A great discussion of how a drug gets approved and the unapproved, maybe

201009070009.jpg by CarbonNYC

The saga of Avastin and breast cancer
[Via Respectful Insolence]

One of the most frustrating aspects of taking care of cancer patients is that in general, with a handful of specific exceptions, we do not have good curative therapies for patients with stage IV cancer, particularly solid tumors. Consequently, we are forced to view patients with stage IV cancer as “incurable” because, the vast majority of the time, they are incurable. Over the years, we have thrown everything but the kitchen sink at patients with stage IV disease, largely with dissapointing results. That’s not to say that the few specific exceptions to which I alluded are not a reason for hope. After all, patients with colorectal cancer and liver metastases used to have a median survival of around 6 months, but these days, with newer chemotherapeutic regimens like FOLFOX plus Avastin, median survival has more than tripled. While expecting to live less than two years is cold comfort to cancer patients with this particular clinical situation, the prognosis is far better than it was.

Of course, I specifically mentioned Avastin because it’s been in the news a lot recently with respect to my area of clinical specialty, breast cancer. Specifically, beginning in July there started appearing a spate of stories about the FDA considering revoking the approval of Avastin for advanced breast cancer based on recent studies that demonstrate that it does not prolong survival in these patients. Many lay people and patients find this reconsideration of Avastin to be quite puzzling, given that the drug was granted accelerated approval in 2008 and has since gone on to be used fairly widely. Given that the case of Avastin in breast cancer is rapidly becoming a classic case study of how messy science-based medicine can be when practiced in the public eye and debated among pharmaceutical companies, the government, and patient advocacy groups.

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The data now indicate that this drug, which costs up to $100,000 a year to take, may be having very little effect at all, if any, on increasing the survival time for patients or on quality of life. It was approved over the objection of the expert FDA panel dealing with the drug.

That panel has again voted to withdraw approval due to the lack of efficacy of the drug. BUt politicians have begun making this a partisan issue, with women suffering breast cancer being pawns in an election year.

Thus the introduction of what Orac calls the burning stupid. Sure is nice when science-based medicine gets in the hands of politicians with an election coming up.