Tuesday, December 07, 2010

Pfizer's Latest Lyrica DTC Ad Should Be Cited By FDA as Misleading

Do you have "chronic widespread MUSCLE pain?" That's the question asked in a Lyrica direct-to-consumer (DTC) print Ad in a recent issue of Prevention magazine (see image below). "The answer may be over-active NERVES," says the ad. The implication is that Lyrica treats "muscle pain" caused by "over-active nerves."


Yet Lyrica is officially approved by the FDA "to treat Diabetic Nerve Pain, Pain after Shingles, and Fibromyalgia. LYRICA is also indicated to treat Partial Onset Seizures in adults with epilepsy who take 1 or more drugs for seizures." Neither "widespread MUSCLE pain" nor "Over-active NERVES" is mentioned in the approved labeling for Lyrica. And the National Institutes of Health (NIH) says that the causes of fibromyalgia are "unknown."

Pfizer even includes a diagram (left) showing how Lyrica "calms" the nerves, which "can provide significant relief from Fibromyalgia pain."

I think that all this is speculative hocus pocus that is not based on any reputable science at all! This is shameful coming from a company and an industry that promotes itself as being "science-based."

I'd like to see (1) references to scientific data, trials, etc. that supports Pfizer's hypothesis that fibromyalgia, aka "widespread muscle pain", is caused by "over-active NERVES" and (2) data to support the claim that Lyrica "calms" over-active nerves.

FDA "warning letters" often state that "Promotional materials are misleading if they suggest that a drug is useful in a broader range of conditions or patients than has been demonstrated by substantial evidence or substantial clinical experience." If Pfizer has no data to support the claims made in this ad, then the FDA should cite it as being misleading. That's my opinion. What do you think?

12 comments:

  1. Anonymous9:04 AM

    We have seen this type of indication expansion before by over-anxious product teams looking to expand sales. The agency should also take the hit for not making sure claims are absolutely cleared by legal. These types of actions continue to hurt the entire industry and punish the good as well as the bad.

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  2. Anonymous12:31 PM

    they site "overactive nerves" as the underlying cause of fibromyalgia - a common belief in the medical community. they are indicated for fibromyalgia... this is an MOA story for the brand - it reduces "extra signals" of damaged nerves in the brain thus reducing pain. that's how it works. i'm more curious what your motivation is to single out the odd communication and use words like "shameful" when describing those who've developed these pieces. and to the person who mentions the agency should "take the hit" for not passing this by legal - the only thing i can be sure of by your post is that you have a limited understanding (much like "Big Johnny Mack") of the process by which these items are created. it would be impossible for this piece to have been pushed out to the field without signoff from legal counsel. i don't work for pfizer nor an agency.

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  3. Perhaps it is a "common belief" among physicians that "overactive nerves" is the underlying cause of fibromyalgia, but where does this "belief"come from ? (1) EVIDENCE or (2) PFIZER? If there is no evidence, then shame on Pfizer for suggesting that there is.

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  4. Anonymous1:06 PM

    Before slinging mud you may want to find out the answer to that question yourself. You know what they say: "if 'ifs' and 'buts' were candies and nuts we'd all have a Merry Christmas!" You're taking pot shots with little merit. As a result your moral superiority in this case is embarrassing.

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  5. I know I am, but what are you?

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  6. Anonymous10:56 PM

    Well, to be fair, according to the CDC (http://www.cdc.gov/arthritis/basics/fibromyalgia.htm) "fibromyalgia is a syndrome predominately characterized by widespread
    muscular pains and fatigue" and the label indicates that Lyrica "is for the management of fibromylagia" but doesn't really detail what aspects of fibromyalgia, so let's assume muscle pains fall fairly under that umbrella. And if you look at the label, section 14.4, the trial describes pain reduction as measured by VAS (basically a patient reporting system, I believe) so it's likely patients would be reporting muscle pain reduction as well. I'm not a doc though so hope others will chime in on the trial data.

    Label info can be found here: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=31444#section-16.4

    That being said imho, they could have done w/o the artist's depiction of nerve activity reduction (I'll be interested to see how the FDA reacts to that); it's not really clear what the MOA is or how it ties to clinical efficacy (I don't think anyone understands that- it's pretty speculative), and I don't know what the heck "calming nerves" is supposed to mean. Also, the ad notes Lyrica is not an antidepressant but pregabalin has been found to be associated with reduced depression in some studies, so they might have been better off saying it hasn't been approved for the treatment of depression.

    So...this maybe less egregious than you thought but it did raise my eyebrows. I'll be curious to see what the FDA says, if it does weigh in.

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  7. On my FaceBook page (http://www.facebook.com/#!/pharmaguy), my friend Bruce grant advised that I call or write directly to the company with my inquiry..."not wait to be overheard." He also suggested that I check the Brief Summary page for references.

    I will try and contact Pfizer ppl today.

    In response to Anonymous's comment about "widespread muscle pains," I concede that the ad is not so egregrious on that score (ie, substituting "chronic widespread muscle pain" for the official indication, which is "fibromyalgia." But suggesting that this may be caused by "overactive nerves" and that Lyrica "calms" overactive nerves is really what we should focus on here. I have checked the Brief summary page and I do not find a reference to the claim that fibromyalgia (or chronic widespread muscle pain) is caused by overactive nerves or the claim that Lyrica "calms" overactive nerves.

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  8. Anonymous11:32 AM

    10 seconds on PubMed found the abstract below: Perhaps "nerve dysfunction" would have been a better choice of words than "overactive" in the ad, but I don't think it's as egregious as you make it out to be. At the very least there should be a bullet that the mechanism of action of Lyrica is unknown (or is there? You don't present the whole ad, which is a little misleading in itself).

    Neurologic signs and symptoms in fibromyalgia.
    Watson NF, Buchwald D, Goldberg J, Noonan C, Ellenbogen RG.

    Sleep Medicine Institute at Harborview, University of Washington, 325 Ninth Avenue, Seattle, WA 98104, USA. nwatson@u.washington.edu
    Abstract
    OBJECTIVE: To determine the type and frequency of neurologic signs and symptoms in individuals with fibromyalgia (FM).

    METHODS: Persons with FM (n = 166) and pain-free controls (n = 66) underwent systematic neurologic examination by a neurologist blinded to disease status. Neurologic symptoms lasting at least 3 months were assessed with a standard questionnaire. We used logistic regression to evaluate the association of neurologic symptoms and examination findings with FM status. Within the FM group we examined the correlation between self-reported symptoms and physical examination findings.

    RESULTS: Age- and sex-adjusted estimates revealed that compared with the control group, the FM group had significantly more neurologic abnormalities in multiple categories, including greater dysfunction in cranial nerves IX and X (42% versus 8%) and more sensory (65% versus 25%), motor (33% versus 3%), and gait (28% versus 7%) abnormalities. Similarly, the FM group had significantly more neurologic symptoms than the control group in 27 of 29 categories, with the greatest differences observed for photophobia (70% versus 6%), poor balance (63% versus 4%), and weakness (58% versus 2%) and tingling (54% versus 4%) in the arms or legs. Poor balance or coordination, tingling or weakness in the arms or legs, and numbness in any part of the body correlated with appropriate neurologic examination findings in the FM group.

    CONCLUSION: This blinded, controlled study demonstrated neurologic physical examination findings in persons with FM. The FM group had more neurologic symptoms than did the controls, with moderate correlation between symptoms and signs. These findings have implications for the medical evaluation of patients with FM.

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  9. OK. Now YOU do some more research that may take longer than 10 seconds: Who paid for this study?

    The correlation cited in this study does NOT prove that "overactive" nerves or "neurological symptoms" cause FM (ie, chronic widespread muscle pain).

    In any case, the main issue is EVIDENCE that Lyrica "calms" "overactive nerves," not whether or not FM is associated with neurological symptoms.

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  10. Anonymous12:25 PM

    "This work was supported by grant R01 AR 47678-01A1 from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (Dr. Buchwald)."

    You asked for "(1) references to scientific data, trials, etc. that supports Pfizer's hypothesis that fibromyalgia, aka "widespread muscle pain", is caused by "over-active NERVES" "

    While no single study "proves" anything, it does support their claim.

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  11. Anonymous3:27 PM

    john, please explain what credentials you possess or experience you have that would support the concept that you are an authority on the process of claims development or the clinical support necessary for a brand to marketed against them? you are now grasping at straws to uphold an argument that held no water to begin with. you've gone out of your way to create the appearance of impropriety where there was none. stick to identifying trends in marketing. Leave the scrutinizing of pharma messages to those at the FDA. i’ll not be returning to your uninformed, misguided blog.

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  12. I think what Pfizer was trying to avoid saying is, research shows that nerve dysfunction, typically cause by previous head or neck trauma, can compromise the function of the brain stem. The brain stem relays messages from the spinocerebellar tract (sending messages controlling extensor muscle function) to the brain. I invite the public to look at the evidence that gentle NUCCA chiropractic care has a much better chance of correcting nerve dysfunction, and therefore relieving fibromyalgia symptoms than Lyrica

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