Tuesday, June 29, 2010

Julie’s Position on CCSVI Research

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UPDATE: It seems that just as I was publishing the blog below, this press release was also posted: Clinical Trial Testing New Multiple Sclerosis Treatment to Launch in Buffalo1. I am thrilled that this research is being undertaken. I am confident that if these preliminary trials go well that this will go far in allowing other researchers to convince their IRBs to allow similar research at their institutions (and result in additional funding from varied sources).
ORIGINAL POST: I guess that I didn't explain my position on research around chronic cerebrospinal venous insufficiency (CCSVI) well enough, as many people reading my blog on Research Directions Around CCSVI2 seemed to think that I am against treatment trials for CCSVI. It is only because I think clinical trials worthy of publication in peer-reviewed journals (which is necessary for acceptance by the vast majority of doctors) are so important, that I say that there are still many questions to be answered through research before such a trial CAN be undertaken.
Let me explain something - something real, that all of the yelling, screaming and name-calling cannot change, despite how angry, desperate or anxious any of us are. There is a process to conducting clinical trials, especially at major universities in the US. In order to get approval for conducting any trial that involves humans, there is a very, very stringent approval process that has to be passed. A committee called an institutional review board (IRB), also known as an ethical review committee, must approve any study that is to be undertaken at that institution (even studies that just involve asking people potentially sensitive questions about their health have to pass this process). It is the number one job of these committees to make sure that patients are not put at more risk than necessary at these institutions, not only for the sake of the patient, but also as a CYA for the institution itself (no small factor here).
As someone who has worked to get study protocols through this process as a researcher at a university (Johns Hopkins University, to be exact), I can tell you this - there is NO WAY that a treatment trial on CCSVI would make it through an IRB process at this time. No way. There are far too many questions to be answered about:
  • causality of the condition itself and correlation with MS,
  • diagnostic methods are far from perfect,
  • the intervention methods use equipment that is intended for use in arteries,
  • the data that would be collected needs to be agreed upon,
  • the right specialists (neurologists, radiologists, interventional radiologists, vascular surgeons) need to collaborate on the proposals (and convince their departments that this is worth pursuing).
That is not all - the list goes on of what would need to happen to get to "yes" on this one.
In order to move forward on this, there needs to be preliminary data that provides a solid foundation for these pioneer researchers to jump off of and use to convince universities and hospitals that this is a valid (and safe) direction to go. Believe me, an "I don't know" answer that doesn't directly relate to the hypothesis of a treatment trial (namely, something along the lines of "treating CCSVI - using the methods in this protocol - will result in clinical improvement of symptoms of multiple sclerosis3") will kill any trial before it gets off the ground. You can send links of remarkable before and after YouTube videos and links to forums outlining fabulous results, but that does not count as "data" to the people that have to sign off on these studies.
I have learned a couple things over the years about activism and getting results. If we want to move quickly on CCSVI treatment trials, we have to: 1) choose our targets (those people who can get us to the next step), 2) we have to have a very clear vision of what "success" is (I believe it is trials that give us results that are sound enough that the results are accepted by docs, and ideally, insurance companies), 3) we have to understand the steps of how we get to success.
In the meantime, if anyone wants to - and has the means to - get their CCSVI treated, by all means, do so. More power to you. I am very anxious to see this line of research pursued so that EVERYONE who could benefit from this surgery could have access to it - not just the lucky few who are persistent and wealthy enough to find a doc that will do it "off label" or overseas. Unfortunately, this process takes time and a whole bunch of steps that people with MS would like to see skipped.
Read more: Understanding MS Clinical Trials4
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