Overstated Claims Hurt: Cymbalta Ad Is Skewered
12 CommentsBy Ed Silverman // January 3rd, 2008 // 9:26 am
One night while watching TV, Glen Spielmans noticed a ‘Depression Hurts’ ad, which is part of the marketing campaign for Lilly’s Cymbalta, and was struck by what he saw. “I thought the claim that Cymbalta not only alleviated depression but also physical pain for depressed patients was a bit on the incredible side, so I thought I’d see if their claims were supported by data,” he tells us.
And so the psychology professor at Metropolitan State University in St. Paul, Minnesota, conducted a meta-analysis of five published studies that examined Cymbalta and pain relief in depressed patients. What did he find? Overstated claims, he says, as well as incomplete reporting - Lilly, he argues, didn’t provide summaries of all relevant data in three of their trials, which runs counter to the drugmaker’s contention that it maintains a transparent policy toward disclosing all clinical trial data.
“The results indicate a very small and statistically nonsignificant analegesic effect…Additionally, some of the relevant data on (Cymbalta’s) effects have not been reported fully, making it likely that the obtained results reflect an overestimate of its true impact on painful physical symptoms in depression,” he wrote in Psychotherapy and Psychosomatics (here’s the study). “Based upon the currently available evidence, the marketing of (Cymbalta) as an antidepressant with analgesic properties for people with depression does not appear to be adequately supported.”
“This is misleading advertising,” says Spielmans.
A Lilly spokeswoman wrote back to say the drugmaker follows “good promotional practices and promote our products based on claims that we can support from our data,” and that Lilly discloses publicly all research that is “significant,” whether favorable or unfavorable.” She didn’t specifically address his charge, though, that some summaries weren’t disclosed at the time he conducted his research.
The spokeswoman also maintains “clinical trial results show Cymbalta is effective in treating the broad range of depression symptoms, including the painful physical symptoms.” However, she didn’t contend that Cymbalta has a clinically significant impact on treating pain in depressed patients.
The Lilly spokeswoman then criticized Spielmans’ analysis, charging he misinterpreted and, therefore, excluded certain scales. “He also mixed clinical trials that had very different study designs that normally would not be grouped together in such a study,” she writes. “In addition, Dr. Spielmans chose to analyze only five of the nine publicly available duloxetine trials in depressed patients with pain data.”
For his part, Spielmans tells us that he “did not mix studies with drastically different designs. Each study in the meta-analysis examined the effects of (Cymbalta) versus placebo and/or paroxetine (Paxil) in treating pain in patients with depression. This criticism is not valid. It would appear that Lilly has not read my meta-analysis. As stated in my article, two studies were excluded from analysis because they failed to provide sufficient data. I believe that two studies have been published since my meta-analysis went to press. That adds up to nine studies.
“If it is ‘good promotional practice’ to promote Cymbalta as alleviating pain in depression based on a meager and borderline statistically significant effect over placebo, then I suppose good promotional practice is being followed.”
Despite such criticisms, Lilly’s Cymbalta advertising garnered an ‘All-Stars Large Pharma Marketing Team’ award from Medical Marketing & Media. You can read about that here.
Hat tip to WSJ Health Blog and Furious Seasons
Mike L
Most likely, this advertising is designed to prime the market for Cymbalta’s fibromyalgia indication. There are many patients who suffer from both depression and fibro . . . Lilly wants these patients. Is it a coincidence that the “Depression Hurts” marketing campaign began around the same time that Pfizer started promoting Lyrica for fibro? You be the judge.
John Mack
I pointed out last February that the Cymbalta ads were making misleading claims about pain. See http://pharmamkting.blogspot.com/2007/02/egad-how-i-learned-to-stop-worrying-and.html where I said “Lilly’s clever ‘depression hurts’ marketing campaign, IMHO, is based on an indication — ie, pain associated with depression — for which Cymbalta is NOT approved.”
Lisa Van S
New Slogan: Depression may hurt,.. But Cymbalta Kills.
James
Since Cymbalta is not indicated for pain during depression, and since these ads have been running for years, why hasn’t DDMAC issued a sternly worded letter lecturing them?
What? You mean the FDA is unable to protect us at every turn? I’m shocked, shocked to learn that there’s gambling going on at Rick’s Cafe!
So then, if the FDA is asleep at the switch on this one, why do we assume that they should be the all-knowing, all powerful arbiters of all drug indications (off-label) and safety risks (preemption)? Why do we believe that if we simply force disclosure (conflicts of interest), give them more power (off-label again and many other discussions) or throw more money at them (myriad funding bills) that will fix everything?
When will the LVS’s of the world realize that we will *never* be able to trust that the gov’t can take care of us, and start researching what we put in our bodies? How hard is it to read information from all sources, talk to your doctor, synthesize all these data, and then take responsibility for what we put in our bodies?
Getting off the soapbox now. Happy New Year!
Laurie
“How hard is it to read information from all sources, talk to your doctor, synthesize all these data, and then take responsibility for what we put in our bodies?”
For some of us, not hard at all. For the eighty year old without a computer…impossible.
Bottom line is that if we can’t trust the FDA, then why are they there? Most assume that FDA approval means safe drug and take that drug with that reassuring stamp of approval. Sadly, we have learned that this isn’t the case. Major reform is needed.
Dan
What stuck out in this post with me is the spokesperson stating that the claim is, “supported from OUR data”. A bit of a conflict there?
Furthermore, promotional claims through various sources do not get analyzed and approved by anyone outside the drugmaker until an issue is raised. It is at that time that such embellishments are removed from being viewed by others.
Yes, I believe there is real physical pain associated with depression, as well as other types of pain. So I’m quite vexed with deceptions such as this.
henry
The FDA do not need additional funding to watch TV.
yet another example of drug companies misleading the public while the FDA sit and watch, literally.
Justice in Michigan
Re: the FDA’s role, I guess my view is somewhere between James’ and Laurie’s. I agree major reform (and a willingness of regulators to act) are needed. It is also the case that, as I’ve said elsewhere here, without self-regulation by companies, we would need a Stalinist-sized FDA to cover the waterfront, and it wouldn’t - it would just become more corrupt than anything we’ve seen.
Even with the newest reporting requirements, it remains - and will inevitably remain - easy for companies to “comply” in letter but continue to play cat & mouse in a hundred ways. Patients/consumers have even less access than FDA to data which remains concealed, camoflaged, delayed, or denied in all the ways that can happen.
That is why - notwithstanding all its own warts - I think civil liability remains a critical piece of the puzzle (not the answer; just better than FDA exclusively (preemption)).
Preemption would cover any false advertising liability, btw, since they are part of the “labeling” in FDA regulations.
sid
WHAT!!! Something on TV not quite what the ad says — get out! I am sitting in my house, just ate a great meal of melted cheese sandwich maker sandwich, and a silver bullet shake. I washed it down with 8 ounces of avacado-kiwi-lemon juice.
Over the last week, I have met six new women interested in me! I saw something about $3/minute, but that can’t be right, they girls were hot and wanted me! Yesterday I lost 68 pounds, while sitting on the couch. Today my project is to “Bedazzle” all of my clothes for my date this weekend.
And I started a miracle drug that will cure all of my problems with 1 easy dose/day.
For real, you think people who see TV commercials believe everything they see? Luckily it looks like some drugs don’t work on this population anyway - http://www.pharmalot.com/2008/01/jj-schizo-drugs-dont-treat-aggression-study/
Donna
Sid,
I’m Bedazzled by your humor, Love it..:)
Connie
Ya know - I agree with Sid and am very skeptical of the Pharms and I really don’t like the fact that they can advertise on tv. But, I’ve had Fibromyalgia for about 20 years now and Cymbalta is the first of a multitude of antidepressants that the doctors prescribed that did anything for me. I normally toss and turn at least 30 times a night with pain and that just about went away with Cymbalta. I slept through the night better than I have for years.
What I don’t like about it is that it really diminishes emotion, and since my problem is not depression I really don’t care to feel like a zombie – I like a good cry at sad movies!!
Weird – they are just airing the ad right now while I’m writing this.
Tiffany
Cymbalta is an evil killer designed by sub humans calling themselves doctors but secretly inslaved to satin. This life is not easy, but for Heavens sake, If you or a loved one feels sad or depressed…. the only cure is to change your thoughs and you will change how you feel. Sure it requires dicipline but it is the only alternitave to death or sucide. IF I WOULD HAVE NOT REBELLED AGAINST PROFESSIONAL PHYSICIANS AND THE PILLS THEY WERE PUSHING OFF ON ME I WOULD BE DEAD! I DONT CARE WHO YOU ARE OR HOW BAD IT GETS, DOCTORS ARE NOT IN A POSITION TO CRITIQUE A DRUG BECAUSE THEY DID NOT MAKE IT AND THEY HAVE NOT TAKEN IT, THEY ONLY TELL YOU “IT IS GOOD AND IT WILL WORK” BECAUSE THEY WANT YOUR MONEY AND THEY WANT YOUR DEPENDANCE ON DRUGS SO THEY CAN ENSLAVE YOU TOO. YOUR SO CALLED PROBLEM BECOMES MORE COMPLICATED AND YOU END UP DEAD. AND THEY CASH IN AND TAKE ON THIR NEXT VULNURABLE VICTUM.
MY BEST FRIEND DIED A COUPLE MONTHS AGO AND SHE IS DEAD BECAUSE OF THIS DRUG, AND ALL SHE REALLY HAD WAS A BROKEN HEART, THAT SHE WOULD HAVE SURVIVED. DO NOT BECAOME A VICTUM OF THIS KILLER, IF YOU DONT FEEL GOOD FIND GoD hE IS THE ONLY HEALER OF ALL THINGS. hE IS THE ONLY WAY!
FOR GODS SAKE PARENTS AND GUARDIANS DO NOT BE FOOLLED , DO NOT ALLOW YOUR CHILDREN YOUR INNOCENT CHILDREN TO INJEST THIS POISION THAT WE HAVE BEEN SCRIPTED TO BELIEVE WILL HELP THEM. 98 % OF DOCTORS ARE QUACKS AND THEY ARE BRAINWASHED BY SOCIETY AND THE MEDIA, YOU CANNOT TRUST THEM , YOU HAVE TO TAKE RESPONSIBILITY AND PROTECT YOUR LOVED ONES AT ALL AGES.