NAE President William A. Wulf Urges Reforms to Aid U.S. "Innovation Ecology"

William A. Wulf, the president of the U.S. National Academy of Engineering, tells a story about an inventor and entrepreneur who came to him recently and told him of developing a vaccine against deadly pancreatic cancer and other tumors. The vaccine, the inventor claimed, was "extremely effective."

Foreshadowing an age of individualized medical therapies, the vaccine was tailored for just one person, one tumor. Perhaps, in time, the approach could benefit thousands of people. But in a lecture at the AAAS Forum on Science and Technology Policy, Wulf called such a positive outcome unlikely.

Without a change in the United States' regulatory climate, the vaccine "will never be sold in this country," he said. "Why? Because the gold-standard for FDA (U.S. Food and Drug Administration) tests is the randomized, double-blind study." And while that testing regimen helps "guarantee efficacy and safety" for new medical treatments, he explained, "it is literally impossible to do a randomized, double-blind study" on a therapy that applies to only one person.

Wulf said he didn't know whether the vaccine could in fact be effective, but, he said, it is illustrative of a breakdown in the "innovation ecology" of the United States—its system of regulations, tax codes, copyright and intellectual property laws and manufacturing policy.

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