One of the biggest drivers for improving/messing up the University System has been the Research Asssessment Excersises, now called the REF (Research Excellence Framework). These done every 5-7years are supposed to be a mechanism to increase the standard of academics within the university system. In some cases this means bullying and sacking, as a transfer system has been created, where the underperforming are moved out of research into teaching or are culled to be replaced by people with better REF-friendly outputs. This has bloated the number of professors, who demand promotion and better resources and salaries to move… at the same time killing our pensions as now there is not enough money in the system to pay for retiring professors:-(.
E.g. The TV-astronomer Brian Cox was the cited reason of why more people study physics at University….amazing.
A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis.Giovannoni G, Comi G, Cook S, Rammohan K, Rieckmann P, Soelberg Sørensen P, Vermersch P, Chang P, Hamlett A, Musch B, Greenberg SJ; CLARITY Study Group.N Engl J Med. 2010 Feb 4;362(5):416-26.
Pakpoor J, Disanto G, Altmann DR, Pavitt S, Turner BP, Marta M, Juliusson G, Baker D, Chataway J, Schmierer K.No evidence for higher risk of cancer in patients with multiple sclerosis taking cladribine.Neurol Neuroimmunol Neuroinflamm. 2015 Oct 1;2(6):e158.
However it has to be approved by the EMA first and it has to be resubmitted
Today Merck has resubmitted oral cladribine back to the EMA
Merck Receives European Medicines Agency Acceptance for Review of Marketing Authorization Application for Cladribine Tablets
Based on the CHMP review of data on quality, safety and efficacy, the CHMP re-examined its initial opinion and in its final opinion concluded by majority decision that the risk-benefit balance of Movectro in the treatment of highly active relapsing-remitting multiple sclerosis for the following adult patient groups:
- Patients with high disease activity, defined by two or more disabling relapses in the previous year, and one or more T1 gadolinium enhancing lesions or at least 9 T2 hyperintense lesions.
- Patients who despite treatment with disease modifying drugs for at least one year have persistent disease activity, defined by one or more relapses in the previous year while on therapy, and one or more T1 gadolinium enhancing lesions or at least 9 T2 hyperintense lesions.
was unfavourable and that the application did not satisfy the criteria for authorisation and recommended the refusal of the granting of the conditional marketing authorisation.
The grounds for the decision are as follows:
- Serious safety concerns remain, in particular with regard to the higher number of malignancies observed in clinical trials. Therefore serious concerns remain on the long term safety.
- Efficacy data in the restricted population with high disease activity or persistent disease activity despite treatment with disease modifying drugs are not robust enough to outweigh the safety concerns. Therefore the Risk-Benefit balance is not considered to be favourable.
- The lower end of dose efficacy curve has not been sufficiently evaluated. In view of the serious safety concerns, whether a lower dose with a better Risk-Benefit balance exists should have been established.
The following criteria needed for granting a conditional marketing authorisation have not been met:
- The Risk-Benefit balance of the product is positive;
- Fulfilment of unmet medical need has not been sufficiently demonstrated;
- Consequently, the benefit to public health of the immediate availability on the market of the medicinal product concerned does not outweigh the risks inherent in the fact that additional data are still required.
