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Report from the CIRM Standards Working Group meeting

Posted by Susan Fogel on March 10th, 2008

Alan Trounson

Susan Fogel of the Pro-Choice Alliance for Responsible Research filed this report on the recent meeting of the Standards Working Group of California stem cell research program, held on  February 28, 2008 in San Francisco.

When the Standards Working Group (SWG) of the California Institute for Regenerative Medicine (CIRM) met last week, the apparent purpose was to identify the emerging issues on which they were going to work. From all appearances, few working group members expected the bombshell from the new CIRM President, Alan Trounson, that he wanted to open the door to paying women for their eggs for CIRM-funded research, a clear end-run around California law.

The meeting agenda was vague enough for David Jensen of the California Stem Cell Report to call it a "mystery meeting." None of the meeting documents were posted on the CIRM website until I asked for them, and most were finally posted less than 24 hours before the meeting. Still, there was nothing to suggest that anything out of the ordinary was going to be discussed: a memo on pediatric bone marrow transplant clinical trials conducted by Dr. John Wagner; proposed changes to CIRM's Medical and Ethical Standard regulations that had been open to public comment; an item noted on the agenda as pertaining to iPS (Induced Pluripotent Stem cell research) was instead a paean to CIRM written by its biggest cheerleaders - CIRM board (ICOC) chair Bob Klein, new CIRM President Alan Trounson, and outgoing interim President Richard Murphy.

Alan Trounson stepped up to the podium, and certainly surprised nearly everyone in the room with a proposal that the SWG support paying women for their eggs by offering them compensation in the way of discounts on their fertility treatments - "egg-sharing" - if they agree to give up some of their eggs before they have achieved their own reproductive success. Never mind that Proposition 71 itself [PDF] prohibits compensation for egg providers in CIRM funded research; the CIRM regulations [PDF], adopted after a deliberative and public process, prohibit compensation; California statute passed and signed into law in 2006 (SB 1260) prohibits compensation in non-CIRM funded research, and the National Academies guidelines [PDF] prohibit compensation. The only permissible payment is for reimbursement of incurred expenses. Trounson made several assertions: (1) researchers cannot use spare embryos (this is incorrect - there is no California law that prevents people from donating embryos to research), (2) it is highly unlikely that women would give extra eggs when they go through fertility treatments (no evidence here), and (3) it is extremely difficult in California to get human eggs (others pointed out that there is no such evidence; however, SWG member Kevin Eggan stated that he hasn't been able to recruit egg donors in Massachusetts).

When ICOC and SWG member Jeff Sheehy raised the concern that such a situation known as "egg-sharing" could result in women being put at risk for Ovarian Hyperstimulation Syndrome (medical complications from the drugs given to women to induce their ovaries to produce multiple eggs) if fertility clinics induced them to over-produce eggs, Trounson countered by saying "Clinicians wouldn't do that." In stark contradiction, he later stated that reputable physicians would not counsel their fertility patients to donate eggs before they have achieved their own reproductive success, and that is why they have to pay women.

It soon became clear that at least one person in the room knew this was coming. Klein and Trounson had clearly been conspiring on turning California law on its head. Klein jumped in to make the argument that since it is permissible to reimburse women for medical care they might need for health consequences of providing eggs, he had a legal opinion from James Harrison, of the Remcho firm, with a twisted definition of "medical" to include IVF treatment, and arguing that paying women for a portion of their IVF would be "reimbursement" not "compensation." Alta Charo disputed that interpretation, saying that she believes allowing reimbursement for medical expense was intended to leave donors no better or worse off than they had been, and to give them discounted IVF would leave them better off, and not contemplated as a reimbursable expense. [As a sidebar, Mr. Harrison and his law firm, are paid hundreds of thousands of dollars per year to provide legal advice to CIRM. One has to wonder about the taxpayers paying for a legal opinion about how to subvert the law CIRM is supposed to uphold].

Sheehy added that the California voters who passed Proposition 71 thought there would be no compensation, and that he would not have voted for it otherwise. Klein then admitted that he wouldn't have voted for it either.

The larger question is why are Klein and Trounson pushing so hard for SCNT? Breakthroughs in iPS (induced Pluripotent Stem Cells) and other new avenues of research including those using embryos no longer needed for fertility purposes offers CIRM plenty of opportunity for leadership in research, without the health risks to women. As Kevin Eggan stated at the meeting, SCNT is still exciting, but it may become "increasingly passé."

Despite the concerns raised at the meeting, the bottom line is that the SWG agreed on 5 items for their future agenda, and 4 of them involve payment for eggs at some level of procurement.

They then tried to soft-pedal the decision by saying they were only gathering information.

Genomes of the Rich and Famous

Posted by Jesse Reynolds on March 5th, 2008

Francis Collins, George Church, Linda Avey, Craig Venter. Photo via Esther Dyson.

The prospect of biotechnology companies capitalizing on genetic information in order to develop profitable products without properly compensating the studied populations brings to mind biocolonialism, in which politically and economically vulnerable indigenous groups are exploited. But a growing convergence of genomics and information technology may lead, ironically, to the genetic "exploitation" of society's most elite.

A new brief by the ETC Group on the rapidly growing direct-to-consumer genetic testing industry asserts that the genomic data - which clients pay handsomely to have taken from them - will likely be correlated with health data in order to develop new products:

[T]the information gleaned from most genetic tests has very limited use for patients, but it is extremely valuable to companies and researchers trying to establish links between medical conditions and genetic variations, enabling - they hope - the development of drugs targeted to people with specific genetic profiles. In the shorter term, drugs that have been taken off the market due to unexpected adverse reactions in a small percentage of the population could be re-marketed as personalized drugs, intended only for those with the appropriate genetic profile. Through clever (and often misleading) marketing, some companies are persuading consumers to pay for storage of genetic data and health information, which the companies intend to use (e.g., sell) for research and drug development.

The highest profile company in this field is 23andMe, backed by Google both financially and maritally. It recently took the opportunity of the elite gathering, the World Economic Forum, to entice the globe's movers and shakers with one thousand free test kits and memberships. An online photo stream posted by Esther Dyson, a 23andMe investor and board member, reveals the chummy atmosphere as the saliva of the elite is collected. Shown spitting into tubes and schmoozing are the top dogs of media (from Time, the New York Times, the Financial Times), investing (Peter Thiel from Clarium Capital and formerly of PayPal), marketing (Richard Edelman of Edelman, David Kenny of Digitas/Publicis, Sir Martin Sorrell of WPP Group), infotech (Michael Dell of Dell Computers, Anatoly Karachinsky of the IBS group, Geraldine and Loic LeMeur), biotech (George Church, Linda Avey, Craig Venter), academia (Francis Collins), and pop culture (Peter Gabriel, Naomi Campbell, Goldie Hawn, Kurt Russell) .

Not only is Google an investor in 23andMe, it is also a likely future business partner. As the ETC Group points out, the real value will come from correlating genomic data with health information. Sure enough, Google recently announced that it has entered the business of health records management. And 23andMe's privacy statement makes the possibility clear:

To achieve our research goals, 23andMe may enter into partnerships with commercial and/or non-profit organizations that conduct scientific and/or medical research. Such partnerships may allow an organization access to our databases of Genetic Information and other contributed Phenotypic Information, so that, for example, the organization can search, without knowing the identities of the individuals involved, for the correlation between presence of a particular genetic variation and a particular health condition or trait. We may receive compensation from these research partners.

Of course, the half a million SNP's offered by 23andMe - most of which are currently meaningless - for a mere thousand dollars may not meet the high expectations of today's hoity toity. Another Google-backed company, Knome, founded by Harvard's George Church (who is also an adviser to 23andMe), offers a full genome sequence - most of which is currently meaningless - for $350,000. An article in yesterday's New York Times profiled a seemingly happy customer, self-described "transhumanist" Dan Stoicescu:

"I'd rather spend my money on my genome than a Bentley or an airplane," said Mr. Stoicescu, 56, a biotechnology entrepreneur who retired two years ago after selling his company. He says he will check discoveries about genetic disease risk against his genome sequence daily, "like a stock portfolio."...

Biologists have mixed feelings about the emergence of the genome as a luxury item. Some worry that what they have dubbed "genomic elitism" could sour the public on genetic research that has long promised better, individualized health care for all. But others see the boutique genome as something like a $20 million tourist voyage to space - a necessary rite of passage for technology that may soon be within the grasp of the rest of us....

"I feel like everyone's going to have to get it done at some point, so why not be one of the first?" said Eugene Katchalov, 27, a money manager in Manhattan who has met with Mr. Conde [Knome's CEO] twice....

"What the heck am I doing?" Mr. Stoicescu recalls wondering. "And how many children in Africa might have been fed?"

Then he offered up his arm and gave her three test tubes of his blood.

Previously on Biopolitical Times:

Another Bill to Reform the California Stem Cell Research Program

Posted by Jesse Reynolds on March 4th, 2008

Sacramento, the capital of California

For the fourth year in a row, the Democratic chair of the California Senate Health Committee, currently Sheila Kuehl, and her Republican colleague, George Runner, have introduced a bill to address some of the flaws in the California stem cell research program, but none have yet been enacted into law. Judging by the relatively mild reaction this time from the leadership of the California Institute for Regenerative Medicine (CIRM), the latest may stand a chance of passage. That's saying a lot, since the proposition that created the CIRM was written to shield it from legislative oversight: It requires a 70% supermajority in both houses of the Legislature and the governor's signature for any modifications.

The bulk of the current reform bill, SB 1565, addresses intellectual property, requiring that grantees and licensees submit a plan for affordable access to any medical treatments that are developed out of the publicly-funded research. But the long-term impact of the Kuehl-Runner bill would likely derive from the briefer second section, which calls on the Commission on California State Government Organization and Economy (a.k.a. the Little Hoover Commission) to research and issue a report on how the structure of CIRM's governing board "could better ensure public accountability and reduce conflicts of interest."

The Hoover Commission has a good reputation in tackling just this kind of issue. Given that the CIRM's inherently-conflicted board is dominated by representatives of the very institutions vying for a big slice of the public funding pie, the Commission could recommend some significant changes, providing political cover for the Legislature to take real action.

But we won't know until the report is issued next year. In the meantime, There's no shortage of CIRM-related improvements that need to be made in the areas of good government and public interest. Some examples: requiring working group members to publicly disclose their potential conflicts of interest, bringing the CIRM into the normal folds of state governance and accountability, and removing the 70% supermajority requirement for amendment.

But having a neutral body examine the structure of the CIRM's governing board seems like a good place to start. The Commission's report is due out next year.

Previously on Biopolitical Times:

Toles on Meat Recall

Posted by Osagie Obasogie on March 3rd, 2008

As a follow up to my last post on the recent meat recall and the wisdom of eating meat from cloned animals before we know the health effects, here's an editorial cartoon by  Tom Toles that provides another interesting perspective on the recall.

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