Monday, February 23, 2009


Many of us may feel that the USA system of government, in general, and the US FDA in particular is good and beyond reproach. Well that may not be so. These are man-made systems and they have their problems. Even if the system, may be good, the individuals in the system, sometimes makes the whole system flawed. We have recently seen how badly the US financial system have let us all down so very badly, and many of us, all over the world will have to pay ( and some pay with their lives ) because of a few " greedy " men in the US financial system.
No, I am not about to discuss politics here. My interest is medicine and in particular, cardiology.
On 3rd Feb, the US FDA advisory panel on Cardiovascular and Renal drugs, met to discuss the approval of Prasugrel, an ADP receptor blocker anti-platelet agent ( acting much like Clopidogrel ). It is now obvious that 4 days before the meeting of the panel, the US FDA received a phone call from Eli Lily ( the maker of prasugrel ) asking whether it is suitable to include a certain Dr Sanjay Kaul ( Cedar Sinai MC-Los Angeles ) in the meeting. Dr Kaul was scheduled by the FDA to be a panel for the meeting. After the phone call from Eli, Dr Kaul was asked not to go for the meeting. It is wellknown that some of Dr Kaul's research has shown that there were dangers with the use of Prasugrel, including the increase incidence of major bleeding. Of course the panel met without Dr Kaul, and unanimously decided that prasugrel should be approved. One wonder, what may have happen, if Dr Kaul had been present to give opposing views and raise the level of discussion. The approval decision by the FDA means big money for Eli Lily. In a 20th Feb 2009 interview, US FDA officials admit that they may have made a mistake in this issue of not including Dr Kaul at the last moment although he was rostered. Let us see what remedial action they will take to correct their mistake. Will they reconvene another meeting of the panel, and suspend the approval, pending the second meeting?
This to me is a clear example of industry influencing medical decisions. One wonder whether money changed hands to facilitate the non-inclusion of Dr Kaul. Of course there are now red-flags all over the place and everyone is aware that the US FDA is not so " clean " and " transparent " and fair. Nonetheless, there are some practitioners in this country who will swallow whatever the US FDA recommends as gospel truth. I dare say that there were many other decisions made by the FDA with regards to drugs for hypertension and cholesterol lowering which were also equally suspicious. Even device approvals I believe, have these problems. This is not to say that we should not read and examine what the US FDA announces or recommends. But practitioners must study their basis and make sure that the recommendations are sound, proper and without bias. Our patients expects that of us. We we owe that much to them.
Suffice to say that be it USA or Malaysia, there are no angels on earth. Angels dwell in heaven.


2muchtoodo said...

Posts like this do indeed show that humans and human systems can be flawed. Dr. Kaul was allowed to speak, as would anyone with anything to say. However the inclusion of Dr. Kaul in the voting panel would be just as disastrous as to allow a known cheerleader for Lilley. In order to maintain objectivity FDA advisory Panel members must be neutral. They must not have overt (justified or not) leanings one way or the other about any company or its products. Because Dr. Kaul made public statements about Prasugrel, he publicly denied neutrality and therefore recused himself from voting. Note, whether the comments he made were positive or negative, he still would have been asked to step down.

The real point missed in your blog is that despite being human and therefore flawed, the FDA is still one of the most effective government agencies in the world, certainly the most effective regulatory body. Your comments tying the banking system to the FDA are crass at best, and deliberately destructive at worst. Your grammar suggests that perhaps you are new to the U.S. Perhaps you should go back to Malasia and use your ignorance there.

MBI said...

First paragraph of comment by 2muchtoodo is off the mark in my opinion. I would have thought to arrive at any public-interest decision, FDA should afford as much space as possible to the opinions of people like Dr. Kaul. To not call Dr. Kaul to the decision-making FDA meeting on the ground that he had publicly spoken unfavourably about Prasugrel is like not calling such and such Senators to Senate sittings on the nation's economic bailout because those Senators have publicly spoken against such move!

On FDA being an effective government agency, there's no doubt but not necessarilly because of its approval objectivity. It's because it presides over the world's most lucrative pharmaceutical market.