New England Journal of Medicine Says Key Vioxx Study Left Out Data

[banana republican]

http://online.wsj.com/article/SB113406046422917374.html?mod=home_whats_news_us

The New England Journal of Medicine posted an "expression of concern" that three heart attacks among patients on Merck & Co.'s Vioxx painkiller were left out of the data in a crucial study of Vioxx called Vigor, making Vioxx appear safer than it was.

<snip>

In a statement released Thursday, the New England Journal of Medicine said it became aware of the problems with the data when Vioxx plaintiff attorneys subpoenaed a Journal editor regarding the events leading up to the Vigor publication. Gregory D. Curfman, executive editor of the Journal, was deposed on Nov. 21, 2005, the Journal said.

According to the statement, the Journal then learned "that relevant data on cardiovascular outcomes had been deleted from the Vigor manuscript prior to its submission to the Journal and that the authors had withheld data on other relevant cardiovascular outcomes."
The statement adds: "The evidence has raised questions about the integrity of the data on adverse cardiovascular events in the article and about some of the article's conclusions." (Read the full statement.) Adverse cardiovascular events include heart attacks, strokes and deaths. The Journal said it has asked the authors of the Vigor study for a correction.

[Quakerfriend]

1. I worked with some of these MD's in their prior lives and

as a co-investigator on many of their protocols this does not surpise me in the least.

[Mikimouse]

4. It seems we have something in common...

I too have worked as a co-investigator on many clinical trials, and have witnessed the falsification of data on many occasions, specifically in the area of congestive heart failure drugs.

[merwin]

2. What is the percentage of people who have died taking Vioxx?

I personally think it helps more than it hurts. My guess is it's less than .001%

Definately not a drug you would want to take lightly... but also not a drug I want off of the market, considering the amount that it has helped people.

[thecrow]

3. Try having a heart attack yourself before making that statement

You might not necessarily die, but your life would be hell.
Oh and if you only had a stroke from it?
Well your life may be forever changed in ways you could not possibly know.

[merwin]

6. All I'm saying is that there's risks to every drug that you take. That's

why people taking them should be medically supervised and the drug should be taken with all precautions.

It's similar to something like laser eye surgery. You know when you go in there that there's a very small chance that you could come out blind, and it's a risk that each individual must consider.

No drug is without risks.

[MetaTrope]

5. Whoa! Sounds like it's time for Merck to get

a slap on the wrist and a federal handout!

[1932]

7. This study was one of merk's key pieces of evidence in the vioxx trial

they won in NJ and in the one going on right now in TX.