FDA vs. sick people

Last month, the FDA began withdrawing approval of Avastin for treating breast cancer. Over at Pajamas Media, I explained why that violates the rights of sick patients. Now USA Today is attempting to quell the “Outcry over FDA withdrawal of anti-cancer drug Avastin” by painting the drug’s advocates as emotionalist, unscientific crybabies. Here’s the article’s approach in a nutshell:

“The emotional appeal is so compelling,” Fran Visco, president of the non-profit National Breast Cancer Coalition, says of breast cancer patients doing well on Avastin. But, Visco says, “drug approval cannot be based on any individual story. It has to be based on the highest level of science.”

Let’s stop and think about this for a minute. Ms. Visco refers to “breast cancer patients doing well on Avastin.” In other words, she’s talking about actual, living women with a dreadful, fatal disease, who are actually benefiting from the drug. What is Ms. Visco’s attitude toward them? Well, she’s willing to concede emotional sympathy with their anger at losing access to Avastin.

But according to Ms. Vasco, these individual women need to put aside their petty, individual concerns in deference to the demands of science. As she puts it, any given woman’s “individual story” has nothing to do FDA regulators’ quest to reach “the highest level of science.” What is that “highest level of science”? It consists of statistical studies on large aggregates of patients, studies that deliberately ignore the individual patient in favor of averages.

In my article, I talk about the FDA’s idea that Avastin does not “represent a favorable risk/benefit analysis”:

Does that mean the drug fails to help any woman more than it hurts her? Not at all—many individual women benefit from the drug. But the FDA regards such facts as sentimental distractions, to be deliberately ignored when deciding the fate of a drug like Avastin. The FDA’s idea of a risk/benefit analysis deals with health in the aggregate, as revealed in statistics involving large populations, not with the health of individuals.

But can risks and benefits really be weighed at the level of society as a whole? A society is only a collection of individuals. A society doesn’t enjoy life, or suffer—only individuals do. Metaphors aside, a society doesn’t get sick and die—only individuals do. To appreciate the difference, consider how a rational patient with breast cancer decides whether to undergo drug treatment.

Such a patient weighs (among other things) the statistical likelihood of a favorable result against the statistical likelihood of painful side effects. At all times, her judgment is individual and personal: How will my life improve if these tumors temporarily stop growing? How might side-effects interfere with my enjoyment of life? How much better will I feel if the results are above average—or how much worse, if the results are below average? How much is an additional year, month, or week of relatively normal life worth to me?

The FDA’s experts take professional pride in refusing to allow such individual considerations to influence their decisions. Instead, they float among the statistical clouds, observing that Avastin delays tumor growth by only 3 to 12 weeks on average and that some patients actually get worse after taking the drug. From behind a veneer of scientific respectability supplied by charts and graphs that ignore the individual patient, these experts then ask a question to which no rational answer can be given: What is the meaning to society of one month in an individual’s life?

The bottom line is that statistical studies are useful tools for individual risk analysis—but the when the FDA coercively substitutes that collective data for the individual’s rightful choice, the agency turns that science against those who should benefit from it.

Image: Wikimedia Commons

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