Clinton St. Quarterly, Vol. 5 No. 2 | Summer 1983 (Seattle) /// Issue 4 of 24 /// Master# 4 of 24

Provera at Birth Control to subsidiaries in Belgium and Canada. And Upjohn earned the doubtful distinction of being included among Mother Jones magazine’s list of perpetrators in “ the worst corporate crime of the century,” dumping unsafe products in Third World countries. The Mother Jones article accused population control programs of administering the drug without proper medical examinations or follow-ups. It also suggested that women were coerced into taking the shots with bribes of food, free medical care or threats to withhold the same. By now, women’s groups and organizations opposed to wholesale population control in less developed countries were beginning to mount a campaign to end the use of Depo. It was June, 1974, when Nardi returned to her job as a sales clerk in the Port Angeles Peoples store. Never a large girl, only 5 foot 1 inch, 105 pounds, she was now losing weight. She also seemed to be catching every cold that walked by her. Her period started. One week, two weeks, for six weeks she bled. Then it stopped, for awhile. Two weeks later it began again. Hadn’t the doctor told her the shot would stop her periods? The cycle continued. She lost more weight. The happy, energetic woman was becoming lethargic, withdrawn and depressed. Nardi tried to care for her baby but it became harder and harder. Every three months she went back to the doctor’s nurse for her shot. She never saw the doctor; his schedule was full and she and her baby saw a second doctor in the clinic. When the bleeding wouldn't stop Nardi told this to the new doctor. He checked her chart. Why are you taking this shot, he asked. For birth control, Nardi said. He never mentioned it again. He sent her to the hospital for tests. She was extremely anemic. i i i i i i In 1978 Upjohn again asked the FDA to approve Depo Provera as a human contraceptive. Studies of women in other countries revealed no alarming risks from the drug. The FDA still refused. The FDA’s second denial created an uproar in the medical and population control communities. Special legislation was introduced in Congress to allow the export of Depo overseas, even if the government wouldn’t approve its safety. Congressional committee hearings were held to determine if any risks associated with Depo outweighed the obvious benefit of a cheap, almost 100 percent effective, easily administered contraceptive for women in poor, highly populated countries. Some population control experts ranted about “ the tyranny of the beagle dog.” Dr. Davis asked at least for limited approval for use of Depo in “ special” cases, such as the mentally retarded women she worked with. Undaunted, Upjohn asked the FDA for a Board of Inquiry. Such a board, here made up of one member selected by Upjohn, one by the FDA and one “ neutral” member selected by doctors and scientists, is a last ditch effort to overturn an FDA decision. Before the Board could convene however, Upjohn’s ten-year study on rhesus monkey’s was completed. Upjohn asked for a delay. The test results were not good. More and more often Nardi was home, lying in bed, withdrawing from the world. Her husband took care of the baby. They stopped having sex. Nardi snapped at him over nothing. She wouldn’t let her friends in the house. She wouldn’t even let her mother in. Nardi weighed only 74 pounds. She thought about dying. In April, 1975, Nardi noticed she was passing huge blood clots in her menses. She was scared. She called the doctor who had prescribed the shots and the doctor who had said she was anemic. They weren’t in. She called the clinic’s only other doctor. He checked her chart. This drug is too new, he said. We don’t know what’s normal. Nardi was sick and upset. Am I being used as a guinea pig? The doctor wouldn't answer. Talk to your physician, he said. Nardi never went back to that clinic. She stopped getting “ the shot." The rhesus monkey studies done by Upjohn were routine. The FDA requires animal tests on at least two species when investigating a contraceptive for safety. A decision is made based on the worst test outcomes. Upjohn’s monkeys were divided into four groups: 16 received 50 times the normal human dose, 16 received 10 times the human dose, four monkeys received the same dose as humans and four received no drugs at all. Two of the monkeys receiving 50 times the normal human dose had cancerous lesions of the endometrium when they were killed at the end of the study. In one of these, the disease had spread to the lungs. All the monkeys in the two high dose groups suffered chronic inflammation of the uterus. Rhesus monkeys are used to test a drug for potential carcinogenic effect (ability to cause cancer) because studies have shown the species rarely develops “ spontaneous malignant tumors.” Between 1947 and 1973 no uterine cancers were reported in any experiments on rhesus monkeys. Not only were the test results bad, but Upjohn was alse being accused of withholding research findings. Stephen Minkin, a former Chief of the UNICEF Nutrition Program in Bangladesh and now employed as a Health Policy Analyst for the National Women’s Health Network, reported that Upjohn’s test findings also included a cancerous lesion in a monkey in the seventh year of the study. Upjohn had previously said no tumors or lesions were found before the monkeys were killed at the end of the tenth year. Minkin also charged that Upjohn withheld evidence of other side effects in Depo test animals. Among these he listed growth abnormalities in monkeys in all three groups that received Depo, changes in the liver and uterus of the high dose monkeys, and a high incidence of death during the first 85 weeks of the study. Only 28 of the original 52 monkeys survived the whole 10 years. Minkin also said that the four control animals which received no Depo were “ sacrificed” for no reason. In the beagle dog studies, Minkin charged that Upjohn failed to report that, in addition to breast tumors, some of the dogs developed endometrial disease. Three of the dogs died of “ drug induced diabetes,” the adrenal glands of many dogs had atrophied, liver tumors, gallstones and gall bladder cysts were found in low dose dogs, and that by the midpoint of the seven year dog study all the high dose dogs and half of the low dose dogs had died “ from action of the drugs on the uterus.” Minkin said his information came from “ trade secret documents” not usually available to the public or the medical community. He did not say where he got them. Upjohn’s announcement that they found cancer in the test monkeys also moved Malcolm Potts, now Director of the International Fertility Research Program in Chapel Hill, N.C., to contact his friend, Ed McDanial, in Thailand. Together, Potts and McDanial designed research they hoped would show the monkey studies were irrelevant and there was no relationship between Depo and endometrial cancer in humans. They would concentrate on women who had been admitted to McCormick Hospital with confirmed cases of endometrial cancer. Enter Minkin. In an article published in the November, 1981, issue of Mother Jones, Minkin charges that Potts and McDanial used highly questionable research methods. Since none of the nine women they eventually studied had used Depo Provera, they concluded Depo did not cause endometrial cancer. Potts and McDanial did not track down or examine any of the 100,000 women who had been given Depo at McCormick Hospital to see how many of them developed cancer. Too weak to care for herself or her child, Nardi was taken to her parent's home in Port Orchard, near Her period started. One week, two weeks, for six weeks she bled. Then it stopped, for awhile. Two weeks later it began again. Hadn’t the doctor told her the shot would stop her periods? Bremerton. She didn’t know what to do, who to see, so she started calling obstetrician-gynocologists (ob-gyns) in the Bremerton phone book. I would like to see the doctor, she said. She explained about the bleeding, the illnesses, the depression and the shot. I ’m sorry, the doctor isn’t taking new patients, she was told. No one would see her. She called the FDA. They needed to know the name of the drug before they could help her. Nardi didn’t know the name. Nardi’s husband, still in Port Angeles, went to the home of the doctor who first prescribed the shot. What is this stuff, he asked. Depo, Depo Provera, the doctor told him. Nardi called the FDA again. We’ll send you some information, she was told. She was also told the drug was not approved for use as a contraceptive. Nardi contacted the local American Medical Association grievance board. They sent her to an ob-gyn. He said he was a personal friend of the doctor in Port Angeles. After tests this doctor told Nardi she was going through menopause. Had her doctor gotten her written consent to give her Depo? No, Nardi never signed anything. Well, he continued, you might ovulate in a couple years, or you may never ovulate again. I can give you some fertility pills, $7 each, and you can come in five times a month for hormone shots, but I can't guarantee anything. Nardi walked out. On A.ugust 15, 1975, Nardi Townsend called an attorney. In the patient insert supplied by Upjohn when it sells Depo the following potential adverse reactions are listed: breast tenderness, nervousness, insomnia, fatigue, dizziness, thrombophlebitis, pulmonary embolism, breakthrough bleeding, spotting, changes in menstrual flow, loss of periods, edema (fluid retention) weight changes, cervical erosion and changes in cervical secretions, and mental depression. Doctors are advised to closely observe patients with a history of diabetes or psychic depression. The insert also cautions doctors to closely monitor women with conditions that might be influenced by fluid retention, epilepsy, migraines, asthma, and cardiac and kidney functions. An estimated 1750 Seattle women are currently receiving the shot. About 250 of them, including Janice Murray, get it from Dr. Raymond Clark. She’s been getting it for two years. “ For me it really works well,” Janice said. Before getting the shot her period came about every three months. She never has periods, now. “ I’ve forgotten what it ’s like.” She remembers Dr. Clark telling her Depo was not yet approved by the FDA. She was told about the beagle dog studies and he asked her if she was diabetic or had thyroid problems. “ Everytime I go in he asks me if I smoke, but I say no, so I don’t know why he asks.” She was also warned about possible fetal damage if the shot were administered while she was pregnant. Janice isn’t worried about that, though. She plans to have her fallopian tubes cut and never wants children. “ I've had doubts. I’ve wondered,” Janice admits. “ I just figure the chance I’ ll get cancer is about the same as if I took the pill. It’s probably the less of a whole lot of evils.” (ed. note: recent research studies indicate the pill inhibits the development of cervical cancer, although it is still associated with a variety of other side effects, including blood clotting.) Janice hasn’t kept up on the pub- licty around Depo. The only thing that might get Janice Murray to stop using Depo is “ if any of my blood tests or pap smears came out weird,” or if her friends who use it had problems. Janice Murray’s doctor is not doing any systematic study of side effects in his patients. Clark reports having patients who have used Depo for 12 years with no III effects. In addition to giving Depo for birth control, Clark Clinton St. Quarterly 9