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Is There A Wonder Drug in Our Midst?

For better or for worse, virtually all prescription drugs must be officially approved by the Food and Drug Administration (FDA), an immense bureaucracy that regulates the vast segment of our economy that the words “food” and “drugs” imply. (Though, somehow, the FDA can’t seem to get cigarettes off the market.) Before any drug is available for prescription, it must pass muster with a series of clinical trials and meet the approval of several separate committees.

When a drug is approved by the FDA, the approval applies only to specific medical conditions: Drug A is OKd for diabetes, Drug B for migraine, and so forth. Even though it’s not at all illegal to prescribe drugs A or B for other conditions, most physicians, fearing a visit from a malpractice attorney, prescribe according to FDA approval guidelines.

This, of course, presents a problem when a medicine for disease A is found to be helpful for disease B. The term for this is off-label prescribing. When, for example, the blood pressure meds called beta-blockers were found to be excellent at preventing migraines, it took a decade of off-label prescribing before enough clinical trials were conducted to add migraine prevention to the FDA approved-use list for beta blockers.

If a new use is found for an older drug, the pharmaceutical companies are forbidden to breathe a word about it to the public or to physicians until the required clinical trials are completed. When physicians reported the epilepsy drug Neurontin helped patients with chronic pain, migraines, and bipolar disorder, drug reps from Neurontin’s manufacturer Pfizer Labs began spreading the word, with the result that the company was fined $430 million for illegal marketing. These days, a drug rep would sooner cut off her tongue than discuss an off-label use for the med she’s touting.

All this relates to the off-label prescribing of a drug you’ve likely never heard of and probably won’t ever need: naltrexone. This is a medication FDA-approved only for serious addiction to opioid painkillers like Vicodin or OxyContin. It works by blocking the brain’s receptor sites for opioids, so if you take naltrexone and Vicodin together, the Vicodin doesn’t do anything—its effect is completely blocked.

Several years ago, a doctor discovered that people using naltrexone who also had Crohn’s disease reported their intestinal symptoms suddenly improved. He managed to get enough people interested until researchers from Hershey Medical Center at Penn State conducted clinical trials. 15 of 17 patients with Crohn’s reported feeling better and their disease stabilized. It was postulated that somehow the naltrexone altered the immune system for the better. Remarkably, a very low naltrexone dose (4.5 mg) was more effective than the 50-mg dose for opioid addiction. Also, because of this low dose side effects were virtually non-existent.

Thinking then of other autoimmune disorders, researchers began using low-dose naltrexone (LDN) for multiple sclerosis. Again, preliminary studies are very encouraging.

Orphan drugs

Then, naltrexone went generic. This meant the price was quite low and for precisely that reason no drug company would foot the bill for the high costs of obtaining coveted FDA approval. So there it sits, languishing. The term for this? Naltrexone is an orphan drug. One small company recently ran trials combining LDN with the antidepressant Wellbutrin for weight loss and saw very positive results. But the FDA wouldn’t give its approval until the company came up with a larger study that involved more patients. Unfortunately, the company may have run out of money for these costly clinical trials.

What’s interesting is how the medical profession responds to LDN. I have yet to meet a single gastroenterologist who has even heard of using LDN for Crohn’s disease. When I’ve asked if they’d prescribe it, the answer is the standard “Probably not. Let’s wait for FDA approval.” Which will, of course, probably never occur.

Because of its large internet presence, the multiple sclerosis community has plenty of articles on LDN and I imagine patients must be badgering their neurologists a-plenty. MS patients tell me their doctors will write an LDN prescription if asked. But interestingly, it’s never offered to them.

Among doctors whose specialty is weight loss (bariatricians), some are writing LDN prescriptions with Wellbutrin in a proportion similar to that recently blocked by the FDA. To these doctors, the results and the safety profile were satisfactory.

You can read more about the use of LDN for MS here and watch a news report on it here.

Be well,

David Edelberg, MD

Leave a Comment

  1. Mary says:

    This is more procedural, but I preferred getting the whole newsletter via email. Thanks.

  2. coral says:

    I love these weekly missals. It makes me think that the ’60’s are alive and well. They are also very informative. Thank you!!:)

  3. Tina says:

    What dosages of Wellbutrin is recommended? Thank you

  4. Jessica says:

    How much does a clinical trial cost? Has anyone ever conducted a grassroots clinical trial?

  5. Laurie says:

    Funny, my experience was the opposite. My neurologist this year flat refused me LDN, claiming it was a “fad”…though I’m not sure you can call 30 years a ‘fad’. 😉 And I found a friend who had also asked the same neuro for LDN and after pushing a bit, actually got kicked out of our neuro’s office!

    After she refused me, I found a gastroenterologist who actually advertises that he uses it and I went to see if he would give it to me for my MS in combination with some gastro issues I have. Well, that was the easy button – he gave it to me right away. Apparently he has quite a few patients with MS with the same story.

    I just started LDN but after the first pill, I noticed a huge surge in energy. Those 2-5pm “can’t keep my eyes open” worthless hours are now productive! Can’t wait to see what happens in the next few months. And weight loss to go with it would be awesome too. 🙂

  6. Dr E says:

    Hi Jessica
    The Wellbutrin/Naltrexone combo was recently approved by the FDA and is available on prescription. There are no more clinical trials. Here’s a link

  7. Therese Hayes says:

    Laurie would you mind sharing the gastroenterologist who advertises and uses it? My son has crohns and I’ve been to 3 doctors who won’t prescribe it.

  8. Sanna says:

    I was offered LDN by my doctor in Germany for CFS since the beginning of the year. Many people with CFS see improvements, and I think I have as well without any side effects currently. Has Whole Health prescribed it for CFS before?

  9. Dr E says:

    Hi Sanna
    LDN is not routinely prescribed for CFS as the results have been inconsistent. If someone does wish to try it, we’ll be happy to have a pharmacy prepare it for them as it is VERY safe

  10. Johanna says:

    I have taken a combination of Effexor 150 mg and Wellbutrin SR 150 mg for depression, well regulated, for 10 years. I am interested in LDN as an adjunct for weight loss, since I’m happy with my antidepressants. I’d appreciate some guidance in approaching my doctor about this. A friend uses Contrave with good results, with minor side effects that don’t interfere with her job, and research brought me here. Thanks.

  11. Dr E says:

    Hi Johanna
    Contrave of course contains LDN and the amount of buproprion should be okay with your current dose of Wellbutrin.
    You can ask your doctor to write you an rx for the LDN alone and have it filled through a compounding pharmacy

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