The women recounted how their lives had been saved as they pleaded for the Food and Drug Administration not to withdraw approval for Avastin as a treatment for advanced breast cancer. They did so even without evidence that it provides benefit and with evidence that it confers risks. Their efforts were ultimately not successful: the FDA panel voted unanimously to withdraw approval. (Some will quibble with this blunt representation of the question debated at the hearing. To read more about this, look here, here and here, for example, for more nuanced discussion.)
Despite careful consideration of the evidence by the panel, however, the indelible picture presented by the media was of heartless government bureaucrats depriving women of a drug that could save their lives, and by extension depriving children of their moms, parents of their daughters and spouses of their partners in the name of one-size-fits-all, evidence-based medicine.
Read the rest of this post at Health Affairs Blog…
Tags: Avastin, breast cancer, evidence-based guidelines, evidence-based medicine, FasterCures, FDA, Food and Drug Administration, Harold Varmus, Incidental Economist blog, Institute of Medicine, JAMA, Kevin Outterson, LinkedIn, shared decision making, Sheila Rothman, targeted therapy
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Aftershock:
The Center for Advancing Health is funded by
an old prof of mine used to remind us that in making a compromise no one gets what they wanted.
Compromise is the heart of democratic processes but we must find better ways of acknowledging and coping with the necessary element of loss involved, as a public we must learn to mourn.