Tag Archives: cardiovascular disease

Where Are My Generics Medications Made? India, China, or the US?

With the recent recall of valsartan due to carcinogenic Chinese contaminants the issue of where one’s generic medication is manufactured has become more important.

I take two generics: ramipril for my hypertension and rosuvastatin for my cholesterol/atherosclerosis and I had no idea where they came from when I discussed the rise of generics manufactured in China recently.

Where Is My Ramipril Made?

I called my St. Lukes pharmacist, Robert, and asked him if he could give me information on the origin of these pills.

Robert told me that my 10 mg ramipril capsule was distributed by a company called West-Ward located in New Jersey.  West-Ward was an independent Columbus, Ohio company but was purchased in 2016 by a very large pharmaceutical company , Hikma, based in Aaman, Jordan. Now the Hikma web site indicates West-Ward is no more and is simply called Hikma in the US.

According to a 2017  Columbus article

Hikma Pharmaceuticals Plc projects it will end 2017 with about $2 billion revenue, about $600 million of which is from generic drugs made by its U.S. subsidiary West-Ward. In the spring, the company had projected $800 million in generics sales.

Customer service at Hikma informs me that my ramipril was made in their Columbus, Ohio plant.

Where Is My  Rosuvastatin Made?

My rosuvastatin (generic of Crestor) was made by Glenmark Pharmaceuticals which, per wikipedia

 is a pharmaceutical company headquartered in Mumbai, India that was founded in 1977 by Gracias Saldanha as a generic drug and active pharmaceutical ingredient manufacturer; he named the company after his two sons.

Glenmark received FDA approval to market their generic rosuvastatin in the US in July, 2016. and at that time had 115 products authorized for distribution in the US market and 61 drugs pending approval with the US FDA.

My rosuvastatin according to Robert was made in India although the Glenmark product catalog does not reveal this information.

Generic versus Brand Name

I’ve talked about Crestor/rosuvastatin a few times on this blog and the development of a generic version has been very helpful for many of my patients. Looking online today I see that generic rosuvastatin goes for about 10$ per month compared to 260$ for Crestor.

Is it worth paying an extra 250$ per month to get brand name Crestor if, let’s say it was manufactured in the US? For most people it isn’t. For one thing, there is no guarantee of where your brand name drug is manufactured.

Crestor used to be made in a factory in Bristol, UK but this was shut down in 2017 and now I can’t tell where Astra-Zeneca makes the stuff. Frankly, I’m surprised that they are selling any of the drug which used to account for 5 billion dollars of their annual sales.

So 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 never realized how globalized the pharmaceutical industry has become. Hopefully, the FDA is doing a good job of monitoring the safety and quality of products we rely on for our wellbeing which are manufactured all over the globe.

Skeptically Yours,

-ACP

Three More Nails In The Omega-3 Supplement Coffin: Stop Taking Fish Oil Pills (The Complete Post)

If by now you are still taking fish oil supplements despite my last post on the topic I present three more reasons to stop wasting your money and destroying the ocean’s ecosystem.

The first nail: No Reason To Take Fish Oil Pills

A Cochrane review showing shows there is little or no effect of omega 3 supplements on our risk of experiencing heart disease, stroke or death.

This is the most extensive systematic assessment of effects of omega-3 fats on cardiovascular health to date. Moderate- and high-quality evidence suggests that increasing EPA and DHA has little or no effect on mortality or cardiovascular health (evidence mainly from supplement trials). Previous suggestions of benefits from EPA and DHA supplements appear to spring from trials with higher risk of bias. Low-quality evidence suggests ALA may slightly reduce CVD event risk, CHD mortality and arrhythmia.

Second Nail. Peruvian Anchoveta: Put Them On A Pizza Not in A Pill

Paul Greenberg’s recently published book, The Omega Principle, emphasizes the damage the fish oil supplement business is doing to the ocean environment,

During a recent interview on Fresh Air on NPR he summarized the concerns:

GREENBERG: So omega-3 supplements come from this critical layer of the ocean biosphere that are small – what are called pelagic fish. They’re the silvery, little fish like anchovies and herring and other fish called menhaden that most people haven’t heard of, but it’s actually the most caught fish in the lower 48 of the United States. These fish are really essential for ecosystem dynamics in the ocean.

So the way that oceans work is that all the energies coming from the sun – it goes – all that energy is processed by plankton, by phytoplankton. And it’s really these fish that are – these little fish that are used for omega-3 supplements that transfer the energy from plankton to larger fish. So in other words, you know, you have the solar energy going into the plankton. The little fish then eat the plankton. And then they are in turn eaten by larger fish. So if you harvest this middle layer – if you overharvest this middle layer of anchovies, of herring, of menhaden – if you take them out of the picture, there’s no way for the energy to be transferred from phytoplankton up to larger predators. So I guess that’s my main concern here.

So in particular, where are the omega-3 supplements coming from? Most of the omega-3 supplement oil is coming from a fish called a Peruvian anchoveta. And it is the most caught fish in the world. In some years, Peruvian anchoveta harvests have equaled as much as 10 million metric tons. Just to give you some perspective, that’s like one-eighth of all the fish caught in the world. And the crazy thing about it is that those fish are completely, totally edible. I’ve eaten them. They’re delicious. You can have them on a pizza. You could do anything with them. But 99 percent of those Peruvian anchoveta are ground up into animal feed, boiled down into oil and turned into supplements. So to me, to my mind, that is not necessarily the wisest use to be made of this really, really important source both for the ecology of the ocean but also for humans

Nail Three. Save the Krill!

The supplement industry is incredibly creative in their marketing. As the uselessness of fish oil supplementation has become clear, supplement manufacturers have begun touting krill oil as superior to fish oil.

Claims like the following are all over the internet:

Krill have an edge over your ordinary fish – when you take a krill oil supplement, you also get astaxanthin along with your DHA and EPA. It’s an antioxidant. In terms of antioxidant power of potency, it’s been found to be 500x to 6,000x stronger than regular vitamins like vitamin E and vitamin C.

This is just hogwash. There is no good clinical evidence to support any health claim for krill oil in general or astaxanthin in particular. Please read my post on the failure of anti-oxidant supplements and vitamins and recognize that claims of antioxidant power do not indicate any health benefit.

A technical paper from Greenpeace review the importance of krill to to the marine ecosystem in the Antarctic and this paper, entitled “License to Krill” details the problem.

Do you want to be responsible for starving penguins, whales and seals??!

Let me reiterate my original 2013 fish oil post pithy summary:

the bottom line on fish oil supplements is that  the most recent scientific evidence does not support any role for them  in preventing heart attack, stroke, or death. There are potential down sides to taking them, including contaminants and the impact on the marine ecosystem. I don’t take them and I advise my patients to avoid them (unless they have triglyceride levels over 500.)

Prokrilly Yours

-ACP

 

 

 

 

Heart Healthy Breakfast Choices?: Cheerios, Honey-Nut Cheerios and Soluble Fiber Revisited

A reader commenting on my Plant Paradox post questioned nutritional  recommendations to consume fiber. This has prompted me to revisit a post I wrote in 2014 on Cheerios and Soluble Fiber.

I mentioned at that time that Honey-Nut Cheerios was the #1 selling ready-to-eat breakfast cereal and Cheerios #4. This update Screen Shot 2018-07-15 at 7.22.55 AMindicates little has changed in the rankings or consumption of breakfast cereal since then despite a more widespread recognition that added sugar is the major toxin in our diet and that these food items are basically a vehicle for sugar.

Apparently, Americans believe honey is not sugar. But Honey Nut Cheerios contain 9 times as much sugar as cheerios. Here are the top ingredients:

Whole Grain Oats, Sugar, Oat Bran, Corn Starch, Honey, Brown Sugar Syrup, Salt, Tripotassium Phosphate, Rice Bran Oil and/or Canola Oil,

General Mills tries to emphasize the healthiness of Honey Nut Cheerios, focusing on their close relationship with bees and the natural goodness of honey in its advertising along with other factors that we now know are not important (low fat, 12 vitamins and minerals, source of iron).Screen Shot 2018-07-15 at 7.56.32 AM

Little has changed with respect to the science supporting fiber consumption to reduce cardiovascular disease since 2014.  It is still weak and based on observational studies and surrogate biomarkers.

Between the lines below is my original post with current annotations in red.


The skeptical cardiologist usually eschews the breakfast offerings in the Doctor’s lounge. I’m not really interested in consuming donuts, muffins, or bagels with their high carbohydrate load. As I’ve ranted out about previously, the only yogurt available is Yoplait low fat , highly sugared-up yogurt which is arguably worse than starting the day with a candy bar.

A selection of breakfast cereals is available including Cheerios, Raisin Bran, and Frosted Flakes. Occasionally, when I have neglected to bring in my own full-faty yogurt, granola and/or fruit I will open up one of the Cheerios containers and consume a bowl mixed with 2% milk (full-fat, organic milk which I passionately advocate here and here is not available) (2018 update, I have said “cheerio” to all breakfast cereals and no longer eat Cheerios in the doctor’s lounge). 

Pondering the Cheerios packaging and the cute little O’s made me wonder whether this highly processed and packaged food with a seemingly endless shelf life was truly a healthy choice.

The “Ready-To-Eat”  And Allegedly Heart-Healthy Cereal

Cheerios and Honey-nut cheerios were  the #4 and #1 breakfast cereals in the US in 2013, generating almost a billion dollars in sales. Both of these General Mills blockbusters undoubtedly have reached their popularity by heavily promoting the concept that they are heart healthy.

The Cheerios label is all about the heart. The little O’s sit in a heart-shaped bowl. A prominent red heart with a check inside it attests to the AHA having certified Cheerios as part of its checkmark.heart.org program. Additional text states “low  in Saturated fat and cholesterol” and “diets low in saturated fat and cholesterol may reduce the risk of heart disease.”

Is The Fiber In Cheerios “Heart-Healthy” ?

Beta-glucan is a soluble fiber primarily located in the endosperm cell wall of oats. Early studies showed that oats and beta-glucan soluble fiber could reduce total and LDL (bad cholesterol) levels. The mechanism isn’t really known. (see the end of post for possible mechanisms). The Quaker oats web site oversimplifies the mechanism thusly :

“In your digestive tract, it acts as a sponge, soaking up cholesterol and carrying it out of the body”

This narrative fits with the oversimplified and now discredited descriptions of atherosclerosis which attribute it directly to consumption of cholesterol and fatty acids. See here if you’d like to appreciate how complex the process truly is.

The FDA Sanctions Oats As Heart Healthy

In 1997, the FDA reviewed 33 studies (21 showing benefit and 12 not) and decided to allow a health claim for foods that contain oats and soluble fiber. A minimum dose of 3 grams/day of oat beta-glucan was suggested for a beneficial reduction in blood cholesterol and (presumably, although never documented) a subsequent decline in coronary heart disease.

In 1998 Johnson, et al, published the results of a study funded by a grant from General Mills that showed that  inclusion of whole grain oat ready to eat cereal providing 3 grams of beta-glucan as part of a low fat diet reduced  LDL cholesterol by 4% after 6 weeks. HDL was unchanged. Patients in this study consumed 45 grams (1.5 oz) of cheerios at breakfast and then again in the evening. There was a total of 3 grams of soluble fibre in this amount of Cheerios. A control group consumed corn flakes in a similar fashion without change in LDL.

General Mills took this weak data and ran with it and began posting on Cheerios the following statements

 “Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is … clinically proven to lower cholesterol. A clinical study showed that eating two 1 1/2 cup servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol.”

Although the FDA had approved verbiage indicating oats may reduce heart disease “when eaten as part of a diet low in saturated fat and cholesterol” the agency objected to General Mills claiming that Cheerios lowers cholesterol “when eaten as part of a diet low in saturated fat and cholesterol”.

The FDA  issued a warning letter to General Mills in 2009 in which the agency alleged “serious violations” of the FDC Act in the label and labeling of Cheerios cereal.

Based on claims made on your product’s label, we have determined that your Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease.

Lowering Cholesterol Is Not The Same As Preventing Heart Disease

The FDA was telling General Mills that it was OK to say that Cheerios may reduce heart disease but not that it can reduce cholesterol because that made it a drug. It makes no sense.

The only thing that had been demonstrated for oat soluble fiber and Cheerios in particular was a reduction in cholesterol. There has never been a study with oats showing a reduction in heart disease..

It’s the heart disease, the atherosclerosis clogging our arteries and causing heart attacks and strokes that we want to prevent. We could care less about lowering cholesterol if it doesn’t prevent atherosclerosis.

A recent review of studies since the FDA ruling shows that 70% of studies show some reduction in LDL with beta-glucan. Interstingly, the studies which added beta-glucan to liquids were generally positive whereas addition to solids such as muffins usually did not show benefit.

I’m going to accept as evidence-based the claim that whole oats can lower your LDL about 7% if you consume a very large amount of them on a daily basis.

However, the critical question for any drug or dietary intervention is does it prevent atherosclerosis, the root cause of heart attacks and strokes. There has been in the past an assumption that lowering cholesterol by any means would result in lowering of atherosclerosis.

This theory has been disproven by recent studies showing that ezetimibe and niacin which significantly lower LDL do not reduce surrogate markers of atherosclerosis or cardiovascular events any more than placebo when added on to statin drugs. (There is now weak evidence that ezetimibe does lower cardiovascular events ). The recently revised cholesterol guidelines endorse the concept of treating risk of atherosclerosis rather than cholesterol levels.


 

I do like the food writer Michael Pollan’s simple rules to “Eat Food. Mostly Plants. Not Too Much.” and this NY Times piece summarizes much of what is in his short, funny and helpful Food Rules book:

you’re much better off eating whole fresh foods than processed food products. That’s what I mean by the recommendation to eat “food.” Once, food was all you could eat, but today there are lots of other edible foodlike substances in the supermarket. These novel products of food science often come in packages festooned with health claims, which brings me to a related rule of thumb: if you’re concerned about your health, you should probably avoid food products that make health claims. Why? Because a health claim on a food product is a good indication that it’s not really food, and food is what you want to eat.

If you follow Pollan’s dictum you will get plenty of fiber, soluble or otherwise and you will avoid the necessity to obsess over the macronutrients in your diet, fiber or otherwise. Throw in some Cheerios and oatmeal every once in a while if you like them;  in their unadulterated state they are a heart-healthy food choice.

Cheerio,

-ACP

Flaxseed: Plant-Based Omega 3 Super Food or Faux Fish Oil?

Ground flaxseed plus Trader’s Point Creamery full fat plain yoghurt. It’s not pretty but tastes pretty good.

The skeptical cardiologist has a confession to make: he’s been adding ground flaxseed to his typical late morning full fat yoghurt plus berries and almonds.

Adding flaxseed seems dangerously close to dietary behaviour I have been advising against: supplementing instead of eating real food.

Also, I am philosophically opposed to going out of my way to eat any edible that is consistently promoted as a “super food” or a “functional food.” To me, these are meaningless terms and marketing blather

When I began writing this post in 2017 I was getting my flaxseed from Stober Farms (Est. 1901) who had been producing “for over 100 years  the finest flax in the world.”  Stober Farms provided me with “organic Golden Flax Seed which has been Cold-Milled Processed.”

Stober Farms (who have since mysteriously gone into bankruptcy) also informed me:

Flax is digested most effectively when ground. Some grinding methods generate heat when milled, spurring early omega-3 oxidation. Stober Farms uses a unique cold-milled process, which gently grinds the seed without significantly raising the temperature. This proprietary method preserves the nutrients, flavor and extends the shelf life to 22 months.

Honestly, I don’t recall exactly why I began “flaxing” but I suspect I felt it was a good way to boost the fat content in my full fat yoghurt (yes, I am now spelling yoghurt with an h) and berries and perhaps sufficiently satiate me that it would be the only food I would need to consume until dinner or late afternoon.

Two tablespoon (14 grams) is what I typically  imprecisely add. These tablespoons provide 75 kcal of energy which comes from 3 grams of protein, 6 grams of fat, and 4 grams of carbs.  Three of the four carb grams are soluble fibre.

About half of the fat in flaxseed is in the form of alpha-linolenic acid (ALA)(18:3) an omega-3 polyunsaturated (PUFA) fat.  Flaxseed oil contains five times more ALA than walnut oil or canola oil, which are the next highest sources of ALA.

Is Flaxseed A Super Functional Food?

Many seemingly authoritative sites on the internet proclaim that flaxseed is incredibly healthy. For example, Healthline.com’s “Authority Nutrition” (they must be authoritative as authority is in their name)  presents their 10 health benefits of eating flaxseed “backed by science”  and concludes:

They can be used to improve digestive health, lower blood pressure and bad cholesterol, reduce the risk of cancer and may benefit people with diabetes.

But typical of  Authority Nutrition’s overblown claims  these are not truly proven by science. The studies cited are weak; typically short-term tests of biomarkers or animal studies or human studies with very small numbers. Most importantly. these studies , which are often funded by flaxseed promoters are highly likely to be biased in favor of positive results.

Most websites tout the cardiovascular benefits of the omega-3 PUFA in flaxseed, the high percentage of soluble fibre and  the benefits of a chemical which cannot be named (due to a name which is too difficult to pronounce), SDG.

Omega-3 PUFAs and fibre I’ve touched on previously (and positively) but what about the mysterious and unpronounceable SDF. Per a 2010 review article

Flaxseed is the richest source of the lignan secoisolariciresinol diglucoside (SDG). After ingestion, SDG is converted to secoisolariciresinol, which is further metabolised to the mammalian lignans enterodiol and enterolactone. A growing body of evidence suggests that SDG metabolites may provide health benefits due to their weak oestrogenic or anti-oestrogenic effects, antioxidant activity, ability to induce phase 2 proteins and/or inhibit the activity of certain enzymes, or by mechanisms yet unidentified.

Like so many putative wonder phytochemicals, SDG has a “growing body of evidence” for lots of things but actual proof that it does anything worthwhile in humans is lacking and awaits  well done randomized clinical trials

Poorly researched articles on flaxseed are highly likely to tout its anti-inflammatory properties. These properties are seen in rats but unfortunately haven’t been proven in my favorite species, Homo Sapiens ,  Flaxseed doesn’t seem to decrease the inflammatory marker CRP in humans as reported in this systematic review and meta-analysis.

ALA and Cardiovascular Disease

As I’ve indicated in previous posts, evidence supports fatty fish consumption as beneficial in reducing cardiovascular disease presumably by increasing levels of marine omega-3 PUFAs in the body.

The value of fish oil supplementation, however, is not proven (see here).

How does ALA compare to the seafood omega 3s  in preventing cardiovascular disease (CVD)?

In 2012, researchers at the Harvard School of Public Health published a systematic review and meta-analysis of the existing data on ALA and the risk of CVD..

Their introductory paragraph nicely lays out why ALA could be very important to public health:

A large body of evidence supports a potential protective effect of seafood omega-3 (n−3) fatty acids, particularly EPA (20:5n−3) and DHA (22:6n−3), on coronary heart disease (CHD. However, fewer studies have evaluated how the plant-derived omega-3 fatty acid α-linolenic acid (ALA; 18:3n−3) relates to risk of CHD and other cardiovascular disease (CVD) outcomes, and the results have been inconsistent As an essential fatty acid that cannot be synthesized by humans, ALA is mainly consumed from plant sources, including soybeans, walnuts, and canola oil. Compared with seafood omega-3 fatty acids, ALA from plant sources is more affordable and widely available globally. Thus, whether ALA can reduce the risk of CVD is of considerable public health importance.

If plant-derived ALA can provide our omage-3 PUFA needs then perhaps we can stop stripping the ocean of all the menhaden.

In the Harvard analysis when all 27 studies were combined the authors found a significant risk reduction of 14% in CVD events with flaxseed.

There were lots of issues with the data which I won’t bore you with leading the authors to conclude that “ALA consumption may be beneficial “.  They emphasized the need for additional well-designed observational studies and randomized clinical trials in the area.

Since observational studies cannot prove causality, I await a good randomized clinical trial of ALA supplementation before I can recommend ALA supplementing to prevent heart disease.

After Performing This Review Is The Skeptical Cardiologist Still “Flaxing”?

I am. Because I’ve found that when I consume flaxseed I feel 20 years younger, full of vitality. and with a youthful golden sheen to my hair, nails and skin.

Actually, that last sentence is untrue.

I’m still adding ground flaxseed to my yoghurt but not with any expectation that it is reducing my risk of heart attack and definitely not because I perceive it as a super or functional food.

I like the taste, the convenience, and the extra (presumably healthy) calories it provides but I’m still an advocate of just eating real food rather than trying to identify specific nutrients, nutraceuticals or supplements and add them to your diet.

Flaxseedingly Yours,

-ACP

N.B. I did not touch on omega-6/omega-3 ratios in the diet. I’ve been examining that inflammatory (enjoy the pun) topic for years and once I come across a good study that adds to understanding in the area I will likely publish a post on it.

 

The Eggsoneration Continues: Why Does Anyone Eat Egg Whites?

The skeptical cardiologist pointed out in 2013 that there was no good evidence supporting limiting dietary cholesterol to 300 mg per day.  I exulted, therefore, in 2016 , when this long-standing dietary recommendation came out of the US dietary guidelines.

Recognizing that dietary cholesterol doesn’t need to be limited means that eggs and egg yolks are fine.

Egg Whites: A Product of Nutritional Misinformation?

Why, then do egg whites continue to be created and consumed?

On a regular basis, patients tell me that they are eating egg white omelettes because they believe egg yolks are not heart healthy.

Old bad nutritional dogma takes a long time to reverse apparently. To this day, for example, the National Lipid Association still recommends limiting daily cholesterol consumption to <200 mg/ day

Therefore I find it necessary to highlight additional new studies that further eggsonerate eggs.

To wit, I shall briefly discuss two articles that were published earlier this month and brought to my attention by friends and readers who are aware of my rabid support for the egg.

Article One: The Wonderfully Acronymed DIABEGG Study

Entitled  “Effect of a high-egg diet on cardiometabolic risk factors in people with type 2 diabetes: the Diabetes and Egg (DIABEGG) Study—randomized weight-loss and follow-up phase” our fist study was performed in Australia at the Sydney Medical School,

Investigators randomized 128 patients with prediabetes or type 2 diabetes (T2D) to a high egg or a low egg diet.

Throughout all study phases, including the 3-mo weight-loss phase, participants consuming the high-egg diet were instructed to eat 2 eggs/d at breakfast for 6 d/wk (12 eggs/wk). Those in the low-egg group were directed to consume <2 eggs/wk, and to match the protein intake that the high-egg group had consumed at breakfast with 10 g lean animal protein (meat, chicken, or sh) or other protein-rich alternatives, such as legumes and reduced-fat dairy products (also consumed at breakfast). Recommended egg-cooking methods were boiled or poached, but they could also be fried if a polyunsaturated cooking oil, such as olive oil, was used. The prescribed diets were energy and macronutrient matched, as reported previously

At the end of 12 months both groups had lost about 3 kg in weight.
The investigators measured everything they could to look at diabetic and cardiometabolic biomarkers which might suggest adverse effects of egg eating on the cardiovascular system but they could find no difference between the egg eaters and the non egg eaters.
High egg consumption had no adverse effects on the following factors that are felt to be important in the development of atherosclerosis:

-measures of systemic and vascular inflammation [high sensitivity C-reactive protein (hs-CRP), IL-6, soluble E-selectin (sE-selectin)],

-oxidative stress (F2-isoprostanes), the adipokine adiponectin (which also modulates insulin resistance), and

-glycemia [fasting plasma glucose, glycated hemoglobin (HbA1c), and a medium-term measure of glycemia, 1,5-anhydroglucitol (1,5AG)].

The authors suggested that nutritional guidelines stop worrying about limiting eggs.

Article Two: Half A Million Chinese Can’t Be Wrong

This observational study published in Heart found that egg consumption in a huge Chinese population was associated with less stroke, and major cardiac events (MCE):

Compared with non-consumers, daily egg consumption was associated with lower risk of CVD (HR 0.89, 95% CI 0.87 to 0.92). Corresponding multivariate-adjusted HRs (95% CI) for IHD, MCE, haemorrhagic stroke and ischaemic stroke were 0.88 (0.84 to 0.93), 0.86 (0.76 to 0.97), 0.74 (0.67 to 0.82) and 0.90 (0.85 to 0.95), respectively. There were significant dose-response relationships of egg consumption with morbidity of all CVD endpoints (P for linear trend <0.05). Daily consumers also had an 18% lower risk of CVD death and a 28% lower risk of haemorrhagic stroke death compared to non-consumers.

The lower risk for stroke and cardiovascular death in egg eaters persisted after accounting for known CVD risk factors.

(And yes, I agree this is an observational study which we should take with huge grains of salt and pepper).

Are EGG Whites The Skim Milk Scam of The Egg Industry?

I’ve written about the scam that is skim milk but it occurs to me that egg white consumption is equally nonsensical.

What happens to the wonderfully nutritious yolk of the egg when it is brutally separated from its white? It is put in a container and sold as  liquid egg yolk. Makers of mayonnaise are big consumers of liquid egg yolk.

Thus, like dairy farmers who double their sales by selling skim milk and its dairy fat separately, egg producers are probably delighted that Americans are consuming egg whites , allowing them to get two products from a single egg.

As I wrote previously: not everyone is an egg lover and I’m fine with that. There is no evidence that you have to eat them. You could feel towards them as did Alfred Hitchcock :

“I’m frightened of eggs, worse than frightened, they revolt me. That white round thing without any holes … have you ever seen anything more revolting than an egg yolk breaking and spilling its yellow liquid? Blood is jolly, red. But egg yolk is yellow, revolting. I’ve never tasted it.”

For those that don’t find yellow revolting, however, avoiding egg yolk makes no nutritional sense.

Eggsplicatively Yours,

-ACP

What You Should Know About Lipoprotein(a) And Heart Attack Risk

If you have had a heart attack at an early age or one of your parents did but your standard risk factors for coronary heart disease are normal you should consider getting tested for Lipoprotein(a) or Lp(a).

The standard lipid profile that most patients get checks LDL (bad) HDL (good) and total cholesterol along with  triglycerides. While these are useful, I have many patients who have normal standard values but have developed advanced coronary heart disease at an early age despite following a perfect lifestyle (not smoking, regular aerobic exercise, healthy diet.)

The skeptical cardiologist tests such patients for Lp(a) (pronounced LP little a)  and it is quite frequently elevated.

For patients, these are the facts to know about Lp(a)

  1. It is the strongest single inherited (monogenetic) risk factor for the early development of coronary artery disease, heart attacks and strokes.
  2. In addition to increasing risk of atherosclerosis, high Lp(a) is strongly associated with the development of calcific aortic valve disease which can result in narrowing of the aortic valve and aortic stenosis.
  3. Depending on the cut-off used  up to one in five individuals may have elevated Lp(a)
  4. Levels of Lp(a) can be measured with a simple blood test that should cost no more than 50 to 100$. This is not included in standard lipid or cholesterol testing.
  5. Risk for heart attack starts to rise with levels above 30 mg/dl and Canadian guidelines from 2016 (see here)) consider >30 mg/dl to be a risk factor and they recommend measuring Lp(a) in those with a family history of premature CAD or those at intermediate risk.
  6. The European Atherosclerosis Society (EAS, 2010), suggested levels of <50 mg/dl as optimal. The EAS advised measuring Lp(a) once in all patients with premature CVD.
  7. As levels get even higher risk also rises as these graphs show

 

 

 

 

Treatment For High Lp(a)

The lifestyle changes (both exercise and diet) that improve bad and good cholesterol levels have no effect on Lp(a). Our best drugs, the statins, for reducing risk of heart attack and stroke also don’t lower Lp(a) levels.

Only niacin has been shown to reduce Lp(a) across broad populations but there is no evidence that Lp(a) lowering by niacin lowers cardiovascular risk so it cannot be recommended for treatment.(In the AIM-HIGH study niacin did not reduce cardiovascular events in patients with Lp(a) with levels>50 mg/dl, despite achieving a mean Lp(a) reduction of 39%.)

Cholesteryl ester transfer protein inhibitors which raise HDL levels also reduce lipoprotein(a) concentrations, but three such inhibitors have not shown a clinical benefit.

In fact, currently there are no studies showing that lowering Lp(a) with any drug will effectively lower the associated risk of heart attack, stroke and aortic stenosis.

In the not too distant future, effective therapies may emerge. There are promising newer agents (antisense oligonucleotides or ASOs) currently in clinical trials and in limited populations the PCSK9 inhbitors, mipomersen and estrogen have lowered Lp(a) levels.

Why Test For Lp(a)?

If we have no effective therapies that work by lowering Lp(a) why recommend testing for it?

I test Lp(a) for  two reasons.

First, since it is inherited, patients with high levels should consider having first degree relatives tested for Lp(a) to identify those who are going to be at high risk. This provides an early warning of who in the family is most at risk for cardiovascular complications early in life. Such patients should be considered for early screening for subclinical atherosclerosis. In addition, they should be additionally motivated to do everything possible to reduce their elevated risk by lifestyle changes.

Second, I tend to recommend  more aggressive cholesterol lowering in patients who have evidence for early plaque build up for atherosclerotic events early in life than I otherwise would be.     I tend to agree with the approach diagrammed below:

 

With this approach for patients who have had events related to atherosclerosis or advanced CAC for age we work super aggressively on optimizing all risk factors. I try to lower LDL to <70 with statins and with the addition of ezetimibe or PCSK9 inhbitors if needed.

If the patient has more problems with atherosclerotic events despite optimizing risk factors and Lp(a) >60 mg/dl, some experts recommend using apheresis a technique which runs the patient’s blood through a filter which removes LDL and Lp(a). Personally, I have not sent any patients for apheresis and await better studies proving its benefit.

Antiproatherogenically Yours,

-ACP

For those patients seeking more detailed information and references I recommend Dr. Siggurdson’s excellent post on Lp(a)

There is a Lipoprotein(a) Foundation with reasonably informative and accurate website you can peruse here for more information.

Finally, if you want to delve deeply into the data check out this recent JACC review here.

The graphs above and this figure
showing the proposed pro-inflammatory, pro-atherogenic and pro-thrombotic pathways of Lp(a) are from that article.

 

Optimal Home Blood Pressure Monitoring: Must The Legs Be Uncrossed and The Feet Flat?

The new ACC/AHA guidelines for High Blood Pressure were published late last year and they were in favor of using home blood pressure measurement to aid in the management of hypertension.

I was happy to hear this as I am constantly advising my hypertensive patients to buy a home BP cuff, measure their BP once when they get up and again 12 hours later and report the values to me after two weeks.

I have not spent a lot of time instructing them on  exactly how to make the measurement but the new guidelines do specify in detail how this should be done:

• Remain still:

• Avoid smoking, caffeinated beverages, or exercise within 30 min before BP measurements.

• Ensure ≥5 min of quiet rest before BP measurements.

• Sit with back straight and supported (on a straight-backed dining chair, for example, rather than a sofa).

• Sit with feet flat on the floor and legs uncrossed.

• Keep arm supported on a flat surface (such as a table), with the upper arm at heart level.

• Bottom of the cuff should be placed directly above the antecubital fossa (bend of the elbow).

• Take at least 2 readings 1 min apart in morning before taking medications and in evening before supper. Optimally, measure and record BP daily. Ideally, obtain weekly BP readings beginning 2 weeks after a change in the treatment regimen and during the week before a clinic visit.

• Record all readings accurately:

• Monitors with built-in memory should be brought to all clinic appointments.

I monitor my own BP at home and often wonder whether there is scientific evidence to support such a rigid protocol.  Being a contrarian and a skeptic, I typically violate 3/4 of the recommendations that are listed.

It seems like all of the instructions are guaranteed to give you the lowest BP you are likely to experience during the day. The vast majority of the time I am not sitting quietly with my legs uncrossed, my bladder empty and my back straight so following these directions will underestimate my average daily BP.

I’ve spent some time looking into all the instructions and they generally have some scientific studies to support them. For example, the position of the upper arm in relation to the heart does  heavily influence BP readings (more on that in subsequent posts.)

The Mandate To Uncross The Legs

The instruction that most intrigued me was this one:

Sit with feet flat on the floor and legs uncrossed.

A number of questions came to the skeptical hypertensive:

What if you are on an exam table and your feet don’t reach the ground?

Does it really make a difference if your feet are flat on the ground versus slightly crooked?

Does any degree of leg crossing influence BP? Legs crossed at the ankles? Legs crossed at the knee?

And once I began thinking of leg crossing I realized that I spend a lot of my time with my legs crossed. Was this raising my blood pressure and my cardiovascular risk? Did I cross my legs because I liked the feel of a higher blood pressure?

The ACC/AHA guidelines are not alone in this recommendation-take a look at the British Health Service recommendation:

3.5. Measurements should be taken in silence when the patient is relaxed, with both feet flat on the floor and their back and arm supported. Many patients automatically cross their legs, which raises their blood pressure, so it is particularly important to emphasise the need for the patient to uncross their legs when taking their blood pressure.

Apparently the Brits believe that any ambient sound will alter the blood pressure. Talking is right out!

But if talking, ambient sounds and crossing your legs raises your blood pressure shouldn’t we be advising patients to spend their days wearing ear plugs in silence with their legs uncrossed?

Scientific Studies On Leg Crossing

It turns out there are good studies showing that leg crossing raises your blood pressure.

The first was published in 1999 and involved  53 hypertensive and 50 normotensive subjects.

Participants were randomly assigned, using a cross over design to having seated blood pressures measured with their leg in three different postures

  1. Feet flat on the floor and legs uncrossed

    Here I am demonstrating method 2 with my lateral malleolus carefully placed on my suprapatellar bursa. I actually prefer method 1 which is depicted below.
  2. Legs crossed , method 1-popliteal fossa of the dominant leg over the suprapatellar bursa of the non-dominant leg.
  3. Legs crossed, method 2- lateral malleolus (which the article spells mallelous) of the dominant leg over the suprapatellar bursa of the non-dominant leg.

I love the efforts these Calgarian investigators went to in this study to ensure blinding (although spelling is clearly not their forte’). They state “blood pressures were measured by one investigator who was behind a screen and blinded to the leg position of the patient while a second investighator (sic)  ensured that the subject assumed the proper leg position.”

Systolic blood pressure in patients with hypertension increased by 8 mm Hg by method 1 leg crossing and 10 mm Hg by method 2.

Figure from Adiyaman, et al. demonstrating method 1 on the left.

Another study demonstrated that although crossing the legs at the knees influenced blood pressure, crossing them at the ankles had no effect.

A recent review identified 7 studies which support the influence of leg crossing on BP.

 An Inconvenient Truth
If leg crossing raises the systolic blood pressure  8 to 10 mm Hg why aren’t we doctors recommending patients sit with leg uncrossed the majority of the time. Personally, I had never heard there were any health complications to sitting with my legs crossed.
Apparently the myriad health information sources on the internet are near unanimous in their condemnation of leg crossing but the hypertensive effect of this maneuver is usually not cited.
My favorite title condemning the practice was “The surprising and inconvenient truth of crossing your legs.”
I must admit since doing this bit of research I have substantially reduced the amount of time I sit with my legs crossed. And I’ve pondered extensively whether sitting with legs crossed makes me feel any different and why I suddenly and seemingly randomly decide to cross my legs.
I’ve also started asking  friends and colleagues and medical residents how much of the day they spend with legs crossed.
On teaching rounds one morning recently we tested a volunteer resident’s blood pressure with legs crossed and uncrossed. Sure enough, the systolic BP was 10 mm Hg higher with legs crossed.
Chiasmically Yours,
-ACP

 

For those of you itching to read more about BP and leg crossing here are the references:

 

Pinar R, Ataalkin S, Watson R. The effect of crossing legs on blood pressure in hypertensive patients. J Clin Nurs 2010; 19:1284–1288. [PubMed]
Adiyaman A, Tosun N, Elving LD, Deinum J, Lenders JWM, Thien T. The effect of crossing legs on blood pressure. Blood Press Monit 2007; 12:189–193. [PubMed]
Pinar R, Sabuncu N, Oksay A. Effects of crossed leg on blood pressure. Blood Press 2004; 13:252–254. [PubMed]
Avvampato CS. Effect of one leg crossed over the other at the knee on blood pressure in hypertensive patients. Nephrol Nurs J 2001; 28:325–328. [PubMed]
Keele-Smith R, Price-Daniel C. Effects of crossing legs on blood pressure measurement. Clin Nurs Res 2001; 10:202–213. [PubMed]
Foster-Fitzpatrick L, Ortiz A, Sibilano H, Marcantonio R, Braun LT. The effects of crossed leg on blood pressure measurement. Nurs Res 1999; 48:105–108. [PubMed]
Peters GL, Binder SK, Campbell NR. The effect of crossing legs on blood pressure: a randomized single-blind cross-over study. Blood Press Monit 1999; 4:97–101. [PubMed]

Dear Dr. Gottlieb, Full Fat Dairy is “Healthy”. Why Are You Pushing Low-Fat Dairy?

By all accounts, Scott Gottlieb, the Trump appointed director of the FDA is doing a good job.

Vox points out, he has announced substantial FDA moves to reduce cigarette consumption and is committed to improving competition in generic drugs.

However, he gave a recent speech at the National Food Policy Conference  on “Reducing the Burden of Chronic Disease” which indicates he is misinformed on crucial aspects of nutritional science.

Gottlieb indicated he wanted the FDA to play a bigger role in guiding Americans to eat a healthier diet to reduce the burden of chronic disease.

To facilitate this he is looking to define what foods are “healthy”:

We’re keeping all these considerations in mind as we pursue rulemaking to update the definition of “healthy” so it’s based on nutrition criteria and food considerations that are more up-to-date than those being used for the current definition….

Once updating the definition, Gottlieb wants to label food as “healthy” In a way that makes it easier for consumers to understand:

To address this, we’ve had discussions about whether there should be a standard icon or symbol for the word “healthy” that everyone could use on food packages.

Gottlieb goes on to bemoan a focus on nutrients rather than foods but in the very  next sentence recommends a food, dairy, in a form that has one important nutrient stripped from it-fat.

Traditionally, we’ve focused primarily on the nutrients contained in food in considering what is healthy. But people eat foods, not nutrients.

This is why we’re asking the important question of whether a modernized definition of “healthy” should go beyond nutrients to better reflect dietary patterns and food groups, like whole grains, low fat dairy, fruits and vegetables and healthy oils?

Obviously, the first step in getting Americans to eat healthier is to make sure you are doling out the correct advise and in his speech Dr. Gottlieb indicates he has bought into  long-standing fundamental errors. I wrote him the following letter hoping to correct these errors.


Dear Dr. Gottlieb,

Congratulations on your recent appointment as FDA director and kudos for your fine work to date. I read your recent comments on developing an updated definition of “healthy” and the importance of  conveying that information to American consumers  I applaud your efforts in this area as well as your ongoing efforts to limit cigarette smoking and improve generic competition.

I am fine with guiding consumers to healthy foods but I beg of you, let this determination of what is healthy be guided by the actual science, not prior dogma.

In your recent speech you indicate that Americans are not consuming enough dairy and you recommend low-fat dairy which implies that you and the FDA believe that scientific studies have demonstrated that dairy fat is unhealthy.

Five years ago I, too , thought dairy fat was unhealthy and recommended my patients avoid butter, full-fat yogurt and cheese. However, when challenged on this belief, I reviewed the scientific literature on dairy fat and cardiovascular disease.

It turns out when objectively analyzed (as I have written about here and here ) there is no scientific evidence that supports the concept that dairy processed to remove dairy fat is healthier than the original unadulterated product.

In fact, evidence suggests full fat dairy reduces central obesity, diabetes, cardiovascular disease and atherosclerosis in general.

As a result of misguided recommendations to avoid dairy fat, it is virtually impossible in most grocery stores to find full fat yogurt or milk. The vast majority of the dairy aisle is devoted to various low or non fat concoctions which have had loads of sugar and chemicals added and are arguably worse than a Snickers bar.

Dr. Gottlieb ,I am not cherry-picking the data here or relying on out of date studies. I’ve reviewed everything I can find on this issue and reviewed it without bias. Evidence continues to accumulate supporting the healthiness of full fat dairy.

For example, here’s a 2018 review from researchers totally unaffiliated with the dairy industry which asks the question “Dairy Fats and Cardiovascular Disease: Do We Really Need to Be Concerned?”

After a exhaustive review they conclude the answer is no.

recent research and meta-analyses have demonstrated the benefits of full-fat dairy consumption, based on higher bioavailability of high-value nutrients and anti-inflammatory properties. … In general, evidence suggests that milk has a neutral effect on cardiovascular outcomes but fermented dairy products, such as yoghurt, kefir and cheese may have a positive or neutral effect.

Flawed Reasons for Low Fat Dairy Recommendations

As I have written previously, I believe there are three reasons for the failure of major nutritional recommendations such as the 2015  Dietary Guidelines For Americans  to correct previously  flawed advice to choose  non or low-fat dairy over full fat:

1. In  few randomized dietary studies showing benefits of a particular diet over another, non fat or low fat dairy was recommended along with a portfolio of other healthy dietary changes.

The overall benefit of the superior diet had nothing to do with lowering the dairy fat but was due to multiple other changes.

2. The dairy industry has no motivation to promote full fat dairy. In fact, they do better financially when they can take the fat out of milk and sell it for other purposes such as butter, cheese, and cream. (Please read my interview with a plastic surgeon dairy farmer on the skim milk scam here.)

3. Saturated fat is still mistakenly being treated as a monolithic nutritional element.  Although dairy fat is mostly saturated, the individual saturated fats vary widely in their effects on atherogenic lipids and atherosclerosis. In addition, the nature of the saturated fat changes depending on the diet of the cow.

4. Since authorities have been making this low fat dairy recommendation for so long they are extremely reluctant to reverse their advice. It lowers their credibility.

There Is No Scientific Consensus On What Constitutes A Healthy Oil

Finallly, Dr. Gottlieb, I would like to briefly point out that there is considerable ongoing scientific debate about what constitutes a “healthy oil.”

I summarized this last year on a post on coconut oil (which I fear you will also pronounce “unhealthy”).

In many respects, the vilification of coconut oil by federal dietary guidelines and the AHA resembles the inappropriate attack on dairy fat and is emblematic of the whole misguided war on dietary fat. In fact, the new AHA advisory  after singling out coconut oil goes on to cherry-pick the data on dairy fat and cardiovascular disease in order to  support their faulty recommendations for choosing low or nonfat dairy.

Canola and corn oil, the products of extensive factory processing techniques, contain mostly mono or polyunsaturated fats which have been deemed “heart-healthy” on the flimsiest of evidence.

The most recent data we have on replacing saturated fat in the diet with polyunsaturated fat comes from the Minnesota Coronary Experiment performed from 1968 to 1973, but published in 2016 in the BMJ.

Data from this study, which substituted liquid corn oil in place of the usual hospital cooking fats, replaced corn oil margarine for butter and added corn oil to numerous food items, showed no overall benefit in reducing mortality. In fact, individuals over age 65 were more likely to die from cardiovascular disease if they got the corn oil diet.

So, Dr. Gottlieb, please continue your efforts to make Americans healthier but make sure the current scientific evidence actually supports your recommendations. Keep in mind, the disastrous public health experiments of previous decades.


Skeptically Yours,

-ACP

N.B. Some of my posts on dairy fat are below.

Dairy Fat Makes You Thinner

The Skim Milk Scam

More Evidence That Diary Fat is associated with a lower risk of heart disease

What happens to cholesterol levels when you switch to low or non fat dairy?

Dietary Guidelines 2015: Why Lift Fat and cholesterol limits but still promote low fat dairy?

In defense of real cheese.


h/t to the always excellent Conscien Health for bringing Gottlieb’s speech to my attention.


Credit for the featured image of dairy cows from the wonderful Trader’s Point Creamery

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

Still More Evidence That Fish Oil Supplements Do Not Prevent Cardiovascular Disease

Avid readers of the skeptical cardiologist know that he is not an advocate of fish oil supplements.

One of my first posts (1/2013) was devoted to taking down the mammoth OTC fish oil industry because recent scientific evidence was clearly showing no benefit for fish oil pills.

I concluded:

", the bottom line on fish oil supplements is that  the most 
recent scientific evidence does not support any role for them  inpreventing heart attack, stroke, or death. There are potential 
down sides to taking them, including contaminants and the impact on the marine ecosystem. I don’t take them and I advise my
patients to avoid them (unless they have triglyceride levels 
over 500.)"

Despite a lack of evidence supporting taking them, the fish oil business continues to grow,  buttressed by multiple internet sites promoting various types of fish oil (and more recently krill oil)  for any and all ailments and a belief in the power of “omega-3 fatty acids”.

Another Meta-Analysis Concludes No Benefit To Fish Oil Supplements

A publication this month evaluated the 10 randomized controlled trials involving 77 917 thousand individuals that have studied fish oil supplements in preventing heart disease. The writers concluded that fish oil supplements do not significantly prevent any cardiovascular outcomes under any scenario.

It was written by a group with the ominous title of “The Omega-3 Treatment Trialists’ Collaboration.”

The Omega-3 Treatment Trialists’ Collaboration was established to conduct a collaborative meta-analysis based on aggregated study-level data obtained from the principal investigators of all large randomized clinical trials of omega-3 FA supplements for the prevention of cardiovascular disease, using a prespecified protocol and analysis plan. The aims of this meta-analysis were to assess the associations of supplementation with omega-3 FAs on (1) fatal CHD, nonfatal MI, stroke, major vascular events, and all-cause mortality and (2) major vascular events in prespecified subgroups.

The authors conclusions:

. Randomization to omega-3 fatty acid supplementation (eicosapentaenoic acid dose range, 226-1800 mg/d) had no significant associations with coronary heart disease death (rate ratio [RR], 0.93; 99% CI, 0.83-1.03; P = .05), nonfatal myocardial infarction (RR, 0.97; 99% CI, 0.87-1.08; P = .43) or any coronary heart disease events (RR, 0.96; 95% CI, 0.90-1.01; P = .12). Neither did randomization to omega-3 fatty acid supplementation have any significant associations with major vascular events (RR, 0.97; 95% CI, 0.93-1.01; P = .10), overall or in any subgroups, including subgroups composed of persons with prior coronary heart disease, diabetes, lipid levels greater than a given cutoff level, or statin use.

Nothing. Nada. No benefit.

There is clearly no reason to take fish oil supplements to prevent cardiovascular disease!

American Heart Association Sheepishly Recommends Fish Oil Supplements

If the science was conclusive on this in 2013 why did the American Heart Association (AHA) issue an “advisory” in 2017  suggesting that the use of omega-3 FAs for prevention of coronary heart disease (CHD) is probably justified in individuals with prior CHD and those with heart failure and reduced ejection fractions?

The AHA advisory is clearly misguided and relies heavily in its discussion on a 2012 meta-analysis from Rizos, et al. published in 2012.

Oddly, this is the study that prompted me to write my first fish oil post in 2013

The AHA advisory totally distorts the completely negative conclusions of the Rizos meta-analysis, writing:

A meta-analysis published in 2012 examined the effects of omega-3 PUFA supplementation and dietary intake in 20 RCTs that enrolled patients at high CVD risk or prevalent CHD and patients with an implantable cardioverter-defibrillator (total n=68 680). That meta-analysis demonstrated a reduction in CHD death (RR, 0.91; 95% CI, 0.85–0.98), possibly as the result of a lower risk of SCD (RR, 0.87; 95% CI, 0.75–1.01).11

Strangely enough, if you look at the conclusions of Rizos, et al. they are

No statistically significant association was observed with all-cause mortality (RR, 0.96; 95% CI, 0.91 to 1.02; risk reduction [RD] -0.004, 95% CI, -0.01 to 0.02), cardiac death (RR, 0.91; 95% CI, 0.85 to 0.98; RD, -0.01; 95% CI, -0.02 to 0.00), sudden death (RR, 0.87; 95% CI, 0.75 to 1.01; RD, -0.003; 95% CI, -0.012 to 0.006), myocardial infarction (RR, 0.89; 95% CI, 0.76 to 1.04; RD, -0.002; 95% CI, -0.007 to 0.002), and stroke (RR, 1.05; 95% CI, 0.93 to 1.18; RD, 0.001; 95% CI, -0.002 to 0.004) when all supplement studies were considered.

Nothing. Nada. No significant benefit!

The AHA was so confused by their own advisory that in the AHA news release on the article they quote Dr. Robert Eckel, a past AHA president as saying he remains “underwhelmed” by the current clinical trials.

“In the present environment of evidence-based risk reduction, I don’t think the data really indicate that fish oil supplementation is needed under most  circumstances.”

The end of the AHA news article goes on to quote Eckel as indicating he doesn’t prescribe fish oil supplements and the science advisory won’t change his practice:

Eckel said he doesn’t prescribe fish oil supplements to people who have had coronary events, and the new science advisory won’t change that. “It’s reasonable, but reasonable isn’t a solid take-home message that you should do it,” he said.

AHA: Wrong On Coconut Oil and Fish Oil

It’s hard for me to understand why the AHA gets so many things wrong in their scientific advisories. In the case of the recent misguided attack on coconut oil , their ongoing vilification of all saturated fats, and their support for fish oil supplements I don’t see evidence for industry influence. The authors of the fish oil supplement advisory do not report any financial conflicts of interest.

There is, however, one bias that is very hard to measure which could be playing a role: that is the bias to agree with what one has previously recommended.  The AHA issued an advisory in 2002 recommending that people take fish oil. Changing that recommendation would mean admitting that they were wrong and that they had contributed to the growth of a 12 billion dollar industry serving no purpose.

Personally, I am aware of this kind of bias in my own writing and strive to be open to new data and publications that challenge what I personally believe or have publicly recommended.

In the case of fish oil supplements for preventing cardiovascular disease, however, the most recent data supports strongly what I wrote in 2013:

Don’t take fish oil supplements to prevent heart disease.

Americans want a “magic-bullet” type pill to take to ward off aging and the diseases associated with it. There isn’t one. Instead of buying pills and foods manipulated and processed by the food industry which promise better health, eat real food (including fish) eat a lot of plants and don’t eat too much.

Piscinely Yours,

-ACP

N.B. I have no patients on the two prescription fish oil supplements available, Lovaza and Vascepa. I wrote about Vascepa here

Below is an excerpt:

Like the first prescription fish oil available in the US, Lovaza, VASCEPA is only approved by the FDA for treatment of very high triglycerides (>500 mg/dl).

This is a very small market compared to the millions of individuals taking fish oil thinking that  it is preventing heart disease.

The company that makes Vascepa (Amrin;$AMRN)would also like to have physicians prescribe it to their patients who have mildly or moderatelyelevated triglycerides between 200 and 500 which some estimate as up to 1/3 of the population.

The company has a study that shows that Vascepa lowers triglycerides in patients with such mildly to moderately elevated triglycerides but the FDA did not approve it for that indication.

Given the huge numbers of patients with trigs slightly above normal, before approving an expensive new drug, the FDA thought, it would be nice to know that the drug is actually helping prevent heart attacks and strokes or prolonging life.

After all, we don’t really care about high triglycerides unless they are causing problems and we don’t care about lowering them unless we can show we are reducing the frequency of those problems.

Data do not exist to say that lowering triglycerides in the mild to moderate range  by any drug lowers heart attack risk.

In the past if a company promoted their drug for off-label usage they could be fined by the FDA but Amarin went to court and obtained the right to promote Vascepa to physicians for triglycerides between 200 and 500.

Consequently, you may find your doctor prescribing this drug to you. If you do, I suggest you ask him if he recently had a free lunch or dinner provided by Amarin, has stock in the company (Vascepa is the sole drug made by Amrin and its stock price fluctuates wildly depending on sales and news about Vascepa) or gives talks for Amarin.

If he answers no to all of the above then, hopefully, your triglycerides are over 500.

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