Friday, July 17, 2009


There are some of you who believe that the FDA is fair, transparent and right, in the many decisions that she makes. In some ways, what happens in FDA should not affect us/ But the truth is that FDA decision goes a long way to to affecting clinical practice patterns wourlwide.
Well, last friday, FDA approved the use of prasugrel, in the management of acute coronary syndrome, primarily on the basis of the TRITON-TIMI 38 study. That is surprising, as the TRITON-TIMI 38 study showed that there was an excess of clinical bleed in the patients given prasugrel. Also, to base a drug approval base on one clinical trial result alone is unusual. What is even more controversial was that the Dr Sanjay Kaul, a cardiologist member of the FDA Drug Advisory Panel meeting on the 3rd Feb 2009, was disinvited from the Panel meeting after protest from Ely LiLy. That is most strange. Ely Lily has known that Dr Kaul had done an independent analysis on the TRITION-TIMI 38 data can came out with different conclusions, suggesting that majoy bleeding was a major concern. It is obvious that Ely Lily was unhappy to have Dr Kaul at the Panel hearing and requested the Panel chairman to dis-invite Dr Kaul. This was carried out. That meeting approved the use of prasugrel. This got to the ear of the House subcommittee overseeing the FDA budget, and the FDA chairman agreed that it was a mistake to have excluded Dr Kaul, but the approval decision was allowed to stand, and that the FDA ppromise to look into the shortcomings of the approval process and correct the mistake, for the future. Funny that the panel did not choose to re-convene with Dr Kaul there to submit his imput?
This is adds more fuel to the many of us who feel that the FDA needs are-vamp and that in its present state, they are not impartial and have found to be acting on behalf of the big pharmas in many of their approval decisions. Not to forget that the pharma industry is a multi-billion dollar industry and many FDA officers, upon retiring, end up in pharma boards. How convenient. Yes, there is corruption in Malaysia, but it certainly looks like it is not much different in USA. Perhaps it differs only in the quantum of pay offs or golden handshakes.
Coming back to my first point, yes, prasugrel has been approved for us in management of acute coronary syndrome, with a black-bok labelling of the need to observe for major bleeding. Prasugrel, a cousin of clopidogrel, and more powerful, belongs to a group of anti-platelet agent acting on the ADP receptor, thereby blocking plaltelet adhesiveness and aggregation. The fact that it is effective is not in doubt. Perhaps the problem may be that it is too effective, thereby causing bleeds. So far, we have not notice any report of prasugrel resistance, a problem now well recognised with clopidogrel.
Maybe the FDA felt that they needed to end the dominance of clopidogrel, but I must say that they way they did it make it lose her impartial and up-right status. One wonder, how many of the their decisions make previously, those on statins, ACE-I, ARBs, stents, anti-diabetic drugs, etc., too many to name, were also tainted by controversies such as this.
We are indeed waiting for a post-American world, whereby we no longer have to see American as the only big brother, whom we follow, sometimes blindly.

1 comment:

Canadian Pharmacy-Adv-Care said...

Prasugrel belongs to the class of medications called platelet aggregation inhibitors or antiplatelets. It is used to help prevent heart attacks, strokes, and other circulation problems in people who have had severe chest pain or a heart attack and have been treated with a procedure called angioplasty, also called balloon angioplasty. This medicine is also known as
Normally, platelets help the blood to clot when needed, such as after an injury. When arteries become narrowed by fat deposits (plaques), platelets often clump together in the vessels. Unstable plaques can rupture, leading to more platelet clumping that can cause a larger blockage of the artery. This further narrows the arteries and increases the chances of heart attack, stroke, or other circulation problems.
Prasugrel is normally started with a single dose of 60 mg. Thereafter, the recommended adult dose of prasugrel is 10 mg once daily for long term use.

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