The VIOXX hysteria

There is a ridiculous article here which claims, in effect, that the executives of Merck & Co should have been hanged, drawn and quartered for releasing the anti-arthritis drug Vioxx.

It is all rather water under the bridge now so I won't go into great detail but but I believe Vioxx was unfairly impugned and should still be available to the many people it helped.

The attack on it was underpinned by a practice that I have often criticized on this blog:  Looking at relative risk to the exclusion of absolute  risk.  If the absolute risk is tiny, the relative risk seems of only academic interest to me.  There are risks in everything we do so something that has only a tiny absolute risk attached to it should be one of our better options in life, it seems to me.

Anyway, I will comment here only on the one big study that was most used to condem Vioxx.  The VIGOR study compared Vioxx with an accepted "safe" drug in its class: Naproxen.

And it found that using  Vioxx raised the absolute risk of a heart attack by one third of one percent -- from .01 to .04%  I would have interpreted that finding as showing that both drugs were low risk with only trivial differences between them but medical researchers love their relative risk statistics.  Without a heavy focus on RR, most of their findings would be trivial so RR is almost a religion with them.

So they treated these essentially trivial results in a most frightening way: saying that Vioxx was FOUR TIMES as likely to give you heart attacks as its alternative.  And if you ignore that all the risks involved were tiny, that does sound alarming.  In fact, however, it was the usual medical research practice of making mountains out of molehills.  My recommendation from the data would have been that VIOXX is safe, except perhaps for  people with known heart problems

But that's not all.  While the heart attack rate  with Vioxx was elevated, the overall mortality was not!  In other words, Vioxx was not more likely to kill you than its control.  It may have led to a few more heart attacks but it REDUCED your risk of dying from other causes.  So even in relative risk terms it is a safe drug.  When you're dead you're dead.  It does not matter what you died of -- so overall mortality should have been the dominant criterion for evaluating Vioxx.  That it was essentially ignored just shows how hysterical people can get about drug companies.  They pick on trivialities to bring down what they hate as "Big Pharma".

Merck was unfairly persecuted by small minds and Vioxx should still be available to those it helped.  Arthritis is a most disabling condition and for some people Vioxx gave better relief than other drugs in its classs.

I could go on and discuss the other nitpicking associated with the VIGOR study but Humpty Dumpty is now well and truly off his wall so I see no point in going further.  I do however feel very sorry for the people at Merck and also sorry for the people who were   denied the chance to continue with something that was best for their disability.  Vioxx would not have once been so widely used without it being a very helpful drug.

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