Tuesday, December 7, 2010

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

Posted by Princess Eva Angelica at 4:36 AM
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?

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