SC's ban on stem cell therapy in autism called unethical and dangerous (file photo)
Digital Desk, New Delhi. The Supreme Court has given an important and far-reaching decision regarding the treatment of Autism Spectrum Disorder (ASD). The court has clearly said that stem cell therapy cannot be used as a treatment for autism unless it is part of an approved and monitored clinical trial.
This decision is very important for those families who resort to therapies without scientific evidence in the hope of cure. The Supreme Court said that offering stem cell therapy as a routine treatment for autism is unethical and would amount to medical negligence. The court accepted that there is no strong scientific evidence that this therapy is safe and effective.
Where can stem cells be used?
Justice Pardiwala said that stem cells can be used only in approved, controlled and monitored clinical trials whose purpose should be scientific research and not treatment.
The court also made it clear that just because stem cells have been included in the definition of a drug in the Drugs and Cosmetics Act 1940, it does not mean that it can be used as a treatment for any disease.
The Supreme Court also said that there should not be sudden injustice to the patients who are already taking stem cell therapy. But, this treatment cannot proceed in a routine manner. The court directed the National Medical Commission (NMC), AIIMS and the Ministry of Health (MoHFW) to include such patients in approved clinical trials, so that their safety is maintained and treatment does not continue in an unethical manner.
The court said that the consent of the patient or family member is valid only when it is given on the basis of correct, reliable and scientific information. When there is no concrete evidence regarding the effectiveness of stem cell therapy in autism, patients cannot take an informed decision.
The Court held that it is wrong and unethical to give hope to emotionally distressed families for treatment without any evidence. This decision is in accordance with the guidelines of WHO and International Society for Stem Cell Research (ISSCR).
The Supreme Court reiterated that if a doctor provides a treatment that has already been rejected by scientific institutions, it is a violation of standard medical care. In such cases, doctors can be held liable for medical negligence. Treatment should always be in accordance with accepted medical knowledge and professional standards available at the time.
According to ICMR, stem cell therapy in autism is still at the experimental stage and there is not enough evidence to use it as a treatment. National guidelines clearly say that this therapy should be limited to clinical trials only.
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