Clear and Present Danger
Clear and Present Danger
Anytime you see “FDA” and the phrase “panel of experts” in the same sentence, you just know something fun is going to happen!
As is often the case, the unintentionally amusing “logic” that comes from these panels typically creates more confusion than answers. And the latest offering doesn’t disappoint. Meanwhile – amusement aside – it may leave many patients wondering about the wisdom of having a stent inserted into a narrowed artery.
Risk recognized
In the e-Alert “Opening Up” (9/28/06), I told you how the first generation of stents sometimes produced a condition called restenosis – a renarrowing of an artery prompted by scarring and inflammation that sometimes occurs when stents are inserted.
The restenosis problem was at least partly solved with the 2003 introduction of stents coated with medication (drug-eluting stents) that helped control inflammation. Unfortunately, recent trials have revealed that drug-eluting stents sometimes cause blood clots. So now, doctors regularly prescribe blood-thinning drugs for stent patients. And in some cases, this additional precaution may require several months or even a lifetime of medication.
About two months after I sent you that e-Alert, Reuters Health reported on a Cleveland Clinic examination of 14 stent studies that included more than 6,600 patients. The Cleveland team concluded that patients who receive drug-eluting stents are four to five times more likely to experience blood clots compared to patients who receive the bare-metal type of stent.
Of course, this sobering outcome underlines the need for blood-thinning therapy after drug-eluting stents are inserted. But that doesn’t mean the case is closed. Far from it.
Confusion has its day
About a week after the Reuters report, Ivanhoe Newswire covered a Duke University study, which tested a combination of aspirin and clopidogrel (a blood thinner, better known as Plavix) on patients with drug-eluting stents. Their conclusion: The combined therapy lowers heart attack and death risk when used for one to two years after stent implantation.
And how severe is the danger of going without blood thinning medication? According to Ivanhoe Newswire, “Drug-eluting stent patients who showed no major health complications six months after surgery and did not use clopidogrel had more than twice the risk of heart attack or death 24 months after surgery than those who took the drug.”
So drug-eluting stents solve one problem while creating another potentially deadly problem. At least that’s what the Duke and Cleveland Clinic studies clearly agree on.
Here’s where it gets good.
The day after the Ivanhoe report, HealthDay News reported on an announcement from an FDA advisory panel that examined stent safety. The panel of 21 experts concluded that drug-eluting stents might create a risk of blood clots, but “they do not increase the chances of heart attack or death.”
Really? Blood clot risk goes up, but heart attack risk does not? Has the FDA officially entered a bizarro universe where the rules of physics don’t apply anymore?
Back up the money truck
To be fair, the FDA panel members were divided in their assessments. One panelist told HealthDay that the evidence was inconclusive, while another (Dr. Steve Nissen of the Cleveland Clinic) stated, “There is pretty unequivocal evidence.” But on one point the panel was in agreement: More studies of drug-eluting stents are needed.
That’s the ticket! More studies! More stents! More Plavix! More expert panels! More money for everyone! (This offer not available to patients.)
Meanwhile, patients are left to wonder if they really have to rely on medications for protection from medical devices, or if they can do without the devices altogether.
You can use the link below to find “Opening Up” (9/28/06), with information about vitamin therapy to address restenosis, and chelation therapy to remove arterial calcium deposits. http://www.hsionline.com/ealerts/ea200609/ea20060928a.html
