OPINION
Transcending Biology Calls for Transcending Red Tape

Bold predictions about the future in The Singularity is Near: When Humans Transcend Biology, recently released by legendary inventor Ray Kurzweil, are causing reviewers to marvel in awe or disbelief. But while Kurzweil's forecasts are fascinating, the book's analysis of the present is just as important.

Amid discussions of reverse engineering the brain and the possibility of tiny nanobots that will help keep us healthy, Kurzweil points out stumbling blocks to our brave march into the future. America needs to "streamline the regulatory process," he argues. That's because government agencies like the U.S. Food and Drug Administration (FDA) impose burdensome processes that slow down the development of much-needed drugs.

Reform Past Due

"Right now in the United States, we have a five-to-ten-year delay on new health technologies for FDA approval (with comparable delays in other nations). The harm caused by holding up potential lifesaving treatments (for example, one million lives lost in the United States for each year we delay treatments for heart disease) is given very little weight against the possible risks of new therapies," he writes. Kurzweil's point is incredibly important, and he's not alone.

Milton Friedman, Nobel prize-winning economist, said more than ten years ago, "The FDA has done enormous harm to the health of the American public by greatly increasing the costs of pharmaceutical research, thereby reducing the supply of new and effective drugs, and by delaying the approval of such drugs as survive the tortuous FDA process."

With smart people like Kurzweil and Friedman pointing out such a huge government failure, one would think reform would be on the way. So why haven't things changed? Those in charge don't want them to change.

From the bureaucratic point of view, it's preferable to slow down a drug and forgo the benefits of saving lives. That strategy is easier, as it's less likely someone will make a public-relations scandal out of over-caution than if a drug were to be approved too fast and harm a number of people. This plan might start to backfire as medicine becomes more personalized.

Personalizing Treatment

Science writer Ronald Bailey recently noted that after a few patients died from taking Lotronex, a medicine used to treat irritable bowel syndrome, the drug company took it off the market. What happened after that demonstrates a new view of risk from both the public and a perhaps reluctant FDA. A number of patients who had been successfully taking the drug protested its withdrawal, which led the FDA to re-approve Lotronex, with additional precautions, two years after the original approval.

Indeed, the more the scientific community learns about human biology, the more personalized treatments seem to become. This makes expensive large sample tests less necessary or appealing, even for the highly risk-adverse crowd. But Kurzweil's point about the FDA doesn't only affect disease related matters -- national security comes into play as well.

"While a bioterrorist does not need to put his 'inventions' through the FDA, we do require the scientists developing defensive technologies to follow existing regulations, which slow down the innovation process at every step," Kurzweil warns. In a world where terrorists claim to value death more than we value life, regulatory barriers to national defense seem downright stupid.

Getting Up to Speed

Of course, measures must be put in place to ensure that research is conducted with an eye to preventing irresponsible and potentially catastrophic results, but that can be accomplished without a huge bureaucracy breathing down the necks of science professionals. One way to bring safety and efficiency under the same banner is to maintain a set of general guidelines that address only the extremely dangerous aspects of research.

For instance, in the field of nanotechnology, a potential disaster scenario could occur if artificial replicators could copy themselves in an uncontrolled environment, leading to what some call the "grey goo" problem. A way to deal with this issue is to establish a guideline for scientists against such technology but leave the rules open to experiment in other areas.

Meanwhile, The Singularity is Near: When Humans Transcend Biology, provides a fascinating view of the future and a less-than-rosy view of the present. Technology is advancing exponentially, but regulatory bodies are failing to keep pace. It's time to fix things today so the future will turn out even better.

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Sonia Arrison, a TechNewsWorld columnist, is director of Technology Studies at the California-based Pacific Research Institute. She also serves on the Technology Advisory Board for the Acceleration Studies Foundation.

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