Tag Archives: diabetes drugs

From 2012: Largest Healthcare Fraud Settlement In History Involves T2 Diabetes Drug Avandia

Posted on June 3, 2017 | 5 comments

Your friendly neighborhood drug supplier

This will help you understand why I favor diet modification over drug therapy for type 2 diabetes:

“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.”

5 Comments

Posted in Drugs for Diabetes

Tagged Avandia, diabetes drugs, healthcare fraud, Paxil, Wellbutrin

Do the Drug Companies Have Too Much Influence on Diagnosis and Management of Type 2 Diabetes?

Posted on December 28, 2014 | 2 comments

diabetic mediterranean diet, Steve Parker MD

Pharmacist counting pills

MedPageToday has recently completed a series of articles looking at socioeconomic issues related to diabetes drugs that have come onto the market in the last decade. They call it their Diabetes Drugs Investigation. I recommend the entire series to you if you have type 2 diabetes. The authors’ have five major points:

1. “Diabetes drugs improve lab tests, but not much more, particularly in pre-diabetics.” FDA drug approvals were based mostly on whether hemoglobin A1c or blood sugar levels improved, not on improvements in hard clinical endpoints such as risk of death, heart attacks, stroke, blindness, amputations, etc.

2. “Physicians and drug makers have reported diabetes drugs as the “primary suspect” in thousands of deaths and hospitalizations.”

3. “Diabetes drug makers paid physicians on influential panels millions of dollars.” The implication is that the panelists were not totally unbiased in their assessments of drug effectiveness and safety.

4. “Risk of a risk now equals disease.” This is about the latest redefinition of prediabetes which created many more “patients.” Prediabetes can progress to type 2 diabetes over a number of years: one of every four adults with prediabetes develops diabetes over the next 3 to 5 years. Some doctors are even treating prediabetes with diabetic drugs. (I recommend a “diet and exercise” approach.) The authors think the prediabetic label—one third of U.S. adults, including half of all folks over 65—is over-used and over-treated.

5. “The clinical threshold for diagnosing diabetes has crept lower and lower over the past decade.” For instance, in 1997 expert panels lowered the threshold defining diabetes from a fasting blood glucose level of 140 mg/dl (7.8 mmol/l) to 125 mg/dl (6.9 mmol/l). Four million more American adults became diabetics overnight. In 2003, they lowered the threshold for prediabetes from a fasting blood glucose from 110 mg/dl (6.1 mmol/l) to 100 mg/dl (5.6 mmol/l). Boom! 46 million more American prediabetics.

I fully agree with the authors that we don’t know which drugs for type 2 diabetes are the best in terms of prolonging life, preventing diabetes complications, and postponing heart attacks and strokes. Furthermore, we don’t know all the adverse long-term effects of most of these drugs. For instance, metformin had been on the market for over a decade before we figured out it’s linked to vitamin B12 deficiency.

That’s why I try to convince my patients to do as much as they can, when able, with diet and exercise before resorting to one or more drugs. (All type 1 diabetics and a minority of type 2 diabetics must take insulin.) Maybe it’s healthier to focus primarily on drug therapy…but I don’t think so.

RTWT.

Steve Parker, M.D.

2 Comments

Posted in Drugs for Diabetes

Tagged Big Pharma, diabetes drugs, MedPageToday, pharmaceutical industry, prediabetes, type 2 diabetes

A New Drug Treatment Option For Diabetes: Afrezza

Posted on October 4, 2014 | Comments Off

paleobetic diet, low-carb diet, diabetic diet

How about this one?

Well, it’s not really new. It’s our old friend insulin, soon to be available via inhalation with the brand name Afrezza. The U.S. Food and Drug Administration approved it in July, 2014. Click for the package insert.

Who Can Use It?

Adults with either type 1 or 2 diabetes.

Who Should Avoid It Or Not Use It?

those with chronic lung disease such as asthma or chronic obstructive lung disease (COPD)
smokers
pregnant or lactating women
those in diabetic ketoacidosis (DKA)
users who see a significant deterioration in lung function over time

Common Side Effects:

Hypoglycemia, cough, throat pain.

What’s the Dose?

It comes in 4 and 8 unit cartridges. See the package insert for dosing details. Afrezza is a rapid-acting insulin taken at the start of meals, so you’re looking at two or three doses a day. Type 1 diabetics still need to take a basal (long-acting) insulin once or twice daily. As far as I can tell, the type 2 diabetics in the pre-approval clinical studies were all taking one or more oral diabetic drugs in addition to the Afrezza; the inhaled insulin was an add-on drug. The average time to maximum effect of the drug is 50 minutes with the 8 unit dose; blood levels of insulin are back to baseline after three hours.

Anything Else Interesting About It?

The manufacturer recommends a test of lung function before starting the drug, to identify folks with lung disease who shouldn’t inhale insulin. The test is called spirometry or FEV-1 (forced expiratory volume in 1 second). Moreover, spirometry should be repeated six months after start of the drug, then yearly thereafter.

Another form of inhaled insulin—Exubera—was on the U.S. market in 2006 and discontinued by the manufacturer the next year. The problem may have been poor sales or a concern about lung cancer.

You can’t get it at your pharmacy yet. Maybe later this year or the next.

Steve Parker, M.D.

Comments Off on A New Drug Treatment Option For Diabetes: Afrezza

Posted in Drugs for Diabetes

Tagged Afrezza, diabetes drugs, Exubera, inhaled insulin

How Does Your Doctor Choose Your Diabetes Drugs?

Posted on December 28, 2013 | Comments Off

How about this one?

We now have 12 classes of drugs for the treatment of diabetes. Choosing which ones to use is not always straightforward.

It’s easy for type 1 diabetes: insulin.

Type 2’s have more options. Metformin is the unanimous #1 pick. After that, it’s murky.

I recently reviewed the American Diabetes Association’s Standards of Medical Care in Diabetes – 2014. A type 2 treatment algorithm therein mentions only six of the 12 available classes. This gives you an idea of expert consensus on which drugs to use. The classes are biquanides (metformin), sulfonylureas, thiazolidinediones, DPP-4 inhibitors, GLP-1 agonists, and insulins. This is one reason you don’t see much use of bromocriptine and colesevelam.

The American Association of Clinical Endocrinologists also have a type 2 diabetes treatment algorithm, published in 2013. It also addresses prediabetes and overweight/obesity. You’ll see some of the other classes mentioned. It’s confusing because of abbreviations.

Believe it or not, most doctors want to do what’s right for our patients. We want positive results that reduce suffering and death. Does Big Pharma influence the production of guidelines and individual physician drug choices? If I had to guess, I’d say yes. But I don’t have the resources to investigate that in any depth. I know without a doubt that if I recommend a drug and the patient has a bad outcome, it helps me win the malpractice lawsuit if I’ve recommended a guideline-approved drug. Other docs know that, and it’s one of many factors that influence drug choice. We also consider cost (if you bring it up), convenience, patient preference, what our local colleagues are doing, what other illnesses the patient has, potential adverse drug effects, etc.

We don’t know the long-term adverse effects of many of these drugs. That’s why I favor doing as much as reasonably possible with lifestyle modification, such as diet and exercise, before stacking up multiple drugs. If you need drugs, and most with diabetes do, lifestyle modification can help you minimize drug use.

Steve Parker, M.D.