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Medical devices

Most drug-coated stent use never approved by the FDA

Wednesday, February 21, 2007 by: Beau Hodai
Tags: medical devices, drug-coated stents, surgical procedures

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(NewsTarget) A recent report has shown that the majority of drug-coated stents installed in patients by doctors are being used in “off-label” cases -- that is, cases not approved by the Food and Drug Administration.

The report was released Monday in the New England Journal of Medicine, and is a collation of several studies that show 60 percent of drug-eluting stents are applied multiple times in patients with critical health.

Drug-eluting stents, or wire mesh tubes that release a medicine over a period of time that is supposed to decrease risk of arterial plaque build up, are only approved by the FDA for use in patients who have only one blocked artery and no accompanying health problems.

The studies also show that patients who receive drug-eluting stents have a higher risk of developing blood clots, or suffering heart attacks, although it is unclear whether the elevated risk is due to the actual stents, or the patient’s already poor health.

“When you have any type of medical intervention, when you see more complicated patients or lesions, you will see a higher rate of adverse events,” said Dr. Andrew Farb of the FDA, who also wrote a piece on the issue for the journal. “That is what has been observed in these studies. Our goal is to make the medical community at large aware of the issue,” said Farb.

The FDA held a panel meeting on the risks of drug-eluting stents in December.

However, according to Farb the higher incidence of blood clots and heart attacks in drug-eluting stent patients is of “a small concern” as compared to the high rates of off-label use of the devices.

According to Dr. Robert Milcher of the cardiac center at Montefiore Medical Center at New York City, the use of drug-eluting stents in off-label cases has decreased, but remains “an enormous public health concern”.

"Once again we find that so-called evidence-based medicine is often based on untested, unapproved, off-label use of medical devices," said consumer health advocate Mike Adams, author of Natural Health Solutions and the Conspiracy to Keep You From Knowing About Them. "Conventional medicine is largely a hoax. Surgical procedures such as coronary bypass surgery have no safety or efficacy testing requirements whatsoever, many routine surgical procedures have absolutely no medical justification at all, and prescription medications are approved based on fraudulent science, then widely used for health conditions they have never even been tested for. It's no surprise that drug-coated stents are also being widely used under circumstances for which they were never tested."

"Most of what happens in medicine today simply has no scientific standing," Adams added. "Conventional medicine is a false science that now serves primarily as a marketing scheme to generate revenues for drug companies, hospitals, surgeons and doctors."


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