Wednesday, January 17, 2007

Oral Appellate Arguments Set for February in California Stem Cell Lawsuit

Don't expect a stem cell love feast on Valentine's Day in the Court of Appeals in California.

That is when foes of the California stem cell agency will go toe-to-toe with state attorneys during oral arguments as the opponents seek to put CIRM out of business. The foes lost during a superior court trial last year and are now appealing that verdict.

An appellate decision could come in a matter of a few weeks following the Feb. 14 hearing, but given the nature of the legal beast, it probably will be later. Then there is likely to be an appeal to the State Supreme Court, where the case is almost certain to terminate, probably before the end of the year.

Oral arguments will begin at 9 a.m. in the First Appellate Court at 350 McAllister St. in San Francisco.

The BioBay Stem Cell Outlook: Congress to IP

The president of the leading biotech industry organization in the San Francisco Bay Area has a good-news, bad-news position on stem cell research.

The bad news is that the "potential" is more than a decade distant. The good news is that some companies have technology that may bear fruit sooner than the efforts of the California stem cell agency.

Matt Gardner, head of BioBay, discussed the biotech outlook with David Morrill, business writer for the Oakland Tribune, in a question-and-answer interview.

Here is what Gardner had to say on stem cell research:

"Q: One of the industry's hotbeds is stem cell research. Given the ethical and political hurdles, will the potential of this area ever be realized?

"A: Yes, but I think we are still a decade or more away from seeing what that potential looks like. Here again, I think California is in such a leadership position, being able to hopefully realize the promise of the stem cell institute (the California Institute for Regenerative Medicine) and that a tremendous amount of work needs to be done at the basic end of the research. And yet, even with that said, there are companies operating today in stem cell sciences that have technologies that may come to fruition much sooner. There are some early signs from a small number of companies that there is strong potential here. So we can only expect to see that grow as the science around stem cells is understood."
Gardner on intellectual property, a major issue facing the California stem cell agency:
"That's a huge issue for this industry. And the biggest thing to focus on there is that the U.S. Congress is going to visit this issue in 2007. What needs to be kept in mind here is that this industry is built on certainty in intellectual property. Anything that any of our public sector partners do to try and draw that into question will be harmful to this industry, no matter what it looks like.

"Most of these companies, when they are initially funded, are done so on a very clear picture of their intellectual property. Because it may be 15 years before you have product revenue based on the amount of time it takes to develop a product, run clinical trials and get the product approved, everything until then is a value based on intangible assets. Until you have your first product approved in this business, you are valued in the potential of the things you are developing. And the potential value of those intangible assets is all wrapped up in whether you own your intellectual property and how clearly you own it."
Gardner on Congress:
"In the next couple of years I think some issues will be brought up to a new level of discussion. One of the great opportunities is that Nancy Pelosi has a tremendous familiarity with the industry. And so in a new way, the industry has a profile with this speaker that it did not have before. To deal with someone in a leadership position that is committed to these solutions is a huge opportunity for us."

Tuesday, January 16, 2007

Economic Disclosure from the California Stem Cell Report

Here is the annual economic disclosure statement from the California Stem Cell Report. We are filing it because of normal questions that might arise concerning our economic interest in stem cell research.

We, meaning my wife and I, have no investments in biotech firms or any other organizations that could benefit from stem cell research, except through mutual funds, which, of course, we have no control over. We do not hold any mutual funds that are industry specific to biotech.

Beyond that, we are not employed nor do we receive funds from any organization involved in biotech or stem cell activities. Nor is any member of our immediate family (meaning wife and adult children) involved in such a fashion. As far as we know, no distant relatives are involved in biotech or have investments in that area.

We also have no financial connections with organizations that support or oppose CIRM.

All of the above is unchanged from last year.

One would hope that reporters, observers or others trying to influence CIRM (which is not the same as reporters) would be willing to make the same sort of economic disclosure as above. By that we mean specific dollar amounts, from $1 (one dollar) and up – not those wimpy disclosures required under state law or by CIRM.

Beyond the economics, the California Stem Cell Report supports embryonic stem cell research. We believe that CIRM is pursuing a worthwhile endeavor. We also believe that openness, transparency and disclosure are fundamental to good government. That means providing background agenda material well ahead of meeting dates, among other things. Otherwise, meetings can amount to nothing more than sneak-through business, plenty of which can be seen in Congress and the California Legislature.

We also believe in maximum disclosure -- when it doubt lay it out. Specifically all persons with signficant responsibility within CIRM, including members of CIRM working groups, should publicly disclose their economic interests in more detail than required by state law. Outside contractors should disclose their interests as well.

If you have questions or comments on this, you can post them by clicking the word "comment" below or by sending them directly to djensen@californiastemcellreport.blogspot.com. It is possible to comment anonymously by using the "comments" function.

Sunday, January 14, 2007

Two Years Before the Stem Cell Mast

Two years ago this month, the California Stem Cell Report began its journey into the multibillion dollar world of embryonic stem cell research.

Since then, we have published more than 900 items on California's extraordinary and unique effort to pump up one of science's more controversial areas of research. Readers have paged through the website tens of thousands of times. They came from throughout the nation and the world, seeking more information about what the small band at CIRM is doing on King Street in San Francisco. (Editor's note: More recent and additional information can be found in an Sept. 17, 2007, article on Wired.com)

The reception has been generally favorable. "The ultimate source for all things California" is how Jim Fossett, director of health and Medicaid studies at the Rockefeller Institute, described the Report on the blog of the American Journal of Bioethics. "Comprehensive," "first thing I read in the morning," "enormously valuable" are some of the comments from other readers, whose numbers include law firms, newspapers and biotech companies. Studies of the California stem cell agency have cited the California Stem Cell Report (CSCR) as a source. University instructors use it as part of their curriculum.

Yahoo nows ranks the site No. 1 and Google No. 4 when using the search term "california stem cell." The rankings are up from near invisibility on the search engines when we began this endeavor in January 2005, less than a month after the first meeting of CIRM's Oversight Committee.

We started this website largely because we were interested in the subject and wanted to learn more. Given our professional background as a newspaper editor (now retired), former state Capitol reporter and gubernatorial press aide, we figured we might as well write about the subject and share the information with others.

It is not often that one can explore an area that stands on the cutting edge of science and medicine, that combines big business, academia, politics and government in a way never seen before in California, perhaps in the country. Not to mention the heated and sensitive religious, ethical and moral issues surrounding embryonic stem cell research, along with the hopes for cures for millions afflicted with diseases ranging from diabetes to cancer. CIRM is an agency – created directly by the people of the state, not the legislature or governor – that plans to give away $3 billion in public funds, basically unsupervised by the normal processes of state oversight. And its directors – voters decided – come from some of the universities and institutions that would benefit directly from its research and building grants.

We surmised that others would also be interested in CIRM but simply would not be able to find all they wanted to know, given the media's practice of covering only the most high profile news. That has proven to be the case. CIRM is virtually invisible to the public and much of the scientific and business community, if they rely on the mainstream media. It is even something of a low profile matter for the scientific media, and even lower in the business press.

Nonetheless the California Institute for Regenerative Medicine has become a benchmark worldwide and nationally for a number of issues including treatment of egg donors and intellectual property rights. CIRM has pioneered new and higher standards in both areas.

We have attended numerous CIRM meetings and visited CIRM headquarters several times. On one occasion, we covered the CIRM lawsuit trial live, filing items directly from our laptop in the courtroom in Hayward. Our reporting largely relies, however, on the Internet, sifting through government documents, news stories and email from a variety of contacts.

Since we travel regularly, gaining access to the Internet is always a challenge. We have used wireless connections in public libraries in San Mateo, San Diego and Santa Barbara and while at anchor on a sailboat in bays in Mexico. At other times, we filed via satellite uplinks, Internet cafes and hotel Web services and used a datacard for Mexican cellular service.

All of that would have been impossible 10 years ago, prior to today's advances in computer and Internet technology.

We hope the California Stem Cell Report has provided information that cannot be found elsewhere as well as serving as a guide and source of analysis and commentary on the Golden State's ambitious effort. We also hope that it has become something of a repository for the full text of California stem cell information that does not have a good home elsewhere, whether it is the statements of California stem cell chairman Robert Klein, acting in a non-governmental role, or documents from critics of the agency.

We are planning improvements and changes in the Report for 2007 and welcome suggestions from our readers. We are particularly interested in bringing in more voices from the stem cell community. Please let us know what you think. What do you want to see more of? What do you want to see less of? Do you have questions that need answers? You can send them and your suggestions to djensen@californiastemcellreport. Or you can post them directly on the blog by clicking on the word "comment" below. If you wish, Google, the hosting service for the blog, provides for anonymous "comment" postings, whose authorship is totally encrypted.

Stem Cells and 'Things that Go Bump in the Night'

What's going on with those CIRM scholars, those folks whose education is being assisted by the California stem cell agency?

Reporter Bradley J. Fikes of the North County Times in San Diego County wrote about 32 of them, including some from fields such as bioengineering, bioinformatics and chemistry. Among other things, Fikes said that ethical training occupies one-third of the curriculum in this particular program.

Fikes quoted Larry Goldstein, director of UC San Diego's stem cell program, as telling the scholars that they have an obligation to become missionaries – not Goldstein's word – for ESC research. Goldstein said:
"Some of you have been studying fish and flies and things that go bump in the night. It's not always obvious to the public how this relates to humans. For better or worse, the world is watching us, not just in San Diego, but in California."

Friday, January 12, 2007

Stem Cell Humbuggery and Its Implications for California

Citizens of California and the American public overwhelmingly support embryonic stem cell research? Balderdash!

California stem cell Chairman Robert Klein and a host of others cite public opinion polls to support their mission, denouncing critics as opposing the will of the people. That position, however, is a bit of humbuggery – dangerous if uncritically believed by supporters of ESC research.

We have argued that support for embryonic stem cell research is quite soft and that the science is poorly understood by the public. Now comes additional evidence for that contention, including an analysis from a devout supporter.

We will discuss the major implications for CIRM a bit later, but first let's consider the thorough-going discussion of the polling data by Matthew Nisbet, a scholar at American University who has studied the subject for some time. In a piece on the website of the Committee for Skeptical Inquiry, he wrote:
"...(O)verwhelming public support is by no means a 'slam dunk' conclusion. In fact the best available polling data shows that while support for research has increased since 2001, support among American adults lingers at only slight majority levels. "
Nisbet continued:
"We are now going on year six of the stem cell debate, and despite major news attention to the issue, and tens of millions of dollars spent on advertising and communication campaigns across the country, the public still scores relatively low in both knowledge of the science and the politics involved."
Nisbet discussed how the wording of the polling questions shapes their results. He also examined how supporters and opponents frame the stem cell issue. While Nisbet did not discuss in detail the 2004 election that created the California stem cell agency, it was a masterpiece of framing. Prop. 71 became a matter of aiding the sick, including members of each voter's family, and boosting the California economy – short-circuiting the feeble efforts of opponents, who largely relied on faith-based moral arguments.
But Nisbet added:
"In recent years, opponents have also evolved in their message strategy, realizing that they can potentially impact the ambivalent citizen on the issue by pairing the moral interpretation with a 'public accountability' frame that defines funding as only benefiting 'special interest' biotechnology companies. The emphasis on the 'commodification of life' by 'corporate science' may resonate with segments of the public that might otherwise reject religiously-based appeals."
Rachael Laser of The Third Way, a "progressive" pro-stem cell think tank, wrote about the public "ambivalence" on ESC research on the group's blog, in addition to preparing a 9-page paper on the subject (which cited this blog as one of its sources).

She wrote:
"The real story is that the majority of Americans are concerned that our fast-paced scientific progress brings with it significant moral hazards. If you are a Third Way groupie (and really, who isn’t?), you will not be surprised that we call the folks in the middle of this debate the 'stem cell grays.'

"By contrast, the 'stem cell polars' are on the extremes: some think that stem cell research raises absolutely no moral concerns; others beleive that it is so morally offensive that they would not support it even in if they knew it could cure a family member of a dreaded disease.

"But to the stem cell grays, America is sort of like the crazy scientist in the lab – he might well be a genius, but he also might blow his lab sky-hight. This concern is also borne out in a series of Virginia Commonwealth University polls that reveal that 56% of Americans believe that science does not pay enough attention to moral values, and 51% also believe that “scientific research has created as many problems for society as solutions.”

"Until stem cell advocates address these types of concerns head-on, they will continue to battle risky margins or Pyrrhic victories."
Nesbit reinforced Laser's point:
"Given the multitude of competing issues in the world, and given limited time, motivation, and ability, it is in fact quite reasonable for the public to rely on heuristics such as partisanship or religious belief to make up their minds about a complicated issue such as stem cell research. This fact might not fit with democratic ideals or with the preferences of scientists, but it is human nature.

"Political strategists understand this, and it’s why they carefully frame their messages around simplistic interpretations of either 'stem cell research leads to cures,' or 'stem cell research is morally wrong,' pairing these messages with celebrity or religious spokespeople. However, for science advocates who care about winning the short term political battle to overturn Bush’s misguided stem cell policy, there is a delicate balance to be struck. As I have argued elsewhere, narrowly focusing on educating the public about the science or the 'facts' involved in the debate will not move public opinion nor be persuasive.

"In the stem cell debate, science advocates need to make sure that they are honest about the uncertainties in research, while simultaneously communicating the hope for important therapies and treatments. As I have argued in this column, accuracy in communication also means being honest about where public opinion stands.

"The opposition is watching, and when inevitable scandals in science erupt such as the Korean cloning affair, stem cell opponents are going to shower communication channels with claims that scientists are willing to go to any extreme to promote their self-interests, and that embryonic stem cell research is 'junk science.' In our sound bite culture, and especially when research opponents don’t play by the same rules, effectively engaging the public on stem cell research is a major challenge. Yet wisdom and precision is needed. At risk is public trust."
What does all this mean for CIRM? The agency faces a greater burden in maintaining public trust than most other state agencies because of its built-in conflicts of interests and its extraordinary independence from normal state oversight. Consequently its procedures must be perceived to be transparent and blemish-free. Perception is the hallmark here. Otherwise the institute can be easily besmirched as a giveaway program for biotech. A substantial public education effort concerning ESC research is needed to generate deeper and more sophisticated support for the science and medicine. Outreach, outreach and more outreach are the watchwords. That includes a much improved website and establishment of CIRM as the key resource for national and state media to consult on ESC matters. And a regular, strong effort in the state Capitol is necessary to maintain a friendly or at least a neutral environment.

Thursday, January 11, 2007

Stem Cell Stocks: Buying a Will-o'-The-Wisp?

To slightly paraphrase one analyst, anybody buying stem cell stocks solely based on the House vote on ESC research should be prepared for a long, hard ride.

In the wake of the Congressional action, Aaron Smith of CNN prepared a more nuanced report on stem cell stocks than we saw in news reports last week.

Smith wrote:
"In anticipation of today's vote, investor interest in biotech stocks has been whipped up, though biotechs probably wouldn't benefit directly from the funding, even if it's eventually approved.

"'This is a step in the right direction, but if anyone is buying StemCells Inc. based on this one vote, they need to rethink their priorities,' said Steve Brozak, analyst at the investment and research firm WBB, referring to one of the biotechs involved in stem cell research."
The CNN report continued:
"Although StemCells Inc. (down $0.08 to $3.35) stock fell about 2 percent Thursday, the stock's climbed more than 25 percent so far this year. It's the most recognizable name in the industry, analysts say, even though it doesn't stand to benefit directly from the vote.

"'The stock [StemCells] is probably most tied to political movement, just because of the ticker," said Jose Haresco, analyst for Merriman Curhan Ford & Co., an investment research firm, referring to the company's stock symbol of STEM. "It's almost a perfect barometer."

"The stock of Aastrom Biosciences (down $0.08 to $1.46) slumped about 5 percent Thursday, but overall gained about 20 percent this year. Haresco said that StemCells and Aastrom specialize in the use of adult stem cells however, not the ones derived from human embryos, which are the subject of the bill.

"The stock price for Osiris Therapeutics (down $1.37 to $26.77, another biotech specializing in adult stem cells, also gained this year, though it slumped about 5 percent in Thursday trading.

Geron Corp., (up $0.20 to $8.90) a biotech developing stem cell technology which is based on human embryos, has been volatile this year and only pulled into the plus column Thursday, when the stock rallied about 2 percent. The stocks, save for Geron, had run up after news of the possible House vote first surfaced last week.

"'Geron is clearly at the top of the pack," said Brozak of WBB, who rates the company a "strong buy," noting that it is the most advanced in the development of embryonic stem cell technology.

"Geron's most recent stem cell study involved rats, not people, though a spokesman for the company said early-stage human trials will begin in 2007."

Fuel Your Stem Cell Edifice Complex

Looking for some bucks to renovate your aging stem cell lab?

The California stem cell agency is seeking a few good institutions to share $48.5 million that could start filling their coffers by this summer.

Those of you outside of California are out of luck unless you can concoct a California presence very quickly. CIRM announced today that it wants letters of intent for shared facilities grants by Feb. 2.

The agency's press release said:
"The grants will provide funds for the design and renovation of laboratory space, equipment for the new research facilities, and operating expenses for three years. Some grants will include additional funds to train scientists and technical staff in the growth and maintenance of hESCs."
CIRM continued:
"'The ICOC funded grants to train 169 stem cell scientists last year and will award more than $100 million in research grants this February and March,' said Richard Keller, the Institute’s Senior Officer for Scientific and Medical Research Facilities. 'Shared Research Laboratory Grants will ensure that scientists have the physical facilities they need to cultivate new lines of embryonic stem cells, without running afoul of federal restrictions and without endangering federal funding for other research activities.'

"CIRM expects applicant institutions to provide at least a 20 percent match of the total cost for renovation and equipment. They may request up to $2 million for laboratory space development and an additional $500,000 if they plan to offer a stem cell techniques training course. The RFA is open to all academic and non-profit research institutions in California.

"The Request for Applications (RFA) for shared facilities grants is available at http://www.cirm.ca.gov/rfa/pdf/RFASharedResearchLaboratoriesfinal.pdf. Potential applicants must submit letters of intent to CIRM by February 2, 2007. Full applications will be submitted in two parts. The first part will describe the scientific mission of the proposed facility and is due February 23rd; the second part will detail renovation and/or development of the laboratory space (including fixed equipment costs), and is due on March 16th."

The Riddle of the Stem Cell Trinity

Can science, business and government work together in a win-win combination in a unique endeavor involving arguably the most controversial research in the world and billions of dollars in funding?

That is the key question ultimately for the California stem cell agency. Now we have some help in seeking answers to at least two-thirds of the riddle.

The aid comes from an analysis by Harvard business professor Gary Pisano in his new book: "Science Business: The Promise the Reality and the Future of Biotech." Pisano examines the sometimes difficult mix of business and science and their conflicting cultures. He omits the hefty government component represented by an agency such as CIRM, which has deeper hooks into science and business than the NIH.

Pisano, who has a Ph.D. from UC Berkeley, has studied the biotech business for years and has served as a consultant to some biotech companies.

We ran across his book as the result of a review in the Wall Street Journal by Andy Kessler, author of "The End of Medicine." Kessler wrote:
"Can science and business mix? ...The problem, according to the Harvard Business School professor, is that today's corporate structures are allergic to the uncertainty and risk inherent in science."
Kessler noted:
"Cumulative profits for the entire biotech industry are meager. The whole lot of them probably drip red ink if you take out Amgen, a 26-year-old company with $14 billion in annual sales and -- like Genentech and just a handful of others -- real profits."
Kessler continued:
"Mr. Pisano notes that 'drug R&D is a highly complex process; it is expensive, time consuming, and fraught with risk. In these respects, drug R&D is not too different from, say, the development of a new airliner, a new microprocessor, or even an epic movie.' The key word is risk. While an Airbus plane, Intel's Core Duo or 'Apocalypto' may have market risk, their development is undertaken with confidence that the products will at least make it to market; drug companies begin work on a new product with no idea whether it will even make it out of the lab, much less progress through clinical trials and onto drugstore shelves. A new drug might have the potential to be a blockbuster, but, then again, only one drug out of 6,000 newly developed compounds actually goes on sale. 'Productivity' is not a word used often in the drug business.

"'Drug development is a gamble in itself simply because of the hit-or-miss nature of the science -- or the 'profound and persistent uncertainty,' as Mr. Pisano calls it, 'rooted in our current limited knowledge of human biological systems.' But it becomes a staggeringly expensive gamble -- like playing blackjack at a table with a billion-dollar minimum -- because of the facilities required and the legions of experts in chemistry, biology, genomics and other fields who pour their time and energy into research. The 'nature of this process is integral,' Mr. Pisano points out. 'It cannot be broken neatly into different pieces.'"
Kessler's review prompted us to purchase the book, which appears to be very much worth reading. You can find a lengthy excerpt here or purchase it by clicking on one of the Amazon ads at the top of this blog.

Beware the White Coat Crowd

Health industry gadfly Merrill Goozner is taking a jaundiced view of the stem cell arms race in states across the country.

Citing New York's latest proposal and California among other states, Goozner wrote on The Huffington Post:

"Stem cell research is promising, and it shouldn't be impeded by a bunch of anti-science right-to-lifers with God and the president on their side. But like any strain of research, the likelihood of a major medical breakthrough coming from stem cells is probably not that much greater than gene therapy, the human genome project, the war on cancer or any of the multi-billion-dollar medical research programs that came before it. A lot of knowledge and a few good things will come out of stem cell research, but will it make those with severed spines stand up and walk? Call me irreligious, but I'm skeptical."
He continued:
"Of course, there will be some new jobs created for university researchers, their underpaid foreign graduate students, and the white coat crowd in the biotech industrial parks subsidized by the taxpayers. But is this really the best use of government subsidies, especially at a time when the health care sector -- 16 percent of GDP and still growing -- is sapping the vitality of the rest of the economy? Has anyone given any thought to how much some of these breakthrough stem cell technologies might cost, and how the rest of the economy might pay for them?"
Goozner is directs the Integrity in Science Project at the Washington-based Center for Science in the Public Interest.

Wednesday, January 10, 2007

CIRM and Its Embarrassing Secrecy

The California stem cell agency rather foolishly conceals the identity of applicants for its multibillion dollar grant program, contending that unsuccessful scientists and their employers would be embarrassed if the public were to know that they failed to receive funds.

We say foolish because CIRM's rules are a nonsensical exercise as well as poor policy(see the "more disclosure" item below). The institutions themselves are free to release the information that they have applied, and they do. The most recent example is USC. Last fall, UC Irvine did so.

One can only speculate about why the schools release the information, although the process of applying for grants in other areas is often very much a public process. Some cynics have surmised that the release of the information by the schools could be an attempt to serve notice on CIRM and its Oversight Committee that these mighty institutions should not be overlooked when the checks are handed out. Both USC and UC Irvine have representatives on the Oversight Committee, which makes the final decision on who shares in the largess, although those committee members are barred from voting on their own school's grant applications. Of course, more benign reasons exist for universities to tell the public they are seeking grants. But CIRM's secrecy only fuels the fire of conspiracy theories.

USC's item said the school submitted 29 applications for the round of applications reviewed last fall and for the round being reviewed this week.
"'The competition for this funding will be tough, but USC scientists have put together some very exciting proposals,'" said Martin Pera, director of USC's Center for Stem Cell and Regenerative Medicine (CSCRM) and a professor of cell and neurobiology."
The item continued:
"Pera said that researchers from CSCRM and its Stem Cell Core Laboratory 'were pleased to lend our expertise in support of these grant efforts in this first round of CIRM grants.'

"The exercise 'brought together many groups throughout USC, Childrens Hospital Los Angeles and the California Institute of Technology for the first time,' he added. 'As a consequence, a number of new interdisciplinary collaborations have emerged with the potential to develop into world class research programs in stem cell biology and therapeutics.'"
Given the dearth of ESC research funding, any California institution making an effort in the area can be expected to seek grants. Likewise, institutions with stem cell aspirations. But their names and the names of the scientists as well as the general nature of the application should be part of the public record.

Why CIRM persists in concealing the identities of applicants is hard to understand. If it truly wanted to maintain secrecy, it could disqualify an institution whose application became public knowledge, for whatever reason. Then nobody would be embarrassed.

CIRM's Lansing to Receive Oscar

Former Hollywood film executive Sherry Lansing will receive an Oscar this year for, among other things, her role at the California stem cell agency.

Lansing sits on the Oversight Committee of the California Institute for Regenerative Medicine, a position she has held since the agency's inception.

Last summer, she was cited specifically by California stem cell Chairman Robert Klein for making a "critical call" to Arnold Schwarzenegger to nail down the $150 million loan to CIRM that is allowing it pump out the cash this year.

Lansing is engaged in several other endeavors that were cited in the announcement that she will receive the Jean Hersholt Humanitarian Award at the Academy Awards in February. She serves on the board of Stop Cancer and the American Red Cross' Advisory Committee. She is also a regent of the University of California and a trustee of the Carter Center human-rights organization

Comments Sought by Your Mexico Correspondent

Mazatlan is nicely warm this time of year, much more pleasant than cold, cold California was during the holidays. And that's where the California Stem Cell Report is currently moored – Mazatlan, the Pearl of the Pacific.

We have stripped off our jackets and shoes, replacing them with shorts and sandals.

We are ensconced in Marina Mazatlan, which has clean showers and wireless Internet access from the boat. However, like stem cell research, the full potential of the wireless access is yet to be realized.

The link to the Internet has been sporadic. As best as we can determine, the DSL line provided by TelMex, one of the most egregious monopolies in Mexico, needs some sort of new electronic card. It has been ordered from Hermosillo, we are told. When reliable service will return is yet to be determined.

Meantime, we will schlep our hefty laptop in its hefty black Pelican case to the nearest Internet cafe (access cost 90 cents or so American an hour) via bus (40 to 80 cents American one-way). In Mexico, buses are often more convenient and faster than taxis. Both can be quite exciting. Oddly, the bus costs more than a three-mile bus ride in Santa Monica to the CIRM meeting at UCLA last October. That was only 25 cents, an extraordinarily low fare.

We also are working on improvements and changes in this website. Please let us know if there are features or information that you would like to see added. And please let us know about matters that you are not fond of. Send your comments directly to djensen@californiastemcellreport.blogspot.com and or just post them as a comment on this item. You can post your comment – anonymously if so desired – by clicking on the word "comment" below.

Monday, January 08, 2007

More Disclosure in Billion Dollar Giveaway Is In CIRM's Best Interest

California's $3 billion stem cell giveaway program began another important step today – one that is cloaked in nearly total secrecy despite the fact that it involves public funds.

Scientists in San Francisco are reviewing applications for $80 million in major grants. CIRM says their actions are only recommendations. However, the reality is that they are defacto decisions that are unlikely to be overturned by the agency's Oversight Committee.

A certain amount of confidentiality is to be expected, but the agency has gone overboard to protect the tender sensitivities of those seek the funds. It is a practice that will serve the agency poorly should questions arise – as they are certain to do over the next decade – about the propriety of its grant-making process.

We have written repeatedly about failings in transparency and disclosure at the agency. It is also a topic of concern to a number of newspapers and watchdog groups. John M. Simpson, stem cell project director of the Foundation for Taxpayer and Consumer Rights in Santa Monica, Ca., authored an op-ed piece that appeared today in the Oakland Tribune and other California newspapers.

He wrote:
"Everyone concerned claims they want a transparent process to ensure that awards are based on scientific merit, not favoritism and cronyism. Despite mouthing high-minded slogans, the institute's leaders too frequently miss the mark whenever there is a clear opportunity to build faith in its processes by being completely open.

"In California we don't know who applied for the grants or their affiliations. Our stem cell institute need only look to Connecticut where applicants' names and pertinent details are public record for a model of how to conduct the public's business.

"Fortunately at least one California scientist understands the importance of a completely transparent process when dealing with public funds. Connecticut's stem cell peer review committee — the equivalent of California's grants working group — is chaired by Dr. Leslie P. Weiner, professor of neurology at the University of Southern California's Keck School of Medicine.

"The California stem cell institute won't identify the 70 researchers from 23 unidentified institutions vying for 25 grants under the Comprehensive Research Grants program.

"In my personal life, I don't give money to people unless I know who they are, why they want it and what they plan to do with it. It shouldn't be any different with the taxpayers' $3 billion. Another opportunity for transparency and to build public faith in the institute's procedures is being squandered."
So wrote Mr. Simpson, who has followed CIRM's activities for more than a year and is a supporter of ESC research.

As for us at the California Stem Cell Report, if we were one of the scientists making decisions on the grants, we would want to have the maximum amount of openness, including disclosure of the financial interests of our fellow reviewers. Without transparency, it is all too easy for enemies of embryonic stem cell research to impugn the integrity of reviewers and to insuinate – as they most certainly will do -- that something other than good science is playing a role in handing out hundreds of millions of dollars in California taxpayer funds.

Embryonic stem cell research generates more than enough controversy. It is past time for the California stem cell agency to take steps to protect itself and its grant reviewers -- all of whom come the tiny circle of stem cell scientists around the world -- from the inevitable charges of self-dealing, cronyism and favoritism.

Friday, January 05, 2007

The California Poster Child, Stem Cell Wars and Proverbial Church Picnics

Are states running amok with embryonic stem cell research? Should or can the federal government reassert its control? Can workable compromises be found?

Richard Hayes, executive director of the Center for Genetics and Society in Oakland, Ca., addresses these issues in a piece on Bioethics Forum, which is sponsored by the Hastings Center Report.

Hayes writes about the "sorry" state of the stem cell debate:
"This polarized politics has given us the worst of all possible worlds: a policy stalemate at the federal level accompanied by a plethora of state-level stem cell funding programs lacking the sort of planning, ethical oversight, and regulation that biomedical research of such consequence requires. California's $3 billion stem cell program is the poster child of this predicament. Since its inception in 2004 it has been under fire for conflicts of interest, inadequate concern for the health and safety of women who provide eggs for stem cell research, unrepresentative policy-making bodies, and misplaced research priorities.

"These flawed state programs are setting the stage for even greater problems to come. Technologies now under development, including pre-implantation genetic diagnosis for both medical conditions and cosmetic traits, somatic genetic enhancement, and inheritable genetic modification, promise to make the stem cell wars look like the proverbial church picnic.

"If these technologies are embraced by the largely unaccountable infrastructure now being established to support stem cell research, they will be difficult to constrain. Once developed and made commercially available, they would be used disproportionately by the most privileged, and become new and powerful drivers of inequality and exclusion.

"The tragedy of this situation is that public opinion surveys consistently show that a strong majority of Americans support a morally serious middle ground regarding the new human genetic technologies. Americans are not irrevocably opposed to research involving the destruction of human embryos, but they want to make sure it is done only after alternatives have been exhausted, and with effective structures of public oversight in place. Americans want cures for diseases, but few are willing to turn the genetic future of the human species over to dismissively arrogant scientists and profit-hungry biotech boosters. Unfortunately, no organized constituencies with influence comparable to that of the religious conservatives or the research/patient/bioindustrial community exist to represent this majoritarian position in the political arena."
Hayes finds some hope in the approach detailed in "Beyond Bioethics: A Proposal for Modernizing the Regulation of Human Biotechnologies," by Francis Fukuyama and Franco Furger. Hayes said the book "could serve as a rallying point for those desiring an end to the current counterproductive policy stalemate."

Hayes called the book "the most comprehensive analysis of human biotech regulatory policy yet published in the United States. With the 2008 congressional and presidential campaigns now moving into high gear, the report comes at an opportune time. "Beyond Bioethics" should be studied carefully by everyone interested in working towards human biotech policies that can be supported by the great majority of Americans."

Gov. Arnie on Stem Cell Research

Former thespian Arnold Schwarzenegger was inaugurated today as governor of California. He had an enthusiastic but overstated line in his inaugural address about stem cell research. Here it is:
"Because we were leaders in stem cell research, California’s bio-tech industry has boomed, offering new cures for spinal cord injuries, Alzheimer’s, Parkinson’s and other diseases."
His speech is available live today beginning at 11 a.m. PST. (7 p.m. Greenwich Mean Time)

Stem Cell Market Fever: A Cooler Perspective

Are stem cell stocks really rising because of Democratic control of the House of Representatives? Probably not.

Are markets truly rational? Are stock analysts always well-informed? Probably not.

The questions come up because of a few articles concerning the sharp run-up in the price of some stem cell companies, including those based in California, in the last two days. The Associated Press (in the San Jose Mercury News and elsewhere) attributed the increase to the improved prospects of House passage of a measure aimed at encouraging federal embryonic stem cell research.

These daily trading stories are usually ripped off by relatively inexperienced reporters who grab the quickest and catchiest explanations for price rises. Some of those come from analysts who may not be well-informed and who do not understand that a presidential veto is likely again on the stem cell bill – a veto that probably will not be overridden. Even if it is, the National Institutes of Health are already hard-pressed financially and are not likely to come up with major increases in ESC reasearch funding, certainly nothing on the level of California's $3 billion giveaway. Beyond that, the markets have already factored in Democratic control of Congress, which is months-old news.

A more likely cause of the upsurge in stem cell stocks is the wave that boosted biotech stocks generally because of good news about Amgen, among other things. Here is what the Wall Street Journal had to say this morning:
"Amgen, (Nasdaq) the second-largest U.S. biotech company by market value, behind Genentech, gained 2.93, or 4.3%, to 71.33. Bear Stearns upgraded Amgen's shares to 'outperform,' saying the stock already reflects potential impacts from Roche's prospective introduction of a competitive anemia drug. If Roche's drug doesn't reach the market, the upside for Amgen's stock could be 'dramatic,' Bear Stearns said."
Stem cell stocks are thinly traded but may be carried along in a burst of buying in the biotech sector. Traders sometimes spread their bets across a sector.

Also not mentioned in the stories is the impact of automated trading programs that trigger purchases as an entire sector moves, in other words, a computerized bandwagon, which may or may not be rational depending on your point of view.

Wednesday, January 03, 2007

Stem Cell Argonauts To Convene in San Francisco

Since all of you out there are looking at your schedule for the coming spring, be sure to reserve a spot for The Stem Cell Meeting in San Francisco.

Produced by Burrill & Company, the two-day session promises a host of provocative discussions and a broad range of international speakers. Topics range from “Stem Cell Argonauts: Brain Circulation in a Global Economy” to
“The Un-United States: Cell Lines, Border Lines, and the Law.”

According to the preliminary agenda for the March 12-13 event, the keynote speaker will be Ian "Dolly" Wilmut of the University of Edinburgh, whose topic is “Continental Drift: Where Will Stem Cells Take Us?”

So far no speakers from CIRM are on the agenda, but are likely to be there. No speakers from WARF are listed at this point. Beth Donley, then WARF general counsel, served notice at last year's session that CIRM would have to pony up fees to Wisconsin for use of WARF ESC patents.

We caught two days of last year's session. Hundreds of others attended. It was definitely worth taking in.

Early reservations (before Jan. 26) mean a $500 cut in the $1495 registration fee. The conference also offers an academic, government and nonprofit rate of $495. If you want to get more bang for your buck, double up with the CIRM Oversight Committee meeting on March 15 and 16 in Los Angeles. That session is free.

Tuesday, January 02, 2007

Correction

The item below once carried a reference to an article on biotech investing from the New York Times. The article was actually from 2005 not 2006. We have removed the reference.

Stem Cell Snippets: Advocacy, Public Support and Weissman

ESC Gospel – What is going on with Robert Klein's Americans for Stem Cell Therapies and Cures? One current activity is recruitment of more missionaries to spread the ESC gospel. The group has about 150 speakers across the country. It is looking for 1,000. You can read more about the effort on stemcellbattles.com, the blog of stem cell advocate Don Reed. Klein, as most of you recall, is also chairman of the California stem cell agency in addition to presiding over the lobbying group.

Stem Cell Investing – The tough business of biotech investing was discussed in a piece by Andy Pollack of the New York Times. An excerpt: "The difficulty of taking companies public, especially at values they find attractive, has become a lament of biotech venture capitalists, and it is forcing changes in their strategies. Instead of a way to cash out, the initial offering is now a chance to keep a company going until, hopefully, the venture investors can sell their stock later."

Squishy Public Support -- Jesse Reynolds of the Center for Genetics and Society discusses the nature of public support for ESC research and the most recent public opinion polls. Supporters of ESC research find constant hope in the polls. On the basis of decades of watching polls on politics as well as other subjects, the California Stem Cell Report believes that embryonic stem cell research is poorly understood by most Americans and is still a new subject to most persons. That means potentially mercurial support that can be easily undermined by changing events or skillful marketing.

Weissman – Stem "cellist" Irv Weissman speaks on "What Stem Cells Mean to Science, Medicine and California" Jan. 9 at a meeting of Silicom (cq) Ventures in Mountain View. Weissman is director of the Institute for Cancer and Stem Cell Biology at Stanford and helped found three stem cell companies (Cellerant, SyStemix and Stem Cells, Inc.). Tickets are $150 for nonmembers of the venture capital group.

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