Varmus on Ethics and Patents in Genetics

NEW YORK, NY--Harold Varmus, who recently left his post as director of the National Institutes of Health (NIH) in Bethesda, Maryland, to become president of the Memorial Sloan-Kettering Cancer Center, spoke to reporters at a media briefing sponsored by the nonprofit Gene Media Forum on 1 May. Varmus, who was a co-recipient of the 1989 Nobel Prize for his work on the genetic basis of cancer, addressed questions on a range of topics in genetics, including the ethical obligations of scientists and proper use of patents . Edited excerpts of Varmus's responses are below.

Next Wave asked: If research on gene vectors can be used not only to further gene therapy but also--potentially--to aid in the development of biological weapons, should scientists be concerned about the potential applications of their research in genetics (as Joseph Rotblat suggested in a 19 Nov 1999 editorial in Science magazine?)

"I don't think you need to use gene therapy to develop a biological weapon," Varmus said, pointing out that existing organisms--anthrax and smallpox, for example--are already potent weapons. He suggested that the proper approach toward reducing bioterrorism threats is to diminish through political means the likelihood that biological weapons would ever be used. He also called for more research to detect and contain biological weapons.

"We haven't fully exploited the power of science to diagnose infectious illness at a very early stage and very, very quickly," said Varmus, adding that such diagnoses represent "the most important single determinant of whether an adequate response to a biological warfare incident can be managed." Moreover, he believes that investment in technologies such as chip-based methods to rapidly test blood or tissue samples for the presence of anthrax or smallpox would speed the development of related diagnostic tools for regular diseases.

[Read Bill Joy's Response.]

Kevin McKenna, an editor at The New York Times , asked: Do you think the patent process is working now ... in ways that are optimal to foster innovation and produce therapies and diagnostic tools?

In response, Varmus spoke at length about the need to raise the bar regarding just what may be considered patent protected: "When something is discovered that does show the promise of actually being useful in developing commercially successful products, yes, it should be protected." But research tools are another matter. Varmus said he spent "a lot of energy" during his tenure at NIH encouraging researchers to share tools. Varmus recounted an example of overly ambitious postdocs who won't let research tools leave their lab until pieces of paper are signed promising that if somewhere, five steps downstream, someone creates a sellable product, they will receive some compensation. "That's crazy," Varmus said.

"A lot" of Varmus's friends are millionaires thanks to the Bayh-Dole Act of the 1980s, which allows researchers with federal funding to patent their discoveries. "But that shouldn't inspire a whole generation of scientists to be unduly aggressive in the sharing of research tools," he said. "I'm not saying Bayh-Dole should be rewritten, but there should be more discussion about what it means."

It's a balancing act, Varmus recognized. The law does do what it intended to do: encourage private companies to invest in developing new technologies and new drugs.

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