In the following opinion piece, the question is posed about keeping a drug on the market because it helps some people but not others. He is arguing that no matter how much we might be able to predict prognosis of cancer patients, we have to be reminded how each case is different. Since a prognosis is an average, there are some who outpace the average significantly. Unfortunately, with the increased concern for fiscal responsibility over patient choice, health care is losing the argument about individualized care.
Last year, the FDA began the process of revoking Avastin’s approval for breast cancer. Some leading oncologists applauded the decision, arguing that, for the average patient, Avastin doesn’t work very well and has significant side effects.
Patient advocates and thousands of women who credit their survival to Avastin argue that it’s unfair for the FDA to remove one of the few available options for patients diagnosed with terminal cancer. They’re right.
Avastin originally hit the market in 2004 to treat other cancers, and in 2008 the FDA conditionally approved it for breast cancer. Initial testing showed that, on average, Avastin didn’t lengthen patients’ overall survival time. But it did slow tumor growth, giving many patients a longer “progression-free” survival. What this means is that dying patients get a precious few extra months of quality time they can spend with family and friends, travel rather than being confined to a bed, or get their personal effects in order.
A small percentage of patients taking Avastin have been cured of their breast cancer. But the drug’s permanent approval hinged on the results of two additional clinical studies focusing on the progression-free survival end-point experienced by the majority of Avastin users. As before, neither study found an increase in overall survival, but they did record modest gains in progression-free survival—about five and a half months longer than those on the alternative treatment. That wasn’t enough for the FDA, so the agency moved to revoke Avastin’s approval for breast cancer last July…
When well-known scientist Stephen Jay Gould was diagnosed with a rare form of lung cancer in July 1982, he was told the diagnosis meant a median survival time of just eight months. His doctor gave up on him. But he lived another 20 years.
“Means and medians are the abstractions,” he wrote in Discover magazine in 1985. “Therefore, I looked at the mesothelioma statistics quite differently—and not only because I am an optimist . . . but primarily because I know that variation itself is the reality.”
Like Gould’s doctor, the FDA and its technocratic supporters are giving up on breast cancer patients because of their slavish obsession with median response rates. Everyone can agree that, on average, Avastin does not extend most patients’ life expectancy. But some patients have responded incredibly well, living years longer than expected. The medical community calls them “super responders.” Statisticians might describe them as “outliers.” But they’re real people, alive because of Avastin.