TagEMA

Unaccountable

The European Union and its Institutions have been heavily criticised as part of the Brexit debate as been undemocratic and unaccountable to the man or woman on the street. However, it is only when their decisions impact on you, or your patients, that you realise that these critics have a valid point.  Last week the European Medicine Agency’s safety committee (PRAC or Pharmacovigilance Risk...

The Time-to-Think DMT

At an MS Masters Forum in Rome yesterday I was teaching MSologists and MS clinical nurse specialists using a recently created board game, which I like to think of as being MS Monopoly. MS monopoly is based on a game of chance that lets you discuss case scenarios and make treatment choices. Then you roll a dice, which determines the outcome of your choice.  Two things emerge from playing the game...

Hopebird

The debate about what is active and inactive secondary progressive MS will not be settled by the EMA adopting a positive opinion, recommending the granting of a marketing authorisation for siponimod, which is now ‘licensed’ for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease. Siponimod reduces disability progression in people with active...

The Phoenix

Like a phoenix rising from the ashes for the third or fourth time, alemtuzumab is given yet another life. I am sure many neurologists and people living with MS will be grateful, but I don’t agree with its positioning. EMA’s safety committee or PRAC has handcuffed alemtuzumab and is restricting it for adults with relapsing-remitting multiple sclerosis that is highly active despite adequate...

Conspiracy

A reader (see below) sent us the following letter from George Ebers to the EMA dated 9th September 2013. In the letter, George Ebers pulls no punches and makes several controversial claims about Industry, Academics, Journals, Universities, MS Charities and the MS Establishment. Is there a conspiracy theory or not? As it has been 6 years since the letter was sent to the EMA has George Ebers’...

Short- or long-sighted

I saw three patients 9-and-half-years after starting treatment with alemtuzumab as first-line therapy, yesterday. It was a remarkable experience. Only one of the three patients had needed a third cycle of alemtuzumab. All are in long-term remission; i.e. flat-lining on the EDSS, relapse-free and with no MRI activity (NEDA-3). Their EDSS scores yesterday were 1.0, 1.5 and 2.0. All of them are...

Reporting of side effects in RRMS trials

Most research is about investigating the known unknowns. In other words, investigators have a certain hypothesis, but also a range of plausable possibilities as outcomes. However, in some instances the outcome is unexpected – the unknown unknown. Rare side effects are an example of this, and not always evident in the initial randomized-placebo (dummy treatment) controlled clinical trials...

Hepatitis post-alemtuzumab

Another alemtuzumab-related post, this time in relation to alemtuzumab-associated liver injury, which has been also been included as a complication of alemtuzumab treatment in the EMA’s SmPC (summary of product characteristics). Liver or hepatic injury can occur as part of a drug-induced injury as seen in case 2 below or as a delayed, presumably autoimmune, condition as in case 1 below...

Alemtuzumab’s Article 20

Use of multiple sclerosis medicine Lemtrada restricted while EMA review is ongoing EMA has started a review of the multiple sclerosis medicine Lemtrada (alemtuzumab) following new reports of immune-mediated conditions (caused by the body’s defence system not working properly) and problems with the heart and blood vessels with the medicine, including fatal cases. As a temporary measure while the...

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