Tuesday, November 4, 2014

Dosage changes

Last year or maybe earlier this year, I have chemobrain and I can't remember exactly when, the oncologists in the US got together for a big event which they called a conference. They did get a lot of work done and came up with some new recommendations for changes in cancer treatments. One of these was to state that it is better for women with a breast cancer diagnosis to be on Tamoxifen, Femara, or the other AIs for ten years instead of five.

Well someone forgot to tell the FDA this so they FDA says five years and the oncologists all say ten years. But the FDA makes the rules so the oncologists have to bring it up to speed. One woman in Michigan has started an awareness effort to this end.

But it does raise an interesting thought. When a drug is initially approved by the FDA, the approval includes dose sizes, length of treatment, etc. Then additional research is done, whether it is on children instead of adults, or for a different ailment, the FDA needs to change its guidelines so an  amended approval is needed. I am sure there is some fancy process for this involving expensive lawyers drawing up paperwork as well as lots of research time but I have no idea what it is.

In this case, the oncologists came up with their new recommendations and now some one has to get the FDA up to speed so we can all be less confused.

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