{"id":32499,"date":"2014-10-10T11:49:58","date_gmt":"2014-10-10T10:49:58","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=32499"},"modified":"2014-10-10T11:59:02","modified_gmt":"2014-10-10T10:59:02","slug":"the-bmj-today-antidepressants-fda-warnings-and-suicide-under-the-microscope-again","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2014\/10\/10\/the-bmj-today-antidepressants-fda-warnings-and-suicide-under-the-microscope-again\/","title":{"rendered":"The BMJ Today: Antidepressants, FDA warnings, and suicide under the microscope . . . again"},"content":{"rendered":"

\"peter_doshi\"<\/a>For those who like \u201cjournalology<\/a>,\u201d today\u2019s The BMJ<\/em> has many of the ingredients for a rich case study.<\/p>\n

The latest\u00a0published letters to the editor<\/a> are dominated by those taking issue with a previously published research paper<\/a>.<\/p>\n

The paper\u00a0at issue\u2014published this June and authored by Lu and colleagues\u2014probed whether the Food and Drug Administration’s (FDA) 2003-04 warnings about the risk of suicidality in children and adolescents on antidepressants may have had \u201cunintended consequences.\u201d Their research found it did,\u00a0and the authors concluded that after the FDA warnings, consumption of antidepressants decreased while suicide attempts increased. If true, it means\u00a0the FDA warnings had the exact opposite of their intended effect.<\/p>\n

But are the findings sound? In seven separate letters, critics challenge the study\u2019s methods and its findings. In particular, the study\u2019s proxy measure for suicide attempts comes under attack. If the proxy is unreliable, so are the results.<\/p>\n

\u201cWe doubt that poisoning by psychotropic drugs is a \u2018validated proxy for suicide attempts,\u2019\u201d write Mark Olfson and Michael Schoenbaum<\/a> from Columbia University and the National Institute of Mental Health.<\/p>\n

Peter G\u00f8tzsche of the Nordic Cochrane Centre<\/a> calls the outcome variable \u201ca poor surrogate . . . People on SSRIs who attempt suicide don\u2019t usually poison themselves (and cannot really do so with SSRIs), they tend to use violent methods like hanging.\u201d<\/p>\n

John Nardo, a retired psychiatrist at Emory University<\/a>, calls the study \u201cflawed from the start by the absence of usable E codes indicating deliberate self harm,\u201d plus other \u201cunjustifiable assumptions.\u201d<\/p>\n

Thomas Moore, of the Institute for Safe Medication Practices<\/a>, composed a letter that is equally strong in its criticism: \u201cLu and colleagues\u2019 study contains four substantial flaws, any of which would be fatal . . . \u201d<\/p>\n

In response, Lu and colleagues defended their findings<\/a>. \u201cWe agree with Olfson and Schoenbaum that quasi-experimental or observational studies are open to varying interpretation,\u201d write Lu and colleagues, before explaining the arguments to support their favored interpretation of the data.<\/p>\n

The discussion raises some fundamental questions that go beyond the specific debate\u2014questions about how knowledge is produced, disseminated, and corrected when needed in medicine. In their letter, Catherine Barber, Deborah Azrael, and Matthew Miller<\/a>, from Harvard School of Public Health and Northeastern University, say that \u201cthe evidence shows no increase in suicide attempts or deaths in young people after the FDA warnings,\u201d clearly suggesting that Lu et al got it wrong. They conclude: \u201cIt is important that we get this right; sounding unnecessary alarms does nothing to protect our young people.\u201d<\/p>\n

But if the critics are correct, just how do \u201cwe get this right?\u201d Who is \u201cwe\u201d anyways, and how does one \u201cunsound\u201d an unnecessary alarm?<\/p>\n

There is no question that the original paper had impact. The article\u2019s Altmetric score\u2014which claims to track \u201cthe buzz around scholarly articles and datasets online\u201d\u2014is 411, putting it among the highest ever scored in the journal. The paper clearly had some traction\u2014far more than letters ever get.<\/p>\n

If this were a clinical trial, RIAT might be helpful. For misreported clinical trials, I and others proposed a possible mechanism for correcting the scientific literature called RIAT: Restoring Abandoned and Invisible Trials<\/a>. The premise is that by using the underlying data from trials, such as clinical study reports and individual participant data, third parties can help correct the scientific record by republishing misreported trials.<\/p>\n

But the Lu et al. paper did not report on a trial. It was a retrospective, observational study of healthcare claims data. At debate is the appropriateness of the methods, not accusations of misreporting.<\/p>\n

I have no doubt that \u201cgetting it right\u201d is good advice, but I am not sure anybody has worked out just how to do it. Journals are likely just one of the many actors that need to think deeply about this question. The lay media\u2019s general inability to distinguish between experimental and non-experimental research, between correlation and causation, coupled with its general lack of interest in what happens to papers post-publication, seems to also be part of the problem. Perhaps The BMJ<\/em>\u2019s new policy of publishing pre-publication histories and open peer review<\/a> will aid bloggers, journalists, and others who want to really dig into stories, understand how manuscripts become publications, and help us all \u201cget it right.\u201d<\/p>\n

Peter Doshi<\/strong>\u00a0is an associate editor for <\/em>The BMJ.\u00a0<\/em><\/p>\n

Competing interests: I know some of the authors of the published letters referred to in this blog.<\/p>\n","protected":false},"excerpt":{"rendered":"

For those who like \u201cjournalology,\u201d today\u2019s The BMJ has many of the ingredients for a rich case study. The latest\u00a0published letters to the editor are dominated by those taking issue […]<\/p>\n

More…<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5750],"tags":[],"class_list":["post-32499","post","type-post","status-publish","format-standard","hentry","category-the-bmj-today"],"yoast_head":"\nThe BMJ Today: Antidepressants, FDA warnings, and suicide under the microscope . . . again - The BMJ<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/blogs.bmj.com\/bmj\/2014\/10\/10\/the-bmj-today-antidepressants-fda-warnings-and-suicide-under-the-microscope-again\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The BMJ Today: Antidepressants, FDA warnings, and suicide under the microscope . . . again - The BMJ\" \/>\n<meta property=\"og:description\" content=\"For those who like \u201cjournalology,\u201d today\u2019s The BMJ has many of the ingredients for a rich case study. 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