Exercising caution over unproven therapies: India holds public consultation meetings to update stem cell guidelines
by David Kent
Last fall, I wrote on the Eurostemcell documentary film entitled Stem Cell Revolutions: A Vision of the Future, which featured some experimental stem cell treatments in India, and since that time, I have tried to keep my finger on the pulse of what has been happening in India with respect to stem cell therapy.
Last month a pair of interesting statements were made in the India Times:
“As of today there is no approved indication for stem cell therapy as part of routine medical practice, other than bone marrow transplantation.”
This was followed by:
“Hospitals in the city, however, have been making claims of using this therapy to treat several diseases like cancer, leukaemia, spinal cord injuries, cerebral palsy and immune deficiency diseases. Short of alternatives, patients do not mind loosening their purse strings to opt for this expensive therapy if there is hope of recovery.”
While very few would argue that trying out experimental therapies in a controlled manner is unworthy of pursuit, the attachment of high cost to such procedures that are often being borne by local and international patients makes this a wickedly contentious issue. In the face of such controversy and in the wake of bold moves such as the very recent halt that China has put on unapproved stem cell treatments, the Indian government this past month held its fifth and final public consultation on the ethics of stem cell therapy in an effort to update its guidelines to reflect how far its citizens are willing to test things and in what manner the country should move forward. Current guidelines can be found here and it is hoped that these consultations will inform strong evidence-based policy on future stem cell therapies.
However, such evidence does not accumulate on its own, but rather takes a huge amount of effort from trials coordinators, physicians and patients. Together, this underscores the critical importance of running well-controlled and well-regulated trials on stem cell therapies whose results can be shared across the world.
One positive step in the direction of better assessment of current therapies on offer has been from the scientific community. In particular, I am quite pleased that the International Society for Stem Cell Research created the web site A closer look at stem cell treatments in combination with its advocacy efforts for safe stem cell therapies. It shows a deep sense of responsibility and commitment from the expert scientists and clinician/scientists to help people navigate the very murky waters of stem cell therapy. Last year, Irving Weissman spoke about the website’s launch in San Francisco and, amongst many other things, pleaded with scientists to be responsible about which advisory boards they sat on and the ethical approvals that those treatments have put in place.
One thing that I have come to appreciate in my nearly ten years of stem cell biology training is that these cells are extremely potent but still very poorly understood. We have seen evidence of their clinical power in bone marrow transplantations and we are slowly unraveling the inner workings of even more primitive, and more potent, pluripotent stem cells, but we simply do not know that stem cells will behave in the manner we would predict after transplantation into patients. I liken this uncertainty to someone giving a farmer seeds to sow in their field that will give a very high yielding crop, without knowing what it would do to the soil or other plants around it. Would the field be viable in five years? Would other crops be destroyed? Would everything work out just as planned?
With every decision there is a risk and it behooves the scientific and medical communities to be prudent in their approach to stem cell therapy. It is this type of risk assessment that it seems the Indian government is trying to undertake in consultations with its citizenry and its academic and industrial communities. By understanding where people stand on the risks and potential benefits of stem cell therapies and presenting the best evidence possible to help them make that assessment, I suspect that India and other countries doing the same will be in a much better and safer situation in the future.