Cowan Testifies In Continuing Des Controversy

"Since we do not yet have proof of the ifety and efficacy of DES (diethylstilbeIrol) as a 'morning after' pill, I don't link the FDA (Food and Drug Adminis 'ation) should approve its use." [ Armed with her concerns about the rug and a survey of 200 women who had iken DES in Ann Arbor, Belita H. Co..an testified today in Washington, D.C. before Sen. Edward M. Kennedy's health subcommittee. Ms. Cowan teaches "Women's Health Care" at Washtenaw Community College and is medical editor for "herself" magazine. "I have long been following women's health problems as they relate to drug users," she says. The health subcommittee is a part of the Labor and.Public Welfare Committee of the U.S. Senate, of which Sen. Kennedy is a member. "Sen. Kennedy has always been interested in the issue of DES," Ms. Cowan s. "This is not the first time hearings We been held on the drug. The committee itself is very concerned particularly about this drug. "The subcommittee's idea is that the FDA has not been judicious in the matter of laws requiring that there be reasonable proof of the safety and effectiveness of the drug. "The FDA says that it has reasonable proof. The subcommittee feels that (FDA) can't have this proof because there have never been any controlled studies of it." Ms. Cowan took to her testimony several concerns, among them the prescribing habits of doctors who dispense DES, medical protocol in hospital emergency rooms where rape victims are treated and the possible legal liability on the part of emergency room doctors who prescribe DES. She conducted a survey last summer of over 200 women, ages 18 to 31, who had taken DES as a 'morning after' pill in Ann Arbor between 1968 and August, 1974. She interviewed nurses, gynecologists and emergency room doctors at twö Ann Arbor hospitals, the U-M Student Health ervice and a number of Detroit - The purposc oí tne study," she said, J"was to determine how and when DES (was prescribed to wómen and the I precautions taken, if any, to ensure the care'ful monitoring and follow-up of all patients. "What is occurring in Ann Arbor is, I believe, indicative of what is happening in other cities, particularly those with university medical centers." "The 'morning after' pill was tested here at the U-M Health Service at a time when it was not an approved drug," she says. "Some of the students were not aware that it wasn't an approved drug." She went to Washington in 1972, with Ralph Nader's Health Research Group, to explain to the FDA that the drug was being tested without adequate precautions and has been involved in the controversial issue ever since. i Her 1974 study showed "that far from ; being an emergency medication, DES is being used repeatedly as a contraceptive. Twenty-nine per cent of my sample stat ed that they had taken the 'morning aftér' pill at least twice within a year's time. The study showed that DES is being prescribed with carelessness and casualness. "Forty-five per cent were not given a pelvic or breast exam. Fifty-six per cent stated that the doctor did not take a personal and family medical history. Eight women said that they got the 'morning I after' pill not for themselves, but for a'1 friend or roommate. And only 26 per cent were followed-up to see if they were I pregnant," she said in her prepared tesI timony released to The News WednesI day. __- "The study also revealed that DES is being given to women for whom estrogens are contraindicated. Women who eannot take birth control pills are being given the 'morriing after" pill. They are not aware nor are they informed that the morning af ter' pill is estrogen. "Fifty-seven per cent of the sample were unaware that the 'morning after' 11 did not have FDA approval and that i ñau ñot been proven sale 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 régimen." DES, Ms. Cowan says, is the same I drug given pregnant women in the 1 ties, fifties and sixties. Some of the I daughters of these pregnant women have I developed vaginal adenocarcinoma. Yet, she says, "in cases where patients I are warned of the possible association between maternal stilbestrol ingestión 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. "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-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.' " Sixty-five per cent,üL tlie gwn i thc study said that if they had been fully ínformed about DES, "they would not have taken it in the f irst place." Yet, Ms. Cowan also pointed out, "FDA has, unfortunately, gone ahead and approved DES for use in emergency situations, such as rape." She explained why DES ought not lo be given to rape victims by hospital emergency room personnel. "Emergency room doctors take only a cursory medical history. "They often do not find out whether the woman has heart problems, impaired liver function, se veré diabetes, a history of blood clots or history of abnormal genital bleeding. "The doctors do not, and indeed ñÓTMióathóroughenough medical history to find out if there are contraindictions to estrogens. Pregnancy is one contraindication. However, minors who are rape victims sometimes give inaccurate contraceptive or sexual histpries for fear that they 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. "Follow-up is essential when DES is given to the patiënt." However, Ms. Cowan said, there are various reasons why the rape victim is unavailable for a follow-up visit. She may move out of town, live at too great a distance from medical facilities, wish to forget the experience, or may not realize that she needs to come back for a follow-up. "By its faüure to regúlate the use of DES,"'Ms. Cowan charged, "the FDA. has created a drug abuse problem. We know that statistically less than five of every 100 single, unprotected sexual encounters result in pregnancy. I "Therefore, we are subjecting 95 per cent of women given DES to an unnecesisary drug. In dispensing DES to rape victims, we are unnecessarily exposing the majority of them to carcinogenic Irisks. "If DES is to be given out at all, tnen the yery least FDA can do is to ensure that the patiënt is fully informed of all the risks to herself as well as to potential offspring. "There shoüld be a patiënt insert which includes animal test data, all known side effects, contraindications and alternatives to DES. "FDA should define what it means by 'emergency.' Acording to one Ann Arbo1 doctor, an emergency can be anythin , from a ripped condom to a forgott j birth control pill. According to a doe I at Wayne County Hospital, 'If the F were to strictly define emergency, I jpecify the indications for DES, it w affect our prescribing habits becau would be legally important.' ƒ "According to a resident at a loc i pital, 'We are all very concerned _ j lawsuits. If I were in private pra an I might thinkdifferently about DE S( I is, I am covered throuph thp ht - wmch bnngs me to me nnai m the possible legal liability of doe prescribe DES. Recently even th_ d I can Medical Association has :;es fl that the doctrine of informed cc" eludes disclosure by the doctor to the patiënt, including risk of the drug, as well as disclosure native treatments. I "As far as I can teil, few d I suggesting any alternative? JThey could suggest menstrua j lor early abortion. J Also scheduled to testify I Ibefore the subcommittee Wei v. J employés appearing under subpoena; Dr. Peter Greenwald, head of the Cáncer Control Bureau of the New York State Department of Health; a vice president ] of the Eli Lilly Company; the director of the National Cáncer Institute; Alexander Schmidt, head of the FDA; the president of a pharmaceutical company; three DES victims, one of them a DES daughter who has vaginal adenocarcinoma, one the mother of a daughter who died from the disease at 16; and a doctor from Stanford University who has worked with doctors in state medical societies on the i West Coast, trying to edúcate them to the risks associated with DES.