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April 2008 – Volume 4, No. 2
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IMPORTANT MESSAGE FROM CPA PRESIDENT,
DR. PATRICK WHITE, TO PHYSICIANSDon’t believe the media hype
around inefficacy of SSRIsRecent media attention on the efficacy of antidepressants spurred on from a website publication by Irving Kirsch et al has given rise to many questions from patients and colleagues. On behalf of the Canadian Psychiatric Association (CPA), I would like to offer our members and fellow clinicians some guidance as they evaluate this latest study.
It is our recommendation that clinicians continue to recommend the use of antidepressant medications in the treatment of appropriately screened and evaluated patients with this serious illness. And just as would apply in other branches of medicine, no one should consider stopping their medication without first consulting their physician. Our recommendations echo those of the (British) Royal College of Psychiatrists' response to the Kirsch et al and similar reports.
The CPA, in our Clinical Guidelines for the Treatment of Patients with Depressive Disorders (2001), advocates that any proposed treatment should be based upon an understanding of the patient, his or her illness, and the severity of the condition. The current study re-inforces that treatment needs to be individualized to the particular person and her illness, and that the most effective treatment will often include multiple approaches. I made this point with the news media when the report came out, namely that we as clinicians continue to be mindful that medication helps some, but not all people with depression.
It is unfortunate the media coverage obscured the fact that the article does reinforce that antidepressants are in fact effective for persons with severe depression. While the study does pose questions about the scope of antidepressant use in the less severely ill that beg further investigation, it by far does not conclude that antidepressants are ineffective in all cases. While it reports that psychotherapy works as well as medication for persons with mild to moderate depression, it is important to note that other studies have shown most people respond best to a combination of both medication and psychotherapy.
The CPA suggests clinicians consider the following criticisms made by others of the article, which is in fact one of a series of articles dating back over a decade by Kirsch and co-researchers.
- The review combines data from all submissions received by the (US) FDA before drugs are introduced into the US market. Authors do not discriminate between studies which include doses (in dose-finding studies) below the anticipated therapeutic threshold, and studies with more conventional dosing levels. Combining studies in this manner ignores elementary pharmacology, and reduces the ability to discriminate between the active ingredient and the placebo. This criticism has also been voiced about their previous publications.
- The main thesis of the article—that there are many failed clinical trials of antidepressants in the FDA database that are not reported in publications—has been known for many years. Such trials are conducted for a variety of regulatory reasons, including dose finding. To show whether antidepressants work in clinical practice requires different studies, which are not included in this article.
As we know in clinical practice, a substantial number of people do not respond to an antidepressant either:
- at the first dosage they are given, or
- within the usual six-week time frame of many of these studies, or indeed
- to the first antidepressant prescribed.
Therefore, testing any single antidepressant for a short space of time will bias the results towards diminished clinical efficacy. This point, highlighted by many of those who have commented on the report, has been ignored by the authors and any subsequent media coverage.
It is the CPA's view that we need more and better designed long-term follow-up studies to help us understand which patients are more likely to benefit from which specific clinical interventions. Some of the most exciting research in progress at this time concerns attempts to match the antidepressant to the patient from the outset of treatment. This offers great hope for the millions of people suffering from this very disabling and potentially fatal disease.
The CPA has long been concerned about the excessive dependence by our drug investigation and regulatory programs on data derived solely from industry-sponsored research protocols. Such protocols generally are directed to the legitimate but limited drug company purpose of showing that the drug is safe to market and more effective than placebo. We continue to hold that psychiatrists and patients alike need better head-to-head studies comparing one drug with another, to give a better understanding of which drug works best for which patients.
The World Bank estimates that depression is, or soon, will be the major cause of disability among working-age people in Canada. This illness strikes particularly at young adults who, if left untreated, may face a lifetime of disability. Our national mortality from suicide is greater than that from motor vehicle accidents and HIV combined.
To address this very significant public health challenge, the CPA continues to call for significantly more independent dollars for both research and services.
—Patrick J. White, CPA President
© Copyright 2008. Canadian Psychiatry Aujourd’hui. All rights reserved.
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February 08, 2010
