Published in The Hindu on October 24, 2007
The recent announcement of a public-private partnership by three Europe-based pharmaceutical companies and the British government, the first of its kind, for using human embryonic stem cells to assess the safety of investigational drugs gives a boost to stem cell research and clinical trials. The partnership will use only “ethically sourced stem cell lines already banked, or registered to be naked.” Testing investigational drugs in animals during preclinical studies can help in understanding the toxicity of drugs only to a certain extent. That mice lie and monkeys do not always tell the truth are well known facts making it mandatory to conduct clinical trials on humans. The primary objective of undertaking trials on humans is to ascertain the safety of the investigational drugs. The high cost involved in conducting human trials combined with the high failure rates of drugs at this stage of drug development makes it desirable to have a reliable way of assessing the safety of drugs in laboratories. Though unexpected liver toxicity is the single most reason for drug failure during trials, the in vitro system currently used to test for liver toxicity has several shortcomings. The liver cells derived from embryonic stem cells, unlike the currently used cell type screens, are readily available with limited variability, and will survive for longer periods of time without losing their characteristics. The partnership will, in due course, look at heart cells for drug safety assessment.
The collaboration will provide a much needed fillip to stem cell research, still in its infancy, and drug safety assessment. While much research is being directed at using adult stem cells for treating many diseases, similar efforts with human embryonic stem cells are lacking. Pharmaceutical companies have been shying away from embryonic stem cell research as it has been embroiled in ethical controversies. It is commendable that Britain, which has been open to embryonic stem cell research, has been able to draw the pharmaceutical companies out of their shell. It has shown that scientific development cannot be dictated by religious sentiments. While all the three collaborating companies are from Europe, more companies, from Europe and elsewhere, are expected to join the venture. It should not come as a surprise if U.S.-based companies, now hampered by the Bush administration’s strictures on embryonic stem cell research, become partners in the novel initiative. It is time the U.S. administration realised that holding on to a pro-life stand and not expanding federal funding to newly derived embryonic stem cell lines will not be in the country’s interests and will be a big disservice to science and humanity.