This drug could help MS victims... but they can't get it (Lack of Profit puts off trials)

RedNova News ^ | 10-16-05 | Judith Duffy

[cgk]

Further resources for those who are as interested in this possible "new treatment as I am":

Low Dose Naltrexone for Multiple Sclerosis

Low-Dose Naltrexone Homepage

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.

[cgk]

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.

[orionblamblam]

> 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.

[cgk]

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)

[GovernmentShrinker]

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.

[dawn53]

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.

[patriciamary]

What a shame,that this country let's this happen.Those involved in not releasing this drug,should be in prison.

[SunkenCiv]

If it works as suggested, we'll see a bunch of people checking into rehabs for "heroin addiction".

[cgk]

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.

[cgk]

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.

[cgk]

There is some information on a Dr. Bihari's pharmaceutical patent in treating MS and other diseases with LDN here: Patent: 6,586,443

Is this the same as a "use patent"?

[cgk]

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.

[Paul_B]

Thanks. First I've heard of it. Would anyone synopsize how it works?

p.

[Incorrigible]

My wife has MS. She's not a FReeper though so put me on your list if you assemble one.

Thanks.

[dawn53]

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.)

[octobersky]

Thanks for the ping! I'd like to be on an MS ping list, if one is available or if one is now forming. If naltrexone helps alleviate the symptoms of MS, I hope they can find a way to make it more widely available to those who need it.

[OneLoyalAmerican]

Greetings cgk:

The love of my life, Mrs. OLA, suffers from MS. Would you kindly add me to your MS ping list?

Thanks,
OLA

[dawn53]

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.

[TASMANIANRED]

This country hasn't let this happen.

The laws and the legal system have required it.

[Paul_B]

Thanks, Dawn. Someone pointed this out, below. I make no claims either way on this, just passing along the official line. p. http://www.nationalmssociety.org/Clinup-Naltrexone.asp Low Dose Naltrexone Update May 2004—We have received a number of inquiries about the use of low dose naltrexone as a treatment for multiple sclerosis. There are no published clinical data to support the use of naltrexone in MS. Naltrexone is an opioid antagonist that has been approved by the U.S. Food and Drug Administration (FDA) since the early 1990s for the treatment of addictions to opioids and alcohol. At significantly lower doses, it has been marketed on the Internet as a treatment for a variety of diseases, including various types of cancers, HIV/AIDS, Parkinson's disease, Alzheimer's disease, amyotrophic lateral sclerosis (ALS), emphysema, as well as MS and other autoimmune diseases. There are, however, no published reports of placebo-controlled clinical trials demonstrating the safety and efficacy of naltrexone in any of these diseases. The marketing efforts rely entirely on anecdotal reports. Naltrexone is said to work in MS and other diseases by adjusting the level of endorphins in the body to enhance immune function. Enhancement of the immune system, however, is not recommended for anyone with MS. Because MS is thought to be an autoimmune disease, in which the immune system mistakenly attacks the myelin in the central nervous system, the goal of currently approved treatments is to inhibit the overactive immune response rather than boost it. People with MS are advised to avoid any medication, dietary supplement, or other treatment that is touted as strengthening the immune response. Clinical Programs Department, National MS Society, in collaboration with Allen Bowling, MD, PhD Rocky Mountain MS Center