PATIENTS WITH multiple sclerosis (MS) who are taking the drug Tysabri are not being properly monitored for serious side effects because of health service budgetary cutbacks, a leading neurologist has warned.
Following the announcement yesterday of two new cases of progressive multifocal leukoencephalopathy (PML), a known Tysabri side-effect, by the manufacturer, Biogen, Dr Orla Hardiman, consultant neurologist at Beaumont Hospital, Dublin said she was not surprised at the finding. "This shows the surveillance [for side-effects] has worked."
However, Dr Hardiman said she is concerned that not all MS patients in the Republic who are taking Tysabri are being adequately monitored for serious side-effects such as PML.
"Tysabri is a good drug as long as you monitor people adequately. The difficulty is that this is not happening in Ireland. In the absence of a comprehensive approach by the HSE [Health Service Executive] to the issue of additional costs involved in monitoring patients taking Tysabri, patients are at risk."
The MS expert said that patients taking Tysabri, which is given intravenously, must have an MRI (brain) scan performed every six months as well as a comprehensive clinical examination by a consultant neurologist or a clinical nurse specialist. "The recent recruitment restrictions [in the health service] have affected our ability to carry out these checks. The risk of Tysabri rises when the surveillance is not done, so this is a wake-up call for MS patients in the Republic," Dr Hardiman told The Irish Times.
PML is a potentially fatal disease of the central nervous system. The rare condition was first noticed in a small number of patients taking Tysabri in 2005, leading to its withdrawal from the market.
The drug was reintroduced by both the Food and Drug Administration in the US and the European Medicines Agency on condition that a series of safety checks, aimed at picking up PML at an early stage, were offered to patients.
MS Ireland, the patient advocacy group, said in a statement: "We advise all members to continue with their treatment, but to always be vigilant for any changes in their health."
In a statement to the Irish Stock Exchange, the pharmaceutical company Elan confirmed that two new cases of Tysabri-related PML had been identified in the EU.
One patient had been taking the drug for 17 months, while the second was prescribed Tysabri for 14 months. Sources have confirmed that neither patient was being treated in the Republic, where between 100 and 150 people are receiving the MS drug.
Tysabri has been shown to reduce the progression of disability in MS by 42 per cent over a two-year period. In certain patients with a relapsing form of MS, treatment with the drug has succeeded in stopping further relapse.
Elan shares lost half their value in Dublin yesterday on the news of the new PML cases.