- Shloka Jain
Unproven and unsupported therapeutic uses of stem cells have become a worldwide issue and are likely to be resistant to regulatory efforts. There has been a surge of the proliferation of clinics offering unproven therapies which have led to confusion in the public as to what treatments are legitimate, what are the regulations and how can patients know whether a particular stem cell treatment is proven or not. According to the Ministry of Health and Family Welfare, there are about 59 stem cell clinics in India but according to Indian Council of Medical Research (ICMR), almost 500 odd clinics are providing unproven stem cell therapies.[1]
Introduction
Stem Cell Therapy is a procedure of regenerative medicine and non-invasive treatment that replaces damaged cells with undifferentiated and unspecialised stem cells, which further differentiates into specialised cells thereby repairing damaged or diseased tissues in the inflamed area of the body. These cells are special as they can grow into other cell types, allowing it to carry out specific functions depending upon what the body needs at a particular time. For example, a stem cell could become a nerve cell, a red blood cell or a muscle cell. Stem Cell Therapy stands promising when it comes to improving human health, which requires basic and translational research and also a clear understanding of scientific, ethical, legal/regulatory and social standards.
There are several regulatory bodies associated with stem cell research, therapy and treatment in India including, Department of Biotechnology (DBT), Indian Council of Medical Research (ICMR), Medical Council of India (MCI) & State Medical Councils, National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT), Central Drugs Standard Control Organisation (CDSCO), Advertising Standards Council of India (ASCI) and Directorate General of Health Services (DGHS) and relevant state authorities.
The DBT and ICMR jointly formulated a document called “Guidelines for Stem Cell Research” which was later in 2013 changed to “National Guidelines for Stem Cell Research.” In 2017, the guidelines were revised to be in sync with the latest rules and regulations and also to integrate technical and biological advances in the country.[2]
According to these guidelines, “only hematopoietic stem cell transplantation (HSCT) for haematological disorders like blood-forming i.e. hematopoietic stem cells from bone marrow (Bone Marrow Transplantation) and umbilical cord blood is used to treat blood cancers and different blood disorders, and presently other indications of stem cell research stand investigational.” If an unproven stem cell therapy is given to a patient outside a monitored and an approved clinical trial, it will be considered as medical malpractice. The guidelines also provide for definitions and permissible, restrictive and prohibited research practices inter alia.
Deceptive Advertising Claims Regarding Stem Cell Therapy
These guidelines also provide for stringent regulations for misleading and fraudulent advertisements. Advertisements tend to misleadingly attract patients by providing exaggerated claims regarding the benefits of stem cell therapies, and market them as cures for various diseases or conditions without any scientific evidence or regulatory approval. Many private clinics advertise and sell untested and unproven therapies to patients when it has clearly been stated in Chapter 6 of Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 that soliciting of patients directly or indirectly by medical practitioners through advertising or publicity is unethical.[3] Also, Schedule J of Drugs and Cosmetics Act, 1940 and the Drugs and Magical Remedies (The Objectionable Advertisements) Act, 1954 prohibits misleading advertisements and on violation be punished with 6 to 12 months of imprisonment or fine or both.[4] The ASCI reports can be used as a basis by other regulatory bodies to take action against misleading advertisements. Unfortunately, NAC-SCRT, CDSCO and other medical regulatory bodies, have not been able to fully regulate these guidelines, which creates a grey area for taking action against violators. However, in 2019, Tech giant Google took a welcoming step by announcing that it will no longer be publishing ads for unproven or experimental medical therapies i.e. most stem cell therapy, cellular (non-stem cell) therapy and gene therapy because of a rise in clinics advertising and selling unapproved treatments which can lead to dangerous health outcomes. These unproven treatments are endangering patients by preying on the fears and anxieties of those seriously ill. It has decided to only publish ads of those treatments that are tested in regulated and monitored clinical trials.[5]
Stem Cell Tourism
Many stem cell clinics make purporting claims that they can treat ALS, Parkinson’s disease, multiple sclerosis, asthma, etc; which clearly shows that they are not marketing the approved stem cell-related guidelines and because of these claims, patients suffering from deadly diseases travel abroad to such clinics and hospitals that may potentially not be accredited and regulated. This is a case of stem cell tourism.[6] These unproven treatments have had adverse outcomes in the United States causing blindness and tumour growth.[7]
Conclusion
There is an enormous amount of medical and financial risk involved when patients take these unproven treatments which also causes spiritual distress. So, it is important for patients to be informed about the limited number of stem-cell-based therapies which have been proven to be effective and routinely practiced and also the risks, benefits and rationale for those limited number of therapies must be communicated to patients beforehand.
There is a need for a regulation that puts limitations on the ability of stem cell clinics to insert clauses like non-disclosure, non-disparagement, or mandatory arbitration. The patients should be provided with a recourse to file a suit if they are harmed or if they are victims of fraud. If there is a case of medical malpractice or negligence, the patient can file a case under Section 304-A of Indian Penal Code, 1860 and can also visit the consumer forum for protection of his/her interests as a patient (consumer) from fraudulent medical services, specifically those services provided by private stem cell clinics. The field of stem cell research and therapy must be under active review and statutory guidelines for maintenance and implementation of a Code of Practice must be formulated.
Commercial clinics promote their stem cell services as a ‘panacea’ when instead, the therapies for serious conditions require sophisticated solutions. Since there is a fear of stifling innovation at a national level by regulating this field too heavily, clinical stem cell research should thus be explicitly subject to evidentiary and procedural requirements that are set out in advance, so the therapeutic treatment is conducted according to recognised ethical and scientific standards. The creation of a robust social contract in the field of healthcare and law is imperative, so that involvement in research and innovation in regenerative medicine, specifically stem cell research, is substantiated by treatments widely accessible to all.
References
FDA, 2019. Federal Court Issues Decision Holding That US Stem Cell Clinics and Owner Adulterated and Misbranded Stem Cell Products in Violation of The Law.
Google, 2019. A New Policy on Advertising for Speculative and Experimental Medical Treatments.
Indian Council of Medical Research and Department of Biotechnology, 2017. National Guidelines for Stem Cell Research. New Delhi: Division of Publication and Information.
Malathy, I., 2017. Read these new rules before going in for a `stem cell cure'. Times of India,.
Medical Council of India, 2002. Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002. New Delhi.
Mummery, C., 2014. Stem Cells. 2nd ed. Netherlands: Elsevier Inc., pp.291-314.
The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. 7.
Shloka Jain is a fourth year student at Pravin Gandhi College of Law, Mumbai.
[1] Malathy, I., 2017. Read these new rules before going in for a `stem cell cure'. Times of India. [2] Indian Council of Medical Research and Department of Biotechnology, 2017. National Guidelines for Stem Cell Research. New Delhi: Division of Publication and Information. [3] Medical Council of India, 2002. Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002. New Delhi. [4] The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. 7. [5] Google, 2019. A New Policy on Advertising for Speculative and Experimental Medical Treatments. [6] Mummery, C., 2014. Stem Cells. 2nd ed. Netherlands: Elsevier Inc., pp.291-314. [7] FDA, 2019. Federal Court Issues Decision Holding That US Stem Cell Clinics and Owner Adulterated and Misbranded Stem Cell Products in Violation of The Law.