Fibromyalgia, defined as a chronic, widespread pain condition of unknown origin, is a controversial diagnosis. No biological tests exist to diagnose fibromyalgia, and the condition cannot be linked to any environmental or biological causes. While the Associated Press said that doctors agree that suffers' symptoms are real, they don't agree that a disorder called fibromyalgia is behind them. But real or not, there is obviously a huge market for fibromyalgia treatments.
Pfizer's Lyrica was the first prescription medication approved to treat fibromyalgia, though no one can explain exactly how it works. Lyrica was first approved to treat epilepsy. In 2004, the drug was reviewed by the Food & Drug Administration (FDA) as a remedy for diabetic nerve pain. According a New York Times report published last January, the reviewers recommended against approving the drug, citing its side effects. Lyrica causes weight gain and edema, or swelling, as well as dizziness and sleepiness.
But the FDA ignored the advice of Lyrica reviewers, and approved it anyway. Then Pfizer asked the FDA to expand the approved uses of Lyrica to include the treatment of fibromyalgia, and the agency did so in June 2007. According o the Times report, in clinical trials, patients taking Lyrica reported that their pain fell on average about 2 points on a 10-point scale, compared with 1 point for patients taking a placebo. About 30 percent of patients said their pain fell by at least half, compared with 15 percent taking placebos.
Pfizer’s success has encouraged other drug makers to seek approval for their own fibromyalgia drugs. Eli Lilly's antidepressant Cymbalta received such approval last June.
According to the Associated Press, both drug makers are spending big bucks to promote not only their drugs, but fibromyalgia as well. According to the report, key components of their marketing onslaught include more than $6 million in grants to nonprofit groups to pay for fibromyalgia medical conferences and educational campaigns. And that was only in the first three quarters of 2008, the Associated Press said. It's also more than the drug makers gave towards Alzheimer's Disease and diabetes, which are universally recognized as real diseases.
One doctor interviewed by the Associated Press called Eli Lilly's and Pfizer's fibromyalgia promotion efforts "disease mongering". That doctor, Frederick Wolfe, was lead author of the guidelines defining fibromyalgia in 1990, but now doubts the very existence of the disease.
Despite such concerns over the tactics used by Eli Lilly and Pfizer, they do seem to be working. According to the Associated Press, between the first quarter of 2007 and the fourth quarter of 2008, sales rose from $395 million to $702 million for Lyrica, and $442 million to $721 million for Cymbalta.
Following an FDA analysis of some 200 studies, it concluded patients taking the epilepsy drugs had nearly double the risk of suicidal thoughts or behaviors. Earlier this week, FDA officials proposed inclusion of the black box to force companies to issue new medication guides warning patients of potential risks. Eight of the 11 drugs showed an increased risk, while three did not; however, the FDA is proposing warnings on all of the drugs and possibly some older epilepsy drugs. Other drugs include Lamictal, valproate, oxcarbazepine (sold under the brand name Trileptal), Tegretol, tiagabine, zonisamide, levitiracetam, and felbamate. Of the 43,000 patients studied, 30 taking epilepsy drugs attempted suicide and four completed suicide.
Experts continue to urge the FDA to place some type of new warnings on the drugs. "We are looking at a signal that I feel is an important one for the field to be aware of," says Andrew Winokur, MD, a professor of psychiatry and psychopharmacology at the University of Connecticut Health Center.
The FDA’s proposal for a warning sparked controversy as soon as it was announced and the FDA was also criticized in 2005 after placing similar warnings on antidepressant medications when evidence suggested some of the drugs could lead to suicidal behavior. FDA critics said the warnings drove patients away from necessary treatment. The FDA later revised its warnings.
Some experts fear the FDA is making a similar move by suggesting broad warnings for drugs that may not have been studied or analyzed for suicide risk. "We have to be very careful about scaring the patients into not taking these drugs, and I think we have to be very thoughtful about that," says Rochelle Caplan, MD, a professor of psychiatry at University of California Los Angeles and a member of the expert panel. "Overwarning actually has the potential to negatively impact patient care," said Christopher Wholberg, a global medical team leader for Pfizer, which makes Lyrica and Neurontin.
Researchers remain unclear as to the cause of the link between epilepsy drugs and suicidal thought and behavior. "We don't quite know what the phenomenon we're looking at is," says Robert Temple, MD, director of the FDA's office of drug evaluation. "If something is important it gets noticed better if you put a box around it. It doesn't mean don't use this drug. It means pay attention," Temple says. FDA advisors disagreed, saying there was insufficient evidence to support stark warnings that could discourage patients and their doctors from using them. "That's put there to bring attention to it and it comes with a lot of baggage with it," says Larry Goldstein, MD, a professor of Medicine at Duke University and chair of the advisory panel.
Fibromyalgia, defined as a chronic, widespread pain condition of unknown origin, is a controversial diagnosis. While patients who complain of the disorder and their doctors insist that it is real, some in the medical community assert that fibromyalgia is not a real disease. Rather, they say that fibromyalgia is simply a physical response to stress, depression, and economic and social anxiety. No biological tests exist to diagnose fibromyalgia, and the condition cannot be linked to any environmental or biological causes. What’s more, those who dispute that such a disorder as fibromyalgia exists complain that the diagnosis of fibromyalgia itself worsens the condition by encouraging people to think of themselves as sick.
Lyrica is the first prescription medication approved to treat fibromyalgia. Because fibromyalgia patients typically do not respond to conventional painkillers like aspirin, Lyrica affects the brain and the perception of pain. Pfizer’s Lyrica, known generically as pregabalin, binds to receptors in the brain and spinal cord and seems to reduce activity in the central nervous system.
No one knows exactly how Lyrica works. But some say that Lyrica does not work well enough to have warranted its FDA approval. According to The New York Times, in clinical trials, patients taking Lyrica reported that their pain fell on average about 2 points on a 10-point scale, compared with 1 point for patients taking a placebo. About 30 percent of patients said their pain fell by at least half, compared with 15 percent taking placebos.
In 2004, Lyrica was reviewed by the FDA as a remedy for diabetic nerve pain. The reviewers recommended against approving the drug, citing its side effects. Lyrica causes weight gain and edema, or swelling, as well as dizziness and sleepiness. According to the New York Times, in 12-week trials, 9 percent of patients saw their weight rise more than 7 percent, and the weight gain appeared to continue over time.
But the FDA ignored the advice of Lyrica reviewers, and approved it anyway. Then Pfizer asked the FDA to expand the approved uses of Lyrica to include the treatment of fibromyalgia, and the agency did so in June. It was a good move for Pfizer. According to the New York Times, worldwide sales of Lyrica reached $1.8 billion in 2007, up 50 percent from 2006. Analysts predict sales will rise an additional 30 percent this year, helped by consumer advertising. During the first nine months of 2007, Pfizer spent $46 million on Lyrica ads.
Real or not, there is obviously a huge market for fibromyalgia treatments. Now Pfizer’s success has encouraged other drug makers to seek approval for their own fibromyalgia drugs. Eli Lilly has asked the FDA’s approval to market the antidepressant Cymbalta to treat fibromyalgia. Forest Laboratories is also seeking the same approval for milnacipran, an antidepressant sold in many countries, though not the United States. Approval of both for treating fibromyalgia pain is expected later this year.