To support their argument that the FDA had never rejected a Glaxo proposed warning, the Bratt family brief states: "None of the GSK employees in the past 14 years who have, or had, responsibility for communicating with the FDA regarding Paxil could point to any specific, proposed suicide or suicidality language that was rejected by the FDA.
In his report, Dr Glenmullen explains how Glaxo successfully avoided having to include a warning on the label when it obtained FDA approval for Paxil in 1992:
"GlaxoSmithKline's 'bad' Paxil data made it look as if patients randomized to Paxil were no more likely to become seriously suicidal when, in fact, the correct data shows patients on Paxil were eight times more likely to commit or attempt suicide."
"One again," he states, "GlaxoSmithKline's 'bad' Paxil numbers carried the day: The FDA approved Paxil on December 29, 1992 with no warning to doctors or patients of the significant increased risk of suicidal behavior."
The FDA's Dr David Graham, most famous for exposing the risks associated with Vioxx, says the government's attempts to immunize drug companies must not succeed. In an August 30, 2005 interview with Manette Loudon, the lead investigator for Dr Gary Null, (author of numerous books including "7 Steps To Overcoming Anxiety and Depression"), Dr Graham was asked about his views on attempts to pass tort reform.
"I think it's dangerous and wrong," he stated. "We already have an FDA that's been neutralized by industry and sees industry as its client."
Dr Graham said the agency is not going to protect the average citizen from the consequences of unsafe drugs, so the only alternative is the legal system. "That's the only way we have of getting companies to change their behavior," he said and, "tort reform would remove that threat as well."
"It's basically giving companies immunity because now the people who are injured by the drugs can't recover damages that might actually mean something to industry," he advised.
"I mean $250,000 for damages; they blow that in one ad campaign," he stated. "To them, that's nothing."
"But a lawsuit for multiple millions of dollars has more of an impact," he added.
"Now, is that optimal?" he said. "No."
"But the fact is that since we have a regulatory agency that doesn't regulate and we have a public health agency that doesn't protect the public, we have thousands of people who are being injured by products that the FDA knows are unsafe," he told Ms Loudon.
He pointed out that the FDA knew there was a big problem with Vioxx in mid 2000, and did nothing about it. If the FDA is not going to exercise control over companies, he said, there has to be a system in place "that reins companies in."
In addition to the agency's failure to protect the public against Vioxx, Dr Graham also discussed the FDA's attempts to conceal the increased suicide risks that were found in the reevaluation of the pediatric SSRI studies in early 2004. "The FDA had suppressed a report written by a colleague of mine in drug safety and had prevented him from presenting this information in an advisory committee meeting," he explained.
"That information leaked to the media," Dr Graham continued, "embarrassing the FDA because it had been caught suppressing very important information – that most of the antidepressants don't work for treating children."
He told Ms Loudon that someone in his supervisory chain at the FDA even initiated a criminal investigation to identify the person who had leaked the information to the media.
After fighting one of the biggest personal battles of my life, the battle to regain personal control FROM antidepressants, I finally broke free. The countless instances of damage done to "the public" by the over-prescription and misuse of antidepressants (probably prescribed drugs in general) in incontestable. Do you doubt it? Sit in a Dr.'s office and watch the endless parade of cute"former cheerleaders" (male and female) and "Barbies" pushing pills and open your eyes. Research, if you will, the recent publication from none other than "The New England Journal of Medicine" debunking the efficacy of most of the HEAVILY prescribed (over-prescribed?) poison. It should be an eye opener for any thinking person
Political payback to BIG PHARMA, lobbying in the form of such protection from prosecution, is with us forever I fear. Be VERY careful about what you allow yourself to be hooked on by the unscrupulous bastards legally pushing drugs on todays society.
by
vet613 (0 articles, 0 quicklinks, 0 diaries, 15 comments)
on Tuesday, April 8, 2008 at 3:30:25 PM
