How government kills innovation

Nobody knows where Simon Sparrow picked up the bug that killed him.

One sunny April morning six years ago, the curly-haired toddler woke up with flu-like symptoms; by afternoon he was struggling for breath. He went into septic shock. Doctors at the hospital gave him intravenous antibiotics, but the drugs failed.

By the next afternoon, Simon was dead at 18 months old, the victim of a highly drug-resistant bacterium, methicillin-resistant Staphylococcus aureus. The day before, on the way to the hospital, he had learned the word "flower."
"I was insane for a year," said his mother, Everly Macario of Chicago. "You feel like you are in a dream. You feel like you will wake up sometime."

We have come to expect that modern medicine can cure just about any infection. But bacteria are finding ways to evade, one by one, the drugs in our arsenal, and that arsenal is not being replenished with new antibiotics.

Drug companies are abandoning the antibacterial business, citing high development costs, low return on investment and, increasingly, a nearly decade-long stalemate with the Food and Drug Administration over how to bring new antibiotics to market.

Soon, doctors fear, we could be defenseless against bacteria that can resist all existing antibiotics, which would mean more victims like Simon, dead from a staph infection that drugs used to conquer easily.

Dr. Brad Spellberg, an expert on antibiotic resistance, called the situation "catastrophic."

At the core of the problem is a regulatory impasse over whether drug companies seeking FDA approval for antibiotics should be required to run much more stringent clinical trials.

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