$6 billion spent on "murky" ailment

WASHINGTON — Two drugmakers spent hundreds of millions of dollars last year to raise awareness of a murky illness, helping boost sales of pills approved as treatments and drowning out unresolved questions — including whether it's a real disease at all.

Key components of the industry-funded buzz over the pain-and-fatigue ailment fibromyalgia are grants — more than $6 million donated by drugmakers Eli Lilly and Pfizer in the first three quarters of 2008 — to nonprofit groups for medical conferences and educational campaigns, an Associated Press analysis found.

That's more than they gave for more accepted ailments such as diabetes and Alzheimer's. Among grants tied to specific diseases, fibromyalgia ranked third for each company, behind only cancer and AIDS for Pfizer and cancer and depression for Lilly.

Fibromyalgia draws skepticism for several reasons. The cause is unknown. There are no tests to confirm a diagnosis. Many patients also fit the criteria for chronic fatigue syndrome and other pain ailments.

Many doctors and patients say the drugmakers are educating the medical establishment about a misunderstood illness, much as they did with depression in the 1980s.

Textbook example

But critics say the companies are hyping fibromyalgia along with their treatments, and that the grantmaking is a textbook example of how drugmakers unduly influence doctors and patients.

"I think the purpose of most pharmaceuticalcompany efforts is to do a little disease-mongering and to have people use their drugs," said Dr. Frederick Wolfe, who was lead author of the guidelines defining fibromyalgia in 1990 but has since become one of its leading skeptics.

Between the first quarter of 2007 and the fourth quarter of 2008, sales rose from $395 million to $702 million for Pfizer's Lyrica, and $442 million to $721 million for Lilly's Cymbalta.

Cymbalta, an antidepressant, won Food and Drug Administration approval as a treatment for fibromyalgia in June. Lyrica, originally approved for epileptic seizures, was approved for fibromyalgia a year earlier.

Drugmakers respond to skepticism by pointing out that fibromyalgia is recognized by medical societies, including the American College of Rheumatology.

"I think what we're seeing here is just the evolution of greater awareness about a condition that has generally been neglected or poorly managed," said Steve Romano, a Pfizer vice president who oversees its neuroscience division.

The FDA approved the drugs because they've been shown to reduce pain in fibromyalgia patients, though it's not clear how. Some patients say the drugs can help, but the side effects include nausea, weight gain and drowsiness.

Advertising spending

The drugmakers' grant-making is dwarfed by advertisement spending. Eli Lilly spent roughly $128.4 million in the first three quarters of 2008 on ads to promote Cymbalta, according to TNS Media Intelligence. Pfizer spent more than $125 million advertising Lyrica.

But some say the grants' influence goes much further than dollar figures suggest. Such efforts steer attention to diseases, influencing patients and doctors and making diagnosis more frequent, they say.

"The underlying purpose here is really marketing, and they do that by sponsoring symposia and hiring physicians to give lectures and prepare materials," said Wolfe, who directs the National Data Bank for Rheumatic Diseases in Wichita, Kan.

Similar criticisms have dogged drugmakers' marketing of medicines for overactive bladder and restless legs syndrome.

Many of the grants go to educational programs for doctors that feature seminars on the latest treatments and discoveries.

The drug industry's grants also help fill out the budgets of nonprofit-disease advocacy groups, which pay for educational programs and patient outreach and also fund some research.

Group's lobbying

The National Fibromyalgia Association is a $1.5 milliona-year operation that has successfully lobbied Congress for more research funding for fibromyalgia. Forty percent of the group's budget comes from corporate donations, such as the funds distributed by Pfizer and Eli Lilly.

Pfizer gave $2.2 million and Lilly gave $3.9 million in grants and donations related to fibromyalgia in the first three quarters of last year. Those funds represented 4 percent of Pfizer's giving and about 9 percent of Eli Lilly's.

The message in company TV commercials is clear. "Fibromyalgia is real," proclaimed one Lyrica ad.

Researchers who've studied the condition for decades say it's not that simple.

The American College of Rheumatology estimates that between 6 million and 12 million people in the U.S. have fibromyalgia, more than 80 percent of them women.

It's not clear how many cases are actually diagnosed, but Dr. Daniel Clauw of the University of Michigan said pharmaceutical industry market research shows roughly half are undiagnosed. People with fibromyalgia experience muscle pain and other symptoms including fatigue, headache and depression.

After 30 years of studying the ailment, rheumatologist Dr. Don Goldenberg says fibromyalgia is still a "murky area."

"Doctors need labels and patients need labels," said Goldenberg, a professor of medicine at Tufts University. "In general, it's just more satisfying to tell people, 'You have X,' rather than, 'You have pain.' "