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Add to My Group(s)
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By Evelyn Pringle (about the author)
Become a Fan -- Page 8 of 11 page(s)
Dr Singh also told the committee that it was important to recognize that the APPROVE study that led to the Vioxx withdrawal from the market, was not a safety study, it was an efficacy study, designed to add another indication for Vioxx treatment.
It was not a large enough study to detect a heart attack risk, he explained, "that it did find a risk was a lucky break for patients," he said, "but this is not what it was designed to do."
In addition, he told the panel that the FDA approval process needs to be open and subject to public scrutiny and that once a drug is approved, all the data supporting its approval should be put in the public domain.
And since an FDA reviewer had concerns about heart attacks before its approval, Dr Singh said, the FDA could have provided a conditional approval that would have required Merck to complete large safety studies within a certain time frame.
"The failure to conduct large long-term safety studies," he told the committee, "subjected millions of patients over 4 years to a drug whose safety had been questioned by the FDA even before its approval."
"This is not the proudest chapter in drug approval in the US," he concluded.
A group of 12 attorneys, who were appointed by Federal District Judge Eldon Fallon to manage pretrial discovery for all federal lawsuits, has developed a Vioxx trial package that includes a guide for pursing a lawsuit against Merck and contains all the damaging documents and evidence available against the drug giant.
The package also includes parts of video statements made by top Merck officials, and courtroom slides with text and visuals.
It also includes the videotaped deposition testimony of expert cardiologist Dr Eric Topol, one of the first experts to raise questions about the safety of Vioxx and the first expert witness to experience the power of Merck's wrath.
Shortly after learning that Vioxx had been recalled, in October 2004, Dr Topol, wrote an oped for the New York Times, and posted a column on the New England Journal of Medicine's web site, and called for a congressional review of what he called the Vioxx "catastrophe."
"The senior executives at Merck and the leadership at the FDA," he wrote, "share responsibility for not having taken appropriate action and not recognizing that they are accountable for the public health."
A little over a year later, Dr Topol, testified in a videotaped deposition, first played at a Houston jury trial on December 3, 2005, and said that Vioxx posed an "extraordinary risk," and that he had urged Merck to conduct more trials.
Dr Topol said that after the 2000 VIGOR study showed patients using Vioxx faced an increased risk of a heart attack, he began his own evaluations after finding "discrepancies" between Merck's studies and the data submitted to the FDA.
After analyzing 3 Vioxx studies, Dr Topol said he found patients began experiencing higher rates of heart problems "four to six weeks after the start of taking Vioxx."
"There was not any question about" the link between Vioxx and heart ailments, he told the jury.
Dr Topol, testified that 3 years before the drug was pulled off the market, he and two colleagues published a paper in the Journal of the American Medical Association that raised the issue of whether Vioxx caused heart problems.
Become a Fan -- Page 8 of 11 page(s)
It was not a large enough study to detect a heart attack risk, he explained, "that it did find a risk was a lucky break for patients," he said, "but this is not what it was designed to do."
In addition, he told the panel that the FDA approval process needs to be open and subject to public scrutiny and that once a drug is approved, all the data supporting its approval should be put in the public domain.
And since an FDA reviewer had concerns about heart attacks before its approval, Dr Singh said, the FDA could have provided a conditional approval that would have required Merck to complete large safety studies within a certain time frame.
"The failure to conduct large long-term safety studies," he told the committee, "subjected millions of patients over 4 years to a drug whose safety had been questioned by the FDA even before its approval."
"This is not the proudest chapter in drug approval in the US," he concluded.
A group of 12 attorneys, who were appointed by Federal District Judge Eldon Fallon to manage pretrial discovery for all federal lawsuits, has developed a Vioxx trial package that includes a guide for pursing a lawsuit against Merck and contains all the damaging documents and evidence available against the drug giant.
The package also includes parts of video statements made by top Merck officials, and courtroom slides with text and visuals.
It also includes the videotaped deposition testimony of expert cardiologist Dr Eric Topol, one of the first experts to raise questions about the safety of Vioxx and the first expert witness to experience the power of Merck's wrath.
Shortly after learning that Vioxx had been recalled, in October 2004, Dr Topol, wrote an oped for the New York Times, and posted a column on the New England Journal of Medicine's web site, and called for a congressional review of what he called the Vioxx "catastrophe."
"The senior executives at Merck and the leadership at the FDA," he wrote, "share responsibility for not having taken appropriate action and not recognizing that they are accountable for the public health."
A little over a year later, Dr Topol, testified in a videotaped deposition, first played at a Houston jury trial on December 3, 2005, and said that Vioxx posed an "extraordinary risk," and that he had urged Merck to conduct more trials.
Dr Topol said that after the 2000 VIGOR study showed patients using Vioxx faced an increased risk of a heart attack, he began his own evaluations after finding "discrepancies" between Merck's studies and the data submitted to the FDA.
After analyzing 3 Vioxx studies, Dr Topol said he found patients began experiencing higher rates of heart problems "four to six weeks after the start of taking Vioxx."
"There was not any question about" the link between Vioxx and heart ailments, he told the jury.
Dr Topol, testified that 3 years before the drug was pulled off the market, he and two colleagues published a paper in the Journal of the American Medical Association that raised the issue of whether Vioxx caused heart problems.
Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.
The views expressed in this article are the sole responsibility of the author
and do not necessarily reflect those of this website or its editors.
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