Our mental health care remains in the Dark Ages, and Big Pharma continues to corrupt the practice of science.
In the latest and most comprehensive analysis, published in January in the BMJ, researchers at the Nordic Cochrane Center in Copenhagen showed that pharmaceutical companies have not been revealing the full extent of serious harm in clinical study reports, which are detailed documents sent to regulatory authorities such as the U.S. Food and Drug Administration and the European Medicines Agency (EMA) when applying for approval of a new drug. The researchers examined reports from 70 double-blind, placebo-controlled trials of two common categories of antidepressants—selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs)—and found that the occurrence of suicidal thoughts and aggressive behavior doubled in children and adolescents who used these drugs.
The investigators discovered that some of the most revealing information was buried in appendices where individual patient outcomes are listed. For example, they found clear instances of suicidal thinking that had been passed off as “emotional lability” or “worsening depression” in the report itself. This information, however, was available for only 32 out of the 70 trials. “We found that a lot of the appendices were often only available on request to the authorities, and the authorities had never requested them,” says Tarang Sharma, a Ph.D. student at Cochrane and lead author of the study. “I'm actually kind of scared about how bad the actual situation would be if we had the complete data.”
This study “confirms that the full degree of harm of antidepressants is not reported,” says Joanna Moncrieff, a psychiatrist and researcher at University College London who was not involved in the study. “[These harms] are not reported in the published literature—we know that—and it appears that they are not properly reported in clinical study reports that go to the regulators and form the basis of decisions about licensing.”
The researchers struggled for many years to get access to the clinical trial reports, which are often withheld under the guise of commercial confidentiality. “All this secrecy actually costs human lives,” says Peter Gøtzsche, a clinician researcher at Cochrane and a co-author of the recent study....
The fact that antidepressants may cause suicidal ideation has been shown before, and in 2004 the FDA gave these drugs a black box warning—a label reserved for the most serious hazards. The EMA has issued similar alerts. There are no labels about risks for aggression, however....
Taken together with other research—including studies that suggest antidepressants are only marginally better than placebos—some experts say it is time to reevaluate the widespread use of these drugs. “My view is that we really don't have good enough evidence that antidepressants are effective, and we have increasing evidence that they can be harmful,” Moncrieff says. “So we need to stop this increasing trend of prescribing them.”