Science is big business. Johnson & Johnson the pharmaceutical and cosmetics giant is worth trillions of pounds. Another, GlaxoSmithKline, owning brands from Panadol to Sensodyne toothpaste also worth trillions. Astellas Pharma, one of Japan’s major drug companies has recently made big news. They have bought out Ocata, a Massachusetts based company for £247million.
The company’s focus is regenerative medical treatments using human embryonic stem cells (ES). There is widespread controversy about their use, many of you will know and have a different opinion regarding how and when, if ever their use is justified. The very creation of therapeutic stem cells is central to the debate as it involves destruction of embryos. The debate is complex and multisided. Some argue that a life is created therefore termination is unjust. Whereas others feel that a life is formed at a later developmental stage and therapeutic value of these early pluripotent cells is too great not to utilize.
Ocata published promising results of a small scale study in the medical journal The Lanced, attracting world wide attention. The report provides data from four patients. Two with Stargardt’s macular degeneration, affecting vision in children and young adults and two with dry age-related macular degeneration, the leading cause of vision loss in people over the age of 50. The company developed a retinal cell line that one-year after implantation improved vision with no apparent safety issues. Implantation of stem cells can be dangerous as there is potential for adverse proliferation, tumorigenic behaviour and ectopic tissue formation.
However, this data is tentative. The company’s business history is plagued with political and economic set backs. In 2001 a media storm kicked off after the company claimed to have created the first cloned human embryo. Cloning experiments with human embroys are restricted to the private sector, limiting funding. Ocata claims that their products can avoid use of embryonic cells by using induced pluripotent cells (iPS). Discouragingly, this technique is in a turbulent infancy. The genetics of stem cells are not well understood, extensive experimentation with non-viral delivery of pluripotency genes needs to be developed and most scientists believe that embryonic stem cells cannot be replaced in basic research. A scandal in which unregistered shares were sold resulted in another economic setback to settle a civil law suit.
After changing its name and publishing promising results, coaxing ES cells into retinal cells, the company has taken on a more hopeful profile. Japan has a fast-track approval system for clinical trails allowing commercialization of this stem-cell treatment after less rigorous testing. In huge contrast to the US system where limited trials significantly hamper commercialisation. This only illustrates the disparity in policy surrounding science. How is it that in Japan, Ocata, the US born company may thrive due to fewer constraints? Why are there discrepancies in research protocol around the world which limit development, particularly in the medical field? Should there not be a standard procedure for medical trials that provides a unified standard of ethics and care?