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Doctors and their patients need a more balanced picture of the risks and benefits of the popular antidepressants known as selective serotonin reuptake inhibitors (SSRIs), a new report contends.
"The reason that pharmaceutical companies have been able to claim (that) the science points the other way and (health authorities) have been slow to take action has been because of a misguided appreciation of statistical significance" of suicide, said report author Dr. David Healy, a professor of psychiatry in the North Wales Department of Psychological Medicine at Cardiff University in Bangor, Wales.
Healy called for reforms to the drug-approval process so health-care providers and consumers get a more complete assessment of a medication's potential benefits and risks.
"Although data submitted to the FDA show an excess of suicides with every antidepressant licensed since 1987 compared with placebo, this simple but crucial finding continues to be obscured," he said. "Companies actually manipulated the data and did it in such a way that (health authorities) were aware of it and didn't correct it."
Healy himself performed a meta-analysis of published trials and found that the likely risk of suicide for patients taking SSRIs compared to a placebo was 2.6 - more than twice the risk. But new trials should be conducted to settle the issue once and for all, he said.
His main concern now is how this heightened risk could have gone unnoticed and how similar missteps can be avoided in the future. "The solution for me and for the people who need them is to know what the risks really are. We need to have access to the raw data and regulators do as well." Knowing the full picture could mean the difference between life and death, Healy said.
"If we are informed what the risks are, then we don't say, 'it couldn't be the drug,' and increase the dose, which is just the wrong thing to do," he said.
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