ACP Internist Blog

Friday, June 23, 2017

Muddled guidance at menopause

By definition, a muddle is an untidy or disorganized collection. The verb denotes propagating confusion by bringing some topic into just such a state. I regret to say that, accordingly, the United States Preventive Services Task Force (USPSTF) is poised to muddle the management of symptoms, and chronic disease risk at menopause.

As I have indicated recently, and repeatedly over the years, I have enormous respect for the USPSTF, an influential panel of independent experts who generate strictly evidence-based guidelines for clinical preventive services, i.e., those medical practices dedicated to the prevention of morbidity and premature mortality. The group's standards are high, consistent, and transparent, and their conclusions are influential on clinicians, payers, and the government for good reason: they are well informed and reliable.

But they are not infallible. Applying very strict standards of evidence to the medical literature has a well-known liability attached to it: the potential conflation of absence of evidence with evidence of absence. The latter is when we know, decisively, that something does not work. The former, far more common, alas, is when the current state of evidence is insufficient to tell us for sure one way or the other.

The Task Force is no stranger to the problem of absence of evidence. Many times over the years they have concluded, in effect, that they could not reach a conclusion. The customary language has been along the lines of: “evidence is insufficient to assess the balance of benefits and harms for … “ A current example garnering just such guidance, and a letter grade of “I” to denote the insufficiency of evidence, is routine screening for cognitive impairment in older adults.

The Task Force is also able to acknowledge that at times there is sufficient evidence regarding benefits and harms, but that they are too closely balanced on the scales of public health to render a summary judgment. They have recently reached just such a conclusion regarding prostate cancer screening, assigning a letter grade of “C.”

Unfortunately, the latest draft recommendation issued by the Task Force, addressing the use of hormone replacement at menopause to reduce the risk of chronic disease, misconstrues absence of evidence for evidence of absence, and overlooks some crucial evidence into the bargain. The Task Force has rendered a verdict of “D” for that topic, inveighing against it. This is only a draft recommendation at this point, and we are in an open comment period. So here's my comment: the Task Force got this one wrong.

With the possible exception of nutrition, where we seem entirely committed to perpetual confusion despite the clarity of fundamental truths, few topics in medicine have been so badly muddled as hormone replacement (HR) at menopause. For many years, we were all quite confident in considerable, net benefits based on observational studies. During that era, we were surely mistaking some bathwater for the baby.

Then, when randomized trials, notably HERS and the WHI, were conducted, a small surfeit of harms were seen with HR. Note that the surfeit was, indeed, small, and the results of both trials showed a mix of harms and benefits, with no difference between intervention and control groups in total mortality. Rather, the WHI was stopped early once it was clear that hormone replacement was not on track to produce a statistically significant benefit overall.

How did a mix of benefits and harms, no overall mortality difference, and “not consistent with the requirements for a viable intervention for primary prevention of chronic diseases” get translated into a blanket recommendation against HR? By distorting the subtleties of the evidence into the customary and toxic brew that results routinely when medicine and the media cook together: hyperbole, oversimplification, and the banality of sound bites.

The media in general are devoted less to our edification and more to our fleeting but recurrent attention, and titillation. The prevailing mantra is “afflict the comfortable, comfort the afflicted.” This has direct implications for HR at menopause that have concerned me deeply for a decade or more, and is a general threat to understanding in the service of public health.

We had grown comfortable with the idea that HR reduced chronic disease risk, so a qualified reality check indicating that the matter was subject to considerable uncertainties was the truth, but a truth unsuitable for afflicting the comfortable. To afflict the comfortable, the media message needed to be: “hormone replacement will kill you now.” In 2002, there were many headlines along just such lines.

That the benefits and harms were closely balanced was the least of the reasons this media 180 was egregious and harmful. Another, more important matter was that only one very particular, and notoriously bad version of HR had been studied: the combination of horse (rather than human) estrogen (Premarin), with a high-potency, synthetic progesterone (Provera). By way of analogy, we might conduct a study of breathing oxygen at some concentration markedly different from that in our native atmosphere, tally the harms of oxygen toxicity, and issue a blanket recommendation against breathing the stuff. If you don't immediately see the folly in that, I invite you to hold your breath until it comes to you.

But even the fact that there are different approaches to HR, and much better preparations than “Prem/Pro,” was not the biggest problem with the HR-is-bad-for-you-now conclusion. The biggest problem was that: women vary.

All of the data on HR and health outcomes, viewed with careful attention to sub-groups, show a highly significant, age-related pattern. Women who replace ovarian hormones right at menopause derive considerable benefit; women who delay for a decade do not. Summary judgment that ignores this highly significant dichotomy is seriously deficient.

Also misguided is applying the questionable conclusion we have reached about combination HR (estrogen plus progesterone) to other forms of HR, namely estrogen alone. Women who have undergone hysterectomy, a population of some 20 million in the U.S., can take estrogen on its own. The WHI study showed that the use of unopposed estrogen in women with prior hysterectomy who took it early after menopause reduced mortality significantly. Worded differently: the fear of HR induced by our “afflict the comfortable” approach to medical news has killed tens of thousands of women prematurely, and needlessly, over the past decade and a half.

The wrong hormone replacement at the wrong time for the wrong women is sure to impose net harm. The right preparations at the right time for the right women are reliably beneficial. Much decision-making takes place between these obvious extremes, and such decisions should, like those for prostate cancer screening, issue from personal discussions between patient and provider.

Summary judgment against HR is unfounded, misguided, and leads only to the perpetuation of a vintage mistake in new directions. I encourage the Task Force to reconsider this topic accordingly. In the interim, I advise a discussion with your provider about what's right for you, to find a personalized path through the prevailing muddle.

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.
Thursday, June 22, 2017

Compression of disability should be everyone's health goal

What are you doing to maintain vigor as long as feasible? James F. Fries, MD, wrote a classic article in the New England Journal of Medicine, “Aging, Natural Death and the Compression of Morbidity.”

Dr. Fries argues that chronic disease is our foe; avoiding chronic disease allows us to wait longer until we develop morbidity. The ideal situation is excellent health until 90, then die in your sleep.

How do we do that? Unfortunately, some people develop chronic diseases that we do not know how to prevent. However, any physician will tell you that much chronic disease develops because of lifestyle choices. Here is my list of lifestyle choices that predispose to longer morbidity:
1. Smoking. This one is a “no-brainer”. Smoking has so many negative effects that we need a book to discuss the subject.
2. Excess alcohol. Modest alcohol probably helps, but too much alcohol can cause liver disease, heart failure, chronic pancreatitis and brain damage (and this list is probably incomplete).
3. IV drugs. Every time you inject a drug into your system you put yourself at risk for infection. Obviously you can overdose and die right then.
4. Increased waist circumference. I phrased it this way rather than BMI, because waist circumference is a more accurate measure of being overweight or obese.
5. Lack of movement. Yes, exercise delays much morbidity, thus we maintain vigor. Exercise can help in decreasing the risk of increased waist circumference, but it probably has other very important positive benefits. Some data suggest that exercise has a U-shaped curve; excess exercise may actually cause some problems (read the Haywire Heart)

I would love to have comments on other important lifestyle choices. Obviously driving recklessly, extreme sports and going to bars after midnight are bad ideas.

As a physician I advise these things, but my experience suggests that these choices are personal. Some people seem to not really care about the future. At age 68, still vigorous and exercising, I am very happy that I have made health choices. Perhaps going through medical school and residency showed me the “wrong path”, and thus I have avoided many health pitfalls.

Am I just touting my personal choices? That is possible, but for the younger readers I can assure that being vigorous in ones 60s is a great pleasure. I know too many peers and patients who suffer with prolonged morbidity.

I encourage all my friends and colleagues to exercise and live a healthy lifestyle. I understand that our freedom is based on choice. But those who make bad choices are guilty of indirectly abusing those who make good choices. We have too many people who still smoke, drink excessively, never exercise and make poor food choices. This creates a conundrum for health policy.

For the younger readers, you likely have choices to make over the next many years. Make good choices and you will benefit. Indirectly your peers will also benefit.

db is the nickname for Robert M. Centor, MD, FACP. db stands both for Dr. Bob and da boss. He is an academic general internist at the University of Alabama School of Medicine, and is the Regional Associate Dean for the Huntsville Regional Medical Campus of UASOM. He still makes inpatient rounds over 100 days each year. This post originally appeared at his blog, db's Medical Rants.
Monday, June 19, 2017

Why my patient will quit the military

I had an interesting conversation with a patient in the office some time ago. He was sent to me to evaluate abnormal liver blood tests, a common issue for gastroenterologists to unravel. I did not think that these laboratory abnormalities portended an unfavorable medical outcome. Beyond the medical issue he confided to me a harrowing personal tribulation. Often, I find that a person's personal story is more interesting and significant than the medical issue that led him to see me.

I am taking care to de-identify him here, and I did secure his permission to chronicle this vignette. He is active duty military and is suffering from attention deficit disorder (ADD). He likes his job. He was treated with several medications, which were either not effective or well tolerated. Finally, he was prescribed Vyvanse, which was a wonder drug for him. The ADD symptoms melted away. This is when military madness kicked in. He met with military medical officials who concurred that this medicine was appropriate for him. This decision, however, was overruled by a superior, since Vyvanse is a controlled drug, which was prohibited. My patient was told that he could choose between taking this drug or keeping his job. In other words, if he opted for the one drug that worked for him, that he would have to quit. Who wins here?

While I do not know all of the relevant facts, this seemed absurd to me. My guess is that the decision came right out of a policy and procedure manual, which so often contains one-size-fits-all directives that override any measure of common sense. It is this mentality that expels a first grader who kisses a classmate because the school has a rigid zero-tolerance policy against sexual harassment.

When the patient was in my office, he had been off Vyvanse as required by his military superiors. He was not feeling mentally well. Not only was he off of his medication, but he was facing a profound professional decision that would change his life.

And here's the most ludicrous aspect of the situation. The patient told me that other branches of the military had no issue with their servicemen taking Vyvanse. These branches apparently use different policy and procedure manuals.

If this vignette is representative of the how decisions are made in his military branch, then they have a deeper issue to address. Is there a medication that can combat rigid and robotic thinking? If so, let's hope it's not a controlled substance.

This post by Michael Kirsch, MD, FACP, appeared at MD Whistleblower. Dr. Kirsch is a full time practicing physician and writer who 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.

The Greek tragedy of electronic medical records

I've spent a lot of time writing on this blog about the suboptimal nature of electronic medical records and what we need to be doing better. At their best, health care information technology systems can make finding patient medical data unbelievably quick and easy. However, at their worst, they take up an unacceptable amount of physicians' time and also dumb down medicine, reducing our patients' stories to rows of meaningless tick boxes.

If you were to ask any doctor (or nurse) what one of their biggest daily frustrations is, health care IT would be at or near top of the list. The problem isn't with technology itself, which very much represents the future in all aspects of our lives, but rather the fact that the current crop of IT solutions are not properly reconciled with frontline clinical workflow. For more about why these systems were rushed out in response to federal incentives, please watch my video explanation here. Basically, they take far too much time to navigate and turn doctors into “type and click bots.” Medicine is a social and personable professional that will always require a healthy dose of human touch. With statistics suggesting that physicians are now spending only a fraction of their day in direct patient care (sometimes shockingly as low as 10%), there's more need than ever to remember this.

A recent physicians' meeting I attended, served to reinforce my feelings on this subject. A former practicing physician who had read my blog reached out to me to gain my thoughts on the current state of health care and the practice of medicine. She then told me that there was a local area meeting as part of a book launch (focusing on physician job satisfaction) and asked if I'd be interested in going. So there I found myself one day in April in a room with the some of the most interesting and talented physicians I could ever hope to sit down with. All sorts of specialties and a diverse age range, from early career to approaching retirement. As we went around the room and talked about our own experiences, there it was again: The headache of the new world of health care IT. It kept coming up again and again as one of these doctors' biggest reasons for job dissatisfaction and burnout. The endless click boxes, inbox and alert headaches, the extreme lack of time with patients as a result. It was all very familiar.

As I heard these stories one after another, I wondered yet again: How did the medical professional allow this to happen? The group that I was sitting with that evening were such a dedicated and capable group of doctors—yet how they practiced medicine and their visions of what being a doctor would be like, had been shattered. When you take a highly skilled profession and drastically change the notion of what working in it involves, such disappointment is natural and understandable.

My question is, do the world of administrators and IT crowd really comprehend what's happened? Do they understand that doctors don't want to spend over 80% of their day stuck behind a screen? Do they understand that patients dislike it when doctors keep looking at their computer instead of at them?

Another recent article summed up this issue well, by stating that the general public would be shocked and saddened if they saw what the life of a modern-day physician now looks like. How far away this is from the perception of the hero frontline doctor that is portrayed in TV shows, and was the ideal that the current generation of doctors looked up to when they first applied to medical school. Oh, world of regulators and IT professionals, you have got so much to answer for!

So what's the solution to all this mess? Well, for a start, let's realize that going back to pen and paper is not the answer, just like going back to horse and cart was not the solution when the first automobiles flunked. The only answer lies with the world of administrators acknowledging that this is a huge problem, frontline physicians collaborating closely with IT developers, and for major health care technology vendors to have an incentive to improve rather than behave like a typical monopoly once they have a foothold in an organization.

I, myself, have devised my own techniques for getting away from that computer screen and trying to stay true to the ideals of good and thorough bedside medicine—but it's no easy task, and relies more on just accepting that what we have is so cumbersome, and therefore arranging my work routine around that.

A very wise old-school physician I worked with, who recently took early retirement (much to the disappointment of his loyal patients) told me that he felt like practicing medicine had become ”death by a thousand clicks”. That's an analogy any doctor can relate to, and also happened to be the title of another recently released article on the subject.

Until those “dream” IT solutions are developed—that are fast, seamless and integrated with frontline workflow—this Greek Tragedy of what happens when doctors lose control, continues.

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. This post originally appeared at his blog.