(Martha Rosenberg )
But finding new diseases to justify a drug’s existence is the normal way pharma operates, especially Lilly, which agreed to pay $1.42 billion for illegal marketing of its anti-psychotic Zyprexa in January—$615 million for criminally promoting it for dementia—another $62 million to 32 states for illegal pediatric marketing, and agreed to resolve Medicaid fraud investigations into “rebates” at the same time. Lilly—whose diabetes treatment Byetta is tanking since reports last summer of six deaths, at least two from pancreatitis.
But Lilly’s fibromyalgia-fighting drug, Cymbalta (duloxetine)—its second-best seller after Zyprexa—is anything but normal.
Starting with the death of 19-year-old Cymbalta test subject Traci Johnson, who hanged herself in the Lilly Clinic in Indianapolis in 2004 and had no history of mental problems—it has been beset by reports of baffling, rapid, unprovoked, and out-of-character suicides and suicide attempts.
A 37-year-old man described in the February 2008 Journal of Clinical Psychopharmacology with a stable marriage and employment and no history of mental problems tried to kill himself with carbon monoxide two months after taking Cymbalta for back pain.
“The patient was unable to state exactly why he wanted to commit suicide,” write the four physician authors of the Department of Psychiatry and Behavioral Sciences at the University of Kansas Medical Center, who note he returned to normal when the drug was stopped.
A 63-year-old man with no history of suicide attempts or ideation was similarly “unable to explain why he was having thoughts of wanting to die,” say the authors after becoming suicidal two weeks after being put on Cymbalta for fatigue, insomnia, and sadness.
Last January, a Texas man prescribed Cymbalta for peripheral neuropathy because of a job that required him to be on his feet all day, a man with no history of mental problems “had a normal day at work, drove home, said he was going to grab a sandwich for his wife, went and shot himself,” his family wrote a reporter.
In February 2007, a 19-year-old Wisconsin college student recently put on Cymbalta “checked out books for a paper he was to write over the weekend,” emailed his résumé “to see if he could get a spot on Obama’s team for the summer,” and “then hung himself from his loft bed in his dorm,” writes his family. One month earlier, a 21-year-old Midwest college student, recently put on Cymbalta, took his own life three minutes after speaking to his family while driving home and sounding fine, the family wrote a reporter.
Approved as an antidepressant and for diabetic nerve pain in 2004—soon after the Johnson suicide, thanks to an unfazed FDA—Cymbalta soon proved to be the “Swiss Army Knife” of Lilly drugs, says its hometown paper the Indianapolis Star. It was approved for general anxiety disorder and maintenance treatment of depression in 2007, for fibromyalgia in 2008, and with approvals for chronic knee and low-back pain expected shortly.
In Europe, it is in use for stress urinary incontinence, but in the United States, its side effect of urinary retention landed Cymbalta on the FDA’s first Potential Signals of Serious Risks danger list in 2008. (FDA won’t release suicidal rates from stress urinary incontinence trials says reporter Jeanne Lenzer on Slate.com. She estimates the suicidal rates as 400 per 100,000 person-years for middle-aged women.)
But some, like Shannon Brownlee, author of “Overtreated: Why Too Much Medicine Is Making Us Sicker and Poorer,” question the revenue-driven prescribathon. Should drugs “that may have a really serious side effect called suicide,” be used for simple knee or back pain, she asks in the Star.
Cymbalta is also being studied for binge eating, social phobia, chronic fatigue, restless legs disorder, seasonal affective disorder, migraines, attention deficit disorder, and childhood depression (despite known pediatric risks), PMS, menopause, alcoholism, panic disorder, obsessive compulsive disorder, kleptomania, and the important medical condition: tennis elbow.
At the American Academy of Pain Medicine Annual Meeting in January, Lilly presented a study by its own doctors finding Cymbalta was superior to placebo in knee pain—in keeping with its penchant to publish studies by Lilly-funded and Lilly-employed doctors who say Cymbalta is safe.
Cymbalta is also a good use of state and third-party-payer dollars, say Lilly-funded doctors in “Differences in Medication Adherence and Healthcare Resource Utilization Patterns: Older Versus Newer Antidepressant Agents in Patients With Depression and/or Anxiety Disorders” in the 2008-22 CNS Drugs. These doctors are fighting the “restrictive reimbursement policies for newer antidepressants,” in which pharmacy benefits managers are saying, “You want us to spend WHAT”?
Getting benefits managers to cover the $200-a-month cost for Cymbalta prescriptions for fibromyalgia may also be tough since the ailment has no clear cause, blood test, or cure.
Maybe Lilly will offer pointers in the medical courses it is funding.
Martha Rosenberg is a freelance writer.