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Monday, August 29, 2011

Shame on you, New England Journal of Medicine

For specialists in internal medicine, the New England Journal of Medicine is one of the journals you really read. It's not a free throwaway journal or bathroom reading--it's where you find good original research, interesting case studies, cogent editorials. Usually. More or less.

Right now it's "less." A few days ago I posted my review of a recent study on placebos. I found it interesting but somewhat problematic. It's real benefit seems to have been that it has sparked substantive and vigorous discussions about placebos. To save you from reading my entire review, the study basically took asthmatics and gave them either real medicine, fake medicine, "sham" acupuncture, or nothing at all. All the patients reported feeling at least somewhat better, but only the patients treated with real medicine had significant improvement in measured lung function. Another way to state the findings might be "The placebos and the real medicine all made the patients feel better. Oh, and only the real medicine made them actually better." I have a problem with this presentation, as you will read below.

What we've learned about so-called placebos over the years is that "placebo" is not an intervention like a medication or a surgery. It is an artifact of observation. A certain amount of change can be expected any time you study a group of people. "Placebo" is simply all of the change that can't be explained by the primary intervention. Taking the asthma study as an example, simply enrolling people in the study and doing nothing else caused them to feel a bit better. But treating them with real medicine caused them to feel better and get significantly better physically. The bit of "better" that was seen simply by enrolling is referred to as placebo effect, and is a mix of various factors, such as patients' being cared for, regression to the mean, desire to please researchers, and other effects not due to a "real" intervention. It is likely that a good deal of placebo is subsumed in standard care: if you go to the doctor for a broken leg, being cared for and listened to makes you feel better, but setting the bone and placing the cast does most of the work. Good doctors maximize our ability to make people "feel" better along with treating the underlying illness.

The current object of my ire is an editorial published in the Journal to accompany the asthma study. It was written by an anthropologist named Danial Moerman who completely misreads the study, the meaning of placebo, and what a disease actually is. He first fails to understand that there were actually four interventions: "They found that three of the interventions, active albuterol, sham albuterol, and sham acupuncture, were all equally effective in controlling asthma symptoms, as judged by patient-reported improvement. ... The fourth intervention was "no treatment," in which patients were told to wait for several hours and then return home. Waiting had no effect on either subjective asthma symptoms or lung function.

Perhaps I misread the results and the graphs, but it appears to me that the "do nothing" group did in fact report feeling better, just not as much as the other groups. The importance of this lies in the fact that part of the placebo phenomenon is simply being cared for or enrolled in the study (in this case it also involved repeated lung function testing). If this were subtracted out in some way, we might find a much less significant effect. But we are still speaking of "subjective" improvement, an important factor, but not one nearly as important as being able to breathe better.

Professor Moerman, perhaps being used to dealing with less concrete ideas, misses the importance of objective vs. subjective outcomes in medicine. Holding a cancer patient's hand can make them feel better, a lot better in the short term than chemotherapy. But it won't shrink a tumor. Moerman thinks we have it the wrong way 'round: "It is the subjective symptoms that brought these patients to medical care in the first place. They came because they were wheezing and felt suffocated, not because they had a reduced FEV1. The fact that they felt improved even when their FEV1 had not increased begs the question, What is the more important outcome in medicine: the objective or the subjective, the doctor's or the patient's perception? This distinction is important, since it should direct us as to when patient-centered versus doctor-directed care should take place."

First, I hate it when people misuse "begs the question," but that's not important. What's important is that he's asked the wrong question. It's not whether subjective or objective is most important, or whether a "patient-" vs. "doctor-centered" care (whatever that means) is the best model. In medicine, we assess both how a patient feels, and how well they are doing physiologically. We do this in the exam room and we do this in our research. We (meaning doctors and medical scientists) don't think one is "more important" than the other; we know that any intervention is a balance between changing physiology and making a patient feel better. Reading this editorial makes me think of Columbus "discovering" America: it was already here, the folks living here obviously knew it, and he really had no idea where he was anyway.

Another example of his profound ignorance is his complete lack of understanding of common medical conditions: "For subjective and functional conditions, for example, migraine, schizophrenia, back pain, depression, asthma, post-traumatic stress disorder, neurologic disorders such as Parkinson's disease, inflammatory bowel disease and many other autoimmune disorders, any condition defined by symptoms, and anything idiopathic, a patient-centered approach requires that patient-preferred outcomes trump the judgment of the physician."

None of the conditions he mentions above are what he thinks they are. There is nothing "subjective" about the cognitive dysfunction of schizophrenia or the tremors and stiffness of Parkinson's disease. And there are drugs and other physiologic interventions that improve both the way patients feel and objective measures of how they are doing.

It's not so much Moerman's ignorance that disturbs me: anyone can be ignorant. But this piece of idiocy was published in one of the world's most respected medical journals. Well, his ignorance really does disturb me too. He closes with a false dichotomy: "Do we need to control for all meaning in order to show that a treatment is specifically effective? Maybe it is sufficient simply to show that a treatment yields significant improvement for the patients, has reasonable cost, and has no negative effects over the short or long term. This is, after all, the first tenet of medicine: 'Do no harm.'"

As a physician and a patient, I'm unwilling to settle for "no negative side effects over the short or long term." There are no such things as "side effects"; only "effects", some of which we desire, some of which we do not, so risk can only be minimized, never eliminated. The precept is "First, do no harm", not "Do nothing and hope for the best."

References
Moerman, Daniel E. Meaningful placebos--controlling the uncontrollable. N Engl J Med. 365(2):171-172 (2011). DOI:10.1056/NEJMe1104010.

Peter A. Lipson, ACP Member, is a practicing internist and teaching physician in Southeast Michigan. After graduating from Rush Medical College in Chicago, he completed his internal medicine residency at Northwestern Memorial Hospital. This post first appeared at his blog, White Coat Underground at the Scientopia Blogs network. The blog, which has been around in various forms since 2007, offers "musings on the intersection of science, medicine and culture." His writing focuses on the difference between science-based medicine and "everything else," but also speaks to the day-to-day practice of medicine, fatherhood, and whatever else migrates from his head to his keyboard.

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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 Richmond, Va., 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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