With the SSRIs, he says, the FDA should have insisted on a signed informed consent form, that said three things: (1) these are the antidepressants available and only Prozac has been shown to work for children; (2) all the other drugs are no better than placebos; and (3) all these drugs appear to have the ability to increase the risk of suicidal behavior.
As a parent, he stated, if I saw that in writing and the doctor was going to write the prescription for some drug other than Prozac, I could say, "Doc, why are you putting my child on a drug that doesn't work in kids."
According to Dr Graham, the FDA did not want patients to have that information, so it refused to require signed informed consent. And, the companies didn't want parents to have that information because all of a sudden the lucrative "off-label" use of the drugs would have dried up.
Dr Graham also explained that, if the FDA pulls a drug off the market due to safety issues, it not only hurts the marketing of the drug, but also calls into question why it was approved in the first place.
"Therefore," he said, "you get this culture of cover-up, this culture of suppression, this culture of denial, and this culture that demonstrates above all else that industry is the client and not the American people."
Most Americans do not realize that a preemption decision on whether to throw out a lawsuit largely hinges on the judge assigned to the case. Attorneys James Beck and Mark Herrmann run the "Drug and Device Law" blog and they post their personal views on topics that arise in the defense of pharmaceutical company product liability litigation.
On May 17, 2007, they posted a piece called, "Picking Spots In Preemption Cases." The bloggers lamented that "two adverse preemption decisions over the last couple of weeks [ ] have us scratching our heads."
The opinions referred to were Barnhill v Teva Pharmaceuticals, No 06-0282, (SD Ala Apr 24, 2007), and Kelly v Wyeth, 2007 WL 1302589 (Mass Super Apr 12, 2007).
In their blog, Mr Beck and Mr Herrmann discuss the importance of filing preemption motions with judges who are already known to be unsympathetic to private plaintiffs who sue drug companies.
"With respect to Kelly," they state, "the most salient point for us is why a preemption motion was brought at all in a state trial court in Massachusetts – a known pro-plaintiff jurisdiction."
"There's certainly no history of success with preemption motions in prescription medical product cases in Massachusetts," they point out.
"Part of preemption strategy is choosing the jurisdictions in which such motions would have a reasonable likelihood of success," they explain.
"In plain English, you gotta pick your spots," the attorneys advise.
"If defendants go running helter skelter into courts filing preemption motions no matter how hostile the jurisdiction – well, the result is going to be decisions like Kelly," they warn.
"That doesn't do the filing defendant any good," they state. "Nor does it do anyone else defending prescription drug cases any good."
On the other hand, in the September 2007 paper, "The Truth about Torts: Using Agency Preemption to Undercut Consumer Health and Safety," legal scholars, William Funk, Sidney Shapiro, David Vladeck and Karen Sokol, of the Center for Progressive Reform, discuss the importance of jury trials, and the tort system in general.
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.
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vet613 (0 articles, 0 quicklinks, 0 diaries, 15 comments)
on Tuesday, April 8, 2008 at 3:30:25 PM