Senator Charles Grassley of Iowa has begun an inquiry into the use of ghostwriters by Wyeth Pharmaceuticals, to produce medical journals favorable to its hormone replacement therapy drug Prempro. The Senator has asked Wyeth and Design Write, the medical ghostwriting company, to disclose the payments and activities related to the production of the articles and doctors whose names wound up on the publications.
The Senator wrote to the CEO of Wyeth, Bernard J. Poussot, saying that "[a]ny attempt to manipulate the scientific literature, that can in turn mislead doctors to prescribe drugs that may not work and/or cause harm to their patients, is very troubling."
In a response to Sen. Grassley’s letter, Wyeth spokesman Doug Petkus, said that the Senator was recycling old arguments, and that the authors of the articles had substantial editorial control over the content. Although documents show that Wyeth executives brain-stormed ideas, drafted outlines for the articles, titled them, paid ghostwriters and academic authors, and targeted publications to carry the stories.
The investigations from a number of lawsuits have produced pages upon pages of internal corporate documents that have demonstrated the central role played by Wyeth and Design Write in creating a media blitz that promoted hormone therapy for menopausal women.
One such article was published in the American Journal of Obstetrics and Gynecology, said that there was no definitive evidence that progestin (a key ingredient in Prempro) caused breast cancer, and that hormone users were more likely to survive cancer. This article was written over one year after the Women’s Health Initiative linked Prempro to breast cancer.
In 2001, hormone therapy peaked in the United States, and more than 126 million prescriptions were written for American women. Wyeth posted $3 billion in sales that year, but after the Women’s Health Initiative made its findings, sales fell dramatically. Some of the drugs are still available, but they are required to have the cancer warning on the bottle and are prescribed in the lowest doses.
Wyeth has had ghostwriting issues with other drugs, including the diet medications Pondimin and Redux. Merk has also been involved in ghostwriting for the painkilling drug Vioxx, which was linked to heart problems in 2004, and led to countless lawsuits. These companies have developed deliberate media strategies to push their drugs on doctors and patients, regardless of the negative information on their effects published by legitimate studies. Ghostwriting will likely continue to lead to potential health risks to patients, and legal action against doctors and pharmaceutical companies. Hopefully, Senator Grassley’s investigation will lead to strict regulations and penalties for ghostwriting misleading medical articles.
recently named in the 2009 edition of Best Lawyer's In America, David Mittleman has been representing seriously injured people since 1985. A partner with Church Wyble PC—a division of Grewal Law PLLC—Mr. Mittleman and his partners focus on medical malpractice, wrongful death, car accidents, slip and falls, nursing home injury, pharmacy/pharmacist negligence and disability claims.