In October 2010, a report was published entitled “International Medical Tourism From the Netherlands for Gene Therapy”. The goal of this study was to identify the scope of patients from the Netherlands who travel abroad for treatment with experimental or registered gene therapy products, and to investigate the nature of the treatments products.
Gendicine and Oncorine
China’s first approved gene therapy was Gendicine, produced by Shenzhen SiBiono GeneTech in 2003. It is an adenovirus vector carrying the p53 tumour-suppressor gene. An number of Chinese hospitals offer cancer treatments with Gendicine (see video 1 and 2). The treatment is very expensive, and seems to work also for many other tumor types.
In 2005, a second gene therapy product was registered that was developed by Sunway Biotech for treatment of head-and-neck nasopharyngal squamous cell carcinoma. This product, Oncorine (H101), is an oncolytic adenovirus that targets selectively cells that under-express the tumour suppressor protein p53. For more information see section "China and Gene therapy".
However, these registrations have been questioned by a number of experts and specialist in the field. Patients must be warned that the treatments are experimental at best and that Chinese hospitals are cashing in on desperate patients. The registration of these gene therapeutic medicines to treat head and neck cancer followed a fast track at the Chinese State Food and Drug Administration (SFDA), where safety was considered more important than efficacy. The SFDA is the Chinese counterpart of the US FDA. Approval seems to be given on the basis of tumour shrinkage, rather than extension of patient lifetime. There has been quite some concern from gene therapy researchers elsewhere in the world as to the quality of the trials performed and thereby the safety and efficacy of the treatment (Edelstein, 2007). So far, there has been no official statement from a Society for Gene Therapy on concerns related to gene therapy tourism.
Video 1: China's Cancer Drug (YouTube, 7:05)
Video 2: Terminal cancer Cure using Chinas Drug Gendicine (YouTube, 7:04)
In 2008, the International Society for Stem Cell Research issued a press release (“International committee recommends stringent guidelines for translating stem cell therapies from the lab bench to the bedside”) on their concerns on stem cell tourism. The draft guidelines also urge authorities to “prevent exploitation of vulnerable patients” in countries where practitioners are offering and charging patients for stem cell therapies outside an established clinical trial. The number of patients travelling to China for stem cell treatment has been estimated at 2000 (Regulations Are Needed for Stem Cell Tourism: Insights From China").
Finally, be aware that Gene Therapy Net is not intended to replace or constitute the giving of medical treatments or advice. Gene Therapy Net will not answer any questions related to treatments, medical advice or participation in clinical trials.