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Gene card to tell what drugs to avoid by GS Mudur
Scientists have launched a project to develop India’s first personal genetic data cards — credit card-sized plastic-and-magnetic devices that could dramatically expand access to personalised predictive medicine.

In its first phase, the project will capture genetic data to predict a person’s likely response to more than 100 drugs to help him avoid taking medicines that may not benefit him or may cause him serious side-effects.

Scientists also hope to use genetic data to generate probabilistic forecasts of individuals’ susceptibility to a range of diseases — from select cancers to single-gene disorders, from diabetes or heart disease to certain neuro-psychiatric disorders.

A person may get a card by offering a blood or saliva sample that scientists will use to develop a genetic profile. It costs about Rs 15,000 to make the card in the laboratory.

Doctors will be able to scan the card with a mobile phone and access gene-related data stored on a distant computer. But senior science administrators caution that India will need to establish rules for confidentiality and security of genetic data before public release of such cards.

“We’re asking ourselves, ‘Is our society ready for what genome science can offer?’” said Samir Brahmachari, director-general of the Council of Scientific and Industrial Research (CSIR) and the third person to acquire a prototype card after two project scientists.

Genetic testing for disease susceptibility has long sparked concerns about employers or insurance agencies procuring such data in countries where testing is available.

“We’re also concerned about how individuals might use sensitive data,” a project scientist said.

The Indian Council of Medical Research is working with the biotechnology department to develop guidelines for confidentiality of genetic data. This is in progress but is yet to be embedded in law, biotechnology secretary Maharaj Kishan Bhan said.

The project, initiated by researchers at the CSIR’s Institute for Genomics and Integrative Biology (IGIB), New Delhi, stemmed from their study of how gene variations can tell whether a person will or will not respond to a common drug prescribed for asthma — salbutamol.

Since the salbutamol-gene link was discovered about a decade ago, scientists worldwide have established correlations between people’s genetic makeup and their likely response to several other medicines, from antibiotics to anti-cancer drugs.

Research has also revealed associations between gene variations and a large number of diseases. “Genetic susceptibility may be strong or weak,” said Rajiv Sarin, director of the Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Mumbai.

Genetic susceptibility predictions are strong in some forms of breast cancer, ovarian cancer and intestinal cancer, said Sarin, who is not associated with the IGIB project.

The ACTREC itself offers free genetic testing for breast and ovarian cancers. Sarin estimates that among the 100,000 new cases of breast or ovarian cancers in India each year, at least 5,000 would be hereditary and that each of these patients’ families would benefit from genetic testing.

Project scientists at the IGIB said they were trying to determine what bits of genetic information would benefit patients in India the most and to find ways of storing the information in a secure format.

The scientists say that predictions of susceptibility to disorders such as diabetes or heart disease, or to the risk of developing cancer after tobacco use, would have low reliability because such conditions involve multiple genes as well as environmental factors. At best, probability forecasts for such conditions might stir people into changing their lifestyles.

“But genetic data on response to drugs will be of enormous value to doctors —they could avoid giving drugs that won’t help or drugs that will cause serious side-effects,” Brahmachari said. The IGIB researchers are talking to doctors to determine the set of drugs most relevant to Indian needs.

Although the technology itself could be ready within months, project scientists declined to speculate how soon the cards could be made available for public use, saying confidentiality and security issues needed to be resolved first.

Genetic profiling services have been available from some foreign companies and, for limited applications, from Indian diagnostic companies. But they typically offer tests for genetic variations linked with specific illnesses or response to specific drugs.

The biotechnology department had ushered in predictive medicine in India during the 1990s, offering prenatal genetic testing for pregnant women to screen foetuses for genetic disorders such as Duchenne muscular dystrophy, Huntington’s disease or Fragile X Syndrome.

Biotechnology officials estimate that several thousand couples have used genetic screening and terminated pregnancies in which the foetuses were likely to develop genetic disorders.

Some researchers say there are signs that patients in India are able to handle sensitive genetic data responsibly.

“It is not uncommon (to find) one member of the family, say a daughter trying to protect her mother from guilt, requesting us not to tell her mother that she has passed down the gene mutation to her,” Sarin said.

Yet concerns about abuse of genetic testing persist. In a land where women face discrimination, “what would be the impact of a genetic test that reveals an unmarried young woman to be a carrier of a single-gene disorder (that she could pass on to her offspring)”, asked a senior scientist associated with the project.