Every antibiotic, given the ability of bacteria to evolve rapidly to survive, is bound to become ineffective sooner or later. The trick is to ensure a steady stream of new drugs that the resistant microbes have never encountered before. We need medical science to advance more rapidly than the bacteria do.
But lately, it hasn't. Henry I. Miller, a physician and molecular biologist at Stanford's Hoover Institution, says one culprit is obvious. In 2002, the FDA established new rules for the clinical trials used to test new antibiotics—doubling the number of patients required, thus making drug development harder and more expensive.
Research on antibiotics is especially vulnerable to overregulation because they are so much less profitable than many other medicines. Unlike new drugs that patients take permanently for chronic ailments, which produce mighty rivers of revenue, antibiotics usually don't sell at a high price and aren't needed for long, writes Steve Chapman.