“There is good evidence of selective outcome reporting in published reports of randomized trials.”
So begins the abstract of a special report in the Nov. 12 New England Journal of Medicine. In the report, clinical trial and health policy experts examine original company documents and journal articles related to non-U.S. Food and Drug Administration-approved uses of the Pfizer epilepsy drug Neurontin. The report authors found that the company funded 21 studies of off-label Neurontin use for the prevention of migraine, treatment of bipolar disorder, and treatment of nerve pain and pain resulting from injury or illness. In the 12 off-label studies reported in peer-reviewed medical journals, eight had their primary endpoints–the most-important health outcome, such as a significant reduction in pain severity–changed from the time a study was planned and when a study’s findings appeared in print.
As the NEJM article authors concluded, “This practice threatens the validity of evidence for the effectiveness of off-label interventions.”
Once the FDA has approved a medication for one use, doctors can prescribe the medication for any purpose. While drugmakers cannot actively market off-label uses for their products, the medical literature is full of studies that report the success of new, unapproved drug uses. When doctors and pharmacists cannot trust in the truthfulness of such journal articles, the health care providers cannot fully protect and appropriately treat their patients.
Because all drugs have side effects, no medications should be used unless conclusive proof exists that the benefits of a medication outweigh its risk. When drugmakers fudge effectiveness data and promote unapproved drug uses, the companies intentionally put patients’ health in jeopardy.
EJL