Witnessing the regulatory process surrounding the use of Genentech’s Avastin for treating breast cancer has been like watching a dramatic and slow motion game of tug-of-war. In 2007, a US Food and Drug Administration (FDA) advisory panel narrowly voted down the drug, citing a handful of deaths in the company’s pivotal trials due to side effects alone. Then, less than a year later, the agency granted Avastin an accelerated approval after new trial data showed that the drug added 5.5 months of progression-free survival compared to treatment with chemotherapy alone.
But after two more trials showed that patients do not live longer despite the breast cancer’s slowed spread and given Avastin’s somewhat nasty toxicity profile, an FDA advisory committee voted 12-1 last summer to pull the $100,000-a-year drug from the pharmacy shelf — a decision that Genentech appealed in January. Now, a meeting slated for next week will determine the drug’s fate.
The whole kerfuffle has caused uproar on each side of the spectrum. In a New York Times Op-Ed last month, Frederick Tucker, an oncologist in Fredericksburg, Virginia, supported the FDA’s decision, arguing that Genentech’s reinterpretation of its own data is troubling. Regarding patient testimonies, he wrote: “[A]necdote is not science. Such testimonials may represent the human voices behind the statistics, but the sad fact is that there are too many patients who have been treated with Avastin but are not here to tell their stories.”
On the other end are patients and their families who have had success with the drug. For example, Terrance Kalley, the husband of a breast cancer survivor who says she was saved by Avastin, took leave from his small Troy, Michigan automotive tools company to found the Freedom of Access to Medicines campaign, an effort to fight for access to the drug. The organization’s website lists testimonials, has a petition to sign and even a countdown timer to next week’s hearings.
Most recently, Kalley enlisted an anonymous compadre to record a Bob Dylan-esque protest song that has been making the rounds on Youtube. Decked out in a cargo vest in front of a faded American flag, the crooner sings: “They said it was too risky all of a sudden / They said it was kinda dangerous / Like having stage 4 breast cancer isn’t a jump through hell without a parachute.”
We’ll find out next week if the times for Avastin are a-changed.