Polish Academy of Science (PAN) posted notice on their website with regard to publishing ‘Challenges and potential in regenerative medicine’ a joint report by EASAC (European Academies Science Advisory Council), formed by the national science academies of the EU Member States (including PAN) and FEAM (Federation of European Academies of Medicine). The document includes guidelines and warnings against commercial use of some experimental therapies based on the incomplete data available.
EASAC and FEAM joint report warns against choosing shortcuts and offering any ‘miracle drug’ – states prof. Józef Dulak (Jagiellonian University), member of PAN Biotechnology Committee and adds: ‘Time has come for decisive actions for the good of patients, to protect them from expensive and potentially harmful illusions.’
Experts believe that consent for commercial use of some experimental therapies is granted prematurely and based on incomplete data. The pressure from biotechnological companies, competing on the global market, is to blame for the situation.
The enthusiasm regarding regenerative medicine caused serious discord between expectations and realistic capabilities of clinical practice. For that reason Science Academies call on the European Union to protect health regulations, thus safeguarding patients.
‘The results of scientific research are more important today than ever before. EU and Member States regulatory bodies should take all necessary measures not to let public trust toward science be undermined’ – believes the coauthor of the report professor Giulio Cossu form the University of Manchester.
Report recommendations:
It is vital to promote good biomedical science — from fundamental research to its translation to clinical trials.
Proportionate and consistent regulatory authorization for marketing must be based on robust and replicable science.
Researchers must follow professional guidelines on responsible research and its translation, and standard-setting, in pursuit of good practice.
Teaching on regenerative medicine should be part of the medical curriculum.
Patients’ interests must be put first. It is necessary to ensure a robust scientific basis for the clinical intervention and for the endpoints selected for measurement. A crucial criterion for patients, in deciding whether to consent to novel therapies, is that they, at least in Europe, should not be expected to pay clinical research costs.
Engaging with the public and patients and countering misinformation. Providing reliable sources of information.
Source and reports are available on PAN website.
PAN Biotechnology Committee, currently chaired by prof. dr hab. Ewa Łojkowska, Head of Laboratory of Plant Protection and Biotechnology of the Intercollegiate Faculty of Biotechnology of UG and GUMed, for years has been warning against unproven cell therapies. More information is available at the Committee’s website.