Should We Be Concerned About Oral Diabetes Drugs?

Many people are concerned about the side effects of oral diabetes drugs. We have been hearing a lot about them recently and some of the drugs may be dangerous for some people while other people have little or no lasting effects. This I think has to do with the individual and the dosage they are taking. Am I personally concerned? No, and only because I am on insulin and metformin.

I am concerned about my fellow people with type 2 diabetes that are using oral diabetes drugs, and I think rightfully so. I have had blogs in this year pointing out the dangers of the sulfonylureas, thiazolidinediones, DPP-4 inhibitors, and so far, I have passed on the new seventh class of oral drugs, canagliflozin, because it is so new. The FDA has ordered more trials and is studying it further even though it has been approved.

Dr. Peter C. Butler is the chairman of endocrinology at the University of California, Los Angeles. Dr. Butler is the lone doctor fighting Big Pharma and their big guns inside the American Diabetes Association (ADA). Based on his latest study, both the Food and Drug Administration and the European Medicines Agency have begun investigations that could lead to new warnings on the drugs or even to their removal from the market.

““The data are inconclusive,” said Dr. Robert Ratner, chief scientific and medical officer of the American Diabetes Association. He said even if there were some excess risk, it would be “exceptionally low.”” This is the same Dr. Robert Ratner, chief scientific and medical officer for the ADA that says, “Many people with type 2 diabetes who are on medications don't need to do home glucose monitoring at all," Therefore I have a hard time considering him reliable as he is one pushing oral medications and he will criticize anyone creating doubt.

Whether you believe Dr. Butler, you need to read some of the information in the above link. Considering that the majority of type 2 patients are over 50, when he discovers something that raises red flags, he should be listened to and heeded. “Dr. Butler said that after his group presented its rat findings to Merck, “I never heard from them again,” except from company lawyers asking when the study would be published.” “He said that studies done by the drug companies that led to the drugs’ approval by the F.D.A. tended to use young healthy animals that would not be expected to get pancreatic cancer.”

This in a big way pulls the curtains back on how Big Pharma does their research and why they have good results.

This Is Very Sad for Patients

Even though this is a study done in the UK, the question that needs to be asked is “why?”. The title could even be applied to the US. The title of the article is “Clinical Support for Patient Self-Management Is Rhetoric Rather Than Reality, Experts Say.” Unfortunately, the support for patients is even worse in the USA when it involves patients with diabetes. In the USA we have diabetes “experts” that believe that the A1c done quarterly is sufficient. From the American Diabetes Association to the Joslin Diabetes Center, these “experts” spew forth their ignorance.

Those with type 1 diabetes generally receive more education that most type 2 people with diabetes, and rightfully so. Those of us type 2 and using insulin receive more education than type 2 patients not on insulin do. Self-management education is supposed to increase the patient's ability to take ownership of their diabetes and often to self treat their condition. With the current medical healthcare crisis, this would seem prudent to insure the sustainability of health services in terms of cost.

Bringing self-management support discussions and decisions into everyday clinical practices should encourage patients to become more actively involved. Yet, we see example after example in articles where doctors are hesitant to prescribe insulin and use the fear factor to promote stacking of oral medications. As a result, diabetes often becomes progressive and the complications become part of life. In many ways, it is the patients that read blogs like this and go on a mission to educate himself or herself. Some are capable of making the necessary lifestyle changes and need to make many changes. Others have only a few changes to make as expressed in this blog.

In the study, 44 practices were trained in the new self-management approach. This training program was developed by the universities involved in the study and was to help the practices put the patient at the center of their care. It was also to use a range of self-management support resources. More than 5500 patients, one of the largest randomized controlled trials ever completed, were divided into two groups. Even the practices were randomized to receive the training or deliver routine care. Those practices providing routine care were trained after the trial was completed.

Now for the sad part. “Feedback and assessments showed that while practices engaged with and enjoyed the training, they did not use the approach to improve shared decision-making with patients or encourage the take-up of self-management support. There was no difference in results for any patient outcomes or on service use between the group that had the self-management approach and the group which received usual care.”

The comments by the authors really shed no insights into the failure of this study and they are working to analyze the data further. These comments range from adding additional incentives to encourage practices to engage with a self-management agenda, to most forms of intervention fail to embed themselves into the everyday lives of the patients.

Why Is Insulin Considered the Medication of Last Resort?

These are the topics for this blog. Why is insulin considered the medication of last resort? What are the side effects of insulin?

Based on the recommendations of both the American Diabetes Association (ADA) and the American Association of Clinical Endocrinologists (AACE) it would appear that doctors that follow the oral medications route are doing everything correctly. However, after reading the studies, one in Canada and the USA study in Pennsylvania, I feel that the doctors fear insulin and believe in the insulin myths more than their patients. As to the patients fearing needles, yes, there are always a few that have that fear, but most just don't like needles and yet will do what is necessary to maintain their good health.

Whether this is a cover for their lack of being current with the knowledge they need about insulin or their fear of doing something wrong, there is something driving doctors to avoid prescribing insulin. This may be why some doctors use the fear of insulin to keep people on oral medications. It also may be the fear of hypoglycemia that affects their thinking. Of all the excuses, I think the doctors make, probably the more believable is this one by the Canadian doctors when the researchers discovered that many doctors were only familiar with the insulins of past usage and older delivery systems.

Yes, I have enough material to go on an extended rant about the activities of some doctors, but that will not solve the problems of their lack of staying current with the medications, research, and adverse side effects of oral medications. With the current system of shorter time per patient and declining revenues being forced on them by the Centers for Medicare and Medicaid Services (CMS) it is surprising that more serious diagnostic errors are not happening more frequently.

Most doctors will not even have sufficient time to analyze the diabetes algorithm provided by the AACE. This is how bad things are becoming for doctors. And the ADA guidelines probably don't even receive a glance.

The people that need to be hung out to dry are those of the AACE and ADA. They are the ones driving the oral medications market and the AACE algorithm is just another indication of how in bed with Big Pharma the AACE likes to be.

Two other articles create even more concern. Both are in Science Daily and the first one is about the majority of family doctors receiving little or no information about harmful effects of medicines when visited by drug company representatives. What is more disturbing is the same doctors indicated that they were likely to start prescribing these drugs. This is consistent with previous research that shows prescribing behavior is influenced by pharmaceutical promotion.

The second is about a new report that suggests that improved health care and significant reductions in drug costs might be attained by breaking up the age-old relationship between physicians and drug company representatives who promote the newest, more costly, and often unnecessary prescription drugs.

These two articles do point out a larger problem. If the doctors are constantly complaining about not having sufficient time for patients and the CMS cutting reimbursements, then how do they have time to see drug company representatives. Things just don't add up and someone is not counting their time correctly.

Next is a short discussion of the side effects of insulin. The most dangerous of course is hypoglycemia. This is highlighted by my blog of June 20. Apparently the ADA and the Endocrine Society are concerned enough to have issued new guidelines about hypoglycemia. This is an above average report and most people with diabetes need to read this.

Weight gain is common when people with type 2 diabetes start on insulin because they have been forced to wait too long. Their blood glucose levels are higher than they should be and insulin increases the efficiency of glucose absorption by the cells and the excess is stored as fat. If people would just reduce their carbohydrate intake until their blood glucose levels are lower, less weight gain would happen.

Another side effect that many people forget about is during renal problems and fluid retention can be a problem. I also have concern for the small numbers of people that are allergic to insulin. Some are allergic to the analogs and some people are allergic to the older insulins which can still be obtained outside the USA and are legal to import by those needing them. An even smaller percentage is allergic to both types of insulin. Some people will know that they may have an allergic reaction because of the rash that can appear in the surrounding area or this rash can develop over the entire body. The body rash should get immediate attention by a phone call to the doctor.

Many people are not aware of hypertrophy. This is the enlargement of the areas that has received too many insulin injections. This enlargement is often the result of scar tissue which causes insulin to pool in this area and this can increase the enlargement and the scar tissue can trap the insulin and prevent it from getting into the blood stream.

How Do You Find Acceptable Diabetes Food Plans?

This is the topic for this blog. How do you find acceptable food plans (diets)?

I always have fun with this topic. I receive about two questions per month on this and a few are honest questions that are difficult to answer. Others are people just wanting permission to continue consuming the same junk foods they have been. This I will not do and I ask them why they even asked since nothing I say will change their mind. I am not happy with the way I answered one of these questions, but apparently, it was the only way that I was going to get this person's attention. The discussion after I broke through was very gratifying.

Let me be very clear about this – there is not a specific diabetes diet, food plan, or even a clear guideline. Many people eat different meal plans. The success of their meal plan is determined by what their blood glucose meter tells them. This is the key and using your meter is a must, especially at the start and for approximately the first six months. Some are able to get their doctor to work with them to obtain extra test strips and others are not. Some are able to afford extra test strips and make use of them. Still others use what insurance will allow and carefully guard their usage, watch for trends, and other variances. Is this easy when this happens? No, and I have people tell me that they were fortunate to find the extra money for one or two containers of test strips and this was a great help once they got past many of the changes necessary in their food plan.

Admittedly, the American Diabetes Association (ADA) has relaxed their position on carbohydrates, but the Academy for Nutrition and Dietetics (AND) has not. They are promoting calories in the form of whole grains and promoting them very heavily. They are proud to proclaim who their corporate sponsors include. It is not surprising that there is such a conflict of interest.

This section from the 2013 ADA guidelines (two paragraphs) is important enough to quote, “Although numerous studies have attempted to identify the optimal mix of macronutrients for meal plans of people with diabetes, a recent systematic review confirms that there is no most effective mix that applies broadly, and that macronutrient proportions should be individualized. It must be clearly recognized that regardless of the macronutrient mix, total caloric intake must be appropriate to weight management goal. Further, individualization of the macronutrient composition will depend on the metabolic status of the patient (e.g., lipid profile, renal function) and/or food preferences. A variety of dietary meal patterns are likely effective in managing diabetes including Mediterranean-style, plant-based (vegan or vegetarian), low-fat and lower-carbohydrate eating patterns.

It should be noted that the RDA for digestible carbohydrate is 130 g/day and is based on providing adequate glucose as the required fuel for the central nervous system without reliance on glucose production from ingested protein or fat. Although brain fuel needs can be met on lower carbohydrate diets, long-term metabolic effects of very low-carbohydrate diets are unclear and such diets eliminate many foods that are important sources of energy, fiber, vitamins, and minerals and are important in dietary palatability.” The bold in the two paragraphs above is my emphasis.

Now if the AND people would follow instead of mandating 180 to 230 grams per day of carbohydrates or more, we might actually put a dent in the obesity epidemic.

Most of the time I do suggest that people reduce their whole grains intake and if they are interested, they should consider this book by Dr. William Davis after reading my review and several others.

Of course, I always suggest avoiding white rice and most potatoes, but I always suggest they use their meter when possible to find out what they must reduce, limit, or exclude in their food plan. Those that have been successful have been surprised that some types of potatoes and a few types of rice in small quantities do work for them. We all get surprised occasionally when someone finds certain vegetables can be juiced and are very low carb. Most avoid carrots and everyone avoids most fruits except for a small apple (certain varieties only) that can add flavor to the mixture. Some are happy with the leafy greens they use and I will use some of them in what my wife likes.

Eating well balanced meals really makes a difference and I do use supplements when my tests show that I am at the low side or below the recommended ranges. Most of the time I am well within the recommended ranges for vitamins and minerals.

Why Do Studies Use Patients with High A1c's

The last two studies that I have become interested in have used patients with A1c's above 8.0% or above 183 mg/dl (10.2 mmol/L). To me, this is scary and frightening. Maybe I should not even write about this. These people are 1) not receiving education, 2) have received bad education, 3) not receiving support from their doctor, or 4) don't care to manage their diabetes.

Even this last study amazes me in that fact that the peer coaches had A1c's of less than 8.5%. This may have been the surprises, as they may not have expected the drop they received from the peer coached group. The number of peer coaches numbered 24.

Before the study it was stated the coaches had to be recommended by their primary care physicians and received 36 hours of training over 8 weeks. This was based on a curriculum that included instruction in active listening and nonjudgmental communication. Also covered was helping with diabetes self-management skills, providing emotional and social support, assisting with lifestyle change and medication understanding/adherence, and accessing community resources.

Again, the study number was small with almost 300 participants selected. They were randomly assigned to receive either coaching or usual care. Why the patients were assessed using questionnaires is not understood. They also received a clinical evaluation at the start to establish a baseline and again at six months.

At baseline, the patients in the peer coaching group had a mean HbA1c of 10.1% for the 148 patients. At six months, the peer coached group had a mean HbA1c of 9.0% or a drop of 1.1%. Also the peer coached group had 22% with HbA1c's below 7.5%.

Now compare this to the usual care group. The usual care group numbered 151 patients and had a mean HbA1c of 9.8%. At six months, the mean HbA1c was at 9.5% for only a decrease of 0.3%. Only 8% in the usual care group had HbA1c levels below 7.5%.

This is significant even with a small number of participants. And yet, the American Association of Diabetes Educators continues to discourage lay people and won't open a class for them and provide any training. Think what could be the potential benefit for millions of diabetes patients not being served currently by the AADE.