"UC Davis' ban against drug industry gifts, lunches and samples has expanded to include a prohibition of freebies from any company that markets its wares to the large health system.

"University of California, Davis, officials Monday announced the expanded new policy, which took effect Sunday.

"'There was consensus that we really needed to make sure that all our policies ensure that our behavior is totally transparent and ethical,' said Dr. Claire Pomeroy, vice chancellor and dean of the UC Davis School of Medicine. 'I think it's consistent with our values here of really being focused on the patient.'"

Pomeroy is one of 29 members of the Oversight Committee, which has its own set of issues dealing with conflicts of interests.

Stanford and UCLA, whose medical school deans also sit on the Oversight Committee, have similar rules, along with Kaiser Permanente Northern California, Yale and the University of Pennsylvania.

Yolo Stem Cell Proposal Attracts More Attention

A "farmland war," "unethical" – two of the descriptions emerging today in a fresh story about the Northern California land development/stem cell research project involving the head of the state's $3 billion stem cell agency.

CIRM Chair Robert Klein and Angelo Tsakopolous, a Sacramento area land developer, are lobbying for a proposed 2,800-acre land deal near the capital that would also create a stem cell research center with a projected endowment of $200 million. Earlier this spring, Klein's private lobbying organization received a $125,000 contribution from Tsakopolous' company. Klein would chair the proposed nonprofit.

In a story written by reporter Ralph Brave, the Sacramento News & Review today painted a bucolic picture of the development's location, which is hard on a very busy freeway just west of Sacramento. Brave wrote:

"This acreage has become the latest battleground in the ongoing war over the fate of Yolo County’s distinctive dedication to preserving farmland and open space. Although it’s just commenced, this particular battle’s mix of the area’s most powerful real-estate magnate, the head of the state’s stem-cell oversight committee, the re-evaluation of Yolo County’s General Plan governing development, and next year’s elections promises a prolonged, intense struggle that could determine much about the county’s and the region’s future."

The election issue involves at least the chair of the Yolo supervisors, a locally elected official who is seeking a seat in the California legislature. The dispute was characterized as a "farmland war" in a caption on a photo of a portion of the site.

Brave continued:

"Environmental attorney James Pachl told SN&R that Tsakopoulos’ 'proposal is an attempt to bribe the supervisors by offering to contribute to a fashionable charity in exchange for approval of AKT’s development project(AKT is Tsakopolous' company). Perhaps legal, but too unethical for most public officials to consider. The AKT property is valuable farmland, wildlife habitat and open space that should continue to be farmed.' A supporter of stem-cell research, Pachl expressed concern that 'the proposal will create a local political firestorm that will likely stop the project and damage the credibility of stem-cell researchers.'"

The newspaper also brought into its coverage another CIRM official, Claire Pomeroy, a member of the Oversight Committee and dean of the UC Davis School of Medicine.

Brave wrote that attendees at one dinner promoting the project included two Yolo supervisors, Klein and Pomeroy.

Brave said Pomeroy later told him that "it would not be 'appropriate to involve myself in land-use decisions.'"

Last Saturday, reporter Luke Gianni of the Woodland Daily Democrat quoted Pomeroy as saying,

"The concept of a research center for stem cells is a good one and something I support. A new research park in this region, in addition to the stem cell facilities we're currently building in Sacramento, could help complement the promising work our scientists are now doing in regenerative medicine."

Brave's story contained more details on financing the stem cell research facility, provided by Amy Daly, executive director of the Klein lobbying group, Americans for Stem Cell Therapies and Cures.

"Upon approval for residential and commercial development for some portion of the Tsakopoulos 2,800-acre property, 200 acres would be donated to a new nonprofit called Bridge to Cures. One hundred of those acres would be taken to a bank and used as collateral for a loan to finance the building of the research center and its labs. Part of the profits from the residential and commercial development would go into an endowment, to be used as loans, grants and other financing for biotech companies to advance stem cell and other biomedical discoveries into clinical applications."

Daly said the center's labs would be leased to for-profit companies. Earlier, she told the California Stem Cell Report that Klein would chair Bridge To Cures.

Size of the endowment has ranged from $50 to $400 million, depending on the size of the development that might be approved.

To see all the items on this subject, click on the label "yolo" below.

Recent Comments

Yvonne Perry, author of "Right to Recover, Winning the Political and Religious Wars over Stem Cell Research in America," has posted comments on the "Internet radio program" and the "TV coverage" items below.

News Coverage of Monday's WARF Stem Cell Matters

The latest developments in the WARF stem cell patent case received light coverage today among mainstream newspapers.

Stories appeared in three newspapers – the San Diego Union-Tribune, Milwaukee Journal Sentinel and the Wisconsin State Journal.

Coverage was straight forward. Wisconsin State Journal reporter David Walhlberg had this item concerning scientist James Thomson and his stem cell discoveries in 1998.

"...(T)he challengers added a new twist. They said Thomson had 'unique access' to an Israeli scientist who provided him with human embryos and enviable funding from the biotech firm Geron.

"'Had other scientists in the field been given the same access to those limited resources, they, too, would have been able to make the same accomplishment Dr. Thomson did,' the challengers wrote.

"Thomson did not respond to a request for comment Monday. In an e-mail interview last year, he said, "Some very good, simple ideas only seem obvious afterwards.'

"Andy Cohn, WARF spokesman, called the new filing 'a minor step in a long process.'"

Terri Somers of the San Diego Union-Tribune noted this case is a long way from being resolved and could wind up in court following the patent challenge.

No Aussie Location for July 12 Presidential Meeting

The folks down under are not going to have a chance to comment on the selection process for the next president of the $3 billion California stem cell agency.

Australia will be dropped from the list of remote locations for the teleconference meeting of the Oversight Committee on July 12. The site in Australia was listed on the agenda because California stem cell chairman Robert Klein was visiting the country. However, he will return on July 8. We are told that listing the Australian location was an error.

CIRM Takes Another Whack at Hiring President

In another attempt at hiring a new president for the California stem cell agency, directors of the $3 billion effort have scheduled their second unusual teleconference meeting in the last few weeks to consider compensation for the post and candidates for the position.

This one is for July 12. The last such meeting was held on June 26 and ended with no public action. The directors have sealed off any public comment after an embarrassing information leak earlier this year.

In order to act on candidates and compensation, state law requires that advance notice be given. Posting such a notice could just be a hopeful contingency measure in case a deal can be concluded by the meeting date. Nonetheless, a decision must be quite close.

One of the sticking points in the recruitment process has been the $400,000 salary for the position, which apparently has been too low for some. For more details on that see the "ticklish" item posted earlier.

Members of the Oversight Committee are calling in from 14 locations in California, according to the agenda, and one in Australia, where California stem cell Chairman Robert Klein is visiting. Members of the public can listen in at those locations during the public portions of the meeting and speak out as well. The June 26 meeting was almost entirely in executive session.

Twenty-nine persons sit on the Oversight Committee. Presumably more locations will be added as the meeting approaches. Otherwise, there may not be enough members on the teleconference to take legal action.

Melton, Cowan and Trounson Beef Up WARF Challenge

Three prominent stem cell scientists – two from Harvard and one from Australia – have bolstered a challenge to the embryonic stem cell patents held by the Wisconsin Alumni Research Foundation.

They are Douglas Melton and Chad Cowan, both of Harvard, and Alan Trounson of Monash University in Australia. Previously Jeanne Loring of the Burnham Institute had filed statements in support of the challenge to the patents of the discoveries by James Thomson of the University of Wisconsin.

Melton said,

"I very much believe Dr. Thomson deserves the scientific and public recognition he has received. However, he deserves that recognition because he undertook the arduous and timely task of getting fresh and high quality embryos to use as starting material for his work, and sufficient funding for such research, not because he did anything that was inventive... His perseverance and commitment deserve recognition and accolades. But I believe that had any other stem cell scientist been given the same starting material and financial support, they could have made the same accomplishment, because the science required to isolate and maintain human embryonic stem cells was obvious."

Melton's statement was released today by the Foundation for Taxpayer and Consumers Rights and the Public Patent Foundation. They filed the challenge last year in the wake of complaints in the scientific and commercial stem cell community about the restrictions and costs involving the WARF patents. The challenge won favorable preliminary ruling from the federal government, which WARF has responded to.

Carl Gulbrandsen, managing director of WARF, said earlier in a news release that:

"...the patents and publications the (Patent and Trademark Office) relied upon were not relevant to the isolation and proliferation of human embryonic stem cells. Gulbrandsen's comments were echoed by Dr. Colin Stewart, a leading stem cell researcher at the Institute of Medical Biology in Singapore, who submitted a declaration in support of the Thomson patents that emphasized the differences between mouse stem cells, which were prominent in the PTO's rejections, and the human embryonic stem cells that were isolated and characterized by Thomson."

More on the WARF response can be found at this site.

FTCR also has additional material, including the declarations from Trounson, Cowan and Loring, on its site.

The PTO now takes the arguments under submission. It is not expected to render a judgment for many months, perhaps as a long as a year.