All posts by Dr. AnthonyP

Cardiologist, blogger, musician

Is Pitavastatin (Livalo) A Better Statin For You?

The skeptical cardiologist recognizes that perhaps 10% of patients he starts on a statin drug will develop symptoms that are felt to be due to the drug.

Most often the symptom is myalgia-muscle ache.

But other symptoms may develop after the patient starts the drug and given widespread statin fear-mongering on the internet it is common for these symptoms to be attributed to the statin.

Recently a reader left comments on my post on statins and memory problems describing in detail what appears to be a statin side effect:

My doctor had me on a daily 40mg Lipitor. After about 1 month, I noticed that my short term memory was very bad*. (Not a nocebo effect… I had no idea at the time that statins were linked to memory effects.) I did an experiment on myself. I suspected that my memory problems were the result of the statin. (Nothing else seemed to be different besides the fact that I had started taking Lipitor the previous month.) After 2 weeks off of Lipitor, my memory problems went away. Whew. I put myself back on Lipitor (I didn’t want to die of a heart attack, and my “experiment” could have been a victim of confirmation bias + 100 other faults.) After about a month, crappy short term memory returned. Took myself off Lipitor again. AGAIN, after about 2 weeks, by memory was fine again.
Perhaps my experiment wasn’t scientific. Just one subject (me). 100% anecdotal. Perhaps statins are good for your heart. However, I don’t know about you, but I program computers for a living. Try doing that with crappy short term memory. Hint: you can’t do it.

I’ve outlined my approach to these potential statin associated symptoms (PSAS) previously (see here) and if a patient has resolution of the PSAS we typically try another statin to see if the PSAS recurs.

For my reader, it would make sense to try a statin like rosuvastatin or pitavastatin that is hydrophilic and therefore doesn’t cross the blood-brain barrier and enter the brain.

For the more common myalgias I typically try rosuvastatin at lower dosage. If symptoms recur on rosuvastatin I try pitavastatin.

Pitavastatin (Livalo)

Pitavastatin (Livalo) is the seventh statin. It is minimally affected by the cytochrome P450 system (meaning less drug-drug interactions),  water soluble (so it doesn’t enter the brain,) and does not lower Co-enzyme Q10.  These special biochemical characteristics raise the possibility that  among patients who have not been able to tolerate other statins it might be both usable and efficacious.

It has been used in Japan since 2003 and was approved by the FDA for US use in 2010. The Medical Letter was pretty negative about it in 2010 and feels the same way about the recently approved zypitamag (pitavastatin magnesium.)

The Medical Letter’s review of pitavastatin calcium concluded that recommended doses of the drug had not been shown to decrease LDL-C more than other statins with longer safety records and there was no good reason to use it. That conclusion applies to pitavastatin magnesium as well.

Tom Dayspring, the “national treasure” and lipidologist disputes this and has written of the Medical Letter conclusions

Any statin that has been tested in an outcome trial has been successful and there is no reason why pitavastatin would not also reduce events. Most providers used every statin for years before there were outcomes! Pitavastatin was as successful in
regressing plaque volume as was atorvastatin in an IVUS trial called JAPAN-ACS ((J Am Coll Cardiol 2009;54:293–302). The claim regarding LDL lowering is erroneous as pitavastatin is actually more efficacious than fluvastatin, pravastatin, lovastatin, and 10 & 20 mg doses of simvastatin and the last sentence in the Medical Letter using the word “worrisome” is both ridiculous and 100% false – The pharmacokinetics of pitavastatin are extremely clean, better than all of the more lipophilic statins now on the market except fluvastatin (read the reference cited above which compares pitavastatin to all other statins using published data not invective). I cannot remember the last branded drug that was not first in its class to be released that the Medical Letter found any use for including Crestor which is why personally I find little use whatsoever for recommendations of the medical letter.

The Medical Letter does provide a nice summary of statins effectiveness and cost. As you can see Livalo (and any brand name statin) costs a lot more than generic rosuvastatin (276$ versus 8$) and is less effective

statins.png

 

Thus, there is no reason to use any brand name statin unless you have developed side effects on two generic statins with the second one being low dose rosuvastatin.

Anecdotal Pitavastatin Success

Four years ago I identified by vascular screening in one of my patients, a 65 year old woman a >50% blockage in the left  carotid artery.

We started her on 40 mg atorvastatin and she developed a rash. She was switched to rosuvastatin 10 mg and began waking up in the middle of the night with a headache and feeling light-headed. I thought it unlikely this symptom was due to the statin.

She requested that we go back to atorvastatin because she felt it likely the rash was from something else.one month later, complains of arms and legs are very sore and hard time getting dressed in the morning due to soreness. also constipated

We stopped the atorvastatin and a month later she called back indicating that she could feel her arteries clogging.

At this time we started Livalo at 2 mg twice weekly. LDL dropped by 50% to 71 mg/dl and she has tolerated it without side effects ever since.

Supporting Data

Beyond anecdotal support for pitavastatin in the statin intolerant patient we have one abstract presented at the ACC meetings in 2013.

A total of 40 consecutive patients with documented intolerance to any dose of at least two different statins were prospectively enrolled into a protocol whereby they received a trial of pitavastatin therapy at a dose of 2 mg per day.

Forty patients were enrolled and 27 of them (68%) were able to tolerate pitavastatin. LDL cholesterol was reduced from 147±27 mg/dL to 93±25 mg/dL, resulting in an average LDL-cholesterol reduction of 34%. Patients who could best tolerate pitavastatin tended to be males and those with no history of coronary artery disease or diabetes.



Despite what the Medical Letter says about pitavastatin I tend to agree with Tom Dayspring and I and most progressive preventive cardiologists will give pitavastatin at least a trial in our high risk patients with PSAS before giving up on statins in them.


Hydrophilicly  Yours,

-ACP

N.B. Pitavastatin was discovered in Japan by Nissan Chemical Industries and developed further by Kowa Pharmaceuticals, Tokyo. It has been extensively studied in Japanese studies.

The Livalo website tries to hint that their drug might be better/safer for those of Japanese ethnicity but the science on this is not clear. A review on the topic concludes

Pharmacokinetic investigations have noted higher plasma levels of statins in Asians compared with Caucasians, although postmarketing data for all statins have not identified any particular safety issues, even when statins are given at equivalent doses. The potential mechanisms of heightened response to statins in Asians are related to genetically based differences in the metabolism of statins at the level of hepatic enzymes and drug transporters. Studies indicate that lower statin doses achieve lipid improvements in Asian patients comparable with those observed with higher doses in Caucasians. In conclusion, prescribing lower starting doses of statins in Asians appears warranted while research on this subject continues.

Why Stem Cell Injections For Arthritis Are Snake Oil

The skeptical cardiologist has had a few patients undergo stem cell injections for knee osteoarthritis. My sense based on a brief look at the literature in this area was that these stem cell clinics were unproven and over-priced. They typically cost 5 or 6 thousand dollars an injection, are minimally effective (no better than placebo injections), and are not covered by insurance.

I felt compelled to research the area more deeply when I discovered that Ozzie Smith, the Hall of Fame former Cardinal shortstop, had his name attached to a stem cell clinic in St. Louis and actively promoted it on their website. Ozzie, heretofore, my favorite Cardinal, auctioned off  his 13  Gold Gloves and 11 All-Star Game rings in 2012 and now, sadly, is lending his name to a shady area of pseudoscientific medicine.

In the course of my research I came across an incredibly detailed well-written and researched article posted on John Byrne, MD’s Skeptical Medicine website entitled Dubious Stem Cell Clinics.

After reading Byrne’s article I realized that there was no purpose in proceeding any further with my own research-this is what I would post if I had the requisite time, intelligence and skill-so I hope all will read the original.


Byrne notes that although  stem cell treatment is being investigated for all kinds of conditions

, as of 2018, the only legitimate stem cell treatments used in clinical practice are in bone marrow transplantation, burn treatment, bone grafting in orthopedics and corneal generation from limbal stem cells in ophthalmology. And of those, only bone marrow transplantation in cancer patients has a consensus from large scale clinical trials. There currently are no other legitimate treatments that are warranted for general use by current science. We simply are not at that level.

Despite Ozzie Smith’s ringing endorsements there is no evidence for  any benefit of orthopedic stem cell injections or PRP injections, another unproven treatment offered at the Ozzie Smith IMAC Regenerative Center

Experts in the field of stem cell therapy who are not out to make a quick buck are pretty unanimous in this assessment as Byrne notes:

George Daley, MD, PhD, a member of the Harvard Stem Cell Institute’s executive committee and past president of the International Society for Stem Cell Research, added,

“we are seeing a growing number [of legitimate clinical trials] but all such uses are experimental … and there is great skepticism as to whether we have” the scientific knowledge and basis even to “predict that these will be effective.” “It may,” he said, “take decades before there is certainty.” “The only stem cell therapies that have been proven safe and effective,” he said, “are those constituting what is known as bone marrow transplantation for treatment of some cancers.”

However, such limitations do not prevent contemporary snake-oil salesmen from selling dubious treatments to desperate people by making unwarranted claims about stem cell therapies. “Stem Cell” is the new “Magnetic” and “Quantum” in the world of quackery.As with many scams, it is sold using “sciency” words and riding on the coattails of legitimate science.

“Like snake oil salesmen, clinics claiming astonishing curative results from stem cell treatments often do not have licensed physicians administrating the treatments, no scientific evidence supporting their work, and they rely on testimonials for advertising and promoting the value of their product.” 

Byrne goes on to give the history of stem cells, discuss the types of stem cells and why translation of their promise to clinical results has been slow.
In a fascinating section he compares the hijacking of “quantum” for use by pseudoscience peddlers to the hijacking of “stem cell.”

With the promise of what sounds like a magic technology, these clinics offer treatments for conditions across a wide range including orthopedics, pain management, neurologic problems, immune diseases, respiratory diseases, urologic, sexual, cosmetic, cardiovascular and dermatologic disorders. They advertise treatments for aging, diabetes, hair loss, muscular dystrophy, vision problems, gastrointestinal disorders, Alzheimer’s and autism.

Products are on sale now promoting magical-sounding claims of skin rejuvenation with the words “stem cell” attached to their names. Many products promote plant-based stem cell creams (yes, you read that correctly). One company’s advertisement claims, “(our) cutting edge technology brings an innovative anti-aging skin care line. Plant stem cells are the source of unlimited energy and the key to herbal growth and regeneration”.

I found this paragraph to be spot on in describing the techniques of the modern snake-oil salesman and worthy of noting:

Many sites use the language of pseudoscience to make specific-sounding claims, but in reality, are vacuous. Motor City StemCell claims that their products “Control the immune system”, “regulate inflammation” and “provide trophic support”. The operative words here are “control”, “regulate”, and “supports”. Skeptics recognize these as “weasel words”. They do not make specific claims for which the claimants may be held to account. Other weasel words include “boosts” and “enhances”.

When such words are used, often they are accompanied by the Quack Miranda Warning:

“These statement(s) have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.” 
The tactics of selling snake oil have become sophisticated over the years, but the overall strategy has remained the same. Find vulnerable customers (“marks”); make bold claims of a “cure for everything”; claim 100% safety and efficacy; use sciency-sounding technobabble; point to legitimate research as if it supports your claims; promote testimonials from happy customers; charge high fees for unproven or implausible
products and services; attack your critics as being closed minded, or in the pocket of “Big Pharma”; repeat.
Based on my  own research into this area  I totally agree with Byrne’s conclusion
Stem Cell research is a promising field. There may be a day in the future in which there are many disorders that can be effectively and safely treated with stem cell therapy. That day is not here yet.

 

However, we currently have many clinics across the world offering treatments under the guise of “Stem Cell Therapy”. Their claims go well beyond the current science and are therefore not justified. These treatments are not regulated or endorsed by agencies such as the FDA. The consumer will pay large sums of money — tens or hundreds of thousands of dollars — to receive unproven, unregulated “treatments” at their own expense, often under the guise of a “clinical trial”. No legitimate research organization charges participants to participate in clinical trials.

These treatments have unknown risks and unproven benefits. They are marketed with fancy websites, testimonials and expensive dinner seminars by providers — some of whom are actual MD’s or DO’s and should know better — with no regard to scientific standards or ethics. They will use scientific-style jargon and promise miraculous cures for just about anything that ails you. This is a scam.


Yes, indeed this is a scam. And we will have to add some of these attributes to my #1 red flag of quackery.
Weasel words and the Quack Miranda Statement are definitely highly specific markers for quack web health sites.
Protrophicly Yours,
-ACP

Kilimanjaro Rises Like A Limp Wrist Above The Serengeti: Mondegreens, Africa, and Yacht Rock

The newly minted wife (aka the ex-eternal fiancee’ of the skeptical cardiologist) and I love mondegreens and we love to argue about the relative worth of songs.

She, for example, loves “yacht rock” and I abhor it, maintaining that any good song (e.g. one I like) cannot be considered in that annoying genre (Steely Dan’s  “Do It Again”, for example). 

A Mondegreen per wikipedia

is a mishearing or misinterpretation of a phrase as a result of near-homophony, in a way that gives it a new meaning. Mondegreens are most often created by a person listening to a poem or a song; the listener, being unable to clearly hear a lyric, substitutes words that sound similar and make some kind of sense.[1][2] American writer Sylvia Wright coined the term in 1954, writing about how as a girl she had misheard the lyric “…and laid him on the green” in a Scottish ballad as “…and Lady Mondegreen”.[3]

Mondegreens are becoming extinct I fear, as today’s youth do not have to wonder what any particular lyric is-they can just Google it and have the answer in seconds.

Today, however, we hit the jackpot as the ex-EFOSC texted a snippet of the awful song “Africa” by the awful band “Toto” to a friend. I have saved my precious readers the misery of listening to the entire song and herewith present you with the audio snippet:

Misheard or wrong Toto Africa song lyrics.

The wife was impressed with the fact that Toto worked some unusual words into a particular line of the song, which she had always thought was “Sure as Kilimanjaro rises like a leprous above the Serengeti.” When I questioned her as to what a leprous was (a female leper?) she laughed and realized she was thinking leopardess, as in female sphinx-type thing. A friend of hers always heard “rises like a limp wrist,” which explains my blog title.

I told her this sentence made no sense and when I googled her phrase I found somebody else had misread the true lyric to a greater extent as: Sure as Kilimanjaro rises like a leprous above this Africa heat 

The actual silly verse is as follow

The wild dogs cry out in the night
As they grow restless, longing for some solitary company
I know that I must do what’s right
As sure as Kilimanjaro rises like Olympus above the Serengeti
I seek to cure what’s deep inside, frightened of this thing that I’ve become

Now those are some amazingly pretentious and unintentionally humorous words! (This coming from someone who maintains Jim Morrison is a great poet.)

I am not alone in considering this a silly song with pretentious lyrics-

In an article (How Did Toto’s Africa become a millennial anthem?) on the love that millennials have for Toto and Africa, Toto founder and guitarist Steve Lukather is quoted as saying:

“I could never have called this. We’ve always worked, but to have everything blow up again over this silly song… All these young kids are coming to our shows. We’re at half a billion streams, getting ten million a month. All of our albums are selling. It’s a trip for us.

Yes, this is truly a silly song by a bad band but it has produced a wonderful mondegreen.

Please feel free to share your favorite mondegreen.

Mondegreenophilically Yours,

-ACP

N.B. Millennials even love this terrible video of Africa and have watched it 445 million times!

The MESA App-Estimating Your Risk of Cardiovascular Disease With And Without Coronary Calcium Score

Yesterday, I laid out the case for utilizing coronary artery calcium score (CACS) to further refine the assessment of youngish patients risk of developing cardiovascular disease (ASCVD). I referenced the ACC/AHA ASCVD risk estimator tool (app available here) as the starting point but if I have information on my patient’s CACS I use a new and improved tool called the MESA risk score calculator.

It is available online and through an app for Apple and Android (search in the app store on “MESA Risk Score” for the (free) download.)

The MESA tool allows you to easily calculate how the CACS effects you or your patient’s 10 year risk of ASCVD.

The Multi-Ethnic Study of Atherosclerosis (MESA) is a study of the characteristics of subclinical cardiovascular disease (disease detected non-invasively before it has produced clinical signs and symptoms) and the risk factors that predict progression to clinically overt cardiovascular disease or progression of the subclinical disease. MESA researchers study a diverse, population-based sample of 6,814 asymptomatic men and women aged 45-84. Approximately 38 percent of the recruited participants are white, 28 percent African-American, 22 percent Hispanic, and 12 percent Asian, predominantly of Chinese descent.

To use the score you will need information on the following risk factors:

age, gender, race/ethnicity, diabetes (yes/no), current smoker (yes/no), total and HDL cholesterol, use of lipid lowering medication (yes/no), systolic blood pressure (mmHg), use of anti-hypertensive medication (yes/no), any family history of heart attack in first degree relative (parent/sibling/child) (yes/no), and a coronary artery calcium score (Agatston units).

In many cases the CACS dramatically lowers or increases the risk estimate.

In this example a 64 year old man with no discernible risk factors has a CACS of 175
The 10 year risk of a CHD event almost doubles from 4.7% to 7.6% when the CACS is added to the standard risk factors and moves into a range where we need much more aggressive risk factor modification.

On the other hand if we enter in zero for this same patient the risk drops to a very low 1.9%.

It’s also instructive to adjust different variables. For example, if we change the family history of heart attack (parents, siblings, or children) from no to yes, this same patient’s risk jumps to 7.2% (2.6% with zero calcium score and to 10.4% with CACS 175.)

It can also be used to help modify risk-enhancing behaviors. For example if you click smoker instead of non-smoker the risk goes from 4.7% to 7.5%. Thus, you can tell your smoking patient that his risk is halved if he stops.

Discussions on the value of tighter BP control can also be informed by the calculator. For example, if  our 64 year old’s systolic blood pressure was 160 his risk has increased to 6.8%.

How Does Your CACS Compare To Your Peers?

A separate calculator let’s you see exactly where your score stands in comparison individuals with your same age, gender, and ethnicity

The Coronary Artery Calcium (CAC) Score Reference Values web tool will provide the estimated probability of non-zero calcium, and the 25th, 50th, 75th, and 90th percentiles of the calcium score distribution for a particular age, gender and race. Additionally, if an observed calcium score is entered the program will provide the estimated percentile for this particular score. These reference values are based on participants in the MESA study who were free of clinical cardiovascular disease and treated diabetes at baseline. These participants were between 45-84 years of age, and identified themselves as White, African-American, Hispanic, or Chinese. The current tool is thus applicable only for these four race/ethnicity categories and within this age range.

The calculator tells us that 75% of 64 year old white males have a zero CACS and that the average CACS is 61.

Unlike SAT scores or Echo Board scores you don’t want your CACS percentile status to be high. Scores >75th percentile typically move you to a higher risk category, whereas scores <25th percentile move you to a lower risk category, often with significant therapeutic implications.

Scores between the 25th and 75th percentile typically don’t significantly change the risk calculation.

Exploring Gender Differences In CACS

If we change the gender from male to female on our 64 year old the risk drops considerably from 4.7% down to 3.3%. This graph demonstrates that over 20% of women between the ages of 75 and 84 years will have zero calcium scores.

The graph for men in that same range shows that only around 10% will have a zero CACS.

I’ve been asked what the upper limit is for CACS but I don’t think there is one. I’ve seen numerous patients with scores in the high two thousands and these graphs show individuals in the lowest age decile having scores over 2981.

If you want to be proactive about the cardiovascular health of yourself or a loved one, download the MESA app and evaluate your risk. Ask your doctor if a CACS will help refine that risk further.

Antiatherosclerotically Yours,

-ACP

Prevention of Heart Attack and Stroke-Early Detection Of Risk Using Coronary Artery Calcium Scans In The Youngish

Since 1/3 of Americans die from atherosclerotic cardiovascular disease (ASCVD, mostly heart attacks and strokes) and dropping dead is often the first symptom of ASCVD it’s incredibly important to identify early, “subclinical” ASCVD and begin measures to reduce risk.

How early to begin that process is open to debate. The recent sudden death of the 41-year old son of a patient of mine, however, has reinforced to me how crucial it is to begin risk assessment and potential treatments as early as possible, especially in individuals with a strong family history of premature ASCVD.

We use standard risk factors like lipids, smoking, age, gender and diabetes to stratify individuals according to their 10 year risk of ASCVD (using this online risk calculator) but many apparent low risk individuals (often due to inherited familial risk) drop dead from ASCVD and many apparent high risk individuals have no subclinical ASCVD and don’t need preventive therapy.

Recent studies provide compelling support for the early utilization of cardiac imaging in to identify high risk individuals.

Heart attacks and most sudden cases of sudden death are due to rupture of atherosclerotic plaques. Thus, it makes sense to seek out  such plaques, a process I call searching for subclinical atherosclerosis. There are a number of ways to search for sublinical plaques but the two most widely studied are carotid ultrasound screening and coronary artery calcification (CAC) measurement.

I’ve been utilizing CAC (also termed  heart scan, coronary calcium score, or cardioscan) to help assess my patient’s risk of ASCVD for years although the procedure is not covered by insurance and until recently was not strongly endorsed by major guidelines. (For a complete description of the test and the risks/benefits see here). As I pointed out here, in November the new ACC/AHA guidelines finally embraced CAC for

adults 40 to 75 years of age without diabetes mellitus and with LDL-C levels ≥70 mg/dL- 189 mg/dL (≥1.8-4.9 mmol/L), at a 10-year ASCVD risk of ≥7.5% to 19.9%, if a decision about statin therapy is uncertain

Typically, if we have calculated (using the ASCVD risk estimator) a 10 year risk >7.5% we have a discussion with the patient about beginning drug treatment to reduce risk.

To inform the decision and help us “get off the fence” I usually recommend a CAC. To see how this works in a typical sixty something see my posts here and here.

Significant Of CAC Score

As the new ACC/AHA guidelines state:

If CAC is zero, treatment with statin therapy may be withheld or delayed, except in cigarette smokers, those with diabetes mellitus, and those with a strong family history of premature ASCVD.

A duo of studies from Walter Reed Army Hospital have provided more support for the value of the zero CAC for risk prediction and identifying who should get treatment for prevention of both heart attacks and strokes.

Over 10,00 subjects underwent CAC and were assessed for the primary outcomes of all-cause mortality, incident MI, stroke, and the combination of major adverse cardiovascular events (MACE), defined as stroke, MI, or cardiovascular death over an average 11.4 years

Patients were classified on the basis of the presence or absence of calcium and further subdivided into CAC score groups of 0, 1 to 100, 101 to 400, and >400

Patients without a zero CAC had a very low number of events , with a 1.0% rate of mortality and 2.7% rate of MACE over a 10-year period.

On the other hand subjects without any traditional risk factors (n = 6,208; mean age 43.8 years), the presence of any CAC (>0) was associated with a 1.7 fold increased risk of MACE after adjustment for traditional risk factors.

f2.large-3
Patients with CAC who were prescribed a statin had a significantly reduced risk of MACE (aSHR: 0.76; 95% CI: 0.60 to 0.95; p = 0.015), whereas patients without CAC had no associated MACE reduction (aSHR: 1.00; 95% CI: 0.79 to 1.27; p = 0.99). p = 0.097 for interaction between statin treatment and CAC presence. aSHR = adjusted subhazard ratio; CAC = coronary artery calcium; CI = confidence interval; MACE = major adverse cardiovascular event(s)

The red line of the >400 score individuals has a much higher risk of death, stroke and heart attack (myocardial infarction) than the blue (CAC 1-100) or the gray line of the zero CAC scorers.

Furthermore, when these investigators looked at outcomes in those individuals who received statins versus those who didn’t, the zeros didn’t benefit from statin therapy over the 10 year follow-up.

f3.large
Benefit of statin therapy was significantly related to CAC group with benefit in patients with CAC score >100 but not in patients with CAC <100. aSHR = adjusted subhazard ratio; CAC = coronary artery calcium; CI = confidence interval; MACE = major adverse cardiovascular event(s).

But there was a tremendous reduction in bad CV events in those with scores >100 who received statin (red line) versus those who did not (blue line).

Here’s the figure which encapsulates both the risk prediction power of the CAC (and the benefits of statin treatment restricted to those with >0 (blue lines)

f2.large-4

 

Benefits of CAC Testing In The Young

So these new studies provide powerful data supporting the use of CAC in younger individuals to help us refine risk estimates and target the individual at high risk of MI and sudden death. It seems highly appropriate to consider CAC testing beginning at age 40 years as the AHA/ACC guidelines suggest.

But what about the individual who has a strong family history of premature CAD and is age say 35 or 39 years of age. Do we ignore advanced risk assessment? Very few individuals die in their 30s from ASCVD but I have a number of patients who suffered heart attacks in their forties. In addition, the earlier we can start risk modification the better as the process begins very early in life and accumulates over time.

The Coronary Artery Risk Development in Young Adults (CARDIA) Study published in 2017 has demonstrated the early development of nonzero CAC score in the youngish and the predictive value of the high CAC score for mid life ASCVD events.  It was  a prospective community-based study that recruited 5115 black and white participants aged 18 to 30 years from March 25, 1985, to June 7, 1986. The cohort has been under surveillance for 30 years, with CAC measured 15 (n = 3043), 20 (n = 3141), and 25 (n = 3189) years after recruitment. The mean follow-up period for incident events was 12.5 years, from the year 15 computed tomographic scan through August 31, 2014.

The conclusions:

Any CAC in early adult life, even in those with very low scores, indicates significant risk of having and possibly dying of a myocardial infarction during the next decade beyond standard risk factors and identifies an individual at particularly elevated risk for coronary heart disease for whom aggressive prevention is likely warranted.

screen shot 2019-01-19 at 12.36.44 pmI read CAC scans every day and it is not uncommon to see a non-zero scores in individuals in their late 30s or early 40s.

The two sons of another one of my patients both in their late 50s with unremarkable risk factor profiles and both developing anginal type symptoms limiting their activities each underwent multi vessel stent procedures in the last month. If I had seen them  10 to 20 years ago we would have identified the subclinical atherosclerosis building up in their coronaries, started treatment and avoided the need for invasive, expensive procedures.

Other Risk-Enhancing Factors To Consider In The Young

The ACC/AHA guidelines list some “risk-enhancing factors” some of which I find useful.

screen shot 2019-01-19 at 7.33.39 am

Clearly family history of premature ASCVD is important but the devil is in the details. What relatives count? What was the event in the family member? If it was sudden death was an autopsy done?

What about nontraditional lipid/biomarkers?  I consider an assessment of Lp(a) and some more sophisticated measurement of atherogenic dyslipidemia (apoB, LDL-P) and inflammation (CRP) essential.

Interestingly the guidelines include ABI (which I do not find helpful) but not carotid vascular screening which has frequently guided me to earlier therapy in youngish individuals with abnormal biomarkers or strong family history.

Vascular screening in young subjects may detect subclinical atherosclerosis as measured by thickening of the carotid wall (IMT) or early carotid plaque prior to the formation of calcium in the coronary arteries. Advanced IMT precedes the formation of soft plaque in arteries and only later is calcium deposited in the plaque.

It’s never too early to start thinking about your risk of cardiovascular disease. If heart disease runs in your family or you have any of the “risk-enhancing” factors listed above, consider a CAC, nontraditional lipid/biomarkers, or vascular screening to better determine were you stand and what you can do about it.

Included in my discussions with my patients with premature ASCVD is a strong recommendation to encourage their brothers, sisters and children to undergo a thoughtful assessment for ASCVD risk. With these new studies and the new ACC/AHA guideline recommendations if they are age 40-75 years there is ample support for making CAC a part of such assessment.

Hopefully very soon, CMS and the health insurance companies will begin reimbursement for CAC. As it currently stands, however, the 125$ you will spend for the test at my hospital is money well spent.

Skeptically Yours,

-ACP

The Peter Attia Drive Podcast: Longevity, Lipidology, Fructose, and How To Keep Your Face And Joints Young

Lately while exercising I’ve been binge-listening to podcasts from Peter Attia, a cancer surgeon turned “longevity” doctor.

I first encountered his writing while researching ketosis, the Atkins diet and low carb diets in 2012 and found his writing to be incredibly well-researched, detailed and helpful.

I appreciate how he never opts for oversimplification of a topic as this disclaimer at the begining of his post on ketosis indicates:

If you want to actually understand this topic, you must invest the time and mental energy to do so.  You really have to get into the details.  Obviously, I love the details and probably read 5 or 6 scientific papers every week on this topic (and others).  I don’t expect the casual reader to want to do this, and I view it as my role to synthesize this information and present it to you. But this is not a bumper-sticker issue.  I know it’s trendy to make blanket statements – ketosis is “unnatural,” for example, or ketosis is “superior” – but such statements mean nothing if you don’t understand the biochemistry and evolution of our species.

When I first came across his writing he was obsessively monitoring his beta-hydroxy butyrate levels on a ketogenic diet and was partnering with Gary Taubes to launch “the Manhattan project of nutrition”, the Nutritional Science Institute. (NUSI) . Designed to help fund good nutritional research with the ultimate goal of reducing obesity and testing the hypothesis that “all calories are equal” NUSI, unfortunately has floundered (see here.)

He’s always been very rigorous in his thinking and writing in the areas of nutrition, diet and longevity and he is quite brilliant and knowledgeable down to very basic areas of biology and metabolism.

He has started  a podcast in the last year that has featured in depth conversations with some really interesting physicians and scientists. It’s described thusly : “The Peter Attia Drive is a weekly, ultra-deep-dive podcast focusing on maximizing health, longevity, critical thinking…and a few other things. Topics include fasting, ketosis, Alzheimer’s disease, cancer, mental health, and much more.”

The first one that I listened to was with Thomas Dayspring, M.D., FACP, FNLA, a world-renowned expert in lipidology and a fantastic teacher.  If you’d like to dive deeply into cholesterol metabolism, lipid biomarkers, the mechanism of atherosclerosis and cholesterol treatment options, this is a great way to start. 

It’s a five part, 7 hour series of podcasts with the first one here

Some Eye-opening Thoughts About Processed Foods, Sugar and Fructose

Most patients are not going to be up for deep dives into lipidology but I highly recommend Attia’s discussion with Robert Lustig.

I quoted Lustig in a 2015 post entitled “Fructose and the Ubiquity of Added Sugar”

Robert Lustig, a pediatric endocrinologist has talked and written extensively about fructose as a “toxin.” You can watch him here. He’s also published a lot of books on the topic including one which identifies the 56 names under which sugar masquerades.

Lustig is a passionate, articulate and compelling speaker who has contributed significant research in this area. Most recently he has retired from clinical practice and obtained a law degree with the goal of trying to change US food policy.

Attia does a great job of interviewing him as he helps clarify points and guides  Lustig into specific real world problems such as what to feed your children.

In addition, Attia’s staff do a great job of providing “show notes” which summarize the important points, adding helpful context and links and summarizing the content.

Lustig firmly believes:

‘Fructose and glucose are not the same: the food industry would have you believe a calorie is a calorie, a sugar is a sugar…and it is absolute garbage: they are quite different, and it does matter’

Fructose is a monosaccharide that combines with the monosaccharide glucose to form sucrose, which is what most people recognize as table sugar. Processed foods commonly contain a lot of added fructose-containing sugar but also, increasingly they contain high fructose corn syrup (HFCS) which contains up to 65% fructose.

High intake of fructose goes hand in hand with consumption of processed foods. Approximately 75% of all foods and beverages in the US contain added sugars. Consumption of added sugar by Americans increased from 4 lbs per person per year to 120 lbs per person per year between 1776 and 1994. Thanks to a dramatic increase in sugar-sweetened beverages, American teenagers consume about 72 grams of fructose daily.

There are a substantial amount of observational, short-term basic science, and clinical trial data suggesting that all this added sugar, especially fructose, are posing a serious public health problem and Lustig lays out a compelling narrative in this podcast.

Lustig discusses the  fundamental biochemical differences between glucose and fructose- whereas glucose is the energy of life for all animals, fructose is “vesitigial to all animal life” and is basically a storage form of energy for plants.

Your gut bacteria are more adept at metabolizing fructose than you are

Ludwig points out that fructose accelerates the Amadori rearrangement: the browning of your body tissues and potentially contributing to aging. Fructose does not suppress the hunger hormone ghrelin as glucose dose thus “When you consume a lot of fructose your brain doesn’t know you’ve eaten and so you end up consuming more”.

Finally, Ludwig notes, fructose in contrast to glucose behaves like cocaine on the brain. Fructose specifically lights up the reward center ‘and now has been shown to induce the same physiology in the brain that cocaine, heroin, nicotine, alcohol, or any hedonic substance also generates’

There is not a clear scientific consensus on many of Lustig’s points to be honest but he is a very convincing advocate of avoiding sugar in general and fructose in particular from non-real food sources.

There’s a whole lot more in this discussion that is important to at least think about:

-A detailed discussion of NASH and NAFLD (fatty liver disease that is becoming common in obese Americans.)

-Why you need both soluble and insoluble fiber together as opposed to added soluble fiber in a supplement or processed food adition.

-How to change the food system in which 10 companies control almost 90% of the calories consumed in the US

-the importance of eliminating government food subsidies which make junk food cheap. 

-How eliminating food subsidies wouldn’t change the price of wheat or soy, only corn and sugar which where most of our dietary sugar comes from.

Maintaining Youthful Appearance And Function-The Face and The Joints

Attia’s other podcasts touch on many other issues related to longevity. I found his interview with Brett Kotlus, a New York City oculofacial plastic surgeon who specializes in both non-surgical and surgical cosmetic and reconstructive procedures of the eyes and face (How to look younger while we live longer) to be surprisingly enlightening and engrossing.

Attia’s website and podcasts are refreshingly free of advertising and any annoying teasers. This description of the Kotlus podcast is about as close to a mass-market teaser as you will see:

“Using these powerful basics, I’ve seen amazing changes.” —Brett Kotlus, referring to the 3 simple tools people can utilize to protect and rejuvenate their skin

I will not reveal the “3 simple tools” here but the show notes indicate you can skip to the 46 minute mark to hear about them.

Most recently I’ve been listening to his podcast with Dr. Eric Chehab, orthopedic surgeon and sports medicine specialist (Eric Chehab, M.D.: Extending healthspan and preserving quality of life (EP.36).)  As Attia points out, longevity is related to both healthspan and lifespan and our joint health is a major contributor to healthspan.

In this episode, Chebab “explains the measures we can take to live better and maintain our physical health through exercise and the avoidance of common injuries that prove to be the downfall for many. He also provides valuable insight for those weighing their treatment options from physical therapy to surgery to stem cells.”

Because the show notes are so detailed you can read exactly what is discussed in these podcasts and when. For example, if you wanted to skip the early discussion on Eric’s training, fellowship with the New York Giants, and the risk vs. reward of playing football (39:15) and listen to the discssion on The knee joint: common injuries, knee replacements, and proper exercise ” you know to skip to [1:00:00].

Personally, I found all of the preliminary discussion on Springsteen, Pearl Jam  and Chebab’s pre-medical school adventures fascinating.

I highly recommend recommend Attia’s podcasts: they are always enlightening, unbiased, objective and mentally stimulating.

In the world of longevity doctors he is unique in offering solid science-based recommendations and information free of hype,  bias and woo.

Skeptically Yours,

-ACP

Are Probiotics A Panacea Or Pure Hype?: The Gullible Gastroenterologist Weighs In

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.

Gullibly yours,

DSL


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.

-ACP

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.

FDA Recalls More Generic Blood Pressure Meds: Where Are Your Medications Manufactured?

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.

Click the following links to review updated lists of irbesartan products under recall, losartan medications under recall, valsartan products under recall and valsartan products not under recall.

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 also updated the list of valsartan products under recall and the list of valsartan products not under recall.

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.

perspective-1

Patients Discover How Hard It Is To Find Non-Chinese Medications

When I tried to find the source of my generic medications, the results were eye-opening:

 my cholesterol drug is made in India by an Indian company and my blood pressure drug is made in Columbus, Ohio, by a Jordanian company.

I had not realized how globalized the pharmaceutical industry had become.

Many readers also researched the source of the pills they were taking and shared their experience through comments on my blog:

“Frustrated” wrote

My cardiologist changed my blood pressure med to irbesartan. Another generic ARB. I went to get it filled today at a local grocery store pharmacy. I asked where it was made and they showed me the bottle. Guess what? It was SOLCO/Prinston as distributor and Zhejiang Huahai Pharmaceuticals LTD – the same manufacturer as the tainted valsartan. Exactly the same. Despite the recent horrible FDA inspection report of that facility which is posted online here: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM621162.pdf

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.

Mitch writes:

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.

BIS wrote:

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.

Skeptically Yours,

-ACP

Is Trump’s USDA Making School Lunches Great Again?: Not Until They Stop Mandating Low Fat or Non Fat Milk

In 2010 President Obama signed into law the “Healthy, Hunger-free kids  act (HHKA) of 2010” which funded child nutrition programs and free school lunch programs in schools. New nutrition standards for schools were a point initiative of then First Lady Michelle Obama as part of her fight against childhood obesity and her “Let’s Move” initiative.

In May of 2017, President Trumps’s new secretary of agriculture, Scotty Perdue, issued a proclamation (Entitled Ag Secretary Perdue Moves To Make School Meals Great Again) which pledgee to loosen some of Obama’s school nutrition standards with respect to whole grains, salt and milk.

These changes have been finalized recently and have received considerable criticism. For example, Vox’s Julia Belluz wrote a piece entitled  “The Trump administration’s tone-deaf school lunch move” with a subtitle implying that the USDA’s loosening of standards would contribute to already soaring childhood obesity rates.

Belluz summarized the changes

That means 99,000 schools, feeding 30 million kids, can offer 1 percent chocolate and strawberry milk again, more refined white flour products, and, most importantly, freeze sodium levels in school lunches instead of reducing them further.

Criticism of the loosening implies that the original school lunch standards were appropriate and based on state of the art nutritional science, but were they?

The HHKA relied on guidance from the Institute of Medicine which established a committee to put together its report which was published in 2009 and was heavily based on the scientific guidance provided in the 2005 Dietary Guidelines for Americans and the IOM’s Dietary Reference Intake books”

Unfortunately, the 2005 Dietary Guidelines for Americans were not privy to  dramatic changes in our understanding of nutritional science which have occurred in the 13 years since they were written.

The IOM report copied the 2005 DGA in recommending the consumption of low fat or non fat dairy and defined low fat as 1%.

To achieve its aim of reducing saturated fat intake to <10% the IOM chose to force schools to only utilize low fat or skim milk.

 

The IOM and school lunch program recommended eliminating whole milk entirely and only allowing

-fat-free (plain or flavored) or

-plain low-fat (meaning 1%) milk

In 2018 it is very clear to anyone who examines the relevant data (see here, here and here) that dairy fat, despite being predominantly saturated fat is not associated with higher rates of cardiovascular disease, obesity, diabetes or total mortality.

A 2013 editorial in JAMA Pediatrics from Ludwig and Willet challenged recommendations for children to consume 3 glasses of low fat or non fat milk daily and noted:

Remarkably few randomized clinical trials have examined the effects of reduced-fat milk (0% to 2% fat content) compared with whole milk on weight gain or other health outcomes. Lacking high-quality interventional data, beverage guidelines presume that the lower calo rie content of reduced-fat milk will decrease total calorie intake and excessive weight gain.. However, a primary focus on reducing fat intake does not facilitate weight loss compared with other dietary strategies, as shown in observational studies and clinical trials, perhaps because reduced-fat foods tend to have lower satiety value.

Therefore, one of the key components of the HHK is misguided and not science-based.  It has in effect committed all of our children to a vast experiment with unknown health consequences.

How Do New USDA Guidelines Effect Dairy?

The change the USDA recently announced is to allow flavoring in 1% milk. Perdue is quoted as saying:

Because milk is a critical component of school meals, and providing schools with the discretion to serve flavored, 1 percent fat milk provides more options for students selecting milk as part of their lunch or breakfast, I am directing USDA to begin the regulatory process to provide that discretion to schools.

Prior to the mandated changes, the IOM report noted that dairy intake in children was predominantly from milk with >1% dairy fat.

17 percent of the total milk intake was from unflavored 2 percent milk, 16 percent from unflavored whole milk, and 9 percent from flavored milk

The dairy industry basically demanded the right to flavor 1% milk because the mandate to force all school children to drink low fat or skim milk has resulted in less children drinking milk.

And the government’s solution to making unpalatable skim milk tastier to children is to add sugar, something we have learned in the last decade we should not be doing to our food.

As Ludwig and Willet noted:

Consumption of sugar-sweetened, flavored (eg, chocolate) milk warrants special attention. While limit ing whole milk, some healthy beverage guidelines con done, and many schools provide, sugar-sweetened milk, with the aim of achieving recommended levels of total milk consumption in children. Not surprisingly, children prefer sweetened to unsweetened milk when given the choice, leading to a marked increase in the proportion of sweetened milk consumption in recent years. This trend may reflect, to some degree, compensation for the lower palatability and satiety value of fat-reduced milk. However, the substitution of sweetened reduced-fat milk for unsweetened whole milk—which lowers saturated fat by 3 g but increases sugar by 13 g per cup—clearly undermines diet quality, especially in a population with excessive sugar consumption.

The bulk of the dairy industry actually prefers you and your children drink skim milk (see here) and they are happy to adulterate the tasteless, nutritionless beverage with anything that makes it more palatable.

Witness this quote from AgWeb:

This is great news, not only for dairy farmers and processors, but also for schoolkids across the U.S.,” says John Rettler, president of FarmFirst Dairy Cooperative. “This is a step in the right direction in ensuring that school cafeterias are able to provide valuable nutrition in options that appeal to growing children’s taste buds. Their good habits now have the potential to make them lifelong milk-drinkers.”

Adding sugar to mandated unpalatable low fat milk might increase consumption of the beverage but it is definitely not a  step forward for our kid’s health.

This unethical, unscientific experiment might be contributing already  to higher rates of childhood obesity and diabetes.

Making Skepticism Great Again,

-ACP

N.B. To help understand how skim milk despite having less calories than whole milk could actually worsen obesity Ludwig and Willet provide the following instructive  paragraph:

Suppose a child, who habitually consumes a cup of whole milk and two 60-kcal cookies for a snack, instead had nonfat milk. Energy intake with that snack would not decrease if that child felt less satiated and consequently ate just  extra cookie. Rather than weight loss, this substitution of refined starch and sugar (ie, high glycemic index carbohydrate) for fat might actually cause weight gain. Consumption of a low-fat, high glycemic index diet may not only increase hunger, but also adversely affect energy expenditure compared with diets with a higher proportion of fat. In an analysis of 3 major cohorts, high glycemic index carbohydrates, such as refined grains, sugary beverages, and sweet desserts, were positively associated with weight gain, whereas whole milk was not. Of particular relevance, prospective studies in young children, adolescents, and adults observed the same or greater rates of weight gain with consumption of reduced-fat compared with whole milk, suggesting that people compensate or overcompensate for the lower calorie content of reduced-fat milk by eating more of other foods.

full text available here.

The Pearson Potato Theory of Obesity

The skeptical cardiologist developed “Pearson’s Potato Hypothesis” aka the potato theory of obesity a few years ago but became bogged down in frying oil and never published it.

Now I’m really glad I never got around to finishing my post on the theory-it appears that defenders of the potato are legion and vocal. ConscienHealth points out that a NY Times piece on the dangers of french fries quoted a Harvard epidemiologist  (Eric Rimm) as calling potatoes “starch bombs” and weapons of “dietary destruction.”

Potatoes rank near the bottom of healthful vegetables and lack the compounds and nutrients found in green leafy vegetables, he said. If you take a potato, remove its skin (where at least some nutrients are found), cut it, deep fry the pieces in oil and top it all off with salt, cheese, chili or gravy, that starch bomb can be turned into a weapon of dietary destruction.

The article goes on to recommend portion size control when dealing with French fries and further quoted Rimm:

“There aren’t a lot of people who are sending back three-quarters of an order of French fries. I think it would be nice if your meal came with a side salad and six French fries.”

Apparently the notion of limiting one’s French fries is abhorrent to many and Rimm has been attacked by thousands in the twitter-sphere.

I happen to think he’s right so I’ll go out on a limb here and post the essence of my theory without all the backing references and statistics with which I had hoped to buttress it.


Pearson Potato Theory of Obesity:

Because potatoes are cheap,  restaurants add lots of them to dishes to make the dishes seem larger and (to some) better and more satiating. Because the potatoes are so gosh darn tasty when sliced up thinly and fried and salted patrons can’t resist eating them even when they are not hungry. Eating any food when you are full is a recipe for….obesity.


To illustrate this issue I’ve started noting what restaurants serve along with the main dish that I’m interested in.

The vast majority of time breakfast orders come with fried potatoes like those below that came with the egg dish that I ordered.potato egg

I was sorely tempted to eat all these fried potatoes although full from my egg dish because when cooked properly the combination of the crispy fat, salt and warm fluffy potato interior is irresistible. Instead I ate just a few and put the rest in a to-go box, took them home, weighed them on a scale and took this picture.

IMG_8758

Interestingly, the weight of the potatoes that I had not consumed was 150 grams which is roughly equivalent to a large order of fries at McDonald’s. A large order of McDonald’s fries gives you 500 calories with 66 grams of carbohydrates,.

Thus, if I had not been disciplined that morning I likely would have ended up consuming more calories in fried potatoes than the main dish and over half of the calories I consume in a typical full day.

French fries (and their (equally addictive to me) cousin the potato chip) are the side for almost all hamburgers and sandwiches served in the US thus the possibility of unintended excess starch bomb consumption extends from breakfast to lunch to dinner in meals consumed outside the home.

Sweet Potatoes Versus Potatoes

In 2015 I pointed out that sweet potatoes which are embraced by nutrition experts are very similar nutritionally to potatoes.

A serving of either one provides 37 grams of carbohydrates and 4 grams of protein. Sweet potatoes have more fiber ( 6 grams vxs 4 grams) but more sugars (12 grams vs 2 grams.)

The Harvard School of Public health has decided potatoes are not a vegetable:

“However, potatoes don’t count as a vegetable on Harvard’s Healthy Eating Plate because they are high in carbohydrate – and in particular, the kind of carbohydrate that the body digests rapidly, causing blood sugar and insulin to surge and then dip (in scientific terms, they have a high glycemic load).”

but gives sweet potatoes a pass.

If sweet potatoes were as ubiquitous as potatoes and became a staple of fast food restaurants and a side for any and all dishes (and if they were separated out from the rest of the vegetable world), I suspect they would also be associated with weight gain.

If, on the other hand, potatoes were not markers of fast, tasty, and easily prepared and consumed food and were only eaten at trendy locavore restaurants or prepared at home, I think they would no longer be associated with obesity.

So, yes it does make sense to ask for a side salad and limit your fries to six (or perhaps seven on days of debauchery) in place of the typical mountain of potato if you are seeking weight loss.

Spudlimitingly Yours,

-ACP