Medicine in the Loaf

On the 13th December this year, a small change will take place in every mill in the United Kingdom that produces white or brown wheat flour. From that day, each hundred grams of it must contain 250 micrograms of pteroylmonoglutamic acid, better known as folic acid. There will be no announcement at the bakery counter. The sliced loaf, the crumpet, the pizza base and the digestive biscuit will look and taste as they did the week before. But everyone who eats them – man, woman and child, the pregnant and the elderly, the healthy and the sick – will from then on be taking a daily dose of a substance chosen for them by the Department of Health.

The law that brings this about is the Bread and Flour (Amendment) (England) Regulations 2024, with matching instruments for Scotland, Wales and Northern Ireland. It is a statutory instrument, which means that it was made by a minister under powers granted long ago, and laid before Parliament rather than debated by it. So far as I can discover, no Member of either House ever voted on it. Its explanatory note records that the only formal assessment of its effects was a “de minimis” estimate of the costs to business. The minister for public health announced the details in a written statement in November 2024. That was the whole of the democratic process.

I should explain at once where I stand, because the argument now raging about folic acid is conducted almost entirely in terms that do not interest me very much. On one side, the Government and most of the medical establishment say that fortification will prevent about two hundred cases a year of spina bifida and similar defects, and harm no one. On the other, a group of doctors associated with the Health Advisory and Recovery Team – HART – say that the benefits are exaggerated, that the harms have never been properly assessed, and that the one large trial on which the policy ultimately rests shows an excess of dead babies. I have spent some days reading the evidence, and I will summarise it below. But I will say now that I do not think the answer matters to the question that ought to matter. Even if every claim made by the Government were true, and every claim made by its critics false, I should still object to what is being done.

The case for

Neural tube defects arise in the first four weeks of pregnancy, when the tube that becomes the brain and spinal cord fails to close properly. The results range from the mild to the fatal. Anencephaly, in which most of the brain is absent, is incompatible with life. Spina bifida can mean lifelong paralysis, incontinence and hydrocephalus. The defects have always been commoner in the British Isles than in most of Europe, and for much of the twentieth century they were a serious cause of infant death and disability here.

The case for folic acid began with a trial run by the Medical Research Council and published in 1991. Women who had already had an affected pregnancy were given four milligrams of folic acid a day around the time of conception, and the rate of recurrence fell by about seventy per cent. The trial was stopped early because the result was so clear. The following year, a Hungarian trial led by Andrew Czeizel and István Dudás gave women planning a first pregnancy a multivitamin containing 0.8 milligrams of folic acid, and reported six neural tube defects in the control group against none among those given the vitamins. A Cochrane review published in 2015, pooling the trials then available, concluded that folic acid before conception reduces the risk of these defects by roughly two thirds.

Since 1992, British women have therefore been advised to take 400 micrograms of folic acid a day from before conception until the twelfth week of pregnancy. The difficulty is that the defects have formed before most women know they are pregnant, and something like half of all pregnancies are not planned. Most women do not take the supplements at the time they would do any good. Fortification is the answer that public health officials have favoured since the 1990s. The United States made it compulsory for enriched grain products in 1998, Canada at about the same time, and around eighty countries now have some form of it. The American authorities credit it with a fall of about a quarter in the prevalence of these defects. Our own Scientific Advisory Committee on Nutrition recommended it in 2006 and again in 2017. The Government’s figure of two hundred cases a year, or about a fifth of the United Kingdom total, is a model rather than a count. But it is not an unreasonable model.

The case against

The critics make a number of claims. Some are stronger than others, and in fairness to both sides it is worth separating them.

The strongest concerns the Hungarian trial. HART points out that, in addition to the six defects apparently prevented, there were more fetal deaths of every kind in the vitamin group: miscarriages, ectopic pregnancies, very early losses and stillbirths. On their figures, the total was 374 against 304, an excess of seventy. They argue that folic acid may reduce the number of children born with neural tube defects partly by causing the affected embryos to die before birth – a process that has been called “terathanasia”. This is not a new suggestion. It was debated in The Lancet in 1997, when the geneticist Ernest Hook, who had developed the idea, defended it against colleagues who thought the excess could be explained by better recognition of early pregnancies among women who were being closely watched. HART describes the term as coming from the trial’s own principal investigator. So far as I can see, it came from Hook. But the point stands that it was raised by serious people and never conclusively answered.

It is also fair to add two qualifications. The first is that the Hungarian women were not given folic acid alone. They took a multivitamin with a dozen other vitamins and several minerals, while the control group took a supplement of trace elements. Whatever caused the excess, if there was one, it need not have been the folic acid. The second is that later studies have not found the same effect. An American and Chinese study published in The Lancet in 2001, covering about 24,000 women who took 400 micrograms of folic acid alone, found miscarriage rates of 9.0 per cent among those who took it and 9.3 per cent among those who did not. The Cochrane review found no statistically significant increase in miscarriage. The terathanasia hypothesis is not absurd. Neither is it established.

The second claim concerns cancer. HART says that analysis of ten randomised trials showed an increase of 23 per cent in cancers and 24 per cent in prostate cancer. I could not trace the first figure. The second appears to come from a Norwegian meta-analysis published in BMJ Open in 2012, which did find a statistically significant increase of 24 per cent in prostate cancer, though the increase in cancer overall was only seven per cent and of borderline significance. A larger analysis published in The Lancet the following year, covering some 50,000 people in thirteen trials, found a six per cent increase in cancer that was not statistically significant, and a fifteen per cent increase in prostate cancer that was not significant either. Its authors concluded that folic acid did not substantially alter cancer risk over five years. They also pointed out that the trials used doses from half a milligram to five milligrams a day, which is to say an order of magnitude more than fortification is expected to add to the average diet. Our own advisory committee called the evidence on both colorectal and prostate cancer “inconclusive”. This is not the same as saying that there is no risk. It is an admission that no one knows.

The third claim is that folic acid is dangerous for particular groups of people. Here the critics are on firmer ground than they are sometimes given credit for. The NHS itself tells anyone with cancer, a coronary stent, or vitamin B12 deficiency or pernicious anaemia to check with a doctor before taking folic acid. The classic worry is that folic acid can correct the anaemia caused by lack of B12 while leaving the neurological damage to progress unnoticed. The advisory committee found that this did not seem to have happened in America after fortification. But the NHS advice remains, and from December those to whom it applies will have no practical means of following it unless they give up most bought bread, cakes and biscuits.

The fourth claim is that folic acid “is not a vitamin” but a synthetic compound, and that many people convert it poorly because of variants in a gene called MTHFR. The first part is a quarrel about words. Folic acid is a synthetic form of folate, which is the vitamin, and the body must convert it before it can be used. The second part seems to me muddled. The step that limits conversion is carried out by a different enzyme; the MTHFR variants affect a later stage in the use of all folates, natural and synthetic alike. It is true that unmetabolised folic acid can be found in the blood of people who take a lot of it. The advisory committee said in 2017 that there was not enough evidence to know whether this does any harm.

That, as best I can make it out, is the state of the argument. The benefits are real but modelled. The harms are possible but unproven. A reasonable person might come down on either side, or on neither. And this is exactly why the matter should have been left to reasonable persons.

The principle

Consider how the same substance is treated in a doctor’s surgery. Since the judgment of the Supreme Court in Montgomery v Lanarkshire Health Board in 2015, a British doctor has been under a legal duty to tell a patient about any material risk of a proposed treatment, and about the reasonable alternatives, and to let the patient decide. The standard is not what doctors think a patient needs to know, but what a reasonable person in the patient’s position would want to know. A woman offered folic acid tablets by her general practitioner is entitled to ask about miscarriage and cancer, to hear that the evidence is uncertain, and to say no.

The same woman buying a loaf at Tesco will be told nothing and asked nothing. She will not see the words “folic acid” on the front of the packet, and is unlikely to read them in the list of ingredients. If she does, and wishes to avoid them, she must switch to wholemeal bread, or to rye or spelt, or to flour from one of the few mills small enough to be exempt. Organic flour gives her no escape, since the organic standards permit fortification where the law requires it. Nor may unfortified white flour be imported. Everything she eats in a café, a canteen, a hospital or a school will be made with the fortified kind. What would be an assault if done by a doctor without her consent becomes public health when done by a minister to sixty-nine million people at once.

The defenders of the policy have an answer to this, which is that it is not medication at all but nutrition, and that we have been adding things to flour for generations. They are right about the history. Calcium was first added to British flour during the last war, when the “National Loaf” was made from coarse, high-extraction flour that was thought to interfere with the absorption of calcium and to risk an outbreak of rickets. Iron, thiamine and niacin followed. The emergency passed, the National Loaf was abolished in 1956, and the additives stayed. They are all still required by the 1998 regulations that have now been amended.

But this is not an answer. It is a description of how the thing is done. A power is taken in an emergency, or for a purpose that no one could object to. It becomes part of the ordinary furniture of government. Then, when some fresh purpose arises, the machinery is already in place and nobody can remember that it was ever questioned. The fortification of flour with calcium in 1943 is the precedent for folic acid in 2026. Folic acid will be the precedent for whatever comes next. Water is being treated in the same way. Fluoride has been added to the supply of about a tenth of the English population for decades, and in 2022 the power to order it was moved from local authorities to the Secretary of State, who has since approved extending it across much of the North East. Vitamin D is the obvious next candidate, and there are already calls to add it to flour as well.

There is a further point that I find particularly distasteful. The people who will be medicated are, overwhelmingly, the people who eat cheap white bread. The prosperous, who buy wholemeal sourdough from artisan bakers, will be largely unaffected, and those who understand the regulations will be able to avoid them. It is the poor, the old and the busy who will take their daily dose without knowing it. They will also be those least likely to read articles like this, or to have a doctor who will explain why someone with a coronary stent might wish to be careful. It is not the first time that the British state has treated the working classes as a population to be managed rather than as citizens to be persuaded. But it is rare for it to be so candid about the reason. Flour was chosen, the Government explains, because 99 per cent of households buy it. That is to say, it was chosen because it cannot be avoided.

The ancestral temptation

I am of Chinese descent, and there is something in all this that I recognise. Chinese political thought had a phrase for the county magistrate: he was the fumu guan, the “father-and-mother official”. The emperor was the father of the people, and his officials stood in the place of parents to those beneath them. They were to feed them, correct them, keep them from harm, and decide on their behalf what was good for them. The ideal was often benevolent, and sometimes it was even achieved. But it rested on the assumption that the people were children, and that the relationship between ruler and ruled was one of care rather than consent.

English liberty was built on the opposite assumption. The subject was not a child, and the Crown was not his parent. He might be a fool, and he might make choices that harmed himself, but they were his choices. The long argument over compulsory vaccination in the nineteenth century ended, in 1898, with Parliament conceding a right of conscientious objection, because even a Victorian government accepted that there were limits to what could be done to a man’s body without his agreement. I do not think that, in the twenty-first century, a Chinese-style paternalism should be quietly revived in Whitehall, with the magistrate replaced by a committee of nutritionists and the imperial rescript by a statutory instrument.

Nor was compulsion necessary. If the Government believes that folic acid prevents spina bifida, it has other means available. It could give the supplements away. It could advertise them far more energetically than it does. It could encourage the millers to sell fortified flour, clearly labelled, alongside unfortified flour, and let people choose. The Real Bread Campaign has asked for a simple change that would allow any mill to produce some unfortified white flour. Even that modest request has been refused. The reason, I suspect, is that the officials know perfectly well that many people, given the choice, would not choose what they have chosen for them. That is not an argument for compulsion. It is an argument against it.

Conclusion

It may be that, in twenty years, the fortification of flour with folic acid will be regarded as a great and harmless public health achievement, like the draining of the marshes or the building of sewers. It may be that it will be regarded as a mistake, like the thalidomide that was also prescribed to pregnant women with the best of intentions. I do not know, and I suspect that neither do the people who have made it compulsory. The honest answer, on the present evidence, is that it will probably do some good for a small number of people and perhaps some harm to a small number of others, and that for everyone else it will make no noticeable difference at all.

But that is not the question. The question is whether a government may put a substance into the daily food of an entire nation, because it believes that substance will benefit a small minority, without asking Parliament, without assessing the risks to everyone else, and without leaving any easy means of refusal. The answer, in any country that still regards its citizens as adults, ought to be no.

On the 13th December, I shall buy wholemeal.