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Saturday, July 9, 2011 7:49 PM | CCSVI in Multiple Sclerosis Volg link

I believe the CTV report on the heart-breaking death of Maralyn Clarke is going to be the closest thing to an "answer" for us.  This is because, as Dr. David Hubbard comments, her treatment was not done under an IRB-approved trial, and there was no autopsy or follow-up. 

Here is the video  link

What does this mean?   It means there were not specifically approved guidelines on the protocol for her treatment.  Again, I do not want to blame this courageous and beautiful woman for her own death, nor speak negatively about her choices.  I just want to help people understand what this all means, as we move forward.

An IRB (institutional review board) approved trial means there is a multi-disciplinary medical review board that has gone over the specific protocol and has approved it.  It means there is follow-up to the procedure and documentation, should there be any problems. 

Here is more information on IRB approved trials from the CCSVI Alliance:

IRB approved clinical trials generally fall into two types:

  1. National Institute of Health (NIH) Registered Trials
  2. NIH registered clinical trials must conform to an extensive set of regulations and guidelines covering most aspects of the trial, including the ethical treatment of human subjects, use of appropriate scientific methodologies, trial sponsorship, and availability of trial outcome data. Details of these regulations can be found at the Health and Human Services Office of Human Research Protections.

  3. Clinical Trials Sponsored by Educational Institutions and Hospitals
  4. Virtually all educational institutions and hospitals have an IRB designed to review and monitor clinical trials. Educational and hospital sponsored clinical trials may or may not be registered with the NIH, but, because these institutions have experienced IRBs, patients have some assurance that ethical and humane practices are being followed. Educational institutions and hospitals often adopt some or many NIH guidelines on ethical treatment of human subjects. Moreover, educational institutions and hospitals often either post their IRB practices on-line or make them available upon request.

While IRB approval cannot guarantee absolute patient safety (nothing can) during clinical trials, IRB approved trials are nonetheless far preferable to treatment in facilities that have undergone no independent review at all.

 

CCSVI Alliance link

There is a medically documented connection to central venous stenosis, CCSVI and MS.  And many around the world have received symptom relief and healing from treatment.  But there have been complications and issues.  It is wise to weigh all of this when considering treatment.  I wish everyone hope and healing, tempered with knowledge,

 

 

Joan