Stem Cells That Become Embryos: Cont'd (p. 3 of 4)

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C. The Case of the Vanishing Embryo #2: “Just Pluripotent”

As demonstrated in Part I of this analysis, separated “stem cells” from the 2-cell stage through the blastocyst-stage embryo could be totipotent, undergo “regulation” and become whole embryos themselves. This is an established scientific fact in animal studies. These human “stem cells,” therefore, are probably not all “pluripotent.” Once separated from the intact embryo these cells are capable of being “totipotent.”

Yet if the correct scientific term were to be used to describe some of these separated stem cells, i.e., “totipotent,” then it could be argued that they should not be used in research precisely because they can undergo regulation and produce embryos themselves. That would constitute human embryo research and violate the Congressional ban. However, if the term “pluripotent” were used instead, then the implication would be that these cells could not possibly revert to embryos themselves, but rather could only form “some” of the cells and tissues of the adult organism. Culture-produced human embryos (i.e., those that might be produced from separated “human embryonic stem cells”) would vanish as well. That would not constitute human embryo research, and therefore would not violate the Congressional ban. This could be what the NIH Guidelines have accomplished.

IV. Application To Nih Guidelines

[I.] Scope of NIH Guidelines

The term “pluripotent” is used in the very title of the NIH Guidelines to describe all of these separated “stem cells” that are to be cultured and used in research and “therapy” (emphases added):

“For purposes of these Guidelines, ‘human pluripotent stem cells’ are cells that are self-replicating, are derived from human embryos or human fetal tissue, and are known to develop into cells and tissues of the three primary germ layers. …NIH research funded under these Guidelines will involve human pluripotent stem cells derived 1) from human fetal tissue; or 2) from human embryos that are the result of in vitro fertilization, are in excess of clinical need, and have not reached the state at which the mesoderm is formed.” (p. 7)

So the term “pluripotent,” rather than the term “totipotent,” is used to refer to all of the separated “stem cells” from the developing human embryo from fertilization until the formation of the “mesoderm.” New stem-cell-culture-produced human embryos that might have been produced have now completely vanished from sight, and therefore from all considerations and debates.

The choice of the term “mesoderm” here is interesting too. According to current human embryology textbooks, the “mesoderm” is formed “well after the formation of the primitive streak,” in the third week of development post-fertilization (emphases added):

“At the end of the second week the embryo consists of two flat layers of cells, the epiblast and the hypoblast. As the third week…begins, the embryo enters the period of gastrulation, during which the three embryonic germ layers become clearly established. … The first evidence of gastrulation is the formation of the primitive streak,…(pp. 60-61) …After the primitive streak is well established, the majority of cells passing through it spread out between the epiblast and the hypoblast to form the embryonic mesoderm). (p. 62) [Carlson (1999)]

As noted here, gastrulation, the process during which the “mesoderm” is formed, is marked by the beginning of the formation of the primitive streak, usually about day-16 (Carnegie stage 7), and continues to day-18 (Carnegie stage 8) [Larsen (1998), pp. xi, 33; Moore and Persaud (1998), p. 64]. Does this mean that the “mesoderm” to which the NIH Guidelines refer would not even begin to be formed until after the primitive streak is “well-established"—which would be usually closer to day-18? If so, then this “limit” for deriving stem cells from living embryos, a “condition” stated for their use in these NIH Guidelines, would exceed the usual arbitrary 14-day “biological marker” used in many bioethics and governmental studies and discussions to date.

And if by the phrase “the state at which the mesoderm is formed” the NIH Guidelines are referring to that point when the mesoderm of the embryo is completely formed, then the official “limit” for using such embryos could be extended considerably later than day-18. Can't the NIH be more precise than this? Are these official “limits” slowly creeping up the embryological continuum?

Thus, the NIH Guidelines use the term “pluripotent stem cells” to refer to all of these separated “stem cells,” which some of which could actually be “totipotent” stem cells because of their strong inherent capacity to revert to human embryos—regardless of where on a gradient of “totipotency” any particular separated stem cell would happen to fall. #8220;Totipotent” is “totipotent"—i.e., capable of forming new whole human organisms. We know—from the reality of human monozygotic twinning, as well as from well-documented animal twinning experiments—that this totipotent capacity is inherent to all of these cells. Thus this research could entail the production of living human embryos in laboratory conditions. If such research were performed, and if such human embryos were produced, that would constitute human embryo research per se. Such research would violate the existing Congressional ban, and thus is already prohibited.

The “scope” section of these NIH Guidelines also state that the source of these “pluripotent stem cells” are “human embryos that are the result of in vitro fertilization.” [p. 7] However, as noted in Part I of this analysis, most IVF-produced human embryos are frozen down at the 4-8 cell stage—when each of the cells of the embryo are totipotent, not pluripotent. Furthermore, at this stage most of these embryos have no inner cell mass containing purely “pluripotent” stem cells; and it has been scientifically demonstrated that even stem cells from the inner cell mass of a blastocyst can also be “totipotent” and form new whole embryos—as documented in most natural and experimentally induced monozygotic twinning. Whether IVF-produced human embryos are frozen down until just before the completion of the formation of the mesoderm surely remains to be clarified.

Regardless, because the cells from most of these IVF-produced early human embryos are not all “pluripotent,” nor possess inner cell masses containing only “pluripotent” stem cells, these NIH Guidelines could not possibly even apply to these IVF-produced human embryos.

[A.] Research Using Cells From Human Embryos
[1.] Submissions By Investigators:

For research that is “eligible” for NIH funding, the NIH Guidelines require an assurance from intramural and extramural investigators who are intending to use existing NIH funds that their “proposed research using human pluripotent stem cells is not a class of research that is ineligible for NIH funding” [p. 8] (emphases added). Yet because many of these separated “pluripotent stem cells” could actually be totipotent and could form human embryos themselves, such research would constitute human embryo research per se, and thus violate the Congressional ban. Therefore, such research could not be “eligible for NIH funding.”

And the question needs to be asked: Do investigators know the correct human embryology and human molecular genetics required to submit a scientifically credible assurance to the NIH? Do members serving on the Institutional Review Boards (IRB's) have the required scientific knowledge to evaluate and approve such research? And how is this substantiated by the NIH?

[2.] Conditions for Use of “Human Embryonic Stem Cells"

The scientific fact that these separated “human embryonic stem cells” could actually be totipotent and form new living human embryos themselves, as well as the NIH Guidelines' requirement that only IVF frozen embryos can be used as the source for these “stem cells,” has ramifications throughout the rest of the text of these NIH Guidelines. Only a few examples will be presented here.

For example, the NIH Guidelines state (emphases added):

“Studies utilizing pluripotent stem cells derived from human embryos may be conducted using NIH funds only if the cells were derived (without Federal funds) from human embryos that were created for the purposes of fertility treatment and were in excess of the clinical need of the individuals seeking such treatment.” [p. 8]

Clearly, not all of the cells “derived from human embryos that were created for the purposes of fertility treatment"—whether produced by IVF or by any other “fertility treatment"—would be “pluripotent,” but some could be “totipotent” and therefore capable of becoming new whole embryos themselves. Hence it would seem that the “conditions for use” as stipulated in these NIH Guidelines would actually prohibit the use of these cells left over from fertility treatments in federally funded research.

[3.] Informed consent:

“Informed consent” refers to both a process and a document. The purpose of informed consent is to provide a decision maker with the information necessary to make an “informed” decision based on knowledge of the accurate facts involved, as well as to assure that no pressures have been forced on this person's will that would cause him/her to make a decision that was unintended or undesired. The “information” is conveyed to the person by experts who are professionally competent to provide the actual facts that are needed (either orally or in writing), and this informed consent of the person is so documented in writing.

It is of interest that in this section of the “conditions for use” of human embryonic stem cells, the NIH Guidelines note that (emphases added):

“Decisions related to the creation of embryos for fertility treatment should have been made free from the influence of researchers or investigators proposing to derive or utilize human pluripotent stem cells in research.” [p. 9]

While it is admirable that NIH seeks to assure the integrity of the informed consent process by separating the “decision to create embryos” of the donors from untoward pressures from researchers or investigators feverishly seeking the use of these very embryos, it is unfortunate that NIH does not appear to be as interested in providing the same level of integrity of the informed consent process when it comes to shielding these donors from these same researchers and investigators in their “decisions to donate embryos.” Indeed, the integrity of these informed consent processes and documents should be taken as seriously by NIH and by the donors as the integrity of the informed consent processes and documents required to create these human embryos to begin with.

For example, the NIH Guidelines state (emphases added):

“To ensure that human embryos donated for research were in excess of the clinical need of the individuals seeking fertility treatment, and to allow potential donors time between the creation of the embryos for fertility treatment and the decision to donate for research purposes, only frozen human embryos should have been used to derive human pluripotent stem cells.” [p. 9]

Informed consent should have been obtained from individuals who have sought fertility treatment and who elect to donate human embryos in excess of clinical need for human pluripotent stem cell research purposes.” [p. 9]

Again, the Guidelines stipulate that informed consent should have included “a statement that the embryos will be used to derive human pluripotent stem cells for research that may include human transplantation research,” that derived cells and/or cell lines “may be kept for many years,” and that “embryos donated will not survive the human pluripotent stem cell derivation process.” [pp. 9-10] (emphases added)

Given the scientific uncertainties involved in this research and being presented to these potential donors, it would seem to be next to impossible for them to be sufficiently informed to give ethically and legally valid informed consent. Are these decision makers being given the accurate scientific information that these living embryos of theirs are already real whole living human beings—or are they told, or the implication conveyed, that these embryos are just “potential human beings,” or “just a bunch of loosely connected undifferentiated 'stem cells' no bigger than the period at the end of this sentence"—as the NIH public relations have actively depicted these tiny living human beings for many years now?

Are these potential donors informed that the separated “stem cells” that would be derived from their own donated IVF-embryos could in fact totipotent, and therefore could naturally try to revert to new living embryos themselves, to be perpetuated in a continuous laboratory system in which even more laboratory-derived embryos could be produced, cultured, and killed for experimentation and “therapy”? Would these donors really not care if their own living progeny—created out of a sincere yet desperate and almost panicky desire to have their own children—were reproduced over and over again for years in laboratories around the world, cultivated in vitro or even in vivo in other women or even animal surrogate wombs, and used for whatever compelling research projects await science in the future? Can scientists document empirically that these scenarios could or would not take place?

Do these informed consent forms advise the potential donors that embryos derived from their embryos could be produced, possibly kept in cultures for many years, and also used in “human transplant research,” and that untold numbers of these embryos would not survive later derivation processes either? Are these potential donors informed that any culture-produced progeny (or their “stem cells") could be used to form human or animal chimeras, or used in “positive eugenics” research in which their progeny could be permanently genetically altered for generations to come? Or could these donors just go into denial and pretend they didn't understand this information, or refuse it—and would this constitute true ethically and legally valid informed consent?

Should every consideration be given to the fact that so much of the same scientific “misinformation” is often disseminated by these “same researchers and investigators” themselves—especially through the media, press—indeed possibly through these official NIH Guidelines themselves? Wouldn't such public-generated “misinformation” be prejudicial to the donor’s decision making as well?

Don't all involved in the informed consent processes and documentations bear serious moral and legal responsibilities for producing, conveying, disseminating, attaining, or accepting scientific “misinformation” in these donor “informed consents”?

What possible scientific, moral, ethical, legal or social merit would such “informed consent” processes and documents possess? And who is morally and legally accountable and responsible for such “uninformed consents”?

It would seem that the use of so much questionable science, and the pressures and influences to which confused and anxious potential donors of human embryos have been subjected, would preclude these potential donors from giving any ethically or legally valid informed consent.

Next page: [B.] Research Using “Human Fetal Stem Cells” | 1, 2, 3, 4