“The
"The interests of patients, the NHS and industry can be at odds and we have
no confidence that the Department [of Health] is capable of achieving the
balance required. The ‘cross-dressing’ role of the Department in this regard
does not serve the public as well as it should." (p.95, para. 335) [2]
This submission is dedicated to the memory of Bernard Bihari, MD
11 November 1931 — 16 May 2010, who discovered the human uses of LDN.
Contents
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Page Who we are 3 Summary 4 1. Introduction 5 2. LDN and Patient Access to it 6 3. How is a research submission for an “old” medicine presented, and who can present it 6 3.6 The HTA 7 3.10 “Orphan Drugs” 7 3.15 “Well established use” 8 4. Market Failure 8 4.1 Pharmaceutical industry – no profit 8 4.3 Patient charity organisations 8 5. The Role of Clinical trials 9 5.2 Manipulation 9 5.9 Ethics 10 6. Is it useful to dismiss patient experience as “anecdotal”? 11 7. Statistical Analysis of prescription medicines 11 8. Recommendations 12 Appendix Patient campaigns and activities 14 Footnotes 15 |
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Who we are
Celia
Danks - celia@dawsholm.demon.co.uk
John Donnelly - john@carnebeach.com http://www.ldndatabase.com/
Margaret Schooling - margaret.schooling@neuf.fr
Nuala
White - nualawhite@btinternet.com
There is now an increasing
evidence base for Low Dose Naltrexone (LDN), showing it is a safe and effective
treatment for immune system disorders. We are a group of laypeople who help
campaign for the licensing of LDN as we know it has helped us and many others.
Three of us take it ourselves, and two have close family members who take it.
We (or family members) are using LDN to treat cancers, multiple sclerosis and
rheumatoid arthritis.
This submission is supported
by:
Dr.
mail@philboyle.eu mail@fertilitycare.net
j80jsd@yahoo.co.uk http://www.delivermyprescription.co.uk/
Dr. Tom Gilhooly, G.P. http://tomgilhooly.com/drtom.html
http://www.essentialhealthclinic.com/?gclid=CL660ojog5gCFQXtlAodgCisCg
Dr. Bob Lawrence, Managing
Director, Dietary Research Ltd.
http://www.msrc.co.uk/index.cfm/fuseaction/show/pageid/650
Brendan Quinn, M.P.S.I., Pharmacist http://www.quinnspharmacy.ie/
There is increasing evidence that an "old",
out-of-patent medication known as Low Dose Naltrexone (LDN) is a safe,
effective, inexpensive and increasingly sought after treatment for immune
related disorders. However, despite its potential benefits both in terms of
healthcare and for the economy as a whole, it is not as generally available as
it would be if it were licensed. (Sections 1. and 2.)
LDN campaigners have taken the matter to government
and followed government advice. However further difficulties can be foreseen.
(Section 3.)
The government identified market failure as
responsible for this situation. We argue that there is an over-reliance on
pharmaceutical industry investment, calculated as it is on potential profits.
Although patient charities could be expected to see beyond commercial
considerations, they do not. As a result, healthcare benefits can be neglected.
(Section 4.)
Despite the growing evidence base in favour of LDN,
calls for regulatory assessment are rejected for the lack of "robust"
evidence - large-scale clinical trials funded by the pharmaceutical industry.
The industry's central and exclusive role in assessment procedures is
questioned and alternative procedures need to be considered. (Section 5.)
The Department of Health has no centralised system in
place to evaluate patient experience of, and medical observation of, the
efficacy of prescribed medicines. As patients and doctors are the "end
users" of the NHS this omission is difficult to understand. Patients must
know that their well-being is a priority. (Section 6.)
To overcome these flaws we suggest that the efficacy
of prescription medicines should be included in the regulatory system using
statistical analysis. (Section 7.)
Responses to the Scottish Parliament Petitions
Committee demonstrate the difficulties we face, and the 2005 House of Commons
Health Committee report largely explains them. We fully endorse the
recommendations made by the latter and ask that additional forms of evidence be
taken into account (8.1 & 8.2).
We recommend that a centralised collection and
statistical analyses of patient experience and medical observation be included
in the regulatory system to improve the regulatory oversight of the safety and
efficacy of prescribed medicines. (8.3)
We recommend the examination of overlaps and gaps in the
remits of government health agencies with a view to reform, (8.4-8.7) the
examination of the role of patient charities, (8.8) also with a view to reform,
(8.9) and regulation to ensure transparency in the publication of scientific
papers and the peer review process. (8.10 & 8.11)
Recommendations 8.12 and 8.13 are specific to LDN and
an Annex shows how LDN campaigns continue on a number of fronts.
The
1.1 Naltrexone is an
out-of-patent medicine originally licensed at full (50mg – 200mg) dose to treat
addiction in the
1.2 Low Dose Naltrexone (LDN)
is an off-label, low dose (maximum 4.5 mg) medicine used since 1985 for a range
of conditions related to a dysfunctional immune system.
1.3 There is now a growing
evidence base to support patient reports that LDN is a safe and effective
treatment for immune related disorders. There is also a growing body of
research in the form of clinical trials and laboratory investigation, albeit
under-funded, that is developing scientific understanding of how LDN
works.
1.4 In response to two public
petitions[3] calling
for the recognition of LDN within the NHS, government health agencies and
patient charitable organisations rejected it as a potential candidate for
inclusion in the regulatory system. The reason given was that the research done
does not meet the entry requirements, that there is no "robust"
evidence supporting it.
1.5 However, it was
acknowledged that this apparent lack of evidence can, in reality, be the effect
of "market failure". According to the government: "Most
research of this kind is done by the pharmaceutical industry. The
Government is aware that occasionally there will be few or no commercial
incentives for companies to fund clinical trials."[4]
1.6 The government went on to
suggest alternative approaches that campaigners are now pursuing. However we
have found that for the layman, the procedures for submitting a research
request are obscure.
1.7 The House of Commons
Health Committee Report of 5 April 2005:
“The Influence of the Pharmaceutical Industry” [5]
has been an essential tool in our understanding of the situation and in the
drafting of this submission.
1.8 We have also drawn on the
responses listed in the Scottish Parliament Petitions Committee website.[6]
1.9 We are aware that the
a)
Savings on the costs of medicines is money that can be re-directed towards many
other needy areas within the NHS that would also benefit the pharmaceutical
industry, or it could be re-directed to other public service areas generally.
b)Individual
health improvement would have a healthy knock-on impact on the economy as a
whole:-
-
less sick leave:
-
less early retirement:
-
fewer calls on hospital and social services.
·
One of the
parties to this submission maintains a website providing links to a
variety of information sources for more information on LDN. In particular we
refer you to an information
pack. This document contains lots of information on LDN from various
sources, including the science behind LDN, and information on clinical trials
to date. [7]
2.1 Typically LDN is taken at
bedtime in a dose of up to 4.5 mg once every 24 hours. This is less than one
tenth of the dose approved by the FDA in the 1960s when full dose Naltrexone
was first used. In over thirty years no safety issues have been reported
following the use of Naltrexone at any dose below 300 mg a day.
2.2 It is legally and
ethically proper for a doctor to prescribe LDN on a "named patient"
basis. While most people would prefer to have their use of LDN professionally
sanctioned and monitored, many patients are refused (sometimes unkindly) on the
grounds of the doctor's personal liability. So patients are far too often
forced to seek alternatives in the form of telephone or internet prescriptions.
How many is not known.
2.3 The number of people
using LDN on prescription across the world is estimated to be over 100,000. We
understand that this estimate was arrived at over a year ago by a survey of
supplying pharmacies, but we are unable to substantiate the figure.
2.4 In the
2.5 Fortunately, the number
of doctors prescribing LDN is rising. For example, at the 2nd
International LDN Conference in
2.6 The dynamic behind this
rise in LDN use is recommendation by word of mouth. Patients tell other
sufferers and/or their doctors about it and when doctors in their turn see good
results, they suggest the treatment to other patients.
2.7 This difficulty of access
is not about the safety and efficacy of the medicine, but is a due to the marginalization
of “off-label” medicines by the regulatory system. The system is designed for
the approval of expensive "new" discoveries, not of "old",
inexpensive medicines that are out-of-patent but with a new off-label use.
2.8 The current regulatory
system therefore is preventing the use of an inexpensive, safe and efficacious
medicine.
3.1 When looking for ways to
bring LDN into the mainstream of availability on the NHS, campaigners found
that there are, apparently, ways to stimulate assessment of an out-of-patent
and off-label medicine, but access to the procedure is likely to falter and
fail if it is not supported by the pharmaceutical industry.
3.2 The House of Commons
Health Committee report explains why the Department of Health runs a system
that makes it difficult for un-funded campaigners to make headway. It also
explains the Department of Health's dual and conflicting role.
"The Department of
Health has not only to promote the interests of the pharmaceutical industry but
also the health of the public and the effectiveness of the NHS. There is a
dilemma here which cannot be readily glossed over. The Secretary of State for
Health cannot serve two masters. The Department seems unable to prioritise the
interests of patients and public health over the interests of the
pharmaceutical industry. We therefore recommend that sponsorship of the
industry pass from the Department of Health to the Department of Trade and
Industry." (p.6)[9]
3.3 About eighteen months
ago, LDN campaigners in the
3.4 The campaigners realised
that a political intervention was necessary to deal with this mindset and they
launched a petition
to N° 10 Downing Street on the government's petition website highlighting
patient and doctor experience of LDN. This was a catalyst that brought the
issue to the attention of politicians, medical professionals, and to the media. [10]
3.5 On 21 December 2009, the
Prime Minister responded
to the petition, saying: "The government is aware that occasionally
there will be few or no commercial incentives for companies to fund clinical
trials." He suggested the HTA is the body responsible for dealing with
"research topics in areas of market failure." [11]
3.6 An initial proposal had
already been made to the HTA but it was rejected
on the grounds that it was not within their “remit”. [12]
3.7 Consequently, on 23
February we submitted a proposal
to the HTA (reference 2322010HTA115208). This was followed up 2 March with an information
pack on trials, research, clinical experience, etc. then available.
The proposal is due to be assessed
during the period 29 June to 9 July.[13]
3.8 Should this submission
pass this initial stage, it will apparently move to the stage where they
"identify topics for research" and then advertise for a research team
to carry out the work which would then apply for funds.
3.9 However, should it reach
this stage, it looks to us as if we would face further difficulties similar to
those we face now:-
-
who would own the research, fund it, organise and manage it?
-
what kind of research team would be ready to study a treatment liable to have a
negative profit impact on the pharmaceutical industry? Ideally any research
done would be independent and belong to the NHS, but given the influence of the
pharmaceutical industry within the NHS, it is hard to see how this could
happen.
-
what sort of timescale would this procedure involve?
3.10 Although LDN cannot be
classed an "orphan drug" (the conditions treated by LDN involve a faulty
immune system, so they are widespread and far from rare) the case of the orphan
drug, nitric oxide, shows that some allowance is made for gaps in the
regulatory system when faced with market failure.
3.11 However, the House of
Commons Health Committee describes how, following clinical trials, the price of
nitric oxide rose more than thirty-fold. The treatment had been used by
neo-natal units successfully for many years and only cost about £2,000 a year.
Once licensed the price rose to over £63,000 a year. (p.32 para. 108)[14]
3.12 LDN currently costs
about £1 a day. If the example of nitric oxide is anything to go by, this would
increase to over £30 a day if it were licensed following clinical trials funded
by the pharmaceutical industry.
3.13 Many LDN users are
terrified that the cost of LDN will increase and they (particularly in the
3.14 The NHS would also have
to ensure that its LDN budget did not increase unreasonably and in an
unjustifiable way.
3.15 A rarely mentioned
approach involves "well-established
use". A "marketing authorisation holder" can vary the
licence or submit an application for marketing authorisation involving a new
use. [15]
3.16 However, if this
approach has to be made by a "marketing authorisation holder", the
same problems arise as described in 4. Market Failure below – there
would be no profit incentive as the drug is out-of-patent.
3.17 It is also unlikely that
the required “off-label” data has been systematically collected in the European
Community for at least ten years.
"Before a drug can receive a licence (marketing
authorisation) in the
4.1 When a medicine is
out-of-patent there is no profit to be made from it. It is understandable how,
in the present profit based regulatory process, no manufacturer can invest in
expensive clinical trials in order to make such a submission even when a new
use for it is discovered. If it were possible to get a new license, there would
still be other cost implications – see paras.3.11 & 3.12 above.
4.2 The regulatory system is
currently designed to sustain this commercial reasoning at the expense of
healthcare benefits.
4.3 Patient charity
organisations hold large funds donated by the public for clinical research. As
they exist to support people with a given illness, it would seem logical that
they would be interested in what those people have to say. However, they are
not. The MS Society rejected a proposal for studying LDN in MS which was
described by the Chief Scientist’s Office as an excellent submission. They did
this without offering any invitation to the investigators to re apply.[17]
Cancer Research
"Currently
there is no robust evidence to show that LDN can benefit people with cancer.
Published information to date largely comprises cell line research and case
studies of individuals who have received low doses of naltrexone for
cancers…………
"There
is not enough robust evidence from trials in people with cancer to know if LDN
is safe for that group of patients." [18]
4.4 Evidence given to the
House of Commons Health Committee report also states that, "instead of
representing the interests of patients, groups" patient
organisations are a "subtle form of marketing" on behalf of
the pharmaceutical industry. (p.76
para 267).[19]
4.5 It is not, therefore,
clear from this how their remit differs from that of the Department of Health
(see 3.2 above) - they "cannot serve two masters" either.[20]
4.6 In fact, unlike
government health agencies where some patient input concerning research topics
is, in theory anyway, accommodated, Cancer Research
"We
welcome any research into potential new ways to treat cancer. Applications will
be accepted from scientists, clinicians or health care workers in
4.7 Given the pharmaceutical
industry control over the health industry, research teams inevitably depend on
the industry to earn their living. No research team is likely to want to be
associated with a project that could be seen as undermining the industry's
profits.
5.1 Clinical trials have an
essential role in ensuring that medicines are safe and effective (Naltrexone
successfully passed them thirty years ago). However this means they must be
reliable and that public and patient confidence in them is not shaken by
reports of manipulation or questionable ethical practices. We argue that their
pivotal role in the regulatory system, to the exclusion of other processes,
cannot always be justified.
5.2 We would also argue that
while clinical double-blinded trials are an essential tool for new discoveries,
they are less useful for an "old" medicine with a new use.
5.3 Evidence that clinical
trials are not always as infallible as claimed and that medicines have been licensed
after clinical trials have failed was given to the House of Commons Health
Committee with cases of manipulation and inappropriate organisation in order to
arrive at misleading results. (p. 50 para 182) [22]
5.4 A similar point was
recently made in The Guardian:-
"By making
ineffective treatments seem to work, making expensive new drugs seem to be
better than old, cheap ones, and concealing evidence of side effects, selective
publication undermines the whole point of doing research in the first
place."[23]
5.5 The House of Commons
report further reported evidence that even when medicines have failed placebo-controlled
trials, they have still been licensed. (p. 50 para 181)[24]
5.6 Additional questions
arose about how useful clinical trials really are in predicting effectiveness
in clinical practice. (p. 21 para. 56)[25]
5.7
As end-users in need of relief from their illness, patients are encouraged to
trust the kind of medically authoritative reassurance that comes with licensed
medicines. This trust can displace natural caution and many (perhaps most)
patients ignore warnings on the labels that these days accompany all medicines
both innocuous and dangerous. In many cases these lists are long, can be
complicated, and in small print.
5.8 Despite all these
concerns (that one would expect to undermine confidence in clinical trials)
they are consistently referred to as "robust", apparently on the
grounds that participants do not know what they are taking and because placebos
are used.
5.9 Another vital element in the clinical trials process is peer review.
However, in some areas of pioneering
research, there may be few or no suitably qualified peers. This does not mean
the research is invalid, but that further research is needed to establish
whether it is valid or not. At the moment the only research possible within the
regulatory system is full-scale clinical trials. In the case of LDN, no
full-scale clinical trials can take place because of market failure and
regulatory system block, therefore this kind of pioneering research is in a
limbo, and patients are denied access to a potentially beneficial medicine.
5.10 The House of Commons
report also described some ethical concerns about clinical trials, describing
how patients are not necessarily given all the information they need about the
risks involved or about what happens to the information gleaned from the trial.
According to one witness: "The industry takes the data from you,
they let you take all the risks, they conceal the data… they take out the good
bits of the data, the bits that suit them, and market that back to us and call
it science, when clearly it is not". (p. 49 para. 178)[26]
5.11 We would argue that
double-blinded trials using placebos would have an ethically dubious place in
the testing of the efficacy of LDN. They are designed to test "new"
discoveries, but there are ethical difficulties involved in trials on an
"old" medicine like LDN where evidence of health improvement already
exists.
5.12 Given that intervention
in the early stages of an immune system disease can prevent irreparable damage,
it hardly seems ethical to expect people to take placebos for weeks or months.
There are reports that LDN has successfully been used in rapidly debilitating
forms of diseases like MS or cancers. Treatment with placebos could have no
place here. Nor does the question get easier in more advanced cases.
5.13 Similar questions arise
with regard to treatments given in addition to LDN that help it work better. An
example is alpha lipoic acid and/or opioid growth factor in the treatment of
pancreatic cancer, but there are more familiar examples like the need to
overcome deficiencies of omega 3 and Vitamin D3. What place would these have in
clinical trials?[27]
5.14 In a placebo vs LDN
trial, how would reports that taking LDN can halt progression be handled? Would
participants be told that their results would show whether or not LDN is
"just a placebo"? Or would they be made aware of LDN's reputation
that progression could halt while they were on LDN? In either case would such a
trial be ethical?
5.15 Similarly, questions
arise if participants were selected to take part in a trial of a medication
with known side effects and were not informed about alternatives, including
LDN, would that trial be ethical?
5.16 The House of Commons
Health Committee also found evidence that when a pharmaceutical company is
involved in the successful trial of an out-of-patent treatment that has been
safely used for decades, it results in a massive price rise for the same
treatment once it is licensed. (see "Orphan Drugs" paras. 3.10-3.14
above).
5.17 Clinical trials are not
suitable on ethical or reliability grounds for testing a new-use medicine where
it has become established slowly but surely over a considerable period, its
take up is steadily increasing, and it is strongly supported by patient
testimony and clinical experience.
6.1 LDN has already been subject of several
small-scale, low-budget trials[28]
in response to growing patient and doctor testimony about the effectiveness of
LDN – low-budget due to lack of industry support. In industrial and regulatory
terms, however, such testimony is usually referred to as "anecdotal". This may have a different
meaning in this context than it has for the public at large, but for most
people it is more likely to mean "trivial". In our view it is an
overused term that trivialises the evidence, and so casts doubt on what are, in
fact, accounts of significant health improvement.
6.2 If we assume, as we are
surely entitled to, that positive patient experience is the fundamental aim of
health care, why is it rejected in this way?
6.3 When there is a
substantial body of positive patient experience, the only justification for
rejecting it as "anecdotal" is because it has not been the subject of
formal statistical analysis.
6.4 It would appear that when
it comes to medicines, the Department of Health does not view patient
experience as a useful source of information. Consequently no single government
health agency is responsible for it, no systematic information gathering takes
place and no statistical analysis is done.
6.5 There is, therefore, no
overall understanding of what is really happening when patients are given
prescription medicines, whether they are licensed, or whether they are
out-of-patent, off-label prescription medicines like LDN.
6.6 No one should
under-estimate the anger and distress felt when a patient starts to use LDN and
finds that disease progression is halted, but at a stage where s/he has
suffered irreversible disabilities. What is more these people have often taken
conventional treatment which has failed and/or is ineffective but which can
lead to other disorders, often very serious.
6.7 If the regulatory system
is reformed in a way that ignores patient experience in favour of commercial
profit, patient trust in the pharmaceutical industry and the institutions it
works with will be even further undermined.
7.1 We would propose a
variation of "well-established use" based on future rather than past
LDN use. It could eventually become a reliable record of how well the medicine
works and what it's taken for. It is, therefore, worth considering for
incorporation into the regulatory system.
7.2 Patients with similar
diseases, preferably across the immune system dysfunction range, would be
categorised according to whether they choose conventional medication or LDN.
Their progress would be recorded and monitored by their doctors and records
kept by the patients themselves, using criteria such as;-
-
progression/remission, pain levels;
-
routine scans and checks;
-
subsequent diagnosis of other disease(s) during treatment;
-
death rate and cause of death;
-
quality of life;
-
what other treatments/supplements are used.
7.3 Given the agreed safety
of LDN, and to help raise the number of those using it, doctors would be asked
to discuss LDN with their patients as well as conventional medicines. In most
cases a patient will respond better to a treatment they have agreed to use with
their doctor’s support. (We understand that an estimated 30-50% of the health
service medicines budget is wasted because patients do not take what they're
given).[29]
7.4 Most of this information
is already available from GPs and specialists, and given the widespread use of
computers these days, sending the information to a central point for
statistical analysis would not take up much of their time. Ideally this study
would last several years.
7.5 The gathering and
analysis of this information will indicate areas that need more scientific
research, for example why some people respond better to an LDN dose lower than
4.5mg, and why some people have more difficulty getting relief than others.
7.6 Indeed, this kind of
monitoring and analysis should be an essential tool in the efficient running of
the NHS, and that it should take place as a matter of course.
8.1 We find that many of the
quandaries we're facing in our work are explained by the House of Commons
Health Committee report. Its recommendations should form the basis of any
reform.
8.2
The pharmaceutical industry should not have its currently exclusive role in the
regulatory system decision-making process. There are additional kinds of
evidence that should be taken into account when it comes to deciding whether a
medicine should be assessed for licensing.
8.3 A major source of evidence
should be patient experience and medical observation and they should have their rightful place in research and the
regulatory system. To this end we recommend that consideration be given to
proposal in section 7 above, "Statistical analysis of "old"
medicines". This would involve:-
8.3.1
the setting up of a centralised information-gathering unit with a dedicated
team of statisticians;
8.3.2
LDN use should be the first medicine to undergo statistical assessment into its
efficacy for two reasons. Clinical trials and more than thirty years of use
have already established the safety of Naltrexone, and the interests of
patients who are already relying on LDN to maintain their health must be
respected;
8.3.3
Information on all treatments, including LDN, be provided to patients to allow
freedom of choice.
8.3.4
this study would be used as a "pilot" with a view to the
establishment of the systematic reporting and recording of the safety and
efficacy of all prescription medicines.
8.4 Overlaps and gaps in the
remits of government health agencies lead to confusion and wasted public
resources. These remits should be re-examined.
8.5 Only one specified agency
should be responsible for research into a medicine following market failure and
this facility should be widely advertised;
8.6 That agency's remit
should include the duty to explain the procedures in a clear and
straightforward manner and its expertise in the medicine licensing procedures
should be available to individual patients / advocates to help them make viable
submissions;
8.7 When the market has
failed in a given area of medicine, the pharmaceutical industry should have no
influence in how such failure is addressed.
8.8 There are also overlaps
between government health agencies and patient charity organisations. We would
endorse the House of Commons recommendation that industry support for charities
should only come from the industry's charitable funds. (p.77, para. 275) [30]
8.9 Charities must be fully
transparent. All donations, from the pharmaceutical industry and other sources
that could lead to a conflict of interest should be prominently declared. This
would also apply to charity directors and executives who should declare any
personal, potential conflict of interest, for example, if previously employed
in the pharmaceutical industry.
8.10 While we appreciate that
"bad science" must be filtered out, using, for example, the
publication/peer review process, there has to be a system to ensure that this
process is not abused. Therefore we recommend that the publication/peer review
process should be regulated and open to public viewing:-
a)
papers submitted and refused for publication should be recorded together with
the reasons why publication was refused and any further comments from the
author(s) responding to the rejection;
b)
there should be a publicly available record of all clinical trials undertaken
by reputable research institutions, and all reports should be published whether
the trial was successful or failed. The reasons for any trial failure should be
included;
c)
the information thus compiled should be publicly accessible via a suitably
designated on-line library.
8.11 At the same time,
account must be taken of the situation described in 5.9 above where in some
areas of pioneering research, there may be no suitably qualified peers.
8.12 Designate a person or
body to oversee our HTA submission to ensure it is properly considered and, if
accepted, pursued in a meaningful way.
8.13 Use LDN for the pilot
study described in 8.3 above.
Appendix
– Patient Campaigns and Activities
Because so many people use
LDN successfully and because it is so safe, some patients and patient advocates
are campaigning for the immediate acceptance of LDN by the medical profession
for the following reasons:-
- a patient has the right to be informed about LDN and be
given the choice as to whether they try it or not, preferably when they first
present symptoms identifiable as immune system dysfunction, there being no
safety reason why this treatment should not be available on the NHS.
- a patient has the right of access to the purest form of
LDN as provided on prescription by reputable compounding pharmacies:
- a
patient's progress LDN should be monitored, they should have expert support and
advice and help if they experience difficulties.
This has already been
described above.[31]
The Scottish Parliament
Petitions Committee is currently pursuing the case
made by three LDN users (including Celia Danks who is a party to this
submission):-[32]
The Scottish parliament has
listed the documents generated by the petition, some of which have been used in
this submission. In essence, the petitioners' and the Petitions Committee's
concerns have been met with descriptions of how the current system will not
allow consideration of the use of LDN within the NHS.
A very successful campaign
was launched by one of our group, John Donnelly, with a proposal about LDN on
the Irish government's "Your
Country, Your Call" site.[33]
This closed on 30 April and
John's proposal came first with the most popular support.
The Irish government will now
assess the proposals and will announce the one chosen for implementation on 4
September. In the event that the LDN proposal wins, John is envisaging a
clinical trial, probably for cancer patients, comparing survival rates over one
year on patients using or not using LDN. There is a report
about this kind of trial at:-[34]
John also set up a database where users can report their experience of LDN.[35]
The EU Petition Reference No.
is 791/2009 – Low Dose Naltrexone
This petition to the European
parliament is underway and this campaign emphasises the human rights aspects
involved in the general withholding information about a non-toxic treatment as
well as withholding the treatment itself.[36]
The First European LDN
Conference was held in
Mutual support groups usually
owned and moderated by LDN users. In many, if not most cases, members need the
group because they have no doctor, or no doctor who understands LDN, and need
to discuss setbacks, difficulties as well as successes.
http://www.ldnresearchtrust.org/
[2] The House of Commons Health Committee Report, “The
Influence of the Pharmaceutical Industry”,
p. 95, para. 335
Published April 2005. It
is available online at
http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf
[3] An LDN Information Sources website is maintained by
one of the writers of this document.
More detailed information
on the Petitions to
There is also information
on other aspects of our LDN campaign, links to information sources, and Information
Packs.
[4] Prime Minister’s Response to LDN Petition to No. 10 Downing St. http://webarchive.nationalarchives.gov.uk/+/http://www.number10.gov.uk/Page21825
[5] The House of Commons Health Committee Report – See
Footnote 2 above.
[6] The Scottish Parliament Petitions Committee
[7] See Footnote 3 above
[8] 2nd European LDN Conference Website
http://www.bigonglasgow.com/2010/2010-ldn-conference-report-79509
[9] The House of Commons Health Committee Report (p. 6)
[10]LDN Petition to
[11] Prime Minister’s Response to LDN Petition to No. 10
Downing St. http://webarchive.nationalarchives.gov.uk/+/http://www.number10.gov.uk/Page21825
[12] Letter dated 5th Feb 2010 from HTA
available on the LDN Information Website
[13] Our proposal to HTA, information pack, and further
updates on our LDN Information website http://dnausers.d-n-a.net/dnetIogQ/LDN/NIHR_HTA.htm
[14] The House of Commons Health Committee Report (p.32
para 108)
[15] Medicines with a “well established use”, Iain
Colquhoun, The Write Stuff, The Journal of the European Medical Writers
Association. P. 18, Vol. 18, No. 1, 2009.
http://www.emwa.org/JournalArticles/JA_V18_I1_Colquhoun1.pdf
[16] A Response from Professor W Scott, Chief
Pharmaceutical Officer, The Scottish Government
to The Scottish Parliament Petitions Committee. http://www.scottish.parliament.uk/s3/committees/petitions/petitionsubmissions/sub-09/09-PE1296I.pdf
[17] Ref Dr Tom Gilhooly
[18] Cancer Research
[19] The House of Commons Health Committee report (p.76 para 267)
[20] The House of Commons Health Committee report – see
Footnote 9
[21] Cancer research
[22] The House of Commons Health Committee Report (p. 50 para 182)
[23] “Let’s improve medical science, for free” - Article in The Guardian on Sun 9th
May 2010.
http://www.guardian.co.uk/commentisfree/2010/may/09/medical-science
[24] The House of Commons Health Committee Report (p. 50 para 181)
[25] The House of Commons Health Committee Report (p. 21
para 56)
[26] The House of Commons Health Committee Report (p. 49 para 178)
[27] See Footnote 3 above. The easiest way to access the science and the clinical trials is via our Information Pack. It also provides links back to the original sources. Dr Ian Zagon is the foremost authority on all matters relating to Opioid Growth Factor (OGF) and Naltrexone. Dr Bert Berkson has published at least two papers using a combination of LDN & Alpha Lipoic Acid (ALA) in treating pancreatic cancer. Also see Opioid Growth Factor (OGF) in Cancer Therapy, MedInsight Research Institute, Oct 2006. http://dnausers.d-n-a.net/dnetIogQ/LDN/LDN_OGF_medinsight-ogf_review.pdf
[28] See note 27. Most websites that cover LDN give details of LDN clinical trials, and the most comprehensive one is http://www.ldnscience.org/
[29] Discussions with senior Health Officials
[30] The House of Commons Health Committee Report (p.77, para. 275)
[31] Petition to No. 10 Website – see Footnote 19
[32] The Scottish
Petition Website http://www.scottish.parliament.uk/s3/committees/petitions/petitionsubmissions/sub-09/09-subIndexForPE1296.htm
[33] Your Country, Your Call Website
[34] Cancer trial Abstract
http://www.ncbi.nlm.nih.gov/pubmed/15912493?dopt=Abstract
[35] John’s LDN Database Website
[36] EU Petition links
[37] 1st European Conference Website
http://glasgowldn2009.com/2009/04/first-european-ldn-conference-report/
[38] 2nd European Conference Website
http://www.bigonglasgow.com/2010/2010-ldn-conference-report-79509
[39] LDN Conferences in the