Study of Drug for Blood Clots Caused a Stir, Records Show

[highplainsdem]

Source: NY Times

The makers of the blood-thinning drug Pradaxa were so worried that an internal research paper would damage drug sales that some employees not only pressured the author to revise it, but suggested it should be quashed altogether, according to newly unsealed legal documents.

-snip-

The documents show that Boehringer Ingelheim employees openly fretted when it appeared that the results of the research paper, written by Paul A. Reilly, a clinical program director at the company, indicated that some patients could benefit from monitoring of their blood. A certain segment of patients, the paper found, absorb too little of the drug to effectively prevent strokes, while another group absorbs so much that they are at a higher risk for bleeding.

In a draft version of the paper included in the court records, Dr. Reilly and his co-authors detailed specific levels of how much Pradaxa should be in a patient’s bloodstream, and said that keeping some patients within that range would help prevent strokes and bleeding.

-snip-

Dr. Reilly’s paper was published Tuesday in the Journal of the American College of Cardiology, and although many of the conclusions in the draft version remained, references to a patient’s optimal blood-level range no longer appear in the article.

-snip-

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

[arikara]

1. This is the drug that causes uncontrolled bleeding

and if I remember correctly, there is no antidote for it.

I would never take a drug that has been on the market for less than 7 years, that's if I could be compelled to take any pharmaceutical. Anything newer and they are testing them on the patient.

[highplainsdem]

5. Yes. Linked to over 1,000 deaths so far.

[mucifer]

2. Wow that's just evil

Makes you wonder how many studies are influenced by crap like that.

[sendero]

4. easy....

.... look at all the drugs that have been recalled in the last decade or so. This is why I laugh at folks who think "clinical trials" are "science".

they are infused with politics, subjective judgements and are simply NOT any kind of proof.

[Bluenorthwest]

3. In the face of such evil, the DEA and FDA howl about cannbis. What despicable negligence.

The fetid and corrupt nature of our drug 'regulation an enforcement' agencies is so complete that we need to dissolve those agencies and build new ethical 21st century science based policy and agencies to administer that policy. Every single current employee of those agencies needs to be replaced with people who are not accomplices to mendacity and fraud.

[BrotherIvan]

6. Thank God it wasn't covered by Medicare at the time

My mother was tired of the constant blood tests for Warfarin and wanted to get Pradaxa because of the marketing. She was on blood thinners for taking another prescribed drug that was newly approved for osteoporosis prevention and had a blood clot in her lung which almost killed her. Good times.