Buyer Beware: Not All Donor Sperm are Fully Tested

A recent news story out of Fort Worth Texas, Parents Sue Cryogenic Center Over Child’s Cystic Fibrosis ,brought to light a risk that many patients using sperm donors should be aware of. More importantly, it exposes the weak oversight of reproductive technology by both state and federal agencies that are charged with protecting the public’s health.

The news report interviewed Sharine and Brian Kretchmar who decided to buy donor sperm from the New England Cryogenic Center to conceive their second son Jaxon. Jaxon, now 22 months old, is afflicted with cystic fibrosis. He needs daily breathing treatments and wears a vibration vest to agitate his chest and break up the chest congestion which makes it hard for him to breathe. Barring huge advances in treatment, he can expect a shortened and difficult life span. Obviously, they love their son and cherish every moment they will have with him, but they wouldn’t have chosen sperm from this donor if they had known in advance that the sperm donor was not fully tested for cystic fibrosis.

How did this happen? NECC purchased sperm from this donor and 10,000 other units of donor sperm from a defunct Wyoming sperm bank called Rocky Mountain Cryogenics in 1993. It was not until May 25, 2005  that the Food and Drug Administration (FDA) required very specific screening and testing requirements BEFORE  potential sperm donors could be approved as donors. You can find the original law in the Code of Federal Regulations (CFR21 part 1271). There have been several updates to the original law but the core remains unchanged and requires testing for infectious diseases including HIV (type 1 and 2), Hepatitis B and C, Treponema pallidum (Syphillis),  HTLV (type 1 and 2), Chlamydia trachomatis and Neisseria gonorrhea.

Unfortunately, testing for genetic diseases was not (and is not) required by the FDA, except for requiring donors to provide a medical history which might have revealed some genetic disease that would have excluded the donor. This lack of genetic testing and federal oversight was critiqued early and often including this review in 1997, “FDA Approved?A critique of the artificial insemination industry in the United States“. Still today, we have no federal requirement for genetic testing, but many sperm banks, perhaps chastened by the experience of one sperm bank who sold sperm that caused 9 out of  24 offspring to inherit a fatal cardiac defect, have decided to test donors for some of the most common and devastating genetic mutations.  ASRM recommends genetic testing of anonymous sperm donors  but compliance is voluntary.

Where the Kretchmars purchased their sperm from NECC,  they felt that the bank’s website claimed to fully test sperm donors for a host of diseases including CF. The Kretchmar’s decision to use NECC was in part because they appeared to provide a fully tested product. Now CF is a tricky genetic disease because although over 1300 mutation have been identified, even the banks that test for CF test for only the most common mutations (typically less than 100 mutations). Before 2005, few if any donors were tested for CF mutations. It is also unlikely that most of these mutations were even known before 2005. It appears that this was the case with the NECC donor in which he was either untested or minimally tested for CF. The real problem was that NECC sold sperm collected at a time when there were no standards for donor screening so this sperm didn’t meet the more rigorous modern expectations for sperm donor testing, even if those expectations are an industry standard, not a federal law. The complaint against NECC suggests that patients were not informed that donors whose sperm was available for sale were not all fully tested for CF.

Interestingly, NECC was inspected by the New York State Department of Health and that inspector found that some of the Rocky Mountain donors were not even fully tested for infectious diseases, which is mandated by the FDA. They distributed sperm from donors that were not tested for syphillis and gonorhea. Did NECC discard all this untested sperm they acquired from the Wyoming sperm bank in 1993 when these vials failed inspection? They did not. They did, however,  relabel the vials to read ““DO NOT SHIP TO NY.”, but continued to ship it everywhere else, including to the Kretchmars in Texas. As stated by Sharine Kretchmar in her interview, “Why was it okay for my baby to get this disease but it’s not okay for a baby in another state to get it?” Why indeed?

This “do not ship” solution satisfied the NY State Department of Health but it certainly did not make it safe to ship everywhere else.  Furthermore, the New York State Department of Health did not communicate its findings regarding failure to conduct the infectious disease testing  to the FDA according to the report. The FDA would have been interested in the failure to test for the sexually transmitted disease, but its mandate does not cover genetic testing. I don’t know if there is a legal requirement for a state agency to share findings with a federal agency, but it would have promoted the public health in this case.

NECC no longer sells the Rocky Mountain sperm to patients according to a statement issued to the news agency that ran the story. The NECC website now has a more qualified statement regarding testing of CF donors, “Cystic fibrosis (please note that not all donors have been tested for the same number of CF mutations. Please call and speak with an NECC customer representative to find out the specific number of mutations tested on your donor of choice)” and also  “PLEASE NOTE: NECC donors are tested for communicable diseases and genetic conditions according to state and federal regulations at the time of donation. Please contact an NECC client service representative if you have questions regarding testing performed on specific donors.”  As a buyer, you really need to ask very specific questions about EXACTLY what screening questions and what tests your donor had at the time of collection which might have been years earlier under weaker or non-existent regulations or industry standards. Buyer Beware.

© 2012, Fertility Lab Insider. All rights reserved.

©2012 Fertility Lab Insider. All Rights Reserved.

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