FINDING ADDITIONAL DRUGS TO FIGHT DRUG-RESISTANT BACTERIA. I am pleased to see intensity rising almost to violence in debates about FDA statistical methods. This article about the debates says: “At times the debate has been so heated that the acting chairman of an FDA committee opened a 2009 meeting by warning that he didn’t want to read the day next about police ‘having to arrest scientists for breaking shop windows and turning over cars.'” There should be intensity because so much is at stake—a matter of life and death (the article opens by describing the death of a toddler from a drug-resistant bacterium.) The article describes “a nearly decade-long stalemate with the Food and Drug Administration over how to bring new antibiotics to market.” Apparently the FDA is insisting on tests for approval which demonstrate that the prospective drug is better than the old one—a change from previous practice. The article says that; “For years, new antibiotics often were approved based on clinical trials that didn’t have to show the new drug was better than an old one.”

I don’t understand the FDA’s position. What is being sought is a drug to use in the case where the primary antibiotic has encountered a bacterium that is resistant to it. The new drug doesn’t have to be better in all circumstances. It has to be different. It has to work against a particular mutation. Testing to see which drug is better against non-resistant bacteria is irrelevant. And how can a control group be devised to test effectiveness against a mutation which has not yet been encountered?

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