Saturday, June 29, 2013
As most of you know we have been negotiating with the FDA since their warning letter in May 2012 to get their approval to continue our Registry which had already enrolled over 400 MS patients receiving venoplasty. In their most recent request for revisions they have asked that we add EDSS scores before and one year after the treatment. We agree that this is an additional burden and that EDSS scores are incomplete and inaccurate. However, we have no choice and, at least ,in the United States these neurology evaluations should be covered by insurance. We are aware that most insurance is presently not covering the venoplasty itself and patients will have to pay for this themselves. We have approximately 6 IRs that have been waiting to begin doing the procedure again when we get approval. They are listed on our web site where you can also let us know if you might be planning to participate. www.hubbardfoundation.org/participating-irs
Wednesday, June 26, 2013
This week's Neurology Today published a story on PML in patients taking dimethyl fumarate. There have been a total of 4 patients in Europe. Each of the patients had severe and prolonged lymphocytopenia - low lymphocyte counts in their blood. All of them recovered after being taken off fumarates. Severe lympocytopenia occurs in 3% of patients taking fumarates. One of the patients had also been treated with methotrexate, another with steroids. Robert Fox MD interviewed for this story thought that either infection or a significantly altered immune system might be the culprit rather than the fumarate itself. The cause of lymphocytopenia is not yet known, especially since the mechanism of action of fumarates is suppression of oxidative stress, not immunosuppression per se.
Dr Hubbard has been communicating with David Perlmutter,MD http://www.DrPerlmutter.com/ regarding the dosage of Nrf2 activators with those with neurodegenerative disease. Dr. Hubbard is concerned that only one or two tablets per day of the supplemental forms of fumarate derivatives is too low a dose for MS patients.Both Drs Hubbard and Perlmutter are suggesting patients push the dose to three or four tablets per day, or even to the point of getting some flushing or nausea (common with Tecfidera) and then backing off a until they feel better and that would be the working dose.
Dr Perlmutter also suggested that instead of increasing the Nrf2 activator (Protandim or Xymogen Nrf2 activator) patients may add more Turmeric and Sulforaphane along with the product.
When you are making any changes to your medications or supplements you should always consult with your trusted medical professional.