Wednesday, August 31, 2011

Physician questions the need for demographic data with the EMR

Race is a medically meaningless concept.

Spare me the few tired cliches about prostate cancer, diabetes, and sarcoidosis being more common in blacks than whites, or even the slightly increased risk of angiotensin converting enzyme inhibitor cough in patients of Asian descent. We screen Jews of Ashkenazi descent for Tay Sachs without any racial labeling. All that information is readily accessible under the family history section of the medical history. It is no more than custom which dictates the standard introductory format including age, race, and gender. It turns out I've blogged about this before at some length (pretty good post, actually). What is new is the advent of electronic medical records.

Much hullabaloo has been made about federal stimulus funds allocated to doctors as payments for adopting electronic medical records, "up to $44,000!" Here's the problem with that figure, though, including how it breaks down (source here): [M]aintaining [an EMR] costs multiple thousands of dollars a year. Bear in mind that they're not talking about a lump sum payment of $44,000. It's $18,000 the first year, $12,000 the second year, $8000 the next, $4000 the next, and then $2000, for a total of $44,000 spread over five years. FOR A SYSTEM EXPECTED TO COST AN AVERAGE OF $10,000 PER DOCTOR PER YEAR, not counting the start up costs, which run in the vicinity of $50,000. $44,000 over five years for something that will cost us $90,000 over the same period? And that's even if they actually get around to giving out the money in the first place! According to this, in order to qualify for "meaningful use," EMRs must be used for e-prescribing, for communicating with other EMRs like labs and hospitals, and for transmitting information on performance measures (the paternalistic proxy for "quality") to the government.

Just because my electronic systems didn't end up costing me anything, it turns out that even though I bill Medicare less than $25,000, I'm still eligible to apply for some of the stimulus money. So just for sh**s and giggles, I hooked up with a government funded entity whose stated purpose in life is to help me get that money. Cool.

I've had a couple of visits with them so far. It turns out that my freebie EMR has features which I hadn't bothered using yet, mainly because they didn't seem particularly useful in the provision of medical care--that's what I do, remember?--to patients. One of them was a so-called "demographics" section, right below such vital information as patient name, address, phone numbers, and birth date. This section contains three pieces of information I have to enter, one from a set of radio buttons, and two from pick lists, mechanisms that allow for the collection of what is known as "structured data" instead of just information I type into the EMR "free form."

The first item is "ethnicity". There are three radio button options: Hispanic, Non-hispanic, and Unspecified (the default).

The second item is "Preferred Language", to be selected from a pick list. I can only enter one option.

The third item is "Race", again to be selected from a pick list. They include "African or African-American," "Asian or Asian American," "European or Caucasian American," plus several other basically meaningless classifications. (For example, what entry do I use for an individual from the Indian subcontinent?) Unlike "Language," I can enter as many of these options as I wish.

What? The? F?

Aside from the language entry, which could perhaps be useful in a very large, very diverse practice, neither "Ethnicity" (limited to Hispanic or Not) nor "Race" has any possible legitimate bearing on diagnosis, treatment, or any other aspect of medical care. And yet an integral part of government-defined "meaningful use" consists of completing this section of the medical record.

Interestingly, a stated later requirement is for me to submit information from my EMR to the government, ostensibly for what they're currently calling "reporting purposes."

Now, what government function uses demographic data like race and ethnicity (i.e., Hispanic or not)? Would that be the tracking of, say, voting patterns? And doesn't it seem like a handy way to collect that data, neatly sorted by address and birth date, rather than having to use the decidedly old-fashioned, up-to-a-decade-out-of-date but actually legal way of tracking that information through the census?

How Orwellian to require that "meaningful use" incorporate the recording of medically meaningless data.

This post by Lucy Hornstein, MD, appeared at Get Better Health, a network of popular health bloggers brought together by Val Jones, MD. Better Health's mission is to support and promote health care professional bloggers, provide insightful and trustworthy health commentary, and help to inform health policy makers about the provider point of view on health care reform, science, research and patient care.

No 'love in the time of cholera' in Haiti

Is anyone paying attention to the plight of Haiti anymore? Unfortunately the rebuild (after the earthquake on Jan 12, 2010) never really happened and Haiti seems as poor and troubled as ever. Over 800,000 people still live in makeshift tent encampments. Now they are plagued with a cholera epidemic that just won't stop. It is nearly impossible to eradicate cholera when sanitation is poor, clean water is scarce and people have no resources.

Thousands of Haitians live in rural communities that are isolated because of poor roads and no real facilities. Many of these villages are inaccessible to cars or trucks. Poor water hygiene is the cause of cholera in these areas and rains flush contaminated soil into the rivers and people get infected.

Cholera strikes very quickly and children especially become dehydrated from massive diarrhea within hours. Treatment is not difficult if it can be started in time, but the death rate has already surpassed 5,500 since the epidemic began in October. Where there are no roads, no hospitals and no health facilities, there is essentially no prevention or treatment for cholera. Death follows.

Despite my interest in Haiti, I have been unable to understand the government (or lack of) and why the billions of dollars in pledged aide has been so ineffective. We have former Presidents Bill Clinton and George W. Bush in partnership with other governments who pledged to help rebuild Haiti from the ground up. What has happened?

According to National Public Radio, the Pan American Health Organization has decided a large scale cholera vaccination campaign should begin in Haiti. One drug manufacturer offered to donate tens of thousands of vaccines but the Haitian government turned it down because they were worried about civil unrest among people who couldn't get the vaccine. That type of thinking just baffles me and I wonder why there is not more hard diplomacy in Haiti to get the government to do the right thing for its people. If the government is unable to manage the rebuild and put in infrastructure for roads, agriculture, water systems and basic health care, despite the billions of pledged dollars, somehow the international community should take over.

When was the last time Secretary of State Hillary Clinton visited Haiti? Why is there not an outcry from other nations, including the U.S. at what we are seeing just a few miles from our borders.

Partners in Health is still on the ground providing health care. Doctors and Nurses from San Francisco have not forgotten Haiti and another mission to work with local doctors and provide supplies and training is underway. As great as this is, it is just a drop in the ocean of misery for Haiti.

A large scale solution is needed and it must be undertaken by the government of Haiti.

This post originally appeared at Everything Health. Toni Brayer, 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--Menthol makes it harder for minorities to quit smoking

Menthol cigarettes are associated with decreased success in quitting smoking among white, (7%), black (19%) and Puerto Rican (43%) users, fueling evidence for the Food and Drug Administration to ban the flavoring in cigarettes.

today i stopped smoking by Isabel Bloedwater via Flickr and a Creative Commons licenseTo explore whether menthol cigarette smokers are less likely to quit and how race/ethnicity affects this relationship, researchers conducted a cross-sectional analyses of the 2003 and 2006/2007 Tobacco Use Supplement to the Current Population Survey.

In this study, former smokers who recently quit were not excluded in order to study menthol's potential impact on success rather than on quit attempts. Separate models were generated for Hispanics by country of origin. And, five sample restrictions were employed:
1) former smokers who quit within the past five years and all current smokers regardless of quit attempt history. This represents the broadest population of more heavily addicted smokers who may not try to quit because of low self-efficacy;
2) former smokers who quit within the past five years and all current smokers regardless of quit attempt history who do not use other tobacco products, such as switching from smoking to smokeless tobacco, for example;
3) former smokers who quit within the past five years and current smokers who reported ever having tried to quit;
4) former smokers who quit within the past five years and current smokers who reported ever having made a quit attempt, both of whom currently do not use other tobacco products, such as switching from smoking to smokeless tobacco; and
5) past-year cigarette smokers who tried to quit or succeeded in doing so. This is the narrowest subgroup, which most closely reflects the cessation-seeking population found in other studies.

Results, scheduled for the October edition of the American Journal of Preventive Medicine, were released online Aug. 15.

In the broadest sample restriction, menthol smokers were less likely to have quit smoking (adjusted odds ratio [AOR], 0.91; 95% confidence interval [CI], 0.87 to 0.96). This overall finding held against various sample restrictions, ranging from an AOR of 0.90 for sample restriction 3 to a high of 0.92 for sample restriction 2. It was not significant for sample restriction 5 but was consistent as a trend.

This relationship holds among whites (AOR, 0.93; 95% CI, 0.88 to 0.98) and blacks (AOR, 0.81; 95% CI, 0.67 to 0.98). But results differed by Hispanic origin. Among those of Mexican origin, menthol was not significant (AOR, 1.29; 95% CI, 0.99 to 1.61), especially in sample restrictions that represented product switching, such as from smoking to smokeless tobacco. Among those of Puerto Rican origin, menthol smokers were less likely to have quit (AOR, 0.57; 95% CI, 0.37 to 0.87) across all five sample restrictions.

The differences warrant more research into their potential causes, the researchers wrote. For example, Puerto Ricans, who overwhelmingly reside in the Northeast U.S., may live in areas where menthol cigarettes are more heavily marketed. These factors may also explain the results observed for black smokers, as they generally followed the same trend as that for Puerto Rican smokers.

The authors wrote, "Supporting the claim that menthol flavoring makes it harder to quit smoking, particularly for certain subgroups, may be unpopular in some circles. However, the findings from the current study are broadly consistent with other research on menthol flavoring and smoking-cessation outcomes. The evidence suggests that menthol may be one of the mechanisms that drives observed differences in cessation outcomes."
Tuesday, August 30, 2011

Is gluten-free just a fad?

There is a sizable, but still decidedly minority population that can benefit in terms of feeling better by excluding gluten, entirely or mostly, from their diets. There is a population, an order of magnitude smaller, for which it is vital to do so, and potentially even a matter of life and death. For everyone else, going gluten free is at best a fashion statement. Now, let's mill the details.

Photo by the USDA Agricultural Research ServiceGluten is generally described as a protein, which is basically correct. The compound is basically two proteins, gliadin and glutelin, bound together by starch (a carbohydrate). In nature, gliadin is found predominantly in the seeds of various grasses. We typically refer to the edible seeds of grasses as grains.

Grains, in turn, are made up of three parts: the bran or hull, the germ and the endosperm. Whole grains contains all three. Gluten is found in the endosperm, the principal part of the grain retained when grains are refined (and generally considered the least nutritious component). Consequently, gluten is present in grains such as wheat, rye and barley, whether or not they are "whole."

If one adopts the long view of paleoanthropology, grasses are not native human food. We don't digest the stalks per se, and the seeds of most grasses are too small to bother with. Grains therefore entered the human diet only with the advent of agriculture in the Fertile Crescent some 12,000 years ago, when their domestication led to increases in seed size. The large seeds of wheat and other edible grains familiar today are not accidental, but the product of careful nurturing by humans over millennia of the grasses nature provided.

But still, only a dozen millennia, and while that's long enough for human selection to change grains, it's not a long time for natural selection to change humans. One of the important contextual considerations when attempting to explain health effects of gluten observed today is that this really is a recently introduced nutrient, foreign to the Stone Age diet that shaped our biological adaptations.

Those health effects are ever more prominently under scrutiny.

The most significant health problem associated with gluten consumption is, technically, gluten-sensitive enteropathy, long known as celiac disease, celiac sprue or non-tropical sprue. In this condition, the immune system mounts a response to gluten as if it were a dangerous invader, such as a pathogen. The resulting inflammation damages the intestinal lining, leading to malabsorption of diverse nutrients, including both vitamins and minerals. Adverse effects can be severe, ranging from abdominal discomfort, to the manifestations of nutrient deficiencies, to an itchy rash, and over time, increased risk of intestinal cancer. Unaddressed, the condition and its complications can be lethal.

Along with celiac disease, there is also the milder "gluten sensitivity." This term is something of a catch-all, likely referring to various forms of intolerance and true allergy to gluten. The distinction between such conditions and celiac disease is that measurable antibodies to gluten are absent, as is observable damage to the lining and architecture of the intestine. Also absent is the nutrient malabsorption and increased risk of cancer. Recent insights, however, suggest the two conditions may overlap more than previously thought with regard to diverse symptoms.

There is good reason for gluten to loom large in current health lore: the numbers adversely affected by it are rising. To some extent, this is a product of something called "detection bias." The more aware and concerned the health care community is about any given health condition, the more we tend to look for it. The more one looks for any given condition, the more one tends to find it. In contrast, you don't tend to detect what you don't first consider, and for a long time, gluten sensitivity was under the proverbial radar.

Health professionals' sensitivity to gluten sensitivity accounts for some portion of the rising prevalence, but certainly not all. Studies based on blood kept in storage clearly indicate that actual rates of celiac disease have risen over recent decades, as much as four-fold in the past half a century. There is more to this story than better detection.

To my knowledge, no one knows for sure why this is happening, but there are theories. Against a backdrop of genetic vulnerability (both celiac disease and other forms of gluten sensitivity tend to run in families), there are new-age exposures to gluten that may be more likely to trigger immune system responses. In some cases, genetic modifications have increased the gluten content of wheat and other grains. It may be that genetic modifications are also introducing new nutrients into the diet, and some reactions to gluten may be primed by the company it is keeping.

There may also be an influence of nutrient combinations due to modern food processing. Gluten is a widely used texturizer. That it is found in wheat, barley, rye, triticale and possibly oat-containing products is expected. That it is found in everything from candy, to deli meats, to potato chips may be less so. Its use in all these foods is producing novel nutrient pairings, and perhaps these also function at times as an immune system trigger.

In the U.S. today, celiac disease is far from rare, affecting roughly 1% of the population at large. Gluten sensitivity affects 5 to 10 times as many. Celiac disease can be diagnosed by blood tests, biopsies or both, so you will your clinician's help. The only truly reliable test for gluten sensitivity is a trial elimination of gluten to determine if symptoms wax and wane its intake. You can do this with the help of a nutrition expert, or all on your own.

Prevalent as it is, gluten sensitivity still only affects a minority in the general population, but gluten preoccupation appears to affect many more. The potential adverse health effects of gluten in those sensitive to it have reverberated in cyberspace, creating the impression that gluten is a bona fide toxin, harmful to all. This is false; gluten is not "bad" for those tolerant of it, any more than peanuts are "bad" for people free of peanut allergy.

Also abounding are home-grown theories about health effects of gluten, including the argument that going gluten free leads to weight loss. It might, but only because avoiding gluten means avoiding a lot of foods, which in turn tends to mean reducing calorie intake. That lowering calories leads to weight loss is less than an epiphany.

Going gluten free is easier than it once was due to better food labeling, more gluten-free products and ever better guidance, in print and online. But it is still quite hard, given the widespread use of gluten in packaged foods, under a wide variety of aliases. The effort is well-justified for those who are truly gluten-sensitive, but potentially much ado about nothing for others just caught up in the trend.

In addition, the exclusion of whole grain wheat, rye, barley and potentially oats from the diet might reduce overall diet quality and fiber intake. Again, a price worth paying when gluten avoidance is clearly necessary, but cost without benefit for others.

So, as noted at the start: there is a decidedly minority but still sizable, and apparently growing, population that can benefit from excluding gluten (entirely or mostly) from their diets. There is a population an order of magnitude smaller, also growing, for which it is vital to do so, and potentially even a matter of life and death.

For everyone else, going gluten free is at best a fashion statement, and at worst an unnecessary dietary restriction that results in folly. It reflects a tendency to ingest the ever proliferating pop-culture perspectives on diet and health, without first separating the wheat from the chaff.

David L. Katz 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.

QD: News Every Day--Chocolate's good effect is also its bad effect

Eating a lot of chocolate was associated with a 37% reduction in cardiovascular disease and a 29% reduction in stroke compared eating less, researchers reported. But, people are trending toward record obesity by the year 2030, which is a cardiometabolic risk in its own right.

Willie Wonka's factory wasn't the only risky place for those with a sweet tooth.

Chocolate Melting by peter pearson via Flickr and a Creative Commons licenseIn the first study, to evaluate the association of chocolate with the risk of developing cardiometabolic disorders, researchers performed a meta-analysis of randomized trials, six cohort and one cross-sectional, which reported the association between chocolate and the risk of cardiovascular disease (coronary heart disease and stroke), diabetes, and metabolic syndrome for about 114,000 people.

Because the studies reported chocolate consumption differently, researchers qualified the results from each into levels of the highest or lowest chocolate consumption in each trial. Results appeared in BMJ.

Five of the seven studies reported a beneficial association between higher levels of chocolate consumption and the risk of cardiometabolic disorders. The highest levels of chocolate consumption were associated with a 37% reduction in cardiovascular disease (relative risk [RR] 0.63; 95% confidence interval [CI], 0.44 to 0.90) and a 29% reduction in stroke compared with the lowest levels. No significant association was observed for heart failure (RR 0.95; 95% CI, 0.61 to 1.48).

The authors wrote, "[C]hocolate might be a viable instrument in the prevention of cardiometabolic disorders if consumed in moderation and if efforts are made to reduce the sugar and fat content of currently available products." And, the effect would benefit countries where cocoa is grown but not processed with all the fats and extra sugars.

But not so fast for Americans, the authors cautioned. Chocolate snacks pack about 2,100 kJ (500 kcal) for every 100 grams, so excessive consumption causes weight gain, which is a cardiovascular risk in and of itself.

And obesity is on the rise in England and America, according to the latest study on trends.

In another study, researchers looked at the National Health and Nutrition Examination Survey in the U.S. and the Healthy Survey for England from the U.K. and made projections for the probable range of the outlook of growth in obesity prevalence for the next 20 years. Results appeared in The Lancet.

Trends project 65 million more obese American adults and 11 million more obese British adults by 2030. These trends could in turn trigger an additional 6 million to 8.5 million cases of diabetes, 5.7 million to 7.3 million cases of heart disease and stroke, and 492,000 to 669,000 more cancers.

There would be 26 million to 55 million quality-adjusted life years forgone for both countries combined and increased medical costs of $48 billion to $66 billion annually in the U.S. and 1.9 to 2 billion in British pounds annually in the U.K.

The Lancet published the research as part of a much larger series about obesity.
Monday, August 29, 2011

Shame on you, New England Journal of Medicine

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

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

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

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

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

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

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

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

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

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

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

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

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

QD: News Every Day--Half of hospitals buy gray market drugs

Severe shortages for life-saving medications have driven a "gray market" in the wholesale drug supply industry, a watchdog group reports.

And the mark-up on gray market drugs is a budget-buster, reports the Institute for Safe Medication Practices, a Philadelphia-based nonprofit organization devoted entirely to medication error prevention and safe medication use. Purchasing agents and pharmacists at 549 hospitals responded to a survey on gray market activities associated with drug shortages.

The report includes chilling anecdotes from the respondents about pressure from physicians and administrators to ensure drugs are available, and drastic price gouging from the gray market suppliers. Price mark-ups of 10 times or more than the contract price were reported by about a third of respondents from critical access hospitals and community hospitals, and more than half of university hospitals. Examples include a box of calcium gluconate that cost $750 instead of the contract price of $50 (1,400% mark-up), and a supply of propofol that cost $25,000 instead of $1,500 (1,567% mark-up). Oh, and there's exorbitant shipping and handling fees, too.

More than half (52%) of respondents reported buying one or more drugs from gray market vendors during the past two years. Most (80%) of these respondents said gray market purchases increased as drug shortages grew. While most respondents (54%) reported buying products from only one or two gray market vendors, a quarter (25%) of university hospitals reported purchases from more than five.

Even in states that require documentation of authenticity for pharmaceuticals, 50% of respondents bought medications from the gray market during the past two years. Of these, only 35% reported always receiving the required documentation of authenticity. Approximately two-thirds of all respondents never checked the manufacturer's website to see if the secondary distributor was authorized by the manufacturer. Most were unaware that this information is available.

And, 56% respondents get daily solicitations to buy medications no longer available through the manufacturer or usual wholesaler. They often contain high-pressure pitches more suitable to QVC than to health care, such as, "We only have 20 of this drug left and quantities are going fast." And 13% of respondents also are solicited to sell their stocks of drugs into the gray market.

In general, the most common reasons respondents did not buy gray market drugs were concerns about authenticity (74%), ethics (66%), cost (69%), and storage conditions (58%).

Up to 12% of respondents reported awareness of a product authenticity issue, medication error, or adverse drug reactions associated with the use of gray market products in the past two years. Most cited errors include a different product strength, improper storage, recalled or stolen products, illegally imported drugs, questionable chain of custody, and sale of counterfeit products and placebos.

The Institute for Safe Medication Practices suggests a four-pronged strategy:
--The Food and Drug Administration (FDA) needs greatly enhanced authority to manage drug shortages.
--Stronger regulations are needed for pharmaceutical distribution, such as a national law to limit distribution of pharmaceutical products to authorized distributors of record, and to limit price gouging during shortages.
--Minimize the need for buying gray market drugs by planning ahead, forming local coalitions to cooperatively borrow from each other, back-ordering or direct ordering from the manufacturer, and seek out alternatives for drugs in short supply.
--Take stronger regulatory and law enforcement action against illegal activities, such as counterfeiting and theft. Five drug makers are seeking stronger penalties for stealing chemotherapy drugs, for example.
Saturday, August 27, 2011

Great care doesn't exclude excellent bedside manner

The New York Times recently published an article titled, "Finding a Quality Doctor", Dr. Danielle Ofri, an internist at New York University [and a Fellow of the American College of Physicians], laments how she was unable to perform as well as expected in the areas of patient care as it related to diabetes.

From the August 2010 New England Journal of Medicine article, Dr. Ofri notes that her report card showed the following: 33% of patients with diabetes have glycated hemoglobin levels at goal, 44% have cholesterol levels at goal, and a measly 26% have blood pressure at goal. She correctly notes that these measurements alone aren't what makes a doctor a good quality one, but rather the areas of interpersonal skills, compassion and empathy, which most of us would agree constitute a doctor's bedside manner, should count as well.

Her article was simply to illustrate that "most doctors are genuinely doing their best to help their patients and that these report cards might not be accurate reflections of their care," yet when she offered this perspective, a contrary point of view, many viewed it as "evidence of arrogance."

She comforted herself by noting that those who criticized her were "mostly [from] doctors who were not involved in direct patient care (medical administrators, pathologists, radiologists). None were in the trenches of primary care."

From the original NEJM article, Dr. Ofri concluded when it related to the care of patients with diabetes and her report card: I don't even bother checking the results anymore. I just quietly push the reports under my pile of unread journals, phone messages, insurance forms and prior authorizations. It's too disheartening, and it chips away at whatever is left of my morale. Besides, there are already five charts in my box--real patients waiting to be seen--and I need my energy for them.

As a practicing primary care doctor, I'm afraid that Dr. Ofri and many other doctors are making a fundamental attribution error in assuming that somehow doctors can't do both. She is also wrong in thinking that the real patients waiting to be seen are somehow more important that those whose blood pressure, cholesterol, and blood sugars are poorly controlled and the disease literally eats them up from the inside which could result in end organ damage to the eyes (blindness), kidneys (renal failure resulting in dialysis), extremities (amputation), and heart (coronary artery disease) and possibly premature death. They aren't in the office and yet are suffering.

Until we as doctors begin to take responsibility for our performance in hard clinical and objective outcomes like glycated hemoglobin levels, cholesterol, and blood pressure, our patients will pay a price. We should not pretend that bedside manner should trump clinical outcomes nor that clinical outcomes should override the humanistic part of medicine.

It is possible to do both today. It isn't theoretical. I only serve as one example.

I'm a front-line primary care doctor who also takes care of patients. I, like Dr. Ofri, also get a report card on my performance in caring for patients with diabetes.

Based on the medical evidence, my goals are set similarly to hers. For 2010, my performance wasn't perfect but was 88.6%, 80.8%, and 70% at goal respectively.

I suspect critics will immediately begin to make a lot of assumptions of how these scores were achieved, when Dr. Ofri, another primary care doctor had very different outcomes. Is it that I am not a quality doctor? Perhaps I'm too driven by data and have no "soft" attributes like attentiveness, curiosity, compassion, diligence, connection and communication. Perhaps I "fire" those patients who are not able to achieve good outcomes.

I can tell you many patients wish to join my practice and rarely do people choose to leave it. The organization I work for also takes the softer side of medicine, a doctor's bedside manner, seriously. My employer randomly surveys patients on their experience. Does your doctor listen and explain? Do they know your medical history? Do they partner with you in your health? Do you have confidence in the care they provided you?

For 2010, 92.8% rated me very good or excellent on these elements.

So what does this all mean?

We should not automatically assume that doctors with great bedside manner cannot also provide great clinical care.

I can achieve the goals, which patients would want, and still be a doctor with great bedside manner because I work in a functional system like Kaiser Permanente. Primary care doctors are blessed with a comprehensive electronic medical record, are partnered with staff who help patients get the care they need, and are surrounded by specialty colleagues equally as focused to keep patients healthy and well.

So if there is any area of agreement with Dr. Ofri it is that simply giving doctors report cards and telling them to try harder will simply achieve mediocre outcomes. Until a fundamental restructuring on health care is delivered (and simply making appointments longer isn't necessarily going to solve it either), then primary care doctors will continue to leave the specialty in droves. Doctors need to lead change and use tools and skills honed in other industries, whether the Toyota Production model or lean process, which has been utilized by the Virginia Mason Hospital, or usage of protocols and checklists based on scientific evidence as demonstrated by Intermountain Healthcare and Dr. Brent James.

Until we as doctors lead, we cannot or should not expect improvement in patient outcomes. We can no longer hide behind the reasons of our Herculean effort or bedside manner as what should really matter and account for something. Patients expect these attributes intuitively.

With already so many examples of success in the country marrying the art, science, and humanistic part of medicine, the only thing stopping us to re-invent American medicine in the 21st Century is simply ourselves.

This post by Davis Liu, MD, appeared at Get Better Health, a network of popular health bloggers brought together by Val Jones, MD. Better Health's mission is to support and promote health care professional bloggers, provide insightful and trustworthy health commentary, and help to inform health policy makers about the provider point of view on health care reform, science, research and patient care.
Friday, August 26, 2011

Optimism, positive health and stroke risk

Way back in 1946, the chartering documents for a new agency of the U.N., the World Health Organization, defined health as "a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity."

We have made astounding progress in medicine and public health since the WHO charter was crafted, yet we have actualized only part of its comprehensive vision for health. What we call health care today is really just illness care. Even our disease prevention and health promotion programs focus on reducing risk factors for disease. It is the rare initiative indeed that encourages good health for its own sake.

New initiatives focused on the concept of positive health are changing that by helping us understand what it means to be healthy in a comprehensive sense, beyond the simple absence of symptoms and illnesses. The initiatives focus on health assets, which are biological, psychological, social and other characteristics that are associated with prolonged life, reduced morbidity and health care costs, and improved quality of life.

The initiatives have been triggered in large part by the seminal contributions of Martin Seligman. Many are funded by the Robert Wood Johnson Foundation's Pioneer Program. They have already produced provocative results, one of which I discussed last week.

In this post, the second in a continuing series, I review another initiative in the field of positive health. This one examines how optimism impacts the risk of stroke, the nation's third leading cause of mortality and disability after heart disease and cancer.

The study
The classic risk factors for cardiovascular disease (including stroke) include high blood pressure and cholesterol levels, cigarette smoking and diabetes. 'Negative' psychosocial factors like depression, anxiety, work stress, low socioeconomic status and poor social support also predict cardiovascular events. More recently, a few studies have filtered into the literature suggesting that health assets like life satisfaction are also predictive.

However, as the National Heart, Lung and Blood institute recently emphasized, essentially none of these factors are all that good at predicting near term (that is, 1-2 years) cardiovascular events, especially in asymptomatic adults. Furthermore, almost no studies have examined whether positive health assets can impact the risk of stroke, per se.

A study by Eric Kim of the University of Michigan and colleagues has addressed this opportunity. They concluded that optimism was in fact an independent predictor of short-term stroke risk.

To reach this conclusion, Kim's group looked at data from 6,044 adults with no prior history of cardiovascular or cerebrovascular disease. The subjects had participated in the Health and Retirement Study, a nationally representative, prospective study of Americans who were at least 50 years old.

The scientists assessed optimism using the Life Orientation Test, in which participants respond to 3 questions using a 6-point Likert scale. Kim's group created an 'optimism scale' based on participants' responses. The scale ranged from 3 (extremely pessimistic) to 18 (extremely optimistic).

It turned out across the entire survey population, each unit increase on the scale was associated with an age-adjusted 9% decrease in stroke-risk during the 2 year follow-up.

Negative psychological factors like anxiety, depression and neuroticism were also predictive of short-term risk for stroke, but optimism offset their impact.

Of note, the association between optimism and stroke risk persisted after controlling for cardiac disease and dozens of biological, behavioral and sociodemographic factors (including race/ethnicity, marital status, educational status, cigarette smoking history, exercise, alcohol use, diabetes, body-mass index, blood pressure).

What Can We Make of This?
Kim's study is the first to suggest that optimism may protect against stroke in older adults. It is consistent with other research which has shown that positive psychological factors like optimism are associated with a range of cardiovascular benefits, including a reduced risk of rehospitalization following bypass surgery, reduced risk of coronary heart disease and even reduced cardiovascular mortality.

One potential flaw in Kim's study is that stroke incidence was ascertained via self-reporting from participants, based on what they understood from their doctor or by proxy reports for participants that had died (many of the covariates were also self-reported in Kim's study). According to Kim's team however, self-reported stroke has been shown in several other studies to provide an accurate estimate of stoke incidence.

Why might optimism reduce stroke risk? Kim's group mentioned several studies showing that high optimism is associated with health knowledge and the pursuit of healthy behaviors. They hypothesized that optimists might be more proactive about their health in general, perhaps by adopting a healthier lifestyle that minimizes health risks and increases health and well-being.

These theories make sense but require further validation, especially before we can comfortably recommend interventions designed to promote optimism in the effort to reduce the incidence of stroke.

This post by Glenn Laffel, MD, PhD, appeared at Get Better Health, a network of popular health bloggers brought together by Val Jones, MD. Better Health's mission is to support and promote health care professional bloggers, provide insightful and trustworthy health commentary, and help to inform health policy makers about the provider point of view on health care reform, science, research and patient care.

QD: News Every Day--Medical news of the obvious, revisited

"A deeper import
Lurks in the legend told my infant years
That lies upon that truth, we live to learn"

--Schiller: The Piccolomini, Act. ii. Scene 4.

ACP Internist used to run a feature called Medical News of the Obvious which snarkily reviewed medical studies that just didn't seem to cut it, even in today's publish-or-perish world.

Of course, one thing to be wary for when selecting weekly candidates was those studies that only seemed obvious, but actually had a legitimate purpose. For example, some studies seek to test assumptions flouted as "common knowledge." And other studies actually confessed their obviousness, but still forged ahead anyway to learn what could be learned.

Now, Everyday Health has recapped the "12 Biggest Duh Health Studies of 2011," or so they seem. Do hung-over doctors make more mistakes? Do diet and exercise work better together than either one alone? Do heart attack survivors die more often is they continue to smoke? Yes, yes and yes, but how many more, and under what conditions?

Another category of medical news of the obvious is done to confirm what has been known all along. And along those lines comes this study, which confirms the existence of bi-sexual men. As it turns out, this hadn't been confirmed in the lab before now.

And then there's research gets branded as news of the obvious by politicians who have a better grasp of what makes a good sound bite rather than a good study. Politicians in a waste-trimming mood glom onto medical research as a source of budget cutting, but they often don't have the full grasp of what the research is about and how much money was earmarked. NPR reports on two such studies, one of which has become a political catch-phrase: "shrimp on a treadmill."
Thursday, August 25, 2011

Talking about obesity without getting sued

The Washington Times reports, "The leader of the anti-obesity lawsuit movement is threatening physicians-in-training with lawsuits if they don’t warn obese patients about their excessive weight. George Washington University law professor John Banzhaf III, who has led efforts to sue fast-food chains for contributing to America’s extra weight, is scheduled to speak at the annual convention for the American Medical Student Association."

A lawyer warns of obesity suits. He is telling medical students that they need to warn their patients of the risks of their obesity. Not long ago we spoke of a doctor being sued for the way he told a patient she was obese.

Is the bottom line no matter what you do, as a doctor you will be sued?

Maybe as a public service we need to write a legal disclaimer for doctor:
Dear potential patient,

At the advice of counsel, we have been urged to let you know that you are fat. Being fat can make you prematurely die. Please do not be offended in any way. This is a public service message.

I am glad that I am not an internist.

This post by John Di Saia, MD, appeared at Get Better Health, a network of popular health bloggers brought together by Val Jones, MD. Better Health's mission is to support and promote health care professional bloggers, provide insightful and trustworthy health commentary, and help to inform health policy makers about the provider point of view on health care reform, science, research and patient care.

QD: News Every Day--Vaccines cause few health problems

Vaccines cause few health problems, and autism, type 1 diabetes, Bell's palsy or exacerbated asthma have no association to vaccines, concluded the Institute of Medicine from a review of more than 1,000 research articles.

La Vaccine L. Boilly G. Lith. de Delpech. Image from the History of Medicine (National Library of Medicine)The review found convincing evidence of 14 rare health outcomes, including seizures, brain inflammation and fainting. It also found associations between specific vaccines and four other effects, such as allergic reactions and temporary joint pain, although the data was considered only indicative and not convincing.

The review will help the U.S. Department of Health and Human Services administer the Vaccine Injury Compensation Program, and for people filing claims through that program, the staff that administers it and court-appointed "special masters" who rule on vaccine cases.

Convincing evidence shows that the measles-mumps-rubella (MMR) vaccine can lead to fever-triggered seizures in some individuals, although these effects are almost always without long-term consequences, the report said. The vaccine also can produce a rare form of brain inflammation in some people with severe immune system deficiencies.

In a minority of patients, the varicella vaccine against chickenpox can induce brain swelling, pneumonia, hepatitis, meningitis, shingles, and chickenpox in immunocompromised patients and some immunocompetent people, the committee found. The majority of these problems have occurred in individuals with immunodeficiencies, which increase individuals' susceptibility to the live viruses used in MMR and varicella.

First typhoid inocculation, U.S. Army Medical School. Image from the History of Medicine (National Library of Medicine)Six vaccines can trigger anaphylaxis, including MMR, varicella, influenza, hepatitis B, meningococcal, and the tetanus-containing vaccines. They can trigger fainting and inflammation of the shoulder, the committee noted.

Certain vaccines can lead to four other adverse effects, although the data are not as convincing, the report says. The MMR vaccine appears to trigger short-term joint pain in some women and children. Some people can experience anaphylaxis after receiving the human papillomavirus vaccine. And certain influenza vaccines used abroad have resulted in a mild, temporary oculo-respiratory syndrome characterized by conjunctivitis, facial swelling, and mild respiratory symptoms.

The committee's review also concluded that certain vaccines are not linked to four specific conditions. The MMR vaccine and diphtheria-tetanus-acellular pertussis (DTaP) do not cause type 1 diabetes, and the MMR vaccine does not cause autism, according to the results of several studies. Flu shots do not cause Bell's palsy or exacerbate asthma.

The committee focused solely on findings about potential risks of immunizations, and did not draw conclusions about the ratio of benefits to risks. However, the committee members noted that deaths and disability due to infectious diseases have been dramatically reduced over the last century since the majority of vaccines were developed and brought into widespread use.

Le vaccin du croup Andre Brouillet. Image from the History of Medicine (National Library of Medicine)"We do want to emphasize many of the adverse events we examined are exceedingly rare in the population overall, and in most instances any particular adverse event, be it arthritis, meningitis, or any of the other vaccine-adverse events that the committee considered, are not preceded by immunization," the report states. "We chose cautious and scientific language for our conclusions, because, especially with rare events, it is not possible to prove a negative (i.e., the vaccine did not and cannot cause the event). We cannot say that in a certain person at a certain time, some event cannot happen; there is much about biology that is not known."

In related news, one study release earlier this week found no association between flu vaccines and narcolepsy.

A Chinese study concluded that while narcolepsy is highly correlated with seasonal and annual upper airway infections, including H1N1 influenza, the correlation was independent of vaccination.

Researchers did a retrospective analysis of narcolepsy among 629 patients (86% children) in Beijing from 1998 to 2010, in which 182 patients who developed narcolepsy after October 2009 were asked for vaccination history.

Onset was least frequent in November and most frequent in April, with a 6.7-fold increase from trough to peak, researchers found. From year to year, there was a 3-fold increase in narcolepsy after the winter 2009 influenza pandemic. Only 8 of 142 (5.6%) patients reported receiving an H1N1 vaccination.

Big melanoma news as FDA approves vemurafenib (Zelboraf)

In August the FDA announced approval of Zelboraf (vemurafenib) for treatment of some patients advanced melanoma. This is the second drug the agency has approved for this disease in recent months, after nearly two decades of a lack of new or effective therapies for melanoma.

Zelboraf is a pill. This small-molecule drug is thought to work by inhibiting an enzyme in malignant melanoma cells that have a specific BRAF mutation. A few months ago I wrote on this promising new drug, which goes by other names including PLX-0432.

The FDA also approved a companion test, cobas 4800 BRAF V600 Mutation Test, to check for the relevant mutation in patients' tumors. Both the drug and the test are manufactured by Roche.

The other recently-approved melanoma drug, Yervoy (ipilimumab) is an antibody that's given by intravenous infusion. This immune modulator, manufactured by Bristol-Meyers Squibb, works by a completely different mechanism: it blocks an immune system inhibitor, CTLA-4, and so "revs up" the body's healthy immune cells in their capacity to destroy malignant melanoma cells.

Both new drugs are costly. A clinical trial, to test how the two drugs might work together in patients with the relevant BRAF mutation, should open for enrollment in September.

This post originally appeared at Medical Lessons, written by Elaine Schattner, ACP Member, 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.
Wednesday, August 24, 2011

Who pays for medical malpractice litigation?

The short answer: you do. Here's why.

Ask any doctor, at least anyone who has been out practicing clinical medicine for some time, how much the threat of a malpractice suit influences their behavior and odds are, they will tell you, "A lot!" While the degree may vary depending on your specialty, your years in practice, your patient clientele, your prior malpractice history, and the anecdotes you have heard from colleagues, you cannot be immune to the influence of malpractice law as it exists today in the U.S. I had intended to talk about how health care costs are influenced by malpractice, but it is impossible to take up that subject without touching on how my own practice has been affected. And how this directly affects the kind of care I offer my patients.

It has been observed that while most people have negative perceptions of lawyers, most will tell you that their lawyer is a great person. The same has been found true of peoples' attitudes towards doctors, plumbers, auto mechanics and other members of service professions. (Car salesmen, to their misfortune, don't even enjoy that consolation.) Thus it is for malpractice attorneys: Doctors despise plaintiffs' attorneys and look favorably on defense attorneys. Hardly a surprise. And as part of their job, many defense attorneys are engaged by malpractice insurance companies and hospitals not simply to defend malpractice cases after the fact, but to practice "preventive medicine" for malpractice suits. These take the form of lectures and workshops, sponsored by malpractice insurance companies or hospitals, educating us on how to avoid being sued. We listen carefully to the advice of people who make it their profession to defend us. They are the "good guys."

Let me say at the outset that all malpractice defense attorneys will agree and counsel that the best defense is not to commit malpractice in the first place. But they will tell you that the many of the unfavorable judgments they see are not the result of medical errors themselves, but rather errors in patient relations, documentation, office management and other factors that might have easily averted a suit. In fact, they tell us that there are frequently judgments against physicians where the weight of the evidence and overwhelmingly common sense would argue otherwise, due to discrepancies in the way the patient or their family recalls the events. And so we are instructed from time to time on how to do a better job attending to all these factors so as not to leave ourselves open to charges of failing to live up to what is called the "standard of practice."

The last lecture of this sort that I attended began with a recitation of what you might think were preposterous jury verdicts. In one case, a patient was told she needed a test because she might have cancer. She refused it. She went on to get a serious incurable cancer. She sued the doctor for failing to inform her fully of the need for the test. Her reason: "He never told me that cancer could kill me!" Then there was the patient who was told that his brain surgery for a life-threatening blood vessel problem carried a risk of stroke. He sued because, unfortunately, his surgery was complicated by a stroke. His complaint: "He never informed me that a stroke means a partial paralysis!"

Following a series of such cautionary tales, the defense attorney proceeded to instruct us on how we might best avoid such scenarios. An example: 99.9% of all headaches are not due to brain tumors. Numerous scholarly articles in the medical literature have shown how unproductive and wasteful it is to do CAT scans on everyone with a headache. But if the one person in a thousand decides to sue, the plaintiff's attorney will ask, "Doctor, did you know that there was a chance that the patient's headache was due to a brain tumor?" If you start to say, "Yes, I did, but the chances of that were ...," you will be cut off immediately with, "Thank you very much, doctor. So you knew that there was a risk he had a tumor and yet you didn't order a CAT scan, is that right?" So what are we supposed to tell our patients to ensure we don't get sued for failing to inform them of the risk?

The attorney told us that if we thought there was even an infinitesimal chance that a patient's complaint might be a symptom of a cancer, and they ask us, "Doctor, could this be due to a cancer?", we are obliged to tell them "Yes." no matter how remote the possibility and no matter what affect that answer might have on the patient's emotional state.

What might be the effect of our heeding this advice? I'll leave you to wonder until the next entry.

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.

QD: News Every Day--Marital transitions cause weight gain

Women gain weight after marriage and men after divorce, especially among those over 30, likely the result of "weight shock" to people's routines in physical activity and diet, sociologists reported.

The research, led by a sociology doctoral student at The Ohio State University, was presented at a roundtable on Marriage and Family at the annual meeting of the American Sociological Association. They used data from the National Longitudinal Survey of Youth '79, a nationally representative sample of men and women ages 14 to 22 in 1979. The same people were surveyed every year up to 1994 and every other year since then, reported a press release.

Data on more than 10,000 people surveyed from 1986 to 2008 was used to determine weight gain in the two years following marriage or divorce. Researchers separated people into four groups based upon body-mass index: those who had a body-mass index decrease of about 7 pounds for a person 5' 10" tall; those who gained 7-20 pounds; those who gained more than 21 pounds; and those with no gain or who lost less than 7 pounds.

While there have been many studies about weight gain after marriage or divorce, most of them look at average changes in weight and find very small increases or small decreases in weight. But these results may mask the fact that some people actually lose weight, while some stay the same and some have large weight increases, one of the researchers said.

"For most people, the weight gain we see after a marital transition is relatively small, not something we would see as a serious health threat," researchers reported.

The results fit with other research on how marriage affects men and women. Women may have less time for diet and exercise after marriage, and men lose their health benefits gained in marriage after leaving the relationship. Researchers reported that people settle into certain patterns of physical activity and diet over time, and the sudden transition "is a bigger shock than it would have been when you were younger, and that can really impact your weight."
Tuesday, August 23, 2011

Greedy insurance company backs down and the little guy wins!

A few months back, while we were on vacation in Washington, D.C., my 17-year-old son Noah sustained an injury at 1:00 a.m. I was asleep, but this is usually a few hours earlier than he typically retires. In our hotel room's bathroom, he dropped a glass and then managed to step in the wrong place. A sharp shard sliced through the soft skin between his great and second toes. Blood was spurting wildly and he woke me up with a shout. He was spooked.

We gastroenterologists are experienced at stanching bleeding, although I was uncertain how to do so without some kind of scope in my hand. I reflected on my advanced cardiac life saving training, which is a comprehensive, two-hour course that my partners and I take every two years. In between those sessions, I neither think about nor practice any advanced life saving procedures. It doesn't seem rational that a community gastroenterologist should be schooled in temporary pacemakers, when most of us haven't interpreted an EKG in decades.

I still remember the fundamentals of life support, the famed A, B, Cs, standing for airway, breathing and circulation. I decided to apply this to the hemorrhage at hand.

Airway: the windpipe was open and functioning
Breathing: the kid was breathing
Circulation: BINGO!

After going through this brief but critical checklist, I now knew where to focus. No need to intubate him. No need to call the front desk to rush a defibrillator to the room. No need for chest compressions, at least not yet. I considered tightening a tourniquet around his waist to clamp the aorta, but opted instead to apply direct pressure to the wound. Luckily, this high class hotel was equipped with just the medical apparatus I needed--a wash cloth. Once the bleeding slowed and I was able to visualize the wound, I realized that this was no Scotch tape fix. It was time for a field trip to the ER.

The hotel front desk advised me where to take him and 20 minutes later we were in Sibley Memorial Hospital. The care was excellent and the sutures were applied expertly by Gregory Cope, M.D. Two hours after our arrival, we were back in the hotel room. I decided not to rouse the kids at 9 a.m. for our intended trip to Ford's theater, a site that has been deferred for a future trip.

Nothing is certain but death, taxes and emergency medical care bills. I reviewed the explanation of benefits form I received, which are never easy for me to unravel, even though I am somewhat of an insider of the medical profession. One of the two charges that I am responsible amounts to $391.50. I phoned my insurance company, always an opportunity for stress management, and reached a living breathing human being. Of course, I was first greeted by a mechanical voice who assured me that my call was important to them. Melanie, the insurance company customer service representative (Any reader agree with me that the phrase "customer service" is a euphemism?) explained that I had selected an out-of-service facility and was charged accordingly. After some research, she determined that there were in-network hospitals in the Washington, D.C. region. See what I mean about stress management?

"Melanie, let's forget for a moment that I am a doctor and that you are an insurance company tool. It's two o'clock in the morning. I am 500 miles away from home. My son's foot is spewing blood. While you might regard me as irresponsible, I never contemplated whether the hospital was on the formulary. Should I have researched this issue then? How would I have done this at that hour? It's challenging enough to reach a living insurance company soul during ordinary business hours. I wonder what my son would have thought if I told him we had to wait for authorization before we could leave the hotel. I'm sure this would have elevated his opinion of me as a doctor and a father."

Melanie checked with a superior who agreed that under these circumstances they would reprocess the bill as an in-network charge. Victory! How much will I save? Probably, only a few bucks, but some victories are not measured in dollars. I 'stuck it to the man.'

I have learned an important lesson from this experience. The next time I'm traveling with kids, I'm bringing paper cups.

This post by Michael Kirsch, 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.

QD: News Every Day--Door-to-balloon times decrease, but does mortality?

Heart attack patients are now being treated on average 32 minutes faster than they were five years ago, and medical societies are touting it as evidence of the success of national campaigns to treat heart attacks more quickly.

The study, "Improvements in Door-to-Balloon Time in the United States: 2005-2010," found that the average time from hospital arrival to treatment declined from 96 minutes in 2005 to just 64 minutes in 2010. In addition, more than 90% of heart attack patients who required emergency angioplasty in 2010 received treatment within the recommended 90 minutes, up from 44% in 2005.

Also, the study reported that 70% were treated in less than 75 minutes in 2010, compared with 27% five years earlier. And, the median time from hospital admission to emergency angioplasty declined from 96 to 64 minutes during the years studied. The study appears in Circulation: Journal of the American Heart Association.

The analysis includes all patients reported by hospitals to the Centers for Medicare & Medicaid Services for inclusion in the time to percutaneous coronary intervention acute myocardial infarction-8 inpatient measure for more than 300,000 patients from January 1, 2005, through September 30, 2010.

Declines in median times were greatest among groups that had the highest median times to begin with, those more than 75 years old, (median decline, 38 minutes), women (35 minutes), and blacks (42 minutes).

In 2002, only a third of patients received primary PCI within 90 minutes, and a third underwent the procedure more than two hours after arriving at the hospital. Three efforts were launched, Hospital Compare in 2005 by the Centers for Medicare & Medicaid Services, D2B Alliance in 2006 by the American College of Cardiology, and Mission: Lifeline in 2007 by the American Heart Association.

Now, researchers will have to examine how improved D2B times will affect the mortality rates. ACP Hospitalist discussed how they don't necessarily do that its March issue.
Monday, August 22, 2011

Asthma, placebo and how not to kill your patients

A number of years ago I was walking along Lake Michigan with a friend (a fellow medical resident) when she turned to me and said, "Are you wheezing? Do you have asthma?" I had always been physically active and assumed my breathlessness while walking down the trail was due to the thirty extra pounds of pizza and doughnuts I'd acquired during residency. But she was right: I was wheezing and breathless and it didn't feel good at all. I made an appointment with one of the hospital's lung docs who took a good history, did a physical, and ran some pulmonary function tests. And I did have asthma. And it felt much, much better when I used proper medication, a feeling confirmed by my improving lung function tests. (Not too surprisingly, the asthma got even better when I lost 40 pounds and started treatment for my acid reflux.)

I still get mild asthma symptoms from time to time, especially when I get sick, but for many others, the picture isn't so pretty. Asthma kills at least a quarter of a million people every year around the world. If you've ever worked in an ER and seen a kid with a bad asthma attack, you've earned a healthy respect for the disease. If you've ever watched your own kid gasping for breath, begging you to make it better, you've learned to fear it.

As our understanding of asthma has improved, so has our ability to treat it (an ability that is strongly linked to a patient's socio-economic status. Mortality has been rising despite the discovery of better treatments. Wait: let's pull this out of the parentheses ...) Asthma deaths and hospitalizations are largely preventable, and disproportionately affect Black and Hispanic Americans. We know how to treat the disease asthma, but don't know how to treat the people who are affected most.

We understand that asthma is not just a tightening of the airways but also an inflammation that can cause long-term damage. Not only can we treat asthma, but we have objective ways of measuring how well our patients are doing. It's easy and inexpensive to measure airway obstruction and response to medications. We know what works. For this reason, a new study in the New England Journal of Medicine seems both wise and foolish.

(I thought I was so on the ball. I really did. But while I was busy riding my bike, playing with my kid, and looking at rentals with my wife, David Gorski and my other medical blogger pals were out in Las Vegas at TAM discussing the very study I wanted to tell you about.)

The study, called "Active albuterol or placebo, sham acupuncture, or no intervention in asthma," was done for reasons that are not clear to me. It may have been done not to test the effectiveness of asthma therapy but to look at what a "placebo" might really be or do. At least, I think that was the idea. When reading the abstract and full text, it's not actually clear why the study was done. At first it seems as if it were done to see why asthmatics treated with placebo improve: "In prospective experimental studies in patients with asthma, it is difficult to determine whether responses to placebo differ from the natural course of physiological changes that occur without any intervention."

Why ask such a question? We know that poorly-treated asthma is deadly, and well treated asthma much less so. Why do we care about placebo effects here? The authors explain further: "Placebo effects (i.e., benefits resulting from simulated treatment or the experience of receiving care) are reported to improve signs and symptoms of many diseases in clinical trials and in clinical practice. On this basis, the accepted standards for clinical-trial design specify that the effects of active treatment should ideally be compared with the effects of placebo. Despite this common practice, it is unclear whether placebo effects observed in clinical trials (or those that presumably occur in clinical care) influence both objective and subjective outcomes and whether placebo effects differ from the natural course of disease or regression to the mean.

In other words, the authors want to know what placebos actually do to real people, and they chose asthmatics because they are easy to study (there are symptom-assessment tools for subjective data and spirometry for objective data). This makes asthma both the right and wrong choice for the study. It's an excellent model to assess the affect of placebo, but one in which the use of placebo is hard to justify on an ethical basis.

Not surprisingly, they found that "doing something" worked better than doing nothing. More specifically, they found that any placebo will make a patient feel subjectively better than doing nothing at all. They also found that all three placebos (sham acupuncture, fake inhaled medicine, and simply being enrolled in the study without treatment) improved objective measures of lung function, but not nearly as much as real medicine (in fact, not much at all).

In other words, simply attending to a patient makes them feel better. But to get a significant objective improvement (in asthma at least) you must also give them real medicine. Real medicine comprises both active medications and attending to the patient. There is no separate "placebo" that can be given to treat asthma effectively.

This is actually a quite beautiful study. It demonstrates that "placebo effect" is not the same as a real treatment, that real treatment always includes whatever benefit placebo provides, and that placebo is mostly an effect on subjective rather than objective measures of health. You can't fix asthma with placebo, only with real treatment. But we've already known that from decades of studying asthma. So what other justification is there for doing this study?

Our research has important implications both for the treatment of asthma and for clinical-trial design in general. Many patients with asthma have symptoms that remain uncontrolled, and the discrepancy between objective pulmonary function and patients' self-reports noted in this study suggests that subjective improvement in asthma should be interpreted with caution and that objective outcomes should be more heavily relied on for optimal asthma care. Indeed, although improvement in objective measures of lung function would be expected to correlate with subjective measures, our study suggests that in clinical trials, reliance solely on subjective outcomes may be inherently unreliable, since they may be significantly influenced by placebo effects. However, even though objective physiological measures (e.g., FEV1) are important, other outcomes such as emergency room visits and quality-of-life metrics may be more clinically relevant to patients and physicians. Although placebos remain an essential component of clinical trials to validate objective findings, assessment of the course of the disease without treatment, if medically appropriate, is essential in the evaluation of patient-reported outcomes. (Emphasis mine.)

This is folly. First, we have a huge literature on quality of life metrics in asthma. Huge. And we also know that objective changes in asthma are what save patients' lives. Yes, I care how my patient feels, but it is not more "clinically relevant" than how they are actually doing physiologically. Both are important, but not equal. And the idea that comparing active treatment to placebo is not ideal is not new to researchers. It's simply that following the natural history of the disease as a "control" is not usually appropriate (cf. Tuskegee syphilis experiment).

No good clinician would consider treating an asthmatic with placebo. Improper treatment of asthma leads to debility and death. This study chose mild asthmatics, but I still feel very uncomfortable with the ethics of the study design. Rather than using a disease we know how to treat to study placebo, we should be finding ways to get treatment to the millions of people who aren't getting it.

Wechsler ME, Kelley JM, Boyd IO, Dutile S, Marigowda G, Kirsch I, Israel E, & Kaptchuk TJ (2011). "Active albuterol or placebo, sham acupuncture, or no intervention in asthma." New Engl J Med. 365(2),119-26. PMID: 21751905

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

QD: News Every Day--Bad ads biggest fault is a lack of safety information

Few drug ads in peer review journals meet all FDA guidelines, although most ads meet most criteria, and there was little outright bias, a study found. The ads' biggest fault, researchers reported, was the lack of safe prescribing information.

Because the FDA cannot keep up with the sheer volume of drug ads, the agency created the "Bad Ad" program, which asks physicians to report non-adherent or misleading ads. The agency explained that, "With your valuable assistance, FDA can be more effective in limiting the number of misleading promotional messages directed to health care professionals."

But there are no bad ads; they're just misunderstood.

To determine how drug ads in peer-review journals met FDA guidelines, three reviewers looked at ads in the November 2008 issues of U.S.-based journals with an impact factor greater than 10. They excluded journals publishing only review articles and journals without a print edition, and they excluded ads for devices, over-the-counter medications, and disease awareness. Results appeared in the online journal PLoS ONE.

Of the 12 journals that met inclusion criteria, nine published drug ads (including Annals of Internal Medicine; both ACP Internist and Annals are published by the American College of Physicians). These journals published 192 ads for 82 unique products. Six "teaser" ads presented only drug names, leaving 83 full, unique ads.

The assessment tool contained 36 items: three described basic drug characteristics, four described basic features of the advertisement, 21 were adapted from FDA guidelines, and eight were related to safe prescribing information.

Researchers used FDA guidelines to categorize ads as adherent if they contained none of the 21 features used by FDA to classify ads as misleading. They were non-adherent if they contained one or more of those features, and possibly non-adherent if there was incomplete information, rather than non-adherent material. They also evaluated content important for safe prescribing, including benefit quantification, risk information and verifiable references. Two reviewers looked at each ad, and they attempted to determine adherence in a way that was less likely than the FDA to rate ads as non-adherent.

Fifteen ads (18.1%) adhered to all FDA guidelines, 41 (49.4%) were non-adherent with at least one form of FDA-described bias, and 27 (32.5%) were possibly non-adherent. Safe prescribing content was often incomplete, since 57.8% of ads did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present enough efficacy quantification.

Nearly half of physician-directed ads fail to adhere to at least one FDA guideline regulating content, the authors found, although was no single problem for non-adherence. Safe prescribing information was poor, with the majority failing to quantify serious risks, more than one quarter failing to quantify benefits and nearly half providing no verifiable references.

The authors wrote, "Our study is the first in nearly 20 years to provide a systematic assessment of the adherence of U.S. ads to FDA guidance and provides context to inform the FDA's new 'bad ad' program."

The news isn't all bad for the ads, though. Despite the high non-adherence rate, the mean number of biased features was low and most ads satisfied the majority of FDA guidelines. And the authors noted that the guidelines themselves focus on fraud and on balancing efficacy and safety, instead of the features most important for providing prescribers with useful information.

"An advertisement containing no specific efficacy claim, no quantification of drug safety and no verifiable references would adhere fully to FDA guidelines, despite presenting no practical information for clinicians," the authors wrote.

FDA should update and simplify its guidelines for physician ads, the authors concluded. They should be straightforward and objective, require clear risk quantification and absolute benefit information, describe the appropriate patient population, and include verifiable references.
Friday, August 19, 2011

QD: News Every Day--Congratulations on the pay raise you may have missed

Although nearly 70% of medical specialties saw increases in compensation in 2010, increases were marginal, reports the American Medical Group Association's 2011 Medical Group Compensation and Financial Survey.

Primary care specialties saw about a 2.6% increase in 2010, while other medical specialties averaged an increase of 2.4% and surgical specialties averaged around 3.8%. Specialties with the largest increases in compensation were allergy (6.38%), emergency medicine (6.37%), and hospitalist-internal medicine (6.29%).

In comparison, in 2009, primary care and surgical specialties saw about a 3.8% increase, while other medical specialties saw 2.4%.

Operating margins for medical groups are increasingly thin, the group reported in a press release. Only organizations in the Western region were nearing break-even at a loss of $27 per physician. All other regions operated at a loss per physician; Eastern, nealy $1,600 per physician; Southern, nearly $1,900; and Northern, nearly $10,700.

Many of the losses were supplemented by other non-clinical revenue sources and/or funding from health systems.

The AMGA 2011 Medical Group Compensation and Financial Survey represents responses from 239 medical groups employing 51,700 providers (55.6% of groups report more than 100 physicians). The survey was done by a national accounting firm.

In case you missed it ...
A new blog is offering near-daily posts on retractions from the peer review literature. The blog, Retraction Watch, is a watchdog service offered by two journalists with a long history in scientific reporting. The pair offer reactions ranging from withdrawals ranging from simple errors to outright plagiarism.