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…)
“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…)
My ebook Metabolism.com is now available; I think you will find it a great resource for many of the common problems members have asked me about over the past 15 years. Buy it now and use it for years to come. Don’t forget to check out the Weight Loss and Weight Gain Programs included for free!
Chapter 1: What Is Metabolism? 9
Turning Food into Energy 10
The Importance of Hormones 11
Role of Metabolism in Weight Loss or Gain 14
Is My Metabolism Healthy? 16
Chapter 2: What Makes Your Metabolism Fast or Slow? 17
The Role of the Thyroid 22
Chapter 3: How to Increase or Decrease Metabolism 25
Problems with Losing Weight 25
Problems with Gaining Weight 34
A Pleasurable Exercise Routine is a Must 39
Chapter 4: Fact vs. Fiction—Smoking and Weight Loss 41
Chapter 5: Thyroid Treatment 47
How Are T3 and T4 Regulated? 48
Types of Thyroid Diseases 49
Hyper- and Hypothyroidism 49
Thyroid Nodules 51
Is Your Thyroid Nodule Hot? 53
Thyroid Treatments 54
Using Thyroid Function Tests To Diagnose Disease 56
Hyperthyroidism Treatments 57
Hypothyroidism Treatments 58
T3 Plus T4 Combination Therapy 59
How to Talk to Your Endocrinologist 66
The Recent Shortage of Armour Thyroid 67
Chapter 6: Diabetes Treatment 73
The Bad News—Major Stumbles in the Treatment of Diabetes 74
The Call for Tight Glycemic Control 74
2010 Diabetes Treatment Guidelines Lack Credibility 76
Setbacks in Diabetes Drug Development 81
The Failure of Inhaled Insulin 86
Dangerous Commercial Weight Loss Programs 87
Perhaps the Biggest Stumble of Th em All 89
The Good News—What Really Works 90
Diet and Exercise 90
Weight Loss Surgery 94
Incretins 95
Chapter 7: Hormone Treatments 99
Hormone Replacement Therapy—Estrogen 101
Heart Health 101
Breast Cancer 103
Benefits of Estrogen: Brain Function and Blood Pressure 104
Testosterone Replacement for Men 106
Testosterone Replacement Options 107
Benefits of Testosterone Replacement 108
Potential Risks 109
Human Growth Hormone in Adults 111
Diagnosing Growth Hormone Deficiency 113
Benefits of Growth Hormone Supplementation 113
Adrenal Fatigue: Fact or Fiction? 115
Conclusion 117
The Birth Of Metabolism.com 119
My Path Into Endocrinology 121
Recent Contributors On Metabolism.com 125
Appendix 1: Personal Nutrition Profile 127 Appendix 2: Ultimate Weight Gain Program 145 Appendix 3: Food Journal 165
The lawsuits against Avandia are being prepared and opportunists are lining up for a payday. Unfortunately, everyone else will wind up a loser, and here’s why.
Avandia, one of only two available medicines with unique properties to treat diabetes, was approved in 1999. From the very first day Avandia was approved a heated debate arose whether Avandia or its sister drug, Actos, was the better drug for diabetes treatment. Both had similar abilities to lower blood sugar and both had the same downside of causing significant weight gain and fluid retention. Avandia showed a slightly worse effect on cholesterol profiles which convinced many diabetes specialists to choose Actos over Avandia. The choice between drugs has also been heavily influenced by cost considerations such as whether the drug was covered by the patient’s insurance carrier. I personally treated numerous patients with both drugs and found them about equal in all respects.
The lawsuits against Avandia will contend that the medication caused heart attack or stroke. The truth of this contention is very much in question, but the murkiness of the water doesn’t stop the lawyers from trying to take a bite out of the flesh of GSK (GlaxoSmithKline), the maker of Avandia.
Several years ago research studies seemed to indicate a small increased risk of heart attacks in users of Avandia. Ever since there has been a heated debate about whether this was a true risk or just the result of overly aggressive interpretation of the available data. There are two major analyzes on the subject of heart attack risk with Avandia. One, written by a doctor on the payroll of a competing drug company, looked at results from 14 thousand patients on Avandia and found a small increased risk of heart attack or stroke and the other study analyzed another 14 thousand Avandia users and found no such association. Under pressure from the public, in 2007 the FDA placed a strong warning on the label of Avandia regarding the possibility of the drug causing heart disease, but Avandia was permitted to remain on the market. The FDA warning was updated and upgraded in 2010. The publicity surrounding Avandia’s potential risks basically halted the use of the drug in the U.S.
Now enter the opportunists. Advertisements fill my email in-box from lawyers looking for customers who want to sue the drug manufacturer in class action law suits. Try goggling “Avandia side-effects” and you will find the first several pages of results are ads looking for lawsuit clients. In the last month I received two requests for patient records from these lawyers. Both patients had heart disease at the time they started the medication. One patient who recently died was over 80 years old, and the other who had significant heart disease and other diabetes complication to begin with, is still alive more than 7 years after treatment with Avandia. I wonder how much benefit these patients received from the medication which allowed them to survive as long as they did despite all the other problems they had related to their diabetes.
Why should you care about whether a small army of opportunists each get a few thousand dollars from the drug manufacturer and a few lawyers become millionaires? Because it is just this sort of legal action which is convincing drug makers to back away from developing other potential diabetes treatments. It takes a decade and a billion dollars to bring a new drug in front of the FDA. This doesn’t include the cost of developing drugs which fail to even make it to FDA review. Then the FDA approval process is tortuous and uncertain. Passing this hurdle, any new drug can come under attack (like Avandia) for “possible” side effects making the company vulnerable to devastating legal costs and bad publicity. It isn’t economically feasible to develop new diabetes drugs in the United States. As a result, new drug development is grinding to a halt. We will all suffer due to lack of innovation, not only for diabetes treatment but for treatment of many other dangerous diseases.
The FDA just announced its approval of linagliptin (Tradjenta), a new diabetes medication developed by Eli Lilly and Company and Boehringer Inglheim. Linagliptin is the third drug to be approved in the class of medications commonly known as gliptins (scientifically known as dipeptidyl peptidase-4 (DPP-4) inhibitors) which block the destruction of a glucose controlling hormone, GLP-1. Januvia, developed by Merck and Company, was the first of the gliptins to be approved in 2006. Three years later in 2009, Onglyza, developed by AstraZeneca was approved while two other similar drugs were withdrawn from the approval process in the meantime.
Diabetes drugs are evaluated by the FDA for safety and for their ability to combat diabetes by lowering blood sugar. Assuming the drug being evaluated is safe then we will want to know how effectively the new medicine lowers the blood sugar. The glycohemoglobin A1c blood test represents the average blood sugar for the prior 3 months, and is the most concise way of assessing an individuals over all blood sugar control. By determining the ability of a medicine to lower the “glycoA1c†we can get a very accurate idea of the strength of the medicine for diabetes treatment. In general, physicians set a glycoA1c goal of 7% or less for their diabetic patients which equates to an average blood sugar level of 154 mg/dl or 8.6 mmol/L.
Linagliptin passed the FDA’s strigent safety review. Several large studies sponsored by the drug developers show the linagliptin lowers glycohemoglobin A1c by about 0.5. For example, if a person has a glycoA1c of 7.5 % before starting linagliptin, they can anticipate it will be 7.0% when on the medication. This translates to an average blood sugar of 169 mg/dl dropping to 154. This is virtually the same effect found with Januvia and Onglyza, the other medicines in this group.This amount of blood sugar lowering seems feeble but the benefit is even worse then that. Here’s why.
Blood tests are accurate enough for the clinical purposes of physician’s diagnosing and treating their patients. “Clinical purposes†allow for some fuzziness in measurements. Does it matter to a patient’s health if the blood sugar is 200 or 210? Not really. In general, a variation of 10% is acceptable for clinical blood tests, meaning that if a result is given as 100, a repeat measurement of the same blood sample could read between 95 and 105. For the glycohemoglobin A1c test a variation of 0.5 is common with standard laboratory techniques. For an individual on linagliptin there is virtually no way to determine if the change in glycoA1c is due to the medication or is simply within the variation of the blood test. Not very impressive is it?
How much is the average person going to pay for this unimpressive effect? I researched the retail cost of Januvia, the sister drug to linagliptin. Drugstore.com lists a price of $216 for 30 pills after a 18% saving. $7 per pill….wow!! I assume linagliptin will be priced competitively. Compare this to the price of $13 for a month’s supply of metformin, currently the most prescribed oral agent for treating diabetes. In contrast, metformin shows a 1.5% to 2% drop in glycohemoglobin A1c, more than three times that of the gliptins such as linagliptin.
I have used both Januvia and Onglyza in my medical practice. As advertised, I haven’t encountered significant side effects. Also, as advertised the effect of these medicines to lower blood sugar has been disappointing and complaints by patients about the cost has been a constant theme. At the same time my email inbox is stuffed with invitations to join online symposiums with paid experts inevitably focusing on how to ramp up my use of these drugs. The sales pitch is given in inflated marketing lingo as a “change in the treatment paradigm†for treating diabetes. Buyer beware, is my advice for the health care consumer starting a new medication for treating type 2 diabetes.
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.
Without effective intervention the early stage of type 2 diabetes known as prediabetes carries a high risk of progressing to outright diabetes. Metabolism.com provides an up-to-date summary of recommendations from national authorities, for preventing and possibly reversing this life long affliction
Diabetes can be defined simply as elevated blood sugar levels. What exactly is high blood sugar and when should someone be concerned about their level? Does having prediabetes mean diabetes is around the corner? Metabolism.com tackles this tricky but important topic in this comprehensive review.
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.
