- Email: [email protected]
Long-term effects of assisted conception
and
organisational. Many issues pertainefficacy, safety, and appropriate service delivery remained. A need for
Quinacrine sterilisation trials in India delayed The Indian Ministry of Health’s enthusiasm to introduce quinacrine hydrochloride as a contraceptive for women has plummeted. Interest had been generated by a visit to Vietnam by some Indian experts in January, after which there was talk of starting multicentre trials this month to study the efficacy and potential of quinacrine. There was optimism about introducing quinacrine into the official
family-planning programme next year. Quinacrine has been seen as a promising candidate for non-surgical sterilisation of
women.
When inserted into the open-
ing of fallopian tubes with the help of a modified intrauterine device inserter, cause irreversible local constriction. Quinacrine pellets can be inserted by trained non-physicians and without anaesthesia. : Experience with this form of contraception in 1989-92 in 32 000 women in Vietnam had been encouraging (see Lancet 1993; 342: : 213-17). Quinacrine contraception in Vietnam has, however, been halted, amidst much controversy over the
quinacrine
nearly
ing
carcinogenic potential of the drug (see, for example, Lancet 1994; 343: 987-88, and 1040, and 344: 698-700). The Indian health ministry’s change of mind follows another meeting in Vietnam in February held to disseminate research findings. At this meeting a retrospective study of acceptance of quinacrine sterilisation conducted by Hanoi’s health ministry jointly with Family Health International was discussed. According to Indian sources, the shift in position stems from the Vietdecision to re-evaluate the namese trials conducted in Vietnam, to get details of side-effects. The fresh studies are to be handed over to someone in Hanoi Medical School not involved with the earlier clinical trials. The Vietnamese health ministry’s study was based on questionnaires filled by school teachers; it was considered not reliable enough, and had many gaps. Although doubt was not cast on the product at the February meeting, the Vietnamese health ministry’s conclusion was that there were problems-both clinical
:
:
Sanjay
recognised
as a
relatively
common
compli-
cation of assisted conception, but there is little conclusive data on its long-term effects on women, although studies have pointed to a rise in endometrial cancer, breast cancer, and especially ovarian cancer. The working party also found a lack of research on the psychological and psychosocial dimensions of assisted conception. It favoured qualitative studies of the actual experience from the participant woman’s viewpoint, and recommended that men and families also be included. ,
976
variety of complications, including two deaths because of the accidental failure to deliver oxygen during general anaesthesia, : visceral injuries during egg retrievals, pelvic abscesses, serious infections, five serious vascular complications (one with residual hemiplegia), torsion of the ovary, : and cancers discovered during or after :
treatment.
The scant 37 reports of suspected reactions to drugs used during assisted conception to the Australian Registry of Suspected Adverse Reactions to Drugs since 1971 demonstrated the bias arising from voluntary drug surveillance programmes. A system of active notification
monthly
on
Kumar
the Australian Institute of Health and Welfare. Participants should be surveyed systematically and regularly to ascertain the social, emotional, spiritual and physical effects of assisted conception, and satisfaction with care. This should be a requirement for a centre’s accreditation. Among the research proposals made were for the NH & MRC to give priority to research into the long-term effects of assisted conception; for linkage of the database of women developed in studying the use of pituitary-derived hormones and data from cohorts of women held by IVF clinics with the National Death Index and state cancer registries; investigation of the risks to women; collection of minimum data sets by infertility clinics; and use of the proposed government-funded National Longitudinal Study of Women’s Health to investigate the effect of infertility and assisted conception within a large sample. treatment to
A survey of in-vitro fertilisation clinics seeking recalled instances of serious morbidity and known fatalities revealed a wide
ommended
controlled trials to determine the most effective means of quinacrine administration was emphasised. In India, "It is likely that we might go in for toxicological studies", says Ms Adarsh Mishra, Joint Secretary in the Ministry of Health. A final decision is expected within a month. Mishra thinks that it will probably be a few years before clinical trials are conducted in India. Meanwhile, a national daily, Indian Express, has reported that quinacrine has been used by private gynaecologists in the southern state of Karnataka with no major complications in about 200 women. The newspaper also reported that in West Bengal state about 10 000 insertions have taken place over the past few years. Health ministry officials say they have no formal information on these unofficial ventures. They add that fewer than a dozen trials were conducted officially in India a few years ago but the results were not encour-
aging.
Long-term effects of assisted conception After over two years’ study, an Australian National Health and Medical Research Council working party recently issued its report on long-term effects on women from assisted conception. The report says that although short-term outcomes related to pregnancy are well documented, little systematic study has been made of the long-term health effects on women, chil: dren, men, and families. Short-term studies have shown poor perinatal outcomes for infants conceived by in-vitro fertilisation and gamete intrafallopian transfer. Although such outcomes could be explained by the higher proportions of multiple births in assisted conception, singleton infants also have raised rates of preterm birth, very low birthweight, and perinatal deaths. Indications that assisted conception results in higher rates of specific malformation types or impairments and disabilities in surviving infants await confirmation by larger follow-up studies, says the working party. : Ovarian hyperstimulation syndrome is
to
: was rec-
with providers reporting adverse occurrences during
Sandra Coney
of the scientific data linking infant intestinal and chest infections with bottle feedSeveral US states have passed ing has been reported. The evidence that to protect a woman’s right to breastfeed a breastfed baby may have a higher IQ, or in public, but a similar bill in California mothers who feed their babies by bottle has become mired in party politics and may have more breast cancer has been the subject of uninformed and ribald totally overlooked. The Californian vote was along party : comments. Breastfeeding has been described as lines, with republicans leading the opposi"obscene". Legislators have warned that tion. It is a mystery how campaigners for basic family values find the quintessential women would have "to pretty much disbond between mother and child robe and reveal much more than neces"obscene". to do the : sary job". That the bill was killed by one vote in early April is a sad comment on how little Malcolm Potts
Not in front of the children
legislation
organisational. Many issues pertainefficacy, safety, and appropriate service delivery remained. A need for
Quinacrine sterilisation trials in India delayed The Indian Ministry of Health’s enthusiasm to introduce quinacrine hydrochloride as a contraceptive for women has plummeted. Interest had been generated by a visit to Vietnam by some Indian experts in January, after which there was talk of starting multicentre trials this month to study the efficacy and potential of quinacrine. There was optimism about introducing quinacrine into the official
family-planning programme next year. Quinacrine has been seen as a promising candidate for non-surgical sterilisation of
women.
When inserted into the open-
ing of fallopian tubes with the help of a modified intrauterine device inserter, cause irreversible local constriction. Quinacrine pellets can be inserted by trained non-physicians and without anaesthesia. : Experience with this form of contraception in 1989-92 in 32 000 women in Vietnam had been encouraging (see Lancet 1993; 342: : 213-17). Quinacrine contraception in Vietnam has, however, been halted, amidst much controversy over the
quinacrine
nearly
ing
carcinogenic potential of the drug (see, for example, Lancet 1994; 343: 987-88, and 1040, and 344: 698-700). The Indian health ministry’s change of mind follows another meeting in Vietnam in February held to disseminate research findings. At this meeting a retrospective study of acceptance of quinacrine sterilisation conducted by Hanoi’s health ministry jointly with Family Health International was discussed. According to Indian sources, the shift in position stems from the Vietdecision to re-evaluate the namese trials conducted in Vietnam, to get details of side-effects. The fresh studies are to be handed over to someone in Hanoi Medical School not involved with the earlier clinical trials. The Vietnamese health ministry’s study was based on questionnaires filled by school teachers; it was considered not reliable enough, and had many gaps. Although doubt was not cast on the product at the February meeting, the Vietnamese health ministry’s conclusion was that there were problems-both clinical
:
:
Sanjay
recognised
as a
relatively
common
compli-
cation of assisted conception, but there is little conclusive data on its long-term effects on women, although studies have pointed to a rise in endometrial cancer, breast cancer, and especially ovarian cancer. The working party also found a lack of research on the psychological and psychosocial dimensions of assisted conception. It favoured qualitative studies of the actual experience from the participant woman’s viewpoint, and recommended that men and families also be included. ,
976
variety of complications, including two deaths because of the accidental failure to deliver oxygen during general anaesthesia, : visceral injuries during egg retrievals, pelvic abscesses, serious infections, five serious vascular complications (one with residual hemiplegia), torsion of the ovary, : and cancers discovered during or after :
treatment.
The scant 37 reports of suspected reactions to drugs used during assisted conception to the Australian Registry of Suspected Adverse Reactions to Drugs since 1971 demonstrated the bias arising from voluntary drug surveillance programmes. A system of active notification
monthly
on
Kumar
the Australian Institute of Health and Welfare. Participants should be surveyed systematically and regularly to ascertain the social, emotional, spiritual and physical effects of assisted conception, and satisfaction with care. This should be a requirement for a centre’s accreditation. Among the research proposals made were for the NH & MRC to give priority to research into the long-term effects of assisted conception; for linkage of the database of women developed in studying the use of pituitary-derived hormones and data from cohorts of women held by IVF clinics with the National Death Index and state cancer registries; investigation of the risks to women; collection of minimum data sets by infertility clinics; and use of the proposed government-funded National Longitudinal Study of Women’s Health to investigate the effect of infertility and assisted conception within a large sample. treatment to
A survey of in-vitro fertilisation clinics seeking recalled instances of serious morbidity and known fatalities revealed a wide
ommended
controlled trials to determine the most effective means of quinacrine administration was emphasised. In India, "It is likely that we might go in for toxicological studies", says Ms Adarsh Mishra, Joint Secretary in the Ministry of Health. A final decision is expected within a month. Mishra thinks that it will probably be a few years before clinical trials are conducted in India. Meanwhile, a national daily, Indian Express, has reported that quinacrine has been used by private gynaecologists in the southern state of Karnataka with no major complications in about 200 women. The newspaper also reported that in West Bengal state about 10 000 insertions have taken place over the past few years. Health ministry officials say they have no formal information on these unofficial ventures. They add that fewer than a dozen trials were conducted officially in India a few years ago but the results were not encour-
aging.
Long-term effects of assisted conception After over two years’ study, an Australian National Health and Medical Research Council working party recently issued its report on long-term effects on women from assisted conception. The report says that although short-term outcomes related to pregnancy are well documented, little systematic study has been made of the long-term health effects on women, chil: dren, men, and families. Short-term studies have shown poor perinatal outcomes for infants conceived by in-vitro fertilisation and gamete intrafallopian transfer. Although such outcomes could be explained by the higher proportions of multiple births in assisted conception, singleton infants also have raised rates of preterm birth, very low birthweight, and perinatal deaths. Indications that assisted conception results in higher rates of specific malformation types or impairments and disabilities in surviving infants await confirmation by larger follow-up studies, says the working party. : Ovarian hyperstimulation syndrome is
to
: was rec-
with providers reporting adverse occurrences during
Sandra Coney
of the scientific data linking infant intestinal and chest infections with bottle feedSeveral US states have passed ing has been reported. The evidence that to protect a woman’s right to breastfeed a breastfed baby may have a higher IQ, or in public, but a similar bill in California mothers who feed their babies by bottle has become mired in party politics and may have more breast cancer has been the subject of uninformed and ribald totally overlooked. The Californian vote was along party : comments. Breastfeeding has been described as lines, with republicans leading the opposi"obscene". Legislators have warned that tion. It is a mystery how campaigners for basic family values find the quintessential women would have "to pretty much disbond between mother and child robe and reveal much more than neces"obscene". to do the : sary job". That the bill was killed by one vote in early April is a sad comment on how little Malcolm Potts
Not in front of the children
legislation