An FDA warning against the use of stents or angioplasty balloons as a treatment for multiple sclerosis appears to have had little effect. Reuters reports that five months after regulators cautioned the practice remains medically unproven and risky, doctors are still regularly performing the procedure.
A safety alert against the use of a particular product or procedure can only go so far in controlling physicians' off-label use of devices or drugs. Patients, the story explains, are still choosing the treatment even with the risks carefully explained (they want relief from their MS symptoms.). Crucially: the FDA also allows physicians to weld a marketed device or drug for an off-label use, "according to their best knowledge and judgment," as long as the treatment is intended just for "the practice of medicine" and not for research toward expanded use of a product. Stents and angioplasty balloons are indicated to restore or improve blood flow in arteries, generally for various cardiac conditions.
An unsanctioned treatment can carry plenty of health risks and be quite costly, Reuters notes. And device companies risk some liability if they are found to have encouraged the unsanctioned use of their products in medical treatment. So far, that doesn't appear to be the case. Johnson & Johnson ($JNJ), for example, told Reuters it didn't know of any of its balloons or stents being used for the risky procedure. Abbott Labs ($ABT), another major stent/angioplasty balloon maker, denied pursuing research into the new treatment.
The surgical technique using stents and angioplasty balloons was developed just a few years ago, the article explains. Surgeons use it to treat something called chronic cerebrospinal venous insufficiency, also known as CCSVI. What supporters of the procedure believe is that by opening up narrow or twisted neck and chest veins, blood can drain more easily from the brain and help address MS symptoms such as "brain fog" and headaches. But regulators warn that researchers haven't proven beyond a doubt that MS patients even have CCSVI, and that no evidence has shown yet that the procedure is even safe or effective. FDA officials issued their initial warning after the treatment was linked to strokes, paralysis and at least two deaths.
Stanford University aborted its CCSVI program in 2009, Reuters reports, after acknowledging one death and complications with another patient. Two additional patients who received the procedure are suing the university for exposing them to risk. The Cleveland Clinic is studying how to diagnose CCSVI, though others have discounted CCSVI as an MS risk factor, according to the story.
- read the Reuters story