by Marsden Wagner
In South Dakota three months ago, an obstetrician bragged to me over lunch that he had introduced Cytotec for induction into his community. When questioned, he admitted knowing the FDA does not approve such use of this drug and that nevertheless, he does not inform women that it is not approved for this purpose nor does he ask for their informed consent. He scoffed at my suggestion that he is experimenting on women without their knowledge, much less consent. His excuse: "We will wait forever for the bureaucrats in Washington DC at the FDA to approve drugs so we must try them out ourselves if we want progress."
One month later in Oregon a local doctor told me (and repeated it on her local weekly TV Health program) that obstetricians in Medford told her they are thrilled with Cytotec for induction because they can bring women in first thing in the morning, give them Cytotec and have the babies out before 5 p.m.--a welcome return to daylight obstetrics. None of the hospitals in the Medford area required informed consent when using Cytotec for induction. The Oregon State Health Department told me that while collecting their statewide data on induction, they have observed that Cytotec has now become the most common method of induction.
While the United States has a system in place to ensure that all drugs must be evaluated by the FDA before allowed on the market and that certain drugs are to be dispensed only through physician prescription, there is a hole in this system. Once a drug has been approved by the FDA for one use and put on the market, there is nothing to prevent a physician from using that drug for whatever use at any dose. Trials of new uses of drugs are important as long as the trials are done as research and everyone understands that this use is experimental with informed consent from the patient. Misoprostol induction shows potential for certain benefits but these benefits must be documented by careful research which, at the same time, looks carefully for the risks.
We can't just throw drugs at people in an uncontrolled way. If a practitioner hears about a new use and simply starts using the drug this new way, this is experimenting on patients without the usual safeguards in place for research subjects. And while practitioners should report to the FDA on such off label trials and should always report to the FDA on side effects and risks found, in reality only a very small number of practitioners ever report anything to the FDA. As a result, a large information vacuum exists in the United States with regard to what prescription drugs are being used for which purposes and what side effects and serious risks have occurred.
So when practitioners simply begin to use a drug for a new purpose, there follows a phenomenon I have experienced for years as a practicing clinician but rarely see described in print--the informal spread of clinical experience. In hospital corridors, lunchrooms and staff lounges, doctors, midwives and nurses share their ideas and experience.
A recent technology makes it possible to listen in on such clinical chat--online web pages and chat rooms. By accessing the World Wide Web and then using key words such as "misoprostol" and "pregnancy," many web pages and chat lines appear. Clinicians, scientists, policy makers and patients should read these Internet pages from time to time. While clinicians writing on the web are not necessarily representative of all clinicians, it is possible to discover how at least some of today's clinicians think and act. It seems like eavesdropping because of their candor and their blunt way of expressing ideas and opinions and revealing their attitudes.
It is the informal communication of uncontrolled clinical experience which has driven the spread of misoprostol induction as is apparent from the following actual statements taken from the Internet in 1998: (2)
"Cytotec is extremely effective at very low doses, is very cheap, and has been used on many, many women without their being aware that it really is still an experimental use."
"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 (web message emphasis, not mine) and opens it with a couple of contractions. So whatever you do, remember that you must not stay gone too long."
"At my suggestion our high risk OB referral hospital tried Cytotec--one-half tab per vagina--and after two cases of hyperstimulation stopped its use."
"We've seen no cases of hyperstimulation after Cytotec that did not respond to a two-gram bolus of MgSo4. You can almost count on a delivery twelve hours after inserting the Cytotec tablet."
"We are using it at Yale and although there is a format for how to give it, there is still controversy on to whom to give it. Pharmacy uses one of their nifty little pill cutters and sends us one-fourth of a 100 microgram tablet (remember this stuff was made for treatment of ulcers!)"
"I've personally used it twice and had excellent results in women wanting homebirths, but going postdates. I'm attaching my own protocol for anyone interested. Again I warn that I am no expert and I consider this protocol to be a "work in progress"--it will certainly change as I gather experience and information about this drug."
"We are using misoprostol regularly for induction--my department loves it. We use one of the protocols published on OBGYN.Net web page."
"Our biggest fear is that the company will pull Cytotec from the market, since our internist/GI buddies tell us that it isn't worth a darn for its labeled indication."
What is apparent from this Internet medical practice is the lack of appreciation of any borderline between experimenting on patients and practicing medicine on patients and the absence of concern for patient's rights to informed consent.
Also apparent from reading the Internet is the inability of many clinicians to critically review published papers. The general assumption is that since there are, as stated in one web message "gobs of references" (2), the scientific work has been done and it is okay to use this drug for this purpose. The tendency for clinicians to misinterpret scientific papers is in part because of a difference in approach since scientists must believe they don't know while clinicians, in order to do what they do, must believe they do know. A common attitude among clinicians, revealed by Internet messages, is that pregnancy and birth are dangerous until proven safe while technology and drugs are safe until proven dangerous.
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