AP IMPACT: Drugmakers’ push boosts ‘murky’ ailment

By MATTHEW PERRONE, AP Business Writer Matthew Perrone, Ap Business Writer – Sun Feb 8, 11:41 pm ET

WASHINGTON – Two drugmakers spent hundreds of millions of dollars last year to raise awareness of a murky illness, helping boost sales of pills recently 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.

Experts don’t doubt the patients are in pain. They differ on what to call it and how to treat it.

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. Those with fibromyalgia have often had to fight perceptions that they are hypochondriacs, or even faking their pain.

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 pharmaceutical company 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.

AP – Fredrick Wolfe, Director of the National Databank for Rheumatic Diseases and one of the nation’s most … Whatever the motive, the push has paid off. 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. “And it’s mainly being facilitated by the fact the FDA has now approved effective compounds.”

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.

Helen Arellanes of Los Angeles was diagnosed with fibromyalgia in September 2007 and later left her job to go on disability. She takes five medications for pain, including Lyrica and Cymbalta.

“I call it my fibromyalgia fog, because I’m so medicated I go through the day feeling like I’m not really there,” Arellanes said. “But if for some reason I miss a dose of medication, I’m in so much pain.”

A single mother of three, Arellanes sometimes struggles to afford all her medications. She said she is grateful that a local Pfizer sales representative occasionally gives her free samples of Lyrica “to carry me through the month.”

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 Inc. 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.

Pfizer says it has no control over which experts are invited to the conferences it sponsors. Skeptics such as Wolfe are occasionally asked to attend.

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.

“If we have a situation where we don’t have that funding, medical education is going to come to a screeching halt, and it will impact the kind of care that patients will get,” said Lynne Matallana, president of the National Fibromyalgia Association.

Matallana founded the group in 1997 after she was diagnosed with fibromyalgia. A former advertising executive, Matallana said she visited 37 doctors before learning there was a name for the crushing pain she felt all over her body.

A decade later, her patient advocacy group is a $1.5 million-a-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, the AP found. Those funds represented 4 percent of Pfizer’s giving and about 9 percent of Eli Lilly’s.

Eli Lilly, Pfizer and a handful of other companies began disclosing their grants only in the past two years, after coming under scrutiny from federal lawmakers.

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.

Since the 1970s, Wolfe and a small group of specialists have debated the condition in the pages of medical journals. Depending on whom you ask, it is a disease, a syndrome, a set of symptoms or a behavior disorder.

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 widespread 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.'”

While Goldenberg continues to diagnose patients with fibromyalgia, some of his colleagues have stopped, saying the condition is a catchall covering a range of symptoms.

Dr. Nortin Hadler says telling people they have fibromyalgia can actually doom them to a life of suffering by reinforcing the idea that they have an incurable disease.

“It’s been shown that if you are diagnosed with fibromyalgia, your chances for returning to a level of well-being that satisfies you are pretty dismal,” said Hadler, a professor at the University of North Carolina, who has occasionally advised health insurers on how to deal with fibromyalgia.

Hadler said people labeled with fibromyalgia are indeed suffering, not from a medical disease but from a psychological condition. Instead of drugs, patients should receive therapy to help them “unlearn” their predicament, he said.

Research by the University of Michigan’s Clauw suggests people with fibromyalgia experience pain differently because of abnormalities in their nervous system. Brain scans show unusual activity when the patients experience even minor pain, though there is no abnormality common to all.

Clauw’s work, however, illustrates the knotty issues of drug company funding. He has done paid consulting work for the drugmakers, and he’s received research funding from the National Fibromyalgia Research Association, which receives money from the drugmakers.

While Clauw acknowledges that Lyrica and Cymbalta do not work for everyone, he has little patience for experts who spend more time parsing definitions than helping patients.

“At the end of the day I don’t care how you categorize this — it’s a legitimate condition and these people are suffering,” Clauw said.

AP CEO urges better press access to military ops

• By JOHN HANNA, Associated Press Writer John Hanna, Associated Press Writer – Fri Feb 6, 7:09 pm ET
• AP – Tom Curley, president and chief executive of The Associated Press, speaks during the William Allen White …

LAWRENCE, Kan. – The Bush administration turned the U.S. military into a global propaganda machine while imposing tough restrictions on journalists seeking to give the public truthful reports about the wars in Iraq and Afghanistan, Associated Press chief executive Tom Curley said Friday.

Curley, speaking to journalists at the University of Kansas, said the news industry must immediately negotiate a new set of rules for covering war because “we are the only force out there to keep the government in check and to hold it accountable.”

Much like in Vietnam, “civilian policymakers and soldiers alike have cracked down on independent reporting from the battlefield” when the news has been unflattering, Curley said. “Top commanders have told me that if I stood and the AP stood by its journalistic principles, the AP and I would be ruined.”

Curley said in a brief interview that he didn’t take the commanders’ words as a threat but as “an expression of anger.” Late in 2007, Curley wrote an editorial about the detention of AP photographer Bilal Hussein, held by the military for more than two years.

Eleven of AP’s journalists have been detained in Iraq for more than 24 hours since 2003. Last year, according to cases AP is tracking, news organizations had eight employees detained for more than 48 hours.

AP, the world’s largest newsgathering operation, is a not-for-profit cooperative that began in 1846 to communicate news from the Mexican War. Curley has been the company’s president and CEO since 2003.

Before his speech, Curley met for about a half-hour with Lt. Gen. William Caldwell IV, a former spokesman for the U.S. military in Iraq. Caldwell is commander at Fort Leavenworth, Kan., where military doctrines are drafted and a staff college trains both American and foreign officers.

“It’s important for us to be very transparent,” Caldwell said during an interview after Curley’s speech. “If we do those things, ultimately, we’re both trying to do the same thing.”

Curley came to the University of Kansas to receive this year’s national citation for journalistic excellence from the William Allen White Foundation. Curley also won national awards in 2007 and 2008 for his work on First Amendment and open records issues.

Answering questions from his audience of about 160 people, Curley said AP remains concerned about journalists’ detentions. He said most appear to occur when someone else, often a competitor, “trashes” the journalist.

“There is a procedure that takes place which sounds an awful lot like torture to us,” Curley said. “If people agree to trash other people, they are freed. If they don’t immediately agree to trash other people, they are kept for some period of time — two or three weeks — and they are put through additional questioning.”

His remarks came a day after an AP investigation disclosed that the Pentagon is spending at least $4.7 billion this year on “influence operations” and has more than 27,000 employees devoted to such activities. At the same time, Curley said, the military has grown more aggressive in withholding information and hindering reporters.

Curley said a military program to embed reporters with battlefield units in Iraq was successful in 2003, the war’s first year. But afterward, the military expanded its rules from one to four pages, and Curley said they’re now so vague, a journalist can be expelled on a whim if a commander doesn’t like what’s being reported.

“Americans understand hardships and setbacks,” he said. “They expect honest answers about what’s happening to their sons and daughters.”

Caldwell now requires officers who attend Fort Leavenworth’s staff college to blog and “engage” the media. “Not only when it’s good stuff, but when it’s challenging,” Caldwell said.

Curley acknowledged that upon taking office, President Barack Obama rolled back many of the policies instituted by George W. Bush. But he said when the Pentagon faces difficulties again — perhaps in Afghanistan, with the new administration’s focus on it — experience has shown, “the military gets tough on the journalists.”

“So now is the time to re-negotiate the rules of engagement between the military and the media,” he said. “Now is the time to insist that the First Amendment does apply to the battlefield.”

He added: “Now is the time to resist the propaganda the Pentagon produces and live up to our obligation to question authority and thereby help protect our democracy.”

Curley said examining the Defense Department’s spending on its public relations efforts and psychological operations is difficult because many of the budgets are classified.

He said the Pentagon has kept secret some information that used to be available to the public, and its public affairs officers at the Pentagon gather intelligence on reporters’ work rather than serve as sources.

Curley traced the propaganda efforts to former Defense Secretary Donald H. Rumsfeld. He cited a 2003 operations “road map” signed by Rumsfeld, declaring that psychological operations had been neglected for too long. Curley also noted that the current secretary, Robert Gates, has defended such efforts, including in a speech at Kansas State University in 2007.

“But does America need to resort to al-Qaida tactics?” Curley said. “Should the U.S. government be running Web sites that appear to be independent news organizations?” Should the military be planting stories in foreign newspapers? Should the United States be trying to influence public opinion through subterfuge, both here and abroad?”

He also said the Bush administration had stripped hundreds of people, including reporters, of their human rights. He noted that when an Iraqi judicial panel reviewed the evidence gathered by the military against Hussein, the AP photographer, it ordered his release. He declined in an interview to say who said AP could be “ruined” for sticking to its principles, but “I knew that they were angry.”

“This is how you improve the standing of America around the world, by taking the universal human rights we enjoy as Americans and ensuring them for everyone,” Curley said in his speech.

Both the award Curley received at the University of Kansas and its journalism school are named for White, who was publisher of the Emporia Gazette until 1944. A Pulitzer Prize winning editorial writer, White’s commentary and friendships with prominent Americans made him a national figure.

“There’s no doubt that White would have been angered by the last eight years,” Curley said. “The right to access information and the ability to know the source of that information were diminished.”

___

Associated Press writer John Milburn also contributed to this report.