Pay-For-Eggs Legislation Draws More Media Attention

California legislation to allow women to be paid for their eggs for scientific research generated several news articles this week as the measure neared final legislative approval.

The coverage included both pro and con but did not amount to major attention from the mainstream media. And, with one exception, the articles failed to report that the legislation did not apply to research funded by the $3 billion California stem cell agency, which bans compensation for egg providers.

The proposal (AB926) is now on the state Senate floor with a vote possibly coming as early as next Thursday. A spokesman for the American Society for Reproductive Medicine in Birmingham, Ala., an industry group sponsoring the bill, said unequivocally that the Gov. Jerry Brown is expected to sign the measure. (See the Senate floor bill analysis here and a press release on the bill here.)

Assemblywoman Susan Bonilla
Photo Source -- Bonilla's office

The articles about the legislation by Assemblywoman Susan Bonilla, D-Concord, have appeared in the journal Nature, the San Francisco Chronicle and the Huffington Post over the past few days.

Alice Crisci, a California patient advocate writing on the Huffington Post, yesterday remarked that women egg providers should be treated the same as men involved in scientific experiments.

“After all, aren't we past the days when we treat women like they are less capable than men of making sound decisions for their own well-being? It's my body and my choice if I want to donate a dozen of my eggs to science. Who knows -- maybe it's my egg that will be used to find a cure for cancer.”

Debra Saunders, writing a column in the Chronicle on Sunday, said,

“That sperm-egg parity argument is so bogus. When men donate sperm, they risk second thoughts about unknown, random offspring, but they do not risk serious medical side effects. Egg donation, on the other hand, can be hazardous to your health. The New York Times reports, "Egg donors can suffer serious side effects from the powerful hormones needed to generate multiple eggs." And: "The most significant risk is ovarian hyper-stimulation syndrome, which can cause bloating, abdominal pain and, rarely, blood clots, kidney failure and other life-threatening ailments."

Charlotte Schubert, writing in Nature on Tuesday, said,

“In practical terms, the bill would bump up payments from hundreds to thousands of dollars. In Oregon — which, like most states, does not have regulations governing egg donation — women recently received $3,000–7,000 each for eggs used in a study that created stem-cell lines from cloned human embryos.”

Prices for eggs can run substantially higher depending on the characteristics of the supplier.

Bonilla's office said the bill did not come up for a vote during today's Senate floor session but could come up next Thursday.

Compensation for Human Eggs Approved by Key California Senate Committee, But Not For CIRM Researchers

Legislation that would permit women in California to be paid for their eggs for scientific research yesterday cleared a key state Senate committee and is likely headed for the governor's desk.

The measure by Assemblywoman Susan Bonilla, D-Concord, was approved on a 6-1 vote by the Senate Health Committee and now goes to the Senate floor. Earlier, it passed the Assembly on a 54-20 vote.

Some stem cell researchers and other scientists have chafed under state restrictions that bar compensation for eggs while that the same time fertility clinics are paying an average of $9,000 a session for eggs, with some prices going as high as $50,000.

However, the legislation will not affect researchers using grants from the $3 billion California stem cell agency. The agency's regulations bar compensation for eggs in the research that it funds. That means that at least a two-tiered research system would exist in California not to mention another tier created by federal regulations that differ from both those of the stem cell agency and those set by the legislation.

CIRM's restrictions are required by Proposition 71, which created the agency in 2004, and cannot be changed without a 70 percent vote of the legislature. Bonilla's bill requires only a majority vote.

Bonilla's legislation is sponsored by American Society for Reproductive Medicine, the chief industry group for the largely unregulated fertility industry.

The analysis prepared for yesterday's committee session summarized Bonilla's arguments for the measure in this fashion:

“This bill seeks to create equity in the field of medical research compensation by removing the prohibition on compensation for women participating in oocyte (egg) donation for medical research. All other research subjects are compensated for their time, trouble, and inconvenience involved in participating in research. AB 926 ensures that women are treated equally to all other research subjects - allowing them to actively evaluate their participation in research studies. Unfortunately, the ban on compensation has had serious unintended consequences. It has led to a de facto prohibition on women’s reproductive research in California, adversely impacting the same women that the ban intended to protect. With few oocytes donated, fertility research and fertility preservation research has been at a standstill. This greatly affects women suffering from fertility issues and women facing cancer who would like to preserve their oocytes.”

A number of organizations are opposed to the bill including the Center for Genetics and Society in Berkeley and the Catholic Church. The bill analysis summarized some of the opposition arguments in this fashion:

“Egg harvesting exposes healthy young women to multiple synthetic hormones in order to produce many times the normal number of eggs per cycle. One of the potential harms is OHSS, which has resulted in hospitalizations and at least a few documented deaths. These groups state that many experts remain concerned about the long-term risks of these drugs, especially their potential impact on infertility and various cancers. Follow-up research on egg providers, which could establish the frequency and severity of these adverse outcomes, is widely recognized to be grossly inadequate.”

In addition to risk and religious objections, opponents also argue that poor and minority women are likely to be exploited by enterprises seeking their eggs to resell at a profit.

No major stem cell research organizations, including the California stem cell agency, have taken a position on the bill. The legislation has received little public attention, although The Sacramento Bee carried an article last March. Ruha Benjamin, author of "People's Science" and assistant professor at Boston University, also wrote about the measure in April on the Huffington Post. Benjamin said,

“UC Berkeley professor Charis Thompson compares egg donation to 'other kinds of physically demanding service work,' arguing for a 'salary negotiation between the state agency (or relevant employer) and the donor.' This, she contends, is a 'sensible and dignified recognition of [the donor's] work, time, and effort.' And instead of refusing compensation to women, Thompson suggests that we 'direct our efforts to understanding and minimizing' the risks.

“Indeed. Now more than ever, we must redouble our efforts, because the market in eggs appears to be expanding from private reproduction to public research, and increasingly overseas, if the surrogacy industry is any indication of how 'cheaper' women become a reserve army of bio-labor in less regulated regions.” 

Replicating Oregon Cloning in California: Views on the Legality

Oregon's stem cell cloning achievement has triggered some discussion about whether it could be replicated legally in California, which bans paying for eggs as was done in Oregon.

Stanford researcher Irv Weissman said it is “not true” that Oregon's stem cell research would be illegal in California. Leftovers from IVF clinics could be used, he said.

But in response Oregon researcher Shoukhrat Mitalipov said that “SCNT (the process he used) did not work with discarded human eggs.”

He added,

 “SCNT worked with eggs from healthy young volunteers (paid of course). IVF patients (whether paid or not) have reproductive health problems and may not provide acceptable quality eggs for SCNT.” 

Their comments came in emails to the California Stem Cell Report in connection with yesterday's item that said because the Oregon researchers used paid donors for eggs, the research would be illegal in the Golden State.

Weissman said,

 "Not true. They did it with nearly 40 percent efficiency, which does not require paying for eggs, just use leftovers from IVF clinics."

There is no question that it is illegal to pay donors for their eggs in California. The question is whether the research could be done properly without using paid donors. In recent years, researchers at Harvard and elsewhere have said they needed paid donors for stem cell research to properly perform their research and could not find them without providing compensation.

Weissman Says Oregon-style Stem Cell Research Could be Done in California

Stanford researcher Irv Weissman says it is “not true” that Oregon's stem cell research could not be done legally in California.

In a brief email to the California Stem Cell Report, he commented in connection with yesterday's item that said because the Oregon researchers used paid donors for eggs,the research would be illegal in the Golden State.

Weissman said, 

"Not true. They did it with nearly 40 percent efficiency, which does not require paying for eggs, just use leftovers from IVF clinics."

There is no question that it is illegal to pay donors for their eggs in California. The question is whether the research could be done without using paid donors. In recent years, researchers at Harvard and elsewhere have said they needed paid donors to properly perform their research and could not find them without providing compensation.

We have queried Shoukhrat Mitalipov in Oregon concerning his views on Weissman's comments. We welcome other comments as well. Comments can be filed directly by clicking on the word "comment" at the end of this item or you can email them to djensen@californiastemcellreport.com. 

We should also note the comment from researcher Paul Knoepfler of UC Davis who notes that SCNT cloning is permissible in California, which is what was done in Oregon. The state does ban reproductive cloning, however.

Oregon-style Stem Cell Cloning Research Illegal in California: No Pay for Eggs in Golden State

The good news out of Oregon is that some diligent scientists in the Beaver State have accomplished a major advance in stem cell research --- the cloning of human stem cells.

That bad news is that their research would have been illegal in California, and probably will be banned for decades, if not longer – thanks to Proposition 71 of 2004.

The proposition was the ballot initiative that created the $3 billion California stem cell agency, which is hailed internationally as being one of the world leaders in financing stem cell science. Unfortunately, the 10,000-word initiative also contains language that was aimed at winning voter approval of the measure -- not promoting good science.

The team writing the initiative, led by Robert Klein, the former and first chairman of the stem cell agency, put in a provision that made it illegal to pay women for their eggs. The Oregon researchers paid women $3,000 to $7,000 each for their eggs, reflecting the current market rate based on prices paid in connection with IVF. In some cases for IVF, the compensation is dramatically higher. (See here and here.) Stem cell researchers in recent years in the United States have found that they cannot secure an adequate number of donors without matching IVF donor compensation.

While compensation for eggs is a matter of some controversy, strong cases have been made that women should make their own decisions about selling their eggs – not the what some call the nanny state. Of course, that should occur under well-regulated situations. But Proposition 71 backers wanted to remove any possible campaign objections by opponents of stem cell research, and so they inserted the ban along with management minutia and other dubious material.

Can't that be changed, one might ask? Not without a herculean effort. That means another ballot measure or a super, super majority vote in the California legislature plus the signature of the governor. Imagine a measure on the ballot to allow women to sell their eggs. The uproar would be heard internationally. In 2004, when Proposition 71 was approved, it would have been better to leave the compensation issue unaddressed. Then it could have been dealt with through regulation or normal legislation, both of which are far more flexible than ballot measures that alter the state Constitution and state law.

Our quick and limited survey of the news coverage indicated that many of the mainstream media stories omitted the price of the eggs, which may suggest that the issue of compensation is becoming moot.

In related news about the Oregon accomplishment, UC Davis stem cell researcher Paul Knoepfler has posted a good look at the some of the misinformation that is surfacing on the Internet about the research, including its implications.

He said,

“Keep in mind that on day one of the iPS cell era in the stem cell field we had a huge number of misconceptions because we simply had so much to learn. Same is true here.”

Jessica Cussins over at the Berkeley-based Biopolitical Times also has a solid roundup of the coverage of the Oregon research and the analysis of its significance.

Here are links to two blog items from the California stem cell agency on the Oregon research, including one dealing with “cloning hysteria” and a more general look.

CIRM Directors Take Up Revised Research Standards Oct. 27

The Standards Working Group of the California stem cell agency today gave the nod to changes in its standards aimed at achieving consistency with national rules for human embryonic stem cell research.

The proposed regulations now go to the CIRM board of directors at its meeting in Los Angeles Oct. 27-28.

For more on the rules, see the “Research Standards” item on Oct. 11, 2009.

Congressional Bill on hESC Research

A Colorado congresswoman is planning to introduce legislation to codify the president's executive order permitting federal funds to be used for human embryonic stem cell research and to require periodic review of NIH research guidelines.

The Washington Post reported during the weekend:

“Usually, couples who go to in vitro fertilization clinics create more embryos than will be implanted. The remainder are either destroyed or frozen. The NIH regulations and the bill would allow couples to donate their embryos for research as long as they are fully informed of their choices and they are not compensated for the embryos. The guidelines give donors the ability to change their minds 'until the embryos were actually used.'"

The newspaper continued:

“Congress already prohibits federal funding for collecting stem cell lines from human embryos, which are destroyed in the process. But the NIH rules make it clear that taxpayer money will not be used on lines from embryos created solely for research.”

Rep. Diana DeGette, D-Colo., plans to introduce the measure soon, according to the Post. The CIRM Standards Working Group meets this morning to consider revising California regulations to achieve consistency with federal rules.

CIRM Acts on Revised Research Standards This Week

The California stem cell agency Monday takes up changes in its research standards aimed at achieving consistency with national rules for human embryonic stem cell research.

The changes appear to be non-controversial although researchers and other interested parties would be well-advised to listen in on the audiocast proceedings of the 10 a.m. meeting of the Standards Working Group. Its discussions often shed light on questions that may pop up later when the standards are to be applied.

If you can't tune in, CIRM has posted the regulations along with additional details and the Powerpoint briefing slides to be used at the meeting. The documents are also necessary if one wants to follow the audiocast.

The rules being considered by CIRM apply only to research that is funded by the agency. Stem cell research in California that is not funded by CIRM is regulated by the state Department of Health.

From day one, CIRM has banned the use of stem cell lines if they are derived in a process that provides compensation – “valuable consideration” – for eggs or embryos. One of the proposed changes that caught our attention involves an exception to the ban on “valuable consideration” in the case of embryos created in reproductive IVF. The proposed rule states:

“For embryos originally created using in vitro fertilization for reproductive purposes and were no longer needed for this purpose 'valuable consideration' does not include payments to original gamete donors in excess of 'permissible expenses.'”

Having watched laws and regulations formulated for several decades as a journalist, creation of exceptions piques my interest. In this case, I wondered whether money could be made by using the proposed exception. What happens if human eggs have real economic value at some point in the future in terms of research i.e. a high demand and a supply shortage? Is it possible that crafty entrepreneurs could use the cover of IVF to generate eggs to meet that demand?

CIRM firmly believes that will not happen under its proposed rules. Their intent is clear plus CIRM also reviews its grantees' research protocols and audits the institutions, the agency says.

We also asked Hank Greely, a Stanford law professor familiar with stem cell issues, about the matter. Greely, who is not involved with the CIRM regulations, offered this quick and informal response that basically supports the CIRM regulation.

“I think that's a defensible interpretation. She is being paid to 'donate' ('paid to donate' is odd wording, in itself) her eggs for reproductive purposes. She cannot be told, in advance, that not all of her eggs will be used to make embryos for reproductive purposes, because no one knows, in advance, how many eggs she will provide, how many embryos will thrive, and how many the recipient will need for reproductive purposes. She doesn't get any money because of the research use and she doesn't 'donate the eggs for research use' - the woman/couple who pay her for her eggs ultimately donate the embryos made from those eggs for research use. The egg donor gets the same amount of money whether the recipient ends up using all of the embryos created with the donated eggs for reproductive use or none. No more or less money changes hands depending on whether all the eggs are used for reproduction or some of the eggs are used for research.

“Assume I pay you $3 for a six pack of Coke Zero and I tell you I plan to drink as many as I need, which may or may not be all of them. I end up giving one of the cans to my wife. Have you received 'valuable consideration' for donating the can to my wife?”

For an earlier discussion of the regulations, you can see the transcript of the standards group meeting on Sept. 18.

Directions for hearing the audiocast can be found on the standards group agenda.

(Editor's note: An earlier version of this item incorrectly said that the proposed regulations will be considered by the CIRM board Friday. They will be heard by the board at its meeting in Los Angeles Oct. 27-28.)

CIRM Looking for Closer Conformity on Egg Rules

SAN FRANCISCO --As part of its effort to achieve consistency with national standards, the California stem cell agency is moving towards allowing the use by CIRM researchers of embryos created through IVF that originally involved payments.

The CIRM Standards Working Group last week approved the move although specific language is yet to be worked out. Bernie Lo, co-chairman of the group and director of the medical ethics program at UC San Francisco, said the language would be narrowly focused.

Jesse Reynolds of the Center for Genetics and Society of Berkeley, Ca., said he was
“encouraged” by the CIRM direction. Earlier, the group had expressed concern that CIRM might be creeping towards possible creation of a loophole in the Prop. 71 ban on compensation for egg donors.

CIRM hopes to present specific language soon for its proposed rule to the Standards Working Group in a telephonic meeting. The proposal would then go to the CIRM board and from there into the official state regulation process.

In other matters involving the standards group, Alta Charo, a professor of law and bioethics at the University of Wisconsin, who has been a member of the group since its beginning in 2005, is leaving the panel because of her new position as a senior advisor at the FDA,

CIRM hopes to approve a replacement at the board meeting that begins Oct. 27.

Reynolds also praised CIRM staff for the early posting of background material on matters to be discussed at the meeting last week. Additional material has been posted as well on the research standards issues facing CIRM. It all can be found here.

Egg Donor Proposal Stirs Concern; CIRM Says Language is 'Placeholder'

The Center for Genetics and Society Thursday raised “serious concerns” about some of the matters to be discussed at today's meeting of the research standards group of the $3 billion California stem cell agency.

CIRM, however, said the center has “misconstrued the intent of the proposed changes.”

In a letter to CIRM, the Oakland, Ca., organization center referred to preliminary language contained in a briefing paper for the group that dealt with compensation for egg donors, which is banned by CIRM. The draft language, which is intended to conform CIRM rules to others nationally, would “limit the payment restriction to donation of oocyctes provided specifically for research purposes.”

The center said,

“We were startled to see this for two reasons. As you know, both Proposition 71 and California law prohibit paying women to provide eggs for research. This proposed policy would mean that a woman undergoing egg extraction could be compensated or receive other valuable consideration as long as research is not the specifically stated purpose of harvesting her eggs. Diverting eggs for which payments have been made from the reproductive to the research context would be contrary to Proposition 71 and state law.

“We sincerely hope that this is an oversight. We ask the Standards Working Group to reject the proposed language and to clarify that paying women for eggs that will be used for research (beyond reimbursing their expenses) is contrary to law, and will not be done in California.”

CIRM posted a response to the CGS letter on the agency's website. In the response, CIRM referred to National Academy of Sciences guidelines and said,

“The language 'specifically for research' is a placeholder taken directly from the NAS Guidelines. The SWG (standards group) has consistently drawn from the NAS guidelines to provide a model for our regulations. This example is no different. This placeholder language is designed to support policy development. Any proposed regulatory language is subject to SWG review, ICOC approval, OAL review and public comment to ensure the regulatory language is consistent with the intent of the policy.”

Our take? We think CIRM's intent is clear. However, whether the proposed regulatory language achieves that goal is another question. We suspect more artful language will be developed as these proposed changes work their way through the regulatory process during the next few months.

CIRM is to be lauded for posting its 28-page briefing paper well in advance of today's meeting. That allows time for such parties as the Center for Genetics and Society and others to comment thoughtfully on the matters to be considered. It also allows time for CIRM to respond publicly in advance of the meeting. The upshot is likely to be better policy and better regulations and enhance CIRM's image as responsive to the public.

We should also note that the center's letter also raised concerns about the “prospective use for research of paid-gamete IVF embryos could create conflicts of interest for the physician attending an egg provider, and thus put her at increased risk.”

CIRM No-Pay Egg Rules: A 'Stem Cell Debacle'?

A front page article Sunday in the leading newspaper in one of California's stem cell hot spots says that the state laws aimed at boosting embryonic stem cell research are also hobbling it by "creating a shortage of human eggs."

The article was written by Terri Somers of the San Diego Union-Tribune, who follows stem cell business and research issues more closely than any other reporter in the state.

The crux of the problem, she reported, is that Prop. 71 bans paying women for their eggs, creating what some believe to be a shortage.

Somers wrote,

"'This is what I call the great stem cell debacle, and it's ridiculous,' said Dr. Samuel Wood(see photo), who founded Stemagen, a San Diego biotechnology company that is trying to create human embryonic stem cells through therapeutic cloning.

"'The people of California passed Prop. 71 to fund billions of dollars worth of stem cell research including (therapeutic cloning) and then the legislators and leaders of the stem cell institute put guidelines in place that greatly hamper, or virtually eliminate, the possibility of this being successful.'"

Somers continued:

"The institute has distributed $614 million through 229 grants, but only one has involved therapeutic cloning. Several grant requests were denied after doubts were raised that the scientists would be able to obtain enough eggs, called oocytes, to conduct the research.

"'It's clear that without having access to resources, in this case human oocytes, we cannot move forward,' said Shoukhrat Mitalipov, a University of Oregon scientist considered a leader in therapeutic cloning."

Both Mitalipov and Wood had grant applications rejected by the California stem cell agency, Somers reported. But CIRM President Alan Trounson, Wood and Stemagen's chief scientific officer, Andrew French, co-authored a 2006 paper advocating cloning-based stem cell research, according to Jesse Reynolds of Biopolitical Times.

Somers quoted David Smotrich, who runs La Jolla IVF, a fertility practice, as saying the average payment for buying eggs in California is $3,000 to $5,000 but sometimes higher.

She said,

"Wood, who also runs a fertility practice in San Diego, conducted a survey of women who were egg donors for fertility purposes and found that 60 percent would consider doing so for research. All but one would expect to be compensated, at a rate of at least $3,000, he said. Wood hopes the survey will help change state law."

But there is opposition to easing CIRM's payment standards. Somers wrote,

"'People voted for Prop. 71 with the understanding that eggs would not be paid for,' said Jeff Sheehy, an AIDS activist and member of the institute's board. 'We can't suddenly say that the words and law don't mean what we thought they meant.'

"In 2006, the Legislature passed a law prohibiting payment for oocytes donated for research that is not funded by the institute. For that reason, the Legislature should address the issue, said Sheehy, a member of the institute's standards committee. Elected leaders could give the institute direction, he said."

Earlier this year, Trounson raised concerns about egg shortages. In June, he said researchers are "floundering" because they do not have enough eggs. One Harvard researcher, Kevin Eggan, who serves on a CIRM panel, also complained last spring that a $100,000 advertising campaign on the East Coast seeking egg donors had been unsuccessful. The Associated Press has written about the problem as well in a story that circulated nationally.

Recently Singapore, which has launched a major stem cell research effort involving top level American scientists, approved paying egg donors for their time as well as lost wages. CIRM rules allow reimbursement for lost wages but do not permit compensation for lost time.

Somers quoted Marie Csete, CIRM's chief scientific officer, as saying its standards committee will meet in February to discuss egg payments.

Egg Amplification

On Nov. 13, we carried an item on Singapore's new rules allowing egg donors to be compensated for both time and lost wages. CIRM rules permit reimbursement of lost wages but provide for no compensation for time.

Stem Cell Snippets: Eggs to IP

The Price of Eggs – Singapore has made a move on the human-egg pricing front, providing cash for time and lost wages, something that CIRM does not permit on research that it funds. However, Jesse Reynolds of the Center for Genetics and Society in Oakland, Ca., does not believe Singapore's action provides much impetus for efforts to boost incentives for eggs for stem cell research. His reasoning? "The continued lack of success of cloning-based stem cell research, which would use the eggs, and the frequent strides in the alternative methods of cellular reprogramming." However, CIRM President Alan Trounson has warned that the shortage of human eggs is limiting research. Our opinion: If eggs have value, someone is going to pay for them – and maybe a lot -- whether they are in California, Singapore, Korea, China or Poland.

Business and CIRM – The private sector is not giving up on CIRM despite the agency's rejection of all but one business grant application. Twenty-seven business filed letters of intent to apply for $60 million in translational research funding. Fifty-four applications came from non-profit enterprises. CIRM did not break that down between universities and research institutions. Ten grants are scheduled to be approved in April.

Stem Cell IP – If you are interested in CIRM IP matters, you might want to keep an eye on next Tuesday's meeting of the agency's IP Task Force. The agenda calls only for consolidation of non-profit and for-profit rules, but the draft has not yet been posted on the agenda. It is a teleconference meeting with sites in San Francisco, Elk Grove and San Carlos, where the public can participate.

A Re-Look at Friday's Egg Meeting

The California stem cell agency has taken issue with the way we have framed this coming Friday's meeting dealing with human eggs.

It is not really about availability, cost and prices, says CIRM. But rather about stem cell lines and embryos created through IVF treatments and their possible use in CIRM-financed research.

Geoff Lomax, senior officer for the Standards Working Group, said,

"You have got this one completely wrong and framed the meeting in a sensational and inflammatory way which does a disservice to thoughtful policy deliberations."

Lomax prepared the briefing paper – called "Use of Embryos Created for Reproductive Purposes with Paid Gametes" – for use at the Standards meeting later this week.

When we read it, we took a broader perspective, one that concerned the general availability of eggs for research and the economics behind their apparent scarcity.

But first CIRM must deal with the information Lomax presents in his background material as well that which will be brought to the table by others.

He wrote:

"Nationally, the CIRM policy deviates from other jurisdictions that have developed policies to advance stem cell research. This deviation has raised concerns over the ability of CIRM researchers to utilize materials derived under other jurisdictional policies or the National Academies Guidelines."

The issue of the use of human eggs is freighted with emotional and political baggage, plenty of which will surface eventually. But meantime, Lomax is trying to lay the groundwork for a straightforward consideration of practical issues that need attention sooner rather than later.

French, Stemagen, Trounson and Egg Shortages

Biopolitical Times, the blog of the Center for Genetics and Society of Oakland, Ca., took a look recently at ongoing events in the human egg debate, including some developments at the California stem cell agency.

Jesse Reynolds, who has followed the California stem cell movement for years, also commented about research involving Stemagen of San Diego, which has created the first human clonal embryos.

Among other things, Reynolds wrote,

"The medical staff treating the egg providers share the same address, supervisor, and authorship credits as the Stemagen researchers, in violation of requirements that medical personnel not have conflicts of interest with researchers, so that doctors’ duty of care toward women providing egg isn’t compromised."

Reynolds also pointed out a relationship between Stemagen and CIRM President Alan Trounson.

Reynolds wrote:

"He helped recruit his old friend Andrew French from their common homeland of Australia to serve as Stemagen's Chief Scientific Officer. And Trounson, French, and Stemagen CEO Samuel Wood authored a 2006 paper advocating cloning-based stem cell research. So it wasn't surprising when Trounson took his first opportunity... at CIRM Standards Working Group to call for undermining California's prohibition on paying women (beyond their expenses) to provide eggs for research, even though this policy is enshrined in Proposition 71, the statewide initiative that created CIRM, the California Institute for Regenerative Medicine."

Reynold said that Susan Berke Fogel of Pro-Choice Alliance for Responsible Research reported that Trounson and CIRM Chairman Robert Klein "tag-teamed a renewed effort to find a tortured interpretation of Proposition 71 that would allow paying women for eggs" at the CIRM directors' meeting last month. Reynolds said Klein "tried to force a discussion" that would have changed policy and circumvented the Standards Working Group.

We were present during the discussion that Fogel heard. However, we did not have the same impression. There was a discussion of the shortage of human eggs, basically a brief recap of what Trounson told the Standards Working Group last February. Our take is that Klein brought up the subject before the full CIRM board perhaps with intention of setting the stage for some sort of action later this year. That would be the politic thing to do if he wants changes in CIRM's current policies on eggs and cash.

Later this year, the Standards Working Group is expected to conduct a review of CIRM egg policies, probably sometime this fall.

However, Klein and Trounson have a high hurdle to clear. Prop. 71, which Klein says he authored, requires CIRM directors to set standards "prohibiting compensation to research donors or participants, while permitting reimbursement of expenses."

While Reynolds pointed out links between Trounson and French, he also reported that the relationship apparently did not benefit Stemagen recently. Its application for a new cell lines grant was "raked over the coals" by reviewers, according to Reynolds, who quotes them at some length.

We are asking CIRM and Stemagen if they have any comment on Reynolds' posting. We will carry it when we receive it.

Looking For Ways to Avoid the Stem Cell Egg Problem

A $25 million proposal to develop new lines of pluripotent human stem cells, including ones that do not require the use of human embryos or eggs, will come before the Oversight Committee of the California stem cell agency next week in San Diego.

The plan calls for as many as 16 research grants for periods of three years. Funding could come as early as next spring with the release of RFAs as early as this fall.

A CIRM staff report said,

"The ability to derive pluripotent stem cells from new sources will enable scientists to generate disease-specific and genotype-specific cells of many phenotypes. Such cells have great value for drug discovery and understanding specific disease mechanisms. Importantly, methods that will not require the donation or use of either human embryos or eggs will significantly reduce the moral and ethical concerns that surround methods currently in use. Finally, new methods of producing pluripotent stem cells will be particularly important because it may be difficult to obtain excess embryos from many racial groups.

"This RFA will support the generation of new lines of pluripotent human stem cells including:

"• new clinical grade lines of hESCs and other pluripotent human stem cells suitable for future clinical use or other biomedical applications

"• new hESC lines generated using improved methods that may be optimal for differentiation along selective lineages or for studies of disease

"• disease-specific, pluripotent stem cell lines to support the study of the effects of genetic variation on disease development and response to treatment

"• the discovery and implementation of alternative methods for generating pluripotent human cells"

The report also said,

"Awards will be made to support two areas of derivation: the generation of new human lines using excess embryos from in vitro fertilization, and derivations from other sources using new and novel methods."

Stem Cell Snippets: Hanky-Panky to Jobs for Those Love Long Hours

Enviros Against Stem Cell Lab/Classroom Building -- An activist group and the city of Santa Cruz have blocked construction of an $80 million facility at UC Santa Cruz that would house stem cell research activities. A judge halted the project for environmental reasons. The four-story facility would include stem cell labs and service nearly 1,400-science students.

Scientific Integrity – The California stem cell agency has based many of its policies and rules on assumptions of nearly universal scientific integrity. Glenn McGee(see photo), writing in The Scientist and on the blog of the American Journal of Bioethics, indirectly questions those assumptions. He cites studies that show widespread hanky-panky in the authorship of peer-reviewed pieces, particularly in cases where senior researchers claim authorship even when they are marginally involved. McGee also has suggestions for reform. Interestingly, the entry point for his article is a matter that figured in the controversy over approval of a California stem cell agency grant to a subsidiary of the CHA Health Systems of South Korea.

Yolo Stem Cell Land Deal – Land developer Angelo Tsakopolous has shelved his land development deal that would have also established a stem cell research center in Northern California near UC Davis and Sacramento. Jeff Raimundo, a spokesman for Tsakopolous, told the California Stem Cell Report that the controversial proposal has been put off. California stem cell Chairman Robert Klein lobbied local government officials on behalf of the proposal, but they shied away from the effort. The concept of the plan was also supported by the International Stem Society for Stem Cell Research. Tsakopolous is a persistent man, however, and his proposal could well surface again in one form or another.

Stem Cell Lab Grants – On Oct. 2, the California stem cell agency will consider rules concerning administration of $222 million in grants for stem cell lab construction. The Facilities Working Group will take up the proposal prior to consideration by the CIRM Oversight Committee the next day.

NAS Stem Cell Meeting in California – Coming up Oct. 8-9 in Irvine, Ca., is a National Academy of Sciences conference called "Therapeutic Cloning: Where Do We Go From Here?" A host of top flight scientists are listed as speakers. The session will address such questions as sources of eggs and alternative methods of creating pluripotent cells.

Looking for Work? -- If you are interested in working across the street from the home field of the San Francisco Giants baseball team, CIRM is looking for a few good men and women. Jobs available at the agency include associate legal counsel, grants management specialist, paralegal and scientific officers.. Long hours are guaranteed. (CIRM headquarters is near the Giants field.)

Turning Back Time on Mice Stem Cells: Implications for California

Does the news that scientists have found a way to reset the clock on adult mice stem cells mean that the California stem cell institute should fold its $3 billion tent and slink off into the night?

A case can be made that announcement reduces the imperative behind CIRM, formed to fund research into human embryonic stem cells because of President Bush's restrictions on federal financing in that area.

But scientists and CIRM are having none of it. Indeed, the Japanese scientist, Shinya Yamanaka of Kyoto University, who made the initial discovery in 2006 predicts that duplicating the procedure in humans would be "more demanding" than the mouse work.

At least three California newspapers visited the subject today, reporting that CIRM and researchers say the development, if ultimately successful, will take years to prove useful in humans and offers just another avenue for potential CIRM funding.

Carl Hall of the San Francisco Chronicle wrote:

"Arlene Chiu, interim chief scientific officer at the California Institute for Regenerative Medicine, the agency in charge of the state's $3 billion stem cell program, said the new work shows a path around a major bottleneck -- the shortage of fresh human eggs available for research.

"'We are interested in new ways of generating pluripotent stem cells,' she said. 'The important thing to us is the product, not the process. But the rarity of eggs is definitely a challenge.'

"Ethical rules in California and other states forbid paying women who undergo the sometimes risky egg-extraction procedures. Harvard's Kevin Eggan, a senior scientist involved in the new experiments, said Wednesday that he and his colleagues have been unable to find even a single egg donor after a year of looking.

"Ethics aside, Eggan said the real reasons his lab pursued an alternative to egg donation 'are really scientific and logistical in nature.' Researchers, he said, are seeking a way to use nonviable embryos.

"In fertility clinics, somewhere between 3 and 10 percent of women's eggs are improperly fertilized, typically with an extra sperm getting inside. That translates into about 15,000 to 50,000 nonviable, one-celled embryos, also known as zygotes."

Steve Johnson of the San Jose Mercury News quoted Christopher Thomas Scott, executive director of Stanford's Program on Stem Cells in Society as saying much more work needs to be done before the techniques can be used in humans:

"To kind of claim that one study is going to do the trick isn't the way that science works."

Johnson also reported that Arnold Kriegstein of UC San Francisco

"... noted that much of the embryonic stem-cell research going on in California involves examining how to turn cells into treatments. Consequently, he said, the knowledge gained from that will be useful no matter which types of cells - embryonic or reprogrammed - ultimately are determined to be best."

Terri Somers of the San Diego Union-Tribune had this on the impact of the latest research announcement.

"'It's really remarkable work . . . and as big as Dolly (the cloned sheep) in lots of ways,” said Alan Robbins, chief technology officer at Novocell, a San Diego-based stem cell company. 'If it can be translated into humans, then it opens up the way for designer embryonic stem cells.'"

Gautam Naik of the Wall Street Journal also put together an excellent piece with a great deal on the background and implications of the research.

Eggs: The 'Bigger Deal'

The “cheeky new women's blog” on Salon.com has weighed in the egg business in an item posted by writer Lynn Harris. Here is part of what she has to say on the “broadsheet.”

"Should we, indeed, be a little more freaked out by the egg market? To be sure, it is a much bigger deal than the sperm trade: more money, more commitment, more risk. Which leads to the valid concern about the degree to which brokers prey, say, on leggy blond volleyball players with excellent SAT scores and massive student loans. And which, in turn, makes me think it's important to accept, without judgment, that this is a business. As Harvard economist Debora L. Spar, author of 'Baby Business,' wrote: 'We need to acknowledge the market that reproductive technologies have created and then figure out how to channel this market toward our own best interests ... It's no use being coy about the baby market or cloaking it in fairy-tale prose. We are making babies now, for better or worse, in a very high-tech way ... We can moralize about these developments ... or we can plunge into the market that desire has created, imagining how we can shape our children and secure our children without destroying ourselves.'"

Not Enough Info on Egg Donation Risks, Critic Says

The Pro-Choice Alliance for Responsible Research said today that this week's Institute of Medicine report on the risks of egg donations shows "how little scientific data exists about the health risks of egg retrieval."

Susan Berke Fogel, coordinator of the group, made the comment in connection with the document that resulted from last year's conference prompted by the California stem cell agency. She said in a statement:

"By suggesting that researchers must have thousands of women’s eggs now, despite the critical absence of safety data, the report does women a great disservice. A more responsible conclusion would be to call for:
1. Research endeavors that do not require egg extraction procedures solely for research purposes; and
2. Research that will better define the risks of multiple egg extraction, so that meaningful informed consent will be possible. This will serve not only women who may want to donate eggs for research, but women who now undergo these procedures as part of infertility treatments."

The full text of the statement can be found below. It did not appear elsewhere on Web at the time of this posting.