By Shaun Hittle
Pfizer’s new television commercial for the medication Lyrica, features a middle-aged woman who says that her Fibromyalgia (FMS) is real and that she can now live without pain thanks to the medication.
The advertisement for the first FDA approved medication for Fibromyalgia is aimed at making two arguments: that Fibromyalgia is a real condition, and that Lyrica can lessen its symptoms.
Some critics, however, still argue that Fibromyalgia is not a real medical condition and that consumers need to be skeptical of claims made by pharmaceutical companies.
As defined by the National Fibromyalgia Research Association, Fibromyalgia is a pain disorder characterized by sleep problems and pain and stiffness in numerous sites of the body. Estimates regarding the prevalence of this illness vary, but advocacy groups put the total number of sufferers for FMS at roughly six million in the US.
While the condition is accepted by insurance companies and well-known medical organizations, controversy regarding the existence of the disease still exists. In a recent NY times article, Dr. Frederick Wolfe, who authored the 1990 paper that was the first to establish parameters for FMS, was quoted as refuting his earlier claims that FMS was a real illness. “Some of us in those days thought we had actually defined a disease, which this is clearly not,” said Wolfe in the article.
However, as sales for the drug soar, the public and many in the medical community seem to be buying both of Pfizer’s arguments. Fourth quarter sales as reported by Pfizer for Lyrica, which was approved for the treatment of FMS in the summer of 2007, totaled $564 million; a 60 percent increase from the previous quarter, and annual sales of Lyrica totaled $1.8 billion in 2007 (Lyrica is also used for other medical conditions but Pfizer does not detail sales in terms of reason for prescribing).
Trial Results
In clinical trials for Lyrica, patients experienced a decrease in pain by an average of two points on a ten point scale, compared to an average of one point for placebo, and 30 percent of patients reported a pain decrease by half, compared to 15 percent taking placebo.
Despite these results and FDA approval of Lyrica, patient and consumer advocates argue that consumers need to be cautious about claims made by the local pharmaceutical giant.
Dr. Larry Sasich, a pharmacologist at the Lake Erie College of Osteopathic Medicine (LECOM) and former employee of the consumer watchdog, Public Citizen, warns the public that the information they get in 30 second TV commercials is not the entire story when it comes to a drug, its side effects, or its effectiveness.
“People need to have more information,” said Sasich, noting that physicians should be spending more time reviewing the complicated clinical trials and determining their effectiveness. This, according to Sasich, will provide a buffer between the pharmaceutical industry’s claims and more concrete scientific data and research.
But the bottom line for those suffering from FMS, is that the drug’s approval means some hope for alleviating the symptoms.
Sharon Waldrop, President of the Fibromyalgia Association of Michigan, says that her organization welcomes the new drug and hopes other medications might also soon be approved for the illness. “Finally there is a medication that is specifically shown to help treat pain and disturbed sleep patterns patients experience with fibromyalgia,” said Waldrop.
Pfizer’s advertising track record
For those embracing Pfizer’s claims that Lyrica can treat fibromyalgia, a closer look at Pfizer’s track record regarding their advertising of medications may cause consumers to proceed with caution when deciding whether or not to start taking Lyrica.
Consumer’s International, an international consumer watchdog, has compiled a long list on their website detailing Pfizer’s past history of claims by consumers and industry professionals about false and inaccurate advertising. Included in this list is Pfizer’s guilty plea for falsely marketing the epilepsy drug, Neurontin, for off label uses and Pfizer’s claims about Zoloft’s ability to reduce the likelihood that patients would harm themselves, though actual studies showed the opposite.
Lynne Matallana, President of the National Fibromyalgia Association and a sufferer of FMS, says that she does not have concerns about Pfizer’s advertising or the process by which Lyrica was tested. “It a very rigorous process,” said Matallana regarding the required FDA trials.
For those suffering from FMS and for Pfizer, Dr. Sasich’s recommendation for consumers wanting to try new medications might be difficult to follow: avoid using any new drug until it’s been on the market for at least seven years.
Pfizer Spokes-person Stephen Borboroglu, however, con- tends that Lyrica has already been used by seven million patients worldwide since its first approval by the European Union in 2004. “Numerous credentialed experts in the filed have presented data on Lyrica’s efficacy and safety in several peer-reviewed forums…” said Borboroglu, further explain- ing Pfizer’s stance that Lyrica is a safe and effective medication.
Sasich’s statement also gets a strong reaction from Matanalla: “That’s insane…The large majority of people are not going to wait seven years,” Matanalla said
http://www.kalamazooweekly.com/archive.php?id=103
g per night versus placebo in patients with fibromyalgia (FM). SXB is the sodium salt of γ-hydroxybutyrate (GHB). GHB is an endogenous compound, synthesized from γ-aminobutyric acid (GABA) and found broadly in the central nervous system and body. Among 548 randomized patients, a 
30% reduction in pain was experienced by 54.2% and 58.5% of patients treated with SXB 4.5 and 6