"The end result being more votes in favor of COX 2 inhibitors, the drug company wins by votes - not science," Mr Ellison told Crusador.
In the case of the pain relieving Cox-2 inhibitors, the FDA's advisory committee was stacked with experts with ties to the drug makers. Of the 32 advisers who would vote on the drugs, it has since become known that 10 of panel members had consulted in recent years for Vioxx maker, Merck, or Pfizer who made Celebrex and Bextra.
While the committee voted unanimously that all of the drugs significantly increased the risk of heart attack and stroke, in a 17-15 vote the panel said the FDA should allow Vioxx to remain on the market. A tally of the votes showed that without the 9 votes of the 10 members who consulted for the drug makers, the committee would have voted 14 to 8 to ban Vioxx.
However, the panel's recommendation was met with scorn and outrage by medical experts and researchers alike in the media, and in a rare occurrence, the FDA went against the recommendation of its advisory panel and refused to allow Vioxx to remain on the market.
Critics also accuse the FDA of not properly monitoring the marketing activities of the pharmaceutical industry. An investigation by the House Committee on Government Reform found that since December 2001, there has been a sharp decline in enforcement actions taken against drug companies for illegally promoting their products.
The investigation determined that from 1999 to 2001, the FDA sent out 250 "Notice of Violation" or "Warning" letters to drug companies; but for the time period of 2002 through 2004, the agency sent out only 70 letters, which amounts to a reduction of more than two-thirds.
Since the Vioxx and SSRI debacles, Senator Grassley has jumped on the FDA every time there has been any indication that officials might be putting the industry's interest over public safety. Earlier this year, he wrote a letter to the FDA saying he was concerned that it might be "dropping the regulatory ball" on stimulant drugs, prescribed to treat ADHD.
Specifically, he wrote, "I'm concerned FDA's regulatory responsibilities haven't kept pace with the explosion of prescriptions written to treat 2.5 million children with these drugs."
Despite psychiatric and cardiovascular risk signals associated with the drugs, he noted, it appears the FDA has failed to promptly respond to their possible adverse effects. "Such events," he wrote, "may include sudden unexplained deaths, strokes, cardiovascular irregularities or aggression, anxiety and depression."
Sales of drugs, he said, "have zoomed to the moon, jumping from $759 million to $3.1 billion between 2000 and 2004."
"And yet," he wrote, "the FDA seems to have adopted a wait-and-see approach before charting a course of action to study these risks."
In early February 2006, he noted, that an advisory panel had recommended adding the strongest black box warning to ADHD drugs to alert patients about the possible cardiovascular side effects.
"The recommendation," Senator Grassley wrote, "brings even more urgency to the controversy surrounding the explosion of prescriptions being filled with these medicines."
"As the debate unfolds," he warned agency officials, "I will continue to closely track the FDA and urge its timely, thorough review of these drugs."
"With millions of Americans, mostly children, regularly taking these medications," he added, "it is essential the FDA leaves no stone unturned to investigate and review this class of drugs."
No doubt in response to all the intense scrutiny from members of Congress, in late July 2006, the FDA outlined a series of changes it plans to make in the methods used to evaluate clinical trials. One of the proposed changes would require a drug company to notify the FDA immediately if it believes a researcher has committed fraud during a clinical trial.
In the case of the pain relieving Cox-2 inhibitors, the FDA's advisory committee was stacked with experts with ties to the drug makers. Of the 32 advisers who would vote on the drugs, it has since become known that 10 of panel members had consulted in recent years for Vioxx maker, Merck, or Pfizer who made Celebrex and Bextra.
While the committee voted unanimously that all of the drugs significantly increased the risk of heart attack and stroke, in a 17-15 vote the panel said the FDA should allow Vioxx to remain on the market. A tally of the votes showed that without the 9 votes of the 10 members who consulted for the drug makers, the committee would have voted 14 to 8 to ban Vioxx.
However, the panel's recommendation was met with scorn and outrage by medical experts and researchers alike in the media, and in a rare occurrence, the FDA went against the recommendation of its advisory panel and refused to allow Vioxx to remain on the market.
The investigation determined that from 1999 to 2001, the FDA sent out 250 "Notice of Violation" or "Warning" letters to drug companies; but for the time period of 2002 through 2004, the agency sent out only 70 letters, which amounts to a reduction of more than two-thirds.
Since the Vioxx and SSRI debacles, Senator Grassley has jumped on the FDA every time there has been any indication that officials might be putting the industry's interest over public safety. Earlier this year, he wrote a letter to the FDA saying he was concerned that it might be "dropping the regulatory ball" on stimulant drugs, prescribed to treat ADHD.
Specifically, he wrote, "I'm concerned FDA's regulatory responsibilities haven't kept pace with the explosion of prescriptions written to treat 2.5 million children with these drugs."
Despite psychiatric and cardiovascular risk signals associated with the drugs, he noted, it appears the FDA has failed to promptly respond to their possible adverse effects. "Such events," he wrote, "may include sudden unexplained deaths, strokes, cardiovascular irregularities or aggression, anxiety and depression."
Sales of drugs, he said, "have zoomed to the moon, jumping from $759 million to $3.1 billion between 2000 and 2004."
"And yet," he wrote, "the FDA seems to have adopted a wait-and-see approach before charting a course of action to study these risks."
In early February 2006, he noted, that an advisory panel had recommended adding the strongest black box warning to ADHD drugs to alert patients about the possible cardiovascular side effects.
"The recommendation," Senator Grassley wrote, "brings even more urgency to the controversy surrounding the explosion of prescriptions being filled with these medicines."
"As the debate unfolds," he warned agency officials, "I will continue to closely track the FDA and urge its timely, thorough review of these drugs."
"With millions of Americans, mostly children, regularly taking these medications," he added, "it is essential the FDA leaves no stone unturned to investigate and review this class of drugs."
No doubt in response to all the intense scrutiny from members of Congress, in late July 2006, the FDA outlined a series of changes it plans to make in the methods used to evaluate clinical trials. One of the proposed changes would require a drug company to notify the FDA immediately if it believes a researcher has committed fraud during a clinical trial.
Next Page 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9
(Note: You can view every article as one long page if you sign up as an Advocate Member, or higher).
