Natalizumab (Tysabri) first received FDA approval in November 2004, only to be pulled from the market three months later after several patients in clinical trials developed PML.
In June 2006, the FDA allowed the drug back on the market, but with strict conditions. According to those revised guidelines, Tysabri can only be administered by approved doctors at sites that register and comply with a patient-safety program.
The new action was based on reports of 31 confirmed cases of PML as of January 21, 2010.
Multiple sclerosis is a chronic, degenerative disease of the nerves in your brain and spinal column, caused through a demyelization process. Myelin is the insulating, waxy substance around the nerves in your central nervous system, and when the myelin is damaged by an autoimmune disease or self-destructive process in your body, then the function of those nerves deteriorate over time, resulting in a number of symptoms, including:
Imbalance or loss of coordination
If you choose the conventional approach to healing, you should know that neurologists (the specialists who typically monitor these types of diseases) routinely prescribe a variety of very toxic and dangerous medications to their MS patients -- medications that in no way, shape or form address the underlying cause of the disease.
Further, as in the case of Tysabri, the treatment could actually kill you.
Why is Tysabri Even Back on the Market? Tysabri first hit the market in November 2004 under an accelerated program the FDA reserves for drugs it believes will have “extraordinary benefits” to patients. It was touted as the “miracle” drug for MS because the results from the first year of clinical trials showed that MS patients who took Tysabri for one year had a 66 percent reduction in relapses compared to those who took a placebo.
But this wonder drug, which was slated to bring in $2 billion in annual sales within its first few years after release, turned out to have a very dark side.
Tysabri is a type of drug known as a monoclonal antibody, meaning it is derived from a mouse antibody that has been genetically engineered to mirror a human antibody (antibodies are proteins that help your body fight infection).
It is given every four weeks by infusion directly into a vein, where the antibodies bind to immune system cells, inhibiting them from crossing over from the bloodstream to the brain.
Tysabri blocks this movement by attaching to alpha 4-integrin, a protein on the surface of immune T cells that normally enables them to pass through the blood-brain barrier.
However, if destructive immune system cells break free of the bloodstream, they can reach your brain, gastrointestinal tract and joints and cause severe damage.
Trading MS for a Deadly Brain Infection Sure enough, three months after Tysabri first hit the market it was pulled because one in 1,000 people who took it during clinical trials developed progressive multifocal leukoencephalopathy (PML), a rare brain infection that results in death or severe disablement.
Dr. Lawrence Steinman, a Stanford University professor and an MS specialist who has developed MS drugs himself, said he repeatedly warned the FDA of the potential for serious immune-system side effects with Tysabri and drugs like it prior to approval.
Nonetheless, in June 2006 the FDA made yet another counterintuitive decision -- the type that make absolutely no logical sense, and for which the FDA is becoming increasingly known for.
They voted that Tysabri be returned to the market.
Now, nearly four years later, the FDA has added a new label warning to Tysabri, warning health care professionals and patients that the risks of PML increase as more infusions are received. The drug may also cause liver damage.
If you have MS, it is my strong recommendation to not accept these drugs, or the other commonly prescribed MS drugs like prednisone or interferon, as they can seriously harm your health.
You Can Treat MS Naturally More often than not, some form of hidden emotional wound can be found in patients suffering with autoimmune diseases like MS. Typically, this wounding occurred at a very young age, almost always before the age of 7, and typically before the age of 5.
Frequently, these emotional injuries result in physical damage decades later, and we’ve found that without effective intervention to address these underlying emotional injuries, you may not be able to get significantly better.
Strategies like meditation, prayer, Emotional Freedom Technique (EFT) and Meridian Tapping Techniques (MTT) are particularly effective and need to be part of your overall treatment strategy in order to truly address the root of your illness.
Along with addressing the emotional component, you will want to work with a knowledgeable natural health care practitioner who can help you to:
Optimize your vitamin D levels In the near future I believe it could be considered malpractice not to carefully monitor the vitamin D level of patients’ with autoimmune disease, as the evidence is so profoundly compelling of how useful it is in these conditions.
As with virtually all other autoimmune diseases, optimizing your vitamin D levels is an essential step. Ideally, your level should be somewhere between 70-90 ng/ml, which you can find out through a simple blood test. I recommend using LabCorp for this if you’re in the United States.
Ideally you’ll want to raise (and maintain) your vitamin D levels by regularly exposing large amounts of your skin to sunshine, or by using a safe tanning bed.
If for any reason neither is available to you, you can use an oral supplement of vitamin D3. Doses for an oral supplement could be as high as 10,000 IU’s a day depending on your current level, so it’s very important to monitor your levels regularly.
Optimize your essential fat intake You need to make sure you’re getting a good supply of high-quality, animal-based omega-3 fats such as krill oil.
Part of optimizing your essential fats also includes avoiding damaged, processed fats found in most all processed foods. Especially damaging are the refined omega-6 fats found in soy-, canola-, and corn oil. These are usually highly oxidized and also contain trans fats and cyclic fats that embed themselves into your cell membranes, distorting the cellular functions.
Eliminate sugar Another crucial element is to eliminate as much sugar as possible from your diet. Cutting out processed foods will go a long way to reduce excess sugar, in addition to eliminating the majority of damaging fats in your diet.
Eat raw food This is an important principle for optimal health that I normally recommend for everyone. However, I’ve found that for people with severe autoimmune disease, it’s even more important. Some of the most dramatic improvements we’ve seen in patients using nutritional changes have come about as the result of eating their food raw instead of cooked. That includes eggs and high-quality, organic meats as well.
Eat the right foods for your Nutritional Type With Nutritional Typing and some of the emotional work it is very unusual when a person with MS does not improve. Without out a doubt Nutritional Typing has been the most profound nutritional intervention I have ever seen.
Two Final Strategies to Try The above recommendations are the crux of our MS treatment program, and apply to virtually everyone struggling with this disease. If you suffer from MS and apply these strategies, I am confident you will notice a dramatic improvement.
However, there are a few other newer treatments that are worth looking into as well, especially low-dose Naltrexone (LDN), along with alpha lipoic acid.
Low-Dose Naltrexone Naltrexone (generic name) is a pharmacologically active opioid antagonist, conventionally used to treat drug- and alcohol addiction -- normally at doses of 50mg to 300mg. As such, it’s been an FDA-approved drug for over two decades.
However, researchers have found that at very low dosages (3 to 4.5 mg), naltrexone has immunomodulating properties that may be able to successfully treat cancer malignancies and a wide range of autoimmune diseases like rheumatoid arthritis, multiple sclerosis, Parkinson’s, fibromyalgia, and Crohn’s disease, just to name a few.
Dr. Bert Berkson is an expert on this regimen. For more information about his findings and successes using this combination, please review this previous article.
Mercury Detox Mercury is clearly a neurotoxic poison that should be avoided, so avoiding eating fish and refusing or removing mercury dental amalgams are also important aspects. Many still do not realize that the majority of a “silver” filling is in fact mercury, and despite its obvious risks mercury fillings are still used in the field of dentistry.
We are making strong efforts to have mercury eliminated from dental practices in the U.S. and will hopefully succeed in that mission within the next few years. Until then, however, it’s up to you to choose a dentist that has the good sense not to use it.
Additionally, there are now a few new supplements to help eliminate mercury from your system. One in particular that appears to be very effective, developed by Dr. Boyd Haley, is called Oxidative Stress Reliever, or OSR for short.
So I strongly recommend that you hold off on taking any toxic drugs to treat MS, as these drug treatments can leave you with conditions that are worse than those you started with. You are far better off overcoming MS using lifestyle changes that will help to nourish and heal your body from the inside out