Category Archives: Uncategorized

Hydroxychloroquine Cardiotoxicity: A Rare But Potentially Deadly Adverse Effect

The antimalarial drug hydroxychloroquine (HCQ) has been promoted by President Trump as a game-changing treatment for coronavirus infection. Of the drug, Trump declared “What do you have to lose? Take it! Try it if you’d like.”

As with any drug treatment one should consider the risks and the benefits of HCQ before “trying.” For expert virologists and infectious disease doctors, HCQ has not been proven to be beneficial in the treatment of coronavirus infection despite a glimmer of hope from early, small, poorly controlled trials from China and France.

The Chinese and French papers which reported on the use of HCQ with or without azithromycin in patients with coronavirus did not clearly show a clinical benefit. The most recent information suggests no benefits and potential harms to HCQ use.

With benefit unproven, we must be particularly cognizant of the adverse effects of any proposed or experimental treatment, and both HCQ and azithromycin (AZ) have well documented potentially lethal cardiac adverse effects.

I wrote about the risk of QT prolongation and sudden death with azithromycin here

A patient of mine with known left bundle branch block and cardiomyopathy recently contacted me because he had been prescribed HCQ for a rheumatologic disease. To determine if he should take this drug I reviewed the literature on HCQ cardiotoxicity.

Hydroxychloroquine Cardiotoxicity

HCQ is primarily utilized now for the treatment of rheumatologic disorders, most commonly systemic lupus erythematosus ( SLE.)

A recent review of  HCQ use in SLE concluded

HCQ may reduce the risk of flares, allow the reduction of the dosage of steroids, reduce organ damage, and prevent the thrombotic effects of anti-phospholipid antibodies. The drug is generally safe and may be prescribed to pregnant women. However, some cautions are needed to prevent retinopathy, a rare but serious complication of the prolonged use of HCQ

The Johns Hopkins Lupus Center section devoted to “Treating Lupus with Anti-Malarial Drugs” mentions a dozen side effects but does not mention cardiotoxicity.

However, the scientific literature contains numerous case reports of patients with SLE who developed either severe heart failure or conduction abnormalities (sometimes both) with strong evidence that HCQ was responsible.

Joyce, et al, (Hydroxychloroquine cardiotoxicity presenting as a rapidly evolving biventricular cardiomyopathy: key diagnostic features and literature reviewdescribed a case of HCQ cardiotoxicity in 2013 and reviewed the literature on the topic. They emphasized typical findings on cardiac biopsy and concluded:

“although rare, hydroxychloroquine cardiotoxicity can be fatal, particularly if irreversible histopathological changes have occurred prior to drug discontinuation. Given this, regular screening with 12-lead electrocardiography and transthoracic echocardiography to detect conduction system disease and/or biventricular morphological or functional changes should be considered in hydroxychloroquine-treated patients”

The most recent review of HCQ was published in 2018 and identified 127 patients from case reports or case series with cardiac complications from HCQ or chloroquine.

Two-thirds of these patients were female and the majority were treated with chloroquine (58%.)

Patients had been on drug treatment from 3 days to 35 years (median 7 years.)

The median cumulative dose was 1.235 grams for HCQ.

Conduction disorders were the most common adverse cardiac effect noted with 85% of patients

Other non-specific adverse cardiac events included ventricular hypertrophy (22%), hypokinesia (9.4%), heart failure (26.8%), pulmonary arterial hypertension (3.9%), and valvular dysfunction (7.1%).

For 78 patients reported to have been withdrawn from treatment, some recovered normal heart function (44.9%), while for others progression was unfavorable, resulting in irreversible damage (12.9%) or death (30.8%)

To summarize:

  1. HCQ and chloroquine have associated and well-documented, albeit rare cases of potentially lethal cardiotoxicity.
  2. The benefit of these drugs in the treatment of coronavirus infection is currently unproven.
  3. Data from high-quality randomized trials of HCQ treatment in patients with coronavirus is needed before we can assess whether the drug benefits outweigh its risk in COVID-19 patients.

Much has been written in the cardiology literature recently about QT prolongation with HCQ and ECG monitoring and I will publish a separate post on that topic shortly.

Skeptically Yours,

-ACP

A Reliable Source for Reliable Sources During Covid-19

It is a daunting task tracking down reliable information during Covid-19. Misinformation tends to spread like …the coronavirus. The Baker institute Blog is providing excellent succinct summaries of reliable information and sources as the pandemic evolves.

The post below  originally appeared on the Baker Institute Blog April 20, 2020  and was  coauthored by Vivian Ho, Ph.D. (@healthecontx), James A. Baker III Institute Chair in Health Economics, Kirstin Matthews, Ph.D. (@stpolicy), Baker Institute  Fellow in Science and Technology Policy and Heidi Russell, M.D., Ph.D., Associate Professor, Department of Pediatrics, Baylor College of Medicine and Associate Director, Center for Medical Ethics and Health Policy, Baylor College of Medicine.


Having finished our fifth week in isolation, we are encouraged that the nation may have passed its peak date for the number of new cases and new deaths. We update you on efforts to identify treatments for the coronavirus, as well as policymakers’ discussions on when to reopen the economy, what that might look like, and where government funding should be directed. Previous issues are posted here.

Epidemiology and Treatment

Health experts warn us not to expect a single peak day in terms of new cases, deaths, or otherwise. Daily reports of new cases and deaths can fluctuate depending upon the availability of tests and delays in reporting. The New York Times’ juxtaposes a bar graph of the number of new cases by day with a line calculating the 7-day average of these numbers, indicating that the number of new cases has fallen to less than 30,000 per day. The 7-day average of new deaths also has begun to fall, to roughly 2,000 per day.

On Friday Worldometers estimated that 58,000 people in the U.S. have recovered from the coronavirus. Mark Lipsitch, an epidemiologist at Harvard University, provides a compelling case that most individuals who contracted the virus will have an immune response, some better than others. He suggests that the immune response will offer some protection over the medium term — at least a year — and then its effectiveness might decline. This view that contracting the virus yields only temporary immunity, is shared by other experts. Thus, treatments and a vaccine for COVID-19 are crucial in ultimately conquering this pandemic.

To date, researchers and drug companies have launched over 100 human experiments to identify treatments for the coronavirus. However, an article in the Washington Post warns that the lack of coordination across investigations could generate numerous small-scale trials with conflicting answers. For example, there are more than two dozen separate U.S. trials listed for the anti-malarial drug hydroxychloroquine. Some use the drug as a preventive, others as a treatment; some in combination with other drugs, and some with no comparison group. Information from multiple investigations is often better, but coordination across these studies could have yielded larger sample sizes and cleaner study designs, so that results could be used to prioritize treatments. Francis Collins, director of the National Institutes of Health has been working behind the scenes to launch an unprecedented public-private partnership to achieve better coordination.

In the scientific journal Immunity, researchers review the COVID-19/SARS-CoV-2 vaccine development and its challenges  In addition, the WHO cataloged a long list of potential candidates, and an article from “The Scientist” describes frontrunners that hoped to be tested this year, providing details on each vaccine’s approach to target the virus as well as preliminary evidence. Meanwhile, fake news regarding causes of and treatment for coronavirus are circulating through social media. The World Health Organization (WHO) has posted a series mythbuster infographics to dispel rumors such as one that 5G mobile networks spread COVID-19.

Policy Response

Public health experts continue to emphasize that passing the peak number of cases or deaths does not mean that the pandemic is over, and that we will need to maintain social distancing in one form or the other for months to come. More than a dozen states have extended stay-home orders past the White House deadline of April 30th. In the meantime, governors on the east and west coasts were reported last Monday to have formed pacts to decide when they would reopen their economies. Governors of Midwest states followed suit soon afterwards. These pacts will draw on facts and science to create plans to re-open each state in a way that limits new outbreaks of coronavirus. Among the steps are contact tracing, treatment and social distancing measures.

For example, last week we highlighted the recommendation for A National COVID-19 Surveillance System which included capacity to conduct 750,000 coronavirus tests per week. Unfortunately, most parts of the country report test supply shortages that remain “crippling.” Experts emphasize the need for contact tracers, to identify those who could have contracted the virus by coming into contact with someone who has tested positive for the virus. Policy makers are acting on that recommendation, with the C.D.C. planning to hire hundreds of contacts tracers and, it is in discussions to divert 25,000 Census Bureau workers to do contact tracing in the coming weeks and months. Experts suggest that employers can do their part to reduce the spread of coronavirus by offering screening at their place of business. Employers can help workers to safely self-isolate at home and work with local health authorities to improve contact tracing.

As TIME magazine stated, “Public health experts have savaged President Donald Trump’s decision to cut U.S. funding to the WHO.” Critics include U.N. Secretary General António Guterres and the editor-in-chief of the Lancet medical journal, who called the decision “a crime against humanity.” The administration is reportedly withholding funds, because the WHO failed to adequately investigate early information about the virus’s ability to spread between humans and for not criticizing China for its lack of transparency over the virus. This view is echoed in an article in The Atlantic, which points to structural problems at the WHO that make the organization vulnerable to misinformation and political influence, in this case by China. Nevertheless, the U.S. pays for about 22% of the WHO’s budget. Cutting funding for international public health initiatives in the midst of a crisis could have dire consequences for Americans in the future.

Health and Human Services is distributing the first $30 billion in emergency grants to hospitals and doctors from the CARES Act according to their historical share of revenue from the Medicare program for seniors — not according to their coronavirus burden. States lightly hit by the coronavirus, such as Minnesota, are getting more than $300,000 per COVID-19 case, while New York is receiving $12,000 per case. The HHS decision raises the prospects that hospitals in hard-hit areas will be weighing their financial health more heavily than patient well-being for each additional COVID-19 case that comes through their doors.

On the Medical Frontlines

Evidence of strain on the healthcare workforce continues to mount.  The Centers for Disease Control (CDC) published a report estimating at least 9,282 United States health care workers have been sickened by COVID-19, and at least 27 died.  This is likely an underestimate because of how local or state authorities report cases. The CDC concluded that approximately half of these providers were exposed in their workplace.  The worse outcomes were in the over 65 workforce, although death and critical illness occurred at all ages. The first installment of a bi-weekly survey of medical staff across the country was performed by MedPage Today.  The responses suggest that regional variation in the share of the healthcare workforce that is temporarily out, critically ill or dead because of COVID-19 lies between 1% and 20%.  The proportions are much higher in concentrated areas like New York.  For an in-depth account of healthcare workers who died from COVID-19, we applaud the stories found in Lost on the Frontline.

Healthcare workers are particularly at risk when performing nasal swabbing to test for the coronavirus, which requires the provider to stand directly in front of the person being tested. The swabbing generates a natural reflex to cough or sneeze, sending droplets into the air. To that end the first COVID-19 test of saliva was approved by the FDA this week.  This new test will allow patients to spit into a vial and hand it back to the health care worker. The test is not yet available in most health care organizations, and questions remain about its accuracy. But as these hurdles are overcome, this safer, simpler testing would also circumvent the shortage of nasal swabs that is hindering test availability across the country.

In the coming we week, hopefully new cases of the coronavirus and daily death toll continue to decline. We are most concerned about the continuing short supply of coronavirus tests. We hope that federal, state, and local governments aggressively pursue efforts to hire and train contact tracers throughout the country. Debate has begun on what role smartphone apps by Apple and Google could play in contact tracing, and we will follow that discussion closely. We also look forward to reviewing state governors’ developing plans to reopen their economies.


Still socially distanced but ever skeptically Yours,

-ACP

Food and The Coronavirus

Marion Nestle at her blog Food Politics has put together an updated and tremendous compendium of information about food during these troubled times.

I’ve quoted it in detail below.

Key points to keep in mind.

 

To Date There Is No Evidence Of Coronavirus Transmission By Food

 

See her detailed post on this here.

For produce her recommendation is

To be 100 percent safe while eating fresh produce

Do what you would do in countries without safe water supplies—follow the P rules and only eat foods that are:

  • Piping hot (hot temperatures destroy viruses and other microorganisms)
  • Peeled (wash hands before and after)
  • Purified (cooked and not recontaminated)
  • Packaged (industrially packed, frozen, or dried)

As always, wash hands.

If you have fresh produce, wash it.  When in doubt, cook it.

Avoid Dubious Schemes For Immune Boosting.

I have noticed that the snake oil salesmen are doubling down on their products and promoting all kinds of useless immune supplements  Let the buyer beware-these untested products are as likely to lower your immunity as raise it. 

Grocers Have A  Viable Supply Chain And Are Not Shutting Down

Don’t hoard food and supplies that other people may need


From Marion Nestle:

Does food transmit Coronavirus?  

Keeping up with Coronavirus  

How to survive working at home (watch out for junk food) 

How to take action

Advice for the food industry

  • US lays out new COVID-19 guidelines for food industry  The Trump Administration released a set of coronavirus guidelines for all Americans, with special provisions for critical infrastructure industries like food and beverage. Brands have been adapting this week to the new reality, while keeping employee safety a top priority…. Read more

What’s happening with supermarkets and supply chains?

What to avoid: dubious schemes for immune boosting

Who profits from this?

What else?


Still Socially Distanced,

-ACP

No Matter What Some Public Officials Say, the Message You Need to Hear Is “Stay Home”

I was shocked to read the above titled Pro Publica story just now.

But the subtitle of the article, “Mixed messaging from all levels of government is putting Americans at risk and will speed the spread of the coronavirus. No matter what politicians say, public health experts agree. Stay home, even if you feel fine.” is absolutely correct.

The CDC is likely to tell us officially tomorrow what many experts have been saying for a while: avoid public places. Practice social distancing.

On Sunday morning, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, told CBS’ “Face the Nation,” “Right now, personally, myself, I wouldn’t go to a restaurant.”

“The most important thing is for people to change their daily routines and really reduce their social interactions,” said Dr. Joshua Sharfstein, a former federal and state health official who is now vice dean for public health practice and community engagement for the Bloomberg School of Public Health at Johns Hopkins University.

Cancel parties and visits to nonessential shops.

Feel free to take walks in the park.

Socially Distanced,

-ACP

A Message From Italy On Coronavirus and COVID-19

Last month the skeptical cardiologist asked Nicola Triglione, a native of Southern Italy who completed his cardiology fellowship in Milan to give us his perspective on the US and Italian health care systems.

Since Italy is now at the European epicenter of the COVID-19 epidemic and second only to China in number of

Screen-Shot-2020-03-15-at-12.02.17-PM.png
From the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University (JHU)

cases and deaths, American scientists and public health officials are now closely scrutinizing Italy’s response and outcomes.

 

 

I emailed Nicola to see what his situation was and he provided this information and advice for my readers:

Hello everyone from Milan, as you already know Italy is in lockdown over the new coronavirus (Covid-19). The northern regions of Lombardy, Veneto and Emilia-Romagna have been most affected by the outbreak and what’s happening here it’s just surreal. I just wanted to reach out to you because we all have the responsibilities to prevent this. The majority of infections are mild but the pandemic is growing at an exponential speed. The infection is much more aggressive for certain groups: elderly, cancer patients and patient with cardiovascular disease are at higher risk of dying. Hospitals are severely overloaded and the real problem is that medical staff gets sick.

My only take on is: stay home for as long as possible, lots of contagions happen before there are symptoms. Virus doesn’t spread if people don’tinteract. If we can postpone cases the healthcare system will be able to handle contagions much better. I hope the US authorities will stop public gatherings and everything really not necessary. Last but not least, we need to test everybody as limited testing only postpones the problem.

Dott. Nicola Triglione
Medico Chirurgo
Specialista in Cardiologia 

For those who want to learn more about the situation in Italy, watch this video interview with Dr. Cecconi of Humanitas University in Milan discussing the region’s approach to the surge, including clinical and supply management, health care worker training and protection, and ventilation strategies, with JAMA Editor Howard Bauchner.

Antiseptically Yours,
-ACP

Most Important Coronavirus Question: Will I Get Sick And Die?

Alex Berenow at the American Council on Science and Health has written a helpful analysis of the COVID-19 case fatality rate.

With his permission, I’ve reproduced the article in its entirety below.



For epidemiologists, the most important unanswered question about the Wuhan coronavirus, or COVID-19, is the case-fatality rate. But for the general public, the question is much more personal: “Might I – or anyone I love – get sick and die?” from it.

This article was originally published at Geopolitical Futures.


The first person to die from coronavirus on American soil passed away on Feb. 29 at a Seattle area hospital – incidentally, the same hospital where my daughter was born just ten and a half months ago.

For epidemiologists, the most important unanswered question about the Wuhan coronavirus, or COVID-19, is the case-fatality rate. But for the general public, the question is much more personal: “Might I – or anyone I love – get sick and die?” When faced with uncertainty, people make decisions cautiously, and they base them on emotion and personal experience instead of statistics. If enough people answer “Yes,” there could be major repercussions as panic sets in around the world. Small behavioral modifications, such as telecommuting or reducing factory activity to avoid spreading the disease, made by millions of people can have a large impact. The United Nations already estimated $50 billion worth of exports worldwide will be affected, excluding non-trade economic activities such as travel tourism, as manufacturing slows and governments impose measures like port restrictions. This is why it is necessary to develop a “risk of death” profile for COVID-19.

The first substantial effort to do just that was published by the Chinese Center for Disease Control and Prevention. Though these numbers should be thought of as preliminary (and perhaps specific to only China), they allow us to begin to comprehend the risk that our global society is facing. After analyzing 44,672 confirmed cases, Chinese health officials estimated the case-fatality rates by age group:

Of the 416 children aged 0 to 9 who contracted COVID-19, precisely zero died. This is unusual for most infectious diseases, but not for coronaviruses; the SARS coronavirus outbreak also had minimal impact on children. For patients aged 10 to 39, the case-fatality rate is 0.2 percent. The case-fatality rate doubles for people in their 40s, then triples again for people in their 50s, and nearly triples yet again for people in their 60s. A person who contracts COVID-19 in their 70s has an 8 percent chance of dying, and a person in their 80s a nearly 15 percent chance of dying.

The virus can be lethal in a variety of ways. Viral infections in the lungs can trigger an immune response so strong that it fatally damages the lungs. In others, a systemic immune response, called a “cytokine storm,” can cause multiple organ failure. This could explain why some young, healthy people are killed by the virus, such as Dr. Li Wenliang, the 34-year-old doctor who died shortly after alerting the world to this new strain of coronavirus. An older person’s immune system may not be able to fight a respiratory virus. Underlying conditions such as high blood pressure or diabetes can worsen outcomes.

The above statistics are no doubt frightening numbers. But there are at least three major mitigating factors. First, the number of mild or asymptomatic cases is unknown and probably substantial. Second, China is still a poor country with low-quality health care and, at the epicenter of the outbreak in Hubei province, was overwhelmed by the virus. (The case-fatality rate in Chinese provinces outside Hubei, where hospitals aren’t overloaded, is much lower.) Third, smoking is much more prevalent in China than America, especially among men (52 percent in China versus 16 percent in the U.S.), and smoking is a risk factor for poor responses to respiratory infections. Together, this means the case-fatality rate is likely inflated, and it would be a mistake to apply these figures to the United States or other advanced nations.

The real question, then, is how inflated the case-fatality rates are. At this point, it’s impossible to determine because scientists are still collecting data on how widespread the virus is. But to get a sense of how exaggerated these numbers might be, it is useful to examine the case-fatality rate for seasonal influenza. For the 2018-19 influenza season, the U.S. Center for Disease Control and Prevention provides estimates for the number of cases (defined here as “symptomatic illnesses”) and deaths. From these, we can derive case-fatality rate estimates by age group.

If COVID-19 ends up being similar to seasonal influenza, then the case-fatality rates for COVID-19 are inflated by a factor of 20 to 100. Dr. Anthony Fauci, head of the U.S. NIAID, co-authored an editorial for the New England Journal of Medicine in which he wrote:

“If one assumes that the number of asymptomatic or minimally symptomatic cases is several times as high as the number of reported cases, the case fatality rate may be considerably less than 1%. This suggests that the overall clinical consequences of Covid-19 may ultimately be more akin to those of a severe seasonal influenza (which has a case fatality rate of approximately 0.1%) or a pandemic influenza (similar to those in 1957 and 1968) rather than a disease similar to SARS or MERS, which have had case fatality rates of 9 to 10% and 36%, respectively.” [Emphasis added]

We have reason to believe this view is closest to reality. In South Korea, public health officials screened about 100,000 people and detected over 7,300 cases. So far, the death toll is 50, which translates to a case-fatality rate of 0.7 percent. That’s still seven times worse than seasonal flu, but it’s far lower than the initial reports from China.

The Future of COVID-19

Stat News describes two possible scenarios that epidemiologists envision for the future of COVID-19. In the first, COVID-19 becomes just another cold virus, and possibly evolves to become less lethal as well. What we call the “common cold” is actually caused by roughly 200 different viruses. Each year, about 25 percent of common colds are due to four coronaviruses, and some scientists think COVID-19 could eventually join this group as its fifth member. In the second scenario, COVID-19 behaves more like a severe seasonal flu, vanishing in the summer and returning to hit us hard in the winter.

In neither scenario does COVID-19 resemble the Spanish flu of 1918, which disproportionately killed young people. In neither scenario does the virus mutate to become more lethal. Most likely, the opposite will be true. There is an inverse relationship between lethality and contagiousness; that is, the most contagious viruses tend to be less lethal. Evolutionary pressures – namely, the biological imperative to reproduce as far and wide as possible (which means not killing people) – may push COVID-19 down this path.

For now, influenza remains the far bigger global public health threat. Each year, about 1 billion people become infected with seasonal flu, killing some 300,000 to 500,000. This season alone (2019-20), about 20,000 Americans have died from fluincluding 136 children. Yet, very few people fear the flu. Society has accepted it as part of reality, and people carry about their daily lives without excessive concern over influenza. This is the likely future for COVID-19.

Until then, perhaps the last word should be given to virologist Dr. Lisa Gralinski, who told The Scientist, “If you’re over fifty or sixty and you have some other health issues and if you’re unlucky enough to be exposed to this virus, it could be very bad.” While everyone else should remain vigilant and take proper precautions (e.g., washing hands and avoiding crowds) until more data comes in, from a scientific perspective the public alarm is disproportionate to the risk.

© 2020 Geopolitical Futures. Republished with permission. (The original is here.)


Skeptically Yours,

-ACP

Test Your Knowledge of Coronavirus With These Two Quizzes

Since COVID-19 has been sucking all the oxygen out of the information atmosphere I have lost any desire to post on my usual array of semi-cardiovascular topics.

However, Al Lewis  has been hard at work providing us with COVID-19 information relevant to employee wellness through his blog and his company,  Quizzify.

You can test your knowledge of the coronavirus by taking Quiz1 or Quiz2.

Al’s  typically engaging description follows.

When was the last time a sequel was better than the original?  Toy Story 2? Superman 2? A Shot in the Dark

Our first coronavirus quiz did indeed live up to its name by going viral, and will be highlighted in Employee Benefit News next week.

As with the first, doctors at Harvard Medical school have reviewed this new content. As with the first, the sequel also features 10 engaging and reliable coronavirus employee health education questions.  This quiz covers, among other things:

  • boosting your immune system
  • the value of zinc tablets
  • how far a sneeze can spread it, and
  • how to avoid a surprise bill for treating it.

As with the previous quiz, Quizzify customers have much more flexibility, control, visibility and support in their deployment of the quiz than you will. However, owing to the public health emergency, we are making the actual quiz freely available for you to share, eating a loss and forgoing a profit opportunity.*


If your hankering for coronavirus information has not been sated by the quizzes check out his post on 5 easy ways to reduce coronavirus risk you didn’t think of.

Handwashingly Yours,

ACP

Ultra-Processed Foods Contribute Half of the Calories and 90% of the Added Sugar to US Diets

In 2016 I wrote a post entitled “Ultra-Processed Foods Contribute Half Of The Calories And 90% Of The Added Sugar to US Diets.’

In the last week, I have discovered two excellent discussions further supporting the role these ultra-processed foods (UPFs) play in our obesity epidemic

Brazil Leads In Recognizing The Dangers of Ultra-Processed Foods

Last week The Guardian published a long article which does a great job of providing an easily digested background to the concept of UPFs and their influence on obesity. A lot of that background comes from the work of a Brazilian MD, Carlos Monteiro:

The concept of UPFs was born in the early years of this millennium when a Brazilian scientist called Carlos Monteiro noticed a paradox. People appeared to be buying less sugar, yet obesity and type 2 diabetes were going up. A team of Brazilian nutrition researchers led by Monteiro, based at the university of Sao Paulo, had been tracking the nation’s diet since the 80s, asking households to record the foods they bought. One of the biggest trends to jump out of the data was that, while the amount of sugar and oil people were buying was going down, their sugar consumption was vastly increasing, because of all of the ready-to-eat sugary products that were now available, from packaged cakes to chocolate breakfast cereal, that were easy to eat in large quantities without thinking about it.

I highly recommend you read the full article in the Guardian on this important topic. It is extremely well-written  and the author has interviewed both Monteiro and Kevin Hall for the piece.

If your time is limited, I give you what I wrote in 2016 but which appears never to have been publicly published.


The skeptical cardiologist has been ranting about the deleterious effects of added sugars from highly processed food in our diets ad nauseam (see here or here)

I’ve been meaning to follow up on some recent evidence showing the major role that the sugar industry played in vilifying fat and obscuring the dangers of excess sugar in the diet.

Here are two items to help you further understand this process:

  1. In September, a researcher at the University of California, San Francisco, uncovered documents showing that Big Sugar paid three Harvard scientists in the 1960s to play down the connection between sugar and heart disease and instead point the finger at saturated fat. Coca-Cola and candy makers made similar headlines for their forays into nutrition science, funding studies that discounted the link between sugar and obesity.

  2. An observational study published from Monteiro, et al.  in BMJ Open confirms the presumed close association between highly processed foods and added sugar and adds further to the evidence that sugar, not fat, is the major nutrient which most of us should minimize in our diet

Carlos Monteiro and his colleagues begin this paper by noting that dietary guidelines are increasingly recommending limiting added sugar to <10% of dietary calories because of evidence that:

“a high intake of added sugars increases the risk of weight gain, excess body weight and obesity ;type 2 diabetes mellitus, higher serum triglycerides and high blood cholesterol; higher blood pressure and hypertension; stroke; coronary heart disease; cancer; and dental caries. Moreover, foods higher in added sugars are often a source of empty calories with minimum essential nutrients or dietary fibre which displace more nutrient-dense foods and lead, in turn, to simultaneously overfed and undernourished individuals.”

The study analyzed the relationship between processed food consumption, total calories and calories from added sugar using data from the National Health and Nutrition Examination Survey 2009–2010.

They divided foods into four categories:

unprocessed or minimally processed foods (such as fresh, dry or frozen fruits or vegetables, grains, legumes, meat, fish and milk)

processed culinary ingredients’ (including table sugar, oils, fats, salt, and other substances extracted from foods or from nature, and used in kitchens to make culinary preparations)

processed foods’ (foods manufactured with the addition of salt or sugar or other substances of culinary use to unprocessed or minimally processed foods, such as canned food and simple breads and cheese)

ultra-processed foods (formulations of several ingredients which, besides salt, sugar, oils and fats, include food substances not used in culinary preparations, in particular, flavours, colours, sweeteners, emulsifiers and other additives used to imitate sensorial qualities of unprocessed or minimally processed foods and their culinary preparations or to disguise undesirable qualities of the final product.

The most common ultra-processed foods in terms of energy contribution were breads; soft drinks, fruit drinks and milk-based drinks; cakes, cookies and pies; salty snacks; frozen and shelf-stable plates; pizza and breakfast cereals.

The findings:

ultra-processed foods account for 58% of  all calories in the US diet, and contribute nearly 90% of all added sugars. 


Kevin Hall’s Stunning Study

The second item about UPFs was an episode of the podcast Best Known method which featured the NIH nutrition researcher Kevin Hall discussing ultra-processed foods with Ethan Weiss.

The early part of the podcast reviews Hall early training in physics and mathematics and transition into mathematical modeling of metabolism. Ultimately he ended up testing the hypothesis that a diet of UPF with similar macronutrient composition would result in greater weight gan than an unprocessed diet

The results were published in Cell Metabolism last year and are summarized in this neat graphic.Screen Shot 2020-02-17 at 6.53.54 PM

Yes. you read that correctly.

In 20 inpatient adults (10 men and 10 women) the ultra- processed diet caused increased ad libitum energy intake and weight gain despite being matched to the unprocessed diet for presented calories, sugar, fat, sodium, fiber, and macronutrients

Hall had expected negative results from this study but now believes something about UPFs beyond their macronutrient composition causes many individuals to overeat and gain weight. Whereas in 2016 I thought the major culprit was the added sugar in UPFs, Hall’s study suggests it is not just added sugar or missing fiber in the diet that is leading to excess eating and weight gain.

Identifying Ultra-Processed Foods

I provided some guidance on identifying UPFs in my unpublished 2016 post:

If you have difficulty in determining what  foods should be considered  ultra-processed   I recommend  getting a copy of Michael Pollan’s small and delightful booklet, “Food Rules: An Eater’s Manual.”

The first section entitled “Eat Food” provides 21 short, memorable phrases to help you identify and avoid ultra-processed foods: concoctions that he terms “edible food-like substances.”

Some of the key rules:

Don’t eat anything your grandmother wouldn’t recognize as food.

Avoid food products that contain ingredients that no ordinary human would keep in the pantry

Avoid food products that contain high fructose corn syrup

Avoid foods that have some form of sugar (or sweetener) listed among the top three ingredients

Avoid food products that contain more than five ingredients

And one that I particularly like as it emphasizes the misleading health claims of low fat diary:

Avoid food products with the wordoid “lite” or the terms “low-fat” or “nonfat” in their names.

Ultraunprocessedly Yours

-ACP

N.B. As I indicated in “I Am a Keto-friendly cardiologist and I Love Keyto” “I have tremendous professional respect for Ethan Weiss, the cardiologist behind Keyto.  It is ironic that he announced at the beginning of his Best Known Method podcast with Kevin Hall that Keyto was changing its name to KeyEats and its first products are (seemingly) ultra-processed food bars.

An In-depth, Objective Comparison of Mobile ECG Devices: Emay versus Kardia

The skeptical cardiologist has been a huge advocate of personal mobile ECG monitoring to empower patient’s in understanding/monitoring their heart rhythm.

The deserved leaders in this field are the Apple Watch (4 and later) and Alivecor’s Kardia device which comes in single-lead and six-lead flavors.

Both Apple and AliveCor have gotten FDA approval for their mobile ECG device and have a body of published studies supporting their accuracy.

In contrast, there are a number of “copy-cat” mobile ECG devices which have been feeding on the success of Apple Watch and Kardia but do not have the bona fides the two leaders have.

I reviewed the SonoHealth ECG here and found it sorely lacking in comparison to Kardia in terms of accuracy of diagnosis and quality of recordings, the two most important aspects of a personal ECG monitor.

Dan Field, a physician  and reader of my blog, has been evaluating a device similar to the SonoHealth ECG made by Emay.

He has provided a point by point comparison of the two  devices in the chart below

Emay versus Kardia

His summary:

“The Kardia6L was clearly superior in almost every way except for price and even that was within the margin of error. ”

It should be noted that the single lead Kardia mobile ECG is actually cheaper than the Emay and retails for $99.

Let The (Mobile ECG) Buyer Beware

I ended my post reviewing SonoHealth’s ECG with a warning which applies equally to the Emay device:

The SonoHealth EKGraph is capable of making a reasonable quality single lead ECG. Presumably all the other devices utilizing the same hardware will work as well.

However, the utility of these devices for consumers and patients lies in the ability of the software algorithms to provide accurate diagnoses of the cardiac rhythm.

Apple Watch 4 and AliveCor’s Kardia mobile ECG do a very good job of sorting out atrial fibrillation from normal rhythm but the SonoHealth EKGraph does a horrible job and should not be relied on for this purpose.

The companies making and selling the EKGraph and similar devices have not done the due diligence Apple and AliveCor have done in making sure their mobile ECG devices are accurate.  As far as I can tell this is just an attempt to fool naive patients and consumers by a combination of marketing misinformation and manipulation.

I cannot recommend SonoHealth’s EKGraph or any of the other copycat mobile ECG devices. For a few dollars more consumers can have a proven, reliable mobile ECG device with a solid algorithm for rhythm diagnosis. The monthly subscription fee that AliveCor offers as an option allows permanent storage in the cloud along with the capability to connect via KardiaPro with a physician and is well worth the dollars spent.

Skeptically Yours,

-ACP

 

Heartening News For The New Year! United Health Care Paid For This Patient’s Coronary Calcium Scan

Unless you live in Texas you will have to pay out of pocket for a coronary artery calcium (CAC) scan. Insurers and Medicare won’t pay a dime for this simple test which  progressive preventive cardiologists and primary care docs rely on to better determine who is at risk for heart attacks and sudden death.

But as we approach 2020 perhaps this failure to cover our best tool to detect subclinical atherosclerosis can be reversed. To my surprise, earlier this week, a patient of mine revealed to me that United Health Care had reimbursed him for the CAC he had done earlier this year.

It wasn’t easy or straightforward but his process may work for others so I asked him to email me the letter he sent that resulted in coverage which I have copied below.

As discussed in your office today, I was able to get my insurance company (United Healthcare) to reimburse me from the Cardiac Calcium Scoring costs of $125 after filing an appeal through my former employer. Below, as requested, is the simple write up I provided to them.

I visited a cardiologist (Dr. Anthony Pearson) in May 2019 regarding heart palpitations I had with increasing frequency. He performed a variety of diagnostic tests (blood work, Holter monitor, echo stress test), which were all covered by UHC. Because these tests did not show any issues, he suggested I have a Cardiac Calcium Scoring Test, which I completed on May 24, 2019. The test showed that I had serious coronary artery disease (score of over 800), which caused the cardiologist to prescribe a daily baby aspirin and a statin medicine (also covered by UHC). While I was told that the Cardiac Calcium Scoring Test cost is not covered by insurance, this is the one and only test that indicated I was at a severe risk for a coronary artery event (significant or total blockage) and, per the cardiologist, may have saved my life or perhaps avoided an unexpected significant cost (e.g. bypass surgery) by catching the issue early.

To recap, St. Luke’s Hospital did not submit a claim for the $125 cost of the Cardiac Calcium Scoring Test because they said no insurance company pays for this test. This test was ordered by my cardiologist, Dr. Anthony Pearson, and was performed at St. Luke’s Hospital in St. Louis. I am requesting reimbursement for the cost of this test for the reasons stated above

The United Health Care EOB contained this claims summary:

Screen Shot 2019-12-31 at 9.34.20 AM

It would appear the mighty wall that insurers and CMS have put up against paying for CAC scans is crumbling and can be breached.

I highly recommend all patients who have gotten an appropriately ordered CAC go through this process with their insurers to attempt to obtain reimbursement.

Happy Antiatherosclerotic New Year,

-ACP