A discussion/debate posted by Nia Griffith (Llanelli, Labour). UK Article
The basic argument of this article touches on how to make a drug that has existed since the 1980's, deemed safe at 50mg, now being used at a low dose, between 1mg-4.5mg (obviously safe at .5 % - 3% of the 50mg dosage), with low to no side-effects,modestly priced and effective for the treatment of many disorders and diseases (some of these include but not limited to MS, Crohn's Disease, Lupus, AIDS, Cancer Ect.,)
The problem is that the FDA in the US and the administration of food & drugs in other countries have only approved naltrexone at the 50mg dosage; making it difficult to prescribe and only certain pharmacies, called compounding pharmacies, must be used to fill the prescription. The compounding pharmacy will be able to take the 50mg tablet to a 1mg, 3.5mg ect.
The other issues that exist with naltrexone, is that many doctors do not know the benefits of the low dose naltrexone (LDN) and how effective it is as a treatment for many conditions, which in my opinion is the worst barrier there is because of the lack of knowledge. Having zero knowledge about such a safe and effective drug that could be a possible treatment for so many difficult to treat diseases is disturbing.
THE ISSUE: HOW can this drug become more readily available so people can use this as treatment. It took me a long time to find a doctor to prescribe this to me. I first ordered naltrexone from India due to the lack of connections. In time and by joining discussion groups and forums, I was fortunate enough to find knowledgeable people that lead me to the appropriate people & doctors. In reality though, most people will not put in that amount of effort, they'll give up and lose hope or not even know what to do to get the necessary resources that will lead them to success with their goal ...... GETTING THAT LITTLE PILL - NALTREXONE!
First, I want to make it clear that this debate is not about fighting for a very new and expensive drug. Campaigns about drugs are often brought to the attention of Parliament because a patient is fighting to be allowed to have a new and expensive treatment on the NHS. Some of these new drugs are not just expensive because they are new; because of the complex processes required to make them, they will, in fact, often continue to be expensive to produce. Such situations raise dilemmas for decision makers as to how access to such drugs can be funded.
This debate is about a very different problem: making an existing drug that is modestly priced available for the treatment of a wider range of conditions. Clinical trials are needed to get full approval for the drug under discussion, but I ask the Minister to consider whether there is any possible way in which it could be made more widely available.
Sometimes patients are faced with unacceptable options for treatment and find themselves researching possible new treatments. That is usually a road that leads to disappointment, but occasionally something useful is stumbled upon, such as low dose naltrexone, or LDN. The problem is that it is what is called an “orphan drug”, which means its patent has expired, so if someone does research on it, a generic manufacturer can subsequently steal the business.
I understand that naltrexone is proved safe in its normal mode of use, and now has a clinical history of 11 years of use in the UK with no problems reported and only minor side effects. LDN is also very low cost, and can be used to treat many conditions that are both chronic and often very expensive to treat with more conventional remedies. Sometimes those more conventional remedies have severe side effects, which then have to be treated with more expensive drugs.
The purpose of this debate is to ask how a drug such as LDN could be made available to patients who ask for it. The most desirable route would be via clinical trials leading to marketing authorisation and then official acceptance from the National Institute for Health and Clinical Excellence and the NHS. A much cheaper and more immediately practical route is to recognise that LDN is a safe choice for patients without many of the risks of drugs currently in use. Doctors could therefore be given official advice not to deny it to patients who want it or wish to acquire it from pharmacists who make it as a “special” at a fair price. There could also be a mechanism for protecting doctors and allowing patients choice. At present, doctors are in a difficult position. If they prescribe anything that is not on an official list, they leave themselves open to criticism, as well as to being sued and possibly losing their right to practise.
The third route is to get it listed as an over-the-counter drug, such as aspirin or paracetamol. I understand that it is considered safer than paracetamol which is sold over the counter, so this might be a reasonable option that would make prescription very easy.
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