Following the evidence

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.

5 Comments

Filed under Controversies, Dawn Farm, Harm Reduction, Mutual Aid, Policy, Research, Treatment

5 responses to “Following the evidence

  1. Pingback: Impotence instead of cure? Antidepressants accused of killing sex drive « BGTV MEDIA ONLINE

  2. Pingback: America – the antidepressant nation? « Talesfromthelou's Blog

  3. If an antidepressant works for you, and saves your life, none of the above semantic nonsense makes any difference. A new “name” for antidepressants? How arrogant and ignorant is that? If the people for whom ADs WORK made as much noise as the people for whom they don’t work, or the medical advocates who have helped confuse people about Rx drugs for years, citizens would have a more normal picture of these drugs.

    Tylenol doesn’t work for EVERYBODY’S pain. May even lose out to a placebo in some cases. So I propose we can’t call Tylenol a “pain-killer” any more.

    • Hi Dirk,

      I’m hearing your concern that these meds have been very helpful for some portion of the patients that receive them.

      Are you concerned about the state of depression treatment? Pharmacological or otherwise? What should we do about the deliberate deception that has occurred and is occurring? It seems to me that the overselling the effectiveness of these drugs is likely to interfere with the development of more effective treatments, or the use of older treatments that might be more effective (like tricyclics) that might be more effective and much cheaper (but less profitable).

      As for the semantics, these guys were pretty snarky. I can understand getting riled by this. At the same time these guys are responding to the deception in drug marketing to the public and to doctors. I’m concerned about this too and this idea may have problems, but I might welcome something like it with all drugs.

      We do it often already. “This drug is an anti-convulsant, but it also reduces pain from neuropathy in a lot of patients.” Descriptive naming right now is determined by its first use or marketing. Maybe it be better if it was determined by its most predictable and powerful effects on the largest number of people.

      At any rate, I’d be interested in hearing your thoughts about how to solve these problems. (If we even agree that the problems exist.)

      All the best,

      Jason

      • Hi Jason:
        You wrote:
        “It seems to me that the overselling the effectiveness of these drugs is likely to interfere with the development of more effective treatments”

        A valid concern, and one I share. Part of the problem is Big Pharma, naturally. But part of the problem is a lack of understanding when it comes to “metabolic chauvinism,” meaning a drug I take isn’t going to have the exact same effect on you, and vice versa. The end result of this misunderstanding can be things like the ugly “Prozac Kills” campaign.

        And as you say, for a given med, there is a primary use and then often a cluster of secondary indications discovered later. Descriptive naming is a good idea, and more effort should be directed at make these secondary indications better known for the public.

        As for deception, aggressive marketing, etc: In a system of corporate capitalism, and the 3-month long view, how could it be otherwise. This is where the FDA is failing us. And throwing out the baby with the bathwater, when it comes to drugs, punishes sick people as much as it punishes bad corporate practices.

        It’s easy, but entirely fair, to blame some of this on the Drug War, on “Drugs are bad, ‘mkay?” and on the artificial line of distinction drawn between legal and illegal drugs.