The FDA is warning against using an experimental procedure, called transvascular autonomic modulation (or TVAM) as a treatment for nervous system disorders, such as multiple sclerosis and Parkinson’s disease. The treatment involves inflating a miniature balloon in narrowed veins, typically found in the neck, in order to widen them, therefore, improving blood flow. This helps reinvigorate the autonomic nervous system (ANS) by improving communication between the organs and the brain.
The fairly new procedure has historically only been thought to help with if one has specific underlying conditions, and will not serve all patients with central nervous system disorders. It is also based on the same principals as a procedure that was being utilized about a decade ago where people could have Vegas nerve stimulators put in. There is currently no insurance on the market that will cover TVAM, as it is experimental, not supported by the FDA, and is therefore, seen as unnecessary.
TVAM has been long tried in Europe and the United States to treat multiple sclerosis, which causes the destruction of the protective coating of nerve fibers, interfering with signals from the brain and leading to issues with speech, memory, walking and other day to day physical activities. Parkinson’s disease patients, a disorder of the that affects movement, often including uncontrolled tremors, have also undergone TVAM treatment, and it has been used to treat fibromyalgia and other conditions which affect the nervous system that controls breathing, digestion, heart rate and various automatic body functions.
The Food and Drug Administration has been warning patients and physicians for some time against pursuing this risky procedure, claiming it has seen no evidence that TVAM is effective, or safe for that matter. In fact, there is evidence that the treatment is actually extremely unsafe. The FDA first warned against TVAM in 2012, and has recently received a report of a balloon rupturing in a patient’s jugular vein and lodging in a lung. There have also been reports of abdominal bleeding, nerve damage in the brain, blood clots and at least one death.
Canadian researchers conducted a study led by the University of British Columbia and Vancouver Coastal Health testing the procedure on 104 patients with multiple sclerosis and found those receiving the treatment did not improve, and their condition was no better than those not receiving the treatment by the end of the study. Many MS patients seemed to get temporary relief but symptoms came back after a few months or a year.
In a statement submitted on Wednesday, the FDA indicated it was taking action against California physician Dr. Michael Arata of Newport Beach for using TVAM. The administration had warned him on at least two occasions since 2012 that he was inappropriately using TVAM before receiving approval to conduct a trial. Arata originally submitted a response stating that the FDA could not tell him what to do, as the agency has no jurisdiction over his work. He refused to discontinue performing TVAM treatment on his patients, even after admitting he has found no explanation for how or why the procedure works for dysautonomia (nervous system dysfunction). The case is currently pending.
Sources:
http://www.legalreader.com/17292-2/
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