Three Big Ifs

The $45 million California round of ESC research grants has triggered additional interest in stem cell stocks on the Internet.

Writing on stockerblog, an anonymous retired professional in the financial industry issued a rundown entitled “Stem Cell Stocks: The Growth Industry of the Future?”

An excerpt that noted three major caveats:

"There are only a limited number of stocks which are pure plays or semi-pure plays in the stem cell industry. However, if governmental funding increases, if private research continues, and if there are any major breakthroughs, then this could be a very huge industry."

Stockblogger wrote a paragraph each on stem cell companies that are pure or semi-pure plays. The blog is carried also on the "Seeking Alpha" financial website.

Bringing Pizzas to An Appeal?

The Daily Kos, a political blog with huge national readership, carried an interesting piece by patient advocate Don Reed on last week's oral arguments in the California stem cell lawsuit.

Reed was present during the hearing, and, as usual, has a quite personal approach to the affair. Here is a sample of his thoughts as the three appellate judges seated themselves.

“It occurred to me how important the personal element was; I hoped all the judges had slept well, and had a good breakfast or lunch or brunch or whatever. I would have run out and gotten them a pizza if it would have helped. “But there was nothing to be done, no pizza bribes to offer, only to listen, and hope.”

Reed's posting on Kos was a truncated version of his Feb. 15 filing on his own web site, which carried this additional paragraph about a chat he had at the hearing:

“I had a conversation with Ms. (Terri) Somers (a reporter for the San Diego Union-Tribune) on the disastrous shrinkage of newspaper funding—it kills me that newspapers, the foundation of an informed citizenry, are losing ground in every direction—I got to put in my plug for a government bailout of the newspaper industry. If we can bail out the Savings and Loan Industry, why not newspapers, which provide such a vital service to democracy?”

A Prop. 71 for the newspaper business? Probably too risky since even venture capitalists do not seem willing to enter the “dead tree” business -- at least most of them.

Here is a link to Reed's Kos item: http://www.dailykos.com/story/2007/2/15/101926/443
Here is a link to the original column (see his Feb. 15 archives if it does not come up immediately): stemcellbattles.com.

Advisory to Readers

Please bear with us as we continue to work through computer problems
during the next few days. In addition, Google, the service that hosts
this web site, has some issues with its software that create
difficulties in posting items. We are using an alternative method of
filing items that may result in some different, perhaps even weird
formatting.

"New Action Heroes" Win Millions in ESC Research Grants

The word went out this weekend from China to Syracuse: California stands No. 1 in embryonic stem cell research in the United States and, and by at least one account, perhaps in the world.


The occasion, of course, was the approval of $45 million in research grants by the California stem cell agency.

The event generated enormous amounts of favorable publicity worldwide for CIRM and for the cause of ESC research. Gov. Arnold Schwarzenegger  stood before TV cameras and declared that ESC researchers are "the new action heroes."

His theme carried through on San Francisco television station KGO, which aired a more than two-minute-long report by David Louie with loads of sympathetic images of disabled persons and film of confidence-inspiring lab work. Smiles abounded, including some from Roman Reed, who is paralyzed as the result of an injury.

He told KGO viewers:

 

"We are on the road to cures. We are on the road to be able to solve the problems that plague mankind. Millions of people are suffering, and now we're on the road to cure them. This is wonderful."

Reed´s father, Don, stood at Schwarzenegger´s left as he vowed, on camera, continuing support for CIRM.

Reporter Terri Somers of the San Diego Union-Tribune wrote:

"The panel awarded the highest score to a researcher at UCSD (University of California, San Diego), Anirvan Gosh, for his proposed work on coaxing human embryonic stem cells to morph into neurons in the brain, particularly those in the forebrain. It is in that area that Alzheimer's is believed to do damage.

"Gosh's scientific background and the cutting-edge science he proposed impressed the committee, said Zach Hall, president of the stem cell institute."

A number of newspapers wrote that the $45 million in grants exceeded federal spending annually on ESC research. But  Carl Hall of the San Francisco Chronicle reported that the 72 grants covered a two-year period and were about equal to federal ESC spending for the same period. But Hall continued:

"Eighty million dollars in state grants are expected next month, more than enough to make California the world's No. 1 backer of biomedicine's most ethically contentious research."

Mary Engel of the Los Angeles Times reported:

"After more than 12 hours of deliberation Thursday night and Friday morning, the full board made selections from the proposals, which were numbered and had the names of institutions and people removed. The institute staff advised board members, many of whom work for universities or institutions with proposals, on when to recuse themselves because of a possible conflict of interest.

"The process drew some complaints from two government watchdog groups, which pointed out that Connecticut, which has a much smaller stem cell research effort, identified all the institutions and scientists it funded by name, including those rejected. The groups called on the board to publish the names of the California institutions that applied for grants but were denied.

"But even they praised the spirited discussions and lengthy deliberations that went into choosing the grantees.

"`Many of us had expressed concern that the board would act as a rubber stamp and not delve into this in a serious way,´ said John Simpson of Santa Monica-based Foundation for Taxpayer and Consumer Rights. `This is a very good process.´"

The California stem cell agency prepared a press release on awards, quoting stem cell Chairman Robert Klein as saying:

 

"Today marks another milestone in one of the most important public endeavors ever undertaken by California.  Patients and families around the globe will take heart that human embryonic stem cell research is finally beginning to receive the funding it needs and deserves."

As for Syracuse, below is a link to the story there. More than one appeared in China, but here is a link to the Xinhua news agency story.


San Francisco Chronicle: http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2007/02/17/BAGPRO6J7P1.DTL&feed=rss.bayarea

San Diego Union Tribune: http://www.signonsandiego.com/uniontrib/20070217/news_1n17stem.html

Syracuse: http://www.wstm.com/Global/story.asp?S=6102625

 

Los Angeles Times: http://www.latimes.com/news/local/la-me-stem17feb17,1,4500053.story?track=rss&ctrack=1&cset=true

 

Xinhua: http://news.xinhuanet.com/english/2007-02/17/content_5750741.htm


 

Patient Advocate Don Reed on the CIRM Grants

Hi, Folks!

David Jensen was kind enough to allow me a small guest spot in his excellent column.

As you will see, it is not the balanced calm objectivity he always tries for.

I am a supporter of the California Institute for Regenerative Medicine. To me, it is the noblest institution which ever advanced the hopes and dreams of suffering humanity—because its sole function is work for cure, to ease suffering, end pain, and save lives.

Thank you for this opportunity to address you.

Don C. Reed

Oh, and if you would like to see Governor Schwarzenegger, Bob Klein, the Independent Citizens Oversight Committee, Karen Miner, Roman Reed and yours truly in action, go to



http://cbs5.com/video/?id=20865@kpix.dayport.com


---------------------------------------------------------


The California Institute for Regenerative Medicine, the CIRM, is the pride of our nation, the standard for science, and the envy of the world. It did not happen by itself.

Bob Klein dared to dream that California could become the center of the stem cell research universe. He worked tirelessly toward that end, and the Golden State said yes, voting to approve—and fund--the groundbreaking new research.

But lawsuits blocked us, delaying our hopes of cure. Research delayed is research denied. Right now, one hundred million Americans suffer disease and disabilities described as “incurable”, but which might be alleviated or healed with stem cell research. We needed help.

Arnold Schwarzenegger came through. His decision to authorize the $150 million loan was bold, forward-looking, compassionate.

I wish so much that another great champion, Christopher Reeve, could have been with us today. He would have been so proud. The man who, as my son said, was more like Superman in real life than in the movies, gave us a letter saying, “One day, Roman and I will stand up from our wheelchairs, and walk away from them forever.”

I believe in that great dream. And when it happens, when Roman Reed stands up from his wheelchair, we will remember this day.

Thank you, Governor Schwarzenegger. Thank you, Bob Klein. And thank you, California.

Back Online

We are back once again after suffering a terminal computer crash two days ago. We expect to file a report later today and more tomorrow.

CIRM President Hall Speaks to Conflict-of-Interest and SEED Grants

The California stem cell agency will not produce its conflict-of-interest list in advance of Thursday's session to award millions of dollars in public funds to a host of scientists.

CIRM President Zach Hall explains the reasons below in a statement that we received late Wednesday. It is a thoughtful response from a man who is dedicated to the agency's goals and the public good. Nonetheless we disagree with his position. Regular readers are familiar with our stand. Openness in the conduct of the public's business comes first unless compelling and legal reasons exist for confidentiality. When an agency gives away $3 billion in public funds, transparency is paramount.

As an introduction to Hall's statement, we should note that we asked last week for the CIRM conflict-of-interest list, which details which Oversight Committee members will be barred from voting on specific grants because of a legal conflict of interest. The complete list will be provided to the public only after the board makes its decisions, but before each grant is discussed, the names of individual committee members who will be recused will be announced. To understand the full context of this issue, see the previous items on this blog, “Openness,” "Money Machine" and “Shrouded” below. Here is Hall's statement, minus some salutations:

“Just as we were working all-out to prepare for the board meeting, your request arrived. It threw us for a bit of a loop because we had not contemplated such a request; indeed, we had not framed it in the way that you put it. As a result, we have had to think through what we do from a new perspective and to anticipate the ramifications of your request. The first point to make is that we are indeed making such a list – a big task as Dale (Carlson) pointed out – for staff use at the meeting; this work is not yet complete and we do not expect it to be completed until sometime in the morning. Second, we have not given a list like this to anyone outside of CIRM staff before – neither to board members or the public - nor had we contemplated doing so this time.

Two concerns drive our procedures: 1) that we monitor conflict-of-interest carefully and effectively to be sure that board members know when they have a COI and to be sure that they do not participate in the discussion, inadvertently or otherwise; 2) that we focus the discussion and the decision on scientific merit, independent of institution or applicant. At the meeting in September, 2005, when the training grants were approved, each board member received a sheet of paper listing the applications (by number) for which they had a conflict-of-interest. We then made sure that they did not participate in the discussion and their names were not called in a roll call vote. Thus board members did not have information about any recusals but their own.

The process is more daunting this time with 231 applications rather than 26. Each board member will again receive a sheet of paper listing the applications for which they have a COI. Because of the large number of applications and the difficulty of keeping up with the correct application number, we will also announce at the beginning of each discussion, exactly which board members have a conflict of interest. We will do this from a master list that we have made up (are making up), but, as we did before, had not planned to give this list either to board members or to the public. Thus, board members know their own recusals in advance of the discussion, but do not know who is recused from any other application until the discussion on that application begins. We think this is a good procedure.

When you made your request, our initial response was that, although we had not contemplated doing so, there was no reason for us to withhold the information from you when it was ready. On reflection, however, we have realized that if we give a master list to you beforehand, we also have to give to all others, including ICOC members. Passing out the list beforehand will only encourage “decoding” of the lists, as far as can be done, before the discussion to give institutional identifiers to many of the applications before they are reviewed. We believe this is undesirable.

In trying to balance all of these issues, we have decided to follow the procedure outlined above as originally planned, keeping the master list for our own use during the meeting. Those present will hear the announcement, as each application is discussed, of who is recused. After the approvals are completed, we will then make the master list available to you or to anyone else who wishes it.

You would undoubtedly prefer to have it before the meeting, but we believe this is in the best interests of a fair and unbiased proceedings. I apologize for the false start on our part about the procedures that we will follow. This is the first time through for such a large number of grants and we are all scrambling to do the best we can.

The CIRM Lawsuit Appeal: Not a Plus for Opponents

Reporter Paul Elias of The Associated Press used the word “skeptical” three times in his coverage of today's oral arguments in the appeal of the California stem cell lawsuit.

That is how he characterized the appellate court justices during the Valentine's Day hearing concerning attempts to overturn the judgment against opponents of the $3 billion stem cell agency. The hearing also generated rare televison coverage on San Francisco station KGO. The text of the report by Lyanne Melendez was straightforward and appeared favorable to CIRM. But images are what matters on TV, and those were not accessible to us.

The Los Angeles Times also carried a very brief report on its website late Wednesday.

CIRM issued a statement from stem cell Chairman Robert Klein. Among other things, he said,

“Despite the opponents’ efforts, $130 million in Proposition 71 stem cell research funding for scientists is scheduled to be in place by March 15th.”

The opponents, according to press reports, also did not say anything that advanced their arguments beyond those rejected by the trial court judge.

Conflicts, Grants and CIRM Overseers: Openness vs. Fairness

Eighteen months ago, when the California stem cell agency awarded its first grants, members of the Oversight Committee were provided a conflict-of-interest list prior to voting on the grants.

The transcript of the meeting does not make clear exactly what was on that list. Did each member of the committee have a list that showed each grant along with each member of the committee who was barred from voting on that grant? Unknown, based on the transcript.

Last week we asked CIRM for a copy of the conflict-of-interest list for this week's first-ever research grant awards. The information is an important part of understanding the discussion of the grants – who stands to benefit and who stands to lose. It is information that helps give the public and interested parties insight into the process. As we have pointed out, the Oversight Committee has built-in conflicts-of-interest, albeit ones that are legal as the result of voter approval of Prop. 71.

So far the agency has not produced publicly a conflict-of-interest list for Thursday's meeting, but says it will be available before the session. Dale Carlson, spokesman for CIRM, differed sharply with our suggestion in an email to him that CIRM was withholding the list. Here is his response to our continued questions concerning the availability of the list. Carlson's statement provides some insight into the thinking at the agency concerning openness vs. the integrity of the grant review process.

“To the best of our collective recollection, the ICOC members received (in 2005) a list of training grant applications for which they were recused. They did not see which applications their colleagues would be recused from discussing or voting on.

"We are working on a list of potential conflicts each ICOC member might face with each SEED grant application. With 29 members and 231 applications, I'm sure you can appreciate that it is neither a quick nor easy task to evaluate all the statements of economic interest, institutional affiliations, past and current collaborative efforts, etc. Indeed, it is enormously complex. An NIH study section doesn't review 200 applications over the course of a year. We're doing so in but a matter of hours.

"Contrary to your assertion, it is not being withheld. It is simply not finished. We are being extremely diligent. It would be a disservice to the public to provide a document that is incomplete and/or inaccurate. It will be made available when it is finished and in advance of the meeting.

"Given the efforts we have made to ensure each application is judged on its scientific merit, without regard to the affiliations of researchers, there is legitimate concern that disclosing the ICOC members' conflicts may lead some to attempt to ascertain the institutional source of each application. We do not wish to see institutional bias injected into the review process, tarnishing the integrity we have established. Nevertheless, in the interest of transparency, we will assume that risk.

"Finally, no agency in California has ever undertaken so ambitious a program for biomedical research. We are working without a model and without precedent. We have disclosed more information about grant applications and grant reviews than any other California or federal agency, and more than any non-profit grant-making entity.

"We are moving with all deliberate speed to put funds into the hands of scientists, clinicians, and other researchers who can turn stem cells into therapies and cures. We are moving to implement the mandate of seven million California voters. But we will not allow urgency to trump fundamental fairness or the obligation to do what is right. If those objectives require a little additional time, so be it.”

Big Pharma Is Watching

It was stem cells live – surgery and all – in San Diego Tuesday at the Stem Cells Summit.

Terri Somers wrote in the San Diego Union-Tribune about a disectomy broadcast live from Scripps Memorial Hospital as a demonstration of a stem cell therapy that is not years away. The operation involved a Blackstone Medical product called Trinity, a combination of bone and stem cells.

Somers reported that representatives from Big Pharma were at the conference looking for the next big thing. She said:

"Therapies from human embryonic stem cells, which are controversial and receive more media coverage, are much farther from market because the understanding of these cells is nascent, said Tom Baker, a spokesman for San Diego-based Cytori Therapeutics, a stem cell company that sponsored the summit. The summit is an attempt to help people differentiate between the progress in the two fields, and drum up more interest in often-ignored but more advanced adult stem cell research, said Baker, whose company is developing therapies that pull adult stem cells from fat for reconstructive surgery or cardiac problems."

It was stem cells live – surgery and all – in San Diego Tuesday at the Stem Cells Summit.

Terri Somers wrote in the San Diego Union-Tribune about a disectomy broadcast live from Scripps Memorial Hospital as a demonstration of a stem cell therapy that is not years away. The operation involved a Blackstone Medical product called Trinity, a combination of bone and stem cells.

Somers reported that representatives from Big Pharma were at the conference looking for the next big thing. She said:

“Therapies from human embryonic stem cells, which are controversial and receive more media coverage, are much farther from market because the understanding of these cells is nascent, said Tom Baker, a spokesman for San Diego-based Cytori Therapeutics, a stem cell company that sponsored the summit. The summit is an attempt to help people differentiate between the progress in the two fields, and drum up more interest in often-ignored but more advanced adult stem cell research, said Baker, whose company is developing therapies that pull adult stem cells from fat for reconstructive surgery or cardiac problems. “

http://www.signonsandiego.com/news/business/biotech/20070214-9999-1b14stems.html

CIRM's Court Date Draws Coverage

The Valentine Day hearing on the appeal in the California stem cell lawsuit drew two stories today, one in Dow Jones' MarketWatch and the other in the Los Angeles Daily Journal.

Anne Marie Ruff wrote the Daily Journal piece, a fairly lengthy overview of the legal machinations. She quoted yours truly as saying, "California courts are loath to tell voters that they have no business ruling themselves, which is what the initiative process is all about.”

Carolyn Pritchard wrote a shorter piece on Market Watch, covering similar ground. Pritchard linked to a video of an interview with CIRM Chairman Robert Klein. Neither article carried material that would be surprising to readers of this blog.

Sacramento Bee: CIRM Grants 'Needlessly Shrouded'

The Sacramento Bee today endorsed sunshine at the California stem cell agency.

In an editorial headlined "grant process is needlessly shrouded," the newspaper called for legislative changes to open up CIRM. Here is an excerpt:

"Scientists from outside states do much of this review work, and are not required to publicly disclose their potential conflicts of interest. Undoubtedly, some of those scientists have outside consulting work, or personal relationships with researchers seeking funding, that could affect their grant decisions. Yet under the institute's shrouded procedures, it is impossible for anyone -- including researchers applying for grants -- to be assured that grant reviewers are recusing themselves at the proper times.

This lack of public disclosure is the single most glaring problem with the Institute for Regenerative Medicine. While it is momentous that California is now on the leading edge of financing embryonic stem cell research, the institute still hasn't adopted a transparent procedure for policing potential conflicts. Lawmakers, in this session of the Legislature, need to correct that."

The Bee editorial had received two comments from readers as of this morning. Both were generally opposed to ESC research. One asked, "Can we do a recall on ballot initiatives."

We want to assure curious minds that The Bee editorial and our item below, "CIRM Money Machine," only coincidentally appeared within less than 24 hours of each other. No collusion existed. But being a skeptic ourselves, we know that the denial will do no good.

What Do You Think?

Should CIRM continue its policy of secrecy concerning grant applications and the economic interests of those who make de facto decisions on scientists and institutions that should receive tens of millions of dollars of public funds? Let us know by using the comments function below. Just click on the word "comments" and you can leave a note – included an anonymous one that encrypts your identity. See the item below for a discussion of the topic.

The CIRM Money Machine and Potential Scandal

Giving away millions is not always easy.

Eighteen months ago, the talk included references to rubber stamps, "re-reviewing" not to mention honesty and legality.

The scene was Sacramento, Sept. 9, 2005, when the Oversight Committee of the California stem cell agency awarded its first-ever grants, which went for training programs for stem cell scholars at California schools.

The 29-member panel was whipping through the list of soon-to-be recipients when they ran out of applicants with really high scores. It was then that discussion surfaced about whether the board was merely rubber-stamping decisions of its grant reviewers or doing something more.

And it was then that Philip Pizzo, dean of the Stanford School of Medicine, said,

"In a sense our job was to really choose or approve the people who are going to be reviewers, and by way of delegated authority, we're asking them to make recommendations which are really decisions because we don't have all the data."

Pizzo's comment and similar ones by other CIRM overseeers 18 months ago are critical to understanding questions of conflicts-of-interest, openness and transparency at the grant review level. CIRM has imposed a lid of secrecy on virtually all of the doings of the grant review group. Not even the Oversight Committee members, for example, are supposed to know the names of the institutions seeking grants, although it was relatively straight forward to identify a goodly number of the applicants in 2005 based on the bowdlerized information available then. You just needed to be conversant with California institutions involved in stem cell research.

CIRM conceals the names of the applicants lest it embarrass the losers. CIRM says that encourages good science by encouraging potentially rewarding but risky ventures – ones that the authors might not want to vet in public. Moreover, CIRM says the Oversight Committee actually makes the grant decisions – not the grant review committee. Thus such matters as the economic interests of the grant reviewers and their closed-door meetings to give away tens of millions of public dollars are not really important in terms of openness and transparency.

Eighteen months ago, the Oversight Committee only turned down a couple of grant applications that were recommended by the grant review group(the number is not entirely clear from the transcript of the session). The Oversight group is not likely to reject any significant number of recommendations this Friday for SEED grants. If it does, it soon will not have anybody willing to serve on the grant review committee. Moreover, the CIRM directors simply do not have enough information to perform any sort of significant second-guessing of its hard-working reviewers, all of whom are from out-of-state.

CIRM Chairman Robert Klein, in 2005, bridled at Pizzo's remark that reviewers were actually making decisions, which Pizzo conceded was an impolitic choice of words although they clearly reflected the sentiment of a number of committee members. Klein commented again later when Gerald Levey, dean of the UCLA medical school, said, "What is the purpose of discussing everything on an individual basis? Why don't we just vote en bloc? We're just going through this on an individual basis, but it has no meaning."

Klein, who is an attorney, replied,

"We have to go through this on an individual basis because of the laws of the state of California. And to observe the very high standard of conflicts adopted by this board, we have to make sure we have roll call votes on every application. That is the challenge and it is a new process for California as well as a nation."

It IS a challenging and new process, one that does not have to follow the well-trod but not necessarily applicable procedures of older institutions that are fundamentally different than CIRM. The NIH is often cited as a precedent for CIRM's secrecy on grants. But the NIH can easily be controlled by Congress and the President. CIRM is virtually immune from control by the California Legislature and governor.

The California stem cell agency should rethink its policies on financial disclosure and transparency. Opening the doors will help to protect the agency from the suspicions that will certainly surface as the CIRM money machine begins to hand out hundreds of millions of dollars. Not to mention helping to prevent an outright scandal that would be relished by opponents of embryonic stem cell research.

Stem Cell Snippets: Court Appeals, Cheerleading,UC Davis Plans, Pera and Kuehl

Stem Cell Lawsuit Appeal – The time has changed on the oral arguments on Feb. 14 in the appeal of the verdict in the CIRM lawsuit trial. It is now set for 2 p.m.

World's Oldest Cheerleader? – Relentless patient advocate Don Reed says next Friday (when CIRM makes its first research grants) is an "unbreakable date" in San Francisco (actually Burlingame, which is near the airport). In his effort to generate favorable news coverage, he wrote a piece on "StemBlog," which is part of the Stem Cell Action Network. Reed said this about the expected grant announcements, "Worst Scenario: the opposition shows up in full force, which they will– and in support? Old white-haired Don is there by himself, the world’s oldest cheerleader. Best Scenario: a ton of people smiling, including some friends driving wheelchairs, joined in the celebration of a truly historic day, when in the face of seemingly insurmountable odds, a great state led a great nation into a new age."

Losing the Stem Cell Race – The Washington Post and the Sacramento Bee carried an op-ed piece that suggested state efforts to pump up stem cell research are not enough. According to Joseph Fuller and Brock Reeve, the reasons include: "The entry of individual states into the breach left by the federal government has helped drive research activity. But it has also created a patchwork of regulations and funding levels that constrains research collaboration. Expensive and restrictive enabling patents, political controversy and the absence of federal research money, coupled with a long time to market, have made venture capitalists reluctant to invest. In 2005, just over $100 million in venture capital went to stem cell ventures, compared with $500 million in biotech ventures at an equivalent stage."

UC Davis Stem Cell Plans – The campus newspaper at UC Davis has a rundown on $75 million in stem cell research building plans on the campus. Written by Allie Shilin, the piece says: "The newest addition to the center is a 5,160-square-foot Good Manufacturing Practice laboratory to be housed in a 100,000-square-foot renovated portion of the UC Davis Medical Center on Stockton Boulevard in Sacramento."

Reijo Pera – The co-director of the UC San Francisco ESC research center is leaving to join Stanford as director of "human embryonic stem cell research and education for the Stanford Institute for Stem Cell Biology and Regenerative Medicine."

Kuehl's CIRM Legislation – Jesse Reynolds of the Center for Genetics and Society is "encouraged" by State Sen. Sheila Kuehl's proposal to make changes at the California stem cell agency. He writes on Biopolitical Times that her ideas are worthy of support.

Not Enough Info on Egg Donation Risks, Critic Says

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

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

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

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

Text of Fogel Statement

Here is the text of the statement by Susan Berke Fogel, coordinator of the Pro-Choice Alliance for Responsible Research, on the IOM report on the risks of egg donations. Fogel's statement could not be found elsewhere on the Internet at the time of this posting.

"The Institute of Medicine has released a new report of its assessment of the health risks for women who may be asked to provide their eggs for embryonic stem cell research. The report documents how little scientific data exists about the health risks of egg retrieval, and as a reviewer of the report, I believe it misses an important opportunity to lead the way by requiring critically important safety evidence before we ask women to take potentially serious unknown risks with their health.

"There are many paths of investigation in embryonic stem cell research that can move forward while this safety data are being gathered. Scientists can use embryos initially created for in vitro fertilization, but not ultimately used for this purpose and thus available to researchers with the donor’s consent. They can also use stem cells found in amniotic fluid. Even somatic cell nuclear transfer is possible using eggs that do not fertilize during in vitro fertilization.

"Much attention has been given to the known risks of ovarian hyperstimulation that can result from drugs used to stimulate the ovaries to produce multiple eggs. But the risks of drugs used to suppress the ovaries before such controlled hyperstimulation have been much less studied, and the drug most commonly used for this purpose – leuprolide acetate (Lupron) – has never been approved by the FDA for this purpose. We know from the anecdotal reports of hundreds of women harmed by Lupron that such research is essential to establishing an adequate picture of the risks involved. Moreover, the recent drop in breast cancer rates and its link to a decline in hormone replacement therapy (HRT) is a timely reminder of how little is known about the long term effects of large doses of hormones.

"The IOM report accurately states, 'one of the most striking facts about in vitro fertilization is just how little is known with certainty about the long-term health outcomes for the women who undergo the procedure.' It goes on to acknowledge that even 'that limited knowledge is not directly applicable to the safety of ooctye donation for research.' The report then rightfully suggests the need to collect good data, engage in long-term studies, and reduce risks to women.

"Unfortunately, the IOM report elevates SCNT over other avenues of research in the development of future stem cell therapies. By suggesting that researchers must have thousands of women’s eggs now, despite the critical absence of safety data, the report does women a great disservice. A more responsible conclusion would be to call for:

"1. Research endeavors that do not require egg extraction procedures solely for research purposes; and
"2. Research that will better define the risks of multiple egg extraction, so that meaningful informed consent will be possible. This will serve not only women who may want to donate eggs for research, but women who now undergo these procedures as part of infertility treatments.

"Much scientific progress can be made by pursuing avenues of embryonic stem cell research that do not require women to sacrifice their health and well-being while important safety data are being gathered. The decision of whether to proceed with egg procurement for research should be based on adequate scientific evidence. It is premature to ask women to put their health on the line.

"The Pro-Choice Alliance for Responsible Research is a coalition of reproductive health and justice advocates, bio-ethicists, academics, and researchers working to ensure safety, accountability, and transparency in bio-technology from a women's rights perspective."

ESC Research: Doing Well vs. Doing Good

Is embryonic stem cell research an economic boon or boondoggle for California? Or for other states as well?

Writer David Hamilton, formerly of the Wall Street Journal, discussed the subject this week on Slate. Here are excerpts of what he had to say:

"If medical treatments can be derived from stem-cell research, they are at least a decade or two away, if history is any guide. Even then, new therapies envisioned by supporters, such as diabetes treatments that regenerate insulin-producing islet cells, might add to government health-care costs instead of curbing them. The Baker-Deal report (from the 2004 Prop. 71 campaign) figured that stem-cell therapies could save California at least $3.4 billion in health-care costs over the next three decades by assuming the therapies would reduce state spending on six major medical conditions by 1 percent to 2 percent. While the authors cast that as a 'conservative' estimate, they don't even model the possibility that costs might rise instead. Recent medical advances haven't appreciably slowed growth in overall U.S. health-care spending, which continues to rise far faster than inflation.

"Ideally, of course, stem-cell therapies would start a trend in the opposite direction by reducing or eliminating the need for expensive and often lifelong medical care. For that to happen, though, the new treatments would need to largely replace existing ones at a reasonable price, and then doctors would have to use them sparingly—for instance, only on the patients most likely to benefit. None of these assumptions is a particularly good bet under the current U.S. health-care system, in which new treatments are often simply added to older ones, and where insurers so far have tended to pay top dollar for incremental medical advances."

Hamilton continued:

"What about the potential of stem-cell research to spur economic development—can a state that sponsors stem-cell research hope to attract cool scientists who will then draw others, plus a coterie of entrepreneurs and venture capitalists? Biotech companies do tend to cluster in places like San Francisco and Boston, but their overall impact on regional economies tends to be limited. While they often pay high salaries, the vast majority of these companies are tiny, unprofitable startups with fewer than 100 employees. They frequently collapse well before they earn a dollar in sales. Even successful biotech ventures are often bought out by distant drug companies, which sometimes shut down the acquired company while transferring its research activities and any products elsewhere. On top of all that, big states like California and New York are going to wind up competing for some of the very same scientists, VCs, and entrepreneurs, further shrinking the rewards.

"Why did Baker and Deal see dollar signs? The $200,000 stem-cell supporters paid to Deal's firm, the Analysis Group, for campaign consulting might have something to do with it. In an interview, Baker said he didn't think of the report as advocacy but added that 'we knew we were working for people who wanted to pass this thing.' And while he still believes the economic benefits of stem-cell research could be 'quite large,' Baker also describes the report as merely 'one possible version of how things might happen.'"

Hamilton's bottom line:

"None of this means that stem-cell research doesn't deserve government funding. Stem-cell science, after all, remains in its infancy. Nearly a decade after the discovery of embryonic stem cells in humans, scientists still don't know exactly how they work, how to assure their purity, or what unexpected side effects they might have when transplanted into the human body."

Since the Bush administration refuses to support ESC research, Hamilton, concluded "the states are right to ante up where the federal government has failed to. They just shouldn't expect to do well while they're doing good."

Hamilton's piece does not deal with a related reason for the economic argument for ESC research. Creating a dream of riches is an attempt -- generally successful, we might add -- to shift the terms of the debate. It is a no-win proposition if ESC research backers find themselves locked into a discussion of whether they are killing babies.

Media Unexcited by SEED Grant Scores

Tuesday's announcement of the scores on the first-ever research grants to be awarded by the California stem cell agency received virtually no media attention.

A brief note popped in the East Bay Business Times, which is all that surfaced in what one might call mainstream media. But a biotech blog called PIMM published an item and included the scientific ranking of all the proposals. Attila Csordás, posting on PIMM, recommended reading the "WEAKNESSES" (their capitalization) section of the reviews of the grant proposals.

One web site aimed at the big money boys (venture capitalists) also carried a note on the announcement. VentureDeal unfortunately made an error in its item, saying that CIRM was "created by a $300 million general bond" instead of noting that CIRM has authorization for $3 billion in bond funding. (Actually similar errors are not uncommon in reports that we have read over the last two years.) The information on the grant proposals obviously would be useful to investors in the stem cell arena. It gives a quick overview of a number of new areas that some scientists believe are worth exploring including an evaluation of their public value (meaning to California – not as a public company).

Look for the mainline media to hit the actual grant awards next week pretty hard. It is a simple event to cover and will have considerable appeal to television with visuals and interviews with persons who could benefit from stem cell therapy. Freshness of the Congressional debate over stem cell research also will help drive the coverage. Stories will be dominated by numbers and names: How much and which institutions and individuals will be wallowing (sort of) in cash, thanks to a vote of the people more than two years ago.

SEED Grant Recommendations Available

The scored recommendations for funding of SEED stem cell research grants by the California stem cell agency are now available on CIRM's web site.

The posting lists the titles of all the applications, their score, recommendation for funding along with a "public benefit" and "public review report" and a summary of the CIRM working group's review. The public benefit report was prepared by the applicant.

Names of the applicants remain secret.

The Oversight Committee will make the awards next week.