A Tutorial on the Great Vioxx (Rofecoxib) and COX-2 Tragedy of 2004

Vioxx and COX-2 is NOT a Thalidomide situation. The correlation between COX-2 Inhibitors and cardiovascular desease is absurdly weak.  The study purporting to show the causal relationship showed no increased mortality, only an increase in myocardial infarction well within natural statistical variation.  You are much more likely to have a heart attack, and die of a heart attack, if you are sedentary for five years and go out for a run.  For those of us who have known Vioxx, we went from a highly sedentary lifestyle, because we could not move around without great pain, to an active lifestyle, because the pain was gone.  In experimental science, this false attribution of causation is called a 'confounding.'  COX-2 inhibitors don't cause  cardiovascular disease, they eliminate the pain and stiffness that prevents people from putting themselves at cardiovascular risk.  

"Sudden cardiac death and acute myocardial infarction are serious complications of exercise in adults." Thompson, P.D. "Avoiding Sudden Death and Myocardial Infarction", Journal of Sports Medicine, 4-1-2001, http://www.physsportsmed.com/issues/2001/04_01/thompson.htm. Note. 

We can see that many forces did not want a drug that worked, or wanted to make the kind of money that a 'bad drug' can bring in through lawsuits, consulting, and fame.  Many people who know what a confounding is, chose to ignore it.

Raymond Gilmartin of Merck made claims in his speech which are not true:  'That there are many substitutes already available for Vioxx.'  Here is a study from JAMA: 

 

Jan 2002-JAMA, Vol 287,N 1, pp64.

What this says is that 25mg Vioxx is efficacious for 25% more patients than Celecoxib (Celebrex) and nearly 50% more patients than Acetaminophen (Tylenol).  

One of the miracles of Vioxx was that it worked within the hour of the first small pill and the effect was 24 hours.  This is being ignored by the medical establishment.  Typical pain reflect for the replacements is one and half hours after four hours of taking the pill.  Exactly, Mr. Gilmartin, does "replacement" mean?  Most of the 'safe replacements' only partially work with bad side effects that would naturally keep someone sedentary.  

Myocardial infarction is a heart attack, but the survival rate on infarctions is about 80% -- so, unless these were particularly mild heart attacks, more people should have died but there was no increase in morbidity.  We can only conclude that the myocardial infarctions were particularly mild.  Again, the confounding looms.

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