NEW YORK (AdAge.com) -- Given that the disease might not even exist, pharmacy shelves are suddenly getting awfully crowded with treatment options for fibromyalgia.
Forest Laboratories and Cypress Bioscience are set to go to market this spring with a new drug called Savella on the heels of huge sales volumes for Lyrica and Cymbalta, drugs already on the market.
Savella was approved by the Food and Drug Administration in January and was scheduled to be available this month. But last week the companies delayed the introduction after they went back to the FDA for a minor change in the color of the tablets. The review period is four months, meaning Savella could be on the market by late May or early June.
No details are available on planned advertising. Frank Murdolo, Forest VP-investor relations, said only that sales forces from both companies have been assembled and trained, and the companies will co-market Savella.
The drug is real, but is the disease? That seems to be the conundrum.
No true tests
Fibromyalgia has been described as a complex chronic-pain illness that affects about 6 million Americans, mostly women. Some believe fibromyalgia is a misdiagnosis of another condition, in part because while there is no doubt that a patient's pain is real, the cause is sometimes unknown. There are no true tests to confirm the diagnosis, and the symptoms fit other ailments such as chronic fatigue syndrome.
A scathing 2008 article in The New York Times questioned the validity of fibromyalgia. Even the physician who served as the lead author in identifying fibromyalgia in 1990, Dr. Frederick Wolfe, has reversed his position. Mr. Wolfe, head of the National Data Bank for Rheumatic Diseases, now says fibromyalgia is not a disease but a condition that involves the body's reaction to stress and other factors.
As recently as last month, in an Associated Press story, Mr. Wolfe said, "I think the purpose of most pharmaceutical-company efforts is to do a little disease-mongering and to have people use their drugs."
Reached at his Wichita, Kan., research offices, Mr. Wolfe indicated to Ad Age that he indeed believes the purpose of industry efforts is to sell drugs, and the methods for doing this include convincing physicians and insurance companies that fibromyalgia is a real disease; increasing diagnosis by expanding the definition of fibromyalgia; and recruiting patients with MUS (medically unexplained symptoms) to the diagnosis and the treatment.
The pharmaceutical industry, he said, by emphasizing the best results of clinical trials and not addressing long-term effectiveness of treatment, seeks to induce currently diagnosed patients to switch to new and expensive therapies. Taken as a whole, Mr. Wolfe believes that an argument can be made that these activities are inherently corrupt and harmful to society.
Heavy marketing of drugs
He's not alone. Part of the criticism surrounding fibromyalgia is directed at drug companies for their heavy marketing of the treatments.
Eli Lilly made $2.7 billion in sales last year from Cymbalta. Pfizer earned $2.6 billion from Lyrica. Lilly spent $179 million in measured media last year to market Cymbalta, according to TNS Media Intelligence, and Pfizer spent $138 million on Lyrica -- a nearly 100% increase from the $72 million it spent in 2007.
Both were originally approved for other conditions -- Cymbalta for depression, Lyrica for epilepsy -- before receiving FDA approval to treat fibromyalgia.
Despite the controversy, fibromyalgia is recognized by the FDA, the National Institutes of Health, the American College of Rheumatology and most major insurance companies. "It's real," said Janis Nimori. Ms. Nimori, a U.S. Postal Service worker from Corinne, Utah, was one of 2,000 participants in the Savella clinical tries. She told Ad Age that critics of fibromyalgia should live a day in her shoes.
'I was in constant pain'
"You can't tell me it's just a symptom of something else," Ms. Nimori said. "I was in constant pain. Before [being diagnosed with fibromyalgia] I was given other medications. If my knee hurt, it was 'OK, take this.' If it was my back, it was 'OK, take this.' For me, it was a relief to know there was something I could attribute to why I hurt so much all the time."
Ms. Nimori said she was not affected by the marketing of Lyrica or Cymbalta, and fibromyalgia never entered her mind until it was diagnosed by her physician. She tried Lyrica for a day but had a reaction so severe she decided not to pursue that treatment.
Ms. Nimori said she is positive she received Savella in the blind clinical trial and not a placebo. "Before you go into the open study, you have to go three weeks without taking anything, and boy I'll tell you I felt terrible during those three weeks," she said. "Afterward, it helped significantly. It was like, 'Oh, thank you. That was very nice.'"
Ms. Nimori said she will continue to take Savella after it hits the market. "The Savella has helped," she said. "Has it cured me? I still have bad days. But the pain I had in my side, it's helped that significantly."