Natalizumabers at risk of PML are anxious

The NHS has gone mad, it is now playing Russian Roulette with the lives of MSers. #MSBlog #MSResearch

Epub: van Rossum et al. Safety, anxiety and natalizumab continuation in JC virus-seropositive MS patients. Mult Scler. 2013 Jul 4.

Background: The use of natalizumab in MS has been restricted by the risk of progressive multifocal leukoencephalopathy (PML). JC virus carriership, duration of natalizumab treatment and past immunosuppression are known risk factors. This has allowed for calculated risk assessment for individual MSers to be implemented. Not much data are available about the effect of JCV carriership on patient willingness to continue natalizumab. 

Objective & Methods: These investigators evaluated the impact of JCV seropositivity on safety feelings, anxiety and treatment continuation for MSers treated with natalizumab, using a visual analog scale, the Hospital Anxiety and Depression Scale and a decisional conflict scale. 

Results: Seropositivity led to an elevated anxiety level for PML (p = 0.004). However, so far only 3% of patients have discontinued natalizumab because of JCV positivity in our cohort.

Conclusion: Knowing you are at risk of a PML leads to anxiety.

"I assume you all know what anxiety is? Anxiety is a pathological feeling of worry. It manifests as intrusive thoughts that prevent you from functioning normally. Often these thoughts prevent you from sleeping and frequently wake you up in the early hours of the morning with a knot in your stomach and a tight chest. Anxiety can trigger panic attacks. Anxiety is usually linked to depression and most MSers with anxiety have a low mood."

"I have several MSers under my care who are at high risk of PML and have severe anxiety as a result. These MSers are continuously over interpreting new MS-related symptoms as being due to the possible onset of PML. This is very unpleasant, particularly as we are not allowed to de-escalate or switch them from natalizumab to fingolimod in England unless they have failed interferon-beta in the past. In other words if someone has gone onto natalizumab as a first-line drug or from glatiramer acetate, NHS England will not allow us to switch them fingolimod. Their stance is that there is not enough data to justify this switch, i.e. NICE did not cover this group of MSers in their assessment of fingolimod."

"NHS England doesn't realise that there is now ample evidence that switching MSers from natalizumab to fingolimod is safe and effective and is the norm in most countries where clinicians still have responsibility for looking after the MSers in their care. In NHS England the bureaucrats now decide who and who doesn't get treatment. What they don't realise that if one of these high-risk MSers gets PML that they have a 20% chance of dying and a high likelihood of severe disability from PML. NHS England are therefore putting themselves at risk of a medicolegal challenge, in other words they will have to justify their position in a court of law if one of  these MSers sues them."

"I am also not prepared to take responsibility for leaving these MSers on natalizumab if they have expressed a wish to switch. I have suggested in writing that NHS England should take responsibility and that someone in NHS England offices who makes the individual decision to reject an individual funding request or IFR needs to see the MSers concerned, i.e. face-to-face, and explain to them why they can't switch and then write in their medical notes. So far I have yet to hear from NHS England if they would be willing to do this. Why should I take responsibility for a decision that I didn't make? Why should I support a policy from NICE and NHS England that puts MSers under my care at risk? What this shows is that if you are a person living in the UK it is actually the NHS who looks after you and not an individual clinician, i.e. you are patient of big brother. We need to do something about this."

"Although I encourage MSer power, I don't have neurology power. How are we going to drive through the 'early and effective' paradigm if we can't get this sorted? The NHS is deliberately trying to wear us all down."

"It is not a case of if we get a case of natalizumab-associated PML as a result of the current NHS England policy, but when we get a case. What will NHS England do? Blame the neurologist for not stopping natalizumab? In other words we the neurologist should have prevented them from getting PML, by stopping natalizumab and  exposing them to the risk of their MS? NHS England is fully aware of the MS rebound that occurs when natalizumab is withdrawn and that there has been deaths as a result of it. No wonder MSers in England who are JCV+ve and at high-risk of PML, but cannot switch to fingolimod are anxious and depressed. Wouldn't you be?"

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