An SIR session titled “The Sterile Gloves Are Off” featured a heated debate on the proposition “The level of evidence linking chronic cerebrospinal venous insuffiency (CCSVI) and multiple sclerosis is inadequate and the clinical benefits of endovascular treatment are suspect”.
Jim Reekers argued for the motion and Gary Siskin against.
Reekers, professor of Interventional Radiology, University of Amsterdam Medical School, AMC, The Netherlands, began by stating that he had a commitment to “honesty, good evidence-based science and unbiased, non-commercialised medicine.” He used the historical example of Perkin’s tractors to set out his case. Reekers drew a parallel between what happened in the 18th century, when Elisha Perkins, a physician from the USA began to use metal rods to cure inflammation, rheumatism and pain in the head and the face. Perkins applied the pointed ends of the rod on the aching body part and passed them over the part for about 20 minutes. He claimed they could “draw off the noxious electrical fluid which lay at the root of suffering”.
Reekers told delegates that the Connecticut Medical Society condemned the tractors as “delusive quackery” and expelled Perkins from membership, yet he still managed to garner support from surgeons in Copenhagen and Denmark. Perkins talked about 5,000 cured cases,which were certified by professors, physicians and clergymen, noted Reekers, while criticism from other physicians was met with charges of elitism and professional arrogance. He said that in 1800 John Haygarth published a randomised, blinded study where patients derived the same effect from wooden rods.
“Have we learned anything in the last 200 years?,” asked Reekers. “Again criticism from physicians regarding the CCSVI hypothesis are met with charges of elitism and professional arrogance. We also hear the terms ‘pharmaceutical lobby’ and ‘being afraid to lose patients’ being bandied about.”
Referring to the widespread patient testimony about CCSVI, Reekers cautioned: “Remember even with Perkin’s tractors, patients felt better. This is placebo effect,” he said.
He called for a prospective randomised controlled trial, performed by unbiased physicians with one sham arm (with percutaneous transluminal angioplasty for the subclavian vein) which would have independent blinded follow-up in order to settle the issue.
On the issue of deferring a randomised controlled trial, Reekers told Interventional News: “Offering a non-proven treatment, without any objective parameters of success, which is mainly physician- and patient-driven carries a huge risk of damaging the reputation of interventional radiology as being a serious clinical specialty. With any future negative trial outcome, patients will have a strong case to go to court for deceit, and claim damages. Finally, all new introduced techniques in interventional radiology, like uterine fibroid embolization, had objective parameters of technical success which supported their introduction. The so-called abnormality, CCSVI, is completely unproven and is only a chimera.”
Siskin, who argued against the motion, said “as long as a reasonable percentage of patients are telling us that they are “feeling better” and are “satisfied” with their outcome after this procedure, we are going to continue offering it to our patients. It is our responsibility as physicians to do that.”
However, he acknowledged that there has not been enough research on CCSVI and that ongoing research would be critical to the understanding of CCSVI and the role of angioplasty in treating patients with multiple sclerosis.
“It is an important responsibility for us to make sure that appropriate research is performed so that we can grow our understanding of CCSVI as an entity and to determine its influence on multiple sclerosis-related symptoms. It is important that we improve our understanding of the basic science behind CCSVI, validate previously reported data and perform a prospective randomised trial,” he said.
He also argued that “I do not remember any of the pioneers of many of our other procedures waiting until all the questions were answered before performing procedures such as subintimal angioplasty, chemoembolization, radioembolization and uterine fibroid embolization on patients.” He told delegates that his group was currently enrolling into a prospective randomised, blinded trial to evaluate angioplasty as a treatment for CCSVI in multiple sclerosis patients. “I am aware of several other trials getting underway,” he noted.
Gary Siskin told Interventional News: “Interventional radiology has achieved its success as a specialty by constantly looking for new solutions to old problems, and this newly described entity is just another example of that. Many prominent members of our specialty have found preliminary success with treating this condition, which has provided the basis and impetus for further research. The difficulty in finding objective parameters of success and the possibility of discovering that angioplasty is not bringing about the success that patients are looking for should not stop our specialty from performing well designed clinical trials to answer this question. Patients suffering with multiple sclerosis deserve this.”
Before the debate, 80% of the audience voted in favour of the proposition “The level of evidence linking chronic cerebrospinal venous insuffiency (CCSVI) and multiple sclerosis is inadequate and the clinical benefits of endovascular treatment are suspect” and 20% against. After the debate, 74% of the audience voted that they were for the proposition and 26% voted that they were against.