After viewing an ABC report about Baby Gender Mentor
's problems and lack of oversight for the test, Florida Congressman Jim Davis
has urged the FDA to investigate Acu-Gen and to regulate similar baby gender tests, and the Florida Attorney General
has opened an investigation against Acu-Gen.
Initially the issue that particularly concerns us is this unfair trade and deceptive practices.
Charlie Crist, Florida Attorney General
Although Acu-Gen has previously refused to provide any evidence from
trials to support their accuracy claims, or to reveal sales
figures or details behind their method, that may change as the company
has now been subpoenaed by the Attorney General's office.
Clearly, something is going wrong here. When someone is paying the kind
of money that's being paid here to get a laboratory test there needs to
be some protection as far as the safety and effectiveness of the test,
and there needs to be accountability.
Florida Congressman Jim Davis
Both officials were alarmed b the experience of Florida mother Erin
Rivera, who purchased the Baby Gender Mentor test just to learn whether
her unborn baby was a boy or a girl. Erin was told by Acu-Gen's Wang
that her baby had
Trisomy-18, and would likely die at birth. When questioned about Erin's
case by ABC Tampa's Linda Hurtado, Wang said:
This baby going to have developmental problems, and it's probably going to cease to exist right after birth.
C.N. Wang, Acu-Gen President
Aside from the anguish endured by this frightened pregnant mother,
there is very real danger in this sort of diagnosis: most babies
diagnosed prenatally with a trisomy,
such as Down's Syndrome, are aborted before birth.
Thankfully, Erin Rivera never considered that option, and in March delivered a perfectly healthy baby boy named Lucas.
Lucas does not have signs of Trisomy-18 or any other trisomies.
Dr. Raafat Hamzeh, Lucas' pediatrician
Congressman Jim Davis has sent a letter to FDA commissioner Dr. Andrew
regarding the Baby Gender Mentor; here are some excerpts:
I am writing to call on the FDA to investigate
Acu-Gen's Baby Gender Mentor test and provide oversight for similar
gender tests to protect consumers from false medical diagnoses.
...There have been numerous cases where Acu-Gen predicted false and
misleading results for the customers. Furthermore, Acu-Gen refused to
give these customers their guaranteed refund after they showed proof
the test results were wrong. The company cannot supply scientific data
or proof of any clinical trials supporting the test's accuracy.
...It is my understanding that the FDA does not regulate this test,
because they consider it a 'home brew' test. Dr. Eschenbach, this is
very troubling and alarming that no one is monitoring what is happening
with these companies...
Why is the FDA not monitoring these companies in the light of the
claims being made? Is the FDA equipped to monitor these companies? Do
you agree more oversight is needed for products like Baby Gender Mentor?
...I am very concerned with the lack of gevoerment oversight
companies like Acu-Gen receive, especially in light that they are now
making false medical diagnoses.
Florida Congressman Jim Davis in a letter to FDA Acting Commissioner Dr. Andrew von Eschenbach
Excellent questions, Mr. Davis. Why doesn't the FDA monitor these
companies? The answer is that, because of a loophole in FDA
policy, a company may sell genetic testing as a lab service without FDA
approval. Thus, there is no oversight to assure consumers that
genetic tests are accurate, or even useful for the advertised intent.
If this seems like a bad situation to you, Mr. Davis, you aren't alone. For over a decade, federal advisory boards have been calling for regulation of genetic testing. Five years ago, the CDC promised to do so,
yet still nothing has been done. So, although it's already been 8
weeks since you sent your letter to the FDA, don't be too surprised if
you don't hear anything back soon.
Baby Gender Mentor, the at-home DNA test claiming to reveal an unborn
baby's gender as early as 5 weeks of pregnancy, convinced many
customers that their claims of near-perfect accuracy were real by
offering a 200% money back guarantee if your result was
incorrect. "How can I go wrong?" many mothers asked.
The test's maker, Acu-Gen BioLabs, has now retracted the offer of a
double-money-back guarantee, and a 100% guarantee is now offered
instead on the BabyGenderMentor.com and PregnancyStore.com Web
sites. PregnancyStore, the online retailer for the gender test,
indicates that Baby Gender Mentor is currently "out of stock".
(Perhaps until new orange boxes can be printed without the 200%
The 200% money back guarantee is wonderful! The offer put that much more confidence in my decision to order your product!
Testimonial on PregnancyStore.com
While a money-back refund is usually a mark of a legitimate product,
in a gender prediction or gender selection product it's highly suspect
-- because the seller is assured of getting at least half the results
While Acu-Gen formerly "stood behind" a 200% guarantee of the Baby
Gender Mentor's accuracy, customer complaints about wrong test results,
and the company's refusal to make good on the promised refund, have
caused the Better Business Bureau to give Acu-Gen BioLabs an unsatisfactory rating.
Acu-Gen Biolab, Inc. has a pattern of complaints
concerning advertising issues. Consumers state that the company
promises a 99.9% accurate test result for the gender of their unborn
child or a 200% guaranteed refund. Consumers state that the test result
is often inaccurate. Consumers state that when they contact the company
for a 200% refund... the company still does not provide the consumer
with the guaranteed refund.
On 03/13/06 the Better Business Bureau wrote to Acu-Gen Biolab, Inc.
and asked them to substantiate the following claims made on the
company's website: We Guarantee that all test results will be
absolutely 99.9% accurate, explanation of the company's 200% guarantee,
Unsurpassed Accuracy, Unrivaled Earliness, Uncompromised Promptness,
Undoubted Privacy and Totally Safe. As of 03/28/06 the company has not
responded to the Better Business Bureau's request for substantiation or
modification of the questioned advertising claims.
Update: The BabyGenderMentor.com Web site has also stopped selling Baby Gender Mentor.
If you're considering IVF, one of the important decisions you'll make
is the choice of a clinic to perform the IVF procedure. The new
Web site for the Society for Assisted Reproductive Technology
(SART) provides IVF success rates for clinics in the US.
Fertility clinics are required to report the outcome of every ART
procedure to the US CDC
(Center for Disease Control), but getting those statistics published
has generally lagged 2 to 3 years behind. The new SART Web site
seeks to streamline reporting fertility statistics and making them
available sooner. Statistics are currently available through 2004,
putting the US far ahead of Europe, where it generally takes 4 years to
collect publish ART data.
Begging the question of why, in the age of the World Wide Web, we do
not have virtually up-to-the-minute ART statistics? Our local
middle school updates children's grades via the Web once weekly,
yet it takes YEARS to collate a few simple bits of data about a single
In any case, you should beware of putting too much stock in a clinic's
success rate alone, because it's far from telling the whole
story. The pregnancy rate can be misleading if there are too few
cases; for example, one clinic had an impressive 50% pregnancy rate for
women over 40, but it turned out only 4 women over 40 had been
treated. Some clinics are also guilty of "cherry picking", or
treating only patients who seem to have a good chance of becoming
pregnant, and turning away those who may have poor odds.
Over-regulation of fertility treatment in the UK has created a boom in
"fertility tourism" in other countries, as UK couples are driven abroad
to seek fertility treatment that is not available at home. Now
the HFEA, which regulates IVF in the United Kingdom, is wagging a stern
finger at couples considering an "IVF holiday": you'd better
"think twice and consider the risks and implications of going abroad for treatment."
If you live in the UK and you're considering IVF for gender selection,
leaving the country is your only option, because sex selection is
banned in the UK. But couples are fleeing England to undergo IVF
in other countries -- even though IVF would be free of cost at home
under the government health care system -- for many other reasons as
well. In the UK, you may face a long waiting list for IVF; and
often delaying IVF is tantamount to denying it altogether, because one
of the most important factors in IVF success is the mother's
age. Recent regulations denying anonymity to sperm donors
has seen the availability of donor sperm dry up over the past year.
Rules on who is eligible for IVF deny many couples. Strict,
blanket limits on IVF procedures may reduce the chance that IVF will be
successful. And the famous "IVF postcode lottery" in the UK means
that treatment is wildly unequal from one county to the next.
Currently, a saga caused by the arbitrary rules imposed for the
destruction of frozen embryos is being played out in the British
press. The HFEA appears to be insisting on destroying
frozen embryos -- against the wishes of the parents -- because the 5
years permitted to store frozen embryos has elapsed before the couple
could find a surrogate mother. The mother, Michelle
Hickman, underwent an emergency hysterectomy after the birth of
their first child, and cannot carry a baby. The couple hopes to
be allowed to move their embryos to another country, where they will be
safe from the "embryo death row" in the UK. Michelle joins other
families, like the Mastersons and the Whitakers, forced into two
battles: one battle to overcome a medical issue, and another to
convince their own government to permit needed treatment.
Yet, the HFEA urges couples to stay in the UK where "care and treatment
is of the highest standard," and not to travel to another country where
they might be able to make their own decisions regarding treatment, and
retain control of their own embryos and gametes. The HFEA has
taken away choices from its own citizens at home, until little other
option remains to them but to risk seeking treatment abroad.