LDN study for breast cancer...effective!

Fallleaves... you're absolutely right.  What you choose to do - the risks you are willing to take with your own health - is a deeply personal decision.  If it is YOUR decision, then it's an entirely valid one.  However, I was raising the - I believe I did use the word "thorny" - issue especially when dealing with what is, essentially, still an experimental drug that is not fully understood yet, is the problems that arise because of compassionate use.  A very real possibility exists that the drug may help you and you'll enjoy a better quality-of-life and, hopefully, a longer life because of it.  But what if that doesn't happen?  What if that drug does not have the effect expected and it, actually, makes you feel worse?  Sure you can stop taking it, but what if that drug causes irreperable harm in the time it was being taken?  Yes, you've the right to make that choice too, if you desire, but it's impact is going to be far- and wide involving your loved ones and your medical team.  They, as well as you, will also be dealing with the impact of your right-to-chose.

This is the "slippery slope" of compassionate use and right-to-try.  Personally, I feel that there are no easy answers, but I did want to point out that, in many cases, there is much more at stake than the patient's right-to-try; there is their ultimate well-being while they are exercising their right-to-try.  That is so very hard to do when the drug in question has not been fully researched, it's mechanisms not fully understood, and it's emotional- and physical impact on the patient cannot be predicted- or prepared for.  A patient's "rights" has a domino effect that doesn't just involve them.  That's why it is so difficult at times to get enrolled in a compassionate use programme.  Rightly or wrongly, all of these issues are taken into consideration when determining if a patient can receive an untested drug.

Off-label prescribing is always risky, but some doctors feel more comfortable with it than others, and - to date - the decision to do so is still the doctor's.  But there are those doctor's - my own included - who do not agree that this is an ethical practise, even though it is a common one, and are seeking to have off-label prescribing halted unless there is enough scientific- and clinical evidence supporting their decision; in other words, anecdote doesn't cut it.  Doctor's such as my own want to see their colleagues held accountable for off-label prescribing.

And, finally...

Yes, based on this one preliminary study, a potential meaningful mode of action was demonstrated, but - as pointed out in the above statement itself - "... on future application of LDN for enhancing host immunity in cancer therapy ..."  This study has set up the hypothetical model for future research- and development, it hasn't demonstrated by any means that LDN is safe- or effective for use in cancer therapy.  The work done on this study has shown that there is a valid reason to keep on researching.  It has, merely (figuratively speaking), drawn the blueprint on which future construction is going to build.

" In some cases, off-label drugs become the standard of care for illnesses well before the studies proving their suitability for those treatments."

Absolutely.  This can- and does happen.  Unfortunately, in the other cases it does not, which places pharmaceutical companies and regulatory bodies in a tough spot.  They could be providing the one drug that may turn out to be a miracle, but it's far more likely - statistically speaking - that the drug will have no effect or even a negative effect.  Miracle drugs are few- and far between, and usually only come about after years of research and refinement.

Compassionate use, right-to-try and off-label prescribing fall into this huge, murky, grey area where there are no easy solutions.  The medical community and pharmaceutical industry has no choice, but to always focus on clinical ethics and the medical welfare of the patient when it becomes an issue between the patient's right-to-try and the patient's welfare.

I'm not raising these issues to question the personal decisions of others, merely to point out that there are very real, sticky, thorny, murky issues that are exceedingly difficult to sort out, especially when "ethics" is such a fluid- and abstract concept, that varies from person- to person.

SelenaWolf, I value your opinion! You obviously know your stuff, and you present valid issues that we should keep in mind when looking at alt. therapies. When we're dealing with something as important as our health, we really do need to think critically.

Fall, well said and also kudos to Selena for parsing through some of this.

the way i read the alternative forum is there're three ways of thinking. one thinks alternative as a treatment, mostly a primary treatment. and some see alternative treatment as enhancement, more like after chemo which was effective to them with many data to back that up and they see alternative as enhancement, i wouldn't say they see it as complementary. and there's some of us like me, seeing alternative as complementary. 

we all want to think we made the right choice, especially the longer after you're out of the wood, the firmer believer you are.

i don't want to get into the landmine about conspiracy....i don't really think that much into it or really think there's a conspiracy but i do think pharmaceutical  is there to make a buck more than the noble cause.

though i am not stage 4 but i can understand how that feel. because i've been thinking about it from time to time especially this week. sometimes i thought about my future and i stopped myself because i just don't know. because right before my DX, i had a great plan for my career and my personal goals. and now i just don't know. i don't know i'll be working towards my goals or just fighting for my life. i thought my 40s was to build my career and never thought it's for survival. 

That's something I've never thought of, but yes, it makes sense that US doctors would need to be extremely cautious. Here in Canada, I don't think doctors give anything they deem beneficial a second thought. No approval needed by an insurance company and no potential for being sued for off-label prescriptions. We're so laid back here. Nobody sues; they just don't.  I remember having a CT, which normally requires me to sign a release (because of the dye) and they forgot to have me sign. I was feeling so awful that day that they were just so busy making sure I was comfortable that the consent form wasn't a priority. Two days later I got a call from the radiology department asking me to "stop in" and sign the form next time I'm in the neighbourhood. I like when a medical team can do what needs to be done without fear of litigation. I think it makes for better medical care.

I just noticed that no one had posted this info before.

http://www.lowdosenaltrexone.org/ldn_and_cancer.ht...

"NCI Examining LDN Cancer Cases. In June
2002 an oncologist and an oncology physician's assistant from the
National Cancer Institute reviewed some 30 charts of cancer patients at
Dr. Bihari's office. About half were chosen as appearing to have
responded to LDN without question. With patients' permission, copies of
these were sent to the NCI for further data collection on its part for
consideration for NCI's Best Case Series."

One of the noteworthy cases reviewed:

"Breast Cancer. M. is a 41-year-old patient
with breast cancer, diagnosed and
treated elsewhere in 1998, whose course was complicated by a recurrence
involving metastasis to the hip. Outpatient hospice services were
sought. Her walking was so badly impaired that she had to be assisted by
her
friends on her first office visit to Dr. Bihari in June 2000 — at
which time she began LDN. She revisited his office in mid-October and
reported that she not only was able to return to work but also was well
enough to play tennis again. Repeat bone scan in October 2000 showed a
40% reduction in metastatic tumor mass. She then enrolled in an
experimental chemotherapy trial at a major cancer treatment center in
New York in December of 2001 and died of liver failure on the fourth day
of the trial."

i also wonder if it's liver mets or liver failure due to chemo....??

thanks momine.

Hi Mary,

Sorry your dealing with all this crap. I've also been on LDN for MS for about 9 months, and it is indicated for BC too.

Amazing that your UNDIAGNOSED of MS. Were you ever actually DX'ed via MRI or lumbar punct???? I've never heard of anyone being cured of MS only remission. Good for you. Breast cancer sux.........MS sux more!!! I wish you a smooth BC journey and a true healing.

Maureenxox

i took LDN fir a few months but it really affected my sleep so I stopped it, but my doctor was doing his own study on it with diagnosed BC patients, and had very good result

I'm sorry Jojo, I didn't realize you were talking about yourself.  Guess I neglected to read your diagnosis line.  So sorry about your new diagnosis. There are doctors (not oncs from my experience) who are willing to prescribe off-label drugs for advanced cancer patients.  If you make a stink and your prognosis warrants it,  they can be gotten. Not necessarily through insurance or drug plans, but if you have to pay for it out-of-pocket, most are relatively cheap. 

i too obtained mine. By mail with a prescription, good luck......