Wednesday, May 30, 2012

Letter to the FDA dated May 16th, 2012

Letter to the FDA dated May 16th, 2012

"In response to the FDA warning about CCSVI posted on the internet last week, I've attached our IRB-approved Multi-Center Registry and informed consent, and request that you review it for a pre-IDE and advise me as the sponsor on corrective action if appropriate.  I have also attached our analysis of 259 patients that has been accepted for publication by a peer-reviewed medical journal.  Although not a double-blind placebo-controlled study, we obtained MR venography and fMRI BOLD data that advances the science of underlying pathophysiology and diagnosis of venous insufficiency, had no serious adverse events and found statistically significant clinical improvement using the Multiple Sclerosis Impact Scale (MSIS-29).  This study was performed at one site in San Diego, was approved by a local hospital IRB, has been completed and is no longer enrolling.  Our on-going Multi-center Registry was approved by a national IRB, currently has 7 P.I.'s around the country, and has enrolled approximately 365 patients with symptoms of CCSVI, most but not all of whom have multiple sclerosis. You will note that the protocol does not allow recruitment or advertising as the use of venoplasty for neurological disease is not currently FDA approved.  The protocol calls for completion of the Short-Form 36 quality of life questionnaire before and at 1, 6 and 12 months following venoplasty.  The rationale for this Registry is that patients who choose to undergo this procedure should have a repository for collection of their adverse events and changes in their subjective symptoms, and that such a registry will assist in the design of blinded and placebo-controlled studies going forward.

David Hubbard MD" (Hubbard Foundation, May 16, 2012)

In response to this letter, the FDA assigned the Hubbard Foundation a pre-IDE document control number on May 17th, 2012. 

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