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Saturday, Jan. 27, 2007 | In mid-2004, Larry Goldstein was in Montecito, a small community just south of Santa Barbara known for its wealth and for the celebrities that call it home. Goldstein wasn’t looking for star-sightings or the glorious coastal views: He was there to raise money for Proposition 71, an unprecedented $3 billion state bond measure to fund embryonic stem cell research that he helped write.

Less than a year later, he was on Capitol Hill, telling a Senate committee about “the promise of embryonic stem cell research.” Two months after that, he helped pen an opinion piece in The Washington Post in support of congressional efforts to expand federal funding for such research, which President Bush restricted in August of 2001 because of ethical concerns.

Since then, the results of his efforts have been mixed. Though Bush vetoed the 2005 legislation, a Democratic Congress is now poised to once again to push ahead with federal funding for more than just the two dozen stem cell lines currently eligible to receive support from the federal government. The California Institute for Regenerative Medicine, the body created under Proposition 71, is also poised to award its first research grants, though it must rely on a loan from Gov. Arnold Schwarzenegger; the $3 billion in bonds remain mired in lawsuits.

Goldstein, who was appointed as the director of University of California, San Diego’s stem cell research program in September, reflected on the most recent developments in the field in a recent interview. His conclusion: Researchers have made tremendous progress since 2004, and more is on the way.

Can you tell me about your role in writing and passing Proposition 71 in 2004?

Well, there was a group of people that worked with Bob Klein to draft the language of the proposition. There [were] scientists, patients’ advocates, some folks who provided legal advice, and that led to the creation of the text.

What sort of developments in the field of stem cells have we seen since then?

Oh boy, there’s been a fair bit of progress, actually. Better understanding of cancer stem cells, ways of manipulating human embryonic stem cells, differentiating them into different stem cell types, making genetic changes that are useful for studying their behavior. There’s been a bunch of scientific progress.

You know, I think everyone wants rapid clinical progress — putting things into people. But there is a lot of very basic work that needs to be done before it’s even safe to do that. So if you’re looking for a homerun, where someone was cured of a disease, it’s far too early to be thinking about that yet.

And how far away are clinical trials and things of that sort?

Well, no one knows the answer to a question like that. It depends on the rate of scientific progress in the field.

There are companies that are trying to commercialize, who would like to initiate clinical trials with human embryonic stem cells. There’s an existing company called Stem Cells Inc. in clinical trials for Batten disease, using fetal-derived stem cells that just started up. You know, that will unfold in the next several years, and I think it’s too early to predict what things the [Food and Drug Administration] will let in, and at what rate.

How has the political climate surrounding this issue changed, both nationally and closer to home?

Well, it’s become more favorable. Even though President Bush vetoed H.R. 810 last year, it passed by overwhelming majorities in both the U.S. Senate and the House, it would have liberalized federal funding restrictions. Regrettably, the president decided to veto it, but the House of Representatives just passed a new bill, by an even bigger bipartisan majority than last year, and probably the same thing will happen in the Senate. So there’s definitely been progress; we’re not where we need to be yet, in my view, but there’s definitely progress in the dialogue.

A kind of a related topic, in recent months, there’s been two reports that seemed to alter the debate about the use of embryonic stem cells: One suggesting that stem cells can be extracted from a fetus without hurting it, and another arguing that stem cells in amniotic fluid could serve as an alternative.

Those are both wildly overblown. The first one, if you think about it, doesn’t solve the ethical debate whatsoever. Because, if you have a choice between extracting cells from an embryo that is going to be used for a pregnancy, versus extracting cells from an embryo that’s frozen, and is destined to absolutely be discarded, ethically, why would you even risk any possible damage to an embryo that may result in pregnancy? That doesn’t make any sense.

So it doesn’t solve the ethical debate.

What about the second, the amniotic fluid study?

It’s wildly over-interpreted. The evidence that those cells are potent is actually very poor, if you actually read the paper and look at the data. The evidence that they can make neurons and other stem cell types is not that strong. … Remember, science operates on the quality of evidence, not just the headlines. And the authors of that study, in fact, will tell you that they don’t think their work should be used as an excuse not to work on embryonic stem cell research.

It doesn’t change anything, except that opponents of the research seize upon this as a reason not to work with embryonic stem cells. And that would not be scientifically accurate.

In another paper that made the headlines, how significant was UCSD’s discovery that the federally approved stem cell lines were contaminated with animal cultures?

Well, everybody knew that from day one, that human cells are grown in a mixture with mouse cells, because mouse cells make the things that human cells need to grow. Not surprisingly, there are mouse-derived products in the human cells then. There are companies who claim that you can “adapt” the human cells to conditions where they have never been exposed to mouse cells, but nobody really knows what’s going to be required for clinical trials, whether it’s a fatal problem or not.

No matter what, it’s likely that all of the existing lines will turn out to be, well, I’ll use the word “inferior,” not as good as newer lines. It’s like software: The first release is never as good as the third release. The federal lines have always been, in terms of future prospects, inadequate, but we’ve been saying that for years.

A separate topic I wanted to ask you about is your role in this debate. I know that scientists usually try to stay out of politics and don’t like to appear partisan. Yet, on this issue, you have been very outspoken —

Well, let me correct a few things there. This is not about politics, this is about policy. So, when I speak out, I speak out about what’s scientifically accurate, and what are the implications of the highest quality scientific information. I’m absolutely nonpartisan. This is not a Democratic issue, this is not a Republican issue. Brian Bilbray, our local congressman is a Republican, and he’s been a very strong supporter of this. …

This is not Republican-Democrat, and it would be a mistake to characterize it that way.

How has the California Institute of Regenerative Medicine, the body created by Proposition 71 to oversee the research, performed so far?

Well, it hasn’t had enough money to perform. But what it’s been able to do on a shoestring budget is remarkable, I think. They’ve been able to build an administrative structure, judge grant applications and funding, they got training grants out, and I think they did a great job with that. And now they’re in the process of reviewing their first grant applications, funded with the governor’s loan. So I think they’re doing a terrific job. They’re not perfect, but no human institution is perfect.

Do you expect that the litigation over the constitutionality of the measure, at the end, will not be successful?

You’re asking for a legal opinion, and I’m not a lawyer. But from everything I’ve read — and that’s the same things you’ve read — suggests that. The initial Superior Court ruling was strongly in favor. And, of course, the initiative was written with expert legal advice about its constitutionality. So I’d expect that it’ll be fine, once it’s reviewed.

Has this had any effect on the state?

Well, it’s slowed the research down — it’s terrible. So what’s happened is that the legal challenge is wasting taxpayer money in a futile legal challenge that will probably, ultimately, be overturned. … It’s ridiculous: The opponents lost at the battle box, and now they’re trying to win in the courts.

What should we expect form research in this field in the near — and distant — future?

I’m very enthusiastic, and I think there is good reason to be enthusiastic, about the scientific and medical potential of the research in this arena. It is likely to lead to substantial changes to the ways we diagnose and treat human disease in the future. I think the only thing that’s really in doubt is the time — how difficult will the technical problems be and in what time scale will they be solved. But if history is any guide, this is a very powerful technology that has potential — no guarantees, there’s never any guarantees in the world — to be transformative.

— Interview by VLADIMIR KOGAN

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