Dots on a curve

Richard Pazdur, the FDA’s top regulator of cancer drugs, is busy defending his agency’s decision to rescind approval of Avastin for treating breast cancer. In this Wall Street Journal article, he’s quoted as saying “the drug has a marginal effect on tumor growth.” As I indicate in my Pajamas Media article, he’s talking about the drug’s effect on average.

But as we know, averages are drawn from the experiences of actual individuals, some of whom have a better experience than the average. (And even the average experience, he admits, is positive.) Yet the FDA regards it as its professional duty to ignore every particular individual’s benefit, in favor of a collective decision. (The image accompanying this post is an actual slide from an FDA PowerPoint presentation, showing graphically how the agency conceives its risk-benefit analysis as collective rather than individual.)

Wait, did I say the FDA ignores the patients who benefit? That’s not quite true. Toward the end of the article, Pazdur makes a startling admission. “There may be a subset of women who could be helped by Avastin, but Genentech [Avastin’s manufacturer] needs to figure out who they are,” the article says.

Although the phrasing is cagey, Pazdur clearly knows what the rest of the world is shouting—that some women with breast cancer are benefiting from the drug. Nevertheless, he is perfectly comfortable with the FDA’s decision to withdraw approval of the drug. Why? Because some other women don’t benefit, and Genentech cannot yet scientifically separate the two groups.

It never occurs to Pazdur to question whether one individual woman’s right to undergo a successful treatment should hinge on whether some other women can’t share that benefit. To him and his FDA cohorts, sick people are dots on a statistical curve, and it’s only the curve that matters.

Image: Food and Drug Administration, “Overview and Introduction to Drug Regulation,” Slide No. 5

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