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Prempro Litigation and Menopause

American women in the 1990s were told they could help their bodies ward off major illness by taking menopausal hormone drugs. Some medical associations said so. Many gynecologists and physicians said so. Respected medical journals said so, too.

Along the way, television commercials positioned hormone drugs as treatments for more than hot flashes and night sweats — just two of the better-known symptoms of menopause, which is technically defined as commencing one year after a woman’s last menstrual cycle.

One commercial about estrogen loss by the drug maker Wyeth discussed research into connections between menopause and heart disease, Alzheimer’s disease and blindness.

Connie Barton, then a medical office assistant in Peoria, Ill., was one woman who responded to such messages. She says she took Prempro, a hormone drug made by Wyeth, from 1997, when she was 53, until 2002, when she received a diagnosis of breast cancer. As part of her cancer treatment, she had a mastectomy to remove her left breast.

Now Ms. Barton, said that she used Prempro in part because her doctor told her it could help prevent heart disease and dementia, is one of more than 13,000 people who have sued Wyeth over the last seven years, claiming in courts across the country that its menopause drugs caused breast cancer and other problems.

The suits also assert, based on recently unsealed court documents, that Wyeth oversold the benefits of menopausal hormones and failed to properly warn of the risks.

In October, a jury in a Pennsylvania state court awarded Ms. Barton $75 million in punitive damages from Wyeth on top of compensatory damages of $3.75 million.

The documents that have surfaced in the Wyeth cases offer a rare glimpse inside the file cabinets and hard drives of a major drug company. And the cases demonstrate the importance of litigation in detailing exactly how drug makers operate their businesses.

PREMPRO is a combination of Premarin, an estrogen drug derived from the urine of pregnant mares and first approved by the Food and Drug Administration in 1942, with an additional hormone, progestin.

Part of the Premarin saga shows how a drug maker successfully expanded a franchise whose central ingredient is horse estrogens into a billion-dollar panacea for aging women. Yet several hundred pages of court documents also raise questions about another aspect of Premarin’s trajectory: how Wyeth worked over decades to maintain the image and credibility of its hormone drugs even as the products were repeatedly under siege.

Even as evidence mounted of an association of the drugs with cancer — first in the 1970s with Premarin and endometrial cancer, then in the 1990s with Prempro and breast cancer — Wyeth tried to contain the concerns, the court documents show. (A note handwritten in 1996 by a Wyeth employee responding to a new report of breast cancer risks associated with hormone therapy said: “Dismiss/distract.”)
In 2002, researchers halted the largest clinical trial ever conducted of women’s health because participants who took certain combined hormones had an increased risk of breast cancer — as well as a higher risk of heart attack, stroke and blood clots in the lungs — compared with those taking a placebo.

Other parts of the same federal study, called the Women’s Health Initiative, later found that hormone drugs increased the risk of dementia in a subset of participants, those age 65 and older.

Sales of Wyeth’s hormone drugs peaked at about $2 billion in 2001, but after results of the 2002 study came out sales plummeted.

Pfizer is now fighting the Prempro litigation along with lawsuits over its progestin drug, Provera.

Last month, a federal appellate court in St. Louis ruled in the case of a plaintiff named Donna Scroggin that Wyeth’s inaction over accumulating evidence — and the company’s attempts to mitigate cancer concerns by trying to undermine unfavorable scientific reports — could allow a jury to find Wyeth guilty of malicious conduct and award punitive damages.

For its part, Pfizer contends that two state judges in Pennsylvania have reached the opposite conclusion: that juries should not be allowed to award punitive damages because there was insufficient evidence of corporate misconduct.

Prempro now comes in lower doses. Prempro labels say the drug should be prescribed for the shortest duration appropriate for the treatment goals and risks of the individual woman; previous labels on Wyeth’s hormone drugs for decades gave the same advice. The current label also says that using estrogens, with or without progestins, may increase a woman’s chance of heart attack, stroke, breast cancer and blood clots.

MENOPAUSAL hormone therapy has long been pitched as a way to stave off what some doctors viewed as the undesirable aspects of female aging.

Premarin had been available for decades, but Dr. Wilson’s book propelled the idea of hormone “replacement” into the popular consciousness and onto physicians’ prescription pads. The revivifying drugs promised to inhibit the ravages of time on the appearance and the psyche, Dr. Wilson wrote.

As the popularity of estrogen grew, an increasing number of women developed cancer of the uterine lining, the endometrium. In 1975, an F.D.A. panel concluded there was a link between Premarin and endometrial cancer. The company then sent a letter to doctors trying to mitigate such concerns, documents show.

“Dear Doctor,” wrote Dr. John B. Jewell, at the time the medical director of Ayerst, the Wyeth predecessor. “It would be simplistic indeed to attribute an apparent increase in the diagnosis of endometrial carcinoma solely to estrogen therapy.” Women may still receive “proven benefits,” he wrote, by using “the lowest maintenance dose needed to control the menopausal symptoms.” He added that the company planned to study the issue further.

F.D.A. officials then met with company officials, saying they were “incensed” that the letter was “intended to obfuscate the issues,” according to a 1976 memo signed by the F.D.A. and the company. The F.D.A. said it would issue a bulletin saying there was a clear link between estrogen therapy and endometrial cancer. In 1976, the maker of Premarin added a warning to the label about the risk of endometrial cancer.

But the company never conducted further studies on the risk of developing endometrial cancer, according to the St. Louis appeals court decision.

The company instead focused its risk research on the possibility of breast cancers associated with hormone replacement therapy. But two studies published in the mid-1970s in The New England Journal of Medicine reported that taking estrogen therapy had increased the risk of endometrial cancer by at least five times.

Reports in 1975 about endometrial cancer “resulted in a precipitous decrease in estrogen use,” according to a history of hormone therapy in The American Journal of Medicine in 2005.

In 1980, researchers at Boston University Medical Center estimated that the use of hormone therapy had caused more than 15,000 cases of endometrial cancer in the United States between 1971 and 1975 alone.

“This represents one of the largest epidemics of serious iatrogenic disease” — meaning disease caused by physician-administered treatments — “that has ever occurred in this country,” the authors wrote.

Today, physicians prescribe Premarin to women who have had hysterectomies and therefore are not at risk for endometrial cancer.

BY the mid-1990s, after a few studies had reported a protective effect of hormone drugs on the heart, Wyeth had begun to reposition menopausal hormone therapy as a preventive health choice that could help inhibit heart disease and other maladies, according to court documents.

That marketing strategy coincided with the introduction of Wyeth’s new combination hormone drug Prempro, which included a progestin hormone to keep estrogen from causing excessive cell growth in the uterine lining.

In one commercial from a Wyeth research institute, the model Lauren Hutton runs down a beach and warns of the health risks of estrogen loss.

“My doctor said if you don’t replace estrogen that you lose at menopause, your risk for certain age-related diseases could increase,” Ms. Hutton said in the commercial. In a voice-over, a narrator told viewers about studies looking into the connections between menopause and heart disease, memory loss and sight loss.

“Believe me,” Ms. Hutton said, “the time to protect your future is now.”
Sally Beatty, a spokeswoman for Pfizer, said this was a “help seeking” ad, of the type encouraged by the F.D.A. She added that the promotion did not mention any specific drugs, not did it suggest that drugs could cure the ailments described.

The labels for Premarin and Prempro at the time said the drugs were approved to treat moderate to severe symptoms of menopause like hot flashes, night sweats and vaginal dryness and to prevent osteoporosis.

But Wyeth also positioned its menopausal hormone drugs as having larger protective benefits, court documents show.

Wyeth used proxies to promote a wide range of health benefits from hormone therapy, paying millions of dollars to influential doctors and medical groups and helping them develop abstracts for medical conferences and articles for medical journals, according to court documents.

The company also paid $12 million to sponsor continuing medical education programs from 2002 through 2006 at the University of Wisconsin, Madison. The programs, including an assertion that the Women’s Health Initiative and another heart-risk study “miss the mark on quality of life,” reached thousands of doctors.

Doctors were aware in the 1990s that hormone therapy could increase a woman’s risk of breast cancer, says Dr. Carol Bates, the director of the primary care program at Beth Israel Deaconess Medical Center in Boston.

But based on the results of observational studies that had been published, many physicians, herself included, believed that the drugs’ ostensible ability to reduce heart attacks and perhaps Alzheimer’s would outweigh a breast cancer risk, she says.

“In the 1990s, there was actually tremendous pressure to put women on hormone therapy, and it came from a good place,” Dr. Bates says. “But it was taken a bit to the extreme.”
HORMONE therapy — aimed at the symptoms it effectively treats and with full disclosure about its possible risks — has many advocates. Dr. Lynne T. Shuster, the director of the women’s health clinic at the Mayo Clinic in Rochester, Minn., says such regimens can be very worthwhile for treating hot flashes, night sweats and vaginal dryness associated with menopause.

But many women were not so fully informed in the 1990s.

In 1996, for example, a federal study reported that breast cancer risk may have been “substantially underestimated.” Wyeth reacted with plans to dismiss it as “just one more paper,” and try to “overshadow” it by directing journalists to other studies, according to documents cited in the court of appeals decision in Missouri.

In 1997, Wyeth began working with DesignWrite, a company in Princeton, N.J., that is paid by drug makers to develop manuscripts for publication in medical journals. The specific objective of a publication plan for Premarin was to “increase physician awareness on the multitude of benefits that hormone replacement therapy provides” and “diminish the negative perceptions associated with estrogens and cancer,” according to a 1997 DesignWrite proposal prepared for Wyeth.

Over the next decade, Wyeth paid DesignWrite to prepare at least 60 articles for publication in medical journals on the potential benefits of hormone therapy for cardiovascular disease, Alzheimer’s disease, diabetes, colon cancer, vision loss and other health problems, the court documents show.

But Wyeth’s and DesignWrite’s effort hit an obstacle in 2002 when researchers reported the results of the Women’s Health Initiative.

The National Institutes of Health ultimately decided to start using the term “menopausal hormone therapy” instead of “hormone replacement therapy,” says Marcia L. Stefanick, a professor of medicine at the Stanford University medical school who was principal investigator on the Women’s Health Initiative study at her institution.

While the drugs are effective at treating symptoms like hot flashes, she says, the word “replacement” implies that women need hormone drugs after menopause. “But there is no good evidence that women need this after menopause,” Professor Stefanick says.

In 2003, Wyeth added a “black box” warning to the label saying Prempro should not be prescribed to prevent cardiovascular disease.

The same year, the F.D.A. approved a lower dose version of Prempro so women would have more options.

Today, many doctors who once offered hormone therapy to women without symptoms like hot flashes limit the use of the drug to those with symptoms, prescribing low doses for a short time.

“Right now, the big difference is we do not recommend hormone therapy for good health or health promotion or anti-aging,” says Dr. Shuster of the Mayo Clinic.

And even with lower-dose hormones, doctors do not have a uniform view on what constitutes the optimal duration.

If you or a family member has been personally injured because of the fault of someone else: by the use of dangerous and defective drugs, bad products, or toxic injury etc then please contact the Dallas Texas Yaz, Yasmin Defective Drugs Product Liability Attorney Dr. Shezad Malik. For a no obligation, free case analysis, please call 888-210-9693 or Contact Me Online.

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