Wednesday, November 15, 2006

Some not so good news about magic bullets

At the end of July I wrote about a magic drug, in the armanterium of Pfizers future blockbusters, that seemed to be the magic bullet against atherosclorosis. Torcetrapib is a HDL-cholesterol raiser and LDL cholesterol surpressor, that can cause 50-60% plaque reduction. How nice, the initial studies seemd to suggest that it will cause plaques to disappear. God the Almighty knows better.

When the initial studies were followed longer, it appears that this HDL-C raiser, which also lowers LDL-C, also causes hypertension, well not much. Only by 3-4mmHg. When the investigators folowed the initial 1,00 patients of the "Illuminate "studies over the year, they noticed that those on torcetrapib seemed to have higher BP than those on lipitor alone. It is true that the increase in BP was small. Yet a small BP rise in a population could translate into a significant rise in BP in individuals. It is also true that the rise in BP were mainly in those with lowish BP to start.

What does all this mean? Does it mean that tortcetrapib is a non-starter? Not quite. We will have to see what happens to the patients with this small BP rise? Will it translate to an increase in mortality or morbidity, or will this rise in BP negate the good effects of raising the HDL-C and lowering the LDL-C?

One thing is certain. In this current climate of Vioxx and the DES stents, this kind of "bad" news will certainly delay the approval process as I am sure that FDA may want longterm followup data, to make sure that torcetrapib is safe and as effectively as touted. This will mean that Pfizer, who will soon see Lipitor's patent expire, will be in for some lean years as tocetrapib was suppose to be their blockbuster, taking over from lipitor. Although Pfizer may lose, the good news is that medicine has won, this news will certainly make sure that FDA will look at torcetrapib more thoroughly, and that is good for patient care.

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