Freedom of information requests have revealed that
pregnant women may not have been given all the facts before taking an
experimental treatment to prevent female fetuses from being masculinised
as a result of a rare genetic disorder.
Research has provided some evidence that dexamethasone,
a drug normally prescribed to relieve inflammation, can prevent girls
with a rare hormonal disease from developing male genitalia and same-sex
attraction if they are treated as fetuses. But as yet, no clinical
studies show that this treatment is safe, says Alice Dreger
of Northwestern University in Evanston, Illinois. She claims that
researchers have misled an unknown number of pregnant women into taking
the experimental treatment without properly informing them of its risks.
Since the 1980s, Maria New of Mount
Sinai School of Medicine in New York has studied and popularised the
idea of prescribing dexamethasone "off-label" to women at risk of having
foetuses with congenital adrenal hyperplasia (CAH). The treatment is
now taught as standard practice in medical schools. But because the drug
must be given very early in pregnancy before the fetus' gender or CAH
status is known, many fetuses are treated unnecessarily. A child with
two carrier parents has a one-in-four chance of having the disease, and
the treatment only works for girls.
There is little research available on
the effects of dexamethasone, which mimics a steroid hormone. And
because dexamethasone doesn't cure CAH but only prevents masculinisation
of girls, it can be difficult to distinguish possible effects of the
drug from other treatments the children receive after birth.
However, some evidence suggests that
the drug may be harmful to foetuses early in development. A recent study
of 43 children in Sweden who did not have CAH but had been treated with
dexamethasone as fetuses found that 20 per cent of them had some sort
of developmental problem. (Journal of Clinical Endocrinology and Metabolism, DOI: 10.1210/jc.2012-1222).
Through freedom of information
requests to Mount Sinai School of Medicine, Dreger and colleagues
documented what they see as attempts by New's group to circumvent proper
patient consent procedures for experimental use of the drug.
The researchers allege that, according
to New's grant applications, she skipped important steps in patient
consent, promoting treatment as "safe and effective" without informing
parents that the claim is controversial. Years later, New's group then
followed up a fraction of the patients to ask about side effects.
Because New doesn't have a financial
stake in a drug company, the US Food and Drug Administration says that
she is free to promote the treatment as safe and effective.
New declined to be interviewed, but in
a statement from Mount Sinai, spokesperson Ian Michaels said the claims
are "unfounded" because New's practices have previously been cleared by
federal agencies and that the FDA has waived the need for dexamethasone
to be approved as an "investigational new drug".
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