FTCR: CIRM May be Moving Too Hastily

While the California stem cell agency is moving quickly forward with plans for its first research grants, a watchdog group continues to raise questions about whether the results will be affordable and available to Californians.

The Foundation for Taxpayer and Consumer Rights said today that it is "concerned that the pressure to show results from a program that was approved by voters in 2004 and stalled by legal challenges could lead to hastily made and poorly considered grants that waste public money."

The news release continued:

"FTCR also said that the stem cell institute must have policies in place that ensure any treatments and cures developed with taxpayer money are accessible and affordable for all Californians."

The trigger for the foundation's comments is posting of the timelines for application for the research grants. The foundation said that "the letters of intent to apply for CIRM SEED Grants and CIRM Comprehensive Grants will be due Sept. 15. Full applications are due Oct. 13 and Nov. 13 respectively. CIRM envisions awarding the SEED grants in March 2007. The Comprehensive Grants would be awarded in March or April."

Here is a link to the foundation's full statement.

IP Principles for Business Coming Up Next Week

Dividing up the stem cell spoils comes up again next Tuesday as the CIRM Task Force on Intellectual Property looks at "principles" for IP involving for-profit enterprises.

No details have been posted yet for the session, which will also consider comments from the Oversight Committee on IP for non-profits.

The actual meeting will take place at the San Francisco International Airport, but remote sites are available at UC Irvine, Los Angeles and Stanford. Here is a link to the full agenda.

More State Oversight of CIRM Not Likely

Events last week in Sacramento re-arranged the stem cell stage in California.

The California stem cell agency skated past the latest attempt to bring more stringent oversight to its unique, $6 billion effort to turn stem cells into cures. That means that critics of the agency are not likely to be successful at bringing CIRM under more state direction for the foreseeable future.

A hefty scandal is about all that would create a climate conducive to major changes at the agency. At the same time, the door has opened for a state politician or two to seize the stem cell issue.

The quiet demise of the stem cell oversight bill by state Sen. Deborah Ortiz, D-Sacramento, signalled the new arrangements. Ortiz is chair of the Senate Health Committee and a pioneer on California stem cell issues. But term limits are forcing her from office at the end of the year and have reduced her legislative clout.

Assemblywoman Judy Chu, D-Monterey Park, chair of the Assembly Appropriations Committee, Thursday dispatched Ortiz' measure (SB401) to legislative oblivion. No vote was taken as Chu ordered the bill held in committee. Chu indicated, among other reasons, that she did not want to move forward with another stem cell ballot measure, which Ortiz' bill would have been.

Ortiz had a different view. She said the bill would have improved the performance of the agency and ensured access to affordable cures.

"The measure was extensively debated and refined during two years of public informational and legislative committee hearings. It had bipartisan support in both houses of the Legislature, and was supported by public interest groups.

"The bill was steadfastly opposed by the CIRM and the ICOC, the two entities the bill would have opened to increased public scrutiny. This is nothing but an example of a special interest group killing legislation to avoid being held accountable to those it serves."

Normally state departments, of which CIRM is one, are subject to regulation by the state legislature, which approves their budgets and can change their scope or eliminate them entirely. CIRM is radically different. It is a creature of the ballot. Voters altered the state constitution and state law to create the agency. Changes in the agency can only be made by another ballot initiative or by approval of 70 percent both houses of the state legislature and the governor. And that legislative action can only happen three full years after adoption of Prop. 71, which would be in November 2007. The extraordinary, "super-super" vote requirement makes it virtually impossible to tinker with CIRM. It would only 13 state senators to block any changes affecting the agency.

Nonetheless, political hay can be made involving embryonic stem cell research – on all sides of the issue. Gov. Schwarzenegger, who is facing a re-election challenge, made that clear a few weeks ago when he ponied up $150 million to ease the financial strains at CIRM. The impending departure of Ortiz leaves a void in the legislature on stem cell issues. Just who may fill it is unclear. Assemblyman Dave Jones, D-Sacramento, has been mentioned as one possibility. Ortiz was a friendly critic of the agency, although some at the agency did not regard her in that fashion. An unfriendly legislative critic can create considerable mischief, even if he or she cannot effectively make changes legislatively.

If the concept of political hay mixing with stem cell research is troubling, consider the host of continuing public policy issues involving CIRM and the nature of the research, ranging from treatment of egg donors to conflicts of interest. The fact is that politics and stem cell research are inextricably linked. It behooves the agency to keep a close eye on the state Capitol.

California newspapers paid scant attention to the demise of Ortiz bill. Most, if they carried any article at all, relied on a brief from The Associated Press. Reporter Judy Lin of The Sacramento Bee had a somewhat longer piece.

On to the Deadly Vizcaino Plain

We are going to have one of those periodic pauses in postings on the California Stem Cell Report. This time because of air and land – as opposed to sea – travel. On Thursday Aug. 17, we will wing our way from Guaymas on the Mexican mainland to Loreto in Baja California in one of Aero Guerrero's finest tiny planes. (Guaymas is, by the way, where Charlie Chaplin married his first child bride. En route to the US by train from Mexico City with the prospective mother-in-law also in tow, he decided to do the honorable thing. They honeymooned in the port city for several days.)

From Loreto, we will leap into a 1986 VW Vanagon and forge north into the deadly heat of the Vizcaino Plain, average annual rainfall less than two inches a year. With luck, we will arrive in the Old Country (the U.S.) in a few days and resume postings as we re-enter the dirt life(life on land) for a short while.

CIRM Hires Senior Communications Executive

The California stem cell agency has found a communications director, a man with considerable business experience who has also wrestled in the public policy arena in the San Francisco Bay Area and elsewhere.

Dale Carlson officially begins work next Monday. As communications director, his responsibilities will include developing a "clear and consistent message about the new frontier of stem cell research in California" and promoting "a deeper and more sophisticated public awareness of stem cell research and therapy." His duties go beyond dealing with the ink-stained wretches of the fourth estate and include developing communications programs with the public, the patient advocacy community, the legislature and the scientific community.

Carlson was vice president for corporate affairs with the Pacific (stock) Exchange in San Francisco from 1987 to 2005. He dealt with the media, business, public and handled a wide range of responsibilities, including dealing with Web content. Carlson also served in a variety of volunteer positions with civic and nonprofit agencies in the Bay Area, including tours of duty as chair of the San Francisco library foundation and the Treasure Island Development Authority.

Carlson, who has a masters degree in health services administration from the University of Michigan, surfaced in February of this year as an "interim senior communications officer" at CIRM, working on a parttime, volunteer basis.

CIRM has had difficulties since its inception with its communications/PR programs, resorting to hiring Edelman PR for $378,000 for a 16-month contract that expires at the end of this month. One problem was the lack of a senior CIRM official with specific PR responsibilities, which Carlson's appointment seems to solve.

In the interests of full transparency, we must disclose that Carlson is a sailor, as are we. He describes himself as a "competitive" sailor. We are just your average sea dog.

The salary range for Carlson's position is from $130,000 to $195,000. We expect to have the specific figure soon.

Forbes on Private Stem Cell Giving

For more on private stem cell philanthropy and the California stem cell agency, see this Forbes piece. It popped up today after the Wall Street Journal carried its page one story. The timing has all the earmarks of a publication being a tad pressured to push its story into public view after a competitor got the jump on it. Of course, we could be wrong.

CIRM to Examine 'Outline' of $3 Billion Giveaway

The Strategic Planning Advisory Committee of the California stem cell agency has a meeting planned for Aug. 24 to discuss the outline of a plan to give away $3 billion.

Details of the outline are not yet available and may not be available by the time of the meeting, given the way the agency works. Nonetheless the San Francisco meeting is open to the public. See the agenda here but don't expect illumination.

Wrapping up the Private Giving to CIRM

One of the things that the Wall Street Journal is very good at is following the money. Reporter David Hamilton did just that this morning in a page one piece involving the California stem cell agency.

The article wrapped up the private giving and help that has come CIRM's way. It also quoted the critics on the propriety of CIRM's ties to private benefactors.

However, Hamilton did not cite an earlier WSJ piece about how even small financial favors can create a feeling of indebtedness that is not fully comprehended by the recipients of the largesse.

Most of the details of Hamilton's piece are familiar to our readers. But we should note that because of the prestige and wide national readership of the WSJ, his article is likely to have more impact than if it had appeared in a smaller, regional paper. Play prominence -- meaning the front page display -- also counts.

Hamilton's piece additionally looked at the impact of private funding outside of CIRM. He wrote:

"USC has a new building that could become the state's largest stem-cell research center on the drawing board. It also recently hired Martin Pera, a prominent researcher from Australia, to run its new stem-cell research program. That step is notable in part because the federal restrictions sparked fears that U.S. scientists would leave the country to pursue their work.

"UCSF is using private money to renovate an entire floor of a building so that its stem-cell researchers will be able to work in a central location. One team deriving new stem-cell lines currently works in a laboratory at Menlo Park, Calif.-based biotechnology company Geron Corp., while another labors at an off-site leased facility in San Francisco.

"The university also is proposing an entirely new research building at the cost of as much as $100 million. Much of that must be raised privately, although Arnold Kriegstein, director of the university's stem-cell program, hopes CIRM might also be able to kick in some funding. 'Fund-raising is one of the bottlenecks to getting moving as quickly as possible,' says Dr. Kriegstein."

Gritty, Gritty Details on CIRM's Planning Process

For those thirsting for more details on the latest in strategic planning by the California stem cell agency, here is an update on some of the material recently available online. The information included below is being added unannounced to the CIRM site in some sort of willy nilly fashion and can be easily overlooked by the casual browser. But if you are a casual browser of the CIRM Web site, you are probably are not interested in the following. Nonetheless, here it is.

The agency has nearly completed its interviews for the planning process. As of late last month, 59 persons were interviewed with a target of perhaps 70. The list ranges from Bruce Alberts, former president of the National Academy of Sciences, to Leonard Zon of the Harvard Medical School. Also included were a number of the agency's staunch critics.

Last month, the agency held a conference on "Industry and Stem Sells in California: Fostering Research and Development." The presenters came from a blue ribbon array of stem cell-connected companies ranging from Geron to Burrill. Here are links to their Power Point presentations.

Sumit K. Chanda, Ph.D., Group Leader, Division of Cellular Genomics, Genomics Institute of the Novartis Research Foundation

Bruce Cohen, President and CEO, Cellerant Therapeutics

Ann F. Hanham, Ph.D., Managing Director, Burrill & Company

Martin McGlynn, President and CEO, StemCells, Inc.

Thomas B. Okarma, Ph.D., M.D., President and CEO, Geron Corporation

Alan K. Smith, Ph.D., President and Chief Operating Officer, Cognate BioServices

Michael D. West, Ph.D., Chairman of the Board, President and Chief Scientific Officer , Advanced Cell Technology, Inc

E. Edward Baetge, Ph.D., Chief Scientific Officer, Novocell, Inc.

Another conference last month dealt with “The Scientific Challenge: From Basic Research to the Clinic.” The speakers and their Power Point presentations:

Stuart Orkin, M.D., Harvard Medical School, Chair, CIRM Scientific and Medical Research Funding Working Group, “Stem Cells: Looking Back and Ahead”

Jill Heemskerk, Ph.D., National Institute of Neurological Disorders and Stroke, “The SMA Project: A New Approach to Therapy Development at NIH”

Allen M. Spiegel, M.D., Albert Einstein College of Medicine, “Delivering on the Promise of Stem Cell Research: What Will it Take?”

Stephen A. Sherwin, M.D., Cell Genesys, Inc., “The Development of Novel Cellular Therapeutics: Some Lessons from the Private Sector”

Calling the Tune on ESC Research: Therapies or Tools?

As the California stem cell agency wrestles with how to give away $3 billion – otherwise known as strategic planning – along comes a related article in the nation's most prestigious newspaper, the New York Times.

In Monday's edition, reporter Nicholas Wade discussed the split between those who want to see development of stem cell therapies versus those who see embryonic stem cells as a research tool to study mechanisms of disease.

That discussion has rumbled through CIRM for most of its existence, with patient advocates making impassioned pleas for quick results, declaring the longer it takes the more people die – an argument Wade does not explore. Since patient advocates hold 10 seats on the 29-member CIRM panel that ultimately decides who gets the cash, their views are not to be sniffed at. The issue is also near the center of the strategic planning process, which is scheduled to end in December. (See "clashing interests" for a look at the splinter within CIRM.)

Wade wrote:

"Many (scientists) no longer see cell therapy as the first goal of the research, parting company with those whose near-term expectations for cell therapy remain high.

"Instead, these researchers envisage a longer-term program in which human embryonic cells would be a research tool to study the mechanisms of disease. From this, they say, many therapeutic benefits may emerge, like new drugs, which would probably be available at least as soon as any cell therapy treatment."

Wade said there is a "gap between scientists’ views and those of the public and of people for whom the overriding purpose of research with human embryonic stem cells is to generate cells that can restore damaged tissues."

Wade continued:

"Thomas M. Jessell, a neurobiologist at Columbia University Medical Center in New York, said that he hoped to see the research generate new drugs for neurodegenerative diseases within the next five years but that it could be a long time before rational cell-based therapies are effective.
"'Many of us feel that for the next few years the most rational way forward is not to try to push cell therapies,' Dr. Jessell said. Scientists have spent the last five years mostly in learning how to grow human embryonic stem cells in the laboratory and how to make them differentiate, meaning to turn into the body’s various types of mature cells.'"

Wade said:

"Researchers have not, however, abandoned cell therapy, in which cells themselves would be used to regenerate tissue. In Parkinson’s disease, for example, dopamine-producing cells from aborted fetuses, when injected into the brains of Parkinson’s patients, do have an effect, suggesting that a better source of cell could have therapeutic value. 'So it’s the perfect place to go in,' said Dr. Asa Abeliovich of Columbia University Medical Center. Dr. Abeliovich said that with Alzheimer’s disease, in contrast, 'We don’t know how or what to replace.'"

While scientists have preferences on the direction of stem cell research, no research is done without funding. Given the amount of money that CIRM can bring to bear on the subject (10 times the annual spending of the NIH on ESC research), the views of scientists oriented towards use of ESCs as research tools may not be the key factor in determining the main direction of new stem cell research in the United States.

Does Disclosure Mean Only the Second Tier Will Play?

A former president of the National Academy of Sciences has ridden to the support of the "trust us" disclosure and conflict-of-interest policies of the California stem cell agency.

Bruce Alberts, professor of biochemistry at UC San Francisco as well as president of the NAS from 1993 to 2005, said that scientists who make de facto decisions on requests for millions of dollars should not be required to disclose their financial holdings.

Writing in the San Jose Mercury News, he said CIRM has taken "strong measures" to avoid conflicts of interest. Alberts declared:

"Scientists view serving on (grant) review committees as a public service, and many of the best will decline to participate in institute reviews if their private financial information is to be made available for everyone in the world to see. California then runs the risk of wasting critical resources by not making the very best decisions on how to make these important investments for the public good."

Alberts does not address the issue of whether there is a significant conflict of interest problem involving medical researchers generally. But we all know of the continuing string of stories about researchers whose ethics are suspect. More recently, the Wall Street Journal wrote about just how favoritism creeps in and how researchers seem "immune" to feelings of conflicts of interest. The Journal said,

"Studies of psychiatric drugs by researchers with a financial conflict of interest -- receiving speaking fees, owning stock, or being employed by the manufacturer -- are nearly five times as likely to find benefits in taking the drugs as studies by researchers who don't receive money from the industry, according to a review of 162 studies published last year in the American Journal of Psychiatry."

We acknowledge that some scientists may beg off service on the CIRM grant review committees simply for privacy or philosophical reasons. But does that mean only the second tier will serve? Perhaps that is a question to be asked of the 29 persons who oversee the $3 billion California stem cell agency, all of whom must publicly disclose their financial information. One of those persons is the vice chancellor for medical affairs at UC San Francisco. He is also Alberts' boss.

Patient Advocates: More Collaboration Needed, Risky Ventures Okay

Patient advocates from throughout California say they would like the agency over the next 10 years to do everything from curing "many of the diseases that plague society" to improving collaboration and communication among scientists.

Their sentiments were voiced at a focus group called by CIRM last month as part of its strategic planning process. Their mostly anonymous comments can be read in a 17-page summary available on the CIRM web site.

The questions posed to the focus group ranged from how does CIRM measure success 10 years out to balancing high-risk research with the go-safe-but-slow approach.

In terms of 10-year goals, one sentiment jumped out, at least to us. That was the need for more collaboration, sharing and transparency. A variation of that feeling also surfaced during a segment involving public education.

Sometimes one is given the impression that collaboration and sharing go without saying in today's world of instantaneous communications. But apparently not, in the view of a number of patient advocates.

Some of the proposed 10-year measurements of success were more specific, such as this one:

"Success would be that stem cells or their derivatives would have cured many of the diseases that plague society."

Another patient advocate suggested a 10-year goal of one approved therapeutic intervention and three advanced clinical trials.

On the subject of risk, participants endorsed using portions of CIRM's $3 billion for riskier projects, although the proposed percentage varied.

CIRM President Zach Hall commented:

"At the time of the Human Genome Project, there were two proposed approaches to sequencing the genome. Someone who advocated the approach that ultimately wasn't chosen left the NIH to set up a competing project. That was Craig Ventner. The competitive pressure he exerted caused the NIH to change its strategy and accomplish things much faster. Some say they wouldn't have done that without competition from Craig Ventner. It's true the NIH study sections put a big priority on feasibility and likelihood of return. I don't know that we look to you for an answer but we do listen for whether it's more important to have tangible progress or are we willing to risk some of the money on a gamble that may fail."

Hall also indicated that a focus group will also address the question of public education.

Stem Cell Conferences: Eggs, Biocapital and Fair Cures

Get out your calendars, stem cell fans. Coming up are a three hefty conferences in the San Francisco Bay area on stem cell issues.

On Sept. 28, at the request of CIRM, the Institute of Medicine and the National Research Council will hold a conference near the San Francisco airport on the medical risks of egg donation. This is the conference that CIRM has talked about for months. A high-powered group from throughout the country is scheduled to speak.

On Sept. 28-29, "Ethical Worlds of Stem Cell Medicine" is the topic at UC Berkeley. "Academic Industry Alliances" and "Procurement and the Integrity of the Human Subject" are among the topics. The conference overview notes that today's stem cell medical environment has generated a "surfeit of promissory biocapital." The session is sponsored by the Science, Technology and Society Center at UC Berkeley.

On Oct. 14, "Toward Fair Cures: Integrating the Benefits of Diversity in California's Stem Cell Research Program" will be held at the Children's Hospital in Oakland. The conference is sponsored by the hospital, the Greenlining Coalition and the UC Berkeley Project on Stem Cells. CIRM President Zach Hall is scheduled to appear along with Evelynn Hammonds of Harvard. We do not have a Web site for this yet, but you can contact Joe Tayag of Greenlining at joseft@greenlining.org.

Finding Stem Cell Moolah on the Web

Connecticut has set an example for California to follow in raising funds for its embryonic stem cell research efforts – go directly to the people.

The East Coast effort is modest and not exactly ballyhooed. But nonetheless it is on the home page of its stem cell program. Right there with a big dollar sign, it commands: "Make a Donation."

Given the perceived widespread support for stem cell research in the Golden State, it would seem appropriate to make it easy for anybody to make a donation whenever the whim struck. Connecticut can only take checks and is looking into credit cards, but that is hardly an obstacle.

In California, it should be able to be done with a minimum of effort without waiting for the redesign of the CIRM website. At least one state agency, the Department of Motor Vehicles, already takes credit cards, so little would seem to be in the way.

Let the money roll in!

Money Talks in Connecticut Too

California's unprecedented stem cell research effort has drawn attention from throughout the nation and the world. The latest evidence comes from Connecticut, which has a $100 million, 10-year program underway.

As in California, money is an issue. Some in Connecticut seem particularly impressed with CIRM's prodigious fundraising efforts in the private sector. Connecticut's stem cell research advisory committee wanted to know more about it, according to the transcript from a July 18 meeting. All the persons mentioned below are members of that committee, including Ann Keissling, who serves on a CIRM working group.

Myron Genel, professor emeritus Yale School of Medicine:

"I think that Bob, you’re right, that it’s difficult to raise those funds, but I think that Ann earlier and that you Charles were indicating that it’s happening someplace. It’s happening in California. So that -- and I think it was Bob, you talked about you need to have the right strategy. To me a first step would be to confer with California. See what’s making -- allowing them to be successful."

Ann Kiessling, member of the CIRM Standards Working Group and faculty member at Harvard Medical School:

"One of the most straight forward things that they did I think as their overall working group is they sort of looked at the income of people in California and asked most of those people to sit on one of their boards. So they went to the very top income producing people."

Commissioner Robert Galvin, Connecticut state commissioner of public health:

"Wealthiest individuals."

Kiessling:

"The wealthiest individuals in California and they asked them if they would like to, you know, sit on one of the committees. So a lot of those -- "

Galvin:

"And to contribute?"

Kiessling:

" -- well, not necessarily contribute, but you know, that’s a group of people that talk to each other and for instance the co-chair of the Standards Working
Group in California, which is a group similar to this, it’s an advisory group as to how you’re supposed to go about what kind of ethical issues and how the money should be disbursed. The co-chair of that is Sherry Lansing (phonetic), who was CEO of Paramount Pictures for many years. You know, Sherry knows probably almost everybody in California. And the other person who was a very prominent member of that committee was Bob (Klein), who is the one who almost single handedly got the tax, you know, bond measure passed in California. So they really involved the people who could actually contact a lot of people in their committee work."

Galvin:

"That’s a very good point Ann because you’ve got to get to the decision makers."

Given the nature of Keissling's comments, we asked her if she had more to say. Here is her response verbatim:

"One of the most noteworthy aspects of the CIRM committees is enthusiasm and dedication to the task at hand. It has been a monumental task, moved forward with incredible determination and regard for public opinion.

"I think it is a good example of how opening the doors to the public generally has more positive than negative impact on new biomedical technologies, in contrast to the views of some that public involvement may impeed progress.

"My comments about who to involve on committees was meant to reference fund-raising ability -- individuals who both know who might be able to contribute and also have the enthusiasm and dedication to seek the funds. I did NOT mean to imply that especially wealthy individuals were specifically selected for committee assignments, as the quote below seems to suggest, that is not my impression.

"But having one third of the committees be 'lay persons' advocating for a specific disease provided a sense of urgency and dedication that truly supported the enthusiasm of scientists for getting the work done as quickly as doing a good job would allow. One disease advocate that comes to mind is Jonathan Shestack, a movie producer-advocate for autism ('Cure Autism Now') -- a member of the Standards Working Group -- thoughtful, erudite, energetic and driven -- a huge asset to getting the work done timely and as perfectly as possible.

"I've always been a supporter of public involvement in high tech issues, and my California committee experience has strengthened this view."

The exchange involving the committee begins on p. 85 of the transcript.

CIRM Oversight Legislation Set for Thursday Hearing

The legislation to tighten oversight of the California stem cell agency, mentioned in the item below, is now scheduled to be heard next Thursday by the Assembly Appropriations Committee. No time was given but the committee usually is scheduled to begin work about 9 a.m. Ortiz' amendments still have not caught up with the version of SB401 available on the Web.

Proposal to Tighten CIRM Oversight Coming Up Next Week

Sweeping legislation to tighten oversight of the California stem cell agency is likely to come up before the state Assembly Appropriations Committee in the middle of next week, its last stop before it would reach the Assembly floor.

To be enacted, the bill (SB401) by Sen. Deborah Ortiz, D-Sacramento, must be approved by the committee, pass the Assembly and then the Senate, before going on to the governor for his action. If he signs the measure or allows it to become enacted without his signature, it would then be placed on a statewide ballot – not this fall – for voter approval.

Given the governor's $150 million bailout of CIRM, it seems more likely that he would veto Ortiz' legislation. But speculating on what may happen while he is running for re-election is fraught with pitfalls.

The bill is opposed by CIRM and some in the biotech business, although most of the opposition was registered prior to the latest amendments, one of which removed a provision to place the measure on the fall ballot. Other amendments basically conformed the measure's IP policy to what CIRM has already approved.

CIRM Chairman Robert Klein was not apparently satisfied with the position of his agency on the measure last spring. He wrote a harshly worded letter circulated nationally concerning the bill. Klein described Ortiz, a longtime supporter of stem cell research including Prop. 71, as an "ongoing threat" to that entire field of science. CIRM refused to comment on the letter, which Klein wrote as head of Americans for Stem Cell Therapies and Cures, a political advocacy group headquartered in his Palo Alto office.

Patient advocate Don Reed of Hayward, Ca., earlier this year began a letter-writing effort against the measure. However, at the moment it does not seem at the top of his agenda, based on a look at this web site, Stemcellbattles.com.

Ortiz' amendments have not yet caught up with the official version of the bill on the Web, but are likely to do so before it comes up either next Wednesday or Thursday.

Here are links to the Klein letter, a discussion of its "facts," and a background statement from Klein's group.

Stem Cell Alliance Shutting Down

The Alliance for Stem Cell Research, a spinoff of the successful campaign for Prop. 71 in California, is closing its doors.

The group said in a press release:

"Recent legislative efforts have demonstrated that perhaps the most effective way for us to achieve our goals is to play a larger role in ongoing efforts to change the political landscape. In particular, we must take action to end policies that currently impose significant restrictions on the progress of stem cell research.

"As a 501(c)3 public charity, the AFSCR is limited in its
ability to lobby and directly influence legislation and election outcomes. Therefore, the Board of Directors of AFSCR has made the difficult decision to dissolve AFSCR and realign its efforts to campaign for stronger support for stem cell research on both the federal and state level."

The alliance grew out of Cures for California, the campaign organization for the 2004 stem cell initiative.

In response to a query about her plans, Susan DeLaurentis, president of the alliance, said, "I plan to work as a volunteer to get candidates elected who support stem cell research. I will personally stay involved in this issue - there is
much to be done!"

The Immune Feeling of Researchers to Conflicts of Interest

Critics of the California stem cell agency have fresh scientific evidence to bolster their contention that the institute should require additional financial disclosure from members of its working groups.

The latest support comes via an Aug. 4 article in the Wall Street Journal by reporter Shirley S. Wang. She asks the question: "Why do many researchers feel they're immune to conflicts of interest?"

Answer:

"Just as we fool ourselves into thinking we're more ethical, kind and generous than we are, so scientists can be blind to the very real possibility that their work is inappropriately influenced by financial ties. These psychological processes usually operate so subtly that people aren't aware that such ties can bias their judgment.

"Receiving gifts and money creates the desire, often unconscious, to give something back, says Max Bazerman of Harvard Business School. Even small gifts can have an influence. Charities that send out free address labels, for example, get more in donations than those that don't. Customers who are given a 50-cent key chain at a pharmacy spend substantially more in the store.

"Conflicts can be hard to recognize, because 'cognitive bias' comes into play. 'The mind has an enormous ability to see the world as we want,' says Dr. Bazerman."

Wang continues:

"Studies of psychiatric drugs by researchers with a financial conflict of interest -- receiving speaking fees, owning stock, or being employed by the manufacturer -- are nearly five times as likely to find benefits in taking the drugs as studies by researchers who don't receive money from the industry, according to a review of 162 studies published last year in the American Journal of Psychiatry. Studies that the industry funded, but in which the researchers had no other financial ties, didn't have significantly different results than nonindustry-funded studies.

"Studies can be designed in ways that boost the likelihood that results will come out a certain way, says Lisa Bero of the University of California, San Francisco. A new treatment can be compared with a placebo, instead of with a treatment already in use, making finding a significant statistical difference between the two more likely. Dosage and timing of medications, which make a big difference in their effectiveness and side effects, can also be manipulated, she says."

Wang's article attracted attention on the blog of the editors of the American Journal of Bioethics, which described it as "excellent." That site also linked to another related piece by Catherine DeAngelis, editor of the Journal of the American Medical Association, in which she discusses "the sometimes unethical influence of money on medical science, a very serious issue, which has become more evident over the past year or so."

Would more CIRM disclosure from scientists and physicians eliminate conflicts of interest? Certainly not, but it would tell the public when potential conflicts exist. Public disclosure would also allow other interested parties and the public to understand the financial webs surrounding often highly vaunted research. And as we know, from time to time, the early raves for therapies do not stand up to scrutiny for a host of unsavory reasons.
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Clinical Stem Cell Research: Financing and Academic Medical Centers

The California stem cell agency has identified some sticky issues involving clinical research for stem cell therapies, including a "dramatic" shift away from academic medical centers.

The 10-page overview of the clinical research process was prepared as a background document for CIRM's strategic planning process. The paper covers drug development timelines, clinical networks and difficulties in financing clinical research in addition to issues involving academic medical centers.

On the subject of the centers (AMCs), here are a few excerpts:

"We have heard anecdotally of the increasing difficulty that academic researchers face in obtaining funding for investigator-initiated research, which is due to a number of reasons:
"a. Decreased clinical margins at AMCs resulting in less discretionary funding available for research.
"b. The shrinking of the NIH budget.
"c. The general unwillingness of the pharm/biotech industries and the venture capital community to fund research that does not have direct, obvious commercial applications.

"In addition, while academics may sometimes believe that clinical research depends on the AMC, non-academics believe that clinical research, to truly thrive, needs to be present in multiple venues of care. The pharmaceutical industry is seeking more non-academic providers to conduct clinical research, which is creating enormous opportunities for hospitals, physicians and outpatient providers such as the for-profit contract-research organizations (CROs) and site-management organizations (SROs) to fulfill some of the functions traditionally carried out by AMCs. For example, at the beginning of the decade of the 90's, 80% of industry-sponsored clinical trials were placed in AMCs; by 1999 the number was down to 40%. One reason given for this shift is the amount of time it takes to gain protocol approval in academic settings: the initial approval process prior to initiation can take from two to six months in an AMC, compared with one to two months in a private hospital or less than one month in a physician’s practice.

"In an industry where speed is paramount, and where for each day’s delay in gaining FDA approval of a drug the manufacturer loses and average of $1.3 million, such delays are problematic, at best. There has also been a trend in recent years for US pharmaceutical companies to conduct clinical trials outside the US. For example, the number of American sites where clinical trials were underway declined from about 51,000 in 2001 to 48,000 in 2003. During that same period, the number of FDA-approved investigational drug studies in all phases of research rose from about 3,900 to 4,500, but with less research being done at U.S. sites."

The background paper also reported:

"Given the newness, uncertainties, and challenges associated with cell-based licensing by the pharmaceutical industry or investment by the venture capital community) is unlikely to be available for such therapies until there is proof of clinical concept; until methods to consistently produce cells are developed; and until the related business models becomes more accepted. This will likely limit the ability of smaller companies to move promising therapeutic approaches into clinical trials and eventually to patients without additional sources of funding."