Why Did MS Drug Kill Eleven People?
Posted By Dr. Mercola | February 09 2012
By Dr. Mercola
When you take drugs for multiple sclerosis (MS), you may very well be trading MS for another set of health problems, including paying the ultimate price: death.
Health agencies from multiple countries, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency, are investigating reports of 11 deaths in multiple sclerosis patients who took the drug Gilenya.
Gilenya is the first oral drug approved by the FDA to reduce relapses and delay disability progression in patients with relapsing forms of MS.
But even though it is a relative newcomer to the market, having been approved in the United States in September 2010, serious side effects have already emerged.
You Have to Take the First Dose When You're in a Doctor's Office …
This is because Gilenya is known to cause heart-rate problems, so all patients must be monitored for slow heart rate for six hours after they first take the drug.
The drug's maker, Novartis, told CNN that they are aware of the reported deaths among patients taking the drug, and stated the deaths were due to sudden death, heart attack or disruption of heart rhythm.
Of course, they also said the cause of the deaths remains "unknown."
The FDA, who announced in December 2011 that they were investigating Gilenya after a 59-year-old multiple sclerosis patient died within 24 hours of taking the first dose, is aware of the heart effects, but approved the drug anyway. On their Web site, it's stated:1
"Gilenya may cause serious side effects, such as slow heart rate (bradycardia), which may be related to slowed conduction of electrical impulses from the upper chambers of the heart to the lower chambers of the heart. These effects usually do not cause symptoms, but they can cause dizziness, fatigue, and palpitations."Other serious risks, as noted by the drug's manufacturer Web site, include:
Side effects are more the rule than the exception when it comes to MS drugs, but unfortunately they continue to be offered as a first-line treatment for those with MS, even though dietary strategies can be extremely effective.
- Increased risk of serious infections, as the drug lowers the number of white blood cells in your blood. Two patients died who took higher-dose Gilenya, which increases the risk of infection
- Macular edema, a vision problem that can cause some of the same vision symptoms as an MS attack
- Breathing problems
- Liver problems and increases in blood pressure
- Harm to a woman's unborn baby, and therefore contraindicated during pregnancy or breastfeeding
Tysabri: Another MS Drug Linked to Deaths
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.
Then, just three months after it 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 usually results in death or severe disablement. As noted on the Tysabri Web site:
"Tysabri increases your chances of getting … PML … No one can predict who will get PML. There is no known treatment, prevention or cure for PML … Your chances may be higher if you are also being treated with medicines that weaken your immune system, including other MS treatments."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. 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 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. Tysabri, however, is currently back on the market because in June 2006 the FDA voted that Tysabri be returned to the market!
In 2010 they then added a new label warning health care professionals and patients that the risks of PML increase as more infusions are received. There are other risks as well, including liver damage, an increased risk of serious or unusual infection, joint pain, allergic reactions, depression and more. If you have MS, it is my strong recommendation to not accept this drug, Gilenya or the other commonly prescribed MS drugs like prednisone or interferon, as they can seriously harm your health.
Fresh Raw Foods are an Option for Helping Reverse MS
If you've been under the care of the conventional medical system for MS treatment, you may be surprised to hear that people have had success in reversing MS with dietary changes. You most likely will not hear this from conventional neurologists. Nonetheless, in the video above, Dr. Terry Wahls explains how she reversed multiple sclerosis after seven years of deterioration on the best conventional treatments available -- simply by changing her diet!
She began to notice significant improvement in just three months, and at the nine-month mark of her new diet, she was able to go on an 18-mile bike ride! This is astounding when you consider that over the past seven years her condition had deteriorated to the point that she had to sit in a reclined zero-gravity chair and could only walk short distances using two canes.
After looking into a number of diseases that cause brain shrinkage, including not only MS but also Huntington's, Parkinson's and Alzheimer's disease, Dr. Wahls found one common denominator in these conditions is poorly functioning mitochondria. Three nutrients in particular are essential for proper mitochondrial function:
Just by adding those three to her diet, her decline began to slow. But it wasn't until she adjusted her diet for optimal mitochondrial-, myelin-, and neurotransmitter function that she began to improve. She also eliminated processed foods, grains, and starches (which includes potatoes and corn), and within a matter of months experienced astounding improvements. In short, she altered her diet to reflect the Paleo-style diet of the hunter-gatherers of old as follows:
- Animal-based omega-3 fat
- Coenzyme Q10 (CoQ10), or better yet, the reduced version known as Ubiquinol
- 3 cups daily (equal to one dinner plate, piled high) of green leaves, such as kale, which are high in vitamins in the B group, A, C, K, and minerals
- 3 cups daily of sulfur-rich vegetables from the cabbage- and onion- families, mushrooms and asparagus
- 3 cups daily of brightly colored vegetables, fruits and/or berries, which are a good source of antioxidants
- Wild fish for animal-based omega-3's
- Grass-fed meat
- Organ meats for vitamins, minerals and CoQ10
- Seaweed for iodine and selenium
Vital Information for Anyone Who's Been Diagnosed With MS
I do encourage you to share this information with anyone you know struggling with MS, as it is could easily change their life. Risking your life with conventional MS drugs is NOT the only option, but most people are not aware of that. Dr. Wahls story is not an isolated incident; others, too, have recovered from multiple sclerosis without drugs!REFERENCES:
Below you will find a summary of my lifestyle recommendations for MS. Many are identical to the general-health principles I've been teaching for years, but a few stand out as being specifically applicable to the treatment of autoimmune diseases such as MS.
- Optimize your vitamin D levels – This is an essential step, as there are well over a dozen studies showing a link between MS and vitamin D deficiency. While the optimal level for general health lies between 50-70 ng/ml, when treating diseases such as cancer, heart disease, or autoimmune diseases, your level should ideally be somewhere between 70-100 ng/ml. The preferred method to raise (and maintain) your vitamin D levels is by regularly exposing large amounts of your skin to sunshine, or by using a safe tanning bed. If neither is available, you can use an oral supplement of vitamin D3.
As a general guideline, vitamin D experts recommend 8,000 IU's per day for adults, and about 35 IU's per pound for children, but you should take as much as is necessary to elevate and maintain your blood levels within the optimal range.
- Get plenty of animal-based omega-3 fats – Make sure you're getting a good supply of animal-based omega-3 fats, such as krill oil. You also need to avoid damaged, oxidized fats found in most all processed foods. Especially damaging are the omega-6 fats found in soy-, canola-, and corn oil. These are usually highly oxidized and also contain trans fats and cyclic fats that imbed themselves into your cell membranes, distorting the cellular functions.
Even when organic and cold-pressed, the over consumption of these omega-6 rich oils can ignite an inflammatory cascade within our bodies, as the American diet generally contains 20-40 times more omega-6 fatty acids (relative to omega-3 fatty acids) than our bodies are designed to handle; this omega-6/omega-3 imbalance results in the formation of excessive arachidonic acid – the very fuel upon which enzymes like Cox-2 feed, resulting in uncontrollable inflammation. Also, the majority of these three oils are genetically engineered, which can have its own set of adverse health ramifications.
- Eliminate sugar, particularly fructose – Another crucial element is to eliminate as much sugar and fructose as possible from your diet. Cutting out processed foods and sweetened beverages will go a long way to reduce excess fructose, in addition to eliminating the majority of damaging fats in your diet. You simply must keep your daily total fructose intake below 25 grams.
If you haven't yet grasped the toxic nature and profound health dangers of fructose, now's the time to get with it. Sugar can contribute to the development of a number of autoimmune diseases, such as arthritis, asthma, and multiple sclerosis. It also increases uric acid levels, which leads to chronic, low-level inflammation, which has far-reaching consequences for your health.
- Eliminate pasteurized milk and dairy—This is another critical element. Studies have shown that cow's milk consumption is correlated with MS prevalence.2 In fact, a specific antibody cross-reactivity between myelin oligodendrocyte (a component of neurological tissue) and the cow's milk protein butyrophillin was identified in 2004, likely contributing to the immune system of MS patients losing self-tolerance and attacking their own nervous system.3
- Avoid aspartame and commercial fruit juices. Aspartame rapidly metabolizes to methanol, a potent neurotoxin. Additionally fruits and vegetables are also loaded with methanol but when they are consumed fresh it is bound to pectin and your body does not have the enzymes to break it down. However when fruits and vegetables are processed and put into glass jars or cans the methanol dissociates and can be liberated in high quantities.
- Eat plenty of 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 a majority of their food raw instead of cooked.
- Eat fermented vegetables. Optimizing your gut bacteria may be one of the most profound ways to improve your health. In the near future I will be doing a large number of interviews with Dr. Natasha Campbell McBride that go into great detail on how to implement these valuable foods and many other details of recovery.
- Check your iron levels. Excess iron can cause damage to the endothelium, the inner lining of blood vessels, as well as create massive amounts of free radicals. It can also damage your DNA. Therefore, if you have MS it is very important to check your blood for iron overload, a process that is easily done through a simple blood test called a serum ferritin test. The healthy range of serum ferritin lies between 20 and 80 ng/ml. Below 20, you are iron deficient, and above 80, you have an iron surplus. Ferritin levels can go really high. I've seen levels over 1,000, but anything over 80 is likely going to be a problem. The ideal range is between 40-60 ng/ml.
If you find that your iron levels are high, simply donate your blood. Normally a person would require 1-3 blood draws per year, up to as many as one per month if your system can tolerate it, until your ferritin levels have been sufficiently lowered.
- Low-dose Naltrexone and alpha lipoic acid. One of the newer treatment strategies for MS is low-dose naltrexone (LDN), along with alpha lipoic acid. 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, 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, including multiple sclerosis. As explained on the informative website www.lowdosenaltrexone.org, when you take LDN at bedtime -- which blocks your opioid receptors for a few hours in the middle of the night -- it is believed to up-regulate vital elements of your immune system by increasing your body's production of metenkephalin and endorphins (your natural opioids), hence improving immune function.
- Mercury detox. Mercury is clearly a neurotoxic poison that should be avoided, so avoiding fish unless wild caught and verified for purity, and refusing or removing mercury dental amalgams are also important aspects. Certain supplements can also help eliminate mercury from your system, such as chlorella.
- Address early childhood emotional traumas. Last but certainly not least, in my experience with MS patients, there is nearly always a precipitating traumatic emotional event that causes your immune system to crash, leading to the disease. Just as vitamin D deficiency seems to be present in most cases of autoimmune disease, there is also typically an emotional element involved. 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, often before the age of 7, and typicaly before the age of 5. Issues related to this event need to be addressed by using an effective energy psychology tool like the Emotional Freedom Technique (EFT), but only with the help of an experienced practitioner.