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Wednesday, June 8, 2016

Nutrient supplements in the land of the law of unintended consequences

In principle, the law that constrains the marketing of nutrient supplements in the U.S. is the Dietary Supplement Health And Education Act of 1994 (DSHEA). In practice, the law of unintended consequences may exert an even greater influence.

I write this in the immediate aftermath of a meeting with an innovative nutrient supplement company for which I serve as a scientific advisor. My role involves reviewing research evidence, participating directly in new product formulations, and advising on needed research. The role, and the results of the collaboration, are quite rewarding, and have produced at least 1 product I myself take daily, to very good effect. But none of that is the crux of today's story.

I presented to the business team, including gurus of marketing, and the in-house legal counsel, some of my priorities for the information they make available. Those priorities, and my perspective, derive directly from 25 years of patient care. In the typical scenario, a patient reads about some new supplement, is intrigued, and brings something they printed off the Internet to their subsequent appointment with me to get my opinion. What information do I need to make an informed judgment?

For starters, I am somewhat prone to judge this kind of book by its cover. In other words, the tone of any marketing material matters to me. I do not want to see any mention of miracle, or wonder. I don't want to see effects promised, or results guaranteed.

But here, the law is something of a problem for those on the marketing side. Among the salient stipulations of DSHEA is that supplements cannot be marketed to “treat” anything. So, for instance, niacin can still be a nutrient if it “supports healthy metabolism,” or some such very vague thing. But if it treats hypertriglyceridemia (which it does), then it is a drug.

That sounds reasonable in principle: nutrients support general health, drugs treat diseases. But the reality is that nutrients and botanicals overlap substantially with drugs. Niacin is both a drug, and a B vitamin. Coenzyme Q10, a product that in many ways epitomizes the divide between pharmaceuticals and alternatives to them, is a nutrient widely distributed in plants, and also, potentially 1 of the more significant treatment advances for heart failure of the past decade. Say that CoQ10 “treats” heart failure, however, and you run afoul of DSHEA, and face penalties.

What ensues? Marketing hype. If you happen to be marketing a nutrient that seems to be quite effective for treating something in particular, you are not allowed to say so. But when you can't say the very thing that you want to say, and that customers need to know, you are left to gild the lily. Marketing of supplements thus often involves a great deal of language in the service of sales that tends to make me, and I presume most of my colleagues, wince.

The problem? You can't very well whisper and be heard where everyone else is shouting, so the result is something of a marketing hype arms race. This, of course, has the potential to confuse the public about likely effects, and dissuade health care professionals from giving nutrient supplements any consideration at all, a reaction that has been on rather prominent display in recent years. Anyone marketing a supplement, however sound, sensible, and science-based, must compete in this noisy space.

Once I get past that initial impression, my interest turns to the underlying science. I, and my colleagues, want to see the relevant evidence. I want to know if the components of the formulation have been studied, and if so, I would like easy access to those references. I would like to know if the formulation itself has been studied. If those data are not yet available, I want to know if such studies are under way, or planned. If so, I would like information about those plans.

And, of course, if the company cannot provide such substantiation, I am apt to think it doesn't exist. In the absence of such evidence, I will tell my patient, better safe than sorry. Let's stick with what we know.

Once again, however, the law of unintended consequences is at work. Consider, for instance, if a supplement maker uses the results of a randomized, double blind, placebo-controlled trial of osteoarthritis to incorporate a compound found to be effective into its “joint formula.” Including reference to that trial, anywhere in their marketing material or on their website, is taken by regulators as a claim that their product “treats” osteoarthritis, which violates DSHEA. Rather than risk such sanctions, supplement makers generally don't reference the studies.

This is a serious impasse. Doctors need studies to inform their decisions, and in the case of nutrient supplement makers, those tend to be the very studies they can't share. No one does, and no one should, run studies of vague “support for metabolism.” While DSHEA encourages such vague language, the considerable investment of a clinical trial requires perfectly clear outcomes, and decisive measures. Those, in turn, translate to treatment- which cannot be implied. So supplement makers can, and at times do, have a bounty of good evidence to support a particular product, yet be precluded from letting anybody know.

I am by no means suggesting that is always the case. Many supplements that don't work at all are marketed routinely, and some, very successfully. I have always maintained that this was a domain of both baby, and bathwater, and that differentiating is essential. That is true of pharmaceuticals too, by the way.

It is the job of health care professionals to help patients make that distinction. To do so, we need the very information nutrient supplement makers are precluded, for the most part, from sharing. And so it is we are left to make, take, market, and choose nutrient supplements with less information than we should have, because the law of the land is the law of unintended consequences.

David L. Katz, MD, FACP, MPH, FACPM, 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. He is a board certified specialist in both Internal Medicine, and Preventive Medicine/Public Health, and Associate Professor (adjunct) in Public Health Practice at the Yale University School of Medicine. He is the Director and founder (1998) of Yale University's Prevention Research Center; Director and founder of the Integrative Medicine Center at Griffin Hospital (2000) in Derby, Conn.; founder and president of the non-profit Turn the Tide Foundation; and formerly the Director of Medical Studies in Public Health at the Yale School of Medicine for eight years. This post originally appeared on his blog at The Huffington Post.

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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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