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Following the evidence

Posted Jul 14 2012 10:47pm

Ouch :

Fluoxetine HCl 20mg Capsules (Prozac)

Fluoxetine HCl 20mg Capsules (Prozac) (Photo credit: Wikipedia)

Abstract: This paper raises the question about whether the data on the medications we call antidepressants justify the label of antidepressant. The authors argue that a true antidepressant should be clearly superior to placebo, should offer a risk/benefit balance that exceeds that of alternative treatments, should not increase suicidality, should not increase anxiety and agitation, should not interfere with sexual functioning, and should not increase depression chronicity. Unfortunately, these medications appear to fall short on all of these dimensions. Many of the “side effects” of these medications have larger effect sizes than the antidepressant effect size. To call these medications antidepressants may make sense from a marketing standpoint but may be misleading from a scientific perspective. Consumers deserve a label that more accurately reflects the data on the largest effects and helps them understand the range of effects from these medications. In other words, it may make just as much sense to call these medications antiaphrodisiacs as antidepressants because the negative effects on libido and sexual functioning are so common. It can be argued that a misleading label may interfere with our commitment to informed consent. Therefore, it may be time to stop calling these medications antidepressants.

From the conclusion:

If we do not call these medications antidepressants, what are some alternative labels that may better fit the existing data? The effect sizes for many of the “side effects” are larger than the antidepressant effect sizes. Using labels like antiaphrodisiac medications, agitation enhancers, insomnia inducers, suicidality inducers, mania stimulators, or gas busters obviously would not offer the same marketing appeal. Though tongue in cheek, we consider these possible labels to be more accurate than the commonly used label of “antidepressant.” It could be argued that the outcomes with the largest effect sizes should be offered as the primary label for a medication.

These guys are pretty sarcastic. And, their sarcasm is unlikely to be a conversation starter, but I suspect that there is more of this backlash to come.

It brings to mind a comment from a recent episode of On Being  [emphasis mine]:

…individuals are hopelessly biased, they cannot perceive the truth by themselves.

Science is not just an individual activity. We expect our scientists, we exhort them, to be as objective as they can and a good scientist tries to do so very earnestly, but still fails. So therefore, there must be a social process that causes science to work to be a truth-discovering process.

This thing about scientific truth-discovery being a social process  puts it’s finger on something very important. It’s one of the things that so frustrating about hearing people tout evidence-based policies.

Consider the arguments for naloxone distribution . I’ve honestly got no quarrel with it, I just believe that it’s a woefully inadequate response. Of course it’s true that it’s an evidence based policy. I’m sure it saves lives. My problem is that advocates draw a straight line from this truth to universal implementation, AND anyone who balks is anti-science. The problem is that these advocates don’t ask what else we know to be true. For example, treatment also reduces overdose deaths . We fail to discuss what else improves this measure (overdose deaths), we also fail to discuss what other measures are important. If we have that conversation, then we can discuss why it sh0uld or shouldn’t jump to the top of the list without accusing others of being anti-science.

Another example are the evidence-based arguments that opiate substitution medications should be the front-line treatment for opiate addiction . To be sure, these medications reduce opiate misuse. However, there also exists a model, with evidence,  that eliminates opiate use in 78% of patients over 5 years. Why not discuss that? Why not allow discussion of whether reduced opiate use is even a good measure? Or, the best measure?

This social aspect of truth-discovery is too often too exclusive. Of course, we can not and should not give equal standing to every goofball with a pet theory, but the points in the  antidepressant paper above  and the recent  GSK scandal  demonstrate that the current custodians of evidence are all too capable of leading us into policies based on something other than truth while scolding anyone who questions their evidence.

UPDATE: Just to clarify two things.

First, we’re not anti-medication , but we do believe that their benefits are overstated, the adverse effects are understated, that other methods are just as effective or more effective (And, provide additional benefits.) and that they too often constitutes risk management rather than real treatment.

Second, I see naloxone as first aid. I have no interest in interfering with access to first aid of any kind to anyone with any kind of physical crisis. However, first aid should be FIRST aid (Not last aid or only aid.), and meaningful treatment for the real problem should follow. I tend to bristle because these calls for naloxone programs never seem to include calls for access to treatment of adequate quality, intensity and duration following the overdose.

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