Tuesday, May 05, 2015


Last month on 15th April, the FDA, did something unprecedented. The chairman 0f the FDA Division of Cardiovascular and Renal products, Dr Norman Stockbridge, announced FDA approval for the use of Ivabradine ( Coralan ), in the management of heart failure following the publication of the SHIFT data which showed an 18% reduction in heart failure hospitalisation when patients were given Ivabradine. It was unprecedented as usually, dug approvals have to be studied and debated at the FDA Cardiovascular and Renal Drugs Advisory Committee first, voted on and if successful,  before approval was given. This time, this drug by Servier, did not follow this safeguard. Whether Ivabradine will help or harm is an open question. Some like me, feels that there is a potential for real harm. Remember the SIGNIFY study upon which Ivabradine was approved for stable angina and then was subsequently shown to have more combined death and non fatal MI. Ivabradine ( for those who are not so familiar ) is blocks the If current in the SA node, and therefore slows heart rate. As I argued with Servier expert, Dr Ferari in Bangkok when he came to launch the drug about 10 years ago, sinus tachycardia is a compensation for a falling cardiac output in Heart Failure. Blocking the sympathetic compensation without improving cardiac output and also reversing the cause of CCF is potentially harmful.  Anyway, what is the hurry for quick fasttrack approval, "out of the blues"? There are many many drugs for use in heart failure. Why not let the CVS advisory committee study it and vote on it, as was with other cardiac drugs. I smell a rat. Is US FDA sleeping with big pharma?
So the Malaysian government is not the only one. Looks like USA has the same culture too.

     Over the long weekend, I was also studying and reading / listening on the TPPA that President Obama is trying to push through before his term ends. Gosh, this TPPA breaks all rule on fairness and transparency. Obviously engineered by big Corporations in America, they are now leaning on the President and Congress to pass TPPA. I think it is payback time for their funds support in Obama's last presidential campaign. So sad, we are all sold by corrupt Obama. In Obama land, these forms of corruption ( buying politicians at the highest level ) is legal, because of their right of free speech, and yet with TPPA, there is no freedom. All stakeholders affected by TPPA does not have access to the draft of TPPA ( sound like what MOH is doing with the DS law ). To be honest, this TPPA is a monster and although I have been doing some research on it, it is still very woolly in my mind. How can corporations tell the President what to do? How can corporations be allowed to sue the government when they feel like doing so. All of you please take some time to look into this TPPA issue, which will also affect Malaysia as we are one of the 12 signatories. You can find some insight if you care to listen to this you tube, attached below. There are also many more you tubes if ytou care to listen.


The world has gone mad. The President of USA has sold American and by extension, the whole world, to large corporations.
We need an alternate system

So sad.

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