Who Gets to Decide Our Health Care?

On June 28^th and 29^th in Silver Spring, Maryland, cancer patients and their families will gather in protest of the Food and Drug Administration’s (FDA) effort to ration the late-stage breast cancer drug Avastin. These patients credit the drug for extending their lives well beyond what was to be expected.

Unfortunately for patients, the FDA has adopted a Marxist position on the issue – not Karl Marx but Groucho Marx. Groucho Marx once quipped, “who are you going to believe me or your lying eyes?”

Supporters of the FDA’s proposal to limit access to the drug to those who can pay for it out of pocket, argue that since the drug does not affect all patients the same way, the government should save health care costs by moving to deny insurance coverage. That is the basis of rationing and the basis of ObamaCare.

The FDA and their apologists like oncologist Fred Tucker, who took to the New York Times to defend the agency, argue the law of averages ignoring the reality that some patients respond better than others. Greg Conko brilliantly responded to their arguments at OpenMarkets.org in an article entitled “The Medium is not the Message.”

Conko retorted:

Technocrats, including Dr. Tucker, have applauded the decision, arguing that Avastin doesn’t work very well, and that it has significant side effects. On the other side are patient advocates and thousands of women who have benefited from the drug, who argue that it’s unfair for the agency to take away an option for patients who are at risk of dying. “We want to be sure that women who are using Avastin, and for whom it is working, can continue to have access to it,” said Elizabeth Thompson, president of Susan G. Komen for the Cure. The real question ought to be, who gets to decide?

The biggest weakness in the FDA’s case is its reliance on average or median effectiveness. What averages don’t reveal, however, is the fact that some patients respond to a treatment option much better than others. Particularly when it comes to a life-threatening illness, average or median survivability too often masks the fact that some patients respond very well indeed. Pop scientist Stephen Jay Gould made this point quite eloquently in a 1985 essay published in Discover magazine, titled “The Median Isn’t the Message.” In 1982, Gould was diagnosed with a rare form of lung cancer, which he discovered had a median survival time of just eight months. His doctor had given up on him because of the dire prognosis, but Gould actually lived another 20 years, and then died of a different type of cancer. In his Discover essay, Gould wrote:

[A]ll evolutionary biologists know that variation itself is nature’s only irreducible essence. Variation is the hard reality, not a set of imperfect measures for a central tendency. Means and medians are the abstractions. Therefore, I looked at the mesothelioma statistics quite differently – and not only because I am an optimist who tends to see the doughnut instead of the hole, but primarily because I know that variation itself is the reality. I had to place myself amidst the variation.

When I learned about the eight-month median, my first intellectual reaction was: fine, half the people will live longer; now what are my chances of being in that half. I read for a furious and nervous hour and concluded, with relief … I knew how to read the data properly and not despair.

Just like Gould’s doctor, the FDA and its technocratic supporters are giving up on cancer patients because of their slavish obsession with median response rates. Sure, on average, Avastin may not extend a patient’s life expectancy, but you don’t have to be Garrison Keillor to realize that some people really are above average. The expected value, a priori, of the treatment for any given patient does indeed appear very small, so you can understand why a health plan would balk at paying the very high price for Avastin (which varies from about $56,000 to $96,000 per year). But making cost-effectiveness calculations isn’t FDA’s job — nor does the Food, Drug and Cosmetics Act even permit the agency to consider the price. Consequently, the FDA had no business removing the breast cancer indication from Avastin’s label, and anyone who values freedom and self-determination should hope the decision is reversed next month.

There is a reason why patients, led by Terry Kalley the husband of a breast cancer survivor will travel to Silver Spring to protest the FDA’s attempt at rationing – their lives depend on it. To contact Kalley or help spread the word of the patient’s protest, you can email him at AvastinProtest@Yahoo.com.