Guest guest Posted February 11, 2005 Report Share Posted February 11, 2005 > > > > " Senator Says F.D.A. Asked Canada Not to Suspend ADHD Drug > Spotlight on Adderall " > > > " The controversy . . . promises to engulf the F.D.A. > in more questions about its oversight of the > pharmaceutical industry. " > > > [by Gardiner And Benedict Carey, NY times.] > http://www.nytimes.com/2005/02/11/politics/11drug.html? pagewanted=print & posi > tion= > > A day after Canadian officials suspended the use of a hyperactivity > drug amid reports of deaths associated with its use, Senator E. > Grassley of Iowa contended that United States health officials had asked the > Canadian regulators not to do so. > Senator Grassley, a Republican, said on Thursday that the Food and > Drug Administration had made the request of Canadian health officials > because the F.D.A. could not handle another " drug safety crisis. " Mr. > Grassley said he was basing his contentions on reports from whistle-blowers > within the agency. > Dr. , director general of the therapeutic products > directorate at Health Canada, said through a spokeswoman that reports that > F.D.A. had asked Health Canada to refrain from suspending the drug " are > untrue. " > Brad Stone, a spokesman for the F.D.A., declined to respond directly > to Mr. Grassley's contention but said of Dr. 's rejection that, " We > believe the Canadian response is the correct one. " Canadian health > officials, citing 20 deaths among patients taking the British-made drug > Adderall XR, said on Wednesday night that they were suspending sales of the > hyperactivity drug indefinitely. The F.D.A. is allowing the drug to continue > to be sold in the United States, saying there is little evidence that > Adderall XR caused the deaths. > Mr. Grassley, who has been investigating the Food and Drug > Administration for about a year, demanded in a letter written on Thursday > that the agency answer questions about any discussions its officials may > have had with the Canadians about the drug. > Dr. Temple, director of the F.D.A.'s office of medical > affairs, > said the agency's decision to permit the continued sale of Adderall was not > influenced by the controversies swirling around the F.D.A. > " It's still our job to get as close as we can to the right answer and > not panic and do things for the wrong reasons, " Dr. Temple said. > Cabrey, a spokesman for the maker of Adderall, Shire > Pharmaceuticals Group of Britain, said Adderall was safe and effective. " We > are very surprised at the actions of Health Canada, and we disagree with > their interpretations of the data around these extremely rare cases of > sudden death, " Mr. Cabrey said. > The controversy - and the sudden appearance of Mr. Grassley, the > chairman of the Senate Finance Committee, in it - promises to engulf the > F.D.A. in more questions about its oversight of the pharmaceutical industry. > Critics have accused agency officials of being too cozy with drug > makers and of being slower than their counterparts in other nations to > acknowledge drug-safety problems. > The controversy is also bound to fuel a long-running battle over > whether drugs like Adderall and Ritalin are overprescribed to children, and > whether the drugs' longterm risks have been adequately explored. > More than 700,000 Americans use Adderall and its extended release > counterpart, Adderall XR. Shire sold $759 million of Adderall products in > the United States last year and $10 million in Canada. > In the letter Thursday to the F.D.A., Mr. Grassley wrote that reports > given to his staff suggested that the agency was not acting with scientific > integrity. > " Unfortunately, such allegations raise additional concerns about the > culture at the F.D.A., " he wrote. > Dr. of Health Canada described discussions between the two > regulatory bodies as " collegial. " > Differing health regulations govern the differing responses of the > two > agencies to the Adderall reports, Dr. said. Canadian law lets > regulators suspend a drug's sales while safety questions are investigated; > United States law does not. Health Canada approved Shire's application to > sell Adderall XR in January 2004. In September, the company reported to > Canadian authorities that 20 people, 12 of them children, had died suddenly > in the United States while taking the drug. > Shire asked the Canadian regulators for permission to change the > drug's label to reflect the possible dangers, as had been done in the United > States that month. > Some of the deaths, which had not been previously reported to > Canadian > authorities, occurred well before Health Canada approved Adderall XR for > sale, Dr. said. > Canada and the United States both require pharmaceutical companies to > report all adverse outcomes from drugs promptly. > " We were surprised to find these cases, " Dr. said in an > interview on Thursday. > Dr. said that an early analysis of the data suggested that > Adderall XR might be linked to two to three times as many sudden deaths as > Ritalin and its cousin, Concerta, which are prescribed for similar > disorders. > Further, Dr. said that Canadian authorities were uncertain > about how to warn patients about the risks of sudden death. > " It's very difficult to generate a benefit-to-risk balance when the > risk is sudden and unexpected death, " Dr. said. > Mr. Cabrey of Shire Pharmaceuticals said that the company had > forwarded reports of the deaths to Canadian authorities promptly. > Dr. Temple of the F.D.A. said that 7 children taking Ritalin and > Concerta died during the same period that 12 children taking Adderall died, > suggesting equivalent risks. Many had structural problems with their hearts > and several were engaged in vigorous exercise, he said. > There is little evidence that the drugs caused any of the deaths, he > said. " There is a tendency to believe that sudden death doesn't occur in > children. That is wrong, " Dr. Temple said. He added: " Psychiatrists say that > these drugs are needed. To get rid of them for something that may well be a > background rate of death is not responsible. " Doctors have known since the > 1930's that stimulant medications like these can calm hyperactive, or > aggressive, children. But no one knows precisely how the drugs induce this > effect, and there have always been concerns about the drugs' long- term > effect on development. > Prescriptions for these drugs to be used by children with > attention-deficit disorder more than doubled in the 1990's, experts say, > heightening the concerns of some doctors. > The drugs are far more popular in the United States than in Europe. > Last year, doctors in the United States wrote more than 23 million > prescriptions for the four most popular drugs used to treat attention > deficit disorder. > > -- > DO SOMETHING ABOUT AUTISM NOW < -- > > SUBSCRIBE. . . ! > . . .Read, then Forward the Schafer Autism Report. > To Subscribe http://www.SARnet.org/ > Or mailto:subs@d... No Cost! > _______________________________________________________ Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 11, 2005 Report Share Posted February 11, 2005 > > > > " Senator Says F.D.A. Asked Canada Not to Suspend ADHD Drug > Spotlight on Adderall " > > > " The controversy . . . promises to engulf the F.D.A. > in more questions about its oversight of the > pharmaceutical industry. " > > > [by Gardiner And Benedict Carey, NY times.] > http://www.nytimes.com/2005/02/11/politics/11drug.html? pagewanted=print & posi > tion= > > A day after Canadian officials suspended the use of a hyperactivity > drug amid reports of deaths associated with its use, Senator E. > Grassley of Iowa contended that United States health officials had asked the > Canadian regulators not to do so. > Senator Grassley, a Republican, said on Thursday that the Food and > Drug Administration had made the request of Canadian health officials > because the F.D.A. could not handle another " drug safety crisis. " Mr. > Grassley said he was basing his contentions on reports from whistle-blowers > within the agency. > Dr. , director general of the therapeutic products > directorate at Health Canada, said through a spokeswoman that reports that > F.D.A. had asked Health Canada to refrain from suspending the drug " are > untrue. " > Brad Stone, a spokesman for the F.D.A., declined to respond directly > to Mr. Grassley's contention but said of Dr. 's rejection that, " We > believe the Canadian response is the correct one. " Canadian health > officials, citing 20 deaths among patients taking the British-made drug > Adderall XR, said on Wednesday night that they were suspending sales of the > hyperactivity drug indefinitely. The F.D.A. is allowing the drug to continue > to be sold in the United States, saying there is little evidence that > Adderall XR caused the deaths. > Mr. Grassley, who has been investigating the Food and Drug > Administration for about a year, demanded in a letter written on Thursday > that the agency answer questions about any discussions its officials may > have had with the Canadians about the drug. > Dr. Temple, director of the F.D.A.'s office of medical > affairs, > said the agency's decision to permit the continued sale of Adderall was not > influenced by the controversies swirling around the F.D.A. > " It's still our job to get as close as we can to the right answer and > not panic and do things for the wrong reasons, " Dr. Temple said. > Cabrey, a spokesman for the maker of Adderall, Shire > Pharmaceuticals Group of Britain, said Adderall was safe and effective. " We > are very surprised at the actions of Health Canada, and we disagree with > their interpretations of the data around these extremely rare cases of > sudden death, " Mr. Cabrey said. > The controversy - and the sudden appearance of Mr. Grassley, the > chairman of the Senate Finance Committee, in it - promises to engulf the > F.D.A. in more questions about its oversight of the pharmaceutical industry. > Critics have accused agency officials of being too cozy with drug > makers and of being slower than their counterparts in other nations to > acknowledge drug-safety problems. > The controversy is also bound to fuel a long-running battle over > whether drugs like Adderall and Ritalin are overprescribed to children, and > whether the drugs' longterm risks have been adequately explored. > More than 700,000 Americans use Adderall and its extended release > counterpart, Adderall XR. Shire sold $759 million of Adderall products in > the United States last year and $10 million in Canada. > In the letter Thursday to the F.D.A., Mr. Grassley wrote that reports > given to his staff suggested that the agency was not acting with scientific > integrity. > " Unfortunately, such allegations raise additional concerns about the > culture at the F.D.A., " he wrote. > Dr. of Health Canada described discussions between the two > regulatory bodies as " collegial. " > Differing health regulations govern the differing responses of the > two > agencies to the Adderall reports, Dr. said. Canadian law lets > regulators suspend a drug's sales while safety questions are investigated; > United States law does not. Health Canada approved Shire's application to > sell Adderall XR in January 2004. In September, the company reported to > Canadian authorities that 20 people, 12 of them children, had died suddenly > in the United States while taking the drug. > Shire asked the Canadian regulators for permission to change the > drug's label to reflect the possible dangers, as had been done in the United > States that month. > Some of the deaths, which had not been previously reported to > Canadian > authorities, occurred well before Health Canada approved Adderall XR for > sale, Dr. said. > Canada and the United States both require pharmaceutical companies to > report all adverse outcomes from drugs promptly. > " We were surprised to find these cases, " Dr. said in an > interview on Thursday. > Dr. said that an early analysis of the data suggested that > Adderall XR might be linked to two to three times as many sudden deaths as > Ritalin and its cousin, Concerta, which are prescribed for similar > disorders. > Further, Dr. said that Canadian authorities were uncertain > about how to warn patients about the risks of sudden death. > " It's very difficult to generate a benefit-to-risk balance when the > risk is sudden and unexpected death, " Dr. said. > Mr. Cabrey of Shire Pharmaceuticals said that the company had > forwarded reports of the deaths to Canadian authorities promptly. > Dr. Temple of the F.D.A. said that 7 children taking Ritalin and > Concerta died during the same period that 12 children taking Adderall died, > suggesting equivalent risks. Many had structural problems with their hearts > and several were engaged in vigorous exercise, he said. > There is little evidence that the drugs caused any of the deaths, he > said. " There is a tendency to believe that sudden death doesn't occur in > children. That is wrong, " Dr. Temple said. He added: " Psychiatrists say that > these drugs are needed. To get rid of them for something that may well be a > background rate of death is not responsible. " Doctors have known since the > 1930's that stimulant medications like these can calm hyperactive, or > aggressive, children. But no one knows precisely how the drugs induce this > effect, and there have always been concerns about the drugs' long- term > effect on development. > Prescriptions for these drugs to be used by children with > attention-deficit disorder more than doubled in the 1990's, experts say, > heightening the concerns of some doctors. > The drugs are far more popular in the United States than in Europe. > Last year, doctors in the United States wrote more than 23 million > prescriptions for the four most popular drugs used to treat attention > deficit disorder. > > -- > DO SOMETHING ABOUT AUTISM NOW < -- > > SUBSCRIBE. . . ! > . . .Read, then Forward the Schafer Autism Report. > To Subscribe http://www.SARnet.org/ > Or mailto:subs@d... No Cost! > _______________________________________________________ Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 11, 2005 Report Share Posted February 11, 2005 > > > > " Senator Says F.D.A. Asked Canada Not to Suspend ADHD Drug > Spotlight on Adderall " > > > " The controversy . . . promises to engulf the F.D.A. > in more questions about its oversight of the > pharmaceutical industry. " > > > [by Gardiner And Benedict Carey, NY times.] > http://www.nytimes.com/2005/02/11/politics/11drug.html? pagewanted=print & posi > tion= > > A day after Canadian officials suspended the use of a hyperactivity > drug amid reports of deaths associated with its use, Senator E. > Grassley of Iowa contended that United States health officials had asked the > Canadian regulators not to do so. > Senator Grassley, a Republican, said on Thursday that the Food and > Drug Administration had made the request of Canadian health officials > because the F.D.A. could not handle another " drug safety crisis. " Mr. > Grassley said he was basing his contentions on reports from whistle-blowers > within the agency. > Dr. , director general of the therapeutic products > directorate at Health Canada, said through a spokeswoman that reports that > F.D.A. had asked Health Canada to refrain from suspending the drug " are > untrue. " > Brad Stone, a spokesman for the F.D.A., declined to respond directly > to Mr. Grassley's contention but said of Dr. 's rejection that, " We > believe the Canadian response is the correct one. " Canadian health > officials, citing 20 deaths among patients taking the British-made drug > Adderall XR, said on Wednesday night that they were suspending sales of the > hyperactivity drug indefinitely. The F.D.A. is allowing the drug to continue > to be sold in the United States, saying there is little evidence that > Adderall XR caused the deaths. > Mr. Grassley, who has been investigating the Food and Drug > Administration for about a year, demanded in a letter written on Thursday > that the agency answer questions about any discussions its officials may > have had with the Canadians about the drug. > Dr. Temple, director of the F.D.A.'s office of medical > affairs, > said the agency's decision to permit the continued sale of Adderall was not > influenced by the controversies swirling around the F.D.A. > " It's still our job to get as close as we can to the right answer and > not panic and do things for the wrong reasons, " Dr. Temple said. > Cabrey, a spokesman for the maker of Adderall, Shire > Pharmaceuticals Group of Britain, said Adderall was safe and effective. " We > are very surprised at the actions of Health Canada, and we disagree with > their interpretations of the data around these extremely rare cases of > sudden death, " Mr. Cabrey said. > The controversy - and the sudden appearance of Mr. Grassley, the > chairman of the Senate Finance Committee, in it - promises to engulf the > F.D.A. in more questions about its oversight of the pharmaceutical industry. > Critics have accused agency officials of being too cozy with drug > makers and of being slower than their counterparts in other nations to > acknowledge drug-safety problems. > The controversy is also bound to fuel a long-running battle over > whether drugs like Adderall and Ritalin are overprescribed to children, and > whether the drugs' longterm risks have been adequately explored. > More than 700,000 Americans use Adderall and its extended release > counterpart, Adderall XR. Shire sold $759 million of Adderall products in > the United States last year and $10 million in Canada. > In the letter Thursday to the F.D.A., Mr. Grassley wrote that reports > given to his staff suggested that the agency was not acting with scientific > integrity. > " Unfortunately, such allegations raise additional concerns about the > culture at the F.D.A., " he wrote. > Dr. of Health Canada described discussions between the two > regulatory bodies as " collegial. " > Differing health regulations govern the differing responses of the > two > agencies to the Adderall reports, Dr. said. Canadian law lets > regulators suspend a drug's sales while safety questions are investigated; > United States law does not. Health Canada approved Shire's application to > sell Adderall XR in January 2004. In September, the company reported to > Canadian authorities that 20 people, 12 of them children, had died suddenly > in the United States while taking the drug. > Shire asked the Canadian regulators for permission to change the > drug's label to reflect the possible dangers, as had been done in the United > States that month. > Some of the deaths, which had not been previously reported to > Canadian > authorities, occurred well before Health Canada approved Adderall XR for > sale, Dr. said. > Canada and the United States both require pharmaceutical companies to > report all adverse outcomes from drugs promptly. > " We were surprised to find these cases, " Dr. said in an > interview on Thursday. > Dr. said that an early analysis of the data suggested that > Adderall XR might be linked to two to three times as many sudden deaths as > Ritalin and its cousin, Concerta, which are prescribed for similar > disorders. > Further, Dr. said that Canadian authorities were uncertain > about how to warn patients about the risks of sudden death. > " It's very difficult to generate a benefit-to-risk balance when the > risk is sudden and unexpected death, " Dr. said. > Mr. Cabrey of Shire Pharmaceuticals said that the company had > forwarded reports of the deaths to Canadian authorities promptly. > Dr. Temple of the F.D.A. said that 7 children taking Ritalin and > Concerta died during the same period that 12 children taking Adderall died, > suggesting equivalent risks. Many had structural problems with their hearts > and several were engaged in vigorous exercise, he said. > There is little evidence that the drugs caused any of the deaths, he > said. " There is a tendency to believe that sudden death doesn't occur in > children. That is wrong, " Dr. Temple said. He added: " Psychiatrists say that > these drugs are needed. To get rid of them for something that may well be a > background rate of death is not responsible. " Doctors have known since the > 1930's that stimulant medications like these can calm hyperactive, or > aggressive, children. But no one knows precisely how the drugs induce this > effect, and there have always been concerns about the drugs' long- term > effect on development. > Prescriptions for these drugs to be used by children with > attention-deficit disorder more than doubled in the 1990's, experts say, > heightening the concerns of some doctors. > The drugs are far more popular in the United States than in Europe. > Last year, doctors in the United States wrote more than 23 million > prescriptions for the four most popular drugs used to treat attention > deficit disorder. > > -- > DO SOMETHING ABOUT AUTISM NOW < -- > > SUBSCRIBE. . . ! > . . .Read, then Forward the Schafer Autism Report. > To Subscribe http://www.SARnet.org/ > Or mailto:subs@d... No Cost! > _______________________________________________________ Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 11, 2005 Report Share Posted February 11, 2005 > > > > " Senator Says F.D.A. Asked Canada Not to Suspend ADHD Drug > Spotlight on Adderall " > > > " The controversy . . . promises to engulf the F.D.A. > in more questions about its oversight of the > pharmaceutical industry. " > > > [by Gardiner And Benedict Carey, NY times.] > http://www.nytimes.com/2005/02/11/politics/11drug.html? pagewanted=print & posi > tion= > > A day after Canadian officials suspended the use of a hyperactivity > drug amid reports of deaths associated with its use, Senator E. > Grassley of Iowa contended that United States health officials had asked the > Canadian regulators not to do so. > Senator Grassley, a Republican, said on Thursday that the Food and > Drug Administration had made the request of Canadian health officials > because the F.D.A. could not handle another " drug safety crisis. " Mr. > Grassley said he was basing his contentions on reports from whistle-blowers > within the agency. > Dr. , director general of the therapeutic products > directorate at Health Canada, said through a spokeswoman that reports that > F.D.A. had asked Health Canada to refrain from suspending the drug " are > untrue. " > Brad Stone, a spokesman for the F.D.A., declined to respond directly > to Mr. Grassley's contention but said of Dr. 's rejection that, " We > believe the Canadian response is the correct one. " Canadian health > officials, citing 20 deaths among patients taking the British-made drug > Adderall XR, said on Wednesday night that they were suspending sales of the > hyperactivity drug indefinitely. The F.D.A. is allowing the drug to continue > to be sold in the United States, saying there is little evidence that > Adderall XR caused the deaths. > Mr. Grassley, who has been investigating the Food and Drug > Administration for about a year, demanded in a letter written on Thursday > that the agency answer questions about any discussions its officials may > have had with the Canadians about the drug. > Dr. Temple, director of the F.D.A.'s office of medical > affairs, > said the agency's decision to permit the continued sale of Adderall was not > influenced by the controversies swirling around the F.D.A. > " It's still our job to get as close as we can to the right answer and > not panic and do things for the wrong reasons, " Dr. Temple said. > Cabrey, a spokesman for the maker of Adderall, Shire > Pharmaceuticals Group of Britain, said Adderall was safe and effective. " We > are very surprised at the actions of Health Canada, and we disagree with > their interpretations of the data around these extremely rare cases of > sudden death, " Mr. Cabrey said. > The controversy - and the sudden appearance of Mr. Grassley, the > chairman of the Senate Finance Committee, in it - promises to engulf the > F.D.A. in more questions about its oversight of the pharmaceutical industry. > Critics have accused agency officials of being too cozy with drug > makers and of being slower than their counterparts in other nations to > acknowledge drug-safety problems. > The controversy is also bound to fuel a long-running battle over > whether drugs like Adderall and Ritalin are overprescribed to children, and > whether the drugs' longterm risks have been adequately explored. > More than 700,000 Americans use Adderall and its extended release > counterpart, Adderall XR. Shire sold $759 million of Adderall products in > the United States last year and $10 million in Canada. > In the letter Thursday to the F.D.A., Mr. Grassley wrote that reports > given to his staff suggested that the agency was not acting with scientific > integrity. > " Unfortunately, such allegations raise additional concerns about the > culture at the F.D.A., " he wrote. > Dr. of Health Canada described discussions between the two > regulatory bodies as " collegial. " > Differing health regulations govern the differing responses of the > two > agencies to the Adderall reports, Dr. said. Canadian law lets > regulators suspend a drug's sales while safety questions are investigated; > United States law does not. Health Canada approved Shire's application to > sell Adderall XR in January 2004. In September, the company reported to > Canadian authorities that 20 people, 12 of them children, had died suddenly > in the United States while taking the drug. > Shire asked the Canadian regulators for permission to change the > drug's label to reflect the possible dangers, as had been done in the United > States that month. > Some of the deaths, which had not been previously reported to > Canadian > authorities, occurred well before Health Canada approved Adderall XR for > sale, Dr. said. > Canada and the United States both require pharmaceutical companies to > report all adverse outcomes from drugs promptly. > " We were surprised to find these cases, " Dr. said in an > interview on Thursday. > Dr. said that an early analysis of the data suggested that > Adderall XR might be linked to two to three times as many sudden deaths as > Ritalin and its cousin, Concerta, which are prescribed for similar > disorders. > Further, Dr. said that Canadian authorities were uncertain > about how to warn patients about the risks of sudden death. > " It's very difficult to generate a benefit-to-risk balance when the > risk is sudden and unexpected death, " Dr. said. > Mr. Cabrey of Shire Pharmaceuticals said that the company had > forwarded reports of the deaths to Canadian authorities promptly. > Dr. Temple of the F.D.A. said that 7 children taking Ritalin and > Concerta died during the same period that 12 children taking Adderall died, > suggesting equivalent risks. Many had structural problems with their hearts > and several were engaged in vigorous exercise, he said. > There is little evidence that the drugs caused any of the deaths, he > said. " There is a tendency to believe that sudden death doesn't occur in > children. That is wrong, " Dr. Temple said. He added: " Psychiatrists say that > these drugs are needed. To get rid of them for something that may well be a > background rate of death is not responsible. " Doctors have known since the > 1930's that stimulant medications like these can calm hyperactive, or > aggressive, children. But no one knows precisely how the drugs induce this > effect, and there have always been concerns about the drugs' long- term > effect on development. > Prescriptions for these drugs to be used by children with > attention-deficit disorder more than doubled in the 1990's, experts say, > heightening the concerns of some doctors. > The drugs are far more popular in the United States than in Europe. > Last year, doctors in the United States wrote more than 23 million > prescriptions for the four most popular drugs used to treat attention > deficit disorder. > > -- > DO SOMETHING ABOUT AUTISM NOW < -- > > SUBSCRIBE. . . ! > . . .Read, then Forward the Schafer Autism Report. > To Subscribe http://www.SARnet.org/ > Or mailto:subs@d... No Cost! > _______________________________________________________ Quote Link to comment Share on other sites More sharing options...
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