Category Archives: Drugs for Diabetes

From 2012: Largest Healthcare Fraud Settlement in History Involves Diabetes Drug Avandia

Your friendly neighborhood drug supplier

Your friendly neighborhood drug supplier

“Global health care giant GlaxoSmithKline LLC (GSK) agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices, the Justice Department announced today. The resolution is the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company. GSK agreed to plead guilty to a three-count criminal information, including two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce and one count of failing to report safety data about the drug Avandia to the Food and Drug Administration (FDA). Under the terms of the plea agreement, GSK will pay a total of $1 billion, including a criminal fine of $956,814,400 and forfeiture in the amount of $43,185,600. The criminal plea agreement also includes certain non-monetary compliance commitments and certifications by GSK’s U.S. president and board of directors. GSK’s guilty plea and sentence is not final until accepted by the U.S. District Court. GSK will also pay $2 billion to resolve its civil liabilities with the federal government under the False Claims Act, as well as the states. The civil settlement resolves claims relating to Paxil, Wellbutrin and Avandia, as well as additional drugs, and also resolves pricing fraud allegations.”

Source: GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data | OPA | Department of Justice

Regarding Avandia:

“The United States alleges that, between 2001 and 2007, GSK failed to include certain safety data about Avandia, a diabetes drug, in reports to the FDA that are meant to allow the FDA to determine if a drug continues to be safe for its approved indications and to spot drug safety trends. The missing information included data regarding certain post-marketing studies, as well as data regarding two studies undertaken in response to European regulators’ concerns about the cardiovascular safety of Avandia. Since 2007, the FDA has added two black box warnings to the Avandia label to alert physicians about the potential increased risk of (1) congestive heart failure, and (2) myocardial infarction (heart attack). GSK has agreed to plead guilty to failing to report data to the FDA and has agreed to pay a criminal fine in the amount of $242,612,800 for its unlawful conduct concerning Avandia.”

And…

“In its civil settlement agreement, the United States alleges that GSK promoted Avandia to physicians and other health care providers with false and misleading representations about Avandia’s safety profile, causing false claims to be submitted to federal health care programs. Specifically, the United States alleges that GSK stated that Avandia had a positive cholesterol profile despite having no well-controlled studies to support that message. The United States also alleges that the company sponsored programs suggesting cardiovascular benefits from Avandia therapy despite warnings on the FDA-approved label regarding cardiovascular risks. GSK has agreed to pay $657 million relating to false claims arising from misrepresentations about Avandia. The federal share of this settlement is $508 million and the state share is $149 million.”

Does this help you understand why I favor diet modification over drug therapy for type 2 diabetes?

Steve Parker, M.D.

low-carb mediterranean diet

Front cover of book

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Are Particular T2 Diabetes Drugs Better Than Others?

From MPT:

“The number of type 2 diabetes drugs that have a proven cardiovascular benefit jumped from one to three this year, highlighting the changing landscape for diabetes treatments.”

Source: Year in Review: Type 2 Diabetes | Medpage Today

The article notes that liraglutide (Victoza), a GLP-1 analogue, was associated with a 13% relative risk reduction in a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke.

Semaglutide, an experimental GLP-1 analogue, also has evidence for cardiovascular death prevention.

Another diabetes drug, Jardiance or empagliflozin, also has evidence for cardiovascular death prevention. Jardiance is an SGLT2 inhibitor.

Read the full MPT article for more details. I find the cost of these drugs to be an interesting yet little discussed detail.

Let’s assume these drugs actually reduce cardiovascular disease risk in T2 diabetics. What if they increase death and disease rates from cancer and infection? You don’t hear much about that, do you?

We still don’t know much about the long-term adverse effects of most of our diabetes drugs. That’s one reason I tend to favor diet modification as a primary diabetes treatment.

Steve  Parker, M.D.

low-carb mediterranean diet

Front cover of book

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New Insulin Delivery Recommendations 

Going in at a 45 degree angle with a 6 mm needle

Going in at a 45 degree angle with a 6 mm needle

“Many primary care professionals manage injection or infusion therapies in patients with diabetes. Few published guidelines have been available to help such professionals and their patients manage these therapies. Herein, we present new, practical, and comprehensive recommendations for diabetes injections and infusions. These recommendations were informed by a large international survey of current practice and were written and vetted by 183 diabetes experts from 54 countries at the Forum for Injection Technique and Therapy: Expert Recommendations (FITTER) workshop held in Rome, Italy, in 2015.”

Source: New Insulin Delivery Recommendations – Mayo Clinic Proceedings

Here are some bullet points that most insulin users need to know:

  • Average skin thickness is 2 to 2.5 mm, with 90% of people under 3.25 mm.
  • Use the shortest needles: 6 mm for syringes, 4 mm for pen injectors. The short needles help you avoid injections into muscle. Injection into muscle increases risk of hypoglycemia and wide blood glucose excursions.
  • Acceptable injection sites: abdomen, thighs, buttocks, upper arms (usually on the back of the arm).
  • If an arm site is chosen with a 6 mm needle, inject into a lifted skin fold (otherwise you might hit muscle).
  • When using the 6 mm needle, inject into a lifted skinfold if you are a child or normal-weight adult. Alternatively, insert the needle at a 45 degree angle.
  • The preferred site for regular insulin (soluble human insulin) is the abdomen, for faster absorption.
  • Use needles only once. (Admittedly, many get away with multiple uses without much trouble.)
  • Don’t inject into lipohypertrophy areas. Lipohypertrophy eventually is an issue in half of insulin users. It is a localized area of swelling or lumpiness at the site of prior injections. It’s often easier to feel than to see. Injection into these areas causes erratic absorption of insulin, with potential widely fluctuating and unpredictable blood sugar levels.
  • Rotate injection sites to avoid lipohypertrophy.
  • If using cloudy insulins (e.g., NPH and some pre-mixed insulins), gently roll and tip the vial or pen until the solution is milk white.

Click here to read about…

  • How to roll and tip a vial to make cloudy insulin milk white.
  • Proper needle disposal.
  • Insulin infusion sets for continuous subcutaneous insulin injection via pumps.

Steve Parker, M.D.

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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.

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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.

 

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New Evidence Supports Extreme Carbohydrate Restriction in Type 2 Diabetes

Low-Carb Spaghetti Squash With Meat Sauce

Diabetes is a disease of carbohydrate intolerance. Doesn’t that suggest to you that diabetics should reduce or avoid dietary carbohydrates?

The new study at hand was done in Indiana, involving 262 folks with type 2 diabetes. Characteristics of the study subjects:

  • average age 54
  • 66% women
  • BMI 41 (very fat)
  • average Hemoglobin A1c 7.6%

The authors don’t use the term “ketogenic diet,” preferring instead “a diet designed to induce nutritional ketosis” (I’m paraphrasing). For most folks, that’s a diet with under 30 grams of carbohydrate daily, according to the researchers. The study lasted for only 10 weeks.

The drop-out rate was about 10% (25 participants), which is not bad.

Results:

  • Hemoglobin A1c (a test of diabetes control) dropped to 6.5%, a move in the right direction and equivalent or better than that seen with many diabetes drugs.
  • Average weight loss was 7.2% of initial body weight.
  • No severe symptomatic hypoglycemic events.
  • Number and dose of necessary diabetes drugs were reduced “substantially.”

What’s not to love? Why isn’t this the standard of care?

Click the link below to look for details of the Virta Clinic program used in this study.

I put together a Ketogenic Mediterranean Diet for my patients with diabetes. It reduces dietary carbs to 20-30 grams/day. There’s a free version, but consider the low-cost version that includes recipes and extensive initiation and management advice.

Steve Parker, M.D.

McKenzie AL, Hallberg SJ, Creighton BC, Volk BM, Link TM, Abner MK, Glon RM, McCarter JP, Volek JS, Phinney SD
A Novel Intervention Including Individualized Nutritional Recommendations Reduces Hemoglobin A1c Level, Medication Use, and Weight in Type 2 Diabetes
JMIR Diabetes 2017;2(1):e5
DOI: 10.2196/diabetes.6981

low-carb mediterranean diet

Front cover of book

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DPP-4 Inhibitors Increase Risk of Pancreatitis

…although the risk of getting pancreatitis is pretty small in any case.

DPP-4 inhibitors are sometimes called gliptins. They’re used to treat type 2 diabetes.

From Diabetes Care:

“CONCLUSIONS Treatment with gliptins significantly increased the risk for acute pancreatitis in a combined analysis of three large controlled randomized trials.”

Source: Diabetes Care

Speaking of risk reduction, lower your risk of being prescribed a gliptin by reducing your carbohydrate consumption.

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