Paolo Zamboni didn’t buy into the conventional wisdom that multiple sclerosis was an autoimmune disorder resulting in the wearing away of the nervous system’s cellular insulation: myelin. Instead, the vascular surgeon from Italy was so sure that the root cause of MS was something called chronic cerebrospinal venous insufficiency (CCSVI), a vascular disorder which prevents proper blood drainage from the brain and spinal cord. Unfortunately, Zamboni wasn’t the only one who thought MS was caused by CCSVI. He’d managed to convince a great many patients and a small handful of practitioners to buy into his wisdom, as shaky as its foundation was.
That foundation has now gotten a lot shakier. At this year’s Annual American Academy of Neurology Meeting in San Diego, researchers presented findings of a study designed to evaluate the treatment used by Zamboni and others to treat CCSVI. Their neck venoplasty – freeing up blood flow by inflating balloons in veins coming from the brain – was shown to not only be ineffective in treating MS, the procedure actually made matters worse.
The new study compared the outcomes of nine patients who had undergone Zamboni’s treatment with ten who’d received sham surgeries. Six months after the procedure, the patients receiving the neck venoplasty were worse off – while only one of the sham patients relapsed, four of the patients receiving the treatment had relapsed by follow-up. Furthermore, brain scans showed that whether or not patients received the treatment surgery or the sham did not affect the size or number of MS lesions in the nervous system.
The study, led by Adnan Siddiqui and Robert Zivadinov, both at the University of Buffalo’s School of Medicine and Biomedical Sciences, is admittedly a small one. Nonetheless, it is the first double-blind trial of the procedure. And, considering the dubious evidence that chronic cerebrospinal venous insufficiency causes MS in the first place, it is being taken as a fatal blow to a treatment that experts the world over feel should have been shut down before it was begun.
It was Zamboni’s own 2009 study, in which he found that CCSVI was present in 100 percent of the study’s MS patients, that generated the enthusiasm in the first place. The study had problems, however, the most egregious being that Zamboni was not blinded to the treated and placebo groups. Regardless, the study put CCSVI and the neck venoplasty treatment on the map as an MS cure, experimental as it might be, and patients desperate for another option flocked to clinics in abiding countries. By 2010, public support for the treatment was strong enough to prompt the US National Multiple Sclerosis Society to designate $2.4 million to research CCSVI, about 7 percent of its budget, despite overwhelming skepticism from clinicians and scientists.
Zamboni’s assertion that MS is a vascular disorder and not an autoimmune one derives from his idea that the accumulation of blood in the brain raises iron to levels that are damaging to the nervous system. A growing number of studies, however, fail to correlate CCSVI and MS, the most recent and damaging coming just this past October.
At the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis in Lyon, France, data from the largest CCSVI study to date was presented. A total of 1202 individuals with MS were compared to 669 individuals who were either healthy or had some other neurological disorder. They found that the prevalence of CCSVI was the same across all three groups, about 3 percent, and concluded that their data did “not support the role of CCSVI as a potential causal factor in the development of MS.” Unlike Zamboni’s the study was double-blinded – neither the researchers nor the patients knew who was getting the treatment who was receiving the sham surgery.
Just prior to the Congress a similar study had been completed in Canada that had reached similar results. To David Hafler, chairman of the neurological department at the Yale School of Medicine, the $5.5 million the Canadian government used to fund the study could have been better spent. As the told The Globe and Mail, “The debate in the scientific community was brief, swift and is over. The government has squandered precious resources not using peer-review, but instead using emotion and theologic belief and I think shame on the Canadian government for bowing into these pressures.”
Since 2009 over 30,000 MS patients have sought venoplasty to treat their disease. With the Buffalo study, however, that trend may soon subside. In the video below, Dr. Siddiqui (very, very clearly) points out that the study “isn’t the last word,” on CCSVI, but “the first word.” What's unfortunate is that this "first word" didn't come sooner, before tens of thousand of patients had sought treatment and millions of dollars had gone to questionable research. But this is what happens when it's not just the patients who are overcome with wishful thinking.
[Source: ubcommunications via YouTube]