Are Probiotics A Panacea Or Pure Hype?: The Gullible Gastroenterologist Weighs In

Please allow me to introduce myself.  I am the Gullible Gastroenterologist.  I’ve been around for a long long year, and today I have been given the opportunity by my good friend, the Skeptical Cardiologist (SC), to guest-blog on issues involving the GI tract.

As opposed to my skeptical friend, I had been very trusting by nature. But the SC has opened my eyes to the importance of fact-based medicine.  Seems to be a pretty good way to treat patients while making informed decisions based on the facts.

When the SC approached me to comment about probiotics, I jumped at the chance.  What could possibly be easier than discussing the obviously positive effects associated with ingesting good bacteria?  I mean, it says “good” right there in the description!  But then I remembered the SC’s insistence on giving weight to the facts.  And that’s when things started to get a more problematic.

What Are Probiotics?

Probiotics are defined by the World Health Organization as “live microorganisms that when administered in adequate amounts confer a health benefit on the host.”  The hope is that these ingested microorganisms will somehow affect the bacterial environment (the flora or microbiota) that already exists in our digestive tract.  This sounds great in theory, but it is important to realize that this issue is far from straight forward.

Go look in the mirror right now.  No seriously.  Do it.  I’ll wait.  I’m going to guess that you saw a human being in front of you (I hope).  Think about all the cells that made up what you saw.  All the cells in all the tissues that make up you.  It has been estimated that the total number of cells in an average 70 kg male equals 3.0 x 1013.  Now we know that bacteria normally reside in our body, but how many?  This has actually been estimated to equal approximately 3.8 x 1013 cells.  So you are made up of MORE bacterial cells than “you” cells.  Think about that for a second.  These bacterial cells are an intrinsic part of us.  Some have even gone so far as to call our gut flora a separate organ or even, when combined with our immune system, another sense akin to sight, smell, or touch.

So it is clear that the gut flora should be looked upon with respect, and we have known this for some time.  When animals are raised within isolators to create germ-free animals, we can see evidence that the gut microbiota influences normal neurological development and cognition, digestion, immune response, growth, and metabolism.  So somehow changing the gut microbiota might be effective in treating disease or alleviating certain symptoms, right?  Well, that is the idea behind many sources which claim that probiotics boost immune response, improve the health of your digestive tract, relieve dermatological conditions, cure or prevent autism, treat erectile dysfunction, and so on.

But there is a huge gap between the actual science of attempting to alter the gut microbiome and these unsupported ever-growing claims.  The main issue is that the gut microbiome is extremely complicated.  There is great individual variability between the types and concentrations of bacteria that live in my gut, and those that live in your gut.  Even the Great SC has his own unique concoction of gut flora.  In fact researchers have shown that the DNA makeup of the bacteria in an individual’s intestine is like a fingerprint and is remarkably stable in each individual.  Even after a year, these researchers were able to identify participants in their study just from the analysis of their unique gut flora.

So if we all have our unique gut flora, how can we determine what strains of bacteria to use to treat a patient for whatever ailment we are trying to cure?  What dosage or concentration should we use?  By what route should we introduce our special concoction?  Maybe more importantly, is any of this safe for us?  Can probiotics actually do us harm?

This becomes even more problematic due to the under regulation of the sources of these probiotics.  When we obtain these probiotics from various sources, it’s hard to know exactly what is in these products.  Multiple studies have found discrepancies between what we see on the label and what is actually in the bottle.  In 2015, an analysis of 16 probiotic products found that only one of them matched the bacterial species reported on the label.  Furthermore, if we are trying to somehow alter our bacteria microbiota, we would optimally want live bacteria in the product, and we know that this is not always the case.

Gastrointestinal Benefits Of Probiotics

So from a gastrointestinal perspective, what are the scientifically proven health benefits of probiotics?  These appear to be few and far between.  The majority of the studies have failed to reveal any benefits in individuals that are already healthy.  There seems to be no evidence that people with normal gastrointestinal tracts benefits from these products.

What about folks that are not healthy?  Can probiotics cure a gastrointestinal disease or a condition?  

Many people with irritable bowel syndrome (IBS) come to see the Gullible Gastroenterologist every day.  Although some individual studies have shown some positive effect from probiotics on the symptoms that can be associated with IBS, there is not enough data to recommend any particular strain of bacteria for this condition, and these studies are even more problematic given that even the placebo rate for treatment of IBS averages approximately 40%.

For patients with ulcerative colitis, a disease that causes abnormal inflammation in the large intestine, some small studies have suggested some potential benefits, but combining the results of these studies together does not prove any reliable benefit.

There has been no proven benefit regarding the use of probiotics in Crohn’s disease, a condition similar to ulcerative colitis that can affect anywhere in the gastrointestinal tract.

Small controlled studies do suggest that a probiotic preparation called VSL#3 can be effective in a condition called Pouchitis.  This is a specific condition that can affect patients with ulcerative colitis that have undergone a certain surgery to treat the disease.

There is no evidence to suggest that probiotics are effective in treating celiac disease.

Probiotics And C. difficile Infection

And now we get to the intriguing topic of Clostridium difficile associated colitis.  Clostridium difficile infection typically occurs in patients who have received antibiotics for therapy for bacterial infections elsewhere in the body, pneumonia for example.  The antibiotics can alter the bacterial flora of the gut leading to overgrowth of the C. difficile bacteria.  This overgrowth leads to production of a toxin and subsequent inflammation of the colon.  This bacteria can form spores and so in some patients this condition can be very difficult to treat, resulting in multiple recurrences. 

One of the treatments for recurrent C. difficile infection involves fecal transplantation: transferring stool from a healthy patient to the affected individual. 

The Gullible Gastroenterologist had the opportunity to participate in a fecal transplantation procedure.  The stool from a related donor was prepared in a blender by an infectious disease specialist colleague of mine (this is the reason I absolutely do not attend cocktail parties hosted by that particular physician).  I performed a colonoscopy on the patient and the stool mixture was instilled into the patient’s colon. 

The patient did well with no recurrences, and fecal transplant does appear to be a promising tool in the armamentarium in treatment of recurring C. difficile infection.  That being said, there is insufficient data to support routine use of probiotics for prevention of C. difficile colitis or for treatment of active C. difficile colitis.

Why Are Probiotics Ineffective?

So there is little convincing evidence that probiotics positively effect gastrointestinal disorders.  One reason might be that bacteria from a probiotic supplement might not actually succeed in colonizing the human intestinal tract.  A recent study concluded that in some patients, probiotic strains could be identified in samples obtained from some study participants, but in others, those probiotic strains were undetectable. 

In another study, researchers looked at the fecal microbiome in patients that had received antibiotics.  Normally, a person’s microbiome will recover on its own over time after receiving antibiotics.  This usually takes about 21 days without any intervention.  Surprisingly, administering probiotics to these subjects actually delayed recovery of the microbiome to the pre-antibiotic state to greater than five months.  What does this mean?  Is this good?  Is this bad?  The answer is that we just don’t know.  Yet.

Harm From Probiotics?

Can probiotics do harm?  Although these agents are generally felt to be safe in healthy individuals, we don’t know the long term consequences.  Furthermore, probiotics should be used with caution in patients with chronic disease, are immunocompromised, or are otherwise vulnerable (such as elderly patients).

Bottom Line: More Research Needed Before Usefulness Of Probiotics Proven

So the bottom line?  Research on the fecal microbiome is certainly exciting.  This area of study definitely has the potential to be very important and likely holds the key to discovering the underlying pathophysiology to many conditions. 

But in the year 2019, we just do not have enough information to determine which preparations may be helpful, which patients should be targeted, and how. 

Although I am hopeful that someday probiotics might be an effective tool in treating some of the diseases and conditions that my patients suffer from today, I am just not gullible enough to buy into the hype associated with unsubstantiated claims regarding their usefulness until we learn much much more.

Gullibly yours,

DSL


The Gullible Gastroenterologist,

Dave Lotsoff,  lives south of Delmar in University City, Missouri  and when he’s not singing like Jim Morrison for the skeptical cardiologist’s band he practices gullible clinical gastroenterology  in St. Louis.

-ACP

N.B. Probiotics have also been promoted for lowering blood pressure and reducing risk of cardiovascular disease but the proof of benefit is similar to that for GI problems-severely lacking.

It’s far too early to recommend probiotics  for preventing or treating any chronic diseases.

FDA Recalls More Generic Blood Pressure Meds: Where Are Your Medications Manufactured?

In July of 2018, the FDA made a series of voluntary recalls of several versions of the generic blood pressure medication valsartan which were made in China and were contaminated by the “possible carcinogen,”  N-nitrosodimethylamine (NDMA).

At the time I asked readers the question, “Is your BP med made in china and is it safe?” as it became clear that now in the US users of medications must be very aware of the source and quality of the products they put in their body.

Generic prescription medications and OTC products are highly likely to be manufactured out of the US and with minimal oversight.

Since then the FDA has announced multiple other recalls for companies producing angiotensin II receptor blockers (ARBs) in the same class as valsartan, including products containing losartan and irbesartan,. These drugs have been found to be contaminated contaminated with NDMA or another carcinogen  N-nitrosodiethylamine (NDEA).

The recall now includes irbesartan and losartan plus additional lots of valsartan. Thus, some patients who we switched from valsartan to losartan are now having to switch again.

Click the following links to review updated lists of irbesartan products under recall, losartan medications under recall, valsartan products under recall and valsartan products not under recall.

Here’s  the FDA’s valsartan alert notice from 1/2/19

FDA is alerting patients and health care professionals to Aurobindo Pharma USA’s voluntary recall of two lots of valsartan tablets, 26 lots of amlodipine and valsartan combination tablets, and 52 lots of valsartan and hydrochlorothiazide (HCTZ) combination tablets due to the amount of N-Nitrosodiethylamine (NDEA) in the valsartan active pharmaceutical ingredient. Aurobindo is recalling amlodipine and HCTZ only in combination medications containing valsartan. Neither amlodipine nor HCTZ is currently under recall by itself.

Aurobindo is recalling lots of valsartan-containing medication that tested positive for NDEA above the interim acceptable daily intake level of 0.083 parts per million.

The agency continues to investigate and test all angiotensin II receptor blockers (ARBs) for the presence of NDEA and N-Nitrosodimethylamine (NDMA) and is taking swift action when it identifies these impurities that are above interim acceptable daily intake levels.

FDA also updated the list of valsartan products under recall and the list of valsartan products not under recall.

FDA reminds patients taking any recalled ARB to continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition. Some ARBs contain no NDMA or NDEA.

Fortunately, there are multiple generic  and brand nameARBs we can substitute for the recalled products.

perspective-1

Patients Discover How Hard It Is To Find Non-Chinese Medications

When I tried to find the source of my generic medications, the results were eye-opening:

 my cholesterol drug is made in India by an Indian company and my blood pressure drug is made in Columbus, Ohio, by a Jordanian company.

I had not realized how globalized the pharmaceutical industry had become.

Many readers also researched the source of the pills they were taking and shared their experience through comments on my blog:

“Frustrated” wrote

My cardiologist changed my blood pressure med to irbesartan. Another generic ARB. I went to get it filled today at a local grocery store pharmacy. I asked where it was made and they showed me the bottle. Guess what? It was SOLCO/Prinston as distributor and Zhejiang Huahai Pharmaceuticals LTD – the same manufacturer as the tainted valsartan. Exactly the same. Despite the recent horrible FDA inspection report of that facility which is posted online here: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM621162.pdf

Also, the FDA has found another cancer causing chemical in the drug since I last wrote – now there are two. I checked at [MAJOR CHAIN] pharmacy – they use the SAME CHINESE MANUFACTURER. I checked at [MAJOR CHAIN 2] – yep, they use the SAME CHINESE MANUFACTURER. This is really starting to get scary. I’m trying hard to find a pharmacy that has the non-Chinese version (there are 16 other generic manufacturers of the drug). My insurance company only permits me to use the pharmacies I tried today. Funny how everyone is buying Chinese. Does that validate the claims made in the Epoch article. Is this really that Chinese are undercutting everyone else? I’m just disgusted. I will tell you that if I owned a pharmacy I would not purchase my generics from the same company that just caused one of the largest drug recalls in history. It must be really really cheap. Really really cheap.

Mitch writes:

I have been taking Losartan, but became really concerned with the latest news about carcinogens found in two more BP medications. I called EVERY local pharmacy, including big-box stores, grocery store pharmacies, independent pharmacies, and traditional pharmacies. Not a single one has US-made losartan. Every one of them has stock of meds made in either China or India. One pharmacists told me that he had no control of what he sells; it’s all decided on the corporate level. Another said that he would stock the cheapest generic he could find. Still another pharmacy tried to convince me that Citron, Torrent, and Solco are New Jersey companies selling US-made drugs. It takes only a few minutes of Internet research to prove them wrong. Apparently, there is no incentive to stock US-made drugs. I agree, the consumers have to take action and write to their representatives demanding answers from the FDA.

BIS wrote:

I have just had the same experience. My Indian made Valsartan (Camber) was recalled so my doctor switched me to Irbesartan 150 mg tablets which at my local CVS were also manufactured by Camber. I reluctantly took these while searching for US or European made alternatives. I just went to CVS to get my refill. When I got home instead of the Indian Irbesartan I received a bottle manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd.,(ZHP) Xunqiao, Linhal, Zhejiang China. I am a mechanical engineer not a chemistry major but I believe Irbesartan contains API which is what has been the problem from this company. Looking at the internet I see that the FDA has and import alert for this company. The import alert halts all ZHP-made API and finished drug products using the company’s API from legally entering the United States (https://www.pharmacist.com/article/fda-places-zhejiang-huahai-pharmaceuticals-import-alert). Let’s see- did the Chinese use good API in this batch….I called the CVS and asked for alternatives and was told “good luck”. My doctor said he will work with me if I can find non Chinese or Indian medication. I go out of my way to buy American made goods as I have worked in manufacturing my entire career and have made numerous trips to China and seen what goes on. My Chinese colleagues when they come to the US fill their bags with US made baby formula and vitamins (which probably contain Chinese ingredients). If anyone finds a US or European source of BP medication please post it.

What Can We Do?

One of my readers, Kate, made the following suggestion which made a lot sense:

write to the Senate committee that oversees the FDA. Demand more clarity in labeling of prescription bottles – the country of origin should be CLEAR and CONSPICUOUS – just like that little “Made in China” sticker on the photo above – but on the prescription label itself. Right now only the pharmacist’s supply bottle has the labeling. Write your congressman and to:

U.S. Senate Committee on Health, Education, Labor & Pensions

428 Senate Dirksen Office Building

Washington, DC 20510

I would encourage patients who are taking these recalled ARBS (which are really good blood pressure medications) to check their pill bottles and check with their pharmacists to determine if they have been recalled. If the pharmacist can’t replace your medication with an identical ARB that hasn’t been withdrawn, ask your physician for one of the alternatives listed above.

Find out what country you’re generic drugs in general are made in and let your congressional representatives know you want better FDA oversight of off-shore pharmacuetical manufacturing along with complete transparency with respect to country of origin.

Skeptically Yours,

-ACP

Is Trump’s USDA Making School Lunches Great Again?: Not Until They Stop Mandating Low Fat or Non Fat Milk

In 2010 President Obama signed into law the “Healthy, Hunger-free kids  act (HHKA) of 2010” which funded child nutrition programs and free school lunch programs in schools. New nutrition standards for schools were a point initiative of then First Lady Michelle Obama as part of her fight against childhood obesity and her “Let’s Move” initiative.

In May of 2017, President Trumps’s new secretary of agriculture, Scotty Perdue, issued a proclamation (Entitled Ag Secretary Perdue Moves To Make School Meals Great Again) which pledgee to loosen some of Obama’s school nutrition standards with respect to whole grains, salt and milk.

These changes have been finalized recently and have received considerable criticism. For example, Vox’s Julia Belluz wrote a piece entitled  “The Trump administration’s tone-deaf school lunch move” with a subtitle implying that the USDA’s loosening of standards would contribute to already soaring childhood obesity rates.

Belluz summarized the changes

That means 99,000 schools, feeding 30 million kids, can offer 1 percent chocolate and strawberry milk again, more refined white flour products, and, most importantly, freeze sodium levels in school lunches instead of reducing them further.

Criticism of the loosening implies that the original school lunch standards were appropriate and based on state of the art nutritional science, but were they?

The HHKA relied on guidance from the Institute of Medicine which established a committee to put together its report which was published in 2009 and was heavily based on the scientific guidance provided in the 2005 Dietary Guidelines for Americans and the IOM’s Dietary Reference Intake books”

Unfortunately, the 2005 Dietary Guidelines for Americans were not privy to  dramatic changes in our understanding of nutritional science which have occurred in the 13 years since they were written.

The IOM report copied the 2005 DGA in recommending the consumption of low fat or non fat dairy and defined low fat as 1%.

To achieve its aim of reducing saturated fat intake to <10% the IOM chose to force schools to only utilize low fat or skim milk.

 

The IOM and school lunch program recommended eliminating whole milk entirely and only allowing

-fat-free (plain or flavored) or

-plain low-fat (meaning 1%) milk

In 2018 it is very clear to anyone who examines the relevant data (see here, here and here) that dairy fat, despite being predominantly saturated fat is not associated with higher rates of cardiovascular disease, obesity, diabetes or total mortality.

A 2013 editorial in JAMA Pediatrics from Ludwig and Willet challenged recommendations for children to consume 3 glasses of low fat or non fat milk daily and noted:

Remarkably few randomized clinical trials have examined the effects of reduced-fat milk (0% to 2% fat content) compared with whole milk on weight gain or other health outcomes. Lacking high-quality interventional data, beverage guidelines presume that the lower calo rie content of reduced-fat milk will decrease total calorie intake and excessive weight gain.. However, a primary focus on reducing fat intake does not facilitate weight loss compared with other dietary strategies, as shown in observational studies and clinical trials, perhaps because reduced-fat foods tend to have lower satiety value.

Therefore, one of the key components of the HHK is misguided and not science-based.  It has in effect committed all of our children to a vast experiment with unknown health consequences.

How Do New USDA Guidelines Effect Dairy?

The change the USDA recently announced is to allow flavoring in 1% milk. Perdue is quoted as saying:

Because milk is a critical component of school meals, and providing schools with the discretion to serve flavored, 1 percent fat milk provides more options for students selecting milk as part of their lunch or breakfast, I am directing USDA to begin the regulatory process to provide that discretion to schools.

Prior to the mandated changes, the IOM report noted that dairy intake in children was predominantly from milk with >1% dairy fat.

17 percent of the total milk intake was from unflavored 2 percent milk, 16 percent from unflavored whole milk, and 9 percent from flavored milk

The dairy industry basically demanded the right to flavor 1% milk because the mandate to force all school children to drink low fat or skim milk has resulted in less children drinking milk.

And the government’s solution to making unpalatable skim milk tastier to children is to add sugar, something we have learned in the last decade we should not be doing to our food.

As Ludwig and Willet noted:

Consumption of sugar-sweetened, flavored (eg, chocolate) milk warrants special attention. While limit ing whole milk, some healthy beverage guidelines con done, and many schools provide, sugar-sweetened milk, with the aim of achieving recommended levels of total milk consumption in children. Not surprisingly, children prefer sweetened to unsweetened milk when given the choice, leading to a marked increase in the proportion of sweetened milk consumption in recent years. This trend may reflect, to some degree, compensation for the lower palatability and satiety value of fat-reduced milk. However, the substitution of sweetened reduced-fat milk for unsweetened whole milk—which lowers saturated fat by 3 g but increases sugar by 13 g per cup—clearly undermines diet quality, especially in a population with excessive sugar consumption.

The bulk of the dairy industry actually prefers you and your children drink skim milk (see here) and they are happy to adulterate the tasteless, nutritionless beverage with anything that makes it more palatable.

Witness this quote from AgWeb:

This is great news, not only for dairy farmers and processors, but also for schoolkids across the U.S.,” says John Rettler, president of FarmFirst Dairy Cooperative. “This is a step in the right direction in ensuring that school cafeterias are able to provide valuable nutrition in options that appeal to growing children’s taste buds. Their good habits now have the potential to make them lifelong milk-drinkers.”

Adding sugar to mandated unpalatable low fat milk might increase consumption of the beverage but it is definitely not a  step forward for our kid’s health.

This unethical, unscientific experiment might be contributing already  to higher rates of childhood obesity and diabetes.

Making Skepticism Great Again,

-ACP

N.B. To help understand how skim milk despite having less calories than whole milk could actually worsen obesity Ludwig and Willet provide the following instructive  paragraph:

Suppose a child, who habitually consumes a cup of whole milk and two 60-kcal cookies for a snack, instead had nonfat milk. Energy intake with that snack would not decrease if that child felt less satiated and consequently ate just  extra cookie. Rather than weight loss, this substitution of refined starch and sugar (ie, high glycemic index carbohydrate) for fat might actually cause weight gain. Consumption of a low-fat, high glycemic index diet may not only increase hunger, but also adversely affect energy expenditure compared with diets with a higher proportion of fat. In an analysis of 3 major cohorts, high glycemic index carbohydrates, such as refined grains, sugary beverages, and sweet desserts, were positively associated with weight gain, whereas whole milk was not. Of particular relevance, prospective studies in young children, adolescents, and adults observed the same or greater rates of weight gain with consumption of reduced-fat compared with whole milk, suggesting that people compensate or overcompensate for the lower calorie content of reduced-fat milk by eating more of other foods.

full text available here.

The Pearson Potato Theory of Obesity

The skeptical cardiologist developed “Pearson’s Potato Hypothesis” aka the potato theory of obesity a few years ago but became bogged down in frying oil and never published it.

Now I’m really glad I never got around to finishing my post on the theory-it appears that defenders of the potato are legion and vocal. ConscienHealth points out that a NY Times piece on the dangers of french fries quoted a Harvard epidemiologist  (Eric Rimm) as calling potatoes “starch bombs” and weapons of “dietary destruction.”

Potatoes rank near the bottom of healthful vegetables and lack the compounds and nutrients found in green leafy vegetables, he said. If you take a potato, remove its skin (where at least some nutrients are found), cut it, deep fry the pieces in oil and top it all off with salt, cheese, chili or gravy, that starch bomb can be turned into a weapon of dietary destruction.

The article goes on to recommend portion size control when dealing with French fries and further quoted Rimm:

“There aren’t a lot of people who are sending back three-quarters of an order of French fries. I think it would be nice if your meal came with a side salad and six French fries.”

Apparently the notion of limiting one’s French fries is abhorrent to many and Rimm has been attacked by thousands in the twitter-sphere.

I happen to think he’s right so I’ll go out on a limb here and post the essence of my theory without all the backing references and statistics with which I had hoped to buttress it.


Pearson Potato Theory of Obesity:

Because potatoes are cheap,  restaurants add lots of them to dishes to make the dishes seem larger and (to some) better and more satiating. Because the potatoes are so gosh darn tasty when sliced up thinly and fried and salted patrons can’t resist eating them even when they are not hungry. Eating any food when you are full is a recipe for….obesity.


To illustrate this issue I’ve started noting what restaurants serve along with the main dish that I’m interested in.

The vast majority of time breakfast orders come with fried potatoes like those below that came with the egg dish that I ordered.potato egg

I was sorely tempted to eat all these fried potatoes although full from my egg dish because when cooked properly the combination of the crispy fat, salt and warm fluffy potato interior is irresistible. Instead I ate just a few and put the rest in a to-go box, took them home, weighed them on a scale and took this picture.

IMG_8758

Interestingly, the weight of the potatoes that I had not consumed was 150 grams which is roughly equivalent to a large order of fries at McDonald’s. A large order of McDonald’s fries gives you 500 calories with 66 grams of carbohydrates,.

Thus, if I had not been disciplined that morning I likely would have ended up consuming more calories in fried potatoes than the main dish and over half of the calories I consume in a typical full day.

French fries (and their (equally addictive to me) cousin the potato chip) are the side for almost all hamburgers and sandwiches served in the US thus the possibility of unintended excess starch bomb consumption extends from breakfast to lunch to dinner in meals consumed outside the home.

Sweet Potatoes Versus Potatoes

In 2015 I pointed out that sweet potatoes which are embraced by nutrition experts are very similar nutritionally to potatoes.

A serving of either one provides 37 grams of carbohydrates and 4 grams of protein. Sweet potatoes have more fiber ( 6 grams vxs 4 grams) but more sugars (12 grams vs 2 grams.)

The Harvard School of Public health has decided potatoes are not a vegetable:

“However, potatoes don’t count as a vegetable on Harvard’s Healthy Eating Plate because they are high in carbohydrate – and in particular, the kind of carbohydrate that the body digests rapidly, causing blood sugar and insulin to surge and then dip (in scientific terms, they have a high glycemic load).”

but gives sweet potatoes a pass.

If sweet potatoes were as ubiquitous as potatoes and became a staple of fast food restaurants and a side for any and all dishes (and if they were separated out from the rest of the vegetable world), I suspect they would also be associated with weight gain.

If, on the other hand, potatoes were not markers of fast, tasty, and easily prepared and consumed food and were only eaten at trendy locavore restaurants or prepared at home, I think they would no longer be associated with obesity.

So, yes it does make sense to ask for a side salad and limit your fries to six (or perhaps seven on days of debauchery) in place of the typical mountain of potato if you are seeking weight loss.

Spudlimitingly Yours,

-ACP

Life’s Simple 7 And The Prevention Of Atrial Fibrillation

In 2010 the AHA came up with “Life’s Simple 7”-seven modifiable health behaviors and biological factors- as part of its 2020 impact goal to improve the cardiovascular health of all Americans by 20% while reducing deaths from cardiovascular disease (CVD) and stroke by 20%.

The seven factors (LS7) were smoking, body mass index [BMI], physical activity, diet, total cholesterol, blood pressure, and fasting blood glucose, Attainment of optimal LS7 status has been associated with a reduced incidence of coronary heart disease, stroke, and heart failure (HF).

A recent observationsl study found that high LS7 scores was associated with a lower risk of developing atrial fibrillation

Each individual component was categorized as poor, intermediate, or ideal according to the American Heart Association’s LS7 criteria.1 Ideal levels of health factors were: nonsmoker or quit >1 year ago; body mass index <25 kg/m2; blood pressure <120/80 mm Hg; total cholesterol <200 mg/dL; fasting blood glucose <100 mg/dL; ≥150 min/week of physical activity; and a healthy diet score (≥4 components). Study participants who were treated to target levels for hypercholesterolemia, hypertension, or diabetes mellitus were classified as intermediate for the respective health factor. An overall LS7 score ranging from 0 to 14 was calculated as the sum of the LS7 component scores (2 points for ideal, 1 point for intermediate, and 0 for poor). This score was classified as inadequate (0‐4), average (5‐9), or optimum (10‐14) cardiovascular health.

I found this figure from the paper particularly interesting

 

Notice that there is a substantially lower risk of AF with lower BMI , blood sugar and blood pressure  but no relationship between the diet score and AF risk.

Clearly if you can get and keep your body weight down (which improves  blood pressure and diabetes risk) you will be in a lower risk category for atrial fibrillation.

On the other hand, having a total cholesterol <200 mg/dl is not associated with lower  risk of AF and in fact having an ideal score on this parameter is associated with higher risk. A total cholesterol is really not something that is a good marker for CV health and should be eliminated from the Life’s Simple 7 goals.

Even more enlightening is the total lack of any association between “healthy” diet and atrial fibrillation.

The healthy diet score was calculated as the sum of the scores for each of 5 individual components: fruits and vegetables (≥4.5 cups per day), fish (≥2 3.5‐oz servings per week), fiber‐rich whole grains (≥3 1‐oz‐equivalent serving per day), sodium (<1500 mg/day), sugar‐sweetened beverages (≤450 kcal/week). The range is from 0 to 5, with a lower score being unhealthy.

Taken in conjunction with studies showing reduced AF recurrence after weight loss it seems very clear that the single best thing obese afib patients can do to prevent recurrence is lose weight.  And it doesn’t matter what diet they utilize to accomplish the weight loss.

Skeptically Yours,

-ACP

A Heart Healthy Egg Nog Holiday Toast From Dr. and Mrs. Skeptical Cardiologist!

The skeptical cardiologist wrote a post extolling the virtues of egg nog back in 2013.

Today I’m reposting it and wishing all my readers and patients a great Christmas and a fantastic 2019.

IMG_2051-1



It’s Christmas Eve and you are starting to make merry. Time to break out the egg nog? Or should you eschew this fascinating combination of eggs, dairy and (often) alcohol due to concerns about heart disease?

egg

    • Cardiac deaths

increase in frequency

    • in the days around Christmas.

Could this be related to excessive consumption of egg nog?

Egg nog is composed of eggs, cream, milk and booze. All of these ingredients have become associated with increased risk of heart disease in the mind of the public.
Nutritional guidelines advise us to limit egg consumption, especially the yolk, and use low-fat dairy to reduce our risk of heart disease

A close look at the science, however, suggests that egg nog may actually lower your risk of heart disease.

Eggs are high in cholesterol but as I’ve discussed in a previous post, cholesterol in the diet is not a major determinant of cholesterol in the blood and eggs have not been shown to increase heart disease risk.

Full fat dairy contains saturated fat, the fat that nutritional guidelines tell us increases bad cholesterol in the blood and increases risk of heart attacks. But some saturated fats improve your cholesterol profile and organic (grass-fed, see my previous post) milk contains significant amounts of omega-3 fatty acids which are felt to be protective from heart disease.
Milk and dairy products are associated with a lower risk of vascular disease!

Whether you mix rum, brandy, or whisky into your egg nog or you drink a glass of wine on the side you are probably lowering your chances of a heart attack compared to your abstemious relatives. Moderate alcohol consumption of any kind is associated with a lower risk of dying from cardiovascular disease compared to no alcohol consumption.

So, drink your egg nog without guilt this Holiday Season!
You’re actually engaging in heart healthy behavior.

Eggnoggingly Yours,

-ACP

Science Confirms-Eating Chicken Is Not Healthier Than Eating Red Meat

Most Americans take it for granted that if they want to lower their risk of heart disease they should switch from eating red meat to eating chicken. As a result, US and world-wide poultry consumption has tripled since 1980 and surpassed beef consumption.

 

 

 

 

 

 

 

The switch from beef and pork to chicken has been driven in large part by  widespread  recommendations to consume less saturated fat and cholesterol.

For example the American Heart Association (AHA) (in its typically misguided) way says:

In general, red meats (beef, pork and lamb) have more cholesterol and saturated (bad) fat than chicken, fish and vegetable proteins such as beans. Cholesterol and saturated fat can raise your blood cholesterol and make heart disease worse. Chicken and fish have less saturated fat than most red meat.

Instead of listing any facts or studies relevant to your cardiovascular health the AHA choses to repeat the meaningless first sentence again in the last sentence (beef, pork and lamb have more cholesterol and saturated fat than chicken, fish and… beans becomes chicken and fish have less saturated fat than most red meat.)

In between these redundant sentences the AHA lays out the mostly discredited dogma  -“cholesterol and saturated fat…make heart disease worse.”  In the AHA’s opinion all saturated fats, no matter the source are dangerous (see here.) Despite the fact that the Dietary Guidelines of American no longer consider cholesterol a macronutrient of interest, the AHA still wants to focus on it.

At LIvestrong the claim is repeated that by choosing skinless chicken breasts over red meat your bad cholesterol (and risk of heart disease) will be lowered. Furthermore, Livestrong repeats the unsubstantiated trope that you will better manage your weight by eating low fat food.

A chicken breast is relatively low in saturated fat compared to many protein alternatives, especially when the skin is removed. By substituting chicken for higher-fat cuts of meat, you will lower your risk of developing heart disease by reducing your LDL, or “bad” cholesterol. Eating lower-fat alternatives will also help you maintain a healthy weight. Grilling, broiling and baking are great cooking methods to keep the fat content at its lowest.

When we carefully examine the evidence, however, there is no scientific support for either of these claims-switching to chicken from beef has never been shown to reduce your risk of heart disease. In fact, more recent studies show the switch won’t improve biomarkers that predict long-term risk of cardiovascular disease.

And switching to chicken from beef does not improve weight management.

Studies Show No Change in BioMarkers

This 2012 meta-analysis found

Changes in the fasting lipid profile were not significantly different with beef consumption compared with those with poultry and/or fish consumption. Inclusion of lean beef in the diet increases the variety of available food choices, which may improve long-term adherence with dietary recommendations for lipid management.

and this 2017 meta-anaysis of randomized trials

support that the consumption of ≥0.5 compared with <0.5 servings of total red meat/d does not influence blood lipids, lipoproteins, and/or blood pressures, which are clinically relevant CVD risk factors. These results are generalizable across a variety of populations, dietary patterns, and types of red meat.

Eating Fat Doesn’t Make You Fat

Once again I feel like I’m beating a dead horse here but it bears repeating- the concept that switching from a high fat food item to a low fat item will cause weight loss is totally false.

There are actually numerous studies showing that there is no difference between chicken and beef consumption on weight or body fat:

1. Melanson et al. conducted a 12-week randomised, controlled trial of  overweight women on  an energy restricted diet with either lean beef or chicken as the major protein source along with moderate exercise. There was no difference in weight loss or % body fat or blood lipid profiles between the patients on the beef or chicken diet.

2., Mahon et al.  compared consumption of lean beef or chicken as the primary protein source over 12 weeks  in a hypocaloric diet in 61 obese females. There was no difference between the chicken or beef eaters in the amount of weight loss, fat loss or drop in LDL (bad) cholesterol.

Finally, here’s a 2014  RCT study of 49 obese adults who were randomly assigned to consume up to 1 kg/week of pork, chicken or beef, in an otherwise unrestricted diet for three months, followed by two further three month periods consuming each of the alternative meat options.

There was no difference in BMI or any other marker of adiposity between consumption of pork, beef and chicken diets. Similarly there were no differences in energy or nutrient intakes between diets

Vegetarians Uniformly Condemn Chickens As Unhealthy

It’s interesting that a Google search for the healthiness of chicken versus beef yields the standard dietary dogma from mainstream nutritional sources like the AHA or the American Academy of Nutrition and Dietetics but also a large number of sites that want to convince you of how unhealthy chicken is.

These sites are vegan or vegetarian sites such as plantbasednews.org which lists these six “shocking” reasons why you should stop eating chicken:

At least one of the reasons is clearly documented:

-As Consumer Reports reported in 2014, 97% of 300 raw chicken breasts purchased at stores across the U.S. contained  potentially harmful bacteria .

Several of the reasons are more ethical/moral in nature and I leave it up to my readers to decide how important these are to them.

-“The poultry industry has a devastating impact on the environment” related to pollution from factory farms.

-“chickens are intelligent animals”

-“The slaughter of birds is horrifying”

The Guardian.com has a good article on the horror  of  factory farm chicken raising entitled “If consumers knew how farmed chickens were raised they might never eat their meat again” which I recommend to those who are not already familiar with the conditions in which 99.9% of broilers are raised.

One “shocking reason” listed by plantbasednews appears untrue-“chickens are stuffed with cancer-causing arsenic”  The FDA in 2017 indicates that the animal drug which raised arsenic levels in chicken livers (3-Nitro) had been withdrawn from the market.

Bottom Line-No Universal Health Reason To Switch From Red Meat To Chicken

There are many other factors which go into the overall effect of beef and chicken on our bodies. For one thing, how the meat is prepared and what accompanies it will have a much greater influence on health than whether it is chicken or red meat.

It’s time to rid  America of the idea that chicken is healthier than beef-it is not and has never been supported by good scientific studies.

If you’ve been diagnosed with heart disease don’t assume you can only eat skinless chicken breasts as meat for the rest of your life.

The change from beef to chicken definitely won’t help you lose weight.

And it won’t reduce your risk of heart attack or stroke.

Beef in moderation can definitely be part of a heart healthy diet and a weight loss diet. Just be sure to eat plenty of fresh vegetables, nuts, fresh fruit,  legumes,  and fish along with your red meat. and minimize processed foods, added sugars and empty carbs.

Omnivorously Yours,

-ACP

Apple Watch Fails To Notify Patient Of 3 Hour Episode Of Rapid Atrial Fibrillation

Apple claims that its Apple Watch can detect atrial fibrillation (AF) and appropriately notify the wearer when it suspects AF.

This claim comes with many caveats on their website:

Apparently it needs to record 5 instances of irregular heart beat characteristic of atrial fibrillation over at least 65 minutes before making the notification.

This feature utilizes the watch’s optical heart sensors, is available  in Apple Watch Series 1 or later and has nothing to do with the Apple Watch 4 ECG recording capability which I described in detail in my prior post.

Failure To Detect AF

A patient of mine with known persistent AF informed me yesterday that she had gone into AF and remained in it for nearly 3 hours with heart rates over 100 beats per minute and had received no notification. She confirmed the atrial fibrillation with both AW4 recordings and AliveCor Kardia recordings while she was in it.

The watch faithfully recorded sustained heart rates up to 140 BPM but never alerted her of this even though the rate was consistently over her high heart rate trigger of 100 BPM.

The patient had set up the watch appropriately to receive notifications of an irregular rhythm.

Reviewing her tracings from both the AW4 and the Kardia this was easily diagnosed AF with a rapid ventricular response.

What does Apple tell us about the accuracy of the Apple Watch AF notification algorithm? All we know is the unpublished , non peer-reviewed data they themselves collected and presented to the FDA.

From this link on their website Apple says:

In a study of 226 participants aged 22 years or older who had received an AFib notification while wearing Apple Watch and subsequently wore an electrocardiogram (ECG) patch for approximately 1 week, 41.6% (94/226) had AFib detected by ECG patch. During concurrent wear of Apple Watch and an ECG patch, 57/226 participants received an AFib notification. Of those, 78.9% (45/57) showed concordant AFib on the ECG patch and 98.2 % (56/57) showed AFib and other clinically relevant arrhythmias. These results demonstrate that, while in the majority of cases the notification will accurately represent the presence of AFib, in some instances, a notification may indicate the presence of an arrhythmia other than AFib. No serious device adverse effects were observed

This tells us that about 80% of notifications are likely to be Afib whereas 20% will not be Afib. It is unclear what the “other clinically relevant arrhythmias”  might be. If I had to guess I would suspect PVCS or PACS which are usually benign.

If 20% of the estimated 10 million Apple Watch wearers are getting false positive notifications of afib that means 2 million calls to doctor or visits to ERs that are not justified.  This could be a huge waste of resources.

Thus the specificity of the AF notification is 80%. The other important parameter is the sensivitiy. Of the cases of AF that last >65 minutes how many are detected by the app?

Apple doesn’t seem to have any data on that but this obvious case of rapid AF lasting for 3 hours does not give me much confidence in their AF detection algorithms.

They do have a lot of CYA statements indicating you should not rely on this for detection of AF:

It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis. These data are only captured when the user is still. Along with the user’s risk factors, the feature can be used to supplement the decision for AFib screening. The feature is not intended to replace traditional methods of diagnosis or treatment.

My patient took her iPhone and Apple Watch into her local Apple store to find out why her AF was not detected. She was told by an Apple employee that the Watch does not detect AF but will only notify her if her heart rate is extremely low or high. I had asked her to record what they told her about the problem.

As I’ve written previously (see here) the Apple Watch comes with excessive hype and minimal proof of its accuracy. I’m sure we are going to hear lots of stories about AF being detected by the Watch but we need some published, peer-reviewed data and we need to be very circumspect before embracing it as a reliable AF monitor.

Skeptically Yours,

-ACP

Putting The Apple Watch 4 ECG To The Test In Atrial Fibrillation: An Informal Comparison To Kardia

My first patient this morning, a delightful tech-savvy septagenarian with persistent atrial fibrillation told me she had been monitoring her rhythm for the last few days using her Apple Watch 4’s built in ECG device.

Previously she had been using what I consider the Gold Standard for personal ECG monitoring- AliveCor’s Kardia Mobile ECG   and I monitored her recordings through our Kardia Pro connection.

I had been eagerly awaiting Apple’s roll out since I purchased the AW4 in September (see here) and between patients this morning I down-loaded and installed the required iPhone and Watch upgrades and began making AW4 recordings.

Through the day I tried the AW4 and the Kardia on patients in my office.

Apple Watch 4 ECG Is Easy and Straightforward

The AW4 ECG recording process is very easy and straightforward. Upon opening the watch app you are prompted to open the health app on your iPhone to allow connection to the Watch ECG information. After this, to initiate a recording simply open the Watch ECG app and hold your finger on the crown.

Immediately a red ECG tracing begins along with a 30 second countdown.

Helpful advice to pass the time appears below the timer:

“Try Not to move your arms.”

and

“Apple Watch never checks for heart attacks.”

When finished you will see what I and my patient (who mostly stays in sinus rhythm with the aid of flecainide) saw-a declaration of normality:

Later in the day I had a few patients with permanent  atrial fibrillation put on my watch.

This seventy-something farmer from Bowling Green, Missouri was easily able to make a very good ECG recording with minimal instruction

 

 

 

 

The AW4 nailed the diagnosis as atrial fibrillation.

We also recorded a Kardia device ECG on him and with a little more instruction the device also diagnosed atrial fibrillation

 

 

After you’ve made an AW4 recording you can view the PDF of the ECG in the Health app on your iPhone where all of your ECGs are stored. The PDF can be exported to email (to your doctor) or other apps.

ECG of the Bowling Green farmer. I am not in afib.

 

Apple Watch Often “Inconclusive”

The AW4 could not diagnose another patient with permanent atrial fibrillation and judged the recording “inconclusive”

The Kardia device and algorithm despite a fairly noisy tracing was able to correctly diagnose atrial fibrillation in this same patient.

 

 

I put the AW4 on Sandy, our outstanding echo tech at Winghaven who is known to have a left bundle branch block but remains in normal rhythm and obtained this inconclusive report .

 

 

 

 

Kardia, on the other hand got the diagnosis correctly:

 

 

 

 

One Bizarre Tracing by the AW4

In another patient , an 87 year old lady with a totally normal recording by the Kardia device, the AW4 yielded a bizarre tracing which resembled ventricular tachycardia:

Despite adjustments to her finger position and watch position, I could not obtain a reasonble tracing with the AW4.

The Kardia tracing is fine, no artifact whatsoever.

 

 

 

 

 

 

 

 

 

What can we conclude after today’s adventures with the Apple Watch ECG?

This is an amazingly easy, convenient and straightforward method for recording a single channel ECG.

I love the idea that I can record an ECG whereverI am with minimal fuss. Since I wear my AW4 almost all the time I don’t have to think about bringing a device with me (although for a while I had the Kardia attached to iPhone case that ultimately became cumbersome.)

Based on my limited sample size today, however, the AW4 has a high rate of being uncertain about diagnoses. Only 2/3 cases of permanent atrial fibrillation were identified (compared to 3/3 for the Kardia) and only 4/6 cases of sinus rhythm were identified.

If those numbers hold up with larger numbers, the AW4 is inferior to the Kardia ECG device.

I’d rather see the AW4 declare inconclusive than to declare atrial fibrillation when it’s not present but this lack of certainty detracts from its value.

What caused the bizarre artifact and inconclusive AW4 tracing in my patient is unclear. If anybody has an answer, let me know.

We definitely need more data and more studies on the overall sensitivity and specificity of the AW4 and hopefully these will be rapidly forthcoming.

For most of my patients the advantages of the AW4 (assuming they don’t already have one) will be outweighed by its much greater cost and we will continue to primarily utilize the Kardia device which will also allow me to view all of their recordings instantaneously in the cloud.

Conclusively Yours,

-ACP

Don’t Stop Taking Your Statin Cholesterol Drug Based On The Latest News Headline

In a previous post the skeptical cardiologist discussed his approach to a typical sixty-something male, Geo,  who was “on the fence” about taking the statin drug his PCP had recommended (see here.)

After acquiring more information on his level of subclinical atherosclerosis (coronary calcium and vascular screening), and discussing the risks and benefits of statins for primary prevention, I wrote about his experience in using my recommended “compromise approach.”

This approach utilizes a low dose of rosuvastatin taken intermittently with the goal of minimizing any statin side effects, but obtaining some of the benefits of statin drugs on cardiovascular risk reduction.

It worked well for Geo; taking 5 mg rosuvastatin three times weekly lowered his LDL-C (bad cholesterol) by 50%, and he had absolutely no side effects when I reported on him 6 months after starting the drug.

However, when I stayed with Geo and his lovely wife, Wendy, over Thanksgiving in their Annapolis, Maryland house, Geo revealed that he had stopped taking his statin.

Like many patients, he was swayed by a news report suggesting an important “new study” that suggested there was no relationship between cholesterol and heart disease, and that statin drugs were dangerous and should be stopped.

At first I thought the story that he had read was the one I reported here which (appropriately) questions the benefit of statins for primary prevention in patients over the age of 75.

However, after a bit of searching, Geo told me the article that caused him to stop taking his statin was a UK Daily Mail one entitled:

‘No evidence’ having high levels of bad cholesterol causes heart disease, claim 17 physicians as they call on doctors to ‘abandon’ statins

The Daily Mail article says at one point

But the new study, based on data of around 1.3 million patients, suggests doling out statins as a main form of treatment for heart disease is of ‘doubtful benefit’.

Is this really a “new study” that contradicts the great body of evidence showing that statin treatment is safe and effective in preventing heart attacks and stroke in those at high risk for cardiovascular events?

In reality, this is an opinion piece published in a questionable journal* without any new research, and it is the opinion of a collection of well-known (approaching notorious) statin denialists, members of a cult-like organization called The International Network of Cholesterol Skeptics.(THINCS).

Larry Husten, who writes highly informed cardiac journalism at Cardiobrief, gives a good summary of their methods in this description of the authors of an editorial attacking the results of the JUPITER trial:

Nevertheless, the association of the authors with a group like THINCS raises some troublesome questions because, in fact, THINCS members don’t just object to one trial (JUPITER), or just one drug (rosuvastatin), or just the use of statins for primary prevention. They raise objections about ALL cholesterol-lowering trials, ALL cholesterol-lowering drugs, and the use of statins in ALL populations. They constantly harp on the dangerous side effects of  statins, and exploit any bit of evidence they can find to launch their attacks, always ignoring the considerable evidence that doesn’t support their views. So the Archives paper on JUPITER is not really part of the scientific process, since the authors have no interest in the give and take of medicine and science. Their only interest is to attack, at any point, and on any basis, anything related to mainstream science about cholesterol.

The lead and corresponding author, Uffe Ravnskov is the founder of THINCS and author of The Cholesterol Myths – Exposing the Fallacy that Saturated Fat and Cholesterol Cause Heart Disease (2000), which is considered the bible of cholesterol contrarianism.

Ravnskov’s book has been severely criticized in Bob Carroll’s The Skeptic’s Dictionary, which outlines the distortions and deceptive techniques found in the cholesterol skeptics’ arguments.

Harriet Hall wrote an excellent analysis of THINCS 10 years ago at Science-Based Medicine and her concluding sentences are still highly relevant:

“to reject the cholesterol connection and statins entirely is to throw the baby out with the bathwater. In my opinion, THINCS is spreading misinformation that could lead patients to refuse treatment that might prolong their life or at least prevent heart attacks and strokes.”

Indeed, if they were able to convince a highly intelligent patient like Geo, with a science background who also had easy access to the advice of a forward thinking cardiologist to stop taking his statins, who knows how many thousands have been convinced to stop their medications.

So my best advice for Geo and all of you taking statins is the following:

  1. Make sure you really need to be on the drug after engaging in shared-decision making with your physician and learning all you can about your personal risk of cardiovascular disease, the benefits of statins for you, and the potential side effects.
  2. Once you’ve made a decision based on good information and physician recommendation, try to ignore the latest headlines or internet stories that imply some new and striking information that impacts your health-most of these are unimportant.

The evidence for the benefit of statins is based on a deep body of scientific work, which will not be changed by any one new study. There is a very strong consensus amongst scientists who are actively working in the field of atherosclerosis, and amongst physicians who are actively caring for patients, that statins are very beneficial and safe. This consensus is similar to the consensus about the value of vaccines.

Science moves incrementally, and new studies inform those with open minds. The studies in this area that have been most significant in the last few years have actually strengthened the concept that drugs which lower LDL-C without causing other issues lower cardiovascular risk (see here on PCSK9 inhibitors and here on ezetimibe.)

Incrementally Yours,

-ACP

N.B. *The Expert Review of Clinical Pharmacology”is an open access journal, many of which are predatory. Article are solicited and the authors pay to have their work published. For the article in question, the Western Vascular Institute payed the fee. It’s not clear that there is any peer-review process involved.

Some authors have suggested predatory journals are “the biggest threat to science since the inquisition”and I am very worried about the explosive growth in these very weak journals which exist solely to make money.

I realize that writing this piece will engender the wrath of many so before you leave comments impugning my integrity let me reiterate that I receive absolutely nothing from BIG PHARMA. In fact, by writing appropriate prescriptions for statin drugs I reduce my income as my compliant patients avoid hospital and office visits and all kinds of procedures for heart attacks and strokes!

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

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