A survey by metabolism.com reveals that a vast majority of the public believe doctors in the US are overly influenced in their decisions by the pharmaceutical industry. 500 visitors to the website participated in the survey. 419 (84%) answered yes to the question, “Do you feel that US doctors’ decisions are overly influenced by pharmaceutical industry money?† 56 (11%) were not sure, and only 20 (4%) voted no to this question. (more…)
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…)
In a blog at metabolism.com several months ago, website visitors were asked to join an email campaign addressed to Dr. Mack Harrell, President of the American Association of Clinical Endocrinologists (AACE). The purpose was to ask help reversing the existing practice recommendation # 22.4 published by the AACE in 2012, calling for a ban on the use of Armour Thyroid in the treatment of hypothyroidism. With over 800 individuals participating, the campaign appears to have achieved some success as the latest AACE treatment guidelines released last month no longer stipulate that desiccated thyroid is unfit for treatment of hypothyroidism. Instead the statement is issued, “ We recommend that levothyroxine be considered as routine care for patients with primary hypothyroidism, in preference to use of thyroid extracts. “, and…. “ Furthermore, there are potential safety concerns related to the use of thyroid extracts, such as the presence of supraphysiologic (unnaturally elevated, ed.) serum T3 levels and paucity of long-term safety outcome data.†(more…)
Here is a clear example of how the new Diabetes Treatment Guidelines and big Pharma have failed to protect the needs of diabetics who are disadvantaged by economic circumstances and disease. This is the story of one of my patients, an elderly, blind and impoverished woman with blindness due to diabetes. She managed to maintain some degree of independence and did not complain about what a lousy hand life had dealt her. One of the ways she remained independent was by using a device known as an insulin pen. The pen is an all-in-one device equipped with a needle , contains an insulin reservoir and is adjusted to a specific insulin dose by a twist of its dial. With this device she was able to inject her insulin dose daily by herself with sufficient accuracy to control her diabetes. The older method of using a separate syringe and insulin vial required too much dexterity and vision for her to use safely and would have require someone to help her on a regular basis. The type of insulin she uses, NPH, dissolves slowly so her risk of low blood sugar (hypoglycemia) was less than if she used the newer insulins which contain rapid acting insulin. What’s more, NPH insulin is still relatively inexpensive, costing about one half the price of the newer insulins.
I became aware of her problem at her visit with me last week. I learned the NPH insulin pen was being discontinued and there is nothing on the market to replace it. The only insulin pens now available contain insulin with rapid action or are at least twice as expensive as her present pen. What could have caused this sudden shift in the medical supply chain? I recently reviewed the American Association of Clinical Endocrinologists (AACE) new Diabetic Treatment Guidelines (see https://www.metabolism.com/2010/01/18/diabetes-treatment-guidelines-flawed/ ) which dismisses NPH insulin as out moded and recommends the newer (more expensive) insulins be used in its place. The company’s decision to stop making NPH insulin pens coincides almost simultaneously with this new AACE policy statement. In my mind the close timing of the corporate and the professional actions implies cross communications between them. Could the AACE decision to downgrade the use of NPH in some way support corporate economics? I wouldn’t be suprised at all.
Diabetes is the most common cause of blindness in the U.S. . My guess is that there are more blind, and poor diabetics who could make good use of the inexpensive NPH insulin pen. In the case of my patient, we are scrambling to put together a support plan for her so she can maintain her independence, her pocket book and still control her diabetes to a reasonable degree. I hope others in her position can find a similar support network.
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.
