[Debbie L.]

When the FDA rules on the clinical utility of a drug, they use a broad-brush approach that looks at the global outcomes of all patients, determining whether these glacial trends reflect a true climate change. The problem is that while Bethesda, Maryland may not be noticing significant changes in ocean levels, people who live on the Maldives are having a very different experience. As these scientists ponder the significance of Avastin, some breast cancer patients are missing out on a treatment that could quite possibly save their lives.

I'm not sure what this is saying. It's the FDA's fault? I have my issues with the FDA but let's give them some credit. What they are using in their evaluations is the information submitted to them by the drug company's clinical trials. What about the drug companies? Shouldn't it be THEIR job (especially since they are making millions) to figure out who their drug works for, and who it does not work for? If we keep harassing the FDA to approve drugs that appear marginally effective but that probably work strongly in certain subgroups, we are encouraging drug companies to do what they've been doing -- spew out ridiculously expensive drugs, give them to broad populations of people, few of whom benefit and many of whom suffer -- but all of whom pay a lot of $$ for the privilege. I think it should be the drug company's responsibility to find the biomarkers or genetic traits that predict for response.

I don't think there has been any success in tying VEGF expression in breast cancer tumors to Avastin response. See my previous post about host factors -- maybe we will find the answer there (or not). But again, it frustrates me that WE are trying find the answer. The drug company should be looking for that answer, before asking to market ($$) their drug to untargeted populations.

Debbie Laxague