Tag Archives: diabetes treatment

Survey Reveals 84% Feel Doctors in US Overly Influenced by Pharmaceutical Industry


survey

By Gary Pepper, M.D.

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. Continue reading

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New Diabetes Medications Cost 100 Times More than Established Treatments


by Gary Pepper, M.D.

“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.  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 thehttp://www.dreamstime.com/stock-photo-expensive-medicine-image3053770 new diabetes medications are their TV commercial friendly names,  Januvia, Onglyza, Tradjenta, and Nesina.  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.  A three month supply of the established generic drug, glipizide, is $9.99 and metformin is between zero and $41. Continue reading

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What’s Inside My Ebook, Metabolism.com?


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

Relevant Studies

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Avandia Law Suit Brings Out the Opportunists


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.

Gary Pepper, M.D.
Editor in Chief, Metabolism.com

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Are New Diabetes Medications Worth the Money?


(I don’t think so, and here’s why.)

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.

Gary Pepper, M.D.
Editor-in-Chief, metabolism.com

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New Diabetes Treatment Guidelines Flawed


New Diabetes Treatment Guidelines Lack Credibility:

Recently the American Academy of Clinical Endocrinologists issued new treatment guidelines for treating Type 2 Diabetes. Complex medical guidelines are often referred to as a treatment algorithm. One of the stated goals of the AACE algorithm is to focus primarily on the theoretical ability of the diabetic medications to control blood sugar while ignoring the cost of the medication. The rationale to this approach is that controlling blood sugar with more expensive drugs will cost less in the long run since patients will be healthier and have less complications due better control of the blood sugar. On the surface this philosophy seems sound but digging beneath the surface reveals dangerous flaws in this thinking.

1. The first assumption, that newer medications for diabetes are better than older drugs is unsubstantiated. In fact there is ample evidence that newer diabetic drugs are no better than the older drugs for controlling blood sugar. The latest study finding no benefit of the newer diabetes medications is the FIELD study conducted outside of the U.S. This study showed that 5 years of treatment with the older diabetic drugs (sulfonylureas, metformin and insulin) resulted in adequate and prolonged control of blood sugar. In 2007 researchers from Johns Hopkins Bloomberg School of Public Health summarized the results of major studies using older and newer anti-diabetic medications and found no significant benefit of the newer medications.

2. The next assumption, that cost is not a key factor in treatment success contradicts most clinicians’ experience in diabetes care. It is clear to me, that patients are far less likely to comply with using expensive drugs than medications they can more easily afford. Looking at the numbers reveals the vast cost differences between the older (generic) versus the newer (brand) medications. Using figures provided by a local pharmacy I found that the retail cost of a typical two drug therapy for diabetes using older drugs is $59 per month. The retail cost of using two of the new drugs for a month ranges from $481 to $570. In more severe diabetes three drugs per day may be needed. The low cost alternative amounts to $185 per month while the high end alternative with new drugs is $610 per month. Looking at the cost of using insulin shows a similar vast cost difference between the older and newer drugs. Older forms of insulin may cost $100 for a month’s supply while a similar course of therapy with the newer insulin preparations will cost almost $250 per month. How many people will be willing and able to afford the new versus the old drugs, particularly knowing that there may be no health benefit to the more expensive drug combination?

The end result of not being able to afford these prices is non-compliance with medications and the result of non-compliance is higher costs passed on to the medical system. The Medco study from 2005 showed that the least compliant patients were more than twice as likely to be hospitalized compared to the most compliant, and that the yearly cost of caring for non-compliant patients is double that of compliant patients.

3. My next point is possibly the most contentious. The AACE guidelines were produced by a committee of physicians chaired by two distinguished endocrinologists, Dr. Paul Jellinger and Dr. Helena Rodbard. Both doctors are highly respected and accomplished. They are also both highly compensated consultants to the pharmaceutical companies which market the newest generation of diabetes medications. In the disclaimer attached to the committee’s recommendations, both Dr. Jellinger and Dr. Rodbard admit to consulting arrangements with virtually every one of the pharmaceutical companies whose interests are effected by their committee’s findings. I too am a consultant to many of these same companies (at least, until now), but I am not responsible for developing national guidelines for diabetes care. In my opinion the close association of both committee chairmen to the pharmaceutical companies detracts heavily from the credibility of their recommendations. The need for credibility is even more important when the AACE committee advises physicians to avoid using sulfonylureas, the only class of drugs not marketed by any of the big pharma companies. and which also happens to be the cheapest drug class, the drugs with the longest history of use, and the class of drugs many regard as the most effective at lowering blood sugar levels. The sulfonylurea class of drugs is so effective at lowering blood sugar, in fact, they are used as the gold standard by which the effectiveness of all new diabetic medications are compared.

4. In contrast with the AACE, the American Diabetes Association (ADA) has issued more conservative guidelines for diabetic therapy, preserving the role of the older generic drugs. My recommendation is that AACE go back to their committee and reconsider the way they have produced their algorithm. Appointing new leadership whose credentials do not lend themselves so readily to skepticism, would be an important first step in that process.

Gary Pepper, M.D.
Editor-in-Chief, Metabolism.com

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The Avandia Debate: Common Sense Required


More on the Avandia Debate: Common Sense vs. the Statisticians

I previously addressed the issue of “relative risk” in this blog, as it applies to the perceived hazard of using Avandia (rosiglitazone) to treat diabetics. To gain a better understanding of the true Avandia risk, I went back to the actual data submitted by Dr. Nissan et. al. in the meta-analysis which ignited this controversy. What I found supports my notion that the real risk is allowing statisticians to bludgeon common sense into immediate submission with a few technical terms.

In Nissan’s meta-analysis of 42 studies which compared Avandia to other diabetes treatments (“other”), results from a total of 27,843 diabetics were analyzed (15,560 received Avandia and 12,283 “other” treatments). During the study period there were a total of 158 heart attacks (M.I.’s) and 58 deaths from cardiovascular causes. Compared to “other” treatments there were 14 extra M.I’s in the Avandia group then the “other” group. If your first reaction is “gee…14 extra deaths seem unacceptable”, remember there were 2300 more people in the Avandia group for bad things to happen to….see the blog on “relative risk” for more on that issue).

The over-all incidence of cardiovascular death for diabetics in the U.S. is generally accepted as 65% or more and the incidence of heart attack (M.I.) substantially higher. In Nissan’s study of 27,843 total diabetics 65% is equivalent to 17,730 total M.I.’s. The 14 extra M.I.’s in the Avandia group would make the M.I. rate 65.09%. Not a very alarming increase if it were true. In the “other” group if we equalize for the smaller number of participants in that group, we find the M.I. incidence would be higher at 65.12%. ( 72 M.I.’s for Avandia, 91 M.I.’s for “other” treatment).

Another way to look at the magnitude of the supposed increase in Avandia related events,
we find the “excess” number of M.I.’s is equivalent to 1 per 1250. For practitioners who treat diabetes and understand the enormous degree of variation between diabetic patients, trying to pin-point the factors accounting for one M.I. per 1250 in this group would be like trying to isolate one snowflake in a blizzard.

I simply do not believe that there is a way to validate the results of Nissan’s study. Believing the use of statistics can correctly pin-point the cause of 1 in 1250 M.I.’s within the chaos that is diabetes care, in my opinion, is being naïve to the true complexity of this disease and its treatment.

Gary Pepper, M.D.

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