Eight months ago, on the advice of Canadian Institutes of Health Research (CIHR) president, Alain Beaudet, federal Health Minister Leona Aglukkaq announced funding for an early (phase 1/2) clinical study of venoplasty (the so-called “ liberation treatment ”) for chronic cerebrospinal venous insufficiency ( CCSVI). This condition, resulting from blockages in neck or chest veins that drain blood from the brain, has been postulated by Dr. Paolo Zamboni to be an underlying cause of multiple sclerosis.
Several months prior to Ms. Aglukkaq’s announcement, Saskatchewan Premier Brad Wall, whose province has one of the world’s highest rates of MS, committed $5 million for a clinical trial of liberation therapy. However, at the time of the federal go-ahead, plans for the Saskatchewan trial remained in limbo after a proposed study was rejected by the premier’s panel of experts.
Then, in early January, with a national Canadian trial still far off, Saskatchewan moved forward, signing a $2.5 million agreement to send patients to participate in a U.S. government-approved clinical CCSVI trial headed by Dr. Gary Siskin, an interventional radiologist at the Albany Medical Center in New York.
Given the already considerable expertise of Siskin and his colleagues in safely performing venoplasties on hundreds of patients with MS, Saskatchewan’s decision appeared to be a savvy one.
Commenting on his province’s commitment, health minister Don McMorris stated, "Patients need answers as soon as possible about the efficacy of the Liberation Therapy as a treatment for MS. We owe it to them to explore every opportunity to advance MS research and find answers about this treatment. This clinical study will enable Saskatchewan patients to be involved quite quickly in a [double-blind] controlled, reputable research process."
In reply, Dr. Siskin stated, "Our research team is very excited about this partnership. We welcome the opportunity to involve Saskatchewan patients in our efforts to gather reliable data that can help determine whether [venoplasty] effectively relieves MS symptoms.”
Now, just three months after signing the agreement with Saskatchewan, Dr. Siskin’s team has reported the results of an earlier phase 2 study that suggest it does.
Here are the findings, presented by Siskin’s colleague, Dr. Ken Mandato, at this weekend’s annual meeting of the Society of Interventional Radiologists in San Francisco.
During a 4-month period, the Albany group performed venoplasties on 192 MS patients (average age 48.5 years; one-third were male and two-thirds were female). The study group included:
- 96 patients (50%) with relapsing remitting (RR) MS
- 66 (34%) with secondary progressive (SP) MS
- 30 (16%) with primary progressive (PP) MS.
In all, 189 patients (98.4%) underwent balloon venoplasty alone; three (1.6%) underwent venoplasty with stent placement. An average of 2.2 blocked veins were treated per procedure.
Both before and after undergoing venoplasty, all patients completed a Multiple Sclerosis Quality of Life (MSQOL-54) questionnaire that scored 14 components of physical health (PH) and mental health (MH). Pre- and post-treatment PH/MH scores were compared to determine the effect of the venoplasty treatment on the quality of life based on each patient’s subtype of MS and the number of years since diagnosis.
The result? A significant improvement in PH/MH scores was observed in approximately 75% of patients with RRMS and PPMS and in approximately 55% of patients with SPMS.
PH and MH improvement was seen in approximately 75% of patients with a diagnosis of MS made less than 10 years previously and in approximately 63% whose diagnosis was made more than 10 years previously.
On average, patients benefited for 3.5 months following venoplasty.
Commenting on his group’s findings, Dr. Mandato, stated:
“Results of the study were quite exciting and promising. We can attest to significant physical improvements…in greater than 75 percent of those with relapsing remitting and primary progressive forms of multiple sclerosis. Additionally, mental health scores improved in greater than 70 percent of individuals studied.
“[We] hope that this work will provide insights into the design of a prospective, randomized trial that is needed to rigorously evaluate the role of this treatment in MS,” he continued. "As we are still early in fully understanding the condition and its relation to treatment of CCSVI, it is our hope that future double-blinded prospective studies will be performed to further assess the durability of these results."
Happily that “future” trial is to start this month (March, 2012) and, thanks to Premier Brad Wall and his government, it will include Saskatchewan residents.
According to the government of Saskatchewan website:
“Applications are now closed for Saskatchewan multiple sclerosis (MS) patients interested in volunteering for a clinical trial in Albany, New York. The two-year, double-blind clinical trial at Albany Medical Centre will accept 86 Saskatchewan MS patients. In total, 682 people submitted applications online or by phone before the February 24 deadline.
"The high interest in this opportunity shows just how committed Saskatchewan people are to finding answers about MS and being part of a possible solution," Highways Minister Jim Reiter said on behalf of Health Minister Don McMorris. "We will be watching the research process unfold with great interest and with the hope that it will help MS patients in the future.”
According to the minister, “The first of the eligible Saskatchewan patients are expected to travel to Albany in March. Half of those participating [in the trial] will receive the Liberation Therapy procedure and half will receive a placebo procedure.”
So there we have it. Less than two years after committing to a clinical trial to test the CCSVI hypothesis, Brad Wall has kept his promise. Hooray for him.
Yet, I would be remiss if I failed to note my disappointment that, in doing so, Premier Wall has had to turn south, to Albany. Then again, what choice did he have? Over the last two years, while doctors and bureaucrats north of the border made a lot of noise (much of it “no-can-do” and anti-CCSVI), the Americans quietly got on with it, developed the necessary procedures, and generated preliminary clinical data, leaving Canadian medicine and scientific know-how far behind.
Will lessons be learned for the future? One can only hope...
http://healthblog.ctv.ca/post/Unblocking-veins-in-multiple-sclerosis-New-US-study-supports-Zambonie28099s-CCSVI-theory.aspx