Ok, here's what I have so far. Please remember that this is the internet and the information has been gleaned on the net and I cannot verify the facts, since Biogen is giving us nothing, but I know the person who reported this personally and consider them a trusted source.
The number confirmed is now 24, with a new case coming in over the weekend, according to a person who spoke with the FDA today. The FDA confirmed that this number is the number of cases since Tysabri was returned to market in the EU in 2006. It sounds like most of the new cases are in the EU, but reports are coming out that two or three are in the US in large MS clinics. Reporter also says one patient is home after a week of rehab and in her case so far she is not much worse than she was before PML.
The person who reported this conversation with the FDA spokesman today also reports that Biogen medical liasons(not salespeople) will be meeting with neurologists in the larger prescribers to update them. I am thinking that this means all prescribers will be getting a visit or a call if they are in more rural areas like my neuro is. I think most prescribers know the benefit of Tysabri and are not scared about the new numbers. They have the expertise and the testing in place to monitor patients closely and the patients in the US are under TOUCH and seem to be more vigilant and aware of what to watch for and report to their neurologist when they suspect something.
At least one of the patients developed PML two months after starting a drug holiday. It is thought that the chance of PML decreases with drug holidays but the chance of disability progression and damage due to relapses increases when you are off any drugs to treat MS, so it's a tradeoff that each person has to assess for themselves with the information they find. You also stand a chance of developing antibodies and having a lesser rate of efficacy when you restart therapy with Tysabri after drug holiday, and that is a concern for many patients. Lauren Roberts made a good point in which she reminds us to read page 6 of the Tysabri label that comes with every vial (and you should ask for it at every infusion! I get the empty vial, the box and the contents so I can track numbers and dates):
"Experience with monoclonal antibodies, including TYSABRI, suggests that patients who receive therapeutic monoclonal antibodies after an extended period without treatment may be at higher risk of hypersensitivity reactions than patients who received regularly scheduled treatment. Given that patients with persistent antibodies to TYSABRI experience reduced efficacy, and that hypersensitivity reactions are more common in such patients, consideration should be given to testing for the presence of antibodies in patients who wish to recommence therapy following a dose interruption. Following a period of dose interruption, patients testing negative for antibodies prior to re-dosing have a risk of antibody development with re-treatment that is similar to TYSABRI naïve patients"...
I am still on the side of no drug holiday. I trust my doctor and he trusts me to be vigilant. For me, the chance of further disability that I KNOW will occur if I am not on Tysabri outweighs the fear of PML at this point and so far after 31 infusions, I am doing VERY well. I am not saying I won't change my mind, but I need information when it comes up, not when Biogen decides that I need it, and that is why I am hounding Biogen to update US! I'm not afraid to skip a dose and remove some $$ from Biogen's pocket if that is what it takes to get some information, since I have already missed an infusion back in February and had no adverse effects.
I'm also keeping in mind that the competing drug companies have already fed false and misleading information to reporters since Tysabri was first introduced to market, and again when it was returned to market, (including reporting that the fourth PML patient from the trials died and that person heard the news while she was out shopping!) and I am being very careful to ensure that what I am posting comes from reliable sources, most of who were involved with fighting for this drug to be returned to market.
I'll let you know when I get anything further. The buzz on this is all OVER the net in the EU right now, but my French is high school level, my German is even worse, my other languages consist of "where's the bathroom" and "one beer please" and translating takes a LONG time even with available translators on the net!
Another thing to keep in mind is that as a whole, we know more than the hirelings manning the phones at Biogen patient support services. They are only allowed to say what the company and the FDA say they can say, which is why I suggest moving further up the food chain over there. I enjoyed enlightening my person while I was convincing her that I wasn't going to shut up or go away...
