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Commentary

The Right Road To Safe Drugs
Robert Goldberg, Ph.D., New York Post, 12-28-04

Goldberg’s message on drug safety: We can do better.

“The FDA can make drugs safer by embracing cutting edge scientific tools that can reassure each American that his or her medicines are safe and effective.”

The current FDA approval process, “set up when modern molecular biology was in its infancy,” is “good at detecting whether a drug has widespread side effects. It is not so good at discovering whether a small group of people would suffer increased risk of illness or death.” Critics want more of the same status quo – longer, larger clinical trials, that will delay patient access to new medicines for years, if not altogether.

In the long run, molecular science will solve the drug safety problem by creating “a personalized approach [that] identifies which groups of patients might be more likely to get a side effect from a medicine” and optimize drug treatments based on a patient’s genetic makeup.



Project FDA.
  
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