§ 11 am
§ Mr. David Cameron (Witney)
I am delighted to have the opportunity to hold this debate, and congratulate the new Minister on his appointment. The debate follows an early-day motion that I tabled. It has been signed by 199 hon. Members from all parties.
Group B streptococcus, sometimes called group B strep or GBS, is the most common cause of life-threatening infection in newborn babies in the United Kingdom. I suspect that I am not alone among hon. Members in not having heard of it before becoming a Member of Parliament and holding surgeries. We all know about conditions such as Down's syndrome, spina bifida or epilepsy that can affect young children. We are familiar with infections such as HIV, which are screened for during pregnancy. GBS is less well known. It needs to be discussed and understood more fully.
I pay tribute to two brave parents, Craig and Alison Richards, who came to my surgery to explain how their son Owen had died soon after birth with a GBS infection. I also thank Jane Plumb and the charity, Group B Strep Support, which is doing excellent work in raising awareness and helping parents. It is good to see my hon. Friend the Member for Mid-Sussex (Mr. Soames) here, as I know how much he supports her work. Jane also lost her baby and is determined to ensure that other parents do not suffer in the same way. That should be our goal, too.
It is impossible to imagine the pain of parents who have suffered such a loss. They go from the high of seeing their new child born to the low of watching their child die, often in only a few hours. The early-day motion and the recent other publicity on GBS have led to many parents writing to their MPs, to me or to the Minister. They are all desperate to see something done. I want to use my time today to set out the facts about GBS, and to ask questions about what the Government propose to do about it. I do not expect the Minister to have all the answers today, but I hope that this debate marks the start of a process of giving the condition far greater attention in Whitehall and the NHS.
We are talking about largely preventable illnesses and deaths. It is estimated that GBS infects up to 700 babies a year—that is one in 1,000. It can cause septicaemia, pneumonia and meningitis, typically in the first days of life and up to the age of three months. About 10 to 15 per cent.—perhaps as many as 100 babies a year—die from the infection. It is difficult to deal with, because GBS is carried by up to 30 per cent. of adults without symptoms. It is a normal part of our systems that cannot be eradicated. It usually lives in the intestines. Up to 25 per cent. of women carry it at any time without problems or symptoms.
The problem is even more difficult to deal with, because babies are usually exposed to GBS shortly before or during birth. That happens to thousands of babies with no ill effects. It is not clear why some babies develop infections when others do not. A further twist in the tale is provided by the fact that, until now, a reliable test to find out whether an adult is carrying GBS has not been available to the general public. The available test gives positive results correctly 50 per cent. of the time. 265WH The Minister will know that that is no good. Results that should have been positive were wrong as often as they were right.
On the positive side, it is known that GBS infection can be prevented by giving women who carry it intravenous antibiotics from the onset of labour, or from when their waters break until the baby is born. According to Group B Strep Support,The recommended use of intravenous anti-biotics reduces the likelihood of early onset GBS infection developing in a baby born to a mother carrying GBS … from around 1 in 300 to less than 1 in 6,000.Risk factors can also show that a baby is at greater risk of developing GBS. They include waters breaking early, high maternal temperature during labour, or pre-term labour. Therefore, I suggest to the Minister that what is needed is relatively simple: an accurate test to find out whether pregnant women are carrying GBS. That could then be combined with the risk factors to ensure that antibiotics are given. Better still, all mothers carrying GBS could be offered the antibiotics. In that way, we could radically reduce the number of babies who die each year. That is what the issue comes down to.
Until now, reliable tests have been available in the UK only for research purposes, despite the fact that they are not that difficult or expensive to carry out. I will spare hon. Members the details, but it is a matter of taking swabs and placing them in an enriched culture. They have been available in other countries for some time. The US now routinely screens pregnant women late in their pregnancy. The new tests are very accurate and are now available in the UK. OmniLabs Pathology Services is offering them for £18 per test. Nothing comparable is available on the NHS and women can obtain the new service only on the authorisation of a health professional, not all of whom are fully briefed about this vital issue. There is a strong case for urgent action.
I must say to the Minister that the letter that I first received from the Department of Health about the issue on 28 April this year was slightly complacent. It was all about the work of the UK National Screening Committee, rather than GBS. I should have thought that, when a condition is killing 100 babies a year, it would receive more attention. GBS was mentioned just once. The letter explained thatThe current position on screening for GBS is that it should not be offered to pregnant women except in the context of a research project approved by an ethics committee. However, evidence on screening will be reviewed by the NSC by March 2004 following a Paediatric Surveillance Unit Study.At present, we do not even seem to be doing enough for pregnant women who display the early warning signs or the risk factors. In the case of one couple who e-mailed me, their first child had a GBS infection but survived. The second died. I shall tell the House what happened, because it brings home the problem. The e-mail said:My wife gave birth to our second child, a beautiful girl called Erin Clare on the 29th May 2003 … She was 3 weeks premature. Erin died … on the 2nd July 2003 from subdural hemorrhage and group B Streptococcus septicemia. This is extremely painful for us as our first child, Thomas spent 3 days in intensive care due to this infection, he fortunately survived and is fit and well. Despite us 266WH telling the maternity staff … of this fact when my wife was admitted to have Erin, no antibiotics were given during the period her waters had broken or during the labour.That brings home the point that the parents are legitimately asking why antibiotics were not given automatically in the case of the second child.
Testing is routine in the USA, Canada, Australia and parts of Europe. In the United States, the use of antibiotics for at-risk pregnant mothers has brought down the death rate by 70 per cent. We must use their experience rather than feel that we have to replicate all the research. As Robert Feldman, the chairman of the medical advisory panel of Group B Strep Support, said:why do the UK authorities feel they have to undertake detailed, costly and complex independent assessments of the need to screen for GBS carriage (including performing research much of which has already been done elsewhere) when so many other countries have already adopted screening and seen the incidence of GBS infections fall?I accept that there are some differences among medical practitioners about the matter. The Royal College of Obstetricians and Gynaecologists wrote to me, welcoming the debate that I have helped to start. However, it said:Before recommending routine antenatal screening of all pregnant women in the UK, clear evidence is required to demonstrate that it does more good than harm and that the benefits are cost-effective.Surely, again, the answer is to look at the evidence from abroad, rather than waiting too long for our homegrown evidence. In fact, the letter provides a clue about what should be done. It opens with the sentence:GBS … can have … fatal consequences for newborn babies if not identified promptly and managed appropriately.I absolutely agree, but waiting to treat sick babies is too late. How can we identify the babies at risk without screening the mothers while they are pregnant? How can we manage the problem without more training and dissemination of information? Robert Feldman says:'I challenge anyone to produce a scientific paper showing that it is not clinically effective, and I can produce several to show that it is. The same significant drop in rates of neonatal GBS infection has been shown in lots of studies. As to cost effective: it depends how much value you put on babies" lives. I suppose if you value them at £0, it isn't cost effective. But there are lots of more expensive tests available to pregnant women, often for conditions that are much rarer or that can't be treated.This condition can be treated.
Let me ask the most important questions on the issue. First, why is there no proper provision for telling pregnant women about the risks of GBS infection? The number of children who suffer from infections and of those who die justifies more information being given. That is illustrated clearly on all the relevant websites, many of which I have visited.
Secondly, why is no comprehensive briefing and information given to the relevant health care professionals—the GPs, midwives, community nurses and others? I have received letters and e-mails from parents who have had problems with that, saying, "Why was the proper information not given to our health professionals?" So much information is provided about the different syndromes from which children suffer. There are reams of information in general practitioners" surgeries about what to do and what not to do during pregnancy. GBS, however, seems to be ignored.
267WH Thirdly, will the Government consider a comprehensive screening programme, especially now that a proper, reliable test is available? In an ideal world, such a test should routinely be offered to all pregnant women. That would cost money, although as it became standard, the costs would fall. In the short term, however, should not GPs, midwives, community nurses and others advise mothers about the availability of the test?
Let me add a word about the cost. At present, the 600 babies a year who get a GBS infection and survive must cost the NHS a small fortune. Much of the cost of the additional care, medicine and attention that they receive is preventable, to say nothing of the pain that the child will suffer, or the parents" anguish.
I know a little bit about this, being the father of a 15-month-old baby with epilepsy and cerebral palsy. He is in and out of hospital on a monthly basis with endless complications and infections. I have cost the NHS a small fortune. I will always be grateful to it for the care that we have received, and for the vast amount of equipment, medicine, syringes, pumps, specially designed chairs and other paraphernalia that are stacked up in my kitchen now that my child is back at home. His case had nothing to do with GBS, or any preventable illness, but it reinforces in my mind the need to keep children and their parents out of hospital if that is possible.
Group B Strep Support's aim, which I support, is for the routine test to be offered to all pregnant women, with those who are found to have GBS at the 35 to 37-week stage being automatically offered intravenous antibiotics. Even if the Government moved to an interim stage, offering antibiotics to those who tested positive and showed a risk factor, the lives of perhaps half the babies who would otherwise die each year—around 100—would be saved.
Why does not the Minister go the whole hog and try to cut completely the dreadful figures for babies getting infections and dying? I hope that he will give us some clear answers. What is the Government's attitude to the new test, which is now available? What estimates have they made of the cost of introducing it? When does the Minister believe that decisions will be made about this vital issue? Why is the handling of GBS so different throughout the country? From so many of the communications that I have had, it emerges that there is no proper nationwide programme for dealing with the condition.
I hope that the Minister will show great urgency over the issue, will tell us that action will be taken and will, at least, set out a timetable for making the right decisions. I look forward to hearing his reply.
§ Dr. Evan Harris (Oxford, West and Abingdon)
We are all grateful to the hon. Member for Witney (Mr. Cameron) for securing the debate.
I was contacted at around the same time as the hon. Gentleman by two of my constituents from Abingdon who raised concerns about the infection and the effect that it can have on families and society as a whole. I wrote to the Department of Health and received a similar—I suspect identical—reply to the one sent to him.
268WH I should like the Minister to tell us why the Government have not yet instituted a screening programme, and what is their policy. For a screening programme to be introduced, there must be a sufficiently specific, sensitive test that is acceptable and safe. I understand, and I should be grateful if he would confirm, that the low vaginal swab with enrichment meets those criteria. Is there an efficacious intervention after screening that would make it useful for that to be carried out? I believe that there is. There is good evidence that antibiotic prophylaxis would be efficacious for those who have been positively identified as carrying group B strep. The risks are minimal, although the Government, in their letter to me of 8 April—and to the hon. Member for Witney—talked in two parts about risk. The risk of antibiotic anaphylactic reactions is small compared with the benefit. The key question is whether it is cost-effective.
Will the Minister clarify the best estimate of the cost-effectiveness of a screening programme? The Royal College of Obstetricians and Gynaecologists says that 7,000 colonised women would need to be given prophylaxis to prevent one neonatal death from GBS, and that that would require the screening of 24,000 women. It is capable of producing a cost-effectiveness analysis of the programme, but the latest evidence should be made explicit now. The Government can then say that that is why they will not introduce the programme or that they may consider doing so when the National Screening Committee has finished its work. I should be grateful if the Minister could be explicit and specific on that issue.
§ The Parliamentary Under-Secretary of State for Health (Dr. Stephen Ladyman)
I thank the hon. Member for Witney (Mr. Cameron) for welcoming me to my post, for taking the matter so seriously and for organising the campaign. I must confess that, until I took up my job and read the letters to Members of Parliament from the many constituents who have been following his campaign, I was not aware of the seriousness of the issue. I assure him that I shall take it extremely seriously.
I wish to make a promise at the outset: I have an open mind about the matter. I shall be detailing some of the work that I have asked to be done thoroughly and openly. If the results of that research show that the Government's position needs to change, I assure the hon. Gentleman that it will change. I shall take his comments and the results of the research seriously. I also thank the hon. Member for Oxford, West and Abingdon (Dr. Harris) for his speech. If I do not deal with the matters that he raised in sufficient detail, I shall write to him and to the hon. Member for Witney. I also congratulate the hon. Member for Mid-Sussex (Mr. Soames) on his role in the campaign. I shall copy to him any letters that I write as a result of the debate.
I wish to summarise the Government's position. We understand completely the heartache caused by a losing a child, and we want to minimise it as much as we can. The high point of my emotional life was the birth of my daughter, and I cannot imagine the pain that I would have felt if I had lost her soon after birth. I fully sympathise with people who have experienced such problems.
269WH As a Minister, I must ask myself whether the introduction of a new process that will involve the routine screening of all women and—as implied by the hon. Member for Oxford, West and Abingdon—the possible use of prophylactic antibiotics could do more harm than good. The hon. Gentleman said that the risks of anaphylactic shock as a result of prophylactic antibiotics is minimal. We estimate that one in 100,000 mothers will die as a result of prophylactic antibiotics. Given the number of people who we estimate will be receiving prophylactic antibiotics, that means that approximately three mothers will die every two years.
I must be sure that, if the Government introduce the use of prophylactic antibiotics, the benefits will outweigh the fact that three mums will die as a result of the policy. In addition, significantly more mums will have anaphylactic shock during labour, and their babies might be affected by the process. I must be sure that by doing this we are going to save more babies than we harm. That is why the Government are saying that we are not yet convinced of the need to introduce a routine screening and prophylactic process. We have asked for the necessary research to be done, and I assure hon. Members that I will look at that carefully and with an open mind.
There were 377 cases of group B streptococcus in babies out of nearly 600,000 births when we last did a survey in 2001. Of the babies affected in 2001, 39 died. That is the number of babies that we have the potential of saving if we can find the procedure that will save all of them. We estimate that prophylactic antibiotics might save 50 to 60 per cent. of those 39 babies, so we can say that about 20 babies might be saved. However, the use of prophylactic antibiotics would put at risk 16 babies as a result of their mothers going into anaphylactic shock. I hope that hon. Members are beginning to see the tight balance that we will have to strike when the research comes through.
The UK National Screening Committee advises Ministers about all aspects of screening policy. In forming its proposals, it draws on the latest research evidence and the skills of convened multidisciplinary expert groups. It assesses proposed new population screening programmes against a set of internationally recognised criteria. The condition, the test, the treatment options, the effectiveness and the acceptability of the screening programmes are all matters that the NSC advises me on. Assessing screening programmes in this way is intended to ensure that they do more good than harm, and at reasonable cost.
It was said that in the private sector the test costs about £18 a time. If we were to do that nationally for 600,000 people, the price would come down, but even if we could say that it will come down to half that price, we are still talking about £6 million. That is not an insignificant price: I accept that in the context of saving babies" lives it does not look like a great cost, but it is still a significant amount of money.
In the case of group B streptococcus, the NSC currently advises that routine screening should not be offered to all pregnant women. There is insufficient evidence to demonstrate that routine screening, and treating those carrying the organism with intravenous 270WH antibiotics during labour, would be beneficial. There have been no randomised controlled tests comparing different screening strategies—for example, comparing antenatal screening with no antenatal screening, or comparing outcomes of screening with current UK clinical practice. In more than half of all neonatal infections, it is not possible to identify the organism responsible through laboratory culture tests. No study has yet been able to show an impact on neonatal infections overall from screening for group B streptococcus.
Further research is needed in the UK setting. That is being considered. The NSC has commissioned an assessment of the existing evidence of screening for group B streptococcus in pregnancy against the criteria used to assess potential screening programmes. I have asked for that to be done thoroughly and as quickly as possible, and I have asked the NSC to consider the recommendations at its December meeting.
The health technology assessment research and development panel considers research into screening for group B streptococcus to be a high priority for further research, and it will consider more detailed information on commissioning further research at its December meeting. The HTA programme is also currently considering detailed proposals for research into the effectiveness of a rapid test for group B streptococcus carriage that could be used during labour.
The Royal College of Obstetricians and Gynaecologists has commissioned a draft clinical guideline on the prevention and treatment of early onset neonatal group B streptococcus disease. The draft guideline, which is currently on the RCOG website, is expected to be finalised by the end of 2003. I hope that that will give some reassurance about what we are trying to do to ensure that professionals have advice about this situation.
That guideline currently states that routine screening for antenatal GBS carriage is not recommended. The draft guideline by the National Institute for Clinical Excellence on antenatal care does not recommend screening all women for GBS as part of routine antenatal care either. We are aware that antenatal screening takes place in the United States. The US guideline recommends screening at 35 to 37 weeks. It involves rectal and vaginal swabs and treating all carriers of GBS thus identified with intravenous antibiotics during labour to reduce the risk of early onset GBS. Other strategies employed include giving out antibiotics in labour to those women with risk factors for neonatal infections without screening, or a combination of the screening and risk factors approach.
Research in the United States population may not be applicable to the different circumstances of the United Kingdom. As the hon. Gentleman said, we should not reinvent the wheel and repeat the research, but the screening procedures used in the US and Australia reduce the level of GBS in those countries only to the level that we achieve without any screening programme. There is clearly something different about the US situation. We have to find out what it is. It might have something to do with the more routine prophylactic use of antibiotics in food or the antenatal care in the US. The fact remains that this screening process and the use of prophylactic antibiotics only brings the US to our level. We have to understand that before we can move 271WH forward. We do not import the foreign learning because we are not convinced that it will apply to the United Kingdom.
§ Mr. Cameron
I am grateful to the Minister for his open-minded approach. He has clearly thought about this a lot. Will he undertake to hold a meeting with mothers who have suffered in this way and who are quite anxious to come to Parliament to make their views known? Perhaps he could do so when some of the evidence of the research is available. He could explain to them some of the points that he is making now. Will he keep his mind open in the meantime?
§ Dr. Ladyman
I am absolutely happy to do that. I invite the hon. Gentleman to lead that delegation. As soon as he thinks that the time is right, I will be happy to talk to him and other colleagues who are here today if they wish to join the delegation.
The screening test that is used in the United States is unpleasant—it involves rectal and vaginal swabs—and a substantial number of carriers may be missed. We would have to introduce a screening programme for all pregnant women, which would involve 650,000 sets of rectal and vaginal swabs each year. We would end up identifying about 160,000 women a year—a quarter of all pregnancies—who would require prophylactic antibiotics.
I recently appeared before the Health Committee Maternity Sub-Committee. Its message to me was that it wants births to be as natural as possible. It wants women to have as much choice as possible. It wants them to be able to have home births or to move around the ward when they are in labour. If we start down this route, 160,000 women will immediately be put on intravenous drips during labour. Many will not want that. They will find it restrictive.
§ Mr. Nicholas Soames ( Mid-Sussex)
In the excellent speech of my hon. Friend the Member for Witney (Mr. Cameron) and the Minister's reply, mention has been made of the disparate way in which the matter is handled throughout the United Kingdom. I am still awaiting a reply from the chief medical officer on behalf of the group whose headquarters is in my constituency. Would the Minister say a little about the alternative ways in which it is handled throughout the country?
§ Dr. Ladyman
I will certainly ensure that the chief medical officer replies to the hon. Gentleman. I will undertake to get hold of that letter and circulate it among the three hon. Members present, if that is an acceptable way of dealing with the matter.
It is estimated that one in every 10,000 women treated with prophylactic antibiotics would have a serious anaphylactic reaction. That means that 16 babies would be affected by their mother going into anaphylactic shock during labour. I was flicking TV channels last night and saw one programme that showed a woman doing just that. It was extremely unpleasant, and she came close to death. We would have to take that into account if we introduced the routine use of prophylactic antibiotics, and
It being half-past Eleven o"clock, MR. DEPUTY SPEAKER suspended the sitting until Two o"clock.