The Niche

Students from the law and medical schools at Stanford University brought together an impressive group of world-class experts last week to discuss stem cell policy. I’ll describe some (very select) highlights over the next few blogs. Check the site for the Stanford Journal of Law Science & Policy over the next few weeks for powerpoints presentations and audiorecordings.

The people who will assess which human embryonic stem cell lines should be eligible for U.S. federal funding will meet next week, said Story Landis, head of the Stem Cell Task Force at the U.S. National Institutes of Health. In March this year, President Barack Obama charged the NIH with crafting policy to allow the funding of responsible embryonic stem cell research. In July, the NIH declared that this would include cell lines created from embryos made for reproductive purposes and donated without financial inducements and with proper informed consent. Determining proper informed consent is a bit of a minefield, particularly for embryos donated in the 1990s, before much of the debate and consensus-building around the issue occurred. See Stem cell vetting raises concerns, confusion

Continue reading "Stanford conference: stem cells, the new NIH, and delimiting embryo research" »

Posted by Monya Baker on October 09, 2009
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“When you think you have a policy, you’re too late.” That’s the opinion of Pearl O’Rourke, who directs human research affairs at Partner Healthcare Systems She was referring to the pace of research in the stem cell field and the need to fashion policies to protect subjects. Embryonic stem cell research oversight committees are becoming too much of a catchall, she worries.

Insoo Hyun, of Case Western Reserve University, said that the ethical considerations for stem cell–based clinical trials were similar to those for other experimental procedures but with the “heat” turned up — patients are more desperate, procedures are riskier, snake-oil salesmen more of a factor and slots in research trials are fewer. Outside clinical trials, perhaps some of the thinking developed for assessing new surgical techniques could be useful. Organ transplants, after all, did not go through clinical trials. Thomas Okarma, president and CEO of Geron, which is developing an embryonic stem cell product for spinal cord injury, described how he thought the cells might work (one mechanism is the secretion of various health factors, which could have implications for stroke and Alzheimer’s disease). At the same time, he said his company is committed to “maintain[ing] a conservative risk-benefit calculus”, which basically means only trying the riskiest therapies in very ill patients with very few other options, thus reducing the potential to harm patients.

Stanford University’s Hank Greely shared a few thoughts to guide this kind of analysis. Regulators demand that research be safe, but the very uncertainty makes this impossible, he said. That, in a sense, makes those who participate in Phase I trials heroes. No one can be certain what will happen when some new therapy or procedure is tried in humans. And consent is particularly important when the risk is high, he said, indicating that risky procedures should be tested in adult patients before children, even if a procedure is more likely to work in a younger population.

Finally, he lamented the fact that because conversations between regulatory authorities and clinical trial sponsors are confidential, crucial risk-reducing, therapy-speeding knowledge does not spread freely. He called on those involved to reveal the thinking behind regulatory decisions.

Editor’s note: Students from the law and medical schools at Stanford University brought together an impressive group of world-class experts last week to discuss stem cell policy. I’ll describe some (very select) highlights over three blogs. Check the site for the Stanford Journal of Law Science & Policy over the next few weeks for powerpoints presentations and audiorecordings.

Posted by Monya Baker on October 09, 2009
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Perhaps more confusing than making and using stem cells are the intellectual property rules governing such use. In addition to the licenses his company has attained from the Wisconsin Alumni Research Foundation, David Earp, patent counsel for Geron, said that his company had filed more than 300 patents covering a variety of areas: undifferentiated cells; differentiated cells; methods to scale, differentiate and process cells; and ways to grow cells without blood products and feeder layers.

Esther Kepplinger of the law firm Wilson Sonsini Goodrich & Rosati and Robin Feldman of the University of California Hastings College of the Law provided a stem cell–focused tutorial on what criteria a valid patent must establish and what areas a patent can cover. For instance, a patent can cover the cells themselves, the method of producing the cells or the use of cells in therapy or diagnosis.

Kepplinger, who oversaw the assessment of patents at the U.S. Patent and Trademark Office before joining the law firm, said that from what she's seen, the patent office is rejecting more patents and claims have been getting narrower. She also said that because stem cell patents are likely to be of high public interest, they can receive extra scrutiny. Finally, she defended the existence of patents themselves: without them, she said, companies would not make the necessary investments to develop new products.

Aurora Plomer, of the University of Sheffield Law School, described what she considers a sort of drift of the European Patent Office’s directive declaring that uses of human embryos for industrial or commercial purposes are not patentable. The intention of the directive was to prevent fertility clinics from turning embryos into commodities. The interpretation of the directive to cover embryonic stem cells, products made from embryonic stem cells and products made with research using embryonic stem cells is highly flawed, she says.

Editor’s note: Students from the law and medical schools at Stanford University brought together an impressive group of world-class experts last week to discuss stem cell policy. I’ll describe some (very select) highlights over three blogs. Check the site for the Stanford Journal of Law Science & Policy over the next few weeks for powerpoints presentations and audiorecordings.

Posted by Monya Baker on October 09, 2009
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As of 28 Sept in California, 88 human embryonic stem cell lines on a list the NIH is keeping to which institutions plan to submit which lines for an assessment of their eligibility for federal funding.

On July 7, the NIH specified strict informed consent and other criteria under which embryonic stem cell lines must be derived to be eligible for U.S. federal funding. Rather than having to meet the exact criteria of new informed consent requirements, lines derived prior to July 7 must be evaluated individually to ensure that they confirm to the principles behind the guidelines.

All but three lines are from Harvard University and its affiliated Children's Hospital Boston; two are from Rockefeller University in New York, and one is from Children's Memorial Hospital in Chicago. Notably absent are lines from the California universities and the University of Wisconsin. Also absent are lines derived outside the United States. However, Glyn Stacey, head of the UK Stem Cell Bank says that he believes that the guidelines on informed consent established among various groups in the UK complies with that set forward by the NIH. That was published last year in Regenerative Medicine (subscription required).

The list indicates an intent to submit rather than a formal submission, which will require substantial documentation.

See Stem cell vetting raises concerns, confusion

Posted by Monya Baker on September 28, 2009
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After years hearing scientists complain that the U.S. federal government funded research on too few human embryonic stem cell lines, Lana Skirboll, who directs the Office of Science Policy at the U.S. National Institutes of Health, has something to tell the stem cell community: “the ball is in their court.” The NIH announced on Monday that it would be accepting applications to determine whether a line is eligible for funding. The process is not without risks: some scientists are quietly concerned that their informed consent procedures could come under criticism, or that they could lose access to non-federal sources of funding if the lines they wish to work with aren’t cleared by the NIH.

Continue reading "Stem cell vetting raises concerns, confusion" »

Posted by Monya Baker on September 24, 2009
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Cross-posted from In the Field for Elie Dolgin

The International Society for Stem Cell Research (ISSCR) has convened a new committee tasked with weeding out companies that offer unapproved stem cell 'therapies', the ISSCR's new president Irving Weissman announced today at the World Stem Cell Summit in Baltimore, Maryland.

See also an analysis of why unproven, risky stem-cell procedures elude legal restrictions in countries like China, India, Thailand, and the United States.

Last month, Weissman, who also directs the Stanford Institute for Stem Cell Biology and Regenerative Medicine in Palo Alto, California, wrote an opinion article in Cell Stem Cell calling for stem cell purveyors to be judged on three criteria. First, the company should be able to cite peer-reviewed papers from third party investigators showing that the therapy is possible. Second, there should be institutional review board oversight of the treatment. Third, the US Food and Drug Administration or an equivalent agency should give the final green light. "That's the minimum beginning," he said at the meeting.

Weissman revealed that he had convened an 18-member panel of lawyers, FDA regulators, medical ethicists, and stem cell scientists last week to look into the feasibility of establishing an online registry of wayward companies. His idea is for the ISSCR supervisory body to request documentation of the three requirements from all known global stem cell providers. Companies that don't comply would get blacklisted.

Weissman expects the committee to issue a preliminary report in December, with final guidelines published next March.

Image of Weissman by Kris Novak

See an interview Irving Weissman: culturing the unorthodox

Posted by Monya Baker on September 23, 2009
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Cross-posted from In the Field for Elie Dolgin

After the fanfare surrounding President Barack Obama's executive order on 9 March, which lifted Bush-era restrictions on funding human embryonic stem cell research, the White House has been noticeably quiet about further expanding the science — one of Obama's campaign promises. "We need to remind the President of this type of research," Delaware congressman Michael Castle (Republican) said today at the World Stem Cell Summit in Baltimore, Maryland, the fifth annual summit presented by the non-profit Wellington, Florida-based Genetics Policy Institute.

Castle, together with Colorado congresswoman Diana DeGette (Democrat), previously introduced two bills to expand researchers' access to human embryonic stem cell lines. Both bills were approved by Congress but vetoed by former President George W. Bush. Now, both House Representatives are at it again, working on new legislation to augment the executive order and prevent potential policy reversals from future residents of 1600 Pennsylvania Avenue. "I don't like to see science subject to the whim of politics at all," said Castle, who is also working to overturn the Dickey-Wicker amendment, which forbids the creation of embryos for research purposes on the taxpayer's dime.

The bill is unlikely to brought before Congress anytime this year, however. Olivia Kurtz, Castle's senior legislative assistant, told me that Castle and DeGette hope to roll out the bill before the current Congress's term ends in January 2011. In the meantime, they are watching what happens with the National Institutes of Health's expanded guidelines to identify potential shortfalls in the executive order that need remedying. Castle singled out nuclear cloning — the technique that produced Dolly the sheep — as one line of research that deserves further attention.

Posted by Monya Baker on September 23, 2009
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By Elie Dolgin, cross-posted from the Great Beyond

The National Institutes of Health started accepting applications today to evaluate which human embryonic stem cells will be eligible for federal dollars.

A panel of nine scientists, lawyers and ethicists — led by Jeffrey Botkin of the University of Utah — will scrutinize submissions to ensure that they meet the new requirements for informed consent from embryo donors. The working group's "expertise and sound judgment will help NIH move forward in this important effort," NIH director Francis Collins, who will have the final say on the eligibility of particular lines, said in a statement.

The panel will review cell lines made before the guidelines went into effect on 7 July. Fundable lines must be derived from leftover embryos that were created solely for assisted reproduction and donated voluntarily with no financial incentives.

"We're open for business in a new era," Lana Skirboll, director of policy at NIH, told Nature. The working group has not yet appraised any cell lines — including the 21 lines approved under former President George W. Bush, which will need to be reassessed — and will start considering particular cells after scientists submit their petitions on the NIH website. "The speed at which this moves is really in the hands of the scientific community at this point," she said.

Having a mechanism in place to expand the number of eligible cell lines "is what we've been working toward for a very long time," said M. William Lensch, a stem cell researcher at Children's Hospital Boston and the Harvard Medical School, who expects to start submitting requests "sooner rather than later."

Image: James Thomson, University of Wisconsin-Madison

Editor's note:
(See related story: An analysis suggesting that the NIH did not properly evaluate informed consent by donors of embryos from which stem cell lines were derived throw oversight committees into disarray )

Also, see below a list of the other members of the panel and for links to a critical analysis of the ethical review conducted under President George W. Bush's administration.

Continue reading "Submit your stem cells" »

Posted by Monya Baker on September 21, 2009
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Not so much a warning, but certainly bad news for Osiris. The mesenchymal stem cell drug Prochymal did not show efficacy in two large controlled study of graft versus host disease. ( Read that story here)

In more alarming news for at least some investors, Reuters is reporting that the US Securities and Exchange Commission has charged company CellCyte Genetics Corp has given false information to investors claiming that its stem cell technology was heading for human trials. Here’s more from Fierce Biotech

More seriously, a group called Bionet is calling for a clamp down on unregulated stem cell treatments, according to the BBC. The coalition of Chinese and European say patients are being subjected to a lot of hype and potential harm when they travel for these expensive treatments.
They are not the first:
See
Stick to the guidelines and fewer get hurt
Offshore stem cell therapies need sensitive regulation
Stem cell researchers face down stem cell tourism

On a philosophically lighter (though perhaps literally heavier note), mice fed the equivalent of the Atkins diet had fewer and less-active bone marrow and peripheral blood endothelial progenitor cells, compared to two other diet regimens. See the report in PNAS.
Here’s other work on how diet affects stem cells.

Posted by Monya Baker on September 09, 2009
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Francis Collins, the new director of the US National Institutes of Health, says that he had no timetable for when the NIH will re-establish a registry listing human embryonic stem cell lines eligible for human research funding. He did, however, say that the registry would be a “very high priority.”

Last month the NIH announced guidelines for hESC research that outlined strict informed consent criteria for the donation and use of embryos. Existing, well-studied hES cell lines, many previously eligible for federal funding, do not meet these criteria exactly, and the NIH announced that it would soon establish a working group to ascertain whether these lines were derived with adequate informed consent. However, said Collins, the NIH will not seek out which lines to examine. Instead, researchers must submit applications to the working group that document and explain how the lines meet informed consent standards at the time of derivation. This process, said Collins, will ensure that the lines of the greatest scientific interest are examined first. Until then, some researchers worry that funding for their work is in limbo. (See uncertainty around NIH guidelines)

Continue reading "NIH chief's first day: stem cell registry “high priority” but no ETA" »

Posted by Monya Baker on August 18, 2009
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Under former US president George W. Bush, fewer than two dozen human embryonic stem cell lines could be studied with federal funding. That number could soon extend into the hundreds, pending ethical review by the US National Institutes of Health. However, research led by Christopher Scott of Stanford University in California shows that of the 20-odd lines available for funding, researchers have so far depended primarily on just 2 of the oldest human embryonic stem cell lines1.

Scott and colleagues collected data from two major repositories of human embryonic stem cells (hESCs). Of 1,217 requests made to the National Stem Cell Bank in Madison, Wisconsin, between March 1999 and December 2008, 1,052 were for just 3 of the approximately 17 lines available and eligible for funding; of those requests, 941, or 77%, were for just 2 lines (H1 and H9). The research didn’t examine informal lab-to-lab transfers, which might show up as acknowledgements or coauthorship, says study coauthor Jason Owen-Smith of the University of Michigan. “The work we have done, though, suggests that if a lot of folks are avoiding the banks, they are still using the lines that are most requested from the banks. The pattern of concentration we report for publication is even more striking than for cell-line requests.” An analysis of over 500 peer-reviewed articles on research using hESC lines and published between 1999 and 2008 found that roughly two-thirds used just the three most popular lines from the National Stem Cell Bank.

Continue reading "Human embryonic stem cell research stuck on two early lines" »

Posted by Monya Baker on August 10, 2009
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Italian court sidesteps challenge
Three Italian scientists who sued their government over the mysterious insertion of language banning human embryonic stem cell research have been told that individuals cannot challenge funding policy. (For descriptions of the administrative court’s decision see Nature’s News in Brief or ScienceInsider)
See Nature’s news story on the scientists’ decision to sue

Latest Australian stem cell plan revealed

The Australian Stem Cell Centre has not had an easy time, but it’s just announced its plan going forward. According to the Australian newspaper, its board resigned en masse in September last year, shortly after sacking its chief executive officer for favoring commercial activities over more basic research.

The new board was announced this spring.

Now the Centre has announced plans to fund large collaborations with a focus on four areas:
1. Ways to propagate stem cells (i.e. bioreactors and growing surfaces)
2. Ways to make pluripotent stem cells
3. Ways to differentiate pluripotent stem cells
4. Studying adult stem cells and applying insights gleaned from one organ to other organs

The Centre, which was founded in 2002, has been awarded AU$111 in state and federal funding, to be paid in installments over that time.

Posted by Monya Baker on July 23, 2009
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The NIH guidelines in effect as of 7 July don’t specify exactly which human embryonic stem cell lines can be studied with federal funding, but researchers are still pleased. Not only will more lines be eligible for funding, now the NIH has said it will make the time-consuming call of whether embryos used to create lines were donated under fundable criteria (appropriate informed consent, creation for reproductive purposes, donated without financial inducements.) That’s a huge relief for ethics committees at individual universities that might otherwise do redundant, difficult work.

Continue reading "NIH stem cell guidelines please scientists" »

Posted by Monya Baker on July 08, 2009
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Both the Washington Post and the New York Times are running articles today on the state's decision to pay women up to $10,000 for donating eggs for stem cell research. (The Post is the stronger article, but most of the nuances are on the second page). This was covered last week in the Niche and the Great Beyond.)

The articles do not mention the pressing scientific question these eggs might answer: how good are iPS cells? Everyone is excited about induced pluripotent stem cells, but no one understands their limitations. Right now, there is anecdotal evidence that iPS cells don't behave exactly like ES cells, but perhaps that's because the best techniques haven't been worked out yet. The best way to learn this is to compare genetically identical stem cells generated by both methods. For one set of stem cells, you'd take a skin biopsy from Patient A, reprogram the cells to pluripotency. That's iPS cells. For the other stem cells, you'd do somatic cell nuclear transfer: put a nucleus from one of Patient A's cells into an enucleated egg, grow that to a hollow-ball embryo, and use it to make embryonic stem cells. Now you've got both ES and iPS cells carrying patient A's genes.

(BTW: This is a tricky situation for career-minded scientists. Find no differences, no one will notice, AND you'll look foolish if someone else comes along later and sees something you overlooked. Find differences, and worry about looking foolish if you've published an artifact.)

Nonetheless, this is a situation in which people really do need more information for informed debate. Unlike for humans, embryonic stem cells have been cloned for monkeys and mice. iPS cells have also been made from these creatures. Those of you who have genetically identical iPS and ES cells for mice and monkeys, we need to see your results!

My guess is that the scientists hoping to use human eggs in stem cell research believe strongly that they will find something interesting (though of course that in itself does not justify research)

Objections to the research in the articles are 1) that paying women for eggs exploits them and 2) that scientists should avoid controversy. The Post article goes on to describe that women are already paid for eggs, but only if the eggs are intended for making babies, not stem cells.

The articles also did not mention the egg-sharing program which is widely accepted in the UK. Women seeking IVF treatment get a discount for donating unfertilized eggs collected. Also, bioethicist Insoo Hyun has argued that oocyte providers should be given the same consideration and compensation as other healthy research subjects. (See that Nature commentary)

It's unclear whether those objecting to egg payments for stem cells also object to egg payments for in vitro fertilization. But it is true that the most sought-after IVF egg donors are college-educated and so have more options to earn more money. If there is a worry that paying poor, oppressed women for eggs exploits them, why not only allow college-educated women to donate eggs for stem cell research? They can already choose to sell eggs to fertility clinics. (There is precedent for this kind of discrimination; I've been paid for participating in scientific research in which all subjects were required to have a biology degree; this was considered necessary for giving informed consent.)

Posted by Monya Baker on June 26, 2009
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The Interstate Alliance on Stem Cell Research has posted its comments on the NIH draft guidelines as a ppt presentation.
Here’s a twelve-word summary: The language in the draft guidelines could interfere with the guidelines’ intentions.

Continue reading "Comments on the NIH Draft Guidelines" »

Posted by Monya Baker on June 10, 2009
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NOTE: The original posting of this blog contained an error about the 1999 NIH draft guidelines. That has been corrected.
All of you reading the hysteria about the decline of U.S. federal funding for human embryonic stem cells, please take a deep breath. Okay?

The NIH is seeking comment on draft guidelines, not seeking to stop embryonic stem cell research on all old lines. It's even unclear whether the draft guidelines would prohibit research on all the old Presidential lines, as the headlines state.

I’ve been reading the most recent media coverage (Here’s Wired and the Scientist ) in the wake of the commentary by Patrick Taylor in Cell Stem Cell, and I’ve yet to find a researcher who says explicitly that she or he thinks the majority of already extant cell lines will actually be excluded in the final guidelines because researchers didn’t have up-to snuff consent forms. Instead, my guess is, the NIH and stem cell community will have to either 1) laboriously work out whether the consent process used well in the past is sufficiently consistent with that in place now or 2) grandfather in the lines which the NIH had determined in 2001 to have been obtained with proper informed consent. (An analysis published last year found that not all of these lines met such standards and sent institutional review boards into disarray. Read more about that .)

My guess is that people want the NIH to say explicitly which lines can be used so that individual institutions don’t have to hash this through individually, a situation that will cause many people to do redundant work and could result in chaos. In fact, such explictness is one of the requests made explicitly in the template letter provided by the ISSCR.

The broader issues, of course, are whether the NIH will allow funding for lines derived from unfertilized eggs or from embryos created by nuclear transfer, or cloning. The first time the NIH drew up draft guidelines was for President Bill Clinton. Those guidelines did not allow research on embryos, but did allow research on embryonic stem cells created from embryos originally created for purposes of reproduction. (There were some other restrictions as well; see the 1999 draft guidelines). Then there was public comment, then the NIH changed the guidelines to restrict funding to lines from embryos created for reproductive purposes. The upshot of all this, tell the NIH what you think about human embryonic stem cell research by May 26, when the time for public comments close. (You can do that here . I wrote up a summary of the guidelines here.)

Taylor’s commentary is not about whether a specific line should or shouldn’t be used but about the approach that should be taken to informed consent. Put simply, he says, standards evolve constantly, so materials collected in the past should be evaluated according to the standards of that time. He then sets out a thought experiment to show what could happen if standards are applied retrospectively.

Another relevant thought experiment might be what could happen if the scientific community does not weigh in on setting the guidelines that it will need to live by. Hopefully that is not an experiment that will play out in real life. The comment form is here .

Posted by Monya Baker on May 20, 2009
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Stem cell scientists in Ontario expect a boost from their province’s commitment to distribute an extra CAN$100 million for life science funding this year. Researchers in selected areas of life sciences need to state their intent to file by mid June, and submit final applications by August 31, with almost all the funds expected to be allocated by the end of the year.

In explaining the rationale for the program, Ontario's Minister of research and Innovation John Wilkinson specifically named the U.S. stimulus package and President Obama’s move to fund more stem-cell research.

“We are saying to Washington, and to the world -- we are willing to collaborate with you, but no
poaching of Ontario scientists allowed,” Wilkinson said, according to a statement released yesterday by the minister’s office.

Continue reading "Ontario scientists to get $100 million boost" »

Posted by Monya Baker on May 05, 2009
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I just got off a teleconference discussing draft guidelines about what kinds of human embryonic stem cell lines the NIH will fund. Research advocates still have some work to do for final guidelines due out just after the 4th of July. Here's a link to the NIH draft guidelines.

Right now, here's what's not fundable: lines created from parthenotes (made by stimulating an unfertilized egg to divide; these have been created), lines created from cloned human embryo (made by taking an unfertilized egg and replacing its nucleus with that of another person, then using that to make a genetically matched line of embryo; these have not been created), also any embryos made for the purposes of research (i.e. fertilizing eggs with sperm with the intention of using the resultant embryo for deriving stem cell lines; these have not been created as far as I know, and doing so is prohibited in widely accepted scientific guidelines). The embryos used for deriving lines are typically blastocysts (hollow balls of cells, about 5 days old). Much more rarely, younger embryos (solid balls of cells) are used.

Here is what's fundable : all of those lines that have been made from embryos that would otherwise have been discarded by fertility clinic including those diagnosed with certain genetic diseases, provided researchers can document certain conditions: That the embryo donors knew what would happen to the embryos when the lines are made (the balls of cells are typically destroyed), that donors knew the lines would be maintained for years and that if any commercial benefits developed from the lines, the donors would not get them. Interestingly, the NIH did not talk about grandfathering in any of the hES cell lines that were fundable under the Bush administration, and consent issues have been raised surrounding some of those lines. (See When the past catches up with the present)

This is a big expansion of the lines available, though researchers very much want to compare lines between embryos produced from cloning and left-over embryos to try to figure out what controls the machinery that maintains cells in an embryonic state. Interestingly, when Bill Clinton had the NIH issue guidelines during his presidency, the draft forms did allow funding of embryonic stem cell lines created for research purposes, but, after public comment, the final guidelines restricted funding to left-over embryos from IVF. The Bush Administration withdrew these guidelines when it issued its more-restrictive policy. These guidelines wre based on the kinds of research that enjoyed broad public support.

The proposed new NIH policy is both more and less restrictive than policies in the UK and Australia. The UK does not allow research on embryos unless researchers obtain a license from the government, of which very few have been granted. However, these licenses do allow researchers to transfer nuclei into eggs for the purposes of creating embryonic stem cells. In the US, anyone can try such procedures, but they can't get federal money to do so.

I'll post more in a few days as there is more information. A few months ago, Bryn Nelson compared how policy on hES research evolved in the UK, US, and Germany. That seems particularly relevant now. (Persistence pays off)
Also, here's reporting from Reuters.

PS: This came through from the Harvard Stem Cell Institute as I was typing this up.
"The draft guidelines released today clearly reflect a great deal of careful consideration of the scientific and ethical issues involved. We strongly support the development of unambiguous, ethically sound regulation of the field of embryonic stem cell research, and will carefully consider these proposed guidelines and offer detailed response during the public comment period."

Posted by Monya Baker on April 17, 2009
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In a rebuttal to a statement by members of President Bush’s Council of Bioethics, statementdefended the Bush policy on human embryonic stem cell research, William Hoffman, coauthor of The Stem Cell Dilemma, counters that the U.S. has now rejoined the world’s scientific mainstream.

He writes, “The consensus view of countries that have deliberated and established policy is that research on stem cell lines derived from human embryos donated by fertility clinics with consent of the donors is legal and can be funded with public money.”

For the past seveal years, Hoffman has maintained color-coded maps tracking countries’ stem cell policies. In his commentary, he recounts:

“By 2007 34 countries representing some 3.5 billion people – more than half the earth’s population – had policies that permitted public funds to be spent for stem cell research using embryos donated by fertility clinics with consent of the donors. The United States was not among them. Today it is on its way.”

Hoffman’s commentary is posted on the Bioethics Forum of the Hasting’s Center, which also posted the original statement and another opposing commentary by bioethicist Insoo Hyun.

Even as the amount of research grows, it’s worth noting that a friendlier research environment may not translate into a friendlier business environment. Though the work is tightly regulated and requires researchers to obtain national licenses, the UK is one of the more permissive countries for human embryonic stem cell research. However, researchers at the University of Nottingham have studied the commercialization of stem-cell therapy in the UK and found that the resources to turn research into products are likely insufficient.
As noted in the press release: “the industry is dominated by small, young companies lacking the resources to bring products easily and successfully to market and those that do struggle to make sales.”

Posted by Monya Baker on April 06, 2009
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Last week, ten members of Bush's Council on Bioethics issued a statement criticizing President Obama's lifting of the funding ban on human embryonic stem cell research.The statement, posted by the Hastings Center, is available here. See also our previous post.

In the rebuttal also posted by the Hasting Center, Case Western bioethicist Insoo yun first commiserates with the council's hard work. Then he takes them to task, particularly for implying that Bush's policy enabled research. "To say that the Bush compromise is good enough for American stem cell science is an insult to the researchers and to our fellow citizens," Hyun writes. He also points out that embryonic stem cell research has been and continues to be essential to furthering work on induced pluripotent stem cells and that banning reproductive cloning does not logically require the banning of therapeutic cloning.

Posted by Monya Baker on March 31, 2009
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With the U.S. National Institute of Health poised to fund more grants in both non-embryonic and embryonic stem cell research, the California Institute of Regenerative Medicine hopes to focus on the research that can move the science to treating patients. But it’s set to run out of cash. Both Science and the LA Times have written about this recently (links below)

Last Friday’s issue of Science, described the agency’s quest to sell private bonds so that the Institute could pay out grant funds it has already awarded. As things stands now, CIRM is set to go broke in September.

Constance Holden describes the plans of CIRM leader Robert Klein to sell private bonds, noting that he is more optimistic than several others about the possibilities of success.

The article also quotes James Kovach, head of the Buck Institute for Age Research in Novato, California as saying that he expects state initiatives such as CIRM to survive.

Given California’s financial crisis, an editorial in Monday’s Los Angeles Times questions whether the spending is a good use of money, particularly given the agency’s leadership by Klein.

The leadership and governing structure of CIRM have come under a lot of criticism. Its 29-member board is politically appointed and must include patient advocates as well as high-ranking officials from the institutions most likely to receive CIRM funds. Its plans to give loans and grants to companies have been called both essential and overambitious. The agency has also been praised for taking a leadership role in drafting guidelines and for helping to maintain a U.S. pipeline of stem-cell scientists.
Stem-cells the $3 billion dollar question (subscription required)
US policies on human embryonic stem cells (subscription required)
California against cronyism (subscription required)
CIRM’s search for a president (free online access)
CIRM training grants approved, but awards uncertain (free online access, with links to relevant news stories)

Advocates of state funds point out that, even if NIH is allowed to fund more types of research, it is only able to award a small fraction of the grant applications it receives. They also point out states can still fund research that the federal government cannot, particularly research that creates or destroys embryos. The Dickey-Wicker amendment prohibits funds for deriving new lines from early (about 2-5 day-old) embryos no longer needed by fertility clinics as well as for trying to generate new embryonic stem cell lines genetically matched to an existing individual. (See Embryonic education)

For people without subscriptions, there are more excerpts from the Science article on the California Stem Cell Report.

Posted by Monya Baker on March 30, 2009
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Cross-posted from the Great Beyond

Ten members of the 18-member President's Council on Bioethics have criticised US President Barack Obama's recent executive order lifting the restrictions on federal funding for human embryonic stem-cell research.

In their statement, the ten say Obama's order is "a step backward" with regards to "the progress that had been made in reconciling the needs of research and the moral concerns of many Americans". Obama's order reversed a policy put in place by George W. Bush in August 2001, which permitted federal funding for research on human embryonic stem cells, but only on cell lines that had been derived by the date of his speech.

Much of the dispute centers on the source of the embryos that could be used for such research. Obama's order does not specify the source of the embryos: whether they are leftover embryos from in-vitro fertilisation clinics, or are created for the purpose of research. This is the source of much of the council criticism. The story has been picked up predominantly by the conservative press (Weekly Standard).

The statement did not come from the council itself, but rather from ten of its members speaking out on their personal beliefs. The council, created in its current form by Bush in 2001, has come under fire before, for instance in 2004 when one of its members was dismissed after speaking out against Bush's stance on stem-cell research (Nature). The council in its current form is constituted through 30 September 2009.

Posted by Monya Baker on March 27, 2009
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Cross-posted from The Great Beyond

Obama’s decision made scientists cheer, but raised a question for CIRM: how would its leaders make the case that the agency is still necessary – especially when the state is trying to crawl out of a fiscal crisis? The California voters created CIRM in 2004 in part because the federal government wasn’t funding much human embryonic stem cell research. But with the hands of the National Institutes of Health no longer tied, long-time critics have said CIRM should “adopt a secondary role to NIH” or even close shop entirely.

In response, CIRM is repositioning itself more firmly as a translational agency, preparing for NIH to take on some of the burden of funding basic research. At its 12 March board meeting, the agency reordered some of its programs and cut or delayed funding for others to ensure that the agency will have enough money to support its clinically focused disease team grants, which are expected to be awarded this fall.

CIRM will run out of money this September because the state’s fiscal crisis stopped bond funding from flowing to the agency. The state has authorized CIRM to sell up to $400 million in private bonds to fill the gap. The board members were asked to vote on recommendations prepared by CIRM staff on ways to cut back on expenses in anticipation that $100 million of these bonds will be sold this year. The board endorsed some of the CIRM staff’s recommendations, including funding one set of grants that it awarded in January – $17.5 million to train undergraduates and master’s level students to work with stem cells – and delaying funding for twelve months a second set of grants awarded in January that will give $40.6 million to graduate students, postdoctoral and clinical fellows already working in stem cell research labs.

But the board also voted to rejigger a list of priorities drawn up by CIRM staff. The board’s vote lowered the priority of a set of basic biology grants that were to be awarded this year and boosted the priority of part of the funding for the disease team grants, which will be worth a total of $210 million.

The move protects the full amount of funding for the disease team grants, potentially worth up to $20 million apiece, which will be given to 10 to 12 groups of scientists that aim to put stem cell-based therapies into clinical trials within four years. The disease team program is designed to be a jewel in CIRM’s crown, demonstrating the agency’s special role in translating stem cell science into treatments. The move to prioritize the grants came after patient advocates on the board argued that federal funding can now flow to basic biology research: “The NIH funds that [basic] work,” said board member Joan Samuelson of the Parkinson’s Action Network.

CIRM chief communications officer Don Gibbons said the board’s action answers the critics who said that Obama’s policy change has made the agency less necessary: “This action shows that, yes, there is a place for CIRM, and we are doing something different from NIH,” Gibbons said.

The board also voted to elect two vice-chairs: current board member Duane Roth and California Democratic party leader Art Torres. Torres will draw a $75,000 salary, far less than the $332,000 salary discussed last fall, when CIRM drew some flak for awarding board chair Robert Klein a $150,000 salary on the same day that Governor Arnold Schwarzenegger warned that the state was facing “financial Armageddon”.

CIRM President Alan Trounson had the day before the board meeting endorsed the idea that CIRM should carve out a special role for itself as a translational research agency. “Wouldn’t our natural niche be somewhere between the basic science and the clinic? I think this is where we should be,” Trounson said at an 11 March meeting in San Francisco meeting to discuss the future of the agency.

But some scientists at that meeting were worried by that idea. “This push of getting out there to the clinic has some risks,” warned Arnold Kriegstein of the University of California San Francisco at the meeting. “There’s a risk that little will be learned at great cost” if patients are harmed in poorly designed early clinical trials, Kriegstein said.

And Warner Greene of UCSF’s Gladstone Institute of Virology and Immunology cautioned against “turning over the reins” of basic science to the NIH: “It’s foolish to expect now that the disease teams will succeed,” he said.

CIRM chief scientific officer Marie Csete sought to ease such fears at the 11 March meeting: “We are not abandoning basic science,” she said, adding that any CIRM-funded clinical trials will proceed with caution. “No one wants another name like Jesse Gelsinger in this field,” she said, referring to the 18-year-old who died in 1999 as a result of his participation in a gene therapy trial.

But, Csete pointed out that CIRM has “a shorter timeline” than the NIH,” and feels a special responsibility to California taxpayers who created CIRM hoping to get a real return on their investment. “First and foremost, we want to get to the end goal, which is cures,” Csete said.

Posted by Monya Baker on March 13, 2009
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On Monday, President Obama lifted federal restrictions on funding human embryonic stem cell research, just in time for scientists to apply for NIH grants in stem cells and regenerative medicine.

The Washington Post has a very nice collection of articles, including transcripts of Obama’s speech and a Q&A with Harvard’s David Scadden, and an analysis of the key questions Obama’s order leaves to the NIH. One link can lead you to all the rest.

The New York Times reports that stem-cell researchers won’t be flush with cash, even in California, and examines financial woes at the California Institute of Regenerative Medicine.

The most chipper story, titled “Life injected into Bay Area stem cell companies”, is from the Contra Costa Times.

It includes an anecdote from Michael West, who helped found stem cell companies Advanced Cell Technologies and Geron. West recalls a conversation with Bob Swanson, founder of biotech superstar Genentech.

“"I remember he pulled me aside and told me that stem cell research is going to be just like recombinant DNA was for the industry," West said. "Once the political cloud was lifted, the industry just exploded."

Posted by Monya Baker on March 11, 2009
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Just last week, three labs reported on two techniques to reprogram human cells without permanently inserting the viral genes normally necessary to render cells pluripotent. At least one headline proclaimed that ES cells were obsolete.

If that were the case, one would expect yesterday’s move by President Obama to allow funding for more embryonic stem cell lines to be greeted with a yawn. It wasn’t. The removal of the funding ban made headlines both Friday and Monday. The International Society for Stem Cell Research characterized its scientists as ‘elated.’ Many scientists saw it as the end of a lost almost-decade of research progress.

US News and World Report has rounded up much of the coverage. See Nature’s coverage here.

Scientists are flooding into the race to reprogram adult cells to behave like embryonic stem cells (i.e. to make induced pluripotent stem cells), but they need embryonic stem cells for comparison.

James Thomson of the University of Wisconsin, the first researcher to derive human ES cells and one of the first to make human iPS cells, told me that with the new presidential policy, the newer ES cell lines will replace those made back before scientists had optimized the procedure, back when scientists were trying to figure out whether making human ES cells was possible at all.

“The way I grew them originally was pretty bad,” Thomson told me. “You would pick out the couple [attempts] that grew and passage them [treat them so they can multiply in culture]. The real gold standard will be cells that have been made under better conditions.”

And of course, the study of ES cells was what made the production of iPS cells possible at all. It was necessary to determine what genes could be used for reprogramming as well as the conditions in which reprogrammed cells could grow.

Scientists study the cells they believe are best able to answer their questions (and, at least in the US, they follow ethical guidelines put out by the National Academies). Already, the number of new ES cell lines being made is dwarfed by the number of iPS cell lines. While there will probably always be some questions that ES cells, and no other cell types, will answer, many scientists believe that the field will, of it’s own accord, move more and more toward iPS cells.

Those who want ES cell research to stop now should argue their case on moral, not utilitarian, grounds. The utilitarian argument is best answered by the scientific community.

Posted by Monya Baker on March 10, 2009
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Cross-posted from The Great Beyond on behalf of Erika Check Hayden.

Stem cell researchers may have to wait no longer: President Barack Obama appears ready to lift the ban on U.S. federal funding for research on human embryonic stem cell lines created after August 9, 2001.

The ban was put in place by President George W. Bush, who was responding to concerns among abortion opponents that research on human embryonic stem cells is morally problematic because it involves destruction of embryos. Obama will reportedly sign an executive order overturning the ban on Monday, 9 March. The Washington Post also reported that Obama will likely “simply lift the restriction without caveats and let the [U.S. National Institutes of Health] work out the details.” The NIH is currently formulating ethical guidelines and policies that scientists for scientists who want to apply for federal grants to work with human embryonic stem cells.

Obama’s action comes after research advocates had expressed concern over what they considered Obama’s delay in meeting his campaign promise to overturn the ban. “Obviously, we have concerns and would like to see this done,” Tony Mazzaschi, interim chief scientific officer at the Association of American Medical Colleges in Washington DC told Nature last month.

There has also been extensive discussion about whether the ban should simply be overturned by executive order, or whether the job should be done through legislation that would prevent more flip-flops on stem cell policy under future presidents. Now it appears the ban will be overturned both through Obama’s expected executive order and through legislation, as lawmakers have already introduced bills to undo the ban. Similar bills have previously been passed by Congress, but were vetoed twice by Bush; they would likely be signed into law by Obama if Congress passed them again.

Now, scientists are excited at the chance to undo what they see as political interference that has slowed a promising area of research. Human embryonic stem cells can turn into any cell type in the body, making them potentially powerful tools for investigating disease, and possibly treating it. “I feel vindicated after eight years of struggle, and I know it's going to energize my research team,” George Daley of the Harvard Stem Cell Institute and Children's Hospital of Boston told the Associated Press.

Daley and other researchers have been excited by the development of human induced pluripotent stem cells (iPS cells), which have many of the properties of stem cells yet seem less ethically problematic because they are made from adult cells, such as skin cells. Yet they have also cautioned that the cells are not exactly the same as embryonic (ES) stem cells, so there is still a need to continue both lines of research.

“At this point we clearly still need ES cells,” Konrad Hochedlinger of Harvard Medical School in Boston, Massachusetts, told Nature last fall. “It is unclear to what extent ES cells and iPS cells are really equivalent to each other, and showing this will require much more work.”

More stories: New York Times, BBC, and many others. And stay tuned to nature.com/news for more in-depth coverage from Nature.

Posted by Monya Baker on March 07, 2009
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After a lot of wondering about when it would happen, several news outlets are announcing that President Obama will overturn restrictions on funding human embryonic stem cell research on Monday morning, still within 50 days of his taking the oath of office. Some pundits had expected Obama to lift the restrictions within the first days of his presidency, feeding speculation that Obama wanted federal funding for the research to be authorized by Congressional authority.
Here's the story from the Washington Post. The discussion of the topic on CNN touted that it was bipartisan.

It will be interesting to see if this changes the grants that the NIH can offer in its Challenge grants governing stem cells.

Here's Reuters, which says that details are sparse but will include general measures to increase scientific integrity in the administration.

See links to previous coverage on this blog.
What's Obama waiting for?
News round-up: Obama and the funding ban.

Here's a comparison between how the UK, Germany, and US have pursued policies around human embryonic stem cell research.

Posted by Monya Baker on March 06, 2009
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Senators Tom Harkin and Arlen Specter are expected to reintroduce the Stem Cell Research Enhancement Act, legislation to lift the Bush Administration's restrictions on funding stem cell research.

The blog Pennsylvania Avenue quotes speculation that the stem-cell research bill, cosponsored by two Republican sponsors and three Democratic sponsors could lead to a quick bipartisan victory. The Senators are, as reported by American Chronicle, Dianne Feinstein (D-CA), Tom Harkin (D-IA), Orrin Hatch (R-UT), Ted Kennedy (D-MA), and Arlen Specter (R-PA).

A very short piece in the New York Times identifies the legislation as the same one vetoed by President Bush. That means the Representative sponsors of the legislation are Mike Castle and Diane DeGette. That was vetoed twice by Bush; it’s second time up was covered here.

Just prior to announcments that this legislation was imminent, Meredith Wadman’s article in Nature explored the notion of whether Obama would want Congressional action to accompany his lifting of stem cell policy. See that and related articles here.

Posted by Monya Baker on March 02, 2009
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Meredith Wadman's article on NatureNews explores why Obama has not yet lifted the ban on federal funds for human embryonic stem cell research. Some say that he's preoccupied with the economic crisis; others that the Administration feels simply reversing the executive order isn't enough, and so new legislation is required. One worry: the Dickey-Wicker amendment, which predates the Bush funding ban, might be interpreted to prohibit funds for the research. This legislation, which has been renewed yearly ever since its enactment in 1995, prohibits the use of federal funds that create or destroy embryos. Many legal scholars doubt it would apply to research on cells after the embryos have been derived, but the concern is real.

For more reading, see my news round-up last week.
Also see advice that advocacy groups offered Obama on stem cell research. The group American Progress, in particular, offered strong advice to have hES research supported by Congressional legislation.

Finally, see our comparison between how hES research policy has developed in Germany, the United Kingdom, and the United States.

Posted by Monya Baker on February 24, 2009
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President Obama has promised Democrats that the ban on the federal funding for human embryonic stem cell research will be lifted. See this blog post from the Washington Post. The first paragraph of this Washington Times article describes the context of one such promise, and then abandons further policy discussion to describe presidential air travel. Meanwhile, this more analytic piece in the Philadelphia Inquirer describes why Obama seems to prefer legislative action to allow embryonic stem cell research, and why scientists seem to prefer it too, as it would mean that subsequent presidents couldn’t re-impose the ban by fiat. More than a swift lifting of the funding ban, Obama seems to value implementing the economic stimulus package and coordinating with Congress.

Also on the ban-lifting topic,The Journal of New England Technology has a local round-up of stem cell scientists excited about the funding ban's banishment, noting that it’s not just academic grants that will soon be eligible for funding, but small business grants as well. The well-written article surveys several scientists in both academia and industry.

Continue reading "News round-up: Obama and the stem-cell ban" »

Posted by Monya Baker on February 06, 2009
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When Obama was elected, advocates for embryonic stem cell research rejoiced merely at the prospect of fewer funding restrictions. Now they are developing policy recommendations.

Here’s a round-up of what three groups are advocating, all recommend lifting the federal funding restrictions. Everyone expects that to happen, though there is some speculation, that he'll work with Congress to lift the ban rather than using an executive order. (See story in Newsmax.)
Also, here's a subscription-only piece in Nature Medicine, Challenges anticipated in removal of embryonic stem cell restrictions, which concludes that just lifting the ban will not open floodgates of new research.

The most specific requests are contained in 40-pages from the American Progress group, whose leader, John Podesta, is on leave to advise the Obama transition. A Life Sciences Crucible: Stem cell research and innovation done responsibly and ethically offers specific guidelines to the President, Congress, and NIH, and for establishing the best national stem cell registry and stem cell bank. In particular, the report suggests provisions for stem-cell research coded into federal legislation and suggests that the role of the Recombinant DNA Advisory Committee (RAC ), which reviews human gene-therapy protocols, be expanded to review cell therapies as well. In a position that many scientists will disagree with, the report commends WARF for striking a good balance in protecting investments and allowing research to proceed. In a position most scientists will support, states funding stem-cell research are urged not to drop their efforts.

The Coalition for the Advancement for Medical Research has its 11-page A Catalyst for Cures: Embryonic Stem Cell Research, aimed more at the public than informed policymakers. This report says that ES cell research has come a long, long way, with cells that can now be coaxed into neurons, heart muscle and more. However, ES cell research has even further to go before the cells can be used for practical applications. These include drug testing and modeling disease in a dish. From page 9 on, the report summarizes progress on specific diseases and research investments in companies. It also points out that research takes a long time: it took 45 years after poliovirus was isolated before the Salk vaccine was produced.

The Center for Genetics and Society has a nine page report, three pages of which focus on stem cells. CGS supports human ES cell research, but has spoken out against therapeutic cloning because the experiments require eggs to be collected from women, and the group worries that the technology could be applied to reproductive cloning. Its recommendations call for legislation to prohibit human reproductive cloning (but not therapeutic cloning) and make Stem Cell Research Oversight committees accountable to the NIH. It also calls for greater study and public discussion of issues raised by human biotechnology, as well as federal oversight of assisted reproductive technology.

Finally, Harvard professor and former president of the International Society for Stem Cell Research puts forth his recommendations in a collection of advice from experts ranging from climate change, FDA, and infrastructure. (It's the final essay in this collection. Your inbox, Mr. President)

If I’ve missed your group, send an email to the Niche at nature dot com.

Posted by Monya Baker on January 20, 2009
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Posted on the Great Beyond for Natasha Gilbert

Reports in the British media that grant applications to create hybrid human – animal embryos for research were turned down on moral grounds, have been rejected by the funding bodies and scientists involved.

The story broke in the Independent newspaper on Monday, which claimed Stephen Minger, a leading stem cell scientist at King’s College London, said that the grant applications may have been blocked by scientists on the funding committees who are morally opposed to the creation of cloned hybrid embryos.

But when Nature spoke to Minger he said the Independent misinterpreted his comments, adding he did not have any evidence that moral objections led to his proposal being rejected.

“I was not saying that religious or moral opposition to the proposal led to its rejection,” he said.

Continue reading post on the Great Beyond

See a summary of the UK Academy of Medical Sciences Report describing issues around chimera research.

Also, a Lutheran divinity scholar making a theological case for chimeras

Posted by Monya Baker on January 14, 2009
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California’s Fair Political Practices Commission (FPCC) decided that Burnham Institute President violated conflict-of-interest rules by writing a letter to the California Institute of Regenerative Medicine appealing a decision that an affiliate of his institute was ineligible for funding.

CIRM did not change its decision, but John Reed was a member of CIRM’s governing board at the time, and the FPCC concluded that Reed violated rules by attempting to use his official position to influence a “prior-made government decision that could not be appealed.”

This ends an investigation that was launched over a year ago at the request of CIRM watchdog, John Simpson. “I hope Dr. Reed and all members of the board have learned from this,” Simpson said in a statement. Though Simpson had previously called on Reed to resign, he says it would now be acceptable for Reed to rejoin the Institute’s 29-member board. Simpson's organization, Consumer Watchdog has posted a copy of the FPCC letter.

Based on its analysis of the situation, the FPCC concluded that “although the matter raises ethical concerns, we are closing the matter with a warning letter.” It also stated that failure to comply with the rules in future could result in fines of $5,000 per violation.

A statement from Robert Klein, head of CIRM’s governing board, said that the FPCC’s decision supported his belief that the violation of rules was inadvertent.

After the complaint became public, both Reed and Klein said that sending the letter was a mistake. At a public hearing in November 2007, Klein attributed the mistake to growing pains of a new agency, and Simpson called on both Klein and Reed to resign, saying they had shown poor judgment.

As usual, Teri Somers has a clear account in the San Diego Tribune.

Posted by Monya Baker on January 12, 2009
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Salaries and appointments for CIRM officials
After lots of people (including me) indulged in headlines touting half-million suppositions, the CIRM board decided to pay Bob Klein $150,000 a year for what it deemed a half-time position. The San Francisco Business Times provides a nice overview, including the potential hiring of California Democratic Party Chairman Art Torres for the vice-chair position at just over $300,000 per year, and Governor Schwarzenegger’s concerns about paying both these positions. The Sacramento Bee has an article on Torres.

Some companies get tools grants
In the last round of grants for creating new pluripotent stem cell lines, biotech companies cried foul that only applications from academics got the dough. (See What got funded.) They have less to complain about in this round. And while San Diego was bitterly disappointed that San Francisco (my fair city) won the seat of the California Institute of Regenerative Medicine, they should be cheered that four San Diego biotechs won grants. In addition, Duane Roth, one of the biggest “go-to” people in the San Diego biotech community, is reported to be Schwarzenegger’s pick for the vice-chair position eyed by Torres. XConomy reports that funds will soon be flowing to NovoCell for a pouch that can be used to transplant insulin-secreting cells without triggering an immune response, to Invitrogen (now known as the hard-to-Google “Life Technologies”) to use stem cells to model neurodegenerative disease, to Vala Sciences to make heart cells from stem cells, and to a joint effort by Fluidigm (which is in South San Francisco) and StemGent for techniques to find better ways to induce differentiated cells to pluripotency. The San Diego Tribune describes some funded technology more fully, along with the disappointments of one of the industry applicants that did not get funded. The two other companies to win grants were Gamma-Medica Ideas (with offices in Northridge, California, plus Norway and Canada) for ways to visualize single stem cells in the body and Vistagen (based in South San Francisco) for ways to use stem cells to screen drugs for potential liver toxicity.

Here is a list of the 23 grants awarded to 18 institutions, along with links to each application. Awarded funds totaled $19 million. This round of grants was targeted to develop technologies that could speed the development of therapies rather than become therapies themselves.

Posted by Monya Baker on December 12, 2008
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CIRM added yet another country to its list of collaborators, Spain, on December 3rd.
That’s the fifth country this year. The others are
Japan (Nov 18)
UK (Oct 20)
The Australian state, Victoria (June 18) and
Canada (June 18)

I went to the signing ceremony of the UK collaboration, where race-card-driver-turned-executive-turned-British-official Paul Drayson met with CIRM head Bob Klein to sign the three-page memorandum of understanding. They let me read it. It wasn't very specific.. Patent laws for each country would still apply, for instance. Though researchers will still apply for grants from their respective geographic locales, they will formally be able to name collaborators far, far away.

In other news, the chair of CIRM’s governing board, Robert Klein, may be seeking a salary of $508,750, according to the California Stem Cell Report. (See posts on Dec 1 and Dec 4). The folks over on King Street seem to be doing well, according to their salary schedule. Just before CIRM president Alan Trounson was hired at just under a half million dollars a year, I wrote an article chronicling the Institute’s search for a president and trolled through tax filing to find salaries of the scientific heads of several grant-giving agencies. (See that here, but note that the figures are a bit old.)

Posted by Monya Baker on December 05, 2008
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A study in Cell Stem Cell finds that web sites that offer stem cell treatments over the Internet make lots of bogus claims, and the leading organization of stem cell scientists has issued a patient handbook of questions to ask potential providers, plus guidelines for the clinical translation of stem cells.

We have an excellent commentary that explores the issue from the view of various stakeholders including patients, providers, regulators, and scientists. It’s written by Doug Sipp of RIKEN in Japan and Sorapop Kiatpongsan of Harvard and Thailand’s Chulalongkorn University. Here is the NatureNews story.

This feature charts dilemmas faced by practitioners and patient advocates.
Stem cell researchers face down stem cell tourism

This news story includes opinions from diverse members of the task force and others in the community.
Stem cell society condemns unproven treatments

Links to a story in the popular press and a draft of a news story is below.

Continue reading "Stopping snake-oil stem cell treatments" »

Posted by Monya Baker on December 03, 2008
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News reports today say stem-cell companies are getting a boost from expectations that federal support for embryonic stem cell research will soon be less restricted, even if the companies don't work in embryonic stem cells. Crain's Detroit Business quotes officials of Oncomed, Aastrom, and more. The Bay Area newspaper also has a thoughtful piece.

StemCells Inc. has just announced a $20 million equity financing from an un-named institutional investor, through a shelf registration. The company has a Battens disease trial using neural stem cells derived from fetuses.

One of the menstrual stem-cell companies just announced a deal with the NIH. According to the press release, iron nanoparticles will be used to follow the human cells as they circulate around a mouse engineered to have breast cancer. (Actually, the press release only says "breast cancer model"; I''m guessing it's a mouse, though it could be a dog or a worm.) The ability to track cells is important, and so is figuring out how mesenchymal stem cells track to different organs. In fact, they may even help breast cancer metastasize. (See The dark side of mesenchymal stem cells.) Mesenchymal stem cells seem to come from many sources, and menstrual blood seems like one of them. (CryoCell is one of several companies that charges customers to bank cells for applications that have not yet been developed and may never be. See Stem cell banking: life line or sub-prime? For more on mesenchymal stem cells in general, see Questioning the self cell. For more on menstrual stem cells see Mesenchymal stem cells in the womb ).

Continue reading "Stem-cell companies anticipate friendlier federal environment" »

Posted by Monya Baker on November 18, 2008
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On Sunday, members of Obama's transition team said President-elect Barack Obama would review executive orders issued during the Bush Administration, and likely reverse many of them quickly after inauguration. Human embryonic stem cells was high on the list of likelies. This isn't a surprise, but the swiftness suggests that it is a priority, and also something that Obama must consider a relatively easy step.

Here's what the New York Times had to say. The stem cell research bit is described more fully on page 2, but no surprises.

Posted by Monya Baker on November 10, 2008
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In a historic US election, human embryonic stem cell research is coming out ahead.

In Michigan, scientists will now be able to derive new human embryonic stem cell lines from embryos donated by couples getting fertility treatments. See article in the Michigan Free Press.

A Colorado measure that would define a fertilized egg as a human being was also defeated. See the Los Angeles Times.

President-elect Barack Obama has also pledged to restore federal funding for human embryonic stem cell research.

Posted by Monya Baker on November 05, 2008
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Someone from the NAS outreach office noticed my recent post on Obama's science plan and suggested the following NAS work would be of interest to those fllowing the debate.

We recently published “2008 Advisements to the National Academies’ Guidelines for Human Embryonic Stem Cell Research”, which offers a common set of ethical standards along with a straightforward account of stem cells and stem cell research. We believe that this publication would be of interest to anyone following the Stem Cell debate.

This report is available for free online reading and download, along with the following resources that will further inform your readers.

1. Read or download for FREE the entire text of the book in HTML and pd.

2. Podcast: “Stem Cells and the Future of Regenerative Medicine”

This podcast is devoted to the basics on stem cells.

-You may subscribe to this podcast at http://www.nap.edu/podcast.html

3. Other Stem Cells related books from the National Academies

Guidelines for Human Embryonic Stem Cell Research

Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research

Cord Blood: Establishing a National Hematopoietic Stem Cell bank Program

Posted by Monya Baker on October 28, 2008
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One of Barack Obama’s science advisors addressed the annual gathering of science writers this Sunday in Palo Alto, CA. John McCain’s campaign declined to send anyone, which meant that the entire time slot could be taken by Sharon Long, a Stanford professor and member of the National Academy of Sciences, who advises Obama in her personal capacity.

She didn’t mention stem cells during her 45-minute talk, but instead described “returning integrity to scientific advising in the White House”, a veiled reference to widespread complaints that Bush has filled advisory positions with people who agree with him rather than top scientific minds. (See an earlier post, Surgeon General Censored ).

During the question period, I asked whether she was concerned about the leadership role of the U.S. National Institutes of Health in stem cell research. States have grown their own regulatory and funding infrastructures to promote stem cell funding, and while researchers tell me they are very grateful for the money, they also tell me that these state-by-state systems are inherently inefficient and create bureaucracy blockades to collaborations. When I asked Long whether this was a problem, she said that Barack Obama would allow the NIH to fund human embryonic stem cell research.

I chased her down afterward to get her to answer the question I’d asked, and she seemed familiar with the issue, acknowledged it as a problem, but said it was “too granular” to be considered at this time. (For more on this issue, see a Patchwork quilt of funding and State initiatives strain stem-cell scientists )

Overall, I thought the priorities she described reflected the issues I hear scientists talk about. Often, these speeches induce yawns, full of vague platitudes of how very important science is, time-worn hang-wringing, etc. There was some of that, of course, but there was also a plan to double science funding over ten years, plus the acknowledgement that turning funding taps on and off discourage young people to enter the field.

There also seemed to be considerable thought of how a president should get scientific advice. Obama has pledged to follow recommendations produced from the National Academies of Sciences, which lists 60 positions that they feel could benefit from high levels of expertise. Obama’s science and technology advisor would report to the President (that role got kicked out of the White House under the Bush administration). By creating a hybrid position, a President Obama could have that person working before all the Congressional approvals went through. (For our columnist thinks scientists might be a bit too obsessed on this issue.)

Here’s a link to Obama’s science plan as well as takes on individual issues . John McCain outlines his ideas on technology, climate change, agricultural policies, energy and other science-related issues as separate topics.

Nature covered the U.S. election extensively last month.

Posted by Monya Baker on October 27, 2008
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Cheaper genome scanning
Next year, the cost of sequencing a human genome will fall to $5000, according to start-up Complete Genomics in a story in The New York Times. The start-up expects that individual people will be the chief customers, but I’d imaging those characterizing stem cell lines wouldn’t mind getting some additional data, both about the existing variety of stem cell lines and about how individual stem cell lines change genetically as they adapt to culture. (See our commentary on how to assess a stem cell genome.)

Paperwork for embryo donors
Besides providing more genetic diversity, newly derived embryonic stem cell lines could be derived and maintained under better conditions for culture and informed consent. While recent surveys show individuals are willing to donate unwanted frozen embryos for research, an article in The Los Angeles Times describes some of the paperwork burdens involved.

Private money for Stanford stem-cell building
Meanwhile, BusinessWire founder Lorry Lokey is giving $75 million to Stanford for a stem-cell facility, according to the San Jose Business Journal. In the article, the Stanford Graduate and entrepreneur compares stem cells to the silicon chip. The total cost of the building will be $200 million, of which $44 million is coming from tax-payer funded California Institute of Regenerative Medicine; the university and other contributors are supposed to foot the rest of the bill.
Also, here’s a story from the San Francisco Chronicle.

Posted by Monya Baker on October 06, 2008
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Maryland has just issued requests for proposals in stem cell research for a series of five-year grants for projects with supporting data plus two-year grants for more exploratory research. Graduate students and post-docs across the U.S. can apply to work in Maryland stem-cell labs for fellowships worth up to $55,000.

Elsewhere, initiatives to push stem-cell products toward commercialization are hitting snags. A few weeks after its head was ousted and its board resigned en masse, the Australian Stem Cell Centre has a new interim head and board of directors. (See The Age) The agency has been having a tumultuous time, sparked by debates over whether to follow basic or commercial research. Though a 2006 review of the centre gave it good marks, the ASCC board fired it head Stephen Livesey, after a negative review of the centre. He told an Australian newspaper, that he was frustrated by stakeholders’ skeptical attitudes toward commercialization. See Infighting clouds stem cell centre’s future .

The Australian quotes Alan Trounson, head of the California Institute of Regenerative Medicine, co-founded ASCC in 2002, said the organization “needed to restructure”. Ironically, the structure of the California Institute of Regenerative Medicine is currently undergoing a review of its structure and efficacy. (See The Great Beyond ) CIRM itself is obligated to help stem cells become commercial therapies. It is offering a loan program for biotechs. Biotechs are also eligible to apply for grants which carry an obligation to pay some royalties to the state for commercialized products. At the same time, CIRM must make sure that these therapies will be accessible to Californians. On Monday, California governor Arnold Schwarzenegger vetoed bipartisan legislationguaranteeing access to Californians and making it easier for the agency to fund other sorts of research.

As possibilities for commercialization increase, so will the tumult.

Posted by Monya Baker on October 01, 2008
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The National Academies updated their guidelines on human embryonic stem cell research. Although the guidelines don’t carry the force of law, they are standard practice in both industry and academia in the US.
The amendments re-affirm that women cannot be paid to donate eggs for ES cell research, and clarify that they can be reimbursed for expenses. They also say that potential uses and experiments with induced pluripotent stem cells are broadly the same as ES cells, that if a researcher only wants to study an existing stem cell line in vitro, the ethical review of the research can be expedited. Also, embryonic stem cell oversight committees (ESCROs) should conduct regular audits and make detailed information on ES cell research at their institutions publicly available.

Posted by Monya Baker on October 01, 2008
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In Madison, Wisconsin, the former US secretary of health bellows: “Some inner hope!” Tommy Thompson yells at the crowd—a room full of stem cell research advocates—preaching to the converted that embryonic stem cells give disease sufferers a reason to believe in a better life.

This is an unusual conference: patients and patient representatives plus industry executives, politically active scientists, lobbyists, ethicists, policy experts and more are here.

Although the conference organizer stresses that the meeting is not partisan, the crowd and some speakers are vocally anti-Bush because of his refusal to fund human embryonic stem cell research. Thompson tells the crowd that the policies could easily have been more restrictive and describes how Bush called in pro-research Thompson to debate anti-research Karl Rove on the issue. (The president munched a peanut butter sandwich during the impromptu but lengthy discussion; a few days after that he announced his compromise position to fund lines created before August 2001.) After relating the story, Thompson warns them not to be too harsh on Sarah Palin; they might need to work with her.

Later that afternoon, Alta Charo, a professor of law and bioethics at the University of Wisconsin–Madison, says debates over the moral status of five-day-old embryos are simple compared to what will come when cell-based products enter full-fledged trials for spinal cord injury and the like. She delineates problems with cell therapies, going from the difficult animal studies (monitoring cell transplants for months in infection-prone rodents) to the “polarizing debate around class and access to health care” that will ensue if an expensive cell therapy hits the market.

In between there is the hurdle of conducting clinical trials. When that happens, she predicts, the number of patients hoping to participate in trials far exceeds the number that can be enrolled.

Indeed, one of the scientists here told me privately that the constant invocation of "the 'C word'" (cure) made him uncomfortable. Even if cell-based therapies help, most are a long way from being tested, and they are more likely to improve a patient’s condition than to reverse it.

The exuberant attitude worries scientists, but it’s part of US culture, says Charo. The American mindset is optimistic and forward thinking. That means US patients often assume that 'the new thing' must be better than the current standard. “Without controlled trials, we can be sorely misled. People can undergo terrible ordeals for something that might be worthless.”

This is something that Wise Young thinks about nearly every waking moment. The neuroscientist from Rutgers University, in New Jersey, has courted controversy by reaching out to help organize stem cell networks in China and elsewhere, urging commercial practitioners to disclose their procedures (some refuse). Patients would go anyway, he says, despite the high cost and risk. “No matter what we do and what we say, medical tourism will occur until we start providing something that will satisfy the demand.”

Young calls for greater willingness to do clinical trials in the United States and for scientists to talk with and monitor patients before and after they go abroad for poorly documented procedures. Anecdotes are very hard to assess, particularly for spinal cord injury. Over time, patients’ conditions do tend to improve somewhat, and performance can vary significantly from month to month.

A coordinated group of scientists who would assess patients at multiple time points before and after they undergo procedures could provide invaluable information, even in the absence of a clinical trial, suggests Graham Creasy, chief of Spinal Cord Injury Service at the VA Palo Alto Health Care System in California. Indeed, this has been done on a smaller scale already, one for a clinic in Portugal, another for a clinic in China. An evaluation showed no significant improvement in patients’ condition. But there are problems with the approach. Medical experts in the United States worry that even this kind of inquiry could legitimize and thus encourage potentially harmful approaches that disqualify patients from future trials in the United States. Besides, what incentive would the medical tourists have to participate in these inquiries?

BTW: The International Campaign for Cures of Spinal Cord Injury Paralysis provides information for the general public on participation in clinical trials. (This is different from paying money to a far-off clinic for undocumented procedures, but similar questions apply.)
The International Society for Stem Cell Research has proposed draft guidelines for the clinical translation of stem cells and is seeking comments until the beginning of October.

Related stories
Stem cell society condemns unproven treatments

Stem cell researchers face down stem cell tourism

Here are all three blogs from the conference

Companies have company

Stem cell trials balancing hope and harm

Stem cell therapies, ready for success?

Posted by Monya Baker on September 25, 2008
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Here is a preview of an article that will be on the site next month.

Sermons railed against the creation of monsters. Headlines invoked the spectres of “frankenbunny” and “mootants”. Scientists were branded as Nazis — or worse.

And yet the research community in the United Kingdom won over a majority of the public and convinced Parliament to approve some of the most permissive embryonic stem (ES) cell research provisions in the world, expected to be finalized this autumn. So British stem cell scientists might be forgiven for being a mite critical of the low profile adopted by their counterparts in countries such as the United States and Germany.

“In other countries, scientists just keep their heads down,” says Stephen Minger, director of the Stem Cell Biology Laboratory at King’s College London. “Even with the approved lines, they don’t admit to doing embryonic stem cell research”.

For Minger, an American ex-pat, that’s the wrong way to go. He and other UK researchers speaking this July at the European Science Open Forum in Barcelona, Spain, said they had overcome fierce opposition by being at the front of the national debate over legislation governing human stem cell research. Once passed into law, the updated Human Fertilisation and Embryology Bill will expand the existing regulatory framework to include four new types of human–animal hybrid embryos.

Far less ambitious efforts in both the US Congress and Germany’s Bundestag to bolster research on human ES cells have met with scant success. The obvious question is whether Britain’s expansionist strategy can be tailored to fit the cultural realities elsewhere.

Continue reading "Stem cell research: persistence pays off" »

Posted by Monya Baker on September 22, 2008
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The Center for Genetics and Society has launched a BioPolicyWiki with several entries related to stem-cell research, including obtaining human eggs for research and creating embryonic stem cells through nuclear transfer (research cloning). The Center opposes both practices, but clicking around I felt that the team that put it together had made a sincere effort to acknowledge both sides. Mostly, the content classifies countries’ policies touching on relevant research.

Meanwhile, FoxNews describes stem-cell researchers apprehension over Presidential candidate McCain’s positions, while WiredNews considers that his proposal for a very restrictive policy is, for the most part, mere pandering to the conservatives.

Posted by Monya Baker on September 19, 2008
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Australia issues cloning license
Australia has issued its first license for making stem cells from cloned human embryos, according to news reports. The recipient is a fertility company called Sydney IVF, which says it has access to 7,200 human eggs. The project will use only eggs obtained with appropriate informed consent and that could not be used for in vitro fertilization.
Several research groups have already reported cloning human embryos. However, despite multiple continuing attempts, no one has reported a successful dderivation of human embryonic stem cells through this method.
The advantage of cloned hES cells would be that they would be genetically matched to an existing individual. The cloning process could also help answer questions about `reprogramming’, or how cells shift genetic expression to become one or another type of cell. Recently, push to clone hES cells has diminished with the invention of a reprogramming technique that genetically engineers adult skin cells, but scientists are still eager to compare both techniques.

See a blog entry describing previous attempts, plus links to other groups attempting this work in Europe.

Posted by Monya Baker on September 16, 2008
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Scientific American is running a long interview with Representative Diana DeGette, who has worked on legislation to overturn the federal ban on funding for embryonic stem cell research. Her book Sex, Science and Stem Cells: Inside the Right Wing Assault on Reason, has just been released.

Reading the interview reminded me how frequently European scientists are surprised that debates in the US link research on embryonic stem cells with contraception and sex education.

(For the record: no embryos being used for research on embryonic stem cells came from sex. These are embryos that formed outside a woman's body and have never been in a womb. A survey last year found that couples who have extra embryos left over after fertility treatment are much more willing to donate them for research or to have them destroyed than to give these embryos to other couples seeking fertility treatment.)

The scientists who read this blog will probably be more interested in a role for the NIH to provide ethical oversight at the federal level for cell-based research.

Continue reading "Sex, science, stem cells, and federal oversight " »

Posted by Monya Baker on August 12, 2008
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New Scientist is reporting that South Korea has refused disgraced scientist Hwang Woo-suk request to resume work to make stem cells from cloned embryos. Nature's Asia correspondent tells me no Korean institute has been approved to do human nuclear transfer (human cloning to make embryonic stem cells but not new people) since the Korean health ministry revoked Hwang's license in early 2006.

Once featured on the country’s postage stamps, Hwang has been on trial for over two years for misusing funds and for obtaining eggs from junior female lab members in ethically shady ways.

Nature previously reported rumours that Hwang was attempting work in Thailand, and both Hwang and former colleagues are working with start-up companies to clone dogs that would serve both pet owners and industries that rely on canines for drug-sniffing.

Related articles:

Dog cloners baring their teeth

Disgraced cloner Woo-suk Hwang attempts a comeback

Hwang’s “clone” was really a parthenote, Daley reports

A collection of stories on the rise, fall, and fraud of the scientist who claimed to be the first to clone human embryonic stem cells

Posted by Monya Baker on August 02, 2008
Categories: Ethics, Policy | Permalink | Comments (0) | TrackBacks (0)

UPDATE: Since I wrote this, Americans for Cures contacted me to say that Bob Klein will remain on the board of the organization but has resigned from the presidency.

The head of California’s stem cell funding agency has resigned from the presidency of a stem-cell advocacy group, according to a public interest group that monitors the government agency . Consumer Watchdog, a non-profit taxpayer advocacy group, has repeatedly denounced Robert Klein, the chair of the governing board of the California Institute of Regenerative Medicine (CIRM), for conflicts of interest.

In 2004, Klein largely drafted and campaigned for Proposition 71, the legislation that led to the creation of CIRM, which is funded through $3 billion in state bonds to promote stem-cell research. Since then, Klein, a real-estate developer, has headed the boards both for CIRM and for the Americans for Cures Foundation, a stem-cell research advocacy group.

Consumer Watchdog’s John Simpson called for Klein’s resignation from either group after Americans for Cures derided a state legislator. Americans for Cures lambasted Senator Sheila Kuehl for sponsoring a bill that could limit the prices that CIRM-funded companies could charge for therapies. Advocates of SB 1565 say the legislation will ensure access to medical benefits from stem-cell research; critics believe it will discourage companies from developing cures. This has been chronicled extensively in the blog, California Stem Cells Report, which reports that both Klein and Americans for Cures have apologized. (See posts from July 10 to July 15.)

Staff at Americans for Cures would not officially confirm or deny that Klein had left the organization, nor would the group’s vice president for public policy, Don Reed. However, Reed did imply that the research-advocacy group would soon have a new president. “Bob is the flame of our faith, but he has to face the reality that he has so much work to do,” he said.

The most recent flap is not the first time that Simpson has called on Klein to resign. In November last year, Simpson said Klein demonstrated extremely poor judgment by encouraging John Reed, president of the Burnham Institute and a CIRM board member, to speak with CIRM staff when a Burnham researcher’s grant was denied.
(See my account of the incident here )

CIRM is an unprecedented organization with an unusual governing structure. Coverage of the agency by Nature and Nature Reports Stem Cell is nicely summed up at this posting on the Niche.

Posted by Monya Baker on July 15, 2008
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The California scientists most likely to receive state grants for making new cell lines were those who proposed comparing embryonic stem cell lines and induced pluripotent stem (iPS) cell lines. Overall, thirty-two percent of all grant applications (16 of 50) were funded. Four of the five grants that proposed comparisons got funds. The unfunded grant application crossed into less favored categories, as it also proposed making lines from parthenotes and through nuclear transfer. None of the grant applications that sought to make cell lines using human oocytes were funded. Two proposed cloning through nuclear transfer, one proposed stimulating unfertilized eggs to divide into parthenotes, and one application proposed using both methods.

Success rates for grants proposing the derivation of only ES or only iPS cells were each 33%, but there were twice as many grants for iPS cells. That’s astounding considering that the grant program was announced in October 2007, a month before the first publications that human cells could be successfully reprogrammed.

Four proposals to make pluripotent lines using cells derived from the placenta, testes, or amniotic fluid were rejected. But a proposal to make spermatagonial stem cells, ES cells, and iPS cells was funded and highly praised, with reviewers particularly keen to see a comparison of iPS and spermatagonial stem cells from the same individual.

Continue reading "What got funded: statistics on California’s new stem cell line grants" »

Posted by Monya Baker on July 02, 2008
Categories: Ethics, Funding and Resources, Policy | Permalink | Comments (2) | TrackBacks (0)

Kristofer Eisenla, spokesperson for Representative Diana DeGette, called to say that when I was talking with him about DeGette’s position that his meaning was not that there was absolutely no oversight over research, but rather that there was no federal oversight of cell-based research. DeGette is drafting legislation that would provide federal oversight and eliminate the federal ban on funding for research on certain embryonic stem cell lines. Eisenla says he’s hoping legislation will be written before the August recess.

Here’s the news story from Nature Reports Stem Cells

Posted by Monya Baker on May 22, 2008
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UK’s Parliament is discussing legislation that includes regulations governing research on early human and hybrid embryos. At the same time, the bill will seek to change the time limit on abortions; moving the time at which a pregnancy can be ended to earlier than the current 24-week term. I think these debates should not be conflated. One considers whether to allow the creation of early stage embryos in lab dishes by combining human and animal cells that will not be implanted in humans and will be destroyed before they can develop beyond the squashed-ball, the-size-of-a-pinhead stage. I don’t think anyone believes the chimeric embryos would even be capable of developing to full term, . The other considers the conditions under which a woman can choose to terminate a pregnancy.

An account from Nature.com is now available.
Here is a straightforward account from the Press Association and another from Reuters. The Science Media Centre has collected enorsements from prominent scientists and patient advocacy groups, that combining human chromosomes and animal eggs could lead to techniques for creating cells that could be used to treat devastating diseases.

Last year, Nature Reports summarized the UK Academy of Medical Sciences report on the benefits, risks, and unknowns on creating animal-human chimeras and comparing it to ethical guidelines from different scientific societies. Forgive the self-plug, but it’s one of the most comprehensive I’ve seen, particularly for something as short as it is. (If readers send in other good links, I’ll post them.)

Continue reading "UK parliament debates embryo research" »

Posted by Monya Baker on May 12, 2008
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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
Categories: Cloning, Ethics, Policy, Reprogramming/Pluripotency | Permalink | Comments (0) | TrackBacks (0)

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
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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
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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
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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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