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Tuesday, August 6, 2013

More on estrogen and evidence of effect

Colleagues and I conducted a careful analysis of data reported in a methodologically robust clinical trial and published in a prestigious journal to reach this conclusion: Failure to take estrogen over the past decade has resulted in tens of thousands of premature deaths among women in the U.S. who have undergone hysterectomy. Estrogen significantly lowers the mortality rate among younger women in this group.

Perhaps it is inevitable when you assert that tens of thousands of women have needlessly lost a decade or two of life, and that the death toll is ongoing and probably rising, you will raise some hackles. And, perhaps it's inevitable that when you identify the causes of this public health crisis, the identified causes will push back.

The causes in this case involve no "bad guys," no malice, and no ill intent, however. Rather, we might invoke a confluence of predictably unfortunate happenstance. The findings of large clinical trials make headlines. Headlines are, traditionally, designed for maximal titillation, meaning they are over-simplified and over-generalized as they were in this particular case. And, alas, in the case of hormone replacement, the headlines stuck--with all subtlety lost. A cultural aversion to hormone replacement overtook patients and clinicians alike. We are simply reporting the unintended consequences.

Peers pushing back against our paper have no real cause to do so. We are not accusing anyone of anything other than the unintended, adverse effects of medicine-meets-media business as usual. We are not refuting the value of the Women's Health Initiative (WHI). Quite the contrary; our data are from the WHI. The WHI has not done harm -- misapplication of the WHI findings has done harm.

We are certainly not saying that every woman with a hysterectomy should take estrogen. Our argument is exactly against the oversimplification of one-size-fits-all approaches. Headlines invite just such dumbing down, and our very point is that we need to get past the headlines to the relevant nuances. Good clinical care is not well informed by aversions or knee-jerk reactions. It is well informed only by the thoughtful application of the best possible information to a given individual patient's circumstance.

In all of the commentary I have found, I see only one consistent challenge to our paper: It's based on a mathematical model and the assumptions are uncertain. Perhaps, but consider this: Evidence-based medicine, in its entirety, involves extrapolating the results of the best research to the care of patients. That, of course, is far less robust than a formal attempt to link the two in a mathematical model. It really is just informed observation. Evidence-based medicine comes down to this: "A clinical trial suggests a benefit from X in some people, and it seems to me that you, my patient, are enough like those people to benefit from X as well, and on that basis, I recommend/prescribe X for you."

Make no mistake, that's exactly what evidence-based medicine is: the application of results in one group (the trial participants) to all patients in the real world who seem to resemble that group. Examining this issue is not a seat-of-the-pants exercise in my case; I have published a textbook on the subject.

Which brings us back to estrogen. My colleagues and I, including Dr. Philip Sarrel, simply took the published results of the estrogen-vs.-placebo branch of the WHI study conducted among women who had undergone hysterectomy, and asked and answered this question: If these results pertain to all women in the U.S. who meet the description of women in the trial, what would it mean? What it would mean is tens of thousands of premature deaths over a decade, just as we reported.

Peers have no business challenging the application of clinical trial data to the world at large in this one instance just because they don't like the implications. If clinical trial data do not pertain to the world at large, then why on earth do we waste time (and fortunes of money) doing clinical trials in the first place? If what happens in the WHI stays in the WHI, if it only pertains to women in the trial, then someone owes the taxpayers an explanation for a boondoggle to the tune of almost half a billion dollars.

But that's not the case. Clearly, the intent from the start was to generate data in this huge clinical trial with real-world application. Clearly, the intent from the start was to extrapolate the WHI findings to all other women like those in the trial. That's exactly what we did, merely adding the rigor of a cautious mathematical model.

If our very straightforward model translating the results of a clinical trial to the real-world population corresponding to the trial participants is really questionable, then it follows that so is everything about evidence-based medicine. Our peers simply cannot have their evidence-based cake and eat it, too.

My colleagues and I stand confidently, if unhappily, behind our conclusion that "estrogen aversion" has killed tens of thousands prematurely, and may do much worse if we don't start approaching hormone replacement as the subtle, individualized clinical challenge it deserves to be. If there really is a problem with this assessment of estrogen, we have a much bigger problem to confront as well: There may be no such thing as reliably evidence-based medicine. Or maybe we just look the other way when the evidence is telling us something we don't want to hear.

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 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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