FDA approved, Cheap Miracle Drug? or Scam?

[Billy T]

This does not seem like a scam to me, but would like to hear the views of some more knowledgeable than me. I note that the MS market, alone is 11 billion dollars annually as the drugs available are both expensive and chronic maintence use. The makers of these MS drugs support the MS Society, which does not seem interested in this cheap, generic, FDA approved, out of patent drug:

Naltrexone itself was approved by the FDA in 1984 in a 50mg dose for the purpose of helping heroin or opium addicts, by blocking the effect of such drugs. By blocking opioid receptors, naltrexone also blocks the reception of the opioid hormones that our brain and adrenal glands produce: beta-endorphin and metenkephalin. Many body tissues have receptors for these endorphins and enkephalins, including virtually every cell of the body's immune system.

In 1985, Bernard Bihari, MD, a physician with a clinical practice in New York City, discovered the effects of a much smaller dose of naltrexone (approximately 3mg once a day) on the body's immune system. He found that this low dose, taken at bedtime, was able to enhance a patient's response to infection by HIV, the virus that causes AIDS. [Note: Subsequently, the optimal adult dosage of LDN has been found to be 4.5mg.]

See more at: www.lowdosenaltrexone.org
There is also a Yahoo group with nearly 1000 contributions each month, at: http://health.groups.yahoo.com/group/lowdosenaltrexone/
but to read posts you need to join group and I did not.

What do you think? Is this a cheap, near miracle, like aspirin, or mass placebo hysteria?

 

[Hercules Rockefeller]

That is a very hard question to answer without delving into a huge amount of complex science. I can’t do it.

My former research area was oligodendrocyte migration during CNS development. It was basic dev boil but the big picture was the application of novel oligodendrocyte biology findings to MS and other demyelinating diseases. It certainly sounds feasible to me that a drug that modulates immune system functioning might play a role in MS treatment as the autoimmune component of MS is well known.

 

[Billy T]

At the site is this list of diseases it helps with:

Bladder Cancer
Breast Cancer
Carcinoid
Colon & Rectal Cancer
Glioblastoma
Liver Cancer
Lung Cancer (Non-Small Cell)
Lymphocytic Leukemia (chronic)
Lymphoma (Hodgkin's and Non-Hodgkin's)
Malignant Melanoma
Multiple Myeloma
Neuroblastoma
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer (untreated)
Renal Cell Carcinoma
Throat Cancer
Uterine Cancer
ALS (Lou Gehrig's Disease)
Alzheimer's Disease
Ankylosing Spondylitis
Autism Spectrum Disorders
Behcet's Disease
Celiac Disease
Chronic Fatigue Syndrome
CREST syndrome
Crohn's Disease
Emphysema (COPD)
Endometriosis
Fibromyalgia
HIV/AIDS
Irritable Bowel Syndrome (IBS)
Multiple Sclerosis (MS)
Parkinson's Disease
Pemphigoid
Primary Lateral Sclerosis (PLS)
Psoriasis
Rheumatoid Arthritis

IF ONLY HALF TRUE, IT IS A MIRACLE DRUG.

 

[cosmictraveler]

If it states that it "helps" then it doesn't claim to cure anything. Aspirin can make the same claim as well as many other drugs now available.

 

[Billy T]

If it states that it "helps" then it doesn't claim to cure anything. Aspirin can make the same claim as well as many other drugs now available.

AFAIK. at least half of the diseases on the post 3 list have no cure. If you are suffering from one like MS* and can not even walk then being helped to do that makes a huge difference in your life, even if you are not cured.

Your point may be true but not of much value.

------------------
*Victims of MS do not spend 11 BILLION dollars annually on drugs that only "help" if they did not think that just being helped was worth while. If this drug is as effective as the still under patent, expensive to make drugs, then there is the potential to save JUST the MS victims 10 BIILLION dollars annually. If it also works on even half of the other diseases in the post 3 list the savings would exceed 100 billion dollars annually! I can understand why drug companies and the disease organizations they often support are not very interested in clinical tests of it, etc.

 

[Orleander]

...*Victims of MS do not spend 11 BILLION dollars annually on drugs that only "help" if they did not think that just being helped was worth while. ...

People who have MS are not victims.
They spend billions on meds that only help. They are the multiple forms of interferon beta. It doesn't cure, but it helps.

 

[parmalee]

Two other uses for naltrexone are for the prevention of escalating tolerance in habitual opiate/opioid users (in ultra-low dosage) and the treatment of alcoholism, by which it works via the same principle for the treatment of narcotics addiction: the patient does not derive satisfaction from alcohol intake.

For the, ahem, "treatment" of autism, the idea is that autistics produce unusually elevated levels of endogenous opioids and, understandably, get off on this and strive to produce even more via stimming. In the 70's, some Dutch guy (Panksepp?) observed that autistics behaved quite like junkies (asocial behaviors, etc.), and subsequently did some tests to confirm his suspicions. It's not a widely accepted theory, to my knowledge. Anyhow, some folk like to dope up little Jimmy with naltrexone so he won't be such an embarassing, shameful social retard. [/rant]

I can see how low dose naltrexone would be beneficial in the treatment of many diseases if co-administered with opiates/opioids. Otherwise, I don't know.

 

[Billy T]

People who have MS are not victims.
They spend billions on meds that only help. They are the multiple forms of interferon beta. It doesn't cure, but it helps.

I don't want to go far into dicusssion of terms, but use "victim" when something bad happens to you, that you did not bring on yourself, so am courious why one who is sick with MS is not a victim of MS?

AFAIK all five standard MS drugs do act via the immune system, but I think TEVA’s copaxone is not interferon beta. TEVA claims it is unique. I own stock in TEVA but have not keep up with it much, as it is in my “never sell” folder. Here is some nearly three year old notes from when I decided to buy into TEVA:


6Oct06: A continuing (6 years now) study of relapsing-remitting multiple sclerosis (RRMS) patients (n=285) taking immunomodulatory therapies (IMTs), found that 41of 79 taking COPAXONE (glatiramer acetate injection) had remained on treatment continuously, whereas less than thirty percent of patients 55 of 206 taking Avonex, Betaseron, or Rebif (all interferon beta drugs) remained in the study. Of the 96 still in study were: 52% or 41 of the 79 originally on COPAXONE, 29% or 14 of 49 on Rebif, 27% or 21 of 77 on Betaseron , and 25% or 20 of original 80 on Avonex . (96 = 41+14+21+20)

BIIB & ELN’s TYSABRI (in two-year, double-blind study of 942 patients AGAINST PLACBO ONLY) significantly reduced corticosteroid use in hospital, and increased the proportion of MS patients with no disease activity. Cost per relapse avoided, was lowest for TYSABRI than for the five other approved disease-modifying therapies. (calculated using the US wholesale drug cost, drug administration costs, patient monitoring and treatment of relapses costs. The costs associated with adverse events were not assessed. The cost per relapse avoided for TYSABRI was between $12,730 and $23,274)

20Oct06 - Avonex (Interferon beta-1a), the most prescribed MS therapy worldwide, may now be stored at room temperature (up to 77 degrees F or 25 degrees C) in its prefilled formulation for up to 7 days.

I believe TEVA’s Copaxone is gaining market share, especially in the USA. (In part, I think, as suggested in the 6Oct06 paragraph - they switch to and stay with Copaxone more - and switch from it less.)