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Concern over withdrawn MS drug
[Posted: Tue 01/03/2005 www.irishhealth.com]
By Deborah Condon
A multiple sclerosis drug, which received fast-track approval by the American Food and Drug Administration (FDA) last year, has been withdrawn from sale following the death of a patient.
While the drug, Tysabri, is not licensed in the European Union, up to 20 Irish people may have received it. The MS Society of Ireland is advising these people to contact their neurologist immediately.
However the society has insisted that 'the vast majority of the approximate 6,000 MS patients in Ireland have nothing to fear' from the FDA's announcement.
A spokesperson for the Irish Medicines Board (IMB) told irishhhealth.com that because the drug is not licensed for use in Ireland, the number of potential Irish users is not known to them. However it is 'monitoring the situation'.
According to a statement from the FDA, Tysabri received 'accelerated approval' in November 2004. It described the drug as 'an innovative treatment that represents a new approach to treating patients with relapsing forms of MS'.
However it made the decision to suspend sales of the drug after it received a report from the manufacturer that one person had died and one other person had possibly developed PML (progressive multifocal leukoencephalopathy). This is a serious disorder of the nervous system. Symptoms include mental deterioration, vision loss and paralysis. There is no cure or effective treatment for PML and death usually occurs within four months of onset.
"Although the relationship between Tysabri and PML is not known at this time, because of the serious and often fatal nature of PML, the FDA concurred with the company that the drug be voluntarily withdrawn from marketing and that the use of Tysabri in clinical trials be suspended until more is known", the FDA said.
The patient who died was one of 3,000 patients taking part in a clinical trial of the drug in the USA. The FDA estimates that a further 5,000 patients have received the drug there through their family doctor, however it emphasised that because it was just recently approved, these patients have only received 'at the most a few doses of Tysabri'.
The MS Society has said that the established MS treatments available in Ireland, such as Rebif and Avonex, are not affected by this news and patients should continue to take their medication as normal.
"Tysabri represented a great hope for MS patients in Ireland. Whilst this news is disappointing, we should all wait for further news. It is likely that several months of further testing will now be required to confirm if Tysabri can return to the market", the society said.
It added that in the clinical trials, some of the people taking part were taking a combination of Tysabri and another drug, Avonex.
"It may be the case that the combination of these drugs causes the problems. Perhaps Tysabri alone will still be an affective drug in the treatment of MS."
|John(johnwilliams) Posted: 01/03/2005 20:51|
|Did you ever see such a media frenzy about a medicine before? It wouldn't by any chance have something to do with the value of shares on the stock market? This points up a number of anomalies. Firstly, it shows the massive profits made by the huge pharmaceutical companies when one drug, not even on the market in Europe, can have such a dramatic effect on its profits. Secondly, it shows where the priorites of the pharmaceutical companies lie. Instead of notifying neurologists so that they could start the process of changing their patients to other medicines, the first people to hear about it were the stock exchange traders.|
|Anonymous Posted: 03/03/2005 09:47|
|A sad refelection on the priorities of Big Pharma.|
|Elaine(ElaineDunne) Posted: 03/03/2005 18:53|
|The suspension of the MS Drug and its consequences seem to be related to the Drug Companies and the Shareholders. What about the people with Multiple Sclerosis who were waiting for the drug to be approved? How come so many insiders in Biogen were able to cash their shares in before the news broke about the suspension of the drug, and how come this drug - the trials for which were supsended in Ireland - were then given the fast track and given accelerated approval. The best we can do (those of us with Multiple Sclerosis, and those that are living with it) is to get on with life. It seems to be all about money and profit, not the patient and the care they deserve. What about L.D.N. - which only costs in the region of €480 annually, and has been approved for so many other ailments and illnesses - why is this not being tested for M.S., and many people with Multiple Sclerosis are finding it beneficial......down to money or in the case the lack of it! To other people with Multiple Sclerosis I say....keep your chin up, and stay as well and as positive as possible..|
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