QDIS Blog

Merck has released some preliminary data for a large clinical trial regarding Arcoxia (etoricoxib), Merck’s second generation Cox-2 inhibitor. It has generated quite a bit of news recently and here are some of the articles.

• Merck’s Vioxx Heir - Forbes.com
• Merck Sees Successor to Vioxx - New York Times
• Merck Provides Preliminary Analyses of the Completed MEDAL Program for ARCOXIA(TM) (Etoricoxib): • Financial News - Yahoo! Finance

Since it will likely be at least three years before any other studies related to COX-2 inhibitors are released, these results will be examined in great detail. Many people want to understand what it is that may be behind the increased risk of hear attack. There are already some people pointing out that they are comparing Arcoxia to Voltaran (diclofenac) from Novartis. Not everyone thinks Voltaran is the best comparator.

I would say that I think coming up with a new pain relief that is safe and effect is needed. I have talked to several people who would almost rather take the risk of cardiovascular problems than continue to put up with the daily chronic pain. Although the FDA now recommends Aleve (naproxen) as the pain relieveer with the lowest risk of the pain medications for arthritis. Arcoxia is approved in about 62 other countries and it is interesting that now, without releasing all the study details, Merck has decided to push the FDA for approval in the US. It was interesting that one side effect seems to be an increase in blood pressure. Merck has stated they will release the full details before the end of this year including articles in peer reviewed journals.

Technorati Tags: Arcoxia, etoricoxib

Email Ed Vawter

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A recent article came across my desk and I thought it misrepresented the facts and wanted to make some comments on it. The article was in the Signs on San Diego site.

SignOnSanDiego.com > News > Health — Study: FDA advisers typically recommend approval for drugs and devices

The article implies that something improper may be occurring with the process of having external experts make recommendations on drugs and devices I would point out that the whole drug development process involves weeding out those candidates that do not preform well at early stages. It is in the best interest of the company developing the drug that they be able to make a go-no go decision as soon as possible. Therefore, only the drug candidates that have a very high potential to be approved make it to the point of filing an new drug application (NDA). It is not surprising to me that the majority of those get approved. It should also be noted that just because an expert panel recommends approval, does NOT necessarily mean it will be approved.

While I do acknowledge that there have been some conflicts of interest that were not made transparent in the past, I think there has been some progress made in this regard. I just hope that reason prevails and this isn’t used as another bullet against the FDA.

Technorati Tags: drug development, FDA

Email Ed Vawter

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