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Wyeth in court over HRT drugs

Plaintiff lawyers allege that US firm failed to warn patients of associated risks

The first of 5,000 lawsuits over hormone replacement therapies, Prempro and Premarin, has begun, with plaintiff lawyers attempting to prove that the manufacturer of the drugs, Wyeth, failed to warn patients of their link to an increased risk of breast cancer.

In the case at US District Court in Arkansas, a 67-year-old woman, Linda Reeves, alleges that she took first Premarin and then Prempro (marketed as Premia Continuous in the UK) for eight years before being diagnosed with breast cancer in May 2000. Her attorneys have pointed to a large government-funded 2002 study known as the Women's Health Initiative, which was stopped after it linked HRT drugs to an increased risk of heart disease, breast cancer and stroke.

The New Jersey-based pharma firm denies that its HRT treatments caused Ms Reeves' cancer and asserts that it warned of the breast cancer risks associated with HRT.

Ms Reeves' lawyers introduced as evidence a September 1983 memo alerting Wyeth executives of the US Food and Drug Administration's (FDA) call for extensive safety testing of Prempro, including a review of its cancer risks.

The memo said that the requested review `would be very costly and would take many years' adding `the results of the studies might prove to be embarrassing'. The plaintiff lawyers allege that Wyeth researchers may have been aware of cancer risks associated with HRT drugs as early as the 1970s.

Wyeth lawyers said Ms Reeves had said in a deposition that she didn't read a patient information slip provided with her prescription which noted a potential breast cancer risk.

On the first day of the hearing, Lynn Pruitt, representing the drugmaker, said that most women who take HRT never develop breast cancer and that most women who have breast cancer are not on HRT.

Premarin contains oestrogen and Prempro is a combination of oestrogen and another hormone, progestin. As many as six million women had taken Prempro to treat symptoms of menopause between its launch in 1994 and the time when the Women's Health Initiative study was released.

The swathe of lawsuits comes at a time when Wyeth is closing a door on another set of cases concerning its withdrawn fen-phen diet drug. The firm has had to set aside more than $21bn to cover settlements and legal fees over claims the drug caused heart damage to some patients and left others with a lung disease.

However, analysts said that Wyeth's potential liability in the Prempro and Premarin litigation will not approach anywhere near that of its diet drug liability.

30th September 2008

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