In fact, in the early 1990s, it was the FDA safety officer Dr David Graham, of recent Vioxx fame, who raised concerns about the risk between antidepressants and suicidality, but no one listened, Ms Menzies says.
Fourteen years later, the FDA finally ordered black box warnings labels on SSRIs alerting physicians about the increased risk of suicidality. Ms Menziess describes the FDA during these years as "complacent, ignoring its own internal scientist when they raise concerns, and in the pocket of industry."
She believes that the FDA would never have confronted the issue had it not been for the public outcry from victims, consumer groups, courageous experts willing to place their careers on the line, investigative reporters and pressure from certain members of Congress; and yes, she says, "lawyers uncovering the drug industry's dirty little secrets through legal discovery and speaking out about the dangers."
Over the past couple of years, a growing number of lawmakers have been turning up the heat on both the FDA and the industry in response to their combined failure to reveal the problems found in studies conducted on drugs like SSRIs and Vioxx.
At one point, Senator Charles Grassley (R-Iowa), Chairman of the Senate Finance Committee, came right out and accused the FDA of suppressing studies in order to protect industry profits and the careers of certain FDA officials.
"The Vioxx example showed that the FDA and Merck were too close for comfort," Senator Grassely told Health News on March 12, 2005. "Testimony and documents at our Finance Committee hearing showed that the FDA allowed itself to be manipulated by Merck," he said.
The results of a trial that took place in 2000, surfaced that showed that 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, Senator Grassley pointed out, but the FDA did nothing to change the labeling for nearly 2 years, he said, while Merck marketed its product on nightly TV.
On November 18, 2004, Senator Grassley drew enormous media attention when he held hearings on Vioxx, and FDA scientist, Dr Graham, testified that he determined that Vioxx may have caused tens of thousands of heart attacks and strokes but that his superiors at the FDA pressured him to keep quiet.
"The estimates range from 88,000 to 139,000 Americans," Dr Graham told the committee. "Of these, 30 to 40 percent probably died," he advised. "For the survivors," he added, "their lives were changed forever."
To put the number of injuries into perspective, Dr Graham told members of the committee that instead of side-effects from a drug, to think of it as if they were talking about jetliners.
"If there were an average of 150 to 200 people on an aircraft," he said, "this range of 88,000 to 138,000 would be the rough equivalent of 500 to 900 aircraft dropping from the sky."
"This translates to 2-4 aircraft every week," he advised, "week in and week out, for the past 5 years."
"If you were confronted by this situation," Dr Graham asked the panel, "what would be your reaction, what would you want to know and what would you do about it?"
He noted the problems with the FDA's reliance on a 95% paradigm. In other words, he said, a drug is considered safe "until you can show with 95% or greater certainty that it is not safe."
Next Page 1 | 2 | 3 | 4 | 5 | 6 | 7
(Note: You can view every article as one long page if you sign up as an Advocate Member, or higher).
