Congressman urges FDA to investigate Acu-Gen's Baby Gender Mentor, and to regulate similar baby gender tests
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.