Friday, June 28, 2013

Dear FDA: Please stop regulating ultrasound machines and fecal transplantation

The Food and Drug Administration was created in 1927 in order to carry out the mission of the Food and Drug Act put into effect by Theodore Roosevelt in 1906. In the early 1900s and before, patent medicines killed and maimed people in gruesome ways and adding chemical substances to foods to mask the fact that they were rotten or substandard was felt to need some sort of legal response. The FDA initially was predominantly an organization designed to regulate sales and interstate transport of foul and dangerous foods and medicines.

Over the years the job of the FDA has expanded as technology has advanced, to include evaluation of new drugs and devices, including those designed and produced outside the U.S. The FDA has undoubtedly protected countless people from poisonous and malfunctioning medical products. There have also been stories of egregious failures of the FDA (see this New York Times article of 2009 regarding their inability to police conflicts of interest in biomedical research) which are often attributed to lack of funding and overwork.

In the last few weeks the FDA has caused me, personally, significant grief and frustration. I am shocked and angered, as a citizen, when cortisone products containing mold result in death and disability in hapless patients and when food additives which contribute to a nationwide obesity epidemic go unchecked, but a couple of things hit closer to home than these.

I have been shopping online for the last 8 months for an affordable ultrasound machine that I can use to train myself in some of the more specialized applications of the technology. I can't see spending $40,000 for an American machine, so I have been looking at who in the world produces ultrasound machines for the rest of the world, which also can't afford the super-expensive technology. I found the perfect machine, a laptop-sized scanner with four different transducers, so I can get good at vascular, thyroid, musculoskeletal and intestinal ultrasound, and was able to buy it from the Chinese manufacturer for a bit over $4,000. I thought that after learning how well it worked it would be something that I could afford to donate to a project overseas. It was delivered to the shores of the U.S. last week and is probably not going to ever get to me because it is not FDA approved. Ultrasound machines are felt to be of low to minimal risk to humans, so the FDA approval process is not as long as for, say, invasive medical devices, but it is too laborious and expensive for Chinese companies to go through, especially with their lower-end models which they can sell just fine everywhere else in the world. I wrote the FDA investigator a letter explaining my plans but I think the chances of getting my machine are pretty poor.
The other potentially life threatening stupidity regards the increasing use of fecal transplant to treat a very difficult to treat health care associated infection, Clostridium difficile. I have written about this in several blogs, and will not further harp upon the details, but repopulating the intestinal flora of a person who has this particular infection (and probably several other conditions as well, such as inflammatory bowel disease and even obesity) really works, carries minimal risk compared to our standard of care and is really cheap.

I now read that the FDA has decided it needs to regulate fecal transplant. They want to treat it as an "investigational new drug" (IND). This classification is primarily to protect the consumer while fast-tracking a drug which clearly is needed into regulated use.

According to the FDA site, the purpose of FDA regulation of IND's is to regulate interstate transport and establish safety before development and marketing. These two purposes are completely irrelevant to fecal transplant, which never needs to be transported across state lines and needs no development or marketing. Also, if the substance to be approved is poop, I submit that poop is not one thing. Even if the FDA did approve or reject a particular stool as being safe and effective, that is hardly known to be the case for a different sample.

Why, you may ask, is fecal transplant important to me personally? It is just such a fantastically great idea, with world shifting implications in terms of living in healthy harmony with our commensal bacteria, and it has also saved a couple of my patients.

Both of these situations are excellent examples of how the economics of medicine in the U.S., with endless deep pockets provided by insurance companies of all ilks, fails to support the development of therapies that do not make money and are inexpensive. If a therapy or device does not have a powerful company or set of financially interested advocates to get it into accepted practice, it can potentially go nowhere for a long time. And if such a thing does make it up through the grass roots to acceptance, the FDA is right there to throw up a roadblock.

So why? If they have inadequate resources and lots to do, can't they perhaps go out there and protect us against dangerous things instead of fussing with fecal transplants and my ultrasound machine? There was an outcry early in the AIDS epidemic, at which time the IND fast track and several other modifications of FDA procedures helped to allow medications into the market for patients dying for lack of options. It took some really powerful physician advocates and dying poster children to get these changes made. Perhaps a champion will stand up for the many other great ideas failing to thrive due to inappropriate regulation.

Janice Boughton, MD, FACP, 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.

The end of antibiotic stewardship, 2013 edition

Back in the 1990's when I was a wide-eyed infectious disease fellow, I'd wonder out loud to my co-fellows Sara Cosgrove and Dan Levy why it was that we needed an oncologist's approval to prescribe chemotherapy but any clinician could prescribe antibiotics. My reasoning was that if you make a mistake with chemotherapy in a cancer patient, you only harm that one patient, but when untrained clinicians prescribe antibiotics all willy-nilly they harm the whole planet. Well, it's 2013 and I'm still wide-eyed and have the sinking feeling that antibiotic prescriptions are about to go way beyond willy-nilly. And I'm a bit scared.

The reason for my worry is this paper by Hanne Albert and colleagues in the European Spine Journal. In the study, patients with 6 months of low back pain and Modic 1 changes on MRI were randomized to 100 days of antibiotics (amoxicillin + clavulanic acid). The reasoning behind antibiotics for back pain is a study that found P acnes and C propinquum in surgical specimens from lumbar herniated disks. Anyway, the study reported improved primary and secondary outcomes with treatment and no change with placebo.

So why am I worried? Just look at the headlines from my Google search. I would normally link to these articles, but I don't want to send traffic to posts that aren't appropriately skeptical of this single trial and the public health implications of giving everyone with back pain 100 days of antibiotics. One UK surgeon was even reported to have said this finding is worthy of the Nobel Prize. Yikes.

For an appropriately skeptical and balanced discussion of this study and the surrounding hype, please read this Observation in BMJ by GP Margaret McCartney. After I read the study and Dr. McCartney's excellent commentary, I forwarded them on to Sara Cosgrove. It was therapeutic for me to share my concerns with an old friend. But now I'm back to panicking.

Eli N. Perencevich, MD, ACP Member, is an infectious disease physician and epidemiologist in Iowa City, Iowa, who studies methods to halt the spread of resistant bacteria in our hospitals (including novel ways to get everyone to wash their hands). This post originally appeared at the blog Controversies in Hospital Infection Prevention.

QD: News Every Day--Better preventive care alone may not control Medicare costs

Better preventive care may not be enough to control costs in Medicare patients, according to a new study.

Most U.S. health care spending is due to a small proportion of patients, but it is not known how much of the spending in this group is related to preventable services. Researchers sought to answer that question by using standard 5% Medicare files to determine standardized costs of inpatient and outpatient services for individual patients across 2009 and 2010. Patients in the top cost decile for 2010 were considered high-cost patients, and those in the top cost decile for 2009 and 2010 were considered persistently high-cost patients. In all, 1,114,469 Medicare fee-for-service beneficiaries 65 years of age or older were included. The study's main outcome measure was the proportions of acute care emergency department (ED) visits and acute hospitalizations that were considered preventable in high-cost patients. The results were published online June 24 by JAMA.

Patients in the high-cost group were older and had more comorbid conditions than patients who weren’t considered high-cost. They were also more likely to be men and more likely to be black. Approximately 33% of total ED costs in 2010 were due to high-cost patients, and of these, 41% were considered potentially preventable compared with 42.6% of ED costs in the non-high-cost group. For inpatient costs, 79% were due to high-cost patients, and of these, 9.6% were related to preventable hospitalizations compared with 16.8% of costs in the non-high-cost group. In the persistently high-cost group, 43.3% of ED costs and 13.5% of inpatient costs were considered preventable. Geographic regions with more primary care physicians and more specialist physicians also had higher preventable spending among high-cost patients.

The authors concluded that although more than 70% of Medicare acute care spending in 2009 and 2010 involved high-cost patients, only approximately 10% of these expenditures appeared to be preventable. They also noted that because a higher number of primary care physicians and specialists in a region was associated with more spending among high-cost patients, spending may not be reduced by improved access to primary care alone. "Our findings suggest that a complementary approach to saving money on acute care services for high-cost patients may be to additionally focus on reducing per-episode costs for high-cost disease entities through clinical innovation and care delivery redesign," the authors wrote.
Thursday, June 27, 2013

A new target for food companies

Food companies use sophisticated science and psychology to get people to buy their food. Using combinations of salt, sugar and fat, among other things, they entice us and cause actual addiction. Although many people are rightfully concerned given the levels of obesity, diabetes and other health problems, I think they're missing out on a segment of the population that might actually benefit from their craft.

Not infrequently do I see patients, often elderly, who have a problem many of us could only wish for. They have a poor appetite. This may be due to many factors, including diminished smell and taste, poor vision, and dry mouth. What they need is food meant to appeal to them.

One of the tricks used to sell us more food is vanishing caloric density. Foods like Cheetos, that quickly melt in the mouth, fool the brain to think there are less calories than there really are, so people eat more of them. If you're malnourished, that might be a good thing. The food engineers should create foods that people with a poor appetite will actually want to eat. Throw in some vitamins and fiber, and just maybe they would get physicians to recommend them.

Daniel Ginsberg, MD, FACP, is an internal medicine physician who has avidly applied computers to medicine since 1986, when he first wrote medically oriented computer programs. He is in practice in Tacoma, Washington. This post originally appeared on his blog, World's Best Site.

Government wants patients to report medical mistakes - is this a mistake?

I'm all for enhancing patient safety. Count me in on reducing medical errors. I acknowledge that medical mistakes harm patients and many can be prevented. The medical profession should promulgate and support any initiative that accomplishes these objectives.

The public has become suspicious of the medical community who seem to circle the wagons when external scrutiny of its actions is threatened. Yes, sunlight is the best disinfectant, but many of these shining lights are murky shadows that do not illuminate as intended.

The government and insurance companies are now providing financial penalties if certain medical quality benchmarks are not met. While this sounds attractive and overdue when it is expressed in a headline or a slogan, the true motivations and capability of these efforts have been questioned. Is it really about safety?

I have tried to expose throughout this blog the fallacy that the medical malpractice system serves as a deterrent and improves medical quality. I reject this lame claim and maintain that this unfair medical malpractice system diminishes medical performance and harms patients. For those, who dare to enter this chamber of horrors, I invite you to bravely peruse the posts that are securely stored in the Legal Quality category of this blog. I have commented on various plaintiff attorneys' blogs and I'm always struck how so many of them feel that the current system is well designed, fair and provides necessary justice to their injured clients. I regard much of this as self-serving ideology that crumbles through gaping credibility cracks. Would we regard a physician as credible who vigorously opined that our health care system needs no reform?

Our government has a new initiative to protect patients. In this pilot program, patients would notify the government of suspected medical errors by doctors, pharmacists and hospitals. An investigation would ensue.

Good idea? Sure, the concept is reasonable but how would it be implemented? Realize that most of the reported "errors" would not be mistakes at all, just as most lawsuits against doctors are ultimately dismissed as no true negligence was present or could be proved. Many of these "errors" would be recognized complications of medical treatment which are blameless events. Other complaints might relate to perceived inadequate physician communication or indifferent bedside manners. Other true errors might be too minor to warrant reporting such as a patient's IV (intravenous) line had to be inserted repeatedly or a patient was given the wrong meal which resulted in no untoward effect.

Medical records would have to be reviewed in every case and medical personnel interviewed to try to ascertain the facts. Where would we summon the manpower and the resources to investigate the gazillions of complaints that would be forthcoming once sick folks and their families are encouraged to serve as medical quality officers with a duty to report to serve the greater good?

Even in a medical malpractice case, it is vexing to discover the truth after months of intense medical record scrutiny, discovery and depositions. How would this new system aim to get to the truth after a cursory review of the circumstances?

One way to encourage physician support of such as effort would be if the facts and opinions that are uncovered would be kept confidential and privileged from use by the plaintiffs' bar. With this provision, then we would know that safety is the priority objective.

Finally, I think that medical error reporting should be reported to hospitals where the alleged errors occurred, and not to the federal government. The hospital is much better suited to provide review and oversight of its own patients and personnel. They know the players and are better positioned to evaluate the situation thoroughly and efficiently. I recognize that there is a conflict of interest here and that there would need to be independent voices participating to assure that there is no cover up or slanting of the facts to protect those who have erred or the institution.

Does this post agitate you? Have I strayed beyond the Bloggers Code of Ethics? Have I made a mistake here or even been negligent? Your role is clear. I am a practicing doctor. You think I have erred. Now, do the right thing. Report me.

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.

Statins and exercise

Several years ago, one of my best friends complained that a statin was interfering with his exercise routine. While I believed him, I was a bit skeptical. We have known for some time that statins can impact muscles, pain and even rhabdomyolysis. But what about routine exercise?

Consider this excerpt from an article at the New York Times: Can Statins Cut the Benefits of Exercise?

"But until the current study, no experiment scrupulously had explored the interactions of statin drugs and workouts in people. And the results, as it turns out, are worrisome.

"The unmedicated volunteers improved their aerobic fitness significantly after three months of exercise, by more than 10 percent on average. But the volunteers taking the statins gained barely 1 percent on average in their fitness, and some possessed less aerobic capacity at the end of the study than at its start.

"Why there should be such a discrepancy between the two groups' fitness levels wasn't clear on the surface. But when the researchers looked microscopically at biopsied muscle tissue, they found notable differences in the levels of an enzyme related to the health of mitochondria, the tiny energy-producing parts of a cell. Mitochondria generally increase in number and potency when someone exercises.

"But in the volunteers taking statins, enzyme levels related to mitochondrial health fell by about 4.5 percent over the course of the experiment. The same levels increased by 13 percent in the group not taking the drug.

"In effect, the volunteers taking statins "were not getting the same bang from their exercise buck" as the other exercisers, says John P. Thyfault, a professor of nutrition and exercise physiology at the University of Missouri and senior author of the study."

Statins remains important medications. My enthusiasm has waned on treating patients without known atherosclerotic disease or equivalent (type II diabetes mellitus). We should use statins more sparingly, focusing on those who get enough benefit to make any potential side effects a reasonable risk.

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 Associate Dean for the Huntsville Regional Medical Campus of UASOM. He also serves as a frequent ward attending at the Birmingham VA Hospital. This post originally appeared at his blog, db's Medical Rants.

QD: News Every Day--Experts recommend screening for physical frailty in older patients

Patients older than age 70 should be screened for physical frailty, a panel of experts recently recommended.

The panel, which represented an international group of medical organizations, including the American Medical Directors Association and the American Federation for Aging Research, met in December 2012 to define frailty, look at screening and treatment, and determine what patients should be screened. It reached the following consensus definition of frailty: "a medical syndrome with multiple causes and contributors that is characterized by diminished strength, endurance, and reduced physiologic function that increases an individual's vulnerability for developing decreased dependency and/or death."

The panel also determined that according to the available evidence, frailty could be prevented or treated with exercise, protein calorie supplementation, vitamin D, and reduced polypharmacy. Primary care physicians and geriatricians can use simple screening tests, including the FRAIL scale, the Cardiovascular Health Study Frailty Screening Measure, and the Clinical Frailty Scale, to identify patients who are frail or at risk for frailty, the panel said. The panel recommended such screening for all patients older than 70.

"To successfully combat frailty, our medical practice must be targeted, strong, and sustained," the panel concluded. "With the aging of our population, we cannot wait and must implement the screening and management of frailty into clinical practice worldwide."

The panel's recommendations appear in the June Journal of the American Medical Directors Association.
Wednesday, June 26, 2013

Are we over-treating high blood pressure?

JAMA Internal Medicine released an opinion piece that is sure to start some fights. In it, Iona Heath, a retired, well-regarded general practitioner in the UK argues that we are over-treating mild high blood pressure. To understand her arguments, we have to dig a bit into what we know.

Hypertension affects about a third of American adults. Most Americans who have heart attacks, strokes, or heart failure have hypertension. It's estimated that high blood pressure contributes to over a third of a million deaths yearly in the U.S. It's also under-treated, with fewer than half of hypertensive patients having their condition under control.

But it's more complex than that. We divide treatment of blood pressure into primary prevention and secondary prevention. Secondary prevention is simple: once you have had a hypertension-related problem such as heart attack or stroke, the statistics clearly show that tight control of blood pressure prevents another event. Anyone who argues otherwise is, in my opinion, out of their mind.

Primary prevention is a bit murkier, and the subject of Dr. Heath's article. The idea is that by treating high blood pressure before the heart attack (or stroke, or kidney failure, etc.) we can prevent these from happening in the first place. There is little debate about this, but over the years there have been vigorous discussions about what levels of blood pressure to treat. In the U.S. we often rely on the Joint National Commission, a panel of experts who review the data every few years and make recommendations.

The current recommendations are based on decades of evidence that shows the risk of heart disease doubles with each increase of 20 mm Hg to the systolic blood pressure (the top number). In people who do not have other risk factors for heart disease, the goal is to keep the blood pressure under 140/90.

Heath argues that this is too aggressive, and that we over-treat people whose blood pressures run in the 140-160/90s range. She bases her opinion on a recent review published by the Cochrane Collaboration, an evidence-based medicine group that keeps an eye on such things. The review included data from four studies (they use fairly strict selection criteria).

Cochrane's conclusions were fairly clear: When data from the four studies were analyzed, the treatment of mild hypertension did not prevent important outcomes such as heart attack and stroke, but did cause side-effects.

At what level to treat high blood pressure is a hugely important question, given its impact on the nation's health. As I said above, we're talking about people who don't already have other heart risks, and we're talking about whether or not to commit them to long-term treatment. We're also talking about patients who have not been able to bring their pressures down through proper diet and exercise (which, unfortunately, is a whole lot of people).

So what evidence is there to treat so-called low risk people with mild high blood pressure?

The World Health Organization and the JNC both recommend an aggressive approach to treating high blood pressure, even in so-called "low-risk" patients. They do this for a variety of reasons, including some pretty compelling data. Heart and kidney risk rises with blood pressure: there is no "safe" level of high blood pressure. In patients with other risks, the benefit is clear, but what about low-risk patients? Given that many if not all of them will progress with age, and that heart and kidney damage is cumulative, it seems unwise to wait until they either get very high or develop a complication of their hypertension.

It's not that the evidence is conclusive; the Cochrane report reminds us that there may be hazards and costs to treating those with lowest risk, which, statistically, is nearly a tautology. Of course those with less risk will show less immediate benefit. The real question, one which is difficult to study due to ethical considerations, is how much are we helping our mildly hypertensive patients by lowering their numbers.

One Cochrane report combining four studies is not about to change the way most of us practice medicine. Given the disease burden caused by high blood pressure, none of us should rush to raise our treatment thresholds. While Dr. Heath raises some interesting points, her call for significantly raising the treatment threshold (to 160/100) should be discarded until stronger evidence supports her ideas.

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.

QD: News Every Day--Cancer risk appears higher in heart failure patients

Patients with heart failure may be at a higher risk for cancer, according to a new study.

Researchers used data from the Rochester Epidemiology Project in Olmstead County, Minn., to compare 596 heart failure patients with healthy controls matched for age, sex and date over two 11-year periods. They found that cancer risk in patients with heart failure was 48% higher between 1979 and 1990 and 86% higher between 1991 and 2002 than risk in patients who did not have heart failure, after adjustment for BMI, smoking, and Charlson comorbidity index. Risk for death was 56% higher in heart failure patients with an incident cancer diagnosis compared to heart failure patients without cancer.

The study authors noted that they did not have data available on health care utilization and that they could not analyze cause-specific death or types of cancer, among other limitations. However, they wrote that risk for cancer after heart failure appears to be increasing over time and is associated with higher mortality rates, and that their results emphasize "the importance of non-cardiac morbidity and of cancer surveillance in the management of [heart failure] patients."

An accompanying editorial called the findings novel but said they should be interpreted with caution. Future studies, the editorialists said, should look at temporal trends in cancer incidence among heart failure patients, how cancer surveillance affects cancer diagnosis, and how cancer treatment affects mortality. Other factors that could increase cancer risk, such as medications and diet, should also be examined, they wrote.

The study and editorial were published online June 25 by the Journal of the American College of Cardiology.

Pandemics, and humans as 'part of the main'

Life is stressful enough without anticipating the next great pandemic. There is the inevitable turmoil in the Middle East, North Korea's nuclear program, cancer-causing genes, the risk of calling your organization something that will make the IRS go through your underwear drawer, and doubts about the right amount of salt to eat. Really, that ought to be enough! We just don't need pandemic influenza or a new coronavirus to keep our adrenal glands stimulated.

But need them or not, folks, they are out there. And since we do, perennially, have plenty to worry about, it won't help much to add new worries to the list. But it might help a whole lot if we skipped worry altogether, and went directly to work. It might help a whole lot if forewarned produced collective responses that led more reliably toward forearmed. The basic requirement here, other than the allocation of some resources to support public health, is a willingness to think of ourselves in a context larger than ourselves. We'll come back to that.

First, a brief orientation to two of the more imminent threats about which we should not worry, but for which we should prepare.

The first is a new variant of avian influenza, H7N9. We have been fussing about pandemic flu for some years now, and have watched bird flu and swine flu contenders come and go without recent global catastrophe. That's great, and let's hope the trend continues, but dodging bullets for a while should not cause anyone to think that bullets are reliably innocuous. Only one needs to hit you.

The new flu strain has thus far infected only relatively few people, and only in isolated areas in China. But the mortality rate appears very high. The virus is different enough from recent flu strains that our immune systems would likely be caught largely unprepared by it were it to circulate globally. Those are the hallmarks of a pandemic threat. It doesn't mean this is the bullet we won't dodge; it just means it could be.

The coronavirus in the Persian Gulf seems to be a new infection in humans. Like the current avian flu strain, it has infected few people, and only in one part of the world. But it, too, has thus far killed a high percentage of those infected. I was in commentary on these topics, some of which has recently graced the pages of the New York Times, has placed an emphasis on inter-species transmission of germs. As noted, the new flu strain is avian, meaning it incubates in birds, poultry specifically in this case, before humans get involved.

The coronavirus, which has thus far infected fewer than 100 in the Persian Gulf region, but killed 55% of those infected, almost certainly originates in animals as well. A variety of bat is a prominent suspect at present.

The transmission of pathogens from animals to humans, either directly or through the intermediacy of other animals, produces zoonoses: human diseases of animal origin. Most of the great outbreaks of the modern era involve this mechanism. It is almost certainly true of HIV, and we know it to be true of influenza, including the infamous pandemic of 1918.

Various factors contribute to this risk. An ever-growing human population, our crowding into the last few enclaves of wild species, is an important issue, discussed too seldom and addressed too feebly. Our various assaults on the planet and climate are forces favoring genetic change in all species struggling to adapt, and in some cases, those adaptations may come at our peril. If nothing else, climate change invites the spread of microbes to areas from which cooler temperatures once barred them.

The world is ever smaller. Flu strains incubating in China can be in New York or Los Angeles or Washington, D.C., in the span of a day. This is a world in which an incurable bacterial disease, spread by a tiny insect native to Asia, decimates the citrus crop in Florida.

The concept that we, the planet, and all other species are in this together has a name: One Health. The One Health movement emphasizes the need to monitor the places where people and wild and domestic animals interact as potential sites of new human perils, and the need to manage ecosystems in ways that preserve their native health and balance. The movement, catalyzed a decade ago in large part by my friend and colleague, veterinarian Dr. Steve Osofsky, and his colleagues at the Wildlife Conservation Society, also emphasizes the importance of critical support for public health, including surveillance for emerging diseases, because we can either pay a bit now, or pay dearly later. And there is, of course, attention to the relentless growth of the human population as well.

We speak as if humans are somehow separate from all else: There is natural, and "man-made." But we are, inescapably, part of the main. We can pretend we are not all in this together. We can pretend there is us, and them. We can pretend that what we do to the planet will not come back to haunt us. We can pretend that there is space on earth for continued growth of the human population. We can pretend that the ills of other species are not our problem.

But reality is asserting itself ever more ominously. The only real defense we have against the looming perils is an end to all the pretense. For there is just one health, and there is just one game, and everyone's skin is in it.

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.

FDA shoots self in the foot

Last week I blogged about the FDA's ruling to classify human stool as an investigational new drug, making it more difficult for patients with recurrent C. difficile infection to undergo fecal transplantation, an incredibly effective therapy.

I was scheduled to perform a fecal transplant on a patient this morning, but notified her a few weeks ago that we could not proceed because of the new ruling. She asked to keep the appointment with me anyway. She presented to clinic this morning and informed me that she had performed the transplant at home a few days ago. And she was happy to report that she was feeling much better!

As it turns out, I have at least three more patients in the process of preparing for self-administered fecal transplant at home. The instructions for doing so are readily available on the Internet. I suspect this do-it-yourself movement will now become widespread. It's ironic that the attempt by the FDA to regulate this procedure in the interest of safety appears to be driving a completely unregulated and more risky response.

Someone should have reminded the FDA that unlike the usual investigational new drug, which is impossible to obtain outside of a highly regulated and structured mechanism, human stool is readily available, easy to procure, and impossible to regulate. These patients are highly motivated, know the data on effectiveness, and won't be told no!

Michael B. Edmond, MD, FACP, is a hospital epidemiologist in Richmond, Va., with a focus on understanding why infections occur in the hospital and ways to prevent these infections, and sees patients in the inpatient and outpatient settings. This post originally appeared at the blog Controversies in Hospital Infection Prevention.
Tuesday, June 25, 2013

What underlies the costs of dementia

A story in the New York Times concerned the projected costs of dementia in the United States. Pam Belluck did a top-notch job covering the new findings of a RAND analysis, published in the New England Journal of Medicine. The researchers found that the financial impact of dementia rivals that of cancer and heart disease.

Dementia affects nearly 15% of people over 70 of age in the U.S., these researchers found. They used various statistical tools, adjustments, estimates, etc., to estimate the costs of care for an individual with dementia: it typically ranges between $41,600 and $52,300 per year. The tallies are huge for the population, involving some $109 billion per year for "care purchased in the market" or $215 billion if you include the "estimated monetary value of informal care", i.e. home care by relatives, days off from work and things people do all the time to assist old friends, family members and others in their communities.

The Times headline about dementia-related expenses doubling between now and 2040 and the NEJM article, focus on dollars and cents. And that's fair enough. Unless we're going to leave aging folks to die of thirst in a metaphorical woods, or purposively give them a woefully large dose of painkillers in a clinical setting, or otherwise kill them, we've got to find a way to take care of elderly people who need help.

But, and I hope this doesn't come across as heartless, I don't think it's reasonable to consider dementia in the very elderly along the same lines as illnesses that affect younger people, like lethal viruses, brain cancer or multiple sclerosis, to (randomly) name a few. Some degree of cognitive decline is normal, and aging is normal. It's natural, if you will, like grief, distraction and other aspects of the human experience. I don't really see the costs of dementia, when it doesn't occur prematurely, as "medical." Rather, it's the price we pay for extending human life by feeding tubes, screening for and treating cancers, placing pacemakers, performing dialysis and giving other treatments that so many live beyond a ripe old age.

What's not considered, left unaddressed, untended, is whether a legitimate goal of health care is to prolong life beyond a certain point. Few may be willing to mark that point, but I do think we're missing it. If we can afford the research, technology and consequences of extending life by what some might consider unnatural processes is a really tough question.

This post originally appeared at Medical Lessons, written by Elaine Schattner, MD, FACP, a nonpracticing hematologist and oncologist who teaches at Weill Cornell Medical College, where she is a Clinical Associate Professor of Medicine. She shares her ideas on education, ethics in medicine, health care news and culture. Her views on medicine are informed by her past experiences in caring for patients, as a researcher in cancer immunology and as a patient who's had breast cancer.

Basic statistics should be a core competency of every citizen of the world

A medical educator recently argued in her blog that medical school admissions requirements should minimize requirements in math and science topics, especially areas like calculus and physics. There is no question that medicine, and even informatics for that matter, require knowledge and competency in many areas beyond math and science.

However, the problem with the math we teach to potential healthcare professionals and informaticians, indeed to everyone in society, is that we teach the wrong math. I took three semesters of calculus in college and can say that I have almost never used any of it. On the other hand, I had almost no education in statistics, a type of math I use not only in my work, but also in my function as an informed citizen. Indeed, most health care professionals, whether clinicians or researchers, use statistics daily. Likewise, as thoughtful citizens in society, we also encounter statistics daily in the news and other aspects of our lives.

For these reasons, I believe that statistics should be a core competency of every citizen in the modern world.

It is not even the mathematics in statistics that are most important, but rather the concepts and the thinking they engender. Every citizen in the world should understand the basic concepts of inferential statistics and be able to answer such questions as:
--What does statistical significance mean? How is it different from a clinical (not necessarily in the medical context) significance?
--What is the difference between absolute and relative risk? What is the meaning of large relative risk differences in the setting of small absolute risk?
--In health-related topics, how do we discern and compare different types of health risks?
--Also in health, what do sensitivity and specificity of diagnostic tests mean, and how does prevalence impact the risk of disease in the face of positive or negative diagnostic tests?

One of the most articulate advocates of this view is John Allen Paulos, whose books Innumeracy and A Mathematician Reads the Newspaper inform us why basic numeracy and statistical competency are so important. These kinds of engaging writings, and basic education about statistics, should be a part of every high school education, not to mention in the education of clinicians and informaticians.

This post by William Hersh, MD, FACP, Professor and Chair, Department of Medical Informatics & Clinical Epidemiology, Oregon Health & Science University, appeared on his blog Informatics Professor, where he posts his thoughts on various topics related to biomedical and health informatics.

QD: News Every Day--Azithromycin may benefit non-eosinophilic severe asthma exacerbations

Azithromycin did not reduce the rate of severe exacerbations and lower respiratory tract infections in patients with severe asthma, but may benefit patietns with non-eosinophilic severe forms, a small randomized controlled trial found.

The double-blind, placebo-controlled trial in Belgium randomly assigned low-dose azithromycin (n=55) or placebo (n=54) as add-on treatment to combination therapy of inhaled corticosteroids and long-acting beta-two agonists for 6 months.

Results appeared in Thorax.

The rate of severe exacerbations and lower respiratory tract infections was not significantly different between the two treatment groups: 0.75 (95% CI, 0.55 to 1.01) in the azithromycin group versus 0.81 (95% CI, 0.61 to 1.09) in the placebo group (P=0.682).

But, azithromycin was associated with a significantly lower rate of severe exacerbations and lower respiratory tract infections than placebo in subjects with non-eosinophilic severe asthma (blood eosinophilia less than 200/┬ÁL): 0.44 (95% CI, 0.25 to 0.78) versus 1.03 (95% CI, 0.72 to 1.48) (P=0.013).

Azithromycin significantly improved scores on the Asthma Quality of Life Questionnaire, but there were no significant between-group differences in the score for the Asthma Control Questionnaire or for lung function.

Long-term treatment with azithromycin was associated with an increased proportion of macrolide-resistant oropharyngeal streptococci, but there was no evidence suggesting that colonization with macrolide-resistant organisms increased the risk of lower respiratory tract infections or pneumonia.

Researchers noted that the significant reduction in the severe exacerbations and lower respiratory tract infections in azithromycin-treated patients with non-eosinophilic severe asthma, possibly due to antibiotic properties or anti-inflammatory and immunomodulatory effects, warrants further study.
Monday, June 24, 2013


It feels dangerous to write this, but ... my practice seems to be working.

I am now running and hiding from lightning bolts, meteors, or stray arrows shot in the air by a Scottish soldier. I am also expecting a raid on my office by the IRS, CDC, and BBC tomorrow morning.

But as afraid as I am to admit it, the thing that was once just a good idea is now actually growing and improving. We are up to about 300 patients (with a big infusion when a local TV network did a story on my practice) and have enough money to pay bills without a visit from uncle bouncy. While we've started to discuss when we will hire another staff person (probably a nurse), neither me nor my nurse Jamie (may her name be ever blessed) feel overwhelmed at this point. We can handle this volume, which speaks well for the future when we actually have a fully-working system.

The past few weeks have been totally consumed by my need to have an underlying system of organization. After fighting valiantly against the idea for the first two months, I succumbed to the necessity of building my own IT system and have been seeing the many benefits of that decision. Despite being totally obsessed with how data tables connect and whether I've left a parenthesis off of a script I've written, I now have a place to put data, have a pretty decent task management system, have an integrated address book, and have discussed integration with my phone system vendor, my secure messaging developer, and a lab order/result integration vendor. I've also found some strong local tech talent who gets what I am doing and yet doesn't simply see the market potential for my software.

The reality is, my whole focus is on the practice model, and that model seems to work. As my business and medical care management systems click into place and become more functional, growing the practice should not be a problem. We continue to get several new patients signing up every day, and now the reluctant spouses of established patients are joining (which is a very good sign for both my practice and for their marriages).

Let me appease the gods and state clearly that this is by no means a sure thing. There are many, many things that could go wrong. A successful start-up requires not only a good idea and hard work; it also needs requires luck (or at least to avoid bad luck). I could get cancer, my building could burn down, or our city could be overrun by a mob of psychotic llamas. We all know the llama apocalypse is happening; it's just a question of when, not if. So I accept the fact that I am, to a great extent, in the hands of the fates (and llamas).

That being said, it is encouraging to see the first stage of the practice running reasonably well. The key will be to keep doing what I am doing: working, working and working. In some ways, the satisfaction of my patients should not surprise me, as the care they got from the health care system sets the bar very low. I am frustrated because I am not yet building care plans for patients or calling to check up on people as much as I would like, but that's not care that any of my patients are used to getting. They are used to being ignored unless they are sick. They still wonder if they can make an appointment, when I would gladly talk about their problem on the phone. They are simply happy that we still have an average waiting time of about 30 seconds.

Having been under high pressure over the past few months, my recent success makes it very tempting to take a deep breath and slow down a bit. Am I simply setting goals of care higher than they need to be? I think about these things while in the shower. I'm not sure why the pelting of my head with water makes me think better, but it does.

While wetly contemplating my obsession (and whether this was a sign of strength or stupidity), I remembered a physician worked under during my residency at Indiana University: Dr. Larry Einhorn. Dr. Einhorn is credited for the use of Cis-Platinum therapy in testicular cancer, a treatment which made a lethal disease in young men largely curable, even at very advanced stages. He was one of the group who cured Lance Armstrong of his advanced cancer, and was already quite famous when I was there nearly 20 years ago. This group of docs was not only amazing in their clinical and research skills, they were very good teachers and treated us residents with kindness and respect. It was truly an honor and a pleasure to train under them, and I strongly considered oncology as a career because of them.

One of the attendings told me that what made Dr. Einhorn so great was that he didn't stop at the first breakthrough. He didn't say, "Hey, this cures 75% of advanced testicular cancer! I am going to name this the Einhorn treatment protocol and be real famous!" Instead, he focused on refining and improving the treatment to where, while I was there, the cure rate was well over 90%.

That's not a character flaw, that's the definition of character. While I am nowhere near in accomplishment to that of Dr. Einhorn, I am tempted to listen to the happy patients, the complements from colleagues, and the band of groupies that gather on the handicap ramp each morning for my autograph. I am tempted to think I've accomplished something before the job is done. I am encouraged by the fact that I can handle 300 patients with just a nurse to help. I am encouraged by the fact that I am recovering from nearly having my practice impaled by "meaningful use certified" EMR products and may actually have a system that really improves care.

But I am a long way from where I initially planned to go, and there will always be more I can do. The foundation is laid, but foundations are generally unacceptable (and uncomfortable) places to live. So, I take a deep breath and dive back into all the work I have ahead of me. I hope things continue to improve, but I won't count on it. People have told me "You'll do it. I am confident you can make it work." But their assurances don't include the footnote that says: "As long as you continue to work most of your waking hours, and avoid doing something really dumb." That's no slam dunk.

And don't forget about the llama apocalypse.

After taking a year-long hiatus from blogging, Rob Lamberts, MD, ACP Member, returned with "volume 2" of his personal musings about medicine, life, armadillos and Sasquatch at More Musings (of a Distractible Kind), where this post originally appeared.

Medical telephone etiquette (and lack thereof)

This post may be in the nature of a rant. It may not even be entirely a medical topic, but it touches on my medical practice and one of its constant frustrations: communication between us physicians and between us and our patients, and the tools we use. In this case, I mean the telephone.

It's a shame we still need to use telephones. Using the phone used to be easy, but now it's more of an inconvenience and a frustration for all concerned. The days of a simple phone call to the doctor being promptly and courteously answered by a receptionist and a simple message taken are bygone. Now we are usually greeted by the "automated attendant." What an abominable excuse for communication that has become. The patients think the process has become frustrating and sometimes infuriating, but it has become that way for me as a physician as well.

Here are just a few irritants I would like to know who devised so I can post their names on the Internet.

1. "Your call is very important to us." A doubtful proposition to begin with when it's the same greeting everyone receives while waiting. But can they really expect us to be even more convinced of our importance after hearing it repeated for the fourth time?

2. "If this is a true medical emergency, hang up and call 911 immediately." Only a moron or someone living in a cave the past 30 years would wait to listen to that advice from a recorded menu while they or their loved one is gasping for breath!

3. "Please listen carefully to the following options." Of course I am listening to the options carefully! You had me at "You have reached the office of ..." God forbid I choose the wrong one and wind up in automated limbo. But do you need nine different options? I might listen patiently to three, but can I be forgiven if my attention wanders after #8? And just in case you think you already know the options, you may be told that "our menu has changed." I sometimes wonder what item on the menu is the special of the day!

4. A human being answers, and the first words out of (usually) her mouth are, "Dr. Smith's office, please hold." followed by hold music. And don't get me started about hold music consisting of advertisements for whoever you are holding for. My hospital is a notable offender there.

5. The person answering actually gives me what would seem to be an option: "Can you hold?" If I am in a good mood and my hands otherwise occupied, I say "Certainly, I'm very good at it." If the matter is more pressing I say, "No, I can't. This is Dr. Sack and I need to speak with Dr. X right away." Amazing how quickly I get results. If I am in a foul mood, I am sorely tempted to answer "Can you hold?" with "Hold what?"

6. I get a human being but one who was never taught old-fashioned telephone etiquette. The person answering the phone doesn't identify himself/herself. Sometimes it doesn't matter. But often it helps to know who took the message and if they are someone I can expect knows who I am. I called the ICU last week and the person at the desk answered "Hello?" I said "This is Dr. Sack. Who is this?" She replied "the ICU". To which I responded, "I know that. I called you!"(I am thinking, "You ninny!"). What's so hard about answering "ICU, Betty."?

7. The interminable human recitation. This corporate "professional greeting" is infecting more and more doctor's offices now that more and more of my colleagues are working for Big Brother. (Did I say that? I mean The Hospital.) I used to get "Surgical Specialists, Jasmine speaking." Now I am greeted with "Big Hospital Surgical Specialists, an affiliate of Big Hospital Medical Group, with affiliates in Gotham and Podunk, Jasmine speaking. How may I assist you?" And the poor receptionist has to repeat this oration several dozen times a day! It's a wonder she has time to do anything else!

8. And my personal bugaboo: the emergency room page. I receive a summons on my pager (actually a text to my phone from my service) to call the ER. The secretary answers and says, "Yes, Dr. Jones needs to speak with you about a GI bleeder. I'll get him." Then 3 minutes go by. Now I am tethered to the line. I wonder if I should just pitch a tent. Then someone picks up and asks who I am holding for. Then, apologies. Or after several minutes I get tired of waiting, hang up and call again. "Oh, he didn't pick up? I'll try again." Sometimes I get paged as I am putting on clothes in the morning. Have you ever tried buttoning a shirt with a phone in your hand? Thank goodness for the speaker phone!

9. The patient whose phone line is busy when you return their call. Sometimes it is because they are summoning the ambulance. Most of the time it's just thoughtlessness.

10. My receptionist buzzes me: "Dr. Sack, doctor so-and-so is on line 4." My receptionist sometimes fails to mention that it isn't "doctor so-and-so"; it's her secretary. There's little that makes me feel as foolish as having offered an enthusiastic greeting to my colleague only to hear, "Just a minute, I'll put her on." I suppose my staff probably perpetrate the same thing on other doctors when I call them. But lately they have been learning to tell me, "It's Dr. Jones' office on the phone. Pick up on 4, they are getting him."

All these nuisances and inconveniences are the reason why I think we doctors are entering a new era. The landline has been obsolete among the youth of our nation for over a decade. Soon it will be a thing of the past for us doctors as well. Now if I want to call my friend Doctor X, and I have his cell phone number, I dial that myself. It's amazing how well that works and how much it frees up our receptionists for more important tasks, like answering the patient calls and actually speaking with them immediately!

David M. Sack, MD, is a Fellow of the American College of Physicians. He attended Harvard and Johns Hopkins Medical School. He completed his residency at Lenox Hill Hospital in New York City and a gastroenterology fellowship at Beth Israel-Deaconess, which he completed in 1983. Since then he has practiced general gastroenterology at a small community hospital in Connecticut. This post originally appeared at his blog, Prescriptions, a series of musings on medicine, medical care, the health care system and medical ethics, in no particular order.

Few Americans understand basics of new health care law

I wrote about the massive confusion about ObamaCare (the Affordable Care Act) but it seems that it is much worse than I thought. The Kaiser Family Foundation came out with a poll that shows 42% of Americans don't even know that ObamaCare is the law. Seven percent of people think the Supreme Court struck it down and 12% think Congress repealed it.

I understand that there is confusion about the way it will work and who will be affected. But my advice to Americans is TURN OFF THE DAMN TV. Really, we are blessed to live in an age where information about any subject is available with the click of a mouse and people seem to know more about the Kardashians than they do about a health care law that is as important as Social Security or Medicare legislation.

I'm not surprised, however that most Americans said they don't have enough information to understand how ObamaCare will affect them. The Administration should have hired the same marketing firm that did the Super Bowl ads or even the clever ads for Dollar Shave Club. Sure, I get that health care is more complex than a Pepsi ad, but at least doctors and hospitals should have some understanding of it by now. This is a huge marketing FAIL so far.

According to the Washington Post, the Administration is waiting until the optimal time to roll-out the details. A public awareness campaign is slated for this summer, as open enrollment will begin in October. That seems way too late to me. Helping 30 million Americans understand that they will be buying insurance, making sure there are networks to care for these people, understanding the subsidies that most will get and understanding the various plan options is a huge undertaking and it will be here in 5 months. I would say ObamaCare is in a pot of boiling water right now.

It is the private insurers (Cigna, Well-Point, Blue Cross, United Healthcare, etc.) that will have the exchange products to sell. Has anyone ever truly understood their coverage provisions when dealing with these insurance companies? Now imagine three tiers of new insurance products to choose from, with varying co-pays and pricing. Now imagine covering Americans who don't use computers or have never really dealt with the insurance system. Now imagine different options being offered in each state.

I would say there is a lot of work to be done by the Department of Health and Human Services.

This post originally appeared at Everything Health. Toni Brayer, MD, FACP, is an ACP Internist editorial board member who blogs at EverythingHealth, designed to address the rapid changes in science, medicine, health and healing in the 21st Century.

QD: News Every Day--HPV rates fall in post-vaccine era despite low inoculation rates

Prevalence of the four human papilloma virus (HPV) types susceptible to the vaccine have fallen by more than half in the past four years, despite less than a third of teen girls receiving the complete series of three doses, a study found

HPV vaccination using the quadrivalent vaccine (HPV-6, -11, -16, and -18) was introduced into the routine immunization schedule in the United States in late 2006 for girls ages 11 or 12 years, with catch-up vaccination recommended for ages 13 to 26. A 2010 national survey found that 49% of teenage girls ages 13 to 17 had received at least one dose and that 32% had received three doses

A study reported results in The Journal of Infectious Diseases.

Among girls ages 14 to 19, prevalence of the four HPV types covered by the vaccine decreased from 11.5% (95% confidence interval [CI], 9.2 to 14.4) in 2003-2006 to 5.1% (95% CI, 3.8 to 6.6) in 2007-2010, a decline of 56% (95% CI, 38% to 69%).

Among groups outside the recommended ages, prevalence did not differ significantly between the two time periods (P greater than .05). The vaccine effectiveness of at least one dose was 82% (95% CI, 53% to 93%).

Researchers wrote, "This decline is encouraging, given the substantial health and economic burden of HPV-associated disease."
Friday, June 21, 2013

Gardasil is good

Crowdsourcing of medical decisions seems to be more and more common. Spend even a little time on Twitter or Facebook and you will see people posing medical questions to "the crowd." Since crowdsourcing is inevitable, it does no good to whine about the questionable practice of asking groups of (not so) random people for medical opinions. Medical professionals have an obligation to educate, and these questions can generate useful and lively discussions; they are opportunities.

The other day a friend (a real friend) posed a question on Facebook: Should she get her kid a Gardasil shot. Gardasil (NYSE:MRK) is a vaccine that protects against infection with human papilloma virus (HPV). The virus causes genital warts and a number of cancers including cervical, penile, and oral cancers. The vaccine protects against these, but to be effective, it should be given before a child is sexually active (the usual advice is nine years old), an idea upsetting to some people.

The responses to her question ranged from "Do it!" to "Are you crazy? No way!" This gives us a great opportunity to examine her question and answer with facts that can help parents make decisions. There will be no "naming and shaming" here, just answers to the comments and questions culled from the discussion.

"Go read with Dr. Mercola has to say." If you're not familiar with the world of medical conspiracy theories, you might not be familiar with Joe Mercola, a family practice doc in Illinois. He is way out there. Those of us who monitor wacky and dangerous medical ideas think of his website as a "target-rich environment," a place to find the most misguided and false medical advice. This response is simply a call to recognize the authority of an internet doctor who has a terrible reputation among most other medical professionals. Needless to say, Mercola doesn't like Gardasil and publishes a ton of questionable pieces on the topic.

"The shots only prevent a few strands of the virus when there are so many more. My OBGYN also told me the other day that most young women will have HPV during their teen years but those cases should clear themselves up before they're 21." We'll ignore the incorrect biology here ("strands of the virus" probably means "strains," but the correct terminology is "types"). The truth is Gardasil only protects against four of the 120 types of HPV, but these are the types that matter. Types 16 and 18 cause about 70% of cervical cancers and nearly all of the other HPV-related cancers. Types 6 and 11 cause most genital warts, and while warts don't lead to cancer, they are certainly a public health problem. And while it's nice that "most cases should clear themselves up" this is not always the case. Pap smears are our current method of early detection for cervical cancer. The test is pretty good, but certainly not better than prevention. I would hate to deny someone the vaccine simply because the disease "should clear itself up," and then have to explain to them why they have cancer.

"Has your child tended to have bad reactions to other vaccinations? Does your child have food intolerances and allergies, or some other auto-immune problem? Then you might not want to give it ... But I guess if there is a chance that it saves some people from developing cervical cancer it is worth it if the child is otherwise healthy and robust." Allergies and "auto-immune" problems aren't relevant. In fact, people with immunodeficiencies such as HIV are much more susceptible to cervical cancer and other HPV-related cancers. A child does not have to be "otherwise healthy and robust" to benefit from the shot.

Other arguments against the HPV vaccine also fail to hold water. Despite sensational news reports, the shot has not caused an epidemic of fainting or led to deaths. The national Vaccine Adverse Event Reporting System (VAERS) is a clearinghouse for reports of vaccine side effects. It is simply a collection of people's stories and health officials try to follow up on them to see if they have any merit. If you wished, you could make a report to VAERS that Gardasil caused you to become a communist. It's a system designed to gather as much data as possible without regard to quality. The quality control comes on follow up, where most "reactions" have been found to be either minor ("irritation at injection site," "feeling faint") or unrelated to the vaccine.

Merck, the maker of Gardasil certainly hopes to profit from the drug (doctors usually make very little or even lose money on vaccines). The fact that there is a profit motive does not make the vaccine bad, it simply means that any data coming directly from Merck should be given a bit more scrutiny. The HPV vaccine is a good one, and protects against several important cancers. My kiddo is going to get it as soon as she next visits the doctor, and if I had a son, he'd get one too.

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.

Hand hygiene causes obesity

Subtitle: "Or how you can associate almost anything with a weak study design."

One of my favorite epidemiological study designs is the temporal association "ecological" study that attempts to infer causation by showing one exposure increasing and one outcome increasing and then implying that the exposure is causing the outcome. You know, "Hey, they are both going up so one thing causes another." Vaccine use and autism rates anyone?

So, just for fun I've produced the graph and as you can see, through the efforts of CDC, WHO, VA and many individually hard-working IPs, hospital epidemiologists and clinicians, hand hygiene compliance has increased. And as you can also see obesity is also increasing, ergo hand hygiene causes obesity! Just try to disprove it!

Now, why am I wasting time with such an exercise? Because there is a paper in this June's ICHE that uses a similar study design and comes to an equally incorrect and perhaps dangerous conclusion. The study used 2008-2011 data from Ontario to compare yearly hand hygiene compliance rates to quarterly MRSA rates and monthly CDI rates. The study found that despite increases in hand hygiene compliance there was little change in MRSA and CDI rates over this period. The author then concluded: "This study supports the emerging evidence that once a threshold level of hand hygiene compliance is achieved, there is very little if any benefit to attempting to achieve higher rates of hand hygiene compliance among health care providers."

Well, except that you can't conclude that from such a study design. For one, the author didn't have exposure and outcome from the same time periods. Why would we think average hand hygiene compliance over an entire year would correlate with monthly CDI rates and quarterly MRSA rates? And how can we not consider other factors at play like the emergence of NAP1 or CA-MRSA during this period? Maybe there's even a Simpson's Paradox here, but that's a topic for another day. Oh, and keep washing your hands. I doubt we've reached a "threshold" of compliance!

Addendum: Probably the biggest flaw in this study is the accuracy of the reported hand hygiene compliance rates. No doubt the rates are lower than reported.

Eli N. Perencevich, MD, ACP Member, is an infectious disease physician and epidemiologist in Iowa City, Iowa, who studies methods to halt the spread of resistant bacteria in our hospitals (including novel ways to get everyone to wash their hands). This post originally appeared at the blog Controversies in Hospital Infection Prevention.

QD: News Every Day--Soy associated with premenopausal hot flashes in white women

Moderate soy intake may influence menopausal symptoms in premenopausal women, a study concluded.

To evaluate the association of vasomotor symptoms (such as hot flashes, night sweats, joint aches/pains, and headaches) with soy intake and equol production, researchers conducted a cross-sectional analysis of women ages 45 to 56 with regular and no skipped menses who were not taking hormones.

The study looked at associations among 1,513 premenopausal women with a mean age of 48.5 years who responded to the survey to determine associations between race/ethnicity and vasomotor symptoms (ever/never, past 2 weeks), while controlling for age and body mass index; headache and joint pain; and vasomotor symptoms within race by soy intake.

Results appeared at Menopause.

As expected, vasomotor symptoms varied by race. Compared with white women, Native American women were most likely to report ever having vasomotor symptoms (66.7%), followed by black (61.4%), white (58.3%), Hawaiian/Pacific Islander (45.5%), mixed-ethnicity (42.1%), Vietnamese (40.0%), Filipino (38.9%, P less than 0.05), Japanese (35.9%, P less than 0.01), East Indian (31.3%, P less than 0.05), Chinese (29.0%, P less than 0.001), and other Asian (25.6%, P less than 0.001) women. Hispanic women were less likely to have vasomotor symptoms (41.7%) than non-Hispanic white women (58.8%, P less than 0.001).

Among white women, but not among other women, soy intake was associated with vasomotor symptoms (P=0.03). Researchers wrote, "Among white women, those reporting vasomotor symptoms seemed to be more likely to have moderate [less than 4.3 mg/d] soy intake, whereas those not reporting vasomotor symptoms seemed more likely to have no soy intake."
Thursday, June 20, 2013

A better POLST and informed consent for resuscitation

To resuscitate or not to resuscitate, that is the question. Whether 'tis nobler to beat the heck out of a person on his or her way out in the hope of saving his or her one precious life, or to allow death to proceed at its own pace with expectation of a peaceful passing.

The United States has come a long way in the last two decades since 1991 when the Patient Self-Determination Act was instituted. In most hospitals patients are asked what their wishes are regarding resuscitation and many states have instituted POLST (Physician's Orders for Life Sustaining Treatment) forms which spell out which interventions are acceptable to individual patients when they are very sick, things like blood transfusions, antibiotics, feeding by nasogastric or gastric tubes, intubation and ventilation and chest compressions and electrical cardioversion in the event of cardiac arrest. Theoretically we discuss these things with every patient when they come into the hospital, but we don't really do it very well which results in misunderstandings and needless misery.

When the patient is competent to discuss life sustaining treatments the conversation often goes like this:

Doctor: "What would you want done if your heart were to stop? Would you want us to do chest compressions and put a tube down your throat so we can support your breathing?"

Patient: (Why are they asking me this? Am I gonna die? Of course I want them to save me. My heart could stop right now! What about my grandkids?) "Sure, I'd like that. Just give it a try. But I don't want to be kept alive if I'm a vegetable."

Doctor: (I sure don't want to break all of this nice guy's ribs and traumatize his upper airway and, if we did get his heart started again, have him helpless in the ICU while we try to decide whether to put a feeding tube down and send him to a nursing home. With any luck he'll die in his sleep when he's not in the hospital.) "OK then. We'll put you down as full code. Just sign here."

I went online to see how other countries do this, and found that there is a great deal of variation. In many Middle Eastern countries resuscitation is performed on all hospitalized patients in the event of cardiac arrest, regardless of patient or family preference. In Australia there are many different policies which are different in different hospitals, and may or may not involve patient and family participation in decision making. In England the patient is involved in these discussions if he or she is competent, but if not, the doctor makes the decision, and if the family has an opinion this is taken into consideration but the doctor really has the final say.

I read an online discussion about an 86-year-old-nursing home resident in the UK with heart failure who was admitted to a hospital and suffered a cardiac arrest. He did not have cardiopulmonary resuscitation CPR due to a nurse thinking he had a do-not-resuscitate order, which he did not. After the event it was agreed that CPR would not likely have saved him, but it was the discussion after the article that was particularly interesting. About half of the people said that it was terrible that mistakes like this ended in a patient not getting life-saving CPR and that in many cases doctors made these decisions and "played God." The other half were people who said that they had seen CPR on old people and it was brutal and hardly ever worked.

Clearly doctors should not get to or have to "play God." Clearly, also, people who we ask to make these decisions, patients or families, usually don't know what we are really talking about when we ask them to make a decision about resuscitation ("code status.") Physicians are much less likely than our patients to request resuscitation in the event of cardiac arrest. I think our values are pretty much the same as those of our patients, we just know more about what cardiopulmonary resuscitation and its aftermath really look like.

So here is a good solution that preserves the autonomy of the patient while allowing the physician to do his or her job, which is taking care of the patient while following our Hippocratic Oath to "do no harm".

CPR, intubation and ventilation are medical procedures, just like a tonsillectomy or a hip replacement. There are expected risks and benefits. The risks are not insignificant and the magnitude of the expected benefits vary with each patient. If a patient really wants CPR, he or she or a surrogate decision maker should sign a consent form (well in advance of experiencing a cardiac arrest) which includes risks and benefits. The benefits, of course, would be to live and recover enough to be able to leave the hospital. In the least complex patient, 1 in 5 of those who have a heart event which requires CPR can be expected to survive to hospital discharge. In the most complex, the expectation is 1 in 20 or less. The risks include, but are not limited to: pain; broken ribs; punctured lungs; trauma to mouth, teeth and upper airway; aspiration pneumonia; loss of brain function; multi-organ failure, prolonged dependence on caregivers including being confined to nursing home; monetary expense, and all the usual complications of prolonged intensive care unit and hospital stays. Also, should we not be successful, loss of the opportunity to die in peace.

Presently our POLST forms say none of that. Different states have different forms, but I have been involved in completing ones in California, Oregon, Idaho and Washington and they share similarities. They start with a check box for CPR or DNR. Then there are other boxes specifying the general level of interventions, including comfort care (giving only treatments that provide comfort without attempt to prolong life), limited interventions (lengthen life, but generally not in an intensive care setting and not using advanced life support techniques) and full treatment (everything, dialysis, ventilator, electrical cardioversion, the works.) Then there may be questions about whether artificial nutrition by IV or tube is acceptable, whether blood products are OK, whether antibiotics should be used. It is really hard for a patient or family to get through all of these questions, and many of them are too complex for a person without healthcare experience to understand. Still, they are a good starting point for discussion.

In general the patients who I talk to just want me, as the doctor, to make the right decisions at the right time that are most likely to get them what they want. Most of them want as much good life as possible, the relief of whatever discomfort or disease brought them in, and to have this done as quickly and economically as possible so they can go home. We have no box for this on the POLST form.

I would propose that we should add this box, up at the top, as an alternative to "CPR" vs "DNR." I would propose that the choice be called "Resuscitation at the discretion of physician, guided by my goals of care." This would allow a nuanced decision about resuscitation--from none at all if the patient had been declining and not responding to treatment and was found unresponsive and pulseless (a situation which almost never results in success) to full resuscitation for a witnessed collapse with ventricular fibrillation in a patient who had a pretty good level of function.

This does, however, require another piece of paper, which I think should be part of any patient's admission to the hospital, and probably part of the chart at the primary care doctor's office. This would be "goals of care." There was an article in the New England Journal of Medicine last year that talked about altering our ideas of success in medical care to reflect how well we helped a patient achieve their goals rather than focusing on specific markers of disease control. Some patients value not being dizzy and not taking a bunch of expensive pills more than they value good blood pressure control, for instance.

I think it is important to know, at the time of hospitalization, what a patient really wants. Do they really need to be discharged by a certain date or time? Do they have lousy insurance and need their care to be as thrifty as possible? Do they really value pain control, or sleep at night, or making sure to have a certain meal on time? Do they need quiet, or visitors? Do they want to avoid antibiotics or medications that can cloud their thinking? Do they think that spending time in a nursing home would be OK? Are they hoping to die in the hospital because their burden of disease is becoming intolerable? Do they want to make it home for Christmas or live until a grandbaby is born? We don't ask these questions and we should, or at least somebody should.

If a person chooses "CPR" or "RDP" (resuscitation at the discretion of physician) they, or their surrogate, really need to read and sign the informed consent form for resuscitation, because they do need to know what this means.

I hate filling out forms, but if they help focus treatment so it is more appropriate and if they help me understand my patients and communicate with them more effectively, I'm OK with that.

So, the bottom line: In order to have patients make better decisions about resuscitation, we need to share more information with them and allow them to depend on our clinical judgment to help them have the outcomes they really want. To do this we should: first add a box to the POLST form that specifies "resuscitation at the discretion of physician" as an alternative to "CPR" or "DNR". Second, we should create an informed consent for resuscitation which makes clear expected risks and benefits and have everyone who wants resuscitation sign it. Third, we should make sure that patients are asked about their goals of care at the time of admission to the hospital and that physicians read them and honor them as much as is practical. Fourth, for those unable to complete a POLST form or give informed consent for resuscitation, physicians should make the decision about whether to resuscitate based on most patients' goals of care and good clinical judgment. This is, after all, what we would do for such a patient with any other procedure that we perform in the hospital.

Janice Boughton, MD, FACP, 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.

If rounding did not exist, would I create it?

@JoshHerigon asks (after an interesting back and forth on Twitter yesterday): I'm saying--if you never knew what "rounding" was, would you still develop a system for meded/pt care that looks like our rounds?

The answer is yes, but it deserves an explanation.

One cannot avoid rounds on inpatient rotations. Rounds are simply the process of seeing all the patients and making clinical decisions with those patients. If one is caring for patients in the hospital, then one must see all the patients. Rounds in that sense are a tautology.

But I do not think that is the question. The underlying question refers to medical education. Should attending physicians see the patients with the learners and teach during those visits? Again I say yes.

We have learned from this article: "The most consistent finding was that more patients cared for per day was associated with higher examination performance. More structured learning activities were associated with higher examination scores for students with lower baseline USMLE 1 achievement."

Clearly, one cannot learn medicine without patients. Osler famously said, "He who studies medicine without books sails an uncharted sea, but he who studies medicine without patients does not go to sea at all."

Seeing patients as a student or resident without having the attending physician discuss the findings, demonstrate the physical findings, and explicate the thought process almost nullifies the experience. We learn much at each level of training. Each year we become more sophisticated. Seeing patients directs our growth.

What is the best way for the attending to give feedback to students and residents? I (and many others) believe that rounding provides the ideal setting for practical teaching.

If I had to invent rounding, it would be for the combined benefit of the learners and the patients. I do believe that when well done, rounding represents the critical teaching activity for learners, and the most important exercise for patients.

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 Associate Dean for the Huntsville Regional Medical Campus of UASOM. He also serves as a frequent ward attending at the Birmingham VA Hospital. This post originally appeared at his blog, db's Medical Rants.

QD: News Every Day--Comorbidities associated with GI bleeds more than aspirin, NSAIDs

Nongastrointestinal comorbidity may be a larger independent risk factor for gastrointestinal bleeding than previously thought, and may contribute more to bleeding than other recognized risk factors, a study found.

Upper gastrointestinal bleeding rates continue despite decreasing incidence of peptic ulcers, news treatments for Helicobacter pylori infection, and prophylaxis against ulceration from nonsteroidal anti-inflammatory drugs.

To investigate whether comorbidity itself increased the risk of gastrointestinal bleeding, researchers conducted a matched case-control study using primary care and secondary care data collected in England from April 1997 through August 2010. More than 16,000 patients with nonvariceal gastrointestinal bleeding were matched to five controls (nearly 82,000 patients).

Results appeared in the June issue of Gastroenterology.

Comorbidity had a strong graded association with gastrointestinal bleeding, the authors wrote. The adjusted odds ratio for a single comorbidity was 1.43 (95% confidence interval [CI], 1.35 to 1.52) and for multiple or severe comorbidity was 2.26 (95% CI, 2.14% to 2.38%).

The additional population attributable fraction for comorbidity (19.8%) was considerably larger than that for any other measured risk factor, including use of aspirin (3.0%) or NSAIDs (3.1%).

The largest association with a bleed was among patients with a previous Mallory-Weiss syndrome, which reflects the inherent risk of bleeding in recurrent vomiters. The highest variance inflation factors were for angiodysplasia (1.48) and dialysis (2.35).

Researchers wrote that this study contradicts current beliefs that the bleeding stems from known iatrogenic causes, such as NSAIDs prescribed for analgesia or antiplatelet agents prescribed for cardiac and cerebrovascular disease, and that this would be reduced by increasing use of proton pump inhibitors.

They wrote, "Instead, we have demonstrated that the extra contribution of these medications to bleeding cases was not large after considering the contributions of other risk factors present in the population. Therefore, simply increasing PPI prescriptions in patients on high-risk medications might not have as large an impact as previously thought."
Wednesday, June 19, 2013

The kibosh

Over the past several days I have spent a lot of time talking to patients, trying to explain why I've had to cancel their upcoming fecal transplant. The FDA has ruled that stool is an investigational new drug (IND), which now imposes a huge bureaucratic hurdle to getting a much needed therapy for patients with recurrent or intractable C. difficile infection. Today's Omaha World-Herald covers the new ruling and features our fellow blogger Dan Diekema, MD, FACP.

Even before the FDA did this, there were already hurdles for patients who are really suffering a great deal. First, there are few physicians who are providing this therapy. I have had patients drive over 8 hours to come for a treatment that is quite primitive but amazingly effective. For the doctor it's time consuming and the reimbursement is very poor. Nonetheless, I have felt morally compelled to provide this therapy and as a result I have many thankful patients. Then there is the issue of insurance companies not covering the cost of donor testing, which costs $1,500-2,000. Now there's the additional burden of the FDA red tape and the numerous documents required by institutional review boards.

So now I must apply for an IND number, which requires that I send the FDA my protocol. On the 30th day after receipt of my documents the FDA will let me know whether I can proceed. When I talked to the FDA officer yesterday she informed me that the FDA is only interested in fecal transplants with regards to safety. They want to ensure that donors are appropriately screened. Thus, I need to send them my protocol for donor testing and then I will get a ruling. I asked the officer what the FDA was looking for and was told that they can't say but will either approve or not approve my protocol. Now wouldn't it have made more sense for the FDA to review the literature and consult experts about what optimal testing of donors and safeguards should be for the procedure and simply require practitioners to follow their guideline instead of the guess-what-I'm-thinking-and-wait-30-days game?

Ok, enough Debbie Downer. Now something positive: here's an article about a pathology resident at Emory University, Dr. Hunter Johnson, who goes beyond the call of duty and serves as a stool donor. In the article he talks about how important it is to perform on command. I learned that lesson the hard way. When I first starting performing fecal transplants, I explained to patients the important exclusions for donor selection, such as no recent foreign travel and no recent antibiotics. But I never thought to tell patients that choosing a donor who has problems with constipation is probably not a wise choice until the day the patient arrived for a transplant with his donor but with no stool specimen in hand. Constipation is now on my list of exclusion criteria for donors!

Michael B. Edmond, MD, FACP, is a hospital epidemiologist in Richmond, Va., with a focus on understanding why infections occur in the hospital and ways to prevent these infections, and sees patients in the inpatient and outpatient settings. This post originally appeared at the blog Controversies in Hospital Infection Prevention.