Magnus: Do We Need More Guidelines?

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

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

Writing in the San Jose Mercury News, he said:

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

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

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

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

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

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

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

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

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

Stem Cell Counsel Owed $110,000

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

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

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

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

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

The Pluripotent Presidential Candidate

From PajamasMedia, quoting political consultant Dick Morris:

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

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

Comments Update

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

Promoting California's Stem Cell Giveaway

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

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

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

Hint: the opposition will definitely be there…"

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

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

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

Legislators Target California Stem Cell Agency

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

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

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

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

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

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

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

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

Carlson also said:

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

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

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

Rationale Behind Kuehl's Stem Cell Legislation

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

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

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

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

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

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

Good to See a Lively Debate

We would like to call your attention, once again, to the comments feature on this Web site, particularly the exchange on the "$100 Million Grant" a few items below. That exchange brings in new information and expands the discussion concerning the California stem cell agency, which is one of the goals of this particular Internet enterprise.

Making a comment is straightforward. Just click on the word "comment" at the end of each item and a form will pop up. You can even make your comments anonymously. Google, which is the site housing the California Stem Cell Report, encrypts the name of the sender so that it is not available to yours truly or others.

CIRM Presidential Search: Bids for Search Firm Perhaps Next Week

Bids could go out in a few days for a presidential search firm to assist in finding a new executive for the California stem cell agency.

The current president, Zach Hall, has the authority to move forward and sign contracts up to $250,000. The search firm contract, which is not likely to exceed that amount, would not have to go to the Oversight Committee, as we presumed in the item below.

Responding to our query, Dale Carlson, spokesman for the institute, also said no documents, other than the presidential criteria, were distributed at Wednesday's presidential search meeting concerning the bid process, timetable or "interim action."

CIRM Presidential Search: Concern Over Leaks, Search Bids Likely

The California stem cell agency is moving to ask for bids from firms to help in the search for a new president of the $3 billion agency.

The Presidential Search Subcommittee Wednesday voted 12-1 to seek the bids, we have been told. Presumably that will require ratification by the full Oversight Committee later this month.

Joan Samuelson, a member of the Oversight Committee, was reportedly the only negative vote, saying she wanted to define the job before hiring the search firm.

Some members of the search committee also were not happy about the disclosure that James Battey, the federal stem cell chief, was approached about the job. Their concern was that other good candidates might be driven off.

However, Battey's name was certain to come up as are the names of others who were considered in 2005. At least the names that became public. The California Stem Cell Report has a strong bias towards openness on the part of public agencies, including CIRM. However, this is one case where confidentiality is important. A job search for president that has all its candidates on public display is a poor way to hire good people. That said, it is difficult to control leaks on a high profile job such as CIRM president.

Confidentiality starts with the Oversight Committee. If they discuss names with outsiders, they can expect leaks. Candidates themselves will also lead to leaks if they discuss the job with others, which is likely to be part of their process of evaluating CIRM.

The Oversight Committee can also expect situations like Battey's. His name apparently emerged because of the way the NIH works. That could happen with other candidates as well.

As for the California Stem Cell Report, we will carry the names of candidates if they emerge in news stories and perhaps under other newsworthy circumstances.

CIRM Presidential Search: Battey Approached

One of the directors of the California stem cell agency has approached federal stem cell chief James Battey to see if he is once again interested in seeking the presidency of the state's $3 billion research effort.

Nature magazine reported today that Battey, chair of the NIH stem cell task force, had been approached. He was a candidate for the position in 2005 but dropped out of consideration.

In a piece by Meredith Wadman, Nature reported that Battey "has been excused from all stem cell related work" at the NIH. He remains as director of the National Institute on Deafness.

Nature, which did not say which CIRM director had approached Battey, wrote:

"The search committee hasn't discussed a shortlist 'with any real seriousness,' member Joan Samuelson, founder of the Parkinson's Action Network, told Nature on 29 January. 'We need to think about what talents and what skill set we need in the new president. And we should be clear about that before we write a job description,' she said."

The magazine continued:

"Battey is highly respected within the NIH as an able administrator who rarely makes trouble, but who will speak frankly when necessary. During the controversy over tightened conflict-of-interest rules at the agency, Battey said bluntly that if it adopted the stringent set of rules thatwas first proposed, he would resign (see Nature 435, 397; 2005). The rules were loosened before they were finalized.

"Battey's absence from his NIH stem-cell duties became publicly apparent at a 19 January Senate committee hearing on human embryonic stem-cell research. There, Story Landis, director of the National Institute of Neurological Disorders and Stroke, testified on behalf of the agency. She is now acting chair of the Stem Cell Task Force. It has also emerged that Battey will not be attending a meeting of stem-cell funding agencies being held in Singapore this week."

When Battey withdrew from consideration for the CIRM presidency in May 2005, he told the California Stem Cell Report that the position at CIRM was "exciting and important" but that his current position at NIH was also an "important opportunity."

We queried Battey to see if he has more to say currently on the subject. He did not.

CIRM Guide to the $100 Million Grant Process

The California stem cell agency has posted on its Web site a useful guide to its plans for handing out more than $100 million in research grants, including timelines and other procedures.

Much of the information has been available before but it was scattered and hard to find. Now it has been compiled in a tidy package. Some of the information is fresh. For example, the memo said:

"In the first week of February, we will release a list of all the SEED Grant applications. That list will include the title of the research proposal, the numeric score (1 to 100) it received from the Grants Working Group, and the Working Group’s recommendation (Recommended for funding, Recommended if funds available, or Not recommended for funding at this time). From our Web site, viewers can click on the application number to open a public abstract of the proposal, a statement of its benefits to California, the applicant’s proposed budget, and a summary of the Working Group’s review."

The memo also reiterated the agency's intention to maintain its secrecy concerning the names of those seeking millions of dollars in government funds – a dubious practice adopted because that it is the way it always been done (at least on the federal level) to protect rejected applicants from embarrassment. We should note that some of the applicants have already disclosed that they have applied, making the attempt at secrecy a bit ineffectual and raising questions about why the applicants disclosed when the granting agency prefers secrecy.

The memo was prepared originally for use by the ink-stained wretches of the media, but it has value for anyone interested in the grants. You can clip it and post it on the outside of your petri dish.

MSU Clears Cibelli of Misconduct

Stem cell scientist Jose Cibelli, a member of one of the working groups of the California stem cell agency, has been cleared of misconduct by Michigan State University but it is not known whether he will return to his advisory work with CIRM.

Cibelli asked for the MSU investigation as a result of his connection with the Korean stem cell scandal. He was the co-author of the fraudulent March 2004 paper that reported the first-ever closed human stem-cell line.

A letter signed by the university intellectual integrity officer was provided by Michigan State University to the California Stem Cell Report. The letter said in part:

"The excerpts below summarize the findings of the IC(investigative committee):

'After considering all the testimony and evidence available to it, the IC finds that the Respondent did not commit Misconduct.'

"The report further states:

'His support for, and participation in, the 2004 manuscript were motivated by his natural enthusiasm for NT cloning and human ES cell research, his hopes that the field will progress and his well-meaning desire to participate appropriately in that overall effort.'"

Dale Carlson, spokesman for CIRM, told the California Stem Cell Report:

"Cibelli was an enthusiastic, valuable member of the group and we'd like very much to see him back."

Carlson added that further information would have to wait until CIRM President Zach Hall returns from a trip to Singapore.

Cibelli voluntarily withdrew from active participation in the standards working group after the Korean scandal erupted.

Below is the full text of the MSU letter concerning Cibelli. We have asked the university for a complete copy of the report that is referred to in the letter.

Text of Cibelli Letter

Here is the complete text of the letter supplied by Michigan State University concerning Jose Cibelli:

January 26, 2007

This letter is to inform you that Michigan State University has just completed its Investigation into the Allegation of Misconduct in Research against Dr. Jose Cibelli, Professor, Department of Animal Science and Physiology, under MSU’s Procedures Regarding Allegations of Misconduct in Research and Creative Activities. The Investigative Committee (IC) found that no Misconduct in Research occurred.

Immediately after learning that the paper he co-authored, “Evidence of a pluripotent human embryonic stem cell line derived from a cloned blastocyst”, Science 303:1669-1674, reported data from fraudulent research, Dr. Cibelli voluntarily went to MSU’s University Intellectual Integrity Officer (UIIO) seeking an evaluation of his contributions to the manuscript. Dr. Cibelli’s review included a Preliminary Assessment by the UIIO, an Inquiry conducted by three colleagues of an Inquiry Panel and a formal Investigation conducted by three colleagues who comprised the IC. Review of Dr. Cibelli’s case took approximately one year.

The excerpts below summarize the findings of the IC:

After considering all the testimony and evidence available to it, the IC finds that the Respondent did not commit Misconduct.

The report further states:

His support for, and participation in, the 2004 manuscript were motivated by his natural enthusiasm for NT cloning and human ES cell research, his hopes that the field will progress and his well-meaning desire to participate appropriately in that overall effort.

Please consider this finding of no misconduct in future interactions with Dr. Cibelli.

Sincerely,

James M. Pivarnik, Ph.D.
University Intellectual Integrity Officer

FTCR: No to Research and 'Big Name' for Next CIRM President

The California stem cell agency should not hire a "big name" as its new president, and he or she should not be allowed to conduct research on the side, according to one of CIRM's watchdogs.

John M. Simpson, stem cell project director for the Foundation for the Taxpayer and Consumers Rights, sent a letter to CIRM today and issued a press release on the subject, following the ealier item ("Move with Dispatch") below in the California Stem Cell Report. (Also see Simpson's comment on that item in which he quotes an unidentified Oversight Committee.)

In his letter, Simpson said:

"The next president must be an extremely competent hands-on scientific administrator, who can set up and maintain transparent and accountable management systems. He or she must be able to interact with the public, state officials, legislators and the media in a transparent, honest and accountable fashion.

"In the past there has been some suggestion that the president might continue to maintain research laboratory as part of the president's role. This should not be allowed. The presidency of CIRM is more than a full-time job. A person trying to manage CIRM's activities and conduct meaningful research simultaneously would do justice to neither activity.

"Members of the search committee should avoid the temptation of seeking a 'big name' scientists known for his or her discoveries. The emphasis must be on the individual's skill in scientific management and administration."

Simpson's statement came as CIRM posted a seven-page document on its Web site describing proposed criteria for the new president. That document, coming only one day before the meeting of the presidential search subcommittee, will serve as the framework for that panel's discussion. Other background information relating to hiring a search firm, whether that process should be open to bids, timetable for hiring and "interim action" was not available. The lack of that information makes it extremely difficult for the public to comment intelligently and belies CIRM's ostensible commitment to openness and transparency.

Much of what is contained in the presidential criteria document, which presumably emanated from the office of stem cell Chairman Robert Klein, is predictable. A preliminary look, however, raises suspicions about whether it is a first step in shifting the existing balance between the president and the chairman (see the section on management reporting lines of authority). The overlapping, dual leadership at CIRM has been a troubling aspect of the agency since its earliest days, surfacing in public conflicts involving Klein and current President Zach Hall, who is retiring by about mid-year. Prop. 71 codified the dubious executive structure in a state law that is nearly impossible to change without another vote of the people.

The 3 p.m. meeting of the search subcommittee will be in San Francisco, but remote locations are available to the public in Washington, D.C., Los Angeles, UC San Francisco, UC Berkeley, La Jolla, Ca., Carlsbad, Ca., Stanford University and the San Francisco city attorney's office. The agenda does not indicate specific room numbers in some cases. Email CIRM directly, info@cirm.ca.gov, or phone the agency at 415-396-9100 if you would like more details on the locations.

CIRM's Presidential Search: Time to Move with Dispatch

Should the next president of the $6 billion California stem cell agency also conduct research? Should he or she receive a higher or lower salary than the current CEO? Can a suitable successor be on board by June? Can good candidates be found who also can work in the dual leadership environment at CIRM?

Those are some of the questions likely to be addressed as CIRM's presidential search committee convenes on Wednesday with remote sites for the public available from Washington, D.C., to Chico, Ca.

The specific agenda for the meeting is a bit sketchy as of this writing, reminiscent of CIRM meetings of yore in which background material was not available until the day of the meeting, making it difficult for even CIRM Oversight Committee members to comment intelligently much less the public.

On the table are job summary and criteria, the search process and possible competitive bidding for a search firm, the time table and "interim actions." The last item would seem to involve a temporary appointment while the search for a permanent replacement for Zach Hall continues. The 69-year-old Hall has indicated he wants to be off the job no later than June.

The last presidential search in 2005 failed to produce a result until September of that year, three or four months after it had been expected. And that was a man, Zach Hall, already filling the spot on a temporary basis.

The tenuous legal position of CIRM, which then faced the lawsuit now on appeal, was one of the reasons for the apparent difficulty in hiring a president. Another matter of concern among some candidates was whether they could conduct research and whether CIRM would provide facilities. That came up in August 2005 at a meeting of the search subcommittee.

Issues involving the dual leadership at CIRM – a president and chairman with overlapping responsibilities – surfaced early in 2005 with the search subcommittee. It is likely to be a continuing concern although stem cell Chairman Robert Klein has indicated he may give up his post in 2008. But even if he does, another question arises: Who would replace him and can the next president hammer out a new working relationship with the next chair?

California is an expensive place to live, especially the San Francisco Bay Area, where CIRM is headquartered. So compensation becomes especially important for those from out of state. The CIRM salary scale drew protests as excessive in 2005, but it is not likely to be revised downward.

Most involved with CIRM seem to agree that Hall's performance has set a high standard. He laid the difficult groundwork that may have deterred some early candidates. His performance has also clarified for the the Oversight Committee what is needed in a president and creates certain expectations. CIRM is a tiny organization with about 20 employees, substantially fewer than the 29-person Oversight Committee that oversees it. Leadership changes are always difficult for any enterprise. But smaller organizations are more susceptible to disruption than larger ones with substantially more momentum or, for that matter, inertia. CIRM could suffer if too much time passes without a permanent replacement for Zach Hall.

What Will WARF Say This Year?

Today is the last day for saving $500 on registration for the The Stem Cell Meeting in March in San Francisco. Last year, this was the forum that triggered the WARF patent flap. Here is the registration page.

A Look Behind the WARF Patent Announcement

The folks who challenged the WARF stem cell patents and triggered a fresh wave of negative publicity for one of Wisconsin's more sacrosanct institutions deserve credit for this week's surprising announcement concerning more liberal access to the critical keys for ESC research.

That credit is deserved despite WARF's predictable assertion that the organization really has not changed its position. Additionally, part of the backdrop to its announcement seems to involve the abrupt departure last year of WARF's longtime counsel, Beth Donley.

Previously WARF had taken a hardline position on its ESC cell patents, serving notice that it would defend them aggressively. Donley was in the forefront of that position, which is where an attorney should be when her job is to defend an organization's IP. But the ultimate question for WARF really was whether it wanted to appear to be standing in the way of research that could benefit millions of ailing persons all because WARF was grubbing for dollars. We suspect that was a position that made WARF's directors uncomfortable.

Nonetheless, Andrew Cohn, government relations manager for WARF, in response to questions from the California Stem Cell Report, said:

"Our position has not changed. People completely overreacted to comments made (last spring) by a WARF staff person (Donley) in response to a question. They did not report the second sentence of her response which was WARF has no intention of interfering with the CIRM grant process. The policy announced this week was just a clarification on a policy that was misunderstood many people."

Of course, if WARF wanted to clarify its position it could have made its announcement concerning its patents last spring instead of this week.

Following Donley's statement last year, John M. Simpson, stem cell project director of the Foundation for Taxpayer and Consumers Rights in Santa Monica, Ca.; Jeanne Loring, a stem cell scientist with the Burnham Institute in La Jolla, Ca., and the Public Patent Foundation legally challenged the WARF patents, triggering a spate of articles that did not portray WARF as a benign non-profit.

The Simpson alliance is still not satisfied with WARF's position and plans to continue their efforts.

The Sacramento Bee said that Simpson, Loring and the Patent Foundation deserve credit for WARF's "change." It also noted, in an editorial, the benefits of having a friendly critic (Simpson et.al.):

"The California Institute for Regenerative Medicine -- apparently unwilling to pick a fight with WARF -- hasn't joined the patent challenge. Now, ironically, it may benefit from the activism of Simpson and Loring."

In addition to Simpson's coalition, others do not think WARF went far enough. Writing in The Scientist, Alison McCook said,

"Jonathan Auerbach, president of GlobalStem, Inc., agreed that the patents remain a significant 'roadblock' for research. The changes to the licensing terms don't affect in-house industry research, and if GlobalStem receives, for example, an NIH small business grant of $100,000 for human ES cell research, the company would still have to turn over a sizeable proportion -- perhaps in the range of $75,000 -- to WARF in licensing fees, Auerbach noted. Loosening the restrictions 'is progress, but it's not enough,' he told The Scientist. "

Aaron Lorenzo of Bioworld Today additionally reported:

"Some industry sources told BioWorld Today that the new policy doesn't go far enough - WARF said companies still will need a license when they want to conduct internal research, which potentially is debatable given recent Supreme Court rulings on patent law, or develop a product for the market. But those same critics nonetheless feel that the overall bent of the change in attitude represents a positive step."

As for Donley's role in all this, scuttlebutt is floating around in the stem cell world that one of the reasons for her departure from WARF involved a re-examination of the foundation's position on stem cell patents. One report has it that she gave only three days notice.

Whatever the reasons for its announcement, WARF is doing the right thing, and it should receive credit for moving in the right direction. So should Simpson and company for lighting the way.

Ebert on WARF and the Patent Challenge

Lawrence Ebert, a patent attorney in New Jersey, has a different take on WARF and the stem cell patent matter. Among other things, he faults The Sacramento Bee and challenges the challenge to the patents:

"Patent claims are not invalidated because earlier researchers paved the way for later researchers. PubPat's anticipation argument for human embryonic stem cells is based on a prior reference which is not enabled as to human embryonic stem cells. To look in a different area, the work of Galileo (and others) may have paved the way for the Wright Brothers, but no one achieved three dimensional flight control before the Wright Brothers, or taught how three dimensional flight control could be achieved. PubPat's obviousness argument is based on the assertion: recipe for mouse embryonic stem cells renders obvious recipe for human embryonic stem cells. If this were true, it probably would not have taken 15 years between mouse and human."

Reading the Economic Entrails of ESC Research

Is embryonic stem cell research a cash cow? Or just another public policy chimera?

The questions have surfaced again in news reports concerning two old studies by economists. One is the much-noted 2004 campaign study by Laurence Baker of Stanford and Bruce Deal, managing partner of the Analysis Group of Menlo Park. The other was prepared in the middle of last year by Richard Gilbert of UC Berkeley. Gilbert's study was relatively pessmistic compared to the Baker study.

Writer Malcolm Maclachlan of the Capitol Weekly in Sacramento tackled both of the studies in a recent piece called "Stem Reality Check." Maclachan wrote:

"Gilbert was careful to note that he is not accusing Baker and Deal of any dishonesty in their study. For instance, Gilbert writes in his report that they were clear with their assumptions and the fact that these numbers were estimates of money that could be made many years in the future. If anyone took these numbers as guarantees, he said, they probably did not do so via a careful reading of Baker and Deal's report.

"'As with anything, people believe what they want to believe,' Gilbert said.

"However, Gilbert does bring up two main issues he has with assumptions made in the report. First, he said they take a 'prospective approach' to their estimates--that is, they try to estimate the number of viable new therapies that will be created. Gilbert said that a 'retrospective' approach would be more appropriate, 'based on actual royalty generation by research funded by universities, hospitals and research institutions.' That approach takes note of the fact that big money makers--for instance, the cancer drug Taxol, which made $67 million for Florida State University in 2000 alone--are exceedingly rare.

"Second, Gilbert takes the authors to task for not fully factoring in a concept called 'the time value of money.' Not only does inflation rob money of its value over time, Gilbert said, but money tied up in stem cell research is also money not available to be invested elsewhere. Though Gilbert writes: 'In their defense, the authors report only projected revenue flows, not the value of those revenues.'

"By combining these two concepts, Gilbert estimated that a better real money value of the returns California could see would be reduced to between $31 million to $62 million.

"'I don't think this is terribly surprising to a lot of people,' Gilbert said. 'Basic research is rarely a cash cow.'

"Baker took the critique in stride. He noted that circumstances have changed greatly since he wrote the report, especially in terms of an improving political situation for stem cell research in Washington.

"'It's a complicated area that's evolving all the time,' Baker said. 'I don't know if there's a right way to do the estimates.'"

The Capitol Weekly also wrote:

"So why should people be paying attention to a 7-month-old critique of a 28-month-old report? Because other states are starting to propose big money for stem cell research--and at least one of the same players from Prop. 71 is involved in other states initiatives, said Jesse Reynolds, project director on biotechnology accountability with the Oakland-based Center for Genetics and Society.

"For instance, Deal wrote a report used to promote a stem cell initiative in Missouri which estimated that the state could save up to $3.8 billion in healthcare costs over 20 years from stem cell research. Amendment 2 merely protects stem cell research in the state; it did not put forth any money. It passed in November with a bare 51.2 percent of the vote. Deal did not return a call seeking comment for this story.

"This coming November, New York voters will decide on a $1 billion bond for stem cell research. In neighboring New Jersey, they'll vote on $500 million. Both of these dwarf the previous number 2 state stem cell effort, Reynolds said, the $100 million over 10 years approved by the Connecticut General Assembly in June, 2005."

Here's what really lies at the bottom of ESC petri dish: If there were sure money to be made in ESC research, venture capitalists would be pumping gazillions into it. And there would be no need for efforts like the California stem cell agency.