The APPG meeting for off-patent drugs will be held on the afternoon of Thursday 15th October 2015.

This evidence session will hear from key stakeholders including medical research charities, academics, clinicians, regulators and commissioning groups to explore the market failure which prevents cheap, potentially life-saving drugs from being routinely available, and to consider possible solutions. We believe LDN fits into this category. 

6 years ago we wrote a blog about ‘off patent drugs’:-

“LDN - not generic, - out of patent branded!”

We have often referred to LDN as a generic drug, but in fact this is incorrect. Naltrexone is a branded but out of patent drug whereas generic implies an altered or non-original formulation compared to the original branded product. Only the low dose part is an alteration to the branded use. LDN can be made from generic formulations of Naltrexone and a good quantity of LDN in use is, but this is not necessary to acquire LDN, the original formulation is still being made.

So we need to accurately classify this therapy as an out of patent branded drug in a new use. The issue of generic drugs is full of pitfalls and not all generics live up to the branded drugs they replace, sometimes with bad consequences. We must avoid getting grouped with that class. LDN is just an off-label use of a branded product.

The problems for LDN all stem from the expiry of the patent leaving it in need of non-business driven funding to achieve its potential. The problem of out of patent branded drugs is very serious and means that such drugs get stranded in a no man’s land where they have to fight to get recognition. This is ridiculous when they offer answers to diseases. Either we want to tackle sickness or we want to profit from it.

The people must decide, so we are telling them the options – re LDN – so they can. If we do not do this, then profiting from sickness will remain the only option for our health, and look where that is taking us!

Firstly, a huge THANK YOU to all who read our urgent request last week and contacted your MP. Our voices were heard and I am happy to report that a sufficient number of MPs turned up for us now to form the much needed All Party Parliamentary Group.

From Nia Griffith MP:-

"The first meeting was a success and we had enough MPs to establish and formalise the APPG. This is an important step in tackling the obstacles which are preventing Drs prescribing LDN on the NHS. We are now going to look at setting up an official inquiry."

When a drug is in use and there exists doctors who can produce evidence of individual patient successes, then the clinical evidence exists. When a drug is considered to be ‘off label’ or ‘off patent’ by the licencing system, we need corrective measures to enable such a drug to get into mainstream use.

Formalising the APPG is an important first step in helping make this happen. The proposal for future APPG meetings will be focussed on ‘evidence sessions’:-

               -   The Patient Perspective
               -   Health Professionals and Regulators
               -   Researchers and Pharmaceuticals

This will provide our MPs with the knowledge needed to explore the options with making an off-label therapy like LDN available through existing pathways without Drs fearing being brought to scrutiny by the GMC, and to also enquire how we can encourage more trials and research to take place.

We need to allow Drs to use their training to connect this causality to a positive outcome in the absence of clinical trials.

From Professor Patricia J McLaughlin, Professor of Neural & Behavioural Science, Penn State University College of Medicine:-   

“With the widespread use of low dosages of naltrexone, the impact of this opioid antagonist biotherapy is broad-based. The need to develop new biotherapies that are non-toxic, and target the underlying pathophysiology of diseases is an urgent, unmet medical need.”

LDN’s time has come – we know too much about it to put it back in the bottle. We need more Drs to read the thorough and solid on-going research with Naltrexone that has been published by Penn State (over 30+ years), and how by modulating the OGF-OGFr axis has the potential for treating cancer, autoimmune diseases or complications associated with diabetes so it can be prescribed effectively.

We, the patients and doctors, understand this. We are fighting for the use of the LDN method which uses the biotherapy approach to medicine by harnessing the body’s own chemistry to enhance homeostasis, control cell proliferation and therefore help manage the diseases for which it is applicable.

It’s now our chance to help get this message across to our MPs which we hope to achieve at the APPG meetings. We look forward to your continued support – thank you!