The skeptical cardiologist has of late been obsessed with a Beatles song. It is the fifth song on the second side of the four mop tops seventh studio album and the third George Harrison contribution to Revolver, arguably the best record album of all time.
With a subscription to Apple Music I can listen to the entire Beatles catalogue now and one day I Want To Tell You (IWTTY) began playing. I hadn’t closely listened to this song before but at 25 seconds in someone begins playing very loudly two notes on a piano and keeps playing them for 8 seconds. The effect is strikingly dissonant but mesmerizing.
It turns out much has been written about this section of I Want To Tell you (along with anything else remotely related to The Fab Four.)
The two notes are F and E and they are being played by Paul McCartney emphasizing the flattened ninth (and highly dissonant) portion of the chord E 7 b9.
Tim Riley in his Beatles song by song analysis, “Tell Me Why” writes of IWTTY:
The guitar line is central, the backbone for the esoteric lyrics, and the piano’s annoying dissonant figure at the end of each verse disrupts its stability.
The piano conveys the frustration of the singer, and its single-note solo is the peace he wants to attain
I’ve also seen this section described as “creating a frustrated bitonal disonance ( G sharp 7 diminished against E7 or E7 flat 9)
Lacking formal music training, apart from in his sitar studies…later described the harsh-sounding E7♭9 as, variously, “an E and an F at the same time” and “an E7th with an F on top, played on the piano”.
Writing in Rolling Stone’s Harrison commemorative issue, in January 2002, Mikal Gilmore recognised his incorporation of dissonance on “I Want to Tell You” as having been “revolutionary in popular music” in 1966. Gilmore considered this innovation to be “perhaps more originally creative” than the avant-garde styling that Lennon and McCartney took from Karlheinz Stockhausen, Luciano Berio, Edgar Varese and Igor Stravinsky and incorporated into the Beatles’ work over the same period.
The Wikipedia entry goes on to say that the chord “became one of the most legendary in the entire Beatles catalogue.”
Harrison was deliberately using the chord’s dissonance to create an emotion.”The musical and emotional dissonance is then heightened by the use of E7♭9, a chord that Harrison said he happened upon while striving for a sound that adequately conveyed a sense of frustration.”
“speaking in 2001, Harrison said: “I’m really proud of that as I literally invented that chord.”
I thought it highly unlikely that George Harrison “invented” (literally or figuratively) the seventh flattened ninth chord but had no way of checking the accuracy of the Wikipedia quote (from Guitar World magazine.) or the context. Was Harrison that musically naive, was he joking or did he mean something else?
Later that day I sat at my Kawai baby grand piano and began playing songs from The Encylopedia of Jazz.
One of my favorites from this book is Satin Doll (written in 1953 by Duke Ellington and Billy Strayhorn) and as I was playing it I realized that it was loaded with flattened ninths. There’s a D7flat9 when the word Satin is sung. These chords make the song more complex and memorable.
Next I played my favorite song in this Jazz book i “Lullaby of Birdland” (music written by George Shearing in 1952) which features two 7flat9 chords (F# and B7) in the second measure (played with the words “that’s what I.”) Later on in the song we are treated to 7flat 9 in D and the chord that George Harrison claimed to have literally invented E7b9.
Here’s Ella Fitzgerald singing it with Duke Ellington
So a cursory review reveals that the chord was being utilized a lot in 1953 (and that I have a special attraction to its complexity.)
Perhaps Harrison can claim he was the first to appropriate the chord in rock and roll music? Alas, we know that an F#7b9 is prominent in the Beach Boys’ Caroline, No which was released in March, 1966, 3 months before the Beatles released IWTTY.
He may not have invented the chord or even been the first to use it in rock and roll but his use in IWTTY coupled with McCartney’s hammering on the F and E have made me forever cognizant of that song’s beauty.
For that plus his brilliant guitar work and songwriting during and after The Beatles I will be eternally grateful.
N.B. Dear Readers. If any of you have access to the Guitar World interview of 2001 (from Wikipedia-Garbarini, Vic (January 2001). “When We Was Fab”. Guitar World. p. 200) wherein Harrison is alleged to claim he invented the magical 7b9 please share it with me.
Also, please note there is a new button on my website which allows you to sign up for my weekly emal newsletter (which i promise will be mostly related to cardiology and not esoteric musical chords.)
The ACC meetings in New Orleans have wrapped up and I must stop letting the good times roll.
In the areas I paid attention to I found these four presentations the most important:
1. After the historic back to back presentations of the Partner 3 and Evolut trials it is clear that catheter-based aortic valve replacement (TAVR) should be the preferred approach to most patients with severe symptomatic aortic stenosis.
Both TAVR valves (the baloon-expanded Edwards and the self-expanding Medtronic) proved superior to surgical AVR in terms of one year clinical outcomes.
2. The Alcohol-AF Trial. It is well known that binge alcohol consumption (holiday heart) can trigger atrial fibrillation (AF) and that observational studies show a higher incident of AF with higher amounts of alcohol consumption.
This trial was the first ever randomized controlled trial of alcohol abstinence in moderate drinkers with paroxysmal AF (minimum 2 episodes in the last 6 months) or persistent AF requiring cardioversion.
Participants consumed >/= 10 standard drinks per week and were randomized to abstinence or usual consumption.
They underwent comprehensive rhythm monitoring with implantable loop recorders or existing pacemakers and twice daily AliveCor monitoring for 6 months.
Abstinence prolonged AF-free survival by 37% (118 vs 86 days) and lowered the AF burden from 8.2% to 5.6%
AF related hospitalizations occurred in 9% of abstinence patients versus 20% of controls
Those in the abstinence arm also experienced improved symptom severity, weight loss and BP control.
This trial gives me precise numbers to present to my AF patients to show them how important eliminating alcohol consumption is if they want to have less AF episodes.
It further emphasizes the point that lifestyle changes (including weight loss, exercise and stress-reduction) can dramatically reduce the incidence of atrial fibrillation.
Apixaban (Eliquis, one of the four newer oral anticoagulants (NOAC)) versus warfarin for patients with AF: which is safer for prevention of stroke related to AF?
Triple therapy with low dose aspirin and clopidogrel plus warfarin/NOAC versus clopidogrel plus warfarin/NOAC: which is safer in preventing stent thrombosis without causing excess bleeding in patients with AF and recent stent?
Briefly, they found:
The NOAC apixaban patients compared to warfarin had a 31% reduction in bleeding and hospitalization. No difference in ischemic events.
Adding aspirin increased bleeding by 89%. There was no difference in ischemic events. (Major or clinically relevant nonmajor bleeding was noted in 10.5% of the patients receiving apixaban, as compared with 14.7% of those receiving a vitamin K antagonist (hazard ratio, 0.69; 95% confidence interval [CI], 0.58 to 0.81; P<0.001 for both noninferiority and superiority), and in 16.1% of the patients receiving aspirin, as compared with 9.0% of those receiving placebo (hazard ratio, 1.89; 95% CI, 1.59 to 2.24; P<0.001).)
This means that the dreaded “triple therapy” after PCI in patients with AF with its huge bleeding risks no longer is needed.
It also further emphasizes that NOACs should be preferred over warfarin in most patients with AF.
The combination of choice now should be a NOAC like apixaban plus clopidogrel.
4. REDUCE-IT provided further evidence that icosapent ethyl (Vascepa) significantly reduces major cardiovascular events in patients with establshed CV disease on maximally tolerated statin therapy.
The results of the pirmary end point from the REDUCE-IT were presented at the AHA meeting last year and they were very persuasive. At the ACC, Deepak Bhatt presented data on reduction of total ischemic events from the study and they were equally impressive. Adding the pharmaceutical grade esterified form of EPA at 2 grams BID reduced first, second, third and fourth ischemic events in this high risk population.
The benefit was noted on all terciles of baseline triglyceride levels. Thus, the lowest tercile of 81 to 190 mg/dl benefitted as well as the highest tercile (250 to 1401).
Although I dread the costs, it’s time to start discussing adding Vascepa on to statin therapy in high risk ASCVD patients who have trigs>100 .
As I wrote previously I didn’t learn anything from the much ballyhooed and highly anticipated Apple Heart Study . It’s entirely possible more participants were harmed than helped by this study.
Please allow me to introduce myself.I am the Gullible Gastroenterologist.I’ve been around for a long long year, and today I have been given the opportunity by my good friend, the Skeptical Cardiologist (SC), to guest-blog on issues involving the GI tract.
As opposed to my skeptical friend, I had been very trusting by nature. But the SC has opened my eyes to the importance of fact-based medicine.Seems to be a pretty good way to treat patients while making informed decisions based on the facts.
When the SC approached me to comment about probiotics, I jumped at the chance.What could possibly be easier than discussing the obviously positive effects associated with ingesting good bacteria?I mean, it says “good” right there in the description!But then I remembered the SC’s insistence on giving weight to the facts.And that’s when things started to get a more problematic.
What Are Probiotics?
Probiotics are defined by the World Health Organization as “live microorganisms that when administered in adequate amounts confer a health benefit on the host.”The hope is that these ingested microorganisms will somehow affect the bacterial environment (the flora or microbiota) that already exists in our digestive tract.This sounds great in theory, but it is important to realize that this issue is far from straight forward.
Go look in the mirror right now.No seriously.Do it.I’ll wait.I’m going to guess that you saw a human being in front of you (I hope).Think about all the cells that made up what you saw.All the cells in all the tissues that make up you.It has been estimated that the total number of cells in an average 70 kg male equals 3.0 x 1013.Now we know that bacteria normally reside in our body, but how many?This has actually been estimated to equal approximately 3.8 x 1013 cells.So you are made up of MORE bacterial cells than “you” cells.Think about that for a second.These bacterial cells are an intrinsic part of us.Some have even gone so far as to call our gut flora a separate organ or even, when combined with our immune system, another sense akin to sight, smell, or touch.
So it is clear that the gut flora should be looked upon with respect, and we have known this for some time.When animals are raised within isolators to create germ-free animals, we can see evidence that the gut microbiota influences normal neurological development and cognition, digestion, immune response, growth, and metabolism.So somehow changing the gut microbiota might be effective in treating disease or alleviating certain symptoms, right?Well, that is the idea behind many sources which claim that probiotics boost immune response, improve the health of your digestive tract, relieve dermatological conditions, cure or prevent autism, treat erectile dysfunction, and so on.
But there is a huge gap between the actual science of attempting to alter the gut microbiome and these unsupported ever-growing claims.The main issue is that the gut microbiome is extremely complicated.There is great individual variability between the types and concentrations of bacteria that live in my gut, and those that live in your gut.Even the Great SC has his own unique concoction of gut flora.In fact researchers have shown that the DNA makeup of the bacteria in an individual’s intestine is like a fingerprint and is remarkably stable in each individual.Even after a year, these researchers were able to identify participants in their study just from the analysis of their unique gut flora.
So if we all have our unique gut flora, how can we determine what strains of bacteria to use to treat a patient for whatever ailment we are trying to cure?What dosage or concentration should we use?By what route should we introduce our special concoction?Maybe more importantly, is any of this safe for us?Can probiotics actually do us harm?
This becomes even more problematic due to the under regulation of the sources of these probiotics.When we obtain these probiotics from various sources, it’s hard to know exactly what is in these products.Multiple studies have found discrepancies between what we see on the label and what is actually in the bottle.In 2015, an analysis of 16 probiotic products found that only one of them matched the bacterial species reported on the label.Furthermore, if we are trying to somehow alter our bacteria microbiota, we would optimally want live bacteria in the product, and we know that this is not always the case.
Gastrointestinal Benefits Of Probiotics
So from a gastrointestinal perspective, what are the scientifically proven health benefits of probiotics?These appear to be few and far between.The majority of the studies have failed to reveal any benefits in individuals that are already healthy.There seems to be no evidence that people with normal gastrointestinal tracts benefits from these products.
What about folks that are not healthy?Can probiotics cure a gastrointestinal disease or a condition?
Many people with irritable bowel syndrome (IBS) come to see the Gullible Gastroenterologist every day.Although some individual studies have shown some positive effect from probiotics on the symptoms that can be associated with IBS, there is not enough data to recommend any particular strain of bacteria for this condition, and these studies are even more problematic given that even the placebo rate for treatment of IBS averages approximately 40%.
For patients with ulcerative colitis, a disease that causes abnormal inflammation in the large intestine, some small studies have suggested some potential benefits, but combining the results of these studies together does not prove any reliable benefit.
There has been no proven benefit regarding the use of probiotics in Crohn’s disease, a condition similar to ulcerative colitis that can affect anywhere in the gastrointestinal tract.
Small controlled studies do suggest that a probiotic preparation called VSL#3 can be effective in a condition called Pouchitis.This is a specific condition that can affect patients with ulcerative colitis that have undergone a certain surgery to treat the disease.
There is no evidence to suggest that probiotics are effective in treating celiac disease.
Probiotics And C. difficile Infection
And now we get to the intriguing topic of Clostridium difficile associated colitis.Clostridium difficile infection typically occurs in patients who have received antibiotics for therapy for bacterial infections elsewhere in the body, pneumonia for example.The antibiotics can alter the bacterial flora of the gut leading to overgrowth of the C. difficile bacteria.This overgrowth leads to production of a toxin and subsequent inflammation of the colon.This bacteria can form spores and so in some patients this condition can be very difficult to treat, resulting in multiple recurrences.
One of the treatments for recurrent C. difficile infection involves fecal transplantation: transferring stool from a healthy patient to the affected individual.
The Gullible Gastroenterologist had the opportunity to participate in a fecal transplantation procedure.The stool from a related donor was prepared in a blender by an infectious disease specialist colleague of mine (this is the reason I absolutely do not attend cocktail parties hosted by that particular physician).I performed a colonoscopy on the patient and the stool mixture was instilled into the patient’s colon.
The patient did well with no recurrences, and fecal transplant does appear to be a promising tool in the armamentarium in treatment of recurring C. difficile infection.That being said, there is insufficient data to support routine use of probiotics for prevention of C. difficile colitis or for treatment of active C. difficile colitis.
Why Are Probiotics Ineffective?
So there is little convincing evidence that probiotics positively effect gastrointestinal disorders.One reason might be that bacteria from a probiotic supplement might not actually succeed in colonizing the human intestinal tract.A recent study concluded that in some patients, probiotic strains could be identified in samples obtained from some study participants, but in others, those probiotic strains were undetectable.
In another study, researchers looked at the fecal microbiome in patients that had received antibiotics.Normally, a person’s microbiome will recover on its own over time after receiving antibiotics.This usually takes about 21 days without any intervention.Surprisingly, administering probiotics to these subjects actually delayed recovery of the microbiome to the pre-antibiotic state to greater than five months.What does this mean?Is this good?Is this bad?The answer is that we just don’t know.Yet.
Harm From Probiotics?
Can probiotics do harm?Although these agents are generally felt to be safe in healthy individuals, we don’t know the long term consequences.Furthermore, probiotics should be used with caution in patients with chronic disease, are immunocompromised, or are otherwise vulnerable (such as elderly patients).
Bottom Line: More Research Needed Before Usefulness Of Probiotics Proven
So the bottom line?Research on the fecal microbiome is certainly exciting.This area of study definitely has the potential to be very important and likely holds the key to discovering the underlying pathophysiology to many conditions.
But in the year 2019, we just do not have enough information to determine which preparations may be helpful, which patients should be targeted, and how.
Although I am hopeful that someday probiotics might be an effective tool in treating some of the diseases and conditions that my patients suffer from today, I am just not gullible enough to buy into the hype associated with unsubstantiated claims regarding their usefulness until we learn much much more.
The Gullible Gastroenterologist,
Dave Lotsoff, lives south of Delmar in University City, Missouri and when he’s not singing like Jim Morrison for the skeptical cardiologist’s band he practices gullible clinical gastroenterology in St. Louis.
N.B. Probiotics have also been promoted for lowering blood pressure and reducing risk of cardiovascular disease but the proof of benefit is similar to that for GI problems-severely lacking.
It’s far too early to recommend probiotics for preventing or treating any chronic diseases.
In July of 2018, the FDA made a series of voluntary recalls of several versions of the generic blood pressure medication valsartan which were made in China and were contaminated by the “possible carcinogen,” N-nitrosodimethylamine (NDMA).
At the time I asked readers the question, “Is your BP med made in china and is it safe?” as it became clear that now in the US users of medications must be very aware of the source and quality of the products they put in their body.
Generic prescription medications and OTC products are highly likely to be manufactured out of the US and with minimal oversight.
Since then the FDA has announced multiple other recalls for companies producing angiotensin II receptor blockers (ARBs) in the same class as valsartan, including products containing losartan and irbesartan,. These drugs have been found to be contaminated contaminated with NDMA or another carcinogen N-nitrosodiethylamine (NDEA).
The recall now includes irbesartan and losartan plus additional lots of valsartan. Thus, some patients who we switched from valsartan to losartan are now having to switch again.
Here’s the FDA’s valsartan alert notice from 1/2/19
FDA is alerting patients and health care professionals to Aurobindo Pharma USA’s voluntary recall of two lots of valsartan tablets, 26 lots of amlodipine and valsartan combination tablets, and 52 lots of valsartan and hydrochlorothiazide (HCTZ) combination tablets due to the amount of N-Nitrosodiethylamine (NDEA) in the valsartan active pharmaceutical ingredient. Aurobindo is recalling amlodipine and HCTZ only in combination medications containing valsartan. Neither amlodipine nor HCTZ is currently under recall by itself.
Aurobindo is recalling lots of valsartan-containing medication that tested positive for NDEA above the interim acceptable daily intake level of 0.083 parts per million.
The agency continues to investigate and test all angiotensin II receptor blockers (ARBs) for the presence of NDEA and N-Nitrosodimethylamine (NDMA) and is taking swift action when it identifies these impurities that are above interim acceptable daily intake levels.
FDA reminds patients taking any recalled ARB to continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition. Some ARBs contain no NDMA or NDEA.
Fortunately, there are multiple generic and brand nameARBs we can substitute for the recalled products.
Patients Discover How Hard It Is To Find Non-Chinese Medications
Also, the FDA has found another cancer causing chemical in the drug since I last wrote – now there are two. I checked at [MAJOR CHAIN] pharmacy – they use the SAME CHINESE MANUFACTURER. I checked at [MAJOR CHAIN 2] – yep, they use the SAME CHINESE MANUFACTURER. This is really starting to get scary. I’m trying hard to find a pharmacy that has the non-Chinese version (there are 16 other generic manufacturers of the drug). My insurance company only permits me to use the pharmacies I tried today. Funny how everyone is buying Chinese. Does that validate the claims made in the Epoch article. Is this really that Chinese are undercutting everyone else? I’m just disgusted. I will tell you that if I owned a pharmacy I would not purchase my generics from the same company that just caused one of the largest drug recalls in history. It must be really really cheap. Really really cheap.
I have been taking Losartan, but became really concerned with the latest news about carcinogens found in two more BP medications. I called EVERY local pharmacy, including big-box stores, grocery store pharmacies, independent pharmacies, and traditional pharmacies. Not a single one has US-made losartan. Every one of them has stock of meds made in either China or India. One pharmacists told me that he had no control of what he sells; it’s all decided on the corporate level. Another said that he would stock the cheapest generic he could find. Still another pharmacy tried to convince me that Citron, Torrent, and Solco are New Jersey companies selling US-made drugs. It takes only a few minutes of Internet research to prove them wrong. Apparently, there is no incentive to stock US-made drugs. I agree, the consumers have to take action and write to their representatives demanding answers from the FDA.
I have just had the same experience. My Indian made Valsartan (Camber) was recalled so my doctor switched me to Irbesartan 150 mg tablets which at my local CVS were also manufactured by Camber. I reluctantly took these while searching for US or European made alternatives. I just went to CVS to get my refill. When I got home instead of the Indian Irbesartan I received a bottle manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd.,(ZHP) Xunqiao, Linhal, Zhejiang China. I am a mechanical engineer not a chemistry major but I believe Irbesartan contains API which is what has been the problem from this company. Looking at the internet I see that the FDA has and import alert for this company. The import alert halts all ZHP-made API and finished drug products using the company’s API from legally entering the United States (https://www.pharmacist.com/article/fda-places-zhejiang-huahai-pharmaceuticals-import-alert). Let’s see- did the Chinese use good API in this batch….I called the CVS and asked for alternatives and was told “good luck”. My doctor said he will work with me if I can find non Chinese or Indian medication. I go out of my way to buy American made goods as I have worked in manufacturing my entire career and have made numerous trips to China and seen what goes on. My Chinese colleagues when they come to the US fill their bags with US made baby formula and vitamins (which probably contain Chinese ingredients). If anyone finds a US or European source of BP medication please post it.
What Can We Do?
One of my readers, Kate, made the following suggestion which made a lot sense:
write to the Senate committee that oversees the FDA. Demand more clarity in labeling of prescription bottles – the country of origin should be CLEAR and CONSPICUOUS – just like that little “Made in China” sticker on the photo above – but on the prescription label itself. Right now only the pharmacist’s supply bottle has the labeling. Write your congressman and to:
U.S. Senate Committee on Health, Education, Labor & Pensions
428 Senate Dirksen Office Building
Washington, DC 20510
I would encourage patients who are taking these recalled ARBS (which are really good blood pressure medications) to check their pill bottles and check with their pharmacists to determine if they have been recalled. If the pharmacist can’t replace your medication with an identical ARB that hasn’t been withdrawn, ask your physician for one of the alternatives listed above.
Find out what country you’re generic drugs in general are made in and let your congressional representatives know you want better FDA oversight of off-shore pharmacuetical manufacturing along with complete transparency with respect to country of origin.
The skeptical cardiologist wrote a post extolling the virtues of egg nog back in 2013.
Today I’m reposting it and wishing all my readers and patients a great Christmas and a fantastic 2019.
It’s Christmas Eve and you are starting to make merry. Time to break out the egg nog? Or should you eschew this fascinating combination of eggs, dairy and (often) alcohol due to concerns about heart disease?
Could this be related to excessive consumption of egg nog?
Egg nog is composed of eggs, cream, milk and booze. All of these ingredients have become associated with increased risk of heart disease in the mind of the public.
Nutritional guidelines advise us to limit egg consumption, especially the yolk, and use low-fat dairy to reduce our risk of heart disease
A close look at the science, however, suggests that egg nog may actually lower your risk of heart disease.
Eggs are high in cholesterol but as I’ve discussed in a previous post, cholesterol in the diet is not a major determinant of cholesterol in the blood and eggs have not been shown to increase heart disease risk.
Full fat dairy contains saturated fat, the fat that nutritional guidelines tell us increases bad cholesterol in the blood and increases risk of heart attacks. But some saturated fats improve your cholesterol profile and organic (grass-fed, see my previous post) milk contains significant amounts of omega-3 fatty acids which are felt to be protective from heart disease.
Milk and dairy products are associated with a lower risk of vascular disease!
Whether you mix rum, brandy, or whisky into your egg nog or you drink a glass of wine on the side you are probably lowering your chances of a heart attack compared to your abstemious relatives. Moderate alcohol consumption of any kind is associated with a lower risk of dying from cardiovascular disease compared to no alcohol consumption.
So, drink your egg nog without guilt this Holiday Season!
You’re actually engaging in heart healthy behavior.
Apple claims that its Apple Watch can detect atrial fibrillation (AF) and appropriately notify the wearer when it suspects AF.
This claim comes with many caveats on their website:
Apparently it needs to record 5 instances of irregular heart beat characteristic of atrial fibrillation over at least 65 minutes before making the notification.
This feature utilizes the watch’s optical heart sensors, is available in Apple Watch Series 1 or later and has nothing to do with the Apple Watch 4 ECG recording capability which I described in detail in my prior post.
Failure To Detect AF
A patient of mine with known persistent AF informed me yesterday that she had gone into AF and remained in it for nearly 3 hours with heart rates over 100 beats per minute and had received no notification. She confirmed the atrial fibrillation with both AW4 recordings and AliveCor Kardia recordings while she was in it.
The watch faithfully recorded sustained heart rates up to 140 BPM but never alerted her of this even though the rate was consistently over her high heart rate trigger of 100 BPM.
The patient had set up the watch appropriately to receive notifications of an irregular rhythm.
Reviewing her tracings from both the AW4 and the Kardia this was easily diagnosed AF with a rapid ventricular response.
What does Apple tell us about the accuracy of the Apple Watch AF notification algorithm? All we know is the unpublished , non peer-reviewed data they themselves collected and presented to the FDA.
In a study of 226 participants aged 22 years or older who had received an AFib notification while wearing Apple Watch and subsequently wore an electrocardiogram (ECG) patch for approximately 1 week, 41.6% (94/226) had AFib detected by ECG patch. During concurrent wear of Apple Watch and an ECG patch, 57/226 participants received an AFib notification. Of those, 78.9% (45/57) showed concordant AFib on the ECG patch and 98.2 % (56/57) showed AFib and other clinically relevant arrhythmias. These results demonstrate that, while in the majority of cases the notification will accurately represent the presence of AFib, in some instances, a notification may indicate the presence of an arrhythmia other than AFib. No serious device adverse effects were observed
This tells us that about 80% of notifications are likely to be Afib whereas 20% will not be Afib. It is unclear what the “other clinically relevant arrhythmias” might be. If I had to guess I would suspect PVCS or PACS which are usually benign.
If 20% of the estimated 10 million Apple Watch wearers are getting false positive notifications of afib that means 2 million calls to doctor or visits to ERs that are not justified. This could be a huge waste of resources.
Thus the specificity of the AF notification is 80%. The other important parameter is the sensivitiy. Of the cases of AF that last >65 minutes how many are detected by the app?
Apple doesn’t seem to have any data on that but this obvious case of rapid AF lasting for 3 hours does not give me much confidence in their AF detection algorithms.
They do have a lot of CYA statements indicating you should not rely on this for detection of AF:
It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis. These data are only captured when the user is still. Along with the user’s risk factors, the feature can be used to supplement the decision for AFib screening. The feature is not intended to replace traditional methods of diagnosis or treatment.
My patient took her iPhone and Apple Watch into her local Apple store to find out why her AF was not detected. She was told by an Apple employee that the Watch does not detect AF but will only notify her if her heart rate is extremely low or high. I had asked her to record what they told her about the problem.
As I’ve written previously (see here) the Apple Watch comes with excessive hype and minimal proof of its accuracy. I’m sure we are going to hear lots of stories about AF being detected by the Watch but we need some published, peer-reviewed data and we need to be very circumspect before embracing it as a reliable AF monitor.
This approach utilizes a low dose of rosuvastatin taken intermittently with the goal of minimizing any statin side effects, but obtaining some of the benefits of statin drugs on cardiovascular risk reduction.
It worked well for Geo; taking 5 mg rosuvastatin three times weekly lowered his LDL-C (bad cholesterol) by 50%, and he had absolutely no side effects when I reported on him 6 months after starting the drug.
However, when I stayed with Geo and his lovely wife, Wendy, over Thanksgiving in their Annapolis, Maryland house, Geo revealed that he had stopped taking his statin.
Like many patients, he was swayed by a news report suggesting an important “new study” that suggested there was no relationship between cholesterol and heart disease, and that statin drugs were dangerous and should be stopped.
At first I thought the story that he had read was the one I reported here which (appropriately) questions the benefit of statins for primary prevention in patients over the age of 75.
However, after a bit of searching, Geo told me the article that caused him to stop taking his statin was a UK Daily Mail one entitled:
‘No evidence’ having high levels of bad cholesterol causes heart disease, claim 17 physicians as they call on doctors to ‘abandon’ statins
But the new study, based on data of around 1.3 million patients, suggests doling out statins as a main form of treatment for heart disease is of ‘doubtful benefit’.
Is this really a “new study” that contradicts the great body of evidence showing that statin treatment is safe and effective in preventing heart attacks and stroke in those at high risk for cardiovascular events?
Larry Husten, who writes highly informed cardiac journalism at Cardiobrief, gives a good summary of their methods in this description of the authors of an editorial attacking the results of the JUPITER trial:
Nevertheless, the association of the authors with a group like THINCS raises some troublesome questions because, in fact, THINCS members don’t just object to one trial (JUPITER), or just one drug (rosuvastatin), or just the use of statins for primary prevention. They raise objections about ALL cholesterol-lowering trials, ALL cholesterol-lowering drugs, and the use of statins in ALL populations. They constantly harp on the dangerous side effects of statins, and exploit any bit of evidence they can find to launch their attacks, always ignoring the considerable evidence that doesn’t support their views. So the Archives paper on JUPITER is not really part of the scientific process, since the authors have no interest in the give and take of medicine and science. Their only interest is to attack, at any point, and on any basis, anything related to mainstream science about cholesterol.
The lead and corresponding author, Uffe Ravnskov is the founder of THINCS and author of The Cholesterol Myths – Exposing the Fallacy that Saturated Fat and Cholesterol Cause Heart Disease (2000), which is considered the bible of cholesterol contrarianism.
Ravnskov’s book has been severely criticized in Bob Carroll’s The Skeptic’s Dictionary, which outlines the distortions and deceptive techniques found in the cholesterol skeptics’ arguments.
“to reject the cholesterol connection and statins entirely is to throw the baby out with the bathwater. In my opinion, THINCS is spreading misinformation that could lead patients to refuse treatment that might prolong their life or at least prevent heart attacks and strokes.”
Indeed, if they were able to convince a highly intelligent patient like Geo, with a science background who also had easy access to the advice of a forward thinking cardiologist to stop taking his statins, who knows how many thousands have been convinced to stop their medications.
So my best advice for Geo and all of you taking statins is the following:
Make sure you really need to be on the drug after engaging in shared-decision making with your physician and learning all you can about your personal risk of cardiovascular disease, the benefits of statins for you, and the potential side effects.
Once you’ve made a decision based on good information and physician recommendation, try to ignore the latest headlines or internet stories that imply some new and striking information that impacts your health-most of these are unimportant.
The evidence for the benefit of statins is based on a deep body of scientific work, which will not be changed by any one new study. There is a very strong consensus amongst scientists who are actively working in the field of atherosclerosis, and amongst physicians who are actively caring for patients, that statins are very beneficial and safe. This consensus is similar to the consensus about the value of vaccines.
Science moves incrementally, and new studies inform those with open minds. The studies in this area that have been most significant in the last few years have actually strengthened the concept that drugs which lower LDL-C without causing other issues lower cardiovascular risk (see here on PCSK9 inhibitors and here on ezetimibe.)
N.B. *The Expert Review of Clinical Pharmacology”is an open access journal, many of which are predatory. Article are solicited and the authors pay to have their work published. For the article in question, the Western Vascular Institute payed the fee. It’s not clear that there is any peer-review process involved.
Some authors have suggested predatory journals are “the biggest threat to science since the inquisition”and I am very worried about the explosive growth in these very weak journals which exist solely to make money.
I realize that writing this piece will engender the wrath of many so before you leave comments impugning my integrity let me reiterate that I receive absolutely nothing from BIG PHARMA. In fact, by writing appropriate prescriptions for statin drugs I reduce my income as my compliant patients avoid hospital and office visits and all kinds of procedures for heart attacks and strokes!
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.
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.