Monday, 27 July 2009

Brain-eating side effect noticed late

Extreme rationalists in medical science often lambast “quacks” for “preying” on those suffering from chronic incurable illness by offering untested alternative treatments. According to them we should listen to the “professionals” and use only approved drugs, otherwise we are asking for trouble and probably putting money in the pockets of pseudo-doctors.
Meanwhile UK medical professionals have been loudly criticising the body in charge of NHS drug approval, NICE, for only allowing a drug called rituximab to be given to rheumatoid arthritis (RA) patients as a last resort once joint damage has already occurred.
Following a favourable clinical trial, the hope-inducing headline on the BBC website was “Drug slows early stage arthritis”, and the chief executive of the National Rheumatoid Arthritis Society moaned that doctors were 'not allowed to use this (drug)...when patients would benefit the most'.
But in May this year there was another, less appealing, headline about rituximab on a press release direct from US medical experts:”Popular cancer drug linked to often fatal 'brain eating' virus”.
The viral brain infection known as PML is fast moving as it destroys the tissues, causes forgetfulness and moodswings before killing the person after just two months.
The discovery that at least 57 patients taking rituximab had conclusively died of PML in a decade was unearthed by an important international collaboration of physicians called RADAR which spots any possible dangers caused by drugs after they are licensed.
And this discovery is not a one-off scare. Rituximab is a relatively new type of drug called a monoclonal antibody which acts on the body's immune processes. So far two other monoclonal antibodies have also been taken off the US shelves for their association with the brain eating virus.
Rituximab is mostly used as a cancer drug for lymphoma patients but is also licensed in the US for RA. It is also used 'off label' by doctors for lupus, multiple sclerosis and auto-immune anaemia.
It is in these patients that the danger has become clearer since, in cancer patients, loss of brain function and death within months may not seem unexpected.
But now there are three known deaths of RA and lupus patients on rituximab who had suddenly developed depression or dementia symptoms caused by the virus eating away the brain.
Dr Bennett of RADAR comments that “it was especially unusual for patients with autoimmune anaemia-like illnesses who have not received a large number of other drugs”.
I feel extremely glad that an organisation like RADAR exists. Following RADAR's urgent investigations Dr Bennett found that physicians had been reluctant to report cases of the virus in patients taking rituximab because the forms for reporting adverse drug events involve “a lot of work”. So the cases had gone unnoticed for over a decade.
So why is the National Rheumatoid Arthritis Society pushing this drug towards people who are suffering from milder forms of RA, which is not fatal like cancer? As Dr Bennett says:”People have been lulled in to a false sense of security that this drug is harmless and that it only does good things. No drug is perfect.”
Could it be that doctors (reassured by official stamps of approval) have prescribed drugs that may accelerate fatal illness, rather than restore life? Surely not?

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