New concerns on Wyeth hormones

Wyeth's hormone replacement therapies got a double ding in the news today: Congressional investigators are reportedly looking into the drugmaker's use of ghostwriters, worried that marketing types helped craft journal articles supporting the drugs; and at the breast cancer symposium over the weekend, researchers drew further connections between hormone replacement and the disease.

Sen. Charles Grassley, who's been probing various pharma companies, wrote Wyeth and DesignWrite, a medical-writing-and-education firm, asking for info on payments for article prep and for info on how docs were recruited to byline those articles. In the letters, the Wall Street Journal reports, Grassley questioned the integrity of using ghostwriters. But Wyeth said that professional medical writers do help with articles, but the scientists have complete control over the final product.

Grassley's staff released internal corporate documents showing that company execs came up with ideas for journal articles, drafted outlines, paid writers to write them, recruited academic authors and chose publications to run them, the New York Times says. Ten articles were completely written before the company sent them to their "authors" for review. According to one document, any revisions were subject to the company's approval, the paper writes.

Meanwhile, breast cancer researchers were presenting an analysis of the Women's Health Initiative study, which was halted when scientists saw a higher risk of breast cancer among women taking Wyeth's Prempro. The new report, presented at the symposium in San Antonio, showed that taking the progestin/estrogen combo doubled the risk of breast cancer, amounting to a few extra cases per thousand women per year, the WSJ Health Blog reports. The risk rose when women started the drugs, peaked at the end of the study, and declined after they stopped taking the hormonal therapy.

- read the WSJ story
- check out the news in the NYT
- see the Health Blog post