According to Dr Graham, by allowing Vioxx to stay on the market, the FDA is responsible for 140,000 heart attacks and 60,000 dead Americans. "That's as many people as were killed in the Vietnam War," he points out.
He says the FDA could have prevented many of the heart attacks and deaths simply by banning the high dose Vioxx back in 2000 when the agency learned about the results of the VIGOR Study. "But the FDA did nothing for almost two years," he states. "They were "negotiating" with the company over a label."
"The FDA made bad decisions," Dr Graham said, "based of its culture and its institutionalized biases that favor industry, and as a result thousands of Americans died."
During a July 18, 2005, speech on the Senate floor, Senator Grassley proclaimed, "this country's confidence in the FDA has been shaken."
It has not been shaken, he said, by one isolated incident or whistleblower. "It has been shaken because multiple drug safety concerns have been exposed by more than one courageous whistleblower."
"Dr. Graham's testimony before the Finance Committee," he told members of Congress, "suggests that the problems are systemic."
"Oversight of the FDA," Senator Grassley advised, "exposed the cozy relationship that exists between the FDA and the drug industry."
"It revealed that the FDA negotiated for almost two years with Merck," he said, "about how to change the Vioxx label so people would know about the risk of heart attacks."
According to Dr Graham, the Vioxx disaster would not have been as severe in the absence of direct-to-consumer advertising. "I submit," he told Ms Loudon, "that the numbers would have been far lower than what they were."
Due to heavy marketing of new drugs, Dr Graham says, lots of patients and doctors will use a new drug that is no better than another drug already on the market, even though the FDA does not require that new drugs be at least equivalent to, or better than, the drugs that are already there. All the drug maker has to prove is that a drug works better than a sugar pill, he says.
Silencing scientists to protect the industry has become habitual under the current politically appointed rulers of the FDA. According to Shane Ellison, author of "Health Myths Exposed," pharmaceutically compliant politicians have "democratized" the drug industry. "This means that drug approval is a matter of 51% telling the other 49% that deadly drugs are safe and necessary," he reports.
"Science and choice," he warns, "no longer prevail at the FDA or at pharmaceutical companies."
Mr Ellison is a former pharmaceutical industry chemist who says he felt a responsibility to reveal the truth about the industry's sordid tactics after he witnessed first-hand how they deceive the public, according to a September 3, 2005, interview with Crusador Editor, Greg Ciola.
"To go against the 51% means losing your career," Ellison said. "Therefore, the majority of scientists choose to please drug companies, not the general public."
As an example, Mr Ellison discussed Dr Curt Furberg, a member of the FDA's drug safety advisory committee. Dr Furberg, he says, came forward to reveal that Bextra also caused heart attack and stroke. In the British Medical Journal, Dr Furberg said that his studies showed Bextra to be no different than Vioxx, and warned that Pfizer was trying to suppress that information.
"Immediately thereafter," Mr Ellison said, "Dr. Furberg was barred from serving on the panel that is responsible for considering the safety of cyclo-oxygenase-2 (COX 2) inhibitors."
He says the FDA could have prevented many of the heart attacks and deaths simply by banning the high dose Vioxx back in 2000 when the agency learned about the results of the VIGOR Study. "But the FDA did nothing for almost two years," he states. "They were "negotiating" with the company over a label."
"The FDA made bad decisions," Dr Graham said, "based of its culture and its institutionalized biases that favor industry, and as a result thousands of Americans died."
During a July 18, 2005, speech on the Senate floor, Senator Grassley proclaimed, "this country's confidence in the FDA has been shaken."
"Dr. Graham's testimony before the Finance Committee," he told members of Congress, "suggests that the problems are systemic."
"Oversight of the FDA," Senator Grassley advised, "exposed the cozy relationship that exists between the FDA and the drug industry."
"It revealed that the FDA negotiated for almost two years with Merck," he said, "about how to change the Vioxx label so people would know about the risk of heart attacks."
According to Dr Graham, the Vioxx disaster would not have been as severe in the absence of direct-to-consumer advertising. "I submit," he told Ms Loudon, "that the numbers would have been far lower than what they were."
Due to heavy marketing of new drugs, Dr Graham says, lots of patients and doctors will use a new drug that is no better than another drug already on the market, even though the FDA does not require that new drugs be at least equivalent to, or better than, the drugs that are already there. All the drug maker has to prove is that a drug works better than a sugar pill, he says.
Silencing scientists to protect the industry has become habitual under the current politically appointed rulers of the FDA. According to Shane Ellison, author of "Health Myths Exposed," pharmaceutically compliant politicians have "democratized" the drug industry. "This means that drug approval is a matter of 51% telling the other 49% that deadly drugs are safe and necessary," he reports.
"Science and choice," he warns, "no longer prevail at the FDA or at pharmaceutical companies."
Mr Ellison is a former pharmaceutical industry chemist who says he felt a responsibility to reveal the truth about the industry's sordid tactics after he witnessed first-hand how they deceive the public, according to a September 3, 2005, interview with Crusador Editor, Greg Ciola.
"To go against the 51% means losing your career," Ellison said. "Therefore, the majority of scientists choose to please drug companies, not the general public."
As an example, Mr Ellison discussed Dr Curt Furberg, a member of the FDA's drug safety advisory committee. Dr Furberg, he says, came forward to reveal that Bextra also caused heart attack and stroke. In the British Medical Journal, Dr Furberg said that his studies showed Bextra to be no different than Vioxx, and warned that Pfizer was trying to suppress that information.
"Immediately thereafter," Mr Ellison said, "Dr. Furberg was barred from serving on the panel that is responsible for considering the safety of cyclo-oxygenase-2 (COX 2) inhibitors."
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