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.

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.

Verified by MonsterInsights