MS Drug Continues to Cause Disastrous Side Effects

In the latest blow to the controversial multiple sclerosis drug Tysabri, the U.S. Food and Drug Administration has ordered a new label be put on the drug, warning that the risk of developing progressive multifocal leukoencephalopathy (PML), a rare but deadly brain infection, increases as more Tysabri infusions are received.

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:

 Muscle weakness 

Imbalance or loss of coordination

Astigmatism

Tremors

 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

Single, unhappily married men have a higher stroke risk

If you are single or not happy with your marriage, you may have a higher chance of having a fatal stroke and dying of the condition.

"We tend to underestimate how dysfunctional relationships can cause such incredible stress," said M. Gary Neuman, marriage counselor, rabbi and author of New York Times best-seller "The Truth About Cheating." "It takes a toll on the human body."
Stroke is a rapid loss of brain function due to disturbance in the blood supply to the brain, caused by blocked or burst blood vessel.
Symptoms of a stroke are sudden and happen quickly. They include weakness, numbness, blurred vision, confusion, slurred speech, and a sudden, severe headache that is different from past headaches.
10059 men studied
Findings of the study are based on the data of 10,059 Israeli government workers who participated in the Israeli Ischemic Heart Disease Study in 1963.
The researchers tracked the national registry and other records of the participants for 34 years till 1997.
For the study, factors like the age, socioeconomic status, and known stroke risk factors such as obesity, blood pressure, and smoking were also taken into account.
The statistical analysis also took into account whether the men had diabetes and heart disease at the beginning of the study.
Outcome of the study
On analysis, the researchers found that 8.1 percent of the single men died of stoke during the study period compared to 7.1 percent of the married men.
When age and stroke risk factors were taken into account, single men had a 64 percent elevated risk of having a fatal stroke compared to the married men.
Those who reported displeasure with their marriage (3.6 percent) also had 64 percent higher chances of having a fatal stroke compared to married men who were comparatively happy with their marriage.
More research required
Regardless of the findings, the researchers have outlined the need for more research as the present study lacked data as to whether the participants' marital status changed over the years or not.
Also, more research is needed to ascertain what is it about singlehood or a stressed marriage that aggravates stroke risk.
The study was presented at the American Stroke Association's (ASA) International Stroke Conference 2010.

Caltech scientists find first physiological evidence of brain's response to inequality

The human brain is a big believer in equality - and a team of scientists from the California Institute of Technology (Caltech) and Trinity College in Dublin, Ireland, has become the first to gather the images to prove it.

Specifically, the team found that the reward centres in the human brain respond more strongly when a poor person receives a financial reward than when a rich person does. The surprising thing? This activity pattern holds true even if the brain being looked at is in the rich person's head, rather than the poor person's.
These conclusions, and the functional magnetic resonance imaging (fMRI) studies that led to them, are described in the February 25 issue of the journal Nature.
'This is the latest picture in our gallery of human nature,' says Colin Camerer, the Robert Kirby Professor of Behavioural Economics at Caltech and one of the paper's coauthors. 'It's an exciting area of research; we now have so many tools with which to study how the brain is reacting.'
It's long been known that we humans don't like inequality, especially when it comes to money. Tell two people working the same job that their salaries are different, and there's going to be trouble, notes John O'Doherty, professor of psychology at Caltech, Thomas N. Mitchell Professor of Cognitive Neuroscience at the Trinity College Institute of Neuroscience, and the principal investigator on the Nature paper.
But what was unknown was just how hardwired that dislike really is. 'In this study, we're starting to get an idea of where this inequality aversion comes from,' he says. 'It's not just the application of a social rule or convention; there's really something about the basic processing of rewards in the brain that reflects these considerations.'
The brain processes 'rewards' - things like food, money, and even pleasant music, which create positive responses in the body - in areas such as the ventromedial prefrontal cortex (VMPFC) and ventral striatum.
In a series of experiments, former Caltech postdoctoral scholar Elizabeth Tricomi (now an assistant professor of psychology at Rutgers University) - along with O'Doherty, Camerer, and Antonio Rangel, associate professor of economics at Caltech - watched how the VMPFC and ventral striatum reacted in 40 volunteers who were presented with a series of potential money-transfer scenarios while lying in an fMRI machine.
For instance, a participant might be told that he could be given $50 while another person could be given $20; in a second scenario, the student might have a potential gain of only $5 and the other person, $50. The fMRI images allowed the researchers to see how each volunteer's brain responded to each proposed money allocation.
But there was a twist. Before the imaging began, each participant in a pair was randomly assigned to one of two conditions: One participant was given what the researchers called 'a large monetary endowment' ($50) at the beginning of the experiment; the other participant started from scratch, with no money in his or her pocket.
As it turned out, the way the volunteers - or, to be more precise, the reward centres in the volunteers' brains - reacted to the various scenarios depended strongly upon whether they started the experiment with a financial advantage over their peers.
'People who started out poor had a stronger brain reaction to things that gave them money, and essentially no reaction to money going to another person,' Camerer says. 'By itself, that wasn't too surprising.'
What was surprising was the other side of the coin. 'In the experiment, people who started out rich had a stronger reaction to other people getting money than to themselves getting money,' Camerer explains. 'In other words, their brains liked it when others got money more than they liked it when they themselves got money.'
'We now know that these areas are not just self-interested,' adds O'Doherty. 'They don't exclusively respond to the rewards that one gets as an individual, but also respond to the prospect of other individuals obtaining a reward.'
What was especially interesting about the finding, he says, is that the brain responds 'very differently to rewards obtained by others under conditions of disadvantageous inequality versus advantageous inequality. It shows that the basic reward structures in the human brain are sensitive to even subtle differences in social context.'
This, O'Doherty notes, is somewhat contrary to the prevailing views about human nature. 'As a psychologist and cognitive neuroscientist who works on reward and motivation, I very much view the brain as a device designed to maximise one's own self interest,' says O'Doherty. 'The fact that these basic brain structures appear to be so readily modulated in response to rewards obtained by others highlights the idea that even the basic reward structures in the human brain are not purely self-oriented.'
Camerer, too, found the results thought provoking. 'We economists have a widespread view that most people are basically self-interested, and won't try to help other people,' he says. 'But if that were true, you wouldn't see these sort of reactions to other people getting money.'
Still, he says, it's likely that the reactions of the 'rich' participants were at least partly motivated by self-interest - or a reduction of their own discomfort. 'We think that, for the people who start out rich, seeing another person get money reduces their guilt over having more than the others.'
Having watched the brain react to inequality, O'Doherty says, the next step is to 'try to understand how these changes in valuation actually translate into changes in behaviour. For example, the person who finds out they're being paid less than someone else for doing the same job might end up working less hard and being less motivated as a consequence. It will be interesting to try to understand the brain mechanisms that underlie such changes