Health

Advertising: When a Corporate Donation Raises Protests

WHEN the Columbus Children’s Hospital agreed to name a new lobby after two retail chains to thank their corporate parent for a $5 million donation, everyone was all smiles. The same was true when the Ohio hospital renamed itself Nationwide Children’s Hospital, to acknowledge a $50 million gift from Nationwide insurance, a large local company.

But a coalition of children’s advocates contends that the hospital went too far by agreeing to name a new emergency department and trauma center after another locally based retailer, Abercrombie & Fitch, in exchange for a $10 million donation.

The coalition, which includes the Campaign for a Commercial-Free Childhood, several pediatricians and Parents for Ethical Marketing, is asking the hospital to reconsider the decision made in June 2006 to accept the donation. The plea is being made now because ground is to be broken this year for the building to house the emergency and trauma facilities.

The 15 organizations and 80 individuals that compose the coalition contend that naming the new center after Abercrombie & Fitch — known for provocative advertising and revealing clothing — sends a grievously wrong message.

“It is troubling that a children’s hospital would name its emergency room after a company that routinely relies on highly sexualized marketing to target teens and preteens,” the members of the coalition wrote in a letter that was sent on Tuesday to the hospital’s office in Columbus, Ohio.

“The Abercrombie & Fitch Emergency Department and Trauma Center marries the Abercrombie brand to your reputation,” said the letter, addressed to five senior officers of the hospital. “A company with a long history of undermining children’s well-being is now linked with healing.”

The complaint is an example of negative reaction to the increasingly prevalent practice of naming public facilities after corporate sponsors, donors and supporters.

Opponents who complain about the growing commercialization of the American culture are upset that private companies are able to brand stadiums, parks, schools, school buses and hospitals.

About a dozen hospitals across the country bear corporate or sponsor names, including at least two other children’s hospitals: Mattel Children’s Hospital U.C.L.A. in Los Angeles and Hasbro Children’s Hospital, the pediatric division of Rhode Island Hospital in Providence.

Naming a facility for Abercrombie & Fitch “is more egregious,” said Susan Linn, the director of the Campaign for a Commercial-Free Childhood in Boston, because of the reputation of the retailer as “among the worst corporate predators” for “sexualizing and objectifying children.”

“Selling corporate naming rights is a slippery slope, and this is way down that slope,” said Ms. Linn, who is also the associate director at the media center at Judge Baker Children’s Center, an affiliate of the Harvard Medical School.

The sex-drenched images of toothsome young men and women that Abercrombie & Fitch has used for years to sell its own-brand apparel in ads, posters and catalogs have made the company and its chief executive, Michael S. Jeffries, billions of dollars — and countless enemies.

The opponents of the company’s campaigns, which are typically shot by the fashion photographer Bruce Weber, contend they cross the line by presenting undressed teenagers and 20-somethings in overly sexualized situations. The company describes its ads as playful and celebratory of the free spirit of today’s young Americans.

Last month, the police in Virginia Beach, Va., removed two large posters — part of the chain’s national campaign — from the windows of an Abercrombie store in a mall and charged the manager with an obscenity misdemeanor. One poster showed a woman with a breast mostly exposed and the other displayed three shirtless young men, one of whom was also revealing part of his backside.

The city of Virginia Beach subsequently decided against prosecuting the store manager.

Other times, however, the opponents of the Abercrombie approach have prevailed; in 2003, the company discontinued its popular magazine-style catalog, A.& F. Quarterly, because of mounting complaints from parents about its racy contents.

And a year later, the company, based in New Albany, Ohio, agreed to pay $50 million to settle a suit that accused it of discriminating against minority employees for promotions and cultivating a white-only image.

As for the coalition’s protests against the hospital naming, Tom Lennox, a spokesman at Abercrombie & Fitch, said on Tuesday, “We are proud of our longstanding relationship with the hospital and pleased to help secure its bright future.”

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A call from a reporter to Nationwide Children’s Hospital for a response to the letter from the coalition was returned by Jon M. Fitzgerald, the president of the Nationwide Children’s Hospital Foundation.

“I like to focus on the philanthropy of it,” Mr. Fitzgerald said, adding, “I don’t feel comfortable addressing” any of the objections raised in the letter.

“Two years ago, Abercrombie & Fitch made a very significant philanthropic gift,” Mr. Fitzgerald said. “In honor of that gift, we chose to offer recognition of their tremendous support of our organization.”

Mr. Fitzgerald took issue with a contention in the letter that the hospital agreed to “sell naming rights” to Abercrombie & Fitch in exchange for the $10 million.

“We don’t sell naming rights,” Mr. Fitzgerald said. “We as a nonprofit accept gifts to support our mission. We’re looking for philanthropic support.”

The ground-breaking for the building in which the facilities are to be housed will probably take place in late fall, he added, with completion scheduled in 2012. The new lobby, to be named after the Limited Too and Justice retail chains owned by Tween Brands, also will be in the new building.

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Abercrombie & Fitch has been a frequent target of criticism from organizations and activists like those that wrote the letter. They also include the National Institute on Media and the Family, Teachers Resisting Unhealthy Children’s Entertainment and Dr. Alvin F. Pouissant, the nationally known professor of psychiatry at the Harvard Medical School.

One school of thought holds that complaints from parents and the establishment only elevate the brand’s appeal with the target audience.

“There’s always a ‘forbidden fruit’ aspect to what adolescents do; that’s probably why they smoke,” said Dr. Victor Strasburger, professor of pediatrics at the University of New Mexico School of Medicine, who also signed the letter. A main goal of the letter is “trying to influence the decision-makers at children’s hospitals to act responsibly,” Dr. Strasburger said. “We’ve reached a point in our society where it seems there’s no such thing as bad publicity,” he added. “We have to pull back from that.”

Lilly Waited Too Long to Warn About Schizophrenia Drug, Doctor Testifies

ANCHORAGE — Eli Lilly, the drug maker, could and should have warned physicians as early as 1998 about the link between Zyprexa, its best-selling schizophrenia medicine, and diabetes, an expert witness told jurors Friday in a lawsuit that claims that Zyprexa has caused many mentally ill people to develop diabetes.

Instead, Lilly hid Zyprexa’s risks from doctors to protect the drug’s sales, according to the witness, Dr. John Gueriguian. Lilly waited until 2007 to add strong warnings to Zyprexa’s label to reflect the drug’s tendency to cause severe weight gain and blood sugar changes.

Lilly put “profit over concern of the consumer,” Dr. Gueriguian said Friday near the end of four hours of testimony.

Zyprexa, a drug for schizophrenia and bipolar disorder, is by far Lilly’s top-selling product, with worldwide sales of $4.8 billion last year.

The company has said it did nothing wrong and fully disclosed what it knew about Zyprexa to the Food and Drug Administration.

Dr. Gueriguian is testifying on behalf of the State of Alaska, which has sued Lilly to recover its costs for treating Medicaid patients who developed diabetes after taking Zyprexa. The trial is being heard in state court in downtown Anchorage before a jury of seven women and five men.

Dr. Gueriguian is a specialist on diabetes and was a medical reviewer for the Food and Drug Administration for 20 years before retiring in 1998.

At the F.D.A., he recommended against the approval of Rezulin, a diabetes drug that was later withdrawn for causing severe liver damage in patients.

Under examination by Tommy Fibich, a lawyer from Houston who is representing Alaska, Dr. Gueriguian methodically reviewed about a dozen documents in which Lilly scientists and executives discussed the potential links between Zyprexa and diabetes.

Zyprexa was introduced in September 1996 and hailed as a breakthrough medicine for the treatment of schizophrenia.

But doctors quickly began to report to Lilly that patients suffered severe weight gain, high blood sugar and even diabetes after taking the drug.

By the fall of 1998, the combination of adverse-event reports, clinical trial data that showed hyperglycemia and weight gain, and problems in animal studies should have been enough for Lilly to warn doctors about Zyprexa’s links to diabetes, Dr. Gueriguian said. Instead, the company did nothing.

Documents from 1999 and 2000 also showed that Lilly was accumulating evidence of Zyprexa’s risks but not sharing it with doctors, he testified.

And in 2002, only 10 months after Lilly began selling Zyprexa in Japan, medical regulators in that country required Lilly to warn doctors against using Zyprexa in diabetic patients.

But Lilly did not issue a similar advisory to doctors in the United States. Instead, the company advised its sales representatives not to discuss diabetes with doctors unless the doctors brought it up first, according to another document presented at the trial.

“We will NOT proactively address the diabetes concerns,” the document, an internal Lilly memorandum, said.

Court recessed on Friday before lawyers for Lilly could cross-examine Dr. Gueriguian. They will have the opportunity to do so on Monday.

A lawyer for Lilly said after Dr. Gueriguian’s testimony that the company had shared all it knew with the F.D.A. and that the question of the link between Zyprexa and diabetes was still a subject of scientific debate.

When Anxiety Is at the Table

FOR some of us the trouble starts before we even step into a restaurant.

If Carole Johnson, a retired school administrator who lives near Sacramento, Calif., happens to have a distressing thought while passing through a doorway, she needs to “clear” the thought by passing through the door twice more, doing it precisely three times.

My own challenge is fighting the urge to return to my parked car and check yet again that the parking brake is secure. If I don’t, how can I be sure my car won’t roll into something — or worse, someone?

Ms. Johnson and I are but two of the estimated five to seven million Americans battling obsessive-compulsive disorder, an anxiety disorder characterized by intrusive distressing thoughts and repetitive rituals aimed at dislodging those thoughts. We are an eclectic bunch spanning every imaginable cross-section of society, and we battle an equally eclectic mix of obsessions and compulsions. Some of us obsess about contamination, others about hurting people, and still others about symmetry. Almost all of us can find something to obsess about at a restaurant.

Sometimes the trouble is the element of public theater in the dining room, meaning we have to indulge in our often-embarrassing rituals under the eyes of so many strangers while trying not to get caught. Or it might be worrying about the safety of the food and the people who serve it.

Many of the situations that unsettle people with obsessive-compulsive disorder — driving, for instance — provoke at least some level of anxiety in just about everyone. But restaurants are designed to be calming and relaxing. That is one of the main reasons people like to eat out.

To many of us with obsessive-compulsive disorder, those pleasures are invisible. We walk into a calm and civilized dining room and see things we won’t be able to control. This feeds directly into one of the unifying themes of the disorder: an often crushing inability to handle the unknown.

“The common thread, I think, has something to do with certainty,” said Dr. Michael Jenike, medical director of the Obsessive Compulsive Disorders Institute at McLean Hospital in Belmont, Mass., which is affiliated with Harvard Medical School. “If you have O.C.D., whatever form, there seems to be some problem with being certain about things — whether they’re safe or whether they’ve been done right.”

If lack of certainty is our common challenge, than warding off uncertainty is our common quest. For some of us battling obsessive-compulsive disorder, that means scrubbing our hands to make sure they’re clean, or checking and re-checking everything around us in the name of safety. For others, the need is to arrange various items in order, or repeat actions in ritualized sequences in vain attempts at removing doubt.

These quirks lead to some serious complications in our lives, especially when we find ourselves in a place that triggers obsessive-compulsive behavior, like a restaurant. Once Ms. Johnson gets past the door, she often needs to try out a few tables, looking for one that feels right, as a frustrated maître d’hôtel looks on.

Personally, I am fine with just about any table, although the wobbly ones can spell big trouble. I have harm obsessions, which means I am plagued by the fear that other people will be hurt by something I do, or don’t do. Seated at a less-than-sturdy table, I conjure images of fellow diners being crushed or otherwise injured should I fail to notify the restaurant’s management. This is called a reporting compulsion in the vernacular of the disorder, and before I learned to fight these urges, many a manager heard from me.

One of them was the woman running a coffee house I frequent. One day while sipping my latte at a fake-marble table I leaned forward, and the far end of the tabletop lifted. This barely moved my coffee cup, but it sent my nerves right through the roof. Before I realized it I was crouched over, my head upside down beneath the table. The only responsible thing to do, I decided, was to ask the woman behind the counter to come over for a look. Her lack of concern only exacerbated my problems.

Forget the tabletop, my friend Matt Solomon tells me; it’s what’s on top of the table, and precisely where, that really matters. Mr. Solomon is a 39-year-old lawyer in Fort Worth with order compulsions. To enjoy a meal he needs to separate the salt and pepper shakers, and, ideally, place a napkin holder or other divider midway between them.

Why? He can no more answer that than Ms. Johnson can tell you why she needs to chew her food in sets of three bites or drink her beverages three sips at a time. Three is her magic number. That is about as refined an explanation as any of us can give for our compulsions, rituals that we understand are entirely illogical.

Some of our other concerns may seem familiar. I imagine most diners, for example, have noticed and perhaps even struggled to remove white detergent spots that can sometimes be seen on silverware. But few, I suspect, have gone to the lengths Jared Kant has to get rid of them. Mr. Kant is a 24-year-old research assistant living outside of Boston who has obsessive fears of contamination. (He first came to my attention when I read a memoir he wrote about living with obsessive-compulsive disorder.) Last year he visited a Chinese restaurant with several friends, one of whom pointed out that their silverware was spotted and seemed dirty. Mr. Kant collected all the utensils at the table and attempted to sterilize them by holding them above a small flame at the center of a pu-pu platter, quickly attracting the attention of their waiter.

Ah, waiters, and waitresses. And bartenders. For some with obsessive-compulsive disorder, the success or failure of a dining experience can hinge on the appearance of a restaurant’s staff.

Mr. Solomon, for example, feels compelled to inspect the hands of anyone serving him. Cuts and scrapes are objectionable because in his mind, they can lead to his contracting a disease that could kill him.

This past Halloween, Mr. Solomon ate at the bar of a steakhouse, where he was served by a bartender dressed in a devil costume. He noticed a small red stain on the man’s right knuckle, and couldn’t rule out the possibility that the stain was blood. Trying to avoid things the bartender had touched, Mr. Solomon used a straw to drink from his water glass and swapped the silverware the bartender had placed in front of him for another set from farther down the bar.

Coincidentally, Mr. Solomon and Mr. Kant have each battled contamination issues on both sides of the counter. Mr. Solomon spent years working as a bartender, often consumed by thoughts of becoming deathly ill. He was convinced that one of his regular customers was carrying a fatal virus, and came up with strategies to minimize contact. “I would always quickly put his change down before he could try to take it from my hand,” he said.

The challenge for Mr. Kant was serving lattes. In his late teens, while training to be a barista, he learned of the potential dangers from improperly handled milk. He became obsessed with the possibility of harming customers through inadvertent negligence. Even worse was the prospect that he might never know. “My biggest fear was that one day I would find out that a customer had come down sick, brutally sick with something, and the only thing they knew was that they’d had a latte,” Mr. Kant said.

I can’t imagine handling even the most basic server duties, like adding up the items on a customer’s bill. I struggle enough with checking and rechecking my tip calculations. And that’s just one of my challenges at the end of a meal.

As part of my harm obsession, one of my concerns is that germs from my mouth will hurt others. Although I try to keep my fingers away from my lips and their germs while I’m eating, I’m rarely successful (it’s not as easy as it sounds). By the end of the meal I believe that my hands are contaminated. The problem is that I need them to scribble my signature on the check. If I’m lucky, I will have remembered to bring my own pen; if not, I may feel compelled to “table-wash” my hands, a little trick I developed over the years: I use the condensation on the outside of a cold water glass to rinse off the germs. (Forget drying my hands, by the way; my napkin would only re-contaminate them.)

Once the check is signed, I must be sure that it is really signed. At my worst, I have opened and closed the vinyl check holder again and again, seeing my signature each time, yet unable to feel certain. I’ve left the table, only to return to check again. And again.

Help is available, in the form of a therapy called exposure response prevention. As the name suggests, the technique calls for exposing people with obsessive-compulsive disorder to situations that trigger obsessions, then preventing them from acting on them. The therapy addresses low-level anxieties, and works up from there.

With restaurant cleanliness, for example, a therapist might have an client rate his anxiety about challenges ranging from simply touching spotted silverware to eating from a spotted plate. Then the therapist would ask him to face those situations while fighting the compulsion to clean or replace spotted items.

The therapy attempts to alter behavior, but it appears to alter much more than that. Dr. Sanjaya Saxena, the director of a program for obsessive-compulsive disorders at the University of California at San Diego, said that exposure response prevention therapy “certainly is changing the brain at the molecular level — that is, at the level of particular proteins that are expressed and created and on the level of neurotransmitter function.” In that sense, he said, “behavioral therapy is biological therapy.”

I am no brain scientist. I understand almost nothing about proteins and neurotransmitters. But my own extensive work with this particular form of torture (that is, directed treatment), with medication, has progressively allowed me to take back much of the life my disorder stole from me.

Today I travel extensively, sharing my recovery story and working with groups like the Obsessive Compulsive Foundation to raise awareness. In my job as a radio news anchor, I don’t have to eat out much, but when I’m on the road for work related to the disorder, I wind up eating in a lot of restaurants. I can honestly say I’m starting to enjoy it. In fact, while I still like ice water with my meal, I often find myself drinking from the glass, not washing with it.

Now when I say check, please, I’m simply asking for my bill.

Cholesterol Drug Has No Benefit in Trial, Makers Say

A clinical trial of Zetia, a cholesterol-lowering drug prescribed to about 1 million people a week, failed to show that the drug has any medical benefits, Merck and Schering-Plough said on Monday.

The results will add to the growing concern over Zetia and Vytorin, a drug that combines Zetia with another cholesterol medicine in a single pill. About 60 percent of patients who take Zetia do so in the form of Vytorin, which combines Zetia with the cholesterol drug Zocor.

While Zetia lowers cholesterol by 15 percent to 20 percent in most patients, no trial has ever shown that it can reduce heart attacks and strokes — or even that it reduces the growth of the fatty plaques in arteries that can cause heart problems.

This trial was designed to show that Zetia could reduce the growth of those plaques. Instead, the plaques actually grew almost twice as fast in patients taking Zetia along with Zocor than in those taking Zocor alone.

Patients in the trial who took the combination of Zetia and Zocor were receiving it in the form of Vytorin pills. The trial, called Enhance, lasted two years and covered about 720 patients with extremely high cholesterol, mostly in the Netherlands.

Dr. Steven Nissen, the chairman of cardiology at the Cleveland Clinic, said the results were “shocking.” Patients should not be prescribed Zetia unless all other cholesterol drugs have failed, he said.

“This is as bad a result for the drug as anybody could have feared,” Dr. Nissen said. Millions of patients may be taking a drug that has no benefits for them, raising their risk of heart attacks and exposing them to potential side effects, he said.

Still, patients who are taking Vytorin or Zetia should talk to their doctors if they are concerned and not discontinue taking the medicines on their own, Dr. Nissen said.

Dr. Howard Hodis, a cardiologist at the University of Southern California, also said he was concerned by the trial’s results. Growth in fatty plaques — called atherosclerosis — is highly correlated with heart attacks and strokes, Dr. Hodis said.

“Clearly, progression of atherosclerosis is the only way you get events,” Dr. Hodis said. “If you don’t treat progression, then you get events.”

The results of the trial “necessitate further investigation — that just can’t be ignored,” Dr. Hodis said.

Both companies’ stocks were down in mid-day trading in New York on Monday, with Merck’s share price off by 2.4 percent and Schering-Plough’s down nearly 6 percent.

The results will also add to the controversy surrounding a long delay in releasing the results of the trial. Merck and Schering-Plough completed the trial in April 2006 and had initially planned to release the findings no later than March 2007. But the companies then missed several self-imposed deadlines, citing the complexity of the data analysis from the study and saying they did not know when or if the data would be ready for publication.

Last month, after several news articles highlighted the delay, they finally agreed to release the results soon.

For Merck and Schering-Plough, which jointly market Zetia and Vytorin and share profits from the drugs, the trial’s results are a serious setback. Zetia and Vytorin are important contributors to both companies’ profits, especially to Schering, which is smaller and less profitable than Merck.

Analysts estimate that about 70 percent of Schering’s earnings depend on the drugs. The controversy over the trial is also a problem for Merck, which is trying to repair its reputation after withdrawing the painkiller Vioxx from the market in September 2004.

In the United States, Zetia and Vytorin combined account for about 20 percent of the overall cholesterol-lowering market. More than 100 million prescriptions have been filled in the United States for Zetia and Vytorin since the Food and Drug Administration approved them in November 2002 and August 2004 respectively. Both drugs cost about $3 a day.

Because Zetia reduces cholesterol differently from statins like Lipitor and Zocor, doctors often prescribed it as an additional therapy for patients whose cholesterol remains high even after they are already taking statins. But even before Zetia was introduced in 2002, some cardiologists argued that statins had positive cardiovascular effects that go beyond their ability to reduce cholesterol, and that Zetia lacks those effects.

The Enhance trial covered patients with a gene that causes them to produce very high levels of low-density lipoprotein cholesterol, commonly called L.D.L., or bad cholesterol. Patients in the trial had L.D.L. levels of about 320 milligrams per deciliter at the beginning of the trial, about three times the level cardiologists recommend.

Over the two years of the trial, patients who took Zocor alone reduced their L.D.L. by 41 percent on average, while patients who took Vytorin reduced their cholesterol by 58 percent. Yet despite the larger cholesterol reduction, patients taking Vytorin actually had more growth in fatty plaques in their carotid arteries than those on Zocor. The carotid artery runs through the neck and delivers oxygenated blood to the brain.

Drug Approved. Is Disease Real?

Fibromyalgia is a real disease. Or so says Pfizer in a new television advertising campaign for Lyrica, the first medicine approved to treat the pain condition, whose very existence is questioned by some doctors.

For patient advocacy groups and doctors who specialize in fibromyalgia, the Lyrica approval is a milestone. They say they hope Lyrica and two other drugs that may be approved this year will legitimize fibromyalgia, just as Prozac brought depression into the mainstream.

But other doctors — including the one who wrote the 1990 paper that defined fibromyalgia but who has since changed his mind — say that the disease does not exist and that Lyrica and the other drugs will be taken by millions of people who do not need them.

As diagnosed, fibromyalgia primarily affects middle-aged women and is characterized by chronic, widespread pain of unknown origin. Many of its sufferers are afflicted by other similarly nebulous conditions, like irritable bowel syndrome.

Because fibromyalgia patients typically do not respond to conventional painkillers like aspirin, drug makers are focusing on medicines like Lyrica that affect the brain and the perception of pain.

Advocacy groups and doctors who treat fibromyalgia estimate that 2 to 4 percent of adult Americans, as many as 10 million people, suffer from the disorder.

Those figures are sharply disputed by those doctors who do not consider fibromyalgia a medically recognizable illness and who say that diagnosing the condition actually worsens suffering by causing patients to obsess over aches that other people simply tolerate. Further, they warn that Lyrica’s side effects, which include severe weight gain, dizziness and edema, are very real, even if fibromyalgia is not.

Despite the controversy, the American College of Rheumatology, the Food and Drug Administration and insurers recognize fibromyalgia as a diagnosable disease. And drug companies are aggressively pursuing fibromyalgia treatments, seeing the potential for a major new market.

Hoping to follow Pfizer’s lead, two other big drug companies, Eli Lilly and Forest Laboratories, have asked the F.D.A. to let them market drugs for fibromyalgia. Approval for both is likely later this year, analysts say.

Worldwide sales of Lyrica, which is also used to treat diabetic nerve pain and seizures and which received F.D.A. approval in June for fibromyalgia, 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.

In November, Pfizer began a television ad campaign for Lyrica that features a middle-aged woman who appears to be reading from her diary. “Today I struggled with my fibromyalgia; I had pain all over,” she says, before turning to the camera and adding, “Fibromyalgia is a real, widespread pain condition.”

Doctors who specialize in treating fibromyalgia say that the disorder is undertreated and that its sufferers have been stigmatized as chronic complainers. The new drugs will encourage doctors to treat fibromyalgia patients, said Dr. Dan Clauw, a professor of medicine at the University of Michigan who has consulted with Pfizer, Lilly and Forest.

“What’s going to happen with fibromyalgia is going to be the exact thing that happened to depression with Prozac,” Dr. Clauw said. “These are legitimate problems that need treatments.”

Dr. Clauw said that brain scans of people who have fibromyalgia reveal differences in the way they process pain, although the doctors acknowledge that they cannot determine who will report having fibromyalgia by looking at a scan.

Lynne Matallana, president of the National Fibromyalgia Association, a patients’ advocacy group that receives some of its financing from drug companies, said the new drugs would help people accept the existence of fibromyalgia. “The day that the F.D.A. approved a drug and we had a public service announcement, my pain became real to people,” Ms. Matallana said.

Ms. Matallana said she had suffered from fibromyalgia since 1993. At one point, the pain kept her bedridden for two years, she said. Today she still has pain, but a mix of drug and nondrug treatments — as well as support from her family and her desire to run the National Fibromyalgia Association — has enabled her to improve her health, she said. She declined to say whether she takes Lyrica.

“I just got to a point where I felt, I have pain but I’m going to have to figure out how to live with it,” she said. “I absolutely still have fibromyalgia.”

But doctors who are skeptical of fibromyalgia say vague complaints of chronic pain do not add up to a disease. No biological tests exist to diagnose fibromyalgia, and the condition cannot be linked to any environmental or biological causes.

The diagnosis of fibromyalgia itself worsens the condition by encouraging people to think of themselves as sick and catalog their pain, said Dr. Nortin Hadler, a rheumatologist and professor of medicine at the University of North Carolina who has written extensively about fibromyalgia.

“These people live under a cloud,” he said. “And the more they seem to be around the medical establishment, the sicker they get.”

Dr. Frederick Wolfe, the director of the National Databank for Rheumatic Diseases and the lead author of the 1990 paper that first defined the diagnostic guidelines for fibromyalgia, says he has become cynical and discouraged about the diagnosis. He now considers the condition a physical response to stress, depression, and economic and social anxiety.

“Some of us in those days thought that we had actually identified a disease, which this clearly is not,” Dr. Wolfe said. “To make people ill, to give them an illness, was the wrong thing.”

In general, fibromyalgia patients complain not just of chronic pain but of many other symptoms, Dr. Wolfe said. A survey of 2,500 fibromyalgia patients published in 2007 by the National Fibromyalgia Association indicated that 63 percent reported suffering from back pain, 40 percent from chronic fatigue syndrome, and 30 percent from ringing in the ears, among other conditions. Many also reported that fibromyalgia interfered with their daily lives, with activities like walking or climbing stairs.

Most people “manage to get through life with some vicissitudes, but we adapt,” said Dr. George Ehrlich, a rheumatologist and an adjunct professor at the University of Pennsylvania. “People with fibromyalgia do not adapt.”

Both sides agree that people who are identified as having fibromyalgia do not get much relief from traditional pain medicines, whether anti-inflammatory drugs like ibuprofen — sold as Advil, among other brands — or prescription opiates like Vicodin. So drug companies have sought other ways to reduce 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.

Exactly why and how Lyrica reduces pain is unclear. In clinical trials, patients taking the drug reported that their pain — whether from fibromyalgia, shingles or diabetic nerve damage — 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.

The F.D.A. reviewers who initially examined Pfizer’s application for Lyrica in 2004 for diabetic nerve pain found those results unimpressive, especially in comparison to Lyrica’s side effects. The reviewers recommended against approving the drug, citing its side effects.

In many patients, Lyrica causes weight gain and edema, or swelling, as well as dizziness and sleepiness. 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. The potential for weight gain is a special concern because many fibromyalgia patients are already overweight: the average fibromyalgia patient in the 2007 survey reported weighing 180 pounds and standing 5 feet 4 inches.

But senior F.D.A. officials overruled the initial reviewers, noting that severe pain can be incapacitating. “While pregabalin does present a number of concerns related to its potential for toxicity, the overall risk-to-benefit ratio supports the approval of this product,” Dr. Bob Rappaport, the director of the F.D.A. division reviewing the drug, wrote in June 2004.

Pfizer began selling Lyrica in the United States in 2005. The next year the company asked for F.D.A. approval to market the drug as a fibromyalgia treatment. The F.D.A. granted that request in June 2007.

Pfizer has steadily ramped up consumer advertising of Lyrica. During the first nine months of 2007, it spent $46 million on ads, compared with $33 million in 2006, according to TNS Media Intelligence.

Dr. Steve Romano, a psychiatrist and a Pfizer vice president who oversees Lyrica, says the company expects that Lyrica will be prescribed for fibromyalgia both by specialists like neurologists and by primary care doctors. As doctors see that the drug helps control pain, they will be more willing to use it, he said.

“When you help physicians to recognize the condition and you give them treatments that are well tolerated, you overcome their reluctance,” he said.

Both the Lilly and Forest drugs being proposed for fibromyalgia were originally developed as antidepressants, and both work by increasing levels of serotonin and norepinephrine, brain transmitters that affect mood. The Lilly drug, Cymbalta, is already available in the United States, while the Forest drug, milnacipran, is sold in many countries, though not the United States.

Dr. Amy Chappell, a medical fellow at Lilly, said that even though Cymbalta is an antidepressant, its effects on fibromyalgia pain are independent of its antidepressant effects. In clinical trials, she said, even fibromyalgia patients who are not depressed report relief from their pain on Cymbalta.

The overall efficacy of Cymbalta and milnacipran is similar to that of Lyrica. Analysts and the companies expect that the drugs will probably be used together.

“There’s definitely room for several drugs,” Dr. Chappell said.

But physicians who are opposed to the fibromyalgia diagnosis say the new drugs will probably do little for patients. Over time, fibromyalgia patients tend to cycle among many different painkillers, sleep medicines and antidepressants, using each for a while until its benefit fades, Dr. Wolfe said.

“The fundamental problem is that the improvement that you see, which is not really great in clinical trials, is not maintained,” Dr. Wolfe said.

Still, Dr. Wolfe expects the drugs will be widely used. The companies, he said, are “going to make a fortune.”