§ 7.9 p.m.
§ Barones Robson of Kiddington rose to ask Her Majesty's Government whether, in the light of medical opinion that it is necessary, they will establish a large-scale, multi-centre study into toxoplasmosis in pregnancy.
§
The noble Baroness said: My Lords, in tabling this Unstarred Question, I want to refer to the Government's document, The Health of the Nation, in which they state:
The strategic role of the Department of Health is … to monitor and assess the health of the nation and take the action necessary … to improve and protect health".
I think that everyone would agree that the best way to start to improve and protect the health of the nation is to ensure that, as far as is humanly possible, every baby born in this country is a healthy baby.
§ Toxoplasmosis in pregnancy is a clear example of how the Department of Health might implement the role that it has set itself. Toxoplasmosis is a common infection. It is caused by a parasite living in soil, on unwashed fruit and vegetables and in infected cat faeces. The infection is usually mild, giving flu-like symptoms which can often go unnoticed. An amazing statistic is that 70 per cent. of women in France are immune against toxoplasmosis because they have had it earlier in life, whereas only 30 per cent. of women in Britain are immune. I do not know whether that has something to do with how we handle soil and wash vegetables. I do not think that anyone knows the reason, but it is an interesting fact. The statistic proves that the danger is greater for pregnant women in this country than for those in France.
§ When a pregnant woman catches the infection, she may pass it to her unborn child, who may suffer from blindness, hydrocephalus and brain damage. A large number of the babies will have no symptoms at birth, but they will need to be clearly and closely monitored for six to nine months. Some may develop blindness as late as in their teens. Estimates of the scale of the problem in the UK broadly agree that two women per thousand will contract toxoplasmosis for the first time in pregnancy. With an average of 700,000 births each year, that means that 14,000 pregnant women will have new toxoplasma infections each year. The research indicates that 40 per cent. will pass the infection to their foetus. That could amount to as many as 600 babies per year.
§ However, it is known that toxoplasmosis in pregnancy is preventable, testable and treatable. Pregnant women should be routinely made aware of how to avoid the infection. Work on that has been carried out largely by the Toxoplasmosis Trust in this country. It has distributed over 1 million leaflets in the past five years, trying to inform women what to avoid 1274 when pregnant. Blood tests will identify the toxoplasmosis infection and could be included in routine ante-natal care.
§ Spiramycin is the orthodox treatment that is used to prevent the transmission of toxoplasmosis from an infected mother to her foetus. It has been used and studied in France and Austria, where the incidence of congenital toxoplasmosis has dropped dramatically. In Austria, for example, following treatment, the incidence of affected babies has fallen from between five and seven per 1,000 births to as low as one in 10,000 births. Surely such a reduction is worth achieving.
§ What action is necessary in this country? I believe that it is for the Department of Health to regularise the situation on toxoplasmosis in pregnancy. A number of steps are appropriate. In the short term, all pregnant women should be informed about toxoplasmosis and how to avoid it. Such a crucial task cannot be left to a small charity to undertake. As I have said, that charity has done a magnificent job, but it is up to the Department of Health to see that that information is given to pregnant mothers.
§ I also believe that the Department of Health should bring together all the relevant professional groups to discuss clinical guidelines. That would at least standardise the treatment of pregnant women who are identified as being infected with toxoplasmosis. One of the problems is that there is no standard system for dealing with the infection across the different centres. Some centres are very good and provide very good treatment; others are not so good. We cannot afford to allow mothers who unfortunately happen to be infected to have their babies in centres that do not provide the best service.
§ The most important role for the Department of Health is to obtain epidemiological information, as proposed by the Royal College of Obstetricians and Gynaecologists in its working group in 1992. It emphasised the need for further research. It is not alone in that, because in 1991 the Select Committee on Health also stated that more research was required. We recommend that the Government should commission the appropriate epidemiological research to establish the incidence of toxoplasmosis. The problem is that real information on the number of pregnant women who contract the disease and infect their babies is clearly lacking. It is inappropriate to take a decision for or against screening without that information. I hope that the noble Baroness realises that I am not asking for a national screening programme. We would not dream of asking for that until all the relevant information is available on which we can base a decision about screening.
§ Over the past five years, numerous requests have been made for that crucial research to be undertaken. I believe that in October this year the Toxoplasmosis Trust wrote to the noble Baroness, Lady Cumberlege. I am not aware of whether it has received a reply or whether the Government are prepared to undertake that very important research programme. Such research needs to be carried out on a multi-centre basis, covering the country. Various small research programmes have taken place but, because they are small and do not cover large 1275 enough areas, they have come up with many different answers. That is why it is important that we have a national multi-centre research programme.
§ I urge the Government to undertake that research as a matter of urgency. We all want all babies to be born healthy. To me, the results of this infection are frightening because it can manifest itself so much later in life. I hope that the Government will accede to this request.
§ 7.20 p.m.
§ Lord ReaMy Lords, the Unstarred Question asked by the noble Baroness deals with a parasitic disease of which few of us will have heard, and, yet, surprisingly, as she pointed out, many of us may have acquired it. Our immune system will have dealt with it with no more than minor, flu-like symptoms. The organism is a single-celled protozoan (or, strictly speaking, sporozoan). It is in the same group as some tropical parasitic diseases. It affects animals as well as man, so technically speaking it is a zoonosis. Domestic cats are known to harbour the organism, as are some farm animals, sheep in particular.
I am pleased that the noble Baroness, Lady Trumpington, is to answer the debate because she has had experience as a Minister in the Ministry of Agriculture, Fisheries and Food and the Department of Health. I am sure that she was chosen to answer the Question for that reason.
While adults, if infected, can suffer mild and occasionally prolonged glandular fever-like symptoms, the disease can, as the noble Baroness pointed out, cause much more severe damage to the unborn foetus if the organism crosses the placental barrier in pregnancy. It is newly acquired infections by mothers during, or shortly before, pregnancy, that concern us.
As the noble Baroness said, the rate of infection of pregnant women by the organism is about two per thousand (0.2 per cent.); that is, 1,200 to 1,400 (not thousands) per annum in the country. In 40 per cent. of those cases, according to several studies, the foetus also acquires the infection. It crosses the placental barrier and leads to some 500 to 600 affected foetuses. It is thought that about 10 per cent. of those (50 to 60 or so) are harmed seriously by the infection. Some are infected seriously with blindness and brain damage.
During a professional lifetime, I can remember treating only one adult case of toxoplasmosis. I had one sad infant case, nearly 40 years ago now. The child had hydrocephalous and blindness due to choroido retinitis, which fits the bill of toxoplasmosis. That child did not survive long. That diagnosis was not established, but it sounds exactly like the type of problem that arises, not commonly but enough to cause concern in this country. Most doctors will not have met a known case of toxoplasmosis during a whole professional lifetime. However, the infection is not so rare that it never gets into the news. The publication Rolling Stone on 24th March 1971 reported:
Roy Harper, popular British singer and guitarist, almost had to delay a tour of Britain when he caught a rare (in humans) flu-like virus"—1276 That is wrong; it was not a virus—called toxoplasmosis while giving mouth-to-mouth resuscitation to a pregnant sheep".The disease is rare but as perinatal and infant mortality rates from all other causes decrease, further progress in reducing the risk to babies depends upon rooting out rare causes of death and disability so that they can be identified and eliminated. In most cases, that means prevented rather than cured, because treatment is too late.In France, again as the noble Baroness said, there is the same percentage of new infections in pregnancy, but a much higher prevalence in the country as a whole. In France, all mothers are screened when they book for pregnancy and again later in pregnancy. All women in France have to have a toxoplasmosis tests before they can obtain a marriage licence. Several other European countries routinely screen all pregnant women for toxoplasmosis. The noble Baroness mentioned Austria, but Finland and Denmark do so also, and I gather that Germany is planning to do so.
I have not seen the details of the multi-centre research programme mentioned in the Question, but it would seem to fall properly within the province of direct Department of Health-funded research through the Public Health Laboratory Service. Its reference laboratories are equipped properly to do the accurate Sabin-Feldman dye test which identifies the infection. It has the expertise. Blood is taken routinely from pregnant women during pregnancy. It is merely a question of sending it to the correct laboratory.
Unfortunately, with a fairly rare disease, large numbers of blood samples have to be examined to detect significant differences in rates which may vary around the country. For instance, 100,000 samples would be needed to detect 200 cases. That is probably the number needed to show any statistical significance. However, there are cheaper, less sensitive screening methods than the dye test. For instance, there is a skin test which might be used initially to screen for possible infected women, which would reduce the cost of the whole exercise.
It is not appropriate to discuss research methodology across the Floor of the House. But it is appropriate that the risks to the next generation of a disease which is known to cause blindness and mental retardation, and which is largely preventable but not so easily curable, should be known as precisely as possible. As the noble Baroness said, we are not asking for a full-scale screening programme, as in France, to be initiated without further consideration. We are asking that the Government should allow the evidence to be collected upon which to base a balanced decision as to whether we should start having a routine toxoplasmosis screening policy in pregnancy. Surely that is a reasonable request.
§ 7.26 p.m.
Barones TrumpingtonMy Lords, I am grateful to the noble Baroness, Lady Robson, for giving us the opportunity to explain the Government's policy on toxoplasmosis and our position on research, as well as for her forbearance in allowing me to take the place of 1277 my noble friend Lady Cumberlege. As the noble Baroness said, and as the noble Lord, Lord Rea, detailed, toxoplasmosis is a very unpleasant, albeit rare, disease in babies. As a government we must aim to prevent people, particularly pregnant women, from catching it.
The noble Baroness, Lady Robson, asks whether a large-scale study of toxoplasmosis in pregnancy should be established. It is our aim that centrally commissioned research should result in real improvements in services, and in improvements in the health of the population. For that reason, priorities for the whole of our research programme are reviewed regularly according to criteria, which include the extent and seriousness of the condition and the contribution which research can make into developing health policy.
We recognise that the birth of a child affected seriously by congenital toxoplasmosis is a tragedy for the child and for the family involved; but looking at it in terms of the epidemiological data, congenital toxoplasmosis is not a frequent problem. I should like to add to the knowledge of the noble Lord, Lord Rea: the number of babies born each year who are damaged by the disease probably lies between 15 and 50. A research study is currently under way based at the Institute of Child Health, and covering a number of regions. It is investigating the extent of long-term eye damage associated with congenital toxoplasmosis.
In 1992, a Royal College of Obstetricians and Gynaecologists multidisciplinary working group reviewed the case for prenatal screening for toxoplasmosis infection at our request. The group concluded that a national screening programme would not be appropriate because of the possibility that it might cause more harm than benefit.
The main reasons for its advice are, first, that there is uncertainty about the effectiveness of the treatment; secondly, that the currently available tests are not sufficiently sensitive and specific; thirdly, that, in order to detect infections occurring during pregnancy, testing would need to be repeated at regular intervals because women may become infected without having any symptoms; and, fourthly, but perhaps most worryingly, that there is a risk of unnecessary terminations.
The key issues are, therefore, reliability of testing and safety and effectiveness of treatment. A study of the epidemiology of toxoplasmosis in pregnancy may allow us to make more precise estimates of prevalence. However, it would not necessarily alter current conclusions on the balance of risk and benefit of a national screening programme or on the appropriate management of toxoplasmosis in pregnancy.
The report of the RCOG working party, which was published in 1992, included up-to-date information on management. The department funded distribution of the document, which was sent to all obstetricians. Recently, there have also been helpful review articles in journals such as the British Medical Journal. These will help doctors to keep up to date.
The noble Baroness, Lady Robson, asked for standard guidelines to be instigated by the Department of Health. It is not for the department to produce medical guidelines; that is the role of the relevant professional 1278 bodies, including the Royal Colleges. The department will consider commending to the health authorities clinical guidelines from professional bodies.
The main agency through which the Government support bio-medical and clinical research is the Medical Research Council. The noble Baroness will be well aware that the MRC receives its grant-in-aid from the Office of Public Service and Science under the Chancellor of the Duchy of Lancaster. It is an independent body which decides what research to support.
As regards toxoplasmosis, the MRC is currently funding two major studies. One is aimed at improving diagnosis in adults and the other at development of a vaccine. In addition to this MRC-funded work, universities and medical schools which are supported by public funding may also be funding research into toxoplasmosis. The MRC is always willing to consider scientifically sound proposals for research in competition with other proposals.
The Department of Health is not currently funding any research into toxoplasmosis. The department funds research through its centrally commissioned programme. As I explained earlier, research is funded according to agreed priorities, to inform policy and healthcare decisions. In addition, the NHS has a needs-led research and development programme, which identifies R&D needs in particular areas. The advisory group in mother and child health consulted a wide range of interested organisations, including the Toxoplasmosis Trust, to identify broad areas where research is needed. Priorities for R&D relating to mother and child health will be announced and the report will be widely disseminated in the New Year.
Barones Robson of KiddingtonMy Lords, I was not asking for research into how to treat toxoplasmosis; I was asking for a study of the incidence all over the country. That is quite different.
Barones TrumpingtonMy Lords, I am aware of what was asked for; I am merely putting forward a different aspect. I answered the noble Baroness's point by saying that it is not the role of the Department of Health to produce such guidelines; it is for the professional bodies. Perhaps I may continue because I have more encouraging news.
The most important challenge is to prevent toxoplasmosis infection, in particular in pregnant women. Although research is in hand, there is no short-term prospect of a vaccine and so our priority is to inform women of the simple measures that they can take when they are pregnant in order to protect themselves from toxoplasmosis. I am pleased to see the noble Baroness nodding in agreement.
Toxoplasmosis is preventable and there can be no substitute for hammering home the basic message of good old-fashioned hygiene. Handwashing is vital before and after food preparation and handling raw meat. Everyone, in particular pregnant women or those trying to conceive, should be aware that meat must be thoroughly cooked before consumption and that fruit 1279 and vegetables should be thoroughly washed. This applies especially to home grown vegetables if cats live in the neighbourhood.
Attempts to reduce the incidence of toxoplasmosis have concentrated on health education measures, in particular among pregnant women, and the Government have taken positive steps in this area. The department produces a leaflet called, While you are Pregnant—safe eating and how to avoid infection from food and animals, which contains information on avoiding toxoplasmosis. The Health Education Authority produces its pregnancy book, which also contains information on toxoplasmosis and which is provided to 1280 women when they first attend antenatal clinics. The Institute of Child Health is co-ordinating a multicentre European study on infection risk factors, which will further inform the advice given to pregnant women. We also greatly appreciate the achievements of the Toxoplasmosis Trust in educating the public in prevention; and the department provides core funding to assist the Toxoplasmosis Trust in its work. This amounted to £15,000 in 1994–95.
I hope that the noble Baroness and the noble Lord will understand from what I have said that the Government not only take the condition seriously but are actively supporting measures to fight it.
§ House adjourned twenty-two minutes before eight o'clock.