The powers of financial capitalism had another far-reaching aim, nothing less than to create a world system of financial control in private hands able to dominate the political system of each country and the economy of the world as a whole - Carroll Quigley, President Clinton's history professor at Georgetown University, quoted from his book, Tragedy and Hope: A History of the World in Our Time. Trust our lives to the ill defined corporate greedy guts model. Profit over Life? Contempt for life? Science suppression spells disaster in countless arenas of our lives - Evolution Freedom Survival The Promise of New EnergyDid FDA Know Of Avandia Dangers In 2002?
Years Ago, Agency Was Warned of a Drug’s Risks
WASHINGTON, May 22, 2007
(CBS/AP) The consumer advocacy organization Public Citizen claims that the Food and Drug Administration knew about problems associated with the diabetes drug Avandia for nearly five years. Avandia is linked to a greater risk of heart attack and possibly death, reported a new scientific analysis published online Monday. Pooled results of dozens of studies revealed a 43 percent higher risk of heart attack and a 64 percent greater risk of cardiovascular death, according to the review published by the New England Journal. Public Citizen sent a letter to the FDA complaining that an internal FDA memo from 2002 indicates that FDA scientists recommended labels for Avandia and Actos, another common diabetes drug, be changed to include a warning that there had been reports of heart failure for patients using the drugs. The group claims that despite the memo, the labels have not been changed. “The failure of the FDA to act on the recommendations made almost five years ago by its Division of Drug Risk Evaluation is yet another case in which the conclusions of scientists who are engaged in post-market drug safety review are not taken seriously enough or addressed soon enough,” said Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen in a news release. “As a result, millions of people — to the detriment of their health — are prescribed drugs whose risks are dangerously understated, instead of being prescribed safer, equally or more effective alternative drugs.” The group has called on the FDA to either ban the drugs or include black-box warnings on their labels. Meanwhile, across the country, people who are taking Avandia are trying to figure out what to do. The American Diabetes Association has fielded 70 calls from patients since Monday's report in the New England Journal of Medicine that Avandia is linked to a significantly higher risk of heart attack and possibly death. Pat Russo is one of them. She has been taking Avandia for three years, but on Tuesday phoned her doctor when she read news reports that it might raise the risk of heart attack. “We're taking a wait-and-see approach,” said the 60-year-old business manager from Pennsylvania. For now, Russo's doctor has advised her to stay on the medicine. And she has a checkup scheduled in a few weeks. Avandia’s maker, British-based GlaxoSmithKline PLC, contends the drug is safe and that more rigorous studies did not confirm a higher heart attack risk. Most experts say the actual risk to any single patient does appear to be small but that more studies are needed. The suggestion of a greater heart risk is especially troubling, though, because two-thirds of diabetics die of heart problems. More than 6 million people worldwide have taken Avandia since it came on the market in 1999 ...full text
WASHINGTON, May 22, 2007
(CBS/AP) The consumer advocacy organization Public Citizen claims that the Food and Drug Administration knew about problems associated with the diabetes drug Avandia for nearly five years. Avandia is linked to a greater risk of heart attack and possibly death, reported a new scientific analysis published online Monday. Pooled results of dozens of studies revealed a 43 percent higher risk of heart attack and a 64 percent greater risk of cardiovascular death, according to the review published by the New England Journal. Public Citizen sent a letter to the FDA complaining that an internal FDA memo from 2002 indicates that FDA scientists recommended labels for Avandia and Actos, another common diabetes drug, be changed to include a warning that there had been reports of heart failure for patients using the drugs. The group claims that despite the memo, the labels have not been changed. “The failure of the FDA to act on the recommendations made almost five years ago by its Division of Drug Risk Evaluation is yet another case in which the conclusions of scientists who are engaged in post-market drug safety review are not taken seriously enough or addressed soon enough,” said Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen in a news release. “As a result, millions of people — to the detriment of their health — are prescribed drugs whose risks are dangerously understated, instead of being prescribed safer, equally or more effective alternative drugs.” The group has called on the FDA to either ban the drugs or include black-box warnings on their labels. Meanwhile, across the country, people who are taking Avandia are trying to figure out what to do. The American Diabetes Association has fielded 70 calls from patients since Monday's report in the New England Journal of Medicine that Avandia is linked to a significantly higher risk of heart attack and possibly death. Pat Russo is one of them. She has been taking Avandia for three years, but on Tuesday phoned her doctor when she read news reports that it might raise the risk of heart attack. “We're taking a wait-and-see approach,” said the 60-year-old business manager from Pennsylvania. For now, Russo's doctor has advised her to stay on the medicine. And she has a checkup scheduled in a few weeks. Avandia’s maker, British-based GlaxoSmithKline PLC, contends the drug is safe and that more rigorous studies did not confirm a higher heart attack risk. Most experts say the actual risk to any single patient does appear to be small but that more studies are needed. The suggestion of a greater heart risk is especially troubling, though, because two-thirds of diabetics die of heart problems. More than 6 million people worldwide have taken Avandia since it came on the market in 1999 ...full text
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