Boehringer Withheld Pradaxa Analysis, Unsealed Files Show

http://www.businessweek.com/news/2014-02-25/boehringer-kept-pradaxa-analysis-from-fda-unsealed-files-show

Boehringer gave U.S. regulators one analysis of data gathered after the drug’s October 2010 approval that showed the number of people who died from bleeding was less than expected, according to internal documents made public in lawsuits over the product. The company didn’t share a second analysis showing a higher death rate, the documents show.

Why did they lie to regulators? Because they knew Pradaxa would have never been approved.

 

Hold on there, my libelous friend. There's no proof in that article that BI "lie[d]" to the regulators.

BI didn't supply a second analysis because they felt the deaths were not related to their drug. Until we know what exactly the FDA requested from BI, you can't convict them of any wrongdoing.

Anyone can make statistics look good or bad, it all depends on the agenda of the statistician and the input used. It's ccalled Junk Science. Just look at how Junk Science made John Edwards wealthy and great doctors ruined, because juries were full of thoughtless idiots like you.

I can't wait for the day you're wrongly accused of something and someone slanders you prematurely before you were able to fully defend yourself.

This is the crux of the issue in the article you cited, and you call BI "li[ars]"?:

"That effort produced two separate analyses by the company, according to the unsealed court documents. One, looking only at people whose primary cause of death was bleeding, found 5.8 of 10,000 patients died per year. The other, which included anyone who had a major bleeding event and died for any reason, found a rate of 19.5 fatal events per 10,000 patients per year, the documents show."

Is it just me or are those on pradaxa already cardio event deaths waiting to happen, and you would connect their deaths to pradaxa just because they had a bleeding event without looking at the true cause of death and the nexus of pradaxa usage?

Shame on you.

 

Don't also forget this article:

http://www.nytimes.com/2014/02/06/business/study-of-blood-clot-drug-pradaxa-unnerved-its-maker-documents-suggest.html

You have to wonder how mad the FDA is about these different issues raised by these two different articles.

 

can't talk about it

 

All BI needs to do is donate millions of dollars to the DNC and Obama's library, and the Clinton appointed Democrat Federal District Judge will drop the lawsuits.

Sadly, you know this is the truth.