Thursday, September 12, 2013

September FDA Update

We had expected to receive a response from the FDA the day after Labor Day but did not. David called  the FDA on September 3rd and spoke to one of the reviewers who was very friendly. She said we were down to minor issues and sent the document to us.  This latest deficiency notice focused on the frequency of adverse events noted in the literature and, once again, said they recommended but do not require a sham control group. Once again, we explained that patients had to pay for this treatment themselves and were certainly not going to pay for a sham treatment.  David called the agency again to ask why they keep asking the same question each month and the reviewer he spoke to said they understood that we couldn't provide a control arm but "we're required by congress" to mention study design considerations in all correspondence.

Of course a double blind placebo controlled trial  is the only way to prove once and for all if venoplasty helps MS patients but this is a very difficult and expensive study to do.  We sympathize with Dr Siskin that he had difficulty recruiting subjects who might only get a sham procedure.

 Our philosophy with the Registry is to continue collecting data and improving venoplasty technique under the auspices of the FDA to keep up the momentum until such a double blind placebo controlled study can be done.

Here is a very brief summary of where we stand with the FDA:

 It's not funded, patients or their insurance must pay for the procedure.  There are ultrasounds before and at 1 week and 1, 6 and 12 months.  The FDA is also allowing only one brand of stent under clearly constrained circumstances, and requiring that patients have an EDSS score before and at 12 months.  Otherwise it's pretty straightforward quality-of-life and adverse event form completions.  Approximately 100 people have expressed interest in participating and a group of very experienced interventional radiologists around the country are waiting to begin ( we're not posting their names yet until they have a chance to review the final FDA requirements).

1 comment:

  1. This is wonderful news that you are seeing the light at the end of the tunnel. As a patient, I wanted my data to count so CCSVI finally gets into mainstream medical practice.

    Thank you for your perseverance and for keeping us informed.

    Sandra Birrell
    National CCSVI Society