However, in an obvious effort to try and level the playing field for the little guy, in 2004, Representative, Maurice Hinchey (D-NY), chastised the administration for taking the FDA in a radical new direction, "seeking to protect drug companies instead of the public," and persuaded the House to cut $500,000 from the budget of the chief counsel's office as a penalty for the FDA's aggressive opposition to citizen's lawsuits.
Although the FDA's current Chief Counsel, Sheldon Bradshaw, might not have the direct and visible financial links to Big Pharma of his predecessor, critics say, he certainly does not represent a changing-of-the-guard in political leadership at the FDA.
"In fact," Attorney Menzies says, "following in his predecessor's footsteps, Bradshaw submitted a legal brief in support of Pfizer's federal preemption arguments."
Judges across the nation have flat-out rejected the FDA's argument. A Minnesota court said it declined "to treat statements from a single FDA legal brief as declarations afforded the preemptive force of law."
A California court ordered the brief stricken from the record calling it "hearsay and irrelevant," and an Illinois judge said it "contains nothing more than legal argument by [FDA] counsel."
Most recently, in a June 6, 2005, Vioxx court hearing, the FDA's position on preemption hit a major road block with New Jersey State Court Judge, Carol Higbee, who is handling the Vioxx cases, when she labeled the FDA's Final Rule's preamble "a political statement by the FDA." She scoffed at the agency's preemption claim and said:
"It is contrary to the U.S. Supreme Court's decisions. It is contrary to all the law on preemption. ... In addition to being contrary to the law of the land, it is also contrary to the Constitution of the United States."
Judge Higbee ended her comments by throwing cold water on any planned attempt by Merck's legal team to give the preemption argument a whirl, by telling them right-out in open court: "I am not going to allow you to use it."
Speaking to the Consumer Federation of America in March 2005, Senator Grassley, basically said the FDA can't be trusted to protect citizens against dangerous drugs like Vioxx because the agency is to "cozy" with companies like Merck.
Based on a clinical trial that took place in 2000, he told the audience, both the FDA and Merck were aware that heart attacks were 5 times more likely in patients taking Vioxx than among those taking a similar drug, but the FDA did nothing to change the labeling on the drug for nearly two years, while Merck aggressively marketed Vioxx on nightly TV.
Describing whistleblowers as "patriots" who risk their careers in the interest of public safety, Senator Grassley recounted the controversy over Vioxx that was fueled in large part by the efforts of FDA scientist, Dr David Graham, to shed light on the drug's potential risks.
Senator Grassley described how the FDA "disregarded and stonewalled" concerns raised by its own scientist. "Dr. Graham completed a study that found an increased risk of heart attacks and strokes in patients taking Vioxx," he told the Federation. "His immediate supervisor, however, dismissed this study as 'scientific rumor."
"The very same month that Dr. Graham warned the FDA of the cardiovascular risks of Vioxx," Senator Grassley continued, "the FDA approved the use of Vioxx for children."
He told the audience how the director of FDA's office of new drugs suggested that Dr. Graham water down his Vioxx conclusions and how Dr Graham replied that in good conscience he could not. "When Dr. Graham was asked to present his findings at my committee's Vioxx hearing," the Senator said, "he was also undermined."
News reports that day show that acting FDA Commissioner Lester Crawford called Dr Graham a "maverick who did not follow agency protocols."
"This statement," Senator Grassley told the Federation, "made on the eve of the hearing, could logically serve no purpose other than to intimidate Dr. Graham."
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