Dr Dan Vasella, Chairman of the Board of Directors, Novartis

Letter Sent: 

http://dl.dropbox.com/u/66292082/GILENYA%20SAFETY%20-%20Open%20letter%20to%20Dr%20Daniel%20Vasella%20FINAL%20AS%20SENT.pdf

Summary:

After investigating 15 deaths the European Medicines Agency (EMA) is under the impression that Novartis amended the Gilenya product labeling to state that GILENYA SHOULD NOT BE USED IN PATIENTS WITH A HISTORY OF CEREBROVASCULAR DISEASE.

However, following discussions with the FDA, Novartis chose to ignore the EMA reference to ‘cerebrovascular disease’ (and thereby any obvious links to the venous pathology of MS).  There is a disingenuous reference to 'stroke' which neurologists are using to tell patients means only arterial strokes are of concern.  Neurologists are ignoring the myriad of vascular conditions being found in people with MS, such as CCSVI, and may be unaware of the EMA contraindication for cerebrovascular disease.

The UK Department of Health has confirmed that clinical trial data in relation to patients with MS and CCSVI has not been studied and the drug is not specifically licensed for use in patients with CCSVI.    

The UK Department of Health is leaving it up to individual doctors to decide whether Gilenya is a safe treatment.  

Sadly neurologists are wilfully ignorant of overwhelming in vivo evidence demonstrating MS specific post-mortem findings underlying the venous pathology of MS, let alone the crucial importance of CCSVI in this context. 

http://www.ms-info.net/ms_040504.pdf 

Doctors’ professional standing and livelihoods depend on a medical system shaped and dictated to by risk takers in the business world like Dr Dan Vasella.   

How many of us will be sacrificed on the altar of Novartis’ share price rather than be investigated and treated for the venous conditions we actually have?