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Monday, Nov 9, 2009
The enthusiastic discussion of Cytotec in medical chat rooms sheds light on why the drug has become so popular in the United States. "You can almost count on a delivery 12 hours after inserting the Cytotec tablet," said one doctor. Another doctor added a cautionary note: "I must say that I have heard some great things about Cytotec myself. I know some people who have used it and say that they have pretty good luck with it. It sounds like your ladies are pretty happy with its effects -- two-hour labors and such. Just be careful. I would have to say that the biggest danger is leaving the woman alone. The stuff turns the cervix to complete MUSHIE [emphasis in original] and opens it with a couple of contractions. So whatever you do, remember that you must not stay gone too long."
Over the past 30 years, I have watched as wave after wave of medical fads have washed over the institution of modern childbirth. But one thing, unfortunately, hasn't changed: The push to discover a panacea to cure the pain and inconvenience of childbirth drives doctors to experiment -- and the women are usually the last to know.
In this case, to be sure, the demands of the women themselves are part of the problem. The Cytotec controversy is inextricably tied up with the increasing rate of induced labor in the U.S. Until fairly recently, induced labors were fairly rare: Now, one birth in five is induced, with only a small percentage of these inductions being medically necessary. Harried doctors in the HMO age are driving some of this, but women, too, are demanding faster labors. (This is not surprising, considering that the United States has the shortest maternity leave in the industrialized world.) If this trend increases, we can expect to see an accompanying rise in the medical problems that result when the strongest muscle in the human body -- which is also paper thin -- is stimulated to contract violently.
How was it that Cytotec came to be used as an obstetric drug in the first place? Misoprostol was originally developed by G.D. Searle & Co. of Chicago to prevent gastric ulcers in people who take anti-inflammatory drugs such as aspirin for arthritis pain. In 1988, it was approved by the FDA solely for this use. Yet it is quite legal for physicians to prescribe drugs for indications other than those for which the drug has received FDA approval.
This common practice, known as "off-label" use, usually involves prescribing one drug for another purpose. (Incidentally, no such loopholes exist for the use of pharmaceutical drugs in most Western European countries.) With misoprostol the practice seems particularly egregious: taking a medication meant for oral ingestion and inserting it vaginally.
According to Claudia Kovitz, public affairs specialist for Searle, the company does not intend to apply for FDA approval of Cytotec's use in starting labor. Indeed, why should it? At 13 cents a dose, with women taking no more than three doses per birth, the drug is too cost-effective to waste a heap of money on research whose primary result might only be to make the drug illegal to prescribe.
So what protection do pregnant women have when it comes to drugs that are prescribed for another purpose? Very little, according to Laura Bradbard, spokeswoman for the FDA. "People think we have more authority than we have. We approve a product for a particular indication, based on the data we receive. A physician is free to use a drug for any use he or she feels will benefit a patient. There are no safe drugs. You need to do your homework, ask a lot of questions and speak with your physician about your case and the medications," Bradbard said.
And even when the FDA approves a drug, there are no guarantees. "Once a drug reaches the marketplace, that's when we find out all the adverse events, because we have only seen it in 3,000 to 6,000 people perhaps," said Bradbard. "Then it goes into the marketplace, where you have a million prescriptions. Then a reporter will say to me, 'You are approving things too fast. You didn't find it.' Well, we can't find it. It's mathematically impossible. We have to have it in the marketplace and then we have to make warnings."
But Holly and her husband, like most patients who receive Cytotec, never received any warning. "We didn't know it wasn't FDA approved," she said. "We would have never let them use me or my baby as guinea pigs."
