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Thursday, February 11, 2010

The Society shares in the public urgency to expeditiously advance any lead that has the potential of stopping, repairing or preventing MS.

CCSVI Research Funding Timeline
January 12, 2010 – Investigators whose letter of intent meet guidelines are invited to submit full research proposals.
February 9, 2010 – Deadline for proposals.
May 2010 – International panel of experts conducts an expedited review of all applications received through this special request for applications.
June 2010 – Funding decisions announced.
July 1, 2010 – Anticipated start date for funding of any successful research applications.

Taking advantage of the organizations' international scope, the applications will undergo an accelerated review process by an international panel being convened in cooperation with other MS Societies to ensure an expedited, coordinated response. If this hypothesis is confirmed, it could open up new research avenues into the underlying pathology of MS and new approaches to therapy.

Background: In a recent study by Dr. Zamboni and colleagues, the team evaluated abnormalities of blood outflow in major veins draining from the brain and spinal cord to the heart in 65 people with different types of MS, compared with 235 people who were either healthy or who had other neurological disorders. They used sophisticated sonography techniques to detect abnormalities of venous drainage. The investigators reported evidence of slowed and obstructed drainage in the veins draining the brain and spinal cord in many of those with MS. They also reported evidence of the opening of “substitute circles” – where the flow is deviated to smaller vessels to bypass obstructions, and these were often found to have reverse flow (reflux) of blood back into the brain.

The investigators call this venous obstruction “chronic cerebrospinal venous insufficiency,” or CCSVI. The treatment status of the people with MS (i.e., whether or not they were on an MS disease modifying drug) did not appear to influence whether they showed signs of CCSVI. The authors speculated that the reverse flow of blood back into the brain might set off the inflammation and immune-mediated damage that has been well described in MS. This study was published in June 2009 (J Neurol Neurosurg Psychiatry 2009; 80:392-399).

It is proposed, but not yet proven, that CCSVI may be corrected through endovascular surgery. This surgery is being called “liberation therapy” in some reports. One study getting underway was described at the 2009 ECTRIMS meeting in September. It involves a collaboration between researchers in Italy, Buffalo (NY) and Birmingham (AL) who are attempting to treat venous obstruction in 16 individuals using balloon dilation such as has been used for many years to treat blocked arteries.

In a small, open-label study by Dr. Zamboni and colleagues published in December 2009, the team evaluated the safety and preliminary outcomes of vascular surgery (percutaneous transluminal angioplasty) in 35 individuals with relapsing-remitting MS, 20 with secondary-progressive MS, and 10 with primary-progressive MS. (J Vasc Surg 2009; 50:1348-1358) They reported some positive impacts and suggested that controlled trials were necessary to better determine potential safety and benefits of this procedure.

Next Steps: The National MS Society has prompted communications between MS Societies worldwide and leveraged resources to ensure an open exchange of information and a coordinated and expedited approach to conducting and evaluating additional research on CCSVI. On December 16, 2009, the Society released a worldwide Request for Applications to the scientific community to explore CCSVI, and is collaborating with the MS Society of Canada and possibly other societies to convene an international panel of experts to conduct an accelerated review of proposals. We are also working with our sister MS Societies around the world to assure that our research strategies are coordinated. Through an internationally coordinated and expedited review process, new CCSVI research projects are expected to begin July 1, 2010. (See Research Funding Timeline above for more details.)

According to the Buffalo Neuroimaging Analysis Center, although 500 subjects have already been selected for their initial combined transcranial and extracranial venous doppler evaluation study, they are still seeking participants for a larger-scale clinical study with the aim of evaluating the prevalence of venous obstruction in people with MS. This study does not involve treatment of obstructions. The Buffalo investigators released preliminary findings in a press release and plan to continue the study.

To get the quickest answers and most reliable results about benefits and risks of any surgical procedure that might attempt to address blood flow in or out of the brain, it is crucial that such surgery be performed only as part of controlled trials, especially since there have been anecdotal reports of surgical attempts to treat CCSVI in people with MS resulting in adverse events, including one reported death.

Many questions remain about how and when this phenomenon might play a role in nervous system damage seen in MS, and at the present time there is insufficient evidence to prove that this phenomenon is the cause of MS.

Frequently Asked Questions About CCSVI and MS

Q: What is the National MS Society’s view of CCSVI?
A: In trying to find the cause and more effective treatments for a disease as complex and unpredictable as multiple sclerosis, the Society is steadfast in its commitment to pursue all promising avenues of research that can lead to improved treatments and ultimately, a cure. It is important for researchers to think outside the box and we believe Dr. Zamboni has done this. His hypothesis is a path that must be more fully explored and Dr. Zamboni himself has stated that additional research is essential to evaluate it.

Q: Will the National MS Society fund research into CCSVI in MS?
A: The National MS Society is pursuing follow-up research in how CCSVI might be involved in the MS process and we have invited investigators from around the world whose research is relevant to MS to submit proposals to apply for grants that would explore this lead. These applications will undergo an accelerated review process and an announcement on what grants are to be funded will be made in the late spring.

Q: Do the reports of a possible association between insufficient vein drainage and MS mean that MS is caused by venous insufficiency?
A: Based on results published about these findings to date, there is not enough evidence to say that obstruction of veins causes MS, or to determine when this obstruction may occur in the course of disease. Dr. Zamboni's preliminary research reported that 47% of the people who had the blockage in their internal jugular veins treated surgically had a recurrence of blockage by the end of the initial study. This is one of many reasons why additional research into what all this information might mean to the worldwide effort to arrest MS is so important.

Q: If CCSVI turns out to be important in MS, can it be treated?
A: It is too soon to determine how CCSVI might best be treated. Surgical procedures for CCSVI in MS are still experimental and should be undertaken only as part of formal clinical trials that include all of the standard safeguards that are followed in such trials because of known adverse events and at least one death that occurred as a result of a surgical treatment protocol.

Q: How can I get involved in research on CCSVI in MS?
A: A larger-scale clinical study is getting underway in Buffalo, New York and is now recruiting participants nationwide with the aim of evaluating the prevalence of venous obstruction in people with MS. This study does not involve treatment of venous obstructions.

Q: While research is underway to better understand the possible relationship between CCSVI and the MS disease process, why should I not try this endovascular surgery to prevent my MS from worsening?
A: Though this is a decision that patients with MS need to make with their neurologists, we are not recommending experimental endovascular surgery at this time because of known adverse events and at least one death that occurred as a result of the surgical treatment protocol.

For anyone considering endovascular surgery, the following are some of the possible adverse events that need to be considered:
Complications and even death can occur including the risk of infection at the puncture site, risk for damage to the blood vessel, risk of internal or external bleeding if anti-coagulants are used, and, if a stent is inserted in an attempt to keep the vein from narrowing once more, there is a risk that the stent may become dislodged and go to the heart, which could cause death or the need for emergency heart surgery.

Q: I have MS. Should I be tested for signs of CCSVI?
A: We do not recommend testing for signs of CCSVI unless you are involved in a research study exploring this phenomenon, since at this time there is no proven therapy to resolve any abnormalities that might be observed, and it is still not clear whether relieving venous obstructions would be beneficial or safe.

Q: Does CCSVI make the standard treatments of MS meaningless?
A: No. There is ample evidence proving that the FDA-approved therapies for MS provide benefit for people with most forms of MS.

Q: Should the Society be doing more to support the work of Dr. Zamboni, as some people have suggested?
A: Dr. Zamboni has called for more research to move his preliminary CCSVI research forward and the Society is leading the way in advancing that effort. We have reached out to MS scientists from around the world to fund projects that will explore Dr. Zamboni’s leads, have expedited the grant review process, and brought together international MS organizations and experts to share information and move the research process forward. As in all pilot research, Dr. Zamboni’s work has raised as many questions as it has potentially answered. The Society’s role is to help ensure long term that while we are seeking to stop MS and repair the damage done by the disease, we are also working to ensure that whether someone is diagnosed with MS today or ten years from today that there will be safe and effective treatment options available. It is research such as this that has made MS a treatable disease today.

Q: What are some of the questions raised in Dr. Zamboni’s research that need to be explored?
A: Why has venous obstruction recurred in such a large percentage of patients who underwent the endovascular surgery and what does that mean to the disease process for these individuals? Is there abnormal venous obstruction in all people with MS? How do we determine who might best benefit from endovascular surgery? Can Dr. Zamboni’s results be replicated in larger controlled and blinded studies of MS patients? If so, when does CCSVI occur in the course of the disease – is it a cause or effect of the disease process? How can we address the known risks associated with endovascular surgery? Acknowledging the questions that Dr. Zamboni himself has raised only helps in designing the necessary research to secure the needed answers.

Q: Is it true as some people have suggested that the Society’s dependence on money from the pharmaceutical industry is impeding its support of Dr. Zamboni’s research?
A: No. Less than 4% of the Society’s annual income is received from the pharmaceutical industry. The majority of the funds that the Society uses to support our research and service programs come from special events and the donations of private individuals committed to ending MS. Further, we are fast-tracking our efforts to fund research regarding CCSVI and working in partnerships with MS organizations and experts worldwide to better understand and move forward Dr. Zamboni’s findings.

Q. How can I continue to be informed of CCSVI developments as they occur?
A: As new information becomes available about CCSVI, it will be posted on the National MS Society’s Web site, www.nationalMSsociety.org

1 comment:

carol said...

Thank you MS Society for this statement. Since there are so few early responses to do clinical trials, I hope they all qualify for funding and add valuable information quickly.

If those results are promising, -we should know within a year or 2, get ready to put a moratorium on EAE studies, and shift emphasis on large scale CCSVI projects; offering treatment.

We will also need stem cell and related studies for repair of old lesions. i bet some of the centers who initially declined will be happy to do this work if it is supported going forward by meaningful results in the early studies.