Comment re Pay-for-Eggs Item and Forbes Article

One of the authors of an op-ed piece in The Sacramento Bee has filed a comment in connection with an item today on the California Stem Cell Report. The item dealt with the California pay-for-eggs bill, which was also the subject of an op-ed piece in The Sacramento Bee as well as an article yesterday on the Forbes magazine website that discussed the op-ed piece critically.

A quotation from the article was contained in this item earlier today.

Here is the text of the comment from Nancy Scheper-Hughes, a professor of anthropology at UC Berkeley and director of Organs Watch.  Diane Tober, associate executive director of the Center for Genetics and Society of Berkeley, was the other author.

“Dr. Diane Tober and Prof. Nancy Scheper-Hughes  are 'pro choice'  social scientists who are concerned about the absence of any evidence-based medicine on the long term effects of hyper-stimulation for oocyte (egg) production in young women research subjects. We are not concerned about abortion, right to life, or obstructing  needed and valuable research on stem cells. We are concerned about the safety for potential research subjects who are being actively recruited to participate in  invasive medical procedures without any medical research studies on the possible risks and consequences of egg multiplication and extraction. We are on record that we  fully support stem cell research but not at the expense of unprotected egg donors.”  

Pay-for-Eggs Legislation Now Before California Gov. Jerry Brown

California's pay-for-eggs bill is now officially on Gov. Jerry Brown's desk, awaiting his signature or veto.

The measure, AB926 by Assemblywoman Susan Bonilla, D-Concord, was sent to the governor at 4:45 p.m. PDT yesterday. On July 1, it easily won legislative approval and has been held in legislative processing since then. The governor has 12 days to act on the measure or it becomes law without his signature.

The legislation would remove the state ban on payment to women for their eggs for scientific purposes. Currently women who provide their eggs for fertility purposes can be compensated. Fees run as high as $50,000 in some cases, depending on the characteristics of the woman providing the eggs, but generally are in the $10,000 range or less. The bill does not affect the ban on the use of funds from the California stem cell agency to compensate egg providers.

Bonilla's bill is sponsored by the $5 billion-a-year fertility industry, which is backing it on motherhood and sexual equity grounds. Supporters say women should receive payment for their eggs just as men are paid for their sperm. They also argue that more eggs are needed for research into fertility problems. In the stem cell field, scientists have also said it is nearly impossible to find women who will provide eggs unless they are paid.

Opponents contend that the process of stimulating production of eggs can be risky or dangerous. They say that the longterm effects of the process have not been studied well. They also argue that it will lead to exploitation of low income and minority women to produce eggs that then can become a profitable commodity for the largely unregulated fertility industry. (For more informationon on the bill, see here, here and here.)

In one op-ed piece in The Sacramento Bee, opponents cited the late philosopher Ivan Illich, who was much admired by Jerry Brown, who considered him a friend. Illich was quoted as warning "against the processes of medical industries which 'create new needs and control their satisfaction and turn human beings and their creativity into objects.'"

The industry group says, however, that Brown is committed to signing the bill.

The measure surfaced in the news yesterday in an article on the Forbes magazine website by Jon Entine. He wrote,

“Should activist groups, working through legislators, exercise their control over women’s reproduction? Do we really 'own' our own bodies? Or does that tenet only hold when nanny groups say it’s okay?”

(One of the authors of The Sacramento Bee op-ed piece criticized in the Forbes article later filed a comment concerning their position.)

The egg legislation may have implications for regulation of stem cell research by the state Department of Public Health(again not involving the California stem cell agency). Last month the California Stem Cell Report asked Hank Greely, a Stanford law professor and chair of the state department's Human Stem Cell Research Advisory Committee, about the measure. He replied,

“Well, if (when?) AB 926 is signed, I think our committee should meet to consider what recommendations we would make to the (the department) as a result of the bill.  Those recommendations could lead, if the committee and the department agree, to a revision of the state guidelines.  As a matter of law, a statute, particularly a subsequent statute, trumps a guideline where they are in conflict, but basically I expect we'll see what the committee thinks and what the department decides.  I don't wish to guess at the results of either process.”

Another question that was not discussed publicly during the debate on the legislation deals with whether human eggs provided with compensation would be subject to state sales tax at any stage in the process. A check of the tax code, however, makes it clear that eggs are tax free. The code states that “any human body parts held in a bank for medical purposes, shall be exempt from taxation for any purpose." The definition of “bank” includes research facilities, and "medical purposes" includes research.

CIRM's Roth Remains Hospitalized

Duane Roth, a co-vice chairman of the $3 billion California stem cell agency, is displaying no apparent brain damage following a bicycle accident 11 days ago in the mountains east of San Diego.

Bruce Bigelow of Xconomy reported this morning,

“MRI diagnostic imaging showed no apparent brain damage, but he remains sedated, according to his brother, Ted Roth. While doctors see nothing that would prevent Duane Roth from a good recovery, told me by phone yesterday his caregivers are moving slowly to give him time to heal.”

Roth is also CEO of Connect in San Diego, a technology industry assistance organization.

Skimpy Coverage of Alpha Clinic Concept Approval

News coverage of approval of the California stem cell agency's ambitious, $70 million Alpha clinic plan has been quite light but does include one article in the Los Angeles Times, the state's largest circulation newspaper.

The concept proposal was ratified last week by the agency's board with RFAs scheduled to be posted in October. The agency is seeking to build a basis for a robust stem cell clinic business in California that would have an international reach and give the state dominance in the industry.

Karen Kaplan's story in the Times last week quoted CIRM President Alan Trounson as saying in 2010 about agency's goals.

“If we went 10 years and had no clinical treatments, it would be a failure. We need to demonstrate that we are starting a whole new medical revolution.”

The stem cell agency was created by voters in 2004 and funded with $3 billion in borrowed money. It will run out of funds for new grants in 2017.

Outsourcing-Pharma.com caught up with the plan this week in a story that said,

“The opportunity to run trails under the well-funded CIRM could be a boon for CROs (contract research organizations)....But the difficulties of handling the stem cells and gathering enough patients to enroll in a trial may prove daunting for whatever company tries to conduct the trials.”

The article also quoted CIRM spokesman Kevin McCormack as saying,

 “No one has reached out to us yet because the specific details of what we are looking for in the clinics have not yet been decided.”

That said, considerable information is available here, here, here, here and here.)

Also reporting on board approval of the Alpha clinic plan was GenNews.

California Stem Cell Agency Looking for New Home in Two Years

The California stem cell agency is located south of Market Street in San
 Francisco, close to the San Francisco Giants ballpark(upper right).  Since
 the agency has been there, the area has grown from seedy to gentrified. 

Some not-so-good news surfaced today in San Francisco involving the $3 billion California stem cell agency.

The news has little to do with its science efforts but everything to do with where it is located and its overhead expenses. The agency will be forced out of its free office space – 20,000 square feet – in two years. The free space was provided under an $18 million recruitment package and is worth at least $1 million a year, according to the agency's auditors.

The bad news is that the San Francisco office-space market is sizzling hot. Google, Yahoo, Microsoft and other technology firms are scrambling for space in Baghdad-by-the-Bay, as the city is sometimes known. According to a story this morning by James Temple in the San Francisco Chronicle, the firms are looking for a total of about 800,000 square feet and are prepared to pay well for it.

One nearly completed deal involving Yahoo would cost about $48 per square foot for a 10-year lease. If CIRM paid at that rate, it would have nearly $1 million in additional costs annually. However, leasing rates are expected to rise substantially in the next year or so. Also involved in a move would be the cost of parking, which could run about $360,000 a year.

The stem cell agency is already examining its options for new offices, including some sort of special deal with the City of San Francisco.

Former State Sen. Art Torres, onetime chairman of the state Democratic Party and co-vice chairman of CIRM, briefed agency directors on the matter at its meeting in May. He said,

“I met with the mayor of San Francisco(Ed Lee), who's a dear friend, and he encouraged us to be aware that he's very committed to helping us find some space in San Francisco. Whether it means tax credits or incentives to a potential landlord, we still have to work that out. Obviously we still have to work out what the space will be. But the fact that the mayor has indicated very explicitly that he wants to keep us in San Francisco, I think it will bode well for us down the road.

“The current owner of the property (Stockbridge Capital Partners) has not been happy that for ten years they've had to supply free rent to us. And what they didn't anticipate was having to provide for over $755,000 in operating costs, which they thought some donors would take are of. Those donors -- some of whom passed away and others who chose to give money to other institutions, UC San Francisco, in particular, to the stem cell lab, which was very much appreciated, I know, by UCSF – but at the end of the day, there's no room for negotiations with this current owner.”

CIRM Director Joan Samuelson asked Torres whether future rent would also be free. Torres, who is also president of San Francisco's Public Utilities Commission, replied,

“I would not work on that assumption. I would work on the assumption somewhere between a dollar and more, again, dependent upon what kind of tax incentives the City of San Francisco would provide. We're very fortunate that my son(Joaquin Torres) is the deputy mayor for economic development, so we also have him working on this as well.”

Samuelson replied,

“I'll ask more questions offline.”

California Stem Cell Official Duane Roth in Improving Condition

Duane Roth, the co-vice chairman of the California stem cell agency, is improving after he was hospitalized for treatment of a serious brain injury sustained in a bicycle accident Sunday in the mountains east of San Diego.

According to a report on Xconomy.com, Roth's brother, Ted, said yesterday, 

“Were certainly moving in the right direction. We're now looking at the recovery phase.”

The article by Bruce Bigelow said Roth has passed through the most critical period following surgery at the UC San Diego hospital.

Roth, the 63-year-old CEO of the San Diego technology organization, Connect, is in serious condition in a medically induced coma.

The governing board of the California stem cell agency yesterday took special note of Roth at its meeting and sent its best wishes to him and his family.  

Stem Cell Agency Board Concludes Meeting

The governing board of the California stem cell agency concluded its meeting today at 2:33 p.m. PDT. The California Stem Cell Report has also concluded its coverage today's session.

CIRM Posts Alpha Clinic Press Release

The California stem cell agency this afternoon posted its press release on the $70 million Alpha stem cell clinic plan. Here is where it can be found.

Another $23 Million to Recruit Star Stem Cell Scientists to California

California's $46 million effort to lure stem cell research stars to the Golden State was expanded today by another $23 million.

Directors of the stem cell agency approved the funds on a 14-4-1 vote. CIRM directors Jeff Sheehy and Francisco Prieto were among those opposing the move. Prieto declared,

“We are coming up against finite resources. We have better ways to spend our money."

 Sheehy said that CIRM is contributing to inflation in stem cell science with its lucrative recruitment grants. 

Those supporting the expansion said that the grants have had a great impact on the field, not only bringing in individual scientists, but accompanying researchers in their labs along with grants from other sources.

The additional funds will go to institutions that have not already benefited from one of the earlier grants in the program. Up to four awards are expected to be made.

The CIRM staff proposal on the plan said,

“A number of California institutions have not yet been able to secure a confirmed Research Leadership award but would benefit greatly from the recruitment of emerging or established leaders in stem cell biology. Participation in the CIRM program could bring additional, exceptional researchers to California, strengthen and synergize with other efforts to build up local sustained research communities in stem cell biology and medicine and provide ongoing leadership at the cutting edge of California regenerative medicine.”

All of the California institutions involved with the winning researchers have representatives on the governing board of the stem cell agency. They are not allowed, however, to vote on grants to their institutions or researchers -- only on proposals such as today's $23 expansion.

Applications are due in January with final approval scheduled for next May. The program is not open to businesses.

$35 Million Research Grant Round to Remove Stem Cell Roadblocks

Directors of the California stem cell agency today approved a $35 million program aimed at removing bottlenecks to pushing stem cell therapies into the marketplace.

The plan would provide grants of up$1.2 million for about 20 awards with competition open to both business and non-profit institutions. Pre-applications are expected to be due in October with approval next summer.

California Stem Cell Agency Launches $70 Million Alpha Stem Cell Clinic Project

The California stem cell agency today approved a $70 million plan to create a network of “Alpha” stem cell clinics that is aimed at making the Golden State one of the leading purveyors and developers of stem cell therapies in the world.

The 29-member governing board of the California Institute for Regenerative Medicine (CIRM)adopted the plan on a 19-1 vote. The negative vote came from Joan Samuelson, who questioned whether the plan was premature and whether existing scientific research justified development of the clinics. 

Sherry Lansing, a patient advocate board member and former head of a Hollywood studio, said the proposal is “one of the most exciting proposals that we have ever had in front of us.” She said it was the “beginning of this dream coming true.”

Under the far-reaching proposal, which CIRM President Alan Trounson has been promoting for two years, the agency will finance five stem cell clinics at established institutions in California with grants of up to $11 million. Another $15 million will be allotted for a stem cell information and coordination center. Major matching contributions will be expected from award winners over the five-year terms of the grants.

The effort is aimed at drawing in clinical trials and patients from the around the world and creating a central bank of knowledge, know-how and regulatory expertise. It will also guide efforts to build profits into stem cell therapies and to develop strategies to attract investors and philanthropists. (For more information on the plan, see here, here, here, here and here.)

Trounson said in a statement,

“These clinics have the potential to revolutionize how we deliver stem cell therapies to patients. Stem cell therapies are a completely new way of treating diseases and disorders so we need a completely new way of delivering those in a safe and effective manner. These clinics will help us do just that and the clinical trials carried out in this network will fulfill the agency’s promise of bringing new therapies to patients who need them.” 

The journal Nature Medicine has reported that the Alpha clinics would be the first-ever “clinical trials network focused around a broad therapeutic platform.”

The CIRM board heard no negative comment on the plan other than the remarks by Samuelson. . However, not everyone sees a need for it. Mahendra Rao, director of the Center for Regenerative Medicine at the National Institutes of Health(NIH) , says its surveys of researchers have not shown a demand for such centers. In May, a researcher at institution that likely would be an applicant filed a blistering, anonymous comment on the California Stem Cell Report, describing it as a "boondoggle" and "irresponsible." The scientist said,

“Another boondoggle for some medical schools but made to order for private operators like for-profit cancer, dialysis, and laser eye specialty clinics that do one procedure.  I can see each of the medical schools gifted with one as they each were gifted with about 25 million dollars for stem cell institute buildings.”

The researcher continued,

“The NIH at various times has tried to organize clinical trials groups with infrastructure, like quick reaction forces, ready to gear up for a new trial at the drop of a hat. They mainly did nothing but suck money, kept staff employed, because there are generally few drugs ready for early human trials and each treatment that is brought along requires a unique contract, ethics reviews, and different facilities, equipment and staff than planned for.  The latest incarnation are CTSAs or CTSIs, clinical and translational science centers funded by the federal NIH that most if not all California medical schools already have.”

The RFA for the proposal is expected to go out in October and approval of funding coming one year from now. Here is the link to today's CIRM press release on the plan. 

Alpha Clinic Applicant Qualifications

The chart above outlines the criteria for applicants for grants in the $70 million Alpha clinic plan.

Stem Cell Directors Take Up $70 Million Alpha Clinic Proposal

Directors of the California stem cell agency have begun discussion of the $70 million Alpha stem cell clinic plan. The staff is laying out the proposal at this hour.

California Stem Cell Agency Has $577 Million Remaining for New Research Awards Out of $3 Billion

The California stem cell agency has only $577 million left for future research awards over the next four years, its directors were told this morning.

The figure was reported by CIRM staff this morning as part of its regular briefing on the financial status of the research effort, which began work in 2004 with $3 billion that the state is borrowing through issuance of state bonds. The method of funding will cost roughly $3 billion more in interest costs.

The agency expects to run out of funds for new grants late in 2017 and is considering ways to raise cash for future operations..

.

Stem Cell Directors Begin Meeting with Report from Alan Trounson

Today's meeting of the governing board of the California stem cell agency began at 9:35 a.m. today with a a report from chairman J.T. Thomas, updating the board on his activities. CIRM President Alan Trounson has now begun his report dealing with stem cell research publications over the last few months.

California Stem Cell Board Meeting Delayed

The business portion of today's meeting of the governing board of the California stem cell agency was scheduled to begin at 9 a.m. PDT. However, that session has been delayed as the board hears a presentation on MS. The business session may begin about 15 minutes or so.

Coming Up: Live Coverage of Today's California Stem Cell Meeting

The California Stem Cell Report will provide live, wall-to-wall coverage of today's meeting of the governing board of the $3 billion California stem cell agency.

At the top of the agenda is a $70 million proposal aimed at creating a string of Alpha stem cell clinics in California that would serve as a foundation for the state's stem cell business. Also on tap are other proposed grant programs, including a $23 million expansion of a researcher recruitment effort and a $35 million round aimed at removing roadblocks to turning research into cures.

Stories will be filed as warranted throughout the day based on the Internet audiocast of the proceedings. 

Interested parties can also listen in on the meeting via the Internet. Instructions can be found on the agenda.  

Stem Cell Lines and Paid-for Eggs: Stem Cell Agency Delays Action on Easing Restrictions

A key panel of the California stem cell agency today balked at approving a plan to ease restrictions on using stem cell lines derived from women who were paid for their eggs.

The proposal had been scheduled to be taken up tomorrow by the governing board of the $3 billion agency, but the board's standards working group delayed action.

In response to a question, Kevin McCormack, a spokesman for the agency, said in an email,

“It was felt that more discussion was needed before moving to a vote so another meeting is going to be scheduled.”

In 2006, the CIRM governing board approved regulations that banned the use of CIRM funds for stem cells lines derived using compensation. That rule would be modified under today's plan, which would permit the CIRM governing board to approve the use of such lines following a staff study evaluating scientific and ethical issues. Their use would be allowed if the lines would “advance CIRM's mission.”

The delay came after four organizations, including the Center for Genetics and Society in Berkeley, argued that the plan is vague and did not adequately address safety issues.

The four-page statement by the groups said that the plan does not appear to have met “numerous concerns” raised in 2009 in a document co-authored by the CIRM staff. Those concerns include long-term risk and ethical issues.

Under the proposal, the groups said that the agency governing board

“...will decide whether to approve a grantee’s request to use a stem cell line created with paid-for eggs on the basis of whether doing so 'will advance CIRM’s mission.' This criterion is much too vague, and doesn’t include consideration of the health or welfare of the women who undergo egg retrieval. Protecting the well-being of women providing eggs is not even mentioned (though perhaps it could be considered as an element of the fifth of five 'factors to be considered by the ICOC(the agency board),' 'whether the donation…was consistent with `best practices’ at the time of donation').”

The standards group also heard from a UCLA researcher who argued on behalf of the change. Kathrin Plath said she and her colleagues wanted to use a paid-for stem cell line from the Oregon experiment that cloned human stem cells.

(An earlier version of this item said the change under consideration would ease restrictions on "purchasing" stem cell lines. The word "purchasing" was changed to "using.")

Here is the text of the statement by the four organizations.

CGS July 2013 Letter Opposing Changes in CIRM Cell Line-Egg Regulations

$70 Million Alpha Stem Cell Clinic Project Garners Mainstream Media Attention

California's $70 million plan for a chain of “Alpha” stem cell clinics today received its first major attention from the mainstream media.

The story came in the state's largest circulation newspaper, appearing this morning on the home page of the website of Los Angeles Times.

The Alpha project would create five clinics around the state and a coordination/information center under a concept that comes before the governing board of the state's $3 billion stem cell agency at its meeting tomorrow in Burlingame, Ca. Funds could be awarded as early as a year from now. (For more information, see here and here.)

Reporter Eryn Brown quoted Natalie DeWitt, special projects officer for CIRM, as the stem cell agency is known, and Maria Millan, a CIRM medical officer. Brown wrote,

“Clinics to conduct trials of stem cell therapies have different needs than clinics designed to deliver conventional therapies, DeWitt and Millan said. They need special facilities for handling the cells safely, as well as imaging equipment to track the cells once they're delivered into a patient’s body.  Some of this infrastructure already exists, but other parts of it still need to be perfected.  Establishing clinics to house multiple trials might create the critical mass needed to get the infrastructure in place, they said....

"Additionally, they said, CIRM hopes that such collaboration would encourage stem cell companies to share information -- speeding their own work and also helping out policymakers and insurers who are trying to figure out how they'll pay for stem cell therapies in the future.”

The Times quoted the California Stem Cell Report as saying last week,

 “The Alpha clinics are aimed at creation of a sturdy foundation for the stem cell industry in California, capitalizing on the burgeoning, international lure of stem cell treatments.”

The proposal envisions Alpha stem cell clinics at major, established institutions around the state. It is possible that two could be located in the Los Angeles area at institutions such as UCLA, USC, Cedars-Sinai or the City of Hope, all of which have representatives on the stem cell agency's governing board. Other likely locations are in the San Francisco Bay area and San Diego, again at facilities such as Stanford, UC San Francisco and UC San Diego that have representation on the agency board.

Institutions competing for the grants, including businesses, will be subject to closed-door. peer review prior to final action by the full governing board.  

UCLA Researcher Calls for Easing of Restrictions on Stem Cell Lines Derived from Eggs From Paid Providers

A UCLA researcher has spoken out in support of a proposal to allow use of California stem cell agency funds to purchase stem cell lines derived from eggs provided by women who have been paid for the service.

Kathrin Plath, an associate professor, said in a letter to the agency that she and her colleagues would like to use a line from the Oregon SCNT experiment by Shoukhrat Mitalipov in which human stem cells were cloned. Currently agency funds cannot be used for that purpose as a result of regulations that are the extension of a state law that bars use of agency funds for payment for eggs.

The agency's standards group meets later today to consider changing those regulations. The proposal will then go before the full board tomorrow.

Plath, who has received $5 million from CIRM, said,

“In my lab, we are ... interested in understanding what happens to the somatically silenced X chromosome when differentiated cells are reprogrammed by SCNT. The key question is: are these SCNT-ESCs more similar to iPSCs or fertilization-derived ESCs with respect to the epigenetic state of the X chromosome. Furthermore, it has been shown in mouse reprogramming that the active X chromosome becomes deregulated during SCNT-based reprogramming, and we would like to address this problem in the human system as well.

“We believe that the comparison of the epigenetic states between fertilization-derived ESCs, SCNT-ESCs and human iPSCs is important for a better characterization of these cells and understanding of their epigenetic nature.”