Wednesday, May 30, 2012

Dr. McGuckin (Vascular Access Centers) dropping out of Multi-Center Registry

Citing concerns about the FDA warning, Dr. McGuckin has notified the Hubbard Foundation that VAC is dropping out, and will no longer be enrolling patients.  We understand that many of you who were treated through VAC may have concerns regarding follow up data collection and treatment. We do not have any answers regarding this as of yet, but this is a concern of ours as well. As we know more, we will keep you updated.

Surprise FDA Inspection May 29, 2012

FDA Site Visit

May 29th, 2012, the FDA made a surprise visit to one of our Multi-Center Registry sites. They asked to see all of our documentation and will be returning again May 30th, 2012. They provided no information on the reason for the visit or why that site was chosen first but did say that they would be doing inspections “all over the country”. The FDA did not shut down the site and as we have posted before we have already applied to the FDA for an exemption. Although the FDA’s primary intent is to prevent “advertising non approved uses for stents and balloons” it is unclear, so far, whether they also will stop research on CCSVI.

The Hubbard Foundation intends to continue to collect data on adverse events and changes in symptoms related to venoplasty (and ,hopefully, soon in relation to dietary and supplement interventions). An analysis of our first 259 patients has been accepted for publication and our multicenter Registry has collected data on over 400 people so far. We can’t see why the FDA would not want this data to be collected but we’ll keep you posted.

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.