FDA grapples with oversight of fecal transplants

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 so-called fecal transplants to treat Clostridium difficile, commonly referred to as C-diff, a bacterial infection that causes nausea, cramping and diarrhea. The germ afflicts a half-million Americans annually and kills about 15,000 of them.

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.

Most researchers agree that the FDA's concerns are warranted. Patients can contract HIV, hepatitis and other viruses and parasites from fecal matter that is not properly screened. Additionally, there are no long-term studies on potential side effects of stool transplantation.

FDA officials declined to be interviewed for this story, but said in a written response that the fecal transplantation "shows promise in treating C. difficile infection that has not been responsive to other therapies."

More at http://www.theeagle.com/news/health_fitness/fda-grapples-with-oversight-of-fecal-transplants/article_54320a25-3646-5ff0-9328-0e79d436d7a3.html .

[font color=green]Yes, that's correct--none of the FDA officials wanted to give a shitty interview.[/font]