The Current and Future Fight Over Avastin is NOT About Science

Earlier today the Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee voted to withdraw the accelerated approval that the FDA had granted the drug Avastin for use in treating breast cancer.  This process was started last December, and will reach some kind of resolution by the end of next month.  Today’s meeting was a first-of-its-kind review requested by the drug manufacturer, Genentech.

The rationale behind the withdrawal, per the FDA announcement last December (boldface mine):

“The agency is making this recommendation after reviewing the results of four clinical studies of Avastin in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.”

This kind of argument should be familiar to those who have followed debates over changes to screening procedures that were an attempt to respond to the significant side effects of those screenings, or the questionable effectiveness of the screenings.  The regulators are trying to balance the risks of the disease (which affects a small segment of the population), against the consequences of the treatment or screening (which may affect a larger percentage of the population, or have a larger overall negative impact).  That kind of risk calculation doesn’t happen for those who have the disease or a family history of the disease.

As you might expect, patient advocates are not keen on the FDA decision, and several protested the hearing.  Some see the setback as an example of a regulatory agency walking back the accelerated approval process in favor of more government control.  But the language used in one part of this Wall Street Journal editorial suggests how this isn’t really about the science, because that’s what they talk about.  Dr. Pazdur heads the FDA office responsible for cancer drugs (boldface mine):