Friday, September 29, 2006

Two Days and Two Very Different Stem Cell Conversations

Biopolitics, biocapital and, yes, even biopiracy were all part of the rhetoric at a stem cell and ethics conference in San Francisco on Friday.

This one was offered up by UC Berkeley and UC San Francisco and was a tad different than the egg risk conference staged a day earlier by the Institute of Medicine and CIRM, also in the San Francisco area.

The expression "biopiracy" was never heard at the CIRM session. It would have shocked the room of physicians and scientists. Yet in many ways the concerns were the same both days. "Do no harm" was heard more than once at the CIRM conference, which explored some of the obligations of the medical and science commnity to egg donors.

"What do we owe each other," was a central theme of the UC conference, according to historian David Rothman of Columbia University, one of its final speakers.

He noted that it is a question that would not have been asked at the time of the creation of the National Institutes of Health.

Our read, albeit sketchy, on the group at UC San Francisco on Friday was that many in it were generally hostile concerning the stem cell efforts at CIRM and elsewhere around the world. More so than the usual critics who turn up at CIRM meetings. We were told that two scientists had refused to appear before the group when it was trying to arrange speakers.

Given that environment, and to his credit, Arnold Kriegstein, director of the stem cell program at UC San Francisco, appeared as the final speaker. He acknowledged that one concern of stem cell researchers is fraud. "We seem to be blessed with more of it more than the rest of science," he said.

Kriegstein said his researchers are trying to perform their work in an ethical way, which he said requires vigilance in a fast-moving area such as stem cell research.

A video recording of the session was made on Friday along with what appeared to be a transcript. Hopefully, those will be available on the Web site of the Science, Technoloogy and Society Center at UC Berkeley, which sponsored the conference.

Thursday, September 28, 2006

Kleffman's Coverage on Egg Risk is First Out of the Cyberspace Gate

Online news reports on today's egg risk conference came early. Reporter Sandy Kleffman of the Contra Costa Times wrote a piece that is now available on the Web, many hours before it will appear tomorrow in the recycled-tree version of the publication.

Here is her lead:

"The women who donate eggs to California's $3 billion stem cell research program may take great pride in serving as medical pioneers, but they could also face psychological and health risks that have not been fully explored by scientists, experts said Thursday.

"Many of the nation's top scholars in fertility and women's health gathered in Burlingame for an all-day hearing to assess how much is known about the risks egg donors face.

"Their conclusion: Many questions remain."

Scientists Call for More Study of Egg Donation Effects

The dome did not blow off the Capitol, so to speak, at today's much-heralded conference on the medical risks of egg donation.

Probably nobody really expected an explosion anyway. But the meeting did force attention on a difficult and controversial issue – one that needs considerable tending not only for the sake of the women donors but for the general cause of embryonic stem cell research.

The occasion was the Institute of Medicine's "Public Workshop on Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research" – a title almost as heavy as the subject.

CIRM instigated the meeting, seeking more input for its efforts to craft solid standards for stem cell research. And CIRM was paying attention. Several staffers were there and at least one Oversight Committee member. CIRM President Zach Hall opened the session and was there for the entire day, taking copious notes during the end-of-the-session summary by Linda Giudice, chair of the session and chair of the Department of Obstetrics, Gynecology and Reproductive Sciences at UC San Francisco.

The bottom line on the meeting: The process of extracting eggs has risks, but they are minimal, as understood by medical science at this point. But weaknesses exist in the current data, which primarily involve women who sought IVF because of fertility problems. More study needs to be done on "healthy" individuals who undergo the process solely for the purposes of donating eggs.

Giudice noted that despite 20 years of IVF in this country, not much is known on the health outcomes of those treated. "Varied" and "limited" are how she described the studies.

Giudice outlined some "challenges" facing scientists. They include differences in the way ovaries are stimulated to produce large amounts of eggs, finding alternate sources (possibly cadavers) and organization of the donation process.

While the meeting was devoted to medical issues, lying in the weeds were policy questions. Minimizing risk to donors can translate to changes in CIRM's research standards. And creating a database on the health of donors could be the focus of a CIRM grant.

The meeting was Webcast by the Institute of Medicine and presumably will be available online for viewing at your convenience at some point. CIRM had a court stenographer making a transcript which may be accessible online in a couple of weeks. And the California Stem Cell Report will have more on the session in the next few days.

Meanwhile, for those of you who were there or even those who were not, your comments or questions are invited. Just click on the word "comments" below. They can even be posted anonymously with your identity concealed even from the otherwise all-knowing California Stem Cell Report.

Wednesday, September 27, 2006

Multimillion Dollar Stem Cell Lab Building Program: The First Step

Building tens of millions of dollars in biomedical research facilities is the topic for next Monday's meeting of a working group of the California stem cell agency.

The Scientific and Medical Facilities Working Group will consider criteria for its initial grants which are likely to be approved early next year – upwards of $2 million per institution has been discussed at possibly 15 different locations. Funds would go for lab renovations and equipment.

Also on the agenda for the San Francisco meeting (no remote locations available) is a panel discussion on construction of biomedical research facilities. James Kovach, president of the Buck Institute on Aging; Rebekah Gladson, campus architect at UC Irvine, and Curtis Williams, vice president for capital construction, USC, are scheduled to take part.

The working group has 11 members. Six are patient advocates from the Oversight Committee. Four are real estate specialists, and the 11th is the chair of the Oversight Committee, Robert Klein, whose career has been in real estate development.

Egg Donation: 'People Think You Just Go In and Grab Some'

A day in the life of an egg donor:
"Somehow overcoming her fear of needles, (Julia) Thurman reported for a checkup midway through her regimen of ovary-stimulating shots. She felt fine, but her arms were tender from repeated blood draws -- four that week alone.

"A circle of red dots ringed her bellybutton, a calendar of shots past. Just below her bikini line was a greenish bruise.

"Four days later, the hormone surge was impossible to ignore. Thurman shuffled into the clinic, pale and slumping.

"'I don't feel very good today. My stomach hurts.' Her voice was flat. On the ride over, she thought she might throw up.

"'Is it your ovaries?' asked the doctor, Stephen Boyers, head of the division of reproductive endocrinology at UC Davis Medical Center.

"'It's my stomach.' She patted the spot.

"'That's your ovaries,'" Boyers replied.

"Thurman lay back for an ultrasound exam. Follicles showed on the computer screen as dark blobs like plums. 'These are ready,' the doctor pronounced."
That's an excerpt from an exceptional story by reporter Edie Lau of The Sacramento Bee on the experiences of one egg donor at the University of California at Davis. She followed a woman through the process, laying out the details in a vivid but restrained account. The name of the woman was changed in the article for privacy reasons.

Another excerpt:

"Thurman herself knew nothing at first of the arduous process called superovulation that drives the ovaries to produce up to dozens of eggs at one time. She did not know about the daily hormone shots in the stomach, how ovaries swell from the size of walnuts to the size of oranges or grapefruits, or of the 12-inch needle used to extract the eggs.

"Nor did she know about the hundreds of personal questions she'd have to answer during the screening, or the dozens of clinic visits required for invasive and uncomfortable tests and probes.

"More important, she did not know about the risks involved. Data about complications are scattered, inconsistent and incomplete, leaving even scientists without a full understanding of potential dangers.

"The lack of reliable information has spurred the state stem cell agency, the California Institute for Regenerative Medicine, to sponsor the first workshop on the subject. The meeting takes place Thursday in San Francisco."
The article was the result of cooperation between UC Davis and the woman involved. Lau wrote:
"Revealing a world usually hidden by medical confidentiality policies, the UC Davis Medical Center fertility clinic allowed The Bee to follow a donor through the process if she were not identified.

"Thurman agreed to share her experience so others could glimpse the complex procedure required to donate eggs. 'I think people think you just go in and grab some,' she said."
UC Davis and Thurman are to be commended for allowing Lau to pursue her story. Lau's perceptive reporting and restrained writing have added significantly to the discussion of women, eggs and stem cells.

Tuesday, September 26, 2006

Ortiz Legislation to Protect Egg Donors Signed Into Law

In a week when egg donations and stem cell ethics are the subject of some considerable attention, Gov. Schwarzenegger has signed the nation's first legislation aimed at protecting women who donate eggs for embryonic stem cell research.

The measure – SB1260 – was authored by Sen. Deborah Ortiz, who is one of the leading and early California advocates of stem cell research.

Marcy Darnovsky of the Center for Genetics and Society of Oakland, Ca., called the signing a "victory for women's health." She said,
"Similar provisions have been adopted as law in other countries and recommended as voluntary guidelines elsewhere in the United States, but the new California law is the first of its kind in the country."
Darnovsky continued:
"The passage of SB 1260 has taken on added importance because several biotechnology companies and research teams in California have begun experimenting with cloning techniques (known as somatic cell nuclear transfer or SCNT), which require large numbers of women’s eggs. An increasing number of scientists believe that if it is ever perfected, SCNT will be useful as an indirect research tool, not as the basis of medical treatments. But following revelations late last year of fabricated data and fraudulent claims of success by cloning researcher Woo Suk Hwang, what many have called a 'cloning race' has resumed.

"We hope that the Reproductive Health and Research bill is a step towards the consistent and comprehensive national regulation of stem cell research that the United States so urgently needs."
The bill signing comes two days before the CIRM conference on medical risks of egg donation and a UC Berkeley/UC San Francisco conference on stem cell ethics. (See separate items below.)

Ortiz' office summarized the measure, which deals with non-CIRM research, in a press release:

"SB 1260 ensures that women who are considering donating eggs for stem cell research are fully informed of the potential risks. The donors must provide written and oral consent before taking fertility or ovarian stimulation drugs and undergoing assisted oocyte production procedures. In accordance with the National Academy of Sciences, SB 1260 limits compensation to only allow reimbursement for direct expenses. This will ensure consistency between the procurement of eggs in California and other countries that have similar embryonic stem cell research programs and streamline international collaborations and the sharing of stem cell lines. It also ensures consistency with the limitations enacted in Proposition 71, the 2004 initiative that created the California Institute for Regenerative Medicine."
Ortiz said,
“Stem cell research holds great promise for chronic and life-threatening diseases that affect more than 100 million Americans. We all want biomedical research to move forward, but we must ensure that women who provide eggs for research are fully educated about potential reproductive health risks.”
Ortiz, a Sacramento Democrat, authored legislation in 2002 that made California the first state to authorize embryonic stem cell research. She is leaving the legislature this year because of a law that limits the number of terms an individual can hold office.

The Republican governor, who is in a campaign for re-election, buried the signing of the measure in a generic press release about a number of bills he signed related to women's health.

Here are links on the signing and the legislation: Ortiz press release, governor's press release, statement by Darnovsky, a text of the legislation and the last legislative analysis of the bill.

Coming Up

California legislation aimed at protecting women who donate eggs for stem cell research has been signed by the governor. We will have an item on it within the hour.

Live Webcast Set for CIRM Egg Donation Conference Thursday

For those of you who can't make the Institute of Medicine/CIRM daylong conference on the latest information on the medical risks of egg donation, you can catch all of it on a live Webcast.

The Thursday event is being held in San Francisco to "to assess and explore the nature and magnitude of risks, evaluating areas where more data are required, and assessing what is known about the potential for reducing risks through changes in procedures." Ethical and policy issues will not be a prime topic.

Advance registration is required for the conference, and the deadline is past, but you might be able to slip in. Here is the link to the registration site.

If not, the Webcast links will be active beginning at 7:30 a.m. PDT on Thursday. The institute advises that it is important to test your links in advance, which can be done at any time. See this site for details.

More Attention Needed to Public Needs in Stem Cell Research

More attention should be focused on the public obligations of embryonic stem cell research, says a UC Berkeley faculty member in an article in "Trends in Biotechnology."

David Winickoff, who is a discussant at a two-day stem cell and ethics conference later this week in the San Francisco Bay area, wrote:
"In the USA the selection of funding priorities, IP policies, a regime of egg donation in California, and other public initiatives will help set the national and international trajectory for hESC research. Considering the high stakes of these policies, more attention should focus on the public obligations of government-funded hESC research and its commitment to an equitable distribution of risks and benefits as policies are implemented. Taking a cue from the UK, centralized stem cell banking in California would bring general gains in efficiency and create a pragmatic opportunity to construct an ethical and legal architecture for long-term public return. This vision of stem cell banks as social infrastructure would provide useful flexibility in the face of a fast-evolving ethical frontier and help build trust between scientific institutions and society."
Winickoff, an assistant professor of bioethics and society, will appear on the panel on Friday at UC San Francisco on academy-industry alliances. Here is a link to the full schedule and other details.

Monday, September 25, 2006

Governor's Press Release on Azziz

Here is the link to the governor's press release on Ricardo Azziz.

LA Doc Named to CIRM Oversight Committee

The California stem cell agency has added a new member to its Oversight CommitteeRicardo Azziz, a physician who is chair of the Department of Obstetrics and Gynecology at Cedars-Sinai Medical Center in Los Angeles.

Gov. Arnold Schwazenegger appointed Azzis to the 29-member panel, replacing Keith Black, who resigned earlier this year.

Azziz is also a professor at the UCLA school of medicine and vice chair of the obstetrics department there. Previously he was with the University of Alabama.

Here is a link to the CIRM press release and the Cedars press release. Here is his bio page at Cedars. As far as we can tell, the governor's press office has not yet issued a release on Azziz.

Watchdog Group Praises CIRM IP Task Force

The California stem cell agency is sort of like the weather – as they say, everybody complains about it, or so it seems sometimes.

Now comes a note from one of the folks who has done some pretty consistent complaining, but also seems to be able to work with CIRM.

He is John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights of Santa Monica, Ca.. He said in a letter to Ed Penhoet, chair of the CIRM Intellectual Property Task Force:
"The IP Task Force, under your chairmanship and with the stellar staff support of Mary Maxon and Scott Tocher, has so far exemplified a perfect model of soliciting and considering input from all stakeholders."
The impetus for Simpson's remark was what he called a "disturbing suggestion from some biotech industry representatives that the Task Force's process was other than transparent, orderly and consistent."

He referred to a Sept. 15 letter.from the California Healthcare Institute concerning IP policies for businesses. Written by David Gollaher, president of the biomedical industry group, the letter said that the organization "remains concerned" particularly about the process through which the Oversight Committee and the Task Force have "addressed or failed to address substantial concerns" of the CHI.

Gollaher said he was "especially dismayed by the apparent disregard" of some CHI comments concerning access to CIRM-financed therapies by the uninsured and public agencies. He also expressed concern about the process involving "right to practice" language.
"We would have expected any decision-making have included input from all interested stakeholders. This, unfortunately, was not the case. In the future, CHI urges the ICOC to ensure its processes are transparent, orderly and consistent."

Stem Cell Snippets: Sherry Lansing to Stanford Freebies

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

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

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

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

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

Sunday, September 24, 2006

Open Access: Suber Rebuts

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

Open Access: Time to Catch the Wave

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Friday, September 22, 2006

Not Coming Up

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

IP Policy for Business Moves on to Final Step

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

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

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

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

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

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

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

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

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

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

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

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

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

Secrecy Broken on CIRM Grant Applicants

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

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

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

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

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

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

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

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

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

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

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

Earlier the California Stem Cell Report asked CIRM for names of the scientists and institutions, but was rebuffed by the agency. Here is part of its response:
"California law allows an agency to withhold certain information when the public interest in doing so outweighs the interest in disclosure. In this case, the public benefits more when the application pool for grants is as large and robust as possible, and the review process for those applications is as free of potential bias and conflicts of interest as possible.

"In light of the nature of the scientific profession, where reputation is the currency of the realm, ensuring confidentiality of applicants encourages the broadest range of research that may be funded, because applicants will not risk embarrassment or humiliation by being identified with a particular score or outcome if they are not funded. Novel or trend-setting research proposals are more likely to be submitted, and the public is thereby more likely to see the research and the field advance."
CIRM continued:
"Finally, confidentially ensures that the ICOC review process is conducted 'blind,' such that ICOC members are unaware of the identities of applicants, thus ensuring that conflicts of interest are avoided. Publicizing the names of the applicants would subvert this process and undermine the policies underlying it."
Given CIRM's inability to enforce confidentiality or secrecy, it would seem in its own best interest to level the playing field and minimize the ability of big players to exploit weaknesses in the system. One wonders about the reaction of a less well known stem cell scientist to the publicity move by Kierstead. Is that scientist going to have more or less confidence in the CIRM grant-making process? Is he or she going to be more or less likely to submit a grant? Will he or she be more or less inclined to play by rules that CIRM cannot enforce?

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

Coming Up

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

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

Wednesday, September 20, 2006

Open Access and Fading Print

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

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

CIRM Defends Secrecy on Grant Letters of Intent

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

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

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

Here is the statement from Carlson:

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

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

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

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

"Finally, confidentially ensures that the ICOC review process is conducted 'blind,' such that ICOC members are unaware of the identities of applicants, thus ensuring that conflicts of interest are avoided. Publicizing the names of the applicants would subvert this process and undermine the policies underlying it."
Our comment: We are seeking only the names of the scientists and their insitutions – not the other information filed with the letters.

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

Tuesday, September 19, 2006

CIRM Grant Program Stimulates More Comment

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

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

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

"It also demonstrates again the need for the full public disclosure of the financial interests of the scientific advisors who will winnow down the applications and recommend who gets the taxpayers’ money."
We should add that the 29-member Oversight Committee will make the final decisions on the grants. But it is unlikely to reach down into hundreds of applicants and pull out one that was rejected. The recommendations by the review committee will be de facto decisions in all but a tiny fraction of cases, as was demonstrated in the earlier round of grants for training programs in 2005.

That said, it does not detract from truly impressive outpouring of letters of intents. As Zach Hall, president of CIRM, declared:
"We are quite excited about the strong response for our first research grants. It's clear that California scientists are eager to get started. The excellent response ensures that we will have a vigorous, high quality program of human embryonic stem cell research in California."

CFAC Says Applicant Secrecy is Bad Policy

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

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

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

Sunshine Needed on the Secret Names of Stem Cell Grant Applicants

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

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

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

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

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

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

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

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

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

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

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

"Bottom line: You want our money. Tell us who you are and ask for it in public."
According to an analysis of the state Public Record Act by the California attorney general's office, "...(A)ccess to information concerning the conduct of the public's business is a fundamental and necessary right for every person in the state."

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

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

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

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

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

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

The younger Eggan, who is a Harvard stem cell scientist and a member of the Standards Working Group of the California stem cell agency, said:
"I think the most important thing to me about this is the message that the MacArthur Foundation is sending. This points to the mainstream importance of embryonic stem cell research."
The announcement of the winners also contained an interesting sidelight on one of discussions at CIRM regarding intellectual property and providing access to therapies for the uninsured.

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

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

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

Monday, September 18, 2006

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

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

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

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

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

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

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

After representatives of the University of California plumped for the issue at an IP Task Force meeting last month, Sheehy was emphatic. He said,
"This is really important for patients....An activist list serve that I'm on, they're looking at purchasing subscriptions so that people can get access to the data.

"We give up our bodies so people can study us....The state of California is paying for this research. And from a patient perspective, the idea that a study would be published with CIRM funding, having used California residents potentially as subjects of experiments, and we could not read those studies, we cannot access them is just unconscionable."
Appearing before the Task Force were John Ober, director of policy, planning and outreach, Office of Scholarly Communication, University of California, and Lawrence Pitts, professor, Department of Neurological Surgery, UC San Francisco, and former chair of the UC Academic Senate.

We queried Ober later for more on the issue. He cited a May 2005 letter by UC President Robert Dynes to Robert Klein, chair of the CIRM Oversight Committee, seeking an open access policy. The information provided by Dynes said an open access policy would achieve several important goals, including the following:
"Accelerate research progress and provide California’s public access without cost to a collection of published results of taxpayer ...funded research.

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

"Secure a searchable collection of peer-reviewed research publications that (CIRM) and the ICOC can use to manage its research portfolio and measure scientific productivity and progress."
Perhaps the foremost advocate of open access is the Public Library of Science. See its open access section for even more on why it says "everything we publish is freely
available online for you to read, download, copy, distribute and use (with attribution) any way you wish."

CIRM Working Group Member Wins a MacArthur

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

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

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

He recently said:
"Doing a nuclear transplant is like playing the most difficult video game in the world. Imagine building your own Xbox before you play, and the game hardly works. It's like in Super Mario Brothers, where you have to do it over and over again until you master it."
As a MacArthur fellow, he will receive $500,000 over the next five years.

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

News Briefing Tomorrow on Stem Cell Issues

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

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

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

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

For more details on tomorrow's conference call, email

Sunday, September 17, 2006

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

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

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

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

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

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

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

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

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

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

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

Love and Reed Mentioned in Massachusetts Political Coverage

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

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

Wedge wrote:

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

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

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

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

'Desperate Companies, Delusional Researchers'

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

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

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

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

"In this case, the weak link was the media, on whom the public relies for accurate and critical reporting. Instead of reading the scientific paper closely—which would have revealed that the embryos were destroyed—most reporters took the press releases issued by ACT and Nature at face value. Given ACT's sketchy history of swindling, seasoned journalists should have known better."
As for the physical location of the center and ACT, CGS is in Oakland which is linked by an underwater tunnel and draw bridges to the island (Alameda) in San Francisco Bay that houses ACT.

Saturday, September 16, 2006

CIRM's Financial Watchdogs Vote for Disclosure

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

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

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

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

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

Democratic state Controller Steve Westly, chair of the panel, requested that CIRM "explore a streamlined grant process that would spur collaboration and innovation by requiring scientists to share research results," according to a press release. The release also said:
"Westly recommended the Institute’s Intellectual Property Committee review and report on the policies of research organizations that earmark a portion of research funding for grants that require annual disclosure of results."
Casaleggio told the California Stem Cell Report that the financial committee will receive a report from the controller's staff on CIRM's IP policy at its next meeting.

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

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

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

Friday, September 15, 2006

FTCR: Lockyer Should Dump CIRM Financial Overseer

California Attorney General Bill Lockyer should oust a former lobbyist for the California Teachers Association from the panel that oversees the financial dealings of the California stem cell agency, a watchdog group said today.

The Foundation for Taxpayer and Consumers Right called on Lockyer to disqualify John Hein from his position on the Citizens Financial Accountability Oversight Committee because Hein did not meet the legal requirement that he have a medical background.

John M. Simpson, stem cell project director for the Santa Monica group, said in a press release that CTA had contributed $526,200 since 2003 to campaign organizations linked to Democratic Assembly Speaker Fabian Nunez, who appointed Hein in December 2004. (We should note that it is unlikely that the money is a quid pro quo involving the appointment. Nonetheless, Nunez and the CTA are politically close.)

Simpson said,
"When you are appointed to an important position without the qualifications, it's a political payoff. It's clear Hein got this position because of the California Teachers Association's political clout."
According to a San Francisco TV station, Nunez stands by his appointment. Hein told the station, KGO, that he did not have a medical background, saying that he also told that to Nunez.

Nunez' office has not responded to inquiries for comment from the California Stem Cell Report.

Stem Cell IP for Business Coming Up on Thursday

The California stem cell agency is close to approving rules for dividing up the booty from therapies developed by businesses as a result of grants from CIRM.

That is the central issue next Thursday afternoon at a session of the agency's Intellectual Property Task Force. Next stop for the IP rules is the Oversight Committee meeting Oct. 11, which makes the final call.

So if you represent a business with a stake in this issue, now is the time to make your voice heard.

The specific agenda item involves a draft IP policy that is based on principles approved at an Aug. 29 meeting of the Task Force. As far as we know, the California Stem Cell Report is one of only two media to carry a report on that session, including some of the details of the principles. You can find our report here. Here is a link to the other,

CIRM has not yet posted the draft of its proposed policy on its web site. We will let you know if and when it becomes available.

Also on the Task Force's agenda is a presentation on open access policies for scholarly articles published by CIRM grantees. This is a far-reaching issue. We will carry a preview on the matter in the next few days.

Remote access to the San Francisco meeting next week is available in Chico, Irvine, Elk Grove and La Jolla.

Stem Cell Research Regulations Up Next Week -- But Not CIRM's

Regulations for California embryonic stem cell research that is not funded by CIRM are the topic at a meeting next Wednesday by advisory panel to the state Department of Health Services.

The group has been working since last winter on the proposals as the legislature debated and passed related legislation (SB1260) by Sen.Deborah Ortiz, D-Sacramento. That bill is now before governor for his signature or veto.

The meeting is in Oakland but the committee has created a toll-free conference line that is available to members of the public who wish to participate wherever their geographic location, a move to be commended.

For those of you who think it is odd that there are two sets of rules for stem cell research in California, that is a function of the initiative process that created the stem cell agency. It is governed by the provisions of Prop. 71, which did not undergo the normal legislative process and which is virtually untouchable by the legislature or the governor. ESC research not funded by CIRM is governed by a state law that was passed by the legislature and signed by the governor.

Transcripts and minutes of previous meetings can be found here.

Latest on Legal Qualifications of CIRM Financial Overseer

State Controller Steve Westly plans to seek a legal opinion about whether one of the appointees to the board that oversees the finances of the California stem cell agency is legally qualified.

The man in question is John Hein, a former lobbyist for the California Teachers Association. He was appointed to the Citizens Financial Accountability Oversight Committee by Assembly Speaker Fabian Nunez nearly two years ago..

The Foundation for Taxpayer and Consumers Rights of Santa Monica, Ca., challenged the appointment and called on Hein to resign because he does not have the medical background as required by Prop. 71.

David Louie, reporting for San Francisco television station KGO, said,
"Hein turned down an on-camera interview. However, he acknowledged he has no medical background. And he said he pointed that out to Assembly Speaker Nunez.

"A spokesman for Nunez says he stands by the appointment and believes Hein's experience in health care issues and managing health care contracts qualifies him.

"State Controller Steve Westly will seek a legal opinion of Hein's appointment.

"Steve Westly, (D) State Controller: 'Mr. Hein certainly has a deep financial background, and we welcome him on the committee. We will ask him to talk with the attorney general's representative to make sure his being part of this is in compliance with the law.'"
As for other matters on the agenda of the committee, we have an inquiry into the state controller's office.

Thursday, September 14, 2006

Text from ACT's Ethics Chair to U.S. Senate Subcommittee

Last week officials of Advanced Cell Technology of Alameda, Ca., appeared before a U.S. Senate subcommittee and were scolded by two U.S. Senators in connection with ACT's extraction announcement last month. Here is the complete prepared text of Ronald M. Green, director of Dartmouth's Ethics Institute and chair of Ethics Advisory Board to ACT, to the Senate Labor, Health & Human Services and Education Appropriations Subcommittee. The statement of Robert Lanza follows this item. Both statements were supplied by ACT at the request of the California Stem Cell Report.

(September 6, 2006) Good morning, Mr. Chairman and distinguished members of the committee. My name is Ronald M. Green. I am a professor at Dartmouth College and Director of Dartmouth’s Ethics Institute. I also serve as the chairman of Advanced Cell Technology’s Ethics Advisory Board. I would like to emphasize that I am a university-based bioethicist and that I have no financial interest whatsoever in ACT’s technology.

I believe that the method of stem cell derivation announced by ACT researchers in their August 24 report in the journal Nature represents a real opportunity to move human embryonic stem cell research forward in this country in a way that respects the ethical sensitivities of the vast majority of our citizens.

Dr. Lanza has already touched on some of the key ethical issues. He has stressed how this research could be conducted in the context of preimplantation genetic diagnosis(PGD) without adding any additional risk of harm to the embryos involved in this procedure.

Dr. Lanza has also shown that the extracted individual cells cannot reasonably be regarded as individual or independent human beings. No cells extracted at this stage of embryonic growth could go on to full term development.

There are two remaining ethical concerns that I would like to address. First, there is the connection between this new method and both IVF and preimplantation genetic diagnosis (PGD). Some people object to both these technologies because they involve the manipulation of embryos and because parents using these procedures can elect not to implant some of the embryos produced in this way. But this objection is made by only a small minority. The overwhelming majority of Americans support both procedures. IVF helps infertile couples have children and PGD allows those who carry dread genetic diseases to have healthy children. Both procedures help people have children that otherwise would never have been conceived or born. In this respect, both are profoundly “pro-life.”

Second, there is the concern that the embryos used in this research did not survive the experiment. Since the publication of the Nature report some critics have emphasized this fact even though it remains true that the method developed by ACT scientists requires no further destruction of any embryos. I would like to point out that because this research was privately funded, this experiment was legal. It was also approved by ACT’s Ethics Advisory Board and by an additional institutional review board that was mandated under Massachusetts law. The embryos used were donated by people who had fully consented to the research and understood, and even required, that the embryos would not be allowed to go on to further development.
It is not unique that the initial research needed to develop morally acceptable methods or materials do not meet everyone’s approval, but this does not impugn the methods or materials produced as a result of that research. One example is the polio vaccines we use today. Some of the initial research on these vaccines was conducted with a technique that required the use of tissues from aborted fetuses. Later, this approach was replaced by other methods.

Almost no one today refuses polio vaccination for their children on the grounds that they object to the methods used in the first experiments. I would point out that even President Bush has been willing to use the harmless downstream results of research to which he objects. All of the stem cell lines being used in federally funded research today were produced by embryos that were destroyed for this purpose before the President’s August 2001 directive. The President could have said that none of these lines should be used because they were created in a way he regards as morally objectionable. But he did not. He concluded that so long as no future harm is done, this valuable resource could be used.

Thanks to this research breakthrough, we are in exactly the same position today. If Congress were to approve legislation that funded research on lines generated by this new method, and if President Bush were to permit such legislation to pass into law, both the members of Congress and the President could honestly turn to the American people and say that no human embryo ever again needs to be harmed or destroyed to produce the stem cell lines we need for federally funded research.

Many scientists believe that we need several hundred new federally funded stem cell lines in order to have the genetic diversity needed for research. Well over 2,000 PGD procedures are conducted in this country each year. If just one out of three of the couples using this procedure authorized the harmless derivation of a cell line from the extracted cell of each of the embryos they chose to implant, we could produce at least fifty new cell lines every year from now on. The derivation of these cell lines would cause no harm to any of the donor embryos, a fact of critical importance for both the ethical and legal authorization of this research.

Let me conclude by stating that I am not a scientist. Although I have been impressed by the quality and the integrity of ACT scientists, their work will have to be replicated by other researchers before we can say that it is ready for wide use. But if Congress begins the legislative initiatives to test this method and fund research based on it, we can begin to move toward the kinds of cures and therapies that stem cell research promises.

Text From Lanza's U.S. Senate Appearance

Last week, Robert Lanza of Advanced Cell Technology of Alameda, Ca., appeared before a subcommittee of the U.S. Senate. Two U.S. senators excoriated him in connection with ACT's announcement of a new method of extracting ESC. Here is the complete text of what Lanza prepared for the Senate Labor, Health & Human Services, and Education Appropriations Subcommittee. The text was supplied by ACT at the request of the California Stem Cell Report.

(September 6, 2006) Good morning, Mr. Chairman and distinguished members of the committee. My name is Robert Lanza and I am Vice-President of Research & Scientific Development at Advanced Cell Technology, a biotechnology company in the field of regenerative medicine. I am also an Adjunct Professor at the Institute of Regenerative Medicine at Wake Forest University School of Medicine.

I would like to thank you for the opportunity to testify today on our technique for obtaining human embryonic stem (hES) cells from single blastomeres. As you know, hES cell lines are conventionally isolated from leftover embryos created for couples seeking in vitro fertilization (IVF). I join with the sponsors of Senate Bill HR 810 in my belief that scientists funded by the NIH should have access to stem cells derived from the hundreds of thousands of such surplus embryos that will otherwise be discarded. I know that you share my frustration that this important legislation was vetoed by the President.

Therefore, at the outset, I would like to make it absolutely clear that the single-cell derivation technique we’ve developed is not a replacement for existing methods of generating embryonic stem cell lines. In fact, our intention is quite to the contrary. We think it would be tragic not to pursue all the options and methods currently available to us to get this technology to the bedside as soon as possible. That being said, our hope is that the new method we describe in Nature can be used to increase the number of stem cell lines that qualify for Federal funding within the framework of existing US laws and regulations – and thus give the field a very much needed jump-start.

Current US law prohibits the use of federal funds for research in which human embryos are harmed or destroyed. As a result of this policy, the field of stem cell research has been crippled by the lack of quality stem cell lines. At present, there are only a handful of NIH-approved lines, all of which are potentially contaminated with animal pathogens that could lead to serious health risks; whereas others are difficult to grow and have started to display genetic abnormalities. Nor do they reflect the genetic diversity of the population, both in terms of their clinical potential and their value to those of us trying to understand the cause of various human diseases.

The approach we have developed does not involve the destruction of embryos, nor do the biopsied cells ever develop into an embryo at any point. The procedure is commonly known as PGD (preimplantatation genetic diagnosis) and is a well-established technique that has been used for a decade by IVF clinicians to generate thousands of healthy babies worldwide. In PGD, a single cell – known as a blastomere – is removed from an 8-cell-stage embryo for genetic testing. By growing the cell overnight, the resulting cells could be used for both PGD and the generation of stem-cells without affecting the clinical outcome of the procedure or the subsequent chances of the couple having a child. Numerous reports show that the survival rate is unaffected by the biopsy procedure, and that the subsequent development and chances of implantation are the same for both normal and biopsied embryos In our study, multiple individual cells where removed from embryos in the same way as would be employed in the clinical setting with PGD. Although those particular embryos were not allowed to develop further, we also carried out studies which confirmed that the biopsy procedure we used could be used without destroying the embryo. I want to be entirely clear on this point. The embryos used to create stem cell lines in our study were destroyed; however, in control experiments, single-cell biopsied embryos were allowed to continue development, and they did indeed develop to a more advanced (blastocyst) stage – they were all frozen and remain alive.

In fact, they continued development at the same rate as nonbiopsied embryos. We also showed that individual biopsied cells had the capacity to generate stem cells. Nineteen ES-cell like outgrowths and two stable embryonic stem cell lines were derived from 91 blastomeres. These stem cell lines have been growing for more than 8 months, and are genetically normal and able to generate cells from all the germ layers of body, including nerve cells, blood cells, and even retinal cells that could be used to prevent blindness.

Of course, hES cells derived this way could be of great potential benefit, not only for the medical research community, but also for the children and siblings born from transferred PGD embryos as well. The cells would be genetically identical to the child, and could be frozen down and used throughout the lifetime of the person – for instance, if they develop diabetes or heart disease.

I would now like to address several objections to the use of this procedure. First is that the technique may not be entirely without risk to the embryo, however minimal. We agree, and until remaining doubts about safety are resolved, we do not recommend the procedure be applied to healthy embryos outside the context of PGD. However, in PGD a cell is already removed and could be used to create stem cells without any added risk to the embryo. Second, concerns have been raised as to whether individual cells, such as those used in our study, are totipotent and could potentially generate a human being. It is our opinion that this is not the case.

Recent reports show that cell fate is already being determined at the 2 to 4 cell stage. Importantly, individual cells from an 8-cell-stage embryo, such as those used in our study, have never been shown to have the intrinsic capacity to generate a complete organism in any mammalian species – not even in a mouse or rat. And finally, questions have been raised whether the technique is completely applicable in the clinical setting. We believe it is and are working on procedures that can be utilized by clinicians in the IVF clinic environment. And thus, we believe it is now possible to create new stem cell lines without destroying human embryos. With the support of Federal funding, the single-cell derivation technique could provide new robust (and animal-product-free) stem cell lines for medical research and human clinical trials.

Since I testified here a year ago, we’ve managed to move the singlecell derivation technique from the mouse to the human. But in the meantime another million people have died of diseases that could potentially be treated – and possibly cured—using future stem cell therapies. How long are we going to allow this intolerable situation to continue? Stem cell scientists sorely need more lines that qualify for Federal funding. Make no mistake about it, there are many promising alternatives out there, but the conventional and singlecell derivation techniques are a reality – here and now. There are those who would want to set this research back, but there is a very real human tragedy out there, and it would be a shame not to use this opportunity to try to lessen the misery of so many Americans with disorders and disabilities. This is my hope, and it could start here with this Committee. Now is the time to move, while the United States is still in the forefront of this research, and while there is still time enough to develop therapies that could be used to help alleviate the suffering of those we know and love.

Thank you for the opportunity to address your Committee. I hope you find these comments helpful to your work.

Feds Could Take Up WARF Stem Cell Patent Dispute Next Month

The U.S. Patent Office could announce some time next month its decision on whether to step into the multimillion dollar WARF stem cell patent controversy.

Writer Joe Vanden Plas of the Wisconsin Technology Network indicated that was the likely timetable in an article that also quoted WARF as saying it expects the Patent Office to review the challenge to the patents by the Foundation for Taxpayer and Consumer Rights of Santa Monica, Ca. However, the issue is not likely to settled for several years.

WARF's hold on stem cell patents has troubled some in the business for years. The California foundation filed its challenge after WARF said it wanted to charge the California stem cell agency for use of its patents because the state expected to generate royalties. At stake are potentially millions of dollars in royalties not only in California but throughout the nation.

Vanden Plas said that the Public Patent Foundation (which represents the California foundation) challenged the WARF patent on the basis of "what it said was unseen 'art' or evidence that the previous work of other scientists made the derivation of human embryonic stem cells obvious and therefore unpatentable."

Vanden Plas' article also briefly discussed the agreement reached between WiCell, an arm of WARF, and Advanced Cell Technology of Alameda, Ca., to disribute new stem cell lines involving ACT's new technique.

FTCR: Hein Should Resign from Stem Cell Panel

One of the members of the Citizens Financial Accountability Oversight Committee for the California stem cell agency, which meets today for the first time, is not qualified and was appointed as a "political payoff," a watchdog group said today.

The Foundation for Taxpayer and Consumers Rights of Santa Monica, Ca., said in a press release that the appointment of John Hein by Democratic Assembly Speaker Fabian Nunez "smacks of cronyism and the pay-to-play culture that dominates California politics."

John M. Simpson, stem cell project director for the foundation, noted that Prop. 71 requires members of the oversight committee to have "medical backgrounds and knowledge of relevant financial matters."

Hein was a longtime lobbyist for the California Teachers Association and now heads the political and policy consulting firm of HC&A of Sacramento, Ca. Hein was also a key negotiator in the education deal with Gov. Schwarzenegger that collapsed a few years back.

Calling on Hein to resign, Simpson said the CTA, a politically influential union in California, has been a longtime backer of the Nunez and contributed $12,800 to Nunez in election cycle preceding Hein's appointment.

Wednesday, September 13, 2006

Wanted: Fresh Human Eggs

What is the going price for human eggs these days? It runs as much as $50,000. But there are still not enough eggs to fuel the stem cell research machine, according to two articles in the Los Angeles Times today.

Reporter Karen Kaplan wrote:
"While the world debates the morality of stem cell research, scientists are grappling with a more basic issue — a shortage of eggs that they say is crippling their work."
One example that Kaplan reported involved Advanced Cell Technology of Alameda, Ca. The company has used newspaper ads to recruit women, some of whom declined after learning they would not be compensated beyond expenses. Kaplan wrote:
"After 10 months, one woman has passed the physical and mental health exams. She was scheduled to begin the egg retrieval regimen last week and could have eight eggs ready to harvest in early October."
Reporter Lee Romney examined the California scene including legislation (SB1260) by Sen. Deborah Ortiz, D-Sacramento, and the California stem cell agency.

Romney discussed the issue of possible exploitation of women egg donors, particularly low income, minority women. She also quoted Radhika Rao, of UC Hastings College of the Law in San Francisco and a member of a state commission that crafted guidelines for stem cell research, as saying,
"If you pay women a lot and they're white, it isn't exploitation?"

Tuesday, September 12, 2006

The Unexpectedly (to some) Long Life of CIRM

When is a 10-year embryonic stem cell research program not a 10-year embryonic stem cell research program?

Answer: When it is the California Institute for Regenerative Medicine.

Confused? We were too. We have been operating under the mistaken impression that the California stem cell agency has a 10-year life span that began when voters created it in 2004. In fact, CIRM has life in virtual perpetuity. And it can fund itself with the state's general obligation bonds apparently until it hits the $3 billion cap. All of which raise some interesting questions about life after $3 billion.

Two years ago when Prop. 71 was approved, news accounts repeatedly referred to a 10-year period in connection with the agency. Sometimes the time span was linked with the ability to issue bonds. Sometimes not. But regardless of context, 10 years kept popping up. Even the economic report by the Analysis Group, which was paid for by the Prop. 71 campaign, referred to funding over 10 years. And today the web site of the Alliance for Stem Cell Research, a spin off from the campaign organization, uses the 10-year term. The ballot measure itself says the intent of the measure was to authorize funding over a 10-year period. However, the analysis of the initiative by the state's legislative analyst is clearer. It says:
"The measure states its intent, but does not require in statute, that the bonds be sold during a ten-year period."
The longevity of CIRM came up when we wrote an item that said only 60 percent of the agency's life span remained.

That prompted a response from Dale Carlson, chief communications officer for CIRM, who asked for a correction. He acknowledged that he too was once under the misapprehension that CIRM would pass on at age 10. He said,
"I seem to have inherited a common misconception that CIRM is authorized to exist for only 10 years. I assume that stems from language in Prop. 71 regarding the issuance of an average of $295 million in bonds over 10 years, or it may be a legacy from the campaign. Whatever the case, there is in fact no timeline or deadline or sunset provision in Prop. 71.

"We are authorized to issue up to $350 million in bonds in a single year. Anything short of that can be rolled over to subsequent years. We don’t expect the funding to remain constant year over year. Instead, we expect to set each year’s amount based on the state of our strategic plans, the current research environment, scientific advances, newly recognized needs and opportunities, etc. It will be a dynamic process. Many (if not most) of the grants we award are likely to extend out over several years.

"The litigation has an effect, of course. It delays the issuance of authorized public general obligation bonds. It does not mean, however, that we’ll be issuing more than $350 million in a single year to 'catch up', nor that our effective half-life is shortened. The litigation is likely to extend the CIRM’s life and funding program, to make up for the delayed issuance of GO bonds."
As we remarked earlier, all of this raises interesting questions about life after $3 billion, a date that may not occur until about 2017 or perhaps several years later.

Given the nature of organizations and bureaucracies, it is not likely that CIRM will want to close its doors after the $3 billion runs out. It will be an organism that will want to survive, and there may well be good reasons for its life to continue. The state could fund it through the budget process, but without the usual oversight it gives other state agencies, which do not have the constitutional independence that CIRM does. It could also turn to private fundraising, as it has done so already to the tune of $50 million. California's biotech industry may find it useful to provide hundreds of millions of dollars to CIRM to continue pursuing work that is basic to the well-being of the business. Of course, some folks might object to a state agency behaving in such a fashion. But CIRM is virtually immune to control by the governor or the legislature.

And then there is a provision within Prop. 71 that provides for use of "alternate financial plans" instead of state bonds if they would significantly lower borrowing costs.

Is there a lesson in all this? Just the usual. Never assume. Expect the unexpected. Re-read the rules and instructions. However, there may be some folks who will not be happy to find that CIRM has perpetual life.

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