Monday, March 07, 2005

Update On My Last Entry

Read this article in Medical News Today:

"ViroLogic, utilizing its proprietary eTag(TM) assays will test tumor samples from lung cancer patients treated with Iressa to evaluate the utility of these assays in targeting patients who would most likely benefit from Iressa."

So obviously the people of AstraZeneca read my blog today. They then immediately brokered this deal with ViroLogic to do a cancer biomarker study. Presumably this will facilitate the development of a commercial assay for one or more of the mutations that would be expected to predict a good response to Iressa.

But seriously, two questions:

1) Why didn’t they plan for this in the first place? They knew that these mutations in the epidermal growth factor receptor protein were the likely mediators of the drug’s response. (There must be involvement of other factors as well because the drug does have activity in tumors without the mutation.)

2) More importantly, why are we only now finding that Iressa doesn't do what it's supposed to do (extend life in patients with advanced lung cancer) after it’s already been on the market for almost two years?

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1 Comments:

Blogger chargemaster said...

These are excellent questions. I think some other questions need to be asked and may have been asked in your earlier post. What is the FDA doing about this? Do they even know about this information? Is the pharmaceutical company the only ones who track the drug AFTER it's been approved? What are they (FDA) doing about these issues?

And one question that might be even more controversial.

Did the FDA know that this drug had no clear advantages over current market drugs? Why would you market it?

As to your prior post, I have to disagree with your view on a "fast track" program to approval. I believe that the fast track program, if used properly, could help fund and find better treatments for many diseases. But as you said, just because the new drug causes a clinical response, it doesn't mean it is a drug that should be approved. I believe if the study finds out that the drug is no better than current drugs or treatments on the market the funding and the study should be stopped.

However, that gets into the questions you asked at the end of your second posting. Who is making sure this is being checked?

I believe the FDA is the proper route for new drugs but it seems to me ,and I believe the general public believes this as well, that they are getting sloppy.

Hopefully I didn't ramble too much. I've gota bad sinus infection and the drugs I'm on don't help much when I'm writing.

March 09, 2005 12:01 PM  

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