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Vioxx and Celebrex can stay


NUKE_CLEVELAND

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Not quite yet. The FDA Advisory panel has said the benefits outweigh the risks and the drugs SHOULD stay on the market, but the FDA hasn't made ruling yet. That said, they will most likely follow the Panel reccomendations, including stricter warnings, narrowing the subset of patients for which the drugs are prescribed, and possibly limiting or doing away with direct-marketing them to the public.

 

There will also likely be a large-scale risk assessment study commissioned.

 

I think keeping the products available is the right decision given what is currently known, and provided that they will follow the other Panel reccomendations.

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If I were Merck, I'd be looking to bring in a new CEO. Gilmartin was a moron for pulling the drug off of the market in the first place. They could've easily kept it on the market and alerted the doctors and patients of these side effects (which were in only in a very small percentage of patients). And it's not like pulling the drug would've kept them safe from class-action lawsuits. All that could possibly accomplish was a hit to their bottom line and eventual layoffs.

Edited by TheBigHurt35
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QUOTE(winodj @ Feb 18, 2005 -> 09:01 PM)
They oughta pull em off direct marketing though. I got a problem with the advertisement of prescription medication to mass markets. If you can't advertise tobacco, you shouldn't be able to advertise a product with a potential side effect of kidney failure if taken in recommended doses.

 

Not that I necessarily disagree, but then alcohol ads would have to be pulled as well.

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The whole "ask your doctor about [insert drug here]..." direct-marketing culture is problematic. It's good for consumers to be educated and informed about options, but the incessant ads shoved down our throats tell us to march in to our doctor's office and WE TELL HIM what he should be prescribing us. If he disagrees, we go find another doctor, and so on, until we find one that will give us the drugs the TV told us WE NEED (of course, we neglected to listen to the 2-minute litany of possible side effects that are almost as bad as the original condition). At that stage, we are essentially self-medicating, and as we are seeing that can mean trouble.

 

Compounding the problem of course, now you can get just about any drug you'd want online with little or no worries that anybody will actually check to see if a doctor has actually prescribed it to you.

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QUOTE(FlaSoxxJim @ Feb 18, 2005 -> 10:00 PM)
The whole "ask your doctor about [insert drug here]..." direct-marketing culture is problematic.  It's good for consumers to be educated and informed about options, but the incessant ads shoved down our throats tell us to march in to our doctor's office and WE TELL HIM what he should be prescribing us.  If he disagrees, we go find another doctor, and so on, until we find one that will give us the drugs the TV told us WE NEED (of course, we neglected to listen to the 2-minute litany of possible side effects that are almost as bad as the original condition).  At that stage, we are essentially self-medicating, and as we are seeing that can mean trouble.

 

Wasn't it until only recently that the FDA would allow prescription drugs to be advertised on TV?

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QUOTE(TheBigHurt35 @ Feb 19, 2005 -> 10:34 AM)
What do you mean, "why"?  Maybe because, like tobacco, alcohol has very negative effects on one's health with little benefit?  Hell, at least presecription drugs have some important medical use.

I think wino is suggesting the important part is that these side effects are occurring even when the drugs are "used as directed," within reccommended dosages. IF (and that's a big IF), alcohol were used at the so-called "recommended dosages," people wouldn't be dropping dead, developing psorosis and other alcoholism-related illnesses, etc., and we're told there may ven be slight benefits.

 

Again, of course it's a big if. Even with hard liquor ads pulled years ago, the beer adult beverage industry is phenomenally irresponsible in their advertizing. All the "know when to say when" and "drink responsibly" tag lines in the world don't dilute the message that to be hip and young and popular and sexy tou need to drink brand X and lots of it.

 

Wholly apart from the drug ad issue, I think alcohol advertizing has it's own problems.

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QUOTE(FlaSoxxJim @ Feb 19, 2005 -> 10:37 AM)
I think wino is suggesting the important part is that these side effects are occurring even when the drugs are "used as directed," within reccommended dosages.  IF (and that's a big IF), alcohol were used at the so-called "recommended dosages," people wouldn't be dropping dead, developing psorosis and other alcoholism-related illnesses, etc., and we're told there may ven be slight benefits.

 

Again, of course it's a big if.  Even with hard liquor ads pulled years ago, the beer adult beverage industry is phenomenally irresponsible in their advertizing.  All the "know when to say when" and "drink responsibly" tag lines in the world don't dilute the message that to be hip and young and popular and sexy tou need to drink brand X and lots of it.

 

Wholly apart from the drug ad issue, I think alcohol advertizing has it's own problems.

 

 

Tastes great!

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QUOTE(TheBigHurt35 @ Feb 19, 2005 -> 02:31 PM)
Yep.  Aside from what they're selling, they use sex to do it.  You think the FDA would allow a Viagra commercial featuring the Coors twins? :lol:

 

 

Yeah, one on each arm of some old geezer who has a big smile on his face. Might I suggest grandpa from "Road Trip"?

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QUOTE(TheBigHurt35 @ Feb 18, 2005 -> 01:45 PM)
If I were Merck, I'd be looking to bring in a new CEO.  Gilmartin was a moron for pulling the drug off of the market in the first place.  They could've easily kept it on the market and alerted the doctors and patients of these side effects (which were in only in a very small percentage of patients).  And it's not like pulling the drug would've kept them safe from class-action lawsuits.  All that could possibly accomplish was a hit to their bottom line and eventual layoffs.

Merck handled the whole situation like assholes. They knew of the sideeffects and instead of informing the public they did nothing. They actually deserve the lawsuit, even though I freaking hate 99% of all attorneys because they are freaking bastards (notice I'm leaving it open because I do know a few nice ones).

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QUOTE(Chisoxfn @ Feb 19, 2005 -> 03:08 PM)
They knew of the sideeffects and instead of informing the public they did nothing.

 

Uh, wrong. They pulled the drug from the market when the post-launch follow-up studies showed potential cardiac issues in a small fraction of patients.

 

Vioxx went through about 8-10 years of clinical trials in humans and significant FDA scrutiny. Merck played by the rules and doesn't deserved to be demonized.

Edited by TheBigHurt35
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It's the FDA head honchos who are the real villains here. It took David Graham blowing the whistle on them to bring to light the fact that he and his colleagues were being silenced about riskes they were aware of regarding Vioxx and other drugs.

 

EDIT: And the following link can go in the thread about killing the state-shopping in class action drug suits, but it's wholly relevant here and this appears to be the thread with more legs...

 

I'd feel better about the move to scuttle the lawyers' easy route to class action payoffs if we didn't also have to deal with this:

 

http://www.ahrp.org/infomail/04/07/26.php

 

To summarize, the Bush Administration has been actively blocking individual citizens who have been seriously harmed from drug-related hazards from suing drug manufacturers.

 

The argument, seemingly sound on the surface, is that a judge or jury finding that a drug or device is unsafe, that finding directly conflicts "with the conclusion [of reasonable safety] reached by the FDA after years of rigorous testing and evaluation."

 

The problem is, it's bulls*** if the people at the FDA are actively and willfully witholding information from consumers about product safety. Consumers are f***ed over up front because they are not given all the facts about very potent drugs. Then they are being f***ed over at the back end when their reasonable avenues of legal recourse are being taken away when they suffered from taking the drugs while unaware of KNOWN serious issues.

 

Without looking for any fights, I would like to see a response to this situation from Nuke and Killa, or Eye, as they are among the most vocal in favor of shutting down the multi-state class actions or other such reforms. I agree with them in principle, but as the reality is that the FDA and the Sdministration are so seriously stacking the deck against individual claimants, I see this as one more avenue injured citizens are excluded from.

Edited by FlaSoxxJim
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