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Hoag doctor’s reports credited with prompting FDA warning

An MS procedure may do more harm than good

by Caitlin AdamsPublished: May 11, 2012 02:15 PM

Hoag Memorial Hospital Presbyterian’s Dr. Michael Brant-Zawadzki yesterday received an email telling him to watch for an FDA alert regarding an experimental treatment for multiple sclerosis. Dr. Brant-Zawadzki was already very familiar with the procedure, known as “liberation therapy.”

In an article he coauthored with three colleagues published earlier this month in the Journal of the American College of Radiology, Brant-Zawadzki, executive director of Hoag’s Neurosciences Institute, argued that there was little evidence to support liberation therapy as an effective treatment of MS and said that it is more likely that the procedure can cause further harm to MS patients, rather than improve their symptoms.

Brant-Zawadzki’s article and subsequent interactions with the FDA are being credited with encouraging the agency to take a closer look at the experimental new treatment, first described by an Italian doctor in 2008.

“I’m grateful to the FDA for taking the issue so seriously and for its leadership in assuring that patients with MS are fully informed about this questionable procedure, and particularly the potential risks,” he said. “Our primary mission as doctors is to promote the health and well being of our patients, and offer treatment using best practice guidelines. Today's FDA action supports our mission.”

Multiple sclerosis is a neurological condition, usually manifesting for the first time in young adults, that ranges in symptoms and severity, from fatigue and tingling sensations to chronic pain and the inability to walk, eat or communicate. There is no known cure for MS, and treatments are often therapies aimed at avoiding attacks or preventing disability. The cause of MS is not known.

The therapy described in the FDA alert is based on Dr. Paolo Zamboni’s theory that MS may be caused or influenced by a narrowing (stenosis) of the veins in the neck and chest (the internal jugular and azygos veins), described by Zamboni as “chronic cerebrospinal venous insufficiency,” or CCSVI. The supposed condition is hypothesized to compromise blood flow away from the central nervous system. However, there is no consensus in the medical community that CCSVI exists as a proven medical condition.

The liberation procedure aims to treat MS by “correcting” CCSVI through the use of balloon angioplasty – inserting a catheter to clear an obstruction or blockage in the vein. Stents are sometimes used instead; a tube structure is inserted to widen and support a blood vessel, improving blood flow through the vein.

In an October 2011 report on the treatment and theories behind it published in the O.C. Register, Brant-Zawadzki described the method as “faith healing.”

"The doctors who offer it believe in it; the patients believe in it; but there's no empirical evidence that CCSVI is a medically recognized syndrome," he told Register writer Courteney Perkes.

Brant-Zawadzki coauthored "The 'Liberation Procedure' for Multiple Sclerosis: Sacrificing Science at the Altar of Consumer Demand," along with three colleagues: Dr. Daniel Bandari and Dr. Jose Puangco, both from Hoag's Neurosciences Institute in Newport Beach, and Dr. Barry Rubin, of the Toronto General Hospital's Division of Vascular Surgery. In the article, they argue that there is no proven link between CCSVI and MS, and that these therapies are consequently not a “silver bullet” to the problem of MS. The article points out that a number of private practices promote and provide the procedure as an outpatient service for cash payment, accounting for the popularity of the treatment, but provide little in the way of follow-up care. Additionally, liberation treatments may come with extreme risks to the health of the patient.

In the Journal article, Brant-Zawadzki reports two cases of two MS patients who underwent differing forms of the liberation treatment at a “local outpatient facility.” The first patient, a woman, developed a headache and high blood pressure following the procedure but was still allowed to return to her hotel. After vomiting and losing consciousness, she was rushed to Hoag’s emergency room, where it was discovered that a subdural hematoma, bleeding in the brain, developed following the treatment. After five days, the family decided to discontinue treatment, and the patient died in the hospital.

In the second documented case, a man, experienced complications immediately following the procedure, including difficulty communicating, a facial droop and double vision. He was taken directly to Hoag’s emergency department, where an MRI scan revealed that an acute obstruction of blood to the brain stem had caused a severe stroke. After five days in Hoag’s stroke management care unit, his condition stabilized and the patient was transferred.

Both patients were from Canada, where the treatment is not available; Canadian officials announced last month that the government plans to fund a clinical trial examining the experimental CCSVI treatment.

While the procedure has met with some degree of success in treating some MS cases, main criticisms mirror those that Brant-Zawadzki has identified – that there is no proven link between CCSVI and MS and that there has been no documented testing or studies of the procedure. In its alert, the FDA points out that using stents and balloon angioplasty in the neck and chest veins, as described in liberation treatments, are not approved uses for the devices, and that it has not been found to be safe or effective to use them in that way.

Still, demand for the treatment has been high in the MS community, since patients may live a lifetime of pain with little hope for relief.

In their article, Brant-Zawadzki and his colleagues write, “When consumerism and patient advocacy groups pressure the scientific and political establishment, reasonable accommodation is warranted. The question is, What is reasonable? It may be that the operators believe in the therapy as much as the understandably desperate patients. The subsidiary question is, When is healing 'faith healing'?”

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