July 23, 2015

Authors with Conflicts Lead Most Diabetes Studies

Why am I not surprised? On October 25, 2011, the British Medical Journal (BMJ) had an article that showed just over one in five (21 percent) of articles published in six leading medical journals in 2008 have evidence of honorary and ghost authorship. This was done to hide what the latest article discloses.

Diabetes research is dominated by a small group of prolific authors, raising questions about the imbalance of power and conflict of interests in this field, argue experts in The BMJ this week. I will let you read the details as they are rather revealing and point out how much conflict of interest exist in the studies published about diabetes.

With the elderly discrimination in studies and the degree of restricted participant selection, the pharmaceutical industry is working to make sure that all trials are favorable to their products. Example: the trial with rodents that were normal rodents that ended up having Avandia pulled from the market. Then the multitude of rodent trials using extremely healthy rodents were used to get Avandia returned to the market.

In most trials, anyone over the age of 65 is normally excluded and anyone under the age of 65 with more than one medical condition is generally excluded. This way for the human studies, they have the healthiest individuals with diabetes to obtain the most positive results. An extreme example would be the glycemic index, which was, arrived at by using only healthy individuals. Yet again, those of us with multiple chronic conditions and over the age of 65 often do not receive the same results. Granted we cannot do the tests necessary to determine how the glycemic index affects us, but this is what they depend on and this is true for the pharmaceutical industry as well.

I am surprised at the doctors that just assume that because the clinical trials say a drug may be safe, they prescribe it to the elderly without the concern they should have.

Now think about the latest class of drugs, SGLT2 and the side effect of DKA (diabetic ketoacidosis). When the different drugs in this class arrived on the market, did we hear about this side effect? No, because they did not want us to know that now many people with type 2 diabetes could now develop DKA. Before this, it was a rare occurrence among people with type 2 diabetes. Yes, it did happen, but now it is more common.

The real problem now is doctors don't know how to treat it as almost every indication is that there is nothing wrong, blood glucose levels are in the normal range and there is no arrow saying that DKA is present. Yet, it is as deadly as DKA in type 1 diabetes.

This is the result of conflicts of interest not revealing this problem before the drug became available on the market.

This is the reason a few writers (including me) keep pointing out the conflicts of interest as we can see what can happen with the doctors and patients that blindly follow evidence based medicine and think they have all the answers when the trial is based on random controlled trials. What many people forget is the principal of the bell curve in which the majority can be covered, but there is always some that fall at the extremes and present problems that often are ignored during the trial phase. Those with conflicts of interest wish these outliers would disappear.


Gretchen said...

Did they know about the DKA problem before the drug went to market?

Bob Fenton said...

According to one unpublished study, they did. I was made aware of this study by accident by a relative who was researching on a related topic. The symptoms were the same, but the researchers did not refer to it as DKA, but as a potential dehydration problem. It was after the drug was approved that it was recognized as a potential DKA and then it was not made known.