by Gary Pepper, M.D. Chances are, if you have diabetes you have heard about a new class of drugs to treat high blood sugar (glucose). The first of these new medications to gain FDA approval in the U.S., in 2013, is Invokana manufactured and promoted by Janssen Pharmaceuticals and Johnson & Johnson. In the last year and a half the number of these drugs known as SGLT2 inhibitors, has multiplied faster than tribbles to include Farxiga, Xigduo, Jardiance and Invokamet. Prescriptions for these medications are also showing explosive growth, increasing 300% since January 2014. A recent forecast by Express Scripts calls for this one class of drugs to be responsible for about a 20% increase in the yearly cost of prescriptions per all members per year for the next 3 years . The explanation behind the eager adoption and dissemination of this brand new class of medications may eventually serve as a tragic lesson for diabetic patients and for the medical community in general. (more…)
“New is not always better.” This caution seems reasonable when considering the value of the recently approved medications for treatment of Type 2 (adult type) diabetes. Â These drugs include three new classes of medication referred to as GLP-1 analogs, DPP-4 inhibitors and most recently SGLT-2 inhibitors. The focus of this discussion will be the most widely prescribed of the newcomers, the DPP-4 inhibitors.
The first thing consumers will notice about the new diabetes medications are their TV commercial friendly names, Â Januvia, Onglyza, Tradjenta, and Nesina. Â Mix these newcomer drugs together into a single pill with the venerable low cost generic metformin and the names becomes Janumet, Kombiglyze, Jentadueto, and Kazano.
The next thing a consumer will notice is the price tag. At the local pharmacy in Jupiter, Florida the retail prices of a 3 month supply of Januvia, Onglyza or Tradjenta are all about $1100. Â A three month supply of the established generic drug, glipizide, is $9.99 and metformin is between zero and $41. (more…)
Obesity Related Type 2 Diabetes is More Severe in Teens than Adults
by Gary Pepper, M.D. and Andrew Levine, Pre-Med, Univ of Central Florida
The recently published TODAY study found obesity related type-2 diabetes mellitus (T2DM) is more severe as a teen than as an adult, and high risk of developing diabetes could be tied to weight gain at an early age.
Between 2004 and 2009 the “Treatment Options for Type 2 Diabetes in Youth Study Group” (TODAY) gathered 700 participants who met the American Diabetes Association’s criteria for this disease. The participants were monitored for between two to six years. TODAY’s goal was to assess treatment options and the clinical progression of obesity related T2DM in youth. The mean age of the 700 participants in the TODAY study was thirteen, the majority being female. Sixty percent of the 700 participants were African American or Hispanic, with the remainder being Caucasian. The mean duration of diabetes for the study’s’ participants was less than seven months. A major worrisome finding from the study is a majority of participants were also discovered to have dyslipidemia, an abnormally high amount of fats (cholesterol, triglycerides) in the blood, as well as high blood pressure (hypertension). (more…)
If you ask the average person to define diabetes, a typical response might be “it’s when you have unhealthy eating habits and an overabundance of sugar in your blood.† Although that is not far from the truth, a more accurate definition is that diabetes is a disorder in the way our body uses insulin to process digested food for energy and storage. A good part of what we eat is broken down into glucose, the principle form of sugar in the blood. Diabetes occurs when there is not enough insulin to push the glucose into our cells. This deprives the body of the energy it needs because glucose is metabolized as fuel by all the organs in the body. Therefore in diabetes despite an elevated amount of sugar in the blood, the cells are actually starving for energy. We sometimes conceive of glucose in the blood as the enemy , but without it we would die. (more…)
Results of a recent study of military service members show that low vitamin D levels are associated with an increased risk of developing Type 1 diabetes (juvenile onset diabetes). The spokesman for the study, Cedric Garland PhD, explained that healthy people with vitamin D levels over 60 nmol/L
One aspect of lifestyle that is often overlooked is time spent sleeping. Getting adequate sleep is often sacrificed due to the demands of job and family. In the Sleep Heart Health Study over 1400 men and women were surveyed about their sleep habits and its relationship to diabetes and prediabetes. It was found that sleeping less than 6 hours per night was associated with increased risk of having diabetes. Interestingly, in those sleeping more than 9 hours per night there was an increased risk of diabetes and prediabetes.The authors of the study recommend trying to get between 7 and 8 hours of sleep per night to minimize the chances of developing blood sugar problems. To learn more about ways of preventing diabetes see pages 90 to 98 in my ebook “Metabolism.com”
Maintaining ideal body weight with diet and exercise is also crucial for avoiding diabetes and prediabetes.In overweight adults for each2.2 pounds(1 kilogram) gained per year the risk of developing diabetes increases about 50% over the next ten years. By losing 2.2 pounds per year the risk of developing diabetes is reduced about33% for the next 10 years (J Epidemiol Community Health. 2000; 54(8):596-602).
Speak to your healthcare professional to find out if you are at risk for developing diabetes and to learn ways you can avoid it.
Gary Pepper M.D.
Editor-in-Chief, Metabolism.com
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The mission of the The Thyroid Project is to encourage sharing of information and experience between the public and the medical community about the treatment of hypothyroidism (low thyroid function). For at least the past few decades there is a growing awareness of “something missing†in the way suffers of hypothyroidism are treated for their disease.
Too many patients, as documented in an on-line study of 12,000 individuals conducted by the American Thyroid Association published in June 2018, (https://doi.org/10.1089/thy.2017.0681) , complain of persistent symptoms of hypothyroidism despite what their doctors believe is successful treatment with levothyroxine (brands include Synthroid, Unithroid, Tirosent, Levoxl). We believe something needs to be done to resolve this conflict between patients and their doctors.
By Gary M. Pepper, M.D. Ozempic, Rybelsus, Trulicity, Wegovy, Saxenda are the central players in the weight loss craze sweeping across the globe. Metabolisim.com has been monitoring this phenomenon from its beginnings in 2008 with its report “Lizard Spit Reduces Blood Sugar and Appetite”, regarding the first drug in this class, Byetta (exenatide). Caught In the middle of the current chaos are the medical experts who treat diabetes and have been prescribing these medications for more than a decade. Here is a brief commentary from one such board certified endocrinologist; “I started treating Type 2 diabetics with GLP-1 agonists more than 10 years ago. In some respects, these medications have revolutionized the treatment of diabetes by lowering blood sugar effectively and promoting weight loss at the same time, a unique combination of benefits. Not everyone benefits from these drugs to the same degree unfortunately, and I have seen lots of patients experience unacceptable side effects from them. Nothing though, has prepared me for what is happening now. Too often, I find myself confronting someone who expects me to prescribe one of these drugs just so they can lose weight. Sadly, one extreme example was someone who, despite battling a life threatening medical condition, was insistent on getting a prescription. At the same time my diabetic patients are scrambling to find a place to buy their medications if they can even afford it. It is disheartening, to say the least, and I dread the negative interactions with some of my patients I now face almost daily.”
Off- Label Use
The FDA is the U.S. government’s department tasked with evaluating and approving drugs for specific medical conditions. When a new medication is approved for treating a medical condition by the FDA the agency will, at the same time, set strict guidelines for exactly which patients may use the newly approved drug. When a medication is used “off-label” it means that these limitations are being overridden by the provider for a potential benefit which outweighs the drugs risks. It is a general misconception that off-label means illegal; it does not. This practice has been going on for ages and more than 20% of prescriptions in the United States are prescribed off-label. A common example is the use of beta-blockers (approved for heart problems) for the treatment of performance anxiety.
GLP-1 agonist drugs, as discussed recently by metabolism.com. were originally approved for the treatment of Type 2 diabetes in adults. In the past few years most of these same medications have gained unprecedented popularity for their “off-label” weight loss benefit. Of the 5 GLP-1 agents presently in U.S. pharmacies only Wegovy (semaglutide) and Saxenda (liraglutide) are FDA approved for treating obesity. Of these two, Wegovy is the newer and had been much more popular that its sister drug Saxenda, probably due to being dosed only once weekly compared to daily for Saxenda and less likely to cause side effects. Due to Wegovy’s soaring popularity, its manufacturer, Novo Nordisk, increased the price of Wegovy two times since its initial release.
by Gary M. Pepper, M.D. and Sam Jeans, MSc The global anti-obesity drug market, in 2021was valued at over $2 billion. Within one year this figure had skyrocketed to $8 billion and is expected to climb to nearly $ 20 billion by 2027. This astounding growth is a reflection of soaring obesity rates, and the arrival of a new class of weight loss medication fueling a craze both in the USA and across the world.
The FDA and global health regulators, until very recently, had maintained a very tight ship when it comes to treating obesity with medication, placing the emphasis on diet and exercise rather than weight loss drugs. Since the 80s, anti-obesity drugs continued to be controversial, and a more stringent FDA implemented ongoing safety trials along with other precautions. There is some speculation that a shift in attitude toward approval of weight loss medication by the FDA , is underway
Weight loss drug controversies are far from over and, in fact, may soon rival the amphetamine crisis of the 70’s. For that reason, metabolism.com has felt it important to provide our guide to weight loss drug issues, past and present.
Anti-Obesity Drugs Timeline
Prescription drugs for lifestyle diseases such as obesity were marketed heavily throughout the 1950s to the 1970s. Amphetamines entered the public domain after the Second World War where they were used extensively in the military.
In the 50s, walk-in clinics prescribed diet pills with other medications almost at random, with or without genuine concern for one’s weight. These brightly colored pills became known as “rainbow pills”.
In the 1960s and 1970s, the so-called “rainbow pill diet” of pills was finally coming to an end as the FDA began to systematically ban many of the drugs involved. A high-profile expose by investigative journalist Susanna Mcbee, published in Life magazine, brought attention to this new modern public health crisis.
The rainbow pill diet combined amphetamines, laxatives, thyroid hormones, and even diuretics to produce extreme weight loss, combined with benzodiazepines, barbiturates, and steroids to reduce side effects, and antidepressants to suppress medication-induced insomnia and anxiety.
In 1968, rainbow pills were linked to over 60 deaths, with numerous accounts of their devastating impact surfacing in the news and media. Within just two months, 48 million pills were seized and destroyed. Nevertheless, amphetamine-based diet pills remained extremely popular throughout the 1970s. In 1978, some 3.3 million prescriptions for amphetamines were written each year, with some 50 million pills a year ending up in the black market.
In 1979, the FDA banned amphetamines as a weight loss aid, but that is hardly the end of the USA’s love affair with obesity medication.
Here’s a brief timeline of recent anti-obesity drugs:
Lack of energy and inability to lose weight are constant challenges for many people and are every day complaints encountered in the doctor’s office. Almost anyone can find some relief from these problems by accessing the healing properties of physical activity. Mentioning to a patient the need for ‘more exercise’ often causes rolling of the eyes, sighing, shrugging, snorting or worse yet, the hundred-yard stare. We all know exercise is important but who has the energy for that? It seems like a vicious cycle. Surprisingly, when done correctly, exercise can improve energy with the additional advantage of promoting weight loss and restoring tone and stamina. It is helpful to remember that the human body was designed for a lot more physical activity and a lot less food than we are privileged to experience in present day life. It therefore takes will power and knowledge to maintain the environment required for optimal health. Here are eight steps to get in the swing of regular exercise. Some suggestions may surprise you.
