Now, as I’ve said, this isn’t unexpected. I know that one of the results of our online petition at the Welsh Government was that the Chief Medical Officer advised that if patients needed more frequent injections then they should supplement with oral tablets.
It’s a long and convoluted story that involves several agencies and I will do my best to explain the process although I will have to confine my report to the situation in the UK.
These are the people who will approve or reject the newly developed medicine; and they will take some convincing. Only after the new drug has been subject to many years of testing on volunteer patients, and a comprehensive investigation into any side-effects and any other possible complications has taken place will the evidence be placed before the MHRA. The MHRA is composed of various departments made up of highly skilled and knowledgeable doctors, pharmacists and other scientists. Visit their website and you will begin to understand the scale of the work that the agency is involved in. It’s they who are currently involved in the evaluation of e-cigarettes whilst at the same time producing new standards for blood transfusions. And it is the MHRA who will eventually be responsible for deciding whether any pharmaceutical company’s new 1mg or 2mg oral tablet will be safe to treat Pernicious Anaemia. The decision shouldn’t be too difficult as we know that 1 or 2mg tablets are used to treat the disease in other parts of the world.
The precedent has been set.
In a word it’s money.
Now we know that the British National Formulary (BNF), that little booklet that is produced twice a year by the Royal Pharmaceutical Society and the Royal Society of Medicine which acts as a reference for doctors to consult in order to treat patients correctly, used to recommend a 1mg injection of Hydroxocobalamin every month when the injection was introduced at the start of the 1960’s. For some reason, and I can find no scientific basis for this, that recommendation was changed in 1974 to an injection every two months and then in 1984 to every three months. When I met with the editor of the BNF a year or two again she told me that any change in the treatment would have been based on ‘evidence based research’. Yet I can find no evidence of this. I’m not calling anyone a liar – I just haven’t been able to find any papers that the decisions to change the treatment was based on. Some people say that because Hydroxocobalamin replaced Cyanocobalamin the treatment was changed because Hydroxocobalamin is retained longer by the body which is a highly suspect argument that I go into in my last book and so I won’t repeat it here.
And three of those ‘know when it’s due’ indicating that they are right at the edge of their treatment envelope.
Secondly, what about ‘wellness’? The patients’ blood may have returned to normal but that might not mean that they would do as well on tablets as they did on injections.
Thirdly, the recommended amount of B12 replacement therapy is based on a study that began in 1947 on just seven individual patients – 7!
There are other arguments I can make.
Then there’s other evidence such as where tablets have been introduced to treat patients with Pernicious Anaemia doctors still keep on prescribing the injections and anyway, patients are easily able to purchase injectable B12 from other sources and treat themselves. The British Medicine’s Act that stated that medicines that are injected are available only on prescription was passed in a world that was very different from today; a world without easy access to injections in pharmacies across the world or from internet sources. If my doctor stopped my injections and told me to take oral tablets I would simply carry on self-injecting and I suspect a great many other patients would do so too. And there’s one final piece of information in my arsenal – the recent Guidelines on treating Cobalamin states that injections remain the most reliable method of treatment and that patients would prefer them as they are tried and tested.