Successful action against illegal cell therapies
Stem cell and other cell therapies are associated with great hopes, both among physicians and patients. Great progress is expected, especially in the treatment of difficult-to-treat and chronic diseases. For this very reason, however, it is absolutely necessary for the authorities to keep a close eye on this new field of medicine. This is to ensure that hope is not turned into a mere "business with hope" by unscrupulous providers and their hunt for a quick buck, and ultimately into an unfulfilled promise with disappointed expectations for patients. The Federal Bureau of Safety in Health Care (BASG) Enforcement is currently enjoying great success in combating illegal incidents related to "experimental" cell therapies .
The smooth cooperation with the Federal Criminal Police Office, international drug authorities, the Austrian customs and the Vienna Municipality has now led to the first legally binding criminal conviction against an Austrian physician. Together with foreign colleagues, he had offered a "treatment concept" in which unapproved, dubious cell preparations were administered. The "therapies" applied there have a dubious, at best experimental status. No meaningful clinical data was available on the safety or efficacy of the preparations in question. The preparations were manufactured in unlicensed, uncontrolled laboratories abroad. Consequently, necessary and valid standards, which are supposed to serve patient safety, were grossly disregarded and not complied with. Moreover, the patients had to pay the considerable costs of these untested treatments out of their own pockets.
For some time now, stem cells and cell therapies have been the focus of medical science. A large number of worldwide studies are being conducted to find out for which diseases such cells can be used to cure or alleviate. Cell preparations, such as stem cells, are systematically tested under recognized standards within the framework of officially approved clinical trials. Thus, every patient who is willing to participate in a clinical trial can be guaranteed, on the one hand, the proper production of the administered preparations and, on the other hand, a highly supervised follow-up. The scientific findings obtained in this way serve to further develop the efficacy and safety of new therapeutic approaches.
However, an essential criterion of clinical trials is also that the treatment must be free of charge for the patients. In addition, these studies must always be approved by the authorities to prevent patients from being exposed to unnecessary risk and to ensure that the treatment concept is scientifically/therapeutically meaningful, plausible and ethical. Neither was present in said case, and patients were therefore recklessly exposed to uncontrolled, unnecessary, and unapproved risk.
In addition to the case described above, there are currently more and more suspicious reports, not only in Austria but worldwide, according to which an increasing number of desperate, seriously ill patients are being promised a dubious "cure" with the help of novel cell therapies in exchange for payment of high amounts. These are all purely experimental treatments that are used without the appropriate authorization. In addition, it is not proven to what extent these cells in question have been manipulated, and the manufacturing quality of the preparations used is also mostly unclear and inadequate. The effect that these cells have in the body has not been sufficiently investigated. Under these conditions, neither patient safety nor successful treatment can be guaranteed.
The Federal Office for Safety in Health Care warns both physicians and patients against such risky, unapproved and uncontrolled interventions.
Queries (technical): Dr. Christoph Baumgärtel, Tel.: 050555/36004 E-mail: christoph.baumgaertel@ages.at Queries (for media): Communications Management, Tel.: 050555/25000 E-mail: presse@ages.at
