Wednesday, February 28, 2007

eGAD! How I Learned to Stop Worrying and Love Cymbalta!

Like most Rx drugs these days, Cymbalta started life approved for one specific indication -- major depressive disorder -- and was later approved for another -- diabetic neuropathic pain -- and now yet another -- generalized anxiety disorder (GAD).

GAD is one of those "real medical conditions" that no one has heard of until a drug has been approved for its treatment.

But it may surprise you to learn that you may suffer bouts of GAD without even knowing it! Here's a patient story taken from the Web site of the National Institute of Mental Health (NIMH):

"I always thought I was just a worrier. I'd feel keyed up and unable to relax. At times it would come and go, and at times it would be constant. It could go on for days. I'd worry about what I was going to fix for a dinner party, or what would be a great present for somebody. I just couldn't let something go."

People with GAD, says NIHM, "are overly concerned about health issues, money, family problems, or difficulties at work."

Sound familiar?

If you are like me -- one teenager in college constantly overdrafting his expense account and another teenager spending his savings pimping his ride -- you'd be a worrier about money and family problems too! And every day!

But to be truly diagnosed with GAD "a person [must worry] excessively about a variety of everyday problems for at least 6 months," according to NIMH. GAD affects about 6.8 million adult Americans and about twice as many women as men.

Now I just know that Lilly, the company that markets Cymbalta, will make the most of these numbers and portray ordinary worriers like you and me as GAD sufferers.

There some precedent in how Lilly markets Cymbalta that makes me believe it will exaggerate the GAD indication. Lilly's clever "depression hurts" marketing campaign, IMHO, is based on an indication -- ie, pain associated with depression -- for which Cymbalta is NOT approved.

There may be some truth that pain is associated with depression -- Lilly's animated video for physicians says "[depression] is also often associated with a physical component including low energy, changes in sleep and appetite, as well as vague aches and pains of varying degrees of severity..."

Recasting depression's association with "vague aches and pains of varying degrees of severity" into "Depression Hurts" is a stretch in my opinion. Also, I am at a loss as to how "vague aches and pains" fall under the approved labeling for diabetic neuropathic pain. It seems to me that the Depression Hurts campaign smacks of off-label promotion.

Given that, I am worried that Lilly will engage in a bit of GAD disease mongering to sweep as many unsuspecting worriers into doctors' offices demanding Cymbalta. I know I sure would like to stop worrying about my kids every day!

8 comments:

  1. Anonymous9:29 AM

    Can I ask why you refer to GAD as a "real medical disorder" in quotes, as if to imply that it is a bogus disease that is being foisted by drug companies? I certainly learned about it in medical school, and I think the DSM-IV seems to agree about its existence.

    That's not to say that drug companies don't disease monger, but GAD, and anxiety disorders in general, affect not a small proportion of the population.

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  2. Not totally "bogus," but I would say unknown to the general public. It may be listed in the DSM-IV, but that tome is not without its critics that claim it is sometimes used to legitamize "bogus" conditions. Physicians who vote to include diseases in that compilation sometimes are not unbiased and stand to benefit when their "specialty" is recognized.

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  3. I'll agree that GAD is indeed real, but that this is certainly one of the diagnoses that is easiest to monger, as the DSM-TV criteria for GAD are indeed somewhat vague. It's also important to consider that the impact of Cymbalta over a placebo seems pretty small according to the only published study on the topic. I would say more about Cymbalta's effect on GAD symptoms, but the data on Cymbalta for GAD are strangely missing from Lilly's allegedly comprehensive clinical trial database, which increases my suspicion. There were supposedly three GAD trials conducted, yet only one has been published and the data from the other two appears to be nowhere in sight.

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  4. Anonymous9:44 PM

    Ultimately, it’s up to the doctor to participate and prescribe for their patients, so if anyone should be concerned about this type of behavior it’s the doctor.

    Excellent post Mr. Mack.

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  5. I can't help wondering what disorder covers the category of people who don't worry about "family PROBLEMS", or "DIFFICULTIES" at work?

    Do all those people who complain of sleepless nights because of difficulties at work (which they have to try to sort out the next day) need more medication for their 'disorder' than those who just roll in to work oblivious to the difficulties?

    Could the people who are oblivious to difficulties at work be the same people who cause the difficulties in the first place?

    Is that disorder not in the DSM because people who vote whats in and whats not are oblivious to their own affliction?

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  6. Sounds great to me

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  7. April3:43 PM

    Worry, and debilitating fear are very different. It is not easy to understand unless you have allowed anxiety to keep you from achieving in life..to keep you from living.
    i at one point in my life was unable to write a check to pay for whatever in front of the whoever salesperson. I would begin trembling, and many times the pen would fly out of my hand. I laugh about it now, because it is funny NOW that I got over that fear.
    It was all about fear and serious self criticism that kept me in a constant state of self loathing. I would never think to defend myself, for fear of you name it.
    I'm a different person now, but I remember how painful it was to feel 2 minutes away from a heart attack, knowing I had to introduce myself in my first day in a History course in college...lucked out first day as time did not permit me that horror, so I missed the second day in hopes he would forget to catch me next time.
    And on and on...oh, and I worried about everyday problems too.
    There are other antidepressants used for GAD, Zoloft being a big favorite

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  8. From WSJ Health Blog
    http://blogs.wsj.com/health/2007/12/26/study-puts-the-hurt-on-antidepressant-claims/

    December 26, 2007, 2:18 pm

    Study Puts the Hurt on Antidepressant Claims

    Posted by Shirley S. Wang

    A new analysis of published data on the efficacy of the antidepressant Cymbalta in treating depression-related pain suggests the drug’s maker, Eli Lilly, overstates its claim that Cymbalta relieves physical as well as emotional pain.

    Our curiosity piqued, we went to the study author, Glen Spielmans, an assistant professor of psychology at Metropolitan State University in Minnesota. He told the Health Blog he became intrigued by Lilly’s “Depression Hurts” campaign to market Cymbalta for depression-related pain.

    He conducted a statistical review, or “meta-analysis,” of five published studies that looked at the relationship between duloxetine and reduction of pain symptoms in people with depression, published in this month’s issue of the journal Psychotherapy and Psychosomatics. [http://content.karger.com/ProdukteDB/produkte.asp?Aktion=ShowAbstract&ArtikelNr=110055&Ausgabe=234134&ProduktNr=223864]

    Spielmans, who does not receive drug industry funding, found only a tenuous relationship between Cymbalta and pain relief (the significance level was .057, while anything lower than .05 is usually considered significant). And the magnitude of the effect was .115, in the “very small” range.

    “I think it’s certainly misleading at best, and completely false at worst,” Spielmans told the Health Blog of Lilly’s marketing of Cymbalta.

    “We don’t believe so,” Michael Robinson, medical adviser on the duloxetine team at Lilly’s U.S. affiliate, told the Health Blog. “We adhere to good promotional-practice procedures and we only promote on evidence that is substantiated and shows a significant effect in multiple studies.”

    Which studies were picked or excluded from the meta-analysis could affect the results, says Robinson, though it isn’t clear from the selection of studies whether they would have skewed the results against Cymbalta. “We continue to believe that duloxetine has analgesic efficacy,” he says.

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