Clone The Truth

Clone The Truth: a campaign committed to ensuring that the truth about adult and embryonic stem cell and related research is made known, and that factual errors and bias in the media regarding stem cells are elucidated and corrected.. Posts in this category pertain to this campaign and also to ensuring that the deceptively worded and ill-advised Missouri Constitutional Amendment 2 is repealed.

The Vatican and Stem Cells: A Tale of Two Headlines

Filed in Religion, Science, Social IssuesTags: Christianity, Clone The Truth, Cloning, Media Bias, Sanctity of Life, Stem Cells

The Vatican recently issued a statement on bioethical issues, entitled Dignitas Personae (The Dignity of the Person), which serves as the authoritative ruling for the Catholic Church in condemning, among other things, embryo-destructive stem-cell research and human cloning.

The foundational tenet for the ruling is, as astute readers may surmise, the inherent dignity of the human being. The statement makes this point explicit in its opening sentence (pg. 1 of 23):

The dignity of a person must be recognized in every human being from conception to natural death.

The statement attempts to differentiate between human dignity, which has inherent moral value, and scientific research, which does not have inherent moral value apart from the moral implications of the applications of that research. The statement goes so far as to reiterate the church's support for and participation in such research (pg. 2 of 23):

The church therefore views scientific research with hope and desires that many Christians will dedicate themselves to the progress of biomedicine and will bear witness to their faith in this field.

Having made clear this differentiation, the statement lays out the foundation of its ruling: 1) all human life has inherent dignity and moral worth, 2) life begins at conception, therefore 3) human life at the embryonic stage of development deserves all the dignity and respect due human life at all other stages of development (pg. 3 of 23):

The body of a human being, from its very first stages of development, can never be reduced merely to a group of cells. The embryonic human body develops progressively according to a well-defined program with its proper finality, as is apparent in the birth of every baby.

It is appropriate to recall the fundamental ethical criterion expressed in the Instruction Donum Vitae in order to evaluate all moral questions which relate to procedures involving the human embryo: 'Thus the fruit of human generation, from the first moment of its existence, that is to say, from the moment the zygote has formed, demands the unconditional respect that is morally due to the human being in his bodily and spiritual totality. The human being is to be respected and treated as a person from the moment of conception; and therefore from that same moment his rights as a person must be recognized, among which in the first place is the inviolable right of every innocent human being to life.'

From this foundational position, the statement makes the logical conclusion that embryo-destructive pursuits (including embryonic stem cell research) are immoral.

So, given this position, I would expect a headline such as "Vatican document condemns cloning, stem cell research", just as a matter of course. But how do the ostensibly upstanding journalists at the Honolulu Advertiser portray the ruling? Why, "Vatican condemns modern science research", of course.

Contrast that gem of journalistic integrity with the (Minneapolis/St. Paul) Star-Tribune's take: "'Dignity of a person' reinforced in Vatican bioethics document."

Well now, that sounds just a little bit more accurate.

Rubin’s Most Recent Libel of ESC Opponents

Filed in Politics, Science, Social IssuesTags: Clone The Truth, Cloning, Media Bias, Missouri, Sanctity of Life, Stem Cells

There are lies, damn lies and anything uttered by Donn Rubin.

--Mark Twain, paraphrased

Missouri Coalition for Lifesaving Cures (sic) chairman Donn Rubin has already proven himself to be a spin master, but his latest screed is downright slanderous.

In this op/ed piece (h/t Secondhand Smoke), Rubin lauds recent advancements in stem cell research, in which differentiated (adult) stem cells have been induced to revert to a pluripotent (i.e. "embryonic") state. He then goes on to claim that Missourians who oppose embryonic stem cell and cloning research (actually, he refers to such opponents as "stem cell research opponents" - as usual, intentionally obfuscating the difference between research with adult and embryonic stem cells) would have stood in the way of the research that led to these advances.

I think now is as good of a time as any for a good, old-fashioned, paragraph-by-paragraph fisking of Dehr Spinmeister.

Anti-stem cell groups would deter successes.

I defy Rubin to identify even one "anti-stem cell group." To my knowledge, no such group exists. If it does, it is by no means mainstream, and is certainly no credible threat to ESC proponents in Missouri.

Missouri Coalition for Lifesaving Cures lauds the stem cell advances occurring around the world as tremendous steps in medical science's ongoing battle to cure disease, and we eagerly await further discoveries as scientists continue the ethical exploration of this new medical frontier.

An excellent example is last month's widely covered advances in Wisconsin and Japan where scientists were able to reprogram an ordinary skin cell to assume much of the versatility of embryonic stem cells. And, even more recently, this month scientists in London used embryonic stem cells to develop a stem cell "patch" to repair scar tissue from heart attacks and American scientists used embryonic stem cells as a novel way to test the safety of drugs.

As the Secondhand Smoke post points out, the development of the "stem cell 'patch' to repair scar tissue from heart attacks" was in a Petri dish only.

All of these advances demonstrate how important Missouri's constitutional protections are, ensuring that our patients and families have the same access as other Americans to whichever approaches prove most successful and lead to the best medical treatments and cures.

Amendment 2 provided no meaningful protection for either the research that led to these advances nor for any potential treatment derived from them. Neither the research nor derived treatments were or have been threatened. The debated has always concerned Somatic Cell Nuclear Transfer (SCNT, a.k.a. cloning) in order to create viable human embryos for the express purpose of being destroyed in order to harvest pluripotent, embryonic stem cells. The research Rubin cited did not involve anything in that debate.

Moving on - all that was just Rubin's wind-up; now we get to his screwball:

If stem cell research opponents had their way, none of this outstanding science would have been possible. Ironically, they would have blocked the very groundwork that led to the technique they now seem to embrace — the reprogramming of ordinary skin cells into embryonic-like stem cells.

Again, there are no such "stem cell research opponents" but rather opponents of human cloning and embryo-destructive research. In fact, many of us in that camp have very adamantly expressed that we must center our debate not on the ethical nature or efficacy of research involving embryonic stem cells themselves, but rather on the ethical nature and necessity of human cloning and the destruction of viable human embryos for the purpose of that research.

Further, "reprogramming of ordinary skin cells into embryonic-like stem cells" in no way involves either human cloning or the destruction of viable human embryos; rather, it involves induction of a normal, differentiated skin cell into a pluripotent state.

But Rubin doesn't stop there:

For years, anti-stem cell groups in Missouri have discounted the unique lifesaving potential of embryonic stem cells, dismissing evidence presented by the vast majority of leading medical and patient organizations. We're glad to see that they are beginning to accept this lifesaving potential.

(Still waiting for Rubin to identify one of these "anti-stem cell groups in Missouri"...) To the contrary, we have not "discounted the unique lifesaving potential of embryonic stem cells" - with the exception of the uniqueness of that potential. Again, we do not oppose research involving pluripotent (even embryonic) stem cells; rather, we oppose the cloning and/or destruction of human life in order to obtain those stem cells.

As for the "unique lifesaving potential" of ESCs, if that potential had been demonstrated sufficiently, the research would have support from the normal means of funding: the private sector; however, the private sector has indicated - by virtue of the direction of its funding - that it believes in the potential of adult stem cell research. Ironically, it is Rubin and his ilk that continue to ignore and discount the future potential and already proven efficacy of adult stem cells.

They may have joined the bandwagon in celebrating a single technique, but they fail to acknowledge that the advance with reprogrammed cells was merely an initial step that can only achieve its medical potential through additional embryonic stem cell research. The scientists who led these advances, James Thomson of Wisconsin and Shinya Yamanaka of Japan, have stated clearly and unequivocally that all stem cell research must continue. It would be a tragedy if their successes were misused to cut off other important avenues of medical research.

Rubin makes absolutely no sense here. Why would research that neither started nor ended with embryonic stem cells require "additional embryonic stem cell research"? And Rubin outright lies about Yamanaka's beliefs on the subject of continued embryonic stem cell research. This International Herald-Tribune article (h/t ProLifeBlogs) quotes Yamanaka (emphasis added):

Yamanaka was an assistant professor of pharmacology doing research involving embryonic stem cells when he made the social call to the clinic about eight years ago. At the friend's invitation, he looked down the microscope at one of the human embryos stored at the clinic.

The glimpse changed his scientific career.

"When I saw the embryo, I suddenly realized there was such a small difference between it and my daughters," said Yamanaka, 45, a father of two and now a professor at the Institute for Integrated Cell-Material Sciences at Kyoto University. "I thought, we can't keep destroying embryos for our research. There must be another way."

And again (emphasis added):

He said he had never handled actual embryonic cells himself, and the American lab uses them only to verify that the reprogrammed adult cells are behaving as true stem cells. "There is no way now to get around some use of embryos," he said."But my goal is to avoid using them."

Far from having stated "stated clearly and unequivocally that all stem cell research must continue," Yamanaka clearly and unequivocally wants to eliminate the need for the use of embryos for stem cell research - in fact, by his very words, it is his goal. Rubin's misuse of Yamanaka's research advances and intent in order to bemoan the alleged misuse of those advances moves beyond irony into audacity. It is simply beyond the pale for Rubin - who repeatedly dismisses embryos as "cells in a Petri dish" - to mis-characterize the intent of Yamanaka - who has stated that he sees little difference between a research embryo and his own daughters.

Not only has Rubin no respect for the sanctity of all human life, but he also has no shame.

In the following statement, Rubin hoists his over-used canard, in this case, a tripartite reiteration:

If those seeking to repeal Missouri's constitutional stem cell protections get their way now, they would block the important research required to bring the new technique to its full lifesaving potential.

Those whose aim it is to ban all embryonic stem cell research in Missouri cannot have it both ways. They cannot continue to oppose the very research that is required to achieve the lifesaving goals that they now claim to embrace.

Those who threaten to repeal Missourians' access to stem cell research should step back and allow scientists to conduct the work necessary to achieve the goals that I hope we all share — to cure disease and improve the lives of patients and families.

There you have it: Rubin's imagined opponents desire to "repeal Missouri's constitutional stem cell protections," to "ban all embryonic stem cell research in Missouri," and to "repeal Missourians' access to stem cell research."

We've covered this one, but one more time, for the sake of thoroughness: we do not wish to repeal Missouri's constitutional stem cell protections (per se - I have no problems with protecting stem cell research, though I don't believe such an issue has any place in a state constitution; it is a constructionist matter, not a moral one). We do, however, wish to repeal Missouri's constitutional protection of human cloning. Further, the repeal of that protection would in no way whatsoever impact research such as Dr. Yamanaka's, since his research neither began with nor resulted in an embryonic cell of any kind - much less, one procured through the destruction of a cloned human embryo.

Neither do we wish to ban all embryonic stem cell research in Missouri. We do wish to ban all human cloning, and oppose the destruction of human embryos for such research. Further, we oppose public funding of such research - and therein lies the key issue, and the Stowers (and other ESC researchers) cannot get sufficient private-sector funding, and want the government to foot the bill.

Likewise, we in no way wish to repeal Missourians' access to stem cell research. We fully support research involving adult stem cells, and any other research not involving the destruction of human embryos. We also support their right to seek private funding for whatever legal research they wish to pursue.

Rubin shows his usual lack of honesty and forthrightness; however, in this piece Rubin displays outright slander of his "opponents" and an intentional misrepresentation of Dr. Yamanaka's intentions.

Donn Rubin is a liar. I only wish I could see what Mark Twain would actually have said about him.

Follow-Up to Matt Franck Anti-Cloning Measure Article

Filed in Politics, Science, Social IssuesTags: Clone The Truth, Cloning, Media Bias, Missouri, Sanctity of Life, Stem Cells

About a week ago, I wrote about this Post-Dispatch article, written by Matt Franck. I discussed the perceived bias in the article with respect to Amendment 2 and the efforts of supporters of the HJR11 anti-cloning measure the article discussed.

As I try to do whenever I discuss someone's writing, I emailed the author to let him know of my blog post, and to allow (and to solicit) a response. To my pleasant surprise, Mr. Franck responded to my email. In the interest of fairness, based upon his response, I would like to re-visit the question of bias in his reporting of the Amendment 2 issue.

Mr. Franck responds:

My ability to respond to your email in detail is limited by time. But let me reply in brief. The stated aim of lawmakers who support HJR11 and its Senate counterparts is to essentially negate Amendment 2. Yes, I understand that the proposal doesn't mention the amendment. But the fact remains, it would make SCNT illegal -- something specifically protected under Amendment 2, and a procedure at the heart of the push to pass the ballot measure.

Here, I agree with Mr. Franck that part of the underlying intent of HJR11 was to overturn parts of Amendment 2; however, the further intent of HJR11 was to expose the intentional deception and hypocrisy of Amendment 2 and that of its supporters and their $30 million propaganda campaign.

The Coalition for Lifesaving Cures states "Fact #3" on their "Fact Sheet" that "Amendment 2 clearly and strictly bans any attempt to clone a human being.":

Amendment 2 bans human cloning and makes any attempt to clone a human being a felony crime. Opponents of stem cell research claim that making stem cells in a lab dish is the same thing as "human cloning." Medical experts and most other people disagree with that view and understand that "human cloning" means creating a duplicate human being – not making stem cells in a lab dish.

The truth of the matter - as exposed by Amendment 2 supporters' objections to HJR11 - is that, currently, (embryonic) stem cells cannot be made "in a lab dish"; they must be harvested from an embryo. To date, stem cells must be harvested from embryos resulting from natural or in vitro conception. The comment about "making stem cells in a lab dish" is in reference to embryos produced via Somatic Cell Nuclear Transfer (SCNT) - or, in other words: cloning.

The issue centers around the correct identification of the entity produced by SCNT. Biologically and genetically, that entity is an embryo, genetically identical to the donor of the somatic cell from whom the clone was produced. In fact, for the purposes of harvesting stem cells from the entity resulting from SCNT, that entity must prove to be a viable embryo that undergoes self-directed development from the initial single-celled zygote into a 5-7 day-old embryo at the blastocyst stage.

The Coalition continues to divert this issue by intentionally mis-identifying this entity as a "clump of cells", a "ball of cells", or other similar terms. Doing so provides a means to avoid the reality that SCNT produces a cloned embryo. Thus, they are able to ignore the biological and genetic reality, and claim some arbitrary "birth of a cloned human" as the "cloning" that is "strictly" banned.

The media coverage - for whatever reason - has tended to favor the Coalition's position with respect to terminology. It is the reason that many of us make a concerted effort to find and correct this misinformation wherever it is propagated in the news media. Thus, in response to Mr. Franck's article, I wrote in my email to him:

Second, you state:

"Opponents of Amendment 2 had wanted lawmakers to send a ballot measure
to voters in November 2008. The proposed amendment would have asked the
public to ban all forms of human cloning, including when the research is
used solely to produce embryonic stem cells. Voters specifically
protected that form of research by passing Amendment 2 last year."

This statement is inaccurate. The result of of human cloning is NEVER
"solely...embryonic stem cells". This research - somatic cell nuclear
transfer - ALWAYS results in the production of a living embryo of the
same species as that of the gamete and somatic cell from which the
embryo was produced. Should SCNT of a human egg and somatic cell nucleus
ever succeed, the result will be a human embryo. Any stem cells
resulting from this process will and must come from the destruction of
that embryo. They cannot be produced apart from the embryo using SCNT.

On that point, Mr. Franck responds in his email:

On your second point -- yes, I know and agree that SCNT produces an embryo [which] is then harvested for stem cells. I think you misread my use of the word solely. I did not mean to imply that all that is produced are stem cells.

I appreciate Mr. Franck clarifying this point in his response. He goes on to address the question of his personal bias in regard to the Amendment 2 issue:

There are limits to the territory that I can cover in a 350-word story. In lengthier stories -- of which I have written several -- I deal with these issues more thoroughly. Even so, I stand by my story.

...For three years, I have strived to cover this issue with detachment and fairness. And I believe that if you ask around, I have a good track record in this regard.

While I certainly infer a bias in the end result of the article in question, I want to be fair in asserting the source of that bias. To that end, I did my best to research Mr. Franck's past articles. He was kind enough to send me the copy of a rather lengthy piece he wrote, and of which I found a copy at the Center for Genetics and Society website. I also found recent Post-Dispatch articles here and here, as well as a copy of an article reposted here.

After reading this broader sample of Mr. Franck's writing on the Amendment 2 issue, I believe that he is correct in his assertion that he has made every effort to deal with the issue with detachment and fairness. While I disagree with repeated use of incorrect and/or potentially misleading terminology (such as referring to an embryo as a "ball of cells" or "clump of cells" or "cluster of cells"), an overall reading of his articles lends me to believe that he has attempted to present each side of the issue fairly.

I believe any overt bias inferred from these articles - and in particular, the article I originally critiqued - results from the limited scope of a shorter article and, more importantly, the editorial bias of the Post-Dispatch.

Finally, I would like to thank Mr. Franck for taking the time to respond to my email. Not many reporters would take the time to do so - especially to respond to someone being critical of that reporter's work.

Post-Dispatch Misleads on Anti-Cloning Measure

Filed in Politics, Science, Social IssuesTags: Clone The Truth, Cloning, Media Bias, Missouri, Sanctity of Life, Stem Cells

The St. Louis Post-Dispatch today reported that MO House Bill HJR11 was killed in committee yesterday. Unfortunately, the P-D could not see past its own bias in order to report accurately on the measure. Ironically, in order to spin the truth, the article exposes the hypocrisy and deception of Amendment 2.

To begin with, take the opening paragraphs of the article:

A House committee killed legislation Monday designed to largely invalidate a new constitutional amendment protecting stem cell research.

The 3-4 vote by the House Rules Committee all but ends efforts this legislative session to overturn Amendment 2, which 51 percent of voters approved in November.

Based on this reporting, one would infer that the measure refers either to Amendment 2 in particular or stem cell research in general. To the contrary, the wording of HJR11 references neither stem cells nor Amendment 2. In fact, the words "stem cell" - or any derivation thereof - do not appear anywhere within the text of the measure:

Be it resolved by the House of Representatives, the Senate concurring therein:

That at the next general election to be held in the state of Missouri, on Tuesday next following the first Monday in November, 2008, or at a special election to be called by the governor for that purpose, there is hereby submitted to the qualified voters of this state, for adoption or rejection, the following amendment to article III of the Constitution of the state of Missouri:

Section A. Article III, Constitution of Missouri, is amended by adding thereto one new section, to be known as section 38(e), to read as follows:

Section 38(e). 1. The general assembly may enact laws concerning health care research, including controlling taxation, appropriations, and use of public resources for health care research, and regulating research that could pose a risk to human life or health.

2. It is unlawful to engage in human cloning. For the purposes of this section and section 38(d) of this article, "human cloning" means the creation of a human zygote, human blastocyst, or human embryo by any means other than the fertilization of a human egg by a human sperm.

3. The provisions of this section supersede any provision of section 38(d) of this article that is inconsistent with this section.

As you can see, the measure makes no mention of either Amendment 2 or stem cells. How on earth, then, could the author make such a claim? Examine the next paragraph for the answer:

Opponents of Amendment 2 had wanted lawmakers to send a ballot measure to voters in November 2008. The proposed amendment would have asked the public to ban all forms of human cloning, including when the research is used solely to produce embryonic stem cells. Voters specifically protected that form of research by passing Amendment 2 last year.

The deception seems to get ever more subtle. To wit [emphasis added]:

The proposed amendment would have asked the public to ban all forms of human cloning, including when the research is used solely to produce embryonic stem cells.

Did you catch it? The problem with this statement is that "the research" - that is, human cloning - is never used "solely to produce embryonic stem cells", since the result of human cloning is - always and by definition - a human embryo, not just embryonic stem cells.

The problem with this rationalization is the same problem that the proponents of Amendment 2 had during their 30 million dollar campaign of deception: the claim that Amendment 2 would "strictly ban human cloning". In fact, as both an educated reading of the wording of the amendment as well as the double-speak found in this P-D article reveal, Amendment 2 not only did no such thing, it actually made human cloning constitutionally protected in the state of Missouri.

This duplicity is further revealed by the actions of the house committee that killed the measure [emphasis added]:

"I'd say that a third (of House members) will be happy they don't have to vote on this," said Shannon Cooper, R-Clinton.

Cooper, who serves as chairman of the House Rules Committee, said he voted against the measure simply because he supports Amendment 2.

If Amendment 2 "strictly bans human cloning" - as its supporters claims it to do - why would an Amendment 2 supporter vote against a measure that would allow Missouri voters explicitly to ban all forms of human cloning? Any proponent of Amendment 2 could only oppose such a measure if in fact human cloning were a part of Amendment 2. That supporters of Amendment 2 oppose this measure demonstrates that their claim that Amendment 2 "strictly bans human cloning" was an outright lie.

Cooper - and those like him - should be ashamed of himself, and is a disgrace to the Missouri Republican party. Duplicity, hypocrisy, lying, and subverting the democratic process have no place in the Republican Party. For one, if his beloved Amendment 2 "strictly bans human cloning" then what does he have to oppose in HJR11? For another, even if he legitimately opposes HJR11, how dare he deny the voters of Missouri the opportunity to exercise our democratic right?

The truth, which should now be plainly evident to all, is that Amendment 2 constitutionally protected human cloning for the purpose of human-embryo-destructive research, and that the proponents of Amendment 2 knew this truth and intentionally mislead Missouri voters into believing that passing Amendment 2 would "strictly ban human cloning".

More Re-Definition of Terminology

Filed in Politics, Science, Social IssuesTags: Clone The Truth, Cloning, Missouri, Sanctity of Life, Stem Cells

First, they tried to re-define "embryonic" as "early". Next, they tried to re-define "cloning" as "implantation". Now, they're trying to re-define "cure".

Adult stem cells have thus far produced at least 72 human treatments. It appears that one of the latest tactics of the pro-Amendment 2 Coalition is to refute that fact (emphasis added):

Winship says there have been no proven cures found with embryonic stem cell research and said adult stem cells are a proven - and ethical - alternative.

"The reality is, it’s still zero" cures "for embryonic stem cells," she said.

Farrow said embryonic stem cell opponents would do anything to derail the initiative, including overstating the potency of adult stem cells.

"You’ll hear our opponents say that there are between 65 to 100 adult stem cell cures. That’s simply not true," Farrow said.

"The truth is there are only nine adult stem cell cures, and we believe that research needs to go forward," she said. "But adult stem cells have been researched for over 50 years. The first earlier embryonic stem cell research didn’t start until 1998. We haven’t even had a full decade of research with embryonic stem cells."

What on earth could possibly explain such disparity? Apparently, the Coalition, in an attempt to level the playing field in their favor, have begun applying a "FDA-approved" qualification (emphasis added):

Dr. William Neaves is with the Stowers Institute Medical Research. "This is a contest between society and disease, not between adult stem cells and early stem cells," says Neaves.

Researchers say embryonic stem cells hold infinitely more potential than adult stem cells for curing disease. They say the claim about dozens of treatments already developed from adult stem cells is not true. "At best, only nine of those diseases have, after 50 years of research with adult stems cells, FDA-approved therapies that are available to patients," says Neaves.

The Coalition is obviously hedging on the belief that the general public have no real understanding of what FDA approval is, what it means, or how it happens. I will try to give a brief overview.

FDA is divided into various "centers". I work for a pharmaceutical company that manufactures, packages, and sells drugs. We are under the direction of FDA's CDER: the Center for Drug Evaluation and Research. Medical devices - pacemakers or defibrilators, for example - are under the direction of CDRH: the Center for Devices and Radiological Health. Stem cell treatments are under yet another center - CBER: the Center for Biologics Evaluation and Research.

In order for a drug, device, vaccine, or other treatment (hereafter, treatment) to get FDA approval, a rigorous and intensive process is required. The sponsor (company requesting approval) must complete a submission application including all the data supporting the approval request. For a new treatment, the submission would include data from three phases (Phase I, Phase II, Phase III) of clinical studies. These clinicals are the heart of the company's justification for requesting approval. Phase I clinicals are very small (less than 100 participants) studies, generally using healthy humans, to determine physiological interaction of a treatment with humans. Phase II clinicals follow successful of Phase I, and are controlled, small-scale (a few hundred participants) studies using people who have the condition for which the treatment is indicated, used to determine preliminary data with respect to the effectiveness of the treatment, and any side effects associated with the treatment. Phase III clinicals follow successful completion of Phase II, and are controlled (or uncontrolled), large-scale (a few hundred to thousands of participants) studies used to determine the effectiveness of the treatment for the general population, and to ascertain the overall risk-benefit relationship of the treatment.

Based on these data, in addition to other aspects of the submission (stability data for a drug, for example), FDA will approve or reject the application. Once FDA has approved an application, the sponsor can legally market and sell the treatment in the US.

As with many other treatments, due to the nature of the conditions for which stem cell treatments are intended, such treatments are not always well-suited for typical clinical trials. FDA is aware of and working to reconcile the difficulty of translating stem-cell treatments into clinical trials.

Note, however, that other mechanisms exist, prior to or in lieu of FDA final approval, for treatments to be used (legally and effectively). Two such mechanisms are the Treatment Investigational New Drug (Treatment IND) approval, in which "FDA will permit an investigational drug to be used under a treatment IND if there is preliminary evidence of drug efficacy and the drug is intended to treat a serious or life-threatening disease, or if there is no comparable alternative drug or therapy available to treat that stage of the disease in the intended patient population", and the parallel track policy, in which "patients with AIDS whose condition prevents them from participating in controlled clinical trials can receive investigational drugs shown in preliminary studies to be promising."

Some treatments - such as prenatal drugs - may never proceed through all clinical phases and final approval, but may be given to patients as investigational treatments for non-approved indications as long as the patient gives informed consent (which is also required for participation in clinical studies). Such is the case for Treatment INDs discussed above.

The bottom line is this: all treatments administered in the US must have FDA approval, whether in the form of a final New Drug Approval (NDA), or as an Investiational New Drug approval (IND). So, of the more than 72 treatments currently in use, every single one in use in the US has FDA approval of one form or another.

That said, much stem cell research and advancement takes place outside the borders of the US and outside the control of FDA. Any treatments derived from such research would not be subject to FDA approval; therefore, any implication regarding such approval is

This argument is not unique to the Missouri Amendment battle. In this 07/06 letter to Science, Do No Harm refutes the argument for the straw man that it is, and also points out that some 1170 clinical trials involving stem cells currently exist, including some 565 trials currently active and seeking participants - while not one single clinical trial is underway for embryonic stem cell treatments. Moreover, the letter points out that there are currently no peer-reviewed references to embryonic stem cell-derived human treatments. The above-referenced list of 72 human treatments derived from adult stem cells, which Do No Harm maintains, includes only those treatments for which peer-reviewed scientific publication of their effectiveness exists.

Yet again, the Coalition can only offer mistruths and deception.

Ayn Rand Institute Hypocrisy

Filed in Politics, Science, Social IssuesTags: Clone The Truth, Cloning, Media Bias, Sanctity of Life, Stem Cells

Mary Meets Dolly parses a despicable attempt at rationalization of the inhumanity of human embryos by David Holcberg and Alex Epstein of the Ayn Rand Institute.

The authors use several tactics. Here is the first:

But embryos used in embryonic stem cell research are manifestly not human beings--not in any rational sense of the term. These embryos are smaller than a grain of sand, and consist of at most a few hundred undifferentiated cells. They have no body or body parts. They do not see, hear, feel, or think. While they have the potential to become human beings--if implanted in a woman's uterus and brought to term--they are nowhere near actual human beings.

Unfortunately for them, human embryos are, by unbiased definition, human beings. Genetically, they are fully human. They are not "potential" humans. The self-direct their growth and development, meaning the human embryo manifestly exhibits initiative toward that end. Just because some activist SCOTUS judges arbitrarily conferred "personhood" on human beings only upon the point of birth does not change the scientific evidence, knowledge, and general belief that life exists intrinsically at the moment of conception.

The second tactic is as follows:

The "pro-lifers" accept on faith the belief that rights are a divine creation: a gift from an unknowable supernatural being bestowed on embryos at conception (which many extend to embryos "conceived" in a beaker). The most prominent example of this view is the official doctrine of the Catholic Church, which declares to its followers that an embryo "is to be respected and treated as a person from the moment of conception; and therefore from that same moment his rights as a person must be recognized."

But rights are not some supernatural construct, mystically granted by the will of "God." They are this-worldly principles of proper political interaction rooted in man's rational nature. Rights recognize the fact that men can only live successfully and happily among one another if they are free from the initiation of force against them. Rights exist to protect and further human life. Rights enable individual men to think, act, produce and trade, live and love in freedom. The principle of rights is utterly inapplicable to tiny, pre-human clusters of cells that are incapable of such actions.

I guess, by this logic, every one of our Founding Fathers was a "pro-lifer". May I remind of the following:

We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty and the pursuit of Happiness.--That to secure these rights, Governments are instituted among Men, deriving their just powers from the consent of the governed...

The endowment of rights is not a function of nor dependent upon the capacity of the person to take advantage of those rights; rather, the intrinsic worth of the person is recognized by the unconditional endowment of those rights. The authors' same logic applies to justification for euthanasia of the elderly, the incapacitated, the mentally retarded, or anyone else not deemed inherently "worthy" of such rights as life, liberty, and the pursuit of happiness. It is the height of arrogance that these authors would deign to set themselves up as arbiters of the inherent worth of any person, no matter at what stage in that person's development.

The logical progression of this line of rationalization leads to the following harrowing statement:

In fact, to attribute rights to embryos is to call for the violation of actual rights. Since the purpose of rights is to enable individuals to secure their well-being, a crucial right, inherent in the right to liberty and property, is the right to do scientific research in pursuit of new medical treatments. To deprive scientists of the freedom to use clusters of cells to do such research is to violate their rights--as well as the rights of all who would contribute to, invest in, or benefit from this research.

The last person to try such reasoning did so in order to implement said scientific research on another group of humans deemed unworthy of the rights to life, liberty, and the pursuit of happiness. The end result: the death of millions of Jews in the Holocaust.

Having fully lost all grasp of reality, the authors resort to what is now the commonplace argument for ESC research:

And to the extent that rights are violated in this way, we can expect deadly results. The political pressure against embryonic stem cell research is already discouraging many scientists and businessmen from investing their time and resources in its pursuit. If this research can lead, as scientists believe, to the ability to create new tissues and organs to replace damaged ones, any obstacles placed in its path will unnecessarily delay the discovery of new cures and treatments for diseases such as Parkinson's, Alzheimer's, and osteoporosis. Every day that this potentially life-saving research is delayed is another day that will go by before new treatments become available to ease the suffering and save the lives of countless individuals. And if the "pro-lifers" ever achieve the ban they seek on embryonic stem cell research, millions upon millions of human beings, living or yet to be born, might be deprived of healthier, happier, and longer lives.

Yet these hypocrites ignore new treatments for such conditions being developed and used every day, when such treatments are derived from adult stem cell research. They gloss over the glaring failure thus far of ESC research to yield even a single viable treatment. They facilitate the propogation of false hope for those suffering from diseases that likely no stem-cell (adult or embryonic) derived treatments will ever help, such as Alzheimer's.

The authors leave us with this conclusion:

The enemies of embryonic stem cell research know this, but are unmoved. They are brazenly willing to force countless human beings to suffer and die for lack of treatments, so that clusters of cells remain untouched.

To call such a stance "pro-life" is beyond absurd. Their allegiance is not to human life or to human rights, but to their anti-life dogma.

If these enemies of human life wish to deprive themselves of the benefits of stem cell research, they should be free to do so and die faithful to the last. But any attempt to impose their religious dogma on the rest of the population is both evil and unconstitutional. In the name of the actual sanctity of human life and the inviolability of rights, embryonic stem cell research must be allowed to proceed unimpeded. Our lives may depend on it.

To claim that an embryo is not a human being is beyond absurd. The proponents of embryonic stem cell research know this, but are unmoved. They are brazenly willing to force their dogmatic, culture-of-death views on the rest of the American people, who continue to demonstrate their disdain for human cloning for any reason, and their disapproval of the destruction of human embryos for research purposes. So, let's recap:

Pro-Life

  • Recognizes intrinsic value of life at every age and stage of deveopment
  • Supports the entirely ethically uncontroversial, already proven, and immensely promising adult stem cell research
  • Opposes embryonic stem cell research because the process destroys human embryos, recognized as intrinsically valuable human life

Culture of Death

  • Denies the inherent worth of life based on developmental stage, mental capacity, age, ability to contribute to society, or any other socially or politically expedient reason
  • Ignores the many advances in adult stem cell research, and the tens of thousands of people whose lives have been improved or even saved by such research
  • Rationalizes an untenable position by attempting to redefine terms and change boundaries, and intentionally give false hope by knowingly making unrealistic claims

Ayn Rand is rolling over in her grave.

Researchers Get OK, Reporter Gets Confused

Filed in Science, Social IssuesTags: Clone The Truth, Cloning, Sanctity of Life, Stem Cells

So much mis-information, so little time...

Two teams of Boston scientists announced Tuesday that they will attempt to creating the world's first cloned human embryonic stem cells.

Technically speaking, stem cells, by definition, clone themselves. Stem cells are self-replicating.

Harvard Stem Cell Institute and Boston Children's Hospital researchers said they will try to develop a powerful new tool to explore the biology of and create disease-specific stem cell lines that could lead to the treatment of a wide range of now-incurable conditions afflicting tens of millions of people worldwide.

Note to reporter: stem-cell research - especially embryonic stem cell research - is not required to explore the biology of a "wide range of now-incurable conditions." (Though, given the poor grammatical structure of the lead-in sentence, I'm unsure whether she meant "biology of...a wide range of now-incurable conditions" or "biology of...stem cell lines.")

Researchers plan to initially focus on diabetes and then expand to include neurodegenerative diseases, such as Amyotrophic Lateral Sclerosis, better known as Lou Gehrig?s Disease, and blood disorders.

Note, again, to reporter: adult stem cell treatments are already proving effective in these areas.

The method, called somatic cell nuclear transfer, involves removing the nucleus, which contains DNA, from an affected cell and replacing it with the nucleus from a donor cell, researchers explained. The cell is then forced to divide into multiple cells that are genetically identical to the healthy donor cell. The method has already proven successful in animal research. Patients with diabetes, blood disease and neurodegeneration will donate the cells. Embryos that were created through in vitro fertilization that have been deemed incapable of producing a pregnancy will be the source of the embryonic cells.

This has to be the most inaccurate explanation of SCNT I've yet seen. Just to clarify:

In somatic cell nuclear transfer the nucleus of a somatic cell (a cell other than a sperm or egg cell) is removed and the rest of the cell is discarded. In parallel, the nucleus of an egg cell is removed. The nucleus of of the somatic cell is then inserted into the denucleated egg cell. The egg, now containing the nucleus of a somatic cell, is stimulated in such a way that it begins to divide.

So, to correct:

  • Enucleated somatic cells are not necessarily "affected" cells; they are simply non-gametic cells from the person to be cloned.
  • The enucleated somatic cell is not placed into an enucleated somatic cell; it is placed into an enucleated egg.
  • The result is not simply another cell; it is a zygote genetically identical to the donor of the somatic cell.
  • The resultant zygote is not merely genetically identical to the donor somatic cell; it is genetically identical to the donor of that somatic cell.
  • The resultant zygote is not forced to divide into multiple cells; it is electrically induced to begin self-directed mitosis, from which the single-cell zygote proceeds into the various stages of embryonic development, and beyond.
  • IVF embryos have absolutely nothing to do with SCNT. Using IVF embryos is an alternate, and currently, only successful, means of harvesting embryonic stem cells.

Moving on:

Human embryonic stem cell research has long been at the center of controversy because in extracting healthy cells, days-old human embryos are destroyed. Embryonic cells are used because they are capable of developing into any cell or tissue type in the body. Opponents of the work claim that no potential medical benefit can justify the destruction of what they view as a human life.

"What they view" as human life? Embryologists universally agree that first, the blastocyst from which stem cells are harvested (and which is destroyed in the process) is an embryo, and second, that embryos, being self-directing in their growth and development, are living. Thus, human embryos are human life.

Harvard President Lawrence Summers is hopeful the research will lead to millions of people being able to live healthier lives.

"While we understand and respect the sincerely held beliefs of those who oppose this research, we are equally sincere in our belief that the life-and-death medical needs of countless suffering children and adults justifies moving forward with this research," Summers said in a release about the work.

Then again:

"Given that embryos are human beings, they have a right to self and a right to life. Exploiting their parts (ie, cells) or killing them for research is moral trespass that society should not allow. Even if the research might, and let’s be clear, might benefit others, this trespass is not justified."

--James Sherley, Ph.D. associate professor of biological engineering at MIT

Comparing Stem Cell Poll Questions

Filed in Politics, Science, Social IssuesTags: Clone The Truth, Cloning, Sanctity of Life, Stem Cells

Anne Leonard of the Stem Cell Research Blog compares stem cell poll questions, and their divergent results.

The first poll question, from the Coalition for the Advancement of Medical Research (CAMR), which polled 72% strongly/somewhat in favor:

Embryonic stem cells are special cells which can develop into every type of cell in the human body. The stem cells are extracted from embryonic cells produced in fertility clinics and then frozen days after fertilization. If a couple decides the fertilized eggs are no longer needed, they can choose to donate the embryos for research or the clinic will throw the embryos away. Scientists have had success in initial research with embryonic stem cells and believe that they can be developed into cures for diseases such as cancer, Parkinson’s, heart disease, juvenile diabetes, and spinal cord injuries. Having heard this description, do you strongly favor, somewhat favor, somewhat oppose, or strongly oppose medical research that uses stem cells from human embryos?

The second poll question, from the U.S. Conference of Catholic Bishops, which polled 48% opposed:

Stem cells are the basic cells from which all of a person's tissues and organs develop. Congress is considering the question of federal funding for experiments using stem cells from human embryos. The live embryos would be destroyed in their first week of development to obtain these cells. Do you support or oppose using your federal tax dollars for such experiments?

She then, after comparing the two poll questions, comes to the following conclusion:

I find the CAMR question better designed (despite its use of “success”) and more objective than the Bishops’ question, which has a lot of ambiguity in it. Maybe I am reading with my own biases and knowledge—but I think providing information about an issue yields a better question than vague and unspecific language.

Huh? The Bishops' question is more "vague" and has more "ambiguity" than the CAMR question? Let's compare, shally we?

Ambiguous:

The stem cells are extracted from embryonic cells produced in fertility clinics and then frozen days after fertilization.

Stem cells are not extracted from "embryonic cells", they are extracted from embryos (destroying them in the process).

Not Ambiguous:

The live embryos would be destroyed in their first week of development to obtain these cells.

Ambiguous:

Scientists have had success in initial research with embryonic stem cells and believe that they can be developed into cures for diseases such as cancer, Parkinson’s, heart disease, juvenile diabetes, and spinal cord injuries.

Embryonic stem cell (ESC) research has yielded no success whatsoever in treating any human injury, illness, or condition.

Not Ambiguous:

Congress is considering the question of federal funding for experiments using stem cells from human embryos.

So, exactly, which poll question is more vague and ambiguous?

More interestingly, and which the post doesn't even address, is this follow-up question in the Bishops' poll, which polled 81% against:

Should scientists be allowed to use human cloning to create a supply of human embryos to be destroyed in medical research?

This question is actually better in comparison to the CAMR question, since the two are more comparable. The entire IVF embryo question is really a red herring, since ESR research proponents prefer "fresh" embryos, and consider frozen embryos to be inferior. Thus, ESR research will come primarily from SCNT-cloned embryos, against which this poll question shows strong opposition.

Never Give Up, Indeed

Filed in Politics, Science, Social IssuesTags: Clone The Truth, Cloning, Missouri, Sanctity of Life, Stem Cells

Apparently, Lene Johansen doesn't think that those who support banning human cloning should keep challenging the Stem Cell Initiative.

No, we will never give up. It has something to do with the Initiative, through an intentionally deceptive attempt to re-define "cloning", claiming that the Initiative bans human cloning, while in reality it constitutionally prohibits the legislature from banning human cloning.

So, no; we won't give up, until every Missourian knows the truth. Missourians have the right to make informed decisions about this issue.

Say What?

Filed in Politics, Science, Social IssuesTags: Clone The Truth, Cloning, Missouri, Sanctity of Life, Stem Cells

Among other things in this article on the one-year anniversary of Massachussetts' pro-embryonic stem cell (ESC) research legislation, I found this little gem [emphasis added]:

After years of honing his skills in Massachusetts, the 34-year-old stem cell researcher received an offer from a privately endowed research center in Kansas City.

There was only one hitch. In Missouri, Cowan said, he feared his type of research could land him behind bars. In contrast, he felt Massachusetts had put out a welcome mat.

Talk about sensationalism! "Land him in jail"? Really? Considering that none of the research being conducted in Massachussetts is illegal in Missouri, that fear is rather spurious.

Oh, and a side note: I would harbor a guess that the "privately endowed research center in Kansas City" mentioned in the article is none other than the Stowers Institute, founded by the same Jim and Virginia Stowers who are bank-rolling the Missouri Stem Cell Initiative.

The article has more of the usual mis-information. After generally getting the facts straight for most of the article, we come to the following critical failure:

At the heart of the stem cell debate is a procedure known both as somatic cell nuclear transfer or therapeutic cloning.

The basic science involves taking an egg from a woman, removing the 23 chromosomes that would normally match up with 23 chromosomes from a sperm, and replacing them with a full 46 chromosome nucleus from any cell of an adult, essentially creating a single cell clone.

The egg is then induced to begin reproducing until there is a ball of a few hundred stem cells that have the ability to transform themselves into any type of cell in the body. The goal is to use those cells to create cures or treatments for disease.

Good information, up to "single cell clone" - but then the article gets it wrong. That "single cell clone" is no longer an egg, but a zygoe: a single-cell embryo. The embryo proceeds through mitosis (cell division) and into the various stages of embryonic development. At the stage in question - the blastocyst stage - the embryo is comprised of inner and outer cell masses. The outer cell mass will later become the placenta, and the inner mass (which contains the stem cells) progresses into the fetal stages of human development.

In order to use those stem cells, the embryo must be destroyed. A "ball of cells" is not removed from the developing embryo; a developing human being is killed.

The article's conclusion falls under the category of "unintentional irony" [emphasis added]:

Despite his enthusiasm, Zon tries to temper public expectations about the research.

He said the short term goal -- over the next five years or so -- is to gain a greater understanding of human development and use tissue created through human embryonic stem cell research to experiment with potential treatments for diseases.

The longer term goal -- over the next 10 years -- is to create new cells to actually replace defective parts.

"We are just at the beginning," he said.

The only thing realistic here is the last sentence. Every indication is that any real progress with ESC research is, at a minimum, decades away. How giving the impression that meaningful results are 5-10 years away constitutes "tempering public opinion", I can't fathom.