When Poop Becomes a "Drug," Docs Better Watch How They Speak to the FDA
There appears to be a little hangup in all the good news about poop helping cure intestinal infections. You see, when you discover that something, anything, acts as a cure for disease, well, that something becomes, in the parlance of the U.S. Food and Drug Administration, a “drug.”
And as a drug, that something must go through a strict approval process. All kinds of testing and forms to fill out. Can take years. Except the doctors using poop to eradicate recurring infections of Clostridium difficile bacteria don’t have years. They have patients who need the treatment now.
The New York Times article reporting on the research results (which is the most emailed article at the NY Times, by the way) noted at one point:“Dr. Lawrence J. Brandt, a professor at the Albert Einstein College of Medicine in New York, said that the Food and Drug Administration had recently begun to regard stool used for transplant as a drug, and to require doctors administering it to apply for permission, something that he said could hinder treatment.”
Now, I can understand that Dr. Brandt might become impatient with the FDA and its rules. It has used those rules to require food sellers to remove information from the Internet in which they even hint that certain foods can relieve certain medical conditions and thereby improve health. So if food can be considered a drug, why not poop?
So here’s some advice for Dr. Brandt to deal with his impatience:
*Try not to lash out at the FDA. If they hold up your treatment, definitely don’t say, “You guys are full of shit!” Instead, try the soothing-voice approach, as in, “You guys are sooooo full of shit.”
*Try not to threaten the guys and gals at the FDA. Definitely don’t tell them, “You guys better move it, or the shit is going to hit the fan!” Rather, say something that might be appealing, given the new status of poop, like, “The sooner you guys approve this, the sooner we can all bathe in the shit that is going to fly around here.”
*Keep a lid on the personal accusations. You might be tempted to tell one or the other FDA operative, “You guys really have you heads up your asses.” Temper it a bit. Something more positive, like, “Hey, try sticking your head up your ass, you may find some of the meds I need.”
*Don’t question the FDA commitment to improving health. When an official talks about how the approval process “takes time,” don’t get accusatory, as in, “You guys don’t give a shit about whether people suffer.” Give him or her an incentive. “Next time you shit, think about how you could be helping people.”
You see, it doesn’t have to be adversarial. Dealing with the FDA can be smooth and easy. No shit.