Pfizer in court again, this time for Wyeth's menopause treatment Prempro
Oct 27th 2009 8:15PM
Updated Dec 4th 2009 5:17PM
On Monday, a Philadelphia jury, which had earlier found a link between a woman's breast cancer and the hormone-replacement drug she was taking, also found that Wyeth hid and ignored evidence of the drug's potential cancer risk. The jury awarded Connie Barton an undisclosed amount of punitive-damages.
Barton's case is one of 9,000 Prempro lawsuits across the country. About 1,500 are pending in Philadelphia alone, opening up the door to more potential liabilities for Pfizer, which just recently was ordered to pay a record $2.3 billion fine for illegally marketing painkiller Bextra, which is now off the market.
The drug, Prempro, from Pfizer's unit Wyeth, is a combination of hormones estrogen-progestin (Premarin and Provera) and is taken as a menopause treatment.
Barton took Prempro for five years before she was diagnosed with invasive breast cancer in 2002. Wyeth's lawyer George McDavid had argued that Barton had breast cancer before she began taking Prempro. The jury was not convinced and found that Prempro caused Barton's breast cancer. She was awarded $3.75 million in compensatory damages in September. The punitive award was sealed pending another verdict in a second Prempro case in the same courthouse.
Once again, this case highlights the reasons for the public's longstanding distrust and mistrust of pharmaceutical companies. The AP reports that Esther Berezofsky, one of Barton's lawyers said, "They knew back in the 1970s that these drugs had the potential to cause breast cancer, so they didn't have the studies done." Wyeth, the lawyer added, consistently downplayed bad results.
Only on Monday, Booster Shots reported that a new study by French researchers examined how clinical trials are being reported in medical journals. They found that even though "The reporting of harm is as important as the reporting of efficacy [...] harm is frequently insufficiently reported." Often hard data is not being provided in the publications, and when it is, it is often distorted.
It is interesting that in the editorial to this study, Dr. John Ioannidis of the University of Ioannina School of Medicine in Greece, attributed some of the under-reporting to companies intent on "silencing the evidence." He singled out Merck's (MRK) Vioxx -- the painkiller that doubled the risk of heart attack and stroke, and Pfizer's Neurontin -- an epilepsy drug that the FDA linked to an 80 percent increase in suicidal thoughts and behavior. "In these cases," Dr. Ioannidis wrote, "marketing needs prevail over scientific accuracy and clinical prudence."
During its court case, Wyeth, told jurors that women are now fully informed of the risks and benefits of Prempro. Further, in arguing against the punitive damages, a lawyer, on behalf of Wyeth, said the drug maker changed its practices and policies such as letting its consultants ghostwrite medical journal articles, promoting off-label drug use and giving gifts to doctors. Attempts to reach the company were not immediately answered.
Sales of the drug have plummeted since 2002 when a large federal health study, the Women's Health Initiative, linked the therapy to breast cancer and cardiovascular risks. The study was stopped as a result. Another study this year also showed that lung cancer seems more likely to prove fatal in women who are taking the combination drug.
Berezofsky claims that 200,000 women who got breast cancer could have avoided it had they not taken Prempro. However, Prempro and the combination hormones remain on the market. More than six million women have taken hormone-replacement medicines to treat menopause symptoms such as hot flashes, night sweats, and mood swings.
So far, Wyeth has lost five of eight trials regarding this matter since 2006. All cases are on appeal. In cases in Arkansas and Nevada, some damages were set aside or reduced.