Directly promoting drugs for purposes outside those approved by the US Food and Drug Administration (FDA), so-called "off-label" use, is illegal for drug companies. However, it is not illegal for physicians and scientists to discuss off-label use with colleagues, deliver lectures, and author peer-reviewed studies. But according to a new study, published today (August 7) in PLoS Medicine, only 15 percent of physicians and scientists involved in such promotion adequately disclosed relevant relationships they maintained with pharmaceutical companies in published studies.
"The major finding is both unsurprising and disturbing," said public health researcher Susan Chimonas of Columbia University, who was not involved in the study, by email. "The current disclosure system is woefully insufficient."
The study, led by physician scientist Aaron Kesselheim of Harvard Medical School, looked at the publications of scientists and physicians named in prosecution cases against drug companies involved in illegal marketing of off-label drugs. Complaints, which ...