also administers it as treatment for severe menstrual cramps, premenstrual tension and endometriosis. (Upjohn is currently studying Depo to see if it alleviates Premenstrual Syndrome, PMS.) When he first began using Depo, his patients got 400 milligrams every six months instead of the 150 m illigrams every three months he now gives. He has lost contact with about 40 percent of the 7,000 Depo patients he has treated and has no idea if any of them suffered long-term side effects. Most of his patients use the drug for two to five years. He hasn’t noticed any increase in endometrial or cervical cancer in these women. Clark discounts human studies showing an increase in sterility among women who use Depo Provera. Those studies, he says, were done on women from poor areas where “ unfortunate lifestyles” (promiscuity, prostitution) and frequent pregnancies are likely to produce tubal infections that lead to sterility. “ If you limit studies to women with one child and the same husband you won’t find that problem,” Clark claims. He thinks, however, that Depo is a good contraceptive for young women with “ unfortunate lifestyles.” “ Some of these people are so poorly motivated,” he says, they need something they don’t have to think about for birth control. Dr. Nora Davis is at Children's Orthopedic Hospital in Seattle. She prescribes Depo Provera precisely because its major side effect is to stop women’s periods. Most of her patients are mentally retarded. Some cannot change their own napkins or tampons. Others have heavy, uncontrolled bleeding which makes it d iff icult for their caretakers to keep them clean. Rather than cause cancer Dr. Davis believes Dfepo is “ an anti-cancer drug.” She says it is a safe alternative for young women to use until they are old enough to decide if they are capable of being parents. She feels Depo is better than the pill, being pregnant or “ God help us, abortion.” It is also preferable to parents “ railroading” retarded women into permanent sterilization. The handout which parents and patients at Children’s receive along with Upjohn’s package insert does not mention the beagle dog studies or rhesus monkey studies indicating Depo may cause cancer. Although Davis says the drug is a “ stand-by” till the young woman makes a decision about children, the pamphlet urges only women who never want children to use Depo. It gives short shrift to Depo's known side effects, mentioning only irregular bleeding, weight gain and loss of sex drive. Harborview’s Women’s Clinic in Seattle gives Depo to some patients. A nurse-practitioner at the clinic said because Depo is not FDA approved its use “ gets sticky.” “We don’t really want publicity,” she said. Her superior, Dr. Vinette Zabriskie, said Harborview is not doing any formal studies of its Depo patients or tracking any pattern of side effects. She is not aware of any complications among the women who use it. Harborview requires a signed consent form before administering Depo. It says the effect of Depo on a fetus is not known and therefore, women should not use it if they think they are pregnant and should not get pregnant for up to nine months after their last injection. It also says, as Upjohn admits, that a return to fert ility after using Depo could take as long as 18 months. The form does not list the other known side effects of Depo except to mention that irregular bleeding may occur in the first few months. Nardi sued the Port Angeles doctors. Following that action, she claims, her mother-in-law and aunts were told never to come back to the clinic. She says the c lin ic ’s doctors also refused to treat her baby when he fell and dislocated his elbow. When Nardi found herself pregnant in January, 1977, she had to go to the neighboring town of Sequim to find a doctor who would see her. Nardi told this man about the Depo. He said he’d do some reading on it. When she was five months along he reported that the baby might get skin cancer. Her son, breast fed on Depo-laced milk, might be sterile, but they wouldn’t know until he reached puberty. He also told her she had a “pre-cancerous” condition. He cauterized her cervix. Later, a Seattle doctor froze Nardi’s cervix. Her pap smears returned to normal. Nardi told her friends about Depo. One day, one of them mentioned hearing of a 16 year-old g irl getting the shot from the same doctor who gave it to Nardi. Nardi said she'd like FirstJapan Poem By Harvey Stein Drawing by Dana Hoyle I am on the train from the airport to Tokyo, and I’m the only white man in the world. My eyes drink the faces around me — was that a Caucasian? — no, just a mirage, a ghost of memory. In 1982, the samurai army wears dark blue suit and tie, the industrial serf dusts his crops with black ash, but the faces — every face is a calligraphy, a crack in the machine. Emperors descended from the sun goddess, rivers of silk and moss-covered buddhas, the beggar monk lost in the clouds — tales of these seep through the faces. The gangster bum was lying on the park bench, two joints missing from his pinky, white patch over one eye, 50 yen piece (the one with the hole in the middle) stuck in his ear. Later that day, behind the pagoda tower guarding the imperial palace, the sun sets orange in the dark moat, where the waters run at right angles. Behind the wheel, commuters whip home. See the hunched over, stunted old lady at the crosswalk? See her white silk kimono laced with dark designs, hear the clack of wooden sandals on concrete, the Datsun barking at her heels? What stories could she tell? Now look — she walks down the alley, enters the arcade, sits down with grace, immobile in front of the vertical pinball machine that almost plays itself — silver balls pop up every second in some kind of molecular madness, then fall in epileptic pathways back down. It’s 1982 in Tokyo, where East meets West, where the hot subway wind comes up the stairs smelling like burnt metal, just like in New York. The Emperor’s children wipe the day’s sweat from their brows, add up the last column of figures on a scrap of newspaper., slouch and scowl, closing their almond eyes. They drop their drunken heads, and settle into the long ride home. to talk to this girl. A few nights later, Nardi’s phone rang. The young woman on the other end wouldn't give her name. She was scared; she didn’t want her parents to know she was using birth control, even though she had jus t gotten out of the hospital with symptoms similar to Nardi's. Nardi told the girl, whatever you do, don’t ever take Depo again. Nardi never heard from her again. On January 10, 1983, the Board of Inquiry requested by Upjohn in 1978 finally opened its hearings. The testimony of Upjohn and the FDA focused on one issue — do the animal and human studies on Depo Provera give conclusive evidence of Depo’s safety as a contraceptive? At the heart of Upjohn’s disavowal of its own animal studies linking Depo with cancer is the argument that breast cancer in beagle dogs and endometrial cancer in rhesus monkeys has nothing to do with whether women will get cancer. Beagle dogs, according to Gordon R. Duncan, an Upjohn research manager, have a different mammary gland physiology than humans. Specifically, Upjohn argues, beagles and humans react differently to progestins, the class of hormones which includes Depo Provera. However, it is commonly accepted among cancer researchers that a substance which is carcinogenic in one species of animal is probably carcinogenic in others although this does not mean it will cause cancer in all other species or that it will always cause cancer in the same organs or tissues. So, while Upjohn was rhetorically asking how Depo could cause endometrial cancer when it was being used to treat endometrial cancer, Dr. Gisela Dallenbach-Hellweg, a German pathologist, was testifying to the Board that her examination of the tissue studies done by Upjohn indicated the monkeys did not have endometrial cancer, but, instead, had cancer of the cervix and the endocervix. Anti-Depo observers at the hearings said the most telling testimony came from Dr. Robert N. Hoover, chief of the environmental epidemiology branch of the National Cancer Institute. Acfcording to Dr. Hoover, “ the fact that a particular drug may be given to treat a tumor doesn’t mean that it may not have some function in causing that tumor.” He further criticized the results of the human studies at Chiang Mai, Grady Memorial in Atlanta and Los Angeles County-USC Hospital for poor follow-up rates, the small number of women studied, the short- time some women were followed and poor record-keeping. “We have to see whether the human evidence ameliorates the animal studies or not, and there are no relevant human studies (editor’s emphasis) on which to evaluate that.” Because of the questions raised over what type of cancer the rhesus monkeys really had and the efficacy of the Upjohn studies, the Board concluded its hearings withbut making a decision about Depo. Instead, they mandated that an independent panel of pathologists study the tissue samples and slides prepared by Upjohn and report their findings to the Board. It was disturbing when, a few weeks after the conclusion of the hearings, witnesses began receiving copies of a letter sent by Catherine L. Coop, attorney for the FDA’s National Center on Drugs and Biologies, to Dr. Judith Weisz, chairwoman of the Depo Board. Coop’s letter said, “ ...it appears that, since the close of the first phase of the hearing on January 14, 1983, and the Board's expressed interest in having these tissues examined by a consulting pathologist, Upjohn (or someone in its behalf) has cut additional tissue blocks from the two monkeys of particular interest.” Coop’s concern is that this action by Upjohn will make it impossible for the Board’s consultants to obtain accurate data from those monkeys. When, or what, the Board of Inquiry will decide no one knows. And their decision is only a recommendation. FDA Commissioner Arthur Hayes has the final word of Depo. Gena Corea, author of The Hidden Malpractice, a study of medicine’s sexist attitude toward woman, believes the focus of the Depo debate has always been political, not scientific. “Who knows on what basis the decision will be made,” Corea says. She testified at the hearings. “The way the hearings went may be irrelevant to the outcome.” The Reagan administration — Hayes is a Reagan appointee — is opposed to contraception, or so it would appear. Population control lobbies are very strong, however, and Hayes may be more concerned about the appearance of U.S. hypocrisy — that it will let a drug be used on women in other countries but not on its own women — than with whether Depo is safe. “ It is people with certain values — Upjohn, the population controllers — who have created the entire body of knowledge on Depo Provera,” Corea adds. “ They are the ones doing the research. Those values effect their evaluation, the kinds of questions they ask, the type of research they do and the statistical tools they employ to evaluate their results.” Those who oppose Depo also have certain values — that unproven drugs not be used on healthy women. What matters is what happens to women over a long period of time.” Dr. Nora Davis was invited to testify at the hearings and declined. “ The hearings have been taken out of the scientific arena and into the circus arena,” she says. “ There is a lot of hype and hysteria without any evidence to back it up.” Davis is convinced that Depo is “ the safest contraceptive ever developed.” If the FDA does not approve it, it will not be because it isn’t safe, it will be because of “ vicious feminists” and “ moral majority” groups. “ I happen to be a feminist,” Davis says, “ but not a vicious one,” which she considers The National Women’s Health Network to be. Davis claims to get two or three “ salvos” a week from a “ vituperous” lawyer for the Network. 10 Clinton St. Quarterly
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