Stem cell therapy for autism outside approved clinical trial is medical malpractice: Supreme Court

"Therefore, if a medical practitioner, in blatant disregard of such authoritative guidelines choose to offer stem cell therapies for ASD, as a clinical service, outside of an approved clinical trial, then such medical practitioner would be considered as having failed to act in accordance with reasonable standard of care," held the top court bench comprising Justice JB Pardiwala and Justice R Mahadevan.

The bench concluded that since therapeutic use of stem cells in ASD is not recognised as ‘a sound and relevant medical practice’ as per the knowledge available at present, "the medical practitioners who offer the same as a clinical service, outside of an approved and monitored research/clinical trial, fail to meet the reasonable standard of care owed by them towards their patients."

"Hence, until there is further research which establishes this as a sound and relevant medical practice, stem cell ‘therapies’ for ASD cannot be offered by medical practitioners as a clinical service, outside an approved and monitored clinical trial/research setting," held the bench.

The Apex Court made these observations while considering a public interest litigation (PIL) raising concerns over the widespread promotion and administration of stem cell therapies by ASD by clinics across the country, even though there is no proven clinical efficacy and regulatory approval available for this. Further, the PIL alleged that such therapies were being carried out even though SCT remains at an experimental stage for this condition.

It was argued by the petitioners that the individuals diagnosed with ASD and their caregivers were being induced to undergo costly and unproven procedures, often in the hope of a cure, without there being any safeguards available for this in regulated clinical trials. It was also submitted that such therapies were being administered in violation of the existing regulatory framework under the Drugs and Cosmetics Act, 1940, the New Drugs and Clinical Trial Rules, 2019, and the National Guidelines for Stem Cell Research, 2017.

During the pending case proceedings, multiple regulatory and institutional developments took place, including recommendations by the Ethics and Medical Registration Board (EMRB) of the National Medical Commission (NMC), publications by the Indian Council of Medical Research (ICMR), and decisions by the Ministry of Health and Family Welfare. These documents were also placed before the top court bench.

While considering the matter, the Supreme Court bench examined the settled principles governing medical negligence and the standard of care, including precedents such as Indian Medical Association v. V.P.Shantha, Jacob Mathew v. State of Punjab, Kusum Sharma v. Batra Hospital, and M.A. Biviji v. Sunita. 

Referring to these case proceedings, the top court bench reiterated that a doctor’s conduct must conform to a "practice acceptable to the medical profession of that day" when "judged in the light of the knowledge available at the time of the incident".

"The jurisprudence makes it clear that if an intervention is characterised by the relevant scientific community or regulatory authorities, as unproven, experimental, obsolete, or lacking justification, such an intervention cannot be defended as exercise of due care and reasonable judgment by a medical practitioner," the bench noted at this outset.

"We have already concluded that since therapeutic use of stem cells in ASD is not recognised as ‘a sound and relevant medical practice’ on the basis of present scientific knowledge, medical practitioners who offer the same as a clinical service, outside an approved and monitored research/clinical service, fail to meet the reasonable standard of care owed by them towards their patients," it concluded.

During the proceedings, the Supreme Court bench also examined the National Guidelines for Stem Cell Research, 2017, and the Evidence-Based Status of Stem Cell Therapy for Human Diseases, 2021, published by the ICMR and the Department of Health Research.

Referring to these, the court noted that these documents consistently indicated that stem cell therapy for ASD lacks sufficient scientific evidence and it is not recommended as standard or routine treatment.

Further, the bench observed that the scientific literature reflects wide variation in stem cell types and routes of administration in experimental settings, underscoring the absence of uniform, validated clinical protocols.

The Apex Court also relied on the recommendations dated 06.12.2022 issued by the Ethics and Medical Registration Board of the National Medical Commission, which, after reviewing available scientific evidence, had concluded that there is insufficient and inadequate scientific evidence on the efficacy of stem cell therapy in ASD, and that Stem cell therapy is not recommended as a treatment for ASD in clinical practice. These recommendations were later approved by NMC.

"A perusal of the EMRB-NMC Recommendations dated 06.12.2022, read with the EBSSCT, 2021, the NGSCR, 2017 and the National Ethical Guidelines respectively, formulated by the ICMR indicates that the therapeutic use of stem cells for treatment of ASD is not recommended as routine clinical treatment. These documents indicate that the therapeutic use of stem cells for the treatment of ASD is not recognized as a sound and relevant medical practice due to the lack of scientific support and empirical evidence regarding its efficacy. It is categorically mentioned therein that any stem cell use in patients must only be done within the purview of an approved and monitored clinical trial with the intent to advance science and medicine, and not offering it as therapy. Therefore, every use of stem cells in patients outside an approved clinical trial is unethical and shall be considered as malpractice. Therefore, medical practitioners who offer such stem cell therapy as a routine clinical service and not in a research/clinical trial setting, could be said to be failing to meet the reasonable “standard of care” owed by them towards the patients as expounded by this Court in M.A. Biviji (supra) and V.P. Shantha (supra)," the bench observed at this outset.

However, while holding that stem cell therapies for ASD cannot be offered as routine clinical services, the Supreme Court also clarified that this does not preclude research in approved and monitored clinical trial settings. It also added experimental treatments may only be administered within regulated clinical trials, subject to ethical approvals and statutory safeguards.

While answering the question of whether patients can exercise autonomy in stating that they would still like to choose a particular treatment and give consent for the same, the Apex Court clarified that this treatment can't be demanded as a matter of right by the patient because there is no adequate information about it.

"As regards the question whether patient autonomy enables a person to give consent to an unproven treatment, we are of the considered view that a treatment cannot be demanded by a patient as a matter of right. This Court’s dictum in Samira Kohli (supra) underscores that adequate information as regards a particular treatment, is the bedrock and the consent thereto should be on the basis of such adequate information. It is undisputed that stem cell therapy for treatment of ASD does not fulfil the essentials of ‘adequate information’. The validity of consent stems from the nature and information available about the treatment. In the absence of such knowledge, the patients may remain under therapeutic misconception and anticipate such results from an unproven treatment as may be expected from routine treatment and care. Following through with the medical treatment even when patients are under such misconception is, in our view, a gross violation of medical ethics. Therefore, even though the patient may have voluntarily opted for such procedure, yet, such choice does not amount to a valid consent to undergo the treatment due to the lack of ‘adequate information’ to form its basis. Having said so, we clarify that one would still have the liberty to participate in an approved and regulated research/clinical trial involving stem cell therapy for ASD," it held.

While the bench too cognisance of the profound difficulties faced by the individuals diagnosed with ASD and their caregivers which often drive them to explore experimental or unproven interventions in the hope that even partial symptomatic relief may be achieved, it also concluded, "We respect the choice of the parents/guardians, however, it remains to be seen whether the individuals or their parents/guardians/caregivers can demand a right to choose a medical intervention merely because they claim to have consented to undergo such therapies on the basis of an informed understanding of its risk-benefit analysis. Therefore, we find it apposite to address ourselves on what is a valid consent for the purpose of undergoing a medical treatment."

To view the order, click on the link below:

https://medicaldialogues.in/pdf_upload/supreme-court-stem-cell-therapy-324835.pdf

Also Read: NMC slams Stem Cell Therapy for treating Autism Spectrum Disorder, declares it as Professional Misconduct