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The Limitations of Voluntary Guidelines

Posted by Pete Shanks on August 21st, 2012


ASRM logo

The American Society for Reproductive Medicine (ASRM), the professional organization of the assisted reproduction industry, sets guidelines for its members on a range of practices including third-party egg providers, sex selection, and multiple embryo implantation. Unfortunately, these guidelines are routinely ignored, even by many members of ASRM, and sometimes even selectively quoted to justify practices they are meant to discourage.

An article in Fertility and Sterility by Klitzman et al. (abstract) is the latest piece of evidence. The title describes it:

Recruiting egg donors online: an analysis of in vitro fertilization clinic and agency websites' adherence to American Society for Reproductive Medicine guidelines

The full article is behind a paywall, but it is summarized in this Reuters piece:

A sizable share of the U.S. organizations recruiting egg donors online don't adhere to ethical guidelines, including failing to warn of the risks of the procedure and offering extra payment for traits like good looks, according to a U.S. study.

Reuters also mentions that "[e]thical standards set forth by the ASRM specify that donors should be at least 21 years old," but that "[m]ore than 40 percent of the sites [visited by the study's authors] also recruited women between the ages of 18 and 20."

Websites that recruit women to provide eggs are more likely to offer higher amounts to those with (for instance) better grades or specific ethnicity if the organizations are not affiliated with ASRM, but so do more than a quarter of those that claim to follow the guidelines. And, says the report (behind the paywall):

Websites that pay more for traits were more likely to refer to or quote ASRM's guidelines on compensation, but often just mentioned the $5,000$10,000 compensation range that ASRM deems acceptable given justification-not the stipulations discouraging trait-based payment variation. In this way, websites not following this aspect of the guidelines may gain credibility to website users simply by quoting the section of the guidelines that they do follow.

The ASRM ethics committee report on financial incentives [pdf] not only states that "payments to donors in excess of $5,000 require justification and sums above $10,000 are not appropriate" but urges compensation less than that, as well as counseling for donors, a minimum age of 21, and making a good-faith effort "to avoid accepting women who have already made a high number of donations." Nevertheless, according to the study, some websites "increased their payment to donors by $500 for each successful prior donation"; almost half recruit women who are under 21; and only about 8% even mention risks to future fertility, at least in their public presentations.

This unfortunate news should not be a surprise. A 2009 Associated Press piece summed up the situation on multiple embryo implantation with this headline:

Most Fertility Clinics Break the Rules

The ASRM guidelines on this issue [pdf] state that, for women under 35 years old, no more than two embryos should be transferred, and "consideration should be given to transfering only a single embryo." That recommendation has been in effect since at least 2006. According to the Centers for Disease Control (CDC), the number of embryos transferred has indeed been declining. In 2010, for which preliminary data are now available, transfers for women under 35 averaged 2.0, down from 2.1 the year before and 2.2 in 2008.

In 2009, the last year for which full statistics are available, well over half of reporting clinics exceeded the guidelines: 60% transferred an average of more than 2.0 embryos for women under 35 using their own eggs and fresh embryos; 13 out of 441 averaged 3.0 or more. (Rates for use of non-donor frozen embryos and donor eggs were marginally lower.) Since the average in 2010 was what is supposed to be the maximum, it is fair to say that an awful lot of clinics are still not following guidelines.

So with regard to at least two matters that significantly affect women's health recruiting women to provide eggs for other people's fertility treatment, and deciding how many embryos to transfer into a woman trying to become pregnant the ASRM's own members fail to follow best practices and ethical guidelines.

To be sure, the ASRM is in a bind. They cannot get too far ahead of their members, and yet they have to rein their members in or they may face the kind of government intrusion many of them vigorously oppose. Moreover, ASRM's ability to affect non-members is "pretty limited," as Sean Tipton, their Director of Public Affairs, admits:

"There's no question that there are some agencies that don't seem particularly interested in what our guidelines are, and we don't know how to impact their behavior."

The ASRM probably could impact the behavior of their members by rescinding the membership of clinics that don't follow the agreed-upon rules. And that might well have some effect, by way of public opinion, even on non-members. But whether or not a particular clinic or recruiter is a member of ASRM, perhaps it's time to acknowledge that voluntary guidelines are not working, and start seriously considering binding regulations.

Previously on Biopolitical Times:





Posted in Assisted Reproduction, Biotech & Pharma, Egg Retrieval, Pete Shanks's Blog Posts, Reproductive Justice, Health & Rights, US Federal


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