Monday, October 17, 2011


I have for many years ( whenever I am given a platform / forum ) held the view that true evidence based medicine is a myth. More than half the clinical trials undertaken by industry, was never completed, as they were yielding negative results and so industry did not wish to have it know. Just under half the results of clinical trails undertaken by universities and governmental bodies were published, a figure higher than industry funded research. Even the FDA is not given all the data, except for the ones that apply for registrations. Negative trial data, may prove to be as important as positive trial data, for patient care, in the sense that negative trial data, may help us to avoid pitfalls in therapy.
This blog is in some way prompted by 2 reports in the medical journals last week.
In the Oct 11th issue of the British Medical Journal, Dr Jennifer Neuman of the Mount Sinai School of Medicine New York, looked into the guideline committees of the USA and Canada from 2000 - 2010, writing guidelines on management of T2DM and dyslipidemia. There were 14 guideline committees in all. She found that there were 288 committee members involved from 2000-2010. 138 had declared conflicts of interest with industry with interest in the committees guidelines, ranging from honorarium, to trips, consultancy fees and lecture fees, etc. 6 were even chairperson of the panel ( who had declared conflict of interest ). 5 of the members did not even declare their conflict. Showing that about 50% were conflicted, with 6 as chairperson.
I remember, way back in the 90s, I was asked to serve in a guidelines committee to write the Malaysian guidelines on management of hyperlipidemia. Of course I was giving opposing opinions to the chairperson. I was never invited again to any guidelines committee.
The second paper is a bit more serious. Drs Harlan Krumholz and Dr Joseph Ross of the Yale University, New Haven, wrote a commentary in the Journal of the American Medical association, calling for more transparency and ful disclosure of all clinical trial data, to the professionals and also public, so that we can see the raw data for ourselves, and not through the eyes of so called conflicted ( some severely conflicted ) experts. They were largely in support of a movement called the "Cochrane Collaboration" which had called for full disclosure of clinical trial data to not only the governing body, but also to the professionals and the public. That these data should be freely available.
Perhaps by so doing, we could have avoided the approval and then recall of Vioxx and also avandia ( two recent examples ).
Now, only information required for approval, is declared to the FDA, prompting severe massaging of numbers to make it look robust and very clean, when the truth in fact may not be so. The industry calls it marketing. Once approved by the FDA, we in 3rd world countries, accept it as gospel truth. Many of our guidelines writing committee are essentially "cut and paste" committees as they do not have the raw data, and accepts all the p-values and hazard ratios told to us by the Europeans and Americans. So sad. When they are wrong, we automatically follow too.
We in the 3rd world are easily "bought off". I can say that in my little and limited experience with Malaysian guideline committees, 100% of the committee members are conflicted. Can I also say that some of them are "severely" conflicted. They travel, the shop, they eat, and they holiday with industry, regularly.
Take the guidelines, especially those in 3rd world countries, who like to ape the West, with a large pinch of salt. Know the guidelines and also know your "stuff". Be very critical of the information, when it does not make medical sense. Do not just follow blindly. The life of your patients is in your hands. They trust that you would have done that before you treat them. We owe that to our patients.
Evidence based medicine, nice to have, difficult to achieve. Doctors, you are each responsible to your patient

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