Wednesday, September 30, 2015

Killing antimicrobial stewardship (part 2)

I posted a piece regarding the 21st Century Cures Act, which would provide incentives to hospitals to use new antibiotics. This is terrible policy, in my opinion. Through comments on Twitter and this blog, as well as conversations with colleagues, there was concern raised that my cited source was incorrect. While the New York Times is not infallible, it's pretty damn good. In all honesty, I read the text of the bill myself before posting but found it unintelligible (maybe I was too tired at the time).

Anyway, a highly reputable group, the Center for Disease Dynamics, Economics and Policy (CDDEP), has bailed me out. They cite the same sentence from the New York Times editorial that I did in my previous post, and add, ”We at CDDEP couldn't agree more.” Even better, they argue that stewardship not development of new drugs is the ultimate solution to the antibiotic resistance crisis. I highly recommend their post, which you can find here.

Michael B. Edmond, MD, FACP, is a hospital epidemiologist in Iowa City, IA, with a focus on improving the quality and safety of health care, and sees patients in the inpatient and outpatient settings. This post originally appeared at the blog Controversies in Hospital Infection Prevention.
Tuesday, September 29, 2015

This is a very bad idea

I was stunned when I saw this headline in the New York Times last week: “Court sides against FDA in ‘off-label’ drug promotion case.” In case you missed it, here is the lede: “The maker of a prescription fish-oil pill won an early victory Friday against the Food and Drug Administration over its right to publicize unapproved uses of its drug.”

The gist of the story is that the pharmaceutical company successfully claimed that restricting its ability to promote off-label use with (in the words of the court) “truthful and non-misleading information” violated its First Amendment right to free speech.

Let me be clear here. I am all for maintaining the longstanding prerogative that physicians and other licensed prescribers have to prescribe approved medications for unapproved indications. That's not what this is about.

This is about unleashing the marketing machines of pharmaceutical companies to push their products in a way that circumvents the safeguards built into the current FDA approval process. That process includes weighing all the available evidence, published and unpublished, to determine if a compound is “safe and effective” for the stated indication. An eloquent defense of that process by Jerry Avorn appears coincidentally in the current issue of the Annals of Internal Medicine.

Under the terms of the recent court ruling, it seems that a drug company could get approval of a new agent for 1 narrow indication, and then cherry pick limited data to market it for much broader use. This is a gigantic, dangerous loophole that does not serve the public interest.

Here's something else that appeared in the New York Times the same day: the obituary of Frances Oldham Kelsey, who, in 1960, was a physician at the then newly established Food and Drug Administration. It was Dr. Kelsey who blocked the approval of thalidomide in the United States. That courageous and unprecedented step prevented untold tragedies and strengthened the precedent to regulate pharmaceuticals.

Sadly, I fear she is already spinning in her grave.

What do you think?

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. He then held a number of senior positions at Mount Sinai Medical Center prior to joining North Shore-LIJ. He is married with two daughters and enjoys cars, reading biographies and histories, and following his favorite baseball team, the New York Yankees, when not practicing medicine. This post originally appeared at his blog, Ausculation.
Monday, September 28, 2015

Medicare Part D--the insurance plan to cover medication for seniors: has it helped?

In 2003 the Medicare Modernization Act added a prescription drug plan to the benefits available to seniors and disabled adults. The act did a few other things, including introducing health savings accounts and defining Medicare Advantage Plans. The prescription drug plan rolled out in 2006, after which time seniors who bought the extra coverage had some help paying for their ever more expensive drugs. Today the government pays about $70 billion per year to provide this service, 11% of the total cost of Medicare.

The purpose of Medicare Part D was to allow seniors, often the most financially vulnerable of our patients, to be able to afford to pay for medications without impoverishing themselves. Since medications are such an important part of treating the diseases of aging, the government hoped that seniors who were able to pay for necessary medications would be healthier, requiring fewer hospitalizations and emergency room visits. This improvement seemed likely to, at least partially, offset the costs of the program.

Medicare Part D is a private insurance plan which costs the insured, on average, $30 a month and pays some or all of the costs of prescription drugs, depending on how expensive they are. Different plans are different, but most stop paying after having paid out $2,970, but will pay all but a small amount once the patient's out of pocket costs exceed $4,750. The period of time during which the patient must pay all of their drug costs is called, euphemistically, the “donut hole.” Since the total cost of medications is not covered by the premiums people pay, Medicare subsidizes the difference.

In June, the Annals of Internal Medicine published an article which looked at the health benefits experienced by patients on Medicare due to Part D. They were unable to detect any improvement in health or utilization of hospital or emergency room services in Medicare recipients after the initiation of part D in 2006. They did find, however, a 14% increase in the use of prescription drugs. The study certainly would not be able to detect the fact that some seniors certainly did benefit by being able to afford life-saving medications, but on the level of the total population of patients on Medicare, there was no evidence that Part D improved health.

In some ways, Part D coverage is wonderful, despite this study's results. It is definitely less common, since its inception in 2006, to see older people stopping their medications because they can't pay for them. It is also less common for patients to have to choose between having money for food or doctors' appointments and paying for prescriptions. Sometimes I find that, because of the occasionally wonderful oddities of insurance, Medicare insured patients can actually afford the newest and best drug that truly has a positive impact on their lives. The ability to take a drug with a more convenient dosing schedule or with fewer side effects may not keep a patient out of the hospital but it can surely improve their quality of life. Having to stop a medication because of the “donut hole” coverage gap can lead to emergency room visits or hospitalizations, however. A much more expensive Part D without a “donut hole” might have a more impressive outcome.

On the other hand, however, prescription drug coverage that leads to a 14% higher utilization of medications might very well lead to worse health outcomes, which could help explain the findings of this study. In the years since Part D was rolled out, there has been a huge increase in the amounts of opiate pain medications prescribed, and many of the patients who use these are seniors. The epidemic of chronic prescription opiate use and abuse often reduces older peoples' ability to get around and increases falls. Other prescription drugs, even those felt to be pretty much harmless, often have interactions that are much more prominent in bodies that are aging. Side effects are also more common as we age, and can be devastating. Being able to afford more drugs undoubtedly can increase the risk of hospitalization, emergency room visits and disability in a significant subset of patients on Medicare.

When Medicare Part D was adopted it was clear that it benefited the pharmaceutical industry. It was expected, however, to be a win/win situation, with newly insured patients healthier as a result of their improved access to medications. The bill included the requirement that the government not be able to negotiate drug prices with drug companies, which the Veteran's Administration is allowed to do. This results in considerably higher costs for drugs for Medicare recipients than for VA insured patients. So Part D is expensive, and is probably considerably more expensive than it needs to be. People do like being able to get any medication prescribed or recommended by their physician, which is a limitation in a system like the VA's where there is a pretty set and pretty narrow formulary of drugs available. But formularies don't define which medication a patient can take, only which one will be provided at low cost by the dispenser. Negotiating prices within Medicare Part D, with an associated formulary could still allow choice and probably save lots of money.

Does Medicare Part D prescription drug coverage help? It depends on the patient. It clearly does help the person on a fixed budget who finds him or herself in need of several medications which might add up to a few hundred dollars a month or more. A healthy but not wealthy 70 year old might have a sudden heart attack and find that he has diabetes which he had known nothing about having not visited a doctor for years. That patient might well be discharged from the hospital on 6 new medications which would throw his budget into an uproar, but might well keep him in good health for years. For patients with fewer needs or more abundant income, prescription drug coverage may do no good at all. For some patients whose ability to afford medications means that they will take ones which adversely affect their health, Part D is a hazard. Certainly 70 billion dollars a year and 11% of the healthcare budget is pretty pricey. The Medicare drug benefit probably needs a major overhaul in light of the data that it does not appear to have a significant or cost saving health impact on the population.

Janice Boughton, MD, ACP Member, 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.

Healing and human touch

Early this summer, I spent several days in a hospital bed, tethered to an IV, with what proved in retrospect to be anaplasmosis (a nasty bit of tick-borne business), complicated by viral meningitis. The latter was likely due to the immunosuppression of the primary infection. It was all rather unpleasant.

Among other things, I had a constant, moderate headache punctuated by crushing head pain, easily the worst headaches I've ever experienced. I was given narcotics when the pain was at its worst, and they didn't do much for me, despite their 2 distinct advantages. The first is that these drugs are genuinely effective at treating pain; the second is that I had every reason to expect them to work.

The latter matters, because placebo effects are real. They are not a therapeutic effect attributable to the specific actions of a drug or modality. They are a therapeutic effect that is independent of that specific action, and are thus deemed “nonspecific.” They relate to our expectations. When we expect a treatment to work, our body reacts accordingly, and that, in turn, can be therapeutic.

This should be no great surprise. Most of us have heard of the “endorphins” accountable for a runner's high. These, essentially, are the body's native narcotics, and it is receptors to such compounds that explain why non-native narcotics work at all. They are chemically enough like our own, endogenous analgesics to bind to the same receptors.

In any event, narcotics really do work; and, as a physician who has prescribed them many times to good effect, I had every reason to expect them to work. Even so, they didn't do much for my headaches.

In contrast, my wife's head massages were stunningly effective. This may in part be due to the fact that massage is effective in the treatment of pain. Colleagues and I have studied massage for osteoarthritis, and published very encouraging results. That research, sponsored by the NIH, is on-going, as we explore longer term effects, cost-effectiveness, and mechanisms.

For now, those mechanisms remain mostly speculative. Massage may influence local blood flow, and inflammation. Its immediate effects may relate partly to the phenomenon known as “gating,” in which sensory stimuli simply block out the transmission of pain stimuli in the spinal cord, although this does not explain the benefits that persist long after the massage is done. Much of the on-going work suggests that the effects of massage may relate principally to relaxation responses, and the autonomic nervous system.

I will go out on a limb, though, beyond the limits of the scientific evidence we have, to suggest that my wife's loving hands had something unique to do with it. Catherine is not a trained massage therapist. She is, in fact, a neuroscientist, although that is not necessarily relevant. I think the relevant consideration is that she loves me. She put her hands on my head in a fervent effort to relieve my pain and did.

At the time, I was just greatly relieved, and deeply grateful. Catherine's hands held the answer that narcotics did not have. These weeks later, with those headaches receding into memory, and the episode into family lore, I am reflecting on the therapeutic modality of human touch.

To some extent, the mechanisms of my relief may have been those of massage in general, whatever exactly those are. But there are reasons to speculate further, just as there is cause for cautious skepticism.

A device called Cefaly prevents migraines in roughly 50% of those who try it according to the available data. Structurally a visor (or, perhaps, tiara), the device produces an electromagnetic field. According to the company, the device “generates precise micro-impulses in order to stimulate the nerve endings of the trigeminal nerve.” This, in turn, so goes the tale, prevents migraines.

This is particularly intriguing because the visor merely sits on the head, rather as my wife's hands sat against my own. There are no direct connections between Cefaly and the trigeminal nerve; no wires running into the central nervous system. The device generates an electromagnetic field on the surface of the body, and the rest ensues.

Human beings generate electromagnetic fields as well. This is not conjecture; technology exists to image these fields. Since the fields emanate around our bodies, they overlap as we approximate 1 another before ever we touch.

In fact, the distinction between touch and proximity is substantially a matter of virtual (albeit, obviously important) reality. The surfaces of solid objects cannot truly touch, as they are held apart by atomic forces and the vacant spaces they populate. What we perceive as surface against surface, in all of its variations from momentary to momentous, agony to ecstasy, is really the juxtaposition of the energy field of one object with that of another.

This raises provocative questions about the contentious non-touch modalities of touch particular to “alternative” medicine, such as Reiki and therapeutic touch. My wife is trained in neither, but she was acutely sensitive to my pain, and passionate about relieving it. Did that contribute?

I cannot say. Nor can anyone say for sure at this point that non-touch modalities of touch are effective. But some are inclined to say they cannot be, and that, too, is beyond the pale of evidence, and even inattentive to some. Certainty against, like certainty for, given mechanisms in the absence of full understanding is comparably anathema to the progress of science. Were it otherwise, the sun would still be revolving around our planet, rather than vice versa.

That electromagnetism can be used to treat at least certain varieties of pain seems to be an established, data-born fact. That human beings generate such fields, and that these fields overlap when human beings are in close proximity to one another, are also factual assertions. What rests for now in the realm of conjecture and competing claims is whether or not some people, by training or innate aptitude, can discern such fields as some animals are known to do; whether such fields can be willfully manipulated; whether the willful manipulations of any such field elicits meaningful, predictable responses in a neighboring field; whether intention has anything to do with any such effects; and whether there is real therapeutic potential in the mix. Presently consigned to the realm of informed conjecture, reliable answers await an array of fastidiously thoughtful studies, yet to be done. My contribution is to note that those who contend such effects cannot exist are at least as disrespectful to the current state of evidence and understanding as those who make exaggerated claims in the other direction.

For now, I am uniquely qualified to declare the surprising efficacy of my wife's scalp massage, by whatever sundry mechanisms. Not because I am a physician; not because I am a researcher; not because I have studied pain and pain relief, and published relevant studies, all of which are true.

Rather, and simply, because the pain, and the relief, were entirely in my own head.

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.
Friday, September 25, 2015

The youth code

“We think it's a really good idea for us to go ahead and get you on blood pressure medicine. As a matter of fact, this particular medication gives you an added bang for your buck since it protects your kidneys and lowers your blood pressure.” Our patient raised his eyebrows gently and tried not to look as reluctant as I know he felt.

My resident chimed in. “Since you have diabetes, this particular medication is shown to help keep your kidneys from becoming weaker. You know that can be a big issue with diabetes.”

Mr. Amos (name changed) shifted in his chair nervously. “I hear you,” he said. But from what I could see, hearing definitely didn't mean he was feeling this plan.

Nope.

If you saw Mr. Amos walking down an Atlanta street, he's the last person you'd expect to be carrying with him diagnoses of diabetes and high blood pressure. He was, by our standards, young. Just shy of his fourth decade and with boyish looks that suggested he was far younger. Lean in build and tall in stature, no spare tire in sight. “Amos,” as he told his to call him, had been athletic all of his life and examining him quickly let any physician know that he still maintained that lifestyle.

Yup.

But Amos was a victim of genetics. His mama and his daddy had been affected by diabetes. Two sisters were diabetic and grandparents, aunties and uncles all up the family tree had equally representative medical histories. Diabetes and hypertension simply ran in his family. It wasn't a “you gained too much weight” thing or a “you smoke/drink/use thing” either. But nonetheless, for whatever reason, that high blood pressure dog didn't hunt with him.

Nope.

Now when it came to the diabetes? Amos was awesome. He took his insulin and counted carbs. He did the things we asked of him and, though he occasionally had a few dietary indiscretions, he mostly adhered to our recommended meal suggestions. His number always looked great which made seeing this young, fit man a joy.

But.

Somehow he always managed to shake his providers off when it came to starting something for his blood pressure. He'd come up with some compelling gameplan to increase his physical activity and watch his salt. And since he was generally such a motivated and great patient, it wasn't unreasonable for someone to give that a shot. That is, the first 2 times.

Mmm hmmm.

On this day, though, from the chart review it was clear. Amos' genes were just too stubborn. For us to do right by him, he'd need blood pressure medication. And you know? This wasn't personal. It was just the standard of care.

So in the hallway before we'd gone back together to see Amos, my resident told me that he was pretty adamant about not taking blood pressure pills. I asked my resident if he knew why our patient was so against taking something for his hypertension and he admitted that he honestly didn't know. And so. That was one of the first things I explored when I encountered him.

“So, Mr. Amos. What is it about blood pressure pills that gives you such a bad taste in your mouth?”

He squinted his eyes and seemed to be thinking. I could tell that my question caught him off guard. “I guess I just feel like I can control it, you know? Without an extra pill.”

That was reasonable. I thought for a bit about who he was, young and male. I imagined him having some trepidation about the potential for erectile dysfunction, a very real concern in many men who take antihypertensives. So I asked.

“Do you feel concerned that taking something for your blood pressure might affect your nature?”

And yes, I said “nature” because this is Georgia and I've been working at Grady for a while. Long enough to know that “nature” is a safe and all-encompassing way to discuss not only what is found in the nether region but its function as well.

Amos' eyes flung open at that question and then he chuckled. “Good Lord. I hadn't even thought of that.” He shook his head and shuddered.

So that wasn't it. And what's funny is that I felt sort of lost at that point because I was so sure that this was his issue that I'd already lined up my talk points to counter his concerns.

What was it, then? What had this compliant with appointments guy so gun shy with taking something for his blood pressure?

“You know what? I guess I just … it's weird … I just see myself as too healthy for all that. And too young.” Amos laughed again, this time at his admission to us. “I know it probably sounds crazy. But something about having high blood pressure just doesn't seem like it should be attached to me. It's like I just can't accept that, you know?”

“You don't feel that way about the diabetes, though?” I asked.

“Naw. Little kids get diabetes. Skinny folks and all sorts of folks, you know? Jay Cutler is a pro football player and he's got sugar. So I know that happens to people like me. But high blood pressure is something that just seem like it goes with smoking and eating bad and needing to lose weight. And even though I know it ain't personal, I always feel lightweight offended when folks come at me talking about my blood pressure. It's like I feel like they mixing me up with somebody else.”

“I guess it's crazy to think that somebody could run 13.1 miles and still have high blood pressure.”

“Exactly. Especially when they do all the right stuff along with it and they aren't that old. I just keep waiting for somebody to tell me they looking at the wrong chart.”

Wow.

Now this? This was some real talk. Amos stuck a pin straight into the thing that stops so many youngish people from seeking a doctor's care. Hell, it's stopped me from getting care as regularly as I should, too.

Yup.

It seems like there's this line in the sand where some of us feel it's reasonable for us to have certain diseases. Hypertension and high cholesterol? Those are for the older folks. So a lot of the young ones look at it as some kind of fluke when you tell them they have it. Like you aren't talking to them in real life. Just for pretend.

And this? This is a tough mountain to move. Our myopic view of our reflection and how that plays into the likelihood of anything being awry with our health. Amos gave me a lot to think about.

So you know what I did? I told him just what I'm telling you. That I understood how he felt and got it that it seemed like some kind of crazy betrayal to keep tacking this diagnosis of high blood pressure on to his chart. Then we discussed family history and how “essential hypertension,” that is, the kind that runs in families, works. And how people like him, despite their half marathons and burpees in the morning, needed some pharmocologic interventions in the morning, too.

This resonated with him. I mean, it did enough to get him to take that medication. And no, he didn't like the idea but he did get it that continuing to put this off was like him drinking poison but expecting someone else to die from it.

Yep.

So what's my take away from this encounter? Hmmm. Well, first of all it's this idea that it really benefits me and my patients when I really push myself to think about the WHY of a patient's position instead of just my own agenda. I also was reminded to just slow down and listen instead of tracking ahead with my scripted comeback since real people improvise and canned/planned dialogues feel like exactly that. And lastly? I think I recognized the power of just being honest with my patients about what's going on in my head and giving them a platform to share what's happening in theirs.

I learn so much from my patients at Grady. And I'm glad.

Yeah.

Kimberly Manning, MD, FACP, FAAP is an associate professor of medicine at Emory University School of Medicine in Atlanta, Georgia where she teaches medical students and residents at Grady Hospital. This post is adapted from Reflections of a Grady Doctor, Dr. Manning’s blog about teaching, learning, caring and growing in medicine and life. It has been adapted and reprinted with permission. Identifying information has been changed to protect individuals’ privacy.
Thursday, September 24, 2015

'The scandal isn't what's illegal; the scandal is what's legal'

This quote, attributed to Michael Kinsley, is applicable to a very disturbing trend that is having an increasing impact on antimicrobial availability: the acquisition of exclusive marketing rights (usually by small private firms) to inexpensive generic drugs in order to jack up their prices astronomically. The antimicrobials pyrimethamine, albendazole, cycloserine, flucytosine, and doxycycline have all experienced price increases of up to 5,000%, and there have been several recent posts on the Emerging Infections Network about how this is limiting availability of these agents for those who desperately need them.

I hope this New York Times story about the pyrimethamine saga draws more attention to this trend, and leads to some regulatory reforms to prevent this obvious price gouging. Because, you guessed it, there is nothing illegal about this under U.S. law.

Fortunately, because it engenders bad press when people suffer and/or die due to unavailability of an essential drug, some of these “pharmaceutical companies” (I put that term in quotes, because the company that owns marketing rights to pyrimethamine is founded and run by a hedge fund manager) will immediately send out the drug at a reduced price (or even without charge) if contacted by the treating physician.

Such saints, these folks are.

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. This post originally appeared at the blog Controversies in Hospital Infection Prevention.

Is testosterone treatment safe and effective?

Testosterone, the hormone most responsible for “maleness” in men, naturally declines with age. Drug companies have capitalized on this fact, and on the vague symptoms that make up the non-medical, popular term “andropause.” Supposedly, low or even low-ish testosterone levels can make men feel bad—really, really bad. Symptoms attributed to this putative condition range from sexual dysfunction, to fatigue, mood changes, and irritability. Unfortunately, all of these symptoms are common and vague, making it difficult to find out if low testosterone is responsible for the symptoms.

This uncertainty doesn't diminish the popularity of prescription testosterone. Sales in the U.S. top $2 billion yearly. Men often report feeling better when taking the male hormone, and clinics are popping up catering to “anti-aging” therapy which often includes testosterone therapy.

Because of the uncertainties of efficacy, testosterone replacement in men is medically controversial. Companies advertising treatment for “Low T” are often accused of disease mongering. The drug's safety is also uncertain.

A study published in the New England Journal of Medicine in 2010 concluded that testosterone treatment increased the risk of cardiovascular events such as stroke and heart attacks. The effect was serious enough that the study was halted early.

Unfortunately, the paper focused on older men with a variety of health problems, leaving the question of whether hormone treatment might be safer in healthier men.

A study released this month in the Journal of the American Medical Association tried to answer some of the lingering questions about treatment. Rather than looking at rates of heart attack and stroke, they monitored the thickness of the carotid arteries and the presence of calcium in heart arteries. These are often seen as “stand-in” measures for the risk of heart attack and stroke.

The authors did not see any significant progression of vascular disease. They also failed to see any improvement in quality of life.

Both of these studies have significant limitations, but taken with the rest of the relevant medical literature, there seems to a small but significant risk of testosterone therapy in some patients, and there seems to be little benefit.

Testosterone replacement therapy certainly has its place in modern medicine, especially in people with certain types of hormone problems. Its growing use suggests, though, that it is used much more than the evidence of safety and efficacy would justify.

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 at Forbes. His 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.
Wednesday, September 23, 2015

Patient survives death sentence; is it medical negligence?

Doctors do not know everything. We make mistakes and mistakes in judgment. Sometimes we make the mistake of speaking when we should keep silent. At times, patients ask us questions that we can't or shouldn't answer; and yet we do. It shouldn't be our objective to force certainty into an issue which is amorphous and murky.

Here's a response that I recommend in situations where certainty is elusive.

“I don't know.”

I saw a patient for the first time when he was sent to me for a colonoscopy. Prior to the procedure, we interviewed him to be acquainted with his medical history. We are always particularly interested in the cardiac and pulmonary history, as these conditions impact on the risk of the procedures and the anesthesia. This patient had a lung resection. He related the details which left my staff and me aghast.

“The doctors told me that I had cancer and would be dead in 3 months.”

Of course, it is not possible for a spectator to imagine the horror of this pronouncement. To know the date of your upcoming demise, a fate that is only known to those on death row, is cruel torture. In this case, the doctors were wrong on 2 counts. This man wasn't going to die. And, he didn't have cancer.

What a horrible error that didn't need to happen. While I didn't have the medical details, here's what I think happened. He had a CAT scan of the chest because he was having respiratory symptoms. A mass was found. The physicians then followed up with a PET scan, which is a special radiographic test used to determine if a mass is cancerous. While this result isn't as definitive as a biopsy, a positive result usually portends unfavorable news. Oncologists use PET scans routinely. My guess is that this patient's PET scan result was on fire and the patient was told that his days were numbered. Surgery was scheduled. When the final pathology of the resected lung specimen was issued, not a cancer cell was in sight. This patient had a fungal infection and completely recovered.

This was a colossal error, even though the outcome was a blessing. If a patient is wrongly told that his condition is benign, and he has cancer, then the same error assumes a very tragic proportion. My patient lived to relate his saga to the world.

Could he have successfully sued his treating physicians? I think he had a reasonable case for pain and suffering damages, including perhaps, unnecessary surgery. No case was ever filed. I would hope that an unexpected gift of life would render a lawsuit to be a trivial pursuit, even if the case had legal merit. He feels perfectly well now. The damages diminished and faded while his life endured.

I recognize that others may have a different view of what transpired here. They may focus on what was taken from him and that he deserves to be made whole. They may not feel that he has been given life, as his life was never truly in jeopardy.

I've done about 25,000 colonoscopies and I've confronted scores of colon cancer. I know it when I see it. When I see a lesion that concerns me, I share this concern with the patient and his family after the procedure. But, I still wait for my biopsy specimen results before issuing an authoritative declaration. Shouldn't I wait until I have 100% of the data before speaking with 100% certainty?

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.
Tuesday, September 22, 2015

Communication between primary care and hospitalists

This past weekend I spent 2 days in Greenville, S.C. as a guest lecturer. During that trip I had time to chat with some hospitalists. During our conversations I explored a classic problem, the inpatient-outpatient handoff.

Talk with hospitalists and you will discover their angst about getting outpatient information on their admitted patients. Talk with primary care physicians and they echo the angst when seeing recently discharged patients.

Personally, I have experienced both sides of this conundrum. It would seem to the average person that this problem would have an easy answer. Here is my list of challenges:
1. Identifying the primary care physician (PCP)
2. Contacting the PCP or their office
3. Transmitting information (HIPAA rears its head as a perceived barrier)
4. Finding out how the PCP wants to receive the information
5. Discordant computer systems

A hospitalist shared with me the results of a meeting with a group of referring PCPs. Each one wanted the discharge information in a different way.

An integrated health system should make this easier, but too many patients exist outside any one system.

Can we emulate the VA and have a truly integrated medical record for all hospitals and outpatient settings? That rhetorical question could spur a day long symposium. We have the privacy barrier, the hacking potential barrier and the profit barrier (for those who sell expensive electronic health records).

So we redo tests and spend more health care dollars. We have patients get inadequate follow-up without the benefit of collegial information sharing. We get patients doctor shopping for more opiates. We get drug interactions because doctor B has no idea what doctor A prescribed. We have patients taking too much medication leading to additional side effects.

But we cannot blame the health care system, because we do not have a health care system.

And patients get caught in the midst of the chaos.

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, September 21, 2015

Industry-funded research: conflict or confluence?

The great public health imbroglio disclosed over recent weeks, in which widely, highly-regarded scientists were found to be running on Coca-Cola funding to enlighten the world about calories and energy balance, continues to reverberate through all forms of media. You have no doubt encountered a bounty of commentary, perhaps including my initial reaction, and more recently, the mea culpa and pledge of better methods ahead in the Wall Street Journal by Coke's CEO, Muhtar Kent. I've encountered it, too, and in addition, have heard directly from some of those most intimately involved, on both sides of the divide.

As the allegations, apologies, rebuttals, sanctimony, and snark have all propagated themselves through the Twitterverse, I have come to the conclusion that this particular crisis of trust in public health nutrition is part of a much larger crisis of trust in public health nutrition, which in turn is part of a far larger, sociocultural crisis, never better expressed than in Cool Hand Luke: What we have here is failure to communicate.

We don't, in general, communicate anymore; we vituperate. We adopt some opinion to which we are natively inclined, and propound it into the ether. Somewhere out there in cyberspace, a kindred spirit, who for all we know may be a delusional sociopath, corroborates our world view. A few other voices of unknown pedigree join the chorus, and we have established the absolute truth and correctness of our view. Of course, others with opposing views have done just the same. Welcome to the world of cyberspatial echo chambers, in which everyone seeks and finds only those opinions they already own, and no one listens to any arguments in favor of what they already know to be wrong.

In public health nutrition, this is costing us all dearly, and playing only into the hands of those who profit from din, discord, and perennially benighted procrastination. We have had opportunity for decades to apply a set of fundamental nutrition priorities, time honored, evidence-based, to the addition of years to lives, and life to years. Instead of rallying around this common ground, however, we have carved it all up into diverse nutrient fixations, dug in, hunkered down, and commenced to hurl epithets and disdain.

This devolution of constructive dialogue into competing monologues is culture-wide, and perhaps nowhere better illustrated than in the U.S. Congress. Even as we, the people, are all frustrated by partisan antipathy so intense that a given party will renounce its own core values and favored policies if required to obstruct and stymie the opposition, we propagate the same tendency. We repudiate it, but as far as I can tell, ever more of us practice it, from the sets of television studios to living rooms, from the halls of science to schoolyards; on topics ranging from climate to guns, civil rights to nuclear containment. We are masters of the failure to communicate.

And that, in turn, underlies the debacle, and debacle it is, of Coca-Cola's salient involvement in our education about calories. We have approached the topic of industry-funded research with the customary subtlety of a sledgehammer, allowing for only two positions: It is all good, or all bad. That encourages proponents to invite us to follow where research should never have gone in the first place, as in the current case. It encourages detractors to propound a brand of piety at odds with practical advance in the real world. The tendency fabricates opposing corners, and fails to draw a line. In the absence of a line, signifying propriety, there is no way to say on which side of that line a given venture resides. So here we are, with proponents running amok, and opponents raving mad.

Were we more adept at communication, and the nuance it requires, we might readily draw that missing line. It would differentiate conflict of interest, from confluence.

Before concluding with that distinction and its implications, I humbly offer a reality check to the purists among my colleagues who renounce industry-funded research wholesale in the ostensible service of public health. Well-intended though such protestations may be, they are devoid of nuance, and misguided.

A blithe, dismissive, and undifferentiating contempt for industry funded research is contempt for virtually all advancement in modern pharmacotherapy, immunization, and medical technology, all of which are applied daily to the relief of miseries, and the extension of countless lives. It is contempt for the next, new chemotherapeutic agent that treats a cancer nothing else can. It is contempt for the new antibiotic that works despite multidrug resistance. It is contempt for the incipient vaccine that will prevent HIV, or Ebola, or chikungaya, or Powassan.

We may, in our want of subtlety, be emulating the drama of our policy makers who hone the craft of castigation, and refine the art of disparaging sanctimony. Among the many illustrations of this is the high-profile case of Al Gore. Back in 2009, he was excoriated by critics, climate change deniers salient among them, for deriving profits from his “green economy” investments. The accusation was that Gore was advocating for the work of companies most likely to prove personally profitable. Gore's rebuttal was the obvious one: he had advocated first, invested after. He had done what we have all been advised to do in proverb, as an expression of consistency, commitment, and integrity: put our money where our mouths are. Do more than talk about what matters to us; act on it. If that is wrong, then much of the lore on which we were all raised is wrong, and our parents are a pack of story-telling hypocrites.

Let us, then, give our parents the benefit of the doubt, and allow for the possibility that funds and faithfulness to a cause may genuinely align. And let us return to the case of calories and Coca-Cola, and the opportunity for opposing factions to come together, and draw a line.

I propose that industry-funded research is not the problem; conflict of interest is the problem. And I would propose that confluence of interest is very different from conflict, but the two are routinely conflated.

If there are generally understood or expected health effects of any given product, and an entity with a vested interest, be it a pharmaceutical company, a technology company, or a food company, funds research to explore the particulars of those effects, i.e., how much, how often, for whom, and by what mechanisms, that is a potential confluence, rather than conflict, of interest. To ensure it is so, rules of research engagement must apply. The researchers must be authorized to publish results be they favorable or unfavorable to the company's interests. The researchers must be autonomous; methods must defend against bias; and there can be no quid pro quo. Given suitable, contractual terms, private entities can, and do, participate in advancing our understanding.

If, however, the marketing, messages, and aspirations by any given private entity for its product or service are at odds with the generally understood or expected health effects, then that company is, ipso facto, conflicted with regard to the unvarnished truth. That entity is an unsuitable funder of research, the goal of which must be true understanding, however stuttering the course to that ideal may prove to be.

Examples are rather self-evident. Given the widely recognized health benefits of vegetables and fruits, produce companies or trade groups funding research to explore such effects would be confluent, not conflicting, with the interests of public health. Vested interest, and public interest, could readily commingle. Given the widely recognized health (and weight) detriments of sodas, a soda company cannot possibly approach research on the topic of energy balance without conflict. Coca-Cola's role with the Global Energy Balance Network is the very prototype of conflict.

I humbly suggest that replication of such perilous folly becomes less likely in a world that supplants sequential monologue with actual dialogue, in which nuance is permissible, and in which a failure to communicate is not the national pastime. We will, I think, more reliably identify, and renounce, conflict of interest, when we allow for the occurrence of confluence.

The intersection of interest, and investment, is not invariably conflict, although it certainly can be exactly that. Sometimes, it is a confluence that serves the interest of investor, investigator, and public alike. Differentiating between the 2, just like distinguishing baby from bathwater, is in the interests of us all.

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.
Friday, September 18, 2015

Coordination of what?

I'm glad that the new CDC Vitals Signs report, based upon a modeling study of the impact of regionally-coordinated interventions to reduce healthcare associated infections (HAIs) due to selected multiple drug resistant organisms (MDROs) and Clostridium difficile, is gaining some media attention. The investigators modeled three different scenarios for control: (1) status quo, (2) “augmented” efforts at selected individual facilities, and (3) augmented activities coordinated across a health care network. Using data from various sources to inform the model (Emerging Infections Program and National Healthcare Safety Network for disease burden; Orange County, California and the VA system for patient movement across healthcare facilities; and experience from the UK and Israel for reductions in MRSA, C. difficile, and carbapenem-resistant Enterobacteriaceae (CRE) after national interventions), the model suggests that prevention approaches coordinated by public health authorities could reduce HAIs due to CRE by 55-74%.

This analysis has several limitations, most of which are pointed out by the authors in their discussion—models are models. And I don't think anyone disagrees that coordinating infection prevention activities across health care systems is a desirable goal. The sad fact, though, is that we are very far from achieving this goal. I think Judy Stone has a good take on this, here. Furthermore, even if public health funding were increased enough to provide resources for state and regional coordination of MDRO control, the impact would depend upon each facility's capacity to implement basic infection control practices (as the authors point out, “Optimizing implementation of basic infection control practice within individual facilities will be of fundamental importance to this effort”).

So while we wait for the inevitable boost in public health funding that is sure to come from our current Congress, we should remain focused on improving the basic “horizontal” infection control practices of individual facilities. It is not possible to know in advance which patient harbors a life-threatening bacterial pathogen (resistant or not), so it is best to assume that everyone does.

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. This post originally appeared at the blog Controversies in Hospital Infection Prevention.
Thursday, September 17, 2015

Another rant about how drug companies are not acting for the common good

A few weeks ago I was feeling angry and disappointed when I noticed that many of the articles I was reading in my favorite medical journal were funded by companies who made the products those articles evaluated (that blog here). This is nothing new, but it looks to me like there are increasingly more of these articles which celebrate products and fewer interesting articles about the science of medicine.

The other thing that is particularly irritating about this trend, if it is a trend, is that the drugs and devices that are being sold are increasingly more expensive and benefit fewer and fewer people. The reason they benefit fewer people is that they are designed for very specific, and often pretty rare, diseases. Also, since they are so expensive, only a subset of these few people can afford them. They must be very expensive because they benefit fewer and fewer people, so in order to make the money to pay for the research to come up with these drugs and devices, the companies charge small fortunes, which are paid, usually by insurance companies for those who have insurance, and those costs are handed on to everyone who buys insurance or pays taxes.

So drugs and devices are getting more expensive and less useful. But why is this true? Apparently the low hanging fruit of drugs has been picked. We have more drugs for high blood pressure, high cholesterol, infections, diabetes, seizure disorders, depression and lung disease than you can shake a stick at. What's left is rare conditions or subsets of what people commonly get, like cancers with specific genetic profiles.

Also, treating diseases that have millions of sufferers is fraught with trouble. If a company produces a drug or device that helps many people who are likely to live a long time in basically good health, any side effect, even a rare one, will eventually become evident, with terrible consequences including lawsuits and even withdrawal of a blockbuster from the market. If a company produces a drug that gives a few people with terrible diseases a few more months or even years of life, not only are those patients often willing to spend a fortune on the drug, but they are very unlikely to notice a rare side effect or be able to connect it with the drug.

So what we are getting now from the pharmaceutical industry (with occasional exceptions) is wickedly expensive drugs of limited scope, whose safety and effectiveness is never studied adequately. These cost so much that they will likely increase the already unsustainable price of medical care. We all share the burden of those costs. The only non-regulated way to fix this problem is to quit agreeing to pay these high costs for miracle (or not so miracle) drugs. I'm not sure that, in our culture, we are willing to make that choice.

Janice Boughton, MD, ACP Member, 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.

Janice Boughton, MD, ACP Member, 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.
Wednesday, September 16, 2015

Doctor, who's your boss?

As a relatively young physician, I always enjoy my conversations with the older members of our profession, who've seen so much change over the last few decades. I'm fascinated with their stories about how different the medical world was when they were residents, how treatments were so novel, and how they used solid clinical skills to get to the diagnosis. Those were the days when the family doctor would know their patients inside out, visit them at home, and follow them in the hospital. Those were the days when physicians didn't have to spend huge chunks of their day navigating inefficient computer systems or dealing with mountains of bureaucracy.

Another theme that emerges is how physicians have ceded so much of their power and control to third parties and health care administrators, who have proliferated vastly in number. I've heard stories of how not so long ago, it was the doctors who were the bosses at all levels in health care. I remember talking to a general surgeon in Florida who recalled to me an incident 25 years ago when he saw a major patient care issue, how he burst into the CEO's office, slammed the patient's chart on the table and voiced his disgust with what had happened. The CEO calmed him down and then apologized profoundly for the problem, assuring him that it would be addressed. The surgeon felt like he was the boss, and that hospital administration existed to serve the best interests of doctors and their patients. Needless to say, that wouldn't happen today!

While I can't speak for the different environment that doctors used to work in before my time, I can say that after the best part of a decade in clinical practice, it's obvious that the number of health care administrators has, and continues to, increase exponentially. And while most of the ones that I've worked with have been perfectly pleasant on a personal level, the fact that so much of what a physician does nowadays is also processed by an army of administrators—whether it's related to productivity, efficiency (including length of stay), or admission status—is pause for thought. Who is actually running the show here and is the tail wagging the dog?

I remember a time in a previous job when a new administrator, relatively young and fresh out of education, had been hired by the hospital to help process metrics and perform administrative tasks within the group. He had been given some title such as “Administrative Director”, and had gone up to the medical floors to introduce himself to the nurses. When I later went up to the same floor, I was told by some of the nurses that they had just met “my boss.” Excuse me?! It was very telling that this could have happened, and that he had given the impression that he was somehow in charge of a group of 20-plus experienced doctors.

Many physicians believe that only physicians should ever be their boss (whether or not they are also officially administrators). Not random non-clinical folk who don't understand the rigors of frontline medicine. For me personally, I have only ever worked in situations where physicians have officially been my “boss,” and thankfully most of these have been entirely supportive. I also ultimately consider the patients to be my boss. But as health care consolidation and the ranks of employed physicians expands, it's a question all of us need to think about: Who's your boss, doctor?

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.

Today's lesson: Take your zoo off and put your smile on

I ran across 2 great quotes regarding the white coat today:
• In a piece in KevinMD.com published today, Shivam Joshi, an internal medicine resident, writes about doctors wearing their white coats in grocery stores. He describes the white coat as ”20 square feet of a microbiological zoo.”
• Over at BMJ, Edmond Fernandes argues in an essay that physicians in India should stop wearing white coats. Here is the money quote: ”[White coats] are mere symbolism and wearing them does not itself confer status or professionalism. Dressing presentably and sporting a smile are more important than white coats.”

Michael B. Edmond, MD, FACP, is a hospital epidemiologist in Iowa City, IA, with a focus on improving the quality and safety of health care, and sees patients in the inpatient and outpatient settings. This post originally appeared at the blog Controversies in Hospital Infection Prevention.
Tuesday, September 15, 2015

Thinking, physiology and medical education

I have written this many times. Medical students and residents want their educators to model the thought process. Yesterday I spent some time with a colleague discussing this concept. We agreed that data are retrievable, but using data is the key to good doctoring.

Medical education, at least in the first two years of medical school, does not focus enough on the thought process. Jerome Kassirer in a very important paper proposed that we actually teach clinical reasoning throughout medical school. He emphasizes that we should focus our efforts on understanding actual case presentations.

The theory proposes that memory of clinical medicine and clinical reasoning strategies is enhanced when errors in information, judgment, and reasoning are immediately pointed out and discussed. Rather than using cases artificially constructed from memory, real cases are greatly preferred because they often reflect the false leads, the polymorphisms of actual clinical material, and the misleading test results encountered in everyday practice.

As educators we should strive for understanding rather than memorization. Clearly in medicine we do have to memorize many facts, but that process goes much more smoothly if we have a cognitive framework on which to hang our data. If we understand, we can categorize our differential diagnoses and thereby use that process to narrow our diagnostic possibilities. For example, when we have a patient with anemia, the thoughtful physician first asks if the anemia is a production problem, a destruction problem or a blood loss problem. If it is a production problem, then we must ask if there is a nutrient deficiency or a primary bone marrow deficiency. As we match the physiology and pathophysiology to the patient's presentation we can construct a logical storyline to understand how and why the patient is presenting at this time with this finding.

While I do not have data, many learners tell me that this style of teaching has become less common. Since our research showed that learners want understanding learned when their teachers make their thought processes explicit, we should work hard to emphasize this point.

If you are a clinical educator, ask yourself if you focus on lists or the reason for the lists. If you are a learner (and actually we all are) are you more attracted to teaching that focuses on helping you understand rather that listing factors.

Of course, I have created a straw-man argument with which almost no one would disagree. Please share any reflections you have of this teaching style.

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.

Right call; wrong reason

There were several news stories last week that reported that Pfizer had abandoned its efforts to have its Lipitor brand of atorvastatin made available over the counter, without a prescription. I was never a big fan of OTC statins (more on that later) but I was struck by the reason that Pfizer put out: “The study did not meet its primary objectives of demonstrating patient compliance with the direction to check their low-density lipoprotein cholesterol (LDL-C) level and, after checking their LDL-C level, take appropriate action based on their test results.”

Left unstated (and unclear) in this is exactly what the appropriate action was supposed to be. I guess they were implying that patients were supposed to check how they responded to the drug and then figure out if they should keep taking it, change the dose or seek professional advice about next steps.

Here's the irony with that. The current practice guidelines of the American College of Cardiology and American Heart Association for the management of high cholesterol no longer advise physicians to check how patients respond to statin therapy, or to adjust the dose up or down to achieve a “target” LDL-cholesterol level. Instead, they suggest that we assess a patient's overall cardiovascular risk using an online calculator, which includes consideration of the patient's age, blood pressure and other risk factors, and then prescribe moderate or high-dose statin (or no statin) based on the result. No more checking the on-treatment LDL-cholesterol.

So it seems that Pfizer determined that they should not go forward because patients are not capable of doing what doctors are not supposed to do. Makes no sense to me.

Nevertheless, this strikes me as the right decision for the wrong reason. Despite the low toxicity and high therapeutic value of statins, I don't think they should be offered OTC. The analogy with other formerly prescription only medications like H2 blockers or antihistamines is poor. Those drugs are useful for episodic use for symptomatic conditions, not continuous treatment of silent ones. Statins may be more like vitamins, something that (if indicated) should be taken regularly. Given the importance of cholesterol management, I believe that if a patient needs the drug, it should be prescribed at a therapeutic dose (higher than what was going to be offered OTC). If the patient doesn't need the drug, then why take it at all? I also think that the best way to make that determination is in consultation with a physician.

What do you think?

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. He then held a number of senior positions at Mount Sinai Medical Center prior to joining North Shore-LIJ. He is married with two daughters and enjoys cars, reading biographies and histories, and following his favorite baseball team, the New York Yankees, when not practicing medicine. This post originally appeared at his blog, Ausculation.
Monday, September 14, 2015

Chewing the fat, again

Among my numerous colleagues, friends, and correspondents are more than a few who circulate every abstract, however obscure the source, suggesting that saturated fat has been fully exonerated, or that everything we ever thought we knew about dietary fat, health, and weight has been utterly renounced.

I confess that to some degree, I engage in counter-measures, circulating studies that show rather the contrary. Generally, my interest is balance and the weight of evidence, so I will circulate any study I consider important, whatever the conclusions. But to the extent that I represent opposition to the inclinations du jour (or du news cycle, which lasts much less than a whole jour, these jours), it is not, by any means, because I have a low-fat chip on my shoulder. Rather, as I have indicated before, I have little tolerance for the Newtonian nonsense of New-Age nutritionism: for every dietary trend, fad, or fashion, an equal, opposing, reactionary trend, fad, or fashion.

So it is that when cutting fat let us down, mostly because we approached the enterprise as a pack of gullible nincompoops, we didn't thoughtfully reconsider the proposition of mono-nutrient fixations. That might have been genuinely constructive, but at odds with the Newtonian impulse. We opted for the latter, an equal, opposite, reactionary boondoggle. Decades later, the cycle has repeated many times, and here we are, propelled this way and that by Newtonian inertia, awash in hyperendemic obesity and chronic disease, accompanied by massive food industry profits.

This, then, is the prelude to brief remarks about two recent studies that rebut many of the currently fashionable rebuttals about dietary fat.

The first was a brief, metabolic ward study by perhaps the world's leading authority on energy balance, Dr. Kevin Hall at the National Institutes of Health. The timing was somewhat ironic, given the recent, high-profile implosion of an effort overseen by other scientists, purportedly devoted to the elucidation of energy balance. That, however, is another story, already told.

Dr. Hall has developed sophisticated, and influential energy balance equations that elaborate often-neglected nuances, such as the fact that the calories required to maintain weight decline as weight declines. This, by the way, accounts for the notorious “weight loss plateau“ on which so many dieters land, even as they profess their on-going adherence to the program. Their claims are legitimate, and Dr. Hall's equations validate them.

Dr. Hall's study was both small, and of short duration, but rigorously controlled. It compared isocaloric reductions in dietary fat versus dietary carbohydrate, and showed that body fat content declined significantly more with restriction of dietary fat. This seems a quaint throwback to what we thought we knew before we learned that everything we thought we knew was a big fat lie, or a big fat surprise, but it's not. It's entirely current, meticulous research.

The second paper is one of those systematic reviews and meta-analyses we can't seem to get enough of these days, and of which we arguably get too many to propagate anything other than perennial confusion. In any event, this review, by the widely respected Cochrane Collaboration, concluded that reductions in the percentage of total calories from fat lead consistently to reductions in body fat and body weight, too. This also seems to fly in the face of what we now prefer to think about what we once thought we knew.

I note these two publications partly because they are, indeed, both noteworthy. But I note them in particular in the service of balance, and better hopes for nutritional science than a never-ending sequence of misguided action followed by errant reaction.

Science is a method for answering questions; it is, in essence, a tool. A tool is never much better than the service to which it is called. A hammer, for example, is a perfectly good tool, but a dubious choice for opening windows, although it would do the job. You might use a microscope for diagnosis the next time your toaster won't work, and you may even notice formerly undetected flaws in its façade. You are unlikely, however, to discern at high magnification the fact that it isn't plugged in.

I am not at all interested in a resurrection of a preferential focus on wholesale dietary fat restriction. We should long since have recognized that questions about this or that macronutrient and weight are rather like the use of a hammer to open a window. An outcome is generated, and mums the word about the shards of glass all over the floor.

In the real world, health, weight control, and lifelong vitality are achieved on diets that vary considerably in macronutrient composition, but that all adhere to the same basic theme: wholesome foods, in sensible combinations, plant foods predominating. A vast array of research evidence from diverse sources, including randomized controlled trials, attests to the same. Alas, it just does not seem to satisfy our Newtonian impulses, or penchant for vituperations, religiosity, and procrastination.

We know how to eat well, for weight control and health, and sustainability; we just don't want to swallow it. We would rather, it seems, just keep chewing indefinitely, on fat, or carbs, depending on your palate, and the news that broke 8 minutes ago.

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.
Friday, September 11, 2015

The Pied Piper of empathy

I was sitting at a lunch counter the other day chatting with one of my former small group advisees about his career interests. Gunan, who is now an intern, was rotating on the oncology service. During our conversation he told me about how much he was enjoying his experience.

“That's right in line with your chosen field of radiation oncology, right?”

“Yep.”

“Good stuff,” I replied.

“I think I just … I don't know. I just like taking care of people with cancer.”

Wait, huh?

I wasn't sure what to say to that. I mean, can a person technically like cancer? Is it even okay to say that? I wasn't so sure.

Gunan saw my wheels turning and clarified, “I've figured out what it is about cancer that makes me like it.”

Like. Cancer. Uh, okay.

I raised my eyebrows. “Oh yeah? What's that?”

Gunan paused for a moment to find his words. I think he wanted to be sure that it didn't come out wrong. After a few seconds he finished chewing his bite of sandwich and spoke. “You know what it is? Peoplerespect the cancer diagnosis. No matter who they are, they do.”

I squinted my eyes at this concept which pushed him to go on. From there he fleshed out the idea pointing out that there aren't too many other things that every person old or young fully respects like a cancer diagnosis. He described how even the most difficult patients straighten up the moment it gets uttered. Family members step in to help, even estranged ones come from the woodworks, because it's cancer. Almost like having a U.S. president walk into a room. Essentially, it's kind of like the universal last word of diagnoses.

Now this? This was a pretty thought provoking idea. And especially so since I'd never thought of diagnoses as rungs on some sort of ladder of respect.

Hmmmm.

“That's deep, man.”

Lame reply, I know. But that's all I could say because this was such an interesting perspective, and one that I believe was extremely accurate.

Yep.

Gunan gave me something to really chew on that day. This idea of diseases being hierarchal and having one that is the President Obama of them all, cancer.

Heart disease is exponentially more likely to take out any person than cancer. It also has a much, much greater chance of disabling or redefining a life than cancer. And, though a lot about cancer is terrifyingly mysterious, when it comes to heart disease? Meh. Not so much. High blood pressure, obesity, inactivity, elevated cholesterol, and family history are just a few things that greatly increase the chance of a person getting heart disease. And you know? Society has done a pretty darn good job of getting that memo out.

Yup.

And sure, if someone doesn't seem so stressed about potentially getting something like heart disease, surely they'd feel the wake up call if they actually had it, right? In my experience, I'd say that answer isn't in the affirmative. While some folks definitely straighten up and fly right after a heart attack or some other cardiac event, many, many people don't. Nor do the people around them.

But cancer? That's a whole different story.

The other diagnosis that doesn't get it's full respect is HIV. All of the aforementioned things about heart disease ring true for HIV. This virus? We know about it. Like, all about it. There are ways to prevent and treat it, too. But perhaps even more than heart disease, it gets treated like an annoying tick on a dog's butt, something to ignore or not even look for until your forced.

I've told people that they were HIV positive. I've held their hand and walked them through the process of getting into care, too. But unlike cancer, it doesn't arrive with the same amount of boundless empathy. And worse, many times it prompts people to run in the other direction.

The patients are usually somewhere between really, really adherent to all that you suggest or totally in denial. And you know? That doesn't happen so much with cancer.

Nope.

Compared to cancer, HIV, as the late comedian Rodney Dangerfield would say, gets ”no respect at all.”

Nope.

It's true. AIDS and heart disease just don't get the respect that they absolutely deserve, man. And don't even get me started on mental illness which really gets disrespected.

But cancer? For some reason it's on a lonely list of diseases that somehow escapes all that. Even the most ill-equipped, contentious, poorly resourced and opinionated patients and families respond swiftly to that 6-letter word. They become more pleasant, cooperative and agreeable. They try what you suggest and listen when you speak. It's pretty damn remarkable.

Yeah. My former advisee was totally right. And it's a fascinatingobservation, isn't it?

So what is it about cancer? Is it the terminal nature of many of its forms? Is it the ruthlessness of it in how it strikes or the triumph of those who overcome its prickly grasp? Is it our universal fear of it that makes us all feel some need to show strong empathy lest we awaken the cancer-gods and find ourselves stricken out of some punitive wrath? Maybe it's all of this. Or none of it. Whatever it is, there's just something about malignancy that makes everybody listen just a little bit closer, follow up a little more carefully, and immediately get onto our best behavior.

And you know? It's not just the patients and their families, either. Doctors are also in this same camp. Our empathy heightens for patients carrying a cancer diagnosis. I know for sure that this is so because I've felt it inside of me and witnessed it time and time again at Grady Hospital.

Let me give you an example.

I took care of this super-cantankerous gent named Mr. Kelly with a longstanding stronghold of alcohol abuse on my service recently. He'd been admitted several times over the years for withdrawal and complications of his alcoholism. That man had a very sick liver and never once got hospitalized on a “soft call.”

Nope.

But even though he didn't walk the line on illness severity, that didn't make him nicer or uniquely appreciative of his healthcare providers. He was difficult. Due to his illness and unstable housing, Mr. Kelly's hygiene was poor and frankly, that made it unpleasant to care for him. And, if I man be frank, downright noxious. He also argued with staff and, due to fear and frustration, wasn't so nice most days. The team and nursing staff lost empathy for him. People went in only when absolutely imperative. And even though people held their eye rolls, you could feel them whenever his name came up in a discussion.

Yup.

But then he had that MRI that showed a mass on his liver. A mass with features pathognomonic for hepatocellular carcinoma, that is, liver cancer. A blood test and additional studies confirmed what we thought. Not only did Mr. Kelly have this bad diagnosis--he wasn't really a candidate for any interventions that could lead to a meaningful recovery.

Nope.

And that moment? That second when we scrolled through the MRI images and hit that big oval mass on his liver? It was a turning point. Suddenly we all began rooting for him in a different way. And I'm embarrassed to admit it but something about knowing this about him made me want to see him more and spend time in his room. The heavy cloak of foul dank odor that hit you when walking through the threshold somehow seemed insignificant now. And his “difficulties” suddenly seemed like “quirks” instead.

Yeah.

But you know? Mr. Kelly changed, too. The minute we sat in that room at eye level and shared that information, a switch turned on in him. Or off. Or whatever it was, he changed. He asked questions and listened. His family members took his calls and he took theirs. There were cards on his window sill and balloons tied to his bed rail. And the nurses, like me, in unspoken solidarity rallied around him to make sure he was comfortable and that all was well.

Yup.

One could argue that his advanced liver disease, cirrhosis and alcoholism were already equally as life threatening if not more than this new diagnosis. His life expectancy, chance for recovery from his liver damage, all of it already portended a very poor prognosis. And we, the physicians and nurse, knew that. Yet somehow when someone threw hepacellular carcinoma into the mix, we lined our ducks up and offered this man a new dignity. It's true.

And you know? I'm not sure how I feel about that. I'm not.

I talked to my friend Wendy A. about this whole concept. This idea of disease hierarchy and how some illnesses we throw our shoulders back to salute and how others get a head nod and that's it. I asked her thoughts on how cancer especially wins when it comes to that and why that was. And her take on it is that no person is exempt from the potential cancer diagnosis. She said, for this reason, perhaps, we all revere it.

Perhaps.

And I still don't know how even the ones that some cancer patientsseduced into their lives through tobacco use or other finger-wag worthy habits garners the same empathy. But they do. Like, not these attitudes that the man who has sex with men got what what he had coming to him when he found out he had AIDS or how the lady who had a stroke after using crack cocaine got what she deserved. Again, regardless of the etiology, cancer escapes all that. Somehow it justdoes.

Yeah.

So the Pollyanna positive girl in me has decided that this speaks to some innate thread of good in all of human kind. And how, as awful as cancer can be, it's amazing that there exists something that stands out as a pied piper for humanism and care for human suffering made palpable.

Yes. That.

You know? I don't even know why I wrote about all of this. But I do know this: The complexity of what we do is mind-blowing, man.

Yeah.

Kimberly Manning, MD, FACP, FAAP is an associate professor of medicine at Emory University School of Medicine in Atlanta, Georgia where she teaches medical students and residents at Grady Hospital. This post is adapted from Reflections of a Grady Doctor, Dr. Manning’s blog about teaching, learning, caring and growing in medicine and life. It has been adapted and reprinted with permission. Identifying information has been changed to protect individuals’ privacy.
Thursday, September 10, 2015

Stopping the spread of disease, overdose deaths from opioid use

Heroin use is soaring in the U.S., and with it deaths due to overdose. Many users begin with prescription pain killers but move on to heroin when the cost of getting high on pills becomes prohibitive.

Paralleling this trend is the increase in HIV and hepatitis C infections spreading through injection drug use.

But heroin and other opiate abuse is hardly new, and preventing death and disease from its use isn't rocket science. We Americans have insisted on treating substance use disorders as a criminal problem first and a medical problem—well, almost never. And we can't claim we don't know how to do better.

We've known for many years that needle exchanges prevent infections. We know that methadone treatment (a legal, oral replacement for heroin) reduces HIV infections. In southern Indiana and adjacent Kentucky, HIV and hepatitis cases have soared due to injection drug use. Needle exchange programs are getting off the ground slowly, and are actively opposed by lawmakers who think these programs encourage drug use.

This shows a profound ignorance of addiction. Addicts don't choose to inject based on the availability of clean needles; they inject using any damn thing they can because if they don't they get sick. There is no viable “moral hazard” argument here.

In addition to the spread of infection, IV drug use is leading to increasing number of overdoses, an approximate 200% increase in the last 10 years. Drug treatment programs can help reduce overdoses, but so can “overdose kits.” In some areas, law enforcement officers are carrying these kits, which are used to administer naloxone (Narcan), a medication that reverses the effect of heroin and other opioids. An auto-injector, similar to an Epi-pen, is now available by prescription. Evzio (Kaléo) won expedited FDA approval for this product, which is priced at about $60.

Given that naloxone has no abuse potential and is very safe, this should be made available without a prescription.

We've known for decades how to fight opioid overdoses and how to slow the spread of disease from IV drug use. What's taking us so long?

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 at Forbes. His 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.