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Alert Number 48

Vioxx Is Out but How About Celebrex?

Date: October 9, 2004

In the recent Topics Alert (Alert Number 45, October 1, 2004) we discussed Merck's recall of Vioxx because of significantly higher risk of cardiac toxicity. Vioxx was the direct competitor of Celebrex, the other popular COX-2 inhibitor on the market. From the patient's perspective it is reasonable to ask how safe is Celebrex? Is the problem related to just Vioxx or is it a problem that effects all COX-2 inhibitors?

The latest issue of the prestigious New England Journal of Medicine addresses this issue. The editors thought it important for patients to have access to this article and made the full text PDF available free of charge at the following link: Simply click on the link to read the full article. The statistics are a little complicated, and the results can be sliced and diced in any number of different ways depending on the question being asked and who is doing the asking. Here is one clear take-home point, quoted from the article:

"It seems to be time for the FDA urgently to adjust its guidance... In the absence of such guidance, what should physicians and their patients do? Selective inhibitors of COX-2 remain a rational choice for patients at a low cardiovascular risk who have had serious gastrointestinal events, especially while taking traditional NSAIDs. It would also seem prudent to avoid coxibs in patients who have cardiovascular disease or who are at risk for it."

That seems clear. If you have cardiac risk factors, stick to plain old NSAIDs rather than use COX-2 inhibitor Celebrex for the odd pains and aches. But how about the cancer prevention aspects of Celebrex? I know many of you take Celebrex because of its potential ability to fight the CLL. The NEJM article does not address the cancer prevention aspects of COX-2 inhibitors.

OSU03012 is an exciting new molecule that is derived from Celebrex. A recent Topics Alert, Number 46, discussed the latest paper (Ohio State, Dr. John Byrd, et. al.) on this subject. This seems to be the way to go. Hopefully OSU03012 will retain (or enhance!) the CLL fighting aspects of Celebrex and at the same time get rid of potential cardiac risk problems of COX-2 inhibitors. If things pan out, OSU03012 may have a good profile of efficacy with low toxicity.

Here is something to think about: OSU03012 is not the intellectual property of any big pharmaceutical company. It seems to have been developed at the NCI and the preclinical work is being done at Ohio State University. Who is going to push for the development drugs such as this, that may be very useful in CLL? Without big dollar profit incentives driving them, drugs like OSU03012 will make it all the way into clinical trials only if we the patients take an interest and push for them. Right now, we are still a small and fragmented patient community. Any power that CLL Topics has to speak on our behalf depends totally on your grassroots support for our work. Speak up, folks. Do your bit to make more patients, doctors and the regulatory agencies aware of our existence. We can never raise enough money to compete with the "big" cancers, neither do we want to do that. But it is time our voices are heard more clearly, and that needs a grassroots mandate and involvement from the patient community.

Be well,


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