President's Bioethics Council IVF Report Caves in to Fertility Industry

Dianne Irving’s Comments
Dr. Dianne N. Irving, M.A., Ph.D.
copyright January 16, 2004
Reproduced with Permission

"Initial versions of the report also contained politically divisive language, now removed. Instead of using the word "embryo," for example, early drafts used phrases such as 'child to be' or 'future child.' ... 'There is a lot to like in this report, ... ', said Sean Tipton, a spokesman for the American Society for Reproductive Medicine, which represents fertility doctors and lobbied the council hard. ... The American Infertility Association, representing fertility patients and families, applauded the revised draft, saying in a statement that it was 'relieved' ... ." (Rick Weiss, "Bioethics Panel Calls for Ban on Radical Reproductive Procedures", The Washington Post, http://www.washingtonpost.com/wp-dyn/articles/A21071-2004Jan15.html)

Imagine that in the year 2004 the term "embryo" is now considered as "politically divisive language". It leaves one breathless to see how far our culture has come to caving in to political correctness -- without the least consideration as to the destructive and lethal consequences not only to these "embryos" but to adult members of our society at large. What kind of fools do we now suffer ourselves?

To refer to an already existing human embryo, who science has documented for over a hundred years is a new already living human being, as "a child to be" or "future child" is ridiculous on its face, and oddly reminiscent of the draconian government public policies of recent major bioethics British eugenicist and Oxford don R. M. Hare (mentor of Peter Singer).

Believing that early human embryos -- indeed even human newborns and young children -- are just "possible people", Hare's edict for sound public policy would be one that "produces that set of people, of all possible sets of people, which will have in sum the best life, i.e., the best possible set of future possible people." Imagine! Therefore, he claimed that "the maximum duty that is imposed on us is to do the best impartially for all the possible people there might be by having an optimal governmental family planning or population policy, which means necessarily excluding some possible people." [R. M. Hare, "When does potentiality count? A comment on Lockwood", Bioethics 2:3:214 (July 1988); for a thorough scientific and philosophical rebuttal of 23 current bioethics "arguments" for "delayed personhood" including Hare's, see Irving, "Philosophical and scientific expertise: An evaluation of the 'personhood' arguments", Linacre Quarterly 60:1:18-46 (Feb. 1993) at: http://www.lifeissues.net/writers/irv/irv_04person1.html].

This is pure unadulterated gobbledygook, apparently similar to the new edicts of the President's Bioethics Council. In caving into such politically correct bioethics jargon, the Council seems to be oblivious to the fact that such "possible people" for bioethicists like Hare also includes adult human beings such as Alzheimer's and Parkinson's patients, the mentally ill, the mentally retarded, drug addicts, alcoholics, the comatose (temporarily or permanently), the emotionally ill, the frail elderly, the physically disabled, etc. This means that critical medical treatments can be refused patients or removed from them without their consent, live organs can be removed, or, as bioethicist Dr. Richard Frye (Senior Scholar, The Hastings Center) publishes, we have a strong moral obligation to use such non-person human beings ("possible people") in purely experimental destructive research for the greater good of society IN PLACE OF THE HIGHER PRIMATES WHO ARE PERSONS. If "possible people" like "embryos" means that they can be mutilated and destroyed in destructive experimental research for "the greater good of society", then what's wrong with using adult "possible people" for such purposes too? Nothing, according to bioethicists.

But the fateful tenor of the President's Bioethics Council report on the "possible" regulation of the in vitro fertilization (IVF) industry is as expected, and was already apparent in recent publications and web postings by industry leaders. One example is that of RESOLVE, the National Infertility Association, which posted several of their Letters of Testimony to the President's Bioethics Council on their website: (http://www.resolve.org/main/national/advocacy/letters/Presidents-Council-Letter-20031216.doc). Leon Kass had already assured them that:

  1. The practice of in vitro fertilization per se is acceptable: "First, we appreciate your assurance that you see the practice of assisted reproductive medicine as 'by and large healthy', ... ."
  2. Human embryos do not possess "human status": "In fact, the only result we can see of a law commanding doctors to treat the microscopic embryo as a 'patient' is a not-so-subtle conferring of 'human status' on embryos, which the Council has allegedly disavowed because of disagreement over the moral status of embryos."
  3. Embryos produced by IVF could be used in purely experimental research: "We expressed two concerns about this proposal: first, that it could be construed to prohibit the use of embryos created ex vivo for any purpose other than pregnancy, thus potentially prohibiting all research that involves embryos or embryonic cells. ... You assured us that neither of these interpretations is intended and that you would adjust the language to make this clear."
  4. The cloning of human beings by means of somatic cell nuclear transfer (SCNT) is acceptable: "Ooplasmic transfer and nuclear transfer are two experimental therapies that are sometimes confused with but are in fact unrelated to cloning. RESOLVE has no stated policy for or against these therapies, but accepts the Council's statements that it does not wish to prohibit them." (footnote #3, http://www.resolve.org/main/national/advocacy/testimony/Presidents-Council-Testimony-200306.jsp)
  5. The number of embryos transferred to initiate a pregnancy would not be limited: "The second concern about this proposal was that it could be misconstrued to prohibit the transfer of more embryos than the parents intend to have as live-born children ... You assured us that it was not your intentions -- in this provision or in any of the proposals -- to limit the number of embryos that may be transferred to a woman during fertility treatment."
  6. "Parents" do not necessarily need to be the parents raising the child: "You told us that the word 'parents' was not being used in the sense of requiring that those who provided the gametes also needing to be the parents raising the child; you suggested that a term such as "two biological progenitors" would be used instead."
  7. Donors of human embryos, eggs, and sperm may be financially "compensated", and reimbursed for the cost of the IVF "treatment" that produced the embryos: "We spoke only briefly about the prohibition on 'the buying and selling of human embryos, eggs, and sperm.' ... From the October meeting transcripts, we understand that the Council has decided not to ban egg and sperm donation when the donors are compensated. ... You also indicated that you would not object to reimbursement for embryo storage fees or the costs of the treatment that produced the embryos."

This should give considerable pause to any one truly concerned about the direction that public policy making on such fundamental human issues is currently taking.

In reading these Letters of Testimony, it should also become clear to even the most skeptical that most of the "biological materials" (embryos) required for such unethical research as human cloning, human embryonic stem cell research, and human genetic engineering (in which living human embryos are destroyed) derive from IVF "clinics", especially through the donation by women of their "surplus" human embryos. Indeed, much unethical research requiring the killing of these human embryos involves "IVF research" itself -- e.g., in order to "improve IVF techniques". No IVF research, no human cloning, human embryonic stem cell research, or human genetic engineering. In RESOLVE's own words: "Finally, we wish to reiterate that, as a nonprofit organization committed to helping individuals overcome disease, RESOLVE is also committed to scientific progress in finding cures and treatments for infertility. We remain concerned that some of the proposals in Part III of the Council's recommendations may stymie valid scientific research that could help infertile couples, and urge the Council to obtain further information from a broad range of clinical and basic science researchers before moving forward." (http://www.resolve.org/main/national/advocacy/letters/Presidents-Council-Letter-20031216.doc).

The only way that such inherently unethical research has been and can be "justified" is to redefine the embryonic human being as something other than what it is in reality, as something less than human.

We've seen this for decades now with their propagation of the fake scientific term "pre-embryo" -- and the ever-lengthening list of fake scientific "pre-embryo substitutes" (e.g., the immediate product of fertilization or cloning is "just a blob of tissues", "just a group of stem cells", "just an egg that is fertilized", etc.). In these Letters of Testimony RESOLVE has introduced yet another "pre-embryo substitute" in order to justify unethical research and medical practices: now the immediate product of fertilization is "just fertilized human tissue"!!! As RESOLVE states it: "RESOLVE supports and defends the right of individuals to be free from interference in making the very personal decision about the uses of their own body tissues, including reproductive tissues and fertilized reproductive tissues." (emphasis added)(http://www.resolve.org/main/national/advocacy/testimony/Presidents-Council-Testimony-200306.jsp).

As has been known and documented for over a hundred years, and as acknowledged by the International Nomina Embryologica Committee for decades, the immediate product of fertilization (natural or artificial IVF) is a new living human BEING, an individual, an organism. Each of us human beings began as a single cell zygote! This is a basic objective scientific fact, yet this accurate science has been allowed to be caste as just a "personal opinion", or a "belief" to be weighed and measured along with other "personal opinions" and "beliefs".

It is not an "opinion" nor a "belief" -- it is an objective scientific fact. And public policy -- even in democratic, pluralistic, multicultural societies -- deconstruct or deny this objective scientific fact at their own peril. As a living human being, this individual has an equal right to be respected and treated as fully as any other human being. And that includes the right to life, the right to caring natural parents, the right not to be experimented on and mutilated, etc. RESOLVE responds by defining a human BEING only in terms of qualities and characteristics of normal adult human beings. This is nothing more than an inept attempt to mimic the classic Peter Singer definition of "person" only in terms of "rational attributes" and "sentience" -- which would define out of "personhood" all mentally and physically disabled. But at least Peter Singer would allow them "humanhood". RESOLVE refuses even that, and The President's Council on Bioethics agrees. Woe is us -- adults.


RESOLVE'S LETTER OF TESTIMONY, Dec. 2003:

http://www.resolve.org/main/national/advocacy/letters/Presidents-Council-Letter-20031216.doc

RESOLVE: The National Infertility Association

Letter to President Bush's Bioethics Council, December 16, 2003

... First, we appreciate your assurance that you see the practice of assisted reproductive medicine as "by and large healthy," and that you are principally concerned with the intersection of assisted reproductive technology (ART) with genomic knowledge and the potential future societal effects. Your focus, therefore, is on the potential extremes that can be envisioned ... We discussed the proposal to "[p]rohibit the initiation of a human pregnancy (using embryos produced ex vivo) for any purpose other than to attempt to produce a live-born child." We expressed two concerns about this proposal: first, that it could be construed to prohibit the use of embryos created ex vivo for any purpose other than pregnancy, thus potentially prohibiting all research that involves embryos or embryonic cells. This interpretation could arise if the parenthetical were seen as a rephrasing of the phrase "initiation of a human pregnancy" or if the vague concept of "initiation" were construed to mean "fertilization" rather than transfer of embryos to the uterus for implantation. You assured us that neither of these interpretations is intended and that you would adjust the language to make this clear.

... The second concern about this proposal was that it could be misconstrued to prohibit the transfer of more embryos than the parents intend to have as live-born children. In some cases, for example, four embryos might be transferred in an attempt not to have four live-born children but to have one or two children, since the implantation potential of embryos is considerably less than 100%, embryo quality may vary greatly, and it may require the transfer of four or more embryos to have one child. You assured us that it was not your intentions -- in this provision or in any of the proposals -- to limit the number of embryos that may be transferred to a woman during fertility treatment. We look forward to seeing language added to this proposal to make that position clear. In addition, we trust that you will also ensure that nothing in this proposal would be used directly or indirectly to prohibit legal therapeutic reduction.

... We also spoke about the proposal to "[p]rohibit attempts to conceive a child by any means other than the union of egg and sperm obtained directly from no more and no less than two adult human parents." You told us that the word "parents" was not being used in the sense of requiring that those who provided the gametes also needing to be the parents raising the child; you suggested that a term such as "two biological progenitors" would be used instead. You also stated that it was not the Council's intention that this provision would prohibit ooplasmic transfer.[3] However, the requirement of "two biological progenitors" could certainly be construed to forbid treatments where the DNA of a third person might also be present in the embryo since the means would involve more than two biological (or genetic) progenitors. [Footnote 3: Ooplasmic transfer and nuclear transfer are two experimental therapies that are sometimes confused with but are in fact unrelated to cloning. RESOLVE has no stated policy for or against these therapies, but accepts the Council's statements that it does not wish to prohibit them.]

The phrasing "by any means other than the union of egg and sperm obtained directly" also could be construed to forbid ooplasmic transfer and nuclear transfer since means "other than the union of sperm and egg" are also involved. (In nuclear transfer, for example, after the union of sperm and egg, the nucleus is transferred to another previously fertilized and enucleated embryo. This could be viewed as involving a means "other than the union of egg and sperm obtained directly" from two biological progenitors.) Since "union" is not a scientific term, it probably would be wise to make it clear that ICSI (intracytoplasmic sperm injection) is not excluded from that term. If it is the Council's intention not to prohibit such treatments, then the language will have to be explicit and expanded. We will await the next wording of the provision.

We spoke only briefly about the prohibition on "the buying and selling of human embryos, eggs, and sperm." From the October meeting transcripts, we understand that the Council has decided not to ban egg and sperm donation when the donors are compensated; we also understand that language banning compensated surrogacy has been eliminated. But we remain unclear about the Council's position on embryo donation. We suggested, and have confirmed, that in the practices of which we are aware, embryo donors are not currently paid for their embryos, per se. They may be reimbursed for additional testing and legal fees they incur as part of the donation process. You also indicated that you would not object to reimbursement for embryo storage fees or the costs of the treatment that produced the embryos. Again, we will await the Council's future decrees on this subject.

Conferring Human Status on Embryos: In Part II, subsection B, the Council proposes that ART physicians "[t]reat children-to-be [embryos] as patients." At our meeting, you clarified that only the embryos actually transferred to a woman's uterus ought to be treated as "patients" of the doctor, but we remain quite unclear about what this means. As we pointed out, ART physicians are seeding to help women and couples become pregnant, and the sine qua non of a pregnancy is a viable embryo. Thus, the interests of the doctor, patient, and embryo (to the extent one might impute interests to an embryo) are already aligned.

We cannot see what is added by directing doctors to treat microscopic embryos as "patients". What change in behavior is sought? Are physicians to undertake an oath of loyalty to the microscopic embryo? Seek its informed consent? The concept is dubious. Once the embryo has been transferred to the uterus, moreover, the fertility specialist typically does not provide any further treatment but waits in hope that the embryo will implant and the patient can be transitioned to an obstetrician for monitoring of her pregnancy. In fact, the only result we can see of a law commanding doctors to treat the microscopic embryo as a "patient" is a not-so-subtle conferring of "human status" on embryos, which the Council has allegedly disavowed because of disagreement over the moral status of embryos.

There is a related proposal in Part II, subsection E to "[c]reate and enforce minimum uniform standards for human subjects protection." Since adult infertility patients already have "human subjects protection" when participating in clinical trials, this provision must seek to extend human subjects protection to embryos [emphasis in original] This concerns us because it suggests that embryos would be subject to literal human-subjects analysis by Institutional Review Boards (IRBs).

IRBs traditionally assess the risks and benefits to a human subject from their participation in research. If embryos were treated as "humans" for such purposes, which again suggests an imputation of human status to embryos, the results could be devastating for infertile couples. In the course of IVF, individual embryos may fail to develop, even as others progress and become longed-for babies. When some fail to develop, it could (wrongly, we believe) be seen as violating the risk-benefit analysis for those particular embryos. Even something as commonplace and advantageous to treatment as embryo cryopreservation could be called into question by the misapplication of a human-subjects risk/benefit analysis to embryos, since some embryos may be damaged by the freeze-thaw process. Such an outcome could halt fertility treatment in its tracks. Fewer babies would be born to infertile couples, which would undermine the societal good of procreation. Thus, we strongly urge that it be made clear that IRB "human subjects protection" is not intended for individual embryos.

... Finally, we wish to reiterate that, as a nonprofit organization committed to helping individuals overcome disease, RESOLVE is also committed to scientific progress in finding cures and treatments for infertility. We remain concerned that some of the proposals in Part III of the Council's recommendations may stymie valid scientific research that could help infertile couples, and urge the Council to obtain further information from a broad range of clinical and basic science researchers before moving forward.

(signed) Lee Rubin Collins, Board of Directors, and Erin Dramer, Director of Government Affairs.


RESOLVE'S LETTER OF TESTIMONY, June 2003:

http://www.resolve.org/main/national/advocacy/testimony/Presidents-Council-Testimony-200306.jsp

Transcript: RESOLVE Testifies before PresidentŐs Council on Bioethics (June 2003)

... RESOLVE is a national non-profit organization that has for 30 years been providing compassionate support and information to those suffering from the disease of infertility. RESOLVE works to increase public awareness of the issues surrounding infertility and the various family building options available to those working to resolve their infertility. ... Like all prospective parents, infertility patients have as their foremost concern the safety of their future children and carefully consider that the actions they take can determine the quality of health, well-being and life experience of their offspring. ... Infertility patients are well informed about their care and question in minute detail every single contingency associated with treatment and weigh carefully the risks and benefits of each contingency, ... . ... We are adamant that this mainstream medicine should not be equated with reproductive cloning ... . ... RESOLVE supports and defends the right of individuals to be free from interference in making the very personal decision about the uses of their own body tissues, including reproductive tissues and fertilized reproductive tissues.


washingtonpost.com:
http://www.washingtonpost.com/wp-dyn/articles/A21071-2004Jan15.html

By Rick Weiss
Washington Post Staff Writer
Friday, January 16, 2004; Page A02

Bioethics Panel Calls for Ban on Radical Reproductive Procedures

A presidentially appointed bioethics commission yesterday approved near-final wording for its highly anticipated report on human reproductive technologies, calling for enhanced professional guidelines for fertility doctors and a federal ban on certain radical procedures, such as creating animal-human hybrids.

But the report stops short of recommending broad new regulations relating to baby making, which the fertility industry had feared and fought against.

The report, "Biotechnologies Touching the Beginnings of Human Life," will be issued by the President's Council on Bioethics, a panel of scholars and scientists commissioned by President Bush in 2001 and chaired by University of Chicago scientist-philosopher Leon Kass.

The council has previously addressed such intensely controversial issues as human embryonic stem cell research and cloning. But its nine-month foray into human reproductive technologies -- a field that encompasses not only basic research but also a medical specialty that performs 100,000 fertility procedures a year at a cost of about $1 billion -- took the group through especially treacherous political, ethical and economic terrain.

Initial discussions by the council last summer left many fertility specialists convinced the council was, as some said then, "out to get us." Those fears were stoked by recent writings by Kass and other council members expressing grave reservations about the fate of the human race should it continue to tinker with its embryonic roots.

In fact, the council did discuss at length the fertility industry's relatively unregulated status. Concerns were raised about the "slippery slope" that could lead fertility doctors -- or at least a few rogues among them -- to try increasingly far-reaching techniques to achieve pregnancies, at the risk of producing grotesque mistakes.

Several council members were critical of the profession for not proving the safety of its techniques before trying them in women. Early versions of the report called for far more public disclosure of the fates of all embryos made in fertility clinics as well as detailed tracking of the health of all babies born by in vitro fertilization (IVF) and other techniques.

In the latest draft, however, those provisions have been dropped, in part because of concerns that systematic tracking of IVF children would constitute an invasion of their privacy and could stigmatize them. Instead, the council calls for greater attention to professional ethics -- including better informed consent for women about the risks and costs of fertility treatments -- and a federally funded and voluntary study of the health of IVF children.

Initial versions of the report also contained politically divisive language, now removed. Instead of using the word "embryo," for example, early drafts used phrases such as "child to be" or "future child."

All told, Kass said, the draft approved yesterday -- which now faces only minor edits before being released -- is a "modest" document but one that the nation and Congress should be able to get behind.

"It's a community expression of boundaries," Kass said, "and shifts the burden of persuasion to the innovators who want to cross those boundaries."

Beyond its call for professional reforms, the council recommends that Congress at least temporarily prohibit the gestation of human embryos in animal wombs and the fertilization of human eggs with animal sperm, and vice versa.

It also asks Congress to outlaw any transfer of an IVF embryo to a woman's womb for any purpose other than to produce a live-born child -- a measure aimed at preventing the "farming" of fetuses for body parts.

And the draft calls for a ban on the creation of human embryos from cells obtained from a human fetus -- a technique now technically feasible that could lead to the birth of a child whose parent was never born.

"There is a lot to like in this report, and we certainly are pleased to have Dr. Kass and his colleagues join our longtime call for additional federally funded research in this area," said Sean Tipton, a spokesman for the American Society for Reproductive Medicine, which represents fertility doctors and lobbied the council hard.

Congress has long blocked federal spending on human embryo research, leaving it to fertility clinics to finance their own studies. And federal funding for follow-ups of U.S.-born IVF children has been minimal.

The American Infertility Association, representing fertility patients and families, applauded the revised draft, saying in a statement that it was "relieved" the council had decided not to recommend new restrictions on egg and sperm donation or surrogacy arrangements.

© 2004 The Washington Post Company

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