[Biomedical Journal Article] Debate: Is the long term use of psychiatric drugs harmful?
Yes—Peter C Gøtzsche
Psychiatric drugs are responsible for the deaths of more than half a million people aged 65 and older each year in the Western world, as I show below.1 Their benefits would need to be colossal to justify this, but they are minimal.1 23 4 5 6
Overstated benefits and understated deaths
The randomised trials that have been conducted do not properly evaluate the drugs’ effects. Almost all of them are biased because they included patients already taking another psychiatric drug.178910 Patients, who after a short wash-out period are randomised to placebo, go “cold turkey” and often experience withdrawal symptoms. This design exaggerates the benefits of treatment and increases the harms in the placebo group, and it has driven patients taking placebo to suicide in trials in schizophrenia.8
Under-reporting of deaths in industry funded trials is another major flaw.Based on some of the randomised trials that were included in a meta-analysis of 100 000 patients by the US Food and Drug Administration, I have estimated that there are likely to have been 15 times more suicides among people taking antidepressants than reported by the FDA—for example, there were 14 suicides in 9956 patients in trials with fluoxetine and paroxetine, whereas the FDA had only five suicides in 52 960 patients, partly because the FDA only included events up to 24 hours after patients stopped taking the drug.1
No—Allan H Young, John Crace
Psychiatric conditions are common, complex, costly, and often long term illnesses. More than a fifth of all health related disability is caused by mental ill health, studies suggest, and people with poor mental health often have poor physical health and poorer (long term) outcomes in both aspects of health.26
Raised standardised mortality rates and reduced life expectancy have been reported in people with psychiatric disorders such as psychosis and mood and personality disorders.27 These increased death rates are only partly because of suicide and mostly attributable to coexisting physical health disorders. There is thus a clear need for psychiatric disorders to be treated to attempt to reduce the long term harm associated with them. The key question is whether psychiatric drugs do more harm than good.
All therapeutic interventions may potentially do both good and harm, and thorough evaluation of the relative benefits and harms of a treatment should be done for psychiatric drugs no less than for any others.28 These evaluations of benefits and harms are based on group data, which have to be applied to judgments for individual patients and can therefore be advisory only; the individual’s subjective experience is crucially important to consider.
What about harms?
Worldwide, regulatory agencies are responsible for ensuring that drugs work and are acceptably safe. Postmarketing surveillance continues after drugs are licensed. This can further refine, or confirm or deny, the safety of a drug in the general population, which unlike study populations includes people with varied medical conditions. Several approaches are used to monitor the safety of licensed drugs, including spontaneous reporting databases, prescription event monitoring, electronic health records, patient registries, and record linkage between health databases.30 These safeguards work to ensure drugs available do more good than harm.30
Nevertheless, many concerns have been expressed about psychiatric drugs, and for some critics the onus often seems to be on the drug needing to prove innocence from causing harm rather than a balanced approach to evaluating the available evidence.
Whether concerns are genuine or an expression of prejudice is not clear, but over time many concerns have been found to be overinflated. A few examples may be illustrative.
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