Posted on 11/02/2005 11:03:13 AM PST by cgk
By INVESTIGATION By Judith Duffy Health Correspondent
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."
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 GBP10,000 per patient spent every year on beta interferon, a drug available on the NHS that is used to reduce MS attacks.
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 use of naltrexone in low doses was first tried in the mid1980s 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 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 GBP25 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 GBP10,000 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."
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."
Mark Hazelwood, director of the Multiple Sclerosis Society Scotland, said the organisation 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."
Despite the difficulties, those who are convinced the drug is worth investigating are continuing the fight for clinical trials. The LDN Research Trust is trying to raise GBP37,500 to fund the first stage, which would aim to prove the drug's safety.
In Scotland, Gareth Marr, a 27-year-old mental health nurse diagnosed with MS in 2002, has started an internet petition to request government funding for LDN trials. He aims to present this to the Scottish parliament in future.
"From looking at the evidence on the internet, a lot of people seem to be getting a benefit from it, " he said. "A lot of people are trying really hard to get it and finding it really difficult, and many people are having to pay for it. It would just give them another avenue."
Irene Oldfather, Labour MSP for Cunninghame South, has also raised parliamentary questions about LDN on behalf of constituents. But she believes it should be the drug companies who take on the responsibility of funding trials.
"At the moment they don't have a cure for MS and the treatments are limited. If there is something that could be of benefit, then we should certainly explore every avenue possible to look at how to get some kind of clinical trial under way, " she said.
"There is money there in the pharmaceutical industry surely for some company to undertake a small research project."
However, while representatives for the pharmaceutical industry acknowledge it is a "difficult area", they point out that drug companies are commercial organisations.
Richard Ley, a spokesman for the Association of British Pharmaceutical Industry, said it cost on average GBP550 million to bring a medicine to the market.
"If you have got a medicine that is already developed, what you're talking about is the clinical trials, which are a very expensive part of it, " he said.
"It would have to go through a whole range of clinical trials to show it did actually work and could be licensed. That sort of money just can't be used unless there is the prospect of some sort of reasonable return at the end of the day."
NEED TO KNOW
An estimated 10,500 people in Scotland have MS, the most common neurological disorder diagnosed among young adults. The country has the highest prevalence rate in the world.
The disorder attacks the central nervous system and usually strikes between the ages of 20 and 40 years.
NEED TO KNOW MORE?
www. ldnresearchtrust. org
www. petitionthem. com
www. mssociety. org. uk
Low Dose Naltrexone for Multiple Sclerosis
RemedyFind: Feedback from MS patients using Low-Dose Naltrexone
PubMed: Low dose naltrexone therapy in multiple sclerosis
MS Society: Low Dose Naltrexone Update
Initial findings seem to suggest this drug would also be beneficial to those with immune-suppressed conditions including HIV/AIDS, cancer, Parkinson's, ALS, Alzheimer's, Crohn's, etc.
Forgot to mention: because naltrexone is available in generic form, the monthly cost for low-dose naltrexone is $15.00 ($45 for a 90-day supply).
A HUGE difference from the cost of most of the ABC-R drugs currently prescribed for MS, which has everything to do with why the drug companies won't back the clinical trials.
Rebif costs $1380 a month, currently, at my pharmacy.
> The cost of LDN to Lawrence's patients is around GBP25 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
Ummm... huh? Who ever heard of a Really Neato Wonder Drug that sold for about a buck a month??? Shoot, aspirin sells for more than that.
PING!
(ONE-TIME ping to those who had expressed interest on previous threads relating to new MS treatment options... if you would like to be pinged on future articles on this treatment or other future/promising MS treatments, let me know and we may start an MS list if there isn't already one around here.).
:o)
I don't know anything about UK patent law, but in the US a "use patent" can be obtained, on previously patented drugs and even on generic supplements which could never be eligible any other kind of patent (melatonin is an example). The patent prevents anyone from selling the substance under a claim that it is effective for the patented use.
However, even under US law, this particular drug might be a tough case for getting a use patent, due to the fact that this off-label use has been so widely publicized by multiple sources, including medical professionals, that this use of it would probably be classified as "general knowledge" at this point, and thus not patentable. And there's also the problem that, outside of the NHS, and perhaps within it as well, once there is official documentation of a certain drug's effectiveness for a certain purpose, a doctor could presumably prescribe a different brand of the same drug, which does not actually make the use claim, and thus doesn't have to pay the patent-holder.
Hey,
I have MS. I know quite a few people that take LDN (I don't, I use Betaseron.)
They get their doctors or neuros to prescribe it.
Some neuros won't, some will.
Of those I know who are taking the drug, some feel it's a wonder drug, some notice no difference in symptoms, and some do worse.
I was under the impression that trials of some sort had been run on LDN, or were about to be run.
What a shame,that this country let's this happen.Those involved in not releasing this drug,should be in prison.
If it works as suggested, we'll see a bunch of people checking into rehabs for "heroin addiction".
Hi! I think there is a small trial involving less than 50 patients in Germany using LDN for MS, over a 10 day period or similar. I read a mention of it when researching LDN in the past day. I know there is a current study on LDN for Crohn's here in the U.S.
I'm hoping some more news comes out. I will ask my neuro about it; she may let me try it out. I take Rebif for my RRMS. My grandmother has MS also, and only does the Swank Diet. She does quite well.
LOL is that the exchange, a buck a month? I can't mentally process converting pounds and such. I only know when I checked the prices here from the LDN pages, the US pharmacies had it at $45 for 3 month-supply.
Is this the same as a "use patent"?
One of my major peeves is that foundations such as the MS Society aren't helping to research the treatment and determine if it is indeed viable for MS. For all the money they receive to "find a cure", they don't seem to be willing to promote this or even put money towards the clinical trials needed here. The research fund, a measly $20,000 to most of the drug companies and foundations, is being funded by MS patients themselves. Sad.
Thanks. First I've heard of it. Would anyone synopsize how it works?
p.
My wife has MS. She's not a FReeper though so put me on your list if you assemble one.
Thanks.
You'll notice that the NMMS gets sponsorships from the major pharmaceuticals (plus LDN has not had a trial, but IMHO, the major pharmaceuticals would not want it to go to trial because if it is proven effective, and is "cheap", what chance do the interferons have at $1500 bucks per month.)
Greetings cgk:
The love of my life, Mrs. OLA, suffers from MS. Would you kindly add me to your MS ping list?
Thanks,
OLA
Where the interferons are immune modulators, LDN supposedly enhances the immune system, a so called "immune booster" which many neuros believe is a no-no for MS.
I know neuros that even warn an MS patient to stay away from Echinacea. Their reasoning, since MS is an auto-immune disease (they believe) and one's own immune system turns on the patient, attacking and destroying myelin, then anything that boosts the immune system would be bad.
It is true that during a cold, flu, infection, a person with MS may go into a flare, and it is presupposed that this is because the immune system starts to "work" to control the infection/flu/cold, and at the same time gets bumped up and starts the MS symptoms flaring.
And that has been the big controversy with using LDN for MS. Bilhari originally noted that it seemed to help HIV patients, and that would make sense because their immune systems are suppressed, but the action of LDN to help an auto-immune disease, where the immune system seems to be hyped, so to speak, is where the controversy lies.
And with the relapsing-remitting nature of MS, it's always hard to evaluate what is actually a drug induced improvement and what is just the natural course of the disease as it remits.
This country hasn't let this happen.
The laws and the legal system have required it.
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