Scottish Sunday - This drug could help MS victims... but they can’t get it

The Potential of Low-Dose Naltrexone in Treating Multiple Sclerosis

SIX months ago, multiple sclerosis sufferer Neil Lucas was finding it increasingly difficult to cope with everyday life. He had problems walking and writing and had little energy.

Then the 40-year-old began to take a drug, normally used to treat heroin addiction, which is claimed can alleviate the symptoms of MS. He says he saw an improvement within days. “It’s not a cure, but it has helped my wellbeing and my stability,” he said. “My walking was deteriorating and it brought me back from that. If you put me on a six-mile hike I’d have a bit of an issue, but at least I can get on with life.”

Anecdotes of MS Patients

Lucas is one of a number of MS patients convinced that the drug naltrexone, in low doses, is helping their condition. Internet websites and chat rooms are packed with anecdotal evidence of its benefits.

Yet the drug has not been licensed for use in MS – essential if it was to be available on the NHS – and only a limited number of GPs are willing to prescribe it privately in the UK. The large drug firms are not willing to pay the substantial cost of essential clinical trials as they would not have the exclusive rights to market it as an MS treatment, as the patent on the drug has expired.

Some experts believe the drug could help sufferers for a fraction of the £10,000 per patient spent every year on beta interferon, a drug available on the NHS that is used to reduce MS attacks.

The LDN Research Trust

Linda Elsegood, diagnosed with MS at the age of 44, was so ill two years ago she could barely make it to her daughter’s wedding. In just a few weeks, she claims she was “given her life back” by using the drug. She felt so strongly about it that she launched a charity, the LDN Research Trust, to try to get trials up and running and help others to get access to low-dose naltrexone (LDN).

Elsegood said she saw her symptoms improve within three weeks of beginning to take LDN in 2003.

“When my daughter got married my health was such that I couldn’t really stand for very long, I had no energy, I was in bed – I was a complete mess. I feel like I have been given my life back.“I’m not saying it is going to work for everyone, but those that would like to try it should be allowed to without the fight.”

The Potential of LDN

The use of naltrexone in low doses was first tried in the mid-1980s by Dr Bernard Bihari, a New York-based medic who claims it is useful in a wide range of autoimmune disorders, including MS. Interest in the drug has been increasing in the last decade, and earlier this year the first conference on LDN was held in New York.

One medic who backs it is Dr Bob Lawrence, who supplies around 400 UK patients with LDN through his private company based in Wales.

“I no longer need to advertise as people simply pass on the information,” he said. “Many GPs, once they see that their patients get better on LDN, are really quite enthusiastic in promoting this method and in giving it to their patients.”

The Cost and Potential of LDN

The dose used to treat MS patients is just a fraction of that which has been tested for use in heroin patients, at under 5mg compared with 50mg. The cost of LDN to Lawrence’s patients is around £25 a month, but he claimed that if the drug was produced in bulk for a mass market, it could drop to as little as 50p a month. That could mean huge savings for the NHS, as it costs more than £10,000 a year for a single patient on beta interferon. Yet Lawrence claimed the cheap price of the drug was part of the reason why there is a lack of interest by pharmaceutical companies in investing in clinical trials on LDN. He also pointed to the fact the patent on the drug has now expired.

He said: “As soon as they do a trial, all the other companies capable of producing naltrexone are going to jump on the bandwagon and, without any of the liability and penalty of paying for the research, can simply produce a copy of LDN.”

The Need for Clinical Trials

In Scotland, which has the highest incidence of MS in the world, Dr Tom Gilhooly has been prescribing LDN privately for a year after researching it following a request from a patient. The Glasgow GP agreed that a lack of potential profits was a major factor in the lack of studies on its potential benefits in treating MS.

“I think we will find out significant amounts about MS from studying LDN,” he said. “But we’re never going to find the answers from the drug companies as they’re going to make no money from it, so why should they invest in research and development?”

However, Gilhooly cautioned against viewing LDN as a “wonder drug” and said his patients had experienced mixed results from it.

“There have been people who have got worse on it, there have been people it has done nothing for,” he said. “But it is a very interesting, variable response and I think this is where we really need trials, as there is something happening for quite a lot of people.”

The Call for Clinical Trials

Mark Hazelwood, director of the Multiple Sclerosis Society Scotland, said the organization was aware of anecdotal reports of the benefits of LDN.

“It is clear the next step should be a trial,” he said. “It is a way of demonstrating whether something has a positive effect, and equally it is a way of identifying potential side effects and negative effects as well, which is important.”

But he said the expense of funding a clinical trial meant the drug would have to be a “reasonable bet”.

“There is a difficulty with LDN in as much as there isn’t a strong scientific case for thinking it will be of benefit to people with MS,” he said. “It goes against current understanding of what’s going on in MS and how to deal with it. That doesn’t mean to say it is absolutely wrong, but it does make it harder to justify whatever the funder is putting money into it.”

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