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Low Dose Naltrexone (LDN): Miracle Cure or “Why Not” Drug?

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Naltrexone is a blocker of opioid receptors and is used in patients who have overdosed on narcotics, but at low doses, there is lab-based work, largely conducted by a single group, that suggests that low dose naltrexone can have immunostimulatory properties and even directly kill cancer cells by a process called apoptosis, a self-destruct program built into cells when they become too mutated (cancer cells that are growing and dividing can turn off this signal). At websites like www.lowdosenaltrexone.org and www.ldninfo.org, there are descriptions of anecdotal reports of patients with various different cancers who have done well, attributed to the LDN. To the credit of the people running these sites, there are caveats that these are not scientifically conducted trials. That’s fine, but there are certainly some people writing on patient and caregiver-mediated online communities who are intimating that LDN is a miracle drug and using terms like cure for lung cancer.

I don’t want to be a wet blanket, but I do think it’s important to inject a little caution here. In my mind, LDN fits in with DCA or noni juice or many other proposed interventions that are viewed by some as a “why not?” intervention and others as a miracle treatment that is not being studied or addressed by the oncology medical community or pharmaceutical industry because of a supposed profit motive keeping those groups from wanting to cure cancer. I and most people in the “allopathic”/standard medical pathway recognize that there is major interest in complementary and alternative medicine (CAM) approaches in the general population. What’s not clear to me is whether the majority of people seeking CAM interventions are looking more for a complementary approach and generally accept conventional medicine strategies, or whether there is a significant portion of the people favoring LDN and other less established interventions because they have a fundamental distrust of the medical and pharmaceutical establishments and believe that the people with the power actually want to suppress the ideas that could cure cancer.

As someone who really believes in knowing your source, I recognize that I’m speaking as someone from the medical establishment. I also recognize that there is some reason for distrust of a lot of large establishments with the collapse of entire industries recently for good reason. But even if you have that much distrust of the health care and pharmaceutical industries, I can’t understand why someone wouldn’t think that either the pharmaceutical company or physician with an actual cure for cancer wouldn’t be enticed by the fame and fortune that this would offer. While I think there are several very reasonable arguments in discussing LDN or many other strategies that aren’t widely accepted in conventional medicine, in my opinion saying that the pharmaceutical industry and the medical establishment are withholding the cure for cancer devalues the discussion.

Getting to those fairer points, it’s very appropriate to note that approaches that don’t stand to earn someone a significant profit have a remarkably lower chance of being funded. A couple of decades ago, US tax dollars dictated the decisions about what research was conducted in the US, and this meant that not every potential intervention stood to make pharmaceutical companies a billion dollars per year. Now, we don’t fund much actual cancer research in humans, focusing much more on lab-based work, which is a good start but won’t get you to the finish line. That work is being funded overwhelmingly by the pharmaceutical and biotech industry, and their interest is to make money. So until we start actually bothering to fund clinical (human) research in cancer through a source other than big pharma, inexpensive drugs aren’t going to be studied. This doesn’t mean that they don’t work, but the medical world presumes that things don’t work unless genuine clinical research proves otherwise.

The fundamental gulf is that many patients and family members are happy to have the promise of a treatment and try it in the absence of evidence that it isn’t helpful. In some ways, the medical community requires this as a driver of early clinical trials, which have the potential that an untested new treatment will be a real breakthrough. But when a treatment can be administered outside of a clinical trial, whether it’s LDN or DCA or mangosteen juice, it’s quite feasible to flock to a treatment that might possibly be helpful but may well be of no benefit or even harmful.

And what is the harm? Let’s presume that it doesn’t have significant adverse effects on its own (it does appear to be pretty safe). There is a very real precedent of treatments that were felt to be either neutral or beneficial actually being harmful when tested properly. No lung cancer expert would have expected that the EGFR inhibitor iressa (gefitinib) would actually have a significantly harmful effect on the survival of lung cancer patients, but that’s exactly what it did in SWOG protocol 0023. Not only did things not turn out as we’d have predicted, but I strongly suspect that lots of people would be getting lots of EGFR inhibitor therapy in this setting if we just had people do their treatment without taking several steps back and carefully reviewing the outcomes. LDN or other untested approaches could be detrimental, but anecdotal reports aren’t going to tell us that. Yes, people on the discussion forums can say that they’re alive and feel great 18 months after their doctor told them that that they should “get their affairs in order”. Do we have any idea how many people tried LDN and aren’t on the discussion forum to tell us it didn’t work?

So what? I’d be happy to accept that if conventional medical approaches aren’t offering anything remotely helpful, there’s little or nothing to lose. I suppose the value of what typically turns out from standard treatment to be months, and occasionally years, is in the eye of the beholder. Particularly if the “tested” approaches are exhausted, I agree that there’s little to lose. But if people forgo a benefit proven to improve survival by two months in a broad patient population in favor of an approach that is largely hyped on weaker evidence, there’s some real risk of loss there.

But maybe that’s not much to you. In that case, the real risk that I see is that people may become fixated on a hope that is “false hope”. Some people try these approaches with an understanding and expectation that they may be a long shot, and here I really see no harm in trying. But I cringe when I read people describing LDN and DCA and other treatments as “miracle treatments” and cures for metastatic lung cancer. I would love for this to be true: my ego could take it, and I’d be happy to find another job if oncology becomes obsolete because LDN cures everyone’s cancer. But I think these people calling LDN a miracle are setting a lot of people up for a lot of disappointment. I don’t portray my proven treatments in such a grandiose way.

In the end, it’s humbling to know that the whole premise of GRACE, offering vetted information about cancer from knowledgeable experts, is a bit undermined if people are just as happy to follow medical advice from the person in the waiting room as from their doctor. Medical care isn’t a movie recommendation. But some of this stems from a distrust of the medical community by wide segments of the population, and it’s fair to say that current system is far from perfect.

I’d welcome your thoughts. These are big issues.


16 Responses to Low Dose Naltrexone (LDN): Miracle Cure or “Why Not” Drug?

  • Terryl says:

    I had read and wondered about LDN. And yes it is something I would be willing to try, but only after my Onc says he has run out of options for me. I believe in evidence based medicine. But I also believe that when those options have been exhausted I will have nothing to lose by trying a little noni juice :). As a nurse I often see, and am intrigued by the phenomenon where people are willing to take the advise of “someone in the waiting room” , sometimes even above the advice of their physician. I think it is but human nature, especially since the advise is often accompanied with the word “cure”. I think that often times the interest in non conventional medicine stems from the desire to have options other than the unpleasant ones the traditional medical community has to offer. After all, chemo and radiation are not nearly as pleasant to take as noni juice. I do trust the medical and pharmaceutical industries….to a point. I think it is unfortunate that many alternative treatments aren’t better studied and documented, because therein may lie some of the answers we seek. I will resort to CAM only when/if I run out of options. However, until they are, I am putting my faith in that which has been studied and documented.

  • Dr. West says:

    And I really think that’s a very reasonable approach. I am very hopeful that there are other potentially helpful treatments out there that we don’t know of yet, and only a subset of them will be developed by the pharma/biotech industries. I personally believe that there’s a different threshold between trying something without any established value after the more proven treatments have been exhausted and leapfrogging (or piggybacking) a relatively untested approach over one that has already shown value in trials.

    -Dr. West

  • cards7up says:

    LDN has been approved by the FDA, (off label?). From all that I have read, I don’t see much improvement for those with any ext. LC with mets. Most of the info provided by the LDN org. dates back to 2001. Are they doing more testing, and why can’t there by clinical trials on humans? I haven’t read of any side effects, which in itself worries me, because there are always side effects. I know of someone with NSCLC stage IV doing only LDN, because they didn’t want the side effects of chemo. Nothing has improved and condition has actually worsened, with needing a blood transfusion. Constant anemia. I know this is probably caused by the progression of the disease itself. What it always comes down to is personal choice. I also don’t believe in anything that says miracle cures without scientific proof. So I think I’ll stick with the medical intervention. Thanks for listening. JC

  • Dr West says:

    One thing that I think is helpful about pursuing LDN on its own, even though I don’t recommend or prescribe it, is that at least it’s possible to learn from that experience. A problem, though, is that very often people are taking it with chemo or tarceva or some other intervention, they show a response, and somehow the LDN gets a lot of the credit when it’s really hard to know which part of the treatment is contributing what, outside of doing a full-fledged, properly conducted trial (the same, by the way, can be said for many investigational agents being tested by big pharma when they’re added to standard treatments, which is why it’s appropriate to be skeptical until controlled studies show that the arm getting chemo + drug X is truly better than the same chemo alone or with a placebo in very similar patients). I think LDN and other agents that don’t have a good financial incentive to be studied are in a bind because they don’t have a big pharma backer, which is almost required these days for drug development. Perhaps federal research funding should really concentrate on enabling these “orphan” agents to be tested with federal research dollars to give them a chance. Perhaps we’ll even end up finding a effective treatment or two that won’t end up costing a phenomenal amount of money.

    -Dr. West

  • reginac says:

    Well, I learned this week that the lump that was removed from my scalp was of the same cancer type as that in my lungs, so fifth line treatment was discontinued and there don’t seem to be any clinical trials in the area that would be directly applicable to me, so I am considering LDN as a next step.

    Are there significant side effects? Would I be precluded from taking ibuprofen for a headache because it would be blocked by the naltrexone?

    I realize this is like whistling past the graveyard, but psychologically it seems so darn scary to face this without any sort of pharmacological weapons.

  • certain spring says:

    Regina, Although I know that yours was a comment, not a thread, I did want to say how sorry I am that you’ve hit a new roadblock, and to send all very best wishes.

  • Dr West says:

    I have never used LDN and have never studied it, so I can’t give a detailed assessment of what to expect. Despite the zealous advocacy for it, it hasn’t been studied yet in any comprehensive manner — my view is that the line of argument is based on an assortment of case reports that are selectively highlighted to support people’s preconceived biases. Still, I think there is likely to be little harm in patients who aren’t requiring narcotic medications. And so re: your question about ibuprofen, LDN shouldn’t be an issue with that: it would only be an issue for people who are requiring opioid pain medications to manage their pain.

    Good luck.

    -Dr. West

  • mdconnor says:

    On June 27, 2011 I had a record 14 cm Pancreatic Acinar Carcinoma tumor taken off the tail end of my pancreas. They also took my spleen, left adrenal gland, 80% of my pancreas, 33% of my stomach and part of my colon. 90 lymph nodes were clean and a 14 week post-op CT was also clean.

    Oncology recommended chemo and radiation despite no evidence of cancer at this time. I asked a few questions and had already researched it but the bottom line is it would make me sick, it would degrade my immune system and it would NOT cure me if the cancer comes back. Why did they even ask?

    I am on no required drugs but in the last 60 days I have started a LDN/ oral Alpha Lipoic Acid regiment on my own. I also take 600 mg of Tagamet daily and researching/using DMSO for stitch rejection incision complications. NO side effects that I am aware of. Drugs.com shows some possible side effects if taking 50 mg daily but I only take 6 mg daily. It also says no serious side effects until you take 300 mg daily. It does make opium based pain killers ineffective (to some degree) so this may be something to consider.

    If my cancer comes back I plan on letting folks know what I did and that it did not work. Until then, time for tennis. I have been playing again (and winning) for two months now.

  • Dr West says:

    I don’t think any of the faculty think the evidence or the system for evidence-based medicine is perfect. Absence of proof isn’t proof of absence, and yes, the value of evidence is only as good as what gets tested. My real concern isn’t that patients or physicians should limit our considerations to what has ironclad evidence, but rather that we can’t make broad presumptions about the value of anything that hasn’t truly been tested, whether that’s a supplement or the latest numbered compound from the lab of a big pharma company. So essentially, absence of proof shouldn’t be presumed benefit either.

    As for creating websites, the problem I would fear most, besides the practical challenge in terms of time, is reporting bias, and recall bias. We could have a website reporting responses to EGFR inhibitors, but I suspect that the cases that would lead people to go to the site and enter information is the most striking cases, either unusually favorable or unusually unfavorable. While getting anecdotal reports of most dramatic successes or the worst toxicities might provide a sense of the range of what a treatment is capable of (good and bad), it doesn’t create a proper context if you don’t have the true denominator. Most patients getting an EGFR tyrosine kinase inhibitor have neither a phenomenal and long-lasting response (unfortunately) or horrific side effects (fortunately), but we wouldn’t get an accurate picture from only getting the reporting from extremes. I just wouldn’t have any confidence that people would be motivated to report the full range of experiences with a treatment, and we’d be left with a very inaccurate picture of what the treatment does.

    -Dr. West

  • RTC1 says:

    Dr. West, I feel that your last post requires a reply. I’m checking in too late/too early to write substantively and with care. I look forward to re-reading this thread and responding to your interesting points.

    RTC1

  • kacer says:

    Well, I have no experience myself with LDN, but currently use ‘unconventional’ treatment for my MS (Multiple Sclerosis), dad was dx w/ non-small cell lung cancer last month, looks like it was caught fairly early as there were NO signs of it 10 months ago when he had a chest x-ray looking at something else.

    As there seems to be little/no knowledge here regarding LDN, I thought I might share what I have found since researching into LDN as a possible complementary treatment for my MS. Now since I saw info w/regard to LDN with cancer treatments while looking into it for the MS, I have been looking into it for dad’s cancer.

    You do NOT want to use LDN IF you are currently ON any opioids. (and ibuprophen, not being an opiod would/should still work/be ok)
    You do NOT want to use LDN IF you are taking one of the few chemos that by DESIGN supresses the immune system (altho why you would be recommended a drug that not by accident, but by design makes YOU weaker… I just do not get)
    You DO want to take LDN if the chemo you are on has the SIDE EFFECT of weakening the immune system.
    If you DO take LDN you should remain on it the rest of your life. It does NOT ‘cure’ so much as it forces remission. Stop taking it and 3-12 months you are very likely to have a recurrence of disease, just because you feel better and the cancer is gone or has stopped spreading/growing does not mean you are ‘cured’. You have only been forced… or in this case your body has been tricked into remission.

    There are no side effects reported, on LDN aside from some people have minor sleep disturbances for a couple of weeks after starting it especially if one starts on the 4.5mg dose instead of titration up from 1.5 to 3 to 4.5, but as I understand it, that IS NOT advised with cancer patients, only with auto-immune diseases.

    And Dr. West, I agree that ‘absence of proof does not, or should not be proof of benefit’ but I hope you would also agree that absence of ‘empirical evidence’ = no benefit. All that means is no one has decided to spend $1.6 billion or so to conduct a study to obtain the evidence when they cannot make those funds back by selling a pill for $10+ each. Especially once the patent has expired. And Naltrexone is up.

    And yes, patients themselves might/might not do accurate reports, however those of Dr. Bihari, Dr. Burt Berkson, Dr. McCandless, Dr. Jill Smith, Dr Terry Grossman, Dr Joseph McWhirter, Dr David Gluck, Dr Patrick Crowley, Dr Bruce Cree, Dr. Tom Gilhooly and many MANY other doctors have reported their various case studies, and those while not empirical evidence, their findings are compelling. I’m not saying throw caution to the wind, however, for the last 14 years I have been using myself as a human lab rat, because I had nothing to loose, and lots to gain. I should have been dead by now (from MS, not cancer) or at least in a wheel chair, but when you are sleeping out of necessity 17.5 hours/day, and remaining conscious for the other 6.5 hours is pure torture, you cannot be long for this world unless something changes. I have refused all MS drugs, since the one I did try took me from 2-3 exacerbations/year to 9 in a year’s time. And most of them the side effects are worse than the disease. Or at least the potential side effects seem to be. As I stated only tried the one for 18 months… that was at least 6-12 months too long, fortunately the damage seems to have been repaired once I got off the interferon beta 1A.

    And yes, I think the most reported would be the greatest successes and the greatest failures. And, in some cases the greatest failures might be death, and kinda unlikely to report anything once dead, MAYBE a spouse/relative might, however JUST looking at successes, I think we can see that largely the LDN cases reported by doctors the survival rate (over 5 years) DOES appear to be better than the 4% by ‘conventional’ standards (I’m only thinking about lung cancer non-small cell that has metastasized to elsewhere, since that’s where dad is, atm). Unfortunately, Dr. Bihari passed away in his 80’s and I’m not sure all his patients continued being reported after his death.

    My contention is non toxic, no serious side effects, no minor side effects beyond some minor sleep disturbances. No drug interactions beyond opiates or drugs that purposely ‘cripple’ the immune system. I fail to see a down side. Not saying there IS no down side, but given the numerous ‘ambulance chaser’ ads on tv and all the FDA’s pulling ‘approved’ drugs left and right… I’m not sure we can say that about much, but do YOU know of any drug when given at 1/10th (ok, really 1/11.11th) of the ‘tested’ and approved dose that is more toxic? The concept lacks… any… perceivable…. verisimilitude.

    But since

  • tatt says:

    I worked with doctors for many years. During that time I learnt of several medical treatments that were widely accepted but not evidence based. As an example the importance of dietary fibre was considered “alternative” for many years, then became a craze among doctors. I believe it’s now recognised to help some people but not others. Meanwhile many “early adopters” solved their bowel problems by adding fibre to their diets. Others found it didn’t help and went back to relying on conventional medicine.

    A further example – there are double blind clinical trials on the benefits of Xylitol for dental decay and a few that show it’s effectiveness against a variety of bacteria. It is not being researched for other applications because there is little financial benefit from something off patent. Doctors don’t recommend it, even to those where clinical trials show it would have benefit. Meanwhile many people have been using it happily to prevent ear and sinus infections.

    I am currently investigating low dose naltroxene as a possible treatment for ME – one of those conditions where doctors offer you little and alternative views can help. Those who passively accept the treatments recommended by their doctors may be made worse (graded exercise anyone?) while those who listen to the person in the waiting room may find, for example, that they are coeliac and haven’t had the right blood tests to identify it. Conventional medicine can work very well, when it fails you the woman in the waiting room may be more helpful than your doctors.

    What is needed is for the medical profession to actually listen to patients sometimes and for governments to fund research, (as the Finnish government did with Xylitol) on the most promising “alternatives”.

  • carasm says:

    Since my mother was DXd with a GBM IV (Brain Cancer) and was given little hope for survival past 10-18 months at her age (then 66) it’s been 25 months and LDN helps her tremendously. She’s not on steroids or any other RX. She still feeds and bathes herself and walks around the block. The late side effects from the radiation are causing many side effects now and chemo brain is horrible, especially if you were taking chemo made specifically to cross the blood brain barrier. LDN may not be a cure for all, but for some it really is.

    I was diagnosed with a stage four glioblastoma (brain cancer) in February of last year [2011]. After a full course of chemo and radiation, in mid November, I learned about an inexpensive prescription medication, low dose naltrexone. Prior to starting this medication, I was deteriorating. I required a walker and could go only short distances. I had significant memory loss. With all the standard treatment, I was given 10 months to live. The average prediction is 14 months, even after excision, 3.2 cm of tumor remained. After I learned about and obtained a script for low dose naltrexone I gradually regained my ability to walk normally, without a walker, my thinking became clearer. In short, I regained function. I take no other prescription drugs except LDN. — Laura Arasmo, RN

  • carasm says:

    Defeat Cancer: 15 Doctors of Integrative and Naturopathic Medicine Tell You How, page 395.

    Dr. Finn Scøtt Andersen, MD:

    Low Dose Naltrexone (LDN) is another excellent cancer treatment remedy that we’ve been giving our patients for over ten years. Many Internet websites describe the benefits of low-dose naltrexone for treating cancer, so its use in treating cancer is becoming well known. It’s also beneficial for treating autoimmune diseases. Patients who take [LDN] feel dramatically better within days because it releases endorphins, kills cancer cells via apoptosis, and reduces inflammation.

    The first person to take this medication for cancer was a woman from France, who had four brain metastases from melanoma. This is a very agressive cancer and there was nothing that conventional oncologists could do for her. She had heard about Dr. Bernhard Bihari, the medical doctor who discovered the clinical effects of LDN, and went to hear him speak in Paris. She asked him for some LDN, which he gave her. She began to take it, in a dose of 3 mg daily. Seven months later, the brain metastases disappeared! She took LDN for twelve years, but after twelve years, she stopped, as every time she took a pill, she was reminded that she had cancer. About seven months later, she began to have multiple metastases on her lungs and on the skin of her arms. She called Dr. Bihari and resumed taking LDN for another seven months, during which time her lung and skin metastases disappeared. She was 42 years old at the time, I don’t know what happened to her since then. Now, LDN is given to many cancer patients [this is not the case in the US].

  • soaplady says:

    I understood the point of Dr.West’s comments to be the danger of taking an “unproven” treatment instead of one that has been subjected to the rigor of clinical trials. Fair point as anyone can bear witness to the innumerable cancer “cures” touted …everywhere. And, lay persons not touched by cancer seem to think that “cancer” is a disease with one mechanism.
    I wish that my own cancer had a lot of rigorous human trials behind it’s standards of care but, alas, it is a rare one so the options are not good at all once it has metastasized. I have had retroperitoneal Leiomyosarcoma (LMS) since 2007. It was mis-diagnosed for eight months. It probably metastasized within a year of diagnosis but the lung tumors were so small and (uncharacteristically) indolent that they were overlooked. Metastasis to lungs and liver confirmed in 2011. The gold-standard for LMS is surgery. But doctors are often reluctant to do surgery in cases of metastatic disease and encourage one to do systemic treatment. The absolute best numbers for LMS for chemo response are around 30% – 45% and those numbers do not represent cures but extra time measured in months. If the standard chemos do not get a response, the numbers fall to about 10% for some more months. I have been very lucky that, for those years, my LMS was lazy. But, after surgery for the liver mets, I got more aggressive in trying alternatives. I tried a copper-chelation drug that had some decent animal studies (and some human ones but not LMS) and a sound rationale in antiangiogenesis. I think it helped but, evidently, not enough as I now have four new “somethings” sprinkled all around me. Or, maybe it was a waste of time and money and my LMS was just that lazy for two years. The upside is that it gave me a sense of doing something so that was empowering. Now I am trying LDN along with some other Rx and OTC. There is not much else to do for me at this point while we are “watching and waiting” if these “somethings” turn out to be the Big Bad. If this significantly slows (or, miracle of miracles, the LMS goes away), I do understand the scientist’s mind that would want to know if it was a synergistic approach or one element, like the LDN, that “worked.” But, as a patient, I do not care. I just want the time to spend with my family and friends. I also like the idea that I am being proactive and doing something. I was persuaded to do chemo (doxorubicin and Dacarbazine) in 2011. I did two cycles and saw no decrease in lesion size. It did seriously stomp my platelet factory. I am just returning to low normal numbers after two years. It also got rid of my toenail fungus which is the only positive thing I can say about it. To return to Dr. West’s concerns, I am an informed patient and cannot imagine a scenario where I would choose something “alternative” vs a standard of care should my disease “take off.” I seem to have had the time these years to implement both. The docs were happy and, actually, surprised that the copper-chelation worked as well as it did as long as it did. They are “on board” with me doing the LDN. I don’t have much to lose. Those barely effective chemos are still in the toolbox should it look like I need to go to them.

  • rojan says:

    I had a patch of red scaly skin on my chest that itched a lot. I didn’t pay too much attention to it because I thought it was psoriasis, it looked exactly like the pictures of psoriasis. It grew over time to be a bit larger than a quarter (not exactly that shape) and became somewhat thick. I had the occasion to visit the dermatologist because of of a suspicious spot on my back, and when they saw the ‘psoriasis’ on my chest they took a punch of it for biopsy. The pathology report identified it as squamous cell carcinoma, and surgery was scheduled for a month and a half later. I took 50mg tablets of Naltrexone and dissolved them in 50ml of distilled water, kept the solution in the fridge, and took 3ml at 1:00AM each morning. The results were dramatic. In 2 weeks the squamous cell carcinoma lesion shrunk to half it’s size, and at 6 weeks the lesion had shrunk to a small thin dot. Before the LDN it had been steadily growing. I went ahead and had the surgery to remove what was left. I wouldn’t have believed it had I not tried it, but LDN does work on cancer, at least on squamous cell carcinoma of the skin. I have the pictures to prove it.

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