The Drug Trial of the Century
Prempro, a drug containing a combination of two hormones, estrogen and progestin, was supposed to relieve menopause symptoms like hot flashes, night sweats and mood swings. Many health leaders and women’s advocacy groups lobbied for many years for the government to undertake a clinical trial to test the downsides of older women taking hormone replacement drugs. In 1997, the National Institutes of Health undertook a study to investigate the link between hormone replacement therapy and cancer as well as other serious chronic diseases in older women.
Same Drug, Different Marketing
Breast cancer is the most commonly diagnosed cancer among women in the United States, according to the Centers for Disease Control. Rates have been decreasing in recent years with the sharpest decline seen in 2002 and 2003 — a 14 percent decline in women 50 to 69, probably due to the dramatic decrease in the numbers of women continuing to take Prempro after the end of the Women’s Health Initiative. To stay viable in the market and respond to scientists’ criticism of the company’s marketing practices, Wyeth has re-formulated the drug and promoted smaller doses taken for shorter periods of time. Sales of the hormone drug dropped to about $900 million in 2006 from $2 billion in 2001, the year before the Prempro trial was stopped. Before that, hormone replacement therapy was routinely prescribed for all women reaching menopause not only to relieve the unpleasant symptoms of menopause but to avert heart disease and brittle bones, and keep women’s skin soft and supple in the post-menopause years, off-label benefits promoted by Wyeth but largely unproven.
In a large clinical trial sponsored by the government, Prempro was shown to cause excessive numbers of cases of breast cancer, heart attacks, strokes, dementia, and other health crises in women. Because of these dire and unexpected outcomes, the clinical trial was stopped years ahead of schedule, and in 2003, a year later, the FDA required Prempro to carry a black-box warning about serious side effects, the most severe warning the FDA can impose short of removing a drug from the market.
In the government’s halted clinical trial of hormone therapy for menopause, one out of four women taking Prempro (26%) developed breast cancer, one out of three (29%) heart attacks, four out of 10 (41%) strokes, and double the number of Prempro users experienced blood clots, dementia, lupus or urinary incontinence, compared to women in the control group. Is it any wonder that there are more than 10,000 Prempro lawsuits on file in state and federal courts, currently?
The first of these lawsuits went to trial in the summer and fall of 2006 and 2007. Three out of four cases were settled in the plaintiff’s favor with cash awards. Plaintiffs in these actions successfully argued that Wyeth misled them and their doctors using deceptive advertising techniques, persuading them that the drug would keep them looking and feeling youthful, a totally unsubstantiated claim, and protect them against heart disease, another false claim. Wyeth failed to warn physicians and patients about Prempro’s side effects and health risks, although several previous studies had shown Prempro to be a factor in breast cancer. But it was not until 1997, when the Women’s Health Initiative trial was launched, that definitive evidence of a positive link to breast cancer and other serious chronic diseases were firmly established.
Deadly Deceptions
Lawyers for women suing Wyeth say the company never performed any long-term tests of its hormone replacement drugs, Prempro and Premarin (estrogen only). Instead, the company urged doctors to put their patients on the drugs for life, in effect making the patients the unwitting test subjects in a long-term observational study of drug effectiveness and side effects. Unfortunately, this secret trial was not only unscientific, but illegal without the consent of physicians and their patients.
Wyeth had made the case in court that because the drug (Prempro) had been approved by the FDA, product liability suits are pre-empted or barred, because federal law gives the FDA the exclusive right to determine whether a drug’s label, or detailed package insert, contains adequate warnings about health risks.
A Superior Court judge in New Jersey (June 27, 2007) issued a pre-trial ruling that being approved by the FDA does not protect companies from being sued. The FDA regulations on label warnings are a floor, not a ceiling. Drug companies can strengthen warnings and add new ones. In another pre-trial ruling in the same case, the judge ruled that a doctor prescribing a drug does not preclude a patient from suing over alleged harm. In New Jersey, in addition to product liability suits, Prempro plaintiffs can also sue under New Jersey’s Consumer Fraud Act.
As a result of intense lobbying by consumer and physician groups urging greater FDA monitoring of drugs after-market, the Congress passed a law in 2007 to expand FDA’s authority.
As of July, 2008, about 250 Prempro lawsuits were pending in New Jersey and about 10,000 had been filed nationwide. The outcome of early drug trials are beginning to be known and the manufacturer, Wyeth, has settled several lawsuits before they went to trial, indicating that the company already sees the handwriting on the wall.
If you have questions or think you might have a case against Prempro, fill in one of the brief questionnaires on this website and we will ask an experenced and knowledgeable attorney to respond with a free consultation.
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