Who Deserves To Be A Wikipedia Article?: The Deletion of Dr. Malcolm Kendrick

Scottish primary care physician and author of The Great Cholesterol Con Dr. Macolm Kendrick began his blog post yesterday with these words:

I thought I should tell you that I am about to be deleted from Wikipedia. Someone sent me a message to this effect. It seems that someone from Manchester entitled User:Skeptic from Britain has decided that I am a quack and my presence should be removed from the historical record.

Although I don’t agree with Kendrick’s statin denialism I do find him an informative, entertaining and different voice in the field of atherogenesis and it didn’t seem right that he should be deleted from Wikipedia.

Apparently, articles on Wikipedia can be proposed for deletion and at Wikipedia: Articles for deletion/Malcolm Kendrick there is an ongoing battle between the forces fighting for deletion of kendrick those fighting for maintenance of his Wikipedia entry.

This wikipedia comment is what initiated the deletion proposition:

Malcolm Kendrick is a fringe figure who agues(sic) against the lipid hypothesis. He denies that blood cholesterol levels are responsible for heart disease and in opposition to the medical community advocates a high-fat high-cholesterol diet as healthy. Problem is there is a lack of reliable sources that discuss his ideas. His book The Great Cholesterol Con was not reviewed in any science journals. Kendrick is involved with the International Network of Cholesterol Skeptics, I suggest deleting his article and redirecting his name to that. Skeptic from Britain (talk) 20:29, 2 December 2018 (UTC)

I have no idea what are valid criteria are for a human becoming an article on Wikipedia (in fact I’ve often thought that I should have an article) but none of the “Skeptic from Britain’s” arguments would sway me to delete Kendrick’s article.

Wikipedically Yours,

-ACP

The Marvelous Marion Nestle’ and Her Food Politics: From A2 Milk to Helpful Hops

The skeptical cardiologist follows a few blogs/websites regularly because they provide consistently good commentary or reporting on topics I’m focused on.

Prominent among these is http://www.foodpolitics.com which Marion Nestle’* writes.

Almost every post that she creates provides me with unique and fascinating information or understanding about food and the food industry.

Let me take a few recent examples.

Farmer’s Share of Thanksgiving Dinner.

On Thankgiving Nestle’ highlighted this report from the National Farmer’s Union which revealed that farmer’s get only 11 cents from the typical American family’s Thanksgiving dinner. It’s a particularly low portion of the overall money spent on the turkey that goes to farmers because:

“The major integrators who control the poultry markets have used their extreme bargaining power to suppress the earnings of the men and women who raise our chickens and turkeys while simultaneously taking in record profits for themselves,” Johnson said. “While poultry growers take all the risk of production, they are receiving just 5 to 6 cents per pound for turkeys and chickens. The integrators take those same turkeys and chickens, process them, and then mark up the retail value nearly tenfold.”

Capture-78-500x648

A2 Milk: Healthier?

Nestle’ has written extensively about the pervasive influence of the food industry on nutritional research in her books including her recently published Unsavory Truth: How Food Companies Skew the Science of What We Eat.

She has long been at the forefront in pointing out that industry-sponsored research is highly likely to be favorable to the product the industry sells.

A2 milk, which has taken over a large share of the Australia and New Zealand dairy market based on shaky scientific studies which suggest it is healthier than the standard A1 milk is now being promoted in the US.

A recent Nestle’ post points out that

 claims for A2 milk’s better digestibility were based entirely on studies paid for by—surprise!—the manufacturer (as I explain in my latest book, Unsavory Truth: How Food Companies Skew the Science of What We Eatfood industry funding of nutrition research produces highly predictable results and, therefore, is not good for science, public health, or trust)

Stripping the Healthy Polyphenols From Corn

Nestle’ wrote recently of a study sponsored by Kellogg’s which demonstrated what happens to the healthy phytosterols in corn when it is processed:

In FoodNavigator, I read a report of a study finding that processing of corn into breakfast cereal flakes strips out phenolic compounds and tocopherols (vitamin E) associated with good health.

Just as processing of whole wheat into white flour removes the bran and germ, so does the processing of corn into corn flakes.

The germ and bran (hull) layers of grain seeds contain the vitamins and minerals—and the phenolics.  What’s left is the starch and protein (endosperm).

To replace these losses, manufacturers fortify corn flakes with 10% to 25% of the Daily Value for 12 vitamins and minerals.

This study is further evidence for the benefits of consuming relatively unprocessed foods.

Of particular interest to me is the authors’ disclosure statement:

This work was funded in part through gifts from the Kellogg Company and Dow AgroSciences.

The authors declare no competing financial interest.

This makes this study a highly unusual example of an industry-funded study with a result unfavorable to the sponsor’s interests.  The authors do not perceive Kellogg funding as a competing interest.  It is.  Kellogg (and maybe Dow) had a vested interest in the outcome of this study.

Beer Hops and Alzheimer’s

One of Nestle’s posts caught my eye as she mentioned a Japanese study**  which showed that beer hops help mice with Alzheimer’s.

If the findings hold true in humans we should all be chugging hoppy  IPAs with really high IBUs as the paper concluded:

The present study is the first to report that amyloid β deposition and inflammation are suppressed in a mouse model of Alzheimer’s disease by a single component, iso-α-acids, via the regulation of microglial activation. The suppression of neuroinflammation and improvement in cognitive function suggests that iso-α-acids contained in beer may be useful for the prevention of dementia.

Sadly, we must take this paper with a grain of malt, as the lead author works at “Research Laboratories for Health Science & Food Technologies, Kirin Company Ltd.” Kirin being a prominent Japanese brewery.

Nestle’s posts are short, well-referenced and consistently high quality.

I’m going to update my “blogroll” (something I’ve failed to do for several years) with Food Politics and I highly recommend signing up for email delivery of her posts if you are interested in food, nutrition and the interaction between the food industry and nutritional science.

Lupulusly Yours,

-ACP

N.B.

*Marion Nestle is Paulette Goddard Professor of nutrition, food studies, and public health, emerita, at New York University, and Visiting Professor of nutritional sciences at Cornell. She has a PhD in molecular biology and an MPH in public health nutrition from UC Berkeley. She lives in New York City.

**Nestle’s post actually references a different Kirin sponsored study in mice (Matured Hop-Derived Bitter Components in Beer Improve Hippocampus-Dependent Memory Through Activation of the Vagus Nerve) than the one I reference above which was truly related to Alzheimer’s.

 

Skeptical Cardiologist Lowers His Cardiovascular Risk By Marrying The Eternal Fiancee’

The skeptical cardiologist shed his skepticism about marriage today and tied the knot with his Eternal Fiancee’.

This decision was not based on the findings of a recent meta-analysis of 34 studies with more than two million participants that found that that compared with married people, those who were unmarried  ( never married, widowed or divorced)  were 42 percent more likely to have some form of cardiovascular disease and 16 percent more likely to have coronary heart disease.

No, I was not influenced by these observational data which show a 43% increase risk of coronary heart disease death and a 55% increased risk of death from stroke.

Headlines like this from Time magazine:

How Marriage Can Actually Protect Your Heart Health

had no bearing on my decision.

This skeptical cardiologist found the perfect woman for his skeptical ways,

And observations that unmarried patients have longer delays in seeking medical help which influences the timing and benefit of invasive cardiac procedures that reduce mortality played no role in this decision.

Neither did the prospect that a spouse would encourage a more healthy lifestyle and better adherence to treatment nor the buffering hypothesis which suggests that informational or emotional resources from a spouse promote adaptive behaviour and may reduce excessive neuroendocrine response to acute or chronic stressor.

Nope. It was pure and unadulterated love.

Blissfully Yours,

-ACP

Becoming Enlightened About More Stringent Blood Pressure Goals: Sapere Aude!

The skeptical cardiologist and many of his patients with hypertension have a decision to make: what should our BP goal be?

Given that we have data now on over 1 million patients one might think that the answer would be clear and that there would be a consensus amongst all the experts.

Messerli and Bangalore, writing in a recent special hypertension issue of JACC, however, clearly articulate the “blood pressure landscape schism” that currently exists.

This figure from their paper (subtitled “Schism Among Guidelines, Confusion Among Physicians, and Anxiety Among Patients”) shows the marked difference in BP goal and treatment recommendations for the same patient in recent American and  European Cardiology and American Family Practice Guidelines.

The 2017 American College of Cardiology (ACC)/American Heart Association (AHA) guidelines—which aide approximately 25,000 cardiologists in the United States—indicate that her BP should be <130/80 mm Hg (1). The 2018 European Society of Hypertension (ESH)/European Society of Cardiology (ESC) guidelines—which aide approximately 75,000 physicians—indicate that her BP should be <140/90 mm Hg (2). The 2017 American College of Physicians (ACP)/American Association of Family Physicians (AAFP) guidelines—which aide approximately 250,000 family practitioners and internists in the United States—indicate that her BP should be <150/90 mm Hg

 

 

 

 

 

 

 

 

 

 

 

Messerli and Bangalore use a second figure to graphically illustrate the potential consequences of the differing guidelines.

Stroke Mortality for Upper Limit of On-Treatment Systolic Target BP as per Various Guidelines Absolute risk of stroke mortality is 5% for the suggested on-treatment target BP of the ACC/AHA guidelines, 8% for target BP of the ESH/ESC guidelines, and 14% for target BP of the ACP/AAFP guidelines. Abbreviations as in

Cardiovascular death rates thus may vary three-fold depending on what BP goal we choose.

This marked variation in treatment recommendation highlights that they

are not only an evaluation and interpretation of evidence in question, but also a judgment weighted by personal, regulatory, and organizational preferences that can vary from physician to physician within a country and across geographical regions.

Physicians and patients (hopefully through shared decision making) are going to have to do some thinking on their own.

Messerli and Bangalore quote Immanuel Kant in this regard:

Enlightenment is man’s emergence from his self-imposed nonage. Nonage is the inability to use one’s own understanding without another’s guidance. This nonage is self-imposed if its cause lies not in lack of understanding but in indecision and lack of courage to use one’s own mind without another’s guidance. Dare to know! (Sapere aude.) “Have the courage to use your own understanding,” is therefore the motto of the enlightenment.

As a 64 year old who has emerged from his nonage with hypertension, I have carefully examined the latest American hypertension guidelines especially in light of the SPRINT study and elected to add a third anti-hypertensive agent to get my average BP below 130/80. It’s worked for me with minimal  side effects but I carefully monitor my BP.

If I notice any symptoms (light-headed, fatigued) suggesting hypotension associated with systolic BP <120 mm Hg I tweak my medical regimen to allow a higher BP.

Like all of my patients I would prefer to be on less medications, not more but when it comes to enlightenment about the effects of hypertension, it is now clear that lower is better for most of us in our sixties down to at least 130/80*.

Sapere Audaciously Yours,

-ACP

*N.B. In the SPRINT study the BP was obtained using an automatic BP cuff after 5 minutes of rest with the patient unobserved and averaging 3 recordings one minute apart.

This “research grade BP” averages about 12 mm Hg less than a routine single clinic obtained BP (see here.)

The BP Schism

What Can You Really Learn From Celebrity Bob Harper’s Heart Attack And Near Sudden Death?

Until recently I had never heard of Bob Harper (The Biggest Loser) but apparently he is a celebrity personal trainer and had a heart attack and nearly died.  He  is known “for his contagious energy, ruthless training tactics, and ability to transform contestants’ bodies on The Biggest Loser” (a show I’ve never seen.)

When celebrities die suddenly (see Garry Sanders, Carrie Fischer) or have a heart attack at a youngish age despite an apparent healthy lifestyle this get’s people’s attention.

The media typically pounce on the story which combines the seductive allure of both health and celebrity reporting.

It turns out Harper inherited a high Lipoprotein (a) (see here) which put him at high risk for coronary atherosclerosis (CAD) which ultimately caused the heart attack (MI)  that caused his cardiac arrest.

To his credit, Harper has talked about Lipoprotein (a) and made the public and physicians more aware of this risk factor which does not show up in standard cholesterol testing.

Since his heart attack, Mr. Harper of “The Biggest Loser” has embarked on a newfound mission to raise awareness about heart disease and to urge people to get tested for lp(a).

Harper As Brilinta Shill

Unfortunately , he has also become a shill for Brilinta, an expensive brand name anti platelet drug often prescribed in patients after heart attacks or stents.

At the end of the TV commercial he says “If you’ve had a heart attack ask your doctor if Brilinta is right for you. My heart is worth Brilinta.”

At least this video is clearly an advertisement but patients and physicians are inundated  by infomercials for expensive, profit-driving drugs like Brilinta.

This Healthline article pretends to be a legitimate piece of journalism but is a stealth ad for Brilinta combined with lots of real ads for Brilinta.

Harper As Lifestyle Coach.

Harper also changed his fitness and diet regimens after his MI reasoning that something must have been wrong with his lifestyle and it needed modification.  For the most part he talks about more “balance” in his life which is good advice for everyone. His fitness regimens pre-MI were incredibly intense and have been toned down subsequently.

After his heart attack, Bob abandoned the Paleo lifestyle for the Mediterranean diet, as it’s been proven to improve heart health and reduce the risk of a heart attack, stroke, and heart-disease-related death by about 30 percent. But recently, he’s moved closer to a vegetarian regimen.

Of course, vegans and vegetarians have seized on this change in his diet as somehow proving the superiority of their chosen diets as in this vegan propaganda video:

Unfortunately there is no evidence that changing to a vegan or vegetarian diet will lower his risk of repeat MI.  Those who promote the Esselstyn, Pritikin or Ornish type diets claim to “reverse heart disease” and to be science-based but, as I’ve pointed  out (see here) the science behind these studies is really bad.

In fact, we know that neither diet nor exercise influence lipoprotein(a) levels which Bob inherited.  Some individuals just inherit the risk and must learn to deal with the cardiovascular cards they’ve been dealt.

What Can We Really Learn From Bob Harper’s Experience?

  1. Lipoprotein (a) is a significant risk marker for early CAD/MI/sudden cardiac death. Consider having it measured if you have a a) strong family history of premature deaths/heart attack (b) if you have developed premature subclinical atherosclerosis (see here) or clinical atherosclerosis (heart attack, stroke, peripheral vascular disease) or (c) a family member has been diagnosed with it.
  2. Everyone should learn how to do CPR and how to utilize an AED. (see here for my rant on these two incredibly important 3-letter words). Harper was working out in the gym when he collapsed. Fortunately a nearby medical student had the wherewithal to do CPR on him until he could be defibrillated back to a normal rhythm and transported to a hospital to stop his MI.
  3. Dropping dead suddenly is often the first indicator that you have advanced CAD. If you have a strong family history of sudden death or early CAD consider getting a coronary artery calcium scan to better assess your risk.

Focus on celebrities with heart disease helps bring awareness to the public about important issues but we can only learn so much about best lifestyle or medications from the experience of one individual, no matter how famous.

Brilliantly Yours,

-ACP

Has REDUCE-IT Resurrected Fish OIl Supplements (And Saved Amarin)?

The answers are no and yes.

There is still no reason to take over the counter fish oil supplements.

In fact, a study published Saturday found that fish oil supplementation (1 g per day as a fish-oil capsule containing 840 mg of n−3 fatty acids, including 460 mg of eicosapentaenoic acid [EPA] and 380 mg of docosahexaenoic acid [DHA]

did not result in a lower incidence than placebo of the primary end points of major cardiovascular events (a composite of myocardial infarction, stroke, or death from cardiovascular causes) and invasive cancer of any type.

However, another study  published Saturday (REDUCE-IT) and presented at the annual American Heart Association Scientific Sessions to great fanfare found that an ethyl-ester formulation (icosapent ethyl) of eicosapentanoic acid (EPA, one of the two main marine n-3 fish oils)  reduced major cardiovascular events by 25% in comparison to placebo.

When I wrote about Icosapent ethyl (brand name Vascepa) in a previous blog post in 2015 there was no data supporting its use:

A fish oil preparation, VASCEPA,  available only by prescription, was approved by the FDA in 2012.

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 Amarin 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.

And although elevated triglycerides confer an elevated CV risk nearly all prior trials evaluating different kinds  of triglyceride-lowering therapies, including extended-release niacin, fibrates, cholesteryl ester transfer protein inhibitors, and omega-3 fatty acids have failed to show reductions in cardiovascular events

REDUCE-IT, Amarin trumpeted widely in September (before the actual data was published)  now provides impressive proof that it prevents cardiovascular disease. Has the skeptical cardiologist changed his mind about fish oil?

Vascepa Is Not Natural Fish Oil

Although Amarin’s marking material states “VASCEPA is obtained naturally from wild deep-water Pacific Ocean fish” the active ingredient is an ethyl ester form of eicosapentoic acid (EPA) which has been industrially processed and distilled and separated out from the other main omega-3 fatty acid in fish oil (DHA or docosohexanoieic acid).

Natural fish oil contains a balance of EPA and DHA combined with triacylglycerols (TAGS).

So even if the REDUCE-IT trial results can be believed they do not support the routine consumption of  over the counter fish oil supplements for prevention of cardiovascular disease.

Does REDUCE-IT  Prove The Benefit of Purified High Dose EPA?

REDUCE-IT was a large (8179 patients) randomized, double-blind placebo controlled trial

Eligible patients had a fasting triglyceride level of 150 to 499 mg per deciliter  and a low-density lipoprotein (LDL) cholesterol level of 41 to 100 mg per deciliter  and had been receiving a stable dose of a statin for at least 4 weeks. In 2013 the protocol was changed and required a triglyceride level>200 mg/dl.

Participants were randomized to icosapent ethyl (2 g twice daily with food [total daily dose, 4 g]) or a placebo that contained mineral oil to mimic the color and consistency of icosapent ethyl and were followed for a median of 4.9 years. A primary end-point event occurred in 17.2% of the patients in the icosapent ethyl group, as compared with 22.0% of the patients in the placebo group.

More importantly, the hard end-points of CV death, nonfatal stroke and heart attack were also significantly lower in the Vascepa arm compared to the “placebo” arm.

These results are almost unbelievably good and they are far better than one would have predicted given only a 17% reduction in triglycerides.

This makes me strongly consider prescribing Vascepa (something I heretofore have never done) to my higher risk patients with triglycerides over 200 after we’ve addressed lifestyle and dietary contributors.

Perhaps the high dose of EPA (4 grams versus the 1 gram utilized in most trials) is beneficial in stabilizing cell membranes, reducing inflammation and thrombotic events as experimental data has suggested.

Lingering Concerns About The Study

Despite these great results I have some concerns:

  1. The placebo contained mineral oil which may not have been neutral in its effects. In fact, the placebo arm had a significant rise in the LDL cholesterol.
  2. Enrolled patients were predominantly male and white. No benefit was seen in women.
  3. Higher rates of serious bleeding were noted in patients taking Vascepa
  4. Atrial fibrillation developed significantly more often in Vascepa patients (3.1%) versus the mineral oil patients (2.1%)

Finally, the trial was sponsored by Amarin Pharma. This is an aggressive company that I don’t trust.  The steering committee consisted of academic physicians (see the Supplementary Appendix), and representatives of the sponsor developed the protocol,  and were responsible for the conduct and oversight of the study, as well as the interpretation of the data. The sponsor was responsible for the collection and management of the data. All the data analyses were performed by the sponsor,

After i wrote my negative piece on Vascepa in 2015 a number of Amarin investors attacked me because Vascepa is the only product Amarin has and any news on the drug dramatically influences its stock price. Here is the price of Amarin stock in the last year.

The dramatic uptick in September corresponds to the company’s announcement of the topline results of REDUCE-IT. Since the actual results have been published and analyzed the stock has dropped 20%.

High Dose Purified and Esterified EPA-Yay or Nay?

I would love to see another trial of high dose EPA that wasn’t totally under the control of Amarin and such trials are in the pipeline.

Until then, I’ll consider prescribing Amarin’s pills to appropriate patients* who can afford it and who appear to have significant residual risk after statin therapy*.

But, I will continue to tell my patients to stop paying money for useless OTC fish oil supplements.

Megaskeptically Yours,-

ACP

N.B.* Appropriate patients will fit the entry criteria for REDUCE-IT described below.

Patients could be enrolled if they were 45 years of age or older and had established cardiovascular disease or were 50 years of age or older and had diabetes mellitus and at least one additional risk factor. Eligible patients had a fasting triglyceride level of 150 to 499 mg per deciliter (1.69 to 5.63 mmol per liter) and a low-density lipoprotein (LDL) cholesterol level of 41 to 100 mg per deciliter (1.06 to 2.59 mmol per liter) and had been receiving a stable dose of a statin for at least 4 weeks;

So either secondary prevention (prior heart attack or stroke) or primary prevention in patients with diabetes and another risk factor.

 

 

Coronary Artery Calcium Scan Embraced By New AHA/ACC Cholesterol Guidelines: Will Insurance Coverage Follow?

The skeptical cardiologist has been utilizing coronary artery calcium (CAC) scans to help decide which patients are at high risk for heart attacks, and sudden cardiac death for the last decade. As I first described in 2014, (see here) those with higher than expected calcium scores warrant more aggressive treatment and those with lower scores less aggrressive treatment.

Although , as I have discussed previously, CAC is not the “mammography of the heart” it is incredibly helpful in sorting out personalized cardiovascular risk. We use standard risk factors like lipids, smoking, age, gender and diabetes to stratify individuals according to their 10 year risk of atherosclerotic cardiovascular disease (ASCVD) but many apparent low risk individuals (often due to inherited familial risk) drop dead from ASCVD and many apparent high risk individuals don’t need statin therapy.

Previously, major guidelines from organizations like the AHA and the ACC did not recommend CAC testing to guide decision-making in this area. Consequently, CMS and major insurers have not covered CAC testing. When my patients get a CAC scan they pay 125$ out of their pocket.. For the affluent and pro-active this is not an obstacle, however those struggling financially often balk at the cost.

I was, therefore, very pleased to read that the newly updated AHA/ACC lipid guidelines (full PDF available here) emphasize the use of CAC for decision-making in intermediate risk patients.

 

 

 

 

 

 

 

 

For those patients aged 40-75 without known ASCVD whose 10 year risk of stroke and heart attack is between 7.5% and 20% (intermediate, see here on using risk estimator) the guidelines recommend “consider measuring CAC”.

If the score is zero, for most consider no statin. If score >100 and/or >75th percentile, statin therapy should be started.

I don’t agree totally with this use of CAC but it is a step forward. For example, how I approach a patient with CAC of 1-99 depends very much on what percentile the patient is at. A score of 10 in a 40 year old indicates marked premature build up of atherosclerotic plaque but in a 70 year old man it indicates they are at much lower risk than predicted by standard risk factors. The first individual we would likely recommend statin therapy and very aggressive lifestyle changes whereas the second man we could discuss  taking off statins.

Neil Stone, MD, one of the authors of the guidelines was quoted  as saying that the imaging technique is “the best tiebreaker we have now” when the risk-benefit balance is uncertain.

“Most should get a statin, but there are people who say, ‘I’ve got to know more, I want to personalize this decision to the point of knowing whether I really, really need it.’ … There are a number of people who want to be certain about where they stand on the risk continuum and that’s how we want to use it,”

Indeed, I’ve written quite a bit about my approach to helping patients “get off the fence” on whether or not to take a statin drug.

I recommend reading “Are you on the fence about taking a statin drug” to understand the details of using CAC in decision-making and the follow up post on a compromise approach to reducing ASCVD risk.

Deriskingly Yours,

-ACP

Full title of these new guidelines includes an alphabet soup of organization acronyms

2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol

N.B. For your reading pleasure I’ve copied the section in the new guidelines that discusses in detail coronary artery calcium.

Two interesting sentences which I’ll need to discuss some other time

-When the CAC score is zero, some investigators favor remeasurement of CAC after 5 to 10 years

CAC scans should be ordered by a clinician who is fully versed in the pros and cons of diagnostic radiology.

In MESA (Multi-Ethnic Study of Atherosclerosis), CAC scanning delivered 0.74 to l.27 mSv of radiation, which is similar to the dose of a clinical mammogram 

-4.4.1.4. Coronary Artery Calcium

Substantial advances in estimation of risk with CAC scoring have been made in the past 5 years. One purpose of CAC scoring is to reclassify risk identification of patients who will potentially benefit from statin therapy. This is especially useful when the clinician and patient are uncertain whether to start a statin. Indeed, the most important recent observation has been the finding that a CAC score of zero indicates a low ASCVD risk for the subsequent 10 years (S4.4.1.4-1–S4.4.1.4-8). Thus, measurement of CAC potentially allows a clinician to withhold statin therapy in patients showing zero CAC. There are exceptions. For example, CAC scores of zero in persistent cigarette smokers, patients with diabetes mellitus, those with a strong family history of ASCVD, and possibly chronic inflammatory conditions such as HIV, may still be associated with substantial 10-year risk (S4.4.1.4-9–S4.4.1.4-12). Nevertheless, a sizable portion of middle-aged and older patients have zero CAC, which may allow withholding of statin therapy in those intermediate risk patients who would otherwise have a high enough risk according to the PCE to receive statin therapy (Figure 2). Most patients with CAC scores ≥100 Agatston units have a 10-year risk of ASCVD≥7.5%, a widely accepted threshold for initiation of statin therapy (S4.4.1.4-13). With increasing age, 10- year risk accompanying CAC scores of 1 to 99 rises, usually crossing the 7.5% threshold in later middle age (S4.4.1.4-13). When the CAC score is zero, some investigators favor remeasurement of CAC after 5 to 10 years (S4.4.1.4-14–S4.4.1.4-16). CAC measurement has no utility in patients already treated with statins. Statins are associated with slower progression of overall coronary atherosclerosis volume and reduction of high-risk plaque features, yet statins increase the CAC score (S4.4.1.4-17). A prospective randomized study of CAC scoring showed improved risk factor modification without an increase in downstream medical testing or cost (S4.4.1.4-18). In MESA (Multi-Ethnic Study of Atherosclerosis), CAC scanning delivered 0.74 to l.27 mSv of radiation, which is similar to the dose of a clinical mammogram (S4.4.1.4- 19). CAC scans should be ordered by a clinician who is fully versed in the pros and cons of diagnostic radiology.

Downloaded from http://ahajournals.org by on November 11, 2018

from Grundy SM, et al.
2018 Cholesterol Clinical Practice Guidelines

The Painful EHR Transition

For the past 6 weeks I and the several hundred other ambulatory  physicians who belong to the St. Luke’s Medical Group have been going through a difficult transition; we’ve changed the software that we use to manage patient information.

Seven years ago we made the painful transition from paper patient charts to an electronic health record (EHR) called eClinical Works. This process required lots of scanning but by 2015 when i wrote “I Absolutely Love and Abhor My EMR” I had become very facile and comfortable with the software.

During this current transition to an EHR called Cerner,  we had to drastically reduce the number of patients seen per day in the office as we learned how to streamline workflow and as bugs were worked out of the system. We have struggled mightily with the simplest of tasks such as renewing patient prescriptions, scheduling tests, or reviewing test results. Stress levels for everyone, assistants to physicians, went through the roof as we spent hours clicking, refreshing, and re-entering data ion our frequently crashing computers.

My apologies to all the patients that had to be rescheduled during this process and to any who had to wait excessively for something as simple as a follow up appointment. The bugs aren’t completely out but we are making progress.

And my apologies to readers of the skeptical cardiologist as this EHR transition plus other work and social demands have left me no time to write.

Atul Gawande, a surgeon and excellent writer has written a great piece for the New Yorker entitled “The Upgrade: Why doctors hate their computers.” which nicely details why doctors have reached a point where they  “actively, viscerally, volubly hate their computers.”

Prior to our Cerner transition I was in a good relationship with my various Mac laptops but for the last 6 weeks interacting with the EHR has made me a stressed, anxious and borderline depressed physician.

I am only 6 weeks into the new EHR but Gawande, who has been using Epic* since 2015 writes that “I’ve come to feel that a system that promised to increase my mastery over my work has, instead, increased my work’s mastery over me.”

“A 2016 study found that physicians spent about two hours doing computer work for every hour spent face to face with a patient-whatever the brand of medical software. In the examination room, physicians devoted half of their patient time facing the screen to do electronic tasks. These tasks spill over after hours and the result has been epidemic levels of burnout among clinicians.”

The first 6 months of any EHR transition are by far the most difficult as all users gain proficiency with the workflow and as most patients are newly entering the system.  Hopefully, 6 months from now the computer will not be my master and I and my staff will not be burned out.

Skeptically Yours,

-ACP

*Epic is the most widely used EHR by ambulatory physicians. Gawande makes the claim that “more than half of Americans have their health information in the Epic system. ” This graph indicates Epic is definitely the market leader but seems to have less than 50% of patients.

 

On the other hand, this recent report indicates that ” Cerner leads the worldwide EHR market with Epic taking the second spot, Allscripts in third and GE Healthcare at fourth.”

 

 

AliveCor’s Mobile ECG With Kardia Pro Is Eliminating Any Need For Short or Long Term Cadiac Monitors For Most of My Afib patients: A Tale of Four Cardioversions

I described in detail in March (see here) my early experience in utilizing AliveCor’s KardiaMobile ECG  device in conjunction with their Kardia Pro cloud service to monitor my patient’s with atrial fibrillation (afib). Since that post the majority of my new afib patients have acquired the Kardia device and use it regularly to help us monitor their afib.

This capability has revolutionized my management of atrial fibrillation. In those patients who choose to use AliveCor there is really no need for long-term monitors (Holter monitors, Zio patches, cardiac event monitors) and no need for patients to come to the office to get an ECG when they feel they have gone into afib.

When one of my Kardia Pro patients calls with symptoms or concern of afib, I quickly pull up their chart at Kardiapro.com and review their recordings to determine if they are in or out of rhythm. Most treatment decisions can then be handled over the phone without the need for ordering a monitor or an emergency room or office visit.

One 24 hour period will suffice to show how important KardiaPro is now to my management of my patients with afib

A Day In The Afib Life

Tuesdays I spend the day working in the heart station at my hospital. Typically, on these days I will supervise stress tests, read ECGs and echocardiograms, perform TEES and electrical cardioversions. On a recent Tuesday I had 3 patients scheduled for cardioversion of their atrial fibrillation.

The day before one of these patients called indicating that he suspected he had reverted back to normal rhythm (NSR) based on his Kardia readings. He had had a prior cardioversion after which we know (thanks to daily Kardia recordings) he reverted to afib in 5 days. Subsequently we had started him on flecainide, a drug for maintenance of NSR and scheduled him for the cardioversion.

Not uncommonly after starting flecainide patients will convert to NSR but if they don’t we  proceed to an electrical cardioversion.

I logged into KardiaPro and reviewed his dashboard and sure enough his last two ECGs showed sinus rhythm. I congratulated him on this and we canceled his cardioversion for the next day, saving the lab the time and expense of a cancellation the day of the procedure. The patient avoided much stress, time and inconvenience.

Screen Shot 2018-10-13 at 7.27.49 AM
ECG recordings showing the patient had transitioned from afib (bottom two panels) to NSR (top two panels) after starting flecainide.

It is important to note that in this patient there was no great jump in heart rate with afib compared to NSR. For many patients the rate is much higher with the development of afib and this is often detected by non ECG wearable monitors (like an Apple Watch.)  But for patients like this one, an ECG is the only way to know what the rhythm is.


A second patient with afib who had elected not to acquire an AliveCor ECG device showed up for his cardioversion on Tuesday and after evaluating his rhythm it was clear he had spontaneously reverted back to NSR.  Prior to my adoption of KardiaPro this was a common and scenario.


The third scheduled cardioversion of the day showed up in afib and we successfully cardioverted him back to NSR. I had not addressed utilizing AliveCor with him. Prior to the procedure he asked me about likely outcomes.

My standard response to this question is that we have a 99.9% success rate in converting patients back to NSR at the time of the cardioversion. However, I can’t predict how long you will stay in NSR after the cardioversion. NSR could last for 5 days or it could last for 5 years. Adding medications like flecainide or amiodarone can significantly reduce the risk of afib recurrence after cardioversion.

At this point he asked me “How do I know if I am in afib?” Whereas many afib patients immediately feel bad and are aware that they have gone out of rhythm, this man like many others was not aware.

Prior to AliveCor my answer would have been to check the pulse daily or look for evidence of high or irregular heart rates on BP monitors or fitness wearables. This scenario provided a wonderful opportunity to test the AliveCor’s accuracy at detecting AF in him. I pulled out my trusty AliveCor mobile ECG and prior to the cardioversion we made the recording below

img_0702.jpg

After the cardioversion we repeated the Alivecor recording and the rhythm (AliveCor’s interpretation) had changed from afib  to NSR.

Needless to say, this patient purchased a Kardia device the next day and since the cardioversion he’s made a daily recording which has confirmed NSR. I just logged into Kardia Pro and sure enough he made a recording last night and it showed NSR.


Later in the week I received a call from a patient I had electrically cardioverted a few days earlier. His Kardia device had detected that he had gone back into afib.

I logged into my Mac and saw his KardiaPro chart below.

Kardia Pro displays green dots corresponding to NSR and orange triangles corresponding to afib with 100% accuracy in this patient.

 

 

With perfect precision KardiaPro had verified NSR after the cardioversion lasting for 36 hours. For some reason after dinner the day after the cardioversion, the patient had  reverted back to afib. This knowledge greatly facilitates subsequent treatment and eliminates the need for in office ECGs and long term monitors.


Utilization of the Kardia device with the Kardia Pro monitoring service has proved for me to b a remarkable improvement in the management of patients with afib. Managing non Kardia afib patients feels like navigating a forest with a blindfold.

The improvement is so impressive that I find myself exclaiming to my assistant, Jenny, several times a week “How do other cardiologists intelligently care for afibbers without AliveCor?”

I have a few patients who balk at the 15$ per month charge for Kardia Pro and ask why the device and this monthly charge aren’t covered by insurance or Medicare. Given the dramatic reduction that I have noticed in my use of long-term monitors  as well as  office and ER visits in this population, CMS and third-party insurers would be wise to explore Kardia monitoring as a more cost-effective way of monitoring afib patients.

antifibrillatorily Yours

-ACP

N.B. I realize this post appears to be an unmitigated enthusiastic endorsement of a commercial product which is quite uncharacteristic for the skeptical cardiologist.

One might wonder if the skepcard is somehow biased or compensated for his endorsement of Kardia.

In all honesty, this sprung from my love of the device’s improvement in my afib management and I have received no payment, monetary or otherwise from AliveCor and I own none of their stock (and I’m not even sure if it is on the stock market.)

Why We Need To Replace Hippocrates’ Oath And Apocryphal Trope

The skeptical cardiologist has never liked the Hippocratic Oath and so was quite pleased to read that it is gradually being replaced by more appropriate oaths with many medical graduates taking an excellent pledge created by the World Medical Association.

Here’s the first line of the Hippocratic Oath

Asclepius with his serpent-entwined staff, Archaeological Museum of Epidaurus

I swear by Apollo the Healer, by Asclepius, by Hygieia, by Panacea, and by all the gods and goddesses, making them my witnesses, that I will carry out, according to my ability and judgment, this oath and this indenture.

Much as I enjoy the ribald hi jinx of the gods and goddesses in Greek mythology and appreciate the back story behind words like panacea and hygiene* I just don’t feel it is appropriate to swear an oath to mythical super beings.

Let Food Be Thy Medicine-The Apocryphal Hippocratic Trope

Hippocrates is often cited these days in alternative medicine circles because he is alleged to have said “let food be thy medicine and medicine thy food.”

I’ve come across two articles that are well worth reading on the food=medicine trope which is often used by snake oil salesmen to justify their useless (presumably food-based) supplements.

The first , entitled “Hey, Hippocrates: Food isn’t medicine. It’s just food” comes from  Dylan Mckay, a nutritional biochemist at the Richardson Centre for Functional Foods and Nutraceuticals, He writes:

Food is so much more than medicine. Food is intrinsically related to human social interactions and community. Food is culture, love, and joy. Turning food into medicine robs it of these positive attributes.

A healthy relationship with food is essential to a person’s well-being, but not because it has medicinal properties. Food is not just fuel and it is more than nutrients — and we don’t consume it just to reduce our disease risk.

Seeing food as a medicine can contribute to obsessing about macronutrientintake, to unfairly canonizing or demonizing certain foods, and to turning eating into a joyless and stressful process.

People tend to overvalue the immediate impact of what they eat, thinking that a “super food” can have instant benefits while undervaluing the long-term effects of what they consume over their lifetime.

The Appeal to Antiquity

The second article is from the always excellent David Gorski at Science-based Medicine entitled let-food-be-thy-medicine-and-medicine-be-thy-food-the-fetishism-of-medicinal-foods.

Gorski notes that just because Hippocrates is considered by some to be the “father of medicine” and his ideas are ancient doesn’t make them correct:

one of the best examples out there of the logical fallacy known as the appeal to antiquity; in other words, the claim that if something is ancient and still around it must be correct (or at least there must be something to it worth considering).

Of course, just because an idea is old doesn’t mean it’s good, any more than just because Hippocrates said it means it must be true. Hippocrates was an important figure in the history of medicine because he was among the earliest to assert that diseases were caused by natural processes rather than the gods and because of his emphasis on the careful observation and documentation of patient history and physical findings, which led to the discovery of physical signs associated with diseases of specific organs. However, let’s not also forget that Hippocrates and his followers also believed in humoral theory, the idea that all disease results from an imbalance of the “four humors.” It’s also amusing to note that this quote by Hippocrates is thought to be a misquote, as it is nowhere to be found in the more than 60 texts known as The Hippocratic Corpus (Corpus Hippocraticum).

Gorski goes on to point out that:

this ancient idea that virtually all disease could be treated with diet, however much or little it was embraced by Hippocrates, has become an idée fixe in alternative medicine, so much so that it leads its proponents twist new science (like epigenetics) to try to fit it into a framework where diet rules all, often coupled with the idea that doctors don’t understand or care about nutrition and it’s big pharma that’s preventing the acceptance of dietary interventions. That thinking also permeates popular culture, fitting in very nicely with an equally ancient phenomenon, the moralization of food choices (discussed ably by Dr. Jones a month ago


We’ve learned a lot about medicine and nutrition in the last 3 thousand years. We can thank Hippocrates, perhaps, for the idea that diseases don’t come from the gods but little else.

It’s time to upgrade the physician pledge  and jettison the antiquated Hippocratic Oath.

We now have real, effective medicines that have nothing to do with food for many diseases. It’s important to eat a healthy diet.

But the food=medicine trope is just too often a  marker for pseudo and anti-science humbuggery and should also be left behind.

Hygienically Yours,

-ACP

*From Wikipedia, an explanation of the Gods and Goddesses mentioned in the Hippocratic oath

Asclepius represents the healing aspect of the medical arts; his daughters are Hygieia(“Hygiene”, the goddess/personification of health, cleanliness, and sanitation), Iaso (the goddess of recuperation from illness), Aceso(the goddess of the healing process), Aglæa/Ægle (the goddess of the glow of good health), and Panacea (the goddess of universal remedy).


The Physician’s Pledge

  • Adopted by the 2nd General Assembly of the World Medical Association, Geneva, Switzerland, September 1948
    and amended by the 22nd World Medical Assembly, Sydney, Australia, August 1968
    and the 35th World Medical Assembly, Venice, Italy, October 1983
    and the 46th WMA General Assembly, Stockholm, Sweden, September 1994
    and editorially revised by the 170th WMA Council Session, Divonne-les-Bains, France, May 2005
    and the 173rd WMA Council Session, Divonne-les-Bains, France, May 2006
    and the WMA General Assembly, Chicago, United States, October 2017

  • AS A MEMBER OF THE MEDICAL PROFESSION:

  • I SOLEMNLY PLEDGE to dedicate my life to the service of humanity;

  • THE HEALTH AND WELL-BEING OF MY PATIENT will be my first consideration;

  • I WILL RESPECT the autonomy and dignity of my patient;

  • I WILL MAINTAIN the utmost respect for human life;

  • I WILL NOT PERMIT considerations of age, disease or disability, creed, ethnic origin, gender, nationality, political affiliation, race, sexual orientation, social standing, or any other factor to intervene between my duty and my patient;

  • I WILL RESPECT the secrets that are confided in me, even after the patient has died;

  • I WILL PRACTISE my profession with conscience and dignity and in accordance with good medical practice;

  • I WILL FOSTER the honour and noble traditions of the medical profession;

  • I WILL GIVE to my teachers, colleagues, and students the respect and gratitude that is their due;

  • I WILL SHARE my medical knowledge for the benefit of the patient and the advancement of healthcare;

  • I WILL ATTEND TO my own health, well-being, and abilities in order to provide care of the highest standard;

  • I WILL NOT USE my medical knowledge to violate human rights and civil liberties, even under threat;

  • I MAKE THESE PROMISES solemnly, freely, and upon my honour.

 

 

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

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