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


April 4, 2009 - 3:35 am     Print This Post Print This Post     view / write comments

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Dr West

     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.

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  1. April 4, 2009 - 8:27 am

    Well Dr. West, you hit it right on the head!
    My wife and I have had several conversations here with you during our battle with stage 4 nsclc and will continue.
    I was one who asked you your opinion on LDN while Cathy is taking Tarceva. Our concern was that LDN may do something to take away from the Tarceva. We also asked our oncolgist the same question and got the same answer so we then decided NOT to use the LDN (our oncologist agreed to write a scrip if we wanted it.)
    From our viewpoint, hard decisions have to be made each step of this battle and there are no easy answers. Diet, chemo types….on and on. We realize that many of our questions do not have answers which must be very frustrating to the doctors as well. We look to you for our answers and in many cases we put our lives in your hands, (well in Gods hands and yours.) So when we hear of something that has done good for another, we want to jump in head first. I do think most of us come to our doctors with information and ask their opinion prior to making a decision. It is when the doctors inform us there is nothing else they can do that we feel free to try things like LDN.
    You are correct when you say folks have a fear many drugs are not being tested because no money can be made on these drugs. Another reason we have to make decisions at the right time when it come to drugs like LDN. We feel we have no other choice and perhaps it will keep us alive.
    Keep in mind that the technology for digital photos was around and kept off the market for many years because Kodak and other film producing companies stood be hurt. I am not saying someone out there has a cure for any and all cancers but I am saying we should understand how things can go in a wrong direction. Another example is the sale of tobacco. We find out a certain pesticide or chemical in paint can cause cancer and it is off the market but tobacco companies have deep pockets and still go on selling.
    So my good Dr. West, Thank you for being here. Thank you for your honest opinions and your expertise! Know that you are a comfort to many of us dealing with this beast!
    Regards and God Bless,

    Bill & Cathy

    bayrealtor
  2. April 4, 2009 - 2:42 pm

    Two questions:
    1. Has there been any clinical testing of LDN at all?
    2. DCA was moving toward a small, Canadian clinical test the last I recall. Any word on that?
    Thanks!–Neil

    neilb
  3. April 4, 2009 - 9:44 pm

    Dr. West -

    Thank you. You made an excellent point with this statement: “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…”

    Indeed!

    I’m not sure it’s just the inexpensive drugs that aren’t being studied; it could be the moderately expensive, but not super-profitable drugs and treatments . While I agree that probably no one is intentionally withholding a cure for cancer, I worry that big pharma’s “profits first” mindset and the greedy business climate biases the type and amount of research directed to cure(s), and even directed to “better” (i.e., less toxic, more targetted) treatments while waiting for a cure. (This presumes there will ever be a “cure” — which is a perhaps touchy topic for another thread).

    Just some other questions along this line: As the patents expire on cholesterol-lowering drugs and their manufacturers search for other “cash cows,” how might that affect research on cancer treatment and cure? If other disease/research arenas promise more profit, what happens to cancer as a priority research area? Given that lung cancer is already low on the list for types of cancer research, does it fall even lower?

    Ultimately, it seems that we need to adopt new and better models (or return to an older, better model), where private-public partnerships in cancer research are driven by something beyond obscene profits, while still satisying the realistic business need to “make a buck.” Until then, suspicion and distrust will drive cancer patients and their families to these “why not” drugs — some of which may cause harm, and maybe some that work for a certain number of patients or at least do not cause harm (except, perhaps, by raising false hopes).

    Hopefully, the Obama Administration will place a priority on better cancer research models (and research ion generral) and provide corresponding funding. Said resources have been lacking for at least the last eight years when the Bush Administration cut funding to cancer research in harmful, perhaps criminal, increments.

    Newsman Sam Donaldson was on NPR’s “Talk of the Nation” April 1. Donaldson is a 14-year survivor of Stage III melanoma. He made some very good comments on cancer during his interview. Just to quote:

    “Cancer…is always stalking… We gotta ged rid of this disease. This is one thing… we can throw money at. I used to cover the congress and I’d listen to debates on the house floor. ‘…You can’t cure this problem by throwing money at it!’ Oh, yes, you can ladies and gentlemen. Let’s get more money, and thank goodness President Obama [has it] in his budget..In one year, President Bush’s budget… actually cut REAL DOLLARS from NIH so they had down to about 11% of peer-reviewed proposals to study whether the thing that worked on the rats worked on human beings. That’s a shame. …It’s a crime…”

    Stepping down from my soapbox now.

    Catharine
  4. April 5, 2009 - 11:52 pm

    Thank you all for your thoughtful comments.

    To my knowledge, there has never been a prospective study published or formally reported that described an experience with just LDN or DCA and no other active treatment, or even one of these with a standard treatment for which we know what to expect. It would be a huge step forward to see a 20 patient prospective trial that just isolated the effect of the LDN or DCA.

    I can assure you that I’ll be on the lookout for any reports in the medical literature or at major meetings that cover these topics. I would be thrilled to have something new to be optimistic about. But my goal is to keep the “marketing claims” and hype in line with the evidence — and I’d like to apply the same standards to a treatment being tested by a large pharma company as well as a proponent of LDN. I don’t want anyone to mislead the cancer community with unjustified promises.

    I also don’t want to be too heavy-handed about the profit motive. There’s no question that these companies are looking for profitable drugs, but the clear majority of individual people working at these companies actually take pride in providing treatments that help people, as opposed to just trading stocks.

    Finally, the good news is that the pharmaceutical industry is well aware of the value in the lung cancer world and has no interest in ignoring it, even if the American Cancer Society and NIH don’t provide nearly enough support for lung cancer. And that’s not likely to change as cholesterol or heartburn medicines go off patent.

    -Dr. West

    Dr. West
  5. April 6, 2009 - 2:50 am

    I shouldn’t have been so lazy. A Google search for dca cancer canada got me right to the University of Alberta’s DCA home page. The latest update there (from October 2008) indicates that their two trials have each enrolled about half of their intended number of patients (50 patients sought in a phase II study for brain cancer, and 30 patients sought in a phase I study for “solid tumors”, presumably including lung cancer).

    So it appears that around 40 people had begun participating in those trials as of six months ago. Obviously, the best those trials can do (when they report, probably in late 2009 or in 2010; it should take too long after accrual is complete, as they’re seeking people with no other treatment options) is provide evidence that further study is warranted (or not).

    neilb
  6. April 6, 2009 - 2:51 am

    “shouldn’t take too long”, not “should”, and here’s the web site:
    http://www.depmed.ualberta.ca/dca/

    neilb
  7. April 6, 2009 - 7:47 pm

    Very interesting! According to the government clinical trials database, there is also a planned trial in glioblastoma with radiation and temozolomide coming up (http://clinicaltrials.gov/ct2/results?term=dichloroacetate+).

    Dr Pennell
  8. April 7, 2009 - 3:50 am

    Neil,

    Kind of you to only call yourself lazy: I could have done that search too. I would really welcome some results from trials of these approaches and definitely believe they deserve the opportunity to be tested and gain broad utility if the studies support that.

    -Dr. West

    Dr. West
  9. October 7, 2009 - 10:54 am

    I don’t agree that physicians and others stand to make large sums of money by perscrining LDN. It is an existing,approved drug. Drug companies are not going to offer doctors kickbacks for prescribing this, unlike expensive chemotherapy drugs or Erythropoiesis Stimulating Agents, which get overprescribed and overdosed and are known to excellerate cancer growth and kill people.

    I have come to the conclusion that doctors don’t educate themselves in integrative medicine precisely because there is no financial incentive. I wanted to add a demethylator (decitibine) and an HDAC inhibitor (Phenylbutyrate) to my taxol infusions to enhance effect but can’t get a doctor to think outside of what drug companies designate standard treatment. We need a way to incentivize doctors to find creative strategies. Right now most doctors just do what they have to do to get paid and to avoid any liability.

    I would love to find an exception in the Dallas, TX area.

    mlee_realtor@yahoo.com
  10. October 7, 2009 - 11:48 am

    I don’t think I said that docs who offer LDN are making large amounts of money from it or stand to. But there are many standard treatments that don’t make large sums of money for docs but are still justifiably considered the standard of care, if they have the evidence behind them that they work. Oncologists don’t profit particularly by giving cisplatin or recommending aspirin for heart disease.

    I don’t think it’s so much what the drug companies consider to be standard as what the FDA and widely accepted professional guidelines designate to be the best standards, which is based on the evidence. I would be very supportive of enrolling a patient on a clinical trial that looks at the effect of adding decitabine or an HDAC inhibitor to paclitaxel or another standard chemo drug, but I would have absolutely no confidence that this would be a beneficial and not harmful combination without clinical evidence to support that supposition. Whether it’s LDN or avastin or an HDAC inhibitor, there are plenty of examples where combinations can be detrimental. “Creative” can kill people rather than help, and the fact is that we live in a society where there are lawyers just salivating over the opportunity to call creative treatment reckless and substandard as they sue you. Creative isn’t going to happen until we change the legal system, so that we wouldn’t anticipate that doctors will be crucified for practicing in a less conservative fashion.

    -Dr. West

    Dr West