Surrogacy in the Market of Desire

The State of Florida has spilled no small quantity of ink outlining the legal confines of gestational surrogacy (see particularly sections 742.13-742.17, here).  Legally permitted gestational surrogacy in Florida does not include “bringing in and harboring aliens, sex trafficking of children, forced labor and furthering slave traffic,” however; these charges were leveled against Esthela Clark in 2015. Clark had held a Mexican woman in her one-bedroom apartment, repeatedly inseminating her with semen from Clark’s boyfriend. When the woman failed to become pregnant, she was forced to have sex with two strangers, and placed on a diet restricted to beans.  On 29 March 2017, the 47-year-old Clark from Jacksonville, FL, pled guilty to one count of forced labor. The woman had been forced to clean Clark’s apartment. (See story here.)  What happened to the issues surrounding the smuggling of the woman across the border in order to be a surrogate for Clark and her boyfriend?

On the other side of the globe, India is arguably the world’s leading provider of surrogate mothers, with the industry estimated several years ago as “likely worth $500 million to $2.3 billion.”  India legalized surrogacy in 2002, and is now considering reining in its surrogacy situation:

     The Surrogacy (Regulation) Bill, 2016

 

  • The Surrogacy (Regulation) Bill, 2016 was introduced by Minister of Health and Family Welfare, Mr. J. P. Nadda in Lok Sabha on November 21, 2016.  The Bill defines surrogacy as a practice where a woman gives birth to a child for an intending couple and agrees to hand over the child after the birth to the intending couple.
  • Regulation of surrogacy:  The Bill prohibits commercial surrogacy, but allows altruistic surrogacy.  Altruistic surrogacy involves no monetary compensation to the surrogate mother other than the medical expenses and insurance coverage during the pregnancy.  Commercial surrogacy includes surrogacy or its related procedures undertaken for a monetary benefit or reward (in cash or kind) exceeding the basic medical expenses and insurance coverage.
  • Purposes for which surrogacy is permitted:  Surrogacy is permitted when it is, (i) for intending couples who suffer from proven infertility; and (ii) altruistic; and (iii) not for commercial purposes; and (iv) not for producing children for sale, prostitution or other forms of exploitation.

In their 2012 Journal of Medical Ethics article, Deonandan, Green and van Beinum formulate eight “Ethical concerns for maternal surrogacy and reproductive tourism

Robustness of informed consent

Custody rights

Quality of surrogate care

Limits of surrogate care

Remuneration

Multiple embryo transfers and abortion

Medical advocacy

Exploitation of the poor

Of the eight ethical concerns Deonandan et al found in the Indian experience of surrogacy, at least five of them were present in the Florida case described above –and that would-be surrogate was not even pregnant! It seems that India is not the only entity that should reconsider commercial surrogacy.

 

— D. Joy Riley, M.D., M.A., is executive director of The Tennessee Center for Bioethics & Culture.

The Semantics of Therapy, Part II

A previous blog post of “The Semantics of Therapy” posed three questions about the human genome being a “patient” to be treated. One reader found the post “provocative and disturbing” and called for further explanation and discussion of the questions posed. That will take some time and several postings.

The first of the questions to be considered is this: If the “patient” is a genome, to whom does the researcher answer?   An answer from recent history may shed some light on this important issue.

33 infertile couples underwent a novel procedure at New Jersey’s Saint Barnabas Medical Center during the years 1996-2001. Embryologist Jacques Cohen used cytoplasmic transfer–ooplasm from the oocytes of fertile women was transferred into the eggs of infertile women–in the hope of establishing pregnancies in the latter. The outcome was 13 pregnancies and 17 babies from the Saint Barnabas experience (see accounts here and here).

According to a 2014 BBC article, one resulting pregnancy, which ended in miscarriage, revealed a missing X chromosome in the fetus. The same anomaly was noted in another child: one of a set of twins from a different pregnancy. Later, one child showed evidence of developmental delay. In 2014, Cohen estimated that the worldwide experience of cytoplasmic transfer between oocytes had resulted in the births of 30-50 babies, although the FDA had effectively stopped the procedure in the U.S. in 2002.

What had the follow-up on the babies born through cytoplasmic transfer been in 2014?

Due to a lack of funding, Cohen says, it hasn’t been possible to find out about how any of the children like Alana who were born from cytoplasmic transfer are doing. But the St Barnabus Institute is now starting a follow up study to check their progress (BBC).

In October 2016, Chen, et al, published “A limited survey-based uncontrolled follow-up study of children born after ooplasmic transplantation in a single centre,” in Reproductive BioMedicine Online.  Twelve of thirteen couples responded; parents of quadruplets did not:  “One couple disclosed the use of egg donor to their child. One reported intention to disclose; six were undecided and four reported they would not disclose.” (Article here.)

This admittedly biased study and a few newspaper-based profiles appear to constitute the follow-up of significant genetic intervention in babies-turned-human-subjects. So what will the future hold?

The recent committee report on human genome editing had this to say about heritable genome editing:

As with any new procedure, carefully monitored clinical trial protocols would be required for germline genome editing, with attention to monitoring off-target events as well as the efficiency and correctness of the specific edit. Unlike conventional clinical trials, germline genome editing trials would likely require long-term prospective follow-up studies across subsequent generations. This follow-up would entail study of the future children affected by the intervention, none of whom would have been party to the initial decision to participate in a research trial. . . . Even those who have volunteered to be research subjects cannot be compelled to participate in long-term follow-up. Nonetheless, encouragement is permitted. . . . (download available here)

Should we be comforted by the “long-term prospective follow-up” and the permitted “encouragement” that may be necessary?  Presumably the long-term prospective follow-up will be dependent upon the monies allocated for same (when the money runs out, so does the interest?).  When the State is involved, what kind of “encouragement” might be involved?

On the other hand, what about any anomalies that may be caused by these procedures?  Will pregnant women be “encouraged” to abort such offspring?  If born, will the resulting children be treated, or only followed like any other long-term science experiment?  Who explains to these, and indeed, all of the children born through germline genome editing, that they are indeed long-term experiments?

 

— D. Joy Riley, M.D., M.A., is executive director of The Tennessee Center for Bioethics & Culture.

A Conflict of Interest is NOT an Ambiguity

Oregon Senate Bill 494 has been described as a “euthanasia bill” that is “intentionally ambiguous,” and as a piece of legislation that would “allow the starving and dehydrating of patients who suffer from dementia or mental illness.”

What has received less press is the composition of the 13-member committee who would be perpetually in charge of advance directive forms in the state, with no oversight by the legislature. Who would those persons be? According to the bill, the 13-member “Advance Directive Rules Adoption Committee” would include

  • The Long Term Care Ombudsman or that individual’s designee
  • 12 members appointed by the Governor
    1. one representative of primary health care providers
    2. one who represents hospitals
    3. one clinical ethicist affiliated with a health care facility
    4. two health care providers with palliative care or hospice expertise
    5. one who represents persons with disabilities
    6. one who represents “consumers of health care services”
    7. one who represents “the long term care community”
    8. one who has expertise in “advising or assisting consumers with end-of-life decisions”
    9. three members from among those proposed by the Oregon State Bar:
      • an expert in elder law
      • an expert in estate planning
      • an expert in health law

Why is the State of Oregon so interested in making sure their appointees are in charge of advance directives?  Is it because the state is so concerned about the health of its citizens?  Hardly, when those citizens in the health care system are described not as patients, but consumers.  Stacking the committee with lawyers who are experts in estate planning and elder and health law seems to assure the state that they will get their pound of flesh.  The State is aware of this:  deceased consumers no longer need their money or their organs.  The conflict of interest inherent in this scheme is not ambiguous.

 

— D. Joy Riley, M.D., M.A., is executive director of The Tennessee Center for Bioethics & Culture.

Excuse Me, Doctor, What Exactly Do You Profess?

The late Edmund Pellegrino, M.D., revered medical educator, ethicist, and physician, often made the point that a professional professes something. Merriam-Webster  confirms that the etymology of the word, profession, includes the Latin for “public declaration.”

The Hippocratic Oath, probably penned by members of the Pythagorean sect, according to Ludwig Edelstein (see Ancient Medicine: Selected Papers of Ludwig Edelstein. Baltimore: Johns Hopkins University Press, 1987), has for centuries been accepted as the gold standard for the practice of medicine. Nigel M. deS. Cameron (The New Medicine: Life and Death After Hippocrates. Chicago: Bioethics Press, 2001)
 explicates the Hippocratic Oath as containing four parts:

1.   Covenant with Apollo and others

2.   Duties to teacher

                            Regard teacher as equal to parent

                            Treat him as a partner in livelihood

                            Share money with him when needed

                            Consider his children as siblings

                            Teach medicine to own children, children of teacher, and pupils who take the oath

3.  Duties to patients

                            Use treatment to help the sick, never to injure or wrong them

                            Give no poison to anyone though asked to do so, nor suggest such a plan

                            Give no pessary to cause abortion

                            In purity and in holiness to guard the practitioner’s life and art

                            Use no knife on “sufferers from stone,” but allow others trained to do so

                            Enter houses to help the sick, not to participate in wrong doing or harm

                            Keep oneself from fornication with woman or man, slave or free

                            Not to divulge, but guard as holy secrets those things that are heard by the practitioner

4.  Sanction

Oath-taking by medical students has increased in the last 50 years, as reported by Neil Chesanow, in “Is it time to retire the Hippocratic Oath?” Medscape, 25 Jan 2017.  The form of oath taken by medical students has also changed. Many schools have re-written the oath in “updated” language, and a good number of students craft their own.

Do they swear not to have sex with their patients? Do the medical students or newly minted physicians now swear not to give poisons or pessaries? What oaths are taken in those states where physician-assisted suicide has been made legal? It would be good for the public to know. Perhaps it is time for physicians to post on their walls (actual and virtual) exactly what it is they profess to be and to do.

 

— D. Joy Riley, M.D., M.A., is executive director of The Tennessee Center for Bioethics & Culture.

 

The Semantics of Therapy

What is therapy? This is one question that should occur to the reader of Jill Neimark’s “Unexpected Risks Found In Replacing DNA To Prevent Inherited Disorders.” In referring to the birth of the baby born of three parents last year, the author names it “mitochondrial replacement therapy”:

Using a technique called mitochondrial replacement therapy, the researchers combined DNA from two women and one man to bypass the defect and produce a healthy baby boy — one with, quite literally, three genetic parents.

Jill Neimark is not alone in this use of the term. Shoukhrat Mitalipov, who has lobbied several nations for funding for such research, and his co-author, Don P. Wolf, make that claim in their 2014 paper, “Clinical and Ethical Implications of Mitochondrial Gene Transfer.” Mitalipov and Wolf state that because the changes produced by mitochondrial replacement techniques are “permanent” and “would be transmitted through generations,” this qualifies as “germline gene therapy.” Therapy, according to the Oxford Dictionary of English, is “treatment intended to relieve or heal a disorder;” its Greek roots mean “healing” and “minister to, treat medically.”

Who, then, is treated therapeutically in “mitochondrial replacement therapy”? Is it the child? When John Zhang formed in the laboratory five embryos, each from three progenitors, only one embryo was transferred to a woman’s uterus. That child, a boy, was born in 2016. Readers are not told the disposition of four of the embryos that were not “normal.” If they were destroyed, one could not say that the mitochondrial replacement was for them therapeutic. If the child born of three parents lives a “normal” life, was the mitochondrial replacement therapeutic for him? From a scientific point of view, no, for he did not exist prior to his conception.

It appears, then, that the beneficiary of the mitochondrial replacement “therapy” is the genome. If this is true, a host of difficulties present themselves. Three of these are

  1. If the “patient” is a genome, to whom does the researcher answer?
  2. What other interventions in the genome will be needed? Who decides? Is there a limit?
  3. If the mitochondrial genome of a child so conceived reverts to that of his nuclear-genome-mother, as Mitalipov in his December, 2016, Nature letter reports as a possibility, then what recourse is possible?

— D. Joy Riley, M.D., M.A., is executive director of The Tennessee Center for Bioethics & Culture.