Scientists have called on the European Union to protect biomedical sciences from false claims – amid commercial attempts to exploit stem cell and genetic treatments.
The European Academies of Science (EASAC) and Medicine (FEAM) have urged caution that while there is broad potential of regenerative medicine applications with biomedical science, there is a gap between expectations and the realities of translating regenerative medicine technologies into clinical practice.
This has resulted in some regulators becoming increasingly permissive, they warn.
Professor Volker ter Meulen, co-chair of the EASAC-FEAM working group and past president of EASAC, said: “Stem cell and gene-based therapies hold great medical promises. But we are alarmed over a trend to lower requirements of evidence. Also, we see an increasing problem of commercial clinics offering unregulated products and services.”
The report’s key recommendations include: the need to promote good biomedical science with a commitment to well-planned, first-in-human trials with reliable, shared and objective end points; ensuring researchers follow professional guidelines on responsible research; include the teaching of regenerative medicine in the medical curriculum; and putting patients’ interests first.
Professor Giulio Cossu of the University of Manchester said with the market for regenerative medicine expected to grow fast over the next years, it is natural that there are high hopes both from desperate patients and the biotech industry.
“As a result, regulators are pressured to accelerate authorisation procedures for stem cell and gene-based therapies. This trend puts patients at risk,” he said.
“We are now at the threshold of being able to correct major genetic and other diseases. But for many diseases, more evidence is needed, especially for the more complex polygenic and acquired degenerative disorders. The consequences of not addressing the critical scientific issues for evidence-based implementation would be to waste investment, research efforts and aspirations to cure.”
The Academies say the idea of regenerative medicine is to tackle diseases, which, up to now, are incurable, while cosmetic applications are inappropriate for the time being.
“So far, regenerative medicine has proven itself only in few specific clinical indications, for example for skin disorders,” explained EASAC Biosciences Programme Director Dr Robin Fears.
“Yet, we see an increasing number of unregulated clinics promising a wide range of benefits on the basis of poorly characterised medicinal products with little evidence of effectiveness. They usually advertise their services via the internet with the primary intention of financial profit.”
The scientists therefore urge the EU to resist the pressure and put patients first. “When countries lower regulatory standards in their eagerness to support national economic interests, it is even more important for the EU as a major global player to defend the principles of international cooperation in health regulation”, says Prof. George Griffin, Co-chair of the Working Group and President of FEAM.
“We all want cures to be available in the shortest time frame possible. But our analysis and recommendations aim at ensuring that regulatory procedures are robust, transparent and evidence-based,” concludes Cossu. “Scientific research and proof are more important than ever. The EU and national regulators should be wary of not undermining public trust in science.”
EASAC-FEAM Report: https://easac.eu/publications/details/challenges-and-potential-in-regenerative-medicine/
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