Pharma firm settles $13M suit over HRT
A B.C. court has approved a $13-million settlement for women who say hormonereplacement drugs gave them breast cancer, ending Canada’s first class-action lawsuit over the risks of a onceubiquitous treatment.
This month’s decision endorsing Wyeth Canada’s eight-figure payout highlights a still-simmering controversy over drugs prescribed widely for decades to make menopause more bearable, before triggering an international pharmaceutical-safety uproar.
Their popularity collapsed almost overnight when a landmark 2002 study suggested they made women more likely to suffer heart attacks, stroke and cancer.
Ever since, though, those findings have been heatedly debated. Wyeth, which dominated the HRT market in Canada with the products Premarin and Premplus and is now owned by Pfizer, denies in the settlement that its medicines caused cancer or that it is liable legally.
The country’s professional organization for obstetriciansgynecologists also says they are safe and useful for many post-menopausal women, but Health Canada and the Canadian Cancer Society urge women to avoid the treatments if possible.
Dianna Stanway, lead plaintiff in the class action, is convinced there is a cancer link, and said Thursday she always hoped the lawsuit would help warn other women of the risk.
“It’s very traumatic,” said the resident of Sechelt, B.C. about her brush with the disease. “My main object was that other people knew that this causes cancer.”
Like hundreds of thousands of Canadian women, Ms. Stanway took hormone-replacement therapy to counter hot flashes and other effects of menopause.
And for the eight years she was on the drugs, the 69-yearold says no one ever suggested they might harm her. When news of the 2002 study broke, she asked to be taken off the medicines.
The next year, though, a regular mammogram found a malignant tumour, leading to surgery and radiation treatment.
Manufacturers had enough evidence even before 2002 to warn patients of such side effects, charges Doug Lennox, the Toronto lawyer who spearheaded the suit.
“We had leading experts from across North America who were prepared to give testimony that the company should have known better, and did know better.”
But Pfizer said Thursday that its Wyeth subsidiary admits no wrongdoing, always acted responsibly in conducting studies on the risks and benefits of the drugs, and still stands by them.
“Hormone therapy medicines are an important treatment option for many women with symptoms of menopause,” the company said in an emailed statement. “It is widely accepted that science cannot determine what caused or contributed to any individual woman’s breast cancer except in rare circumstances where genetics play a role. “
Meanwhile, at least two other Canadian class-action lawsuits over the same issue remain in the works. In the U.S., Pfizer has paid out more than $1 billion in numerous other HRT cases.
Almost 18 per cent of Canadian women aged 50-69 were taking the drugs in 2002, a practice fuelled in part by research that hinted the pills might actually protect against cardiovascular disease. By 2004, after the U.S. government-funded Women’s Health Initiative (WHI) results were published, that rate had dropped to less than five per cent.
The WHI research found evidence of a variety of risks, and some benefit: for every 10,000 patients, seven more cases of heart disease, eight more strokes, eight more invasive breast cancers, 18 more blood clots, and six fewer colorectal cancers.
Later research has suggested that women who stay on the drugs less than five years and are younger may not face such dangers. The Society of Obstetricians and Gynecologists of Canada, which receives some funding from Pfizer, says hormone therapy is safe for women who take it early in menopause and for less than five years.
Others are less enthusiastic. Health Canada says combined estrogen and progestin are not recommended for longterm use in post-menopausal women.
The Canadian Cancer Society urges avoiding HRT except to relieve severe menopausal symptoms that don’t respond to other treatment.
A review of past studies on HRT and heart health published by Britain’s respected Cochrane group in March concluded there is no evidence that it prevents deaths or heart attacks overall, and may slightly increase the risk of stroke. However, for younger women in the first decade after menopause, it might somewhat reduce the number of deaths and heart attacks, it suggested.