This is what Joyce Bichler remembers:
"By January of '72, I couldn't deny it anymore, because the bleeding had really been quite heavy. There was one time when I would stand up, and it felt literally like I was hemorrhaging, and I couldn't get to the bathroom in time . . . I remember sitting in the doctor's office with my mother and sister . . . I remember asking him, 'What are the chances of its being cancer?' And I remember how defensive he got. He said, 'Don't even use that word' . . .
"And when they said, 'vaginectomy,' I just, you know, I really felt everything spin.
"Because I had never heard of such a thing before. I didn't know how they could do it."
Vaginectomy : the surgical removal of the vagina. The surgeons also removed Bichler's uterus, Fallopian tubes, appendix and left ovary. She was 18 years old.
This is what Anne Needham remembers:
"When (the doctor) did do the internal exam, he just freaked. He jumped up and said, 'Oh, my God, I've never seen anything like this before.' I went into shock. He ran across the room . . . he called the nurse in. He said to her, 'Look at this.' He said, 'You've got to go to the hospital. You've got to go to the hospital right now.'"
One of Needham's vaginal tumors was the size of a dime; the second was the size of a nickel. Her vagina, along with the rest of her reproductive system, was surgically removed. She was given an artificial vagina, made from the grafted tissue of her buttocks. She was 20 years old.
On April 22, 1971, in a startling article in the New England Journal of Medicine, a Boston physician named Arthur Herbst reported that during the previous five years, he had examined eight young women with an extremely rare form of vaginal cancer. The disease was called clear-cell adenocarcinoma. It was deadly if not rapidly treated, and its sudden appearance in girls as young as 15 was so extraordinary that Herbst and his colleagues at Massachusetts General Hospital had pored through the patients' records, trying to find some medical link.
They found it. During pregnancy, the mothers of seven of the young women had taken a widely prescribed synthetic estrogen called Diethylstilbestrol, or DES. From 1941 on, despite published reports linking estrogens with cancer in laboratory animals, the drug had been given to hundreds of thousands of women (the figures vary, but estimates range up to two million) as a way to prevent miscarriages or bleeding during pregnancy. The Herbst study, and those that followed it, established that daughters born to these mothers were likely to have a condition called adenosis -- the presence of mucous-producing nonmalignant tissue in the vagina -- which required frequent and costly medical exams.
And in some cases -- .14 to 1.4 per thousand, according to a Herbst follow-up -- DES daughters developed clear-cell adenocarcinoma. Vaginectomy was the most widely accepted treatment, for those who lived.
Joyce Bichler's mother had experienced bleeding.
Anne Needham's mother had suffered two miscarriages.
Six weeks ago in the New York State Supreme Court in the Bronx, a six-person jury ruled that Eli Lilly & Co., one of the largest early producers of drugs containing DES, must pay $500,000 in damages to Joyce Bichler. Even though Bichler could not prove that Eli Lilly made the specific DES product that her mother took, the jury accepted the argument of Bichler's attorney: That Lilly was one of the largest early manufacturers of DES, that DES was inadequately tested before marketing, that DES caused Bichler's cancer, and that Lilly must therefore assume the responsibility.
Two weeks ago, in a second suit in Chicago, a jury awarded $800,000 damages to Anne Needham. Needham's mother, unlike Bichler's, had found clear records of the precise drugs she had taken -- her husband was the pharmacist who filled the prescription. White Laboratories, the New Jersey-based company that manufactured the drug, was found to have been negligent in its testing and marketing of DES. As Needham's attorneys argued in closing, the drug "scarred her, physically as well as emotionally, for life."
The Michigan attorneys who argued Needham's case have lawsuits pending on behalf of about 315 DES daughters in 18 states. In Boston, a U.S. District judge has agreed to hear what may develop into a multimillion-dollar class action against six drug companies on behalf of Massachusetts DES daughters.
One New York law firm has lawsuits demanding $20 million in punitive damages on behalf of each of three DES daughters -- one of whom has since died of cancer. There are suits pending in almost every state in the nation, and the sums of money involved are potentially large enough to dwarf the estimated $141 million paid out to young victims of the West German-made sedative called Thalidomide.
White Laboratories is withholding comment on the Needham case, while the company decides whether to appeal. Eli Lilly has already filed an appeal. "If we're responsible for whatever a drug company does, whether it was our drug or not, you've changed the whole tort system in the United States," says Edwin Heafey, an Oakland attorney who has represented Lilly for 22 years.
He says the predistribution testing was extensive, and conducted by the leading researchers of the day.
And it cannot be conclusively proven that DES causes vaginal or cervical cancer, Heafey says. "We're talking, in the cancer situation world-wide, about a very small, minute incidence of the disease," he says. "Twenty-five percent of the people that die in America this year will die from cancer. Then you take the 346 (the number of young women listed since 1971 in an international tabultion of clear-cell adenocarcinoma cases) and how many were exposed to estrogen/230. (So) Twenty-five percent (of them) had the same thing and were not exposed to DES . . . There's something else going on in the girls that have it, and I really believe that." The Constant Reminder
"I was the underdog," Joyce Bichler says, "and they were the big guys, and going into that trial they were laughing at us. They didn't think we had a chance. And we just stuck in there and fought back. And we won." $5Bichler is 25 now, a San Francisco social worker with wiry dark hair and blue-gray eyes that do not flinch as she talks about the raw details of her medical history. She is married to a speech pathologist, whom she loved seven years ago when she became ill in New York, and who would not go away after her operation, despite Bichler's insistence that no man could ever find her attractive again.
"It's something that is brought to mind every single night of your life," Bichler says slowly. She is sitting on her living room couch, hands in her lap, absently twisting her gold wedding ring. "It's not like -- I guess there are some surgeries where you just have a hysterectomy, you can forget about it and kind of go on living. But with this type of surgery you have the outward appearance of being okay . . . but in your private life, you can never really forget what happened."
"It's something you have to face constantly."
In 1971 she was a freshman, hesitantly pre-med, at New State University at Stonybrook. When she first noticed that her menstrual periods seemed longer and more frequent, she blamed the change in habitat -- she had never lived away from home before. But by early 1972, when the blood was coming between periods and she sometimes thought she would faint, Bichler went to a doctor.
"The first thing he asked my mother was, did you take anything during pregnancy with me?" Bichler says. "And my mother said yes, she remembered specifically taking something, but she couldn't remember what it was."
Bichler's mother, in her two previous (and successful) pregnancies, had bled during the first three months of each. The new doctor monitoring the pregnancy with Joyce urged Mrs. Bichler to take DES.
There was nothing particularly unusual about the doctor's advice. Thirteen years earlier, a husband-and-wife doctor team at Harvard University had begun a series of tests on pregnant women which led them to conclude that DES helped prevent miscarriages and generally improve pregnancy. By the 1960s, some researchers had come to believe that DES does not prevent miscarriages after all -- but in 1954, when Bichler was born, the conclusions of the Harvard team were still accepted by many doctors.
But there was also a body of medical opinion -- some of the studies go back as early as the 1930s -- which linked estrogens to cancer in laboratory animals. Why hold the drug companies responsible for not heeding these studies, while exempting the doctors? David Fine, the Cambridge attorney working on the Massachusetts class action suit, says drug companies are expected to be the final authorities on all medical research concerning their products. "It's just impractical to expect that a single physician would keep current with active literature affecting all the drugs he prescribes," he says.
Joyce Bichler was in the hospital for a month. She remembers waking to the sound of her own screams, seeing the blurred faces of her mother and boyfriend in the room, and slipping back under the painkillers. The surgeons left in one ovary and a small portion of her vagina, which they told her she would be able to stretch enough for an altered but functional sex life. Then Joyce Bichler left the hospital, went home to the Bronx, and shut herself up in her bedroom.
She snapped at her boyfriend, picking fights, convinced he must really want to leave her. "I couldn't understand how any guy could still like me," she says. "I really thought, 'This is it. No man is ever going to look at me.'"
Six months after the operation, as the family sat around the dinner table one night, they began to talk about a lawsuit.
There were two possible obstacles that have continued to hamper other DES suits over the years. First, statutes of limitation: In Illinois, for example, a DES daughter must sue within two years after she learns the drug made her ill. And in some states, such as New York, the countdown begins not with the discovery of the injury but with the injury itself -- so that if a woman learns she has cancer after the statute of limitations has expired, she may be without legal recourse.
Because of New York state law, Bichler was safe there. But like thousands of other DES daughters, she was never able to find the precise record of the drug her mother took. Many of these dated medical files have been lost over the years; organizers in DES task forces say they have heard so many stories of records that were burned up in office fires that they suspect a few physicians are deliberately lying or destroying files to avoid lawsuits.
Bichler's attorneys, led by former New York State Supreme Court Justice Leonard I. Finz, decided on an unusual approach. They would select a major, early producer of DES -- Eli Lilly & Co. They would declare from the start that there was no way to prove Lilly made Mrs. Bichler's drug -- but that the drug companies had shared a common responsibility to test DES more thoroughly before marketing the drug. It was a premise untested in the American courts, and it worked. Not Even a Worry
"There was no drug, as of 1947, as investigated as estrogen," Heafey the Lilly lawyer, says. He sits at the desk in his ninth floor law office, flanked by bound transcripts from the Bichler and Needham trials, shaking his head. "Put yourself back in 1941 and '47, and try to figure out what kind of airplanes we were flying, what kind of technology it was . . . There was no one that even suggested, in writing, a worry, just a worry, that there'd be a side effect on the offspring."
Did Lilly test the effectiveness and carcinogenic potention of DES before marketing it?
"Lilly relied on the universities to do all the testing," Heafey says. Harvard, the best people . . . If I were Lilly, and you gave me $100 million, and you said, 'Okay, go test the drug in 1947, the best persons to have test that drug were White (Dr. Priscilla White, a respected Boston physician and reasearcher) and the Smiths (Drs. George and Olive Smith, the doctors who originally promoted the use of DES for spotting and miscarriages): They were the state of the art. They knew more about this subject than anybody alive."
Furthermore, Heafey says, Lilly did run animal tests on DES -- at least six, according to the company's now-in-complete files. He denies the charge by Bichler's attorneys that those tests were inadequate to ferret out carcinogenic potential.
What about the medical research that linked estrogen to cancer in laboratory animals?
Heafey spreads his palms. "The other day they gave a mouse peanut butter and he got cancer," he says. "If that knowledge really meant what the rhetoric of the plaintiffs' lawyers says it means, why are they still using estrogens?
" . . . That's the trouble with animal studies," Heafey says. "They're informative, but you can't go crazy when you read them . . . There are a lot of things that are carcinogenic in animals that are not in humans. The doctors knew that, and they know it now."
Members of the national task force called DES Action have said from time to time that if drug companies had contributed more time or money to the afflicted women, the companies might not be facing such massive legal problems today. Reaction?
"Lilly has spent, since 1971, in excess of a million dollars for assistance and grants and support of DES clinics and symposiums and a colloquium in New Orleans," Heafey says. "They sent out 240,000 letters to medical doctors . . . notifying them of the first Herbst report."
He says that in 1976 alone, Lilly gave $210,000 to research grants for the study of DES and its complications, and that much of the research in the first years after the Herbst report was directed toward finding out "whether the adenosis girl was in trouble."
Although adenosis -- the vaginal condition which shows up in many DES daughters -- is not in itself harmful, the condition was thought at first to be precancerous: a few women with adenosis, in what is now considered extreme overreaction, were given vaginectomies. There is still no consensus as to whether the condition has much chance of changing to cancer, but some DES daughters with extensive tissue changes must undergo semi-annual exams that cost $100 or more with a special instrument called a colposcope.
Heafey says Lilly has not funded such exams. As to whether the adenosis girl was in trouble, "the conclusion," he says, "was that she is not."
Heafey finds it appalling that his company must share the blame simply because it produced and distributed DES.
"I think it's all over for pharmaceutical companies or for drug research if hat ever became the law," he says. "The ball game is over. It's all in the brief. Talk about money . People forget that drug companies are made up largely of doctors. They're not made up of some Wall Street, pin-striped -- I go back to Lilly and they're all wearing smocks. I go back in their labs, and they're all breaking their tails trying to figure out what causes cancer."
One more thing. "This drug wasn't a money-maker, either," Heafey says. "Christ. It was a very, very small shelf item for Lilly." Stark Terror
In 1973, when Anne Needham was a 20-year-old junior college student in Chicago, she developed a rash under both arms. She changed deodorants. The rash eased and then got worse. Her dermatologist suggested she see a gynecologist, noting that a yeast infection sometimes causes rashes. Needham made the gynecologist appointment and went shopping for a birthday card with her boyfriend.
She was standing in the store, she says, when she felt stabbing pains in her abdomen. She started to bleed. She thought she had better sit down fast, and as she was heading out of the store toward their parked car, Anne Needham blacked out.
The doctor who treated her -- who found the tumors, who ordered the biopsy, who called Mrs. Needham and labored over telling her what would have to happen -- had delivered the baby Anne. "He kept saying, 'Anne, we'll take care of it, don't worry about it,' Anne Needham says. "I was thinking, my God, can they take this out of my body, has it spread, has it metastasized . . . It wasn't until afterward that I got to the clinic and realized what they were going to do."
Carefully, voice in check, Mary Needham says into the telephone from Chicago: "It was a long time before I realized that the responsibility in a sense was mine, because I did not want to abort this baby. I had lost two babies previously before I became pregnant with Anne. She has always been a treasure, as all children are . . .
"They kept hounding me with this idea that I had taken this drug that had caused cancer in the fetus," Mrs. Needham says. Her voice is breaking.
"You go through such hell . . . First of all you go through a horrible terror, a stark terror. The first girl (at the hospital with the same condition as Anne's) had passed away . . . You see your daughter crawl on the floor because she can't stand up, can't talk and can't walk . . . Yes. You do feel guilty. Stark terror. You don't know whether she's going to live or die."
Anne Needham's vaginectomy and hysterectomy were conducted at the Mayo Clinic in Rochester, Minn., one of four government-aided DES centers in the country. She remembers how the moments of clarity pinged odd and improbable in the hours before her reproductive system was cut away: would it work, would she live, would the skin graft from her buttocks make a scar above the bikini line and please could the doctors be careful about that because she had already picked out her new swimsuit.
Needham came home in late March 1974 -- cramping, hobbled, and slightly incontinent. "You feel like a little old lady," she says. "It didn't start to hit me, I don't think, until about six months later . . . I really blocked a lot of it out of my mind . . . I felt like I had this word cancer , imprinted on my face . . . I felt like it made me older, real fast."
It was not until the Mayo Clinic sent routine questions to the Needham family, asking whether Mrs. Needham had taken any hormones during her pregnancy that the family looked back into the records and discovered that Anne Needham was a DES baby. The drug was called Dienestrol. "I didn't really realize what I was getting into," Anne Needham says. But she sought out legal help.
She thinks, now, that she may go back to school. Once she wanted to be a nurse, but now she does not know what she wants. She has broken up with her boyfriend. She can bicycle, and jump rope and walk without pain. "I still have a lot more growing up to do," Anne Needham says.
And the money?
"Nothing can pay for what happened," Bichler says. "There's really no amount that can compensate . . . But the real victory is in the verdict. We have put the drug companies on notice, saying that all drugs they put out must be safe and effective -- and that they must be held accountable."
She says this near the beginning of the interview, in what sounds like the voice of a public figure: quiet, strong, assured. The edge comes later.
"It's just -- " Bichler hesitates. "It's not something that just happened, I've got cancer, and at least I'm alive. But it's the feeling that it never should have happened. It could have been prevented. It should have been prevented. But it never should have happened to me. And that is very difficult to live with."