Cymbalta Promotion QuestionedMar 18, 2009 | Parker Waichman LLP Eli Lilly recently spent millions promoting Cymbalta as a treatment for the controversial disease, fibromyalgia. Now, the Epoch Times places the figure donated by the company to nonprofits to “educate” doctors about the disease at nearly $4 million. Fibromyalgia, a chronic, widespread pain condition of unknown origin, is a controversial diagnosis with no biological diagnostic tests, nor links to any environmental or biological causes.
Some criticized Lilly for seeming to ignore established diseases such as diabetes and Alzheimer’s in order to fund research on fibromyalgia, said the Epoch Times, noting that Cymbalta—generically known as duloxetine—is Lilly’s second highest selling drug.
Cymbalta has long been linked with suicidal problems, yet is being researched for a wide and growing array of ailments. Approvals are expected for its use in the treatment of chronic knee and low-back pain and, said the Epoch Time. According to the report, it is also being studied as a treatment for binge eating, social phobia, chronic fatigue, restless legs disorder, seasonal affective disorder, migraines, attention deficit disorder and childhood depression. Research is also looking into Cymbalta as a possible remedy for PMS, menopause, alcoholism, panic disorder, obsessive compulsive disorder, kleptomania, and tennis elbow.
The drug, which is linked to serious pediatric risks, continues to be looked at for treatment of childhood depression, the Epoch Times said.
The Epoch Times detailed some troubling situations involving Cymbalta (some were outlined in the February 2008 Journal of Clinical Psychopharmacology by four physicians from the Department of Psychiatry and Behavioral Sciences at the University of Kansas Medical Center), including:
- The hanging death of a 19-year-old test subject in a Cymbalta Clinical Trial at the Lilly Clinic in 2004 who had no prior history of mental illness.
- The carbon monoxide suicide attempt by a man in his late 30s after taking Cymbalta for back pain for a couple of months
- Suicidal ideation in a 63-year-old man with no prior history of such ideation and who was prescribed Cymbalta for fatigue, insomnia, and sadness.
- A Texas man prescribed Cymbalta for peripheral neuropathy suddenly killed himself.
- A 19-year-old college student recently prescribed Cymbalta hanged himself after completing some routine job search tasks.
- A 21-year-old college student recently prescribed Cymbalta, took his own life three minutes after speaking to his family while driving home and sounding fine.
Soon after the first suicide, an unflinching U.S. Food and Drug Administration (FDA) approved Cymbalta as an antidepressant and for diabetic nerve pain in 2004, said the Epoch Times. It 2007 it was being prescribed for general anxiety disorder and maintenance treatment of depression; and, in 2008, it was being prescribed for fibromyalgia.
WA Today reported that in Australia, Lilly was making a “concerted effort” to promote Cymbalta off-label at up to “twice the approved dose” for depression-related physical pain. In that country, WA said that Lilly was fined $100,000 and had to remove all promotional material. Lilly appealed, claiming its material was “educational”; the appeal was dismissed. Lilly mailed an apology to all Australian doctors for "any unintentional confusion" over the marketing of Cymbalta, admitting the material might have been misleading, and might have suggested using a higher than appropriate dose of the drug, reported WA Today.
Eli Lilly has faced scandals over drug promotions before. It recently agreed to pay $1.42 billion in the U.S. to settle claims it illegally marketed Zyprexa.