What Happens with Stem Cells After 2008? More of the Same.

David Jensen, whose California Stem Cell Report remains the authoritative source for anything going on around stem cells in California, has been reporting on the proceedings of a stem cell conference being put on by Stanford and Burrell and Company. Several speakers have been apparently saying something we’ve been arguing for a while now--- regardless of who wins, the presidential election of 2008 is not likely to produce any major changes in what one speaker called the “bizarre patchwork” of state funding and regulation of embryonic stem cell research. While many stem cell advocates would like to see a set of uniform federal standards and a big uptick in NIH funding, the likelihood of either of those things happening anytime soon after 2008 seems increasingly remote. While a new president, especially a Democratic one, might well sign the bill President Bush has vetoed once and is threatening to veto again to expand the number of stem cell lines eligible for federal research support, that’s likely to be all that happens. A major increase in NIH funding for ESC seems unlikely—one speaker at the conference even raised the possibility that NIH might even try to steer money away from ESC research because of all the state and private money already in play. Even if there’s a sizeable increase in stem cell funding, it would only make NIH one funder among many, and not likely the biggest one at that. NIH would have to increase its ESC funding roughly by a factor of eight to be competitive with California’s budget, and that doesn’t even include the funding in play from other states and private donors. While Congress could independently pass a law preempting individual state laws and establishing a uniform set of ESC research standards, the odds of that happening are less than slim. There’s no clear national consensus around a whole host of issues that would have to be addressed in such a bill, and the possibility that Congress could unify itself around one approach seems too remote to contemplate. What seems likely to happen instead is more of what we’ve got now—more states weighing in with ESC funding programs of widely varying sizes (look particularly at what New York and Wisconsin wind up doing) and ESC research being heavily supported in some states and illegal in some others. There will be increasingly vocal debates over royalties and product pricing that will be resolved in a wide range of ways, and conflicts between the rules that apply to collaborating researchers located in different states. This “bizarre patchwork” is markedly less efficient and more administratively difficult than a single funding source and set of rules would be, but it’s an accurate reflection of conflicting and diverse public views about ESC that don’t show any sign of going away anytime soon.
- Jim Fossett, Director, States and Bioethics Program of AMBI & The Rockefeller Institute

No Pressure, Jon

San Francisco Chronicle reports that Robert Klein, real estate magnate and chair of the California Institute for Regenerative Medicine, the Proposition 71-funded Master of Ceremonies for $3 billion in stem cell research to be doled out beginning in May, has at long last given an interview. In it he discusses the controversy concerning when the money will be given out for stem cell research, and more important the rules that will be used by CIRM to do so.

The guidelines are required by Proposition 71, and while it can revise the guidelines that it puts in place now, it needs good guidelines at the outset, not only because of the law but because of swirling controversy in California about the ties of CIRM board members to the institutions that will be asking for money.

So where will these guidelines come from? The National Academies, who have engaged Virginia bioethicist Jonathan Moreno to run a committee on model guidelines for conducting stem cell research.

'It would be better for us all to be on the same page,' said Jonathan Moreno, director of a biomedical ethics center at the University of Virginia and co-chair of the National Academies committee. During a telephone interview Wednesday, Moreno said the national [Academies?] guidelines are expected to be out by April after a final round of outside reviews and revisions. 'The committee has been running since August, and people say, 'Gee, you're taking a long time,' ' Moreno said. 'But this is hard. For academics, this is a breakneck pace.'

It will be helpful indeed for California's stem cell funding group to get the Moreno committee report, which will join several other sets of recommendations on how individual states', states collectively, and the nation should pursue specific standards for stem cell research.

But it is difficult to see how any group writing guidelines for national stem cell policy - or even for state and national policy - can cover both the issues inherent in national dilemmas, and the issues present in the states' differing legal, clinical, political, economic, and social situations, and still be finished in eight months.

And in this case, Moreno and his group are being asked to produce a report that does all of this while taking care to address the issues about model guidelines that would be appropriate to the very, very special "California world," with its own behemoth budget and complex allocation issues.

It remains to be seen whether California will create its own ethics group or ethics research division within Proposition 71, and it would be dangerous indeed for the state to avoid doing so. California state stem cell policy might not be something you want - for the long term anyway - to have "phoned in" at the last minute. What Californians really need to do is hire Jonathan Moreno away from Virginia! - Glenn McGee

Proposition 71 Has Created a Monster

AP reports that first amendment groups are furious over tight secrecy concerning how $3 billion in tax dollars will be spent. ContraCostaTimes reports on "growing" complaints that the stem cell legislation offers too many opportunities to use stem cell money in California to make institutions rich. And it is certainly true that the stakeholders are running the show: "Many of the 29 board members, appointed by the governor and other elected officials to run the agency, represent research universities and the biotech industry, both of which are expected to win millions of dollars worth of grants."

Dear Geron. Please, Please Stay in Maryland. California is ... Well ... They Don't Have Annapolis!

The Herald-Mail ONLINE reports that Maryland is going to try to scrape together some money to compete with California. Will Geron move to California? You've got to wonder just how much more complicated state stem cell politics can get.

What Do Ethicists Say, Dude?

California newspapers haven't usually quoted California ethicists, and their understanding of bioethics is somewhat hampered by the fact that there aren't so many bioethics programs in California that there is a big impact on policy. Until now. UCSD's research ethics program director Michael Kalichman is profiled as part of this big piece on "what an ethicist is."

Real Estate Investor to Run California Stem Cell Program

Just out from the official Governor's Office press release:

Governor Arnold Schwarzenegger today announced his selections for leadership of the Independent Citizens Oversight Committee (ICOC) which oversees the California Institute for Regenerative Medicine created by the passage of Proposition 71. The proposition, supported by the Governor, was approved by voters in November and will fund stem cell research that may offer cures for ailments ranging from Alzheimer’s disease to diabetes and cancer. The Governor announced his nomination of Robert Klein for chairman and Edward Penhoet for vice chairman of the ICOC.

The Stem Cell Debate is Dead

In this editorial in the San Jose Mercury News, David Magnus and Art Caplan argue that with the passing of California's prop. 71, it is long past time to stop worrying about the President's policies or the tired issue of whether ex vivo embryos are people. The new stem cell debate is going to be about when the science justifies moving to clinical trials, worries about the therapeutic misconception and conflicts of interest. I know I am not the only one who feels like i've gone back in time--substitute enthusiasm for stem cell research for gene therapy. We argue in this piece that we should learn some lessons from that experience.

WANTED: Czar for California Stem Cell Research Agency ... Must Be Rested & Ready to Be Most Powerful Person in Biotech

LA Times reports:

With less than a week before the debut of California's new $3 billion stem cell institute, intense behind-the-scenes debate is growing over who should head the agency and whether a Friday deadline for filling the post will allow the best candidates to be considered. The debate is expected to crest Monday when Gov. Arnold Schwarzenegger and three other state elected officials must, under the tight deadlines set by the state's embryonic stem cell initiative, put forward their nominee to chair the new agency.

The chairperson will immediately become among the most influential officials in the field of biological research, running much of the day-to-day operations of an institute that will dole out some $300 million a year in grants, more than 10 times what the federal government now spends yearly in the stem cell field.

Bernard Lo is quoted.

On the Way to Regulating Stem Cells in California

News from the National Academies conference in Irvine, California this week. Moreno, Charo, Lo are quoted. "R. Alta Charo, a bioethics professor at the University of Wisconsin at Madison, told the audience that, for anyone who believes embryonic stem-cell research is unregulated and has slipped through the cracks, she had brought 35 slides dedicated solely to the field's current regulations."

Why No Bioethics on the California Proposition 71 Governing Council?

Why doesn't California put a bioethicist on its Proposition 71 governing board dealing with the $3 billion to be allocated for stem cell research? University Chancellors and Presidents are being nominated up and down as schools' and institutes' top guns clamor to be public intellectuals on this big-ticket funding item, no doubt in part to ensure that their shop gets some of the money. The proposition guarantees seats on the board to some institutions (including the 5 UCal schools), but why in the world can't there be some slots dedicated to bioethics?

No matter what your position on stem cell research, there simply must be a dedicated stem cell ethics expert among the governors. If it weren't so serious a matter, one would have to laugh at the idea that these University and institute administrators are properly trained to think about how and whether to dispense the money and for which studies. It is a question several are beginning to ask anew, echoing concerns from those who opposed Prop 71 but themselves supported hES research. Bioethics in California has always been a developing phenomenon, although the Stanford center is arguably among the top programs in the nation. Hopefully at least some of the ballast for deliberations about which programs should be funded will be provided by people in stem cell bioethics in California. But that is a very, very short list of people.

Even more important, California should finally begin to build up some bioethics programs, particularly in the universities that plan to do significant new stem cell research. If the past is any predictor, that will not be easily accomplished in California, where bioethics has just never really taken a foothold in terms of university budgets and powerhouse faculties. There are plenty of good people in bioethics in California, but it is difficult to identify a group of major research centers in bioethics in the state, despite its preeminent place in biotechnology research. Proposition 71 should be the full employment act for California bioethics, to borrow Art Caplan's description of the role ethics money in the Human Genome Project had on bioethics in the 1990s. But if it is business as usual in the most populous state in the nation, bioethics may become an unfunded sport for university CEOs. That would not only hurt bioethics, it would hurt the people of California, who are clearly hoping for a careful, smart use of the $3 billion windfall for stem cells. For them, ethics has to stay in the mix in a serious way.

California DNA Law Worrisome Threat to Privacy

In a move that has privacy advocates worried, California voters approved proposition 69, an aggressive DNA-collection program. The new law, officially called the DNA Fingerprint, Unsolved Crime and Innocence Protection Act, will collect data from anyone convicted of, or arrested for a felony. It is expected to add the genetic data of about a million people to California's databank over the five years, making it the largest state-run DNA databank in the country.

What Happens When Your State Allocates $3 Billion for Stem Cell Research

Answer? Everyone wants to do stem cell research. Berkeley, though, is at a disadvantage, and it is interesting to watch as they deliberate about how to make up for the lack of a medical school.

Britain? Stem Cell Leaders? Meet California.

They are running scared in Britain. After months of believing their own press about a purported mass exodus of stem cell researchers, there are some pretty scared venture capitalists now in London. Financial Times' Clive Cookson delivers a eulogy for the era of mass optimism, complete with lots and lots of quotes from folks like Roger Pederson. The UK, by the way, spends just over 25% of the annual amount California has just allocated for stem cell research.

SF Chronicle: Proposition 71 Passes

11:32PM - San Francisco Chronicle is projecting a clear win for Proposition 71, which allots $3 billion for stem cell research including ESR. My debating partner Mel Gibson is apoplectic and all over California TV complaining. The Proposition 71 story is beginning to filter out nationwide but it seems to be the dominant web story in California, from among some 13 propositions on the ballot there.

Wisconsin is Petrified of Stem Cell Migration UPDATED

Wisconsin Business reports that California's Prop 71 will create a "giant sucking sound" as big stem cell labs and important scientists are vacuumed up by California. The article asks how much will it take to lure James Thomson? Interesting question...several weeks ago we blogged Alta Charo's comments regarding the threat of Bush policies to Wisconsin. One could be cynical about that threat, given that Wisconsin holds so much intellectual property in stem cell research that Wisconsin profits no matter who is doing the work. But Alta is clearly right that Wisconsin could lose its key figures in stem cell research to Prop 71 and to California.

Monitor on Stem Cells

Somebody at the Christian Science Monitor has decided that it is bioethics week. This stem cell piece does a great job of establishing the real effect that $6 billion in Prop 71 money for stem cell research in California would have on the rest of the nation and on the stem cell debate. Great quotes from Annas, Caplan and Kahn.

Prop 71/Stem Cell Conference in Los Altos

Proposition 71, on the Nov. 2 ballot, poses a quandary for California voters. The "California Stem Cells for Research and Cures Initiative" entails two major questions: Should the state of California assume additional debt through a constitutional amendment? Should the state of California fund contentious research and development in an area that has been typically carried by the federal government, biotech, big pharmaceutical companies and venture capital? Community Connections of Los Altos has scheduled two discussions with experts in the scientific and ethical communities so voters can be better informed. Henry T. (Hank) Greely, law professor at Stanford University, and Jennifer C. Lahl, the national director of the Center for Bioethics and Culture, will discuss the ethical issues surrounding stem cell research 7-9 p.m., Oct. 17. The talks will be moderated by Los Altos Hills resident Tom Gutshall, CEO of Cephied. Both talks will be held at Main Street Cafe & Books, 134 Main St., Los Altos. - David Magnus

Update: Salk & Stem Cells

We previously noted the Salk hES ethics symposium. They've put up video, including "teachable" talks from Wolpe and Zoloth; those are available here.

Grow a GM Crop, Go to California Jail

Not everything in California is about stem cells these days. Breaking News Technology section of the Globe and Mail is reporting a new wave of statutes in California counties banning, well, everything about GM crops. The laws are up November 2nd and many have quite significant criminal penalties. This is a first in the U.S.

Advanced Cell to California

From Chris Mooney, an LA Times story today on the planned opening of anAdvanced Cell Techology facility in California. Lanza at ACT is right that lots of companies will be moving west, but one can be sure that there are those in the U.S. hES research community - those who weathered the last two ACT-created microscandals - who are wondering why ACT couldn't keep moving west until they get to Singapore...