Details are coming in slowly but surely regarding the fourth suspected case involving Tysabri and the brain infection called PML...
- Brian McGlynn, a spokesman for Elan, said it was "absolute speculation" to conclude that a fourth person had the infection. Elan and Biogen are co-developers of Tysabri
- Mr. McGlynn said the patient had NOT participated in the Tysari clinical trials-- as the other three confirmed PML patients had done. That means this patient could have received only 3 or 4 doses of Tysabri, at maximum, given the drug was introduced at the end of November 2004 and pulled just months later.
- The report made to the FDA is light on details. It lists more than 20 symptoms and conditions of the patient, including PML, without stating how the diagnoses were made. This paucity in detail seems strange given the seriousness of the matter...
- The patient had been taking Tysabri (the question of when her last dose was is not answered), Avonex, and "two other multiple sclerosis drugs" (unnamed)
- The FDA received the report on April 18th.
- Elan CEO Kelly Martin commented last week that he was very confident Tysabri would return to market
- Mr. McGlynn said that at the time, Mr. Martin "knew that there was an unconfirmed report and it continues to be unconfirmed-- Nothing has happened to make us no longer stand behind the statements he made."
Our thoughts: 20 separate symptoms and conditions, very light detail on how PML diagnosis was made (it usually requires a spinal tap and MRI), no confirmation of PML diagnosis, multiple MS therapies in combination, very few doses of Tysabri, and a unanimous 'ho-hum' from Biogen and Elan make us think this event may pan out to be a whole lot of nothing, but we will certainly await further information with baited breath.
Biogen will also hold an investor's conference call tomorrow that would almost certainly address this issue at some point.
Clicking "read more" will provide the link to the excellent New York Times article that summarizes much of this information, as well as the Biogen conference call details.
Further Reading
4th Patient on MS drug may have brain infection (Free Registration Required)
Biogen Conference Call
Conference Call link (live at 10am EST, recorded thereafter)
