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Efforts to promote Cymbalta for Fibromyalgia symptoms

Wed, 20 Oct 2004

Cymbalta (duloxetine) was approved by the FDA as a treatment for depression in adults. No doubt in an effort to expand the drugs' market, Eli Lilly tested the drug in patients with fibromyalgia. The published report claims women who took the drug for fibromyalgia "had significantly less pain and discomfort than those who took the placebo."

However, in one of the primary measures of pain there was no significant difference between the two groups at the end of the 12-week trial.

In clinical trials testing Cymbalta 6 subjects committed suicide - including a 19 year old, healthy volunteer. Given that Cymbalta is one of a class of drugs that have severe psychiatric adverse effects - including a causal relationship with suicide--why would anyone prescribe such a potentially lethal drug to relieve chronic pain?

Of note, the study and the investigators are paid consultants or employees of Eli Lilly.

One of the authors, Michael J. Detke, has been credited by knowledgeable insiders with resurrecting duloxetine after it had failed as an antidepressant in earlier clinical trials. Not only is Detke an employee of Eli Lilly, but he has positions at Indiana University Medical School; McLean Hospital, Belmont, Massachusetts; and Harvard Medical School, Boston, Massachusetts.

This is an emblematic example of the interconnected collaborations between drug companies and prestigious academic institutions.

Instead of developing life-saving drugs - such as much needed new antibiotics--the focus of drug research - even at Harvard Medical School - is on marketing drugs whose effectiveness is no greater than placebo. Inasmuch as they have serious adverse side-effects (that placebos don't) they can be marketed as: "Placebo-plus."

Contact: Vera Hassner Sharav
212-595-8974


http://www.usnews.com/usnews/health/briefs/pain/hb041015b.htm

US News & World Report
Antidepressant Cymbalta Helps Relieve Fibromyalgia Symptoms?
October 15, 2004
By Elizabeth Querna

Fibromyalgia affects between 3 and 6 percent of the population, mainly women, causing chronic pain all over the body as well as headaches, fatigue, and other complications. It is still not well understood, though studies have linked the disease to abnormal amounts of the chemicals serotonin and norepinephrine, which are also associated with depression. Some researchers from the University of Cincinnati and other places wondered if drugs that are used for depression could also help fibromyalgia patients.

What the researchers wanted to know: Does Cymbalta, an antidepressant with the generic name duloxetine, help patients with fibromyalgia? What they did: The researchers recruited about 200 patients from around the country and split them into two equal groups. One group received Cymbalta for 12 weeks, and the other group received a placebo for the same amount of time.

Participants completed several questionnaires to measure the amount of pain and discomfort the disease caused them at the beginning of the study, and then at the end of each of the first two weeks and every second week for the remaining 12 weeks of the study. Researchers also tested the participants for depression.

What they found: Women who took Cymbalta had significantly less pain and discomfort than those who took the placebo. For men, who made up only 11 percent of the study, there was no effect from taking the medication compared with a placebo. Depression played no part in whether or not the drug worked to control pain. The change in the level of women's pain was particularly pronounced after a month of taking the drug, then leveled off a bit before dropping again near the end of the study.

What it means to you: Cymbalta could be a good therapy for people suffering from fibromyalgia. Because the disease is not well understood, no one knows the best way to treat it or why certain drugs work and others don't. Other antidepressants, including Prozac, Elavil, and Endep, have also been shown to reduce symptoms of the disease, so those types of drugs may become a standard treatment.

Caveats: In most tests, Cymbalta improved the score of participants.

However, in one of the primary measures of pain there was no significant difference between the two groups at the end of the 12-week trial. Also, because the trial lasted only 12 weeks, it is impossible to tell how well the drug would control treatment for a longer period of time. Lastly, the primary researcher on the project has received more than $10,000 in consulting fees from Eli Lilly, the manufacturer of Cymbalta, and other researchers also have ties to the company.

Reference: Arnold, L.M. et al. "A Double-Blind, Multicenter Trial Comparing Duloxetine With Placebo in the Treatment of Fibromyalgia Patients With or Without Major Depressive Disorder." Arthritis and Rheumatism. September 2004, Vol. 50, No. 9, pp. 2974 - 2984.

Source: U.S. News & World Report

Research Article

A double-blind, multicenter trial comparing duloxetine with placebo in the treatment of fibromyalgia patients with or without major depressive disorder

Lesley M. Arnold 1 *, Yili Lu 2, Leslie J. Crofford 3, Madelaine Wohlreich 2, Michael J. Detke 4, Smriti Iyengar 2, David J. Goldstein 5, Duloxetine Fibromyalgia Trial Group

1 University of Cincinnati College of Medicine, Cincinnati, Ohio

2 Eli Lilly and Company, Indianapolis, Indiana

3 University of Michigan, Ann Arbor

4 Indiana University Medical School and Eli Lilly and Company, Indianapolis, Indiana, McLean Hospital, Belmont, Massachusetts, and Harvard Medical School, Boston, Massachusetts

5 Indiana University Medical School and PRN Consulting, Indianapolis, Indiana

*Correspondence to Lesley M. Arnold, University of Cincinnati Medical Arts Building, Suite 8200, 222 Piedmont Avenue, Cincinnati, OH 45219

Drs. Crofford and Arnold have received consulting fees or honoraria in the last 2 years from Eli Lilly and Company (Dr. Crawford <$10,000, Dr. Arnold >$10,000).

In addition to the authors employed by Eli Lilly and Company listed above, Dr. Goldstein's wife is employed by Eli Lilly and Company.

Funded by:
Eli Lilly and Company

ABSTRACT

Objective

To assess the efficacy and safety of duloxetine, a serotonin and norepinephrine reuptake inhibitor, in subjects with primary fibromyalgia, with or without current major depressive disorder.

Methods

This study was a randomized, double-blind, placebo-controlled trial conducted in 18 outpatient research centers in the US. A total of 207 subjects meeting the American College of Rheumatology criteria for primary fibromyalgia were enrolled (89% female, 87% white, mean age 49 years, 38% with current major depressive disorder). After single-blind placebo treatment for 1 week, subjects were randomly assigned to receive duloxetine 60 mg twice a day (n = 104) or placebo (n = 103) for 12 weeks. Co-primary outcome measures were the Fibromyalgia Impact Questionnaire (FIQ) total score (score range 0-80, with 0 indicating no impact) and FIQ pain score (score range 0-10). Secondary outcome measures included mean tender point pain threshold, number of tender points, FIQ fatigue, tiredness on awakening, and stiffness scores, Clinical Global Impression of Severity (CGI-Severity) scale, Patient Global Impression of Improvement (PGI-Improvement) scale, Brief Pain Inventory (short form), Medical Outcomes Study Short Form 36, Quality of Life in Depression Scale, and Sheehan Disability Scale.

Results

Compared with placebo-treated subjects, duloxetine-treated subjects improved significantly more (P = 0.027) on the FIQ total score, with a treatment difference of -5.53 (95% confidence interval -10.43, -0.63), but not significantly more on the FIQ pain score (P = 0.130). Compared with placebo-treated subjects, duloxetine-treated subjects had significantly greater reductions in Brief Pain Inventory average pain severity score (P = 0.008), Brief Pain Inventory average interference from pain score (P = 0.004), number of tender points (P = 0.002), and FIQ stiffness score (P = 0.048), and had significantly greater improvement in mean tender point pain threshold (P = 0.002), CGI-Severity (P = 0.048), PGI-Improvement (P = 0.033), and several quality-of-life measures. Duloxetine treatment improved fibromyalgia symptoms and pain severity regardless of baseline status of major depressive disorder. Compared with placebo-treated female subjects (n = 92), duloxetine-treated female subjects (n = 92) demonstrated significantly greater improvement on most efficacy measures, while duloxetine-treated male subjects (n = 12) failed to improve significantly on any efficacy measure. The treatment effect on significant pain reduction in female subjects was independent of the effect on mood or anxiety. Duloxetine was safely administered and well tolerated.

Conclusion

In this randomized, controlled, 12-week trial (with a 1-week placebo lead-in phase), duloxetine was an effective and safe treatment for many of the symptoms associated with fibromyalgia in subjects with or without major depressive disorder, particularly for women, who had significant improvement across most outcome measures.

________________________________________

Received: 11 July 2003; Accepted: 26 May 2004


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