Health: Birth Defects

Lord Rooker Excerpts

Wednesday 6th November 2013 Lords Chamber

Asked by

[Lord Rooker]

To ask Her Majesty’s Government what assessment they have made of the impact of fortifying white flour with folic acid on the number of pregnancies affected by neural tube defects.

[Lord Rooker (Lab)]

My Lords, I am very pleased to have the opportunity to raise the subject of fortifying white flour with folic acid in the interests of public health.

Deficiencies in folic acid have been found to lead to neural tube birth defects, including spina bifida and hydrocephalus. It is both a national and an international issue. Public health policy has been to encourage those planning to become pregnant to ensure a voluntary input of folates, either by supplement or by folate-rich foods, in that crucial period covering conception and the first 12 weeks. However, this policy is known to fall on deaf ears in some socioeconomic groups, and does not cover the issue of unplanned or unintended pregnancies. In some countries, where bread is part of the staple diet, it has been found that fortifying bread flour with folic acid can cover both the issues of the target group and unplanned pregnancy.

Bread has been a staple food in the UK for centuries. Consumption has fallen a little but it still contains more than 10% of our daily intake of key nutrients and remains a major source of them. Since the 1940s, just after the war, most of our bread flour has been fortified with four added nutrients, and that is still the case today. On 5 August this year, at the start of the Recess, Defra announced the result of the consultation on the bread and flour regulations, which was that the mandatory fortification of flour will continue on health and scientific grounds.

The idea of folic acid fortification has been around for many years. I can confirm from my own personal experience that in 1999, as Minister for food safety—before my Food Standards Agency days—I was lobbied on the issue by a leading scientist during a journey to a food conference. My initial reaction was, “It’s mass medication”. But I soon realised it was not then, and it is not now. By 2007, Her Majesty’s Government had been advised by the independent Scientific Advisory Committee on Nutrition and the Food Standards Agency to go down the route of mandatory fortification. This advice was reinforced in 2009-10, during my term as chair of the Food Standards Agency.

Scientists involved in the research, such as Professor Nicholas Wald of the Wolfson Institute of Preventive Medicine, have chased the issue up over the years. Others, such as Professor Colin Blakemore, have raised more generally the issue of the lack of feedback from government on advice from scientists, where there seems to be no clear decision on policy or action to be taken, or not taken, on the basis of the advice. He cited folic fortification as a recent example.

Delay has been caused by some scientific doubts regarding the effect of too much folate in the diet, which might be the cause of some rare cancers. Justifiably, Ministers and Chief Medical Officers required reassurance on this aspect. I believe—and this is why I am raising the issue now, after leaving the FSA—that the publication in March this year of the paper by Vollset et al in the Lancet puts the concerns to rest. The study analysed data on 49,621 individuals in 13 evenly randomised trials and found that there was no significant effect of folic acid supplementation on the incidence of cancer of the large intestine, prostate, lung, breast or any specific site. Furthermore, in interpretation, the scientists pointed out that the fortification of flour and cereal products involves doses of folic acid that are on average an order of magnitude smaller than the doses used in the trials they examined.

On 1 July the noble Earl, Lord Howe, the Health Minister for England, told Parliament that Ministers were “taking stock”. Has that included talking to Ministers in the other three countries of the UK? More than 50 countries are fortifying flour with folic acid, including the United States, Canada, Iran, Argentina and South Africa. So far, none in Europe are, due to the concerns I have mentioned, which are no longer justified.

Australia introduced mandatory folic fortification in September 2009. It has been found, in a paper by Brown et al in the Medical Journal of Australia in January 2011, that,

“the introduction of mandatory fortification with folic acid has significantly reduced the prevalence of folate deficiency in Australia, including in woman of childbearing age”.

A study in the American Journal of Medical Genetics in 2010 found that food fortification with folic acid prevents neural tube defects but not other types of congenital abnormalities. The study covered more than 3 million births in Chile, Argentina and Brazil over a 25-year period, according to the authors, Lopez-Camelo et al. The paper by Blencowe et al in 2010 in the International Journal of Epidemiology concluded:

“The evidence supports both folic acid supplementation and fortification as effective in reducing neonatal mortality from NTDs”.

So it works.

The latest study, published earlier in the year in the Lancet, clears the way to vastly improve the health position in the UK. We start from a low position. England has the highest rate of unintended or unplanned pregnancies after the USA—well in excess of 200,000. As such, the women concerned will see no need for supplementation. So far as the pregnancies that are affected by neural tube defects are concerned, there are hidden and avoidable family tragedies involved.

The best figures I have—they are a little old but I am advised they are the best—are those used by SACN, the Scientific Advisory Committee on Nutrition, in its report, drawn to my attention by the Shine charity. In England and Wales, there were 178 neural tube defect-affected births from 853 neural tube defect-affected pregnancies. That means that there were 675 terminations. In Northern Ireland, there were 11 affected births and no terminations. In Scotland, there were 49 affected pregnancies with 50% terminations. That means that there were more or less 238 neural tube defect-affected births and 913 affected pregnancies, with around 700 terminations. These will be late, following the 20-week scan, when neural tube defects show. In summary, therefore, there are 150 to 200 babies born with neural tube defects leading to spina bifida and other conditions, with a total of 750 to 1,000 pregnancies. Eighty per cent of the neural tube defect-affected pregnancies are terminated.

Nothing I say diminishes my life-long support for a woman's right to chose, but it is self-evident that decisions for termination based on neural tube defect-affected pregnancies would decline with folate increases. More than one in 1,000 pregnancies in the UK is affected each year. Folic fortification has been shown in the countries that have a mandatory policy to have prevented between 27% and 50% of cases of neural tube defects. Based on these figures, we have a potential to save 100-plus neural tube defect-affected births per year in UK; and significantly we could prevent hundreds of late terminations every year. Putting it crudely, the current reduction in the number of babies born with neural tube defects is actually brought about by the termination of pregnancies. I do not like the idea that in the past some DoH officials have claimed that NTD is well managed.

The Prime Minister said at PMQs on 27 February that,

“conditions such as spina bifida have come down and that folic acid has an important role to play”.—[Official Report, Commons, 27/2/13; col. 311.]

They have “come down” as terminations go up, due to the rate of diagnosis getting more accurate. What we need is primary prevention. Putting folic acid in white bread flour is not mass medication. Those who wish to avoid it just avoid white sliced bread. It gets to the groups of women most difficult to get to.

I want to hear what assessment the Government have made of the impact over the past seven months while they have been taking stock of the operation in England and what discussions have taken place with the devolved Administrations and their Chief Medical Officers. It is better to have a UK solution, as I know that flour mills are not always in the most convenient locations for four separate policies.

The science policy advice to government is to do it. Scientific concerns have been raised and cleared. It is not mass medication; it saves lives and misery, and it saves money. It reduces the hidden cost of the present policy, namely the costs of terminations as a management tool. It produces more healthy babies and improves public health.

[Lord Wallace of Saltaire (LD)]

My Lords, one speaker has scratched. That will allow us to stretch speaking times from seven to nine minutes, provided that the next four speakers all observe that when 9 comes up on the clock, they stop.

--- Later in debate ---

[Baroness Jolly (LD)]

I am grateful to the noble Lord for securing this debate on this very important issue, and I thank all noble Lords for this thoughtful and informative debate. The department is considering this issue very seriously. We know that approximately one in every 1,000 pregnancies is affected by a neural tube defect, which can result in miscarriage, neonatal death or lifelong disability. We also know that poor folate status is an established cause of neural tube defect-affected pregnancies, and therefore how important folic acid is for women of childbearing age. I will take your Lordships briefly through the detail of how the Government are currently taking action to reduce the risk of women having insufficient levels of folate—a risk that may result in potential neural tube defects such as spina bifida in unborn children.

It is possible to get all the folate you need from food in a healthy diet, but for women who are trying to conceive or are newly pregnant, getting enough particularly matters. That is why, since the 1990s, the Department of Health has advised women who can become pregnant to take folic acid supplements before conception and for the first 12 weeks of pregnancy, and to increase their intake of folate-rich foods. That advice is promoted as strongly as possible through all the channels we use to communicate with women and health professionals. NICE guidance ensures that health professionals are equipped with comprehensive advice on folic acid and on action to take with women who may become pregnant.

For women, advice is disseminated through a variety of sources such as the NHS Choices website, which sets out why folic acid is important for pregnancy and gives guidance on taking supplements. The Department of Health also provides funds to the charity Tommy’s to produce The Young Woman’s Guide to Pregnancy, which advises young women to take folic acid. Start4Life, a campaign to give the best start in life to nought to two year-olds, gives information on five key healthy behaviours during pregnancy, one of which is taking folic acid and vitamin D supplements. Their leaflets are written in a friendly and accessible style and are very popular with healthcare professionals as a tool to facilitate conversation with parents and expectant parents. The NHS Information Service for Patients offers to send e-mails and texts to women and their partners in the fifth week of pregnancy to remind women to take their folic acid.

Folic acid supplements are widely available and cost as little as £1 for a month’s supply, but are also available on NHS prescription. Pregnant women and women who have had a child in the previous 12 months are exempt from prescription charges, as are people on certain benefits or those who qualify through the NHS low-income scheme. We also offer free vitamin supplements containing folic acid without an NHS prescription to pregnant women and new mothers in very low-income families throughout the UK who are supported by the Healthy Start scheme. More than 150,000 pregnant women and new mothers are eligible to claim vitamins through that scheme. However, we know that some women do not take supplements, and of those that do, some start too late. That is of real concern to the Government and health professionals, and an area on which the Chief Medical Officer is keen to see action, as she set out in her recent annual report.

In 2000 the Committee on Medical Aspects of Food Policy first recommended the fortification of flour with folic acid to reduce the risk of NTD-affected births. Your Lordships will be familiar with the developments of the scientific advice since then. The Government are very grateful for the full advice which has been provided by consecutive expert committees and for the rigour and scrutiny with which the Scientific Advisory Committee on Nutrition—better known as SACN—considered the issue for its report in 2006 and its subsequent reviews of evidence. The noble Lord, Lord Rooker, will know that SACN sought to understand and clarify the risks of fortification carefully as it sought to make clear the benefits of its recommendation.

The advisory committee concluded in 2006 that mandatory fortification of flour with folic acid would reduce the risk of NTD-affected pregnancies, but that there was a potential risk to some population groups, particularly older people, including a potential increased risk of bowel cancer. In 2007, the then CMO asked SACN to further consider the evidence in this regard. In 2009, SACN’s majority view was that the new evidence did not provide a substantial basis for changing the original recommendation. However, it recommended fortification only if accompanied by a number of other actions, including restricting voluntary fortification of foods with folic acid, developing guidance on supplement use for particular population groups, and implementing measures to monitor evidence of long-term exposure to intakes of folic acid above the guideline upper limit per day.

SACN’s recommendation about monitoring and review explicitly reflected concerns around the potential for the numbers of people consuming levels of folic acid above the guideline upper limit. Health Ministers considered it prudent to ensure that all available evidence on the risk of colon cancer was peer-reviewed and in the public domain, which noble Lords referred to earlier, and the evidence was published in the Lancet this January. Following publication, Ministers confirmed earlier this year that they were taking stock of the issue. I assure the noble Lord who, as former chair of the Food Standards Agency, will understand this better than many, that because of the complexity of the issue it is essential that we weigh up carefully the risks and benefits in coming to a decision, and that we fully think through the implications of the other recommendations made by SACN. We are now doing that, and, thanks to the expert scientific committees and the consideration of this by the FSA and others, there is a wide range of evidence and advice to consider.

I pay tribute to the work of the voluntary sector, and in particular to one organisation mentioned earlier in this debate, Shine, which supports individuals and families as they face the challenges arising from spina bifida. It works tirelessly to raise awareness of the importance of folic acid and in May this year held the first ever national Folic Awareness Day.

Noble Lords have asked many questions, and I will work through them in the time I have available. However, if there are any still outstanding I will be happy to write to noble Lords after the debate. The noble Lord, Lord Rooker, asked whether we had talked to Ministers in Scotland, Wales and Northern Ireland. As noble Lords are aware, food and health policies are devolved issues and discussions on fortification outside England are for those Administrations. However, the views of those authorities will be taken into consideration by Ministers.

[Lord Rooker]

I am sorry to interrupt, but this dismissal of devolution is symptomatic of Westminster; it just does not do devolution. Rather than simply saying that it is a matter for them, it would be better to have a UK-wide policy. Is the Minister admitting that Ministers in England—this is what we are talking about here—have not discussed the matter with Ministers in Scotland, who may take their own route, as they are free to do, and that the four chief medical offices have not discussed the issue among themselves?

[Baroness Jolly]

My Lords, I am telling noble Lords what I have been briefed. I am more than happy to write to noble Lords and, if they are happy for me to do so, leave the letter in the Library for everyone to check. I will also need to respond to the noble Lord, Lord Rooker, on his question regarding terminations.

The noble Countess, Lady Mar, asked about the risks and benefits, and assessing impacts, of fortification, giving due consideration to the implications of additional recommendations by SACN. We will take into account the views of the Chief Medical Officer, who raised the issue in her annual report, and of the devolved Administrations. The other point raised by the noble Countess was on ensuring that NTDs are avoided in pregnancy and on preventing vitamin B12 masking. We need to get this right. SACN considered the amount of folic acid to recommend and also recommended developing guidance on supplement use for particular population groups, along with implementing measures to monitor evidence of long-term exposure to intakes of folic acid. We are carefully weighing the benefits and risks of SACN’s recommendations and will take account of all views.

The noble Baroness, Lady Grey-Thompson, asked what foods would be considered for fortification. Currently, breakfast cereals are voluntarily fortified with folic acid in the UK. The FSA considered other foods, including soft drinks, fruit juice, milk and chewing gum, when it made that recommendation, but the consumption rate of these products is not considered to be universal across women of child-bearing age and would therefore not be suitable for fortification. Other foods were also considered. Bread was finally decided upon as the universal food as—to answer a point raised by both noble Baronesses—it is universally consumed across the population and all socioeconomic groups: more than 90% of households eat bread. Fortification of wheat flour would also include other wheat-based products such as pizzas, pastries and biscuits.

I think I have replied to several points that were raised.