April 21, 2013

Key Diabetes Issues Not Being Addressed

When I read the title of this article, I had to clap and hope that I was reading it correctly and that the title was not all hype. The article did not disappoint me. They did not come out and state (the authors are being polite) that many studies were practicing age discrimination, but they did state, “despite the fact that nearly 20% of adults worldwide aged 65 years and over have diabetes, less than 1% of trials specifically targeted this age group, while 31% actually excluded patients over 65 years and almost all excluded those over 75 years.” Also only a small percentage of the studies included children 18 years and younger.

Of the studies they analyzed, just one in ten studied prevention or behavioral therapies and two thirds focused on drug therapy. The research has been published in Diabetologia, the journal of the European Association for the Study of Diabetes (EASD). The research was done by Dr Jennifer Green, Duke University Medical Center, Durham, NC, USA, and colleagues. Why they had to publish outside the USA would be speculation on my part, but does raise some interesting thoughts.

The one shortcoming I can see is that they emphasize some trials, but never account for the total number of the trials or 100%. In one method they account for two thirds or about 67% and one in ten or 10% for a total of about 77% and then in another method they list 75% of the studies as being therapeutic and 10% as preventive or 85%. This leaves 15% to 23% of the trials unaccounted for which is a major fault.

It is interesting that they mention that most of the studies were small to medium size. The statement that most were designed to enroll 500 or less participants (91%) is just outrageous for developing studies of clinical importance. Then the fact that many of the studies had a mean/median time to completion of 1.8/1.4 years also makes the studies of little clinical value. It is like they were looking for specific results and running the trials for longer periods would have exposed undesired results. This last statement is my thoughts.

Since the trials were taken from those registered with ClinicalTrials dot gov we must be concerned about some of the discussion. This statement does come into the discussion and we need to raise the validity concern, “"Only a tiny proportion of the trials analyzed--1.4%--listed primary outcomes including mortality or clinically significant cardiovascular complications," says Dr Green. " Furthermore, distribution of registered trials by country does not reliably correlate with diabetes prevalence."”

ClinicalTrials dot gov does not include 100% of trials around the world, but does include many when a pharmaceutical industry wants product approval from the Food and Drug Administration and wants the test results available to the FDA.

Even though this type of study is needed, I do feel that more material should have been evaluated and disclosed. I would like to see a study like this for USA studies only and see how skewed the results are. I am very concerned about the age discrimination in most trials. Not only because they discriminate once you reach the age of 65, but they also discriminate against those under the age of 18.

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