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Old 08-29-2007, 07:07 AM
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Default Drug Warning Labels Should Include FDA Ties to Big Pharma
By Martha Rosenberg, AlterNet. Posted August 28, 2007.

Ninety-two percent of FDA advisory meetings in the last decade included a member with financial ties to drug companies. A look at how that affects the drugs that are allowed on the market -- even after they're shown to be deadly.


They're just dropping like Chinese imports -- prescription drugs that turn out to be deadly after FDA approval.

Not just Vioxx -- recently found to cause kidney problems on top of the heart attacks for which it was pulled -- but its seven deadly sisters named by the FDA's Dr. David Graham before Congress in 2004: Crestor, Meridia, Serevent, Lotronex, Arava, Accutane and Bextra.

After a post-Vioxx damage control campaign -- "FDA has confidence in the safety and efficacy of Crestor" read AstraZeneca ads which the FDA pulled -- it wasn't that confident. The cholesterol drug Crestor was found in the heart journal Circulation to be eight times more likely to cause rhabdomyolysis, kidney failure or spillage of protein in the urine than other cholesterol drugs.

Thirty users of Meridia, Abbott Laboratories' weight-loss drug, died of cardiovascular problems from 1997 to 2003 and 224 other experienced nonfatal strokes, heart attacks and other cardiovascular ailments according to FDA reports.

And Accutane manufacturer Hoffman-La Roche Inc. goes to trial this October in Madison County, Illinois -- where the first Vioxx trial occurred -- to defend charges that its acne drug caused Jason Peipert's inflammatory bowel disease, which ruined the young soccer star's career.

Then there's Sanofi-Aventis' notorious antibiotic Ketek -- blamed in the death of four and liver injury or failure of 37 since 2004 -- whose primary clinical trials doctor, Anne Kirkman Campbell, is in federal prison in Lexington, KY for forging data for money. (Test subjects included her entire staff and members of her family.)

Another doctor upon whose clinical data Ketek was approved conducted trials while his medical license was on probation and was arrested for cocaine and gun possession soon after.

And consider the atypical anti-psychotics whose marketing was also "atypical," with 29 percent of AstraZeneca's Seroquel sales coming from off-label Alzheimer use, even though studies say it worsens the condition. Or Eli Lilly settling 29,000 lawsuits from inadequate warnings about Zyprexa's diabetes, weight gain and pancreas infection side effects.

Finally there's GlaxoSmithKline's Avandia, prescribed for 1 million Americans for type 2 diabetes and now known to increase the risk of heart attack by 43 percent and cardiovascular death by 64 percent.

Avandia is more expensive and dangerous than older drugs and NOT more effective, said Dr. Graham to a joint panel of experts convened to consider the drug in July -- a charge he could also level against the other suspect drugs and Big Pharma itself.

But instead of pulling the purloined drugs, the FDA just adds warnings and subtracts uses.

Ketek is no longer recommended for sinus infections; just community acquired pneumonia.

Meridia is only recommended for people who have to lose 30 pounds or more who don't have poorly controlled hypertension, a history of heart disease, stroke or severe liver or kidney disease.

And Accutane users are clearly warned about suicidal behavior, birth defects and inflammatory bowel disease risks to the drug on the label.

Because pulling the drugs not only affects sales, company image and stock price, it feeds lawsuits. ("The drug was so unsafe they PULLED IT FROM THE MARKET.")

Besides, thanks to fast-tracking and six-month approvals, no one knows if a drug is dangerous anyway until a critical mass of human guinea pigs takes/tests it. Only about 3,000 people are tested in clinical trials that are conducted premarket, and what if the drug harms one in every 3,001? Do you really think lethal tests on beagles and other mammals keep you safe? Talk about dying in vain.

But finally, pulling a drug after approval just casts light on the approval process itself, which is teeming with conflicts of interest. Ninety-two percent of FDA advisory meetings in the last decade included a member with financial ties to drug companies, according to USA Today -- the FDA calls them sponsors -- and federal law against using experts with financial conflicts of interest was waived 800 times.

Too bad THAT can't be on the warning label.
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Old 08-29-2007, 08:37 AM
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And this is the group that tells us about medical marijuana?? VV
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Old 08-30-2007, 01:05 PM
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You might not have heard about the latest from India. They make a lot of the generic drugs sold around the world including the good old USA. The quality control of these drugs is akin to the quality control of chinese toy makers. The wast products from making these drugs is a highly toxic soup that the Indian Mfgrs. have been dumping helter-skelter accross the Indian countryside, killing the fields and rivers the people use to grow crops and survive on. Another Kudos to big Pharma as they hold the patents these drugs are manufactured under and basaically own controlling interest in the Indian Companies.
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Old 08-31-2007, 08:53 AM
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this is another great list of reasons to disband the FDA and let non-bureaucratic, politically independent labs do the work.

what a joke it would be if our wonderful government controlled the UL listing that keeps our household electronics up to safe standards!!

i can see it now - houses, cars randomly burst into flames because the committee of the committee of the agency of pseudo-oversight was on vacation and some new government employee found the rubber stamp...






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Old 08-31-2007, 09:16 AM
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this is another great list of reasons to disband the FDA and let non-bureaucratic, politically independent labs do the work.

what a joke it would be if our wonderful government controlled the UL listing that keeps our household electronics up to safe standards!!

i can see it now - houses, cars randomly burst into flames because the committee of the committee of the agency of pseudo-oversight was on vacation and some new government employee found the rubber stamp...






.
Watch it, that kool-aid you're drinking is getting toxic,~LOL~.
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Old 08-31-2007, 10:45 AM
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Watch it, that kool-aid you're drinking is getting toxic,~LOL~.
seriously, look at the UL system. the keyboard you're using right now, the monitor, the remote to your movie screen tv, the tv itself, pretty much everything electronic.

why don't we have people getting killed by these things all the time? is it because of laws, or agencies, or is it because of integrity and true dedication to the benefit of society? government is a parasite, it never wants what is best, only what makes it fatter.


the government created the FDA as a cash cow to pilfer an industry that is vital to Americans. they can say what is legal or not legal depending on who contributes the most to the campaigns. slash the FDA down to a dozen scientists and let them work with a couple universities and some medical schools to develop a new system that actually works; a private lab would be developed with sensible methodologies and much greater benefit to everyone.






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Old 08-31-2007, 11:29 AM
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Originally Posted by 7xstall View Post
seriously, look at the UL system. the keyboard you're using right now, the monitor, the remote to your movie screen tv, the tv itself, pretty much everything electronic.

why don't we have people getting killed by these things all the time? is it because of laws, or agencies, or is it because of integrity and true dedication to the benefit of society? government is a parasite, it never wants what is best, only what makes it fatter.


the government created the FDA as a cash cow to pilfer an industry that is vital to Americans. they can say what is legal or not legal depending on who contributes the most to the campaigns. slash the FDA down to a dozen scientists and let them work with a couple universities and some medical schools to develop a new system that actually works; a private lab would be developed with sensible methodologies and much greater benefit to everyone.






.
Well, as I mentioned in the Indian post, there is a situation where no government controls exist and the corporations are dumping the toxic soup to save money, do you think they would do less here in the USA if there were no government regulations, you are a dreamer. the corporations exist for one reason and one reason only, the bottom line. If there were no Governmental regulations on them, this country would look like India within a decade, with wages pennies on the dollar, nothing but bosses and peons, toxic waste in our cities, countryside, national parks looted for their resources, this country would be a virtual shithole. Think about that and get back to me. We both know there is no such thing as corporate conscience.
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Old 08-31-2007, 11:39 AM
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look at your indian article again, med. they have lots of regulation and laws, no enforcement. sound familiar? anyone like the idea of sovereign borders?

even if you want to say corporate conscience doesn't exist, surely you understand that people make up the corporations. those people have a voice. not so in government. it's a machine.





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Old 08-31-2007, 11:56 AM
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look at your indian article again, med. they have lots of regulation and laws, no enforcement. sound familiar? anyone like the idea of sovereign borders?

even if you want to say corporate conscience doesn't exist, surely you understand that people make up the corporations. those people have a voice. not so in government. it's a machine.





.
Wrong, we are the voice in government. It starts at the schoolboard and local politics, get involved. Find candidates that support your views and vote for them, sign national petitions to force congress to act. As far as the people in corporations, they cowtow to the ones above them and the CEOs cowtow to the Board, and the greedy investors demand more profit from their shares, so the responsibility to humanity is put way way back on the back burner. Without regulations and fines for not following them (although sometimes with miniscule fines, it is more profitable to go ahead and break the rules) The corporations would be even worse than they are.
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Old 08-31-2007, 12:18 PM
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so you'll tell me that it is impossible for a government to isolate itself from the will of the people; tyranny is an impossible thing to achieve? lol, you must have fallen into the kool aid barrel, med!!

government can simply abolish opposition itself. however, no one can restrain the market! this is a fundamental fact. we all have a voice in the market.

what if a corporation could force you to buy their products on a regular basis? would you like that? that's the government. they exploit the market of disparity, war and discontent. they manipulate and contrive in order to grow and abolish competition. it's a chain reaction and it's under way in our country right this second.

anyway, government has done nothing in india to prevent the pollution.




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