Bro-seph: Okay, make 7...He also asked me when Christmas is this year, so I think we are both suffering from brain melt at present.
me: UP yours?
Bro-seph: Hey, watch your language!
Some disturbing news came out today. An NEJM editorial today ripped Merck a new one on withholding data on Vioxx in a publication. NYT summarizes the journal pretty well. I know the Vioxx controversy is old news at this point to most, but I think this article points out what a massive mistake can be made by tiny missteps.
Data on Vioxx were published in the NEJM in 2000, but these data left out three patients who had cardiovascular events. This is where it gets very complicated, and yet not at all complicated. The data published in the 2000 article was for a specific part of the study. Merck quickly released a statement today (to avoid any trouble, I'm not linking to it, but it's easy to find on their site), that claims that the publication "fairly and accurately described the results of the study as of the pre-specified cutoff for analysis." The accurately part is true in that statement; the fairly part is highly debatable.
You could quibble this way and that for quite some time on the finer points of this, but I will point you to the one statement in the NEJM article that did me in:
"We determined from a computer diskette that some of these data were deleted from the VIGOR manuscript two days before it was initially submitted to the Journal on May 18, 2000."To me, that was the proverbial nail in the coffin. When a manuscript like this is written, quite often the original author puts together a draft that gets edited along the way by all kinds of people. This means that, at some point, someone thought it was worth mentioning these cardiovascular events. And worse yet, it means that, at some point, someone else thought there was a reason to omit this information. That is willful. That is hard to defend.
I suppose this news really has been bothering me very much because I have a good many friends that have an association with the company. These friends are not evildoers. Were they presented with the ethical quandary, they very likely would have acted opposite. A lot of them really believe in what they do. And when someone at the top makes a mistake like this, it sullies their reputation and their sense of purpose. Ten years ago, Merck was one of the best regarded pharmaceutical companies around. It was considered an extremely conservative company, that erred always on the safe side when it came to protecting patients. A decade later, it has become the most often cited example of why pharmaceutical companies are evil. Certainly, I feel badly for the patients that were put at risk due to this mistake. But I have to own that I also feel really badly for people who put hard labor into working at the company that lets them down. Ugh, the corporate world.
In much, much lighter news, I had a
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