CAREFUL,
exacting, high-tech - that's the image US sperm banks like to project
to their customers. They run limited genetic tests on their donors and
trace medical records back three generations. They also screen for
chemical exposure, drug use and even do complex psychological profiling.
Equally
interesting is what sperm banks don't do - and are not required to do
by law. They don't verify that all the medical or personal information
that donors give them is correct. They don't routinely test for the
majority of known genetic diseases. They do not confirm that the sperm
the woman requested is the sperm that ends up in her body. And they
don't always know where to find donors or recipient families should a
concern crop up.
Now
a small, not-for-profit company is beginning to fill in these gaps. In
doing so, it threatens to expose just how common errors in the American
fertility industry might be, and how little oversight exists to stop
these problems from happening or to deal with them if they do occur.
In January this year, the Donor Semen Archive
(DSA) was quietly launched in Ann Arbor, Michigan, to store
donor-related DNA samples - from donor offspring, viable frozen samples
of semen, used donor semen vials and syringes, and donors themselves -
each filed against the donor's number. Its purpose is to keep a record
of as many donors as possible, to make it much easier to answer any
concerns that may arise about donors' health or identity, and identify
whether any other children born to that donor might be at risk of
genetic disease, for example. Run by a non-profit arm of Ann
Arbor-based biotech company Cayman Chemical, the DSA's director, Kirk
Maxey, hopes the archive will help keep tabs on an industry that he
feels has been under-regulated.
Each
year about 50,000 American women undergo donor insemination, which
involves inserting living sperm into the body. Unlike IVF, in which all
live births are recorded by the Centers for Disease Control, there is
no dedicated record of babies conceived through donor sperm in the US.
There are around 20 sperm banks in the country.
Since
2005 the Food and Drug Administration has regulated the screening and
testing of donors for infectious diseases, including HIV and hepatitis
B and C, and the collection and storage of semen, but from that point
on there is no supervision.
This is in stark contrast to the UK, where the Human Fertilisation and Embryology Authority
(HFEA) collects data on live births, ensures that each donor helps
create no more than 10 families, and holds a register of data on donors
that offspring can access when they reach 18 or are seeking a marriage
license.
In
the US, errors are often detected only when the recipient family
notices something amiss, such as a baby whose skin colour doesn't tally
with the purported donor. Maxey himself was a sperm donor for 16 years,
but quit when a lab technician told him she had stolen a vial of his
sperm and inseminated herself. "I'm convinced that every conceivable
misstep and perversion has happened," he says. "Many, many women with
blue eyes have picked blue-eyed donors and ended up with brown-eyed
kids."
Charles Sims, founder and medical director of California Cryobank,
a sperm bank in Los Angeles, admits that such mistakes do happen. At
his bank, he says there have been just two known cases of a woman
getting the wrong sperm, and both were discovered by the clients.
However, such errors are rare, and extraordinary steps are taken to
avoid them, he says.
The American Society for Reproductive Medicine
in Birmingham, Alabama, agrees that few complaints are made about donor
insemination. "The record of problems is quite thin," says spokesman
Sean Tipton. However, in its short life, the DSA has already begun
investigating a number of irregularities. In one case, two women with
the same donor who met through the Donor Sibling Registry
- a service enabling people conceived through artificial insemination
to contact genetic relatives - noticed something odd: one profile of
the donor said that he had straight hair, while another said it was
curly. DNA testing revealed that they had been fathered by two
different men.
In
another case, four children were born to different mothers who used the
same donor, but the mothers now think that one child has a different
father. As with any product, sperm banks do have some responsibility to
give their buyer the item that they paid for, but so far these are
untested waters. In March this year, a couple who had undergone IVF
filed a lawsuit claiming emotional distress after their clinic used the
wrong sperm. The clinic says it has no legal responsibility for the
mix-up, however.
While these cases may be worrying enough, medical concerns loom larger. Last year, doctors in Ann Arbor published a report of five children in Michigan,
born to four different mothers, who had all inherited an identical
mutation for a rare genetic disease called severe congenital
neutropenia. All five were the offspring of a single sperm donor. The
sperm bank did not know how many children the man had fathered in total
nor whether he was still donating elsewhere (New Scientist, 23 May 2006).
Maxey
argues that if the semen had been independently archived, it could have
been taken out of circulation after the first child was diagnosed.
Instead, it was used for at least two more years.
The
DSA is also investigating a similar case in which a child was born with
a severe cranio-facial abnormality. The mother wants to purchase a new
vial of the sperm to test if the mutation came from the father, but the
sperm bank is refusing. It is under no legal obligation to test the
sperm, nor is the donor required to be tested.
These
cases highlight the fact that there is little guidance on what to do if
a donor is suspected of having a harmful mutation. The American
Association of Tissue Banks issues voluntary guidelines encouraging
traceability, but only six sperm banks are accredited by it. One of
them is California Cryobank, which in a separate case is trying to
track down all families who may have had children by one of their
donors, who they now suspect carries a recessive gene for a metabolic
disorder. Tracking down the families is a laborious task, admits Sims,
"but we have an ethical obligation". All sperm banks ask mothers or
their doctors to report live births and mention any problems, but few
recipients bother, and there is no legal obligation to register these
details. In the UK, fertility clinics are obliged to report live births
to a central registry.
Maxey
believes all used vials should be sent for sequencing as a matter of
course, with the DNA profile then filed against donor number. "Somebody
should be doing it," agrees Laura Shanner, a bioethicist at the
University of Alberta in Edmonton, though she thinks it should be the
government's responsibility rather than the DSA's.
Both
Shanner and Arthur Caplan, a bioethicist at the University of
Pennsylvania in Philadelphia, are worried that the DSA is violating the
principle of informed consent - donors give sperm on the understanding
that it will only be used for conception, not genetic testing.
"Surreptitiously keeping samples in a biobank without explicit consent
is unethical," says Caplan.
Meanwhile,
the DSA continues to compile detailed genetic and personal profiles.
Maxey says that like many people, he assumed that sperm banks kept
records of all the resulting children. In fact, when he asked, the
clinic had no idea how many offspring had been born to him, where they
lived and whether or not they were healthy. "It dawned on me that we
were missing a piece of the needed quality control in donor
insemination," he says. Eggs and embryos too
It's
not just sperm banks that make mistakes. An audit of a bankrupt
Californian egg donor registry has revealed that thousands of donated
eggs have mysteriously gone missing. Melinda Lansford, the former
medical records supervisor at the Options National Fertility Registry,
decided to go public last month after she was diagnosed with aggressive
thyroid cancer.
Options
was one of the biggest egg donor registries in the US, matching egg
donors with recipients across the country. It filed for bankruptcy in
2005 following a damaging court case in which an egg donor referred to
as "Elizabeth" discovered that a doctor had given some of her eggs to a
second infertile couple without her consent or knowledge.
An
audit of 12 years of records, detailing how many eggs each donor
produced and what happened to them, suggests that Elizabeth's eggs were
not the only ones to be "shared". Records indicate that 596 embryos and
2189 eggs remain unaccounted for. In total, 80 separate medical
facilities and 102 doctors have been implicated in the mistakes,
involving 229 donors. "It has happened once, and appears to have
happened several more times," Lansford told The Orange County Register, which broke the story.
The
scandal follows a similar incident at the University of California,
Irvine, in which doctors gave away embryos belonging to infertile
couples. At least a dozen babies were born as a result.
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