Guest guest Posted November 18, 2004 Report Share Posted November 18, 2004 Dear SSRI Friends, I wish I had time to document the cruel and mentally abusive power hungry spirit breaking mentality of DHR social workers that are currently in the process of slowing destroying a Mother who loves her children torturing her with daily visits to wear her down to a frazel so they can have an excuse to get their brownie points earning DHR Federal subsidies that reward them for breaking up familes and not helping them stay together. I happened to call her for a short hello when I got in the car on the way to lunch and found her sobbing in dispair 20 minutes after they'd left. They've just about broken her down making her loose all home and that she's a bad Mother. It makes me so disgusted I don't know what to do. She's a better Mother than those wives with wealthy husbands that leave their kids with the nannies to go get their nails done. She's facing Thanksgiving and Christmas unable to work with injuries sustained in a auto accident that wasn't her fault threatened with having her children taken away from her because she can't work because of the injuries and can't pay for the medications that she doesn't want them to take because of the side effects. Maybe someone on this list will help me help her for Christmas Santa. She's got 3 disabled children-probably from the fatherh being a Gulf War vet. I've already checked into the Kroger that's not far from her and they will take a credit card payment over the phone if anyone wants to give her some food for Thanksgiving. I also have permission to give anyone her phone number that is willing to help her in case you doubt the horrificness of her story. The DHR social workers even wouldn't give her the money to take the handicapped bus to her hydrotherapy recommended for her hip that will require a hip replacement. As soon as I can I'm going to get an congressional investigation going with a congressman but if anyone will help her through Thanksgiving and Christmas I can assure you you will be doing a good think. Anyonen who might not believe I am who I am can find my phone number on the internet under Lenox Chiropractic Clinic in Atlanta 404 233 4433 and my licensure under the Ga. Secretary of State and call me to verify the authenticity of this plea. I've met her myself and her 3 children. God gave those children to her to raise-not the U.S.Government to seize and control with SSRI's!!!!If anyone is willing to help her out financially I could probably even get the manager at the Walll-Mart to do the same thing for Santa. As a Mother it just breaks my heart. I'd like to move in with her and be there with a video camera every time those SS officers came terrorizing that poor woman daily with their ongoing threats before they finally deprive her of her OWN CHILDREN. Dr. Lance, D.C. Thank you, Dr. Sanrda Lphone if [hhond aorm her k r uoebeing o on this wfo the uase ses of doesn't uaesuceorrm her earan This article goes part way in describing what happens. But from what I've heard here and elsewhere, I thought that kids were being put into foster care in the first place because their parents refused to put them on SSRIs. > http://story.news./news? tmpl=story & u=/ap/20041118/ap_on_go_ca_st_pe/vioxx_safety_22 > > FDA Called 'Defenseless' Against Bad Drugs > > 14 minutes ago White House - AP Cabinet & State > > > By DIEDTRA HENDERSON, AP Science Writer > > WASHINGTON - The American public is " virtually defenseless " if another > medication such as Vioxx proves to be unsafe after it is approved for sale, > a government drug safety reviewer told a congressional committee Thursday. > > > " I would argue that the FDA (news - web sites) as currently configured is > incapable of protecting America against another Vioxx, " said Graham, > who warned that the arthritis drug had been linked to an increased risk of > heart attack and stroke. > > > He told the Senate Finance Committee that there were at least five other > drugs on the market today that should be looked at seriously to see whether > they should remain there. He cited the acne drug Accutane, the weight loss > drug Meridia, the anti-cholesterol drug Crestor, the pain reliever Bextra, > and the asthma drug Serevent. > > > Vioxx's maker, Merck & Co. pulled the drug from the market on Sept. 30 after > a study indicated the popular painkiller doubled the risk of heart attacks > and stroke when taken for longer than 18 months. > > > V. Gilmartin, the company president, said in prepared testimony that > Merck acted within four days of learning about the risk. > > > " Given the availability of alternative therapies and the questions raised by > the data withdrawing Vioxx was consistent with an ethic that has driven > Merck actions and decisions for more than 100 years, " he said. > > > Gilmartin also said the company was surprised by the cardiovascular risk > because it differed from past clinical trials. " My wife was a user of Vioxx > until the day we withdrew it from the marketplace, " he said. > > > The Food and Drug Administration (news - web sites) has defended its actions > regarding Vioxx. In a statement issued late Wednesday, the agency cited its > " well-documented and long-standing commitment to openness and transparency > in its review of marketed drugs. " > > > However, Sen. Grassley (news, bio, voting record), R-Iowa, who > chaired the hearing, suggested that an independent board of drug safety > might be needed to ensure the safety of medications after they're approved > for the market. > > > " Consumers should not have to second-guess the safety of what's in their > medicine cabinet, " he said. > > > Graham told the committee that research indicated that Vioxx caused up to > 160,000 heart attacks and strokes. > > > " If we were talking about Florida or Pennsylvania, 1 percent of the entire > state population would have been affected, " he said. " I'm sorry to say Sen. > Grassley, but 67 percent of the citizens of Des Moines would be affected > and, what's worse - the entire population of every other city in the state > of Iowa. " > > > Graham said his research helped to coax the FDA to withdraw a number of > drugs including Fen-phen, a weight loss drug, Lotronex, Baycol and Rezulin. > " During my career I have recommended the market withdrawal of 12 drugs, " he > said. " Only two of these remain on the market today. " > > > At the same time, though, he questioned the agency's commitment to removing > unsafe drugs from the market, since it would call into question their > earlier approval. > > > Sen. Jeff Bingaman (news, bio, voting record), D-New Mexico, said the > problem was within the FDA's own culture. > > > " The culture within the FDA, being one where the pharmaceutical industry, > which the FDA is supposed to regulate, is seen by the FDA as its client > instead, " he said. > > He called on President Bush (news - web sites) to appoint a new head for the > agency. Lester Crawford has been acting commissioner of the agency. > > In the FDA statement, Crawford said the FDA initiated and paid for reviews > of Vioxx and antidepressants after those drugs had hit the market. " That is > evidence the system is working, " Crawford said. > > Critics contend the agency ignored risks in both instances, then intimidated > its own reviewers when they pointed to safety concerns. > > In October, the FDA ordered that all antidepressants carry warnings that > they " increase the risk of suicidal thinking and behavior " in children who > take them. > > The FDA's statement disturbed lawyer Andy Birchfield, who is evaluating > thousands of potential cases against Merck on behalf of injured patients. > > " How can they see that type of problem and look back and say 'We did > everything right'? " Birchfield said. " When they're not willing to recognize > mistakes, we have no hope for them voluntarily taking measures to correct > the situation. " > > Crawford's statement did not mention Graham by name, but suggested that the > reviewer was a maverick who did not follow agency protocol. > > Graham was lead author on a research project that studied the records of > almost 1.4 million Kaiser Permanente patients, including 40,405 treated with > Pfizer's Celebrex and 26,748 treated with Vioxx. The study found that high > doses of Vioxx tripled risks of heart attacks and sudden cardiac death. > > Vioxx was responsible for an additional 27,785 deaths from heart ailments > from 1999 to 2003, Graham concluded. > > He has told congressional investigators that superiors pressured him to > soften his conclusions. > > Crawford said in his statement that the reviewer " voluntarily chose to > revise his conclusions, and he did so, in his own words, " without > compromising my deeply held convictions.' " > > ___ > > On the Net: > > Food and Drug Administration: http://www.fda.gov/ Re: FDA Called 'Defenseless' Against Bad Drugs... 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Guest guest Posted November 18, 2004 Report Share Posted November 18, 2004 Dear SSRI Friends, I wish I had time to document the cruel and mentally abusive power hungry spirit breaking mentality of DHR social workers that are currently in the process of slowing destroying a Mother who loves her children torturing her with daily visits to wear her down to a frazel so they can have an excuse to get their brownie points earning DHR Federal subsidies that reward them for breaking up familes and not helping them stay together. I happened to call her for a short hello when I got in the car on the way to lunch and found her sobbing in dispair 20 minutes after they'd left. They've just about broken her down making her loose all home and that she's a bad Mother. It makes me so disgusted I don't know what to do. She's a better Mother than those wives with wealthy husbands that leave their kids with the nannies to go get their nails done. She's facing Thanksgiving and Christmas unable to work with injuries sustained in a auto accident that wasn't her fault threatened with having her children taken away from her because she can't work because of the injuries and can't pay for the medications that she doesn't want them to take because of the side effects. Maybe someone on this list will help me help her for Christmas Santa. She's got 3 disabled children-probably from the fatherh being a Gulf War vet. I've already checked into the Kroger that's not far from her and they will take a credit card payment over the phone if anyone wants to give her some food for Thanksgiving. I also have permission to give anyone her phone number that is willing to help her in case you doubt the horrificness of her story. The DHR social workers even wouldn't give her the money to take the handicapped bus to her hydrotherapy recommended for her hip that will require a hip replacement. As soon as I can I'm going to get an congressional investigation going with a congressman but if anyone will help her through Thanksgiving and Christmas I can assure you you will be doing a good think. Anyonen who might not believe I am who I am can find my phone number on the internet under Lenox Chiropractic Clinic in Atlanta 404 233 4433 and my licensure under the Ga. Secretary of State and call me to verify the authenticity of this plea. I've met her myself and her 3 children. God gave those children to her to raise-not the U.S.Government to seize and control with SSRI's!!!!If anyone is willing to help her out financially I could probably even get the manager at the Walll-Mart to do the same thing for Santa. As a Mother it just breaks my heart. I'd like to move in with her and be there with a video camera every time those SS officers came terrorizing that poor woman daily with their ongoing threats before they finally deprive her of her OWN CHILDREN. Dr. Lance, D.C. Thank you, Dr. Sanrda Lphone if [hhond aorm her k r uoebeing o on this wfo the uase ses of doesn't uaesuceorrm her earan This article goes part way in describing what happens. But from what I've heard here and elsewhere, I thought that kids were being put into foster care in the first place because their parents refused to put them on SSRIs. > http://story.news./news? tmpl=story & u=/ap/20041118/ap_on_go_ca_st_pe/vioxx_safety_22 > > FDA Called 'Defenseless' Against Bad Drugs > > 14 minutes ago White House - AP Cabinet & State > > > By DIEDTRA HENDERSON, AP Science Writer > > WASHINGTON - The American public is " virtually defenseless " if another > medication such as Vioxx proves to be unsafe after it is approved for sale, > a government drug safety reviewer told a congressional committee Thursday. > > > " I would argue that the FDA (news - web sites) as currently configured is > incapable of protecting America against another Vioxx, " said Graham, > who warned that the arthritis drug had been linked to an increased risk of > heart attack and stroke. > > > He told the Senate Finance Committee that there were at least five other > drugs on the market today that should be looked at seriously to see whether > they should remain there. He cited the acne drug Accutane, the weight loss > drug Meridia, the anti-cholesterol drug Crestor, the pain reliever Bextra, > and the asthma drug Serevent. > > > Vioxx's maker, Merck & Co. pulled the drug from the market on Sept. 30 after > a study indicated the popular painkiller doubled the risk of heart attacks > and stroke when taken for longer than 18 months. > > > V. Gilmartin, the company president, said in prepared testimony that > Merck acted within four days of learning about the risk. > > > " Given the availability of alternative therapies and the questions raised by > the data withdrawing Vioxx was consistent with an ethic that has driven > Merck actions and decisions for more than 100 years, " he said. > > > Gilmartin also said the company was surprised by the cardiovascular risk > because it differed from past clinical trials. " My wife was a user of Vioxx > until the day we withdrew it from the marketplace, " he said. > > > The Food and Drug Administration (news - web sites) has defended its actions > regarding Vioxx. In a statement issued late Wednesday, the agency cited its > " well-documented and long-standing commitment to openness and transparency > in its review of marketed drugs. " > > > However, Sen. Grassley (news, bio, voting record), R-Iowa, who > chaired the hearing, suggested that an independent board of drug safety > might be needed to ensure the safety of medications after they're approved > for the market. > > > " Consumers should not have to second-guess the safety of what's in their > medicine cabinet, " he said. > > > Graham told the committee that research indicated that Vioxx caused up to > 160,000 heart attacks and strokes. > > > " If we were talking about Florida or Pennsylvania, 1 percent of the entire > state population would have been affected, " he said. " I'm sorry to say Sen. > Grassley, but 67 percent of the citizens of Des Moines would be affected > and, what's worse - the entire population of every other city in the state > of Iowa. " > > > Graham said his research helped to coax the FDA to withdraw a number of > drugs including Fen-phen, a weight loss drug, Lotronex, Baycol and Rezulin. > " During my career I have recommended the market withdrawal of 12 drugs, " he > said. " Only two of these remain on the market today. " > > > At the same time, though, he questioned the agency's commitment to removing > unsafe drugs from the market, since it would call into question their > earlier approval. > > > Sen. Jeff Bingaman (news, bio, voting record), D-New Mexico, said the > problem was within the FDA's own culture. > > > " The culture within the FDA, being one where the pharmaceutical industry, > which the FDA is supposed to regulate, is seen by the FDA as its client > instead, " he said. > > He called on President Bush (news - web sites) to appoint a new head for the > agency. Lester Crawford has been acting commissioner of the agency. > > In the FDA statement, Crawford said the FDA initiated and paid for reviews > of Vioxx and antidepressants after those drugs had hit the market. " That is > evidence the system is working, " Crawford said. > > Critics contend the agency ignored risks in both instances, then intimidated > its own reviewers when they pointed to safety concerns. > > In October, the FDA ordered that all antidepressants carry warnings that > they " increase the risk of suicidal thinking and behavior " in children who > take them. > > The FDA's statement disturbed lawyer Andy Birchfield, who is evaluating > thousands of potential cases against Merck on behalf of injured patients. > > " How can they see that type of problem and look back and say 'We did > everything right'? " Birchfield said. " When they're not willing to recognize > mistakes, we have no hope for them voluntarily taking measures to correct > the situation. " > > Crawford's statement did not mention Graham by name, but suggested that the > reviewer was a maverick who did not follow agency protocol. > > Graham was lead author on a research project that studied the records of > almost 1.4 million Kaiser Permanente patients, including 40,405 treated with > Pfizer's Celebrex and 26,748 treated with Vioxx. The study found that high > doses of Vioxx tripled risks of heart attacks and sudden cardiac death. > > Vioxx was responsible for an additional 27,785 deaths from heart ailments > from 1999 to 2003, Graham concluded. > > He has told congressional investigators that superiors pressured him to > soften his conclusions. > > Crawford said in his statement that the reviewer " voluntarily chose to > revise his conclusions, and he did so, in his own words, " without > compromising my deeply held convictions.' " > > ___ > > On the Net: > > Food and Drug Administration: http://www.fda.gov/ Re: FDA Called 'Defenseless' Against Bad Drugs... 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Guest guest Posted November 18, 2004 Report Share Posted November 18, 2004 Dear SSRI Friends, I wish I had time to document the cruel and mentally abusive power hungry spirit breaking mentality of DHR social workers that are currently in the process of slowing destroying a Mother who loves her children torturing her with daily visits to wear her down to a frazel so they can have an excuse to get their brownie points earning DHR Federal subsidies that reward them for breaking up familes and not helping them stay together. I happened to call her for a short hello when I got in the car on the way to lunch and found her sobbing in dispair 20 minutes after they'd left. They've just about broken her down making her loose all home and that she's a bad Mother. It makes me so disgusted I don't know what to do. She's a better Mother than those wives with wealthy husbands that leave their kids with the nannies to go get their nails done. She's facing Thanksgiving and Christmas unable to work with injuries sustained in a auto accident that wasn't her fault threatened with having her children taken away from her because she can't work because of the injuries and can't pay for the medications that she doesn't want them to take because of the side effects. Maybe someone on this list will help me help her for Christmas Santa. She's got 3 disabled children-probably from the fatherh being a Gulf War vet. I've already checked into the Kroger that's not far from her and they will take a credit card payment over the phone if anyone wants to give her some food for Thanksgiving. I also have permission to give anyone her phone number that is willing to help her in case you doubt the horrificness of her story. The DHR social workers even wouldn't give her the money to take the handicapped bus to her hydrotherapy recommended for her hip that will require a hip replacement. As soon as I can I'm going to get an congressional investigation going with a congressman but if anyone will help her through Thanksgiving and Christmas I can assure you you will be doing a good think. Anyonen who might not believe I am who I am can find my phone number on the internet under Lenox Chiropractic Clinic in Atlanta 404 233 4433 and my licensure under the Ga. Secretary of State and call me to verify the authenticity of this plea. I've met her myself and her 3 children. God gave those children to her to raise-not the U.S.Government to seize and control with SSRI's!!!!If anyone is willing to help her out financially I could probably even get the manager at the Walll-Mart to do the same thing for Santa. As a Mother it just breaks my heart. I'd like to move in with her and be there with a video camera every time those SS officers came terrorizing that poor woman daily with their ongoing threats before they finally deprive her of her OWN CHILDREN. Dr. Lance, D.C. Thank you, Dr. Sanrda Lphone if [hhond aorm her k r uoebeing o on this wfo the uase ses of doesn't uaesuceorrm her earan This article goes part way in describing what happens. But from what I've heard here and elsewhere, I thought that kids were being put into foster care in the first place because their parents refused to put them on SSRIs. > http://story.news./news? tmpl=story & u=/ap/20041118/ap_on_go_ca_st_pe/vioxx_safety_22 > > FDA Called 'Defenseless' Against Bad Drugs > > 14 minutes ago White House - AP Cabinet & State > > > By DIEDTRA HENDERSON, AP Science Writer > > WASHINGTON - The American public is " virtually defenseless " if another > medication such as Vioxx proves to be unsafe after it is approved for sale, > a government drug safety reviewer told a congressional committee Thursday. > > > " I would argue that the FDA (news - web sites) as currently configured is > incapable of protecting America against another Vioxx, " said Graham, > who warned that the arthritis drug had been linked to an increased risk of > heart attack and stroke. > > > He told the Senate Finance Committee that there were at least five other > drugs on the market today that should be looked at seriously to see whether > they should remain there. He cited the acne drug Accutane, the weight loss > drug Meridia, the anti-cholesterol drug Crestor, the pain reliever Bextra, > and the asthma drug Serevent. > > > Vioxx's maker, Merck & Co. pulled the drug from the market on Sept. 30 after > a study indicated the popular painkiller doubled the risk of heart attacks > and stroke when taken for longer than 18 months. > > > V. Gilmartin, the company president, said in prepared testimony that > Merck acted within four days of learning about the risk. > > > " Given the availability of alternative therapies and the questions raised by > the data withdrawing Vioxx was consistent with an ethic that has driven > Merck actions and decisions for more than 100 years, " he said. > > > Gilmartin also said the company was surprised by the cardiovascular risk > because it differed from past clinical trials. " My wife was a user of Vioxx > until the day we withdrew it from the marketplace, " he said. > > > The Food and Drug Administration (news - web sites) has defended its actions > regarding Vioxx. In a statement issued late Wednesday, the agency cited its > " well-documented and long-standing commitment to openness and transparency > in its review of marketed drugs. " > > > However, Sen. Grassley (news, bio, voting record), R-Iowa, who > chaired the hearing, suggested that an independent board of drug safety > might be needed to ensure the safety of medications after they're approved > for the market. > > > " Consumers should not have to second-guess the safety of what's in their > medicine cabinet, " he said. > > > Graham told the committee that research indicated that Vioxx caused up to > 160,000 heart attacks and strokes. > > > " If we were talking about Florida or Pennsylvania, 1 percent of the entire > state population would have been affected, " he said. " I'm sorry to say Sen. > Grassley, but 67 percent of the citizens of Des Moines would be affected > and, what's worse - the entire population of every other city in the state > of Iowa. " > > > Graham said his research helped to coax the FDA to withdraw a number of > drugs including Fen-phen, a weight loss drug, Lotronex, Baycol and Rezulin. > " During my career I have recommended the market withdrawal of 12 drugs, " he > said. " Only two of these remain on the market today. " > > > At the same time, though, he questioned the agency's commitment to removing > unsafe drugs from the market, since it would call into question their > earlier approval. > > > Sen. Jeff Bingaman (news, bio, voting record), D-New Mexico, said the > problem was within the FDA's own culture. > > > " The culture within the FDA, being one where the pharmaceutical industry, > which the FDA is supposed to regulate, is seen by the FDA as its client > instead, " he said. > > He called on President Bush (news - web sites) to appoint a new head for the > agency. Lester Crawford has been acting commissioner of the agency. > > In the FDA statement, Crawford said the FDA initiated and paid for reviews > of Vioxx and antidepressants after those drugs had hit the market. " That is > evidence the system is working, " Crawford said. > > Critics contend the agency ignored risks in both instances, then intimidated > its own reviewers when they pointed to safety concerns. > > In October, the FDA ordered that all antidepressants carry warnings that > they " increase the risk of suicidal thinking and behavior " in children who > take them. > > The FDA's statement disturbed lawyer Andy Birchfield, who is evaluating > thousands of potential cases against Merck on behalf of injured patients. > > " How can they see that type of problem and look back and say 'We did > everything right'? " Birchfield said. " When they're not willing to recognize > mistakes, we have no hope for them voluntarily taking measures to correct > the situation. " > > Crawford's statement did not mention Graham by name, but suggested that the > reviewer was a maverick who did not follow agency protocol. > > Graham was lead author on a research project that studied the records of > almost 1.4 million Kaiser Permanente patients, including 40,405 treated with > Pfizer's Celebrex and 26,748 treated with Vioxx. The study found that high > doses of Vioxx tripled risks of heart attacks and sudden cardiac death. > > Vioxx was responsible for an additional 27,785 deaths from heart ailments > from 1999 to 2003, Graham concluded. > > He has told congressional investigators that superiors pressured him to > soften his conclusions. > > Crawford said in his statement that the reviewer " voluntarily chose to > revise his conclusions, and he did so, in his own words, " without > compromising my deeply held convictions.' " > > ___ > > On the Net: > > Food and Drug Administration: http://www.fda.gov/ Re: FDA Called 'Defenseless' Against Bad Drugs... 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Guest guest Posted November 18, 2004 Report Share Posted November 18, 2004 Dear SSRI Friends, I wish I had time to document the cruel and mentally abusive power hungry spirit breaking mentality of DHR social workers that are currently in the process of slowing destroying a Mother who loves her children torturing her with daily visits to wear her down to a frazel so they can have an excuse to get their brownie points earning DHR Federal subsidies that reward them for breaking up familes and not helping them stay together. I happened to call her for a short hello when I got in the car on the way to lunch and found her sobbing in dispair 20 minutes after they'd left. They've just about broken her down making her loose all home and that she's a bad Mother. It makes me so disgusted I don't know what to do. She's a better Mother than those wives with wealthy husbands that leave their kids with the nannies to go get their nails done. She's facing Thanksgiving and Christmas unable to work with injuries sustained in a auto accident that wasn't her fault threatened with having her children taken away from her because she can't work because of the injuries and can't pay for the medications that she doesn't want them to take because of the side effects. Maybe someone on this list will help me help her for Christmas Santa. She's got 3 disabled children-probably from the fatherh being a Gulf War vet. I've already checked into the Kroger that's not far from her and they will take a credit card payment over the phone if anyone wants to give her some food for Thanksgiving. I also have permission to give anyone her phone number that is willing to help her in case you doubt the horrificness of her story. The DHR social workers even wouldn't give her the money to take the handicapped bus to her hydrotherapy recommended for her hip that will require a hip replacement. As soon as I can I'm going to get an congressional investigation going with a congressman but if anyone will help her through Thanksgiving and Christmas I can assure you you will be doing a good think. Anyonen who might not believe I am who I am can find my phone number on the internet under Lenox Chiropractic Clinic in Atlanta 404 233 4433 and my licensure under the Ga. Secretary of State and call me to verify the authenticity of this plea. I've met her myself and her 3 children. God gave those children to her to raise-not the U.S.Government to seize and control with SSRI's!!!!If anyone is willing to help her out financially I could probably even get the manager at the Walll-Mart to do the same thing for Santa. As a Mother it just breaks my heart. I'd like to move in with her and be there with a video camera every time those SS officers came terrorizing that poor woman daily with their ongoing threats before they finally deprive her of her OWN CHILDREN. Dr. Lance, D.C. Thank you, Dr. Sanrda Lphone if [hhond aorm her k r uoebeing o on this wfo the uase ses of doesn't uaesuceorrm her earan This article goes part way in describing what happens. But from what I've heard here and elsewhere, I thought that kids were being put into foster care in the first place because their parents refused to put them on SSRIs. > http://story.news./news? tmpl=story & u=/ap/20041118/ap_on_go_ca_st_pe/vioxx_safety_22 > > FDA Called 'Defenseless' Against Bad Drugs > > 14 minutes ago White House - AP Cabinet & State > > > By DIEDTRA HENDERSON, AP Science Writer > > WASHINGTON - The American public is " virtually defenseless " if another > medication such as Vioxx proves to be unsafe after it is approved for sale, > a government drug safety reviewer told a congressional committee Thursday. > > > " I would argue that the FDA (news - web sites) as currently configured is > incapable of protecting America against another Vioxx, " said Graham, > who warned that the arthritis drug had been linked to an increased risk of > heart attack and stroke. > > > He told the Senate Finance Committee that there were at least five other > drugs on the market today that should be looked at seriously to see whether > they should remain there. He cited the acne drug Accutane, the weight loss > drug Meridia, the anti-cholesterol drug Crestor, the pain reliever Bextra, > and the asthma drug Serevent. > > > Vioxx's maker, Merck & Co. pulled the drug from the market on Sept. 30 after > a study indicated the popular painkiller doubled the risk of heart attacks > and stroke when taken for longer than 18 months. > > > V. Gilmartin, the company president, said in prepared testimony that > Merck acted within four days of learning about the risk. > > > " Given the availability of alternative therapies and the questions raised by > the data withdrawing Vioxx was consistent with an ethic that has driven > Merck actions and decisions for more than 100 years, " he said. > > > Gilmartin also said the company was surprised by the cardiovascular risk > because it differed from past clinical trials. " My wife was a user of Vioxx > until the day we withdrew it from the marketplace, " he said. > > > The Food and Drug Administration (news - web sites) has defended its actions > regarding Vioxx. In a statement issued late Wednesday, the agency cited its > " well-documented and long-standing commitment to openness and transparency > in its review of marketed drugs. " > > > However, Sen. Grassley (news, bio, voting record), R-Iowa, who > chaired the hearing, suggested that an independent board of drug safety > might be needed to ensure the safety of medications after they're approved > for the market. > > > " Consumers should not have to second-guess the safety of what's in their > medicine cabinet, " he said. > > > Graham told the committee that research indicated that Vioxx caused up to > 160,000 heart attacks and strokes. > > > " If we were talking about Florida or Pennsylvania, 1 percent of the entire > state population would have been affected, " he said. " I'm sorry to say Sen. > Grassley, but 67 percent of the citizens of Des Moines would be affected > and, what's worse - the entire population of every other city in the state > of Iowa. " > > > Graham said his research helped to coax the FDA to withdraw a number of > drugs including Fen-phen, a weight loss drug, Lotronex, Baycol and Rezulin. > " During my career I have recommended the market withdrawal of 12 drugs, " he > said. " Only two of these remain on the market today. " > > > At the same time, though, he questioned the agency's commitment to removing > unsafe drugs from the market, since it would call into question their > earlier approval. > > > Sen. Jeff Bingaman (news, bio, voting record), D-New Mexico, said the > problem was within the FDA's own culture. > > > " The culture within the FDA, being one where the pharmaceutical industry, > which the FDA is supposed to regulate, is seen by the FDA as its client > instead, " he said. > > He called on President Bush (news - web sites) to appoint a new head for the > agency. Lester Crawford has been acting commissioner of the agency. > > In the FDA statement, Crawford said the FDA initiated and paid for reviews > of Vioxx and antidepressants after those drugs had hit the market. " That is > evidence the system is working, " Crawford said. > > Critics contend the agency ignored risks in both instances, then intimidated > its own reviewers when they pointed to safety concerns. > > In October, the FDA ordered that all antidepressants carry warnings that > they " increase the risk of suicidal thinking and behavior " in children who > take them. > > The FDA's statement disturbed lawyer Andy Birchfield, who is evaluating > thousands of potential cases against Merck on behalf of injured patients. > > " How can they see that type of problem and look back and say 'We did > everything right'? " Birchfield said. " When they're not willing to recognize > mistakes, we have no hope for them voluntarily taking measures to correct > the situation. " > > Crawford's statement did not mention Graham by name, but suggested that the > reviewer was a maverick who did not follow agency protocol. > > Graham was lead author on a research project that studied the records of > almost 1.4 million Kaiser Permanente patients, including 40,405 treated with > Pfizer's Celebrex and 26,748 treated with Vioxx. The study found that high > doses of Vioxx tripled risks of heart attacks and sudden cardiac death. > > Vioxx was responsible for an additional 27,785 deaths from heart ailments > from 1999 to 2003, Graham concluded. > > He has told congressional investigators that superiors pressured him to > soften his conclusions. > > Crawford said in his statement that the reviewer " voluntarily chose to > revise his conclusions, and he did so, in his own words, " without > compromising my deeply held convictions.' " > > ___ > > On the Net: > > Food and Drug Administration: http://www.fda.gov/ Re: FDA Called 'Defenseless' Against Bad Drugs... 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