OT - FDA Panel Votes to Ban 2 of 4 Asthma Drugs for Asthma

[Guest guest]

And, by the way,http://snipurl.com/7r0zq  [www_associatedcontent_com] Many Doctors Push Flu Vaccine, Don't Get it ThemselvesOther Tips to Stay Flu Free This SeasonBy  F. Sullivan, published Dec 09, 2008As the United States enters the winter season, it is very likely that a bulk of U.S. citizens haven't gotten the flu vaccination to protect themselves against the influenza virus. According to ABC News, many of those people are the doctors and nurses telling us to get the vaccine in the first place. During the 2006-07 flu season, only 40 percent of health care practitioners got the vaccine.=====ALLIANCE FOR HUMAN RESEARCH PROTECTIONPromoting Openness, Full Disclosure, and Accountabilityhttp://www.ahrp.org and http://ahrp.blogspot.comFYITrust in medicine?The New York Times reports (below) that an FDA advisory panel voted to bantwo of the four asthma drugs that FDA drug safety officers had warned, putasthmatic patients at risk of sudden deaths. http://www.ahrp.blogspot.com/http://www.nytimes.com/2008/12/06/health/policy/06allergy.htmlThe Wall Street Journal reports that "the panel stopped short ofrecommending the drugs not be used at all..."http://blogs.wsj.com/health/2008/12/12/why-an-fda-panel-saw-asthma-drugs-differentlyWhich is it?The panel voted to continue marketing Advair, (GlaxoKline) andSymbicort (AstraZeneca) for asthma, but not Serevent (Glaxo) and Foradil(Novartis).The panel's recommendations came after several top F.D.A. drug safetyexperts had recommended earlier this month that all four asthma drugs shouldbe banned from treating asthmatic children and adults because they werelinked to sudden deaths.Dr. Joad, a panel member and pediatrician from the University ofCalifornia Medical Center, said she did not "want to give a drug thatis making the disease you're treating worse."Dr. ez, director of the Arizona Respiratory Center at theUniversity of Arizona, said far too many patients whose conditions could betreated adequately with steroids alone were instead receiving Advair orSymbicort, which are riskier and more expensive. Dr. ez blamed heavymarketing by Glaxo of Advair instead of Flovent, which contains only asteroid. "In the last two years," he said, "I haven't seen a single ad forFlovent, but I have seen many for Advair."However, FDA decisions are far more influenced by the business interests ofprescription drug manufacturers--whom agency officials regard as theirclients--than they are by drug safety considerations affecting Americancitizens.The financial stakes are high: Through the first nine months of this year,Advair's sales were $5.66 billion, and Symbicort's were $209 million. Lastyear, Serevent's sales were $538 million and Foradil's were $362 million.Even if the agency follows the panel's advice, all four drugs will remain onthe market since Serevent and Foradil are also approved to treat chronicobstructive pulmonary disorders like emphysema. So, doctors can prescribethem off-label for just about anything.Trust in industry-funded medical associations?True to form, the following professional medical associations appeared toprotect their financial interests by expressing support for the continueduse of all four of these medicines despite the avoidable risks of death: TheAmerican Academy of Pediatrics, American Thoracic Society, American Academyof Allergy Asthma and Immunology, and American College of Allergy Asthma andImmunology.Contact: Vera Hassner Sharavveracare@...212-595-8974~~~~~~~~~http://www.nytimes.com/2008/12/12/health/policy/12fda.htmlTHE NEW YORK TIMESDecember 12, 2008F.D.A. Panel Votes to Ban Asthma DrugsBy GARDINER HARRISROCKVILLE, Md. - A panel of federal drug experts voted on Thursday that thedrugs Serevent and Foradil should be banned from use in the treatment ofasthma, but the experts said that Advair and Symbicort, which together arefar more popular, should continue to be used.The experts, gathered by the Food and Drug Administration, said that toomany doctors used Serevent and Foradil inappropriately and that asthmaticpatients were often fooled by their own symptoms and used them incorrectly.Serevent and Foradil widen lung airways but increase the risks of deathunless paired with a steroid. The drugs' labels already warn of this riskbut half of patients taking the medicines do not get a steroid. Even whenpatients are prescribed a steroid, many fail to take it.GlaxoKline, the maker of Serevent, and Novartis and Schering-Plough,the marketers of Foradil, argued that doctors want the freedom to mix andmatch these drugs with steroids. But Dr. Joad, a panel member andpediatrician from the University of California Medical Center, saidshe did not "want to give a drug that is making the disease you're treatingworse."Dr. , a top F.D.A. official, cautioned that patients shouldconsult their doctor before stopping any asthma drug regimen. And Dr. said the agency would consider requiring drugmakers to undertakelarge studies to assess the safety of Advair and Symbicort, particularly inchildren.The drugs' makers rejected the committee's decision to ban Serevent's andForadil's use in asthma, although each said that it would cooperate with theagency.Last year, Serevent's sales were $538 million and Foradil's were $362million. Through the first nine months of this year, Advair's sales were$5.66 billion, and Symbicort's were $209 million.Serevent and Foradil are also approved to treat chronic obstructivepulmonary disorders like emphysema. So even if the agency follows thepanel's advice, the drugs will remain on the market.Asthma is caused when airways in the lungs spasm and swell, restricting thesupply of oxygen. The two primary treatments are steroids, which reduceswelling, and beta agonists, which treat spasms. Rescue inhalers usuallycontain albuterol, a short-acting beta agonist.Serevent and Foradil are longer-acting beta agonists intended to preventattacks. Used without a steroid, however, these drugs have been shown toincrease the risks of more severe attacks. Advair and Symbicort combinelonger-acting beta agonists with steroids in a single inhaler.The expert panel voted unanimously to ban the use of Serevent and Foradil inchildren, but for adults, it voted 17 to 10 to ban Serevent and 18 to 9 toban Foradil. It voted unanimously that Advair should continue to be used inasthmatic adults and supported its use in adolescents by 23 to 3 and inchildren by 13 to 11. Symbicort's use in adults was supported unanimously,while its use in adolescents was supported 20 to 5. Symbicort is notapproved for use in children.Earlier, some top F.D.A. safety experts recommended that all four drugsshould be banned from treating asthma, while other agency experts said thedrugs' benefits outweighed their risks.Like other drug-safety controversies, the debate largely pits those whotreat patients against those who study populations. Since the drugs may leadto one death in somewhere from 700 to 4,000 patients, few doctors have seendrug-related deaths, so most focus on their benefits, which allow many oftheir patients to play sports, go to work or lead normal lives.Among the drugs' supporters was Anne Dorsey of Baltimore, who described whenher 13-year-old son, n, nearly died from an asthma attack. nspends much of his life in the hospital and is now taking Advair."I have to ask you not to let him perish" by banning the drugs, Ms. Dorseysaid.Then n stepped to the microphone and in a reedy voice said that Advairhad cut the time spent in the hospital in half. "Life got a lot easier," hesaid, "and without Advair, I don't know what I'd do."The American Academy of Pediatrics, American Thoracic Society, AmericanAcademy of Allergy Asthma and Immunology, and American College of AllergyAsthma and Immunology all support the continued use of the medicines.Some experts say that although long-acting beta agonists may make patientsfeel better, they have few concrete benefits that justify risking death.Dr. P. Hennessy, a panel member from the University of Pennsylvania,called for Glaxo to start a large safety study of Advair. "Given theproblems and the nearly $8 billion in revenue earned from Advair," Dr.Hennessy, "this seems imminently plausible."Dr. ez, director of the Arizona Respiratory Center at theUniversity of Arizona, said far too many patients whose conditions could betreated adequately with steroids alone were instead receiving Advair orSymbicort, which are riskier and more expensive. Dr. ez blamed heavymarketing by Glaxo of Advair instead of Flovent, which contains only asteroid. "In the last two years," he said, "I haven't seen a single ad forFlovent, but I have seen many for Advair."Stan Hull, a Glaxo senior vice president, said, "That's absolutely nottrue.""The reason physicians use Advair over Flovent," he said, "is that Advairhas been shown to be superior to Flovent in providing control over asthma."Doctors face difficult choices with children whose asthma remainsuncontrolled with low-dose steroid treatment. If they increase the steroiddose, the risks include stunted growth, acne, greater vulnerability toinfections and changes to skin, eyes and bone. If they add a long-actingbeta agonist, the risk of death, although small, increases.The beta agonists, by relaxing bronchial spasms, treat mild symptoms andmake patients feel better immediately. Feeling better, these patients maydecide against taking the steroids since steroids have few immediatebenefits. Indeed, patients prescribed both drugs separately get fewerrefills of the steroid than of the beta agonists. Such patients leavethemselves vulnerable to severe attacks and death.Copyright 2008 The New York Times Company~~~~~~~~~THURSDAY, Dec. 11 (HealthDay News) - The safety of four asthma medicationswill be weighed by a U.S. Food and Drug Administration expert panel as twodays of hearings end Thursday.The controversy over these drugs has been going on for several years, withtwo FDA officials recently calling for banning the use of these drugs foranyone under 17.One expert thinks the problem is not with the drugs, but with their misuse."This is an over-interpretation of the risk without adequate considerationof benefit," said Dr. Miles Weinberger, a professor of pediatrics at theUniversity of Iowa. "However, there has been irresponsible marketing of theproducts, salmeterol and formoterol, and irresponsible prescribing by manyphysicians.""Since most patients with chronic asthma can be controlled with inhaledsteroids alone, using these more expensive combination formulations as firstline is inappropriate but strongly encouraged by marketing practices" ofdrug makers, Weinberger said.The products under review are Advair (salmeterol, fluticasone), Foradil(formoterol), Serevent (salmeterol), and Symbicort (formoterol, budesonide).Advair and Symbicort are combination products containing both a long-actingbeta agonist and an inhaled corticosteroid. These drugs relax airwaymuscles, letting asthma patients breathe more easily.In the panel's first day of hearings Wednesday, FDA officials themselveswere split over the risks of the drugs.One official told the panel members that more than 14,000 people may havedied since 1994 after taking the drugs, while another suggested that an evengreater number might have died without them, according to The New YorkTimes.Last week, two FDA officials, who work in the agency's safety division,posted an assessment on the agency Web site, saying asthma sufferers of allages should not take the medicines. But a third FDA official concluded thatAdvair and Symbicort are safe for adults, but that all four drugs should nolonger be used by children 17 and younger, the Times said.The panel is reviewing an FDA study of 110 trials that included 60,954people and found an increase in asthma-related hospitalization,asthma-related intubation, and asthma-related death in asthmatic patientswith the use of these drugs. The risk varied, however, depending on theparticular drug studied.For example, there were 20 asthma-related deaths, 16 among people takinglong-acting beta agonists compared with four patients not taking thesedrugs. All the deaths were in patients taking Serevent, the FDA notes.The increased risk was seen in three of the four drugs, Foradil, Sereventand Symbicort, but was not seen with Advair. The increased risk wasn't seenwhen a long-acting beta agonist was used along with an inhaledcorticosteroid, the agency found.The greatest risk appears to be among children aged 4 to 11; women alsoappeared to be at greater risk than men.Weinberger thinks that long-acting beta agonists should be used only incombination with inhaled steroids."All trials of the combination of long-acting beta agonists and an inhaledsteroid demonstrate substantial additive effect for patients not fullycontrolled on the inhaled steroid alone," Weinberger said. "The sensibleapproach is to use the combination products only after inadequate control isobserved with an inhaled steroid alone."The drug manufacturers believe there is adequate evidence that theirproducts are safe and effective when used properly."AstraZeneca believes that Symbicort exhibits a favorable benefit-riskprofile in patients 6 years of age and older. Symbicort offers an importanttherapeutic option for asthma patients who cannot be adequately controlledon other asthma controller medications [low- to medium-dose inhaledcorticosteroids] or whose disease severity clearly warrants initiation oftreatment with two maintenance therapies," the company said in a statementfiled with the FDA.GlaxoKline said in its statement: "The combination of salmeterol withan inhaled corticosteroid provides unsurpassed asthma control to patients byimproving lung function, preventing daytime and night-time symptoms anddecreasing the use of rescue medications. For Advair, there was no evidenceof increased risk for asthma-related death, asthma-related hospitalization,asthma-related intubation and all-cause death in any database. Therefore, noregulatory action is necessary for this product."A third company, Novartis, noted that "given the benefits associated withlong-acting beta 2-agonist use in asthma, Novartis believes that thebenefit-risk ratio is in favor of formoterol use as currently reflected inlabeling and treatment guidelines. Long-acting beta 2-agonists, includingformoterol, remain an important therapeutic option in the treatment ofpatients with asthma."In 2007, an FDA advisory panel urged that stronger label warnings focused onchildren be added to the packaging for Serevent and Advair.In 2006, after a 2005 panel investigation focused mainly on the drugs' useby adults, the FDA ordered a strong "black box" warning on both medicationsthat they "may increase the risk of asthma-related death."More informationFor more information on asthma, visit the U.S. National Institutes ofHealth.SOURCES: Miles Weinberger, M.D., professor, pediatrics, University of Iowa,Iowa City; U.S. Food and Drug Administration briefing documentsBy ReinbergHealthDay ReporterLast Updated: Dec. 11, 2008Copyright C 2008 ScoutNews, LLC. All rights reservedhttp://blogs.wsj.com/health/2008/12/12/why-an-fda-panel-saw-asthma-drugs-differentlyTHE WALL STREET JOURNAL December 12, 2008, 8:49 amWhy an FDA Panel Saw Asthma Drugs DifferentlyPosted by steinsymbicortAn FDA advisory panel said yesterday that two drugs, Serevent andForadil, shouldn't be used for asthma any more, and two others, Advair andSymbicort, should. So what's the difference between these drugs?This morning's New York Times gives quick overview of asthma by way ofexplanation. Asthma strikes when airways in the lungs spasm and swell,restricting the supply of oxygen. Steroid treatments reduce swelling, andbeta agonists treat spasms.Serevent, from GlaxoKline, and Foradil, from Schering-Plough andNovartis, are longer-acting beta agonists that are supposed to be used withsteroids. If they're not, they can increase the risk for even worse asthmaattacks. The FDA panel worried that a lot of people don't take the steroidas they should.Advair, also from Glaxo, and Symbicort, from AstraZeneca, combinelonger-acting beta agonists and steroids. So while some doctors still hadconcerns about the beta agonist ingredient, the panel gave the combinationdrugs the nod.Both Glaxo and Schering-Plough rejected the committee's recommendation aboutSerevent and Foradil, but said they'd cooperate with the FDA, according toNYT. The FDA isn't required to follow expert panels' advice but normallydoes.Glaxo told Bloomberg it is "confident that our proposed new labeling,medication guide and risk-management plan would help physicians safelymanage the appropriate use of Serevent," and that cutting the drug's asthmaapproval would "deny patients needed treatment for optimal care." Here arestatements from AstraZeneca and Glaxo.~~~~~~~~~THE WALL STREET JOURNALDECEMBER 11, 2008FDA Panel Says Some Asthma Drugs Too RiskyBy JENNIFER CORBETT DOORENWASHINGTON--A U.S. Food and Drug Administration panel said the risks of twoasthma drugs outweighed the benefits of their usage by children and adults.The panel said the risks of GlaxoKline PLC's asthma drug Serevent aswell as Novartis AG's and Schering-Plough Corp.'s Foradil were greater thanthe benefits of the drugs as maintenance treatments. However, the panelstopped short of recommending the drugs not be used at all. Many panelmembers said the drugs' labels should be reworded to tell doctors to useSerevent and Foradil with an inhaled corticosteroid, as current treatmentguidelines recommend.Another Glaxo drug, Advair, uses the active ingredient in Serevent alongwith an inhaled corticosteroid, and has largely replaced use of Serevent.AstraZeneca's Symbicort also includes a corticosteroid.The panel voted 10 to 17 on a question that asked if the benefits ofSerevent outweigh the risks as a maintenance treatment in adult asthmapatients, and six to 21 for adolescents ages 12 to 17. Panel votes onForadil were 9 to 18 for adults, 6 to 21 for adolescents. The panelunanimously said the benefits didn't outweigh the risks for Serevent andForadil in children ages 11 and younger.For Advair, the panel unanimously backed its use in adults, but morenarrowly recommended it for children. The panel voted 23-3, with one memberabstaining, for Advair's use in adolescents ages 12 to 17, and voted 13-11for its use in children ages 4 to 11, with three members abstaining.The FDA has asked the panel of outside medical experts for advice on whetherto allow certain drugs to continue to be marketed for the treatment ofasthma in children and adults amid lingering concerns that the productsincrease the risk of asthma-related side effects.The drugs, known as long-acting beta-agonists, or LABAs, are used by aboutsix million asthma patients whose symptoms aren't well-controlled by otherdrugs including inhaled corticosteroids, which are the backbone of asthmatreatment, and are designed to reduce airway inflammation.Long-acting drugs have been the subject of a continuing FDA safety reviewfor several years and the drugs' labels already warn they could "increasethe risk of asthma-related death." The drugs are designed to prevent thetightening of muscles around the airway. About 22 million Americans,including about 6.5 million children, have asthma, a chronic conditionmarked by narrowing of the airways.The FDA's drug-safety division is recommending that the drugs not bemarketed for children, and in some cases adults, while the agency'spulmonary division stated that removing the products from the market wouldbe "extreme."Both the FDA and the companies presented data to the panel. The FDA'sanalysis of the four drugs said, as a group, that the products are linkedwith an increased risk of asthma-related side effects, with higher risksseen in children. It looked at whether the drugs increased a combinedmeasure of asthma-related death, hospitalization and asthma-relatedintubations, or the placement of a tube in patients' noses or mouths to helpthem breathe. Overall, it found an additional 2.8 asthma events per 1,000patients treated with a LABA compared with patients not receiving the drugs.When looking at specific drugs, the FDA said the risk was seen with Foradil,Serevent and Symbicort "but was not apparent in Advair," which is Glaxo'stop-selling drug as well as the dominant drug in the class. The agency alsosaid the increased risk was far less when using inhaled corticosteroids,which current asthma-treatment guidelines recommend.WASHINGTON--A U.S. Food and Drug Administration panel unanimously backed theuse of GlaxoKline PLC's asthma drug Advair in adults.The panel voted 27-0 in the affirmative to the question that asked if thebenefits of the drug outweighed the risks. Advair is Glaxo's top-sellingdrug and had U.S. sales of $2.9 billion through the first nine months of theyear. The panel voted 23-3, with one member abstaining, in saying thebenefits outweighed the risks in adolescents ages 12 to 17.The panel more narrowly backed the use of Advair in children ages 4 to 11with a vote of 13 to 11, with three members abstaining. Several panelmembers said they struggled with their decision because of a relative lackof clinical data in that age group.The panel is discussing the class of drugs into which Advair falls. Thedrugs, known as long-acting beta-agonists, or LABAs, are used by about sixmillion asthma patients whose symptoms aren't well-controlled by otherdrugs, including inhaled corticosteroids, which are the backbone of asthmatreatment and are designed to reduce airway inflammation. Advair containsboth a long-acting ingredient and an inhaled corticosteroid.The FDA has asked the panel of outside medical experts for advice on whetherto allow certain drugs to continue to be marketed for the treatment ofasthma in children and adults amid lingering concerns that the productsincrease the risk of asthma-related side effects.Write to Corbett Dooren at jennifer.corbett-dooren@...Copyright 2008 Dow & Company, Inc. FAIR USE NOTICE: This may contain copyrighted (C ) material the use of whichhas not always been specifically authorized by the copyright owner. Suchmaterial is made available for educational purposes, to advanceunderstanding of human rights, democracy, scientific, moral, ethical, andsocial justice issues, etc. It is believed that this constitutes a 'fairuse' of any such copyrighted material as provided for in Title 17 U.S.C.section 107 of the US Copyright Law. This material is distributed withoutprofit. =====In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.

[Guest guest]

And, by the way,http://snipurl.com/7r0zq  [www_associatedcontent_com] Many Doctors Push Flu Vaccine, Don't Get it ThemselvesOther Tips to Stay Flu Free This SeasonBy  F. Sullivan, published Dec 09, 2008As the United States enters the winter season, it is very likely that a bulk of U.S. citizens haven't gotten the flu vaccination to protect themselves against the influenza virus. According to ABC News, many of those people are the doctors and nurses telling us to get the vaccine in the first place. During the 2006-07 flu season, only 40 percent of health care practitioners got the vaccine.=====ALLIANCE FOR HUMAN RESEARCH PROTECTIONPromoting Openness, Full Disclosure, and Accountabilityhttp://www.ahrp.org and http://ahrp.blogspot.comFYITrust in medicine?The New York Times reports (below) that an FDA advisory panel voted to bantwo of the four asthma drugs that FDA drug safety officers had warned, putasthmatic patients at risk of sudden deaths. http://www.ahrp.blogspot.com/http://www.nytimes.com/2008/12/06/health/policy/06allergy.htmlThe Wall Street Journal reports that "the panel stopped short ofrecommending the drugs not be used at all..."http://blogs.wsj.com/health/2008/12/12/why-an-fda-panel-saw-asthma-drugs-differentlyWhich is it?The panel voted to continue marketing Advair, (GlaxoKline) andSymbicort (AstraZeneca) for asthma, but not Serevent (Glaxo) and Foradil(Novartis).The panel's recommendations came after several top F.D.A. drug safetyexperts had recommended earlier this month that all four asthma drugs shouldbe banned from treating asthmatic children and adults because they werelinked to sudden deaths.Dr. Joad, a panel member and pediatrician from the University ofCalifornia Medical Center, said she did not "want to give a drug thatis making the disease you're treating worse."Dr. ez, director of the Arizona Respiratory Center at theUniversity of Arizona, said far too many patients whose conditions could betreated adequately with steroids alone were instead receiving Advair orSymbicort, which are riskier and more expensive. Dr. ez blamed heavymarketing by Glaxo of Advair instead of Flovent, which contains only asteroid. "In the last two years," he said, "I haven't seen a single ad forFlovent, but I have seen many for Advair."However, FDA decisions are far more influenced by the business interests ofprescription drug manufacturers--whom agency officials regard as theirclients--than they are by drug safety considerations affecting Americancitizens.The financial stakes are high: Through the first nine months of this year,Advair's sales were $5.66 billion, and Symbicort's were $209 million. Lastyear, Serevent's sales were $538 million and Foradil's were $362 million.Even if the agency follows the panel's advice, all four drugs will remain onthe market since Serevent and Foradil are also approved to treat chronicobstructive pulmonary disorders like emphysema. So, doctors can prescribethem off-label for just about anything.Trust in industry-funded medical associations?True to form, the following professional medical associations appeared toprotect their financial interests by expressing support for the continueduse of all four of these medicines despite the avoidable risks of death: TheAmerican Academy of Pediatrics, American Thoracic Society, American Academyof Allergy Asthma and Immunology, and American College of Allergy Asthma andImmunology.Contact: Vera Hassner Sharavveracare@...212-595-8974~~~~~~~~~http://www.nytimes.com/2008/12/12/health/policy/12fda.htmlTHE NEW YORK TIMESDecember 12, 2008F.D.A. Panel Votes to Ban Asthma DrugsBy GARDINER HARRISROCKVILLE, Md. - A panel of federal drug experts voted on Thursday that thedrugs Serevent and Foradil should be banned from use in the treatment ofasthma, but the experts said that Advair and Symbicort, which together arefar more popular, should continue to be used.The experts, gathered by the Food and Drug Administration, said that toomany doctors used Serevent and Foradil inappropriately and that asthmaticpatients were often fooled by their own symptoms and used them incorrectly.Serevent and Foradil widen lung airways but increase the risks of deathunless paired with a steroid. The drugs' labels already warn of this riskbut half of patients taking the medicines do not get a steroid. Even whenpatients are prescribed a steroid, many fail to take it.GlaxoKline, the maker of Serevent, and Novartis and Schering-Plough,the marketers of Foradil, argued that doctors want the freedom to mix andmatch these drugs with steroids. But Dr. Joad, a panel member andpediatrician from the University of California Medical Center, saidshe did not "want to give a drug that is making the disease you're treatingworse."Dr. , a top F.D.A. official, cautioned that patients shouldconsult their doctor before stopping any asthma drug regimen. And Dr. said the agency would consider requiring drugmakers to undertakelarge studies to assess the safety of Advair and Symbicort, particularly inchildren.The drugs' makers rejected the committee's decision to ban Serevent's andForadil's use in asthma, although each said that it would cooperate with theagency.Last year, Serevent's sales were $538 million and Foradil's were $362million. Through the first nine months of this year, Advair's sales were$5.66 billion, and Symbicort's were $209 million.Serevent and Foradil are also approved to treat chronic obstructivepulmonary disorders like emphysema. So even if the agency follows thepanel's advice, the drugs will remain on the market.Asthma is caused when airways in the lungs spasm and swell, restricting thesupply of oxygen. The two primary treatments are steroids, which reduceswelling, and beta agonists, which treat spasms. Rescue inhalers usuallycontain albuterol, a short-acting beta agonist.Serevent and Foradil are longer-acting beta agonists intended to preventattacks. Used without a steroid, however, these drugs have been shown toincrease the risks of more severe attacks. Advair and Symbicort combinelonger-acting beta agonists with steroids in a single inhaler.The expert panel voted unanimously to ban the use of Serevent and Foradil inchildren, but for adults, it voted 17 to 10 to ban Serevent and 18 to 9 toban Foradil. It voted unanimously that Advair should continue to be used inasthmatic adults and supported its use in adolescents by 23 to 3 and inchildren by 13 to 11. Symbicort's use in adults was supported unanimously,while its use in adolescents was supported 20 to 5. Symbicort is notapproved for use in children.Earlier, some top F.D.A. safety experts recommended that all four drugsshould be banned from treating asthma, while other agency experts said thedrugs' benefits outweighed their risks.Like other drug-safety controversies, the debate largely pits those whotreat patients against those who study populations. Since the drugs may leadto one death in somewhere from 700 to 4,000 patients, few doctors have seendrug-related deaths, so most focus on their benefits, which allow many oftheir patients to play sports, go to work or lead normal lives.Among the drugs' supporters was Anne Dorsey of Baltimore, who described whenher 13-year-old son, n, nearly died from an asthma attack. nspends much of his life in the hospital and is now taking Advair."I have to ask you not to let him perish" by banning the drugs, Ms. Dorseysaid.Then n stepped to the microphone and in a reedy voice said that Advairhad cut the time spent in the hospital in half. "Life got a lot easier," hesaid, "and without Advair, I don't know what I'd do."The American Academy of Pediatrics, American Thoracic Society, AmericanAcademy of Allergy Asthma and Immunology, and American College of AllergyAsthma and Immunology all support the continued use of the medicines.Some experts say that although long-acting beta agonists may make patientsfeel better, they have few concrete benefits that justify risking death.Dr. P. Hennessy, a panel member from the University of Pennsylvania,called for Glaxo to start a large safety study of Advair. "Given theproblems and the nearly $8 billion in revenue earned from Advair," Dr.Hennessy, "this seems imminently plausible."Dr. ez, director of the Arizona Respiratory Center at theUniversity of Arizona, said far too many patients whose conditions could betreated adequately with steroids alone were instead receiving Advair orSymbicort, which are riskier and more expensive. Dr. ez blamed heavymarketing by Glaxo of Advair instead of Flovent, which contains only asteroid. "In the last two years," he said, "I haven't seen a single ad forFlovent, but I have seen many for Advair."Stan Hull, a Glaxo senior vice president, said, "That's absolutely nottrue.""The reason physicians use Advair over Flovent," he said, "is that Advairhas been shown to be superior to Flovent in providing control over asthma."Doctors face difficult choices with children whose asthma remainsuncontrolled with low-dose steroid treatment. If they increase the steroiddose, the risks include stunted growth, acne, greater vulnerability toinfections and changes to skin, eyes and bone. If they add a long-actingbeta agonist, the risk of death, although small, increases.The beta agonists, by relaxing bronchial spasms, treat mild symptoms andmake patients feel better immediately. Feeling better, these patients maydecide against taking the steroids since steroids have few immediatebenefits. Indeed, patients prescribed both drugs separately get fewerrefills of the steroid than of the beta agonists. Such patients leavethemselves vulnerable to severe attacks and death.Copyright 2008 The New York Times Company~~~~~~~~~THURSDAY, Dec. 11 (HealthDay News) - The safety of four asthma medicationswill be weighed by a U.S. Food and Drug Administration expert panel as twodays of hearings end Thursday.The controversy over these drugs has been going on for several years, withtwo FDA officials recently calling for banning the use of these drugs foranyone under 17.One expert thinks the problem is not with the drugs, but with their misuse."This is an over-interpretation of the risk without adequate considerationof benefit," said Dr. Miles Weinberger, a professor of pediatrics at theUniversity of Iowa. "However, there has been irresponsible marketing of theproducts, salmeterol and formoterol, and irresponsible prescribing by manyphysicians.""Since most patients with chronic asthma can be controlled with inhaledsteroids alone, using these more expensive combination formulations as firstline is inappropriate but strongly encouraged by marketing practices" ofdrug makers, Weinberger said.The products under review are Advair (salmeterol, fluticasone), Foradil(formoterol), Serevent (salmeterol), and Symbicort (formoterol, budesonide).Advair and Symbicort are combination products containing both a long-actingbeta agonist and an inhaled corticosteroid. These drugs relax airwaymuscles, letting asthma patients breathe more easily.In the panel's first day of hearings Wednesday, FDA officials themselveswere split over the risks of the drugs.One official told the panel members that more than 14,000 people may havedied since 1994 after taking the drugs, while another suggested that an evengreater number might have died without them, according to The New YorkTimes.Last week, two FDA officials, who work in the agency's safety division,posted an assessment on the agency Web site, saying asthma sufferers of allages should not take the medicines. But a third FDA official concluded thatAdvair and Symbicort are safe for adults, but that all four drugs should nolonger be used by children 17 and younger, the Times said.The panel is reviewing an FDA study of 110 trials that included 60,954people and found an increase in asthma-related hospitalization,asthma-related intubation, and asthma-related death in asthmatic patientswith the use of these drugs. The risk varied, however, depending on theparticular drug studied.For example, there were 20 asthma-related deaths, 16 among people takinglong-acting beta agonists compared with four patients not taking thesedrugs. All the deaths were in patients taking Serevent, the FDA notes.The increased risk was seen in three of the four drugs, Foradil, Sereventand Symbicort, but was not seen with Advair. The increased risk wasn't seenwhen a long-acting beta agonist was used along with an inhaledcorticosteroid, the agency found.The greatest risk appears to be among children aged 4 to 11; women alsoappeared to be at greater risk than men.Weinberger thinks that long-acting beta agonists should be used only incombination with inhaled steroids."All trials of the combination of long-acting beta agonists and an inhaledsteroid demonstrate substantial additive effect for patients not fullycontrolled on the inhaled steroid alone," Weinberger said. "The sensibleapproach is to use the combination products only after inadequate control isobserved with an inhaled steroid alone."The drug manufacturers believe there is adequate evidence that theirproducts are safe and effective when used properly."AstraZeneca believes that Symbicort exhibits a favorable benefit-riskprofile in patients 6 years of age and older. Symbicort offers an importanttherapeutic option for asthma patients who cannot be adequately controlledon other asthma controller medications [low- to medium-dose inhaledcorticosteroids] or whose disease severity clearly warrants initiation oftreatment with two maintenance therapies," the company said in a statementfiled with the FDA.GlaxoKline said in its statement: "The combination of salmeterol withan inhaled corticosteroid provides unsurpassed asthma control to patients byimproving lung function, preventing daytime and night-time symptoms anddecreasing the use of rescue medications. For Advair, there was no evidenceof increased risk for asthma-related death, asthma-related hospitalization,asthma-related intubation and all-cause death in any database. Therefore, noregulatory action is necessary for this product."A third company, Novartis, noted that "given the benefits associated withlong-acting beta 2-agonist use in asthma, Novartis believes that thebenefit-risk ratio is in favor of formoterol use as currently reflected inlabeling and treatment guidelines. Long-acting beta 2-agonists, includingformoterol, remain an important therapeutic option in the treatment ofpatients with asthma."In 2007, an FDA advisory panel urged that stronger label warnings focused onchildren be added to the packaging for Serevent and Advair.In 2006, after a 2005 panel investigation focused mainly on the drugs' useby adults, the FDA ordered a strong "black box" warning on both medicationsthat they "may increase the risk of asthma-related death."More informationFor more information on asthma, visit the U.S. National Institutes ofHealth.SOURCES: Miles Weinberger, M.D., professor, pediatrics, University of Iowa,Iowa City; U.S. Food and Drug Administration briefing documentsBy ReinbergHealthDay ReporterLast Updated: Dec. 11, 2008Copyright C 2008 ScoutNews, LLC. All rights reservedhttp://blogs.wsj.com/health/2008/12/12/why-an-fda-panel-saw-asthma-drugs-differentlyTHE WALL STREET JOURNAL December 12, 2008, 8:49 amWhy an FDA Panel Saw Asthma Drugs DifferentlyPosted by steinsymbicortAn FDA advisory panel said yesterday that two drugs, Serevent andForadil, shouldn't be used for asthma any more, and two others, Advair andSymbicort, should. So what's the difference between these drugs?This morning's New York Times gives quick overview of asthma by way ofexplanation. Asthma strikes when airways in the lungs spasm and swell,restricting the supply of oxygen. Steroid treatments reduce swelling, andbeta agonists treat spasms.Serevent, from GlaxoKline, and Foradil, from Schering-Plough andNovartis, are longer-acting beta agonists that are supposed to be used withsteroids. If they're not, they can increase the risk for even worse asthmaattacks. The FDA panel worried that a lot of people don't take the steroidas they should.Advair, also from Glaxo, and Symbicort, from AstraZeneca, combinelonger-acting beta agonists and steroids. So while some doctors still hadconcerns about the beta agonist ingredient, the panel gave the combinationdrugs the nod.Both Glaxo and Schering-Plough rejected the committee's recommendation aboutSerevent and Foradil, but said they'd cooperate with the FDA, according toNYT. The FDA isn't required to follow expert panels' advice but normallydoes.Glaxo told Bloomberg it is "confident that our proposed new labeling,medication guide and risk-management plan would help physicians safelymanage the appropriate use of Serevent," and that cutting the drug's asthmaapproval would "deny patients needed treatment for optimal care." Here arestatements from AstraZeneca and Glaxo.~~~~~~~~~THE WALL STREET JOURNALDECEMBER 11, 2008FDA Panel Says Some Asthma Drugs Too RiskyBy JENNIFER CORBETT DOORENWASHINGTON--A U.S. Food and Drug Administration panel said the risks of twoasthma drugs outweighed the benefits of their usage by children and adults.The panel said the risks of GlaxoKline PLC's asthma drug Serevent aswell as Novartis AG's and Schering-Plough Corp.'s Foradil were greater thanthe benefits of the drugs as maintenance treatments. However, the panelstopped short of recommending the drugs not be used at all. Many panelmembers said the drugs' labels should be reworded to tell doctors to useSerevent and Foradil with an inhaled corticosteroid, as current treatmentguidelines recommend.Another Glaxo drug, Advair, uses the active ingredient in Serevent alongwith an inhaled corticosteroid, and has largely replaced use of Serevent.AstraZeneca's Symbicort also includes a corticosteroid.The panel voted 10 to 17 on a question that asked if the benefits ofSerevent outweigh the risks as a maintenance treatment in adult asthmapatients, and six to 21 for adolescents ages 12 to 17. Panel votes onForadil were 9 to 18 for adults, 6 to 21 for adolescents. The panelunanimously said the benefits didn't outweigh the risks for Serevent andForadil in children ages 11 and younger.For Advair, the panel unanimously backed its use in adults, but morenarrowly recommended it for children. The panel voted 23-3, with one memberabstaining, for Advair's use in adolescents ages 12 to 17, and voted 13-11for its use in children ages 4 to 11, with three members abstaining.The FDA has asked the panel of outside medical experts for advice on whetherto allow certain drugs to continue to be marketed for the treatment ofasthma in children and adults amid lingering concerns that the productsincrease the risk of asthma-related side effects.The drugs, known as long-acting beta-agonists, or LABAs, are used by aboutsix million asthma patients whose symptoms aren't well-controlled by otherdrugs including inhaled corticosteroids, which are the backbone of asthmatreatment, and are designed to reduce airway inflammation.Long-acting drugs have been the subject of a continuing FDA safety reviewfor several years and the drugs' labels already warn they could "increasethe risk of asthma-related death." The drugs are designed to prevent thetightening of muscles around the airway. About 22 million Americans,including about 6.5 million children, have asthma, a chronic conditionmarked by narrowing of the airways.The FDA's drug-safety division is recommending that the drugs not bemarketed for children, and in some cases adults, while the agency'spulmonary division stated that removing the products from the market wouldbe "extreme."Both the FDA and the companies presented data to the panel. The FDA'sanalysis of the four drugs said, as a group, that the products are linkedwith an increased risk of asthma-related side effects, with higher risksseen in children. It looked at whether the drugs increased a combinedmeasure of asthma-related death, hospitalization and asthma-relatedintubations, or the placement of a tube in patients' noses or mouths to helpthem breathe. Overall, it found an additional 2.8 asthma events per 1,000patients treated with a LABA compared with patients not receiving the drugs.When looking at specific drugs, the FDA said the risk was seen with Foradil,Serevent and Symbicort "but was not apparent in Advair," which is Glaxo'stop-selling drug as well as the dominant drug in the class. The agency alsosaid the increased risk was far less when using inhaled corticosteroids,which current asthma-treatment guidelines recommend.WASHINGTON--A U.S. Food and Drug Administration panel unanimously backed theuse of GlaxoKline PLC's asthma drug Advair in adults.The panel voted 27-0 in the affirmative to the question that asked if thebenefits of the drug outweighed the risks. Advair is Glaxo's top-sellingdrug and had U.S. sales of $2.9 billion through the first nine months of theyear. The panel voted 23-3, with one member abstaining, in saying thebenefits outweighed the risks in adolescents ages 12 to 17.The panel more narrowly backed the use of Advair in children ages 4 to 11with a vote of 13 to 11, with three members abstaining. Several panelmembers said they struggled with their decision because of a relative lackof clinical data in that age group.The panel is discussing the class of drugs into which Advair falls. Thedrugs, known as long-acting beta-agonists, or LABAs, are used by about sixmillion asthma patients whose symptoms aren't well-controlled by otherdrugs, including inhaled corticosteroids, which are the backbone of asthmatreatment and are designed to reduce airway inflammation. Advair containsboth a long-acting ingredient and an inhaled corticosteroid.The FDA has asked the panel of outside medical experts for advice on whetherto allow certain drugs to continue to be marketed for the treatment ofasthma in children and adults amid lingering concerns that the productsincrease the risk of asthma-related side effects.Write to Corbett Dooren at jennifer.corbett-dooren@...Copyright 2008 Dow & Company, Inc. FAIR USE NOTICE: This may contain copyrighted (C ) material the use of whichhas not always been specifically authorized by the copyright owner. Suchmaterial is made available for educational purposes, to advanceunderstanding of human rights, democracy, scientific, moral, ethical, andsocial justice issues, etc. It is believed that this constitutes a 'fairuse' of any such copyrighted material as provided for in Title 17 U.S.C.section 107 of the US Copyright Law. This material is distributed withoutprofit. =====In accordance with Title 17 U.S.C. 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