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

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?

Do We Really Need a Date Rape Drug Marketed for Fibromyalgia?

Do We Really Need a Date Rape Drug Marketed for Fibromyalgia?

Xyrem -- Jazz Pharmaceuticals Inc.’s narcolepsy drug -- is safe and effective, said FDA, which is weighing whether to approve the drug for treating fibromyalgia. Xyrem's active ingredient is Gamma hydroxybutyrate (GHB), a chemical linked to date rape (see "Date Rape Drug May Soon Be Approved for Fibromyalgia!").

Just what the world needs -- another drug to treat Fibromyalgia! Fibromyalgia is "a poorly understood pain condition which is believed to affect three to six million Americans, mostly women," according to an article in the Wall Street Journal.

There are already several drugs on the market in the US for treating fibromyalgia, including Lilly's Cymbalta (see "Cymbalta: A Sweet ROI for Chronic Pain Indication") and Pfizer's Lyrica (see "Battered Woman Imagery in Pfizer's New Fibromyalgia Ad").

It appears that PAIN -- even "poorly understood" pain -- is the holy grail of indications for a variety of drugs seeking a boost in sales. Not only are we becoming a nation of people suffering more pain than any other, we are allowing dangerous drugs onto the market and NOT adequately policing their illegal use and abuse.

You only have to look at how Oxycontin is being abused by our children to realize that these drugs are very profitable to physicians who are engaged in illegal trafficking. Because there will always be unscrupulous physicians who distribute these drugs illegally, no "restricted distribution program," no matter how onerous, will prevent these drugs from reaching our children.

We certainly don't need GHB (aka Xyrem) promoted heavily on TV as are Cymbalta and Lyrica. It won't be long before every college kid realizes that there is a new and easier way to obtain the date rape drug. It's not easy to obtain a drug to treat narcolepsy from a physician. That condition is so rare and confined to a specific group of people that even an unscrupulous physician would not risk prescribing it too freely. But it is easy to prescribe a drug for fibromyalgia, that anyone can complain to suffer from.

Luckily, fibromyalgia is currently thought to affect mostly women and if many college-age men try to get prescriptions, red flags might go up. However, men's pain is an overlooked marketing target and I predict it won't be long that you'll see men in commercials who suffer from fibromyalgia and encouraged to "see their doctors."

IMHO, the unintended (?) consequence of marketing Xyrem under that scenario is more abuse, more date rape, and more college kids being swept up into our prisons.