Duloxetine, Lilly, and Suicide

Duloxetine, Lilly, and Suicide

This is a story that is going to get bigger: Gregg Easterbrook rails against Lilly¹^ in the New Republic, claiming that they have led to the death of a healthy 19-year-old student in Indiana. He makes some salient points, but is probably over the line, especially by his last few paragraphs — see Corante for a good analysis of the column²^. Nonetheless, I think the Easterbrook does have a point.

A number of relevant facts:

• Why were they testing on healthy people? The FDA requires such tests to study side effects, specifically, the metabolization of antidepressants³^
• Why would students participate in such studies? For the extra money — Traci Johnson, the student that killed herself, was getting paid $150/day + meals⁴^, which is really good money for a student
• From the New York Times article: Robert Smith, a Lilly spokesman, said the company did not believe that duloxetine, the drug’s generic name, caused the suicide. “This drug has been studied in 9,000 patients, in depressed and nondepressed healthy people, and we have not been able to discern any signal between duloxetine and suicide or suicidal ideation,” Mr. Smith said.. I could not find the studies totaling up to 9,000; the one study that I did find⁵^ gave a rate of 1 suicide attempt per 115 patient-years, which is not abnormally high for depressed patients. (I think that Easterbrook’s complaint about the suicide rate in test subjects (5/9,000) being too high is specious, as Corante points out; the question is, what is the general suicide rate among depressed patients? It works out to about 2% over the lifetime of the patient for patients that have been treated for depression⁶^, but I have not yet found year-to-year rates by age group)
• Traci was one of 25 healthy students that were taking place in the study — given the small number of students, it makes the probability of some relationship to duloxetine that much higher — the average rate of suicide for people aged 15-19 is 9.7 per 100,000, with a 5:1 male:female ratio. This means that the chances of 1 out of 25 healthy students committing suicide, on the average, is 0.25%; this would be even lower if you took into account the different suicide rates in females vs. males. So, statistically, something looks really suspicious about this.
• Antidepressants have been, in many cases, counterindicated for anybody under 18. The theory is that developing brains react to the drugs differently than adults. Traci Johnson was 19 at the time of the study

The Indianopolis Star claims that the suicide rate for patients was only 0.097 percent, whereas the rate for SSRI antidepressents is 1.5 percent. This figure is suspiciously low (it’s two magnitudes lower!) and I suspect a division error by the paper; it doesn’t match the results in the Journal of Clinical Psychiatry⁷^, which gives a suicide attempt rate just under 1%⁸^.

Financial implications. Lilly had total revenues of 12.5B in 2003⁹^, and estimates for duloxetine ranged as high as $2 billion in 2008¹⁰^. Lilly’s patent on Prozac (fluoxetine hydrochloride) is gone and they are getting quite a bit of competition from generics, so they really want a new, patented medicine in their array of drugs.

Conclusion. I think it will all boil down to one thing: Dr. Joe Glenmullen, a clinical instructor of psychiatry at Harvard Medical School, said that “patients taking antidepressants are most vulnerable to suicidal thoughts three to 10 days after they cease the medication.“¹¹^ (also mentioned in the New York Times article¹²^). If this is true¹³^, then the question is: was Lilly conscientious in making sure that students taken off the drug were tracked? If not, look for a major negligence law suit.

[1] New Republic: Gregg Easterbrook
[2] Corante: The Cold Equations
[3] a) Indianapolis Star b) [and another] c) [and another]
[4] More information on duloxetine
[5] Yahoo Finance: LLY
[6] New York Times: Student Commits Suicide
[7] Have not been able to validate this source yet.
[8] Journal of Clinical Psychiatry 2003;64:1237-1244
[9] The study of 1,279 patients gave a rate of 1 suicide attempt per 115 patient years of experience.
[10] Surgeon General
[11] American Journal of Psychiatry

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