Category Archives: Saturated Fat

Saturated Fats and Health: Reassessment and Proposal for Food-based Recommendations

The skeptical cardiologist has been pointing out for some time that dietary advice to universally restrict consumption of saturated fats is not scientifically based.

Different foods present different types of saturated fats in different matrices and it is not reasonable to assume the overall effect of these foods can be predicted by measuring only saturated fat content.

In particular, there is not a scintilla of evidence that proves dairy fat which contains significant amounts of saturated fat has any harmful cardiovascular consequences. Thus, attempts to advise Americans to consume low fat or non-fat dairy are horribly misguided.

As I wrote in my letter to the FDA and in a recent critique of the AHA  “the suggestion to restrict or eliminate full-fat dairy from the diet is not a proven strategy for reducing the risk of cardiovascular disease, obesity or diabetes and should be eliminated from current dietary guidelines.”

Yesterday, a “State of the Art Review” (Saturated Fats and Health: A Reassessment and Proposal for Food-based Recommendations: JACC State-of -the-Art Reviewwas published in the Journal of the American College of Cardiology by a group of prominent nutritionists which provides substantial backing for my conclusions.

I encourage a full reading of the article but here is the abstract:

“across the board recommendation to limit dietary saturated fatty acid (SFA) intake has persisted despite mounting evidence to the contrary. Most recent meta-analyses of randomized trials and observational studies found no beneficial effects of reducing SFA intake on cardiovascular disease (CVD) and total mortality, and instead found protective effects against stroke. Although SFAs increase low-density lipoprotein (LDL)-cholesterol, in most individuals, this is not due to increasing levels of small, dense LDL particles, but rather larger LDL which are much less strongly related to CVD risk. It is also apparent that the health effects of foods cannot be predicted by their content in any nutrient group, without considering the overall macronutrient distribution. Whole-fat dairy, unprocessed meat, eggs and dark chocolate are SFA-rich foods with a complex matrix that are not associated with increased risk of CVD. The totality of available evidence does not support further limiting the intake of such foods.

Hopefully, the Committee discussing the next version of the Dietary Guidelines for Americans are objectively examining the extensive scientific literature that led to these conclusions.

Skeptically Yours,

-ACP

N.B. As I wrote in a previous post on the cardiometabolic health benefits of full fat yogurt

It is important to look at industry influence on research and publications (along with other biases)  but it is hard to find an expert in these areas who hasn’t had some industry ties. Part of these ties develop because researchers who have concluded a particular food is healthy based on their independent review of the literature will be sought after as a speaker at conferences organized by the support groups for that food.

Fortunately, my evaluations remain unsullied by any food industry ties and, like Dr. Astrup,(lead author on the JACC review) I am not an advocate or activist for specific diets and I am not not strongly committed to any specific diet.

The Distortion of The Death of Dr. Robert Atkins Continues

Three years ago I carefully researched the details of the death of Robert Atkins and wrote about it on this blog. I was motivated by the grossly inaccurate portrayal of him promulgated on vegan and plant-based websites. Elsewhere on this website I have described in detail the death of Nathan Pritikin whose ultra-low fat diet stands in stark contrast to Atkins’ ultra-low carb diet.

The most important point I hoped to make was that we should not judge the benefits of any diet based on how the founder of that diet dies. There is far too much randomness in death and far too much genetic influence over our health to base dietary decisions on one man ( or woman’s) mode of departing existence.

Atkins suffered a completely random event slipping and falling on ice and suffering an epidural hematoma. Pritikin developed leukemia and died after committing suicide.

Unfortunately my article did not end the misinformation rampant on the internet about Atkins so I’m reposting it today for all of you who may be feeling guilty about eating too much on Thanksgiving yesterday.

One of the characters in my story, Michael Bloomberg, has recently announced that he is running for President.


In the spring of 2003 at the age of 72 years, Robert Atkins, the cardiologist and  controversial promoter of high fat diets for weight loss, fell  on the sidewalk in front of his Atkins Center for Complementary Medicine in Manhattan.  He lost his footing on a patch of ice, slipped and banged his head on the pavement.  At the time of his fall his book ”Dr. Atkins’ New Diet Revolution” lead the NY times paper-back best seller list.

He was taken to nearby Cornell Medical Center where a clot was evacuated from his brain. Thereafter he lapsed into a coma and he spent 9 days in the ICU, expiring on April 17, 2003.

screen-shot-2016-11-27-at-8-44-55-amThe cause of death was determined by the New York Medical Examiner to be “blunt injury of head with epidural hematoma.”

An epidural hematoma is a collection of blood between the skull and the tough outer lining of the brain (the dura) which can occur with blunt trauma to the head which results in laceration of the arteries in this area. It is a not  uncommon cause of death in trauma . Actress Natasha Richardson (skiing, see below)  died from this. Nothing about the manner in which Robert Atkins died would suggest that he was a victim of his own diet any more than  Natasha Richardson was.

However, within the year a campaign of misinformation and deception spear-headed by  evangelistic vegans would try to paint the picture that Atkins died as a direct result of what they perceived as a horribly dangerous diet.

Michael Bloomberg, then New York major,  was quoted as saying

“I don’t believe that bullshit that [Atkins] dropped dead slipping on the sidewalk.”

According to the Smoking Gun:

“The 61-year-old billionaire added that Atkins was “fat” and served “inedible” food at his Hamptons home when Bloomberg visited. The mayor’s inference, of course, was that Atkins was actually felled by his meat-heavy diet, that his arteries were clogged with beef drippings. “

Enter The Vegans

Richard Fleming, a physician promoting prevention of cardiovascular disease through vegetarianism and with close ties to an organization  called Physicians Committe for Responsible Medicine (PCRM) sent a letter to the NY Medical Examiner requesting a copy of the full medical examination of Atkins. The NYME office  should have only issued copies of this report to physicians involved in the care of Atkins or next of kin but mistakenly complied with this request.  Fleming, who would subsequently publish his own low fat diet book, conveniently gave the report to PCRM which is directed by animal rights and vegan physicians.

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From the front page of pcrm.org. The two major concerns of the group are converting everyone to veganism and animal rights.

Neal Barnard, the President of PCRM, in an incredibly unethical move sent the letter to the Wall Street Journal with the hope that the information would destroy the popularity of the Atkins diet, a diet he clearly despises..  Barnard said the group decided to publicize the report because Atkins’ “health history was used to promote his terribly unhealthy eating plan..” The WSJ subsequently published an article summarizing the findings.

To this day, advocates of vegetarianism and low fat diets, distort the findings of Atkins’ Medical Examination in order to depict high fat diets like his as dangerous and portray Atkins as a victim of his own diet.

To scientists and thoughtful, unbiased physicians it is manifestly apparent that you cannot base decisions on what diet plan is healthy or effective for weight loss on the outcome of one patient. It doesn’t matter how famous that one person is or whether he/she originated and meticulously followed the diet. It is a ludicrous concept.

Would you base your decision to engage in running  based on the death of Jim Fixx?  Fixx  did much to popularize the sport of running and the concept of jogging as a source of health benefit and weight loss. He died while jogging, in fact. An autopsy concluded that he died of a massive heart attack and found advanced atherosclerosis (blockage) of the arteries to his heart.

Fixx inherited his predisposition to heart disease and couldn’t run himself out of it. Multiple studies over the years have documented the benefit of regular aerobic exercise like running on longevity and cardiovascular risk.

Would you based your decision to engage in  a very low fat diet based on how Nathan Pritikin died?  Pritikin authored an extremely popular book emphasizing eliminating fat from the diet but developed leukemia and slashed his wrists,  committing suicide at the age of 69 years. Would vegetarians accept the premise that their preferred diet results in leukemia or suicidal depression based on Pritikin’s death?

The Distortion of Atkins Death

The NYME report lists Atkins weight at autopsy as 258 pounds. Low-fat zealots seized on this fact as indicating that Atkins was screen-shot-2016-12-17-at-5-32-56-ammorbidly obese throughout his life.  For example, a  you-tube video of an audio interview of Atkinas online posted by “plant-based coach”  has this obviously photoshopped head of Atkins put on the body of a morbidly obese man. Atkins actually weight around 200 pounds through most of his life and a hospital note on admission showed him weighing 195 pounds. A substantial weight gain of 63 pounds occurred in the 9 days after his admission due to the accumulation of fluid volume and swelling which is not uncommon in the critically ill.

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No autopsy was performed on Atkins but the NYME wrote on the document that he had “h/o of MI, CHF, HTN.”

MI is the acronym for a myocardial infarction or heart attack. As far as we can tell without access to full medical records, Atkins never had an MI. He did have a cardiac arrest in 2002. While most cardiac arrests are due to a cardiac arrhythmia secondary to an MI they can also occur in patients who have a cardiomyopathy or weakness in the heart muscle from causes other than MI.

In fact, USA Today reported that Stuart Trager, MD,  chairman of the Atkins Physicians Council in New York, indicated that Atkins was diagnosed with a cardiomyopathy at the time of his cardiac arrest and that it was not felt to be due to blocked coronary arteries/MI. Cardiomyopathy can be caused by viral infections or nonspecific inflammation of the heart muscle and would have nothing to do with diet.

Trager also stated that Atkins, as a result of the cardiomyopathy, had developed heart failure (CHF) and the pumping ability of his heart (ejection fraction) had dropped to 15% to 20%. While CHF can be due to heart attacks causing heart weakness in Atkins case it appears it was unrelated to fatty blockage of the coronary arteries causing MI and therefore likely not related  to his diet.

What Does Atkins Death Tell Us About His Diet 

The information about Atkins death tells us nothing about the effectiveness or dangers of his diet.  In one individual it is entirely likely that a genetic predisposition to cancer or heart disease overwhelms whatever beneficial effects the individual’s lifestyle may have had. Thus, we should never rely on the appearance or the longevity of  the primary promoter of a diet for the diet’s effectiveness.

The evangelists of low-fat, vegan or vegetarian diets like PCRM have shamelessly promoted misinformation about Atkins death to dismiss high fat diets and promote their own agenda. If their diets are truly superior it should be possible to utilize facts and science to promote them rather than a sensationalistic, distorted focus on the body of one man who slipped on the ice and fell to his death.

Epidurally Yours

-ACP

Recent Papers Support The Cardiometabolic Health Benefits Of Full Fat Yogurt

A recent  Marion Nestle post,  Industry-funded studies of the week: Yogurt highlights three papers which strongly support the health benefits of consuming full fat dairy-in particular yogurt.

Nestle does a great job of highlighting food industry ties to nutritional research and publications on her excellent website Food Politics and in her books including “Unsavory Truth: How Food Companies Skew the Science of What We Eat.”

She notes that publication of these yogurt papers was paid for by a big player in the yogurt industry:

These three papers were part of a supplement to Advances in Nutrition published in September 2019: Supplement—6th Yogurt in Nutrition Initiative (YINI) Summit / More than the Sum of Its Parts, sponsored by Danone Institutes International. Publication costs for this supplement were defrayed in part by the payment of page charges.

Yes, these three papers were published in a supplement sponsored by the yogurt industry and therefore must be taken with a grain of salt.

However, a totally unbiased look at the data on yogurt and cardiovascular disease which I have provided here and here comes to the same conclusion. Misguided attempts to make full fat yogurt healthier by eliminating dairy fat have created artificial sugar-laden monstrosities which are actually stealth desserts.

It’s interesting that the dairy industry has been complicit in promoting the idea that low fat dairy is healthier because (as I pointed out here) it allows them to double dip the milk cash cow-skimming off the healthy fat and selling the separated fat and the residual skim milk separately.

The second paper ( Dairy Foods, Obesity, and Metabolic Health: The Role of the Food Matrix Compared with Single Nutrients) was based on a talk that Dariush Mozaffarian gave at the American Society of Nutrition 2018 Congress. I’ve been following Mozaffarian’s work since 2012 and I consider him to be an excellent researcher, writer and thinker who can be trusted to present unbiased information. The content of that talk presented by him at a national scientific congress in front of his academic colleagues is unlikely to be biased.

Here is what he concludes:

The present evidence suggests that whole-fat dairy foods do not cause weight gain, that overall dairy consumption increases lean body mass and reduces body fat, that yogurt consumption and probiotics reduce weight gain, that fermented dairy consumption including cheese is linked to lower CVD risk, and that yogurt, cheese, and even dairy fat may protect against type 2 diabetes. Based on the current science, dairy consumption is part of a healthy diet, without strong evidence to favor reduced-fat products; while intakes of probiotic-containing unsweetened and fermented dairy products such as yogurt and cheese appear especially beneficial.”

It’s important to look at the disclosures for any scientific paper and Mozzafarian has a lot of industry ties to disclose:

DM received an honorarium from the American Society of Nutrition for the preparation of this manuscript. A freelance science writer, Denise Webb, was supported by Danone Institute International to prepare an initial draft of this manuscript for DM based on a recording of his talk and slides at the American Society of Nutrition 2018 Congress. The final manuscript was edited in detail and approved by DM. The funders had no role in the design, analysis, interpretation, review, or final approval of the manuscript for publication…DM reports research funding from the NIH and the Gates Foundation; personal fees from GOED, Nutrition Impact, Pollock Communications, Bunge, Indigo Agriculture, Amarin, Acasti Pharma, Cleveland Clinic Foundation, and America’s Test Kitchen; scientific advisory board, Elysium Health (with stock options), Omada Health, and DayTwo; and chapter royalties from UpToDate; all outside the submitted work.”

The lead author of the third paper Nestle’ highlights ( Effects of Full-Fat and Fermented Dairy Products on Cardiometabolic Disease: Food Is More Than the Sum of Its Parts.)  is Arne Astrup another nutritional writer/researcher who I have a ton of respect for. He’s written extensively on the topic of saturated fat and dairy in multiple publications which were not tied to the dairy industry in any way.

Astrup concludes:

 “Although more research is warranted to adjust for possible confounding factors and to better understand the mechanisms of action of dairy products on health outcomes, it becomes increasingly clear that the recommendation to restrict dietary saturated fat to reduce risk of cardiometabolic disease is getting outdated. Therefore, the suggestion to restrict or eliminate full-fat dairy from the diet may not be the optimal strategy for reducing cardiometabolic disease risk and should be re-evaluated in light of recent evidence.”

His disclosures are extensive but they reveal how wide-ranging his interests are and how dedicated he is to optimizing diet.

AA is a member of advisory boards/consultant for BioCare Copenhagen, Denmark; Dutch Beer Institute, Netherlands; Gelesis, United States; Groupe Éthique et Santé, France; McCain Foods Limited, United States; Novo Nordisk, Denmark; Pfizer, United States; Saniona, Denmark; and Weight Watchers, United States. AA has received travel grants and honoraria as a speaker for a wide range of Danish and international consortia. AA is co-owner and member of the board of the consultancy company Dentacom Aps, Denmark; cofounder and co-owner of UCPH spin-outs Mobile Fitness A/S, Flaxslim ApS, and Personalized Weight Management Research Consortium ApS (Gluco-diet.dk). He is coinventor of a number of patents owned by the University of Copenhagen, in accordance with Danish law. He is coauthor of a number of diet and cookery books, including books on personalized diet approaches. AA is not an advocate or activist for specific diets and is not strongly committed to any specific diet.”

I love what he says at the end of his disclosure statement

“AA is not an advocate or activist for specific diets and is not strongly committed to any specific diet.”

Hooray! That is exactly what we need in the world of dietary recommendations.

I am particularly heartened by the conclusions of these two illustrious international nutritional authorities who have managed to cut through the long-standing nutritional dogma that all saturated fat is bad. As one who has no ties to any food or medical industry group and who is not an advocate or activitist for specific diets I concluded as they have that

  1.  Based on the current science, dairy consumption is part of a healthy diet, without strong evidence to favor reduced-fat products; while intakes of probiotic-containing unsweetened and fermented dairy products such as yogurt and cheese appear especially beneficial.”
  2. It becomes increasingly clear that the recommendation to restrict dietary saturated fat to reduce risk of cardiometabolic disease is getting outdated. Therefore, the suggestion to restrict or eliminate full-fat dairy from the diet may not be the optimal strategy for reducing cardiometabolic disease risk and should be re-evaluated in light of recent evidence.”

As I wrote in my letter to the FDA and in a recent critique of the AHA I would change the verbiage to “the suggestion to restrict or eliminate full-fat dairy from the diet is not a proven strategy for reducing the risk of cardiovascular disease, obesity or diabetes and should be eliminated from current dietary guidelines.”

Two key points that these papers help emphasize:

  1. Eating fat doesn’t make you fat
  2. All saturated fat is not bad for your heart

It is important to look at industry influence on research and publications (along with other biases)  but it is hard to find an expert in these areas who hasn’t had some industry ties. Part of these ties develop because researchers who have concluded a particular food is healthy based on their independent review of the literature will be sought after as a speaker at conferences organized by the support groups for that food.

Fortunately, my evaluations remain unsullied by any food industry ties and, like Dr. Astrup, I am not an advocate or activist for specific diets and I am not not strongly committed to any specific diet.

Skeptically Yours,

-ACP

N.B. Trader’s Point Creamery Yogurt no longer distributes their wonderful products. I’ve started consuming Maple Hill 100% grass fed full fat yogurt and it is quite good.

N.B. #2.Arne Astrup’s bio.

Prof. Arne Astrup is Head of the Department of Nutrition, Exercise and Sports at the University of Copenhagen, and Senior Consultant at Clinical Research Unit, Herlev-Gentofte University Hospital. Astrup attained his medical degree from UCPH in 1982 and a Doctorate in Medical Science in 1986. He was Appointed Professor of Nutrition and Head of the Research Department of Human Nutrition at The Royal Veterinary and Agricultural University, Denmark, in 1990, he led the department throughout its development ever since.

His researches focus on the physiology and pathophysiology of energy and substrate metabolism and appetite regulation, with special emphasis on the etiology and treatment of obesity, including the role of diet composition and of specific  nutrients, lifestyle modification, very-low-calorie diets, exercise, and medication. Major research collaborations include participation in the EU multicenter studies.
He led research that showed that GLP-1 is a satiety hormone in humans, and was instrumental in Denmark being the first country to ban industrial trans-fat in 2014. He is author/co-author of over 600 original, review and editorial scientific papers and more than 1000 other academic publications such as abstracts, textbook chapters and scientific correspondence. He has supervised 32 PhD students to date.

Darius Mozzafarian’s bio (Wikipedia)

Dariush Mozaffarian (born August 19, 1969) is an American cardiologist, Dean and Jean Mayer Professor at the Gerald J. and Dorothy R. Friedman School of Nutrition Science and Policy at Tufts University, and Professor of Medicine at Tufts University School of Medicine.

Mozaffarian is the author of nearly 400 scientific publications and has served as an adviser for the US and Canadian governments, American Heart Association, World Health Organization, and the United Nations.

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.

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.

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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

Low-Fat Versus Low-Carb Diet: DIETFITS Show Both Can Work If They Are “Healthy”

In the ongoing nutritional war between adherents of low-fat and low-carb diets, the skeptical cardiologist has generally weighed in on the side of lower carbs for weight loss and cardiovascular health.

I’ve questioned the vilification of saturated fat and emphasized the dangers of added sugar. I’ve even dabbled in nutritional ketosis.

The science in  nutrition is gradually advancing and the DIETFITS study recently published in JAMA is a welcome addition.

DIETFITS is a  really well done study which provides important insights into three huge questions about optimal diet:

  1. Should we choose a low-fat or a  low-carb diet for  weight loss and cardiovascular health?
  2. Do baseline insulin dynamics predict who will respond to low-fat versus low-carb diet?
  3. Can we predict who will respond to low-fat versus low-carb by genetic testing?

The Details Of DIETFITS

Stanford investigators recruited 609 San Francisco area individuals between the ages of 18 to 50 years with BMI of 28 to 40  and randomized them to a “healthy” low-fat diet or a “healthy” low-carb diet.

During the first 8 weeks of the study, low-fat participants were instructed to reduce fat consumption to <20 gm/ day while the low carb participants were instructed to reduce digestible carbohydrate to <20 gms/day.

Then individuals were allowed to add back fats or carbs back to their diets in increments of 5 to 15 g/d per week until “they reached the lowest level of intake they believed could be maintained indefinitely.”  Importantly no explicit instructions for energy restriction were given.

The “healthy” instructions for both groups were as follows

  1. maximize vegetable intake
  2. minimize intake of added sugar, refined flours and trans-fats
  3. focus on whole foods that are minimally processed, nutrient dense and prepared at home whenever possible

Dietfits Outcomes-Diet And Weight

Major findings

  1. Total energy intake was reduced by 500-600 kcal/d for both groups
  2. The low-fat vs the low-carb intake at 12 months was 48% versus 30% for carbs, 29 vs 43% for fat and 21 vs 23% for protein.
  3. Mean 12 months weight change was -5.3 kg for low-fat vs 6-6.0 kg for low-carb which was not significantly different
  4. There was no difference between groups in body fat percentage or waist circumference
  5. Both diets improved lipid profiles and lowered blood pressure, insulin and glucose levels
  6. LDL (bad cholesterol) declined more in the low-fat group whereas HDL (good cholesterol) increased more and triglycerides declined more in the low-carb group.

Thus both diets were successful for weight loss and both improved risk markers for cardiovascular disease after a year.

DIETFITS- Can Genes and Insulin resistance Predict Best Diet?

Surprisingly, the study found no significant diet-genotype interaction and no diet-insulin secretion interaction with weight loss.

This means that they could not predict (as many believed based on earlier studies) who will benefit from a low carb diet based on either currently available genetic testing or a generally accepted measure of insulin resistance.

As the authors point out, these findings “highlight the importance of conducting large, appropriately powered trials such as DIETFITS for validating early exploratory analyses.”

DIETFITS-Perspectives

As you can imagine this study has led to quite an uproar and backlash from dedicated combatants in the macronutrient wars.

A reasoned summary and response from Andreas Eenfeldt, a low carb proponent can be found on his excellent low carb/keto Diet Doctor site here.

Eenfeldt concludes

If I’m allowed to speculate, the reason that we did not see any major additional benefit from low carb in this study is that the groups ended up so similar when it came to bad carbs. The low-fat group ended up eating fewer carbs too (!) and significantly less sugar, while the low-carb group ended with a somewhat weak low-carb diet, reporting 130 grams of carbs per day.

Eenfeldt emphasizes that low-fat diets never “win” these macronutrient dietary skirmishes:

On the whole, this study adds to the 57 earlier studies (RCTs) comparing low carb and low fat for weight loss.

From a standing of 29 wins for low carb, zero for low fat and 28 draws, we now have 29 wins for low carb and 29 draws. The wins for low fat stay at zero.

Larry Husten at Cardiobrief.org in his analysis of the study quotes a number of experts including Gary Taubes, the low carb pioneering journalist

Taubes speculates “that the weight loss may have been similar not because any diet works if you stick with it and cut calories (one possible interpretation) but because of what these diets had in common — avoid sugar, refined grains, processed foods. Whether the low-carb arm would have done even better had Gardner kept their carbohydrates low is something this study can’t say. (And Ornish [low-fat diet proponent] would probably say the same thing about fat consumption.)”

The low-fat or vegan disciples seem to have had a muted response to this study. I can’t find anything from John McDougal , Dean Ornish, Caldwell Esselstyn or Joel Fuhrman.

Readers feel free to leave comments which  link to relevant analysis from the low-fat proponents.

Dietfits-Perspective Of The Participants

Julia Volluz at Vox wrote a fascinating piece recently which involved interviewing some of the participants in this study.

She points out that although the average DIETFITS participant lost over 10 pounds, “Some people lost more than 60 pounds, and others gained more than 20 during the year.”

LOW_FAT_LOW_CARBS_DIETS1__1_

She obtained permission from the lead author, Christopher Gardner  and interviewed  “Dawn, Denis, Elizabeth*, and Todd — two low-fat dieters and two low-carb dieters — about their experiences of succeeding or faltering in trying to slim down”

LOW_FAT_LOW_CARBS_DIETS1

I highly recommend reading the entire article for details but Volluz concludes

And that leads us to one of the burning mysteries of diets: how to explain why some people fail where others succeed — or the extreme variation in responses. Right now, science doesn’t have compelling answers, but the unifying theme from the four study participants should be instructive: The particulars of their diets — how many carbs or how much fat they were eating — were almost afterthoughts. Instead, it was their jobs, life circumstances, and where they lived that nudged them toward better health or crashing.

DIETFITS-Importance of “Healthy” Diet

Most likely the success of both of these diets is due to the instruction that both groups received on following a “healthy” diet. This guidance is remarkably similar to what I advocate and is something that combatants in the diet wars ranging from paleo to vegan can agree on.

The JAMA paper only provides the description I listed above but Volluz adds that participants were instructed to:

… focus on whole, real foods that were mostly prepared at home when possible, and specifically included as many vegetables as possible, every day … choose lean grass-fed and pasture-raised animal foods as well as sustainable fish ... eliminate, as much as possible, processed food products, including those with added sugars, refined white flour products, or trans-fats … prepare as much of their own food as possible. …

Indeed, if you want to see a very detailed description of the instructional process for participants check out the very detailed description of the methods here.

Yours in Health,

-ACP

N.B. I was searching for a reasoned response to this study from the low fat camp and to my surprise came across this fascinating video featuring the lead author of the study, Christopher Gardner, on (no fat/vegan) John McDougal’s YouTube site. Gardner is clearly on the side of sustainable, local , ethical food consumption but to his credit, his research , publications and comments on DIETFITS don’t reveal this.

The Bad Food Bible: A Well-Written, Sensible and Science-Based Approach To Diet

The skeptical cardiologist has been searching for some time for a book on diet that he can recommend to his patients. While I can find books which have a lot of useful content, usually the books mix in some totally unsubstantiated advice with which I disagree.

I recently discovered a food/diet/nutrition book which with I almost completely agree. The author is Aaron Carroll,  a pediatrician, blogger on health care research (The incidental Economist) and a Professor of Pediatrics and Associate Dean for Research Mentoring at Indiana University School of Medicine.

He writes a regular column for the New York Times and covers various topics in health care. His articles are interesting,  very well written and researched and he often challenges accepted dogma.

Like the skeptical cardiologist, he approaches his topics from an unbiased perspective and utilizes a good understanding of the scientific technique along with a research background to bring fresh perspective to health-related topics.

Last last year he wrote a column, within which I found the following:

Studies of diets show that many of them succeed at first. But results slow, and often reverse over time. No one diet substantially outperforms another. The evidence does not favor any one greatly over any other.

That has not slowed experts from declaring otherwise. Doctors, weight-loss gurus, personal trainers and bloggers all push radically different opinions about what we should be eating, and why. We should eat the way cave men did. We should avoid gluten completely. We should eat only organic. No dairy. No fats. No meat. These different waves of advice push us in one direction, then another. More often than not, we end up right where we started, but with thinner wallets and thicker waistlines.

I couldn’t agree more with this assessment and as I surveyed the top diet books on Amazon recently, I saw one gimmicky, pseudoscientific  diet after another. From the Whole30 approach (which illogically  completely eliminates any beans and legumes, dairy products,  alcohol, all grains, and starchy vegetables like potatoes (see how absurd this diet is here)) to Dr. Gundry’s Plant Paradox (aka lectin is the new gluten (see here for James Hambling’s wonderful Atlantic article on the huckster’s latest attempt to scare you into buying his useless supplements).

It turns out Carroll published a useful book recently, The Bad Food Bible which critically examines diet and I agree with the vast majority of what is in it.

The first three chapters are on butter, meat, eggs and salt. His conclusions on how we should approach these 4 are similar to ones I have reached and written about on this site (see here for dairy, here for meat, here for eggs and here for salt).  Essentially, the message is that the dangers of these four foods have been exaggerated or nonexistent, and that consuming them in moderation is fine.

The remaining chapters cover topics I have pondered extensively,  but have not written about: including gluten, GMOs, alcohol, coffee, diet-soda and non-organic foods.

I agree with his assessments on these topics. Below, I’ll present his viewpoint along with some of my own thoughts in these areas.

Gluten

Carroll does a good job of providing a scientific, but lay-person friendly background to understanding the infrequent (1 of 141 Americans), but quite serious gluten-related disorder, celiac disease.

However, surveys show that up to one-third of Americans, the vast majority of whom don’t have celiac disease, are seeking “gluten-free” foods, convinced that this is a healthier way of eating. Carroll points out that there is little scientific support for this; there are some individuals who are sensitive to wheat/gluten, but these are rare.

He concludes:

“If you have celiac disease, you need to be on a gluten-free diet. If you have a proven wheat allergy, you need to avoid wheat. But if you think you have gluten sensitivity? You’d probably be better off putting your energy and your dollars toward a different diet. Simply put, most people who think they have gluten sensitivity just don’t.

I do agree with him that the “gluten-free” explosion of foods (gluten-free sales have doubled from 2010 to 2014) is not justified.

However, I must point out that my 92 year old father has recently discovered that he has something that resembles gluten sensitivity. About a year ago, he noted that about one hour after eating a sandwich he would feel very weak and develop abdominal discomfort/bloating. He began suspecting these symptoms were due to the bread and experimented with different bread types without any symptom relief.

Finally, he tried gluten-free bread and the symptoms resolved.

If you have engaged in this type of observation and experimentation on your self, and noted improved symptoms when not consuming gluten, then I think you’re justified in diagnosing gluten sensitivity, and by all means consider minimizing/avoiding wheat.

GMOS

Carroll begins his chapter on genetically modified organisms (GMOs) with a description of the droughts that plagued India in the 1960s and the efforts of Norman Borlaug to breed strains of wheat that were resistant to fungus and yielded more grain. By crossbreeding various strains of wheat he was able to develop a “semi-dwarf” strain that increased what was produced in Mexico by six-fold.

Despite the fact that numerous scientific and health organizations around the world have examined the evidence regarding the safety of genetically modified organisms (GMOs) and found them to be completely safe, there remains a public controversy on this topic. In fact a Pew Poll found that while 88% of AAAS scientists believe that GMOs are safe for human consumption, only 37% of the public do – a 51% gap, the largest in the survey.

This gap is largely due to an aggressive anti-GMO propaganda campaign by certain environmental groups and the organic food industry, a competitor which stands to profit from anti-GMO sentiments. There is also a certain amount of generic discomfort with a new and complex technology involving our food.

The National Academy of Sciences analyzed in detail the health effects of GMOs in 2016. Their report concludes:

While recognizing the inherent difficulty of detecting subtle or long-term effects in health or the environment, the study committee found no substantiated evidence of a difference in risks to human health between currently commercialized genetically engi-neered (GE) crops and conventionally bred crops, nor did it find conclusive cause-and-effect evidence of environmental problems from the GE crops. GE crops have generally had favorable economic outcomes for producers in early years of adoption, but enduring and widespread gains will depend on institutional support and access to profitable local and global markets, especially for resource-poor farmers

Carroll does a good job of looking at the GMO issue from all sides. He touches on environmental downsides related to herbicide-resistant GMO crops and the problems created by patenting GMO seeds, but asserts that “these are the result of imperfect farming and the laws that regular agribusiness, not of GMOS themselves.”

Ultimately, despite these concerns, I agree with Carroll’s conclusion that:

“Foods that contain GMOs aren’t inherently unhealthy, any more are  than foods that don’t contain them. The companies that are trying to see you foods by declaring them ‘GMO-free” are using the absence of GMOs to their advantage–not yours.”

Alcohol, Coffee, and Diet-Soda

Carroll does a good job of summarizing and analyzing the research for these three topics and reaches the same conclusions I have reached in regard to coffee, alcohol and diet-soda:

-alcohol in moderation lowers your risk of  dying, primarily by reducing cardiovascular death

-coffee, although widely perceived as unhealthy, is actually good for the vast majority of people

For those seeking more details a few quotes


on alcohol:

“Taken together, all of this evidence points to a few conclusions. First, the majority of the research suggests that moderate alcohol consumption is associated with decreased rates of cardiovascular disease, diabetes, and death. Second, it also seems to be associated with increased rates of some cancers (especially breast cancer), cirrhosis, chronic pancreatitis, and accidents, although this negative impact from alcohol seems to be smaller than its positive impact on cardiovascular health. Indeed, the gains in cardiovascular disease seem to outweigh the losses in all the other diseases combined. The most recent report of the USDA Scientific Advisory Panel agrees that “moderate alcohol consumption can be incorporated into the calorie limits of most healthy eating patterns.”

Keep in mind that moderate consumption is up to one drink per day for women, and two drinks for men (my apologies to women in general and the Eternal Fiancee’ of the Skeptical Cardiologist in particular) and be aware of what constitutes “one drink.”

Also keep in mind that any alcohol consumption raises the risk of atrial fibrillation (see here) and that if you have a cardiomyopathy caused by alcohol you should avoid it altogether.


on coffee:

“It’s time people stopped viewing coffee as something to be limited or avoided. It’s a completely reasonable part of a healthy diet, and it appears to have more potential benefits than almost any other beverage we consume.
Coffee is more than my favorite breakfast drink; it’s usually my breakfast, period. And I feel better about that now than ever before. It’s time we started treating coffee as the wonderful elixir it is, not the witch’s brew that C. W. Post made it out to be.”

Strangely enough, coffee is usually my breakfast as well (although I recommend against adding titanium oxide to your morning java).  Why am I not compelled to consume food in the morning?  Because breakfast is not the most important meal of the day and I don’t eat until I’m hungry.


on diet-soda:

Carroll notes that many Americans are convinced that artificial sweeteners are highly toxic:

“no article I’ve written has been met with as much anger and vitriol as the first piece I wrote on this subject for the New York Times, in July 2015, in which I admitted, “My wife and I limit our children’s consumption of soda to around four to five times a week. When we let them have soda, it’s . . . almost always sugar-free.”

He notes, as I have done, that added sugar is the real public enemy number one in our diets. He reviews the scientific studies that look at toxicity of the various artificial sweeteners and finds that they don’t convincingly prove any significant health effects in humans.

Some believe that artificial sweeteners contribute to obesity, but the only evidence supporting this idea comes from observational studies. For many reasons, we should not highly value observational studies but one factor, “reverse causation,” is highly likely to be present in studies of diet sodas. If diet soda consumption is associated with obesity, is it the cause, or do those who are obese tend to drink diet soda. Observational studies cannot answer this question but randomized studies can.

Carroll points out that:

the randomized controlled trials (which are almost always better and can show causality) showed that diet drinks significantly reduced weight, BMI, fat, and waist circumference.”

Simple Rules For Healthy Eating

Carroll concludes with some overall advice for healthy eating:

-Get as much of your nutrition as possible from a variety of completely unprocessed foods

-Eat lightly processed foods less often

-Eat heavily processed foods even less often

-Eat as much home-cooked food as possible, preparing it according to rules 1, 2, and 3

-Use salt and fats, including butter and oil, as needed in food preparation

-When you do eat out, try to eat at restaurants that follow the same rules

-Drink mostly water, but some alcohol, coffee, and other beverages are fine

-Treat all calorie-containing beverages as you would alcohol

-Eat with other people, especially people you care about, as often as possible

These are solid, albeit not shocking or book-selling, rules that  correspond closely to what I have adopted in my own diet.

In comparison to the bizarre advice from nutrition books which dominate the best-selling diet books, I found The Bad Food Bible to be a consistent, well-written, extensively researched, scientifically-based, unbiased guide to diet and can highly recommend it to my readers and patients.

Semibiblically Yours,

-ACP

Top Skeptical Cardiology Stories of 2017

Science continued to progress in the field of cardiology in 2017. Some cardiology interventions were proven to be more beneficial (TAVR) and some less (coronary stents). A class of cholesterol lowering drugs had a big winner and a big loser. A supplement that many thought, based on observational studies, was crucial to prevent heart disease, turned out to be unhelpful. More evidence emerged that saturated fat is not a dietary villain.

From the skeptical cardiologist’s viewpoint, the following were the major scientific studies relevant to cardiology:

1.  “Thousands of heart patients get stents that may do more harm than good”

Thus read the Vox headline for the ORBITA study which was published in November.

Indeed this was an earth-shattering study for interventional cardiologists, many of whom agreed with the NY Times headline “Unbelievable: Heart Stents Fail To Ease Chest Pain.”

Cardiologists have known for a decade (since the landmark  COURAGE study) that outside the setting of an acute heart attack (acute coronary syndrome or ACS), stents don’t save lives and that they don’t prevent heart attacks.

Current guidelines reflect this knowledge, and indicate that stents in stable patients with coronary artery disease should be placed only after a failure of  “guideline-directed medical therapy.”  Despite these recommendations, published in 2012, half of the thousands of stents implanted annually in the US continued to be employed in patients with either no symptoms or an inadequate trial of medical therapy.

Yes, lots of stents are placed in asymptomatic patients.  And lots of patients who have stents placed outside the setting of ACS are convinced that their stents saved their lives, prevented future heart attacks and “fixed” their coronary artery disease. It is very easy to make the case to the uneducated patient that a dramatic intervention to “cure” a blocked artery is going to be more beneficial than merely giving medications that dilate the artery or slow the heart’s pumping to reduce myocardial oxygen demands.

Stent procedures are costly  in the US (average charge around $30,000, range $11,000 to $40,000) and there are significant risks including death, stroke and heart attack. After placement, patients must take powerful antiplatelet drugs which increase their risk of bleeding. There should be compelling reasons to place stents if we are not saving lives.

I, along with the vast majority of cardiologists, still recommended stents for those patients with tightly blocked coronary arteries and stable symptoms, which were not sufficiently helped by medications. ORBITA calls into question even this indication for stenting.

The ORBITA study investigators recruited 230 patients to whom most American cardiologists would have recommended stenting. These patients appeared to have a single tightly blocked coronary artery and had chest pain (angina) that limited their physical activity.

They treated the patients for 6 weeks with aspirin/statins/ and medications that reduce anginal symptoms such as beta-blockers, calcium-channel blockers or long-acting nitrates. At this point patients were randomized to receive either a stent or to undergo a catheteriation procedure which did not result in a stent, a so-called sham procedure.

The performance of a sham procedure was a courageous move that made the study truly double-blinded; neither the patients nor the investigators knew which patients had actually received a stent. Thus, the powerful placebo effects of having a procedure were neutralized.

Surprisingly, the study found that those patients receiving stents had no more improvement in their treadmill exercise time, angina severity or frequency or in their peak oxygen uptake on exercise.

ORBITA hopefully will cause more cardiologists to avoid the “oculo-stenotic” reflex wherein coronary artery blockages are stented without either sufficient evidence that the blockage is causing symptoms or that a medical trial has failed.

Although this was a small study with a very narrowly defined subset of patients, it raises substantial questions about the efficacy of coronary stenting. If ORBITA causes more patients and doctors to question the need for catheterization or stenting, this will be a  very good thing.

2. Vitamin D Supplementation Doesn’t Reduce Cardiovascular Disease (or fractures, or help anything really).

One of my recurring themes in this blog is the gullibility of Americans who keep buying and using useless vitamins, supplements and nutraceuticals, thereby feeding a $20 billion industry that provides no benefits to consumers (see here and here).

Vitamin D is a prime player in the useless supplement market based on observational studies suggesting low levels were associated with increased mortality and cardiovascular disease

Despite well done studies showing a lack of benefit of Vitamin D supplementation, the proportion of people taking more than 1,000 IU daily of Vitamin D surged from just 0.3 percent  in 1999-2000 to 18 percent in  2013-2014.

I’ve written previously (calcium supplements: would you rather a hip fracture or a heart attack) on the increased risk of heart attack with calcium supplementation.

Most recently a nicely done study showed that Vitamin D supplementation doesn’t reduce the risk of heart disease.

In a randomized clinical trial that included 5108 participants from the community, the cumulative incidence of cardiovascular disease for a median follow-up period of 3.3 years was 11.8% among participants given 100 000 IU of vitamin D3 monthly, and 11.5% among those given placebo.

Aaron Carroll does a good job of summarizing the data showing Vitamin D is useless in multiple other areas in a JAMA forum piece:

Last October, JAMA Internal Medicine published a randomized, controlled trial of vitamin D examining its effects on musculoskeletal health. Postmenopausal women were given either the supplement or placebo for one year. Measurements included total fractional calcium absorption, bone mineral density, muscle mass, fitness tests, functional status, and physical activity. On almost no measures did vitamin D make a difference.

The accompanying editor’s note observed that the data provided no support for the use of any dose of vitamin D for bone or muscle health.

Last year, also in JAMA Internal Medicine, a randomized controlled trial examined whether exercise and vitamin D supplementation might reduce falls and falls resulting in injury among elderly women. Its robust factorial design allowed for the examination of the independent and joined effectiveness of these 2 interventions. Exercise reduced the rate of injuries, but vitamin D did nothing to reduce either falls or injuries from falls.

In the same issue, a systematic review and meta-analysis looked at whether evidence supports the contention that vitamin D can improve hypertension. A total of 46 randomized, placebo controlled trials were included in the analysis. At the trial level, at the individual patient level, and even in subgroup analyses, vitamin D was ineffective in lowering blood pressure.

Finally, if the Vitamin D coffin needs any more nails, let us add the findings of this recent meta-analysis:

calcium, calcium plus vitamin D, and vitamin D supplementation alone were not significantly associated with a lower incidence of hip, nonvertebral, vertebral, or total fractures in community-dwelling older adults.

3. PCSK9 Inhibitors: Really low cholesterol levels are safe and reduce cardiac events

I reported the very positive results for evolocumab and disappointing results for bosocizumab on the physician social media site SERMO in March but never put this in my blog.

As a practicing cardiologist I’ve been struggling with how to utilize the two available PCSK9 inhibitors (Amgen’s Repatha (evolocumab) and Sanofi’s Praluent (alirocumab) in my clinical practice.  I would love to use them for my high risk statin-intolerant patients but the high cost and limited insurance coverage has resulted in only a few of my patients utilizing it.

The lack of outcomes data has also restrained my and most insurance companies enthusiasm for using them.

The opening session at this year’s American College of Cardiology Scientific Sessions in DC I think has significantly changed the calculus in this area with two presentations: the first showing  Amgen’s “fully humanized” evolocumab significantly lowers CV risk in high risk patients on optimal statin therapy and the second showing that Pfizer’s “mostly humanized” bococizumab loses efficacy over time and will likely never reach the market.

The FOURIER study of evolocumab randomized  27, 564 high risk but stable patients who had LDL>70 with prior MI, prior stroke or symptomatic PAD to receive evolocumab or placebo on top of optimized lipid therapy. 69% of patients were recieving high intensity statin therapy and the baseline LDL was 92. LDL was reduced by 59% to average level of 30 in the treated patients. The reduction in LDL was consistent through the duration of the study.

IN 1/4 of the patients LDL was <20! These are unprecedented low levels of LDL.

Active treatment significantly reduced the primary endpoint by 15% and reduced the secondary endpoinf  of CV death, MI, stroke by 20%. absolute difference 2% by 3 years. 

There was no difference in adverse effects between placebo and Evo. 

The next presentation featured data using Pfizer’s candidate in the PCSK9 wars and the acronym SPIRE (Studies of PCSK9 Inhibition and the Reduction in vascular Events (SPIRE) Bococizumab Development Program).

Paul Ridker presented the outcomes data for bococizumab which was actually similar to evolocumab data but given the declining efficacy and development of antibodies to the Pfizer drug over time these were very disappointing for Pfizer and I would presume their drug will never reach the market.

How will these results impact clinical practice?

I am now more inclined to prescribe evolocumab to my very high risk patients who have not achieved LDL< 70. I’m willing to do what I can to jump through insurance company hoops and try to make these drugs affordable to my patients.

I am less worried about extremely low LDL levels and have more faith in the LDL hypothesis: the lower the LDL the lower the risk of CV disease.

Cost is still going to be an issue for most of my patients I fear and the need for shared decision-making becomes even more important.

 

4. “Pure Shakes Up Nutritional Field: Finds High Fat Intake Beneficial.”

As one headline put it.

I recorded my full observations on this observational international study here

Here is a brief excerpt:

The Prospective Urban Rural Epidemiology (PURE) study, involved more than 200 investigators who collected data on more than 135000 individuals from 18 countries across five continents for over 7 years.

There were three high-income (Canada, Sweden, and United Arab Emirates), 11 middle-income (Argentina, Brazil, Chile, China, Colombia, Iran, Malaysia, occupied Palestinian territory, Poland, South Africa, and Turkey) and four low-income countries (Bangladesh, India, Pakistan, and Zimbabwe)

This was the largest prospective observational study to assess the association of nutrients (estimated by food frequency questionnaires) with cardiovascular disease and mortality in low-income and middle-income populations,

The PURE team reported that:

-Higher carbohydrate intake was associated with an increased risk of total mortality but not with CV disease or CV disease mortality.

This finding meshes well with one of my oft-repeated themes here, that added sugar is the major toxin in our diet (see here and here.)

I particular liked what the editorial for this paper wrote:

Initial PURE findings challenge conventional diet–disease tenets that are largely based on observational associations in European and North American populations, adding to the uncertainty about what constitutes a healthy diet. This uncertainty is likely to prevail until well designed randomised controlled trials are done. Until then, the best medicine for the nutrition field is a healthy dose of humility

I wish for all those following science-based medicine a healthy dose of humility. As science marches on, it’s always possible that a procedure we’ve been using might turn out to be useless (or at least much less beneficial than we thought), and it is highly likely that weak associations turn out to be causally nonsignificant. Such is the scientific process. We must continually pay attention, learn and evolve in the medical field.

Happy New Year to Be from the Skeptical Cardiologist the EFOSC!

The skeptical cardiologist and his Eternal Fiancee marveling at the total eclipse of the sun (very accurately predicted by science) in St. Genevieve, Missouri

-ACP

 

Does Eating Saturated Fat Lower Your Risk of Stroke and Dying?: Humility and Conscience in Nutritional Guidelines

A study presented at the European Society of Cardiology  meetings in Barcelona and simultaneously published in The Lancet earlier this month caught the attention of many of my readers. Media headlines trumpeted  “Huge New Study Casts Doubt On Conventional Wisdom About Fat And Carbs” and “Pure Shakes Up Nutritional Field: Finds High Fat Intake Beneficial.”

Since I’ve been casting as much doubt as possible on the  conventional nutritional wisdom  to cut saturated fat, they reasoned, I should be overjoyed to see such results.

What Did the PURE Study Find?

The Prospective Urban Rural Epidemiology (PURE) study, involved more than 200 investigators who collected data on more than 135000 individuals from 18 countries across five continents for over 7 years.

There were three high-income (Canada, Sweden, and United Arab Emirates), 11 middle-income (Argentina, Brazil, Chile, China, Colombia, Iran, Malaysia, occupied Palestinian territory, Poland, South Africa, and Turkey) and four low-income countries (Bangladesh, India, Pakistan, and Zimbabwe)

This was the largest prospective observational study to assess the association of nutrients (estimated by food frequency questionnaires) with cardiovascular disease and mortality in low-income and middle-income populations,

The PURE team reported that:

Higher carbohydrate intake was associated with an increased risk of total mortality but not with CV disease or CV disease mortality.

This finding meshes well with one of my oft-repeated themes here, that added sugar is the major toxin in our diet (see here and here.)

Higher fat intake was associated with lower risk of total mortality.

Each type of fat (saturated, unsaturated, mono unsaturated ) was associated with about the same lower risk of total mortality. 

 

These findings are consistent with my observations that it is becoming increasingly clear that cutting back on  fat and saturated fat as the AHA and the Dietary Guidelines for Americans have been telling you to do for 30 years is not universally helpful (see here and  here ).

When you process the fat out of dairy and eliminate meat from your diet although your LDL (“bad”) cholesterol drops a little your overall cholesterol (atherogenic lipid) profile doesn’t improve (see here).

Another paper from the PURE study shows this nicely and concluded:

Our data are at odds with current recommendations to reduce total fat and saturated fats. Reducing saturated fatty acid intake and replacing it with carbohydrate has an adverse effect on blood lipids. Substituting saturated fatty acids with unsaturated fats might improve some risk markers, but might worsen others. Simulations suggest that ApoB-to-ApoA1 ratio probably provides the best overall indication of the effect of saturated fatty acids on cardiovascular disease risk among the markers tested. Focusing on a single lipid marker such as LDL cholesterol alone does not capture the net clinical effects of nutrients on cardiovascular risk.

Further findings from PURE:

-Higher saturated fat intake was associated with a lower risk of stroke

-There was no association between total fat or saturated fat or unsaturated fat with risk of heart attack or dying from heart disease.

Given that most people still believe that saturated fat causes heart disease and are instructed by most national dietary guidelines to cut out animal and dairy fat this does indeed suggest that

Global dietary guidelines should be reconsidered …”

Amen!

Because the focus of dietary guidelines on reducing total and saturated fatty acid intake “is largely based on selective emphasis on some observation and clinical data despite the existence of several randomizesed trials and observational studies that do not support these conclusions.”

Pesky Confounding Factors

We cannot infer causality from PURE because like all obervational studies, the investigators do not have control over all the factors influencing outcomes. These confounding factors are legion in a study that is casting such a broad net across different countries with markedly different lifestyles and socioeconomic status.

The investigators did the best job they could taking into account household wealth and income, education, urban versus rural location and the effects of study centre on the outcomes.

In an accompanying editorial, Christopher E Ramsden and Anthony F Domenichiello, prominent NIH researchers,  ask:

“Is PURE less confounded by conscientiousness than observational studies done in Europe and North American countries?

 

“Conscientiousness is among the best predictors of longevity. For example, in a Japanese population, highly and moderately conscientious individuals had 54% and 50% lower mortality, respectively, compared with the least conscientious tertile.”

“Conscientious individuals exhibit numerous health-related behaviours ranging from adherence to physicians’ recommendations and medication regimens, to better sleep habits, to less alcohol and substance misuse. Importantly, conscientious individuals tend to eat more recommended foods and fewer restricted foods.Since individuals in European and North American populations have, for many decades, received in influential diet recommendations, protective associations attributed to nutrients in studies of these populations are likely confounded by numerous other healthy behaviours. Because many of the populations included in PURE are less exposed to in influential diet recommendations, the present findings are perhaps less likely to be confounded by conscientiousness.”

It is this pesky conscientiousness factor (and other unmeasured confounding variables) which limit the confidence in any conclusions we can make from observational studies.

I agree wholeheartedly with the editorial’s conclusions:

Initial PURE findings challenge conventional diet–disease tenets that are largely based on observational associations in European and North American populations, adding to the uncertainty about what constitutes a healthy diet. This uncertainty is likely to prevail until well designed randomised controlled trials are done. Until then, the best medicine for the nutrition field is a healthy dose of humility.

 

Ah, if only the field of nutrition had been injected with a healthy dose of humility and a nagging conscience thirty years ago when its experts declared confidently that high dietary fat and cholesterol consumption was the cause of heart disease.!

Current nutritional experts and the guidelines they write will  benefit from a keen awareness of the unintended consequences of recommendations which they make based on weak and insufficient evidence  because such recommendations influence the food choices  (and thereby the quality of life and the mechanisms of death) of hundreds of millions of people.

PUREly Yours,

ACP

Why Are The Dutch So Heart Healthy and Happy (And Tall)? Part I: Is It Their Diet?

The Skeptical Cardiologist and his  eternal fiancee’ recently spent 5 days in the Netherlands trying to understand why the Dutch are so happy and heart healthy.

We were driven by Geo (former statin fence-sitter) from Bruges to Haarlem, a city of 150,000, which lies about 15 km west of Amsterdam and about 5 km east of the North Sea.

 

Haarlem is one of the most delightful towns I’ve ever stayed in.

 

 

I was struck by  the beauty of its architecture, its canals and the happiness, height and friendliness of its inhabitants.

I was lucky enough to have a bike at my disposal. One day I set off randomly, and after 20 minutes of riding on delightfully demarcated bike lanes, I scrambled up a sand dune and looked out at the North Sea.

Just down the road was the  beach resort of Zandvoort, where one can enjoy sunbathing, surfing or a fine meal while gazing at a glorious sunset.

 

 

 

 

Like Amsterdam, which is a 15 minute train ride away, bikes and biking abound in Haarlem, but unlike Amsterdamers, the Haarlemers were universally engaging, polite and friendly. Everything and everyone seemed clean, well-organized, relaxed and pretty…and, well, …happy.

The Dutch High Happiness Rating

The World Happiness Report 2017, which ranks 155 countries by their happiness levels, was released in March of this year at the United Nations at an event celebrating The International Day of Happiness.

The report notes that:

Increasingly, happiness is considered to be the proper measure of social progress and the goal of public policy

Norway was at the top of the happiness list but

All of the other countries in the top ten also have high values in all six of the key variables used to explain happiness differences among countries and through time – income, healthy life expectancy, having someone to count on in times of trouble, generosity, freedom and trust, with the latter measured by the absence of corruption in business and government.

The top 4 were closely bunched with Finland in 5th place, followed by the Netherlands, Canada, New Zealand, and Australia and Sweden all tied for the 9th position.

Despite the immense wealth of Americans, the report notes:

The USA is a story of reduced happiness. In 2007 the USA ranked 3rd among the OECD countries; in 2016 it came 19th. The reasons are declining social support and increased corruption  and it is these same factors that explain why the Nordic countries do so much better.

Dutch children seem to be especially happy.

A UNICEF report from 2013 found that Dutch children were the happiest of the world’s 29 richest industrialized countries.  America ranked 26th, barely beating out Lithuania and Latvia.

Cardiovascular Disease in The Netherlands

Ischemic heart disease (IHD) deaths are due to blockages in the coronary arteries. Typically, this comes from the build up of atherosclerotic plaques in the arterial system and in most countries heart attacks from this process are the major cause of death.

The Netherlands has the third lowest rate of IHD deaths in developed countries, only slightly higher than France and less than half the rate of the USA.Screen Shot 2017-07-26 at 10.53.26 AM

In all developed countries over the last thirty years we have seen a marked drop in deaths due to IHD. In The Netherlands it has dropped 70% and the rate in 2013 was nearly as low as France’s rate.

In addition, the Netherlands has a very low rate of deaths from  hypertensive heart disease. This table from 2008 shows that they are second only to Japan and their mortality rate is a third of that in the US.

A recent update noted

The current Dutch age-standardised mortality from circulatory disease is 147 per 100,000, and only Spain and France have lower cardiovascular mortality rates (143 and 126 per 100,000, respectively). In all other European countries, including for instance Switzerland and Greece, cardiovascular mortality is higher [26].

What factors could be causing all this happiness and heart healthiness?

The Seemingly Horrid Dutch Diet

We have been programmed to believe that heart attack rates are related to saturated fat in our diets.

The fact that the French consume lots of saturated fat and rank so low in IHD deaths has been called the French Paradox as it seems to contradict the expected association.

One thing is clear-the Dutch are not following a whole foods, plant-based diet. They are among the world leaders in consumption of both fat and sugar as the graph below indicates.

While in The Netherlands I sought out raw herring,  a dish which Rick Steves and others indicate is a Dutch obsession.

Since there is evidence that fish consumption, especially fatty ones like herring and mackerel, is associated with a lower risk of coronary heart disease, perhaps this was protecting the Dutch.

I didn’t see much herring consumption in Haarlem (a native Haarlemer informs me that the Dutch raw herring consumption might be confined to older generations or tourists).

It turns out that the Dutch aren’t meeting their own nutritional guidelines for healthy food .

The recommendation to eat fish at least twice a week, of which at least once fatty fish such as salmon, herring or mackerel, is followed by a mere 14 percent of the population. Less than 25% of them meet the recommended daily amount of fish, fruit, and vegetable consumption.

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purple bar=women yellow bar=men orange bar= total

They do catch and export a lot of fish and shellfish and are in the top 10 of seafood exporting countries (99% of all those mussels consumed in Belgium come from The Netherlands).

And, to my great surprise, they eat lots of French, or as I have started calling them, Flanders fries.

 

I personally witnessed  massive amounts of cheese and butter consumption.

In fact, the Dutch average 15% of calories from saturated fat, which is far above the 10% recommended by the Dietary Guidelines for Americans.

A recent analysis of Dutch fat consumption found:

The mean baseline intake of total saturated fatty acids (SFAs)  in the population was 15.0% of energy. More than 97% of the population exceeded the upper intake limit of 10% of energy/d as recommended by the Health Council of the Netherlands.

The Dutch weren’t eating so-called healthy fats as “The main food sources of SFAs were cheese (17.4%), milk and milk products (16.6%), meat (17.5%), hard and solid fats (8.6%), and butter (7.3%).”

Surprisingly, the more saturated fat the Dutch consumed, the LOWER their risk of death from IHD:

After multivariable adjustment for lifestyle and dietary factors (model 4), a higher intake of energy from SFAs was significantly associated with a 17% lower IHD risk (HR per 5% of energy: 0.83; 95% CI: 0.74, 0.93)

The Dutch Paradox

Data shows that  the Dutch are eating lots of saturated fat from dairy and meat, but it appears to be lowering their risk for heart attacks

Yes, despite 40 years of high saturated fat consumption, the Dutch have seen a 70% drop in mortality from heart attacks. Their rate of dying from ischemic heart disease is lower than the US and only slightly higher than the French.

Thus, rather than talk about a French paradox, we should be talking about the Dutch paradox.

For the French paradox many theories, both fanciful and serious,  have been proposed

The one most laypeople remember (due to a 60 Minutes episode in 1991) is that the French are protected by their high red wine consumption. Although this theory proved a great boon to the red wine industry (sales rose 40% the year after Morley Safer made his presentation on 60 Minutes), it has never had any serious scientific credibility.  Current thinking is that all forms of alcohol in moderation are equally protective.

Others have proposed garlic or onion or faux gras consumption. My own theory for the French is that it is fine cheese and chocolate consumption that protects them.

In subsequent posts I’ll lay out the evidence for my startling new theory to explain the Dutch paradox.