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The Risks of Hormone Therapy

Tier women join lawsuit against drug company

Apr 29, 2004 | Press & Sun-Bulletin Like most women, Maureen McCormack struggled through menopause, wondering when the hot flashes and fatigue would end. Little did she know she was in for bigger health problems.

Maureen McCormack sits with Drake, her 2-year-old Pekingese, at her Vestal home. McCormack is part of a class-action lawsuit over hormone replacement therapy. She was diagnosed with breast cancer after taking the hormone treatment Premarin.

Desperate for relief from the hormone rushes and lightheadedness, McCormack, in 1991, asked her gynecologist if anything could ease her discomfort. She received a prescription for the hormone treatment Premarin, which she took until 1998.

McCormack, now 57, was only vaguely aware of potential risks associated with the so-called hormone replacement therapy. Mainly, the Vestal resident was thankful to have some relief for her symptoms.

Then, after seven years of taking Premarin, she was diagnosed with breast cancer.

"You don't think you're going to be one of the people who are going to come down with this awful disease," McCormack says today. "When they discovered the breast cancer, they immediately told me, 'Stop taking Premarin.' I was very angry."

In a 2002 study, the Women's Health Initiative, affiliated with the federal National Institutes of Health, reported that women who underwent certain hormone replacement therapy showed an increased incidence of breast cancer, stroke and other problems.

Those findings caused hormone replacement therapy for menopause to become one of the most controversial subjects in medicine. Because it is so effective in treating the symptoms of menopause, gynecologists still swear by it and continue prescribing the pills for millions of women. But the doctors also are determined to inform patients about recent information regarding risks.

"All the physicians are talking to the patient more about this issue," said Dr. Achala H. Amin, a Binghamton obstetrician and gynecologist. "Most of the women now, they know the risks, and they still want to take it for the quality of their life."

At least four Southern Tier women are suing Premarin maker Wyeth Pharmaceuticals in federal court, claiming millions of dollars in damages for allegedly causing their breast cancers and other health problems. The lawsuits suggest that the drug companies knew about the dangers years before they warned doctors and patients.

Binghamton lawyer Ronald Benjamin, who is representing the four Southern Tier patients and about 40 others, called the drug companies' marketing strategies "downright misleading" in allegedly playing down the risks while emphasizing benefits. Each plaintiff is asking for damages of as much as $65 million to $72 million.

"I'm encouraging women to come out and exercise their rights to go after Wyeth and the other pharmaceutical companies for what I believe is a flagrant abuse of their power," Benjamin said.

Wyeth officials said they could not comment directly on the lawsuits. A company expert on hormone replacement therapy said the Women's Health Initiative data are still being analyzed, and some of the earlier risk findings have turned out not to be statistically significant. The treatment can vary from woman to woman depending on her particular needs and other health problems.

"The therapy has to be individualized," said Dr. Ginger Constantine, Wyeth's vice president of women's health and bone clinical research and development. "It's hard to know if a risk identified by the WHI is a risk associated with the therapy or a risk that the patient otherwise has."

The 2002 findings caused demand for Premarin to plummet. Wyeth projects sales of $1 billion for the product line in 2004, a far cry from the $2.1 billion in revenue in 2001.

Wyeth, based in Collegeville, Pa., has used drug labels, literature, "dear doctor" letters and presentations from sales representatives to emphasize any new knowledge about potential risks from the hormone medications in a timely manner, Constantine said.

"We've clearly, fortunately, stayed on top of the science and changed the label as new science has become available," Constantine said. "The label has been strengthened as new risks have been identified."

Constantine and Amin both said it's important for each woman to weigh the benefits and potential for risk in determining whether to take the pills.

"Many women suffer from so many (menopause) symptoms that they can't live without the hormone therapy," said Dr. Nicole Kerner, a Johnson City native who is an obstetrician and gynecologist and associate professor at Albany Medical College.

"It affects them so much that they can't have a normal life," Kerner said. "The bottom line that you have to get across to women is they have to talk about the individual risk with the doctor. You have to go through the family history and the woman's personal history."

The most troubling symptoms for women experiencing menopause often are hot flashes and vaginal dryness and discomfort.

"If they are so disturbed by the hot flashes and lack of sleep at night and they are tired during the day all the time or have very painful intercourse or discomfort during intercourse, these are the women who should consider hormone therapy," Amin said. "Decreased libido is a real big issue. It can be very painful for these young menopausal women who still want to be intimate with their husbands."

To reduce risks, Wyeth now produces a product with hormone doses that are 52 percent lower than earlier versions. And physicians endeavor not to keep women on the medication for years and years.

"We try to treat the symptoms for as short a time as possible now," Kerner said. "I say, 'Let's see what happens in six months. Let's see what happens after one year.'"

Studies have shown that the hormone therapies have certain additional benefits. They apparently reduce the incidence of hip fractures and development of osteoporosis, Kerner said. The women in the federal study also had fewer cases of colorectal cancer.

Scholars suspect that the estrogen may have accelerated the development of breast cancer. "Estrogen, theoretically, can make the breast cancer show up quicker and grow quicker, but does it cause breast cancer? We don't think so," Kerner said.

But McCormack said she believes the hormone therapy caused her breast cancer, because there's no history of breast cancer in her family.

"You trust your doctors, and I really did," McCormack said. "But I'm not blaming doctors. I'm sure the manufacturer did know a little bit more" about the risks.

Most of the pending lawsuits handled by Benjamin were filed in November in federal court in New York City. One, filed in state court in Onondaga County, may go to trial by the end of this year, he said. Pfizer Inc. also is a defendant in a few of the suits because one of its recently acquired divisions made the Provera brand. Other brands mentioned in the lawsuits are Prempro and Premphase.

McCormack is one of Benjamin's clients in the federal lawsuits. She's healthy now, after undergoing a lumpectomy, 37 radiation treatments and other uncomfortable procedures. Her doctors are careful to monitor her progress through annual mammograms and pap smears.

"I'm not really someone who's out for suing," McCormack said. "I would love to have money, but I don't think that is the main thing. I think they have to be forced to get more information out there to let people know what can happen."

There are alternative treatments to taking the hormones. Antidepressants can reduce hot flashes, Kerner said. A few women are trying vitamin E supplements or herbal remedies containing soy or black cohosh. Others are asking their gynecologist about natural so-called "bioidentical" hormone replacement described in the book The Sexy Years by actress and breast cancer survivor Suzanne Somers, Kerner said.

Less research is being done to evaluate the effectiveness of the alternative treatments because they offer less profit potential for pharmaceutical manufacturers, Kerner said.

Much more clinical research is under way or is planned to help determine exactly how risky the hormone therapies are to women of various age groups. The Women's Health Initiative patients, who are still being evaluated, had a mean age of 62.7. The Kronos Longevity Research Institute in Arizona has begun a five-year study on a younger group of patients; most women who take hormone therapy start when they're in their 50s.

This month, an ongoing Women's Health Initiative analysis determined that estrogen-only therapy does increase the risk of stroke in postmenopausal women and doesn't prevent heart disease. Many women receive combination hormone replacement therapy, involving estrogen with progestin.

This weekend, the American College of Obstetricians and Gynecologists will devote a major session of its annual clinical meeting in Philadelphia to the debate on hormone replacement therapy and its relation to breast cancer and the cardiovascular system.

For McCormack, though, the debate is settled.

"I learned the hard way," she said. "Talk to your doctor and make sure you understand completely what the medicine will do and what the side effects are. When you go in and you're so miserable and you want some help, maybe you should stop and think twice.

"Knowing what I know now, I wouldn't take it."

McCormack has one more bit of advice for women: "Get a mammogram. Don't be afraid. And make sure you have one every year."

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