FDA says Pfizer is trying to win drug approval that lacks study showing efficacy

[Anonymous]

http://www.minyanville.com/sectors/...-advisory-committee-r2526d/5/22/2012/id/41183

In a harsh report on the company’s drug, Food and Drug Administration staff reviewers said Tuesday that Pfizer is trying to win approval for a treatment that lacks an acceptable study showing the product works.

“I recommend a complete response action, based on inadequate evidence of effectiveness,” says FDA reviewer Devanand Jillapalli in a document prepared for Thursday’s advisory panel. Complete response is FDA jargon for a rejection.

 

[Anonymous]

omg...looks like FDA is finally getting some backbone!!

 

[Anonymous]

It worked for Lyrica, why not?

 

[Anonymous]

A great example of how the government stands in the way of commerce. So what if this drug doesn't work! That should not be an impediment to us. As long as people buy it we should be allowed to sell it. Government should stop protecting its citizens and allow corporations to do whatever they want to makes huge profits!!!!

Oh wait, if Richie Rich Romney wins in November that will be exactly what happens........

 

[Anonymous]

A great example of how the government stands in the way of commerce. So what if this drug doesn't work! That should not be an impediment to us. As long as people buy it we should be allowed to sell it. Government should stop protecting its citizens and allow corporations to do whatever they want to makes huge profits!!!!

Oh wait, if Richie Rich Romney wins in November that will be exactly what happens........

As if the Fresh Prince of Bel Air had Hope and Changed anything.

 

[Anonymous]

Pristiq redux. Failed trials of efficacy in the US and Europe. Muscle it through!

 

[Anonymous]

A great example of how the government stands in the way of commerce. So what if this drug doesn't work! That should not be an impediment to us. As long as people buy it we should be allowed to sell it. Government should stop protecting its citizens and allow corporations to do whatever they want to makes huge profits!!!!

Oh wait, if Richie Rich Romney wins in November that will be exactly what happens........

Is this the black teacher berating the kid for wanting to vote for Romney? You're a jack-ass!

 

[Anonymous]

Is this the black teacher berating the kid for wanting to vote for Romney? You're a jack-ass!

Wrong. I'm just making a point to a bunch of mindless Republican golems.

 

[Anonymous]

Wrong. I'm just making a point to a bunch of mindless Republican golems.

Works both ways. How is that Hope & Change working for you? Still in Iraq, Afghanistan and Obama launched a war on Lybia without U.N. or world community approval, assassinated several al quaida, and ran up the deficit 4 trillion in less than 4 years and unemployment still higher than Bush at 8.1% with 14.5% unemployed on U6 measure. Barack is Bush on cocaine!

 

[Anonymous]

Wrong. I'm just making a point to a bunch of mindless Republican golems.

Hey dishonest commie, redundant I know, you failed to mention that pfizer had been in contact the whole time with the FDA explaining everything. The disease is deadly and there's no treatment here in the US, except for a liver transplant.

The drug beat the placebo but not significantly. It is approved in your beloved socialist Europe. If it's good enough for your peasants in europe why should it not be good enough for the peasants here? Instead you would rather see 99%ers suffer and die just to destroy a corporation like pfizer.

I wish there were golem out there to destroy your evil kind.

 

[Anonymous]

fda may say pfizer is trying to win drug approval without efficacy study.
pfizer says fda is clueless & cant tell a side effect from a severed finger.

 

[Anonymous]

Just wait for bosutinib to hit OPDP...

 

[Anonymous]

Just wait for bosutinib to hit OPDP...

I hit my neighber's wife with sildenifil citrate. You down wit OPP?

 

[Anonymous]

Works both ways. How is that Hope & Change working for you? Still in Iraq, Afghanistan and Obama launched a war on Lybia without U.N. or world community approval, assassinated several al quaida, and ran up the deficit 4 trillion in less than 4 years and unemployment still higher than Bush at 8.1% with 14.5% unemployed on U6 measure. Barack is Bush on cocaine!

Oh, how Republican memories are so selective. Let's look back at the Bush Administration:

- They was caught fast asleep at the switch on 9/11 - there's no excuse at all for this.
- The Iraq war was based on nothing but lies and will cost us a trillion dollars.
- The Afghanistan war was supposedly against Al Quaida but Bin Laden was
allowed to slip away and we ended up fighting the Taliban, a group that
never attacked us and are hard to distinguish from our own conservatives.
- For the first time we did not fund a war through taxation. It was thrown on the deficit.
- The cost of both these wars was hidden off the books until Obama was in office.
- A healthcare bill that was completely unfunded and again ended up on the deficit.
- The bursting of the Bush Bubble left the country diving into the 2nd Great Depression.
- Bush couldn't even correctly pronounce common words.

What Obama has done has been highly effective. Only a complete idiot would ignore the total fiasco of the Bush administration and bitch about Obama.......

 

[Anonymous]

just wait for CAPiTA data...

 

[Anonymous]

Oh, how Republican memories are so selective. Let's look back at the Bush Administration:

- They was caught fast asleep at the switch on 9/11 - there's no excuse at all for this.
- The Iraq war was based on nothing but lies and will cost us a trillion dollars.
- The Afghanistan war was supposedly against Al Quaida but Bin Laden was
allowed to slip away and we ended up fighting the Taliban, a group that
never attacked us and are hard to distinguish from our own conservatives.
- For the first time we did not fund a war through taxation. It was thrown on the deficit.
- The cost of both these wars was hidden off the books until Obama was in office.
- A healthcare bill that was completely unfunded and again ended up on the deficit.
- The bursting of the Bush Bubble left the country diving into the 2nd Great Depression.
- Bush couldn't even correctly pronounce common words.

What Obama has done has been highly effective. Only a complete idiot would ignore the total fiasco of the Bush administration and bitch about Obama.......

Jimmy Carter, is that you?

 

[Anonymous]

Hey dishonest commie, redundant I know, you failed to mention that pfizer had been in contact the whole time with the FDA explaining everything. The disease is deadly and there's no treatment here in the US, except for a liver transplant.

The drug beat the placebo but not significantly. It is approved in your beloved socialist Europe. If it's good enough for your peasants in europe why should it not be good enough for the peasants here? Instead you would rather see 99%ers suffer and die just to destroy a corporation like pfizer.

I wish there were golem out there to destroy your evil kind.

On target. The FDA is an arm of the government thats trying to keep costs down.
DAMN the sick, they're expendable.
A shorter name...Obamacare.

 

[Anonymous]

This sounds like Prevnar

 

[Anonymous]

That's the FDAs way of saying; 'pfizer, it will take a 20% higher donation to our budget'.