The price of the drug is not reported. The segment specifies that four suicides, and a higher number of other mental health effects, have been reported to the FDA. It also specifies that 11,000 patients participated in the pre-approval clinical trials and with no reports of similar incidents. But it fails to make clear to viewers the important differences between data from clinical trials and from post-surveillance voluntary reports. The story didn’t quantify potential benefits. The story is fundamentally about alleged harmful side effects of the drug, so this criterion is clearly established. The segment is based on an FDA investigation and labeling changes that follow post-marketing reports of four suicides and mental disorders. This is adequate evidence on which to base this news report. By emphasizing one tragic story about a teenager who took the drug and committed suicide, the segment exaggerates the likelihood that the two are linked. The segment draws on data from pre-approval and post-marketing trials, an interview with the family of a teenager who committed suicide after taking Singulair, and an interview with a clinical specialist in asthma and allergies. It also reports its own observation that information about the side effects is buried on the drugmaker’s website. The perspective of the clinician who prescribes Singulair and other drugs for asthma and allergies provides an adequate, if brief, discussion of treatment options. The segment makes clear that Singulair is widely used. Singulair is widely used, so its novelty is not in question. The report was triggered by the FDA’s action, not a company press release.
Questions about Singulair and suicide