When it comes to the patient voice at the June 28-29 ODAC meeting on Avastin, silence most certainly does not imply consent
FDA's Karen Midthun, who will serve as presiding officer for the second ODAC hearing on the future of bevacizumab's (Avastin) breast cancer indication, has rejected Genentech’s request to allow members of the public to speak at the meeting.
This seems to be in direct contradiction to statements from CDER Office of New Drugs Director John Jenkins, who has gone on the public record that a crucial piece of risk/benefit assessment is the patient perspective.
"I think it's very important to understand the patients' perspective about how they value the benefits and how they are willing to accept the risk … A lot of us are basing these decisions in the abstract. We don't have the disease, we haven't achieved the benefit, and we do not actually have to weigh, personally, that benefit against the risk."
And further, "Regulators and others may not consider those benefits to be very important, but to the patients, they are extremely important and allowed them to go on about their lives.”
Dr. Midthun’s decision to ban patient comment is also contrary to the spirit of the 11/22/10 PDUFA negotiating session, where the FDA said that information about patients’ understanding of existing treatment tools is considered valuable, but is not consistently available during the review process.
The upcoming “Avastin Meeting” is, in all particulars, the perfect opportunity to take the “patient involvement” hypothesis out for a spin. Why is the agency afraid of what patient groups might say? Or does ODAC simply consider the patient voice not relevant? Advice mustn’t only be sought and considered when it supports your position.
After all, in the words of Dr. Jenkins, “We have to be aware of the societal expectations of how we interpret our standard and how we make our decisions.”
