WASHINGTON (AP) – Imagine a low-cost treatment for a life-threatening infection that could cure up to 90 percent of patients with minimal side effects, often in a few days.
It may sound like a miracle drug, but this cutting-edge treatment is profoundly simple – though somewhat icky: take the stool of healthy patients to cure those with hard-to-treat intestinal infections. A small but growing number of physicians have begun using these procedures, called fecal transplants, to treat Clostridium difficile, an intestinal infection that causes nausea, cramping and debilitating diarrhea, afflicting a half-million Americans annually and killing about 15,000.
But fecal transplants pose a challenge for the Food and Drug Administration, which has decided to regulate the treatment as an experimental drug. Stool transplants don’t fit neatly into the agency’s standard framework. And while regulators have shown flexibility in their approach, some critics say the mere presence of government oversight is discouraging many doctors from offering transplants. That’s led some patients to seek out questionable “do-it-yourself” websites, forums and videos.
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