All posts by Dr. AnthonyP

Cardiologist, blogger, musician

RMore Incredibly Bad Science From Dr. Esselstyn’s Plant-Based (Vegan) Diet Study

A while back the skeptical cardiologist exposed “The incredibly bad science behind Dr. Esselstyn’s plant-based diet.

The diet has the catchy slogan “eat nothing with a face or a mother” and Esselstyn was featured in the vegan propaganda film “Forks Over Knives.”

After detailing the lack of science I concluded:

Any patients who were not intensely motivated to radically change their diet would have avoided this crazy "study" like the plague.

This "study" is merely a collection of 18 anecdotes, none of which would be worthy of publication in any current legitimate medical journal.

Three of the 18 patients have died, one from pulmonary fibrosis, one presumably from a GI bleed, and one from depression. Could these deaths be related to the diet in some way? We can't know because there is no comparison group.

The post garned little attention initially but in the last few months several hundred visitors per day apparently read it and Essesltyn followers have started leaving me testimonials to the diet along with nasty comments.

Here’s are some typical ones (with my comments in red)

“If your (sic) not backed by some meat industry or cardiac bypass group I would be much surprised.”

I am completely free of bias. Nobody is paying me anything to do the research and writing I do. My only purpose is to find the truth about diet in order to educate my patients properly. I have  saved many more patients from bypass surgery than I have referred for the procedure.

“it is so arrogant to think the only science could come from clinical studies which may be funded by an interested party.”

Doctors like randomized (and preferably blinded) clinical studies because they minimize the bias introduced by interested parties like patients and zealous investigators (like Dr. E)  motivated to see positive outcomes. Small, non-randomized studies can only generate ideas and hypotheses which larger, randomized studies can prove with a greater degree of certainty.

“the entire nentire western medical system is skewed due to the big pharma influence…unfortunately western medicine believes the only science is the pen and the scalpel..whereas …history is the best teacher of all…”

By pen I assume you mean medications. If we examine history as  you suggest we see that life expectancy was 50 years in 1945  but today in developed countries it is around 80 years. This advance corresponds to (among other things) advances in vaccines, antibiotics, anti-cancer drugs, cardiac and blood pressure medications and surgery: the pen and the scalpel. It does not correspond to following a vegan diet.

“Your foolishness is the embarrassment.”

Thank you for this insightful comment! I’m considering it as my epitaph.

One man felt that changing to the Esselstyn diet dramatically improved his cardiac situation and commented:

“Nothing like bashing something that works just because you want to eat meat. .”

I do enjoy meat in moderation but I also really enjoy vegetables, nuts, fish, legumes, olive oil and avocados. I looked into Esselstyn’s diet in detail because it stands out as particularly misguided in banning nuts, avocados, fish and olive oil to heart patients.

..”.So sicking (sic) to see people talk trash about something that works so well… It saved my life…”

I’m happy you are doing well with your cardiac condition but it is impossible to know what would have happened to you on a more reasonable diet such as the Mediterranean diet (which actually has legitimate scientific studies supporting it). And again criticizing Esselstyn’s ideas and “study” can hardly be considered trash talk.

“I personally have followed dr. esselstyn’s program for what will be 5 years in 11/17 and have made tremendous gains in my cardio pulmonary function….my cardiologist looks at me in wonder…why are you here? and often says , if everyone did what you have…Id be out of business…so…isnt that telling and sad?”

I’m glad you’re doing well with the program, most patients can’t follow this kind of diet for more than a few months.  But perhaps we shouldn’t judge its effectiveness until  we make sure you don’t suffer a heart attack next week. Your cardiologist is wrong: see what I wrote about “dealing with the cardiovascular cards you’ve been dealt.” Some individuals inherit genes that guarantee progressive and accelerated atherosclerosis that will kill them at an early age despite the best lifestyle.

“…the phrase “follow the money” comes to mind…and since theres no big money to be made….science will attempt to dispell the results and thousands of years of history that proves this dietary system works…”

Using a scientific approach to analyze Esselstyn’s diet (which tries to claim a scientific basis) seemed appropriate to me but I wasn’t motivated by money. I’m looking for what is best for my patients, pure and simple.

The Plural of Anecdote Is Not Data

One man wrote:

“But since this is only anecdotal evidence – it must be junk science…”

Esseslstyn devotees like to post what their personal experience is with the diet but as skeptical medicine has pointed out “the plural of anecdote is not data.” 

One woman described in detail a good response her husband had after starting the diet following a heart attack:

I’m concerned about the skeptical cardiologist going after the person of dr. Esselstyn versus the science, such as quoting how you States dr. Esselstyn came up with the diet. So there may be a personal bias there. I’m sure there are more people out there on the esselstyn diet that are not noted in the study years ago. I hope there is another book coming out

I’ve reviewed in detail my comments about how Esselstyn came up with the diet but I am at a loss to find any ad hominem attack.

This woman went on to say

We will keep you posted, as my husband is willing to get another cardiac Cath and 12 months to visually see the difference after the diet.

I have to point out that if his cardiologist performs a cardiac cath (which carries risks of stroke, heart attack and death) for the sole purpose of checking the effect of the diet he is engaging in unethical medical behavior and likely insurance fraud. By the way, I hope that your husband is on a statin like most of Dr. Esselstyn’s are!:)

and a man wrote

Calling Essylstein ilk shows a little too much biased hatred on your part

Please note the definition of ilk “a type of people or things similar to those already referred to.” No pejorative there. And no ad hominem attack.  I wrote:

 It is possible that the type of vegan/ultra-low fat diets espoused by Esselstyn and his ilk have some beneficial effects on preventing CAD, but there is nothing in the scientific literature which proves it.

I should be able to criticize the methods and ideas of Dr. E without it being considered an attack on his person

Completely wrong. Esselstyn has saved my life. His book explains it all, how the endothelium cells get ruined, inflammation … heart attack proof (his words). One does not continue as head of the Cleveland Wellness Center if one is a quack.

Words are easy to come by on the interweb but Dr. E’s are not supported by science and as for the “Cleveland Wellness Center” it is probably not wise to get me started. Dr. E ‘s program is listed as being part of the Cleveland Clinic Wellness Center which is an attempt to capitalize on the market for pseudoscientific enterprises. He is not the director. The director recently came under intense criticism for promoting anti vaccine quackery. (See here).

The Wellness Center promotes so-called functional, integrative, complementary and alternative approaches. (Functional medicine is fake medicine!) These are approaches that have not been proven to work and could arguably be called quackery. (Let me be clear, however, I am not calling Dr. Esselstyn a quack but the fact that he is part of the Wellness Center does not add any scientific validity to his work.)

“I’m sure there are more people out there on the esselstyn diet that are not noted in the study years ago. I hope there is another book coming out”

Fake News, Fake Science

As a matter of fact, Dr. E has been hard at work over the last 30 years and has added a grand total of 176 patients who are considered “adherent” to the diet: about 6 per year. The “original research” was published in The Journal of Family Practice in 2014. Unfortunately the bad science present in the original publication has only been amplified.

In addition to any randomization or suitable control group for comparison, the data collection techniques are unacceptable:

“In 2011 and 2012 we contacted all participants by telephone to gather data. If a participant had died, we obtained follow-up medical and dietary information from the spouse, sibling, off-spring or responsible representative.”

In other words, there was no actual systematic review of medical records, autopsies or death certificates, just word of mouth from whomever answered the phone.

“Patients who avoided all meat, fish, dairy, and knowingly, any added oils throughout the program were considered adherent.”

Imagine, if you will, that your husband died 10 years ago and you received a call from Dr. E’s office or perhaps Dr. E himself and he asks you if your husband “avoided all meat, fish, dairy and added oils.”  For one thing, it would be very difficult for you to answer that question with any degree of accuracy: was your husband cheating on Dr. E’s diet when you weren’t looking, do you remember his entire diet from 10 years ago?

For another thing, you know that the caller has an agenda. If your husband died of a heart problem the caller is not going to be happy until he/she gets you to admit that your husband had some guacamole on Cinco de Mayo in 2002. If he’s alive and doing well, the caller is likely to be satisfied with a simple answer that , yes, he’s following the diet.

Yes, we have more data from Dr. E but it turns out to be even more incredibly bad than the first lot.

Let the anecdotes and ad hominem attacks begin!

-ACP

AfibAlert Versus AliveCor/Kardia: Which Mobile ECG Device Is Best At Accurately Identifying Atrial Fibrillation?

The skeptical cardiologist has been testing the comparative accuracy of two hand-held mobile ECG devices in his office over the last month. I’ve written extensively about my experience with the AliveCor/Kardia (ACK) device here and here. Most recently I described my experience with the Afib Alert (AA) device here.

Over several days I had my office patients utilize both devices to record their cardiac rhythm and I compared the device diagnosis to the patient’s true cardiac rhythm.

Normal/Normal

In 14 patients both devices correctly identified normal sinus rhythm. AFA does this by displaying a green check mark , ACK by displaying the actual recording on a smartphone screen along with the word Normal.

The AFA ECG can subsequently uploaded via USB connection to a PC and reviewed in PDF format. The ACK PDF can be viewed instantaneously and saved or emailed as PDF.

 

Normal by AFA/Unreadable or Unclassified by AliveCor

In 5 patients in normal rhythm (NSR) , AFA correctly identified the rhythm but ACK was either unreadable (3) or unclassified (2). In the not infrequent case of a poor ACK tracing I will spend extra time adjusting the patient’s hand position on the electrodes or stabilizing the hands. With AFA this is rarely necessary.

In this 70 year old man the AFA device recording was very good and the device immediately identified the rhythm as normal.

Chaput AFA SR

ACK recording was good quality but its algorithm could not classify the rhythm.

GC Unclassified

A 68 year old man who had had bypass surgery and aortic valve replacement had a very good quality AFA recording with correct classification as NSRChaput AFA SR

AliveCor/Kardia recordings on the same patient despite considerable and prolonged efforts to improve the recording were poor and were classified as “unreadable”

Scott AC unreadable
Alivecor tracing shows wildly varying baseline with poor definition of p wave

 

False Positives

There were 3 cases were AFA diagnosed atrial fibrillation (AF) and the rhythm was not AF. These are considered false positives and can lead to unncessary concern when the device is being used by patients at home. In 2 of these ACK was unreadable or unclassified and in one ACK also diagnosed AF.

A 90 year old woman with right bundle branch block (RBBBin NSR was classified by AFA as being in AF.

VA AFA read as AF
Slight irregularity of rhythm combined with a wider than normal QRS from right bundle branch block and poor recording of p waves likely caused AFA to call this afib
VA unclassified RBBB
AliveCor tracing calls this unclassified. The algorithm does not attempt to classify patients like this with widened QRS complexes due to bundle branch block.

The ACK algorithm is clearly more conservative than AA. The ACK manual states:

If you have been diagnosed with a condition that affects the shape of your EKG (e.g., intraventricular conduction delay, left or right bundle branch block,Wolff-Parkinson-White Syndrome, etc.), experience a large number of premature ventricular or atrial contractions (PVC and PAC), are experiencing an arrhythmia, or took a poor quality recording it is unlikely that you will be notified that your EKG is normal.

 

One man’s rhythm confounded both AFA and AC. This gentleman has had atrial flutter in the past and records at home his rhythm daily using his own AliveCor device which he uses in conjunction with an iPad.IMG_8399.jpg

During our office visits we review the recordings he has made. He was quite bothered by the fact that he had several that were identified by Alivecor as AF but in fact were normal.

Screen Shot 2017-05-06 at 11.48.47 AM
These are recordings Lawrence made at home that i can pull up on my computer. He makes a daily recording which he repeats if he is diagnosed with atrial fibrillation. In the two cases above of AF a repeat measurement was read as normal. Of the two cases which were unclassified , one was normal with APCs and the other was actually atrial flutter

A recording he made on May 2nd at 845 pm was read as unclassified but with a heart rate of 149 BPM. The rhythm is actually atrial flutter with 2:1 block.

Screen Shot 2017-05-06 at 11.47.37 AM

Sure enough, when I recorded his rhythm with ACK although NSR (with APCS) it was read as unclassified

Screen Shot 2017-05-06 at 11.49.49 AM

AFA classified Lawrence’s rhythm as AF when it was in fact normal sinus with APCs.

AFA Mcgill AF

 

 

One patient a 50 year old woman who has a chronic sinus tachycardia and typically has a heart rate in the 130s, both devices failed.

We could have anticipated that AC would make her unclassified due to a HR over 100 worse than unclassified the tracing obtained on her by AC (on the right)was terrible and unreadable until the last few seconds. On the other hand the AFA tracing was rock solid throughout and clearly shows p waves and a regular tachycardia. For unclear reasons, however the AFA device diagnosed this as AF.

 

 

Accuracy in Patients In Atrial Fibrillation

In 2/4 patients with AF, both devices correctly classified the rhythm..

In one patient AFA correctly diagnosed AF whereas ACK called it unclassified.

This patient was in afib with HR over 100. AFA correctly identified it whereas ACK called in unclassified. The AC was noisy in the beginning but towards the end one can clearly diagnose AFScreen Shot 2017-05-06 at 8.39.06 AMScreen Shot 2017-05-06 at 8.11.53 AM

In one 90 year old man AFA could not make the diagnosis (yellow)

Screen Shot 2017-05-06 at 11.35.40 AM

ACK correctly identified the rhythm as AF

Screen Shot 2017-05-06 at 11.37.51 AM

One patient who I had recently cardioverted from AF was the only false positive ACK. AliveCor tracing is poor quality and was called AF whereas AFA correctly identified NSR>

Screen Shot 2017-05-06 at 8.42.46 AMScreen Shot 2017-05-06 at 8.42.26 AM

 

 

Overall Accuracy

The sensitivity of both devices for detecting atrial fibrillation was 75%.

The specificity of AFA was 86% and that of ACK was 88%.

ACK was unreadable or unclassified 5/26 times or 19% of the time.

 

The sensitivity and specificity I’m reporting is less than reported in other studies but I think it represents more real world experience with these types of devices.

Summary

In a head to head comparison of AFA and ACK mobile ECG devices I found

-Recordings using AfibAlert are usually superior in quality to AliveCor tracings with a minimum of need for adjustment of hand position and instruction.

-This superiority of ease of use and quality mean almost all AfibAlert tracings are interpreted whereas 19% of AliveCor tracings are either unclassified or unreadable.

-Sensitivity is similar. Both devices are highly likely to properly detect and identify atrial fibrillation when it occurs.

-AliveCor specificity is superior to AfibAlert. This means less cases that are not AF will be classified as AF by AliveCor compared to AfibAlert. This is due to a more conservative algorithm in AliveCor which rejects wide QRS complexes, frequent extra-systoles.

Both companies are actively tweaking their algorithms and software to improve real world accuracy and improve user experience but what I report reflects what a patient at home or a physician in office can reasonably expect from these devices right now.

-ACP

Functional Medicine Is Fake Medicine

The skeptical cardiologis, like all advocates of science-based medicine, knows that “integrative” medicine integrates quackery into real medicine.

In many respects quackery and integrative medicine are to real medicine as fake news is to real news.

As Dr. David Gorski at science-based medicine noted last year

Originally known as quackery, the modalities now being “integrated” with medicine then became “complementary and alternative medicine” (CAM), a term that is still often used. But that wasn’t enough. The word “complementary” implies a subordinate position, in which the CAM is not the “real” medicine, the necessary medicine, but is just there as “icing on the cake.” The term “integrative medicine” eliminates that problem and facilitates a narrative in which integrative medicine is the “best of both worlds” (from the perspective of CAM practitioners and advocates). Integrative medicine has become a brand, a marketing term, disguised as a bogus specialty.

Much of this quackery being integrated  is easy to recognize:

 A lot of it is based on prescientific ideas of how the human body and disease work (e.g., traditional Chinese medicine, especially acupuncture, for instance, which is based on a belief system that very much resembles the four humors in ancient “Western” or European medicine); on nonexistent body structures or functions (e.g., chiropractic and subluxations, reflexology and a link between areas on the palms of the hands and soles of the feet that “map” to organs; craniosacral therapy and “craniosacral rhythms”); or vitalism (e.g., homeopathy, “energy medicine,” such as reiki, therapeutic touch, and the like). Often there are completely pseudoscientific ideas whose quackiness is easy to explain to an educated layperson, like homeopathy.

However, lately I’ve seen the word functional used to describe a lot of bogus and pseudo-scientific medicine. From the institute of Functional Medicine’s website comes a completely indecipherable description:

Functional Medicine addresses the underlying causes of disease, using a systems-oriented approach and engaging both patient and practitioner in a therapeutic partnership. It is an evolution in the practice of medicine that better addresses the healthcare needs of the 21st century. By shifting the traditional disease-centered focus of medical practice to a more patient-centered approach, Functional Medicine addresses the whole person, not just an isolated set of symptoms.

Dr. Gorski notes that  functional medicine has been integrated into well-respected academic programs:

“there are modalities being “integrated” into medicine whose quackiness is not so easy to explain. Perhaps the most popular and famous of these is a specialty known as “functional medicine” (FM) whose foremost practitioner and advocate (in the US, at least) is Mark Hyman, MD, a man whose fame has led him to become a trusted medical advisor to Bill and Hillary Clinton. Perhaps Hyman’s greatest coup came in 2014, when the Cleveland Clinic Foundation hired him to create an institute dedicated to FM, an effort that has apparently been wildly successful in terms of patient growth. Never mind that around the same time Dr. Hyman teamed up with rabid antivaccine activist Robert F. Kennedy, Jr. to write a book blaming mercury in the thimerosal preservative that used to be in vaccines for causing autism, an idea that was shown long ago to have no scientific merit.

To fully understand the bogusness of functional medicine I highly recommend you take time to read Dr. Gorski’s excellent and detailed article at science-based medicine . It’s entitled

Functional medicine: The ultimate misnomer in the world of integrative medicine

From SBM:

Dr. Gorski’s full information can be found here, along with information for patients. David H. Gorski, MD, PhD, FACS is a surgical oncologist at the Barbara Ann Karmanos Cancer Institute specializing in breast cancer surgery, where he also serves as the American College of Surgeons Committee on Cancer Liaison Physician as well as an Associate Professor of Surgery and member of the faculty of the Graduate Program in Cancer Biology at Wayne State UniversityFunctional Medicine

Dysfunctionally Yours,

-ACP

Dr. P’s Heart Nuts: Preventing Death In Multiple Ways

The skeptical cardiologist has finally prepared Dr. P’s Heart Nuts for distribution. IMG_8339The major stumbling block in preparing them was finding almonds which were raw (see here), but not gassed with proplyene oxide (see here), and which did not contain potentially toxic levels of cyanide (see here).

During this search I learned a lot about almonds and cyanide toxicity, and ended up using raw organic almonds from nuts.com, which come from Spain.

I’ll be giving out these packets (containing 15 grams of almonds, 15 grams of hazelnuts and 30 grams of walnuts) to my patients because there is really good scientific evidence that consuming 1/2 packet of these per day will reduce their risk of dying from heart attacks, strokes, and cancer.

IMG_7965The exact components are based on the landmark randomized trial of the Mediterranean diet, enhanced by either extra-virgin olive oil or nuts (PREDIMED, in which participants in the two Mediterranean-diet groups received either extra-virgin olive oil (approximately 1 liter per week) or 30g of mixed nuts per day (15g of walnuts, 7.5g of hazelnuts, and 7.5g of almonds) at no cost, and those in the control group received small nonfood gifts).

After 5 years, those on the Mediterranean diet had about a 30% lower rate of heart attack, stroke or cardiovascular death than the control group.

It’s fantastic to have a randomized trial (the strongest form of scientific evidence) supporting nuts, as it buttresses consistent (weaker, but easier to obtain), observational data.

Trademark

I applied for a trademark for my Heart Nuts, not because I plan to market them, but because I thought it would be interesting to possess a trademark of some kind.

The response from a lawyer at the federal trademark and patent office is hilariously full of mind-numbing and needlessly complicated legalese.

Heres one example:

"DISCLAIMER REQUIRED
Applicant must disclaim the wording “NUTS” because it merely describes an ingredient of applicant’s goods, and thus is an unregistrable component of the mark.  See 15 U.S.C. §§1052(e)(1), 1056(a); DuoProSS Meditech Corp. v. Inviro Med. Devices, Ltd., 695 F.3d 1247, 1251, 103 USPQ2d 1753, 1755 (Fed. Cir. 2012) (quoting In re Oppedahl & Larson LLP, 373 F.3d 1171, 1173, 71 USPQ2d 1370, 1371 (Fed. Cir. 2004)); TMEP §§1213, 1213.03(a).

The attached evidence from The American Heritage Dictionary of the English Language shows this wording means “[a]n indehiscent fruit having a single seed enclosed in a hard shell, such as an acorn or hazelnut”, or “[a]ny of various other usually edible seeds enclosed in a hard covering such as a seed coat or the stone of a drupe, as in a pine nut, peanut, almond, or walnut.”  Therefore, the wording merely describes applicant’s goods, in that they consist exclusively of nuts identified as hazelnuts, almonds, and walnuts.

An applicant may not claim exclusive rights to terms that others may need to use to describe their goods and/or services in the marketplace.  See Dena Corp. v. Belvedere Int’l, Inc., 950 F.2d 1555, 1560, 21 USPQ2d 1047, 1051 (Fed. Cir. 1991); In re Aug. Storck KG, 218 USPQ 823, 825 (TTAB 1983).  A disclaimer of unregistrable matter does not affect the appearance of the mark; that is, a disclaimer does not physically remove the disclaimed matter from the mark.  See Schwarzkopf v. John H. Breck, Inc., 340 F.2d 978, 978, 144 USPQ 433, 433 (C.C.P.A. 1965); TMEP §1213.

If applicant does not provide the required disclaimer, the USPTO may refuse to register the entire mark.  SeeIn re Stereotaxis Inc., 429 F.3d 1039, 1040-41, 77 USPQ2d 1087, 1088-89 (Fed. Cir. 2005); TMEP §1213.01(b).

Applicant should submit a disclaimer in the following standardized format:

No claim is made to the exclusive right to use “NUTS” apart from the mark as shown."

I’ve gotten dozens of emails from trademark attorneys offering to help me respond to the denial of my trademark request. Is this a conspiracy amongst lawyers to gin up business?

Nuts Reduce Mortality From Lots of Different Diseases

The most recent examination of observational data performed a meta-analysis of 20 prospective studies of nut consumption and risk of cardiovascular disease, total cancer, and all-cause and cause-specific mortality in adult populations published up to July 19, 2016.

It found that for every 28 grams/day increase in nut intake, risk was reduced by:

29% for coronary heart disease

7% for stroke (not significant)

21% for cardiovascular disease

15% for cancer

22% for all-cause mortality

Surprisingly, death from diseases, other than heart disease or cancer, were also significantly reduced:

52% for respiratory disease

35% for neurodenerative disease

75% for infectious disease

74% for kidney disease

The authors concluded:

If the associations are causal, an estimated 4.4 million premature deaths in the America, Europe, Southeast Asia, and Western Pacific would be attributable to a nut intake below 20 grams per day in 2013.

If everybody consumed Dr. P’s Heart Nuts, we could save 4.4 million lives!

Meditativeterraneanly Yours,

-ACP

If you’re curious about why nuts are so healthy, check out this recent meta-analysis, a discussion of possible mechanisms of the health benefits of nuts complete with references:

Nuts are good sources of unsaturated fatty acids, protein, fiber, vitamin E, potassium, magnesium, and phytochemicals. Intervention studies have shown that nut consumption reduces total cholesterol, low-density lipoprotein cholesterol, and the ratio of low- to high-density lipoprotein cholesterol, and ratio of total to high-density lipoprotein cholesterol, apolipoprotein B, and triglyceride levels in a dose–response manner [4, 65]. In addition, studies have shown reduced endothelial dysfunction [8], lipid peroxidation [7], and insulin resistance [6, 66] with a higher intake of nuts. Oxidative damage and insulin resistance are important pathogenic drivers of cancer [67, 68] and a number of specific causes of death [69]. Nuts and seeds and particularly walnuts, pecans, and sunflower seeds have a high antioxidant content [70], and could prevent cancer by reducing oxidative DNA damage [9], cell proliferation [71, 72], inflammation [73, 74], and circulating insulin-like growth factor 1 concentrations [75] and by inducing apoptosis [71], suppressing angiogenesis [76], and altering the gut microbiota [77]. Although nuts are high in total fat, they have been associated with lower weight gain [78, 79, 80] and lower risk of overweight and obesity [79] in observational studies and some randomized controlled trials [80].

Was James Comey Mildly Nauseous or Mildly Nauseated?

The skeptical cardiologist was intrigued and disappointed to hear FBI director James Comey state that  “It makes me mildly nauseous to think we might have had some impact on the election.”

Somewhere in my medical training it was drummed into my head that nauseated rather than nauseous is the word he should have used.

I was taught that nauseated means feeling nausea whereas nauseous means causing nausea.

Charles Dickens agrees with my usage. (From Grammarly.com)

Thus, if the smell of rotting fish makes me sick to my stomach I am nauseated  by it but the smell itself  is nauseous or nauseating.

On CNN Erin Burnett interviewed Senator Cory Booker regarding Comey’s comments and I noticed that Booker  always used the term nauseating rather than nauseous. Clearly, he had learned the proper way of using the terms.

As a consequence, I have passed this rigid distinction on to my children and loved ones including my eternal fiancee’. (Another grammatical error I frequently try to correct in those around me is the use of “off of.” When off is a preposition off of  can almost always be shortened to just off and writers who value concision can avoid it.)

Alas, it appears that acceptable usage of these words has changed over the years and the vast majority of my patients say they felt nauseous before they vomited .  I try to stop myself from correcting them because I’m fighting a losing battle.

As WritingExplained.org notes:

Garner’s Modern American Usage says that using nauseous when nauseated is meant (Example: I feel nauseous) is becoming so common that to call it an error is to exaggerate. Still, The Chicago Manual of Style calls this slip-up poor usage.

Clearly the tides are shifting on the usage of these words. There is even some evidence to show that nauseating is now the preferred word for causing nausea, e.g., a nauseating ride, a nauseating smell, a nauseating odor, etc.

It’s entirely possible that 20 years from now my patients will have completely substituted nauseous for nauseated and nauseating for nauseous. Wouldn’t that be ironic?

Perhaps you find this a nauseatingly trivial post with nauseous concepts that nauseate you. If so, please get off my cloud.

Antiemetically Yours,

-ACP

EpiPen Comeuppance: Cheaper Alternatives and A World-Wide Recall

The skeptical cardiologist described his own exciting episode of EpiPen usage while discussing the outrageously increased  costs of the medication in a post last year., writing:

Although the active ingredient, epinephrine, is generic and cheap, and the basic delivery system has been around for decades,  Mylan, the company that purchased the rights to EpiPen in 2007 has increased its price from 57$ per injector to 600$ for 2 injectors.

Lack of generic competition to the EpiPen  is the primary reason that the price could be raised so much and also explains in many circumstances why drug costs are high in the US.

Two developments since then hopefully have cut into Mylan’s unseemly profits from the product: cheaper alternatives and cases of EpiPen failure.

As Fortune noted

Public and Congressional outrage not only forced Mylan to pay a $465 million settlement and launch a cheaper, generic version of the injection device, but it also spurred rivals and regulators to speed competing epinephrine injectors to market to lower costs.

EpiPen Failures and Recall

In April, two cases of EpiPen failures were reported and Mylan initiated a world-wide recall of EpiPen’s manufactured during a certain time period.

This recall announcement spurred me to examine the EpiPens I had, including one I carry in my work satchel and one I have at home.

To see if you have an EpiPen that should be recalled check the black box on the side of the injector for the Lot # and then go to this link on the Mylan webpage to determine if your EpiPen has been recalled. Follow the directions for getting a voucher for a free new one.

If you’re like me, you haven’t actually checked the expiration date for years and will be shocked to find that it was 6 years ago!

Generic AdrenaClick: A Cheaper Epinephrine Auto-injector (EAI)

I called my pharmacist to find out my options for replacing the EpiPen and discovered that my insurance company (UMR) did not cover EpiPens at all. I had already researched alternatives and discovered that Lineage Therapeutics makes one called AdrenaClick and they also are now offering a generic version of AdrenaClick which, with a coupon that is offered at their website, ends up costing 10$.

Fortunately, for me the website informed me that this product is my “GO-TO-CHOICE”:

*Impax authorized generic of Adrenaclick® (epinephrine injection, USP auto-injector), also called epinephrine auto-injector or EAI. Impax EAI contains the same active medicine as EpiPen®. Impax EAI has numbered and color-coded instructions, designed for single-dose use by patients and caregivers. Impax EAI is a low-cost choice that is FDA approved… it’s the GO-TO-CHOICE for affordable, emergency treatment of allergic reactions (Type I) including anaphylaxis.

Consumer Reports has recommended this product. You need to have your doctor write the prescription for “epinephrine auto-injector.” and not for Epipen to insure proper substitution.

The technique for auto-injection is only slightly different from that of an EpiPen and you can view it here.

Shift To The Epi Auto-injector and Stick It To Mylan

It looks like I’m not the only one making a shift to a generic EAI.

This chart shows the dramatic rise that occurred in alternative prescriptions up to February, 2017

 

Mylan stock meanwhile, which dropped precipitously after adverse publicity (and my post?) in the fall of 2016 had been making a recovery but with the failed injections and the recall it is in free-fall again.

So, let’s all stick it to Mylan and when you happen to check your EpiPen and find that it expired 6 years ago replace it with something cheaper.

lancinatingly yours,

-ACP

p.s. I may never get around to writing about a useless drug called Yosprala that is being heavily marketed to physicians. The drug consists of two drugs which are cheap and available over the counter: aspirin and omeprazole (a proton pump inhibitor that reduces stomach acid and therefore ulcers.)

Yosprala sells for 150$/month. You can get either a baby aspirin (81 mg) or a full aspirin (325 mg) for pennies a day and 40 mg omeprazole (prilosec) for 46 cents per day.

Why would you pay 30 times as much for the combination?

If your doctor prescribes this stuff ask him if he has had any lunches with the Aralez pharmaceutical rep.

QardioArm: Stylish, Accurate and Portable. Is It the iPhone of Home Blood Pressure Monitors?

The skeptical cardiologist frequently has his hypertensive patients check their BPs at home and report the values to him.

An easy, accurate and efficient way to record BPs at home, and transmit to the doctor, is my Holy Grail for management of hypertension; QardioArm offers to improve on this process compared to more conventional home BP cuffs.

I recently bought a QardioArm for my father and tested one myself over the last month, and herein are my findings. I compared it closely to my prior “go to”  BP device, the Omron 10 (which I recommended as a Christmas gift here).

Appearance

The QardioArm looks like and is packaged like an Apple product. The box containing the device is esthetically pleasing, and can serve as an excellent storage and transportation mechanism. The case closes magnetically and has a pocket, within which resides the manual.

 

Upon removing the QardioArm, one is struck by how compact, sleek and cool it looks. This is not your father’s BP cuff. There are no wires or tubes coming off it, and the cuff wraps around a red (white, blue or gold) plastic rectangular cuboid.

The cuff/cuboid is small enough to easily fit in a purse or satchel, facilitating portability.

Ease of Use

Once you understand how the device works it is a breeze to use.  However, if you are inclined, like me, to skip reading the instruction manual, you run the risk of being incredibly frustrated.

First, you must download the free Qardio App to your smartphone, create a user login, register and create your personal account. If you don’t have a smartphone or tablet or don’t use the internet, this cuff if not for you. For me, this was a simple, quick process.

After setting up the Qardio App, you pair the QardioArm with the App. This requires the QardioArm be on and Blue Tooth be enabled on your smartphone.

An example of the profoundly negative review individuals give the device when they have not figured out the on/off process. This one on Consumer Reports

You might think that turning on the QardioArm, and knowing it is on,
would be an incredibly easy and obvious process: it is not (unless you pay close attention to the instructions). If you read reviews of Qardioarm on Consumer Reports or Amazon, you will encounter many very unhappy users. This is primarily because some folks could not get it to turn on.


Here are my detailed instructions for turning it on:

  1. There is a small magnet inside the cuff.
  2. The device turns itself on when you unwrap the cuff and it turns off when you wrap the cuff back up. (I am not good at wrapping things up properly and ran into issues initially because of this). When you wrap the cuff up properly you can feel the magnet locking into place and thus turning the device off.
  3. When the device is on there is no light to indicate it is on. A green light flashes on the side when it turns on, but then goes out. Many user reviews indicate frustration with this and often they end up trying to change the batteries, believing that the device is dead. I went through this same thought process initially.
  4. The device turns off “after a few minutes” if not used. You won’t know if it is on or off. If it doesn’t respond when you trigger it from the App, you must carefully rewrap the cuff and then unwrap it. If you don’t trigger the device properly with the magnet, it won’t wake up.

The QardioArm encircling the beautiful arm of the eternal fiancee’ of the skeptical cardiologist. Note: when the cuff is wrapped around my unattractive arm, it fastens properly and does not hang down.

Now that you know how to turn the device on and have paired it with your Cardio App, put the cuff over your upper arm with the cuboid over the inner aspect of your arm,
hit the big green START button and sit back while the cuff is magically inflated and an oscillometric measurement of your blood pressure performed.

 

 

The blood pressure is displayed on the app instantaneously along with pulse. If the device detects irregularity of the pulse (a possible but not reliable sign of atrial fibrillation or other abnormal heart rhythms), it display an “irregular heart beat” warning.

You can have the QardioArm take 3 BPs, a variable amount of time apart, and average the readings.

BP and pulse data can be viewed in tabular or graphic formats and  can be synched with the Apple Health App:

 

Accuracy

I found the QardioArm BP measurements to be very accurate. My medical assistant, Jenny, recorded our patient’s BPs using the “gold-standard” manual technique, and with QardioArm (consecutively and in the same arm), and there was excellent agreement. In one man with a very large arm, she could not record a BP (QardioArm’s cuff fits the arm of most people, and is appropriate for use by adults with an upper arm size between 22 and 37 cm (8.7 and 14.6 inches).  If your upper arm is larger than that, this device is not for you.  In one patient who was in atrial fibrillation, the device properly recorded an “irregular heart beat.”

From the Qardio website:

QardioArm is a highly accurate blood pressure monitor and has undergone independent, formal clinical validation according to ANSI/AAMI/ISO 81060-1:2007, ANSI/AAMI/ISO 81060-2:2009, ANSI/AAMI/IEC 80601-2-30:2009, as well as British Standard EN 1060-4:2004.

QardioArm is a regulated medical device: FDA cleared, European CE marked and Canadian CE marked.

It measures blood pressure with a resolution of 1 mmHg and pulse with 1 beat/min.

The accuracy is +/- 3 mmHg or 2% of readout value for blood pressure, and +/- 5% of readout value for pulse.

Comparison To Omron 10

I spent time evaluating the accuracy of QardioArm because a few online reviewers suggest that it is highly inaccurate for them and Consumer Reports gives it a “poor” rating for accuracy.

Consumer Reports gave the QardioArm an astonishingly low score giving it lower marks than the Omron for Convenience, Accuracy and Comfort. It gave the QardioArm a Poor mark for accuracy. No details of their measurement data are available on the site.

I compared it to the Omron 10 (Consumer Reports highest-rated BP device), and found close agreement between the two.

Simultaneous BP using Omron (above) and QardioArm (left)


I took my own BP with the QardioArm on the left arm and the Omron 10 on the right arm. Multiple simultaneous measurements showed less than 3 mmHg difference in systolic blood pressure between the two.

Unlike Consumer Reports, I found QardioArm superior to the Omron 10 in several areas:

  1. QardioArm is faster. It took 30 seconds to complete a BP measurement, compared to 50 seconds for the Omron 10.
  2. BPs are immediately available on my iPhone with QardioArm, whereas a separate Bluetooth synching process is required for the Omron App. This process never works well for me, as the Omron fails to transmit measurements reliably.
  3. It is amazingly easy to transmit BPs via email to your doctor (or friends if so inclined).

Support

I found the QardioArm website to be very informative and helpful. The manual that comes with the device is very complete and you should definitely read it before using the device. I did not need telephone or email support services, so I can’t comment on those.

Overall Rating and a Caveat

Despite an initial frustration with QardioArm, I ended up really liking this device a lot. This sounds a little silly but the QardioArm improved the esthetic experience of home BP monitoring for me. Because it is compact, sleek and attractive, patients may be more likely to utilize it on a regular basis. In particular, I see it as something that you would be much more inclined to take with you for BP monitoring at work or on vacation.

I will be recommending  this to my tech-savvy, style-conscious patients who require home BP monitoring. Previously, this type of patient would bring in their smartphone and show me the accumulated data from their BP readings. With a QardioArm, they can easily email my office the data and we can have it scanned into their record.

My final caveat: the QardioArm I gave my father for his 91st birthday does not work on his arm. It works without a problem on the arms of his friends and relatives. I have no idea why, but fortunately QardioArm honored their 30 day 100% money-back no questions asked guarantee. I’ve asked him to give me his nonagenarian perspective on the QardioArm experience so I can share it in a future post.


Quriously Yours,

-ACP

Six Things a Cardiologist Loves About Apple Watch Series 1 – None of Which Involve Health

The skeptical cardiologist stopped wearing his initial wearable piece of technology (a Garmin device that constantly prompted him to move, described here), within 6 months of purchasing it; it just wasn’t worth the effort of charging and putting on the the wrist.

I am not alone in finding FitBit type devices not worth wearing after awhile. ConscienHealth points out that sales and stock price of FitBit are down significantly.  Part of this is competition, part saturation of the market, but part must be due to individuals going through a process similar to mine.

The great promise that wearable fitness/sleep/activity tracking devices would make us healthier has not been fulfilled.

A recent study showed that among obese young adults, the addition of a wearable technology device to a standard behavioral intervention resulted in less weight loss over 24 months.

Taking the Apple Watch Plunge

However, knowing I was a fan of all things Apple, the eternal fiancee  bought me a Series 1 Apple Watch, which I have come to love. This love has little to do with how the device tracks my steps or my sleep or my pulse or my movement.

Let me count the ways I do love my Apple Watch…

  1. I can answer my phone without touching my phone or
    If I see a call is coming in from Hackert, my home security company, I have to take it no matter what I’m doing. Here I’m having a conversation about what set off my home alarm just using the Apple Watch

    having it near me or even knowing where my phone is.

    Since I’m constantly misplacing the damn thing, this is a surprisingly helpful feature. There is also the really cool aspect of walking around and having a telephone conversation  using my watch.

During a busy day of seeing patients in the office I typically will receive multiple calls from the ER or other doctors I have to talk to immediately.  Now, I can rapidly screen my calls with a tilt of my wrist and excuse myself to take the call. If I’ve been trying to get ahold of Dr. X to discuss a mutual patient, and he calls while I’m doing a transesophageal echocardiogram, I can have someone touch my watch instead of reaching into my pants for my iPhone, or searching in my office for it, or missing the call altogether.

 I’m missing much less important calls these days.

And although previously I would take calls while driving, the watch makes this process much simpler and therefore much safer.

2. Receiving and responding to text messages does not require accessing my iPhone.

Responding in detail to texts is as simple as touching the microphone icon on the Watch, speaking, then touching SEND. The translator works pretty well.

This doesn’t seem like that big of a deal, but again, the ability to rapidly scan incoming texts with just a tilt of the wrist greatly facilitates expeditious screening and processing.

The Apple Watch allows response via either audio recording (translated seamlessly and quickly to text) or pre-set standard responses or emojis.

 

3. “Hey Siri” function simplifies and makes hands-free and iPhone-free many useful tasks. For example:

  • To set a timer for my (heart-healthy) boiled eggs, I say “Hey Siri, set timer for 11 minutes.” Normally in this situation I avoid setting the timer because I’m too busy to grab my phone, open it, and find the timer app (I know I could use Siri on my phone, but that requires more effort).
  • If I suddenly remember I need to call someone while driving, the “Hey Siri” function allows making the call without taking my hands off the steering wheel.
  • If a brilliant idea for a blog post occurs to me while driving or walking through the hospital corridors, “Hey Siri” can take a note with ease.

4. Checking the time is a lot easier (I know, all watches do this, but I’ve haven’t worn a watch for about 20 years).

The lower left icon triggers the pinging of iPhone. Watch and iPhone must be “Connected” via either bluetooth and proximity or via being on the same WIFI network.

5. If I misplace my iPhone (this happens roughly once per hour when I am at home), I can “ping” it by pushing a button on my Apple Watch: follow the ping and “voila!” I have found my iPhone. Most of the time it is lying under a piece of paper or article of clothing within a few feet of where I’m working, but sometimes it is in an obscure corner for obscure reasons.

Here’s a true story which illustrates my tremendous absent-mindeness and the value of the “ping.”

I haven’t figured out how the Apple Watch knows this but when I’m getting ready to drive to work in the morning it automatically shows me something like this, advising me on the best route to take. Likewise, when I’m getting ready to leave work, it alerts me to best route home. It’s somewhat creepy. Is it keeping a log of my driving patterns?

I left my office Friday evening and after stepping outside I realized I did not have my iPhone in its usual location, the left front pocket of my pants. I searched the pockets in my pants and in the jacket I was wearing to no avail. I began heading back to my office believing that I had left it on my desk but then realized that I might have put it in my satchel. Not in my satchel. A bright idea then occurred to me: ping the iPhone to see if it was in the satchel, but hidden.

Sure enough I heard the iPhone ping. But it was not in the satchel; it was (for obscure reasons) in my shirt pocket (a place that apparently makes it undetectable to me).

6. Information on local weather is immediately available. I have configured my watch “dial” to show me the local temperature. Right now with a flick of my wrist I can see that it’s 17 degrees outside and I’m going to have to dress warmly. I’ve also configured my watch dial to tell me when sunrise/sunset is and what my heart rate is.

These last two things, although immensely interesting, are not that helpful.

Oh, excuse me, my watch timer is telling me my eggs are done.

Pingophilically Yours,

-ACP

P.S. I’m still in the process of evaluating the work-out/sleep/move/mindfulness features of Apple Watch and hope to write about it in the near future.

Feel free to share the things you love or hate about your Apple Watch below.

How Well Does The AfibAlert Remote Hand-Held Automatic ECG Device Work For Detection of Atrial Fibrillation?

I’ve been evaluating the ability of a mobile hand-held ECG device called AfibAlert to detect atrial fibrillation for the last few weeks.

I found that the device made very reliable and consistent recordings of cardiac rhythm and did a reasonably good job of detecting atrial fibrillation (afib).

The device  came in a plastic case with a USB cable for uploading recordings and two metal bracelets which attach to electrodes and provide an alternative recording method.

The device itself is about 6 by 3 by 1 inch.

 

Recordings are made by placing your thumbs on the silver/siver chloride electrodes

After a few seconds the display in the center will give heart rate and after 45 seconds the
device will make a decision about your rhythm:

If it diagnoses normal sinus rhythm a green check appears and if it diagnoses  afib a red telephone appears.

If it is confused you get yellow circular arrows.

As the maker of the device explains:

Lohman Technologies’ patented algorithm analyzes the patient’s heartbeat and the appropriate icon illuminates to show what action is needed. AfibAlert’s® algorithm was validated against 51,000+ ECG strips from the MIT-BIH Atrial Fibrillation Database with known diagnosis. The Afib monitor’s results were excellent, with 94.6% accuracy in detecting the presence of arrhythmias. Each recording produces a 45-second diagnostic quality ECG rhythm strip

The device I tested does not allow you to immediately see the ECG tracing. The recordings are uploaded to a PC via USB cable and then can be viewed as a PDF document.

I made 17  recordings on patients in my office one day. The age range was 50 to 93 years and most  patients were able to rapidly and easily  grasp the device with thumbs appropriately positioned to make interpretable recordings.

Only 2/17  came back. yellow. In both cases, I repeated the recording and the device was able to make the correct diagnosis. Twice I got the yellow signal on an elderly, partially blind patient who had trouble keeping his thumb on the electrode.

In 15  cases of normal sinus rhythm the device correctly identified NSR.

In one case of atrial fibrillation the device correctly identified atrial fibrillation.

 

 

In one case of SR with
APCs the device
incorrectly identified afib

 

Overall the device correctly classified 88% of the tracings. This was superior to the device I normally utilize ( AliveCor/Kardia mobile ECG)  in head to head comparison (I’ll present this comparison in a subsequent post).

My bullet points on the AfibAlert device:

-5 stars for Ease of Recording

-5 stars for Quality of recording

In all cases that uploaded, the recordings were very clear and free of artifact. The device did not upload yellow signal events and I presume more artifact is present in these recordings.

-2 stars for Convenience.

I found the software and uploading to be very awkward and slow. The company indicates new software soon to be released along with the ability to interface directly with iPads or smartphones that hopefully will improve this factor.

The inability to instantaneously view the ECG tracings means I cannot use it in my office to screen patients for arrhythmias. However, if a patient is solely using it to determine if afib is present or absent, this information is available right away.

-3 stars for Accuracy.

It does a reasonable job of identifying the patient who is in normal rhythm versus one in atrial fibrillation.

However, like AliveCor and other devices which strictly look at the variability of the pulse, it can be easily fooled by premature beats, especially when they are frequent, and inappropriately classify these as afib resulting in false positives.

In addition, when afib rates are very slow and thus much less variable it is likely AfibAlert will incorrectly classify them as normal thus resulting in false negatives.

False Negatives and False Positives

False negatives result in delayed diagnosis of afib. Patients will be falsely reassured that their rhythm is normal when it is not.

False  positives result in needless anxiety and testing/treatment.

If afib monitoring devices are to be successful they have to have a very low frequency of both types of inaccuracy.

The solution to inaccuracy of interpretation, of course, is to have a cardiologist over-read the tracings.

AfibAlert recordings are available online for review by your personal physician after being uploaded. This requires your physician to have an account with AfibAlert. There is no capability for having the recordings over read by an online cardiologist for a charge.

As far as I can tell the device is only available for purchase in the US and only on the AfibAlert website.

Interestingly, you cannot purchase AfibAlert  without a prescription from a physician.

Why this is mandated for AfibAlert and not AliveCor is a mystery to me.

 

 

Alertly Yours,

-ACP

 

 

Has The Digoxin Death Knell Sounded: Farewell To Foxglove?

The lovely but deadly foxglove plant encountered randomly on a hike through glorious Wales on a dreary, rainy day.

The skeptical cardiologist is fascinated by the cardiac drug digoxin and the plant from which it is derived, the foxglove.

I wrote about “foxglove equipoise” in a previous post, touching on the contributions of William Withering in the 1700s, to understanding the toxicity and therapeutic benefits of the foxglove, and more recent concerns that digoxin increases mortality in patients with heart failure.

At the American College of Cardiology Scientific Sessions in Washington, D.C. yesterday, a paper showing higher mortality for patients on digoxin may be the final nail in the foxglove coffin.

Despite lack of evidence for its safety in the treatment of atrial fibrillation from randomized trials, digoxin is used in 30% of patients with atrial fibrillation (AF) worldwide, and current AF guidelines recommend it for rate control in patients with AF (with and without heart failure).

The investigators used data from the ARISTOTLE study of apixiban versus warfarin for their analysis.

They looked at mortality in patients taking or not taking digoxin at baseline, using a Cox model with propensity weighting, which included demographic features as well as biomarkers and digoxin levels at baseline. Major findings:

-In patients already taking digoxin, mortality was not higher in digoxin users, however, the risk of death was related to dig levels: for every 0.5 ng/ml increase in dig level, the risk of death rose by 19 percent and if dig level was >1.2 ng/ml the death rate increased by 56 percent. 

Patients not taking digoxin before the trial who began taking it over the course of the study had a 78 percent increase in the risk of death from any cause and a four-fold increased risk of sudden death after starting digoxin use.  Most sudden deaths occurred within six months after digoxin was started.

Risk of death with initiation of digoxin was increased in patients with and without heart failure.

The use of foxglove to treat dropsy is a fascinating and instructive chapter in the history of medicine.

This study added to prior systematic reviews suggests that it is time to end the use of digitalis and close the chapter.

William Withering might turn over in his grave but at least we won’t be sending afib patients to join him prematurely!

Dropsily Yours,

-ACP