Shashank S Tiwari examines some of the ethical, social and regulatory issues linked to Direct To Consumer genetic tests in India.
A recent article in Nature highlighted the ways in which various Indian biotech companies are driving innovation with the support of the government and free-flowing venture capital. The article begins by describing how a young Indian entrepreneur founded a couple of biotech startups, and it highlights one of her, direct-to-consumer (DTC) genetic testing company. Unfortunately, the Nature article does not discuss whether innovation in biotechnology, and more specifically in DTC genetic tests, is responsible to society. This article, therefore, aims to analyze emerging ethical, social and regulatory issues linked to DTC genetic tests in India.
Emergence of DTC Genetic Tests
The business of DTC genetic testing is attributed to the Human Genome Project, a venture that officially began in 1990 with the aim of mapping the entire DNA sequence of the human genome. By 2003, the entire human genome sequence had been completed, paving the way for the emergence of the DTC genetic testing business. When the Human Genome Project was launched, it was promised that the knowledge of the genome sequence would help in understanding disease and human biology. To exploit this knowledge, three companies had launched their consumer genetic services in the USA by 2007– 23andMe, deCODEMe and Navigenics. In subsequent years, many additional companies have started to offer genomics services in the USA and in different parts of the world, including India.
In recent years, a significant number of DTC genetic testing companies have emerged in India. Some notable names include Mapmygenome, The GeneBox, DNA Labs India, Indian Biosciences, Positive Biosciences, Xcode and EasyDNA. These companies offer various genomics services to the public, which include personal genomics (drug response profiles, nutritional needs, predisposition) diagnostics (preconception screening), nutrigenomics (DNA based dietary plans), fitness, sports, paternity, ancestry and pharmacogenomics (the role of genetics in a patient’s reaction to drugs) tests. The general public can buy genetic test kits online through companies’ websites or through e-commerce companies such as Amazon with a cost around INR 3,000 to INR 1,20,000 depending on the nature of each test.
After submitting a DNA sample (saliva or cheek swab), consumers can receive results in a few days. Similar to the West, the proliferation of DTC genetic tests in India has raised many scientific, ethical, social, and regulatory issues such as clinical validity and utility, genetic determinism, and potential misuse of genomics data. Additionally, the marketing strategy of many companies has prompted further questions about the nature of scientific practice in India.
The Ethics of Marketing Strategy
In a time in which the Code of Medical Ethics Regulations and Advertising Acts is poorly implemented and enforced, and in the absence of any guidelines or regulations for DTC genetic tests, companies are free to make exaggerated claims about the benefits of their testing. They may also misrepresent their products to capitalize on the social and cultural beliefs of common people. For instance, a company, as a business strategy, has linked genomics with astrology to entice consumers to buy their tests. The company has even named one of its products Genomepatri, which sounds similar to Janampatri (birth chart) for this purpose. In a promotional message on YouTube, the CEO of the company emphasized the advantage of online genetic tests by highlighting the importance of astrology in human life. She said that the same way Janampatri helps people understand zodiac signs, planets and gotra etc. at the time of birth, genetic tests would help in understanding genetic makeup and genetic characteristics, including any mutations that may be present. Further, she elaborated that a person can enhance positive (genetic) traits through knowledge of genetic features coupled with lifestyle changes. According to her, these preventive measures are similar to astrology in which people do worship, perform yagna etc. to protect themselves from bad effects of the planets.
The above promotional message could be justified in the name of analogy. In communicating a complex scientific concept to a layperson, using analogy is a common practice. However, this particular analogy of astrology with respect to genomics might have far-reaching implications on the practice of science in India. It is worth highlighting that the Indian scientific community, by and large, consider astrology to be a pseudoscience, and any attempt to bring astrology onto scientific platforms has been strongly opposed. This analogy is potentially contrary to the concept of scientific temper as well.
Additionally, the publication of testimonials from eminent personalities on the websites of companies, also raises issues related to medical ethics. Sometimes, they contain statements by leading politicians, industrialists and other public figures of the country. Such testimonials have the potential to mislead the general public, as highly reputed and educated public personalities of the country seem to recommend the products. In addition to above important issues, there are also key scientific concerns with genetic tests that are especially relevant in India.
DTC genetic tests include options such as DNA-based dietary plans, fitness, sports, paternity, and ancestry, to name a few, and they are all non-diagnostic in nature. Moreover, these personal online tests cannot accurately diagnose the presence or absence of a disease; they mostly predict the probability of one. And, because these tests are offered directly to the general public without interacting with a doctor, there are greater chances that consumers may misinterpret the results. The situation is further complicated by the lack of sizable numbers of qualified genetic counselors and geneticists in India.
The lack of available, validated genetic data on the Indian population is another obvious problem with DTC genetic services and this issue has been reported in media coverage. This might be the reason why many Indian companies are using data generated from Caucasian populations as reference data for their tests.
The innovations in genomics need to be sensitive towards emerging ethical, social, scientific and regulatory issues. Unfortunately, at this time India has no guidelines or regulations for genomics medicine though the Indian Council of Medical Research is completely aware of the situation. Indian biomedical agencies and health professionals including scientists need to come forward to produce a regulatory framework to protect consumers from possible health risks and economic exploitation associated with DTC genetic tests.
Shashank S. Tiwari is a PhD in Science and Technology Studies from the University of Nottingham (UK) and is currently working as a Research Fellow at Canadian Institute for Genomics and Society, Toronto, ON, Canada.
The views and opinions expressed in this article are those of the author and do not necessarily reflect the official policy or position of either Confluence or the Indian Academy of Sciences.