I just returned from the annual Oncofertility Consortium Conference and one of the ethical topics that came up was the possibility of disputes over frozen reproductive materials. Before undergoing life-saving cancer treatment, people may opt to freeze gametes, gonadal tissue, or embryos in order to preserve their fertility. If these people die or separate from their partners, a battle over what to do with the frozen reproductive materials can ensue. The best and easiest way to deal with disputes over reproductive material is to try to prevent them before they happen. In this blog, I discuss two ways to prevent such disputes. 

One way is to have the individual with cancer write an advance directive that clearly outlines what should be done with the reproductive material should the patient die. If the reproductive materials are gametes or gonadal tissue, then ultimately the decision of what to do with the reproductive material should be made by individual with cancer, as it is her/his genetic material. If the reproductive materials are embryos, then the individuals who contributed the gametes to create the embryos should come to an agreement about how the embryos should be handled under unfortunate circumstances (e.g. death of the genetic parents or separation of the couple). Many infertility clinics require all patients—both individuals and couples—to complete a document outlining how to handle reproductive materials in unfortunate circumstances and I think this should be standard practice for oncofertility patients as well. 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

Thanks to health care reform, beginning last month women with health insurance no longer have to pay for contraception. While I fully support this legislation, I think it has unintended negative consequences for both women and men. Specifically, I am concerned that this legislation, as well as the debate surrounding it, once again conflates reproduction with women, thereby ignoring men’s reproductive responsibility and autonomy.

This legislation is based on and buttresses our current heterosexual contraceptive arrangement in which women are largely held responsible for contraception, especially in monogamous relationships where couples are more likely to depend upon long-acting, reversible contraceptives (LARCs) or sterilization rather than barrier methods. Women today actively participate in all contraceptive methods except vasectomy, which only accounts for 9% of contraception use in the U.S. Part of the reason for this is due the disparity between the number and types of female and male contraceptives: there are eleven contraceptive options for women, including various types of LARCs, and only two for men—male condoms and vasectomy—neither of which are LARCs. Monogamous couples not ready for sterilization generally don’t delegate contraceptive responsibility to men because male condoms are not well-suited to their needs: they are not nearly as effective as female LARCs (16% versus under 3% failure rate for typical use) and they can interrupt and minimize pleasure during sex.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

A recent New York Times article shares the story of Debra Demidon, who developed severe ovarian hyperstimulation syndrome (OHSS) after undergoing IVF. This potentially life-threatening condition caused her to gain more than 30 pounds of fluid and have trouble breathing, and ultimately landed her in the hospital for 5 days. OHSS is much more common in the US and UK than in Europe and Japan because the former countries rely on high-dose hormones for IVF where the latter countries use lose-dose hormones. Although rare, OHSS following high-dose hormone IVF is now one of the leading causes of maternal mortality in parts of the UK. OHSS is not the only adverse side effect of high-dose IVF for women; there are myriad other possible side effects including increased cancer risk, memory loss, and liver disorders.  Furthermore, there can also be increased risk for children born from high-dose IVF, such as low birth rate. 

Knowing these serious potential health-related outcomes, why is high-dose IVF the dominant and default method used in the US? The main reason is that high-dose IVF produces many more eggs (often 20-30 eggs and sometimes even more) than low-dose IVF produce (8-10 eggs). Given that most insurance companies do not cover infertility treatments (only 15 states have laws mandating insurance companies to cover infertility treatments and there are many exemptions and caveats), many people pay out of pocket for IVF. In order to save money – IVF costs $15,000 - $30,000 a cycle – people are often willing to increase their risks to themselves (choosing high-dose IVF or low-dose IVF) if it means they’re likely to generate more eggs. Individuals in time pressure situations who may only have one shot at gathering eggs, such as cancer patients wanting to preserve their fertility before undergoing treatments that will hopefully save their lives but may render them infertile, may also opt for high-dose IVF.  

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

The Huffington Post recently published a blog by bioethicist and philosopher Rory E. Kraft, Jr. titled “Pregnancy as Harm?” As a friend and former colleague of Dr. Kraft, he and I have had numerous conversations about pregnancy as harm and we have presented on a conference panel together on this very topic. However, it seems—based in part on my students’ reactions and discussions I’ve had with people who don’t work in the field of reproduction—that most people find the idea of pregnancy as harm as counterintuitive or oxymoronic. 

Pregnancy is generally understood as a beautiful, special, and maybe even magical time in a woman’s life. And while it no doubt is for many women, it can simultaneously be harmful. For example, pregnancy can entail various nontrivial, though not life-threatening, discomforts, such as weight gain, back pain, edema, and morning sickness. Furthermore, pregnancy can lead to life threatening conditions, such as gestational diabetes and hypertension, and in many parts of the developing world pregnancy related complications are the leading cause of death for women in their prime. In addition to being painful, giving birth can also cause harms, like hemorrhaging, internal tearing, placental abruption, and nerve damage to the pelvic structures. In addition to physical harms, pregnancy and childbirth also have the potential to lead to mental health problems. Since being pregnant changes women’s hormone levels, it can affect women’s emotional well-being and their overall psychological balance. 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

Around 10% of all people diagnosed with cancer are in their reproductive or pre-reproductive years (under age 45). This means that, each year, approximately 133,000 women, men, and children who are diagnosed with cancer are at risk for infertility due to the very treatments (e.g. chemotherapy, radiation, and surgery) that can save their lives. Given improved survivorship rates, fertility concerns have emerged as an important quality of life issue to cancer survivors and their families. Oncofertility, a new and interdisciplinary field at the intersection of cancer and fertility, is working to address potential infertility as a result of cancer treatment. 

Although more cancer patients are being offered and are using fertility preservation technology (FTP), its cost and the lack of insurance coverage for it are often the major reasons given by oncologists for why they do not provide information on fertility preservation options to their patients. One method of ensuring people in their reproductive years or children who are diagnosed with cancer have access to and insurance coverage for FPT is to create a legal mandate requiring insurance companies to cover FTP for cancer patients. 

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.

In August of this year, the Department of Health and Human Services announced that, as part of its preventive health initiative under the Patient Protection and Affordable Care Act, insurance companies would be required to provide birth control with no co-pay beginning in August of next year. This decision empowers women to have more control over their reproduction and should (hopefully) decrease the percentage of unintended pregnancies, which currently stands at a shockingly high 50 percent. Evidence shows that the medicalization of contraception—that is, positioning physicians as gatekeepers to contraception—increases cost and decreases access. In evaluating what contributes to unplanned pregnancy, 54 percent of women stated cost as an obstacle to contraception use and 66 percent claimed that an inability to obtain contraception played a role.

Today there are eleven contraceptive options for women: female condom, tubal ligation, cervical cap, diaphragm, implant, injectable, IUD, patch, pill, ring, and sponge. On the whole, female methods tend to be more expensive than male methods because most require at least one physician visit and some involve a renewable prescription. Only two of the eleven female-only contraceptives—the sponge and the female condom—do not require seeing a physician. This means that 82 percent of female methods require at least one physician visit in order to acquire the contraceptive. Moreover, 36 percent of female methods require a prescription (injectable, patch, pill, and ring), which means women must continually renew their contraceptive by going to the pharmacy or doctor. Most doctors will not continue renewing prescriptions without seeing their patients yearly, so the initial visit when the doctor prescribes the contraceptive is not enough to ensure continued access to the contraceptive.   

Due to the expense of initiating and maintaining contraception, women spend 68% more out of pocket toward their reproductive health care than men of the same age. Currently 28 states mandate insurance companies to cover contraception to the same extent as they do for other prescription medications. However, 20 of these states have provisions in place for providers, plans, or employers to deny contraceptive coverage for religious or moral reasons.

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.

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.