OT - FDA Safety Scientists Warn About Deaths from 4 Asthma Drugs

[Guest guest]

Companion piece:http://www.naturalnews.com/021872.html============Begin forwarded message:ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org and http://ahrp.blogspot.com FYIThe New York Times reports (below) "Two federal drug officials haveconcluded that asthma sufferers risk death if they continue to use fourhugely popular asthma drugs - Advair, Symbicort, Serevent andForadil...."Sudden deaths among asthmatics still clutching their inhalershave fed the debate."No sooner was Serevent approved in 1994, than the agency began receivingreports of deaths. A letter to the New England Journal of Medicine describedtwo elderly patients who died holding Serevent inhalers. Glaxo warnedpatients that the medicine, unlike albuterol, does not work instantly andshould not be used during an attack.In 1996, Glaxo began a study of Serevent's safety, but the company refusedfor years to report the results until 2003 when Glaxo reported that patientsgiven the medicine were more likely to die than those given placeboinhalers. What led FDA officials to remain silent about the lethal risk for7 years!!!  Glaxo said problems with the trial made its results impossibleto interpret.So, what scientific evidence leads agency officials and others to disagreeabout the drug's safety hazard? Could the high financial stakes involvedhave greater persuasive power than the evidence???Last year, Advair sales were $6.9 billion and may approach $8 billion thisyear, making the medication GlaxoKline's biggest seller and one of thebiggest-selling drugs in the world.  Dr. Katharine Knobil, global clinicalvice president for Glaxo, dismissed the conclusions of FDA's drug-safetydivision as "not supported by their own data." Whose drug safety assessment do you trust?Contact: Vera Hassner Sharavveracare@...212-595-8974http://www.nytimes.com/2008/12/06/health/policy/06allergy.html THE NEW YORK TIMEWDecember 6, 2008Warning Given on Use of 4 Popular Asthma Drugs, but Debate RemainsBy GARDINER HARRISWASHINGTON - Two federal drug officials have concluded that asthma sufferersrisk death if they continue to use four hugely popular asthma drugs -Advair, Symbicort, Serevent and Foradil. But the officials' views are notuniversally shared within the government.The two officials, who work in the safety division of the Food and DrugAdministration, wrote in an assessment on the agency's Web site on Fridaythat asthma sufferers of all ages should no longer take the medicines. Athird drug-safety official concluded that Advair and Symbicort could be usedby adults but that all four drugs should no longer be used by people age 17and under.Dr. Badrul A. Chowdhury, director of the division of pulmonary and allergyproducts at the agency, cautioned in his own assessment that the risk ofdeath associated with the drugs was small and that banning their use "wouldbe an extreme approach" that could lead asthmatics to rely on other riskymedications.Once unheard of, public disagreements among agency experts have occurred onoccasion in recent years. The agency is convening a committee of experts onWednesday and Thursday to sort out the disagreement, which has divided notonly the F.D.A. but also clinicians and experts for more than a decade.Sudden deaths among asthmatics still clutching their inhalers have fed thedebate. But trying to determine whether the deaths were caused by patients'breathing problems or the inhalers has proved difficult.The stakes for drug makers are high. Advair sales last year were $6.9billion and may approach $8 billion this year, making the medicationGlaxoKline's biggest seller and one of the biggest-selling drugs in theworld. Glaxo also sells Serevent, which had $538 million in sales last year.Symbicort is made by AstraZeneca and Foradil by Novartis.Whatever the committee's decision, the drugs will almost certainly remain onthe market because even the agency's drug-safety officials concluded thatthey were useful in patients suffering from chronic obstructive pulmonarydisease, nearly all of whom are elderly.Dr. Katharine Knobil, global clinical vice president for Glaxo, dismissedthe conclusions of the agency's drug-safety division as "not supported bytheir own data." Dr. Knobil said that Advair was safe and that Serevent wassafe when used with a steroid.Michele Meeker, a spokeswoman for AstraZeneca, said that the F.D.A.'s safetydivision improperly excluded most studies of Symbicort in its analysis, andthat a review of all of the information shows that the drug does notincrease the risks of death or hospitalization.Dr. Frattarelli, a Detroit pediatrician and member of the AmericanAcademy of Pediatrics's committee on drugs, said that he was treatingchildren with Advair and that his committee had recently discussed thesafety of the medicines."Most of us felt these were pretty good drugs," Dr. Frattarelli said. "I'mreally looking forward to hearing what the F.D.A. committee decides."About 9 percent of Advair's prescriptions go to those age 17 and under,according to Glaxo. Ms. Meeker could not provide similar figures forSymbicort.In 1994, Serevent was approved for sale, and the F.D.A. began receivingreports of deaths. A letter to the New England Journal of Medicine describedtwo elderly patients who died holding Serevent inhalers. Glaxo warnedpatients that the medicine, unlike albuterol, does not work instantly andshould not be used during an attack.In 1996, Glaxo began a study of Serevent's safety, but the company refusedfor years to report the results publicly. In 2001, the company introducedAdvair, whose sales quickly cannibalized those of Serevent and then farsurpassed them.Finally in 2003, Glaxo reported the results of its Serevent study, whichshowed that those given the medicine were more likely to die than thosegiven placebo inhalers. Glaxo said problems with the trial made its resultsimpossible to interpret.Asthma is caused when airways within the lungs spasm and swell, restrictingthe supply of oxygen. The two primary treatments are steroids, which reduceswelling, and beta agonists, which treat spasms. Rescue inhalers usuallycontain albuterol, which is a beta agonist with limited duration. Sereventand Foradil are both beta agonists but have a longer duration than albuteroland were intended to be taken daily to prevent attacks.Advair contains Serevent and a steroid. Symbicort, introduced last year,contains Foradil and a steroid. In the first nine months of this year,Symbicort had $209 million in sales.The problem with albuterol is that it seems to make patients' lungs morevulnerable to severe attacks, which is why asthmatics are advised to usetheir rescue inhalers only when needed. The long-acting beta agonists mayhave the same risks.But drug makers say this risk disappears when long-acting beta agonists arepaired with steroids. The labels that accompany Serevent and Foradilinstruct doctors to pair the medicines with an inhaled steroid.Copyright 2008 The New York Times CompanyFAIR 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]

Companion piece:http://www.naturalnews.com/021872.html============Begin forwarded message:ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org and http://ahrp.blogspot.com FYIThe New York Times reports (below) "Two federal drug officials haveconcluded that asthma sufferers risk death if they continue to use fourhugely popular asthma drugs - Advair, Symbicort, Serevent andForadil...."Sudden deaths among asthmatics still clutching their inhalershave fed the debate."No sooner was Serevent approved in 1994, than the agency began receivingreports of deaths. A letter to the New England Journal of Medicine describedtwo elderly patients who died holding Serevent inhalers. Glaxo warnedpatients that the medicine, unlike albuterol, does not work instantly andshould not be used during an attack.In 1996, Glaxo began a study of Serevent's safety, but the company refusedfor years to report the results until 2003 when Glaxo reported that patientsgiven the medicine were more likely to die than those given placeboinhalers. What led FDA officials to remain silent about the lethal risk for7 years!!!  Glaxo said problems with the trial made its results impossibleto interpret.So, what scientific evidence leads agency officials and others to disagreeabout the drug's safety hazard? Could the high financial stakes involvedhave greater persuasive power than the evidence???Last year, Advair sales were $6.9 billion and may approach $8 billion thisyear, making the medication GlaxoKline's biggest seller and one of thebiggest-selling drugs in the world.  Dr. Katharine Knobil, global clinicalvice president for Glaxo, dismissed the conclusions of FDA's drug-safetydivision as "not supported by their own data." Whose drug safety assessment do you trust?Contact: Vera Hassner Sharavveracare@...212-595-8974http://www.nytimes.com/2008/12/06/health/policy/06allergy.html THE NEW YORK TIMEWDecember 6, 2008Warning Given on Use of 4 Popular Asthma Drugs, but Debate RemainsBy GARDINER HARRISWASHINGTON - Two federal drug officials have concluded that asthma sufferersrisk death if they continue to use four hugely popular asthma drugs -Advair, Symbicort, Serevent and Foradil. But the officials' views are notuniversally shared within the government.The two officials, who work in the safety division of the Food and DrugAdministration, wrote in an assessment on the agency's Web site on Fridaythat asthma sufferers of all ages should no longer take the medicines. Athird drug-safety official concluded that Advair and Symbicort could be usedby adults but that all four drugs should no longer be used by people age 17and under.Dr. Badrul A. Chowdhury, director of the division of pulmonary and allergyproducts at the agency, cautioned in his own assessment that the risk ofdeath associated with the drugs was small and that banning their use "wouldbe an extreme approach" that could lead asthmatics to rely on other riskymedications.Once unheard of, public disagreements among agency experts have occurred onoccasion in recent years. The agency is convening a committee of experts onWednesday and Thursday to sort out the disagreement, which has divided notonly the F.D.A. but also clinicians and experts for more than a decade.Sudden deaths among asthmatics still clutching their inhalers have fed thedebate. But trying to determine whether the deaths were caused by patients'breathing problems or the inhalers has proved difficult.The stakes for drug makers are high. Advair sales last year were $6.9billion and may approach $8 billion this year, making the medicationGlaxoKline's biggest seller and one of the biggest-selling drugs in theworld. Glaxo also sells Serevent, which had $538 million in sales last year.Symbicort is made by AstraZeneca and Foradil by Novartis.Whatever the committee's decision, the drugs will almost certainly remain onthe market because even the agency's drug-safety officials concluded thatthey were useful in patients suffering from chronic obstructive pulmonarydisease, nearly all of whom are elderly.Dr. Katharine Knobil, global clinical vice president for Glaxo, dismissedthe conclusions of the agency's drug-safety division as "not supported bytheir own data." Dr. Knobil said that Advair was safe and that Serevent wassafe when used with a steroid.Michele Meeker, a spokeswoman for AstraZeneca, said that the F.D.A.'s safetydivision improperly excluded most studies of Symbicort in its analysis, andthat a review of all of the information shows that the drug does notincrease the risks of death or hospitalization.Dr. Frattarelli, a Detroit pediatrician and member of the AmericanAcademy of Pediatrics's committee on drugs, said that he was treatingchildren with Advair and that his committee had recently discussed thesafety of the medicines."Most of us felt these were pretty good drugs," Dr. Frattarelli said. "I'mreally looking forward to hearing what the F.D.A. committee decides."About 9 percent of Advair's prescriptions go to those age 17 and under,according to Glaxo. Ms. Meeker could not provide similar figures forSymbicort.In 1994, Serevent was approved for sale, and the F.D.A. began receivingreports of deaths. A letter to the New England Journal of Medicine describedtwo elderly patients who died holding Serevent inhalers. Glaxo warnedpatients that the medicine, unlike albuterol, does not work instantly andshould not be used during an attack.In 1996, Glaxo began a study of Serevent's safety, but the company refusedfor years to report the results publicly. In 2001, the company introducedAdvair, whose sales quickly cannibalized those of Serevent and then farsurpassed them.Finally in 2003, Glaxo reported the results of its Serevent study, whichshowed that those given the medicine were more likely to die than thosegiven placebo inhalers. Glaxo said problems with the trial made its resultsimpossible to interpret.Asthma is caused when airways within the lungs spasm and swell, restrictingthe supply of oxygen. The two primary treatments are steroids, which reduceswelling, and beta agonists, which treat spasms. Rescue inhalers usuallycontain albuterol, which is a beta agonist with limited duration. Sereventand Foradil are both beta agonists but have a longer duration than albuteroland were intended to be taken daily to prevent attacks.Advair contains Serevent and a steroid. Symbicort, introduced last year,contains Foradil and a steroid. In the first nine months of this year,Symbicort had $209 million in sales.The problem with albuterol is that it seems to make patients' lungs morevulnerable to severe attacks, which is why asthmatics are advised to usetheir rescue inhalers only when needed. The long-acting beta agonists mayhave the same risks.But drug makers say this risk disappears when long-acting beta agonists arepaired with steroids. The labels that accompany Serevent and Foradilinstruct doctors to pair the medicines with an inhaled steroid.Copyright 2008 The New York Times CompanyFAIR 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.