- Email: [email protected]
Indian xenotransplant surgeon seeks damages from government
POLICY AND PEOPLE
Indian xenotransplant surgeon seeks damages from government
T
he National Human Rights Commission (NHRC) has issued notices to the Assam state government and police to reply to the charges of illegal detention and harassment levelled by Dhani Ram Baruah, the surgeon who performed India’s first cluster xenotransplantation in January, 1997. The Indian Medical Association has also been asked to give opinion on the medical and ethical issues involved. Baruah plans to seek damages worth US1·3 billion from the state government. Baruah, with two colleagues, was arrested 2 days after the death of a 32-year-old patient, Purno Saika, on whom he had performed a pig kidney, heart, and lung transplant on the New Year’s day in 1997 at his research centre near Guwahati. Baruah was released after 40 days detention, but was not allowed to
move out of Guwahati for 18 months. During this period, Baruah’s hospital and research centre were raided by the army, communication links broken, the animal farm destroyed, and work at his commercial bioengineering lab in Mumbai came to a halt. The surgeon—a fellow of the Royal College of Surgeons and Physicians, Glasgow, UK—contends that he was wrongly arrested under the Organ Transplantation Act of 1994 since it does not cover xenotransplantation. “If I have committed a crime, why has no chargesheet been filed against me so far?”, asks Baruah. He says he had informed the Assam health ministry on Dec 20, 1996, about his plans to carry out pig heart transplantation and had taken written consent from the patient and his family. A series of animal
experiments and a simulated ex-vivo clinical heart-lung transplantations preceded the cluster transplantation. Baruah says the operation was successful, but the patient died because of severe infection. Now he wants to resume clinical xenotransplantation, for which there are currently no regulations in India. In December, 1997, the Indian Council of Medical Research (ICMR) prepared a draft of ethical guidelines on biomedical research, which say that animal-to-human transplants should not be carried out, given the current level of knowledge. ICMR director general, N K Ganguly says the guidelines will be formalised after the process of public debate is over in the early part of this year. Dinesh C Sharma
India has the largest number of people infected with HIV ith a population nearing one billion and an estimated four million HIV-infected people, India is now considered the country that has the largest number of people infected with HIV in the world. Experts are pointing towards a clear shift in the spread beyond the high-risk groups. “HIV is now firmly embedded in the general Indian population and is fast spreading into rural areas that were previously thought to be relatively spared”, warned Peter Piot, executive director of UNAIDS, at the 2nd Thematic Meeting of UNAIDS Programme Coordinating Board (Dec 9–11, 1998; New Delhi, India). In Tamil Nadu state almost half a million people are infected with HIV and the infection rate is three times higher in villages than in the cities, said Piot. In 5 years, the infection rate among prostitutes has increased from 1% to 51% in Mumbai. Among injecting drug users in Manipur the infection rate has risen from 1% to 55·8%. And among attendees of sexually transmitted diseases clinics the infection rate has shot up from 23% to 36% in 1 year in Mumbai, according to the National AIDS Control Organisation. Although the AIDS explosion is not so evident at present—a figure of 6690 total AIDS cases was given on Dec 19—it is estimated that AIDS will cost India US$11 billion cumula-
W
48
tively by 2000, which is 5% of the gross domestic product. India has relied chiefly on a World Bank loan of $84 million since 1992 to combat AIDS. Negotiations are in the final stages to provide another loan of $200 million (AIDS-II) next year, said Salim Habayeb, principal publichealth specialist of the World Bank.
Preventing more infections?
This loan will allow expansion of earlier efforts in rural areas and greater involvement of states with more targeted interventions. The Bank has no plans to finance antiretroviral therapy as part of its AIDS funding, said Habayeb, although the neglected rehabilitation and home-based care of patients with AIDS might be included. Highly active antiretroviral therapy is too expensive for most Indians so there is increasing acceptance by officials of the need to accelerate vaccine research in India. The Prime
Minister, Atal Bihari Vajpayee, recently underscored the “urgent need to develop our own, type-specific, anti-HIV vaccine”. So it seems that development of a cost-effective indigenous vaccine is likely to get a boost in India. HIV infection in India is considered to be predominantly HIV-1 subtype C. But subtypes A and B, along with some new recombinant subtypes, have also been reported. HIV-2 has also been reported sporadically but its exact status in India remains unclear. Informally, Indian officials concede that India has been under strong western pressure to participate in the international vaccine trial efforts. But there is resistance from within. Although globally 90% of infected people live in areas in which the prevalent subtype is non-B, most candidate vaccines under development and testing are based on subtype B. Addressing a brainstorming session on HIV vaccine development in November, Manju Sharma of the Indian government’s department of biotechnology made it emphatically clear that no HIV-vaccine trial would be permitted unless Indian experts, participating on an equal basis, were convinced of its specific use in India, and if the trials were not being done simultaneously elsewhere. Sanjay Kumar
THE LANCET • Vol 353 • January 2, 1999
Indian xenotransplant surgeon seeks damages from government
T
he National Human Rights Commission (NHRC) has issued notices to the Assam state government and police to reply to the charges of illegal detention and harassment levelled by Dhani Ram Baruah, the surgeon who performed India’s first cluster xenotransplantation in January, 1997. The Indian Medical Association has also been asked to give opinion on the medical and ethical issues involved. Baruah plans to seek damages worth US1·3 billion from the state government. Baruah, with two colleagues, was arrested 2 days after the death of a 32-year-old patient, Purno Saika, on whom he had performed a pig kidney, heart, and lung transplant on the New Year’s day in 1997 at his research centre near Guwahati. Baruah was released after 40 days detention, but was not allowed to
move out of Guwahati for 18 months. During this period, Baruah’s hospital and research centre were raided by the army, communication links broken, the animal farm destroyed, and work at his commercial bioengineering lab in Mumbai came to a halt. The surgeon—a fellow of the Royal College of Surgeons and Physicians, Glasgow, UK—contends that he was wrongly arrested under the Organ Transplantation Act of 1994 since it does not cover xenotransplantation. “If I have committed a crime, why has no chargesheet been filed against me so far?”, asks Baruah. He says he had informed the Assam health ministry on Dec 20, 1996, about his plans to carry out pig heart transplantation and had taken written consent from the patient and his family. A series of animal
experiments and a simulated ex-vivo clinical heart-lung transplantations preceded the cluster transplantation. Baruah says the operation was successful, but the patient died because of severe infection. Now he wants to resume clinical xenotransplantation, for which there are currently no regulations in India. In December, 1997, the Indian Council of Medical Research (ICMR) prepared a draft of ethical guidelines on biomedical research, which say that animal-to-human transplants should not be carried out, given the current level of knowledge. ICMR director general, N K Ganguly says the guidelines will be formalised after the process of public debate is over in the early part of this year. Dinesh C Sharma
India has the largest number of people infected with HIV ith a population nearing one billion and an estimated four million HIV-infected people, India is now considered the country that has the largest number of people infected with HIV in the world. Experts are pointing towards a clear shift in the spread beyond the high-risk groups. “HIV is now firmly embedded in the general Indian population and is fast spreading into rural areas that were previously thought to be relatively spared”, warned Peter Piot, executive director of UNAIDS, at the 2nd Thematic Meeting of UNAIDS Programme Coordinating Board (Dec 9–11, 1998; New Delhi, India). In Tamil Nadu state almost half a million people are infected with HIV and the infection rate is three times higher in villages than in the cities, said Piot. In 5 years, the infection rate among prostitutes has increased from 1% to 51% in Mumbai. Among injecting drug users in Manipur the infection rate has risen from 1% to 55·8%. And among attendees of sexually transmitted diseases clinics the infection rate has shot up from 23% to 36% in 1 year in Mumbai, according to the National AIDS Control Organisation. Although the AIDS explosion is not so evident at present—a figure of 6690 total AIDS cases was given on Dec 19—it is estimated that AIDS will cost India US$11 billion cumula-
W
48
tively by 2000, which is 5% of the gross domestic product. India has relied chiefly on a World Bank loan of $84 million since 1992 to combat AIDS. Negotiations are in the final stages to provide another loan of $200 million (AIDS-II) next year, said Salim Habayeb, principal publichealth specialist of the World Bank.
Preventing more infections?
This loan will allow expansion of earlier efforts in rural areas and greater involvement of states with more targeted interventions. The Bank has no plans to finance antiretroviral therapy as part of its AIDS funding, said Habayeb, although the neglected rehabilitation and home-based care of patients with AIDS might be included. Highly active antiretroviral therapy is too expensive for most Indians so there is increasing acceptance by officials of the need to accelerate vaccine research in India. The Prime
Minister, Atal Bihari Vajpayee, recently underscored the “urgent need to develop our own, type-specific, anti-HIV vaccine”. So it seems that development of a cost-effective indigenous vaccine is likely to get a boost in India. HIV infection in India is considered to be predominantly HIV-1 subtype C. But subtypes A and B, along with some new recombinant subtypes, have also been reported. HIV-2 has also been reported sporadically but its exact status in India remains unclear. Informally, Indian officials concede that India has been under strong western pressure to participate in the international vaccine trial efforts. But there is resistance from within. Although globally 90% of infected people live in areas in which the prevalent subtype is non-B, most candidate vaccines under development and testing are based on subtype B. Addressing a brainstorming session on HIV vaccine development in November, Manju Sharma of the Indian government’s department of biotechnology made it emphatically clear that no HIV-vaccine trial would be permitted unless Indian experts, participating on an equal basis, were convinced of its specific use in India, and if the trials were not being done simultaneously elsewhere. Sanjay Kumar
THE LANCET • Vol 353 • January 2, 1999