FDA — full of poop?
Jacqueline Vance, RN
Every few days I read the Food and Drug Administration (FDA) news to see if there is anything relevant to eldercare that I should be aware of. Recently, I came across an extremely eye-opening item.
But first, some background: Certain doctors are curing Clostridium Difficile diarrhea by performing fecal transplants. (Yeah, I know, GROSS. It's supposed to come out, not go in. I'm with you there!)
But, if you look at the outcomes, it's working in over 90% of the cases. But get this: The doctors who are treating C-Diff with poop may soon need approval from the FDA to continue. See, it seems that according to FDA definitions, poop is considered to be biologic product. (You can't make this stuff up!)
Therefore, if it were a biologic product, it would require an Investigational New Drug (IND) designation before being tested in humans. (Forget that people are already being treated and that the first fecal transplantation in humans was performed in 1958.)
So here's the skinny on how pharmaceuticals get approved: The manufacturer of the drug must first obtain an Investigational New Drug designation from the FDA to legally test the drug on human subjects in the U.S. The application for the IND is based on pre-clinical data, usually from animal studies that shows the drug is safe enough to be tested in humans.
Now to be honest, a research study funded by NIH or some other sort for fecal transplants is not such a bad idea. Researching to see if it is effective to cure other bowel diseases such as Crohn's disease or irritable bowel syndrome, as well as C-Diff would be a great study, and probably not too expensive. But what if, in this biologic drug poop vision, the FDA decides it wants a three-phase trial like they need for all other pharmaceuticals.
A three-phase trial takes many, many years. The three phases are normally*:
- Phase 1: The drug is tested in a few healthy volunteers to determine if it is acutely toxic.
- Phase 2: Various doses of the drug are tried to determine how much to give to patients.
- Phase 3: The drug is typically tested in double-blind, placebo controlled trials to demonstrate that it works.
Now, no pharmaceutical company is manufacturing this poop that is being transplanted. It is being created the good old-fashioned way.
So where are the millions of dollars going to come from to conduct this type of research? Guess whose tax dollars, right? (See my blog on Sequestration and you know how I'm gonna' feel about that one!)
So let's not go overboard, OK? Please. Will everyone who performs the procedure need an Investigational New Drug designation? Will just one center do to prove all is well with “shoveling the poop” to show it is safe, or will every single center need a NIH funded study to be able to transplant the stuff?
I don't know. I just hope we don't waste millions of tax dollars studying poop, and I sure hope no one starts slinging it!
Just keeping it real,
The Real Nurse Jackie is written by Jacqueline Vance, RNC, CDONA/LTC, a 2012 APEX Award of Excellence winner for Blog Writing. Vance is a real life long-term care nurse who is also the director of clinical affairs for the American Medical Directors Association. A nationally respected nurse educator and past national LTC Nurse Administrator of the Year, she also is an accomplished stand-up comedienne. She has not