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Trouble in a ‘Black Box’

Rating

3 Star

Trouble in a ‘Black Box’

Our Review Summary

The focus of the story is on one potential serious harm of anti-depressants in children, i.e. increased risk of suicidality.  The story also discusses the harm of not taking medication.  Newly published observational data suggests there may be an association between the decrease in anti-depressant prescriptions and an increase in pediatric  suicides. A big problem here is using expert comments which are unsubstantiated for describing harms. There is a comment about increased suicide risk vs. increased suicide untreated (but the expert didn’t cite credible references to back the numbers). There is also no discussion of the weak observational data presented. It is not put into context well with the meta-analysis of randomized clinical trials showing a small benefit of antidepressants in teens and a small increase in suicide risk when on antidepressants. None of the authors or experts did a good job (or perhaps it was the reporter) of contextualizing the results.

The story does not provide much quantitative evidence on the benefits or harms of treatment in children and adolescents. The story should have mentioned other side effects of antidepressants such as nausea, sleep disturbance or interactions with other medications. Additionally, the cost of anti-depressant medications are not mentioned. Cost of generic Prozac is about $16/month.  Branded versions are about $80-120/month. 

The patient’s anecdote as the lead for the story suggests that taking anti-depressants is a panacea and thus could effectively treat and prevent relapses of major depression and/or homicidal or suicidal thoughts and behavior. This is not always the case, though, these medications do help many people, especially to engage socially and in psychotherapy.  Psychotherapy or other forms of behavioral therapy– in conjunction with medication-– is often more effective than medication alone, but these treatments are not mentioned.

Lastly, the story does not engage in disease mongering, per se, but, to say the black box warning is "killing kids" may be an overstatement as we only have one year of observational data, and there may be other variables involved in the increased rate of pediatric suicides. 

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The cost of anti-depressant medications are not mentioned. Cost of generic Prozac is about $16/month.  Branded versions are about $80-120/month.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

 The story does not provide much quantitative evidence on the benefits or harms of treatment.  The story notes the 50% drop in prescriptions and the 18% increase in suicides, but we are given no context for these statistics.  Additionally, the story does not provide data on the risk/benefits of anti-depressants in children and adolescents. Recent meta-analysis in JAMA should have been cited.

 


Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

The focus of the story is on one potential serious harm of anti-depressants in children, i.e. increased risk of suicidality.  The story also discusses the harm of not taking medication.  Early data suggests there may be an association between the decrease in anti-depressant prescriptions and an increase in pediatric  suicides.  The link between the two is unconfirmed and there may be other variables as to why teen suicide has increased 18% between 2003 and 2004. The story should have mentioned other side effects of antidepressants such as nausea, sleep disturbance or interactions with other medications. A big problem here is using expert comments – unsubstantiated – for describing harms. There is a comment about increased suicide risk vs. increased sucicide untreated (but the expert didn’t cite credible references to back the numbers)

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The story does discuss the correlation between increased teen suicides and the decrease in prescriptions for anti-depressants. There is no discussion of the weak observational data presented. It is not put into context well with the meta-analysis of randomized clinical trials showing a small benefit of antidepressants in teens and a small increase in suicide risk when on antidepressants. None of the authors or experts did a good job (or perhaps the reporter) of contextualizing the results.

Does the story commit disease-mongering?

Satisfactory

The story does not engage in disease mongering. However, to say the black box warning is "killing kids" may be an overstatement as study data is only for one year, and there may be other variables involved in the increased rate of pediatric suicides. The story would be improved by giving information on frequency of the depression and/or suicide in this group. 

Does the story use independent sources and identify conflicts of interest?

Satisfactory

The story interviews several psychiatrists and researchers not affiliated with the recent study about anti-depressants and suicidality in pediatric depression. The story also provides perspective from a patient’s family and a member of the FDA who argued against the black box warning on certain anti-depressants.  The story properly notes that Eli Lilly, maker of commonly prescribed anti-depressants, funded the recent research.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The patient’s anecdote as the lead for the story suggests that taking anti-depressants is a panacea and thus would prevent major depression and/or homicidal or suicidal behavior. This is not always the case, though these medications do help many people, especially to engage more fully in psychotherapy or socially.  Psychotherapy or other forms of behavioral therapy– in conjunction with medication-– is often more effective than medication alone, but these treatment are not mentioned.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The story notes that anti-depressants are being prescribed to children and adolescents less frequently due to an FDA black box warning about increased suicidality with certain medications. Apprehension about the increased risk of suicide with these medications may make the medications unavailable to those who might benefit from them.

Does the story establish the true novelty of the approach?

Satisfactory

SSRIs (selective serotonin reuptake inhibitors) are not new –they have been available since the 1980s–however, the side effect profile of these medications in younger patients is still not fully understood.  The current data are useful, although the association between suicide and antidepressant use is not particularly novel.

Does the story appear to rely solely or largely on a news release?

Satisfactory

There are multiple sources and independent reporting. The story does not appear to rely  on a press release for information.

Total Score: 5 of 10 Satisfactory

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