The Niche

The first Congressional hearing on stem cells in years came together suddenly. Once called, Representative Diana DeGette (a Democrat from Colorado), who’d previously put together twice-vetoed legislation promoting stem cells said she was planning to put forward another version, one that could include a regulatory role for the NIH, even over research it did not fund.

The goal is to lift the federal funding ban on embryonic stem cells created after August 2001 and also set up the National Institutes of Health as a “key player” in a new system for ethical oversight over all cell-based research.

“All this private and state development is being done without ethical oversight,” DeGette’s spokesperson Kristofer Eisenla told me. “A lot of the substance of the bill is still in development, but the overall goal is that all cell-based research would be done under strict ethical guidelines that would be overseen by the NIH.”

How that would play out is still unclear, but it ould be a huge expansion of the Institute’s role. “Historically, the NIH does not have a regulatory role in research, that’s the FDA’s jurisdiction. It could create a very different dynamic [between scientists and the NIH],” said Michael Werner, head of a consultancy specializing in legislative issues affecting biotech. “All stakeholders want to make sure that research is done ethically and appropriately. We need more details of what the Congresswoman is proposing.”

The title of the hearing was “Stem Cell Science: The Foundation for Future Cures.” John Gearhart, a professor of medicine at John Hopkins University, said that he and others testifying before the committee had submitted testimony on that topic and had not known that DeGette would be proposing an oversight role. Otherwise, he said, there could have been discussion on the guidelines drafted by the National Academies of Science and research institutions' use of embryonic stem cell research oversight (ESCRO) committees. "We did not have the opportunity to respond to her, that all institutions are complying with ESCRO guidelines. We’re not just doing what we want."

DeGette’s spokesperson said that the Representative had been trying to bring the stem-cell hearing before the Committee for years, and that the intention was not to bring anything before President Bush but to lay groundwork for future legislation.

See more coverage by the Denver Post.

The hearing was scheduled late last week when another one was cancelled. Coincidentally, it was just two days after the National Institutes of Health had held a long-scheduled meeting on the challenges and promises of cell-based therapies.

Reports from the hearing said that conversation broke down mainly along party lines, with Democrats interested in scientific advances from embryonic stem cell research and Republicans stating that only adult stem cells were so far the only type that had been used in therapy. A report from BioWorld quotes Harvard’s George Daley that adult stem cells have been around for 40 years and embryonic stem cells around for a decade.

Story Landis, head of the NIH Stem Cell Task Force said that if there was any take-home lesson from the symposium, it was that the best source of cells for cell therapies would depend on the disease. For example, neurodegenerative diseases seemed much more likely to be amenable to work from embryonic stem cells, while blood-derived stem cells were effective with some blood disorders.

“It’s clear that adult stem cells are being used in approved trials or early stage clinical trials and other cases where it’s clear that those cells won’t be very helpful.”

Posted by Monya Baker on May 09, 2008
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Desperate patients need help separating legitimate researchers from quacks, said representatives the biggest organization for stem cell researchers, who announced that they’d decided to draft guidelines for how basic research on stem cells can be responsibly “translated” to research on human patients. The guidelines will cover embryonic stem cells plus those collected from cord blood and adults, as well as stem cells induced from differentiated cells.

At a press conference in Half Moon Bay, California, a panel of highly influential officials and researchers in stem cell science said they were alarmed at “medical tourism” in pursuit of questionable and potentially harmful stem cell procedures. The only established stem-cell treatments are for a handful of blood diseases, they said, but advertisers promise cures for every imaginable disease. Story Landis, head of the National Institute of Neurological Disorders and Stroke and George Daley, president of the International Society for Stem cell Research said their organizations were besieged by patient queries about treatments whose risks and benefits are unknown. The ISSCR plans to produce guidelines to help such patients and their families assess whether practitioners’ claims are credible.

Continue reading "Patients paying for stem cells are probably getting bad science" »

Posted by Monya Baker on March 20, 2008
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Yesterday, the California Institute of Regenerative Medicine named Marie E. Csete, MD, PhD as its chief scientific officer. She's currently at Emory University doing basic research looking at the role of oxygen in stem cell death and differentiation plus applied work in anesthesiology and liver transplants. She has served on CIRM's scientific and medical research funding working group, which reviews grants.

The former CSO, Arlene Chiu, was recruited from NIH. I've heard her praised widely both within and outside the agency for her diligence, fiestiness, for building a grants reviewing process from scratch, and for great ideas in the scientific strategic plan. Chiu resigned shortly after Zach Hall, CIRM's first president, did. (Read about that on the California Stem Cell Report.)

CIRM's structure is unusual; its officials have built-in restrictions that many aren't used to (see our article on CIRM's search for a president). What's interesting in this appointment is that Marie Csete is an MD/PhD with significant clinical expertise, the kind of expertise that CIRM leadership has said is necessary to move stem-cell work from bench to bedside.

Here's a profile of the new CSO written last year by Emory's press office.
Here's CIRM's press release, packed with glowing appraisals.(I couldn't find a link on CIRM's site, so I'll paste my email below)

Continue reading "CIRM has a new scientific head" »

Posted by Monya Baker on March 13, 2008
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On 26-27 February, representatives from 19 countries plus California and the Juvenile Diabetes Research Foundation discussed international collaboration for stem cell research, particularly how to coordinate cell banks and registries. Announcements included that India would become the 20th country to join the forum and that induced pluripotent stem cell lines would not be included in the characterization efforts already well underway for embryonic stem cell lines, but that decision would be reconsidered at the meeting in October. (See our commentary and research highlight on ISCF-funded projects.)
The group of research funders, known as the International Stem Cell Forum (ISCF) was founded in January 2003 through the UK’s Medical Research Council (MRC).
In an interview with me, chief executive of the MRC, Sir Leszek Borysiewicz described the ISCF’s efforts. A shorter, prettier version of this is online at Nature. I expect it will print next week.

Continue reading "Banking on the future of stem cells: Q&A with the head of the UK Medical Research Council" »

Posted by Monya Baker on March 13, 2008
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The former head of President Bush’s council on bioethics, now says there shouldn’t be a ban against cloning human embryos for research. Instead, there should be a five-year moratorium against the process. Writing in the Weekly Standard, Leon Kass decries the fact that the US Congress did not pass a law blocking all forms of human cloning, and then says that this stricter form of the law is unnecessary now that researchers can turn to alternate ways of reprogramming.

Instead, he argues for a law that would ban “all attempts to conceive a child save by the union of egg and sperm (both taken from adults).” That’s because the new reprogramming techniques mean that a skin cell could generate egg and sperm cells, whether taken from a man or a woman (or a boy or a girl, for that matter).

Embryos created for the purposes of research would not be outlawed, but instead banned for four or five years as researchers are given more funds to perfect the reprogramming techniques. He does not rebut, because he does not raise, the argument that stopping work the creation of embryos for research through somatic cell nuclear transfer will delay efforts to prefect reprogramming techniques.

Kass writes “Cloning for the purpose of biomedical research has lost its chief scientific raison d'être” (i.e. making a pluripotent cell line genetically matched to a patient.) That’s because it will probably be much easier to reprogram whole cells from adult biopsies than it will be to pull out an adult cell’s nucleus, plop it into a donated egg, grow that “reconstituted embryo” to a blastocyst and make embryonic stem cells.

Kass is probably right, but he fails to mention two caveats.

First, while many scientists are hopeful that so-called induced pluripotent stem cells will really behave like embryonic stem cells, they still aren’t sure. Possibly, a reprogrammed skin cell could be coaxed into a pancreas cell or a heart cell, transplanted, and then “remember” that it started out as a skin cell. Also, no one wants to use the current technique (using viruses to insert genes at random places in the cells’ chromosomes) to make cells that would actually get put into people. Those are serious problems, but most scientists think they can be overcome.

Second, and more important, many scientists think that to understand how reprogramming works with viruses, they have to understand how reprogramming works in an egg. Most people think that requires transferring adult nuclei into eggs or early embryos, and trying to figure out what happens.

Just a little quibble: Kass says that recent success by Stemagen in cloning a human blastocyst depended on the technique that Shoukhrat Mitalipov’s team in Oregon used to clone monkey blastocysts to make embryonic stem cells . Actually, Stemagen did not use this technique but credits its success not with a new technique but with a supply of high quality eggs.

Posted by Monya Baker on February 21, 2008
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Fifty non-profits and nine companies have applied for the up to 20 disease-specific planning awards offered by the California Institute of Regenerative Medicine. These are small potatoes, intended to support six months of proposal development for the CIRM disease team research awards, multi-year grants for multidisciplinary teams, but the grants will take just as long to award. Recommendations will be made by the Grants Working Group in April, with decisions by the Independent Citizen’s Oversight Committee making the final decision in June. In January, ten companies and 56 teams from university sent letters saying that they intended to apply for these smaller $55,000 grants, according to a story by Terri Somers. Receiving one of these planning grants is not a prerequisite for submitting an application for the bigger grants, though the applications for these should be issued shortly after the planning cycle.

The notion of creating disease-specific teams was first put forth by former chief scientific officer Arlene Chiu, who was brought in by the now-departed president Zach Hall. Though I did not see any amounts listed for the bigger awards, current president Alan Trounson shows support for this idea and the bigger grants. The press release quotes him as saying, “A key objective of the subsequent Disease Team Research Award will be for teams to produce an approvable regulatory filing enabling human clinical testing within four years after the award.” CIRM’s scientific strategic plan written in 2006 projects spending $122 million on disease teams and $60 million on interdisciplinary teams over ten years, though presumably work by researchers funded under these plans would also be eligible for other funding categories.

These programs are also interesting because they are the first time CIRM will give money to businesses, though they do have some strings attached. In addition to grants, CIRM is also offering loans.

CIRM says that funding companies necessary because companies traditionally move science into medicine. Companies that receive CIRM funding to make high-revenue products will be required to give some of this revenue back to the state, and CIRM argues that this investment will yield high returns. In one of our commentaries, Stanford’s Michael Longaker provides a case study of how that might work and how return on investment can be assessed.

Posted by Monya Baker on February 05, 2008
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Both the International Society of Stem Cell Research and the California Institute of Regenerative Medicine have issued statements about stem cell research in the state of the union address, which praised work in reprogramming adult cells to an embryonic-like state and called for expanded funding for “ethical” research. CIRM called it “misleading.” The ISSCR said “a great deal of work remains before these methods can be used to generate stem cells suitable for safe and effective therapies.”

The ISSCR also stated that the FDA has informed fertility clinics of its policy to prevent reproductive cloning. The agency instructed institutional review boards (the committees that must approve research on human subjects) that such investigations are under its jurisdiction and will not be allowed to proceed.

Generally though, the President’s speech held nothing new. The few queries I put out to ask what was meant by “expanded funds” or “legislation that bans unethical practices” were met by the phone and equivalents of shrugs: “who knows?”

I thought a blog in Wired did a nice job of summing it up. “Both sides will applaud the expansion of reprogrammed cell research, then regroup on their side of the debate.”

Here are links to my previous posts on potential ramifications in funding and legislahtion.

Posted by Monya Baker on January 31, 2008
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In his state of the union address, President Bush promised to expand funds for some stem cell research and to ban patenting of human life. (That has interesting implications, as discussed in my previous blog.)

There doesn’t seem to be additional money flowing to the NIH, but the NIH has already been directed to fund “ethically responsible” sources of pluripotent cells, a program announcement for this was described months ago, and there is a supplement program. These additional funds could not be used to directly compare reprogrammed cells with human embryonic stem cells derived from the most advanced techniques. (In one of our commentaries , Markus Grompe, head of the Oregon Stem Cell Center describes what questions these cells could answer and that he has made the decision, on ethical grounds, not to ask questions that would require newly derived human embryonic stem cell lines. In another commentary, the presidents of the California Institute of Regenerative Medicine lay out what some of those questions are and why they are important.)

(Also see my interview with Story Landis, head of the NIH Stem Cell Task Force)

Here’s the transcript of the relevant bit of the State of the Union speech. I have some calls out for clarification, and if anything interesting comes back, I’ll post it later:

On matters of life and science, we must trust in the innovative spirit of medical researchers and empower them to discover new treatments while respecting moral boundaries.

In November, we witnessed a landmark achievement when scientists discovered a way to reprogram adult skin cells to act like embryonic stem cells.

This breakthrough has the potential to move us beyond the divisive debates of the past by extending the frontiers of medicine without the destruction of human life.

(APPLAUSE)

So we're expanding funding for this type of ethical medical research. And, as we explore promising avenues of research, we must also ensure that all life treated with the dignity it deserves.

And so I call on Congress to pass legislation that bans unethical practices such as the buying, selling, patenting or cloning of human life.

Posted by Monya Baker on January 29, 2008
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Last night, President Bush announced expanded funds (see next blog) for research to reprogram adult cells to act like skin cells, but his proposed policy on patents would have more of an impact.

Bush called on Congress “to pass legislation that bans unethical practices such as the buying, selling, patenting or cloning of human life.” While current policy forbids federal funding to be applied to newer human embryonic stem cell lines, this is an actual ban. It could make certain kinds of work illegal, such as making new human embryonic stem (ES) cell lines by cloning human embryos, an advance reported recently by a US company. (Interesting that Bush didn’t include harming or destroying human life.)

However, that part of the legislation is unlikely to get anywhere. The US is actually unusual in that it does not forbid reproductive cloning of new human beings. Nobody is for this, but legislation to ban it always stalls because some legislators insist that bills also ban therapeutic cloning (to make ES cells), so those that back ES research withdraw their support.

What’s more interesting is the patenting part. Patents already exist on deriving human embryonic stem cells. These patents have been widely criticized for being too broad and its holder WARF for being too stingy. If Bush pushed for it, those patents could, perhaps, get invalidated because of this policy. Interestingly, that could bring the US much closer to the European patent position, and could mean a whole new playing ground for the WARF patents covering the derivation of human embryonic stem cells.

At first blush, this may seem like a boon to institutions who could have more freedom to operate. But it may not be as advantageous as one might think.

The University of Sheffield’s Aurora Plomer, Berkeley’s Ken Taymor, and Stanford’s Chris Scott wrote comprehensively on this issue recently in Cell Stem Cell. EU policy “prohibits the patenting of the human body at the various stages of its formation and development,” Human cloning is not patentable, nor is the use of human embryos for commercial purposes permitted. (Aside: But fertility clinics are legal. Why?) Their conclusion is that conflicting interpretations of this policy have stymied research and even allowed companies to play off each other. They even describe how Geron is trying to invalidate a German patent on stem cell derivatives on a morality clause.

Finally, Plomer et al point out that much of the damage may already be done. With other companies and institutions out of the race, Geron (the main holder of commercial rights for the WARF patents) and others that continued research have built up strong intellectual portfolios, much of which will still stand if original patents are invalidated. (Interestingly, they also argue that current US challenges to WARF patents could actually strengthen them, something the challengers don’t believe. (See our commentary by Jeanne Loring.)

Posted by Monya Baker on January 29, 2008
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Work in creating human embryonic stem cells from cloned embryos continues apace, and some of the most interesting stuff regulatory-wise is going on in Europe. (Apologies, many of these links will require a subscription)

First, the scientist to publish a reliable paper on human therapeutic cloning, Miodrag Stojkovic, has gotten a license to try to make stem cells from cloned human embryos in Spain. In the UK, efforts are already underway by Stojkovic’s former colleague and rival, Alison Murdoch. She is collaborating with Oregon scientist Shoukhrat Mitalipov, who was the first to create primate embryonic stem cells using cloned monkey embryos.

Meanwhile, the German Research Foundation has formally announced its skepticism of this technique and is advocating more efforts toward reprogramming human cells.

To help keep things sorted, the European Human Embryonic Stem Cell Registry (sponsored by the European Commission) will supply researchers with information about human embryonic stem-cell lines developed in Europe, including information about use and derivation. The goal is to help researchers make better use of lines already developed.

Posted by Monya Baker on January 25, 2008
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Since the recent announcement of successful reprogramming, editorials carrying statements such as “[r]arely has a president - so vilified for a moral stance - been so thoroughly vindicated” have been springing up across the United States. Now the fightback seems to be gearing up.

Key to their argument is the fact that ‘reprogrammed’ cells – where instead of obtaining stem cells from an embryo ‘induced pluripotent stem cells’ are created from adult human skin – are not yet safe for clinical use.

“For doing basic research on human cells, IPS as a method has won - it's huge. But for the ultimate goal of getting cells into a patient, it's a lot less clear. These cells may never be useful for direct therapy,” says George Q. Daley, a stem cell researcher at Children’s Hospital Boston, in the Boston Globe.

Douglas A. Melton, codirector of the Harvard Stem Cell Institute, is even firmer, saying: “It will never be approved [by the FDA] to put these cells in a patient.”

See also our Q&A on the topic with the head of the NIH Stem Cell Task Force and what scientists had to say

Posted by Monya Baker on December 21, 2007
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One of our recent commentaries brought this response from Doug Sipp, of Japan's RIKEN Kobe Institute:
Charis Thompson raises an interesting question in her article, "Can opposition to research spur innovation?" [1] and one that is particularly timely in light of the recent breakthroughs in the induction of pluripotency in differentiated mouse and human cells. It seems undeniable that resistance to a given field of research from some quarters can prompt support from others; this has certainly been the case for human embryonic stem cell research in the US. However, the furor surrounding human ES cells is not a global phenomenon, and is indeed restricted to a fairly limited number of countries (at least of those capable of conducting significant research efforts). Japan, where the first discovery of the four "Yamanaka factors" was made, provides a reasonably permissive regulatory framework for human ES cell research, and there has never been public opposition to the field of the sort seen in the States. This is not to say that there are not obstacles. As Norio Nakatsuji pointed out in his article, "Irrational Japanese regulations hinder human embryonic stem cell research," there are regrettable bureaucratic hurdles confronting would-be human ES cell researchers [2], but I don't feel that this can accurately be characterized as "opposition" in the sense used in Thompson's article. So it seems a bit inappropriate to use the discovery of induced pluripotency as an example of how opposition can lend impetus to a field of science, and thereby lead to new discoveries. This nonetheless appears to be the thrust of recent mendacious self-serving statements from the Bush administration claiming that the discoveries of Yamanaka and others somehow vindicate the restrictive policies in force in that country [3]. It should be remembered that the original discovery of induced pluripotency was not made by an American lab, and that the uproar, quibbling and qualms voiced in the US have for the most part been only a distant spectacle, not fuel for the engines of scientific discovery. So, while I agree that conflict may spur innovation, I do not think that induced pluripotency was the fruit of such a troubled union.

Doug Sipp
RIKEN Center for Developmental Biology

1 http://www.nature.com/stemcells/2007/0712/071213/full/stemcells.2007.128.html
2 http://www.nature.com/stemcells/2007/0708/070809/full/stemcells.2007.66.html
3 http://blog.wired.com/wiredscience/2007/11/bush-to-greet-g.html

Posted by Monya Baker on December 18, 2007
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This will appear as a regular, archived article on Nature Reports Stem Cells eventually. However, our production cycle will be even slower over the holidays, and I wanted to put this up as soon as possible. --Monya

Nature Reports: Did the induced pluripotent stem (iPS) cell breakthrough happen faster than you thought?

Landis: Yes.

Nature Reports: What do you think of the public response to this breakthrough?

Landis: It’s kind of very sad. Instead of focusing on the scientific potential—what you can learn in terms of reprogramming and the epigenetics of the cells—people seem to have focused on “We don’t need embryonic stem cells” or “Oh yes we do need embryonic stem cells”. It’s as if the science has been consumed by the political argument.

Nature Reports: What still needs to be assessed with induced pluripotent stem cells?

Landis: There are a zillion questions. The assumption on the part of a large part of the public that this does away with the need for embryonic stem cells is premature.

I find it hard to believe that you’d get back to the same starting point that a pristine embryonic stem cell would represent. You don’t know what the undifferentiated state actually is and you don’t know how they [the cells] are going to respond to differentiation.

If you’re taking a fibroblast that’s obviously gone through several developmental stages to get to its differentiated state and then you’re getting it to go back to its undifferentiated state, I would be surprised if it took the same pathway backwards.

[Regarding pluripotent stem cells as disease models] An interesting catch could be that the mutations that give rise to the disease could interfere with the ability to reprogram. Everyone has just assumed that they won’t, but I don’t think we have any data on that.

Nature Reports: How can researchers compare human iPS cells to embryonic stem cells?

Landis: Given that they’ve had the mouse embryonic stem cells and mouse iPS cells for some time and have not yet completed the epigenetic comparison, I think it will take a lot to do the human.

Nature Reports: But comparisons can’t be funded for the newer human embryonic stem cell lines.

Landis: You would be constrained to the identified lines that are available for funding. Obviously it would be better to have more lines. Jamie Thomson[who led one of the groups making the reprogramming breakthrough and was the first to generate human embryonic stem cells] has pointed out that one of the major disadvantages of the limited number of lines is that they come from a pretty narrow genetic repertoire.

Nature Reports: Scientists have called for comparisons between iPS and hES cells, but there is some ambiguity about what kinds of these studies the NIH could fund. For example, can people use data or RNA or techniques from newer embryonic stem cell lines that aren’t eligible for NIH funding?

Landis: That’s kind of outside my paygrade, that kind of regulation. Apparently Harvard has a very good policy that’s written up that outlines what Harvard feels are the appropriate safeguards to make sure that you don’t violate the NIH policy.

Nature Reports: What’s going to happen now in terms of what science is being done and who’s doing it?

Landis: [The buzz makes it sound] like it’s really easy and that anyone who’s cultured cells should be able to make their own pluripotent stem cells. In talking to people on the phone, it sounds like it’s much more complicated than that. Jamie Thompson said that it took him four years.

There will be new grant applications to take advantage of this scientific advance, whether or not they will be outstanding grant applications is unclear. Also, with the advance of SCNT [somatic cell nuclear transfer] in primates, I expect we’ll get more grant applications based on that.

Since this is a new area, and not many investigators have the expertise to make pluripotent stem cell lines, the issue won’t be that there are too many [grant applications] that are outstanding but that there won’t be enough that are outstanding.

Nature Reports: How will grants be chosen?

Landis: One of the most contentious issues at NIH is how much money is assigned by what the review says is the scientific merit of the grant versus how much money is assigned based on programmatic considerations.

If 50 grants come in and none of them are deemed outstanding, the institutes can then say ‘none of them make the payline, but this [research] is absolutely critical.’

Nature Reports: How do you feel about NIH’s leadership role in global science?

Landis: Do we want therapeutic advances using human embryonic research to come out of Singapore, China, Britain? That’s a piece of the tension that exists.

I don’t think that the NIH can do anything except talk about the fact that the science does not support the President’s policy and at the same time to implement the President’s policy.

Posted by Monya Baker on December 17, 2007
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Ten grant applications have been eliminated from consideration for new faculty awards from the California Institute of Medicine because the faculty were endorsed by CIRM board members. But while board members might learn something from the public flap and withholding of potential research funds, the scientists themselves are victims of members’ poor judgment.

CIRM’s board consists of several heads of prominent California research organizations, and the now-rejected grants required letters from applicant’s institutions stating that the institution would support new faculty members with resources like laboratory space, supplies, and mentorship. But in ten cases, these support letters were signed by institution heads who are also members of CIRM’s Independent Citizen’s Oversight Committee. Though the ICOC relies on scientific review panels to help decide on individual grants, it does oversee how funds are distributed. Board members must excuse themselves when discussing and voting on issues that represent conflicts of interest, but it’s unclear whether signing these letters about eligibility constituted a conflict. (A previous, more prominent flap was also about eligibility. CIRM board member and Burnham Institute president John Reed wrote a letter stating that a grant applicant affiliated with his institution was eligible to receive funds after CIRM staff decided that he was not. That prohibited communication is being investigated formally.

The San Diego Tribune has covered the story .

CIRM officials say they welcome investigations. They are making much of the fact that CIRM is breaking new ground and say they are still learning how to deal with public scrutiny and with juggling their dual roles to avoid conflict of interest. They’ve got a point: CIRM is the first state entity to fund scientific research through public bonds, as far as I know. And the board members are in a crazy situation. ( Read more about the unusual organizational structure here.) The legislation that enacted CIRM requires that 5 board members are executives from a University of California with a medical school and that 4 are executives from California research institutes. Those people achieved their positions by demonstrating that they could look after the interest of their research organizations. But because they oversee the biggest funder of stem-cell research, they are supposed to divorce themselves from any benefit their institutes could derive from the funds. Even the most savvy officials could slip up in such a situation, and CIRM officials like to proclaim that they are treading new, boggy ground. Incoming CIRM head Alan Trounson has been criticized in Australia for poorly considered public comments as well.

Let’s hope that experience is a good teacher. CIRM officials are being punished for their missteps, since their institutions are losing funds. The move to reject the applications has been praised by a press release from the Foundation for Taxpayer and Consumer Rights, “It’s simple: stem cell board members cannot take part in any way in grants to their institutions,” said John M. Simpson, FTCR’s Stem Cell Project Director. “The board is not some old-boys’ club for the benefit of the state’s universities. They are public officials and stewards of the public interest. Perhaps a few of these deans need to enroll in Ethics 101 at their universities and get the basics down.” The blog California Stem Cell Report has written about it extensively. CIRM has not issued a press release on the topic yet. When deciding not to fund the grant originally won by the Burnham Institute, CIRM decided not to announce the decision to avoid embarrassing the Institute. But such disclosures will be part of what it takes to keep the public’s trust.

Posted by Monya Baker on December 11, 2007
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Accusations against the chair and another member of California’s stem-cell institute should be referred to the state’s Fair Political Practices Committee, State Controller John Chiang said today at a meeting of the financial committee for the California Institute of Regenerative Medicine (CIRM). A public advocacy group had called for Robert Klein and John Reed to resign after learning that Reed, who is also president of the Burnham Institute, asked CIRM to reconsider its decision that the recipient of a previously awarded grant was not, in fact, eligible for funding because he was not an on-site, full-time employee of the Burnham Institute.
UPDATE on 11/28: Here is the letter from Chiang's office to investigate the charges.
Following Klein’s advice, Reed wrote a letter to CIRM staff in charge of administering the grant stating that David Smotrich, a clinician affiliated with Burnham, should be eligible for the award of $638,000. CIRM staff did not consider the request, and the grant was not awarded.

However, John Simpson of the Foundation for Taxpayer and Consumer Rights said that Reed should resign because, as a member of CIRM’s oversight committee, Reed should not have made requests on behalf of his institution. Simpson also called on Klein, who has no affiliation with the Burnham, to resign, saying he demonstrated poor judgment.

Continue reading "State Controller Recommends Inquiry in CIRM Board Conflict of Interest" »

Posted by Monya Baker on November 27, 2007
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This week, Nature released a paper reporting the first embryonic stem cells made from an embryo cloned from an adult monkey. Next week, researchers in the UK hope to try the same thing with humans. The Oregon-based monkey team needed just over 300 monkey oocytes to make two monkey embryonic stem cell lines. The researchers at the University of Newcastle upon Tyne expect to have twice that number of freshly collected oocytes from women seeking fertility treatments.

They are absolutely not trying to clone a live human. Instead, they will remove the chromosomes from an egg, insert the nucleus of a cell from another person, and stimulate the egg to divide. If all goes as they hope, the egg will form a hollow-ball shaped embryo called a blastocyst, from which the cells to create embryonic stem cells will be collected. (The process will destroy the embryo.)

There are plenty of teams in the US working on the tecnhique. James Byrne, lead author on the recent Nature paper reporting nuclear transfer in monkeys, has joined Rnee Reijo Pera's lab at Stanford. Kevin Eggan at Harvard has his own techniques to apply to human. But these groups have to work with frozen embryos or oocytes otherwise not deemed suitable for implantation.

Shoukhrat Mitalipov, who led the work in monkeys, is working with Mary Herbert’s team in the UK. He would like to attempt the procedures himself at the Oregon Health and Science University, but before that could happen, his institutional review board would need to formulate a policy that would allow researchers to collect eggs and he would need private funding to carry the work out. Regulatory policies in the UK allow researchers to pay for half of woman’s fertility treatment if she provides half of the collected eggs for research, and there is currently a waiting list of women hoping to provide eggs, says Herbert. In fact, the waiting list is growing because of the publicity received.

In the US, such arrangements are often considered compensation. Instead, researchers can ask women to undergo the exhausting and somewhat risky procedure for altruistic reasons. In the UK, research on monkeys is highly regulated and so the research that worked out a successful procedure for cloning primate cells would have been hard to do, says Mitalipov.

What a strange world, where international collaborations depend (at least partly) on differences in local attitudes.

Standford University's Chris Scott has some relevant posts on his stem cell blog.
His take on monkey stem cells is here.

His analysis of the UK versus US egg-sharing situation is here.

Posted by Monya Baker on November 15, 2007
Categories: Cloning, Policy | Permalink | Comments (1) | TrackBacks (0)

The day that President Bush vetoed legislation to expand federal funding for embryonic stem cell research, he also issued an executive order calling for a plan to promote alternate sources of pluripotent stem cells, the details of which were announced today. Like the original executive order, it calls for the NIH Human Embryonic Stem Cell Registry to be renamed the NIH Pluripotent Stem Cell Registry.

The implication is that existing pluripotent stem cell lines are equivalent to embryonic stem cell lines. That’s not true. Many scientists think it could be true someday if current techniques advance, but many believe advancing pluripotent stem cells cannot be done without continuing to study embryonic stem cells.

The plan released today includes a soon-to-be-formalized program announcement to fund grants for research on alternative sources of human pluripotent stem cells including dead embryos, altered nuclear transfer (putting genetic material into an oocyte that will cause it to divide without forming a viable embryo), single cell embryo biopsy, and reprogramming somatic cells. These areas could all prove extremely valuable in understanding disease and testing therapies. Nonetheless, opponents of embryonic stem cell research must acknowledge that if this work is performed instead of rather than alongside work on embryonic stem cells, science will suffer and its fruits could be delayed.

Continue reading "Renaming the Embyronic Stem Cell Registry recasts debate" »

Posted by Monya Baker on September 18, 2007
Categories: Community, Ethics, Policy | Permalink | Comments (1) | TrackBacks (0)

Today, the Human Fertilisation and Embryology Authority (HFEA) in the UK said that scientists could combine human chromosomes with animal eggs and try to make embryonic stem cells. It’s easier to collect unfertilized eggs from, say, cows than it is to collect them from women.

Interested scientists will learn in November if they’ll be licensed to make the attempts, which must be carried out under certain guidelines, but an article this month in Nature Cell Biology reminds us that even if the government says `yes’, some laws of science might say ‘no’.

In chimera-embryos (properly called `cybrid-embryos’ in this context), the chromosomes will be human, but at least some of the mitochondria will not.

Continue reading "Britain gives go-ahead on chimeras. Will science now block the way?" »

Posted by Monya Baker on September 06, 2007
Categories: Cloning, Policy, Reprogramming/Pluripotency | Permalink | Comments (1) | TrackBacks (0)

Germany's advisory committee on medical ethics has recommended easing restrictions on research with human embryonic stem cells. Current law is more restrictive than the US because researchers cannot work with lines created after 2001 no matter who funds the research. Those that violate the law can face jail and fines. Germans are particularly sensitive to human research ethics because of the egregious experiments during the Nazi era, and the federal funding body initially recommended a cautious approach to allowing the research. It reversed its stance last November. Horst Dreier, a member of the National Ethics Council and head of the group that drafted the proposal, said that several members of parliament plan to take up the matter this fall. Federal research minister Annette Shavan is likely to oppose softening the law, but Dreier thinks she might agree to resetting the ban to allow human embryonic stem cell lines created up until January 1, 2007.

Posted by Monya Baker on July 21, 2007
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Good scientists are willing to let their beautiful theories be killed by ugly facts, but President Bush is not. Deep in a New York Times article on the ex-Surgeon General’s testimony on political interference comes yet another example of the Bush Administration plugging its collective ears to unpopular data on stem cells.

Continue reading "Surgeon General censored on stem cells" »

Posted by Monya Baker on July 13, 2007
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Recently, I co-chaired a meeting where scientists made a cogent argument for creating a regional stem cell network. A summary of the meeting will be posted on Nature Reports Stem Cells and circulated as an insert in Nature. I hope that the conversation can continue here.

Posted by Monya Baker on June 26, 2007
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