Monday, December 01, 2008

DRUG USESAGE ON MAIN STREET : MEDICAL EVIDENCE OR PHARMA MARKETING OR OTHERS.

The New York Times, in her 28th Nov 2008 issue carried a long, extensive article on the ALLHAT Trial. The title of the article was " The minimal impact of a large hypertension study " . The article was written by Mr Andrew Pollack, with significant input from a Dr Curt Furberg ( " of meta-analysis to show that short acting CCBs are a danger to the heart " fame ). Dr Furberg was chairman of the ALLHAT steering committee. He subsequently resigned from frustration. I may not agree with everything that Pollack / Furberg say, but I think that their message is worrying and merits consideration. It suggests severe commercialism in Medicine.
We may all remember that ALLHAT was a clinical trial in hypertension. It was a large hypertension study, enrolling 42,000 patients, aged 55yrs and above, with stage1,2 hypertension. The patients were divided into one of 4 groups and given one of 4 drugs, namely a diuretic ( a thaizide ), an ACE-I ( lisinopril ), a CCB ( Norvasc ) and an alpha blocker ( cardura ). The patients were treated and followup for an average period of 4.9years. This trail was largely funded by the NHLBi ( non-pharma public body). The results were announced in the 2002 fall meeting of the American Heart Association. Just to summarise the results, basically, the cardura arm was a non-starter. It was prematurely terminated as there were more CCF admissions when patients were on cardura. As for the rest, the diuretic arm came out best. There was essentially no difference between the ACE-I arm and the CCB arm.
Since 2002, what has happened to the ALLHAT message. Yes the usage of diuretics, in USA has increased to about 40%, but this increase was much less then the usage of ACE-I, CCB and also the "new kid on the block" ARBs. How come such a big study, with such a definitive result, did not result in a big impact? In fact diuretics may be losing her position in clinical importance, by the day.
This gave me an opportunity to understand how physicians in USA ( and I believe that we are no different, maybe worse ) choose our therapy for our patients? Are we evidence based? or otherwise. Read on to understand better.
After the announcement of the ALLHAT results, the pharmas, big and small, when on a concerted effort, basically using their financial might, first to lobby KOL ( key opinion leaders ) to interpret and re-interpret the ALLHAT results in so many ways as to confuse the physicians and basically discredit ALLHAT. The KOL were paid big money to give talks at so many meetings to drive home that message that ALLHAT was severely flawed. Secondly, other trials came onboard, to further show that ACE-I was better then diuretics. Thirdly, phisicians were given incentive trips, holidays and gifts, to make them friendly to pharmas. Have you heard of pharmas taking KOL family members shopping in Paris? and Rome?. KOL are often drafted in Clinical Practice Guideline ( CPG ) committees, so that they will be pharma friendly. After all these are the people who were send to Paris, Barcelona, Rome, Anaheim, New Orleans, Munich, etc. The fact that CPGs are sometimes borrowed whole scale from the West, is not in doubt.
In this article, Mr Pollack / Furberg was writing about pharmas, but I am sure that their comments are just as applicable to devices and device companies. Cardiac devices, othopedic devices, neuro-devices, etc.
I think that I have made my point. Is the practice of medicine based on evidence or on pharma marketing? Or on a more down to earth issue among GPs in Malaysia, cheaper price?
I would like to see a situation where pharmas work with us to promote better drugs and better patient care. Maybe we should make all pharma sponsored trips and pharma sponsored CMEs compulsory declaration to the MMC? Maybe MMC should know who have been going frequently, all over the place on pharma bills, especially the KOL who sits on CPG committees and Government purchasing approval committees. That maybe a good start.

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