Warning: Canaglflozin (Invokana) Doubles the Risk of Amputation in T2 Diabetes

Open wide!

Yesterday the U.S. Food and Drug Administration ruled that Invokana doubles the risk of foot and leg amputations in type 2 diabetics, compared to treatment with placebo. Invokana is an SGLT2 inhibitor called canagliflozin. There are several other drugs in that class, and we don’t know about the risk of amputations with them.

I don’t start any of my T2 diabetic patients on SGLT2 inhibitors. Instead of taking a pill to make your kidneys excrete carbohydrate, it’s smarter to reduce dietary carbohydrate consumption.

Steve Parker, M.D.

Leave a comment

Filed under Drugs for Diabetes

Do SGLT2 Inhibitors Increase Risk of Amputation?

Good question. But we don’t know the answer yet.

European authorities and even the U.S. Food and Drug Administration are looking into the possible connection. Stay tuned. Visit The Low Carb Diabetic site (link below) for more details.

“The European Medicines Agency (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC) has extended the scope of its investigation into the possible link between the sodium glucose cotransporter 2 (SGLT2) inhibitor canagliflozin (Invokana, Vokanamet, Janssen) and amputations to include other drugs of the same class.

Now, the PRAC’s review will include the other SGLT2 inhibitor medicines dapagliflozin (Farxiga, Xigduo XR, AstraZeneca), and empagliflozin (Jardiance, Boehringer Ingelheim), based on the determination that the potential risk may be relevant for them as well.”

Source: The Low Carb Diabetic: EMA Extends Amputation Investigation to All SGLT2 Inhibitors

Steve Parker, M.D.

PS: SGLT2 inhibitors are the drugs that reduce blood glucose by shunting it into your urine. Makes more sense to me instead to reduce your blood sugar by eating fewer carbohydrates, the primary source of blood sugar in most folks.

 

1 Comment

Filed under Drugs for Diabetes

Competition is the Only Way to Improve U.S. Healthcare and Reduce Cost

This is costing way too much

The only way to improve U.S. healthcare while bringing costs down is to introduce serious competition for healthcare dollars.

This post is for U.S. citizens since the federales are going to tinker with our health insurance reform very soon. This would be a great opportunity to make helpful changes  to the system. I have no faith they will do it.

Healthcare in the U.S. consumes one of every five dollars spent in the economy. We are not getting our money’s worth, at least judging from average lifespan.

Karl Dennnger has put a lot of thought into the problem over the last decade, and has a concrete legislative proposal that makes a lot of sense. I endorse it. As you consider the possibilities, you need to keep in mind that the cost of healthcare will drop drastically. Not just by 50%. More like 80% or more. Healthcare will be so cheap you won’t even need insurance to pay for most of it.

How are these price reductions possible? Because the Dennniger plan introduces competition and moves us closer to a free market situation without third-party interference from insurers and government.

Here are the major points:

  • All healthcare providers must publicly post (e.g., on the web) prices which apply to everyone. E.g., not  a price depending on which insurance you have, whether you are paying cash up front, etc.
  • All customers must be billed for actual charges at the same posted prices at the time services or product is rendered. This removes the third party (insurer or government). You file the claim and every one pays the same price. In a way, medical care isn’t too expensive; too often it’s “free,” because someone else is paying. So there’s no comparison shopping. You see posted prices and you pay them yourself when you buy gasoline, groceries, cell phones, computers, TVs, cars, and houses. A valid and collectible bill must be consented to in writing before the service or product is provided. Actual price, no open-ended add-ons.
  • No event caused by or a consequence of treatment can be billed to the customer. (I’m not sure I like this. What about unforeseeable complications like C diff infection after antibiotics, or anaphylactic reactions to drugs? Providers could eventually get insurance to cover those costs, but it would be a brand new insurance market.)
  • True emergency patients who are unable to consent must receive the same price for same service as a person who consents to said service.
  • All medical records belong to the patient and shall be delivered to the patient (customer) at the time of service.
  • Auxiliary services (e.g., x-rays, lab work) may not be required to be purchased at the point of use. Example: an orthopedist wants you to get a knee MRI scan on his machine. You can shop around other places for a cheaper or better-quality MRI scan.
  • All anti-trust and consumer protection laws shall be enforced against all medically-related firms, and any claimed exemptions are hereby deemed void. Stiff penalties and fines for violations. Private lawyers must have access to sue.
  • You are free to purchase any medical test you want if no radiation or drug is required to perform the test. (You can already do this in Arizona, but in many states you need a “doctors order” for the test.)
  • There will be no government payments for care or products when a lifestyle change will provide a substantially equivalent or better benefit, when the customer refuses to implement the lifestyle change. (This point needs some fine-tuning. Who decides when and which lifestyle change would provide an equivalent benefit?])
  • Health insurance companies must sell true insurance, to sell any health-related policy at all. No insurance coverage for an event or condition of which you received treatment over the last 24 months.  If an adverse event occurs, insurance pays for all of it. E.g,, if you get an expensive cancer, the insurance company cannot drop you. The insurance must cover, with a selection of available deductibles, all accidental injuries and true life-threatening emergencies. Medical underwriting is permitted (e.g., insurers can charge higher premiums for smokers, couch potatoes, obese folks, etc. I have long thought that people in the top 25% of fitness, determined by a treadmill exercise test, should get a discount on insurance premiums).
  • All health insurers providers selling true insurance, in whole or in part, must provide within their “true insurance” the ability to replace like with like.” (I don’t know what Karl means by this.)
  • Medicare becomes just another insurance provider. No more Part B (outpatient services).
  • Medicaid is repealed entirely.
  • What about U.S. citizens and “lawful permanent residents” who can’t pay for care but still need attention? For true emergencies, the hospital or Emergency Department bills the U.S. Treasury, who pays within 30 days. For non-emergencies, the provider bills the U.S. Treasury and will be paid within 30 days except no billing for government payment if the condition resulted from a lifestyle decision the patient made. After the Treasury Department pays the provider, Treasury will send an invoice to the customer (patient or taxpayer), which may be settled within 90 days at no penalty. If charges are not paid, they become a tax lien subject to collection from refundable tax credits, tax refunds, other entitlement checks (except Social Security retirement), and windfall amounts (either money or property).
  • Repeal all aspects of Obamacare/PPACA.

You need a break after all that. Almost done. Hang in there!

I don’t recall Karl recommending a specific deductible amount, but often saw mention of $2,000 as a deductible. “Deductible” is what you pay out of pocket before insurance pays anything. I like a high deductible over “first-dollar” coverage, because the high deductible automatically creates 200 million shoppers who are going to check prices for sure before buying healthcare. (Of 320 million people in the U.S., I’m guessing 200 million are adults.)

Karl favors “catastrophic” policies, as do I. Your car needs new tires every few years, oil changes much more often, and periodic repairs, but you don’t expect car insurance to pay for those non-catastrophic costs.

Who would get hurt by this plan? Lobbyists, insurance and healthcare administrators, drug reps, pharmacy benefits managers, and those who refuse to make healthy lifestyle changes.

I don’t recall Karl addressing unreasonable insurance mandates, managed care plans (like Kaiser Permanente in CA), accountable care organizations, liability reform (we need the English Rule), tax parity (businesses buying insurance for employees get a tax break, but private individuals buying their own policies don’t), or much about enforcement. But he may have; Karl’s a very smart guy.

Steve Parker, M.D.

 

5 Comments

Filed under healthcare reform

Average U.S. Woman Today Weighs as Much as the Average Man of 1960

But women now are also about a half inch (2.2 cm) taller, so that explains it, right? Not by a long shot. The author of the article below blames unhealthy food, too much of it, plus physical inactivity. Since 1960, women’s average weight is up 18.5%, and men’s up 17.6%.

Click the link below for details. I quote:

The average American woman weighs 166.2 pounds, according to the Centers for Disease Control and Prevention. As reddit recently pointed out, that’s almost exactly as much as the average American man weighed in the early 1960s.

Men, you’re not looking too hot in this scenario either. Over the same time period you gained nearly 30 pounds, from 166.3 in the 60s to 195.5 today.

Source: The average American woman now weighs as much as the average 1960s man – The Washington Post

Steve Parker, M.D.

PS: You wanna do something about it? Send my book to someone you love.

PPS: Men are also a half inch taller.

3 Comments

Filed under Overweight and Obesity

KarlCare: Karl Denninger’s U.S. Healthcare Reform Plan

The system’s not an emergency situation yet, but will be in a few years

The U.S. needs not only healthcare system reform, but also health insurance reform.

Karl Denninger has fleshed out his U.S. healthcare system reform recommendations in a form ready for legislation.

I’ve only read it once and admit I don’t fully understand it. But I can tell already that it would be a major improvement over our current system.

Steve Parker, M.D.

Comments Off on KarlCare: Karl Denninger’s U.S. Healthcare Reform Plan

Filed under healthcare reform

Low-Carb Diet Works In Overweight Japanese Type 2 Diabetes

This meal is low-carb, and probably low-calorie too

This meal is both low-carb and low-calorie

A randomized controlled clinical trial found superior results in diabetes with a moderate low-carb diet, judging from weight loss and hemoglobin A1c.

I don’t know how many carbs the typical Japanese person eats in a day. In the U.S., it’s 250-300 grams. Here’s how the study at hand was done:

“This prospective, randomized, open-label, comparative study included 66 T2DM patients with HbA1c >7.5% even after receiving repeated education programs on Calorie-Restricted Dieting (CRD). They were randomly allocated to either the 130g/day Low-Carb Diet (LCD) group (n = 33) or CRD group (n = 33). Patients received personal nutrition education of CRD or LCD for 30 min at baseline, 1, 2, 4, and 6 months. Patients of the CRD group were advised to maintain the intake of calories and balance of macronutrients (28× ideal body weight calories per day). [If I understand correctly, a 170-lb (77.2 kg) person would be recommended to eat 2160 calories/day.] Patients of the LCD group were advised to maintain the intake of 130 g/day carbohydrate without other specific restrictions. Several parameters were assessed at baseline and 6 months after each intervention. The primary endpoint was a change in HbA1c level from baseline to the end of the study.

At baseline, body mass index (BMI) and HbA1c were 26.5 and 8.3, and 26.7 kg/m2 and 8.0%, in the CRD and LCD, respectively. At the end of the study, HbA1c decreased by −0.65% in the LCD group, compared with 0.00% in the CRD group (p < 0.01). Also, the decrease in BMI in the LCD group [−0.58 kg/m2] exceeded that observed in the CRD group (p = 0.03).

Conclusions: Our study demonstrated that 6-month 130 g/day LCD reduced HbA1c and BMI in poorly controlled Japanese patients with type 2 diabetes. LCD is a potentially useful nutrition therapy for Japanese patients who cannot adhere to CRD.”

Source: A randomized controlled trial of 130 g/day low-carbohydrate diet in type 2 diabetes with poor glycemic control – Clinical Nutrition

The calorie-restricted diet did nothing for these folks in terms of glycemic  control.

Steve Parker, M.D.

PS: In case you’re wondering, the Low-Carb Mediterranean reduces digestible carbs to 20-100 grams/day.

low-carb mediterranean diet

Front cover of book

 

1 Comment

Filed under Carbohydrate, Weight Loss

How About a Whole Foods Plant-Based Diet?

Carb-rich whole-grain bread

New Zealand researchers found significant long-term weight loss and improved cholesterol levels over six and 12 months with a low-fat vegetarian diet. Surprisingly, this was accomplished without restriction on calories and without an exercise component. Weight loss measured at six months was 27 lb (12.1 kg) and they only gained a little back over the subsequent six months.

The authors think the successful weight loss was from “… the reduction in the energy density of the food consumed (lower fat, higher water and fibre). Multiple intervention participants stated ‘not being hungry’ was important in enabling adherence.”

I scanned the research report pretty quickly and don’t see that they referred to the diet as vegetarian. Here’s their test diet description:

We chose a low-fat iteration of the plant-based diet [7–15% if calories as fat] as this has been shown with previous research to achieve optimal outcomes, especially for heart disease and weight loss. This dietary approach included whole grains, legumes, vegetables and fruits. Participants were advised to eat until satiation. We placed no restriction on total energy intake. Participants were asked to not count calories. We provided a ‘traffic-light’ diet chart to participants outlining which foods to consume, limit or avoid. We encouraged starches such as potatoes, sweet potato, bread, cereals and pasta to satisfy the appetite. Participants were asked to avoid refined oils (e.g. olive or coconut oil) and animal products (meat, fish, eggs and dairy products). We discouraged high-fat plant foods such as nuts and avocados, and highly processed foods. We encouraged participants to minimise sugar, salt and caffeinated beverages.

Perfect diet compliance would make this a vegan diet. I didn’t catch it in the text of the article, but I’m guessing protein calories were 10–15% of the total, and carbohydrates were around 75%.

The researchers called their investigation the BROAD study. All study subjects were overweight or obese adults. A control group ate their regular foods. The intervention group eating the whole food plant-based diet numbered 33, including 7 with type 2 diabetes. All studies like this have people that drop out. I.e., they quit or otherwise get lost to follow-up. Of the intervention group, 75% lasted for six months, 70% stuck with it for the entire 12 months.

 

There weren’t enough diabetics in the study to make statistically significant conclusions, but the authors write, “Hemoglobin A1c reductions favoured the intervention and all intervention patients with a diabetes diagnosis improved while adherent, and two resolved their condition by HbA1c.”

I’d love to see these researchers repeat this study with 50–100 overweight or obese folks with T2 diabetes. Clearly, it’s a radically different diet than what I recommend for my patients with diabetes.

Steve Parker, M.D.

PS: For science nerds, here’s the study abstract:

Background/Objective: There is little randomised evidence using a whole food plant-based (WFPB) diet as intervention for elevated body mass index (BMI) or dyslipidaemia. We investigated the effectiveness of a community-based dietary programme. Primary end points: BMI and cholesterol at 6 months (subsequently extended).

Subjects: Ages 35–70, from one general practice in Gisborne, New Zealand. Diagnosed with obesity or overweight and at least one of type 2 diabetes, ischaemic heart disease, hypertension or hypercholesterolaemia. Of 65 subjects randomised (control n=32, intervention n=33), 49 (75.4%) completed the study to 6 months. Twenty-three (70%) intervention participants were followed up at 12 months.

Methods: All participants received normal care. Intervention participants attended facilitated meetings twice-weekly for 12 weeks, and followed a non-energy-restricted WFPB diet with vitamin B12 supplementation.

Results: At 6 months, mean BMI reduction was greater with the WFPB diet compared with normal care (4.4 vs 0.4, difference: 3.9 kg m−2 (95% confidence interval (CI)±1), P<0.0001). Mean cholesterol reduction was greater with the WFPB diet, but the difference was not significant compared with normal care (0.71 vs 0.26, difference: 0.45 mmol l−1 (95% CI±0.54), P=0.1), unless dropouts were excluded (difference: 0.56 mmol l−1 (95% CI±0.54), P=0.05). Twelve-month mean reductions for the WFPB diet group were 4.2 (±0.8) kg m−2 BMI points and 0.55 (±0.54, P=0.05) mmol l−1 total cholesterol. No serious harms were reported.

Conclusions: This programme led to significant improvements in BMI, cholesterol and other risk factors. To the best of our knowledge, this research has achieved greater weight loss at 6 and 12 months than any other trial that does not limit energy intake or mandate regular exercise.

Source: Nutrition & Diabetes – The BROAD study: A randomised controlled trial using a whole food plant-based diet in the community for obesity, ischaemic heart disease or diabetes

11 Comments

Filed under Vegetarian Diet