Dr. Salvatore Sclafani has an over 40-year brilliant career behind him and his name is well known among multiple sclerosis patients. The chairman of radiology at SUNY Downstate Medical Center in Brooklyn, New York, was not only the first American surgical radiologist to use the Chronic Cerebro-Spinal Venous Insufficiency [CCSVI] treatment, but he was also the first to harshly criticize the recently published Swedish and German studies that negated Dr. Paolo Zambonis theory studies that firmly maintain there is no connection between multiple sclerosis and CCSVI.Sclafani, an expert surgical radiologist of Italian origins, quickly became a fan of the treatment developed by Dr. Zamboni, the Italian surgeon he met several times and who he admires greatly. Sclafani talked to Corriere Canadese/Tandem about the therapy that has stirred debate in Canada. In fact, Ottawa decided a few weeks ago to follow the advice of medical experts from the Canadian Institutes for Health Research and from the MS Society, who discouraged the federal government from allocating funds for experimentation. The federal health minister, therefore, announced that before making any decision, work groups will be organized to analyze and monitor the results of seven studies sponsored by the MS Society costing a total of $2.4 million.
What do you think about Zambonis theory?
Dr. Zambonis theory that an obstruction of the outflow of blood from the brain resulting from a congenital malformation of the vein walls and valves of the jugular and azygos veins causes some of the symptoms of MS and may be at least implicated in the development of the pathology seen in MS seems sound to me. He has done very thorough research on the subject in many different areas including neurology, genetics, embryology, surgery, interventional, radiology, and others. My own experience is that these vein problems are very common in patients with MS.
Have you practiced the CCSVI procedure?
Yes, I treated my first patient in December 2009 and treated about 20 patients until April when my hospital decided that they wanted me to have IRB oversite to continue. My proposal to my IRB [Institutional Review Board] was rejected. They indicated that they would prefer a randomized clinical trial with possible sham operation [a placebo operation] as control. I disagree that we should start such a trial so early. There is too much to learn before doing that definitive test. We are at a standstill for the moment.
Why is there such a controversial debate about Zambonis theory?
It is a radical concept to many neurologists who have held for many years to an autoimmune origin of MS. Actually, the venous association has been around a lot longer more than 150 years but for reasons that are unclear, the idea has never caught the attention of most leaders in this field. There is often resistance to a radical idea. A common resistance was to the idea that stomach ulcers were caused by a bacterium instead of purely caused by high acid. It took a long time for that idea to be accepted. Then there was Dr. Ignaz Semmelweis, who warned that infection of the womb of pregnant women was caused by the fact that doctors did not wash their hands when going from the autopsy room to the delivery room. Even today, some doctors have resistance to washing their hands between patients!
A lot of patients that I interviewed tried this procedure abroad and they were satisfied with the results. However, there is a lot of resistance from the medical community. Is it because the theory is not widely known? Or do you think its also a matter of money?
People do bring up the money issue. I would like to think it is just resistance to change rather than selfishness. It must be a very difficult thing to do to think so far outside the box.
What do you think about the lack of support from the MS societies?
I cannot tell why there is not that much support for this idea by the MS societies. They are going to trust the doctors they have long-standing relationships with. Since the drug therapies do not seem to work for many patients, why not devote more effort to trying a mechanical solution? While it is true that there are seven supported studies to try to determine the validity of the CCSVI Association, most of these trials are run by neurologists, not vascular specialists. Another problem is that these studies are moving along too slowly for patients who do not have a lot of time to wait. These studies should have been completed by now! Hearsay tells me that some have not even started yet. This must be very frustrating to patients.
There is also a political debate involved. In Canada, Saskatchewan was the first province to announce in July that it would fund clinical trials of the CCSVI treatment. Now other provinces have promised they are going to support the research but have still not confirmed anything. The federal government has said it wont invest in clinical trails for now. What is the situation in the U.S.?
The United States lagged behind Canada in terms of paying attention to CCSVI. The Canadian press was all over this early on. I was the only American interventional radiologist who performed this treatment until 2010.
Is there a strong debate in the U.S. regarding the Zamboni MS treatment?
There isnt much debate. There was just slow recognition and interest in treatment by treating physicians who are mostly interventional radiologists. Interest is now snowballing and my radiologists are now getting involved at a very rapid pace. Educational programs are now being set up in our society meetings. I have put on an educational symposium in New York City that was very well attended and received great enthusiasm.
You recently made a comment about German and Swedish studies that denied the link between MS and CCSVI. Were the scientists accurate in their report?
No. They did not follow the diagnostic testing procedure and algorithm described by Dr. Zamboni, and then proceeded to state that they invalidated his observations. It was sort of like one person looking through a telescope and seeing the rings of Saturn and then another person looking through binoculars, not seeing the rings, and then stating that the first observer was wrong. Different instrument of observation, different observations.
Have you ever met Dr. Zamboni?
Yes, I have met him several times. We communicate frequently on subjects of mutual interest. I greatly admire him.
When I spoke to Dr. Zamboni, he was enthusiastic about Saskatchewans decision to fund clinical trials, and he hoped that the other provinces here would do the same. What is your hope for the future?
My hope is that neurologists would join with interventionalists as partners to thoroughly work to optimize the treatment of the venous diseases associated with MS. I would want partners who keep an open mind as we discover the best ways to treat the veins, and hopefully improve the lives of thousands of patients. Dr. Zamboni has created a great team: Fabrizio Salvi, neurologist, Robert Galleati, interventionalist radiologist, Erica Menegotti, to name just a few people in his group that are openly and honestly studying this issue. We need more teamwork to see whether treating the very common associated vein problems improves patients.
Is there anything you would like to add?
I have worked previously on many topics that were controversial in my 40-year career: the treatment of bleeding internal organs after trauma by interventional radiology; the dilation of dialysis access fistulas and grafts and the non-operative treatment of uterine fibroids by interventional embolization. All three faced strong opposition by those who were personally committed to other lines of treatment. Sometimes resistance is strong, sometimes not. But the resistance must be persistently met with data. Eventually, the truth comes forward, and in these three cases lives were saved, and better, less invasive alternatives arose from the controversy. Other controversial areas did not meet with success and were abandoned, not because of opposition, but because the data showed that they did not work better than the established alternative. Such is medical progress. Two steps forward, and sometimes one step back.
Finally, I have never met patients as impressive and as inspiring as MS patients. They are intelligent, curious, knowledgeable, well-connected, independent, yet collaborative and engaged with each other. They are generous, respectful, yet unwilling to be cast in the role of vulnerable population. They are the true drivers of this phenomenon. They control the agenda. And their anger at the establishment and its physicians result from those who will take away their empowerment. It is for them that I now focus the rest of my career on the relationship between CCSVI and MS and other diseases and on an effective treatment strategy.