Howdy folks!

I just woke up and I am happy to be done with work for the week! I have Saturay night off too! My DSD is having her Senior Recital that night and it is also her birthday, and I am looking forward to both!

I had a FULL box of emails today, and a full box on the answering machine, with several calls from people at Biogen. I'll let you all know what they have to say when I call them back tomorrow.

WE ARE having an effect. One of the calls was from someone high up in the company whom I haven't heard from since 2006, after the FDA hearing.

Here's what I have for new information. This information is from a trusted source who was inolved in bringing Tysabri back to market.

"The EMEA says that four (4) of the confirmed 24 PML cases have died. My contact has been quite clear that the early three cases (pre-2006) are not included in the 24 cases, but I hold out hope that the two early deaths account for half of the four reported deaths (US patient whose family declined to follow the recommended PML treatment protocol, and the recent death of the German patient reported by his wife on the German patient website). I am seeking confirmation that the four deaths are indeed all post-2006, and will update as soon as I know more. We do know that a few of the PML patients were in serious condition, so additional deaths cannot be ruled out.
-- EMEA contact does not have information concerning the relative severity of the PML patients who have survived to date. We know that some are in stable and reasonably good condition, along the lines of a severe MS relapse, but others are more serious.

-- EMEA contact reports that all 24 patients had received between 12 and 74 infusions, that 18 of the 24 cases were reported in patients who had received at least 24 infusions, and that although the data are limited, there appears to be a trend for more cases of PML to be reported with longer duration of treatment.

-- EMEA contact reports that one of the concerns of the Committee for Medicinal Products for Human Use has been to increase awareness by healthcare professionals on how to differentiate PML from a relapse of MS and the management of PML cases, and that improved awareness is of course a factor in identifying potential PML cases that can be better evaluated. This suggests to me that EMEA action will likely be limited to updated labeling, improved educational efforts among neurologist and other healthcare professionals, and possibly a TOUCH-like program that could limit the use of Tysabri in inappropriate patients.

-- I am told that as of Friday, October 23, BIIB was aware of only one recent death (I assume the recent German male patient). That means either there were two more recent deaths, that EMEA is counting the two pre-2006 deaths in its total of four, or that someone has their facts wrong.

-- I am told that BIIB believes that they need to develop a profile on a subset of patients that is more subject to PML and that the larger number of PML cases, although unfortunate, can help this effort. No surprise there.

-- BIIB is doing conference calls and visits with the largest Tysabri prescribers this week and next week to disseminate as much information as possible. There may be more information that leaks out over the next couple of days, or we may already know much of what BIIB and the EMEA are disseminating.

I have not yet gotten any breakdown, but I am sure that BIIB will be asked about that in the two conference calls with neurologists that are taking place this evening (5:00 pm and 8:00 pm ET). "

It sounds like there is still some confusion in the numbers, but the majority of patients is coming from the EU.

The EU, especially Germany, is having problems with their doctors prescribing Tysabri to patients who were on methotrexate, azathioprine, etc and not giving enough time for clearance of previous treatments. Hopefully they will get a program similar to TOUCH in place over there or improve their monitoring of patients for early PML symptoms, and learn the subtle differences between PML infection and MS relapses! Most prescribing docs here in the USA are now saying that any activity that even resembles a relapse means an automatic halt to Tysabri, MRI, urine, blood and CSF testing, monitoring, and further treatment, including PLEX and mefloquine if there is even a hint that it might be PML.

The assay developed by Ted Yednock has been sent to a commercial company for testing which will lead to production. As with everything medical, it will have to be approved by the FDA, but I think maybe there might be a fast track on this and we will hear a lot more about it sooner rather than later.

For Linda: The number of 1:400 came from Biogen. I don't have the link in front of me, but perhaps someone here still has it at hand. I will search my files and send it when I find it. My files are all jumbled from the last few weeks as you can imagine and I have to sort and prioritize them!