In mid-2010, I had been diagnosed with MS for about 18 months. After a year of very bad health, including a low-grade fever, extreme fatigue, highly elevated liver function, and what looked like the start of jaundice, I stopped going to my neurologist, stopped taking my traditional CRAB MS med, and switched to a mixture of enzymes, probiotics, and low-dose naltrexone, better known as LDN. That was the year I left the world of traditional medicine, insurance, and embarked on an active search for a different kind of care.
I had been reading a lot about multiple sclerosis, learned of some people who were altering their health with diet and off-label drugs. Low-dose naltrexone was one drug frequently mentioned as helpful to those with MS.
LDN is not considered by many to be an acceptable treatment for MS– the use is off-label. However, it changed my life. I was lucky to find a doctor who wasn’t afraid to prescribe the drug, and I live very close to an experienced compounding pharmacy, which is able to compound the drug.
Naltrexone, in its full-dose form is used to treat addiction. It blocks the opiate receptors that give a pleasant feeling to people addicted to alcohol and other drugs, and prevents substances from giving them a “buzz.” A typical dose in this case might be 500 mg. LDN uses a fraction of this dose, most typically 4.5 mg.
The drug needs to be compounded, which means that the standard dose is ground up and reduce to about 1/100th of the pharmaceutical strength. So, in three month’s time, I consume about one “normal” dose of naltrexone.
I used to live across the street from this particular compounding pharmacy, and it’s still an easy distance from where I live and work. It’s an old fashioned place, with creaky wooden floors, pharmacists who will come and talk to you if you have a question, and a wide array of supplements and medicines that let you know they are clued in to alternative health practices. When you walk into the place, you see how deceptive the narrow store-front and tiny shop is — there’s double the room off to the side of the store where about 10 pharmacists and workers prepare prescriptions.
Let me tell you about LDN.
- it’s off-patent, which means CHEAP
- It works with your body’s endorphin level to have a low-level of constant pain relief. In fact, you must take it during the 6-hour window during which your body releases endorphin in order for it to work
- I can’t get by without it for more than 3 days before my pain level returns to a constant uncomfortable level
LDN works very well for me. The only side effects are deep sleep and vivid dreams. (The most common side-effect is sleep disturbance, so most people build up to 4.5 mg gradually.) The greatest intentional effect is pain reduction, less fatigue, and an ability to lead a pretty normal life.
One of the proponents of the LDN movement is Dr. David Gross, who makes this point on the LDN site I mention above:
“Low Dose Naltrexone (LDN) may well be the most important therapeutic breakthrough in over fifty years. It provides a new, safe and inexpensive method of medical treatment by mobilizing the natural defenses of one’s own immune system.
LDN substantially reduces health care costs and improves treatment of a wide array of diseases. Unfortunately, because naltrexone has been without patent protection for many years, no pharmaceutical company will bear the expense of the large clinical trials necessary for FDA approval of LDN’s new special uses. It is now up to public institutions to seize the opportunity that LDN offers.”
This is why it’s unlikely that any neurologist working at a research hospital is likely to offer you LDN as an option. The compounded prescription retails between $30 and $40 (I pay $25) whereas my old MS drugs retailed at $1700/month (I paid $15 then. It would probably be $25 now). Notice a difference in the reimbursement to the drug manufacturer?
The future of compounded drugs is under threat. The FDA has decided that compounded drugs are dangerous and need more regulation, hence the Compounding Quality Act of 2013.
One of the events that provoked the increased federal regulation on compounding pharmacies was an outbreak of illness and death cased by a drug compounded for fungal meningitis. Here’s a quote from the Wikipedia article that describes the event:
In October 2012, an outbreak of fungal meningitis was reported in the United States. The U.S. Centers for Disease Control and Prevention traced the outbreak to fungal contamination in three lots of a medication called methylprednisolone used for epidural (spinal) steroid injections. The medication was packaged and marketed by the New England Compounding Center (NECC), a compounding pharmacy in Framingham, Massachusetts. Doses from these three lots had been distributed to 75 medical facilities in 23 states, and doses had been administered to about 14,000 patients after May 21 and before September 24, 2012. Patients began reporting symptoms in late August, but, because of the unusual nature of the infection, clinicians did not begin to realize the cases had a common cause until late September. Infections other than meningitis were also associated with this outbreak, which spanned 19 states. As of March 10, 2013, 48 people had died and 720 were being treated for persistent fungal infections.
Compounded drugs are under threat because of the new FDA regulations. Many insurance companies now routinely refuse to cover compounded prescriptions.
Regular prescription drugs of the uncompounded variety are of course, completely safe. Here is an image from the FDA’s own site on fatalities from ADRs or “adverse drug reactions:”
How should one interpret these numbers? According to the same FDA site, it means that:
If true, then ADRs are the 4th leading cause of death—ahead of pulmonary disease, diabetes, AIDS, pneumonia, accidents, and automobile deaths.
To review, the fungal meningitis case was very deadly and severe: 14,000 people took the contaminated medicine. 48 died. 720 needed to be treated for ongoing fungal infection. The event was undeniably a tragedy, and I have no intention of minimizing the loss and suffering it caused.There is nothing wrong with more regulation for safer compounds. However, many insurance companies are now refusing to cover compounded at all. They happily allow for the drugs that account for the figures in the above image.
Want to protect the right for your doctor to prescribe you a compounded drug? This is about CHOICE.
Here’s a site where you can learn more: