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What?? You can't be serious. I do alot of research in the field of genetics, can you tell me exactly where this article was published. I am checking on the validity of it, and I can't find it in any medical publication.
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Many things in the article seem questionable. Let me just say, this is my field of expertise, so I feel compelled to respond. I hope I can help calm some frazzled nerves. At the risk of boring you to tears .
In order for a drug to be classifed as "experimental" and used on humans, the FDA has many requirements. One is that it be tested on animals first, for acute toxicity, exposure to unreasonable risks, preformance of the drug for it's intended purpose. This requires many clinical studies. The article does not mention who developed this drug, or why, nor does it mention who is sponsoring the studies Dr Nice is conducting. Dr. Nice and her volunteers, seem to be the only ones interested in this "experimental" drug. I highly doubt a medical facility like Mt. Sinai would be so vulnerable, as to set themselves up for the obvious lawsuit that this seems to beg for. Developers of drugs, such as a major pharmaceutical companies, use many outlets to test their drugs worldwide, to get the most accurate results possible. Just one DR. using an "experimental drug" would in itself , not pass FDA approval for the drug to be classifed as experimental in the first place, and therefore could not be used on humans. Also, preclinical studies on animals, which is a requirement, could never prove the drug stopped potential animals from being lesibians, nor could a study show that a fetus lacked the desire for motherhood. . Since there is no way to prove the fetus was straight or gay, or lacked a desire to nurture or be a mother, in the womb, before they took the drug. The experiments if they even were conducted, would not be valid, and the subject matter would be so questionable, they would never warrant what is refered to as IND submission for the FDA. So they would never be approved for experimental use on humans. The article seems to be missing some key information. Like where the preclinical studies took place. Who developed the drug, and who is sponsoring the human studies? Dr. Nice and a few colleagues seem to be conducting some studies, but who is sponsoring the studies? |
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The 'experimental' drug is dexamethasone....a glucocorticoid type of steroid.............it's been around for years and this use is in the literature ........they are saying it's experimental because dexamethasone is not FDA approved for use in CAH....it is what is called 'off-label' use.
I have been prescribed the drug when I had pneumonia.... I'm not a big fan of wikipedia, but this is pretty good info..... http://en.wikipedia.org/wiki/ |
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