The Uncertain Legacy of DES : Health: A growing number of medical experts and women whose mothers took the drug are calling for more research into the possible effects on a third generation.
Back when Marillyn Myers was given the synthetic hormone DES, it was considered a miracle worker, a drug that could prevent premature labor, miscarriages and even build “bigger and stronger babies,” according to one drug company’s advertisement.
But for Myers’ daughter Judy Horton and many other “DES daughters,” the so-called wonder drug of the 1940s and 1950s has meant lives of worry and illness.
Horton was exposed to DES, or diethylstilbestrol, 45 years ago when she was still in her mother’s womb. By 1971, the U.S. Food and Drug Administration had barred the drug after it was linked to a rare form of cancer found in the offspring of women who had taken it during their pregnancies.
Although Horton has never developed clear cell adenocarcinoma, the only form of cancer directly linked to DES exposure, researchers from the National Cancer Institute believe that women like Horton who were exposed to DES before birth may have an increased risk of developing other forms of cancer.
Horton was only 29 when she had a hysterectomy after doctors discovered she had cervical cancer. Later, she had a benign lump removed from one of her breasts. Three years ago, she had both ovaries and Fallopian tubes removed after an ovarian cyst ruptured.
“Now, I am worried about my daughters. I am so concerned the drug may be affecting them,” the Mission Viejo woman said. Her eldest daughter, Kimberly, has already had one miscarriage, and doctors have discovered an abnormality in her reproductive organs.
Having seen her mother battle cancer, Kimberly said, “I wonder is this going to happen to me?”
While researchers insist that there is no evidence that DES is passed down genetically to third generations, a growing number of DES daughters, advocates and medical experts are calling for more research into the possible direct and indirect effects of DES on the third generation, as well as its continued impact on DES daughters.
A national DES conference, sponsored by the National Cancer Institute, the National Institutes of Health, the National Institute of Environmental Health Sciences and the National Institute of Child Health and Human Development, will be held this spring in Hunt Valley, Md., to review the latest medical research on DES and prepare a strategy for further studies and public outreach programs.
“Further research is needed before we will know the full pattern of the drug’s effect,” according to Dr. Ruthann Giusti of the National Cancer Institute. “It is critical that we maintain a registry of women who were exposed to DES and follow them . . . to accurately establish what their health experiences have been.”
“Although there is no evidence that DES is passed down genetically to third generations,” Giusti said, there is an “indirect” link between the drug and third-generation babies being born with serious handicaps caused by uterine and cervical abnormalities in the DES daughters.
The conference will also look closely at new evidence from recent animal studies that suggest the drug may impair the body’s immune system. And it will study the reported recurrence of clear cell cancer in women who supposedly had been cured years earlier, according to Dr. Shanna Swan, chief of the reproductive epidemiology program at the California Department of Health in Berkeley.
“The rule was if you were cancer-free for five years, you were cured. Now we have seen women who have been cancer-free for 10 to 15 years and then develop cancer again,” said Roman Silberfeld, a Los Angeles attorney who specializes in DES litigation.
Rep. Louise M. Slaughter (D-N.Y.) said she plans to introduce legislation asking for $2 million for education and outreach programs to inform the public about the risks of DES exposure and the need to seek medical examinations and treatment.
“Most legislators . . . and members of the public are not aware of this problem,” she said. “There are millions of sufferers, and there may be generations we weren’t even prepared to think about.”
During the 20 years since the FDA barred doctors from giving DES to pregnant women, the controversy has led to more than 1,000 lawsuits against drug companies, as well as spawned support groups and advocate organizations to help those exposed to the drug and to educate the public.
DES Action, a consumer group based in Oakland, has been pushing vigorously for more DES research. The DES Cancer Network, headquartered in Rochester, N.Y., offers support and information for clear cell cancer victims.
There’s a movement among residents of Los Angeles and Orange counties to form a Southern California chapter of DES Action. An organizational meeting is planned for Feb. 23 in Westwood.
“The DES story is the prototype of a wonder drug gone wrong. It was a pharmaceutical disaster,” said Margaret Lee Braun, head of DES Cancer Network, a group that offers support and information for clear cell cancer victims.
Although critics of DES contend that pharmaceutical companies did not adequately test the drug before marketing it, a spokeswoman from Eli Lilly & Co., the largest manufacturer of the drug, says that is not true.
“Eli Lilly & Co. believes that it acted responsibly in the development and marketing of DES, and we will continue to vigorously defend that position,” Bette Peterson said.
“Lilly and independent investigators have conducted a variety of studies involving substantial testing and research that have contributed to making DES one of the most studied substances in history.”
Lilly didn’t market the drug until 1947, nine years after it was synthesized, Peterson said. “During those nine years, extensive testing and research was conducted by independent scientists and physicians who determined that DES was an effective therapy in saving babies who would have been lost and that this therapy did not harm the mother or the fetus.”
In response to concern over a possible third-generation link, Peterson said in a statement:
“There has not been any credible scientific suggestion that DES caused genetic injuries to the grandchildren of women who ingested DES during pregnancy. The third-generation claims now being asserted by a few plaintiffs’ attorneys allege injuries resulting from premature births and do not involve claims of genetic damage or defect due to DES exposure.”
Eli Lilly and other drug firms have been sued by hundreds of women who believe that they were harmed by their exposure to the drug.
Last October, a New York state jury slapped Eli Lilly with a $12.2-million verdict in a case involving a woman whose cancer and infertility was linked to her mother’s DES use. It was considered the largest award in a DES case. As the jury was about to decide whether the company should also pay punitive damages, the two sides settled the case out of court. Terms of the settlement were kept confidential. The case was expected to trigger drug companies to settle hundreds of other suits over the anti-miscarriage drug.
Although a number of drug firms manufactured DES, Eli Lilly & Co. had about 75% of the market. Other companies targeted in lawsuits include American Pharmaceutical Co., Boyle & Co., Rexall Drug & Chemical Co., E. R. Squibb & Sons Inc., Upjohn Co. and others.
Because there is a direct link between DES and clear cell cancer--one out of every 1,000 DES daughters will develop it--these cases are the strongest ones to litigate, according to attorneys who specialize in DES lawsuits.
Others not so clear-cut are the new cases involving the third generation.
One such case is that of Iris Rosenfeld, a DES daughter from Orange County, who gave birth prematurely to a baby girl with serious physical handicaps.
Rosenfeld has filed a lawsuit in Los Angeles on behalf of her 5-year-old daughter against the manufacturers of DES. The lawsuit, which is still pending in Los Angeles Superior Court, alleges that Rosenfeld’s exposure to the drug in utero in 1955 resulted in abnormalities in her reproductive organs, which in turn led to the baby’s premature birth and handicaps.
On Christmas Day, 1986, Rosenfeld gave birth to Lara at Fountain Valley Regional Hospital and Medical Center. Two months premature, she weighed just 3 1/2 pounds. Her lungs were seriously underdeveloped and her chances for survival looked bleak.
The next few days were heartbreaking for Rosenfeld as she watched her daughter’s condition quickly deteriorate and her weight drop to only two pounds.
On Lara’s fourth day of life, the baby underwent open-heart surgery. A couple days later, she was treated for hydrocephalus caused by bleeding in her brain. Weeks later a shunt was put in her brain to drain cerebral fluid.
“I was petrified. I thought this can’t be true. I was living a nightmare,” Rosenfeld, 35, recalled.
But the infant survived. She was 2 months old before she was released from the hospital. Her problems haven’t ended. When she turned 2 years old, doctors diagnosed cerebral palsy.
Today, Lara is a bright little 5-year-old who is smart enough to play Junior Monopoly with her mother. “She’s already reading short sentences, and I am teaching her to add and subtract,” said Rosenfeld.
But physically, Lara is severely handicapped. She must use a wheelchair or walk with the help of braces and a walker. She spends many hours in therapy.
Braun, of the DES Cancer Network, says cases such as Rosenfeld’s prove that “the DES nightmare continues.”
Although the numbers are small, there are other such third-generation DES cases around the country involving DES daughters whose babies were born with serious problems due to reproductive abnormalities or premature birth, according to attorney Silberfeld.
Between 40% and 60% of DES daughters have some form of benign abnormality in their reproductive organs, according to Giusti.
These women have a higher risk for premature or protracted labor, which can result in problems at birth. The exact number of women who have given birth to babies with handicaps as an indirect result of their exposure to DES before birth is unknown, Giusti said.
“At this time, there is no evidence that the risk of birth defects, other abnormalities or cancer is any greater for children born of DES-exposed daughters and sons than for other children,” Giusti said.
What is particularly disturbing to DES daughters and advocates such as Braun is “the lack of research that has been done during the past 21 years since the drug was first linked to cancer. DES sufferers feel they were abandoned.”
Pat Cody, a DES mother and a program director of the DES Action League in Oakland, recalls: “My heart sank like a stone when I first read the news report” about the link between DES and cancer. “I felt terrible.”
Cody, now 68, took the drug when she was pregnant with her daughter, Martha. She had one previous miscarriage, and her doctor prescribed DES in hopes of preventing another one.
“Back in the ‘50s there was ready acceptance of the drug,” she said. “Society viewed it as another miracle drug. I took the drug four times a day for seven months. The attitude back then was ‘better safe than sorry.’ ”
Cody was terrified when her daughter began having problems related to the DES exposure. First, Martha had an ectopic pregnancy and lost one of her Fallopian tubes. Later, she developed such a severe case of endometriosis she had to have a complete hysterectomy at the age of 34.
Janice Lauder of Monrovia was 22 years old and a newlywed when doctors discovered she had cervical cancer believed linked to DES. She had to have a complete hysterectomy and partial vaginectomy.
“It was a horrible dehumanizing experience,” Lauder said. “It was like a female form of castration and it has affected my life in very profound ways.” She said her husband, Larry, has been a source of great support. Unable to bear children, the couple adopted a daughter.
A year after her bout with cancer, Lauder, now 40, went to Washington to testify at a Senate hearing. “There was an incredible amount of anger that we are victims of this corporate pharmaceutical industry,” Lauder said. Dispensing this drug to unsuspecting women was an “atrocious thing to do to us.”
“It’s important for more research to be done,” Judy Horton said. “We need to know more about how our children may be affected. Not knowing what to expect is like waiting for the other shoe to drop.”
She also worries about her own mother and how the DES issue has affected her emotionally. “I’m very protective of my mother,” Horton said. “I know our mothers carry a lot of guilt. I know it is hard on my mother and father every time I’ve had to go to the hospital for all the surgery.”
“I want to assure my mother and others who took the drug that we (daughters) understand that they really didn’t know what they were doing” when they took the DES prescribed for them, Horton said.
Sons of women who took DES have their own stories. Bill Kenny, a 34-year-old television screen writer, had testicular cancer, which he believes was related to the DES his mother took when she was pregnant with him.
DES sons, according to Dr. Swan, may also suffer fertility problems and have undescended testicles.
“The notion that DES is a finished story is untrue,” Braun said in testimony to the National Health Institute. “I survived clear cell cancer. But I and 10 million other DES-exposed people do not know what lies ahead of us. We do not know what will happen at the next hormonal junction in life, or in old age.
“Let’s not file DES away under unfortunate ‘blip’ in medical history until we have done our best research and learned all that the DES experience can teach us.”
