FDA rules and the politics of Egg and Embryo Donation

May 30, 2010Carole No Comments »

So unless you have been out of town, say Mars, you probably heard that actress Kelly Preston announced she is pregnant at 47.  CNN published the story and interviewed several celebrity REs who explained that it is possible to get pregnant even at advanced maternal age but usually not with your own eggs.  According to the CDC 2007 National Report, US women who used ART with their own eggs and were over 44 years of age had a pregnancy rate of 4.4% with a live birth rate of 1.8%. Which means that of the less than 5% who achieved pregnancy, more than half lost their baby.

You still have options. Fortunately, the uterus is more forgiving and will carry a pregnancy long after the ovaries have put out the “Do Not Disturb” sign. Using donor eggs and donor embryos is an increasingly common choice. The up side of donor eggs and embryos is you can personally experience pregnancy and birth. The down side of course, is that unless your donor is also a blood relative, the genetic link is missing.  I recognize that many people place great value on having that genetic link and that is part of the reason why patients subject themselves to ART treatments  instead of going straight to adoption. After all, the costs and outcome of adoption are usually more predictable than ART.

Finding a Good Egg Donor. Egg donors come in two flavors, anonymous or known donors. At the lab end, they look the same to us, but then we have the easy part. Your fertility clinic may run their own egg donor program or they may work with egg donors that you bring with you, either from home or through an agency.  Unfortunately, no rating system exists for donor programs. The best thing you can do is go armed with information about what donor agencies are required to do and what is optional.

The Food and Drug Administration regulates the process used to determine if a person is eligible to donate eggs or embryos in order to prevent the transmission of communicable disease. The FDA is interested in the following communicable diseases:

  • Human immunodeficiency virus (HIV), types 1 and 2;
  • Hepatitis B virus (HBV);
  • Hepatitis C virus (HCV);
  • Human transmissible spongiform encephalopathy (TSE); including Creutzfeldt-Jakob disease (CJD)2 ; and
  • Treponema pallidum (syphilis).
  • Chlamydia trachomatis
  • Neisseria gonorrhea.
  • Human T-lymphotropic virus (HTLV), types I and II.(For sperm donors or use of ovarian tissue only)
  • West Nile Virus and Vaccinia (from small pox vaccinations)

The FDA’s mandate for prevention of disease transmission extends only to this list of diseases. Their mandate does not extend to ensuring that donors have a low risk of transmitting genetic diseases. Some donor agencies fill the gap and provide varying amounts of genetic information on their donors. Donor agencies will usually ask the donor to fill out  a three generation family medical history and not much else. Other programs will perform genetic testing on donors.The genetic screening tests that are run are based on the donor’s anticipated risk based on factors like their ethnic background. For instance, if the donor is African American, tests might include looking for sickle cell trait. It is not possible to test for every genetic disease. All of us carry genetic mutations and it is only luck and perhaps a normal dominant gene on our partner’s genome that saves our offspring from chromosomal calamity.

Sometimes you can’t get as much donor medical history as you might want. Adopted persons who have no knowledge of their biological families’ background are not excluded from egg donation in some programs. Sometimes the  recipient is asked to sign a special consent, acknowledging that they understand no extended family medical information is available.  The important thing to know is that except for the mandated FDA screening and testing, there is a lot of variability in the amount of  screening  and information that donor programs provide.

Interestingly, the FDA rules on determining donor eligibility are applied differently depending on social circumstances. If the donor is a known donor, meaning a relative or friend, the FDA requires that they undergo the screening process just like an anonymous donor, but if they are found ineligible to donate, you can still decide to accept their donation. You should understand that to become ineligible, they have had to flunk some aspect of the screening process, either the screening questionnaire, physical exam or blood tests. Ineligible donors are ineligible because they have some risk of transmitting an infectious disease. An anonymous donor could not legally be used under those circumstances, but a known donor could be with the recipient’s informed consent. Obviously, the actual disease risk is the same, whether you know the donor or not, so this known donor exception is based on something else—maybe recognition of the fact that if the donor is related, the recipient may be willing to accept some greater risk of disease transmission to get that genetic link? It’s not obvious to me why the FDA permitted this exception.

Donor Embryo. The FDA also has something of a split personality when it comes to embryo donation. Just 24 hours before the new FDA donor screening laws went into effect on May 25, 2005, there was a last minute change to the rules for embryo donation, essentially making screening of embryo donors optional.

Most couples are not thinking about donating embryos at the front end of treatment. Obviously, they are focused on getting their own family started, not donating their embryos. The donor testing is not typically performed for IVF couples because sexually intimate persons are not considered donors when they want to make a baby so the donor testing is not required by the FDA. Years later, when they decide that they want their “excess’ stored embryos to go to someone else, they become donors. The preliminary version of the FDA regs did not treat these embryo donors any different than egg donors. The full testing was required in advance, which most would not have had. Interestingly, hours before the final law was to go into effect, it was revised for embryo donors, essentially making screening optional. The FDA recommends that embryo donor couples should be tested but if they can’t do it (or won’t do it), the FDA will not interfere with the embryo donation.

Quoted from the regulations:

Circumstance under which : “(a)Donor-eligibility determination not required . You are not required to make a donor-eligibility determination under 1271.50 or to perform donor screening or testing under 1271.75, 1271.80 and 1271.85 for:

(4) A cryopreserved embryo, originally exempt under paragraph (a)(2) of this section at the time of cryopreservation, that is subsequently intended for directed or anonymous donation. When possible, appropriate measures should be taken to screen and test the semen and oocyte donors before transfer of the embryo to the recipient.”

Sometimes testing is performed before the embryos were created because some programs test every IVF patient anyway to fulfill state testing requirements or rule out disease that could cause obstetrical problems.

I have to wonder if political pressure was applied to the FDA to help grease the skids of embryo adoption and forgo the same rigorous testing requirement for embryo donors that it required for egg donors? Did someone point out to President Bush that having the FDA make embryo donation difficult was counter to his interest in promoting embryo donation through church based embryo donation groups like the Nightlight Christian Snowflake Adoption Program? Coincidentally, President Bush was in a photo op with Snowflake babies at the Whitehouse on May 24, 2005 – the day before the regulations went into effect- in which he enthusiastically promoted embryo adoption. Pundits at the time deplored the use of the snowflake babies as a cynical political ploy just as Bush was vetoing the use of discarded IVF embryos for stem cell research.

Another interesting political side note. In August 2008, the  National Embryo Donation Center (NEDC) received a large government grant- your tax dollars at work!- to promote embryo adoption. On the NEDC site is a disclaimer “Materials available in this section have been developed and disseminated by the National Embryo Donation Center, in collaboration with the Baptist Health System Foundation, with grant support from the US Department of Health and Human Services under grant EAAPA941002. The views expressed are solely those of the NEDC and its partners and do not necessarily reflect the official views of the Department.”

Interestingly, the NEDC’s  Frequently Asked Questions page assures clients that embryo donors are screened just like egg donors. That’s not how I understand the FDA regulations. The last FDA inspection I participated in, the FDA inspector did not even want to look at the embryo donation charts, even though they were offered. (Note: The website has since updated their FAQs page with a corrected explanations of the regulations. Couples who created embryos for their own use who because they were sexually intimate and were not subject to the donor testing up front, are not required to be tested down the road when they elect to donate excess embryos.  The FDA does suggest that after the fact testing be provided, if possible, but does not insist on testing for these couples who wish to donate embryos).

We have worked with the various embryo adoption programs before but found that they did little to facilitate the process  but simply put the embryo shipping and receiving labs in touch with one another. Patients have told us that some of these embryo adoption groups required them to sign paperwork that they agreed to transfer all the embryos that are thawed for them. This forces the lab to err on the side of thawing too few embryos just so the patient does not have to risk transferring more embryos than medically advisable.

Some clinics put pressure on patients to donate their embryos because of their own moral perspective. Interviewing a potential RE candidate, I was shocked when the candidate informed me that he would require all his IVF patients to donate their excess embryos or he wouldn’t take them under his care. He didn’t get the job. Some things just need to be up to patients, period. Most programs do offer all the options to patients including donation to stem cell research, donating to the lab for technical training, discarding the embryos or embryo donation to another couple. We offered all the options in a letter to patients when their storage renewal was due.  Most patients chose to discard their embryos after careful consideration of all the options. Donation to stem cell research and embryo donation were the least frequent choices patients made.

But that’s okay by me. Choices about using or donating donor eggs or embryos should belong to patients, not  pundits or politicians.

© 2010 – 2011, Carole. All rights reserved.

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