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LDN transforms a country: Interview with health expert Dr. Guttorm Raknes

Dr. Guttorm Raknes
November 13, 2016
Interview with Dr. Guttorm Raknes of the University Hospital of North Norway and Uni Research Health

Dr. Guttorm Raknes works as a consultant and researcher at the Regional Medicines Information and Pharmacovigilance Centre (RELIS) at the University Hospital of North Norway, Tromsø, Norway. In RELIS, he and his colleagues act as advisors for health professionals in drug-related issues, and are responsible for the processing of adverse event reports in the Norwegian health care system. Dr. Raknes has been working there since 2004 as a medical doctor and as a specialist in clinical pharmacology. In the past decade, he has had this as a part-time position in addition to his main work as a general practitioner. Since 2012, Dr. Raknes has been a researcher at Uni Research Health, and has a PhD in health services research.

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How did LDN come to your attention?

As a clinical pharmacologist, I have been fascinated by off label use of drugs and in particular innovative use of old drugs for new indications. There are many examples of drugs that are efficacious in conditions apparently unrelated to the originally intended use. Old drugs have the advantage that they have been used by many patients over many years; the safety profile is therefore well known. The process of establishing them as new treatment options can thus be shortened, and if the patent has expired, the price is often very low compared to other newly developed alternatives. Typically, the doses of old drugs are often much lower in the innovative use than in the original indications. One important example is aspirin, originally a painkiller and antipyretic. After several decades on the market it turned out to be a very effective inhibitor of platelet aggregation and is now a fundamental part in the treatment of acute myocardial infarction, and in low doses it prevents blood clotting.

A very interesting article in The Economist in 2004, in which open source drug development was discussed, sparked my interest for innovative use of old drugs. The pharmaceutical industry has struggled to keep up with the pace of innovation for the past 20 years. As this article pointed out, drug development is, in reality, information technology and open source approaches where the public (independent researchers, patients or other pharmacology geeks) could contribute to finding solutions to unsolved medical problems. When the commercial potential for drug candidates is limited, the “wisdom of the crowds” could be particularly useful. Examples include tropical diseases and also new uses of old drugs with expired patents, like naltrexone.

A reporter from a Norwegian rheumatology patient magazine made me aware of LDN. She was interviewing me about an article I had written on off label prescribing and wanted to know how this applied to low dose naltrexone. I soon realized that LDN had many interesting features as an example of innovative off label use. I found it particularly interesting that this therapy was the result of a “bottom-up” process driven by patients and researchers apparently independent of the pharmaceutical industry or leading clinical research groups.

I found it particularly interesting that LDN therapy was the result of a “bottom-up” process driven by patients and researchers

The idea that naltrexone, originally used to treat opioid and alcohol addiction, should be efficacious against HIV, cancer and autoimmune diseases seems farfetched at first thought, but laboratory and animal research indicate potential and plausible mechanisms of action. There are even some small, randomized trials that show beneficial effects in multiple sclerosis, Crohn's disease and fibromyalgia. Personally I am not 100% convinced that LDN is efficacious, it simply sounds too good to be true. Although there are an overwhelming number of patients reporting baffling effects of LDN, the evidence in my opinion is far from sufficient to recommend it as standard treatment in any condition. On the other hand, there is no reason to dismiss LDN, and it deserves further investigation. It would be fantastic if future studies show that such a cheap and safe drug is as efficacious as the LDN proponents claim. It could change the lives of millions of patients, and potentially replace less safe and much more expensive drugs.

It would be fantastic if future studies show that such a cheap and safe drug is as efficacious as LDN proponents claim. LDN could change the lives of millions of patients
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us back. What made you want to study the pattern of LDN prescribing?

Before 2013, there was not much of an LDN prescribing pattern to report in Norway. There were just a handful of users, mostly multiple sclerosis (MS) patients. However, after the national TV channel TV2 aired a program where several patients explained how LDN had normalized their function and changed their lives, LDN awareness in Norway exploded. (The program is available with English subtitles here: Family doctors/general practitioners were overrun by patients requesting a prescription for naltrexone, and the only manufacturer of LDN tablets soon ran out of raw materials. By the end of 2013, thousands of patients used LDN.

This unprecedented surge in LDN use was in reality a natural experiment and a unique opportunity to study patient and prescriber characteristics in a population. In Norway, we have a national prescription database (NorPD) that contains information on every prescription that has been collected by Norwegian patients. My coauthor Lars Småbrekke at the Arctic University of Norway and I got access to all LDN prescriptions in NorPD. We wanted to quantify the extent of the “LDN tsunami”, and to identify patient and prescriber characteristics. From the NorPD data we were able to estimate the median naltrexone dose, which was 3.7 mg.

Your study shows that over 70% of Norwegian general practitioners (family doctors) have now prescribed LDN. What do you feel this shows about the general medical practitioner's acceptance of safety of LDN?

It is remarkable that the willingness to prescribe among family doctors was so high despite lack of sufficient evidence or official recommendations. I think most family doctors had almost no knowledge of LDN before 2013 and that they were overwhelmed by the sudden patient interest. I also believe many doctors felt pressured to prescribe LDN. In social media discussion groups, there was much frustration related to the family doctor’s unwillingness to prescribe LDN. Many doctors claimed that LDN was just “snake oil”, and that they were not allowed to prescribe off label. On the other hand, most family doctors have a rather pragmatic approach to patients' wishes. Most patients that required LDN had chronic diseases, or conditions like fibromyalgia or ME. For these patients, the family doctors often already had unsuccessfully tried out different therapies, and I guess many of them after some time found it prudent to give LDN a chance. In that respect, it has been crucial that most family doctors perceived LDN as harmless.

In Norway, are LDN prescriptions reimbursed by the government’s health insurance?

No, LDN is not reimbursed for a number of reasons. An approved indication is normally required, and that is not the case for low dose naltrexone. In addition, leading experts of different medical specialties such as neurology and rheumatology have been rather skeptical and have discouraged the use of LDN. The lack of high quality clinical evidence makes it difficult to defend public funding of LDN. Finally, LDN is very cheap, and for many patients it represents only a small fraction of their disease-related costs. A box of 100 x 3 mg naltrexone tablets costs approximately 400 Norwegian krone (48 USD). There are other examples that the government does not reimburse essential, but low-cost drugs. Low dose aspirin in cardiovascular disease is a notable example.

Your findings clearly demonstrate the unprecedented power of patient advocacy in changing prescribing patterns. Do you feel that this is magnified by a large unmet medical need among patients who are not receiving sufficient benefit from their existing treatments?

Yes, I think it is obvious that patients who want to test LDN have unmet needs. Most of them have diseases or conditions in which there is no treatment that makes them totally symptom free, or they have conditions that are in the spectrum of medically unexplained physical symptoms (MUPS) like fibromyalgia and chronic fatigue where there are few treatment options. These patients are often frustrated that their doctors are unable to help them, and my impression is that this leads to a desperation in which no treatment option is left untried. This includes scientifically unjustified alternative treatments, and I think these patients are particularly prone to trying LDN.

From reading patient stories in social media, there are patients that report very good effects of LDN on MUPS, but there are also many patients that do not experience any positive effects.

Naltrexone is a generic drug and no pharmaceutical company will sponsor the long-term trials you indicate are needed in order to prove its long-term benefits. In view of your article showing a large unmet medical need and the demand for LDN, do you think the Norwegian government may step in to finance such a trial?

It is important to emphasize that our study only proves that LDN has been used extensively in Norway. It cannot be taken as evidence that LDN actually fulfills unmet medical needs or that it is efficacious in any condition. Additional studies are necessary. I believe well-designed studies on LDN should be funded by the government, for example through the Norwegian Research Council.

I believe well-designed studies on LDN should be funded by the government, for example through the Norwegian Research Council

In many ways, LDN poses a threat to the pharmaceutical industry since it could replace many of the most profitable drugs on the market. It is therefore unlikely that commercial interest will initiate adequately sized clinical studies. Recently, the results of the Norwegian NOR-SWITCH were published. This was a directly government supported study where infliximab (Remicade) was compared with biosimilar medications. The study was mainly based on the government's’ desire to reduce costs by using cheaper alternatives. Similar approaches may also be relevant for LDN.

The cost of LDN is a fraction of the cost of the usual treatments used for autoimmune disease. If the uses of LDN that you have described were to continue in the long term and replace existing treatments for many patients, do you foresee a significant positive impact on government health insurance expenditure?
If proven efficacious, the upside of extensive LDN use is enormous

Our study does not document that increased LDN usage has resulted in savings for the government. But if proven efficacious, the upside of extensive LDN use is enormous for the government. It could fully or partially replace very expensive therapies and potentially reduce the need for sick leave and disability payments.

Will you be studying this topic again, especially to understand the patterns of long-term use of LDN amongst Norwegian patients? If so, will you be able to assess whether LDN has replaced these patients’ existing prescribed treatments, and how significant the resulting economic impact may have been?

This is actually only the first in a series of studies on LDN use based on the Norwegian prescription database. NorPD contains limited clinical information, but we will examine whether starting LDN was followed by changes in the prescription of other drugs. One study has already been submitted and others are in progress.

LDN is a generic medication with rapidly growing worldwide use, and without likelihood of any commercial sponsorship for large trials. Do you think that governments should establish funds and take a central role in leading the large trials needed to establish the benefits of treatments such as LDN and similar generic medications?

Indeed. Old off patent medications could be extremely valuable in the future of medicine. We need better systems to capture unknown beneficial effects of pharmacotherapy similar to the international cooperation on adverse effect reporting. The pharmaceutical industry increasingly focuses on drug repurposing, which in some cases may involve generic drugs. Different regulatory programs, like orphan drug initiatives, have also given new life to old drugs. However, as pointed out earlier, there are examples like LDN where the potential reward lies with governments, while the pharmaceutical industry risks lower profits. Here public funding and international cooperation would be important first steps.

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