By Martha Rosenberg
Many are outraged that Eli Lilly gave nonprofits $3.9 million in grants last year for medical courses to “educate” doctors about the pain-and-fatigue ailment fibromyalgia—more than it spent for diabetes and Alzheimer’s, which people already know they have.
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.
My husband’s court date comes up in July.
He had been seeing a therapist and psychiatrist for depression. He received 30 and 60 milligram samples of cymbalta from the psychiatrist. Our only advice was I (his spouse) should watch for “bizarre behaviors”. When he went through the 30 mg., he proceded to take the 60 mg., and I noticed he seemed a little “testy”. Worried, he stopped the cymbalta altogether. Then he had some drinks (vodka) and literally went bananas.
Crying and laughing jags, estreme anxiety, then physical aggressiveness. Wouldn’t allow me to call his dr. or take him to emergency room. He became severely depressed; and I had the feeling my own life was in danger when he ordered me into a room and threatened to kill me if I came out. NEVER have I ever seen him like this. I lay awake and thought he had finally calmed down. But I heard him go outside into the back yard… and then a loud gunshot. I really thought he had killed himself and called 911. All the police saw when they came was what appeared to be a very uncoordinated, naked drunk who had fired a shotgun in our backyard.
I tried to explain about a drug/drinking interraction; and they said if the hospital would admit him he wouldn’t be arrested.
This was not like any overdrinking I had ever seen. His lips, mouth, and tongue seemed to not be working properly and there was a lot of strange grimacing all through his wait after being admitted. It was hours before he went into the “Fragile Care Ward” of the hospital and he had outpatient treatment after staying 4 days.
We didn’t know you weren’t supposed to withdraw suddenly suddenly from any antidepressant. Even with a court date coming up for discharging a sawed off shotgun in city limits (inherited from his Dad), I feel that something even more terrible could have happened. I feel people should be warned about cymbalta.
Is there a class action suit going on?
I’m also trying to find out if there’s a class action suit going on. I want this drug off the market. My husband was on Cymbalta and other psychiatric drugs for depression and anxiety. He was being weaned off the Cymbalta and started on a new drug. He had horrible withdrawal from the Cymbalta – insomnia, crying jags, brain zaps, etc. He drank rust cleaner on 4/26/09 and ended his life.
Camcar: I am so VERY sorry and regret that your dreadful experience with cymbalta is shared by others. I’m still trying to find a class action suit. I have found stories of not only suicide; but also murder. This dangerous drug must be stopped; or at least warnings emphasized.
PLEASE, if anyone knows how to start/join a class action suit, respond… how many more tragedies must happen before it stopped?