One drug, many uses. Good idea?
http://www.indystar.com/apps/pbcs.dll/article?AID= [2008-6-30]
Tag : knee pains
Chance to kill, vengeance, money: why Taliban fighters took up arms
1 hour ago
KANDAHAR, Afghanistan — For some Taliban fighters, killingforeign soldiers was nothing more than a steady job that offeredcold, hard cash.
For Mullah Janan, it was all about hot-blooded revenge.
The bushy-bearded farmer with the towering turban and vacant starewas among three former Afghan insurgents who spoke with TheCanadian Press about why they took up arms against foreigners.
Janan says he has always supported the Taliban politically, withits stern interpretation of Islam and iron-fisted grip on security.
He grew up in Oruzgan province just north of Kandahar, not far fromthe village where Taliban founder Mullah Omar was born.
He blames a NATO bombing of his village for destroying his life -and for compelling him to fight.
"I lost my wife and children," Janan says, speaking softly andstaring blankly across the room.
"Even before this operation, I supported the Taliban. But this wasthe key point that made me a more committed Talib, and made medeclare war against these people."
Janan remained a lowly foot soldier.
He says he never dabbled in explosives, military strategy oranything more sophisticated than firing an AK-47 assault rifle atforeign troops.
He replies coyly when asked whether he killed anyone. But he offersa dismissive shrug when asked whether killing foreigners would havebeen wrong.
"I might have killed several people," he responds with a tightsmile. "If two people quarrel with each other or fight, somethinghappens."
Something has been happening around another former Taliban, MullahMohammed Zaher, for much of his adult life.
At first glance, Zaher hardly cuts an imposing figure with asqueaky high-pitched voice, expressive eyes, neatly pressedclothing and a delicately trimmed beard.
But those eyes narrow when he is asked what he does for a living -does he have a trade?
After an awkward pause, he's asked again: "Are you a farmer, likeMullah Janan?"
Zaher's eyes light up.
He has understood the question and replies: killing enemies is theonly livelihood he's ever had.
"I was very happy when I killed people," he says, a sentimentalsmile slowly creeping across his face. "That was supposed to be mytask and it made me very happy."
There's another twinkle in his eye when asked whether his main goalhad been targeting enemy troops or destroying theirmultimillion-dollar equipment such as tanks.
"I was interested in killing people," he says, smiling again.
Zaher is unemployed now and living with relatives in a crammedhouse in Kandahar city's District Six.
Until recently, he killed NATO soldiers. Before that, he killedrivals during Afghanistan's civil war in the 1970s, killed Sovietsin the 1980s, killed more rivals during another civil war in the1990s, and then killed enemies of the Taliban regime when he servedas a district commander until 2001.
He's upset now.
He says Afghan officials promised him a house and money to leavethe insurgency two years ago, but nobody has delivered.
Zaher says he might go back to his old job - fighting as aninsurgent - if he can't find steady work within the next year.
He says he was getting paid $500 a month from people within thePakistani military who also provided him with a motorbike and arent-free house in Quetta, Pakistan.
He says he fled there from Kandahar in 2003 out of frustration. Asa former Taliban, he says, he faced harassment and extortion fromcorrupt police, military and government officials under the newgovernment headed by President Hamid Karzai.
A younger former Taliban, 30-year-old Mirza Akhun, tells a similarstory of abuse from officials in the new government that pushed himto join the insurgency.
Both he and Zaher say it was the promise of a house, a livingallowance and the ability to live peacefully in Kandahar that luredthem into abandoning the insurgency. They complain that thepromises have not been kept.
While their reasons for fighting were as vastly different as theirrank within the insurgency, Janan and Zaher share one thing incommon: they know nothing about Canada.
"I know it is a country," Zaher says. "I have never been there. Ido not know much about it, except for the name."
It's unlikely that either killed a Canadian soldier. Janan says hefought outside Kandahar, and Zaher says he stopped blowing up NATOconvoys in the winter of 2005-06 - around the time Canadiansentered Kandahar province in force.
Zaher says he killed many NATO soldiers with the bombs thePakistanis taught him to build.
At first he refuses to describe those bombs to a Canadianjournalist out of fear he would reveal too much to the enemy. "Yourmilitary will steal my secrets," he says.
He is assured that the Canadian military has far superior weaponryand no interest in planting improvised explosive devices aroundAfghanistan.
Only then does Zaher hesitantly begin explaining how, with $10worth of plastic jugs, electrical wiring and fertilizer, he canblow up an enemy vehicle.
He says he was also taught in Pakistan how to build moresophisticated remote-controlled bombs.
Around this time, Janan stands up, excuses himself and leaves theroom to pray. On his way out the door, he grumbles at a localofficial that the interview has wasted his entire afternoon.
Zaher is asked why he joined the Taliban in the first place.
During a 90-minute interview he mentioned the salary, themotorbike, the free house, the harrassment from Afghan officialsand even the quality of the curry he was served on a Pakistanimilitary compound.
But why did he join the Taliban in the first place?
"There was a religious component," he says.
"We were fighting for Islam."
A.R. Khan, a Kandahar-based journalist, did additional reportingand provided translation during the interviews.
Do you have diabetes nerve pain? Fibromyalgia? Cymbalta is approvedfor those conditions as well. In Europe, you can use the drug,marketed under a different name, to treat stress urinaryincontinence.
Cymbalta, launched in 2004 as an antidepressant, is quicklybecoming the Swiss Army knife of drugs. With less than four yearson the market, it is racking up one government approval afteranother, and generating billions of dollars for Indianapolisdrugmaker Eli Lilly and Co.
And Lilly isn't done. It recently asked the Food and DrugAdministration to allow the use of Cymbalta for chronic knee andlow back pain. Meanwhile, scientists are testing Cymbalta fortreatment of chronic fatigue, yet the drug has been linked toincreased risk of suicide among people younger than 25.
How one drug can treat so many ailments illustrates howpharmaceutical companies -- under pressure from rising researchcosts and bracing for more generic competition -- are pushing hardto find every possible use for their existing drugs.
"The first and foremost thing a drug company wants to do is findnew uses for existing drugs," said Steven Findlay, a health-careanalyst at Consumers Union and managing editor of Consumer ReportsBest Buy Drugs. "If you can expand a drug into another market, youstand to make a lot of money."
Expanding the use of Cymbalta also shows how Lilly is workingaggressively to shore up its revenue base. Many of the company'stop drugs will lose patent protection beginning in 2011. Thosedrugs, and their billions of dollars worth of sales, supportLilly's campus of labs and offices south of Downtown, home to12,000 workers.
Across the industry, pharmaceutical companies are having troublegetting new medicines out of their research labs. Last year, theFDA approved 19 new drugs, the fewest in 24 years. Lilly hasn'tlaunched a new drug for humans in three years.
"The question you have to ask is, are drug companies using alltheir scientists to look at new uses for drugs they already have,at the expense of developing new drugs?" said Dr. Lon Castle,senior director for medical and analytical affairs at Medco HealthSolutions of New Jersey, one of the nation's largest drugdistribution companies.
Lilly says it is not resting on its laurels. The company'sscientists are developing new drugs for a wide array of diseases,including cancer and multiple sclerosis. In May, the companydedicated the final phase of its $1 billion biotechnology complex,where scientists will research the next generation ofbiopharmaceuticals for such conditions as diabetes and Alzheimer'sdisease.
But analysts say it remains to be seen whether Lilly can launchpromising new drugs before losing patents on existing top sellers.In the past year or so, several of its late-stage drugs have beenshelved, including an inhaled insulin and a drug for treating eyediseases. Last week, the company's most critical experimental drug,a blood thinner called prasugrel, was delayed for three months atthe FDA's request.
In the meantime, the trend of finding new uses for old drugscontinues at full force. Amgen's Enbrel, for example, is approvedfor rheumatoid arthritis, psoriasis and a chronic spinal paincondition known as Ankylosing spondylitis. The drug also is beingresearched for dozens of additional uses, including Alzheimer'sdisease and vasculitis. Pfizer's pain pill Lyrica is approved forthree separate conditions of the nervous system, and the companyplans to seek approval for the drug to treat epilepsy.
"This may speak to the desperation of companies to eke out any andall possible indications from existing drugs, rather than investbig bucks in the search for truly novel entities," said Dr. DanielCarlat, a Massachusetts psychiatrist and frequent industry critic. Multiple uses are good, some say
Yet others look at the same picture and say drug companies aredoing the right thing: using scientific knowledge to broaden theuse of existing drugs. It's legal to market a drug for more thanone condition, as long as drugmakers get FDA approval, a processthat requires submitting clinical proof that the drug is safe andeffective for each condition.
"I think it's kind of remarkable that some drugs can be effectivefor many different things," said Kevin Outterson, director of thehealth law program at the Boston University School of Law. "There'snothing wrong at all with a company going through the studies andshowing the FDA there's another thing the drug can be used for, andgetting it added to the label."
Certainly, the practice of using one pill for numerous ailments hasa long history. Aspirin, for example, has become the workhorse ofthe medicine chest, used by millions of people for such diverseneeds as reducing inflammation, treating a fever, relieving painand preventing heart trouble.
But the stakes are high for a drug such as Cymbalta, which carriessignificant risks. Like all antidepressants, the drug has ablack-box warning that it may increase the risk of suicide inpeople younger than 25. In 2004, a 19-year-old drug-testingvolunteer, Traci Johnson, hanged herself in the Lilly Clinic inIndianapolis while participating in clinical trials for Cymbalta.
The drug also carries a long list of possible side effects, fromnausea and dry mouth to fatigue and constipation.
"I think the question is, should one drug compound do so much?"said Shannon Brownlee, author of "Overtreated: Why Too MuchMedicine Is Making Us Sicker and Poorer."
"This is a drug that may have a really serious side effect calledsuicide," Brownlee said. "Don't we have other drugs available thatare safer and just as effective for such things as the managementof chronic knee and low back pain?"
But Lilly hasn't been shy about promoting the drug. Last year, thecompany spent $183.3 million on direct-to-consumer advertising forCymbalta, promoting its use for depression and pain, according toNielsen Monitor-Plus. That made Cymbalta No. 3 in the nation in adspending, behind insomnia drugs Lunesta, made by Sepracor, andAmbien CR, made by Sanofi-Aventis.
The commercials, which are still running, are designed to makeCymbalta a household name on par with Prozac, an olderantidepressant and Lilly's top-selling drug before its patentexpired in 2001.
The ad blitz has helped catapult Cymbalta to second place in salesamong all Lilly drugs, ringing up sales of $2.1 billion last year,up 60 percent.
Analysts expect Cymbalta to continue growing. Catherine Arnold, adrug analyst with Credit Suisse in New York, predicts Cymbaltasales will hit $4 billion by 2012, putting it in first place amongLilly drugs.
Other analysts agree Cymbalta is a strong engine that could driveLilly's fortunes for years to come.
"From a business point of view, it's a great thing," said LesFuntleyder, a drug industry analyst for Miller Tabak & Co. in NewYork. "If you have the asset, you might as well use it. Butscientifically and medically, it depends, because the farther youmove a drug away from its original indication, and the wider thepopulation you have taking a drug, the greater the chance some rareside effect will pop up." The link between pain and mood
Lilly says Cymbalta is able to do so much because pain and mood --the drug's approved uses -- are thought to be closely connected.
Cymbalta increases activity in two chemicals in the brain:serotonin and norepinephrine. They occur naturally and regulatemood. But Lilly says chemicals also play a role in communicatingpain to the brain.
"All pain travels through the body and into the brain," said Dr.Michael Robinson, a Lilly psychiatrist and associate medicaldirector of Cymbalta. "In order for someone to experience pain,it's perceived by the brain. Cymbalta is a medication that works inthe brain and spinal cord. Based on its mechanism of action, it'seffective in a number of disorders."
Lilly says some pain protects the body, such as the pain you wouldfeel when touching a stove. But other pain, called "bad pain," hasno protective function and sometimes no known causes.
"The bad pain serves no purpose," said Dr. Amy Chappell, aneurologist and Lilly medical fellow. "It's nonphysiological painthat causes lots of unnecessary suffering. All the pains we'vestudied (for Cymbalta) fall into this category. They're all relatedand, we think, are treatable."
Some outside drug experts agree. Craig Svensson, dean of PurdueUniversity's College of Pharmacy, Nursing and Health Science, saidsome drugs are known to work across many diseases that seemunrelated, including different types of pain.
"The drugs may have some commonalities in the way you manage thatpain, even though what initiates that pain or the underlyingdisease is different," he said. The problem with subjective ailments
But how well drugs treat pain and mood is a controversial topic.Such ailments are highly subjective. Doctors have no objectivetests, such as X-rays or blood tests, to measure pain or any kindof psychiatric illness. Instead, they have to rely on theirpatients to describe their symptoms.
And some physicians and researchers question whether fibromyalgia,the latest ailment treated by Cymbalta, is even a genuine disease.An estimated 5 million people, mostly women, are affected with it,according to the Centers for Disease Control and Prevention.
"A lot of doctors deny the existence of fibromyalgia," said Dr.Marcia Angell, former editor-in-chief of the New England Journal ofMedicine. "It certainly cannot be reproducibly diagnosed because somany of the criteria are subjective. So you have a subjectivediagnosis and a subjective outcome. You don't know whether thetreatment has worked or not. . . . It's such a lucrative business,because you can create the disease."
But Lilly defends its use of Cymbalta for pain and mood disorders,calling the drug an important treatment option. And some expertssay drug companies are doing what they are supposed to do: Findways to treat diseases, regardless of the age of the drug.
"Drug companies are certainly facing a tough economic environmentright now," said Joseph DiMasi, director of economic analysis atthe Tufts Center for the Study of Drug Development in Boston."Maybe you can argue it's more profitable to concentrate on findingnew treatments for old drugs. But a good treatment is a goodtreatment, regardless of whether the drug is new or old."
Chance to kill, vengeance, money: why Taliban fighters took up arms
1 hour ago
KANDAHAR, Afghanistan — For some Taliban fighters, killingforeign soldiers was nothing more than a steady job that offeredcold, hard cash.
For Mullah Janan, it was all about hot-blooded revenge.
The bushy-bearded farmer with the towering turban and vacant starewas among three former Afghan insurgents who spoke with TheCanadian Press about why they took up arms against foreigners.
Janan says he has always supported the Taliban politically, withits stern interpretation of Islam and iron-fisted grip on security.
He grew up in Oruzgan province just north of Kandahar, not far fromthe village where Taliban founder Mullah Omar was born.
He blames a NATO bombing of his village for destroying his life -and for compelling him to fight.
"I lost my wife and children," Janan says, speaking softly andstaring blankly across the room.
"Even before this operation, I supported the Taliban. But this wasthe key point that made me a more committed Talib, and made medeclare war against these people."
Janan remained a lowly foot soldier.
He says he never dabbled in explosives, military strategy oranything more sophisticated than firing an AK-47 assault rifle atforeign troops.
He replies coyly when asked whether he killed anyone. But he offersa dismissive shrug when asked whether killing foreigners would havebeen wrong.
"I might have killed several people," he responds with a tightsmile. "If two people quarrel with each other or fight, somethinghappens."
Something has been happening around another former Taliban, MullahMohammed Zaher, for much of his adult life.
At first glance, Zaher hardly cuts an imposing figure with asqueaky high-pitched voice, expressive eyes, neatly pressedclothing and a delicately trimmed beard.
But those eyes narrow when he is asked what he does for a living -does he have a trade?
After an awkward pause, he's asked again: "Are you a farmer, likeMullah Janan?"
Zaher's eyes light up.
He has understood the question and replies: killing enemies is theonly livelihood he's ever had.
"I was very happy when I killed people," he says, a sentimentalsmile slowly creeping across his face. "That was supposed to be mytask and it made me very happy."
There's another twinkle in his eye when asked whether his main goalhad been targeting enemy troops or destroying theirmultimillion-dollar equipment such as tanks.
"I was interested in killing people," he says, smiling again.
Zaher is unemployed now and living with relatives in a crammedhouse in Kandahar city's District Six.
Until recently, he killed NATO soldiers. Before that, he killedrivals during Afghanistan's civil war in the 1970s, killed Sovietsin the 1980s, killed more rivals during another civil war in the1990s, and then killed enemies of the Taliban regime when he servedas a district commander until 2001.
He's upset now.
He says Afghan officials promised him a house and money to leavethe insurgency two years ago, but nobody has delivered.
Zaher says he might go back to his old job - fighting as aninsurgent - if he can't find steady work within the next year.
He says he was getting paid $500 a month from people within thePakistani military who also provided him with a motorbike and arent-free house in Quetta, Pakistan.
He says he fled there from Kandahar in 2003 out of frustration. Asa former Taliban, he says, he faced harassment and extortion fromcorrupt police, military and government officials under the newgovernment headed by President Hamid Karzai.
A younger former Taliban, 30-year-old Mirza Akhun, tells a similarstory of abuse from officials in the new government that pushed himto join the insurgency.
Both he and Zaher say it was the promise of a house, a livingallowance and the ability to live peacefully in Kandahar that luredthem into abandoning the insurgency. They complain that thepromises have not been kept.
While their reasons for fighting were as vastly different as theirrank within the insurgency, Janan and Zaher share one thing incommon: they know nothing about Canada.
"I know it is a country," Zaher says. "I have never been there. Ido not know much about it, except for the name."
It's unlikely that either killed a Canadian soldier. Janan says hefought outside Kandahar, and Zaher says he stopped blowing up NATOconvoys in the winter of 2005-06 - around the time Canadiansentered Kandahar province in force.
Zaher says he killed many NATO soldiers with the bombs thePakistanis taught him to build.
At first he refuses to describe those bombs to a Canadianjournalist out of fear he would reveal too much to the enemy. "Yourmilitary will steal my secrets," he says.
He is assured that the Canadian military has far superior weaponryand no interest in planting improvised explosive devices aroundAfghanistan.
Only then does Zaher hesitantly begin explaining how, with $10worth of plastic jugs, electrical wiring and fertilizer, he canblow up an enemy vehicle.
He says he was also taught in Pakistan how to build moresophisticated remote-controlled bombs.
Around this time, Janan stands up, excuses himself and leaves theroom to pray. On his way out the door, he grumbles at a localofficial that the interview has wasted his entire afternoon.
Zaher is asked why he joined the Taliban in the first place.
During a 90-minute interview he mentioned the salary, themotorbike, the free house, the harrassment from Afghan officialsand even the quality of the curry he was served on a Pakistanimilitary compound.
But why did he join the Taliban in the first place?
"There was a religious component," he says.
"We were fighting for Islam."
A.R. Khan, a Kandahar-based journalist, did additional reportingand provided translation during the interviews.
Do you have diabetes nerve pain? Fibromyalgia? Cymbalta is approvedfor those conditions as well. In Europe, you can use the drug,marketed under a different name, to treat stress urinaryincontinence.
Cymbalta, launched in 2004 as an antidepressant, is quicklybecoming the Swiss Army knife of drugs. With less than four yearson the market, it is racking up one government approval afteranother, and generating billions of dollars for Indianapolisdrugmaker Eli Lilly and Co.
And Lilly isn't done. It recently asked the Food and DrugAdministration to allow the use of Cymbalta for chronic knee andlow back pain. Meanwhile, scientists are testing Cymbalta fortreatment of chronic fatigue, yet the drug has been linked toincreased risk of suicide among people younger than 25.
How one drug can treat so many ailments illustrates howpharmaceutical companies -- under pressure from rising researchcosts and bracing for more generic competition -- are pushing hardto find every possible use for their existing drugs.
"The first and foremost thing a drug company wants to do is findnew uses for existing drugs," said Steven Findlay, a health-careanalyst at Consumers Union and managing editor of Consumer ReportsBest Buy Drugs. "If you can expand a drug into another market, youstand to make a lot of money."
Expanding the use of Cymbalta also shows how Lilly is workingaggressively to shore up its revenue base. Many of the company'stop drugs will lose patent protection beginning in 2011. Thosedrugs, and their billions of dollars worth of sales, supportLilly's campus of labs and offices south of Downtown, home to12,000 workers.
Across the industry, pharmaceutical companies are having troublegetting new medicines out of their research labs. Last year, theFDA approved 19 new drugs, the fewest in 24 years. Lilly hasn'tlaunched a new drug for humans in three years.
"The question you have to ask is, are drug companies using alltheir scientists to look at new uses for drugs they already have,at the expense of developing new drugs?" said Dr. Lon Castle,senior director for medical and analytical affairs at Medco HealthSolutions of New Jersey, one of the nation's largest drugdistribution companies.
Lilly says it is not resting on its laurels. The company'sscientists are developing new drugs for a wide array of diseases,including cancer and multiple sclerosis. In May, the companydedicated the final phase of its $1 billion biotechnology complex,where scientists will research the next generation ofbiopharmaceuticals for such conditions as diabetes and Alzheimer'sdisease.
But analysts say it remains to be seen whether Lilly can launchpromising new drugs before losing patents on existing top sellers.In the past year or so, several of its late-stage drugs have beenshelved, including an inhaled insulin and a drug for treating eyediseases. Last week, the company's most critical experimental drug,a blood thinner called prasugrel, was delayed for three months atthe FDA's request.
In the meantime, the trend of finding new uses for old drugscontinues at full force. Amgen's Enbrel, for example, is approvedfor rheumatoid arthritis, psoriasis and a chronic spinal paincondition known as Ankylosing spondylitis. The drug also is beingresearched for dozens of additional uses, including Alzheimer'sdisease and vasculitis. Pfizer's pain pill Lyrica is approved forthree separate conditions of the nervous system, and the companyplans to seek approval for the drug to treat epilepsy.
"This may speak to the desperation of companies to eke out any andall possible indications from existing drugs, rather than investbig bucks in the search for truly novel entities," said Dr. DanielCarlat, a Massachusetts psychiatrist and frequent industry critic. Multiple uses are good, some say
Yet others look at the same picture and say drug companies aredoing the right thing: using scientific knowledge to broaden theuse of existing drugs. It's legal to market a drug for more thanone condition, as long as drugmakers get FDA approval, a processthat requires submitting clinical proof that the drug is safe andeffective for each condition.
"I think it's kind of remarkable that some drugs can be effectivefor many different things," said Kevin Outterson, director of thehealth law program at the Boston University School of Law. "There'snothing wrong at all with a company going through the studies andshowing the FDA there's another thing the drug can be used for, andgetting it added to the label."
Certainly, the practice of using one pill for numerous ailments hasa long history. Aspirin, for example, has become the workhorse ofthe medicine chest, used by millions of people for such diverseneeds as reducing inflammation, treating a fever, relieving painand preventing heart trouble.
But the stakes are high for a drug such as Cymbalta, which carriessignificant risks. Like all antidepressants, the drug has ablack-box warning that it may increase the risk of suicide inpeople younger than 25. In 2004, a 19-year-old drug-testingvolunteer, Traci Johnson, hanged herself in the Lilly Clinic inIndianapolis while participating in clinical trials for Cymbalta.
The drug also carries a long list of possible side effects, fromnausea and dry mouth to fatigue and constipation.
"I think the question is, should one drug compound do so much?"said Shannon Brownlee, author of "Overtreated: Why Too MuchMedicine Is Making Us Sicker and Poorer."
"This is a drug that may have a really serious side effect calledsuicide," Brownlee said. "Don't we have other drugs available thatare safer and just as effective for such things as the managementof chronic knee and low back pain?"
But Lilly hasn't been shy about promoting the drug. Last year, thecompany spent $183.3 million on direct-to-consumer advertising forCymbalta, promoting its use for depression and pain, according toNielsen Monitor-Plus. That made Cymbalta No. 3 in the nation in adspending, behind insomnia drugs Lunesta, made by Sepracor, andAmbien CR, made by Sanofi-Aventis.
The commercials, which are still running, are designed to makeCymbalta a household name on par with Prozac, an olderantidepressant and Lilly's top-selling drug before its patentexpired in 2001.
The ad blitz has helped catapult Cymbalta to second place in salesamong all Lilly drugs, ringing up sales of $2.1 billion last year,up 60 percent.
Analysts expect Cymbalta to continue growing. Catherine Arnold, adrug analyst with Credit Suisse in New York, predicts Cymbaltasales will hit $4 billion by 2012, putting it in first place amongLilly drugs.
Other analysts agree Cymbalta is a strong engine that could driveLilly's fortunes for years to come.
"From a business point of view, it's a great thing," said LesFuntleyder, a drug industry analyst for Miller Tabak & Co. in NewYork. "If you have the asset, you might as well use it. Butscientifically and medically, it depends, because the farther youmove a drug away from its original indication, and the wider thepopulation you have taking a drug, the greater the chance some rareside effect will pop up." The link between pain and mood
Lilly says Cymbalta is able to do so much because pain and mood --the drug's approved uses -- are thought to be closely connected.
Cymbalta increases activity in two chemicals in the brain:serotonin and norepinephrine. They occur naturally and regulatemood. But Lilly says chemicals also play a role in communicatingpain to the brain.
"All pain travels through the body and into the brain," said Dr.Michael Robinson, a Lilly psychiatrist and associate medicaldirector of Cymbalta. "In order for someone to experience pain,it's perceived by the brain. Cymbalta is a medication that works inthe brain and spinal cord. Based on its mechanism of action, it'seffective in a number of disorders."
Lilly says some pain protects the body, such as the pain you wouldfeel when touching a stove. But other pain, called "bad pain," hasno protective function and sometimes no known causes.
"The bad pain serves no purpose," said Dr. Amy Chappell, aneurologist and Lilly medical fellow. "It's nonphysiological painthat causes lots of unnecessary suffering. All the pains we'vestudied (for Cymbalta) fall into this category. They're all relatedand, we think, are treatable."
Some outside drug experts agree. Craig Svensson, dean of PurdueUniversity's College of Pharmacy, Nursing and Health Science, saidsome drugs are known to work across many diseases that seemunrelated, including different types of pain.
"The drugs may have some commonalities in the way you manage thatpain, even though what initiates that pain or the underlyingdisease is different," he said. The problem with subjective ailments
But how well drugs treat pain and mood is a controversial topic.Such ailments are highly subjective. Doctors have no objectivetests, such as X-rays or blood tests, to measure pain or any kindof psychiatric illness. Instead, they have to rely on theirpatients to describe their symptoms.
And some physicians and researchers question whether fibromyalgia,the latest ailment treated by Cymbalta, is even a genuine disease.An estimated 5 million people, mostly women, are affected with it,according to the Centers for Disease Control and Prevention.
"A lot of doctors deny the existence of fibromyalgia," said Dr.Marcia Angell, former editor-in-chief of the New England Journal ofMedicine. "It certainly cannot be reproducibly diagnosed because somany of the criteria are subjective. So you have a subjectivediagnosis and a subjective outcome. You don't know whether thetreatment has worked or not. . . . It's such a lucrative business,because you can create the disease."
But Lilly defends its use of Cymbalta for pain and mood disorders,calling the drug an important treatment option. And some expertssay drug companies are doing what they are supposed to do: Findways to treat diseases, regardless of the age of the drug.
"Drug companies are certainly facing a tough economic environmentright now," said Joseph DiMasi, director of economic analysis atthe Tufts Center for the Study of Drug Development in Boston."Maybe you can argue it's more profitable to concentrate on findingnew treatments for old drugs. But a good treatment is a goodtreatment, regardless of whether the drug is new or old."
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