Quoted from http://online.wsj.com/article/SB10001424052748703415804575023493628662602.html.html
Monthly Updates Set for MS Drug
JANUARY 25, 2010
Biogen Idec Inc. will communicate with doctors once a month on the occurrence of new cases of a rare brain infection in patients using its multiple sclerosis treatment Tysabri, as the biotech firm strives to find the right balance in keeping the medical and financial communities updated on that number.
The situation is closely watched because Tysabri, a treatment sold with Elan Corp., was previously pulled from the market because of its association with progressive multifocal leukoencephalopathy, or PML, a debilitating and often fatal condition. The infection rate has hurt the sales growth of the drug, which is key to Biogen's future and is Elan's biggest seller.
Since its re-emergence in 2008, Biogen and regulators have struggled with how to provide information on PML because case-by-case updates of a specific side effect are unprecedented. Last summer, the Cambridge, Mass., company stopped providing updates altogether.
As of mid-January, the number of cases stands at 31, which puts the overall incidence rate at about 1-in-1,000 patients, as implied by the drug's label.
Tysabri had more than $1 billion in 2009 sales, but its controversial history has provoked fear in investors and confusion about the disclosure of new cases hasn't helped.
Under the new plan, Biogen will update physicians midmonth and provide information through a password-protected Web site.
It will include the number of PML cases, with an incidence rate broken down by duration of use, as well as a cumulative patient exposure figure, which is different then the quarterly patient count provided to investors.
Investors can get the same information from investor relations, although the company won't be posting it on a public Web site or making an announcement.
Patient services will provide Tysabri users with information upon request, although not with the level of detail given to physicians, or even to investors.
The reason for the disparity between how doctors and patients are updated is because of regulations that restrict direct interactions between patients and drug companies, because those communications could be deemed as promotional activities and thus need to be cleared with regulators.