If you take these drugs which cut your stomach acid by around 90%, you might want to look at the piece wrote earlier in the week for the Daily Mail about the serious side effects they can cause. In the short-term they do of course bring almost instant and blessed relief from the really nasty pain of heartburn and because more and more people are reporting heartburn (obesity makes it more likely) they are now among the most commonly prescribed drugs.
The conventional medical attitude is that their side-effects are relatively mild and reversible and since the drugs are now off-patent, the price has plummeted so they are often given out on a prophylactic basis. But the emergence of a range of nasty side effects with long-term use described in the article – such as dangerously low levels of magnesium, raised risk of infection with the super-bug C.difficile, weaker bones and possibly increased chance of cancer and heart disease – vividly highlights serious shortcomings in our current system of evidence based medicine.
The first failure is that it is pretty poor at picking up side-effects anyway. The so-called “gold standard” randomised controlled trial (RCT) is rarely more than six months – not nearly long enough to spot problems that take time to develop, such a magnesium deficiency. But then once a new drug is released onto the market, patients’ reports, however many there are of them, don’t count as real scientific evidence. They are merely anecdotes. Dr David Healy in his recent book Pharmageddon has a lot of detail on this and has set up a new website to give these “anecdotes” more authority.
More fundamental is the fact that mineral and vitamin deficiency doesn’t feature on most doctors’ radar. Both UK and American drugs watchdogs – the MHRA and the FDA – have recently warned about PPIs and magnesium deficiency and recommend that patients being put on one of them long-term should have magnesium levels checked. But how many doctors will do this? There is widespread scepticism about the need for any kind of mineral or vitamin supplement. How often have you heard them dismissed because: “You can get them all from a healthy balanced diet”.
Not only is the idea that drugs can block the availability of minerals and vitamins barely recognised, but the symptoms of magnesium deficiency - extreme fatigue and weakness, cramps, fits, loss of appetite and an irregular heartbeat – could have a variety of causes. This means deficient patients will be put through a range of tests to get to the bottom of their problem. Unfortunately testing for mineral and vitamin deficiency is hardly common practice and magnesium is not part of regular blood tests.
But it gets worse. Magnesium is not the only nutrient blocked by PPIs. They also reduce availability of vitamin B12 – something else that older people are at risk of anyway, making it hard to finger PPIs as the cause and so stop them. In fact, given that stomach acid is needed for effective digestion, it is likely that PPIs can cut availability of many other nutrients as well.
What’s needed of course are trials to find out what is going on. But they are very unlikely to be done under our current EBM system. In theory, if it could be shown that both magnesium and B12 deficiency was widespread in PPI patients ( a big “if”), the MHRA could ask the companies to run trials. But that is not going to happen now because these drugs’ patents have run out and the companies are no longer responsible.
So we have millions of patients getting these drugs every year, all prescribed in accordance with the principles of EBM. Some have been on them for two decades or more and the number of long-term users is likely to keep rising. One reason for this – mentioned in the article – is that these drugs may make your heartburn worse when you stop taking them. A state commonly known as addiction.
So could this be a major health disaster? We have no way of knowing, now or in the future, because no one with the money to run trials to find out will pay for them. In response to the kind of questions patients have a right to expect answers to – such as: Just how serious is the risk? Who is most likely to be affected?”- our EBM system can only remain silent.