Women's Brain Foundation hat dies direkt geteilt
Founder and pro bono CEO Women's Brain Foundation | MD|Neuroscientists| Board Member|Advisor| Women’s Health| Building and Accelerator
As a former regulator myself, a physician who worked for 7 years with dementia patients and a neuroscientist, I strongly disagree with the decision taken by the European Medicines Agency regarding the rejection for market authorization of #lecanemab. Patients in Europe will not be able to access treatment for #alzheimer as compared to patients in US, China, Japan, Israel, South Corea and Hong Kong. Where do we differ? They should explain it to us. EMA’s argument about small effect of the drug is not a valid one. If so, we shuould retract many other drugs approved for dementia and beyond. Their argument about safety is frankly absurd. “Although most cases of ARIA in the main study were not serious and did not involve symptoms, some patients had serious events, including large bleeds in the brain which required hospitalisation.” If we accept this argumentation than we should retract from the market all antipsychotics -which are mainly prescribed off label for dementia- as they can lead to malignant neuroleptic syndrome and many many more drugs … for which hospitalization is needed as well. This is a decision taken higly likely by colleagues who never worked in a ward for dementia and who are not familiar with latest scientific findings in neuroscience. We have enough measures to assess if a drug is effective and safe after market authorization. A PASS study post approval would have sufficed to clarify doubts. #AI analysis would have done the rest. Discriminating European patients is immoral. As a European citizen, I urge EMA to reconsider their position and allow people in Europe to access innovative solutions for a deadly disease where no treatment or hope exists and where current treatments are prescribed mainly off label and with risk for side effects more severe than ARIA. Eisai EMEA must appeal against this decision. ARIA alias brain swelling showed by MRI in some patients is -in fact- a prove that the drug works: it removes amyloid plaques. I suspect that the reasons for non approval is the lack of knowledge of #alzheimer pathogenesis and the fear that our health care systems are not ready to assorbe innovation as government lack of funds to implement the changes needed to prescribe this drug. Prescriber’s mindset resistant to absorbe innovation makes the rest.