Friday, May 14, 2010

New Drug for Treating MS

I receive letters weekly (sometimes daily) from Big Pharma Cartel promoting their newest drugs.  This weeks announcement stated, “Acorda Therapeutics is pleased to announce the availability of AMPYRA (dalfampridine) Extended  Release 10mg tablets.  AMPYRA is the first in new class of approved multiple sclerosis agents indicated as a treatment to improve walking in patients with MS (multiple sclerosis).”  The letter went on to state that AMPYRA improved walking in patients across all four major types of MS and was effective with or without the use of immunomodulatory drugs.
MS is a very serious illness.  It is characterized by demyelination of the nerve fibers.  Essentially, the nerve fibers lose their outer coating of myelin and degenerate.  Conventional treatment for MS has been dismal.  High doses of steroids are helpful in acute exacerbations of M.S.  However, steroids do not appear to have a significant impact on long-term recovery.   Other treatments, to present date, have failed to show significant improvement in long-term recovery.   Unfortunately, all of the M.S. therapies are fraught with very serious adverse effects.  I have seen many M.S. patients on these different medications, and most of them are fairly miserable with the side effects.
This new drug, AMPYRA, is touted as improving walking in MS patients.  I am interested in any therapy that improves the ability of MS patients to walk.  However, further reading of the mechanism of action and how this drug was studied has caused me concern.
What is the mechanism of action of AMPYRA?  According to the PDR, the mechanism of action “has not been fully elucidated.  {AMPYRA} is a broad spectrum potassium channel blocker.”  Potassium is an intracellular element that is crucial for brain and nerve function.  Without adequate amounts of potassium, nerve cells die.  In fact, potassium shortage can cause a fatal illness—hypokalemia which is characterized by cardiac abnormalities and respiratory paralysis.
So, we now have a MS drug that blocks potassium channel receptors.  I have written in Drugs That Don’t Work and Natural Therapies That Do, “you can’t block an important receptor for the long-term and expect a good result.”  I would venture a prediction that the long-term use of this drug will be problematic.  In fact, any drug that blocks potassium channels in the body, will most likely, have serious adverse effects.    I guess we should assume that Big Pharma has done numerous studies with AMPYRA to ensure its safety and efficacy—right?  Wrong.
Further analysis of this drug found, “The effectiveness of AMPYRA in improving walking in patients with multiple sclerosis was evaluated in two adequate and well controlled (italics added)trials involving 540 patients.[i]
The two “adequate” trials were one trial for 21 weeks (14 weeks of therapy with the drug) and a second trial for 14 weeks (9 weeks of drug therapy).   
The FDA has now approved a potassium channel blocker for use in MS patients based on two short studies that lasted approximately five months (drug use during study).  MS patients will be advised to take this drug indefinitely to help them walk better. 
I say the idea of using a potassium channel blocker is not good.  We are designed with potassium channels for a reason; we should not be using medications to block these important receptors.  My best educated guess is that this drug will be associated with serious adverse effects the longer people take it.  I would not advise any MS patient to rush off and try this drug.  It has not been properly studied and its mechanism of action should cause any physician pause before prescribing it. 
There are many holistic treatments for MS that I have found effective.  First, cleaning up the diet is paramount to helping the body reverse the damage from MS.  This  includes avoiding artificial sweeteners.  Numerous studies have pointed to a correlation with artificial sweeteners and MS.  Furthermore, there are many nutrient therapies that can help MS patients achieve remission as well as improve neurologic functioning including alpha lipoic acid, vitamin C, vitamin D. L-carnitine, and B-vitamins.  Drinking adequate amounts of water and avoiding dehydration is a must for any MS treatment plan.  Finally, detoxifying and removing toxic elements such as mercury from the body is very helpful.  

[i] PDR insert titled “Highlights of Prescribing Information


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