Monday, November 27, 2006

The COX2 controversy continues. Trialists working under lawyers watchful eyes.

There are many studies on COX2 and the heart. Not so long ago, the NHLBI carried out a study on the role of celebrex, naprosen and placebo, in the prevention of Alzheimers. This study was called ADAPT. Although the study was for Alzheimers prevention, the spotlight apparently was on naprosen and by extension celebrex on the heart, not the head.

The trial was terminated early because the naprosen arm showed a slightly increase incidence of CVS events. It may be worthwhile to remember that previous investigators have always felt that naprosen is one of the CVS-wise "safe" COX1 inhibitor. I think the investigators were concerned that if naprosen came out like this, what would the celebrex arm become.

It is also pertinent to note that at about this time, the NHLBI also terminated another trial APC, which was studying the effect of celebrex, on CVS events. The investigators of ADAPT must have been worried that if they continued after what they knew happened in APC, they could be following suit. So they abandoned the trial and terminated ADAPT prematurely.

It is so dificult to do trials under the watchful eyes of the lawyers. Any sniff of any increase CVS risk spells danger and you'd better cut and run. In a situation like COX2 CVS dangers, such a policy will hinder our effcorts to understand what exactly is happening in the problem of COX2 and the heart. The controversy continues and there seems no answer in sight. There are a large number of observational data saying that it is unsafe, and some that says that there is no increase CVS risk, and we have been arguing this for the last three years, and at this point in time, we are none the wiser. It certainly difficult in the great land to do clinical trials under the spotlight of media scrutiny and even worse, the lawyers'scrutiny. Will naprosen or celebrex help Alzheimers. I don't know. Will celebrex and naprosen harm the heart, maybe, but thanks to the threat of litigation no one will know for sure.

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