20100825

Tysabri pt2

So the tysabri infusion issue has been resolved, and I am receiving the infusion as I type this post. Woot! Such a load off mymind!

20100823

Pt.1 of tysabri issue resolved

I've had my physical today. Thanks to doctor Srodulski for getting me in so quickly. He is a king amongst doctors! Part of the physical was having a blood test done and I also needed one for Dr. Katsimakis (my neurologist), so I went to NCH's outpatient lab. Got my blood drawn, and man those ladies at that lab know how to stick people with needles. Graceful, quick and relatively pain free. So all that is done, and hopefully that will be situated by Wednesday in time for my Tysabri infusion. Go Natalizumab!

20100819

If the risk of PML isn't enogh

If you come down with PML,you also risk IRIS.

20100818

Bad news for the tysabri world

Biogen reported five more cases of 'Brain Infection', which I presume to be progressive multifocal leukoencephalopathy (PML). Those are the 1,000:1 odds I live with everyday to keep the MS at bay. Sigh.

20100817

Happy day

So I've had the problem with my treatment resolved. I'll be seeing my regular doctor Monday the 23rd [@ 8A : (] then I'll be having my infusion on Wednesday the 25th.

Its looking like a good day for oral MS treatments

From a NMSS newletter:

EMD Serono has announced that the U.S. Food and Drug Administration has accepted and given Priority Review to its application seeking approval to market cladribine as an oral disease-modifying therapy for relapsing forms of MS. A Priority Review means that the FDA will review the drug in less than the usual amount of time. This designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. The goal for completing a Priority Review is six months from when the application is submitted, meaning that the agency’s approval decision could happen in December 2010, but it might take longer.

In a large-scale phase 3 clinical trial, cladribine tablets significantly reduced relapse rates and other disease activity in people with relapsing-remitting MS. Read more about this study.

In November 2009, EMD Serono announced that it had received a “refuse to file” letter from the FDA for its original cladribine application submitted in late September, which usually means that the agency deems the application incomplete. On June 8, 2010, EMD Serono announced that it resubmitted its application to the FDA for approval of cladribine.

Another oral therapy for MS, fingolimod (Novartis International AG), is currently undergoing final review by the FDA after an FDA advisory committee recommended that it be approved. The agency’s approval decision for fingolimod is expected in September 2010.

20100805

Today was a first

Today was the first time I've ever missed a scheduled Tysabri infusion. Not because of my actions, but because the hospital told me two days before my next scheduled infusion that I need a physical before I can have the infusion. NCH obviously didn't care last month when I was also overdue for a physical. They didn't even tell me until two days before!!! Why can't you look the other way and make sure I get a physical before the next infusion? Its sad as can be when hospitals allow bureaucracy to trump patient care. Shame NCH!

20100803

Infusion Troubles

So the Ambulatory Infusion Center (AIC) called the house today to tell us that I need a physical before my next infusion...which is on Thursday (today is Tuesday). Perhaps they don't like me and just don't want me to show up? Shelby, who answered the phone, was very upset about this and gave the caller a piece of her mind, stating "you wouldn't make a cancer patient wait for their meds!" (Paraphrased, but she was very cordial). So Shelby called my doctors office and - guess what - my primary care doctor is on vacation for two weeks, never mind that physicals are scheduled three months in advance. So I'm up the creek waiting while Shelby tries to figure out what I'll do. Thanks AIC, your indifference towards my treatment (which costs $10K/mo.) is disconcerting. Thank you : (