Sunday, January 29, 2017

Type 2 Diabetes, a Dietary Disease #365: The Dual Pincers of Clinical Practice Guidelines

This article in the Journal of the American Board of Family Medicine begins, “Clinical practice guidelines abound. The recommendations contained in these guidelines are used not only to make decisions about the care of individual patients but also as practice standards to rate physician ‘quality.’” Did you know that? I have for awhile, and it concerns me. I first became aware of it during the funding cuts in Medicare (+/- $750 billion) during the “negotiations” leading up to the passage of the “Affordable Care Act” (ACA, aka Obamacare).
The Journal article continues, “Thus there is an inevitable aspect of guideline development that makes it subject to value judgments and can be unconsciously colored by intellectual, professional, or financial conflicts of interest.” These include biases such as “decisions colored by tunnel vision (job conditioning), ‘seeing what you want to see’ (confirmation bias), decisions limited to the tools at hand (Maslow’s hammer), or other inclinations that can affect judgment.” That last one especially concerns me. Why? Medicare Payment Reform.
We have all become aware of the movement towards Electronic Health Records (EHR). But did you know that there are financial incentives and disincentives for physician compliance? The EHR program, called Meaningful Use (MU), is now in the process of being itself re-reformed. According to a blog post from Impact Advisors, posted before the final rule was issued, “providers simply wanted to ‘check the box’ in order to reach MU thresholds (and thus avoid ‘adjustments,’ i.e., penalties), foregoing the larger opportunity to improve care.”
EHR was Part 1 of a larger reform program of the Center for Medicare and Medicaid Services (CMS). It is still in place, but Part 2, described as “share data” and Part 3, “improve outcomes,” are now part of a new Medicare Payment program designed to overcome the “noted weaknesses of MU.” Part 1 will be transformed and phased in by stages starting in 2017. Parts 2 and 3, now the Merit-Based Incentive Payment System (MIPS), is part of the Medicare Access and CHIP Reauthorization Act (MACRA) and implementation begins in 2019.
Now, according to an AMA email “alert” that I received last fall, CMS has issued its final MACRA rule, detailing the new Merit-Based Incentive Payment System, now called the Quality Payment Program (QPP). In the email, AMA President Andrew Gurman thanked CMS Acting Administrator Andrew Slavitt for being a “sincere partner” during the process. Gurman was very pleased at the influence the AMA’s comments had that “will allow for a reasonably paced progression into the program so that physician practices can learn and adjust…”
He said, “The key elements of the proposed rule that CMS changed based on our recommendations are:”
     Physicians would not have to report in all four MIPS categories to avoid a negative payment adjustment. Instead, the only physicians who “will experience a negative 4% penalty in 2019 [increasing in steps to 9% by 2022] will be those who choose to report no data.”
     Participating in one of 4 options under “Pick Your Pace” will “help the physician avoid penalties.” At the very least if (s)he “chooses to report for only one patient on just one quality measure, one improvement activity, or the 4 required Advancing Care information (ACI) measures, [(s)he] will avoid a negative payment adjustment.”
     The final rule established a 90-day reporting period, “a significant change over the proposed rule, full calendar-year requirement.” If the physician reports for at least 90 continuous days in 2017, (s)he will be eligible for a positive payment adjustment. This adjustment allows the physician to start later, to have more time to prepare.
     A reduction in the program-wide reporting burden from 11 reporting measures to 4 in 2017 and 5 thereafter.
     “An increase in the low-volume threshold to qualify for exemption from QPP participation.” CMS increased the threshold from $10k to $30k in Medicare payments, but kept the 100 Medicare patients per year limitation. So, know that your physician has been incentivized to not accept new Medicare patients, and to drop the old ones.
Does this give you a sense of why your relationship with your doctor has changed in recent years? I started this column feeling a bit angry at my doctor. I end it feeling sorry for him. Look what’s happening to Medicare!

Sunday, January 22, 2017

Type 2 Diabetes, a Dietary Disease #364: “Prediabetes, in other words, is Diabetes”

This title is in quotes because…I think I cribbed it from Kelley Pounds, an RN, CDE, blogger and diabetes educator whose writings I always find interesting and informative. But, alas, I can’t link to it here because I can’t find that title in her Table of Contents. So, a hat tip to Kelley Pounds and this link to her home page.
The point of the title is that Kelley, and I and many other “activists,” and of late, some researchers, are urging the public health establishment in the U. S. and world-wide to take a hard look at the current Standard of Practice for defining Prediabetes and consider lowering or re-defining it. The implications of doing this are momentous; but likewise, if this is not done, the outcomes will be catastrophic. Consider this recent revelation from the CDC: “Life expectancy for the U. S. population in 2015 was 78.8 years, a decrease of 0.1 years from 2014.” That’s the first DECREASE IN LIFE EXPECTANCY in the U.S. since 1999. Think it’s related to our lifestyle?
A ton of evidence associates LIFESTYLE DISEASES with METABOLIC SYNDROME, the major outcomes of which are Type 2 Diabetes and heart disease. That’s why BETTER STANDARDS are needed to address this scourge.
Cardiovascular Disease (CVD), Coronary Heart Disease (CHD), Stroke, Type 2 Diabetes Mellitus (T2DM), Non-alcoholic Fatty Liver Disease (NAFLD), Alzheimer’s Disease, aka Type 3 Diabetes, and even Erectile Dysfunction. Also several types of cancer; A large population study, in “Diabetes Care,” shows that “the relative risks of various cancers imparted by diabetes are greatest (about twofold or higher) for cancers of the liver, pancreas, and endometrium, and lesser (about 1.2–1.5 fold) for cancers of the colon and rectum, breast, and bladder.”
A WebMD stub puts it succinctly: “Metabolic syndrome is a collection of symptoms that can lead to diabetes and heart disease. The good news is that metabolic syndrome can be controlled, largely with changes to your lifestyle.” The five related symptoms, first introduced six years ago to my readers here, and updated here, and then here and here, are: a Body Mass Index (BMI) ≥30, or large waist circumference (men ≥40 inches, women ≥35 inches); elevated triglycerides (≥150mg/dl), reduced HDL, the “good” cholesterol (men ≤40mg/dl, women ≤50mg/dl), elevated blood pressure (≥130/85mm Hg, and/or use of medications for hypertension) and elevated fasting glucose (≥100 mg/dl, and/or the use of medications for hyperglycemia).
In the U.S. the longstanding criteria for a clinical diagnosis of Type 2 Diabetes Mellitus (T2DM) was two consecutive office visits with a fasting blood sugar ≥140mg/dl (7.8mmol/L). In 1997 that standard was lowered to ≥126mg/dl (7.0mmol/L). In 2002 a definition for Pre-Diabetes was added: an IFG ≥ 100 to 125mg/dl (5.6 to 6.9mmol/L) or an IGT of 140 to 199mg/dl (7.8 to 11.0 mmol/L) two hours after a 75 gram glucose challenge. The WHO uses a higher IFG threshold: ≥110to 125mg/dl (6.1 to 6.9mmol/L). Later, in the U. S., the HbA1c measurement was added to supplement or in some cases now to supplant the IFG. In the U. S., an HbA1c between 5.7% and 6.4% is considered Pre-Diabetic and ≥6.5% Type 2 Diabetes. Elsewhere in the world, Pre-Diabetes is defined as an “A1c” ratio between 49 and 56mmol/mol and Type 2 Diabetes as ≥58mmol/mol.
For years leading research scientists like Ralph A. DeFronzo and pioneering clinicians like Richard K. Bernstein have called for a lower standard for the diagnosis of incipient Type 2 Diabetes. These men are leading diabetes specialists who have devoted their lives to combating this disease. They are both superstars.
Now, as I reported in #362, the BMJ (British Medical Journal) has just published a Chinese meta-analysis done on 1,611,339 people. The lead researcher’s takeaway: “Effective intervention in prediabetes is not just for prevention of diabetes, but also cardiovascular diseases.” The majordomos are starting to connect the dots.
Type 2 Diabetes has to be redefined, as DeFronzo and Bernstein would say – indeed have said: “Prediabetes, in other words, is Type 2 Diabetes.”
And at the clinical level today, physicians, using the current standard, have to not treat Prediabetes with temporizing measures, e.g., “We’ll have to monitor your blood sugar” (read: to watch your Insulin Resistance worsen as you eat the Standard American Diet. Clinicians need to tell you: “You are Carbohydrate Intolerant.”

Sunday, January 15, 2017

Type 2 Diabetes, a Dietary Disease #363: Type 2 Diabetes, a Lifestyle Disease

Okay, so which is it? A Dietary Disease or a Lifestyle Disease? It’s both, of course; diet is a part of Lifestyle. But why then is Establishment Medicine comfortable with calling it a Lifestyle Disease and not a Dietary Disease? They would tell you that lifestyle includes such things as doing 175 minutes of exercise a week (which while good, isn’t necessary) and giving up smoking (which while also good, isn’t relevant to diabetes). Forget the epidemiological studies that show an association with Type 2 Diabetes. That’s demographic, not causal.
Exercise is a great habit to have. It builds muscle, keeps you fit, and if you’re a Type 2 or even Prediabetic, it improves your insulin sensitivity. But it’s not necessary. Eating fewer carbs, thereby secreting less insulin, also improves your insulin sensitivity. “Insulin causes Insulin Resistance,” as Dr. Jason Fung recently blogged.
No, Establishment Medicine probably doesn’t want to call Type 2 a Dietary Disease for a number of reasons:
1)  Some clinicians simply don’t know. I know that’s hard to believe, but I’m afraid it’s true. It’s called “tunnel vision.” See #365, to be posted in two weeks, “The Dual Pincers of Clinical Practice Guidelines.”
2)  If you understood that Type 2 Diabetes and Prediabetes are Dietary Diseases, then the “treatment” would be a changed diet, not pills and injections… and you could still advocate for exercise and secession of smoking. Ah, but then it would be a less persuasive and perhaps a less effective argument if it was not linked to the avoidance of Type 2 Diabetes. And, if you didn’t have a prescription to write, the patient would feel “cheated.” The patient wants you, oh omnipotent dispenser of scripts, to “cure” this pernicious disease for them.
3)  If Type 2 Diabetes and Prediabetes are acknowledged to be Dietary Diseases, caused by the dietary advice that Government Dictocrats have mandated and Medical Establishment has peddled for the last 55 years, then your doctor, if he or she were to tell you to change your diet to almost the exact polar opposite of what he or she has been telling you to eat over these many years, they would look pretty silly or just stupid. And the general public, and your doc’s patients in particular, would lose confidence in these omniscient demigods. 
4)  The ADA used to say that low carb diets were not safe. Then, the evidence from controlled trials proved them wrong. Then they said they were safe for a limited time only; then the evidence proved that wrong too. Then they said – actually, they’ve said all along – that low carb diets were too difficult to follow. That’s true for some, but certainly not true for many others. Others found them easier to follow than a low-fat, calorie- restricted, “balanced” diet because weight loss without hunger was possible. And followers of low-carb, high- fat diets, besides keeping the weight off, had better glucose control and better lipid (cholesterol) profiles!
No, it’s easier to see the patient, take a blood sample, and then tell them (in a phone call or a note with your lab test) that, “Your sugar is a little high; we’ll have to monitor that.” And when you continue to eat the same prescribed “balanced” diet, and exercise as you were told, and your blood sugar goes higher still, the doctor will tell you, as Tom Hanks related to David Letterman, “You’ve graduated; you’re now a Type 2 Diabetic.”
Well, what did you expect? You continued to do the same thing and yet you expected a different result? Type 2 Diabetes is a Progressive Disease. Insulin Resistance is a Progressive Condition. Insulin Resistance = Type 2 Diabetes. Insulin Resistance = Carbohydrate Intolerance. The only effective treatment for a Dietary Disease is a different diet. The only effective treatment of Type 2 Diabetes is a Low Carbohydrate Diet. Not “watching your blood sugar” as it progressively worsens. Not treating this symptom – an elevated blood sugar – with a drug that will force your pancreas to secrete more insulin and thus eventually wear out and destroy it. Type 1 Diabetes is a disease of too little insulin. Type 2 Diabetes is a disease of too much insulin. The best way to treat your pancreas, and thus save it, is give it a break! Eat a low carb diet!

Sunday, January 8, 2017

Type 2 Diabetes, a Dietary Disease #362: A Stricter Prediabetes Definition?

A recent Reuters Health Information article in Medscape Medical News headlined, “Meta-Analysis Backs Stricter Prediabetes Definition.” It reports on a new study in the BMJ (British Medical Journal) that “people with a fasting glucose as low as 100mg/dl (5.6mmol/L) are at increased risk of cardiovascular disease.” It also showed increased CVD risk in individuals with an HbA1c as low as 5.7% (39 mmol/mol). What is significant about this Chinese study is that it is very large (53 studies, comprising 1,611,339 people). The big takeaway: “Effective intervention in prediabetes is not just for prevention of diabetes, but also cardiovascular diseases.”
This isn’t news to my regular readers. I have been saying it forever, most recently in the risk analysis presented in #345, “How Diabetic Do You Want to Be? (Part 2). That column was based on the laudatory work of Jenny Ruhl at her website, Blood Sugar 101. Jenny has meticulously collected and provided links to the best research. Her books, “Blood Sugar 101” and “Diet 101,” are awesome too.
Based on the ADA criteria for an Impaired Fasting Glucose (IFG) of 100mg/dl to 125mg/dl (5.6 to 6.9mmol/L), the study found that the association between prediabetes and various co-morbidities is as follows: CVD ↑ 13%; CHD ↑ 10%; Stroke ↑ 6% and All-Cause Mortality ↑ 13%. But the ADA criteria is “contentious,” the authors told Medscape, and “has not been used in other international diabetes management guidelines.” The WHO (World Health Organization), for example, uses a higher cutoff for diagnosing an IFG, 6.1 to 6.9mmol/L (110-125mg/dl), and thus has a higher hazard ratio for “composite cardiovascular disease” of ↑26%.
Similarly, the ADA’s prediabetes criteria for an HbA1c is 39-47mmol/mol (5.7% -- 6.4%), whereas the National Institute for Health and Care Excellence (NICE at NHS) cutoff, 42-47mmol/mol (6.0% -- 6.4%), is different. As a result, CVD relative risks vary from 13% (IFG-ADA) to 26% (IFG-WHO), relative risks for CHD vary from 10% to 18%, and relative risks for stroke vary from 6% to 17%. The authors also argue for the standardization of IFG and IGT (Impaired Glucose Tolerance), and the worldwide incorporation of HbA1c in defining prediabetes.
 But let’s not get lost in the weeds. The bottom line is this: The current cutoffs worldwide for a diagnosis of prediabetes are strongly associated with an increased risk of CVD, CHD, stroke and all-cause mortality. This is in addition to the usual microvascular complications of T2DM of nephropathy (end-stage kidney disease), retinopathy (blindness), and neuropathy (leading to amputations). There is also a similar pattern for dementia.
That’s the message, and that is why I am pleased to see this hue and cry for a stricter and more standardized prediabetes definition. The medical doctor’s response was predictable: “People with diabetes should be followed up and should maintain a healthy lifestyle” (emphasis added by me). And “many drugs prescribed for diabetes may be useful in people with prediabetes (metformin, acarbose).” The latter is also not news, but it is surprising how many doctors don’t know this and do not routinely employ this intervention in clinical practice.
Then, according to Medscape, the study’s lead author, obviously a research physician, suggests that, “First, we need to develop models for risk stratification in people with prediabetes. Second, we will select higher-risk people with prediabetes to evaluate whether drug treatment can prevent cardiovascular disease in them.”
I’m not surprised by this either. Drugs, drugs, drugs. Always treat the symptom (an elevated blood sugar); never treat the cause (Insulin Resistance → Carbohydrate Intolerance). What about “lifestyle modifications”?

Lifestyle modifications address modifiable risk factors. That means you can do something to reduce your increased risk of cardiovascular disease. You can modify your diet by restricting the amount of carbohydrates you eat and thus lower your blood sugar. Ruhl #1: ↓Dietary Carbohydrates = ↓Insulin Resistance = ↓Type 2 Diabetes.

Sunday, January 1, 2017

Type 2 Diabetes, a Dietary Disease #361: “Whistlin’ Past the Graveyard”

As I write this in mid December, I have just learned that two people that I thought I was helping are paying no attention. This news is worse than discouraging. It’s depressing – but not so much for me. I’m trying not to think of myself. I don’t write this stuff for myself. Okay, I do, a little, but I do it primarily for my friends, my faithful readers, and people who stumble on a column through Google. But it’s especially disheartening to learn that people whose health should be of paramount concern to themare ignoring their health and my advice.
Okay, I’m not a health professional, and I’m certainly not a doctor. I don’t have the opportunity to order blood tests and deliver the bad news to the patient. And then, when they are most vulnerable, tell them to take a pill or even to follow a certain way of eating. But I can’t for the life of me (LOL) figure out why anyone would listen to a doctor in the matter of what to eat. I mean, what in bloody hell do they know about “healthy eating.”
Oh, I forgot. Government Dictocrats have been telling us what to eat to prevent heart disease since at least 1977, and updating their advice every 5 years. In fact, it began after President Eisenhower’s first heart attack in 1955. By January 1961, Ancel Keyes had made it onto the cover of Time magazine, and the basic advice then and now is to avoid saturated fat and cholesterol, to eat mostly a plant-based diet primarily with fats from corn and soy bean oil. A diet, per the Nutrition Facts Label on processed food, of 60% (300g) carbs, 10% (50g) protein and 30% (67g) of the aforementioned oxidized polyunsaturated vegetable and seed oils (PUFAs) manufactured by the industrial food giant conglomerates supported by the USDA.
Now it’s true that in recent years the USDA/HHS/FDA have backed off a little. They no longer limit total fat to 30%, but they insist that to the extent that percentage is increased, you do it with those PUFAs, not the saturated fats from animals. And it’s true that the Dietary Guidelines Advisory Committee told the full panel on December 14, 2014, that “Cholesterol is no longer a nutrient of concern for overconsumption,” but after the full panel held Congressional hearings, the final 2015 Guidelines totally water down that recommendation.
There are also lots of news articles appearing now about the benefits of full fat dairy products like milk and yoghurt. But guess what? Have you tried to find full-fat yoghurt in the grocery store recently? Good luck! But what do you expect? Do you think the Government is going to tell you their advice for the last 55 years has been all wrong? Of course not. It’s unthinkable. So, you have to decide for yourself what healthy eating is.
I could even cite several scientific reviews questioning – neigh, disparaging the advice to reduce the intake of salt. I’ve cited them over and over here, here, and here. But, does anyone listen to me? No. Poor, poor me.
Recently I learned that one friend who needed to lose weight that he had gained because of medications he must take – was successful in following a low-carb regimen I had advocated. Then, with his wife, he switched to Weight Watchers. Maybe he did it to support his wife’s efforts. Maybe it’s easier. I hope he’s successful.
Then another friend, who also has medical issues, had on the advice of her physician gone vegetarian. And guess what? She’s tired all the time, and blood tests her doctor ordered showed her to be protein deficient. Quelle surprise! She and her husband, who is in worse shape than she, both have ignored my advice for years.
Okay, I am feeling sorry for myself. But I am also worried for them, and for you too – for their health and yours. Don’t they realize that is all they have that is important (besides each other)? Don’t you realize it?
I just learned a few days ago that another friend died suddenly about a month ago. Maybe this rant is because I’m grieving for him too and for all my other friends and everyone else who is whistling past the graveyard. Thinking about myself, I originally thought of naming this column, “Whistlin’ Dixie,” but that would have made this column about me. This is really about you, my friends: It is you who are whistling past the graveyard.
January 1st is the scheduled publication date for this column. It will also be the 1st day of the rest of your life.