[Note: There are some things that can be "balanced" - like public opinion and mathematical formulas - and some things that can't be "balanced" - like the objective scientific facts. It is unquestionably true that the grossly exaggerated promises of curing patients' diseases and other serious physical problems with "stem cell therapies" has been mostly "hype and hope" and a very cruel trick played on some of the most vulnerable among us. It is also true that the public needs "a more balanced understanding" of this "hype and hope" (to put it mildly). But isn't it just as unfortunate that the false science grounding this very "hype and hope" seems to be so invisible to such "balanced" researchers like Hall, this reporter, or that it garners any public scrutiny or challenge at all? Not a word about the false science involved in the California Proposition 71 campaign is mentioned. Why is it OK to flat-out falsify the science in order to get public support, but not OK to lie to prospective patients about how long it will take before such techniques achieve their goals - "if at all"?
To supplement this glaring void of public awareness and understanding of the use of false science behind California's Proposition 71 and similar legislative efforts by researchers and their supporters, I have inserted directly into the article below a few helpful references for several articles which contain extensive scientific documentation (in concert with the international nomenclature on human embryology) which demonstrate beyond a shadow of a doubt that the very scientific structure on which Proposition 71 - and its "hype and hope" -- was built is textbook wrong. The voting public, especially the patient and family victims of this cruel hoax, and the press should demand immediate answers from these researchers before a court of law - requiring legally binding sworn oaths that their "scientific" claims are true and accurate, as well as legally requiring the xerox copies of the pages from the relevant scientific textbooks which supposedly support their "scientific" claims to be provided to the court and to the public. Otherwise, the "hype and hope" will continue unabated. - Dianne N. Irving, Ph.D.]
(Irving comments in double-brackets; emphases added)
July 4, 2005
A Voice of Balance in Stem Cell Program
Dr. Zach W. Hall is one of our most distinguished scientists and experienced research administrators, with posts at USC's medical school, UC San Francisco, and the National Institutes of Health on his glittering resume.
He is also interim president of the state's new stem cell agency, the California Institute for Regenerative Research. So when St. Francis Memorial Hospital in San Francisco announced that the topic of his speech there last week would be "Stem Cell Research: Hope or Hype?" no one really expected him to accentuate the negative.
[[See original Lancet article on "hope or hype" at: http://www.thelancet.com/journals/lancet/article/PIIS0140673605666342/fulltext; see British Medical Journal article on "hope or hype" at: http://bmj.bmjjournals.com/cgi/content/full/330/7503/1285-a]]
But Hall has taken on an indispensable role since assuming his temporary post in March: the voice of balance. He has been quietly tempering the public's expectation that the $3-billion bond issue approved under Proposition 71 will yield instant medical therapies and cures.
Hall's talk Wednesday evening was a step in that direction. "Based on my experience as a laboratory scientist," he told me before taking the podium, "I know that to make an experiment work, we need to have someone in the lab who really believes in it — and someone who is a skeptic all the way."
Skepticism about the potential of stem cell research was wholly absent from the campaign for Proposition 71. As a scientific undertaking, the stem cell program is unique in that its sponsors, the state's voters, committed their money without receiving the slightest bit of professional scientific counsel. Before making a similar expenditure, any philanthropic foundation or university board would first seek advice from experts about the potential yield in knowledge from the effort, the obstacles ahead and the time frame required.
[[Acknowledgment of the false science grounding Prop. 71 was likewise missing, precluding an "informed decision" by the California voters. Note that a California judge rejected the false science used in the Prop. 71 campaign, in Irving, " Comments: California court rejects false science in Proposition 71" (Nov. 1, 2004), at: http://www.lifeissues.net/writers/irvi/irvi_54proposition71.html. Note too the false science used in Weissman et al's absurd claim that "therapeutic" cloning isn't cloning, that the product of sexual and asexual reproduction is just a bunch of stem cells, that "reproductive" cloning requires the birth of the "product" - and that now the term "stem cells" [unbeknownst to most California voters] includes Weissman's definition of stem cells derived from cloned human beings. See Irving: "Comments: 'The California 'Stem Cell' Initiative'" (Aug. 8, 2004), at: http://www.lifeissues.net/writers/irvi/irvi_06califopposescr.html; "What Human Embryo? Funniest Mental Gymnastics from Medicine and Research" (Oct. 14, 2004), at: http://www.lifeissues.net/writers/irv/irv_82whathumanembryo1.html; "Analysis: Stearns' Congressional Human Cloning Fairy Tale 'Ban'; New Age and Transhumanist Legislation for 'Converging Technologies'?" (Sept. 8, 2004), at: http://www.lifeissues.net/writers/irv/irv_77stearncloningtale1.html; "Playing God by manipulating man: Facts and frauds of human cloning" (October 4, 2003), at: http://www.mocatholic.org/uploads/IrvingCloning3.pdf, and http://www.lifeissues.net/writers/irv/irv_22manipulatingman1.html; and, "Playing God...; Appendix of Church teachings and the 'delayed personhood' ruse" (Oct. 4, 2003), at: http://www.lifeissues.net/writers/irv/irv_74churchteaching1.html.]]
California voters received, instead, a TV campaign promising cures tomorrow for a host of diseases, some of which may never respond to stem cell therapy. The professional cautions are only appearing now, after the money is committed. The shock of discovery that "tomorrow" may be 20 or 30 years away (or may never come) could be severe.
[[ See, "Health groups' funding faulted; Not-for-profit advocates often have strong ties to the drug industry" (June 26, 2005), Sacramento Bee, at: http://www.sacbee.com/content/news/projects/drugs/story/13132395p-13976434c.html; Irving, "Comments: 'Costly Cloning Isn't a Cure-All', or 'The Great Human Embryonic Stem Cell Fairy Tale Exposed'" (December 1, 2004), at: http://www.lifeissues.net/writers/irvi/irvi_49costlycloning.html.]]
Hall understands that sustaining public support requires, among other things, dialing back public expectations. The Proposition 71 campaign "tapped into an amazing reservoir of hope among California voters," he says, "but we need to make people aware of how difficult it is to bring a new therapy to the market."
[[They also need to make people aware of all the false science that has grounded this "hype" from the beginning - including the two laws also passed in California on human cloning and human embryonic stem cell research before the Prop. 71 campaign was launched. See Irving, "Analysis: California's Current Cloning Law Allows Both 'Therapeutic' and 'Reproductive' Cloning; Sets Up Arbitrary Regulatory Committee" (Oct. 26, 2004): http://www.lifeissues.net/writers/irv/irv_83californiacloninglaw.html
See also Irving: "Definitions of a "human organism" and a "human cell" (Oct. 3, 2004), at: http://www.lifeissues.net/writers/irv/irv_78definitions.html; "Human Cloning As Infertility 'Treatments'" (Oct. 10, 2004), at: http://www.lifeissues.net/writers/irv/irv_79cloninginfertility.html; "Scientific References, Human Genetic Engineering (Including Cloning): Artificial Human Embryos, Oocytes, Sperms, Chromosomes and Genes" (May 25, 2004), at: http://www.lifeissues.net/writers/irv/irv_25scientificrefer1.html; "Human Embryonic Stem Cell Research: Are official positions based on scientific fraud?" (July 1999), at: http://www.lifeissues.net/writers/irv/irv_18stemcell.html; "Open Letter to U.S. Catholic Church Hierarchy on Human Cloning and Human Embryonic Stem Cell Research"(February 20, 2004), at: http://www.lifeissues.net/writers/irv/irv_46openletter.html; "Analysis of Legislative and Regulatory Chaos in the U.S.: Asexual Human Reproduction and Genetic Engineering" (Oct. 20, 2004), at: http://www.lifeissues.net/writers/irv/irv_81chaosasexgen1.html.]]
In his speech, Hall described the challenges faced by researchers in this novel science. Embryonic stem cells are intriguing because they can differentiate into any of the specialized tissue cells of the body. This may allow scientists to culture healthy tissue cells in the lab to replace damaged ones in the human body. It may also give researchers a method of studying disease processes at the cellular level, yielding insights that could contribute to the development of other therapies.
But scientists don't yet fully understand how to control the differentiation process. Nor are they sure how well a patient's body will accept stem cell treatments derived from cells donated by a stranger, or whether the growth of implanted cells can be managed.
[[Because of the genetic differences in chromosomal DNA, stem cells derived from "foreign" embryo donors would cause rejection reactions in the patients. Because of the genetic differences in mitochondrial DNA, stem cells derived from human embryos cloned from the patient would also cause rejection reactions in the patients. This is well-known and publicly published even by those researchers in favor of "stem cell research". See Irving, "Playing God...; Appendix Church teachings and the 'delayed personhood' ruse" (Oct. 4, 2003), at: http://www.lifeissues.net/writers/irv/irv_74churchteaching1.html; and http://www.mocatholic.org/uploads/IrvingCloning3.pdf; Irving, "What Human Embryo? Funniest Mental Gymnastics from Medicine and Research" (Oct. 14, 2004), at: http://www.lifeissues.net/writers/irv/irv_82whathumanembryo1.html.]]
The course of cutting-edge science, moreover, is never smooth. Is the public prepared for the disappointments, reversals, and dead ends that invariably accompany the scientific method?
Hall says he believes that a crucial part of the stem cell agency's mission is public education, including admonitions that the journey from today's knowledge to clinically effective treatments is "a long, hard road."
In addition to listing some of the unknowns, he reminded his audience of the difficult histories of some other much-heralded and highly advanced medical technologies.
Recombinant DNA was the stem cell-style biomedical panacea of the 1960s and early 1970s.
[[Recombinant DNA gene transfer is a critical technique for doing genetically-modified somatic stem cell gene "therapies", as well as for germ line cell genetic engineering (eugenics). It was developed decades ago by Weissman's California mentor, Nobel Prize winner Dr. Paul Berg. It was Dr. Berg who was named as a defendant in the recent California law suit in his attempt to "justify" the false science grounding the two already passed California laws on human cloning and human embryonic stem cell research, as well as the on-going Prop. 71 campaign. The judge in that trial found against Dr. Berg et al based on excellent sworn testimony by a real scientific expert who debunked that "California science". See Irving, " Comments: California court rejects false science in Proposition 71" (Nov. 1, 2004), at: http://www.lifeissues.net/writers/irvi/irvi_54proposition71.html.]]
Three decades later, its promise remains uncertain and has been hampered by unseemly haste: In 1999, an 18-year-old patient with a metabolic disorder, Jesse Gelsinger, died after undergoing an experimental treatment as a volunteer. The case arguably set back the cause of gene therapy by years; it raised questions about the researchers' methodology and financial conflicts of interest, and drew out of the woodwork reports of hundreds of otherwise unpublicized adverse experimental events in the field.
[[See original Gelsinger lawsuit at: http://www.sskrplaw.com/links/healthcare2.html. Art Caplan, the chief bioethicist for the Univ. of Penn. Hospital, was also named as a defendant but charges were later dropped. See also: "Bioethics: Gene therapy business: the tragic case of Jesse Gelsinger", News Weekly (Aug. 12, 2000),at: http://www.newsweekly.com.au/articles/2000aug12_bio.html; Sheryl Gay Stolberg, "The Biotech Death of Jesse Gelsinger", New York Times, Sunday Magazine (Nov. 28, 1999), at: http://www.gene.ch/gentech/1999/Dec/msg00005.html; "Death but one unintended consequence of gene-therapy trial", Canadian Medical Association Journal 2001;164(11):1612, at: http://epe.lacbac.gc.ca/100/201/300/cdn_medical_association/cmaj/vol-164/issue-11/1612.asp.]]
Another eagerly anticipated technology — the manufacture of monoclonal antibodies, "magic bullets" that act on specific tumors or antigens — appeared in the mid-1970s. The first drugs were not approved for human treatment until 25 years later, and their efficacy is still under study.
Gene therapy and monoclonal antibodies didn't arrive with even a fraction of the hype surrounding embryonic stem cell research. Plainly, it will take a superhuman effort to resist public demands for hasty human experimentation and clinical trials of stem cell discoveries. The same emotional appeals that stoked public enthusiasm for Proposition 71 from patients in wheelchairs, parents of diabetic children, celebrities with Parkinson's — might be mustered in the future to get treatments into the marketplace before they're ready.
Hall's combination of confidence in the ultimate success of stem cell research and humility about the challenges lying ahead is the most encouraging sign yet that the stem cell program will be a credit to the state, not a boondoggle. He has indicated plans to step down from his post as soon as a permanent president can be appointed; one can only hope that when he departs the agency, his discretion and good judgment don't leave with him.
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