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’:-
- not generic, - out of patent branded!”
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
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
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
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
Formalising the APPG is an important first step in helping
make this happen. The proposal for future APPG meetings will be focussed on
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
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
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!