June 30, 2008

Cymbalta, The Swiss Army Knife Of Drugs

That's the term the Indianapolis Star used in an article this weekend to describe Eli Lilly's blockbuster anti-depressant and it's an apt one. Since being approved for depression in 2004, Lilly has gotten the drug approved by the FDA for generalized anxiety, maintenance treatment of depression (it's never been clear to me why the company needed a long-term indication for depression), diabetic nerve pain, fibromyalgia and stress urinary incontinence (Europe only). The company has also submitted it to the FDA for approval as a treatment for chronic knee and low back pain. I cannot think of a single psych med that has been repurposed so often, although Paxil does have seven indications but those are all for DSMable conditions not pain management.

As I noted recently, one Lilly-run study of the drug for knee pain generated an effect size of 14 percent over placebo. Pretty unimpressive. There have also been published studies questioning just how effective Cymbalta is at treating pain as well as other anti-depressants.


I've been leery of the anti-depressants for pain paradigm for some time now, principally because of the rotten side effects that Cymbalta and other anti-depressants are heir to. Others are leery of Cymbalta and Lilly for other reasons:

"'The question you have to ask is, are drug companies using all their scientists to look at new uses for drugs they already have, at the expense of developing new drugs?' said Dr. Lon Castle, senior director for medical and analytical affairs at Medco Health Solutions of New Jersey, one of the nation's largest drug distribution companies."

It's a fair question, but Lilly has certainly benefitted from the federal and states push to get pain patients away from opiates. As the paper notes in a cautionary way:

"Like all antidepressants, the drug has a black-box warning that it may increase the risk of suicide in people younger than 25. In 2004, a 19-year-old drug-testing volunteer, Traci Johnson, hanged herself in the Lilly Clinic in Indianapolis while participating in clinical trials for Cymbalta. The drug also carries a long list of possible side effects, from nausea and dry mouth to fatigue and constipation.

"'I think the question is, should one drug compound do so much?' said Shannon Brownlee, author of 'Overtreated: Why Too Much Medicine Is Making Us Sicker and Poorer.'

"'This is a drug that may have a really serious side effect called suicide,' Brownlee said. 'Don't we have other drugs available that are safer and just as effective for such things as the management of chronic knee and low back pain?'"

Indeed.

Posted by Philip Dawdy at June 30, 2008 12:01 AM
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Comments

I would like to remember that Traci Johnson - where are you parents, families, friends? I'm caring your daughters photo! - was a healthy 19 years old girl. It was not only her who committed suicide on Elli-Lilly's facilities while taking Cymbalta, not the placebo, during clinical trials. Four others volunteers have also took their lives.
...long list of possible side effects, from nausea and dry mouth to fatigue and constipation.
Possible side effects?
Possible?
:o)
At that time these side effects, and there are many others that are not listed, were already known as side effects of many SSRIs.
I don't know how to classify putting on the market a drug that has killed 5 people during clinical trial.

Posted by: Ana at June 30, 2008 02:11 AM

Best title for a story ever!!!! Had me laughing at 0530!!!! Good job!!!

Posted by: Angie at June 30, 2008 02:38 AM

I agree with Angie, the irony of the title is vast. You have to love Lilly- first with Prozac how one dose fitted all, they minimized that drug's suicide potential until they lost the Kentucky law suit; then with Zyprexa it was the savior from Clozaril, it was the panacea for everything, even for migraines at one point; and now "RE"volta. If you can get into the circle of Lilly, every one of their psychotropic newcomers is hailed as the savior for their stocks, and, like from the movie "Trading Places" with Dan Ackroyd and Eddie Murphy, at the end when the Dukes realize they were had, it is "SELL, SELL, SELL" to their reps.

Do pharmaceutical CEOs have hearts? They kind of remind me of the tin man, banging on their chests and just listening to their echoes.

Their mantra should be, "We'll get you, my pretties, and if we have products for vets, we'll get your little dogs too!"

Posted by: therapyfirst at June 30, 2008 10:42 AM

Well I think we will see even more suicides in the use of this drug for pain than we have seen for depression. Now we will be telling people with serious pain conditions that they need to get off thier pain meds (which can cause depression itself) and get on an antidepressant. And when the antidepressant doesn't work and is making them feel suicidal, depressed or wierd, and they ask to be put back on thier old pain meds they'll be told they're an addict and that the antidepressant is working for thier pain but they just don't want to believe it because they want to get back on the addictive drugs to get high. ... Now I know this will be the case because the DEA will probably work as hard as they can to barrage doctors with propoganda about how effective antidepressants are for pain and how no one should be taking opiate pain relievers unless they are post-op or have cancer or some other terminal disease.

Now the patient will not only have pain that is going untreated and be dealing with being on a psychotroopic they never should have been put on which is probably messing with thier head big time... now they will also be being told that they are and addict, the doctor doesn't believe them, the pain is all in thier heads and they are just choosing to still feel as if they are still in pain as an excuse to get back on opiates.... and they will basicaly be told that this is it for them, that this is far as pain relief goes in the new treatment paradigm... and well if that wouldn't be enough to make a person depressed I don't know what would. And add on top of that the suicide inducing side effects of these drugs and I am sure we will see some people thinking that the best way to escape thier pain is to kill themselves.

.... and who will care at that point? Who will change the system once it's gotten to that point? No one will because pain patients who don't get relief from antidepressants and NSAIDs will be reclassified as addicts and junkies (just wait there will be studies to try and prove this), and as we all know addicts and junkies deserve what they get -least that's the way society acts-. If they kill themselves because they can't live without thier drug of choice who in the government or the medical field is going to care? No one. And those suicides will be sneakily moved from being attributed to the effects of antidepressants on inducing suicidal feelings and behavior, or the ineffectiveness of antidepressants being able to treat sever pain, and those suicides will be attributed to those people being junkies who were in withdrawal and depressed and suicidal because of that... and it will also be because of some underlying mental illness that wasn't diagnosed because junkies and addicts often times also have mental illnesses... and don't blame the antidepressant for not treating thier underlying depression because it was "too buisy" being used in thier bodies and brains to treat the pain for it to also treat the depression... if they want ot treat thier depression issues as well they are going to need another antidepressant or moodstabalizer to take on top of the antidepressant being used as a pain med.

Ah, yes, it's gonna be awsome for so many people... but at least the government will be happy right?

Posted by: katielou82 at June 30, 2008 10:57 AM

Swiss Army Knife? Don't cut yourself.

Posted by: Lilly NC at June 30, 2008 12:56 PM

Maybe the reason Cymbalta is only approved in Europe for incontinence is that there was a higher than expected rate of suicide in the clinical trials testing for urinary incontinence in the U.S.A.

The whole story can be read on www.SSRIstories.com at http://www.ssristories.com/show.php?item=1840

Posted by: Rosie C. at June 30, 2008 01:24 PM

Another case on www.SSRIstories.com involving Cymbalta is a case where a jury found a man "not guilty" of killing his wife due to Cymbalta induced insanity.

The whole tragic case can be read at:

http://www.ssristories.com/show.php?item=1783

Posted by: Rosie C. at June 30, 2008 01:29 PM
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