Please, Sir, May I Have My Gall Bladder Back?

Do we have property rights over our body parts?

Apparently not, as I and several thousand David Sedaris enthusiasts learned recently at the Peabody Opera House where he was promoting his new book, Let’s Explore Diabetes for Owls.

Sedaris related that he was unable to get a surgeon to remove his lipoma (a benign fatty tumor) and give it back to him. His goal was to feed his lipoma to a deformed snapping turtle that he had become obsessed with.

I had not previously thought about retrieving my body parts after surgery but was surprised to hear Sedaris say that it was “against federal law” to return to a patient, their amputated or excised body parts.

I’ve had my appendix and my gall bladder removed and I began wishing that I had asked for them back. Wouldn’t it be nice, I thought, to have a display in my basement of my removed body parts, pickled, and with their important components labeled.

Not only would the display serve as a conversation starter but it would help visiting, budding physicians understand the three-dimensional anatomy of some very interesting body parts.

Unfortunately (or is it fortunately), I have not yet had any of my cardiac structures removed but it is common practice now for surgeons to lop off the left atrial appendage during open heart surgery in patients with atrial fibrillation. This is done in an (perhaps misguided) attempt to reduce their risk of stroke from clots which like to form in the left atrial appendage.

I look at a lot of left atrial appendages by transesophageal echocardiography (learn more about transesophageal echo via this  link to the Amazon.com (this is not (entirely, unabashedly) shameless self promotion-you can’t really buy the book, it is out of print) description of my old textbook on transesophageal echocardiography) and am fascinated by their peculiar shapes.

I would really like to have a row of pickle jars containing left atrial appendices in my basement to invigorate lagging dinner parties and refine my understanding of their function or lack thereof.

Laws On Body Parts

Why would there be a federal law denying one access to one’s own body part?

It turns out there is no federal law but lots of state laws that do exactly that.

Removed body parts fall under the category of infectious waste or medical waste and their disposal is governed by a complex litany of regulations, most of which do not allow them to be given back to their original owner.

This EPA site gives a state by state breakdown of the laws governing medical waste. If you click on the Missouri link, you reach a document from the “Department of Natural Resources,” which defines “pathology wastes.” These wastes include tissues, organs, body parts and body fluids that are removed during surgery and autopsy.

David Mapow, MD has written an extensive treatise, entitled “Do People Have Ownership Over Their Body Parts And If So, Can The State Control Their Ultimate Disposition In The Interest Of Public Health And Safety?”

Mapow’s paper illuminates how far reaching this topic is. It touches on topics as diverse as abortion rights, organ transplantation, cell lines used in cancer research, religious and cultural practices and the public health  versus private interests.

Interestingly, the placenta seems to be the one body part that is getting a pass in some states since some religious and cultural practices encourage either eating or venerating the placenta in various ways.

The Sedaris Solution

Sadly, those of us who would like to possess our removed body parts for sentimental or educational reasons may have to resort to what I shall term “the Sedaris solution.”

At the book signing event after one of his book tour talks, a woman introduced herself as a physician and volunteered to remove his lipoma that night in her clinic. Fortunately, the subversive procedure was successful, the patient survived and the lipoma was thrown to the deformed snapping turtle.

In the end, the snapping turtle, however, showed remarkably good taste and snubbed his nose (beak?) at the Sedaris lipoma.

If you’d like to read the story Sedaris wrote for The New Yorker that introduces the deformed snapping turtle (“Did it help, I wondered, that my favorite turtle was the one with the over-sized tumor on his head and half of his front foot missing? Did that make me a friend of the sick and suffering, or just the kind of guy who wants both ice cream and whipped cream on his pie?”) it is available for free here. It’s a great example of his style, his humour and his oddness.

In Memoriam of my gall bladder,

-ACP

Addendum: Here are the opening paragraphs of Leviathan, the Sedaris New Yorker piece:

“As I grow older, I find that the people I know become crazy in one of two ways. The first is animal crazy—more specifically, dog crazy. They’re the ones who, when asked if they have children, are likely to answer, “A black lab and a sheltie-beagle mix named Tuckahoe.” Then they add—they always add—“They were rescues!”

The second way people go crazy is with their diet. My brother, Paul, for instance, has all but given up solid food, and at age forty-six eats much the way he did when he was nine months old. His nickname used to be the Rooster. Now we call him the Juicester. Everything goes into his Omega J8006: kale, carrots, celery, some kind of powder scraped off the knuckles of bees, and it all comes out dung-colored, and the texture of applesauce. He’s also taken to hanging upside down with a neti pot in his nose. “It’s for my sinuses,” he claims.

“If a vegan diet truly did cure cancer, don’t you think it would have at least made the front page of the New York Times Science section?” I ask. “Isn’t that a paper’s job, to tell you the things ‘they’ don’t want you to know?

Paul insists that apricot seeds prevent cancer but the cancer industry—Big Cancer—wants to suppress this information, and has quietly imprisoned those who have tried to enlighten us. He orders in bulk, and brought a jarful to our house at the beach, the Sea Section, in late May of last year. They’re horribly bitter, these things, and leave a definite aftertaste. “Jesus, that’s rough,” my father said, after mistaking one for an almond. “How many do you have in a day?”

Paul said four; any more could be dangerous, since they have cyanide in them. Then he juiced what I think was a tennis ball mixed with beets and four-leaf clovers.”

 

 

 

 

Which Popular Diets Are Supported By Science?

Which of the currently popular and highly marketed diets are best for weight loss and cardiovascular health? Can science answer this question?
questI just took a 90 minute online “course” taught by Eric Rimm of the Harvard School of Public Health; I think he does a good job of summarizing the scientific evidence on this topic and presenting it in a way that the average layperson can understand.

You can sign up for free here. If you’re not interested in spending your time watching him, here are my take-home points:

1. When evaluating the efficacy of a diet to control weight, the best evidence comes from observational studies that involve tens of thousands patients over decades and/or (preferably) randomized control trials that last at least two years.

2. The Paleo, Wheat-belly, gluten-free, Atkins, South Beach, and Zone diets do not have good evidence supporting sustained weight loss or health benefits. In general, people who follow these diets will be consuming lots of fresh vegetables, nuts and “healthy” fats and avoiding processed food, which is good, and this likely explains any  benefits achieved.

3. Of all the diets, the low-fat diet (Ornish/Pritikin/China Study are the extreme examples of this) is the only one which has strong evidence showing an absence of benefit.

Yes, the diet that was recommended to Americans for 30 years does not help with weight loss in the long run for the vast majority of individuals.

As Rimm says “We need to eliminate the dogma that low fat is needed for weight loss.”

Dr. Rimm spends a good amount of time on this, highlighting findings from a study of 50 thousand women (the Women’s Health Initiative), which lasted for 9 years. In the first year, women on the low-fat diet (counseled to consume <20% of calories in the form of fat), lost more weight than those on the usual diet, however, in subsequent years they gained back the weight and did not differ from the higher fat consuming group.

There was also no difference in the rates of dying or contracting any disease between the two groups.

The problem with the low fat diet was adherence. Although a very small percentage of individuals can remain on a  vegan or really low-fat diet and successfully lose weight and be healthy, the majority of us can’t.

By the end of the study the low fat group had increased their fat consumption to 28% which was not much less than what the usual group was consuming (32%)

Over time, the low fat group gradually added fats because they taste better and they are more satiating.

4. The DASH diet has evidence showing improvement in blood pressure, and cholesterol. The heart of the DASH diet is an eating plan rich in fruits and vegetables, low-fat and nonfat dairy, along with nuts, beans, and seeds.

Unfortunately, it was developed in an era when all fats were considered bad and proof of cardiovascular benefit is lacking.

5. Mediterranean diet. Gets a strong pass from Rimm with multiple studies showing benefits in both weight reduction and reduction of cardiovascular mortality.

The Med diet also demonstrates good long term adherence because of its diversity and inclusion of fat (for taste and satiety).

Improved adherence has been shown to be the major determinant of diet success. When you add regular counseling and support to any diet it works better and can be sustained.

This is the Mediterranean diet I recommend:

1. Lots of fresh fruits and vegetables. These contain fiber, phytochemicals, minerals.

2. Two servings of fish per week.

3. Plenty of nuts (and drupes!), legumes, and seeds.

4. Grains are allowed, preferably all whole grains.

5. Moderate alcohol consumption (1 drink/day for women, 2 drinks/day for men).

6. Olive oil.

7. Meat is allowed.

8. Eggs and dairy are allowed.

Dr. Rimm is still clinging to the idea that all saturated fats should be limited and preferfat replacementably replaced by PUFAs or MUFAs. He presented this graphic (courtesy of Dr. Willet at Harvard), which illustrates the most prevalent concepts about saturated fat replacement.

Risk of heart disease is on the y axis. According to this graph, If you replace saturated fat with trans fat or sugar/refined starch, risk goes up.

If you replaced saturated fat with unsaturated vegetable fats or whole grains, risks go down.

Most nutritional experts now can agree on the importance of the key components of the Med diet and the lack of efficacy of low fat diets.

The disagreement comes in whether moving that arrow down from saturated fat to unsaturated fat is truly beneficial for weight management or cardiovascular health.

Good Fats and Bad Fats?

My own take on the good fat/bad fat controversy is as follows:

There are multiple types of saturated fats and multiple types of unsaturated fats and the scientific evidence is not currently robust enough to make the claim that replacing any saturated fat  with any unsaturated fat is a healthy change.

There is no evidence that low-fat or no fat dairy is healthier than full fat dairy (see here and here). Eating no, or low, fat yogurt with the natural fat replaced by sugar and other additives likely moves the arrow up, raising your risk. This kind of processed food gets a pass from mainstream nutritionists for some reason.

Saturated fat from pasture-raised pigs and cows consumed in moderation is not unhealthy or weight gain promoting.

In the end, Dr. Rimm and I agree on about 95% of the science and recommendations in his course.

Take a look and you can tell your friends that you just passed a Harvard course with flying colors!

 

 

 

Feel Free To Skip Breakfast Again

My apologies for inadvertently publishing an incomplete post this morning. And my thanks to my many readers who notified me of same.

I was asked a question on my Facebook page: “Do I take requests? And would I write about whether eating breakfast was important?”

I do take requests but I already written about breakfast in 2013 in a post entitled “Breakfast is not the most important meal of the day: Feel Free to skip it.”

This request reminded me of a chapter from Melanie Warner’s excellent analysis of the food industry, “Pandora’s Lunchbox.” I had pulled a quote from my iBook version of that book and pondered writing a blog post on breakfast cereal as an update to my previous breakfast post.

The quote was:

“Walk down a cereal aisle today or go onto a brand’s Web site, and you will quickly learn that breakfast cereal is one of the healthiest ways to start the day, chock full of nutrients and containing minimal fat. “Made with wholesome grains,” says Kellogg’s on its Web site. “Kellogg’s cereals help your family start the morning with energy by delivering a number of vital, take-on-the-day nutrients—nutrients that many of us, especially children, otherwise might miss.” It sounds fantastic. But what you don’t often hear is that most of these “take-on-the-day” nutrients are synthetic versions added to the product, often sprayed on after processing. It’s nearly impossible to find a box of cereal in the supermarket that doesn’t have an alphabet soup of manufactured vitamins and minerals, unless you’re in the natural section, where about half the boxes are fortified.”

The Kellogg’s and General Mills of the world strongly promoted the concept that you shouldn’t skip breakfast because they had developed products that stayed fresh on shelves for incredibly long periods of time. They could be mixed with easily accessible (low-fat, no doubt) milk to create inexpensive,  very quickly and easily made, ostensibly healthy breakfasts.

Unfortunately, the processing required to make these cereals last forever involved removing the healthy components.

As Warner writes about W.K. Kellogg:

“In 1905, he changed the Corn Flakes recipe in a critical way, eliminating the problematic corn germ, as well as the bran. He used only the starchy center, what he referred to as “the sweetheart of the corn,” personified on boxes by a farm girl clutching a freshly picked sheaf. This served to lengthen significantly the amount of time Corn Flakes could sit in warehouses or on grocers’ shelves but compromised the vitamins housed in the germ and the fiber residing in the bran”

This is a very familiar story in the world of food processing;  Warner covers, nicely, the same processes occurring with cheese and with milk, among other things.

I ended my 2013 post with these words:

IMG_3549My advice to overweight or obese patients:
Eat when you’re hungry.

Skip breakfast if you want.
If you want to eat breakfast, feel free to eat eggs or full-fat dairy (including butter).
These foods are nutrient-dense and do not increase your risk of heart disease, even if you have high cholesterol.
You will be less hungry and can eat less throughout the day than if you were eating sugar-laden, highly processed food-like substances.

At the time, this seemed like horribly contrarian advice, but in the last year and a half, more and more authorities are agreeing with these concepts.

-ACP

 

 

Is Exercise Impotent In Preventing Obesity?

What if all that exercise that authorities have been recommending  is not helping to stem the rising tide of obesity?

What if all calories don’t have the same ability to add fat?

These twin heresies fly in the face of the usual dogma on the cause of obesity: more calories in (gluttony) than calories out (sloth). The skeptical cardiologist has been pondering these possibilities for some time, since reading Gary Taubes book Good Calories, Bad Calories.

I have been advising my patients through this blog and during office visits that added sugar and  refined  carbohydrates are much more of a culprit in their  weight gain than fat, thus embracing the concept that there are good calories and bad calories

Exercise and Obesity

5Boro Bike Riders crossing the summit of the Queensboro aka 59th Street aka "Feelin Groovy" Bridge

But I also spend a lot of time during my office visits discussing activity levels and encouraging my patients to engage in moderate aerobic physical activity for at least 150 minutes per week.

I do this because there is good evidence that regular physical activity is associated with lower cardiovascular risk, cancer risk, mortality, and improved brain, muscle, and bone function. Exactly  what level and type of exercise is needed to reap these benefits is still up for debate.

I, personally, engage in regular moderate exercise and I think it helps maintain my weight where I want it.

Throwing Down the Gauntlet

A recent editorial in the British Journal of Sport Medicine stridently  makes the claim that exercise is not useful for weight loss as conventional wisdom teaches and that the food industry has been promoting exercise while simultaneously promoting junk food and sugar-sweetened beverages (The link I provided is no longer active because the journal has removed the editorial -“This paper has been temporarily removed following an expression of concern.”)

The authors wrote:

“members of the public are drowned by an unhelpful message about maintaining a healthy weight through calorie counting, and many still wrongly believe that obesity is entirely due to lack of exercise. This false perception is rooted in the Food Industry’s Public Relations machinery, which uses tactics chillingly similar to those of big tobacco. “

Root Causes of Obesity

It would appear that science cannot tell us with total certainty what the cause of our current obesity epidemic is.

After publishing a paper in 2014 that suggested Americans had become less active over the last 20 years, Ladabaum, et al admitted this:

“Although there is no clear answer at this time regarding the relative contribution of energy intake or physical activity (or other variables including dietary components, patterns of activity, and environmental factors, including the gut micro biome) to the public health problem of obesity, we believe that public health messages should continue to emphasize the importance of both a healthy diet and remaining physically active throughout life.”

Is Exercise Amount  A Cause or Effect?

In my own practice, I have observed a tendency for  those patients who regularly exercise or have very physically active jobs to stay thin whereas those who don’t exercise, especially if they have sedentary jobs or are retired, tend to be obese and gain weight.

But, I also note that those patients who take my recommendations on exercise to heart  are also listening to my advice in other areas, including diet and medications and are, in general, much more proactive about their health.

Therefore, I can’t say for sure whether it is the exercise  or the other aspects of a healthy lifestyle (including diet)  being followed in any individual patient that is keeping the pounds off. How much my patients move during the day when they are not specifically exercising may also be playing a role and is hard for me to assess.

There is also the mind-boggling possibility, as Gary Taubes has written about (here and in his book Why We Get Fat) that our genetics are driving both our activity levels and our food consumption:

Ultimately, the relationship between physical activity and fatness comes down to the question of cause and effect. Is Lance Armstrong excessively lean because he burns off a few thousand calories a day cycling, or is he driven to expend that energy because his body is constitutionally set against storing calories as fat? If his fat tissue is resistant to accumulating calories, his body has little choice but to burn them as quickly as possible: what Rony and his contemporaries called the “activity impulse”—a physiological drive, not a conscious one. His body is telling him to get on his bike and ride, not his mind. Those of us who run to fat would have the opposite problem. Our fat tissue wants to store calories, leaving our muscles with a relative dearth of energy to burn. It’s not willpower we lack, but fuel. “

I’m not ready to accept the heresy that exercise and activity have nothing to do with weight gain or loss. I, like most cardiologists, walk the walk and talk the talk of regular vigorous exercise for health benefits, extended longevity, cardiovascular fitness and for helping in weight control.

Exercise is not the be all and end all of weight control because increased consumption of bad or good calories can overcome the most prolonged and intense workouts but it is a useful adjunct.

Still exercising regularly,

-ACP

Stroke Risk Estimation in Atrial Fibrillation: Please Give Me Lip!

The best way we have of estimating a patient’s risk of stroke if they have atrial fibrillation (AF) is by the CHA2DS2-VASc scale.

Stroke Risk EstimationThis scale take the factors we know that increase the risk of stroke and assigns 1 or 2 points. The acronym comes from the first letter of the factors that are known to increase risk as listed to the left.

Most of the factors get 1 point, but prior stroke (S) and age>75 (A) get 2 points.

We then add up your points and use another chart (or app) to calculate the risk of stroke per year.

CHA2 stroke riskYour risk of stroke is very low if you have zero risk factor; it gets progressively higher as you reach the maximum number of 9.

Treatment with an oral anticoagulant (OAC),  either warfarin, or one of the four newer anticoagulant agents (NOACS), is recommended when the risk gets above 1-2% per year.

The higher the risk, the more the benefit of these blood thinners in preventing stroke.

In lower risk patients, the bleeding risk of OAC of 1% per year may outweigh the benefits conferred by stroke reduction.

Both European and American guidelines recommend using the CHA2DS2-VASc score for initial risk stratification. The European  guideline recommends OAC therapy for males with a CHA2DS2-VASc score ≥1 and for female patients with a score ≥2., whereas the American guideline recommends use of OAC if the CHA2DS2-VASc  score is ≥2 for men and women.

I’ve been using the CHA2DS2-VASc scale for several years in my AF patients. I try to review the patient’s risk of stroke and their risk of bleeding during every office visit, and decide whether they should be on or off an OAC.

Initially, it was helpful typing all those capital letters and number twos (although I never took the time to make the twos a subscript) because it helped remind me of the factors.

However, I now view this acronym as a big pain in the neck and I am sick of typing it into my electronic medical records. It is also, really hard to say. Do you say “chad -two-D-S-two-vasc?” That is six syllables! I could have told my patient that warfarin is rat poison during that time.

And, what is with the Sc? Sex category? Why not just an S?

An Easier Term For The Stroke Risk Estimator: The Lip Score

I would like to formally request that this be termed the Lip stroke risk score in honor of Dr. GregoryLip,Greg-Cropped-110x146 Y. H. Lip who developed it at the University of Birmingham (UK).

because (per his bio): 

“The CHA2DS2-VASc and HAS-BLED scores for assessing stroke and bleeding risk, respectively were first proposed and independently validated following his research, and are now incorporated into major international management guidelines.”

birminghamIf the Lip score should somehow be unacceptable, then let’s go with the Birmingham score (recognizing, of course, that this is Birmingham, England and not Birmingham, Alabama). After all, this is what the app I use terms itself and I can type Birmingham a lot faster than CHA2DS2-VASc (even without the subscripts).

The Lip Score will be a great advance in the world of stroke risk estimation for AF patients. It will make all of us doctors creating EMR notes much more efficient, shaving precious minutes off the work day. It will be easier to communicate to patients, medical students and other medical personnel.

Finally, it gives, credit where credit is due, to Dr. Lip, who, according to his bio: “In January 2014, was ranked by Expertscape as the world’s leading expert in the understanding and treatment of AF,”

(I have no knowledge of Expertscape but you can be sure I will be investigating them soon)

Giving Lip service to stroke and atrial fibrillation,

ACP

Low T and Me: Does Testosterone Therapy Increase Cardiovascular Risk?

In the last year, several of my patients have asked me whether it is safe for them to take testosterone for “low T.” They were responding to media reports suggesting that testosterone therapy raised heart attack risk by one-third.

I must admit, I had been skeptical of the legitimacy of the “low T” diagnosis.  Many of the symptoms attributed to testosterone (T) deficiency, it seemed, were just part of normal male aging: decreased libido, fatigue, weight gain, and loss of muscle mass.

Perhaps, I thought, men should just be more willing to exercise regularly and lose weight and accept the indignities of aging that result despite our best efforts.

On the other hand, in the back of mind was the idea that perhaps I, as a sixty-something male with declining strength and endurance, could somehow forestall the ravages of aging by taking T.

I googled “low T” and immediately found some sponsored sites, including “is it low T.com,” which appears to be an educational site for patients. However, the one treatment option that they provide links to is made by Abbvie, the somewhat hidden host of the site. Abbvie is a pharmaceutical company that makes Androgel, the most widely prescribed testosterone cream.

lowTquiz

I answered yes to the 3 questions I thought were just uniform consequences of aging:

1. Reduction in strength and/or endurance.

2. Loss of height.

3. Deterioration in your ability to play sports.

After taking the quiz, I was told that answering yes to 3 of the 10 questions strongly suggests you have low T.

In addition, according to the site, if you answered yes to question 1 (decreased libido) or 7 (less strong erections) you have low T.

Based on this quiz, I and 99% of men my age must have low T!!

In the last 10 years, the use of testosterone therapy has quadrupled, driven by better formulations for testosterone delivery and by direct-to-consumer marketing campaigns that suggest that treating low T will reverse these normal consequences of aging.

As a result, in 2013, 2.3 million American men received testosterone therapy and 25% of these men had no baseline testosterone levels tested.

A year ago, the New York Times editorial board opined on the dangers of overprescribing testosterone and the influence of pharmaceutical companies in over-promoting the drug, in a piece entitled “Overprescribing testosterone, dangerously.”  Articles like this are what have raised patients’ concerns about T therapy and increased risk of heart attack.

Testosterone and Mortality

There is a large body of evidence that shows an association between lower T levels and increased mortality and coronary artery disease. Lower T levels are also associated with higher risk of diabetes and the metabolic syndrome.  Studies also show that T therapy in T-deficient men increase lean mass and reduce fat mass and are associated with a reduction in mortality. A recent review article by Morgenthaler, et al in Mayo Clinic Proceedings, provides a detailed and meticulous summary of these studies and data.

Two recent studies contradict this large body of evidence and gained enormous media attention. The first, by Vigen et al in JAMA 2013, was a retrospective analysis of VA patients which has received extensive criticism for its statistical technique and has been corrected twice. The second study was by Finical, et al in PLoS One 2014, suggesting increased mortality in patients for 90 days after receiving their prescription for T. This study also contains methodologic issues and is hardly conclusive.

Is it Safe to Take T for low T

My recommendation to patients who want to take T after looking at all the data is as follows:

-Make sure that you really have low T.  Your total T levels should be less than 300 ng/dL done in a reliable, certified lab.

-At this time, I don’t see solid evidence that taking T, if you definitely have T deficiency, increases the risk of cardiovascular complications or death.

As with all medications, the shortest duration and smallest effective amount is what you should take. All medications have side effects, some that we know and some that we don’t know. Most of the studies that have been published were on small numbers of patients for short periods of time.

-If you are overweight and/or sedentary, there is good evidence that losing weight and exercising will improve many of the symptoms ascribed to low T.  These will also improve your life expectancy and lower your risk of heart attack.

…And you won’t have to worry about any side effects!

Do I have low T? Like all sixty-somethings my T levels are lower than when I was 30. My endurance is less. I’m losing height. Fat wants to build up in my abdomen, despite my best efforts.

It’s only going to get worse, but I’m willing to accept these as normal consequences of the aging process, rather than introduce external T into my system with its unknown consequences.

I will not go gentle into that good night but will continue to rage against the dying of the light without the wonders of pharmaceutical grade T.

Yours in aging,

-ACP

 

 

 

 

 

Red Yeast Rice: Let’s Lower Our Cholesterol With Unknown Amounts of a Statin Drug

Red Yeast Rice sits atop the "Heart Healthy" shelves at Whole Foods, surrounded by other useless "natural" supplements like ubiquinol (Coenzyme Q-10) and reservatrol.
Red Yeast Rice sits atop the “Heart Healthy” shelves at Whole Foods, surrounded by other useless “natural” supplements like ubiquinol (Coenzyme Q-10) and reservatrol.

Over the years I’ve had a number of patients tell me that they prefer to take over the counter (OTC) dietary supplements containing “natural” cholesterol lowering ingredients rather than the statin drug I have prescribed.

Red yeast rice (RYR)  is a common ingredient in these supplements and is promoted widely and enthusiastically across the internet and in supplement or natural food stores for the purpose of lowering cholesterol and heart disease risk.

RYR  has been used for centuries in China for coloring, food and medicine. It is made by fermenting red rice with a specific  type of yeast (Monascus purpureus).

Red yeast rice contains chemicals that are similar to prescription statin medications. One of these, called monacolin K, is chemically identical to  the statin drug lovastatin (brand name Mevacor).

The History Of Statin Drug Development

The history of the discovery and isolation of lovastatin, the first FDA approved statin, is worthy of a digression here as I think it illustrates the process of discovery, isolation and characterization of a chemical that becomes a safe and effective treatment.

Akin Endo,whose research over decades was crucial to discovering statins, writes that he was inspired by Alexander Fleming, who discovered penicillin in the blue-green mold belonging to the genus Penicillium in 1928.

He writes; “Although no metabolites that inhibited any enzymes involved in cholesterol synthesis had been isolated previously, I speculated that fungi like molds and mushrooms would produce antibiotics that inhibited HMG-CoA reductase. Inhibition of HMG-CoA reductase would thus be lethal to these microbes.”

Endo began analyzing thousands of molds and fungi for biologically active chemicals that would inhibit HMG-CoA reductase.

In 1971, after studying 3800 different strains of fungi he found a promising candidate: citrinin. Unfortunately,

“Citrinin strongly inhibited HMGCoA reductase and, furthermore, lowered serum cholesterol levels in rats. However, the research was suspended because of its toxicity to the kidneys. ”

End spent another 10 years isolating another promising HMG-CoA reductase inhibitor, “compactin, ” from mold and studying it in rats and other animals. Compactin demonstrated marked cholesterol lowering properties in dogs and monkeys and in the few humans who received it but the pharmaceutical company he worked for shut down the project after it appeared that in doses 200 x what were considered appropriate, it increased lymphoma risk in dogs.

The large pharmaceutical company, Merck, got wind of Endo’s studies with compactin, studied his data and realized the potential of similar but safer HMG-CoA reductase inhibitors.  Drugs which inhibited HMG-coA reductase were now being termed statins.

Merck set out to find its own statins and in February 1979 isolated a statin very similar to compactin in chemical structure, called mevinolin, from the fungus Aspergillus terreus.

Endo, working separately and also in February 1979, isolated another statin (named monacolin K) from cultures of Monascus ruber.(RYR).In  the fall of the same year, it was confirmed that monacolin K and mevinolin were the same compound (later both changed to lovastatin).

The drug showed dramatic activity in lowering LDL cholesterol, with very few side effects. This led Merck to begin large-scale clinical trials of lovastatin in patients at high risk and long-term toxicity studies in dogs in 1984. The drug dramatically reduced cholesterol levels and was well tolerated. No tumors were detected. In 1987, Merck gained FDA approval  and lovastatin became the first commercial statin.

Since then, six other statin drugs, some of which are synthesized in the laboratory rather than isolated from mold, have been approved for human therapy. These drugs have prevented thousands of heart attacks and contributed to the dramatic drop in cardiovascular deaths seen in developed countries over the last 30 years.

Ryr And Cholesterol Lowering

This brings us back to RYR and its ability to lower cholesterol. Small studies using a version of RYR that contained lovastatin have demonstrated a reduction in cholesterol compared to placebo.

However, because many red yeast rice supplements contained lovastatin (also called monacolin)In May 1998, the FDA ruled that Cholestin (the RYR product used in the studies showing cholesterol lowering benefit) was not a dietary supplement but an unapproved drug.

As a result,  Pharmanex removed RYR from Cholestin. Since that ruling, the FDA has written warning letters to several other dietary supplement manufacturers to remove drug claims or eliminate red yeast rice with high lovastatin levels from their products, including Heart and Cholesterol (Mason Vitamins, Miami Lakes, Florida)  Cholestrix (Sunburst Biorganics, Baldwin, New York), Red Yeast Rice and Red Yeast Rice/Policosanol Complex , and Red Yeast Rice (Nature’s Way Products Inc, )

A study in 2010, found levels of monacolins varying one-hundred fold in 12 RYR preparations available commercially (total monacolins (0.31-11.15 mg/capsule), monacolin K (lovastatin) (0.10-10.09 mg/capsule), and monacolin KA (0.00-2.30 mg/capsule).

Even more worrisome was that four products had elevated levels of citrinin. You remember citrinin, don’t you? That is the chemical that Endo initially identified as a candidate for cholesterol lowering drug but rejected because it was causing kidney failure in his rats.

Because of limited government oversight and variable manufacturing processes, one can also expect that the same manufacturer will have marked variation of monacolin content and citrinin from batch to batch or bottle to bottle.

Problems With Alternative Medicine In General

These problems with RYR supplements are typical of all supplements.As the the authors wrote

“Our results highlight an important issue with red yeast rice and many other alternative medicines: the lack of standardization of active constituents. Standardization of ingredients is difficult for several reasons: (1) There are variable growth and/or culture conditions and differences in harvesting and processing among manufacturers; (2) medicinal agents from natural sources are complex substances with many chemical constituents, many of which have unclear roles in their pharmacologic activity; and (3) different manufacturers may standardize products to amounts of 1 or 2 chemicals thought to be active ingredients, while other constituents are not standardized and may also have biologic and pharmacologic activity.”

One has to ask, given this background, why would a patient choose to take a “natural” OTC supplement containing an unknown amount of both a). Effective cholesterol lowering chemicals and b)potentially toxic extraneous chemicals over the precisely formulated, carefully regulated, fully studied, pure statin drug available by prescription.

It’s especially baffling to me when one considers that lovastatin comes from RYR. Thus it would have to be considered “natural.”

Akira Endo spent decades carefully identifying the effective and safe chemical portion of RYR. It is now available as a generic costing pennies per pill.

We know exactly how many milligrams you are consuming. We know what benefits to expect and what side effects can occur based on studies in hundreds of thousands of patients who have taken a similar dosage.

You are much better off taking the prescribed statin drug than RYR.

skeptically yours,

ACP

A

Nuts, Legumes, Drupes and Mortality

When I was a child in small town Oklahoma, I collapsed walking home from school one day after eating pecans. Apparently I had never encountered pecans in England where I grew up and I had a very severe, life-threatening  allergic reaction (anaphylaxis.)

My pediatrician was promptly called, drove over, picked me out of the street and (legend has it) with one hand on the steering wheel and the other jabbing me with epinephrine drove me to the local hospital (apparently ambulances were not invented at this time). There I spent several days in an oxygen tent recuperating.

Since then I had, until recently,  concluded (based on my own multiple food reactions and research) that I was allergic to “tree nuts.”

I would patiently explain to the uninitiated that I could eat almonds because they are in the peach family and I could eat peanuts because they are in the legume family: neither one of these, therefore, were true “tree nuts.”

To all whom I gave this seemingly erudite explanation I owe an apology for I have learned the earth-shattering truth that pecans are drupes! They are no more a nut than an almond is!

In fact, even walnuts are not nuts as hard as that is to believe.

Pecans, walnuts and almonds are all drupes.

Why, you may wonder, is any of this botanical folderol of any relevance to cardiology?

Nuts and Cardiovascular Death

For those paying attention to media reports on the latest food that will either kill you or make you live for ever you may already know the answer. This paper published in JAMA made big headlines.

Jane Brody of the New York Times wrote a piece extolling the virtues of nuts entitled “Nuts are a Nutritional Powerhouse”. Medical New Today wrote “Eating Nuts Linked to 20% Cut in Death Rates”.

It turns out, however, that most of what the 136,000 Chinese were eating and half of  the “nuts” the 85,000 low income Americans were eating in that JAMA study  were legumes: peanuts or peanut butter. The authors wrote:

“Our findings … raise the possibility that a diet including peanuts may offer some CVD (cardiovascular)  protection. We cannot, however, make etiologic inferences from these observational data, especially with the lack of a clear dose-response trend in many of the analyses. Nevertheless, the findings highlight a substantive public health impact of nut/peanut consumption in lowering CVD mortality, given the affordability of peanuts to individuals from all [socioeconomic status] backgrounds.”

These findings follow another large observational study published in 2013 which also found (in American doctors and nurses) an inverse relationship between nut consumption and mortality.

“compared with participants who did not eat nuts, those who consumed nuts seven or more times per week had a 20% lower death rate. Inverse associations were observed for most major causes of death, including heart disease, cancer, and respiratory diseases. Results were similar for peanuts and tree nuts, and the inverse association persisted across all subgroups.”

We also have a very good randomized trial (the PREDIMED study) that showed that  the Mediterranean diet plus supplementation with extra-virgin olive oil or mixed nuts performed much better than a control diet in reducing cardiovascular events.

Participants in the two Mediterranean-diet groups received either extra-virgin olive oil (approximately 1 liter per week) or 30 g of mixed nuts per day (15 g of walnuts, 7.5 g of hazelnuts, and 7.5 g of almonds) at no cost, and those in the control group received small nonfood gifts (I wonder what these were?)

After 5 years, those on the Med diet had about a 30% lower rate of heart attack, stroke or cardiovascular death.

Nuts versus Drupes versus Legumes

The evidence supporting “nut” consumption as a major part of a heart healthy diet is pretty overwhelming. But what is a nut and which nuts or nut-like foods qualify?

Let’s lay out the basic definitions:

Nut-Generally has a hard outer shell that stays tightly shut until cracked open revealing a single fruit inside. Examples are hazelnuts and acorns.

Drupe-Has a soft, fleshy exterior surrounding a hard nut. Classic drupes are peaches and plums with interior nuts so hard we won’t eat them. Examples are pecans, almonds, walnuts and coconuts.

Legume-generally has a pod with multiple fruit which splits open when ready. Examples are peas, carob, peanuts, soybeans and beans.

What Nuts Were Consumed in Studies Showing Benefits of Nuts?

Initially participants were given a questionnaire and asked

” how often they had consumed a serving of nuts (serving size, 28 g [1 oz]) during the preceding year: never or almost never, one to three times a month, once a week, two to four times a week, five or six times a week, once a day, two or three times a day, four to six times a day, or more than six times a day.”

After initial surveys, the questionnaires split out peanut consumption from “tree nut” consumption and whether you ate peanuts or nuts the benefits were similar.

Thus, for the most part, participants were left to their own devices to define what a nut is.  Since most people don’t know what a true nut is, they could have been eating anything from almonds (drupe related to peaches) to hazelnuts (true nut) to a pistachio “nut” (drupe) to a pine “nut” (nutlike gymnosperm seed).

Nutrient Content of Nuts

The nutrient components of these nuts varies widely but one consistency is a very high fat content. For this reason, in the dark days when fat was considered harmful, nuts were shunned.

However, in our more enlightened era we now know that fat does not cause heart disease or make you fat.

Please repeat after me “Fat does not cause heart disease or make you fat.”

A one ounce portion of pecans contains 20.4 grams of fat (11.6 arms monounsaturated and 6.1 polyunsaturated) so that 90% of its 204 calories come from fat.

Nuts, of course, also contain numerous other biologically active compounds that all interact and participate in the overall  beneficial effects that they have on cardiovascular disease and mortality.

They are a whole, real food which can be eaten intact without processing and these are the foods we now recognize provide the best choices in our diets, irrespective of fat or carbohydrate content.

They are also convenient, as they are easy to store and carry with you, providing a perfect snack.

If You Think It’s A Nut, It’s A Nut

IMG_3567

Hazelnut Death Experiment (Don’t try this at home!) A single hazelnut was partitioned into halves, quarters, slivers and little tiny bits. Progressively larger portions were consumed at 5 minute intervals. An Epipen (right) was available in case of anaphylaxis.

It turns out, that my attempts to put pecans and walnuts in to a specific family of nuts that increased my risk of dying if I consumed them were misguided.

I’m allergic to drupes.

In fact, I did an experiment recently and consumed a true nut (a hazelnut) and found I had no reaction.

I’m not allergic to nuts!!!

In the world of allergic reactions, thus,  there is no particular value to partitioning nuts from drupes from legumes.

Similarly, for heart healthy diets, it doesn’t matter if you are consuming a true nut or a drupe as long as you think of it as a nut.

Consume them without concern about the fat content and consume them daily and as along you are not allergic to them they will prolong your life.

Skeptically Yours,
-ACP

 

 

 

My MOC Status Has Changed!

I am Board Certified by the American Board of Internal Medicine (ABIM) in both Cardiovascular Disease and Internal Medicine.

Recently the ABIM has changed the rules and started a Maintenance of Certification (MOC) Program which is chock-full of useless forms, fees and tests.

I, and thousands of other doctors have rebelled against this program, recognizing that there is no evidence it will improve doctors care, patient outcomes or overall quality of medical care but that it will fill the coffers of bureaucrats and bureaucratic institutions and fritter away valuable time we could be spending on patients.

I did not pay my several hundred dollar fee the ABIM demanded for 2015.

MOCAs a result, I received this morning an email from ABIM telling me that “your MOC status has changed”. I logged in and found that I was listed as “Certified, Not Participating in MOC.”

I’m still the clinical cardiologist I was yesterday and I still spend hours weekly reading about the latest developments in cardiology that impact clinical care, teaching residents, and giving conferences but I wonder what the ramifications of this will be.

Dr. Wes, a cardiologist who has been a vociferous opponent of MOC is alerting physicians that one ramification is that the SGR bill the Senate is considering would tie doctor evaluations to MOC status.

You can read his comments here. He includes sample letters to send to Congress.

If the federal government puts their weight behind sanctifying MOC, then all physicians will be forced to participate.

I strongly all urge all physicians to consider weighing  in on this with your local congresspeople.

-ACP

The Tie, The White Coat And The Fist Bump

My role models and mentors during my medical training taught me what I considered to be the proper appearance and demeanor of the professional  physician.

The male doctor wore a dress shirt and a tie. The doctor wore a white coat over his/her regular clothes. The more senior the doctor was in the medical hierarchy the longer the white coat and the more impressive the words written on the coat.

Presumably, this professional appearance of the doctor increased the confidence that the patient had in the professionalism of the doctor.

Upon encountering a patient in the hospital room or office exam room, the doctor extends his right hand, greets the patient and smiles and shakes hands.

I wore a tie and a white coat and shook hands consistently during the first 20 years of my practice but gradually these markers of a good doctor have fallen under scrutiny.

The Physician Necktie as Disease Vector

Beginning about 15 years ago studies were published suggesting the physician necktie could become colonized with bacteria and serve as a vector for transmitting bacteria. Some authors, as a result, have called for an end to doctors wearing neckties (bow ties may be an exception).

In the UK, the tie has been banned for those involved in patient care because

“Ties are rarely laundered but worn daily. They perform no beneficial function in patient care and have been shown to be colonised by pathogens.”
After reading about ties as vectors I gradually stopped wearing them at work. Initially, I felt uncomfortable, as if I were not being professional. Somehow, I felt my patients would respect me less. Over time, however, I have reached a point where I only wear a necktie on Wednesdays.
A logical reader might ask why I still wear them at all. I don’t have a good answer for that. Perhaps, I feel a need to wear the dress shirts and ties I have accumulated over the years. Perhaps I don’t really feel the tie is a big contributor to nosocomial infections. Perhaps I want my patients to see that Dr. Pearson can dress professionally on occasion but he chooses not to the majority of the time.
The White Coat As Disease Vector
 
I’ve been wearing a white coat to make hospital rounds since I was a medical student starting on the wards 37 years ago (Yikes! Has it been that long?). The coat gave me an immediate power and respect and identified me as a caregiver.
My two oldest daughters have both undergone a  “white coat ceremony,” recognizing the important and exciting transition from pre clinical studies to actual patient interactions in the health care field.
The white coat serves other purposes for doctors. I keep my billing cards in one pocket and in another I have a case with my business cards. The lapel serves as a convenient  spot to clip my hospital ID badge. I used to carry around EKG calipers or rulers in my breast pocket but as EKGs have increasingly gone electronic I no longer do this.
Presumably the white coat helps keep dirt and vomit and phlegm from patients from  sullying  the “street” clothes of the physician.
However, the down side of all that stuff landing on the white coat and not on the street clothes may be that the white coat is accumulating bacteria that can then be transmitted to other patients.
In a 2009 study, the white coats of 23% (34 of 149) of medical and surgical Grand Round attendees at a teaching hospital were contaminated with S. aureus, 18% (6 coats) of which were resistant to methicillin.
 As a result of studies demonstrating bacterial contamination of white coats, the Society for Health Care Epidemiology of America SHEA recently recommended
White Coats: Facilities that mandate or strongly recommend use of a white coat for professional appearance should institute one or more of the following measures:
  1. HCP should have two or more white coats available and have access to a convenient and economical means to launder white coats (e.g. on site institution provided laundering at no cost or low cost).
  2. Institutions should provide coat hooks that would allow HCP to remove their white coat prior to contact with patients or a patient’s immediate environment.

Laundering:

  1. Frequency: Optimally, any apparel worn at the bedside that comes in contact with the patient or patient environment should be laundered after daily use.
  2. Home laundering: If HCPs launder apparel at home, a hot water wash cycle (ideally with bleach) followed by a cycle in the dryer or ironing has been shown to eliminate bacteria.
Basically, they are strongly suggesting you don’t wear a white coat but if you do, wash it every day and take it off before you interact with the patient.
I must admit it will be difficult for me to stop wearing the white coat. Sometimes I find myself having to pop into the hospital without my white coat (stethoscope around my neck (yes stethoscopes can serve as vectors for bacterial transmission but they can be cleaned between patients)) and I feel like an impostor.
The Handshake As Disease Vector
It has long been my practice to start patient encounter with a hearty greeting and a (somewhat) hearty handshake.
The handshake has a profound cultural role and serves as the international symbol of greeting and departure with connotations of  respect, friendship, congratulations and formal agreement.
In the health care setting, the handshake has been shown to have the power to the improve the perception of the physician’s empathy and compassion. The handshake provides comfort and calms patients.
We’ve known for a long time that shaking hands is an excellent way to transmit diseases. Many of my patients, when they know they have a cold,  will state this up front and decline my handshake. This is something that most people intrinsically understand. Studies have shown that health care workers hands are a common cause of disease transmission in the hospital and this is why hand washing or gelling is mandated in the hospital between patient visits.
Sklansky, et al wrote an editorial in JAMA in 2014 advocating that the hand shake be banned from the health care setting because despite our best efforts at hand hygiene we often fail, either due to poor compliance or limited activity of alcohol based hand rubs against some pathogens (including C. dif).

They suggested some alternative greeting including the hand wave, the bow, placing the right palm over the heart or the namaste gesture from yoga.

Since then, a study has shown that the fist bump (mysteriously termed a dap greeting) does reduce bacterial transmission.

Researchers at Aberystwyth University in Wales (the home country of the skeptical cardiologist!) immersed a donor participants’ sterile-gloved hand into a dense culture of E-coli (a non-pathogenic strain), and after it was dry, exchanged greetings with recipient participants, who also wore sterile gloves.

fistbumpThey tested the handshake, the high five, and the fist bump in a crossover design so that each “donor” and each “recipient” tested all greetings, eliminating potential for bias among the volunteers.

The results (graph to left) showed  twice as many bacteria were transferred during the handshake compared with the high-five, but the fist-bump transmitted only about 10% of the bacteria a handshake did.

Is It Time To Lose the Tie, the White Coat and the Handshake?

It’s hard to teach this old dog new tricks but more and more I will be eschewing the handshake in my patient encounters.

I’m going to experiment with the fist bump (especially for my younger patients) and the bow and perhaps I’ll have signs put up in my exam rooms declaring them “No Handshake Zones.”

DrP
The Non-Disease Transmitting Dr.P. No necktie. White coat washed daily. Stethoscope cleaned obsessively. Hand not extended for handshake but prepared to fist bump. Non-diseases-transmitting ID badge attached.

I don’t think I can abandon the white coat yet. It’s like a security blanket for me. I will experiment more and more with not wearing it and monitor my patient’s reactions.

I will definitely try to wear the white coat for only one day and then send it off to be laundered (I wonder what the environmental consequences of that are?)

Unbiased, evidence-based discussion of the effects of diet, drugs, and procedures on heart disease

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