Promotion of Cymbalta for Fibromyalgia symptoms

From: Dr. Jai Maharaj (usenet_at_mantra.com)
Date: 10/21/04 

Date: Thu, 21 Oct 2004 23:40:19 GMT

Forwarded message from "AHRP" <veracare@ahrp.org>

[ Subject: Efforts to promote Cymbalta for Fibromyalgia symptoms
[ From: "AHRP" <veracare@ahrp.org>
[ Date: 21 Oct 2004 12:45:50 -0500

ALLIANCE FOR HUMAN RESEARCH PROTECTION

Promoting Openness and Full Discloure

www.ahrp.org

FYI

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

veracare@ahrp.org

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

1University of Cincinnati College of Medicine, Cincinnati, Ohio

2Eli Lilly and Company, Indianapolis, Indiana

3University of Michigan, Ann Arbor

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

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

email: Lesley M. Arnold (Lesley.Arnold@uc.edu)

*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

End of forwarded message from "AHRP" <veracare@ahrp.org>

Jai Maharaj
http://www.mantra.com/jai
Om Shanti

Relevant Pages

  • Its Official: Cymbalta Approved for Fibro
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    (alt.med.fibromyalgia)
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    (alt.med.fibromyalgia)
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