Debunking FDA bunkum funk

Having recently attended a highly entertaining cardiovascular conference, I thought I would attempt to cleanse myself of the purely factual reporting I was doing there and open a can of nerdy whoop-ass.

The conference reporting game brings up more happy surprises the longer I do it. By far my greatest pleasure is getting to know the scientists and therapists that are the best at what they do, and talking to them off the record.

One such big cheese said that drug-eluting balloons, which have been transforming the sordid yet inexplicably glamorous world of artery-unblocking in Europe for a while now, have not yet been approved by the FDA in the US. The reason for this strange discrepancy? They are not as profitable for the big businesses involved as the devices that are currently employed.

As a little aside, before I started covering these technologies I had no idea how amazing they were, and I had the privilege of watching some amazing open and endovascular procedures live during the conference. Endovascular techniques are performed by making a small incision in the groin, and often the armpit too, and threading a catheter through these arteries to the area where there is a blockage. The procedures are beamed live from hospitals to the conference centre. A suave surgeon narrates the procedure in a sexy Italian accent as he does it, amid the ghoulish groaning of the patient, who lies, fully conscious, on the table covered in iodine. The arterial blockage can be piledriven through using a sort of minuscule drill, and it can be squashed against the artery wall using little balloons that are inflated once they are fed into the blockage via the catheter. The artery can be held open with a device called a stent, which is like a metal scaffold.

In my naivete, I was shocked to hear my dear turncoat’s words, which were spoken over mouthfuls of delicious faculty lunch and washed down with hot, quintessentially German mountain herb tea. But as I started to think about it, I realised that this was nothing less than a testament to the way the US and many other nations are run.

We have all heard the unsavoury tales surrounding the FDA approval of dangerous drugs, of the immoral marketing of drugs that have resulted in a nation of med-heads, of its flagrant disregard of rigorous science in favour of pushing through profitable drugs, of the sway that big pharma lobbyists hold in Congress… etc.

The fact about endovascular devices – stents, balloons, catheters, etc – is that they are very expensive. And the tight times we are going through might mean that less people in the US are exposed to the benefit of these technologies because their insurance no longer covers it. By people I mean obese individuals with type II diabetes, who incidentally make up an obscene 30% of the US population. No, that’s not a typo. It’s 30%, but what the hell — it’s their right to be fatties, is it not? It’s all about fighting for the choice, even if, like the children and animals we still are, we cannot be trusted to put down the slurpy straw, as Mayor Bloomberg can now attest to.

To get back to the econo-trough, the case is that people are still getting these devices placed. They are still undergoing the procedures, but what is unfortunately being scaled back as a money-saving measure is patient follow-up. Where patients used to be able to claim for a one-month, three-month, six-month, etc, follow-up, most states are now only providing for a single follow-up, which means that late complications cannot be anticipated until it reaches the point that the patient is experiencing acute pain. With one in three cases of stent placement resulting in restenosis (the reblocking of the stent) this is far from a trivial matter. In fact, the only party kept in pocket and risk-free in this scenario is, amazingly, devices manufacturers.

It is great that people are able to have their blood vessels unblocked so that they don’t have to have, as may be the case, their legs amputated, and are therefore able to contribute to society as they were before. But alas, were it that we lived in a saner world, more funding would be placed into dealing with the root causes of cardiovascular disease, such as addiction to unhealthy foods and smoking, possible underlying symptoms of depression, lack of physical exercise, and lack of basic nutritional and culinary education, and I daresay we would all be in a better place.

p.s. The case is no different in countries where big business doesn’t exist, such as poor little Bulgaria, who is simply run, very publicly, by the mafia instead.

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2 thoughts on “Debunking FDA bunkum funk

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