Looking at Legislation to Aid Biotech Biz

"Investors' disinterest" in California biotechnology came up for examination in a recent piece in the Vacaville Reporter, the daily newspaper for the community that lies between San Francisco and Sacramento.

The article by business writer Amanda Janis focused on the "realities of the manufacturing side of biotech." It was of interest to Vacaville readers because of the area's efforts to land biotech manufacturing facilities. But the piece also has interest to California as a whole.

Janis wrote:

"Industry leader Genentech chose to build its new $250 million facility in Oregon, where corporate income tax structures are more favorable. Then there was the start-up firm that passed on Vacaville in order to capitalize on biotech tax breaks offered in Washington. And most recently Chiron parent Novartis announced it would build a $400 million vaccine plant in the United States, but not in California."

She touched on state legislation aimed at helping the biotech business.

"Proposed bills include changing the corporate income tax structure with a four-year phase-in of single sales apportionment tax (an issue Genentech calls its primary legislative concern); sales and use tax exemption on manufacturing equipment; extension of research and development tax credits; and the allowance for companies to sell their net operating losses to other companies, which would gain a tax credit.

"The latter proposal, which has found success in states like New Jersey, has some of the greatest potential impact because of the loss-operating nature of the biotech industry, according to Matt Gardner, president of trade organization BayBio.

"'It takes 15 years for us to get a product,' he noted.

"Another proposed bill in California would help level the playing field, he said, because it would allow for designated "shovel-ready" land, or land that has been pre-zoned, with environmental impact reviews completed."

Legislation to help out the biotech industry has received little notice. But it is likely to become increasingly important to the industry as the CIRM investments ramp up.

WARF to CIRM: Don't Mess With Us

The Wisconsin Alumni Research Foundation has served notice that it is going to slug it out with the California stem cell agency on the matter of stem cell patents.

Referring to comments in California concerning WARF's position on the Wisconsin patents, Andrew Cohn, government and public relations manager for the organization, said, "These folks are absolutely going off the deep end. If it wasn't for WiCell and for the University of Wisconsin, they wouldn't have anything to spend the $3 billion on in the first place."

Cohn was quoted in a piece by Joe Vanden Plas on the Wisconsin Technology Network. Vanden Plas said the patent dispute between California and Wisconsin "promises to be an intense fight." Cohn's pugnacious language certainly seemed to confirm that. His rhetoric was definitely more aggressive than comments made by WARF General Counsel Elizabeth Donley earlier this year.

The Wisconsin article noted that WARF this month was awarded $1 million in a case against Xenon Pharmaceuticals. Cohn said, "WARF has proven over and over again that it will enforce its patents and its contracts. This company [Xenon] made a very, very bad tactical decision by trying to get out of, or trying to ignore the contract they made with us. They are now paying for it dearly."

The starting point for Vanden Plas' article was a statement by the Foundation for Taxpayer and Consumer Rights of Santa Monica, Ca., that said a recent U.S. Supreme Court decision means that WARF has less power to assert "dubious patent claims to control all human embryonic stem cells in the United States."

Stem Cell Snippets: Swells, Scholars and Door Knockers

Here are links to recent, interesting news stories, press releases or information connected to California stem cell issues.

CIRM Gala – Aldrich Tan writing on sanfranciscosentinel.com – Possibly the only coverage of the event, includes many photos with the headline "Swells turn out in force to support CIRM fundraising event."

CIRM Scholars – San Francisco Business Times -- "Demand for fellowships funded by the California Institute for Regenerative Medicine's training grants are far outstripping available spaces, according to Bay Area institutions awarded funding."

Q&A with Alan Lewis, new CEO of Novocell, of Irvine, Ca. – Written by Terri Somers in the San Diego Union-Tribune – Lewis, who is fond of "photographing old door knockers," says, "We expect to be the only company to provide a cell therapy for all insulin-requiring diabetics -- approximately 6.5 million patients in the U.S. alone. We also expect to generate an unlimited source of insulin-producing cells that we can encapsulate to deliver under the skin to this group of patients and hopefully change their lives by reducing dramatically their need for insulin shots as well as the many diagnostic procedures they face each day."

The Chronicle Calls for SB401 Compromise

The San Francisco Chronicle is telling the California stem cell agency and the state legislature's most influential stem cell advocate to settle their differences and move on with stem cell research efforts.

In an editorial, the Chronicle said that it would be better to avoid a ballot measure on the stem cell agency, which would be required by legislation – SB401 – authored by Sen. Deborah Ortiz, D-Sacramento, chair of the Senate Health Committee.

The Chronicle said,

"Ortiz has helped open a dialogue with the CIRM that will prove immensely useful to the public as their money is spent over the next decade. In her bill, she has prodded CIRM to adopt intellectual-property standards that would require for-profit companies using Prop. 71-funded research to return some revenue to the state, and the agency has agreed. She has also asked the board to take publicly available financial conflict-of-interest statements for the scientists who will review grant applications -- and it's still resisting."

The Chronicle continued,

"Far better would be for Ortiz and CIRM to work out their differences -- which, from where we sit, don't look too daunting -- outside of legislation. Ortiz is reasonable and flexible -- last week she agreed not to push SB401 for the November ballot. In recent months, CIRM has made an exemplary effort in trying to balance the concerns of industry, taxpayers and scientists as it proposed high governing standards. Ortiz's move allows not just her, but also a host of other interests, a tremendous opportunity to engage CIRM as it firms up a set of guidelines that take into account what's best for everyone in California.

"The key will be to lock in these regulations so that promises of transparency and checks against conflicts of interest are not dependent on the whims of whoever happens to be in charge of the stem-cell program at any given moment."

There is a bit of a rub in the "lock-in" requirement proposed by the Chronicle. The only way to do that is with a ballot measure. Indeed Proposition 71 is perhaps the best example of locking in matters bettered suited for regulation or legislation. If CIRM were not "locked in" the state constitution, it could have avoided some of the problems that have beleaguered it. Others, however, may well have arisen.

Regulations enacted by CIRM can be changed by CIRM. But Ortiz last year was satisfied with other regulations approved by the stem cell agency. And she may well be satisfied with them again.

Legislation, Budget and More on Oversight Committee Table June 2

CIRM's Oversight Committee is scheduled next week to take up sweeping legislation that would make major changes in the operations of the California stem cell agency.

Also on the table at the June 2 meeting in La Jolla are conflict of interest regulations for CIRM working groups, one of the issues involved in the legislation, SB401 by state Sen. Deborah Ortiz, D-Sacramento. Last week Ortiz said she would modify her bill substantially to mollify critics, including removing a provision that would have placed it on the November ballot.

She has indicated that she is not wedded necessarily to a legislative or electoral answer to her concerns. It may well be that the Oversight Committee may find some common ground at its meeting.

Also on the agenda are a report on the efforts to define an intellectual property policy in connection with grants to businesses, the strategic plan, regulations on human stem cell research and the agency's 2006-2007 budget.

Some of the background documents are available on CIRM's Web site, largely ones that have been previously posted for subcommittee meetings. The report from the legislative subcommittee is not yet available nor is the the 2006-2007 budget or additional information on the the conflict of interest regulations.

San Diego Paper Had It First

A national story earlier this month involving the resumption of the human embryo cloning at UC San Francisco is a good example of how the media works – or doesn't work.

The case in point was a piece in the Wall Street Journal that said UC San Francisco was going to restart its program. The story was a follow on a story in the San Francisco Chronicle, which is obviously read by Journal reporters.

What neither story pointed out was that it was a bit of old news. Reporter Terri Somers of the San Diego Union-Tribune actually had it on Jan. 11, but the San Diego paper is not one that is regularly examined by reporters and editors of national publications or for that matter the San Francisco Chronicle. Her story said,

"California scientists are planning to jump into the field of cloning human embryonic stem cells now that a South Korean scientist who claimed to have mastered the technique has been exposed as a fake."

She focused primarily on research efforts in San Diego, which is a hot bed of stem cell research, mentioning the San Francisco effort deep in her story.

The episode is a good illustration of the tunnel vision of national news gathering organizations -- not just the WSJ -- which rarely detect what is happening outside of what they perceive as the major news centers.

The California Stem Cell Report carried an item in January on Somers' story but also failed to note specifically the UC San Francisco effort. We thank patent attorney Lawrence Ebert for pointing out Somers' work to us.

Devising a Plan for a Multi-Billion Dollar Project: The CIRM Approach

If you are interested in how the California stem cell agency plans to give away $3 billion, check out the agency's Web page on its strategic planning activities.

It is a useful step in the process with information ranging from meeting schedules to biographies of some of the important players.

One of the more interesting items is a summary of a meeting earlier this month by the Strategic Planning Advisory Committee. It itemizes ideas that were broached at the session, ranging from cord blood research to the harvesting of tissue from cadavers. The ideas are just that; the agency cautions that none are endorsed at this stage by CIRM. Nonetheless they provide some idea of what is being seriously discussed.

The document also indicates some concern about CIRM's outreach to researchers. For example, it said,

"CIRM needs to find more aggressive ways to engage and inform scientists about stem cell funding opportunities than sending out grant requests through the CIRM web site or the standard Request for Application (RFA) process. A newsletter might be a one way to accomplish this; to keep the 'buzz' alive and to distribute information."

The Internet postings on strategic planning are a good start on the buzz. One of the notices announces a daylong conference at Caltech on Thursday. The topic is "Funding Structures to Advance Stem Cell Research and Therapy."

Here are the speakers and topics: Michael Rudnicki, M.D., Ph.D., University of Ottawa, Canada, the Canadian stem cell network; Michael Amos, Ph.D., National Institute of Science and Technology, The Advanced Technology Program: Innovative Technology Solutions Through Industry-led Public-Private Partnerships; Ethan Signer, Ph.D., High Q Foundation, Managing the Search for Huntington Disease Therapy; Richard Insel, M.D., Juvenile Diabetes Research Foundation,Research Strategy and Funding Programs of the Juvenile Diabetes Research Foundation, and Jonathan Shestack, Cure Autism Now Foundation, who is also a member of the CIRM Oversight Committee, no topic announced.

The calendar also shows that the Strategic Planning Advisory Committee will meet in San Francisco next Monday at noon. Included will be a report on the Caltech session as well as discussion of funding mechanisms for the private sector and whether new ESC lines should be a focus for early funding.

Another strategic planning meeting involving the CIRM Oversight Committee will come the evening of June 1 in La Jolla. The panel is scheduled to act on a proposed mission statement and objectives.

It is not too early to think about a daylong meeting on July 13 in San Francisco on the topic of "The Scientific Challenge: From Basic Science to the Clinic." Confirmed speakers are: Stuart Orkin, M.D., Harvard Medical School; Joan Samuelson, Esq., Parkinson’s Action Network and a member of the CIRM Oversight Committee, and Allen M. Spiegel, M.D., Albert Einstein College of Medicine.

CIRM also provides an email address for those who want to comment on the plan or make suggestions: scientificstratplan@cirm.ca.gov.

Stem Cell Snippets: Liberal Folly, WARF and SB401

Here are links to some recent, interesting news stories, press releases or other items connected to California stem cell issues.

Problematic payoff on stem cell research – Daniel Callahan in Bioethics Forum -- "The California stem cell initiative had a super-rich real estate tycoon leading the charge, lots of money from the biotechnology industry, the support of celebrities, and that best of American mixes, the possibility of saving millions of lives while making millions of dollars.... We may or may not ever see a payoff from stem cell research, but that’s where the action is, and with the blessing of liberals. This is not a proud moment for us."

WARF not helped by U.S. Supreme Court – Press release from Foundation for Taxpayer and Consumer Rights -- "A ruling by the U.S. Supreme Court this week involving online auction giant eBay means an affiliate of the University of Wisconsin has less power to assert its dubious patent claims to control all human embryonic stem cells in the United States."

San Diego Union-Tribune endorses SB401 – Editorial written prior to Ortiz' proposed changes in the bill -- "Increased accountability and openness from the institute and its oversight board are needed....Instead of fighting the Legislature and those concerned about openness and accountability, the institute's leaders should continue to work closely with lawmakers and reach agreement on what needs to be done. That would be a better outcome than legislation that may, in some places, be too restrictive."

CIRM Meeting Documents Posted in Timely Fashion

The California Stem Cell Report has repeatedly noted that the California stem cell agency regularly falls short of its oft-repeated goal of adhering to the highest standards of openness and transparency.

The chief example is the extreme delay in posting on the Web background material for meetings. Even members of the Oversight Committee have complained about not receiving the material in a timely fashion. The laggardly posting shows in their meetings when it is clear that some members of the committee have not read the material. Of course, they just may not be doing their homework.

This week, a notable and praiseworthy exception occurred concerning the background material. The documents for the Governance Subcommittee meeting Friday were posted about a week ago. That allows the public, interested parties and Oversight Committee members ample time to review the documents. The timely postings also permit individuals to make decisions on whether they want to testify on a particular point.

Among the items on the agenda is a report on contracts, including the $400,000 agreement with PricewaterhouseCoopers to work on the strategic plan, and compensation for CIRM employees. Another item involves discussion and changes in CIRM's gift policies, which may trigger a discussion of the $1 million gala fundraiser next Monday for CIRM.

The meeting can be heard at multiple locations throughout the state, including Stanford University, La Jolla, Carlsbad, Sacramento, San Francisco and Irvine. Persons attending can also comment from those locations. For details, see the agenda.

Ortiz Drops Critical Elements from CIRM Oversight Bill

Major changes will be made in legislation to tighten oversight of the California stem cell agency, including the elimination of provisions that could have required royalties as high as 50 percent on inventions financed with state funds.

The moves may well be an initial step in a compromise on the sweeping legislation by California State Sen. Deborah Ortiz, D-Sacramento, who is the leading legislative voice on stem cell issues. Her decision to strip significant provisions from SB401 makes it clear that CIRM needs to address the other issues in the legislation. Ortiz has made it known for some time that she is not wedded to a ballot measure or legislation to ensure accountability and openness.

Her office indicated late Wednesday that the measure will be amended before it comes up again in the Assembly Appropriations Committee, which is its last stop before it goes to the Assembly floor. The committee Wednesday delayed action on the bill until late next week.

According to Hallye Jordan, director of communications for Ortiz, the senator told the committee that she intends to address critics' concerns that "the bill’s intellectual property provisions are inflexible and will discourage industry participation in stem cell research and that she is carrying the bill for political purposes."

Here is most of Jordan's statement on Ortiz' appearance Wednesday:

"She told committee members that she intends to amend the bill's IP provisions so that they mirror the regulations that the Independent Citizen’s Oversight Committee and the California Institute for Regenerative Medicine (ICOC/CIRM) have already adopted and which are currently under review by the Office of Administrative Law, per the Administrative Procedure Act. In doing so, she noted she is giving up the ability to get a higher share of royalties and better prices that might have been achieved under the original provision of SB401.

"She also said she will amend the bill to make it clear that it will not go on the ballot until after the November 2006 election.

"These amendments are expected to go a long way in addressing critics’ concerns, leaving, perhaps, only the argument that opponents don’t want to have stem cell research back on the ballot. Senator Ortiz and other legislators believe voters have a right to determine whether SB401 will provide public accountability and the appropriate protection of the state’s $3 billion-$7 billion taxpayer-funded investment into stem cell research.

"SB401 is important to ensure that the CIRM, ICOC and working group members are subject to public accountability, and hold meetings in public, make their records public and disclose of their financial interests as required of all public officials.

"SB401 includes exceptions so that the working group members may conduct scientific peer review and protect proprietary or scientific prepublication information when appropriate. The Senator and other SB 401supporters believe the ICOC/CIRM proposed regulations allowing the ICOC president to waive the conflict of interest provisions in 'exceptional' circumstances, do not provide clear, defined criteria as to what constitutes 'exceptional' circumstances. They also are concerned with ICOC/CIRM provisions that exempt from open meeting discussions and public record disclosures 'critical mission' matters, which also are vague and overly broad.

"Senator Ortiz also pointed out that there is no guarantee that the ICOC/CIRM regulations that have been submitted to the Office of Administrative Law will remain intact after the public comment period.

"SB401 is supported by Californians Aware and California Common Cause," Jordan concluded.

The Appropriations Committee staff analysis, prepared by Scott Bain, said the bill's requirement that the Department of Justice review CIRM intellectual property agreements would likely cost around $150,000 annually. The department currently does not have IP expertise. Cost of the state auditing function in the bill was estimated at least than $20,000. Cost of placing the measure on the ballot would be $330,000. Legislation that has a price tag of $150,000 or more is being held for consideration next week as lawmakers wrestle with state budget matters.

Listed in the staff analysis as opposing the bill were CIRM, the Juvenile Diabetes Research Foundation and the Coalition for Advancement for Medical Research. Both groups contend the bill "will have the effect of unnecessarily impeding the research program," according to the analysis.

Under the topic of "concerns," the analysis said,

"The California Healthcare Institute (CHI) expresses concern that this bill applies licensing and other conditions to CIRM grants and loans that are in the best interest of the state, but these provisions may discourage industry participation. The California Institute of Technology, Stanford University, the University of California and the University of Southern California write that they believe CIRM's intellectual property policy should be given a chance to work and be tested before either codifying in statute or making significant changes."

On Tuesday, CIRM's legislative subcommittee met for "consideration" of SB401 and a number of other stem cell-related bills. We have queried CIRM about what action was taken at the meeting, but are still awaiting a definitive response.

Coming Up

Later today we expect to carry the results of today's California legislative hearing on SB401 by California State Sen. Deborah Ortiz. The measure would tighten oversight of CIRM and ensure a return on the state's $6 billion stem cell investment.

Stem Cell Snippets: Eggs, Cloning, David Baltimore

Here are links to some recent, interesting news stories or other items related to California stem cell issues.

Hwang and Prop. 71 – Patent attorney Lawrence Ebert in Ezine.com -- "Eggs will be needed to carry out embryonic stem cell research, and the potential for abuse, and disregard of that abuse, in obtaining eggs is a major, foreseeable, problem. Because the abuse in Korea occurred in the face of strong laws, the assertion that CIRM has adopted strong standards as to egg donation is not the final answer to this issue. Pressure on researchers to obtain significant results can lead to fraud. The Hwang matter involved independent frauds by at least two researchers, and does not fit neatly into the 'one bad apple' box."

Orange County stem cell lines – Writer Gary Robbins in the Orange County Register -- UC Irvine and West Coast Fertility Clinics are teaming up in a $100,000 annual effort "to create at least five new lines of human embryonic stem cells, becoming one of the few groups in the country to try to produce fresh lines for the study of everything from spinal cord injuries to Parkinson's disease."

David Baltimore and stem cell climate – Writer David Epstein in Insidehighered.com – A look at the Washington, D.C., environment for federal stem cell research. CIRM Oversight Committee member Baltimore quoted on the need for a change.

Human embryo cloning – Emily Singer in Technology Review – Overview of human embryo cloning including look at California. "Scientists who had planned to collaborate with Hwang had spent months thinking seriously about what they could do with cloned stem cells, from creating new tools to shed light on the diseases they had studied for decades to investigating new treatments. The excitement those possibilities aroused, along with new influxes of cash from state and private sources, made many unwilling to wait on the sidelines any longer. (Evan) Snyder, a (California) pediatric neurologist and neonatologist who wants to develop new treatments for his patients, is now considering starting his own cloning program."

CGS Criticizes CIRM Fundraising

The Center for Genetics and Society of Oakland, Ca., is pointing out some of the difficulties involved with the unusual – for state government agencies – funding methods of the California stem cell agency.

In its latest newsletter, the center says,

"With the CIRM's ability to issue bonds still hampered by legal challenge, it has turned to novel methods of funding. It has not requested support from the state, a move that would likely open the door to legislative oversight. Instead, CIRM has turned to private sources for donations and below-market rate loans, an approach that increases the likelihood of undue private influence on the agency, and reinforces the perception that CIRM acts more like a private firm than a state body. After months of hints and speculation, CIRM board chair Robert Klein announced that five private foundations will loan $14 million to the cash-strapped agency via risky loans at below-market interest rates. Although it is not surprising that the lenders who agreed to this arrangement are people who have shown past support for biomedical research, the nature of their support reveals a likely interest in how the CIRM will later allocate its $3 billion in grants.

"For example, the foundation established by the founder of the biotechnology firm Amgen, William Bowes, loaned CIRM $2 million. A recent report by a venture capital firm described Amgen as a "stem cell company." Another $2 million came from the foundation created by John Doerr, a prominent venture capitalist who has investments in numerous biotechnology corporations. And Eli Broad, who previously donated $25 million to the University of Southern California for a stem cell research center, also loaned $2 million to the CIRM. It would not be surprising if he was especially eager to see CIRM research funds going to USC."

Big Week Ahead for Legislative Move to Tighten Stem Cell Oversight

Efforts to tighten oversight of the California stem cell agency and ensure that the state benefits from its $6 billion investment come up Wednesday in a key state legislative committee.

If SB401 clears the Assembly Appropriations Committee it goes to the Assembly floor. Then its only other normal legislative stop is the floor of the Senate.

The day before the committee session, CIRM is scheduled to discuss the measure by Sen. Deborah Ortiz, D-Sacramento, during its own committee hearing. Presumably that session is aimed at drumming up opposition to the proposal, which the Oversight Committee has already opposed as premature.

The public is not likely to see most of the important action taking place on the bill. Opponents and supporters will be meeting privately with lawmakers to explain their position. Email and letter-writing campaigns undoubtedly are already underway. Both sides will be asking key opinion leaders and behind-the-scenes operators to contact legislators on behalf of their positions.

Part of the backdrop to the maneuvering is Ortiz' campaign for the Democratic nomination for California secretary of state. She is in a tight contest with many undecided voters. Favorable action and publicity on the bill could help her campaign. The campaign will also color the positions of other lawmakers, who may find themselves making decisions on the electoral impact of the measure – not on its merits.

Here are links to the latest version of the bill and the analysis. Here is a link to more on the bill from the California Stem Cell Report.

Stem Cell Snippets

Here are links to recent, interesting stories, press releases or other items on California stem cell issues.

Dolby gives $16 Million more to stem cell research – Paul Elias of The Associated Press – "Sound pioneer Ray Dolby and his wife gave $16 million to the University of California, San Francisco to start a stem cell center that will perform research without federal funds." Dolby has the institute renamed to replace stem cell with "regeneration;" Dolby says "stem cell" gives bad vibes.


Tougher rules needed for CIRM nonprofit IP -- Press release from Foundation for Taxpayer and Consumer Rights -- "Proposed regulations governing the ownership of discoveries resulting from Proposition 71-funded stem cell research must be strengthened to allow the California Attorney General to intervene if the drugs or cures are unreasonably priced."

Overview of current CIRM controversies – Writer Michelle Chen on the NewStandard website. "Groups that support stem-cell research are warning that the state's massive research-funding plan is not immune to narrow interest groups that could undermine the potential public-health benefits."

Comment on Los Angeles Times editiorial – Patent attorney Lawrence Ebert takes Times to task for simplistic thinking. "To be helpful to Proposition 71, the Los Angeles Times needs to get a fuller grasp of 'where' CIRM currently is and 'what issues' it needs to resolve, especially in the intellectual property area."

Video of Prop. 71 ad – Posted by one of the persons in the ad, who says, "This is a 30-second TV commercial I was featured in with my brother for California's Proposition 71 in 2004 about stem cells' potential to treat cerebral palsy."

Mary Poppins' Latest Position on CIRM Gala

On May 2, we reported that we had queried CIRM on the question of whether it would accept donations at the $1 million gala fundraiser from executives of biotech firms. The agency has responded and says it will accept funds from those executives. And it will not disclose their employer affiliation, although it is not clear whether that information is being gathered. We presume not, but perhaps we are wrong.

The agency has said it will disclose only the names of the donors, a position which pays mere lip service to the principle of disclosure. We are retracting our earlier assertion that Mary Poppins would approve of CIRM's feeble nod in the direction of good and open government. See "gala disclosure" for more on this.

ACT Reports its Cloning Efforts

Advanced Cell Technology today issued a press release on its plans to attempt to clone human embryos and identified members of its Institutional Review Board.

The firm said:"The IRB is chaired by Judith A. Frazier, RN, M.Ed. Ms. Frazier is the Manager of the Metabolic Research Unit at the Jean Mayer Human Nutrition Research Center on Aging (HNRCA) at Tufts University. The Metabolic Research Unit recruits approximately 3,000 adult subjects every year for population, longitudinal, metabolic and free-living nutrition studies. She is also a Vice-Chair of the Tufts-University-New England Medical Center Institutional Review Board. Renee Landers, J.D., serves as Vice-Chair. Ms. Landers is an Associate Professor of Law at the Suffolk University Law School where she focused on Health Law and Administrative Law. The IRB recently held several meetings and has approved the Company’s SCNT program.

"The IRB carefully reviewed the Company’s plan to solicit volunteer donors of embryos and oocytes for the SCNT program. In accordance with California and Massachusetts law and the guidelines set out by the National Academy of Sciences, such volunteer donors will receive no compensation other than the reimbursement of certain permitted expenses and will be required to acknowledge and execute a detailed donor consent form. The Company recognizes that the progress of this program is dependent upon identifying volunteer donors and hopes that the public will recognize the promise of this research for millions of patients and respond accordingly."

Chron First on Embryo Cloning Story

The San Francisco Chronicle was the first to report on the UC San Francisco efforts on cloning of human embryos, a story that the Wall Street Journal carried today.

Reporter Carl Hall wrote a piece on Saturday that said:

"UCSF's project is the only one of its kind on the West Coast, although this type of work also is being pursued by researchers in San Diego and is expected to be a key priority of the California Proposition 71 program.

"The first stage of the work at UCSF is being backed by private donations, and the experimental protocol has passed all the necessary ethical approvals. The research team is led by Renee Reijo Pera, a UCSF associate professor of obstetrics, gynecology and reproductive sciences. She also is co-director of the UCSF Human Embryonic Stem Cell Center."

Hall's piece also contains greater detail on the San Francisco work than reported by the Journal.

Gala Disclosure Mere Lip Service

Years ago, government in California and the United States did not have the laws that now tell us who is giving millions of dollars to lawmakers and political candidates. We did not know what lobbyists were spending and what corporations were backing them.

Today's disclosure laws recognize that the public has a right to know who is attempting to influence the public's business. This month CIRM, which is engaged in $6 billion worth of public business, is also involved in a $1 million fundraiser, probably the first such effort involving a state government agency. CIRM has pledged to disclose the names of donors to the gala, but little else.

The public will not know whether, for example, the Jane Smith who coughs up $10,000 for CIRM is a top executive of Geron, the San Francisco Bay area stem cell firm. Nor will we know whether the John Smith who ponies up $5,000 is a venture capitalist with a $2 million investment in Advanced Cell Technology, of Alameda, Ca.

The names are not real. But neither is the disclosure promised by CIRM. It is better than nothing and to be commended. But it amounts to little more than lip service to the principle of disclosure. We realize that most donors to charities are not normally identified and that there are issues of privacy. But the overriding obligation is to the public – not the donors.

With considerable work, nonprofit watchdog groups such as the Center for Genetics and Society and the Foundation for Taxpayer and Consumer Rights will be able to dig up the economic connections of at least some of the donors. The result will be unpleasant publicity for CIRM. Better that the agency identify donors up front than appear to be concealing information about individuals or enterprises whose economic interests could be affected by CIRM.

While we are on the subject of disclosure, some at the stem cell agency have raised questions about the financial links of the two watchdog groups. Their logic is that if CIRM is compelled to disclose such information, so too should the two groups. However, CIRM is a government agency – not a business or a nonprofit. Nonetheless, nonprofits do enjoy special legal treatment. A good case can be made that they too should disclose the details of their financial backing. We would also argue that news outlets and many of their employees should do the same, a position that almost raised major hackles when we advanced it to a former employer.

For a disclosure from the California Stem Cell Report, see this item.

WSJ Reports on Embryo Cloning in California

The Wall Street Journal reported today that UC San Francisco and Advanced Cell Technology of Alameda, Ca., are resuming a "controversial medical endeavor"-- the effort to clone human embryos.

While the news may not seem surprising to those who have followed California's stem cell efforts, the article may trigger unforeseen and possibly negative public reactions, given the Journal's reach.

Reporters Antonio Regalado and David P. Hamilton wrote:

"Officials at the University of California, San Francisco said Friday that they would immediately resume a cloning program, with the goal of creating new stem-cell lines that can be used to model genetic diseases.

"Separately, executives with Advanced Cell Technology Inc., of Alameda, Calif., said they plan to announce their cloning plans soon. Advanced Cell's vice president of research, Robert Lanza, said the company is recruiting female egg donors and is interested in creating tailored transplant treatments."

The article also said:

"Cloning programs are moving forward thanks to state laws put in place to protect and regulate the research. In California, voters also approved a ballot measure designed to provide as much as $3 billion in stem-cell funding over 10 years.

"UCSF began its cloning effort in 1999, but the program ran into trouble in 2001 after UCSF lost its top stem-cell researcher, Roger Pedersen, who took a job in the United Kingdom, citing a hostile atmosphere in the U.S. Advanced Cell's cloning effort was last active in 2003, Dr. Lanza said, and stopped because of political pressures and because the company lost its source of human eggs."