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   Drug safety under serious threat.
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Bob_Johnson
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Drug safety under serious threat.
« on: Aug 9th, 2004, 9:14am »
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Should Federal courts accept the position (outline in this column), consumers will lose a major protection against adverse drug outcomes.  
 
The present FDA system of approving new drugs gives us a minimum level of protection. Many drug/drug interaction problems do not surface until after the medication has been on the market, sometimes for several years. The FDA depends on health providers to provide reports of adverse outcomes which arise from the actual experience of the doctor/patient. If this evidence is not allowed to be used in Federal courts, the consumer will be lose a major protection.
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SEATTLE POST-INTELLIGENCER
http://seattlepi.nwsource.com/opinion/184574_medsuited.html
 
FDA not court of last resort  
Tuesday, August 3, 2004
 
SEATTLE POST-INTELLIGENCER EDITORIAL BOARD
 
The joke goes: "We're from the government and we're here to help you." The Bush administration would make the punch line even more laughable by adding: "And don't worry because we're always right."
 
The White House has dispatched Food and Drug Administration lawyers around the country to intervene for the defense in lawsuits filed by individuals who say they were injured by prescription drugs and medical devices.
 
Their new argument, which has in fact helped manufacturers win their court cases, is that judges and juries don't have the legal right to second-guess the FDA and injured parties can't recover damages for their injuries if the FDA has approved the damaging product.
 
The arrogant presumption is that the FDA is inerrant. The resultant dangerous public policy would leave individuals no civil redress if the FDA is less than perfect.
 
The nation's intelligence agencies have been shown fatally inept, yet the administration declares the FDA to be perfect.
 
Previous federal policy has been that FDA approval set the minimum standard for product safety and that states had the power to provide additional protection to consumers. The administration would make federal approval not just the floor but also the ceiling, crushing consumers in between.
 
It may be healthy to instill public confidence in the competence of federal regulatory agencies, but it's decidedly unhealthy to mandate such confidence, much less to grant this bizarre sort of sovereign immunity to agency incompetence.
 
© 1998-2004 Seattle Post-Intelligencer
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Bob Johnson
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Re: Drug safety under serious threat.
« Reply #1 on: Aug 9th, 2004, 9:44am »
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So what more will it take, before we, as Americans, stand up and fight this BS? Is everyone [general population, not just us CH'ers] so apathetic that they feel 'if it doesn't affect me, why get involved'?
 
I think the time is coming for anohter 'Boston Tea Party'. Only this time, instead of dumping crates of tea, we weight down the politicians and toss them overboard.
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Samantha_Smith
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Re: Drug safety under serious threat.
« Reply #2 on: Aug 9th, 2004, 12:22pm »
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Unfortunately, this is just a sign of the times.  We have become a litigious society. Some people have suggested that the FDA be dissolved and have privately run/owned companies conduct trials and "approve" drugs. It's just an idea to chew on. Food for thought.
       Samantha
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Re: Drug safety under serious threat.
« Reply #3 on: Aug 9th, 2004, 12:56pm »
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Funny thing about these government entities, Federal, State and Municipal. They all seem to be immune from any sort of litigation. Small price to pay for all the good they do for the masses, right. I guess it goes from one extreme to the other.
 
My case: I was about thirty five, had a daughter with a previous wife, paid child support faithfully. One day at work a squirrelly looking character asked for me in the lobby. He serves me with a non-payment of child support order that further completely tied up my checking, savings and credit cards until the full amount $42,000.00 plus interest and court costs were paid in full.
 
After six months of fucking around with the State’s lawyers and getting no where on a whim I visited a United States Senators office, explained my dilemma and two weeks later I received a letter from the Director of the Oklahoma Department of Human Services acknowledging some sort of clerical error had caused all this. No apology, no sorry we screwed up your credit rating no nothing.
 
About a year later I got my financial house back in order, until next time.  Roll Eyes
 
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« Last Edit: Aug 9th, 2004, 1:00pm by forgetful » IP Logged
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