Blog | Friday, June 28, 2013

Dear FDA: Please stop regulating ultrasound machines and fecal transplantation

The Food and Drug Administration was created in 1927 in order to carry out the mission of the Food and Drug Act put into effect by Theodore Roosevelt in 1906. In the early 1900s and before, patent medicines killed and maimed people in gruesome ways and adding chemical substances to foods to mask the fact that they were rotten or substandard was felt to need some sort of legal response. The FDA initially was predominantly an organization designed to regulate sales and interstate transport of foul and dangerous foods and medicines.

Over the years the job of the FDA has expanded as technology has advanced, to include evaluation of new drugs and devices, including those designed and produced outside the U.S. The FDA has undoubtedly protected countless people from poisonous and malfunctioning medical products. There have also been stories of egregious failures of the FDA (see this New York Times article of 2009 regarding their inability to police conflicts of interest in biomedical research) which are often attributed to lack of funding and overwork.

In the last few weeks the FDA has caused me, personally, significant grief and frustration. I am shocked and angered, as a citizen, when cortisone products containing mold result in death and disability in hapless patients and when food additives which contribute to a nationwide obesity epidemic go unchecked, but a couple of things hit closer to home than these.

I have been shopping online for the last 8 months for an affordable ultrasound machine that I can use to train myself in some of the more specialized applications of the technology. I can't see spending $40,000 for an American machine, so I have been looking at who in the world produces ultrasound machines for the rest of the world, which also can't afford the super-expensive technology. I found the perfect machine, a laptop-sized scanner with four different transducers, so I can get good at vascular, thyroid, musculoskeletal and intestinal ultrasound, and was able to buy it from the Chinese manufacturer for a bit over $4,000. I thought that after learning how well it worked it would be something that I could afford to donate to a project overseas. It was delivered to the shores of the U.S. last week and is probably not going to ever get to me because it is not FDA approved. Ultrasound machines are felt to be of low to minimal risk to humans, so the FDA approval process is not as long as for, say, invasive medical devices, but it is too laborious and expensive for Chinese companies to go through, especially with their lower-end models which they can sell just fine everywhere else in the world. I wrote the FDA investigator a letter explaining my plans but I think the chances of getting my machine are pretty poor.
The other potentially life threatening stupidity regards the increasing use of fecal transplant to treat a very difficult to treat health care associated infection, Clostridium difficile. I have written about this in several blogs, and will not further harp upon the details, but repopulating the intestinal flora of a person who has this particular infection (and probably several other conditions as well, such as inflammatory bowel disease and even obesity) really works, carries minimal risk compared to our standard of care and is really cheap.

I now read that the FDA has decided it needs to regulate fecal transplant. They want to treat it as an "investigational new drug" (IND). This classification is primarily to protect the consumer while fast-tracking a drug which clearly is needed into regulated use.

According to the FDA site, the purpose of FDA regulation of IND's is to regulate interstate transport and establish safety before development and marketing. These two purposes are completely irrelevant to fecal transplant, which never needs to be transported across state lines and needs no development or marketing. Also, if the substance to be approved is poop, I submit that poop is not one thing. Even if the FDA did approve or reject a particular stool as being safe and effective, that is hardly known to be the case for a different sample.

Why, you may ask, is fecal transplant important to me personally? It is just such a fantastically great idea, with world shifting implications in terms of living in healthy harmony with our commensal bacteria, and it has also saved a couple of my patients.

Both of these situations are excellent examples of how the economics of medicine in the U.S., with endless deep pockets provided by insurance companies of all ilks, fails to support the development of therapies that do not make money and are inexpensive. If a therapy or device does not have a powerful company or set of financially interested advocates to get it into accepted practice, it can potentially go nowhere for a long time. And if such a thing does make it up through the grass roots to acceptance, the FDA is right there to throw up a roadblock.

So why? If they have inadequate resources and lots to do, can't they perhaps go out there and protect us against dangerous things instead of fussing with fecal transplants and my ultrasound machine? There was an outcry early in the AIDS epidemic, at which time the IND fast track and several other modifications of FDA procedures helped to allow medications into the market for patients dying for lack of options. It took some really powerful physician advocates and dying poster children to get these changes made. Perhaps a champion will stand up for the many other great ideas failing to thrive due to inappropriate regulation.

Janice Boughton, MD, FACP, practiced in the Seattle area for four years and in rural Idaho for 17 years before deciding to take a few years off to see more places, learn more about medicine and increase her knowledge base and perspective by practicing hospital and primary care medicine as a locum tenens physician. She lives in Idaho when not traveling. Disturbed by various aspects of the practice of medicine that make no sense and concerned about the cost of providing health care to every American, she blogs at Why is American Health Care So Expensive?, where this post originally appeared.