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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.

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Blog log

Members of the American College of Physicians contribute posts from their own sites to ACP Internistand ACP Hospitalist. Contributors include:

Albert Fuchs, MD
Albert Fuchs, MD, FACP, graduated from the University of California, Los Angeles School of Medicine, where he also did his internal medicine training. Certified by the American Board of Internal Medicine, Dr. Fuchs spent three years as a full-time faculty member at UCLA School of Medicine before opening his private practice in Beverly Hills in 2000.

And Thus, It Begins
Amanda Xi, ACP Medical Student Member, is a first-year medical student at the OUWB School of Medicine, charter class of 2015, in Rochester, Mich., from which she which chronicles her journey through medical training from day 1 of medical school.

Auscultation
Ira S. Nash, MD, FACP, is the senior vice president and executive director of the North Shore-LIJ Medical Group, and a professor of Cardiology and Population Health at Hofstra North Shore-LIJ School of Medicine. He is Board Certified in Internal Medicine and Cardiovascular Diseases and was in the private practice of cardiology before joining the full-time faculty of Massachusetts General Hospital.

Zackary Berger
Zackary Berger, MD, ACP Member, is a primary care doctor and general internist in the Division of General Internal Medicine at Johns Hopkins. His research interests include doctor-patient communication, bioethics, and systematic reviews.

Controversies in Hospital Infection Prevention
Run by three ACP Fellows, this blog ponders vexing issues in infection prevention and control, inside and outside the hospital. Daniel J Diekema, MD, FACP, practices infectious diseases, clinical microbiology, and hospital epidemiology in Iowa City, Iowa, splitting time between seeing patients with infectious diseases, diagnosing infections in the microbiology laboratory, and trying to prevent infections in the hospital. Michael B. Edmond, MD, FACP, is a hospital epidemiologist in Iowa City, IA, with a focus on understanding why infections occur in the hospital and ways to prevent these infections, and sees patients in the inpatient and outpatient settings. Eli N. Perencevich, MD, ACP Member, is an infectious disease physician and epidemiologist in Iowa City, Iowa, who studies methods to halt the spread of resistant bacteria in our hospitals (including novel ways to get everyone to wash their hands).

db's Medical Rants
Robert M. Centor, MD, FACP, contributes short essays contemplating medicine and the health care system.

Suneel Dhand, MD, ACP Member
Suneel Dhand, MD, ACP Member, is a practicing physician in Massachusetts. He has published numerous articles in clinical medicine, covering a wide range of specialty areas including; pulmonology, cardiology, endocrinology, hematology, and infectious disease. He has also authored chapters in the prestigious "5-Minute Clinical Consult" medical textbook. His other clinical interests include quality improvement, hospital safety, hospital utilization, and the use of technology in health care.

DrDialogue
Juliet K. Mavromatis, MD, FACP, provides a conversation about health topics for patients and health professionals.

Dr. Mintz' Blog
Matthew Mintz, MD, FACP, has practiced internal medicine for more than a decade and is an Associate Professor of Medicine at an academic medical center on the East Coast. His time is split between teaching medical students and residents, and caring for patients.

Everything Health
Toni Brayer, MD, FACP, blogs about the rapid changes in science, medicine, health and healing in the 21st century.

FutureDocs
Vineet Arora, MD, FACP, is Associate Program Director for the Internal Medicine Residency and Assistant Dean of Scholarship & Discovery at the Pritzker School of Medicine for the University of Chicago. Her education and research focus is on resident duty hours, patient handoffs, medical professionalism, and quality of hospital care. She is also an academic hospitalist.

Glass Hospital
John H. Schumann, MD, FACP, provides transparency on the workings of medical practice and the complexities of hospital care, illuminates the emotional and cognitive aspects of caregiving and decision-making from the perspective of an active primary care physician, and offers behind-the-scenes portraits of hospital sanctums and the people who inhabit them.

Gut Check
Ryan Madanick, MD, ACP Member, is a gastroenterologist at the University of North Carolina School of Medicine, and the Program Director for the GI & Hepatology Fellowship Program. He specializes in diseases of the esophagus, with a strong interest in the diagnosis and treatment of patients who have difficult-to-manage esophageal problems such as refractory GERD, heartburn, and chest pain.

I'm dok
Mike Aref, MD, PhD, FACP, is an academic hospitalist with an interest in basic and clinical science and education, with interests in noninvasive monitoring and diagnostic testing using novel bedside imaging modalities, diagnostic reasoning, medical informatics, new medical education modalities, pre-code/code management, palliative care, patient-physician communication, quality improvement, and quantitative biomedical imaging.

Informatics Professor
William Hersh, MD, FACP, Professor and Chair, Department of Medical Informatics & Clinical Epidemiology, Oregon Health & Science University, posts his thoughts on various topics related to biomedical and health informatics.

David Katz, MD
David L. Katz, MD, MPH, FACP, is an internationally renowned authority on nutrition, weight management, and the prevention of chronic disease, and an internationally recognized leader in integrative medicine and patient-centered care.

Just Oncology
Richard Just, MD, ACP Member, has 36 years in clinical practice of hematology and medical oncology. His blog is a joint publication with Gregg Masters, MPH.

KevinMD
Kevin Pho, MD, ACP Member, offers one of the Web's definitive sites for influential health commentary.

MD Whistleblower
Michael Kirsch, MD, FACP, addresses the joys and challenges of medical practice, including controversies in the doctor-patient relationship, medical ethics and measuring medical quality. When he's not writing, he's performing colonoscopies.

Medical Lessons
Elaine Schattner, MD, FACP, shares her ideas on education, ethics in medicine, health care news and culture. Her views on medicine are informed by her past experiences in caring for patients, as a researcher in cancer immunology, and as a patient who's had breast cancer.

Mired in MedEd
Alexander M. Djuricich, MD, FACP, is the Associate Dean for Continuing Medical Education (CME), and a Program Director in Medicine-Pediatrics at the Indiana University School of Medicine in Indianapolis, where he blogs about medical education.

More Musings
Rob Lamberts, MD, ACP Member, a med-peds and general practice internist, returns with "volume 2" of his personal musings about medicine, life, armadillos and Sasquatch at More Musings (of a Distractible Kind).

Prescriptions
David M. Sack, MD, FACP, practices general gastroenterology at a small community hospital in Connecticut. His blog is a series of musings on medicine, medical care, the health care system and medical ethics, in no particular order.

Reflections of a Grady Doctor
Kimberly Manning, MD, FACP, reflects on the personal side of being a doctor in a community hospital in Atlanta.

The Blog of Paul Sufka
Paul Sufka, MD, ACP Member, is a board certified rheumatologist in St. Paul, Minn. He was a chief resident in internal medicine with the University of Minnesota and then completed his fellowship training in rheumatology in June 2011 at the University of Minnesota Department of Rheumatology. His interests include the use of technology in medicine.

Technology in (Medical) Education
Neil Mehta, MBBS, MS, FACP, is interested in use of technology in education, social media and networking, practice management and evidence-based medicine tools, personal information and knowledge management.

Peter A. Lipson, MD
Peter A. Lipson, MD, ACP Member, is a practicing internist and teaching physician in Southeast Michigan. The blog, which has been around in various forms since 2007, offers musings on the intersection of science, medicine, and culture.

Why is American Health Care So Expensive?
Janice Boughton, MD, FACP, practiced internal medicine for 20 years before adopting a career in hospital and primary care medicine as a locum tenens physician. She lives in Idaho when not traveling.

World's Best Site
Daniel Ginsberg, MD, FACP, is an internal medicine physician who has avidly applied computers to medicine since 1986, when he first wrote medically oriented computer programs. He is in practice in Tacoma, Washington.

Other blogs of note:

American Journal of Medicine
Also known as the Green Journal, the American Journal of Medicine publishes original clinical articles of interest to physicians in internal medicine and its subspecialities, both in academia and community-based practice.

Clinical Correlations
A collaborative medical blog started by Neil Shapiro, MD, ACP Member, associate program director at New York University Medical Center's internal medicine residency program. Faculty, residents and students contribute case studies, mystery quizzes, news, commentary and more.

Interact MD
Michael Benjamin, MD, ACP member, doesn't accept industry money so he can create an independent, clinician-reviewed space on the Internet for physicians to report and comment on the medical news of the day.

PLoS Blog
The Public Library of Science's open access materials include a blog.

White Coat Rants
One of the most popular anonymous blogs written by an emergency room physician.

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