Use of antibiotic in contraceptive trial sparks controversy
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《英国医生杂志》
A clinical trial in India抯 West Bengal state evaluating the antibiotic erythromycin as a female contraceptive has sparked controversy 15 months after the study ended, with doctors accused of pursuing illegal and unethical research.
A paper published this month in the international journal Contraception (2004;69:47-9) says that transcervical administration of erythromycin seemed very safe but had an "unacceptably high" failure rate of 28-35% per cent after 12 months. The volunteers were divided into two groups. Each woman in the first group received a 500mg tablet of erythromycin, while each woman in the second group received ten 50mg pellets of the drug. In both cases the tablets or pellets were placed in the womb. Twelve months after they received the erythromycin, 35% of women who got the tablets and 28% of the women who got the pellets had become pregnant.
Doctors with the Indian Rural Medical Association, a non-governmental organisation in Calcutta, used erythromycin tablets as transcervical contraceptives in 790 women volunteers between August 1999 and October 2002. The doctors placed the erythromycin tables, or pellets, at the fundus, the upper part of the uterine cavity. The assumption behind the trial was that both quinacrine and erythromycin, when placed in the womb, would block the fallopian tubes.
Health activists and other doctors have criticised the study as unethical and say it highlights the ease with which illegal clinical trials may be conducted on unsophisticated, vulnerable populations in India.
The Indian Rural Medical Association has also disassociated itself from the trial, claiming that former members did not conduct the study on behalf of the association.
"We are not involved in contraception research now," said Dr Subir Mullick, the association抯 secretary.
Although the trial was intended to cover only 100 volunteers, the Contraception paper said the number of women enrolled expanded to 790 because of demand from patients. The authors are Biral Mullick and Netai Bairagy, two doctors in Calcutta who had conducted trials of quinacrine as a non-surgical method for female sterilisation during the 1990s. Dr Mullick died last year before publication of the paper.
India banned the use of quinacrine for female sterilisation in 1998 amid doubts about its safety and in response to a petition by activists after it had been used in the illegal sterilisation of more than 30 000 women in India (BMJ 1998;316:955).
The Calcutta doctors said they had conducted the erythromycin trial after a study by Family Health International (a non-governmental organisation in the United States)梡ublished in 2000 (Fertility and Sterility 2000;73:387-94)梚ndicated that erythromycin was more effective in preventing pregnancy than quinacrine.
Critics say the trial illustrates deficiencies in India抯 ability to conduct ethical research. "Regulatory agencies are not strong enough and medical councils refuse to act against errant doctors," said Dr Samiran Nundy, editor of the Indian Journal of Medical Ethics.
"It is not unusual for rural women to seek unproven, potentially hazardous contraception," said Neha Madhiwalla, a social scientist with a non-governmental organisation in Mumbai. "Demand from women is no justification for an unethical trial."
A controversial US doctor, Dr Stephen Mumford, president of the Centre for Research on Population and Security, who has long been campaigning for sterilisation with quinacrine, helped the Indian doctors with the paper. "But I wasn抰 aware of the study until I was asked to assist in writing it up and communicating it to a journal," he told BMJ.(New Delhi Ganapati Mudur)
A paper published this month in the international journal Contraception (2004;69:47-9) says that transcervical administration of erythromycin seemed very safe but had an "unacceptably high" failure rate of 28-35% per cent after 12 months. The volunteers were divided into two groups. Each woman in the first group received a 500mg tablet of erythromycin, while each woman in the second group received ten 50mg pellets of the drug. In both cases the tablets or pellets were placed in the womb. Twelve months after they received the erythromycin, 35% of women who got the tablets and 28% of the women who got the pellets had become pregnant.
Doctors with the Indian Rural Medical Association, a non-governmental organisation in Calcutta, used erythromycin tablets as transcervical contraceptives in 790 women volunteers between August 1999 and October 2002. The doctors placed the erythromycin tables, or pellets, at the fundus, the upper part of the uterine cavity. The assumption behind the trial was that both quinacrine and erythromycin, when placed in the womb, would block the fallopian tubes.
Health activists and other doctors have criticised the study as unethical and say it highlights the ease with which illegal clinical trials may be conducted on unsophisticated, vulnerable populations in India.
The Indian Rural Medical Association has also disassociated itself from the trial, claiming that former members did not conduct the study on behalf of the association.
"We are not involved in contraception research now," said Dr Subir Mullick, the association抯 secretary.
Although the trial was intended to cover only 100 volunteers, the Contraception paper said the number of women enrolled expanded to 790 because of demand from patients. The authors are Biral Mullick and Netai Bairagy, two doctors in Calcutta who had conducted trials of quinacrine as a non-surgical method for female sterilisation during the 1990s. Dr Mullick died last year before publication of the paper.
India banned the use of quinacrine for female sterilisation in 1998 amid doubts about its safety and in response to a petition by activists after it had been used in the illegal sterilisation of more than 30 000 women in India (BMJ 1998;316:955).
The Calcutta doctors said they had conducted the erythromycin trial after a study by Family Health International (a non-governmental organisation in the United States)梡ublished in 2000 (Fertility and Sterility 2000;73:387-94)梚ndicated that erythromycin was more effective in preventing pregnancy than quinacrine.
Critics say the trial illustrates deficiencies in India抯 ability to conduct ethical research. "Regulatory agencies are not strong enough and medical councils refuse to act against errant doctors," said Dr Samiran Nundy, editor of the Indian Journal of Medical Ethics.
"It is not unusual for rural women to seek unproven, potentially hazardous contraception," said Neha Madhiwalla, a social scientist with a non-governmental organisation in Mumbai. "Demand from women is no justification for an unethical trial."
A controversial US doctor, Dr Stephen Mumford, president of the Centre for Research on Population and Security, who has long been campaigning for sterilisation with quinacrine, helped the Indian doctors with the paper. "But I wasn抰 aware of the study until I was asked to assist in writing it up and communicating it to a journal," he told BMJ.(New Delhi Ganapati Mudur)