Ashley,

This is such an awesome blog! I have been taken pretty much any health class that you can think of. Im a phlebotomist and a nurse-to-be and none of the courses, none of the jobs, have have informed me of what this condition really consists of. You really have educated me through this blog. I hope that others who have read feel the same, i wish everyone could read this, maybe they would not be so ignorant to the condition, as many are. Even people in the medical field, like myself. Also, kudos to you! Its incredible what you have had to go through, and you are still positive! I hope you have educated many. I hope people that have read this, that are suffering from the illness, have been inspired from your optimism! Kudos to you, Ashley! Kudos to you!

Margaret,

Let me start off by saying that my information was not intended to be a personal criticism of your drug choice, but rather to educate people about other studies.

The info I got re UCSF was second hand. I did not have details, but what is important that people be aware of ALL the facts. That there are studies [Milan et. al] that show that this drug activates the immune system, as I wrote earlier, is indicative that close attention needs to be paid to the stats and all studies. Activation of the immune system is NOT what you want to happen in MS. Also, studies that are comprised of very small groups of people do not provide reliable outcomes.  I don’t have details handy on this study, but if it’s double-blind, then this means only 20 out of 40 people got the drug and one in twenty people suffered neurological problems. Yet even that’s too small a sample population.

The Standford 10-person study over a very short term, done last year, and was for fibromyalgia and showed fair results, but also indicated that more studies would have to be done before they could conclusively recommend the drug for this purpose. As stated on the Stanford website:

"…….we believe some cautions are in order in interpreting our results. This study was very small; only ten fibromyalgia patients were tested. Therefore, the results must be replicated on a larger scale, with more people. There are also a number of questions to be answered regarding proper dosing, interactions with other medications, and whether or not beneficial effects are maintained over a long period of time.
Consequently, this study should not be interpreted to suggest that LDN is a well-accepted treatment for fibromyalgia pain and fatigue. Although we are pleased with the results of this pilot trial, it is still too early to say how effective LDN will be for individuals not in this study.

http://snapl.stanford.edu/research/ldn.html

The drug may win hands down for halting the progression……but what good is it if there’s a chance of neurological conditions as a result?  

I believe that people should be informed before they make choices. While patient testimonies are good, I’ll always give credence to scientific outcomes of large studies. No one knows the long-term effects [naltrexone used for opiod addiction is short-term].

I want to second what Jayne Crocker has said about LDN. If you have RA or any other auto-immune disease/syndrome, PLEASE to do not dismiss LDN out of hand. (And don’t confuse low-dose naltrexone — max 4.5 mg — with the high-dose daltrexone — 50-100 mg — used for drug addiction. At 4.5 mg LDN has no toxic side effects; it kept me from sleeping in the initial weeks, that’s all (and that’s common with a minority of users).

I’m talking from personal experience. I was diagnosed with juvenile rheumatoid arthritis at age 12, I’ve had Crohn’s disease for 30 years (I’m 56), and I have mitchondrial dysfunction, asthma and allergies. All of those are auto-immune conditions. I started taking LDN just under  six months ago. (I’m also on a no-sugar/starch diet, except whatever sugars naturally occur in fruits/veggies/honey. That kind of diet is a good counterpart to the LDN.) I have seen great improvement in every one of those areas.

I have virtually no joint pain, take half the amount of asthma inhaler I did, don’t have the muscle issues I had (from mitochondrial dysfunction), and my allergies have much improved. As has the Crohn’s, of course. If that sounds too good to be true, it’s only because all of those are related to my faulty immune system, and that system has been steadily improving itself as a result of the LDN. I’ve had much experience, both with RA and Crohn’sm in taking the conventional meds, and that experience was pretty much universally bad (I’m drug sensitive, and of course all of those drugs wreaked havoc on my already messed up digestive system). LDN has been a God-send for me (and thousands of other people). I have no vested interest in it (it’s an inexpensive generic drug! I don’t work for a drug company!) I other people to feel better, as I do. I’m only reporting on how it has remarkably changed my life. I’m feeling as well as I have in many decades.

Elaine,

LOL.  In a way, practically anyone with autoimmune disease is a slug. The medication [e.g., Methotrexate]  itself often wipes us out and if that doesn’t do it, our limitations and the chronic pain can make us clinically depressed and make us feel wiped out. The RBC count is below normal as a result of some of the drugs. [If you’re taking Methotrexate with your Enrbrel, this could account for a lot of sluggishness. Ask your doctor about folic acid, 1-2mg daily. 

Patients who are successful in treatment learn to comply with medication AND to pace themselves. Acceptance plays a large part in outcome, too.

If since beginning Enbrel you’ve been bruising and bleeding more than would be normal, have your physician check for aplastic anemia. I trust you are seeing a rheumatologist for this?

Smiles…okay now that I see it works. Pardon me.

Great sight here Ashley. My name is Deb and I am 55.

I have suffered with RA and Fibromyalgia. RA since the mid 80’s and FM all my life. I went through numerous drugs and still became crippled in both hands. The final drug being Enbrel. I took these miracle shots for 5 years before I began having skin involvment. I was hospitalized 2 times with out of control asthma the last 2 years on this drug. I stopped Enbrel Jan 06 and reported my problems with it to the FDA.

When I started these giant hives that would appear on my stomach to thighs at times a new doctor asked me what I was doing to hurt myself. I told him Enbrel shots. My Rheummy at the time was not concerned so I fired him. I stopped the drug the skin eruptions resolved after 6 months.

My current Rhemmy is afraid to give me anything at this point. I have sufffered with RA since the mid 80’s when having 2 titanium dental implants interferred with my immune system.

Last July I research and found a protocol that is working for me. I take guaifinesen and follow the doctor’s protocol and slowly, very slowly I am able to get up and move again. Anyone interested can see this information here.  http://www.fibromyalgiatreatment.com/

I am so thankful to have found this. It has helped me in all ways across the board. I began warm water therapy and wow does it ever feel so good. I can even jog now in the deep end. It feels so wonderful to stretch my body that became so frozen and near death. I want to live and live abundantly as possible! 

I suffer from carpel tunnel in both hands even though I had joint replacement in both hands in the late 90’s. I have neuropathy in both feet. The FM as lots know can be horrid with the brain fog and the stiff body that hardly wants to move.

I took many many drug over the 20 year period and they did not help me anymore after a short time.

I am now looking into the LDN as well. My doctor (Rheummy) has an open mind so she will research it.

Ashley you are very young yet hon. Reedem the time hon. The years quickly pass.

Thank you for allowing me to share my story. 

Andrea

Would you give a source for your worries about the chances of neurological conditions as a result of taking ldn?

How long do large-scale trials continue in order to determine unforeseen side-effects before a drug goes onto the market?

I notice that Ashley mentions in her article that RA is sometimes treated with cancer drugs or something similar – isn’t this off-label use? Apparently off-label prescriptions are very common, especially for use by children, because they’ve not been trialled on children. Ldn is far from being the only off-label medication being prescribed.

Before anyone takes any medication they should inform themselves about it. As far as ldn is concerned everything that is known about it is freely, generously and openly available. There is advice from doctors and experienced “ldners”; one man has designed a database at www.ldndatabase.com where people can record their experience whether positive or negative; there are radio programmes, audios and videos, ldn forum, books, reports …… I, for example, studied the information for more than six weeks before starting ldn.

No one is trying to hide the fact that large-scale trials have not been done. The report from Stanford you cite explains why this is. By the way that report also says: “We were very encouraged by the results. In six out of ten participants, LDN was significantly better than placebo at reducing fibromyalgia symptoms. LDN reduced daily pain, the highest level of pain, fatigue, and stress. Other symptoms, such as sleep problems, gastrointestinal complaints, and headaches, also seemed to be helped.”

There is an international campaign to raise awareness of the situation and pleading with governments to do something about it. You are not alone in not being prepared to accept anything but large studies and this attitude is respected. At the same time the current evidence regarding ldn is pretty unique in that after 6+ years no serious and/or permanent side-effect has been reported and none of the evidence is motivated by an interest in generating profits or recouping costs – unlike trials funded by pharma companies.

There are inevitably some people who cannot tolerate ldn - the same can be said for penicillin or aspirin and goodness knows what else, but I don’t think anyone has seriously suggested the drugs should not be available to everyone else.

It would be really nice to have the many issues surrounding ldn clarified and explained – at the moment explanations are often theoretical. Among these issues is the effect of gluten and casein in the body and how they affect the way ldn works, there’s a controversy about when the daily dose should be taken, in what form, pre-existing conditions like Lyme disease and candida, do we have to take ldn for the rest of our lives or does it at some point “repair” the immune system for good? - no one has yet dared to stop taking it to find out.

Ashley, thanks for your column, which I’ve been reading and enjoying - though I’m saddened that you’re going through such travails. You raise a terrific point about autoimmune diseases, and chronic illnesses that are not "visible" to others. A friend and I, both Type II diabetics, often remark that we would like to call all those in our lives who are also Type II’s and apologize to them for our sheer ignorance about what this disease REALLY means. Before we were diagnosed, we thought, "Oh, how bad is THAT? So you take a pill, avoid sugar and no big deal." Hah! Like your condition, and countless others, this is a condition that invades every aspect of your life as you navigate the choppy waters. I have another dear friend who struggles with acute fibromyalgia - often in awful pain, exhausted, depressed from the strain of it. And yet she looks fantastic, still vibrantly beautiful - so when she bows out of a date, or needs a couple of days in bed, some look askance. It’s no fun, is it?

In terms of various treatment modalities, I am a believer in being as proactive as possible. I manage my diabetes now, after a substantial weight-loss and general health improvement, mostly by diet, exercise and a minimal dose of two oral meds. But I also include some natural remedies like cinnamon bark capsules and lots of green tea. If an experimental or "off-label" medication came along, I probably would pass on it at this stage, but that would apply only to myself. I do believe in controlled drug trials, and have a couple of acquaintances who have gone that route with varying degrees of success: some worked out fantastically, others not so much. I never criticize the choices a chronically ill person desperate for relief makes unless the choices are completely random and not discussed with the primary care specialist. But when the chips are down, folks are going to look for help, and I can only wish them success in their quest. One thing I always recommend is good nutritional guidance in managing any autoimmune disease or chronic illness. When our bodies are under stress, what we put in them to soothe and nourish can play a huge part in coping and staying as strong as we can to carry on. Eating "clean", whole foods can help counteract the daily exposure to pollutants, too. Best health to all!

Margaret, 

My source for the Milan study in which one out of 20 persons given Naltrexone had increased neurological symptomology was in an online subscription medical journal. You could have easily found the  abstract by googling “ Milan naltrexone Multiple Sclerosis.” Here is the PubMed reference, which says nothing about it being a double-blind study:  

http://www.ncbi.nlm.nih.gov/pubmed/18728058 

While this abstract does not say so, I believe this was a double-blind study.  

Longitudinal studies of those who participate in clinical trials may or may not take place. They’re generally very costly. This is best answered by someone involved with many ongoing clinical trials. Find out how the drug is metabolized. If in the liver or the brain, for example, you would need to know about the half-life and other scientific info.  

Remember that this drug is a generic in the US. What that means is that it’s probably unlikely that there will be much, if any, government funding to do a large scale clinical trial because there’s no incentive for the pharmaceutical company. 

RA and some other autoimmune forms of arthritis are sometimes treated with DMARDS, particularly Methotrexate, which is also used in some cancer treatments, but at a much higher dose. However, these drugs are highly toxic, even at low dose, and are NEVER treated in women who are or who are capable of becoming pregnant.  

Off-label drugs are not illegal. The FDA does not control that, leaving it to a physician’s discretion.  

I can only say once again, you can have a zillion testimonials about the drug, but you probably don’t have all the important information that can only be done in a scientific study.  

I am in no way saying that the drug is bad. I AM saying that people should never decide to take a drug based on the testimonial of those who do take it. Databases are fine empirical documents, but they are not controlled scientific studies. And they can be misunderstood by some people. 

Since the mapping of the genome system an explosion within medicine has caused vastly improved treatments and innovative technologies that are being studied as a way of repairing the immune system.

Elaine,

Are you taking Methotrexate or another DMARD with your Embrel?

I have recently received a lot of emails from young women with RA who have read my book Everything Changes: The Insider’s Guide to Cancer in Your 20s and 30s. 

Your post really helped me better understand what RA is and what the lives of these readers might entail.  Whether it is how to date, have a career, friendships, marriage, children, navigate health insurance … I can see why these issues present such similar challenges for patients like you and me both.

Thanks for the education!

Kairol