2008 Archive

Human Embryonic Stem Cell Research: What if?

Human Embryonic Stem Cell Research:
What if?

Date: May 03, 2007
Time: 10:43am est

As stated by Dr. Story Landis , Chair of the NIH Stem Cell Task Force, before the Senate HELP and Appropriations subcommittee in January of this year, under the current Bush policy, since 2001, the NIH has invested nearly $3 billion on all forms of stem cell research, $130 million of which as gone to human ESC research.

I have heard advocates of human ESC research argue that this relatively small amount of funding (often erroneously referred to as a "ban" on federal funding) is the principle reason why human ESC research is still many years, if not decades, away from even the first human trials with ESC-derived tissues. (At present multiple reasons preclude FDA approval of human trials at this early stage of the research, not least among them the danger of tumor formation).

So the big 'what if' is: What if every penny of the $3 billion had gone exclusively to human ESC research? Would we be any closer today to clinical trials with human subjects using human ESC-derived tissues?

Now, history has demonstrated time and again that we humans are quite inept at predicting the future. Similarly, we have often demonstrated a poor capacity for learning from our past. But I couldn't help asking this very question to some leading stem cell scientists the other day, both advocates of ESC research and opponents, all of whom I trust for their honesty and forthrightness. Some expressed cautious optimism about where ESC research would be today if it had been funded more aggressively, but usually with a quick qualifier to the effect of "there would still be lots of hurdles." Westchester Institute senior fellow and board member of the International Society for Stem Cell Research Dr. Markus Grompe , was emphatically less optimistic: "I am sure that we would still be years away from human trials," he affirmed. "No question about this."

Now, as it turns out, there is in fact a place where three billion dollars is going to be spent almost exclusively on human embryonic stem cell research: California . Remember 'Prop 71' which Californians adopted in 2004? It created the California Institute for Regenerative Medicine (CIRM) with the pledge of $3 billion in state funding over 10 years for human ESC research. Although tied in knots for the past two years by legal challenges, the CIRM was recently able to award its first grants thanks to a bailout loan by Gov. Schwarzenegger.

So, does the CIRM think that in ten years, funded to the tune of three billion dollars, it will be able to deliver clinical trials with ESC-derived tissues using human subjects?

As a matter of fact, the answer is 'no'.

The CIRM's 10-year plan, released last December, is exceedingly cautious in its prognostications and stated objectives-much to the disappointment and dismay of many a 'Prop 71' advocate who three years ago had enjoyed the ride on the "cures tomorrow" bandwagon.

As reported in the Los Angeles Times last December, the CIRM's ten-year plan clearly states that "it is unlikely that the CIRM will be able to fully develop stem cell therapy for routine clinical use during the 10 years of the plan." And CIRM president Zach Hall was quoted as saying, "We picked a goal that we thought was realistic, that, with some luck, would be achieved." So, even with billions of dollars-and "some luck"-over ten years, as stated in the ten-year plan, a group of the world's top stem cell scientists hope only "to show evidence that cell replacement therapy using derivatives of human embryonic stem cells is effective for at least one disease."

Given the degree of hype that has buoyed the cause of human ESC research in public opinion, this sets the bar amazingly low.

The other stated objectives reinforce the idea that most of the CIRM's energies will be spent on understanding the "fundamental biology" of stem cells, and also concedes that monies can and should be directed toward funding research on adult and umbilical cord stem cells.

And then follows the disclaimer:

CIRM faces high expectations for therapeutic results. The public has very high expectations for CIRM, particularly with respect to the time required for the development of new therapies. However, these expectations may not align with timelines required for the development and approval of such therapies. While CIRM has set high goals for itself and will strive to meet the public's expectations, it will be critical that it helps the public understand the nature of the challenges associated with the development of therapies and cures for disease, so that these expectations may be tempered as appropriate.

Now, from the fact that ESC-derived therapies are probably decades away, it does not follow that human ESC research should therefore be abandoned. That conclusion follows, rather, from the fact that embryo-destructive stem cell research is immoral to the extent that it would endanger, damage, or destroy embryonic human lives. And while it is exceedingly difficult to predict the future of embryonic stem cell research, it is surely a lesser challenge to learn from our past, and to understand why we ought to reject a moral calculus that some of our forebears indulged: an ends-justify-the-means exploitation of vulnerable human lives. That's had a sad history, but it still not too late to apply its lessons to our shared human future.

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