IT'S OK TO TAKE ROSI!

Mention ACCORD, ADOPT, DREAM, VADT and RECORD to anyone and chances are many would respond in the negative. These are acronyms for medical trials pertaining to diabetes. For example, ADOPT is actually short for A Diabetes Outcome Progression Trial and ACCORD is Action to Control Cardiovascular Risk in Diabetes Study Group.

Last weekend I was in a medical workshop discussing the updates in Diabetes treatment and for two days I was overwhelmed with the above jargons. To ease us of the burden of absorbing all these packed and meticulous information, the drug company responsible was kind enough to hold it in Westin Langkawi, a beautiful spa resort perched on a hill, facing a small bay not far from Kuah Jetty.

Our room

Avandia or Rosiglitazone (or Rosi, as used by some presenters, implying how comfortable they are with the drug now despite the recent controversy that shrouds it) is a fairly recent oral hypoglycemic agent, used to treat Diabetes. Its usage was on the rise and was getting global acceptance, despite its steep pricing, as it is a diabetic drug in a class of its own with a coveted ability of preserving the pancreatic beta cells and it is thus beneficial especially to young type 2 diabetic patients.

At Temurun Waterfalls on the way to Datai Bay

However, last year, someone called Steve Nissen (who has a fitting resemblance to Salman Rushdie), came out with a meta-analysis that gave a shocking conclusion that Avandia gives an increased risk of cardiovascular events. The finding nearly caused Avandia to be taken off the shelf! After rigorous effort, GSK (the drug company that produces Avandia) managed to retain it in the market albeit a caution tag that comes with the label i.e. Avandia is not to be given to patients with a known heart disease.

Essentially the workshop was to impress upon us that the study done by Steve Nissen was seriously flawed and that Avandia is still a safe drug and should be given to especially the young type 2 diabetics as it gives good glycemic control, bringing down the HbA1c to below 7%, besides preserving the beta cells function in the pancreas as well as giving kidney protection in the long run.

Firstly, to begin with, the study was actually a meta-analysis, meaning that it was a retro review of other trials done before and thus to make a major conclusion out of such a study is rather uncalled for. Scrutinizing Steve Nissen’s meta-analysis, we would find numerous flaws. He had looked into 42 trials and out of it, only 2 were big trials i.e. ADOPT and DREAM which consisted of more than a thousand patients. The rest were small trials with more or less 100 patients. Nissen had made ADOPT, DREAM and all the small trials as the 3 arms of the study and for many of his analysis, the p was never significant in the first 2 arms but was compounded when averaged with the 3^rd arm which was the collection of the small trials. To add salt to injury, some of the small trials were not even trials to prove CV events with Avandia but was included nonetheless.

All these prove to show that researchers would go all out to produce journals to attain good resume. However, many a time, these studies are bogged down with many mistakes and weaknesses and if they get published, imagine the impact it will have on us. KKL told me that there was even a published clinical study which was only done on one single rat! Btw, you might be interested to read this published paper. Someone we know is one of the researchers!

One of the available villas.

Nevertheless, it was a very insightful workshop that has enlightened me on many issues. Besides, staying in Westin was a splendid retreat for both iKelah and I, not to mention the endless array of food provided in all the meals. Heavenly experience indeed!