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Tuesday, August 31, 2004

The Effect of Political Vacuum Upon Embryonic Stem Cells

News@nature.com still has free access for another 24 hours. After that, you need a subscription to one of their journals for access. I think they still will offer free access to their special section, Stem Cell Focus.

Meanwhile, I've taken the liberty of adding two of their articles pertaining to stem cells to my Furl archive. The first is a report on a survey of clinics that perform in vitro fertilization (IVF). The clinics were surveyed regarding their practices followed for the storage and/or disposal of the embryos created in the IVF process. The second is an editorial on the issues raised in the first article.

Published online: 27 August 2004; | doi:10.1038/news040823-15
IVF embryos meet contrasting fates
Emma Marris
Confusion reigns over how US fertility clinics deal with their 'waste'.

What happens to the human embryos created during in vitro fertilization that do not get implanted? A study of IVF clinics in the United States has revealed that they meet incredibly varied fates.

The possibility of using stem cells from human embryos has sparked fierce debate over the moral status of these tiny balls of cells. Although the issue is causing problems worldwide, it has become particularly politicized in the United States. President George W. Bush, for example, is strongly opposed to the harvesting of stem cells from embryos created during IVF. [...]

Some countries, including Britain and Canada, have rules about what happens to the spare embryos, and what level of consent is needed from the couple involved. But there is no such regulation in the United States. [...]

The approaches of the 175 clinics that did dispose of extra embryos varied in the extreme. Some handed the tiny ball of cells over to the couple or individual to take home, whereas some incinerated them as biological waste. Of the clinics that incinerated the embryos, four required the presence of the couple while twenty-five clinics forbade it. Seven clinics even said a prayer during disposal in a quasi-funeral, according to Arthur Caplan, a co-author of the study from the Center for Bioethics at the University of Pennsylvania in Philadelphia.

The majority of clinics surveyed donate extra embryos to research institutions, with the permission of the couple or individual involved, although the clinics varied in the level of consent that was required and how this was obtained. Stem-cell lines derived from these embryos are ineligible for federal funding, however, under current US rules. [...]

"Our results highlight the importance of fully disclosing disposal options when couples first consider enrollment," he says. "Little is known about how clinics deliver this information or about the proportion of couples who, in retrospect, feel they were not fully informed." [...]

What this shows is that there is a political vacuum when it comes to the regulation of IVF clinics. This, I believe, exposes a serious weakness in our political system. Any issue regarding embryonic stem cells is so hot, politically, that no one is willing to address them adequately. At this convention time, we will hear a lot from various politicians who claim to be be courageous. They claim to be willing to take on the tough issues. Mr. Bush does deserve some credit for starting to address the issue, but one wonders how serious he was about the subject, when all he did was authorize federal spending for a few cell lines. He had his bioethics council debate the issues and publish some things, but nothing substantive has come of their efforts.

Our political system is such that it is possible for politicians to avoid dealing with certain topics. Our news media are again failing to call them to action. Of course, the American people also are failing to pay much attention. The issues are raised in medical journals, which the media seem to read from time to time; but apart from that, there seems to be a silent, collective agreement to just ignore the whole thing.

The second article clarifies these issues:

Published online: 27 August 2004; | doi:10.1038/news040823-17
muse@nature.com: A moral minefield
Helen Pilcher
Couples going through IVF should be allowed to choose what happens to their unwanted embryos, says Helen Pilcher.

Who should decide what happens when an embryo created in a fertility clinic goes unused? You might hope, as the potential parent, that the decision would be yours. But you could be disappointed, and so could the researchers who hope to benefit from material that would otherwise go to waste.

Every year, hundreds of thousands of couples undergo expensive, emotionally difficult fertility treatments in the hope of becoming parents. Many opt for in vitro fertilization (IVF), where eggs are fertilized in the lab and implanted back into the mother. But clinics often prepare more embryos than are needed, because they only transfer the best and most couples need more than one treatment cycle. So the question is: what should be done with the 'spare' embryos?

In the United States, there are no laws governing this area. Each of the 400 or so fertility clinics registered with the Society for Assisted Reproductive Technology stands alone, creating and enforcing their own policies. But, according to a recent study 1 , their policies differ... a lot. [...]

But whatever your ethical view, should the offer of donating embryos to medical research really be left to the individual fertility clinics? In Britain, for example, clinics are obliged, if possible, to give couples this option.

If this option is not offered and a couple does not want to store their embryos indefinitely or donate them to other couples with fertility problems, there is only one other choice: to destroy them.

If that happens, we all miss out. Infertile couples have one less option. Researchers miss out on a vital and precious pieces of tissue that could further our understanding of embryology and fertility. Scientific progress is stymied, and medical progress is slowed.

This rare commodity should not be thrown away, at least, not without careful, considered thought. Couples need to give informed consent for any decision made. How is this possible in clinics where only part of the picture is presented?
  1. Gurmankin A. D., Sisti D. & Caplan A. L. Politics and the Life Sciences, 22:2. 2 - 6 (2004).

Dr. Pilcher points out that, in the absence of federal regulation, not only are clinics free to set their own policies, they do not even have to inform couples of the policy the clinic has set. Personally, it is the latter point that disturbs me the most. I am confident that the clinics are careful about the informed consent for the IVF procedure itself. But it appears that they do not have any obligation to get informed consent for the disposition of any unused embryos that may result from the procedure. As far as I can tell from the articles, it appears that they do not even have to inform the couples that there is an issue to be decided at all. The current system of medical ethics appears to be silent on this topic as well, although I have not yet researched that aspect fully.

Clearly, there is work to be done. Politicians, the news media, and the medical profession all need to figure out how to handle these issues.


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