Last week, Health and Human Services Secretary Kathleen Sebelius overruled the decision of Food and Drug Commissioner Margaret A. Hamburg to allow the wider availability of Plan B One-Step® (levonorgestrel, Teva Women’s Health, Inc.) without a prescription to all women of child-bearing age, more specifically to adolescent girls under age 17. This was the first time that a health secretary has ever publically exercised statutory authority to reverse an FDA commissioner. Moreover, Secretary Sebelius was fully supported by President Obama in this action.

However, today’s headline – “Sebelius: Decision to keep Plan B age restrictions not political” – is difficult to believe. Particularly, when Plan B decisions have almost always been political. See here and here.

It’s difficult when a career politician dismisses the professional advice of experts and claims that the decision did not involve political considerations. But what gives credence to the Secretary’s stand is: (1) her pro-choice positions as governor of Kansas, (2) the fact that she’s facing considerable opposition from well-known Democratic leaders around the country, and (3) her willingness to reconsider the issue if the manufacturers of Plan B reapply with additional data about the “significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age.”

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

Gene therapy is experiencing a renaissance, with many of the recent successes in children. For some conditions, the younger the child, the better the genetic correction, because affected tissues degenerate with time. This is the case for adrenoleukodystrophy (ALD), the “Lorenzo’s Oil” disease that strips the insulation from brain neurons. One goal of the not-for-profit Stop ALD is to team gene therapy with newborn screening, to help boys before they begin to lose abilities. 

Should gene therapy be attempted even earlier? Before birth?

Fetal gene therapy is already being done in non-human animals, presumably in preparation for phase 1 clinical trials. Gene therapy is technically more challenging than inserting a shunt to drain a hydrocephalic brain or repairing an open spine, because it entails delivering gene-carrying viruses to affected cells and not anywhere else. It is fetal medicine on a different scale. 

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

The overarching ethical concern related to preimplantation genetic diagnosis/human leukocyte antigen (PGD/HLA) testing is the moral status of the embryo. Many books have been written on this topic and many more are being contemplated. The ongoing public discussion of this and related issues continues to be breaking news, as most recently exemplified by the "personhood amendment" proposed to Mississippi voters who will "decide" the matter on November 8th, 2011.

The question of distributive justice is a key concern in all aspects of reproductive genetics and genetic medicine generally.  Moral and ethical considerations demand equitable distribution of these resources.  Ongoing nationwide campaigns should be directed toward functional medical and scientific education of the citizenry.

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

Donor gamete regulation is an ongoing topic in the United States. What's so special about gametes that causes us to be concerned about their commodification? Commodification itself is not a bad thing. In free societies, supply-and-demand relationships precisely determine prices.

Should a woman be allowed to sell her ova in the same manner as she might sell other services related to her body, such as modeling or in the performing arts? Are there differences between an egg and the collection of cells and tissues that comprise her physical form?

The real issues do not relate to commodification, but rather concern protecting both buyers and sellers. We should also be worried about the interests of children, and the impact on our society of a market which explicitly places a higher price on “whiteness”, “tallness”, “Ivy League–ness”, and so on. If commodification is not an issue, why set a limit on prices?

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

Long ago, in embryology class, we learned about remarkable cells that were totipotent. These embryonic cells had the amazing ability to develop into any other type of cell and also, given the right conditions, to develop into an entire organism. In 1998 researchers announced they had isolated human embryonic cells and the arcane terms totipotent and pluripotent became firmly implanted in the public consciousness. The new ability to isolate and culture these cells launched a brand-new field of biomedicine — stem cell research.

The new field has engendered great hope for the potential development of treatments for deadly genetic diseases and severe chronic diseases such as cancer, stroke, and diabetes. The new field has also created bitter controversies that have raged between supporters and opponents of embryonic stem cell research.

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

Reproductive cloning has the potential to provide great happiness to many people around the world. When available, this newest assisted reproductive technology will enable infertile couples to have children to whom they are genetically related. RC will also be of significant benefit to many other couples and individuals. Those interested in reproductive cloning include many couples who do not have problems related to fertility.

Of course, none of this technology is available as yet. These are very early days regarding cloning research. It’s important to have wide-ranging discussions of the ethical concerns and implications of reproductive cloning well in advance of the development of the techniques themselves.

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

If and when reproductive cloning becomes a reality, there will be plenty of takers. Many families would greatly benefit if cloning could eventually become an additional highly effective strategy for assisted reproduction.

Reproductive cloning would also be of great benefit for same-sex couples, as well as for those prospective parents who are at risk for transmitting a genetic disease.

The availability of reproductive cloning would completely change the landscape of assisted reproduction.

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

A new biomedical abbreviation debuted July 22, ACHM (for Animals Containing Human Material) in a report of the same name from the UK Academy of Medical Sciences. ACHM will soon replace, I hope, the phrase “humans and animals,” which implies to the taxonomically inclined that we are instead fungus, plant, or microbe. Even the editorial in Nature on the report notes “the distinction between humans and animals.”

Perhaps because I write college biology textbooks that treat Homo sapiens as any other animal species, I’ve long thought a new term necessary. “Non-human animal” is cumbersome. And so I was thrilled at the UK’s acknowledgement of our Kingdom membership, joining us to the others distinguished by our lack of cell walls. But I fear ACHM isn’t catchy enough, and may head straight into the abbreviation graveyard of RFLPs, SNPs, and iPS cells, none of which really caught on beyond the scientific community. Neither will ACHM work as an acronym; it sounds like a clearing of the throat.

Semantics aside, the report is important. It prepares the biomedical community for future use of animals in research that will increasingly include human material. Said Professor Martin Bobrow, chair of the working group, “Our report recommends … a national expert body, within the existing stringent system of animal research regulations, to provide specific advice on sensitive types of ACHM research.”

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

Distributive justice does not imply that everyone should have equal access to everything all the time. This would be an extreme position and lead to severe distortions in availability of medical services. Competing needs must be balanced fairly and opportunities to access medical care must be equitable. In the American health care marketplace, however, the bioethical principle of distributive justice receives lip service only. In America, when it comes to health care, minimal attention is paid to matters of fairness.

Opponents of reproductive cloning fear that the resulting children will not be able to live fully independent lives. Opponents fear that these children’s choices will be constrained in numerous ways and assert that an open future — which is a right of every child — will never be possible for a child who is a clone. Reproductive cloning naysayers believe that the human rights of these children will be violated and therefore the process should be banned.

Various premises provide the background to these beliefs. Various mental constructs may significantly constrain the child's choices and development in ways that mitigate the possibility of an open future. In this regard, being a clone violates the child's rights as a human being.

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.