Wednesday, May 9, 2007

Mystery science 2007

There's a dirty secret behind the biotech industry: Despite years of work and billions of dollars sunk into research, the human body remains a mystery. All the laboratory work in the world, and the most convincing computer data, can't predict what will really happen when a drug goes into a test animal, never mind a human being.

That huge uncertainty is behind the extremely high failure rate of potential new drugs. And if you think of the billions in research money that drug companies pour into unsuccessful ideas, you realize it's also responsible for the high cost of the drugs that do succeed. So are there any ways to reduce that uncertainty?

The conclusion of a panel of American and European regulators at the convention today: Maybe. Someday.

Janet Woodcock, a high-ranking FDA official painted a dispiriting picture of an agency buried in paper filings, only slowly bringing the power of computers to bear on all the safety information it has collected over the years. A number of universities and regulators are looking for better, more reliable ways to sort "rat poisons" from the useful, effective drugs.

And in Europe, a large group of companies has created a consortium to see if they can predict which drugs will be toxic. The holy grail is finding "biomarkers" -- specific testable substances that can predict problems later. But all agreed that the vast amount of data required to find even one reliable new biomarker means that the deep uncertainty will be with us for a long, long time.
(By Stephen Heuser, Globe staff)

Posted by Boston Globe Business Team at 12:21 PM

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