From Joe Stover
Sent June 30th
"Hey Mom you should check out this article. It's kind of hard to believe/disturbing."
My son sent me this message and a link to a blog site the day after my post claiming women were being lied to and manipulated by the medical/money machine. He was deeply concerned about pregnant women being given a drug to prevent girl babies from growing up to have typical "masculine" traits. These girls are being labled abnormal because they show a lack of interest in playing with dolls or fantasizing about having babies and they grow up to have little interest in getting married and taking on traditional wife and motherhood roles.
So I looked into it and as justified and disturbing as his concerns were was a bigger issue for me. Once again women and their babies are being experimented upon by the medical establishment without their knowledge or consent. How can that happen you ask? It isn't like someone is sneaking in while the women sleep and are giving them a drug. Of course not; it is much more insidious than that. It involves something few women understand thoroughly called off label use. Don't believe me? Here are two women's stories excerpted from an article that just came out in Time magazine June 18th.
Jenny Westphal, 24, who took dexamethasone throughout her pregnancy at the recommendation of a doctor, says she feels misled. . . She was not asked to give informed consent. Her daughter, now 3, who has CAH (the disorder they were trying to prevent with the dexamethasone!) has had serious and mysterious health problems since birth, including feeding disorders, that are not commonly associated with her adrenal-gland disorder. . . In April, Westphal, who lives in Wisconsin, started doing research online and discovered there was some controversy over the treatment. "I was outraged, frustrated and confused. Confused, because no one had ever warned me about this. I wasn't given the chance to decide for myself, based on the risks and benefits, if I wanted the treatment or not," she says . . . Westphal may never know whether her daughter's problems were caused by dexamethasone, though she will likely always believe they were. That is why so many similar situations, in which experimental drugs are prescribed off-label without informed consent rather than in clinical trials, wind up becoming case studies — not in scientific journals, but exactly where Westphal and her husband are considering taking theirs: to court.
When Marisa Langford found out she was pregnant again, she called Dr. Maria New, a total stranger, before calling her own mother. New, a prominent pediatric endocrinologist and researcher at Mount Sinai Medical Center in New York City, is one of the world's foremost experts in congenital adrenal hyperplasia, or CAH . . . Langford and her husband learned they were silent carriers of the genetic variation that causes CAH when their son was diagnosed with the condition after birth. . . "Dr. New told me I had to start taking dexamethasone immediately," says Langford, 30, who lives in Tampa. "We felt very confident in someone of her stature and that what she was telling us was the right thing to do." . . . Langford says that neither New nor her prescribing physician mentioned that prenatal dexamethasone treatment is an off-label use of the drug (an application for which it was not specifically approved by the government) or that the medical community is sharply divided over whether dexamethasone should be used during pregnancy at all.
In animal studies, dexamethasone has been shown to cause birth defects, but proponents of the treatment note that no human birth defects have ever been associated with the treatment, and that it is uncertain whether findings in lab animals translate to humans. . . "We just don't know what we are doing to these kids," says Dr. Walter Miller, the chief of endocrinology at University of California, San Francisco. "It's not sufficient to say, The baby was born and had all fingers and toes, so it's fine."
Perhaps most controversially, prenatal dex must be given as soon as a woman learns she is pregnant, which is usually several weeks before genetic tests can determine if the fetus is in fact a female affected with CAH — the chance of which is 1 in 8 for parents who already have an affected child or know they are carriers of the genetic disorder. If the baby is healthy, treatment is stopped, but at that point, the fetus has been exposed to the steroid drug for weeks. There is no data on how many mothers receive prenatal dex, but according to the odds, 7 of 8 may be taking medication unnecessarily.
OMG!!! 7 out of 8 don't need it, no long term studies have been done on the safety of the drug for the baby when given prenatally, the women aren't being informed that this is the case? OMG! OMG! OMG! How can this be? What the hell is this off label use thing all about?
Basically it comes down to the fact that any doctor can prescribe medication for anything they want. It doesn't have to first be tested for effectiveness on what the doctor is choosing to use it to treat. It doesn't have to first be tested for safety when used for this purpose. It doesn't have to first be studied for proper dosaging when used for this purpose. In other words when you are given a drug off label they are using you to experiment upon.
So why do doctors do it? Let's head back to the Time article to find out.
It enables doctors to do human research without gaining proper approval. All participants in human medical research are, by law, entitled to the protective oversight of an institutional review board (IRB), a committee that safeguards the interests of research volunteers and ensures they have been fully informed about the potential risks and benefits of an experimental treatment. If doctors are simply treating a patient with an off-label drug, they are not required to obtain written informed consent from patients. But if doctors give treatment with the intent to gain knowledge, they are technically doing research, which must receive IRB approval. . . Ethicists say physicians may sometimes treat patients off-label, then decide later to launch a follow-up study; or, they do follow-up research on patients who have been treated by other doctors. In the process, they have converted these patients into unwitting research volunteers. Some doctors game the system this way, Caplan says, to avoid battles with IRBs.
And there are battles. In the case of prenatal use of dexamethasone there is currently a battle between a Dr. Maria New, a prominent pediatric endocrinologist and researcher at Mount Sinai Medical Center in New York and some members of the Bioethics Forum. They are doing what they can to shut her down with letters, articles and general publicity. And then of course there are the court battles. Remember Jenny Westphal and her 3 year old daughter with mysterious ailments? They are doing just that, taking the doctors to court.
So you think this doesn't effect you since you don't carry the gene for this rare disorder? Think again. Was you labor induced? Are you seeing a doctor that will induce you if you go past a certain calendar date? Are you worried about being induced? Concerned about ending up on the dreaded "pit drip"? What if your doctor whom you trust said, "don't worry. We're not going to use pitocin. We're going to use this little tiny pill instead. You won't even need to be hooked to an IV and it is perfectly safe for you and your baby." What would you think? What would you do? More on this wonder drug and off label use next time.
Letter of concern sent to the CARES Foundation
(Congenital Adrenal Hyperplasia Research Education & Support)
Preventing Homosexuality (and Uppity Women) in the Womb?
Alice Dreger, Ellen K. Feder, Anne Tamar-Mattis, 06/29 http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=4754&blogid=140