T Nation

Stem Cells

This is one of the most balanced articles I’ve seen on the stem-cell issue, and it gives a lot of facts on the controversy:

http://www.techcentralstation.com/092204A.html

Politics and the Debate Over Stem Cell Research

By Elizabeth M. Whelan and Henry I. Miller

Hot-button health issues during this frenetic political season include spiraling health care costs, importation of drugs from foreign countries, and the feds’ war on obesity. Rapidly heating up is the controversy over stem cell research.

On one hand, we have John Kerry and fellow Democrats portraying President Bush as, for ideological reasons, blocking advances in research and treatments for a range of debilitating diseases, including Parkinson’s, Alzheimer’s, heart failure, and some forms of cancer. Kerry’s message is that, if he is elected, the United States will be catapulted to world leadership in stem cell research, with a dazzling array of miracle cures (and saleable products) to show for it. “We’re going to lift the ban on stem cell research. We’re going to listen to our scientists and stand up for science. We’re going to say yes to knowledge, yes to discovery, and yes to a new era of hope for all Americans,” he promised in a radio address on August 7.

On the other, we have the president and many of his supporters arguing – seemingly from the campaign’s talking points – that the Bush administration was the first to provide funding for stem cell research.

Paradoxically, many of these same people remonstrate that the prospects for cures are grossly overstated, that federal funding is not needed, and that the real potential for finding cures lies not in embryonic stem cells (ESCs) but in applications of adult stem cells (ACSs). As Laura Bush said in dismissing as “ridiculous” Senator Kerry’s criticism of the administration’s policies: “We don’t even know that stem cell research will provide cures for anything – much less that it’s very close” to yielding major advances.

Stem cell research and therapy – particularly using embryonic stem cells – are, for many, highly emotive issues. ESCs are obtained via the destruction of early-stage embryos, and many social conservatives who object to this technology describe the technology using the inflammatory rhetoric of the debate over abortion, referring to “killing” and “tearing apart” babies, and “culling” their cells.

Such emotion and passion often lead partisans to obfuscate and speak in a kind of code. Far better, surely, for the critics of ESC research simply to say forthrightly, “I oppose this for religious and moral reasons” – which is clearly their right – and to forgo the quasi-scientific rationalizations.

It is curious, and also inconsistent, that embryo wastage in other contexts has been far less controversial (and also far less political). For decades in the United States and elsewhere, as part of treatment for infertility, embryos have been created and then destroyed, discarded, or kept frozen, when procedures fail or when another embryo leads to a successful pregnancy. Why don’t individuals who demand an end to embryonic stem cell research on the grounds that it “kills potential babies” object as strenuously to the destruction of embryos or their indefinite storage at fertility clinics?

Politicians on both sides of the aisle who are trying to use stem cell research for partisan advantage commonly misrepresent and confuse the issue.

Democrats would have us believe that miracle cures for debilitating diseases are right around the corner – if only the Bush administration would repeal its onerous restrictions. “Some of the most pioneering cures and treatments are right at our fingertips, but because of the stem cell ban, they remain beyond our reach,” Kerry said in August.

Republicans argue that potential ESC therapies are simply a mirage and that the Democrats are cruelly manipulating and deceiving desperate patients. Some, including Laura Bush, emphasize the early nature of ESC research, that no medicines have yet been derived from ESCs, and that no clinical trials are under way. “Embryonic stem cell research is very preliminary. . . The implication that cures for Alzheimer’s are right around the corner is just not right, and it’s really not fair to the people who are watching a loved one suffer with this disease,” said the First Lady in August.

The truth lies somewhere in between. Research is indeed in its infancy: Mouse ESCs have been induced to differentiate into a variety of blood cells but not yet the relatively immature ones that researchers want. Similarly, mouse ESCs have been induced to grow into nerve cells used to treat Parkinson’s disease in mice; the cells did produce the deficient chemical, dopamine, but not in amounts sufficient to reverse the disease. Nevertheless, and although successful therapies may be a decade or more away, most scientists conversant with the field believe that this technology offers enormous potential. Most technology goes through a phase in which the product or process is imperfect, often profoundly so. It is useful to recall that bone marrow transplantation was a dismal failure for about the first decade that it was used clinically.

Republicans claim that President Bush, the first American president to authorize federal spending on ESC research, is really a champion of the field.

Well, yes and no. On August 9, 2001, the president authorized federal spending on human embryonic stem cell research – but only on 64 cell lines which were then in existence (and only about 21 of which are currently available for research purposes). His supporters characterized this decision as a sound “compromise.” Actually, it was a better example of arbitrariness and inconsistency.

In essence, the president argued that, although he was against the use even of early embryos (which are about the size of the period at the end of this sentence) for research because it involved the destruction of human life, federal funding was OK for research using stem cell lines that had already been created from embryos for which “the life and death decision had already been made.” But if it is morally acceptable to use cell lines from embryos created before that somehow magical date of August 9, 2001, why is it not also right to use federal funds to create new stem cell lines from the estimated half-million unused embryos now relegated to the freezers of infertility clinics and slated for destruction? For these as well, the life-and-death decision has been made.

President Bush’s decision to ban federal funding of ESC research (except on existing lines) was based on his belief that embryonic cell research destroys life. But there is an inherent inconsistency here as well. If harvesting stem cells from an early embryo is truly tantamount to harvesting organs from a baby, then the morally responsible policy would be to ban it entirely, not simply to deny it federal funding. But – contrary to charges by the president’s political opponents – there is no ban, merely the prohibition on federal support of research on embryonic stem cell lines created after August 9, 2001.

On this issue, the president has lost some of his usual political allies, including conservative Republican stalwarts Senators Orrin Hatch and Trent Lott. Congressman Dana Rohrabacher (R-CA), who has a 100 percent rating from the National Right to Life Committee, intimates that he personally confronted the dilemma of what to do with spare embryos after his wife became pregnant with triplets through in vitro fertilization. He remains conflicted about what to do with his family’s unused frozen embryos, but says it would be a “horrible waste” to discard them rather than use them for research.

This issue blurs many of the usual polemical lines. Despite the Catholic Church’s firm objections to embryonic stem cell research, for example, an August Wall Street Journal/NBC news poll showed that many Catholics think that President Bush’s policy is either questionable (53 percent) or wrong (37 percent); a previous poll by the same organizations found that 72 percent of white Catholics favor stem cell research.

One strategy might have satisfied most stakeholders and also provided some political cover to President Bush on this issue. When he made his August 2001 policy announcement, the president could have surrounded himself with senior representatives of various philanthropic organizations (such as the Gates, Hughes, and Moore Foundations, for example) that, if they chose to, could fill the funding void for stem cell research left by the restrictions on federal funding. Money is fungible, after all, and these foundations are prodigious supporters of scientific and medical research, and sufficiently wealthy to pick up the slack in a single discrete scientific area. The federal government would thus have been able to claim the moral high ground (arbitrarily and artfully defined though it might be), and embryonic stem cell research would not have been hindered.

Democrats claim that if John Kerry is elected president, he will lift all restrictions on ESC research, putting us back in the race to produce medical miracles.

Actually, it is not quite as simple as that. In the New England Journal of Medicine, Dr. George Q. Daley observed that there exists “an even more restrictive element of government policy [than presidential edict that] prohibits the use of funds for the creation of a human embryo or embryos for research purposes” – namely, a piece of legislation known as the Dickey Amendment, passed in 1996 and renewed every year. Simply electing Senator Kerry will not, therefore, give the green light to such research. Congress bears much of the responsibility for retarding research; thus, President Bush should not be the sole target for criticism, although currently he is perceived as occupying a position of leadership on the issue.

Some commentators who clearly have a moral objection to using ESCs are now aggressively promoting the idea that adult stem cells (ASCs), rather than those from embryos, offer the greatest hope for cures. (Indeed, ASCs are already being used experimentally to treat some blood disorders, leukemias, and other conditions.) Some advocates of this position even accuse the Democrats and their allies in the media of suppressing reports of ASC successes and hyping those derived from ESC research. But why exactly would one reject ASC research if it has such great potential? (Perhaps to keep a political football in play?)

Again, there is some truth on both sides. The NIH acknowledges that ASCs have recently shown greater flexibility or “plasticity” (the ability, under the right conditions, to differentiate into a variety of cell types) and, thereby, to exhibit more therapeutic potential than demonstrated previously. But the NIH also argues that ASCs are more likely to have DNA abnormalities than embryonic ones and may be more difficult to isolate and purify, and that embryonic cells are thought to have much greater developmental potential than adult stem cells.

The NIH’s answer to the controversy over adult versus embryonic stem cells is that we should “simultaneously pursue all lines of research to determine the very best sources of these cells.” In other words, instead of arguing about which type is better on the basis of insufficient data, we should pursue research using both, an approach that we find sensible. Competition in medical research, as in commerce, is constructive.

Some on the right of the political spectrum argue that the private sector, not the federal government, should fund expanded ESC research. Certainly, there is a major role for private investors and other funders, especially as the developments in the field move closer to commercial products or processes. But the reality is that, for decades in the United States, fundamental, pre-commercial scientific research of this sort has been dominated by funding from the National Institutes of Health; and if the United States is going to compete in the worldwide race to find stem cell-based cures, NIH funding (or, as suggested above, private foundations’ picking up the shortfall) will likely be necessary. If there is consensus, or near consensus, among American scientists (and there surely seems to be) that both adult and embryonic stem cell research offer enormous potential to improve the lives and health of Americans, scientists in this country should not be held back. In the face of uncertainty, we advocate a course that offers the real possibility of palpable benefit to large numbers of actual – not potential – people.

We are not so naive as to expect that this continuing debate will lead to a convergence of views, but we would plead for a greater degree of candor, clarity and consistency in discourse. Given the stakes, is that too much to ask?

Elizabeth M. Whelan, Sc.D., M.P.H., is president of the American Council on Science and Health. Henry I. Miller is a physician, fellow at the Hoover Institution, and the author, most recently, of “The Frankenfood Myth: How Protest and Politics Threaten the Biotech Revolution” (Praeger, 2004).

Here is info on the Dickey Amendment, which is mentioned in the article above. The info comes from the Daly article in the New England Journal of Medicine cited in the article above:

http://content.nejm.org/cgi/content/full/351/7/627

[Begin excerpt]An even more restrictive element of government policy prohibits the use of funds for “the creation of a human embryo or embryos for research purposes; or . . . research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death.” Proposed in 1996 by Representative Jay Dickey (R-Ark.) as a rider on the appropriations bill for the Department of Health and Human Services and renewed every year since, the Dickey Amendment prohibits federal engagement in a field of research pertaining to the nature of the human embryo, its disorders of development, and the derivation of new human embryonic stem-cell lines. Although most embryos created in vitro during fertility procedures are deemed unsuitable for pregnancy and are discarded, federal funds may not be used to ascertain what went wrong. Such studies, beyond improving the efficacy of fertility treatments, offer promise for understanding many chromosomal and developmental disorders that originate in the early embryo.

The Dickey Amendment prohibits federally funded scientists from deriving lines that model human disease. The use of somatic-cell nuclear transfer to generate pluripotent lines from patients with disorders such as schizophrenia, Alzheimer’s disease, amyotrophic lateral sclerosis, and diabetes offers new strategies for unraveling the pathophysiology of these conditions, and the derivation of lines from patients with genetic diseases such as sickle cell anemia and immune deficiency hold promise for combining gene therapy with autologous cell-replacement therapy. [End excerpt]

Because they were created using mouse eggs, none of the stem cell lines that Bush has allowed to be federally funded is fit for use in human beings, because of the potential for cross species contamination. I wonder why noone mentions that.

[quote]Sifu wrote:
Because they were created using mouse eggs, none of the stem cell lines that Bush has allowed to be federally funded is fit for use in human beings, because of the potential for cross species contamination. I wonder why noone mentions that.[/quote]

Sifu –

You’ve said this twice, but I haven’t seen it anywhere else – surprising, given it would be a good criticism of Bush. What’s your source on this?

Awesome article BB. I don’t know if I’ve ever seen a more balanced look at things…

http://www.mercurynews.com/mld/mercurynews/entertainment/books/9825155.htm?1c

Posted on Sun, Oct. 03, 2004

Getting the facts on stem cells

By Lynn Yarris

Special to the Mercury News

The Bush administration has severely restricted stem cell research. A Kerry administration would greatly expand it. Supporters can call on Nancy Reagan. Opponents have Laura Bush on their side.

In November, Californians will vote on Prop. 71, the California Stem Cell Research and Cures Act, which would authorize an average of $295 million per year in bonds over the next 10 years to fund stem cell research in California. Since facts often get buried under rhetoric, how are responsible voters to draw reasonable conclusions?

Advocates of stem cell research will tell you that the terrible suffering and death rendered by heart disease, cancer, stroke, HIV-AIDS, Alzheimer’s and Parkinson’s disease, cystic fibrosis, diabetes and a multitude of other afflictions could be greatly eased, if not completely eradicated, by the almost magical potential within these tiny master cells. Even male pattern baldness might be reversed.

With all that potential, why is the federal government investing only a pittance (about $25 million under President Bush, equivalent to the reward it was offering for the capture of Saddam Hussein) into stem cell research? Because there are those who argue that such research is immoral.

Most of the cells in the human body are specialists assigned to a specific organ or type of tissue: heart, skin, breasts, liver, kidneys, etc. Stem cells are different. When they divide, they can produce either more stem cells, or they can produce just about any type of specialized cell. Hence the name, because so many types of specialist cells can stem from them.

If one could direct the fate of stem cells, that is, the specialized type of cell they become, the extrapolated mature cells could be transplanted into a problem area, where, if all went according to plan, they would overcome substandard, diseased cells, and lead to healing and recovery,'' Ann B. Parson writes inThe Proteus Effect.’’

For medical researchers, the ideal stem cells are found in four-day old human embryos (blastocysts). For a sense of proportion, a blastocyst is about the size of the period at the end this sentence. Human embryos that could be grown into blastocysts are in plentiful supply thanks to in vitro fertilization (IVF) technology. A 2003 survey of fertilization clinics in the United States counted nearly 400,000 IVF frozen human embryos, a number that is rapidly rising.

According to experts cited by Parson, at least 10 percent of these embryos will never be used. Researchers could develop this surplus into a source of stem cell lines. However, when stem cells are removed from an embryo, the embryo dies. If you view a blastocyst as a potential human life, this poses a serious moral issue.

Parson quotes from a letter the Rev. Joseph Fiorenza, president of the National Conference of Catholic Bishops, wrote to Congress in 2001: ``The claim that destructive embryo research will achieve a utopian end is, we believe, a hollow promise. In the meantime, however, the killing will be quite real.’’

On the other side, Parson cites prominent scientific leaders who argue that calling a blastocyst a human being is like calling an acorn an oak tree.

On Aug. 9, 2001, Bush announced an executive decision that federally funded stem cell research would be limited to the 78 embryonic stem cell lines already in place worldwide. Bush’s defenders correctly note that this is not a complete ban on stem cell research. However, as Parson points out, a report issued by the National Institutes of Health says that of those original stem cell lines, fewer than 20 are currently available for research, and, as all have been grown with mouse feeder cells, their use in humans is ruled out.

Furthermore, as Parson makes clear, there are some ``positively gargantuan’’ obstacles facing stem cell medicine. Scientists must learn how to rapidly grow embryonic stem cells to therapeutic quantities (it currently takes up to two days for an embryonic stem cell to double), coax them to convert into a desired specialized cell and transplant them to a problem area in a patient. Then there is perhaps the biggest question of all with regards to stem cell medicine.

If you go to the trouble of substituting healthy cells for diseased cells,'' Parson says,what guarantee is there that the new cells won’t suffer the same fate as the old cells?’’

The consensus is that it will take the development of hundreds, if not thousands, of new stem cell lines for the promise of stem cell medicine to be realized. There are already efforts to create human blastocysts using skin cells, or some other alternative to human eggs.

Parson does a thorough and thoughtful job of discussing the potentials of stem cell medicine and the challenges, both scientific and political, that it is facing. By providing readers with enough solid information to make up their own minds on stem cell research, ``The Proteus Effect’’ should have a pretty good legacy of its own. It may well be the most important science book of the year.

THE PROTEUS EFFECT: Stem Cells and Their Promise for Medicine

By Ann B. Parson

Joseph Henry Press, 304 pp., $24.95

http://www.biomedcentral.com/news/20031205/05/

December 5, 2003

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US stem cell researchers chafe
NIH Chief Zerhouni’s comments on adequacy of available lines questioned | By Merrill Goozner

US stem cell researchers are questioning last week’s assertion by National Institutes of Health director Elias Zerhouni that the embryonic stem cell lines that have been made available to government-funded researchers are sufficient to meet their needs.

Zerhouni’s comments came in response to a recent study by a panel of medical ethicists, which suggested the 78 approved lines, a dozen of which are now available for use, will never be used in human clinical trials. The main concern expressed by the panel, which was organized by Johns Hopkins University and included scientists, philosophers, and lawyers, was that human embryonic cells that have been amplified with murine feeder layers might contain unrecognized contaminants.

Zerhouni said those concerns were overblown since no research has yet shown stem cells will be medically useful. Moreover, the Food and Drug Administration has said it has adequate guidelines for human safety in clinical trials that can be applied to those lines, he said.

?The feeling in the [stem cell research] community is that both those arguments are weak,? John Gearhart, a professor of medicine at the Institute for Cell Engineering at Johns Hopkins Medical School and developer of one of the world’s first human embryonic stem cell lines, told The Scientist. ?It’s clear no one will use those lines in humans.?

The biggest fear among researchers is that mouse-fed cell lines, which include all the lines approved by President Bush’s August 2001 edict, may contain unidentified retroviruses that can cause havoc if they cross species. ?Probably none of those cell lines should go into clinical studies,? said Eugene Redmond, director of the Neural Transplantation and Repair Program at Yale University School of Medicine. ?Why spend money and waste time with a cell line that you’re not going to be able to use for therapy??

Instead, the more ambitious researchers in the field are looking for alternatives to government funding so they will not be limited to its approved cell lines. Harvard biologist Douglas Melton, whose two children suffer from type I diabetes, announced at a major stem cell research conference held in Singapore in late October that he has developed 17 new embryonic cell lines that used human feeder layers. He has agreed to share the lines with other researchers.

His work on those lines, which were derived from embryos discarded by fertility clinics, was funded by the Howard Hughes Medical Institute and the Juvenile Diabetes Research Foundation. ?I am hoping that by providing more stem cell lines without restrictions, we will encourage more research in the stem cell field,? he told the conference. Transplanting pancreas islet cells made from human stem cells may one day free diabetes sufferers from taking insulin or risking organ transplants and their attendant immunosuppressive drugs.

Redmond told The Scientist that he would like to have ?one or more? of the lines cited by Zerhouni. ?But I couldn’t use any of the resources in my other (government-funded) stem cell programs,? he said. ?I would have to find another source of money.? The US government is spending only $30 million per year on stem cell research, and stem cell research isn’t far enough advanced to draw much attention from the biotechnology or pharmaceutical industries.

The Bush administration’s continuing restrictions are feeding a brain and resource drain, other researchers warned. The Singapore conference where Melton unveiled his new cell lines was called to highlight that island’s growing investment in stem cell research as a way of boosting its biotechnology industry. One of the conference’s other major surprises was a decision by the New York?based Juvenile Diabetes Research Foundation to invest $3 million in the Singapore program.

The University of California at San Francisco, which lost senior researcher Roger Pedersen to Cambridge University in the United Kingdom in the immediate wake of the Bush decision, this past October announced a major grant from a private philanthropist to shore up its stem cell research program. ?Without private support, this nation’s leading researchers are drawn to continue their research elsewhere,? said Jeffrey A. Bluestone, the interim director of the school’s Developmental and Stem Cell Biology Program.

[quote]BostonBarrister wrote:

Sifu –

You’ve said this twice, but I haven’t seen it anywhere else – surprising, given it would be a good criticism of Bush. What’s your source on this?[/quote]

Sifu’s right and wrong, Thomson’s original paper, (Science, vol. 282 p1145-1147 Nov. 6, 1998) describes the culture method as being similar to primate ES Cells (he cites his own work and I don’t know that one off the top of my head). And it does require the stem cells to be cultured in the presence of other cells, otherwise, the ES cells contact a plastic surface, initiate signals and start differentiating. Mouse fibroblasts appear innocuous enough to prevent differentiation. This data, imho, changes nothing about the debate, the cell lines are inviable for human use/clinical trials, and not much else. Research progresses everyday with “for research purposes only” stickers all over everything, for just that reason. What will eventually happen is someone will show a viable use for the stem cells and then they will have to prove to the FDA that they can effectively (arguable) and safely (arguable) separate their ES cells from mouse fibroblasts and retain viability. Current lines won’t enter clinical trials (even if they were viable for clinical trials, they may or may not survive the rigors of trials) future lines may (depending on the politics) either way, it’s a moot point in the stem cell debate.

The self-reference I forgot:
Proc. Natl. Acad. Sci. 92 (17): p7844-7848 AUG 15 1995.

As you may or may not know, the flu vaccines everyone gets are cultured in chicken eggs (if you have an allergy, you can’t get them). Anyway, there’s a concern about Contamination in some of Chiron’s vaccine. In this case the risk/benefit ratio is smaller than those claimed by ES cell proponents.

[quote]Democrats would have us believe that miracle cures for debilitating diseases are right around the corner – if only the Bush administration would repeal its onerous restrictions.
[/quote]

To paraphrase John Stewart on the Daily Show, “It could take YEARS for stem cell research to find cures for deadly diseases… so why start now?”

That’s some good stuff, Lumpy. Anybody who gets in the way of my test tubes pisses me off! I think congress made a big mistake by limiting stem cell research in any way. You just know it was a knee-jerk reaction to the thought of “fetuses” being useful for something. I can’t blame them, I guess. The republican base is largely pro-life, so they have to pander to them a little bit.

[

To paraphrase John Stewart on the Daily Show, “It could take YEARS for stem cell research to find cures for deadly diseases… so why start now?”
[/quote]

Ah, Lumpy, you’ve made me laugh at work again, that’s the 3rd or 4th time this week. Keep it comin’.