- Email: [email protected]
Warnock Report on Human Fertilisation and Embryology
238 lead added to the over-large quantity of lead already in the environment increases the quantity to levels which are unacceptable in the bodies of many children and contributes to the environmental build-up of this non-degradable neurotoxin." Mr Mitchell’s Bill has the support of some Conservative and Liberal backbenchers too. But the vicissitudes of Parliamentary procedure mean that, now he has introduced it, the measure is destined to join the back ofa very long queue of other private measures from which only the top half-dozen or so have the faintest chance of getting the legislative time necessary to make them law. In theory the Government couldtake Mr Mitchell’s scheme under its wing, either creating a small slot for it in the Government’s timetable for the next Parliamentary session, or incorporating its provisions into some future miscellaneous Bill dealing with, perhaps, environmental pollution or public health. None of this will happen. The present Government has said over and over again that it intends to interfere as little as possible with the freedom of companies to produce goods for which there is a perceived need and a buying public. the Warnock
Report The Health Minister, Mr Kenneth Clarke, has already made it clear he expects a wide-ranging public debate on the issues raised by the Warnock report (see p 217) before any legislation is planned. A Parliamentary debate is an almost inevitable part of this prelegislative process but is unlikely this side of Christmas, since Government business managers give the Warnock report low priority. The battlelines are already being drawn by the all-party Parliamentary Pro-Life Group, under the leadership of the The Start of a
Long Debate
on
Conservative backbencher, Sir Bernard Braine. This group accepts the usefulness of in-vitro fertilisation, and agrees with the Warnock committee’s dislike of surrogate motherhood. But at a press conference in the Commons Sir Bernard bitterly criticised the committee’s "attempt to bamboozle the public into believing that experiments on live embryos are necessary". He accused the committee of selectively ignoring evidence presented to it, in order to create the impression that research on live embryos was the only route to curing genetic diseases. They had "blatantly ignored" the research of successful geneticists who did not use live embryos. According to Sir Bernard the committee’s attitude would accept that researchers would deliberately induce chromosomal abnormalities in previously healthy embryos. "Having discovered how to cause Down’s syndrome in the embryo they would then have to set to work to find the cure, and any attempts would involve waiting to find out whether or not they had been successful." This could not be done within the 14-day limit suggested by the committee. He described the committee’s acceptance of the idea of freezing embryos (where there is no presumed benefit to the patient-ie, the embryo) as "gross, even criminal, negligence". The committee could give no guarantee that children eventually born from frozen embryos would not develop, later in life, some disastrous illness or malformation. The committee’s report claimed the embryo was human and thus deserved to be treated with respect. Yet later on the report sanctioned sale of the embryo, freezing it, killing it, experimenting on it up to 14 days. So where, he asked, does respect begin and end? When the Parliamentary debate comes, its tone is likely to be set by Sir Bernard’s insistence that "the experimenters have got to brought under control". RODNEY DEITCH
Medicine and the Law Warnock
Report on Human Fertilisation and Embryology
ally myself with the bulk of the recommendations in the report published last week (see p 217) and with its sensible and compassionate approach. In particular, I welcome the proposal for a system of licensing and inspection of all premises dealing with, practising in, or undertaking researching in human fertilisation and embryology, with the ultimate sanction of the criminal law at its I
back. I was gratified to find that my own report1 compiled a year ago was much on the same lines with broadly similar recommendations. Save two: on surrogacy; and the breeding of human embryos specifically for research. Both these difficult areas were the subjects of dissenting views in the report. SURROGACY: A CRIMINAL OFFENCE?
In
novel and rapidly moving area, a year can be a long time. my original commentary, profit-making agencies offering surrogate parenthood services, which first appeared in the US, have quickly spread their operations to the UK. In March, 1984, the BMA advised that, in consideration of the difficulties, anxieties, and uncertainties to all the individuals concerned, it was unethical for a doctor to become involved in techniques and procedures to assist surrogate mothers. This statement did "not affect the duty of care of the doctor to a woman who has conceived under these circumstances". The Warnock report now recommends "that legislation be introduced to render criminal the creation or the operation in the United Kingdom of agencies whose purposes include the recruitment of women for surrogate pregnancy or making arrangements for individuals or couples who wish to utilise the services of a carrying mother; such legislation should be wide enough to include both profit and non-profit making organisations. We further recommend that the legislation be sufficiently wide to render criminally liable the actions of the professionals and others who knowingly assist in the establishment of a surrogate a
Indeed, since
pregnancy". Unfortunately, to ban all professional help to infertile couples desperate enough to seek surrogacy offers the worst of all worlds. It excludes any legitimate and limited last-resort licensed agency; and it will drive those for whom there seems no other option into the hands of unskilled, unscrupulous, or foreign operators. For instance, it may not be necessary to travel to the USA or elsewhere: what is there to prevent a foreign ship from hovering just outside British territorial waters and providing just such services banned inside them? A charter for pirate ships sailing under foreign flags? At home, in secret, though less commonplace, I trust, a total ban could produce the equivalent to backstreet abortion. While I am in total sympathy with the BMA’s underlying concern, which has led it to express the view that aiding and abetting or arranging a surrogate pregnancy is unethical, if the doctors are excluded totally, other less desirable operators will step in to fill the gap and the consequences could be disastrous. A further difficulty is raised by Warnock’s paragraph 8.19: "We do not envisage that this legislation would render private persons entering into surrogacy arrangements liable to criminal prosecution, as we are anxious to avoid children being born to mothers subject to the taint of criminality. We nonetheless recognise there will continue to be privately arranged surrogacy agreements ..." The committee then recommend that statute provide that surrogacy agreements are illegal contracts and therefore unenforceable in the courts. It is generally held that a contract for surrogacy is illegal since it would be against public policy and therefore unenforceable in the courts. However, if even a limited Government agency were set up, would it be possible still to argue that surrogacy should be unenforceable, or should only those subject to licensed control come under the law’s umbrella? This would seem the better course. It 1. Brahams D In-vitro fertilisation and related research:
Lancet
1983; ii. 726-29.
why Parliament
must
legislate
239 does not resolve the question of whether the parties directly concerned in arranging a surrogate pregnancy should b committing a criminal offence. The Warnock recommendations seem similar to the attitudes usually exhibited in relation tc abortion. If all parties concerned would be committing a criminal offence, then it would be a matter for the discretion of the prosecuting authorities to decide whether to prosecute or not. This proposal is uncertain and unsatisfactory, though it does retain flexibility in a new and difficult area. Attitudes towards the possibilities offered by advanced technology are likely to adjust and modify with time and familiarity, and it may still be too soon to legislate finally on surrogacy in the way proposed. As the report explains, attitudes towards acceptance of AID have vastly changed over the past thirty years, and there may be an analogy to be drawn. On the other hand, if the rot is not stopped now it will be too late-and that looks like a valid argument too! I would prefer the door to be left ajar for the rare special cases. In particular, I prefer that surrogates did not bear babies biologically their own, because I would believe (though I have no evidence to support this view) that it would be less morally and psychologically difficult for a woman to surrender at birth a child not biologically her own. Further, if the social mother donated the egg and the social father donated the fertilising sperm, it should be legally their baby. In a case involving outside donations, the donations should produce the same result. I wholly agree that surrogacy entered into only for convenience-eg, a busy professional woman who does not want to interfere with her career and hires another woman to bear her
baby-is wholly unacceptable. BREEDING HUMAN EMBRYOS SPECIFICALLY FOR RESEARCH
Here again was a dividing point for the Warnock committee, with three members voting against all research on human embryos, and a further four finding it unacceptable to create embryos specifically for research purposes. The majority recommended that, subject to strict licence and control and a 14-day post-fertilisation maximum, research may be permitted on any human embryos resulting from in-vitro fertilisation. The committee chose for its cutoff point the moment before individual development of the embryo and the formation of the primitive streak. This limit may have to be revised subsequently, but if there is to be breeding of human embryos for research, such an early phase is the most acceptable. A year ago I found myself unable to accept the concept of breeding embryos for research, and today I would still need compelling evidence that it is justified before relinquishing my last, perhaps illogical, reservations. In the end, that evidence may very well come from the effect of effective monitoring and control by a licensing body and its inspectors. I would certainly endorse the Warnock recommendation that such a body should have a lay chairman and not be dominated by scientists. DIANA BRAHAMS,
Notes and News LEUKAEMIA ON THE COAST OF CUMBRIA "We have found no evidence of any general risk to health for children or adults living near Sellafield when compared to the rest of Cumbria, and we can give a qualified reassurance to the people who are concerned about a possible health hazard in the neighbourhood of Sellafield. However there are uncertainties concerning the operation of the plant..." Thus begins the final paragraph to the conclusions of the independent inquiry,’ chaired by Sir Douglas Black,* into the incidence of cancer in west Cumbria, with special emphasis on young people and on leukaemia in the village of Seascale and the former rural district of Millom. From several overlapping studies, published in The Lancet (which will comment editorially next week) or submitted in evidence to the Black inquiry, come pointers to an unusual incidence of leukaemia in Seascale and its neighbourhood. Sellafield, the name for the nuclear complex that contains a fuel processing plant (Windscale) and a power station (Calder Hall), releases radioactivity to the air, pumps liquid waste into the Irish Sea, and also buries it locally. The big question for Sir Douglas and his colleagues was whether the facts of being near the top of tables of local cancer or leukaemia incidence and having a nuclear site in the vicinity are independent. The "qualified reassurance" that they are is reached on radiobiological grounds; exposure to the added radioactivity from Sellafield could not account, on known mechanisms anyway, for the increase found. The numbers of cases are small (and overlap in the different studies) and the report includes a recommendation for case-control and similar investigations and for the extension of studies already reported. Of 14 cases of leukaemia in Millom rural district (of which Seascale was a part) since 1955 and under twenty-five years of age at diagnosis, 5 were born in 1957, the year of the Windscale fire, or in 1958: 1 was in utero at the time of the fire, another was conceived at the time of the fire, 1 was born in Oxford, and the other 2 were five and seven months old at the time. November, 1983, saw the first meeting of the Black committee and the disclosure ofa serious error in the piped discharge from Sellafield, leading to contaminated beaches. Hence the need for closer monitoring of discharges, another Black recommendation. There should also, the report advises, be formal consultations between those who authorise discharges and the Health Departments. By the end of the 1960s the curies discharged to the sea were rising close to the authorised limit. In 1971 the limit was more than trebled "following an expected increase in workload". Sir Douglas and his colleagues found some confusion in the number of different bodies involved in monitoring health and discharges, and emphasise the need for significant health representation on a single body with responsibility in this area. SAFETY OF ULTRASOUND
Barrister-at-law
1984
IN the early days, when ultrasound meant sound navigation and ranging (SONAR), fish were found dead near underwater transducers. For more than fifty years we have known that sound waves at frequencies undetectable to the human ear can be harmful-the question is whether diagnostic ultrasound, especially that used in pregnancy, is dangerous. The US National Council on
Courses, multidisciplinary symposia, and workshops on Computers and Patient Care: Nottingham, UK, Sept 10-15 (UMIT, University Department of Obstetrics and Gynaecology, Queens Medical Centre, Nottingham BG7 2UH).
Radiation Protection and Measurement has now issued two reports the subject-one (NCRP Report no 73) in the context of paediatric radiology, the other a major survey of the whole subject.2 The American Institute of Ultrasound in Medicine’s statement, reaffirmed in1982, reads: "In the low megahertz frequency range
International
Diary
Ist national congress of Medical Oncology: Barcelona, Spain, Nov 14-17 (I’alacio de Congresos, Departamento Convenciones, Avda Reina Ma Cristina, Barcelona 4). 1985
on
*Other members were: Dr A. M. Adelstein, ProfR. J. Dr M. J. Gardner, Prof J. S. Orr, and Prof G. Rose. 1.
nd international conference on Clinical and Basic Factors Influencing Bone Growth: University of California, Los Angeles, Jan 3-5 (Andrew D. Dixon, Schools of Dentistry and Medicine, Dental Research Institute, Center tor Health Sciences, UCLA, Los Angeles, CA 90024, USA).
Berry, ProfM. Bobrow,
Investigation ofthe Possible Increased Incidence of Cancer in West Cumbria: Report of the Independent Advisory Group. London: HM Stationery Office 1984 Pp 103. £ 6·70. on Radiation Protection and Measurements. Biological Effects of Ultrasound: Mechanisms and Clinical Implications (NCRP report no 74). Bethesda, Maryland NCRP. 1984 Pp 266. $15.
2. National Council
Report The Health Minister, Mr Kenneth Clarke, has already made it clear he expects a wide-ranging public debate on the issues raised by the Warnock report (see p 217) before any legislation is planned. A Parliamentary debate is an almost inevitable part of this prelegislative process but is unlikely this side of Christmas, since Government business managers give the Warnock report low priority. The battlelines are already being drawn by the all-party Parliamentary Pro-Life Group, under the leadership of the The Start of a
Long Debate
on
Conservative backbencher, Sir Bernard Braine. This group accepts the usefulness of in-vitro fertilisation, and agrees with the Warnock committee’s dislike of surrogate motherhood. But at a press conference in the Commons Sir Bernard bitterly criticised the committee’s "attempt to bamboozle the public into believing that experiments on live embryos are necessary". He accused the committee of selectively ignoring evidence presented to it, in order to create the impression that research on live embryos was the only route to curing genetic diseases. They had "blatantly ignored" the research of successful geneticists who did not use live embryos. According to Sir Bernard the committee’s attitude would accept that researchers would deliberately induce chromosomal abnormalities in previously healthy embryos. "Having discovered how to cause Down’s syndrome in the embryo they would then have to set to work to find the cure, and any attempts would involve waiting to find out whether or not they had been successful." This could not be done within the 14-day limit suggested by the committee. He described the committee’s acceptance of the idea of freezing embryos (where there is no presumed benefit to the patient-ie, the embryo) as "gross, even criminal, negligence". The committee could give no guarantee that children eventually born from frozen embryos would not develop, later in life, some disastrous illness or malformation. The committee’s report claimed the embryo was human and thus deserved to be treated with respect. Yet later on the report sanctioned sale of the embryo, freezing it, killing it, experimenting on it up to 14 days. So where, he asked, does respect begin and end? When the Parliamentary debate comes, its tone is likely to be set by Sir Bernard’s insistence that "the experimenters have got to brought under control". RODNEY DEITCH
Medicine and the Law Warnock
Report on Human Fertilisation and Embryology
ally myself with the bulk of the recommendations in the report published last week (see p 217) and with its sensible and compassionate approach. In particular, I welcome the proposal for a system of licensing and inspection of all premises dealing with, practising in, or undertaking researching in human fertilisation and embryology, with the ultimate sanction of the criminal law at its I
back. I was gratified to find that my own report1 compiled a year ago was much on the same lines with broadly similar recommendations. Save two: on surrogacy; and the breeding of human embryos specifically for research. Both these difficult areas were the subjects of dissenting views in the report. SURROGACY: A CRIMINAL OFFENCE?
In
novel and rapidly moving area, a year can be a long time. my original commentary, profit-making agencies offering surrogate parenthood services, which first appeared in the US, have quickly spread their operations to the UK. In March, 1984, the BMA advised that, in consideration of the difficulties, anxieties, and uncertainties to all the individuals concerned, it was unethical for a doctor to become involved in techniques and procedures to assist surrogate mothers. This statement did "not affect the duty of care of the doctor to a woman who has conceived under these circumstances". The Warnock report now recommends "that legislation be introduced to render criminal the creation or the operation in the United Kingdom of agencies whose purposes include the recruitment of women for surrogate pregnancy or making arrangements for individuals or couples who wish to utilise the services of a carrying mother; such legislation should be wide enough to include both profit and non-profit making organisations. We further recommend that the legislation be sufficiently wide to render criminally liable the actions of the professionals and others who knowingly assist in the establishment of a surrogate a
Indeed, since
pregnancy". Unfortunately, to ban all professional help to infertile couples desperate enough to seek surrogacy offers the worst of all worlds. It excludes any legitimate and limited last-resort licensed agency; and it will drive those for whom there seems no other option into the hands of unskilled, unscrupulous, or foreign operators. For instance, it may not be necessary to travel to the USA or elsewhere: what is there to prevent a foreign ship from hovering just outside British territorial waters and providing just such services banned inside them? A charter for pirate ships sailing under foreign flags? At home, in secret, though less commonplace, I trust, a total ban could produce the equivalent to backstreet abortion. While I am in total sympathy with the BMA’s underlying concern, which has led it to express the view that aiding and abetting or arranging a surrogate pregnancy is unethical, if the doctors are excluded totally, other less desirable operators will step in to fill the gap and the consequences could be disastrous. A further difficulty is raised by Warnock’s paragraph 8.19: "We do not envisage that this legislation would render private persons entering into surrogacy arrangements liable to criminal prosecution, as we are anxious to avoid children being born to mothers subject to the taint of criminality. We nonetheless recognise there will continue to be privately arranged surrogacy agreements ..." The committee then recommend that statute provide that surrogacy agreements are illegal contracts and therefore unenforceable in the courts. It is generally held that a contract for surrogacy is illegal since it would be against public policy and therefore unenforceable in the courts. However, if even a limited Government agency were set up, would it be possible still to argue that surrogacy should be unenforceable, or should only those subject to licensed control come under the law’s umbrella? This would seem the better course. It 1. Brahams D In-vitro fertilisation and related research:
Lancet
1983; ii. 726-29.
why Parliament
must
legislate
239 does not resolve the question of whether the parties directly concerned in arranging a surrogate pregnancy should b committing a criminal offence. The Warnock recommendations seem similar to the attitudes usually exhibited in relation tc abortion. If all parties concerned would be committing a criminal offence, then it would be a matter for the discretion of the prosecuting authorities to decide whether to prosecute or not. This proposal is uncertain and unsatisfactory, though it does retain flexibility in a new and difficult area. Attitudes towards the possibilities offered by advanced technology are likely to adjust and modify with time and familiarity, and it may still be too soon to legislate finally on surrogacy in the way proposed. As the report explains, attitudes towards acceptance of AID have vastly changed over the past thirty years, and there may be an analogy to be drawn. On the other hand, if the rot is not stopped now it will be too late-and that looks like a valid argument too! I would prefer the door to be left ajar for the rare special cases. In particular, I prefer that surrogates did not bear babies biologically their own, because I would believe (though I have no evidence to support this view) that it would be less morally and psychologically difficult for a woman to surrender at birth a child not biologically her own. Further, if the social mother donated the egg and the social father donated the fertilising sperm, it should be legally their baby. In a case involving outside donations, the donations should produce the same result. I wholly agree that surrogacy entered into only for convenience-eg, a busy professional woman who does not want to interfere with her career and hires another woman to bear her
baby-is wholly unacceptable. BREEDING HUMAN EMBRYOS SPECIFICALLY FOR RESEARCH
Here again was a dividing point for the Warnock committee, with three members voting against all research on human embryos, and a further four finding it unacceptable to create embryos specifically for research purposes. The majority recommended that, subject to strict licence and control and a 14-day post-fertilisation maximum, research may be permitted on any human embryos resulting from in-vitro fertilisation. The committee chose for its cutoff point the moment before individual development of the embryo and the formation of the primitive streak. This limit may have to be revised subsequently, but if there is to be breeding of human embryos for research, such an early phase is the most acceptable. A year ago I found myself unable to accept the concept of breeding embryos for research, and today I would still need compelling evidence that it is justified before relinquishing my last, perhaps illogical, reservations. In the end, that evidence may very well come from the effect of effective monitoring and control by a licensing body and its inspectors. I would certainly endorse the Warnock recommendation that such a body should have a lay chairman and not be dominated by scientists. DIANA BRAHAMS,
Notes and News LEUKAEMIA ON THE COAST OF CUMBRIA "We have found no evidence of any general risk to health for children or adults living near Sellafield when compared to the rest of Cumbria, and we can give a qualified reassurance to the people who are concerned about a possible health hazard in the neighbourhood of Sellafield. However there are uncertainties concerning the operation of the plant..." Thus begins the final paragraph to the conclusions of the independent inquiry,’ chaired by Sir Douglas Black,* into the incidence of cancer in west Cumbria, with special emphasis on young people and on leukaemia in the village of Seascale and the former rural district of Millom. From several overlapping studies, published in The Lancet (which will comment editorially next week) or submitted in evidence to the Black inquiry, come pointers to an unusual incidence of leukaemia in Seascale and its neighbourhood. Sellafield, the name for the nuclear complex that contains a fuel processing plant (Windscale) and a power station (Calder Hall), releases radioactivity to the air, pumps liquid waste into the Irish Sea, and also buries it locally. The big question for Sir Douglas and his colleagues was whether the facts of being near the top of tables of local cancer or leukaemia incidence and having a nuclear site in the vicinity are independent. The "qualified reassurance" that they are is reached on radiobiological grounds; exposure to the added radioactivity from Sellafield could not account, on known mechanisms anyway, for the increase found. The numbers of cases are small (and overlap in the different studies) and the report includes a recommendation for case-control and similar investigations and for the extension of studies already reported. Of 14 cases of leukaemia in Millom rural district (of which Seascale was a part) since 1955 and under twenty-five years of age at diagnosis, 5 were born in 1957, the year of the Windscale fire, or in 1958: 1 was in utero at the time of the fire, another was conceived at the time of the fire, 1 was born in Oxford, and the other 2 were five and seven months old at the time. November, 1983, saw the first meeting of the Black committee and the disclosure ofa serious error in the piped discharge from Sellafield, leading to contaminated beaches. Hence the need for closer monitoring of discharges, another Black recommendation. There should also, the report advises, be formal consultations between those who authorise discharges and the Health Departments. By the end of the 1960s the curies discharged to the sea were rising close to the authorised limit. In 1971 the limit was more than trebled "following an expected increase in workload". Sir Douglas and his colleagues found some confusion in the number of different bodies involved in monitoring health and discharges, and emphasise the need for significant health representation on a single body with responsibility in this area. SAFETY OF ULTRASOUND
Barrister-at-law
1984
IN the early days, when ultrasound meant sound navigation and ranging (SONAR), fish were found dead near underwater transducers. For more than fifty years we have known that sound waves at frequencies undetectable to the human ear can be harmful-the question is whether diagnostic ultrasound, especially that used in pregnancy, is dangerous. The US National Council on
Courses, multidisciplinary symposia, and workshops on Computers and Patient Care: Nottingham, UK, Sept 10-15 (UMIT, University Department of Obstetrics and Gynaecology, Queens Medical Centre, Nottingham BG7 2UH).
Radiation Protection and Measurement has now issued two reports the subject-one (NCRP Report no 73) in the context of paediatric radiology, the other a major survey of the whole subject.2 The American Institute of Ultrasound in Medicine’s statement, reaffirmed in1982, reads: "In the low megahertz frequency range
International
Diary
Ist national congress of Medical Oncology: Barcelona, Spain, Nov 14-17 (I’alacio de Congresos, Departamento Convenciones, Avda Reina Ma Cristina, Barcelona 4). 1985
on
*Other members were: Dr A. M. Adelstein, ProfR. J. Dr M. J. Gardner, Prof J. S. Orr, and Prof G. Rose. 1.
nd international conference on Clinical and Basic Factors Influencing Bone Growth: University of California, Los Angeles, Jan 3-5 (Andrew D. Dixon, Schools of Dentistry and Medicine, Dental Research Institute, Center tor Health Sciences, UCLA, Los Angeles, CA 90024, USA).
Berry, ProfM. Bobrow,
Investigation ofthe Possible Increased Incidence of Cancer in West Cumbria: Report of the Independent Advisory Group. London: HM Stationery Office 1984 Pp 103. £ 6·70. on Radiation Protection and Measurements. Biological Effects of Ultrasound: Mechanisms and Clinical Implications (NCRP report no 74). Bethesda, Maryland NCRP. 1984 Pp 266. $15.
2. National Council