Diskussion:Liberation Treatment der CCSVI
Rise and fall of “liberation therapy" for MS summarized
A new article by Dr. Stephen Barrett discusses the continued promotion of the "liberation procedure" to treat multiple sclerosis and other neurological conditions despite the implausible rationale proposed for it and the failure to show that it is safe and effective. [Barrett S. Studies show that "liberation therapy" for multiple sclerosis doesn't work https://www.quackwatch.org/08Misc/zamboni/overview.html Quackwatch, May 2, 2018]
"Liberation therapy," sometimes called Transvascular Autonomic Modulation (TVAM) http://www.synergyhealthconcepts.com/tvam_transvascular_autonomic_modulation/ is a surgical procedure proposed in 2006 by Paolo Zamboni, an Italian surgeon, to treat a hypothesized condition, "chronic cerebrospinal venous insufficiency" (CCSVI), supposedly linked to multiple sclerosis and other autonomic dysfunction diseases. It involves widening veins in the neck and chest. Barrett's report noted:
Studies in 2014 and 2017 found no association between narrowed veins and multiple sclerosis. In 2017, Zamboni conceded that the treatment doesn't work in treating multiple sclerosis based on results of a clinical trial that he headed. A study by other researchers also published in 2017 also showed that expanding veins did not relieve symptoms of multiple sclerosis.
In 2012, the Food and Drug Administration warned that the procedure was unproven and associated with reports of death; stroke; detachment and migration of stents; damage to the treated vein; blood clots; cranial nerve damage; and abdominal bleeding.
In 2017, FDA warned against additional uses of the procedure.
A lengthy investigative report published by the Milwaukee Journal Sentinel has concluded that about 30 doctors have performed unproven procedures for CCSVI but state licensing boards have given insufficient attention to this problem. [Farber J and others. From hope to medical nightmare: Despite FDA warnings, state boards lag in taking action on controversial MS treatment https://projects.jsonline.com/news/2018/3/28/state-boards-take-no-action-on-controversial-ms-treatment.html Milwaukee Journal Sentinel, Mar. 25, 2018]
Michael A. Arata, M.D http://www.synergyhealthconcepts.com/dr_arata/ who operates Synergy Health Concepts in Newport Beach, California is described on his office Web site as "the most experienced CCSVI physician in the United States, having performed over 1500 procedures."
In 2012, the FDA notified Synergy and Arata that their CCSVI research did not comply with federal regulations.
In 2016 and 2017, the FDA noted that he was still out of compliance and that proceedings were under way to disqualify him as an investigator.
In 2015, James McGuckin, Jr., M.D. signed a consent order in which he agreed to
(a) stop performing angioplasty or stenting for CCSVI or MS patients in the State of Washington,
(b) pay a $17,500 fine,
(c) issue refunds to certain patients,
(d) successfully complete an ethics course, and
(e) comply with monitoring provisions set by the Commission.
The Washington action triggered similar restrictions by licensing boards in Florida, Georgia, Illinois, Indiana, Louisiana, Maine, Maryland, New York, North Carolina, Texas, Tennessee, and Virginia.
McGuckin's Washington medical license expired in November 2015 and was not renewed, but he remains licensed in the other states.