The scientist condemned the FDA's failure to acknowledge the Vioxx risks sooner. "I strongly believe that this should have been, and largely could have been, avoided," Dr Graham told the committee.
Ms Menziess often cites his testimony to demonstrate that the FDA's position on preemption is wrong and states: "Dr. Graham's testimony illustrates why FDA approval and subsequent post-marketing acquiescence should have no preemptive effect."
The Vioxx matter caught the attention of the Senate Finance Committee basically because of the drug's cost to government programs like Medicaid and Medicare. The committee is responsible for oversight of the two programs.
At the November 18, 2004 hearing, Senator Max Baucus discussed the high-costs related to the drug: "In the 5 years that Vioxx was on the market, Medicaid spent more than $1 billion on the drug," he said.
In addition to the prescription costs, government programs are now paying for the damage caused by Vioxx. "Medicaid bears the cost of any additional medical care necessary when drugs cause injury," Senator Baucus pointed out.
By far, the Vioxx debacle is the most serious public health failure to occur since the FDA took on the authority for safety oversight of medical products in 1938.
On September 3, 2005, Shane Ellison, a former pharmaceutical chemist turned whistleblower and author of the book, "Health Myths Exposed," gave an interview to Crusador Magazine and discussed Vioxx and the problems within the FDA.
According to Mr Ellison, the FDA and Merck knew about the dangers of Vioxx for at least 4 years before it was pulled off the market. "Instead of removing the drug immediately," he said, "they kept it on the drug market for matters of wealth not health."
Mr Ellison says compliant politicians have "democratized" the 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 no longer prevail at the FDA or at pharmaceutical companies," he added.
"To go against the 51% means losing your career," Mr Ellison explains. "Therefore, the majority of scientists choose to please drug companies, not the general public."
To substantiate this allegation, Dr Ellison points to Dr Curt Furberg, a member of the FDA's drug safety advisory committee. Dr Furberg went public with findings that Bextra also caused heart attacks and strokes and said studies "showed that Bextra is no different than Vioxx, and Pfizer is trying to suppress that information," in the British Medical Journal.
"Immediately thereafter," Mr Ellison said, "Dr. Furberg was barred from serving on the panel that was responsible for considering the safety of cyclo-oxygenase-2 (COX 2) inhibitors."
"The end result being more votes in favor of COX 2 inhibitors, the drug company wins by votes - not science," he told Crusador.
Another relevant, but little-mentioned fact, is that many FDA officials end up working for Big Pharma. "The old joke is that the FDA is sort of like a showcase for a future job in the drug industry," Robert Whitaker, author of Mad In America, said in an August 2005 interview with Street Spirit.
"You go there, you work awhile, then you go off into the drug industry," he said, "the progression that people make, in essence they're making good old boy network connections, so they're not going to be so harsh on the drug companies."
In addition, when leaving office many federal employees and members of Congress go to work for Big Pharma in one area or another. For instance, of the 1,274 people registered to lobby in Washington for drug companies in 2003, according to an April 2005 report by the Center for Public Integrity, 476 are former federal officials, including 40 former members of Congress.
Ms Menziess often cites his testimony to demonstrate that the FDA's position on preemption is wrong and states: "Dr. Graham's testimony illustrates why FDA approval and subsequent post-marketing acquiescence should have no preemptive effect."
The Vioxx matter caught the attention of the Senate Finance Committee basically because of the drug's cost to government programs like Medicaid and Medicare. The committee is responsible for oversight of the two programs.
At the November 18, 2004 hearing, Senator Max Baucus discussed the high-costs related to the drug: "In the 5 years that Vioxx was on the market, Medicaid spent more than $1 billion on the drug," he said.
By far, the Vioxx debacle is the most serious public health failure to occur since the FDA took on the authority for safety oversight of medical products in 1938.
On September 3, 2005, Shane Ellison, a former pharmaceutical chemist turned whistleblower and author of the book, "Health Myths Exposed," gave an interview to Crusador Magazine and discussed Vioxx and the problems within the FDA.
According to Mr Ellison, the FDA and Merck knew about the dangers of Vioxx for at least 4 years before it was pulled off the market. "Instead of removing the drug immediately," he said, "they kept it on the drug market for matters of wealth not health."
Mr Ellison says compliant politicians have "democratized" the 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 no longer prevail at the FDA or at pharmaceutical companies," he added.
"To go against the 51% means losing your career," Mr Ellison explains. "Therefore, the majority of scientists choose to please drug companies, not the general public."
To substantiate this allegation, Dr Ellison points to Dr Curt Furberg, a member of the FDA's drug safety advisory committee. Dr Furberg went public with findings that Bextra also caused heart attacks and strokes and said studies "showed that Bextra is no different than Vioxx, and Pfizer is trying to suppress that information," in the British Medical Journal.
"Immediately thereafter," Mr Ellison said, "Dr. Furberg was barred from serving on the panel that was responsible for considering the safety of cyclo-oxygenase-2 (COX 2) inhibitors."
"The end result being more votes in favor of COX 2 inhibitors, the drug company wins by votes - not science," he told Crusador.
Another relevant, but little-mentioned fact, is that many FDA officials end up working for Big Pharma. "The old joke is that the FDA is sort of like a showcase for a future job in the drug industry," Robert Whitaker, author of Mad In America, said in an August 2005 interview with Street Spirit.
"You go there, you work awhile, then you go off into the drug industry," he said, "the progression that people make, in essence they're making good old boy network connections, so they're not going to be so harsh on the drug companies."
In addition, when leaving office many federal employees and members of Congress go to work for Big Pharma in one area or another. For instance, of the 1,274 people registered to lobby in Washington for drug companies in 2003, according to an April 2005 report by the Center for Public Integrity, 476 are former federal officials, including 40 former members of Congress.
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