Testimony of Belita H. Cowan on the use of diethylstilbestrol as a "morning-after" pill Senate Subcommittee on Health Washington D.C. I am Belita Cowan, a college instructor My purpose in being here is to inform the Subcommittee of several issues which may not have been brought to the Subcommittee's attention. The first concerns the prescribing habits of doctors who dispense DES (diethylstilbestrol). The second issue relates to medical protocol in hospital emergency rooms where rape victims are treated. The third issue concerns the possible legal liability on the part of emergency room doctors who prescribe DES. Last summer I conducted a survey of over 200 women, ages 18 to 31, who had taken DES as a "morning-after" pill in Ann Arbor, Michigan between 1968 and August of 1974. In addition, I interviewed many nurses, gynecologists, and emergency room doctors at 2 Ann Arbor hospitals, the University of Michigan Student Health Service, and a number of Detroit hospitals. The purpose of the study was to determine how and when DES was prescribed to women, and the precautions taken, if any, to ensure the careful monitoring and follow-up of all patients. What is occuring in Ann Arbor, Michigan is, I believe, indicative of what is happening in other cities, particularly those with university medical centers. For purposes of statistical analysis, I excluded from the numerical tabulations all rape victims, persons already on contraceptives, and those who were not at mid cycle at the time of the unprotected sexual encounter. That left 65 women. The results of the study were published last September, and are included in Table I which is attached to your copy of this report. The study showed that far from being an emergency medication, DES is being used repeatedly as a contraceptive. Twenty-nine percent of my sample stated that they had taken the "morning-after" pill at least twice within a year's time. The study showed that DES is being prescribed with carelessness and casualness. Forty-five percent were not given a pelvic or breast exam. Fifty-six percent stated that the doctor did not take a personal and family medical history. Eight women said that they got the "morning-after" pill not for themselves, but for a friend or roommate. And only 26% were followed-up to see if they were pregnant. The study also revealed that DES is being given to women for whom estrogens are contraindicated. Women who cannot take birth control pills are being given the "morning-after" pill. They are not aware nor are they informed that the "morning-after" pill is estrogen. Fifty-seven percent of the sample were unaware that the "morning-after" pill did not have FDA approval and that it had not been proven safe and effective. Further, the study revealed that many women are not being told of the possible cancerous effects to the fetus if the woman is pregnant. I could not find a single case where a pregnancy test was given prior to and after the DES regimen. Although, I must say that there is no pregnancy test which can accurately detect a 2 or 3-week pregnancy. In cases where patients are warned of the association between maternal stilbestrol ingestion and possible adenocarcinoma in the female offspring, patients are not usually counseled to seriously consider terminating the pregnancy should the "morning-after" pill not work. Six percent of those in the survey stated that they themselves were DES daughters, that is, their mothers took stilbestrol when they were pregnant in the early 1950's. . Of all the doctors I interviewed, only one expressed hesitation about giving the "morning-after" pill to DES daughters. Dr. Ann Pfrender of the U of M Health Service stated that "We don't know the effects of the morning-after pill on DES daughters, so I don't want to give it to them." The most interesting finding of the study is that 24% of the women stated that they did not take all 10 pills in the series. As one woman put it, "I got so sick from the first pill that I never took the rest. I couldn't stand to be that ill. And not surprisingly, 65% stated that if they had been fully informed about DES, they would not have taken it in the first place. Since FDA has, unfortunately, gone ahead and approved DES for use in emergency situations such as rape, I should like to explain why DES ought not be given to rape victims by hospital emergency room personnel. Evidently, FDA has little understanding of emergency room procedures and the treatment of rape victims. Informal studies done by Ann Arbor and Detroit rape crisis counselors have shown that emergency room doctors take only a cursory medical history. They often do not find out whether the woman has heart problems, impaired liver function, severe diabetes, a history of blood clots, or history of abnormal genital bleeding. The doctors do not, and indeed cannot, do a thorough enough medical history to find out if there are contraindications to estrogens. Pregnancy is one contraindication. However, minors who are rape victims sometimes give inaccurate contraceptive or sexual histories for fear that their parents may find out. In most cases, the rape victim is not given adequate information on DES. In fact, she may not even be told what the drug is for or why she should come back for a follow-up. For the first 3 or 4 days after the rape, most victims are in considerable pain and discomfort. It is not unusual for the woman to discontinue taking the "morning-after" pill because she does not want the added discomfort of nausea or vomiting. Besides this, the victim may have already received large doses of penicillan or even Valium, and may not wish to take more drugs. However, Follow-up is essential when DES is given to the patient. follow-up of rape victims is virtually impossible for many reasons. After the rape, the victim may: move out of town or move to another part of town change jobs live with relatives some rape victims initially give false names and addresses be- many rape victims are brought to a county hospital, sometimes when the rape victim comes to the emergency room she may be dis- But the greatest deterrent to follow-up is the cost involved. Most victims simply cannot afford to pay another $30 or $40 for a hospital visit. Finally, follow-up is not considered the responsibility of the emergency room personnel. According to Dr. George Fink of St. Joseph Hospital in Ann Arbor, Michigan, "Our policy is to refer rape cases as well as other emergency cases to follow up with their own family physician or at local medical facilities. Follow-up is not within our capacity. We do not have the set-up, and we do not do it." In reviewing the 1974 rape cases seen at Wayne Co. Hospital in Detroit, one doctor estimated that only about 25% of all rape victims come back for any kind of follow-up, even VD testing. Emergency room personnel neither have the time nor the desire to counsel rape victims about alternatives to DES, risks associated with DES, and carcinogenic effects to the offspring. Many ER doctors feel uneasy about prescribing DES for rape victims because they are unable to determine whether or not the victim is already pregnant. The What FDA fails to realize is that the emergency aspect of treating rape victims has to do with the trauma of the assault. According to the Women's Crisis Center of Ann Arbor, problem pregnancy is secondary. assault itself both physical and psychological is what constitutes the emergency. According to Catherine McClarey, a Washtenaw County Commissioner and rape crisis counselor, "DES is too drastic a measure for the problem. " By its failure to regulate the use of DES, the FDA has created a drug abuse problem. We know that statistically less than 5 of every 100 single, unprotected sexual encounters result in pregnancy. Therefore, we are subjecting 95% of women given DES to an unnecessary drug. In dispensing DES to rape victims, we are unnecessarily exposing the majority of them to carcinogenic risks. If DES is to be given out at all, then the very least FDA can do is to ensure that the patient is fully informed of all the risks to herself as well as to potential offspring. There should be a patient insert which includes animal test data, all known side effects, contraindications, and alternatives to DES. FDA should define what it means by "emergency." According to one Ann Arbor doctor, an emergency can be anything from a ripped condom to a forgotten birth control pill. According to another doctor, Judy Pagano of Wayne Co. Hospital, "If the FDA were to strictly define emergency, and specify the indications for DES, it would affect our prescribing habits because it would be legally important." According to a resident at University Hospital, "We are all very concerned about lawsuits. If I were in private practice, I might think differently about DES. As it is, I am covered through the hospital." Which brings me to the final issue - the possible legal liability of doctors who prescribe DES. Recently, even the AMA has conceded that the doctrine of informed consent includes disclosure by the doctor of risks to the patient, including risk of failure of the drug, as well as disclosure of alternative treatments. As far as I can tell, few doctors are suggesting any alternatives to DES. They could suggest menstrual aspiration or early abortion. In conclusion, DES must be given only under the following conditions: 1) a thorough personal and family history must be taken 3) FDA must provide adequate information in a patient 4) a pregnancy test must be given prior to and after DES therapy 5) there must be follow-up 6) the patient must be informed of alternatives, including menstrual aspiration and early abortion Unless all of these steps are taken, DES should not be prescribed to anyone. |