Archive for April 2010

Respecting a Cautious Approach to MS Treatment – PART II

Thank you for your comments relating to the our blog post “Respecting a Cautious Approach to New Research in MS – Part I.  They raise important questions which require a full explanation.  Our response is not an attempt to change your mind or course of action but rather to clearly set out why CMI  does not, at this time, offer CCSVI testing. Our response to the (paraphrased) comments are as follows:

Why the need for controlled studies and proper protocols?
There have been innumerable “cures” and “treatments” for nearly every human disease.  Many of these were accepted by patients and physicians as being unquestionably useful in the treatment of their disease.  However, the (exceedingly) vast majority of these have been proven over time to either be harmful or of no benefit. The idea of “…first do no harm” is based (at least partly) on recognition of this history and the wisdom of this tenet has withstood the test of time.

One of the reasons that ineffective cures and treatments persist is that measuring the effect of an intervention is not as straightforward as one might intuitively imagine.  The only recognized method of proving whether an intervention is effective is in repeated multi-centre placebo controlled randomized studies. In order to be blinded in an interventional procedure, the physicians measuring the effects cannot be the same as the ones doing the procedure. As well the physicians (or other experts) collecting the data or performing the measurements should be experts in that particular field.  When proper confirmatory studies are performed, the results are often surprising and innumerable well accepted treatments (with sometimes thousands of peer reviewed published articles supporting their use) have subsequently been proven to be of no benefit.

Chronic cerebro-spinal venous insufficiency (CCSVI) as a contributing element in multiple sclerosis is a new concept forwarded largely by a single researcher (Dr. Zamboni) only recently  in the Journal of Vascular Surgery –  December 2009.  This pilot study involved a heterogeneous group of 65 patients.  There was no placebo arm.  There was reported improvement in the relapsing-remitting subtype but not in the progressive subtype.  The annualized relapse rate for the entire treated group remained unchanged (which implies that some people had more relapses after intervention.)  Outcomes were not measured and recorded according to standard research guidelines.  It is impossible to derive any conclusions from this report whatsoever.  Most MS neurologists and other experts from multiple disciplines are, in general, exceedingly skeptical of these initial reports.

Notwithstanding these difficulties, the report has gained worldwide attention.  Patients are understandably desperate to see advances in the field and in therapy  and are enthusiastic about this potentially paradigm shifting idea.  However, there are the 3 questions that should be addressed. First, does CCSVI exist. Second, if CCSVI exists then is it associated with MS and further is it causal.  Third, if CCSVI exists and either causes or worsens MS, does balloon angioplasty or venous stenting improve symptoms.  None of these questions can be answered without proper randomized studies.  At this very moment multiple large scientific studies are being preformed to answer these questions.  If validated the procedure would then be enthusiastically offered by practitioners and clinics, including ours, around the world.

Is the test and treatment for CCSVI safe?
Ultrasound and non-contrast MRI for CCSVI are non-invasive tests which are safe to administer. However, the purpose of performing the examination is to obtain a diagnosis and to determine what therapy is available.  To offer imaging (outside of a trial) is to offer implicit support of the diagnosis and its treatment.

In our Medical Director’s teaching hospital based radiology practice about 1/3 of his time is spent performing vascular interventional procedures.  The most common procedure he performs is venous angioplasty for dialysis patients with central venous stenosis.  In dialysis patients, these venous narrowings have occurred most frequently because of previous (dialysis) catheters.  Treatment is required for symptomatic relief of arm (and possible face) swelling or in order to provide blood flow for (life-saving) dialysis.  The natural course of these stenoses is to recur frequently after angioplasty.  Patients are regularly treated several times each year to treat re-stenosis.  Stenting of central venous stenoses can be problematic because of re-stenosis and occlusion of the stent. The experience of treating jugular vein disease is far more limited than other central veins.  Stenting of the jugular veins is of particular concern because of the mobility of the neck and resulting forces/torsion on the stent.  At least one MS patient has already had serious complications from this treatment being performed in the United States.

Clearly physicians everywhere would like to treat patients who have this common and devastating disease.  However it is our view that to “treat” venous stenoses (outside of a proper clinical trial) without any proper scientific evidence of the effectiveness of this procedure in MS patients would be reckless and unethical.  This opinion is widely held by MS doctors and vascular interventionalists and it is why patients must resort to travelling to Bulgaria or Poland to find a physician who is willing to perform the procedure.

If the patients are prepared to take the risk why don’t we let them decide for the themselves?
Offering imaging of CCSVI at this time (outside of a proper study) is medically questionable (at best) or irresponsible (at worst).  At the moment there is not even a definitive protocol for the test. If the patient is not in a trial then what will be done with the information?  How does the patient (or any of his/her medical caretakers) know how to interpret the meaning of any of the findings?  Performing diagnostic examinations on an ad-hoc basis will not further a patient’s medical care or understanding of any potential link between CCSVI and multiple sclerosis and holds out implied false promise of a diagnosis and therapy. In short, to offer these scans at this time with the current data would violate the core principles on which our clinic was founded and on which it operates.

Is CMI part of a conspiracy to withhold this treatment from MS patients?
We do not believe that there is such a conspiracy, however we can only speak for ourselves. CMI is a privately owned and operated clinic which does not accept money from, nor is it beholding to, any other organization or corporation.

Further, we do not believe we have put “money before people..”.  with our decision not to scan for CCSVI at this time.  In fact we believe the opposite. Though we expect it would be quite profitable for CMI given the desire for this test, we believe it would be unethical and improper for us (outside of clinical trial) to offer and accept money for a service in which there is no definitive protocol, no controlled studies to demonstrate its efficacy and where the treatment risks are unknown and potentially fatal.

We understand that this is cold comfort for those suffering the debilitating effects of this terrible disease. While of little benefit to those who require a cure today, CMI is constantly reviewing the literature and if and when the science determines that there is likely benefit to CCSVI treatment for MS, we will offer the service immediately.

To further support our positioning, please view the latest statement released from Wayne State University, in collaboration with Canadian investigators from the University of Ottawa & McGill.