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Patients successfully lobbied the Italian government to allow an unproven stem cell therapy in public hospitals, overriding the Italian regulators.
Professor Charles ffrench-Constant, Director of the University of Edinburgh’s MRC Centre for Regenerative Medicine, said:
“These unproven and ill-prepared stem cell therapies, for which there is no scientific basis, will do nothing for patients and their families except make them poorer. For a European country that is home to some of the world’s finest and most rigorous stem cell biologists to approve such an approach sends a confused and counterproductive message to the world community.”
Professor Austin Smith, Director of the Wellcome Trust-Medical Research Council Cambridge Stem Cell Institute, said:
“This situation highlights the need for proper understanding of the scientific process and especially of the requirement for evidence. If politicians, doctors or patient organisations ignore the facts, they may unwittingly become party to exploitation of the most vulnerable members of society by approving meaningless ‘treatments’.”
Professor Steve Dunnett, Co-director of the Brain Repair group in the School of Biosciences, University of Cardiff, said:
“Many novel and unproven stem cell therapies involve significant risk and very high cost while offering no detectable benefit for desperate patients and their families threatened with life changing illnesses. As a scientist it is natural to be cautious. However our government has a responsibility to protect all citizens from unsubstantiated marketing of therapies of no demonstrated value, and has a particular duty to protect vulnerable patients from being conned out of their savings for treatments that have no realistic hope of benefit, undemonstrated safety and potential significant risk. European law, directions and regulation provide a well-established framework for determining the safety and efficacy of new treatments, including lowering the bar for novel treatments for orphan or life threatening diseases. However, when companies such as this latest example rely on personal claims of benefit, but withhold access to any scientific assessment, and never publish their results on mechanisms, safety or efficacy in the properly reviewed scientific literature according to widely accepted scientific criteria, then our starting position has to be that the marketing is a scam to which the correct response should indeed be to refuse a licence, and certainly not pay for a spurious ‘treatment’ out of the public purse. The decision of the Italian minister to ride roughshod over existing European licencing criteria, which have been establish for very sound reasons both of health and safety and of protecting patients from blatant fraud, set a dangerous precedent, perpetuating false hopes but with considerable potential to cause real harm and distress for no actual benefit.”
Professor Roger Barker, Professor of Clinical Neuroscience at the University of Cambridge, said:
“The use of unproven stem cells therapies for patients with incurable neurological diseases causes concerns at two levels. One is the exploitation of desperate patients and families seeking cures for diseases that sadly do not have one at the moment.
“The other is that a complication or death with this type of therapy would run the risk of essentially bringing to a stop all stem cell therapies for neurological disorders and this would include some of the more promising therapies that have a strong scientific rationale for working in patients with certain types of disorders such as Parkinson’s disease.”
Professor Michele De Luca, Centre for Regenerative Medicine at the University of Modena, Italy, said:
“Not only is there no evidence that mesenchymal stromal cells (the cells used by Stamina Foundation) can cure all those diseases, there is no rationale for this and no evidence that these procedures are not dangerous for patients. The way things are being authorized is simply illegal. These decisions conflict with European and Italian regulations and laws on advanced therapies and clinical trials. This creates a dangerous precedent. Anyone could avoid using evidence-based medicine procedures and regulations by doing what the Stamina Foundation has done – using the media and patients’ hopes to exert pressure. And English, German, French and other patients could start a sort of medical tourism and ask Stamina to provide them with such unproven therapies.”