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A fine initiative

The recent announcement of a public-private partnership by three Europe-based pharmaceutical companies and the British government 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 banked.” Testing investigational drugs in animals during preclinical studies can help in under standing the toxicity of drugs only to a certain extent. 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 drug safety 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. Unlike cell type screens that are now used, liver cells derived from embryonic stem cells are readily available with limited variability. They will also survive for longer periods of time without losing their characteristics. The public-private partnership recently announced could, in due course, look at heart cells for drug safety assessment.

The collaboration will provide the much-needed fillip to stem cell research, which is still in its infancy, and to drug safety assessment. While much research is being directed at using adult stem cells for treating several diseases, similar efforts for using human embryonic stem cells are lacking. Pharmaceutical companies have been shying away from embryonic stem cell research, which is embroiled in ethical controversies. It is commendable that Britain, open to embryonic stem cell research, has been able to draw the pharmaceutical companies out of their shell and show that scientific development cannot be blocked by irrational considerations. While the three pharmaceutical companies currently involved are from Europe, more companies, from Europe and elsewhere, are expected to join the venture. It should not come as a surprise if United States-based companies that have been dogged by the Bush administration’s obscurantist strictures on embryonic stem cell research come in at some stage. It is time the U.S. administration realised that holding on to a ‘pro-life’ stand and refusing to expand federal funding to newly derived embryonic stem cell lines will be a disservice to the American people and to humanity.

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