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Sham Medical Device Surgery Costly, Dangerous, Controversial

Feb 19, 2014

Some medical device testing appears to be using human beings as placebos in which people undergo bogus surgeries to determine a potential device’s efficacy.

In drug trials, some participants are given placebo drugs, while others are given a real drug so that researchers may measure results. In drug trials, the placebo group is not subjected to the drug being tested. In this so-called “sham surgery” medical device placebo testing, participants are subject to invasive and dangerous surgical procedures.

A recent and major study of a new cardiovascular device is an example of how patients in a sham surgery placebo group undergo unnecessary medical procedures. Placebo patients received anesthetic medications, underwent insertion of a large-bore catheter into a major artery, and agreed to have dye injected into their bloodstreams, according to The Wall Street Journal. Their surgeons worked on them for approximately one hour, as a monitor showed bogus results via radioactive fluoroscopy.

Patients underwent angiogram procedures not knowing if they were receiving legitimate or bogus treatment in the U.S. Food and Drug Administration- (FDA) approved research of a new Medtronic medical device. The device, according to The Wall Street Journal was developed to treat significant high blood pressure that diagnosed as being resistant to traditional medication. Some patients received the legitimate surgery while some patients were randomly chosen to the bogus surgery; the patients themselves served as placebos.

According to The Wall Street Journal report, the methodology, which the agency is considering, comes at a high cost and uncertain benefits, which means that it may take many years before new products reach patients. Apparently, the FDA has encouraged device makers to use the dummy surgical approach in recent years and, The Wall Street Journal wrote that indicates that dozens of similar studies are in progress.

The FDA believes that sham surgeries provide more bias-free and statistically superior results; however, many question use of significantly invasive procedures in the sham surgery model. Those opposed to sham surgery medical device testing argue that the use of sham surgery may be beneficial in minimally invasive procedures in which very low risk devices are being tested. For instance, use of a sham as part of an ongoing surgery in which the sham would be a step in a larger procedure that does benefit the patient, The Wall Street Journal wrote.

Research involving increased risk or harm, with no benefit, appears to be in conflict with the overarching principles overseeing human research. In fact, according to The Wall Street Journal, some of these principles are seen in the Declaration of Helsinki, which is a global treaty on the conduct of medical research. Consider that experiments used in sham surgeries involve patients agreeing to receive unneeded anesthetics, radiation, abdominal incisions, endoscopy, and rectal injections, to name some, The Wall Street Journal indicated. The unnecessary incisions subject people to anesthesia and infection risks.

To address the ethical issues, the FDA will allow placebo patients to join the treatment group at some point; however, that might involve a second surgery. Second surgeries are often not desired by patients and are always more costly. The high cost of sham surgery trials, in general, also impacts domestic innovation with medical device firms seeking less expensive avenues.

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