Clearing the Bio-Informatics Landmines

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Clearing the Bio-Informatics Landmines

In Ride the Wave, Fred Rogers and Richard Lalich point to the awesome potential of personalized medicine based on bio-informatics.1 Knowledge of the individual's genetic makeup will soon allow molecular medicine to reach deep inside each of us to cure most of the maladies that afflict us—and perhaps even slow the rate at which we age.

First we will learn to understand each person's genome; then we will learn to craft treatments tailored to his or her genetic constitution. Because of these breakthroughs, medicine is at a crucial turning point.

But there is more involved here than simply overcoming technical hurdles.

Consider 23andMe, a commercial enterprise launched in 2006 that was merely looking to inform Americans about their potential genetic vulnerability to certain diseases. Regulators from the Food and Drug Administration have dropped the hammer on the company, citing baseless fears that its customers will do something dangerously stupid in reaction to the information that the tests provide.2

The FDA's regulatory labyrinth is not only slow to digest the science behind the genetic testing involved in 23andMe: It also can't quite figure out what to do with the proliferation of molecular biomarkers that can predict treatment efficacy more quickly than the conventional clinical trials the agency relies upon.

As Peter Huber, a senior fellow at the Manhattan Institute for Policy Research, argues in his book The Cure in the Code, 21st-century medicine is being hampered by a regulatory regime built for the science of the 20th century.3

In the late 19th and early 20th centuries, mankind made huge medical advances. For example, thanks to the construction of sewers, the use of vaccines, and the invention of antibiotics, infectious diseases became less widespread and less deadly.

These successes enabled us to live long enough that we now suffer from a qualitatively different set of illnesses: diseases that emerge from the biochemical combinations of our genes and our lifestyles.

Today's prominent maladies—cancer, diabetes, heart disease, and dementia—take decades to develop, and successful treatments must begin decades before patients become clinically ill.

Our conception of illness has thus been transformed. Sequencing entire human genomes has revealed the tremendous biochemical diversity of human beings.

Our susceptibilities are particular to each one of us, and the time when blockbuster drugs, such as penicillin, could treat nearly every patient is over...

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