Selective Reporting of Drug Trials Exaggerates Effectiveness of Antidepressants
What many people have been suspecting all along with regards to the accurate reporting of drug testing was brought to light in the January issue of the New England Journal of Medicine. Drug companies have been engaging in selective reporting of antidepressant drug trials and, by doing so, have been exaggerating the effectiveness of these products.
The comprehensive study examined reviews from the U.S. Food and Drug Administration (FDA) for trials of 12 widely prescribed antidepressant drugs approved between 1981 and 2004. A total of 12,564 patients were involved. In addition, researchers also conducted a systematic literature search to identify whether results of studies had been published in any other medical journals. For those that were published, the researchers continued on to determine if the published versions of the results matched the FDA’s version of the results.
Basically, what researchers found was that the publishing of results and how the results were reported depended entirely on the outcome of each trial. This information comes from Erick Turner, M.D., who is an assistant professor of psychiatry, physiology and pharmacology at Oregon Health & Science University and the Medical Director of the Portland Veterans Affairs Medical Center’s Mood Disorders Program.
Dr. Turner and his group found that according to the published literature, nearly all of the studies conducted (94%) had positive treatment results. This figure varies considerably from data provided to the FDA which showed, in fact, that only about half of the studies (51%) had positive results.
Unsurprisingly, drug companies were found to be very selective in the studies they did publish and were found to engage in deceptive and inaccurate reporting as well. Positive studies, with one exception, were all published. Additionally, 33 of 36 studies that were not positive were either not published or published deceptively as if they were positive, the researchers found. These 33 studies involved 5,212 patients.
“Selective publication can lead doctors and patients to believe drugs are more effective than they really are, which can influence prescribing decisions,” said Dr. Turner. While the doctor did mention that a failure of a study author or sponsor to submit a non-positive manuscript or an editor’s decision not to publish it could have some affect on the process, there was very clear bias in the reporting of some findings and failure to report others. “Doctors and patients must have access to evidence that is complete and unbiased when they are weighing the risks and the benefits of treatment,” he said.