Sen. Charles Grassley (R-IA), a member of the Senate Finance Committee, has repeatedly made the news with his ongoing investigation into drug industry influence on doctors.According to Sen. Grassley, “Any 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.”
Now Sen. Grassley has asked drug giant Wyeth and a medical writing company, DesignWrite, to disclose payments related to the preparation of articles for publication in medical journals. The allegation is that Wyeth paid ghostwriters to write journal articles favorable to its hormone replacement therapy Prempro, and paid doctors to put their names on the articles as authors.
Dozens of pages of internal corporate documents gathered from lawsuits have been released by Sen. Grassley’s staff, revealing the role of Wyeth and DesignWrite to create articles promoting hormone replacement therapy for menopausal women. The documents show that beginning in 1997 Wyeth executives came up with medical journal article ideas, titled the articles, drafted outlines of the articles, and paid writers to draft the content. The Wyeth executives then recruited authors from academia while identifying medical publications that would publish the articles. The company’s role was never disclosed to the editors of the journals or to those who read the studies.
The issue of ghostwriting in medical journals has been raised previously against Merck (regarding its drug Vioxx) and Wyeth (regarding its drugs Redux and Pondimin), and was discussed in books such as On the Take by Jerome Kassirer, M.D., and Science on Trial by Marcia Angell, M.D. However, the documents released by Sen. Grassley’s office provide an in-depth look at the practice of ghostwriting. The World Association of Medical Editors says that ghost authorship is “dishonest and unacceptable.”
Rep. John Dingell (D-MI) has joined with Sen. Grassley to make it a priority to overhaul the FDA, especially as it relates to the influence of drug companies and the drugs they regulate. Grassley has been quoted as saying FDA officials “are too cozy with the companies they regulate.”
In related news, the Association of American Medical Colleges has endorsed principles which will limit the influence of pharmaceutical firms on medical students and residents. Earlier this month, the Association of Faculties of Medicine of Canada followed suit, citing the public’s concern about the perceived coziness between medical schools and Big Pharma. One of the best books about the influence of drug companies on medical school education, clinical practice, practice guidelines, not to mention research and publication, is Overdosed America John Abramson, M.D., of Harvard.
On a related note, the questions raised about ghostwriting articles concerning Prempro reiterate the importance of the HOME Coalition campaign. HOME (which stands for Hands Off My Estrogens!) is a coalition of licensed doctors and concerned citizens who are concerned about the health risks from synthetic women’s hormones, and enraged that the FDA has banned the use of bio-identical hormone, even when prescribed by a doctor. Please contact your congressional representative, senators, and the White House immediately. For a sample letter and a simple interactive form for sending your messages, click here.