TagEMA

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’...

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...

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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