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Subject:
A Study Of Multiple Sclerosis (and other neurodegenerative diseases) A Study Of Multiple Sclerosis
(and other neurodegenerative diseases)
Enclosed is a report I have entitled A Study On Multiple Sclerosis that took over six hours to research for
those who are interested in the financial incentives permeating the pharmaceutical industry. Massive
documented evidence is available to those who look for the information that modern medicine is more
interested in 'treating diseases' than 'curing diseases'. This report presents some of that evidence on
corruption in orthodox medicine as well as viable compatible treatment alternatives and possible causes of
MS.
Included is a link to a web site published by THE UCSF MS CENTER whose members include medical
professionals with very distinguished pedigrees who specialize in MS. On their site they collectively
acknowledge in writing that there is no known cure for MS, but they have medical protocols that include
pharmaceutical drugs that can slow the progress of MS. They also state that the cause of MS remains
unknown.
In essence, they are admitting their training and their science is predicated on treating, as opposed to curing,
MS with a drug, in this case a drug branded Gilenya, that blocks the bodies natural immune system that
fights infectious disease while slowing the heart rate thus obviously creating unnatural stress on that vital
organ.
As an amatuer researcher, I am not qualified to nor am I representing myself as an expert on anything,
especially medicine. Also, I am not offering medical advice and/or my opinion about what anyone's medical
choices should be.
Not many patients of diseases and/or their caregivers have the opportunity to review this kind of information
some would not even take advantage of the opportunity to evaluate it, if they did. This is a long, intensive
study which requires time and dedication to discern the multi-level implications in this report.
My only objective is that others will reach the best conclusions about what to think and do regarding medical
choices with their own lives. It certainly not my desire to distribute misinformation that can cause harm to
anyone. That is why we all should make our own medical decisions.
I hope you will keep it on file and distribute it to others so they can benefit from it, if you agree with me
about my report's value. The contents in this report can be applicable for other neurological degenerative
diseases besides MS [such as diabetes, as well as other diseases], so do your best not to be discouraged by
an 'information overload' complex.
Is the following a tacit admission by the UCSF MS Center that drugs (both pills and injections) that contain
dangerous risk of adverse side effects are marketed and administered based on theory? Read between the
UCSF MS Center lines.
THE UCSF MS CENTER
Multiple sclerosis (MS) is a chronic, often disabling disease of the central nervous system (CNS). Converging lines ofevidence suggest that the disease is caused by a disturbance in immune function. This disturbance permits cells ofthe immune system to attack myelin, the insulating sheath that surrounds the nerve fibers (axons) located in the CNS(i.e., the brain and spinal cord). When myelin is damaged, electrical impulses cannot travel quickly along nerve fiberpathways in the brain and spinal cord. Disruption of electrical conductivity results in fatigue and disturbances of vision,strength, coordination, balance, sensations, and bladder and bowel function.
Causes of Multiple Sclerosis
Although the cause of multiple sclerosis is unknown, evidence suggests that the disease may result from an
environmental agent that triggers the illness in a genetically susceptible individual (could that environmental
agent include a weaponized mycoplasma? Read on.) . These lines of evidence have given rise to both
environmental and genetic explanations for MS.
The environmental theory: The environmental theory proposes that an environmental factor triggers the symptoms
of MS. Support for this theory includes the observation that multiple sclerosis is diagnosed more frequently intemperate than tropical or subtropical climates.
The genetic theory: The genetic theory proposes that susceptibility to develop MS is influenced by genetic factors.
Several lines of evidence support this theory. MS is common in Caucasians but occurs rarely in Native Americans,
Blacks native to Africa, and Asians living in high-risk areas in the United States. This suggests that if an
environmental factor contributes to MS, only those who are genetically susceptible actually develop the illness.
(Cognitive problems, including problems with memory, are common in MS. Between 45% and 65% of people withMS will have some problems with cognitive functioning.) Pharma Not in Business of Health, Healing, Cures, Wellness
http://www.youtube.com/watch?v=AazObF_pHSU THE LAWS OF THE PHARMACEUTICAL INDUSTRY
The main principles governing the pharmaceutical "business with disease": It is not in the financial interests of the pharmaceutical industry to prevent common diseases – the maintenance andexpansion of diseases is a precondition for the financial growth of this industry.
___________________ 1 The pharmaceutical industry is an investment industry driven by the profits of its shareholders.
Improving human health is not the driving force of this industry.
2 The pharmaceutical investment industry was artificially created and strategically developed over an entire century
by the same investment groups that control the global petrochemical and chemical industries.
3 The huge profits of the pharmaceutical industry are based on the patenting of new drugs. These patents essentially
allow drug manufacturers to arbitrarily define the profits for their products.
4 The marketplace for the pharmaceutical industry is the human body – but only for as long as the body hosts
diseases. Thus, maintaining and expanding diseases is a precondition for the growth of the pharmaceutical industry.
5 A key strategy to accomplish this goal is the development of drugs that merely mask symptoms while avoiding the
curing or elimination of diseases. This explains why most prescription drugs marketed today have no proven efficacy
and merely target symptoms.
6 To further expand their pharmaceutical market, the drug companies are continuously looking for new applications
(indications) for the use of drugs they already market. For example, Bayer’s pain pill Aspirin is now taken by 50
million healthy US citizens under the illusion it will prevent heart attacks.
7 Another key strategy to expand pharmaceutical markets is to cause new diseases with drugs. While merely
masking symptoms short term, most of the prescription drugs taken by millions of patients today cause a multitude of
new diseases as a result of their known long-term side effects. For example, all cholesterol-lowering drugs currently
on the market are known to increase the risk of developing cancer – but only after the patient has been taking the
8 The known deadly side effects of prescription drugs are the fourth leading cause of death in the industrialized
world, surpassed only by the number of deaths from heart attacks, cancer and strokes (Journal of the American
Medical Association,April 15, 1998). This fact is no surprise either, because drug patents are primarily issued for new
synthetic molecules. All synthetic molecules need to be detoxified and eliminated from the body, a system that
frequently fails and results in an epidemic of severe and deadly side effects.
9 While the promotion and expansion of diseases increase the market of the pharmaceutical investment industry -
prevention and root cause treatment of diseases decrease long-term profitability; therefore, they are avoided or even
obstructed by this industry.
10 Worst of all, the eradication of diseases is by its very nature incompatible with and diametrically opposed to the
interests of the pharmaceutical investment industry. The eradication of diseases now considered as potential drug
markets will destroy billions of investment dollars and eventually will eliminate this entire industry.
11 Vitamins and other effective natural health therapies that optimize cellular metabolism threaten the pharmaceutical
"business with disease" because they target the cellular cause of today’s most common diseases - and these natural
substances cannot be patented.
12 Throughout the more than one hundred year existence of the pharmaceutical industry, vitamins and other
essential nutrients, with defined functions as cofactors in cellular metabolism, have been the fiercest competition and
the greatest threat to the long-term success of the pharmaceutical investment business.
13 Vitamins and other effective natural health therapies that effectively prevent diseases are incompatible with the
very nature of the pharmaceutical "business with disease."
14 To protect the strategic development of its investment business against the threat from effective, natural and non-
patentable therapies, the pharmaceutical industry has – over an entire century - used the most unscrupulous
methods, such as:
(1) Withholding life-saving health information from millions of people. It is simply unacceptable that today so few know
that the human body cannot produce vitamin C and lysine, two key molecules for connective tissue stability and
disease prevention.
(2) Discrediting natural health therapies. The most common way is through global PR campaigns organized by the
Pharma-Cartel that spread lies about the alleged side effects of natural substances – molecules that have been used
by Nature for millennia.
(3) Banning by law the dissemination of information about natural health therapies.
To that end, the pharmaceutical industry has placed its lobbyists in key political positions in key markets and leadingdrug export nations.
15 The pharmaceutical "business with disease" is the largest deception and fraud business in human history.
The product "health" promised by drug companies is not delivered to millions of patients. Instead, the "products" mostoften delivered are the opposite: new diseases and frequently, death.
16 The survival of the pharmaceutical industry is dependent on the elimination by any means of effective natural
health therapies. These natural and non-patentable therapies have become the treatment of choice for millions of
people despite the combined economic, political and mediaopposition of the world’s largest investment industry.
http://reality101blog.blogspot.com/2009/03/laws-of-pharmaceutical-industry-main.html#comments Evidence Big Pharma Owns The U.S. Government.flv
http://www.youtube.com/watch?v=zr7W07nMiDY Twenty-seven years bring no deaths from vitamins but three million from pharmaceuticals
In 2009, pharmaceuticals were responsible for the death of 37,485 people nationwide.
The statistics come from the Annual Report of the American Association of Poison Control Centers' National PoisonData System (NPDS), and the findings go against the claims of most mainstream doctors and medical officials, whoclaim that pharmaceutical drugs are the only 'science-backed' method to 'treating' illness. However, the reporthighlights the fact that pharmaceuticals oftentimes lead to death and countless other side effects.
Shockingly, the average drug label contains around 70 negative side effects, though many popular brand name drugshave been found to contain 100 to 125. Some drugs even list around 525 negative effects on the label. These drugsare being prescribed by doctors to 'treat' patients, when the drug side effects are routinely worse than the very illnessthey claim to treat.
Pharmaceutical drugs are loaded with toxic side effects and do not eliminate the root cause of disease they claim totreat. Killing 3 million within the last 27 years, and topping traffic fatalities each year, pharmaceutical drugs are adeadly and ineffective option when it comes to combating disease.
http://www.naturalnews.com/034372_vitamins_pharmaceuticals_deaths.html#ixzz1pNiikfCv Fact: 80 percent of U.S. pharmaceuticals made with overseas ingredients, nearly half produced in foreign
facilities never inspected by FDA
Big Pharma advocates (the few that exist outside the corrupt government structure and the drug industry itself)regularly defend the industry with claims that the US Food and Drug Administration (FDA) maintains strict regulatoryprotocols that ensure safety. But a new report reveals that not only are most drug ingredients sourced fromunregulated foreign sources, but nearly half of all drug production facilities are located overseas, most of which havenever been inspected by FDA.
Issued by the US Government Accountability Office, the new report says up to 40 percent of all pharmaceuticals soldin the US are actually manufactured overseas in countries like India and China. A whopping 80 percent of allingredients used to manufacture drugs, including those manufactured in the US, reportedly come from overseas aswell. And the FDA has inspected a mere 11 percent of all foreign drug manufacturing facilities, as opposed to the 40percent it has inspected domestically.
http://www.naturalnews.com/034681_pharmaceuticals_foreign_factories_ingredients.html#ixzz1pNgU6OS3 Drug companies accused of 'conning' the public
Drug companies have been accused of conning the public in a report that claimed more than four fifths of newmedicines offer few benefits.
An estimated 85 per cent of drugs coming onto the market offer only slight advances on existing treatments whilehaving the potential to cause serious harm due to toxicity or misuse, the study concluded.
The author of the research delivered a damning attack on ''Big Pharma'' at a meeting of sociology experts in the US.
Professor Donald Light described the pharmaceutical industry as a ''market for lemons'' - one in which the sellerknows much more than the buyer about the product, and takes advantage of this fact.
''Sometimes drug companies hide or downplay information about serious side-effects of new drugs and overstate thedrugs' benefits,'' said Prof Light, a professor of comparative health policy at the University of Medicine and Dentistryin New Jersey, US.
''Then, they spend two to three times more on marketing than on research to persuade doctors to prescribe thesenew drugs. Doctors may get misleading information and then misinform patients about the risks of a new drug. It'sreally a two-tier market for lemons.'' He alleged that the pharmaceutical industry owned companies in charge of drug testing and provided ''firewalls'' oflegal protection behind which information about dangers or lack of effectiveness could be be hidden.
Companies were assisted by the ''relatively low bar'' for effectiveness that had to be crossed to get a new drugapproved, he claimed.
Prof Light presented his paper, entitled ''Pharmaceuticals: A Two-Tier Market for Producing 'Lemons' and SeriousHarm'' today at the American Sociological Association's annual meeting in Atlanta, Georgia.
http://www.telegraph.co.uk/health/healthnews/7950243/Drug-companies-accused-of-conning-the-public.html Doctors' continuing education depends too much on drug companies: journal
FDA-approved pharmaceuticals kill nearly 270 people each day in the United States alone, and that's according to
conservative calculations published in the Journal of the American Medical Association.
The system that keeps working doctors abreast of medical developments is too reliant on drug company funding andneeds an overhaul, the Canadian Medical Association Journal said in an editorial published Tuesday.
http://www.cbc.ca/news/health/story/2008/03/25/doctor-education.html Doctors Are The Third Leading Cause of Death in the US, Killing 225,000 People Every Year
The author is Dr. Barbara Starfield of the Johns Hopkins School of Hygiene and Public Health and she desribes howthe US health care system may contribute to poor health.
http://articles.mercola.com/sites/articles/archive/2000/07/30/doctors-death-part-one.aspx Legal Drugs Kill Far More Than Illegal, Florida Says
An analysis of autopsies in 2007 released this week by the Florida Medical Examiners Commission found that therate of deaths caused by prescription drugs was three times the rate of deaths caused by all illicit drugs combined http://www.nytimes.com/2008/06/14/us/14florida.html?_r=1&ei=5070&en=b5dbcc1c2b68ddea&ex=1214107200&adxnnl=1&emc=eta1&adxnnlx=1213715039-+Z9xzLU3mYBd0jPZmv4gpA Drug giant Merck has been caught red-handed in a scheme to deceive the FDA and the public over the
integrity of its scientific studies, say top medical authorities.
According to reports that were (amazingly!) published in the Journal of the American Medical Association and detailedin the Washington Post, Merck waged a "campaign of deception" to disguise its in-house study authors asindependent scientists working for universities. This scheme made the studies appear independent and unbiased,allowing them to carry more apparent credibility to FDA officials, doctors and other scientists.
AP Health Writer= WASHINGTON (AP) — Federal health officials are warning doctors and patients that a recentlylaunched heart drug from Sanofi-Aventis SA has been linked to liver damage in a handful of patients.
The Food and Drug Administration said Friday it has received several reports of liver damage with Multaq tablets.
Learn more: http://www.naturalnews.com/023052.html#ixzz1pNFRsaez Drug-Induced Diseases
A 1992 study published in Medical Care examined prescriptions given to people being discharged from a community hospital. It focused on those who were prescribed three or more drugs to treat chronic illnesses.16 The results of this study are quite disturbing, both in what they say about the doctors’ prescribing practices and asevidence of the potential damage that these prescribing practices can do to older adults. Of the 236 peopleintensively studied: 81 percent had one or more prescribing problems with the prescriptions they were given, includinginappropriate drugs, doses or schedule; 60 percent had been given one or more prescriptions for a drug that was an inappropriate choice oftherapy because it was either "less than optimal medication given the patient’s diagnosis" or there wasno established indication for it; 50 percent were given either too high or too low a dose of the drug; 44 percent of the patients were given a combination of drugs that can result in harmful druginteractions; 20 percent were given drugs that unnecessarily duplicated the therapeutic effect of another drug theywere taking.
Summary of Adverse Reactions and the Drugs That Cause Them
Adverse Drug Reaction Number of Drugs Examples of Brand Names
Abdominal pain, ulcers, GI bleeding 48 Advil, Anaprox, Celebrex, Cortone, Daypro, Decadron, Feldene, Indocin,
Motrin, Relafen, Somophyllin, Theo-24, Ultracet, Vioxx, Zithromax
Blocked urination 56 Antivert, Artane, Benadryl, Bentyl, Compazine, Duragesic, Elavil, Felbatol, Haldol, Sinequan,
Tavist, Ultram, Zyban
Urine leakage 84 Aricept, Celexa, Esidrix, Hytrin, Inderal, Lasix, Lexapro, Lithobid, Minipress, Neurontin, Paxil,
Restoril, Tenormin, Valium, Xanax, Zaroxolyn, Ziac, Zoloft
http://www.worstpills.org/public/page.cfm?op_id=5#summary Johns Hopkins researcher speaks out: arrogance of doctors is killing tens of thousands of patients
Peter Pronovost, MD, PhD, is a professor of anesthesiology and critical care medicine at the Johns HopkinsUniversity School of Medicine. Although he works right in the heart of mainstream academic and clinical medicine,Dr. Pronovost is taking an unusual and even heroic step and speaking out about medical errors. Tens of thousandsof people are dying unnecessarily, he says, and one main reason involves the enormous arrogance of many doctors.
In his JAMA paper, Dr. Pronovost points out that each year about 100,000 people die from health care-associatedinfections, another 44,000 to 98,000 die of other preventable mistakes and tens of thousands more die fromdiagnostic errors or failure to receive recommended therapies.
http://www.prisonplanet.com/johns-hopkins-researcher-speaks-out-arrogance-of-doctors-is-killing-tens-of-thousands-of-patients.html Deaths from avoidable medical error more than double in past decade, investigation shows
Preventable medical mistakes and infections are responsible for about 200,000 deaths in the U.S. each year,according to an investigation by the Hearst media corporation.
The precise number of these deaths is still unknown because many states lack a standard or mandatory reportingsystem for injuries due to medical mistakes.
http://www.scientificamerican.com/blog/post.cfm?id=deaths-from-avoidable-medical-error-2009-08-10 Concerns over the fast tracking of new drugs for commercial licensing are raised by a senior doctor in this
week’s BMJ.
It follows approval of natalizumab, a new drug for multiple sclerosis, and its recall three months later, after three trialpatients developed a life threatening condition while being treated.
Natalizumab was licensed by the US Food and Drug Administration in 2004 for use in relapsing multiple
sclerosis on the basis of short term results from two unpublished trials. The FDA granted approval before final
trial and cumulative safety data were available. Natalizumab was predicted to be the leading drug for multiple
sclerosis, with estimated annual sales in excess of $2bn.
Around 3000 patients took part in the trials and nearly 5000 patients have been treated in the United States since itbecame commercially available. In the United Kingdom, natalizumab was due for appraisal by the National Institutefor Health and Clinical Excellence in 2006.
Two of the patients died. But on 28 February 2005, natalizumab was recalled after three trial patients developedprogressive multifocal leucoencephalopathy (PML The approval of natalizumab and its recall after three months raises questions about the fast tracking of new drugs bythe FDA for commercial licensing, says the author, consultant neurologist Abhijit Chaudhuri. It also highlights thepotential risks for patients in trials of new drugs where knowledge of long term efficacy, outcome measures, andsafety is lacking.
Short term solutions for a chronic disease like multiple sclerosis are not likely to be effective, and experience withnatalizumab should be taken as a signal to change the way we treat this disease, he concludes.
http://www.naturalnews.com/020059_drugs_drug_patients.html#ixzz1qQLEUbq\ Accuracy of magnetic resonance imaging for the diagnosis of multiple sclerosis: systematic review BMJ Online First The accuracy of magnetic resonance imaging (MRI) is not sufficient to rule in or rule out a diagnosis of MS with ahigh degree of certainty, finds a study published online by the BMJ today.
MRI has been adopted in England and Wales by the National Institute for Health and Clinical Excellence (NICE) aspart of the recommended criteria for diagnosing multiple sclerosis. Although its accuracy has been assessed, theevidence has not previously been systematically assessed.
http://www.naturalnews.com/019977_multiple_sclerosis_MRI_diagnosis.html#ixzz1qQMayVEs Type this sentence in a search engine:
On July 26, 2000, the Journal of the American Medical Association published a landmark paper by Dr BarbaraStarfield (Johns Hopkins School of Public Health), Is US health really the best in the world? The Devastating Truth About the Obama Health Plan
Jon Rappoport
Insoultions
November 29, 2009
.'On July 26, 2000, the Journal of the American Medical Association published a landmark paper by Barbara
Starfield (Johns Hopkins School of Public Health), "Is US health really the best in the world?" In it, Starfield
revealed what many people inside the medical establishment already knew: every year, like clockwork, the
medical system was killing huge numbers of people. This wasn’t a dream. It was too real. By all rights (but who
cares about rights?) the game was up. The liars and the PR flacks and the public health agencies were going down.
The drug companies were going to take a lethal blow. Hospitals all over America were going to have to confess their
many sins. Of course, that never happened.
12,000 deaths from unnecessary surgeries; 7,000 deaths from medication errors in hospitals; 20,000 deaths from other errors in hospitals; 80,000 deaths from infections acquired in hospitals; 106,000 deaths from FDA-approved correctly prescribed medicines.
The total of medically-caused deaths in the US every year is 225,000.
This makes the medical system the third leading cause of death in America, behind heart disease and cancer.
In the wake of Starfield’s devastating report, other facts came to light: 2.1 million people in America, every year,
are hospitalized as a result of reactions to FDA-approved medicines. Annually, 36 million serious adverse
reactions to those drugs occur.'.
,,,'Barbara Starfield, "Is US health really the best in the world?" JAMA, July 26, 2000. Contains statistics on
medically-caused deaths in the US.
On January 8, 2001, the LA Times ran a piece by Linda Marsa on the effects of medical drugs in the US.
Predictably, the story sank like a stone. It provoked no Congressional hearings, no arrests.
The article described, in a few key paragraphs, a world of trouble. Adverse medical events. From med drugs.
"A 1998 University of Toronto study found that roughly 100,000 Americans die of adverse [medical-drug]
reactions each year, and 2.1 million more are hospitalized."
Marsa offered, in her Times article, a quote from an associate professor of medicine at Harvard, Dr. David Bates, anauthor of a 2000 study on drug effects. The study found that "18 percent of patients complained of drug-relatedcomplications…" Marsa wrote.
Here is the quote from Dr. Bates: "People often have [drug-caused] symptoms for months, but they’re either reluctantto let their doctor know or they weren’t sure if they just felt lousy…But these numbers translate to 36 million adversedrug events per year." Marsa dug out an explanation offered for this horrendous stat by the then-commissioner of the FDA, David Kessler.
Here’s Kessler’s quote from the Times article: "‘If an adverse event occurs in perhaps one in 5,000 or even one in1,000 users, it could be missed in a clinical trial but pose a serious safety problem when released in the market,’noted former FDA Commissioner David A Kessler in a 1993 JAMA article." Kessler was trying to explain (away) 100,000 deaths and 2.1 million hospitalizations and 36 million adverse
reactions PER YEAR from FDA APPROVED DRUGS. He failed dismally. He seemed to be saying, "We can’t do
any better." If true, then Kessler and his colleagues should have abandoned the Agency and sought work
elsewhere.'.
http://www.infowars.com/the-devastating-truth-about-the-obama-health-plan/ Needless to say, the financial ties between the FDA, the pharmaceutical industry, the psychiatric community, and
even doctors play a significant role in the medicating of the population. It was recently reported that 70 percent of
the panel members of the newest edition of the ‘psychiatric bible’, the DSM-5, reported having financial
relationships with pharmaceutical companies.
Explore More:
UK ‘Drug-Driving’ Law Ignores Far Deadlier Legal Drugs http://naturalsociety.com/antipsychotics-prescribed-for-health-issues-not-intended-to-treat/#ixzz1pcPfHtDN In 2009, drugs exceeded the amount of traffic-related deaths, killing at least 37,485 people nationwide.
According to information provided by the U.S. Centers for Disease Control and Prevention, the very
pharmaceuticals that are prescribed to treat life-endangering conditions are now ending lives. The death toll is
partially due to an increase in mental illness medication known as psychotropics, which have been criticized by health
experts as being oftentimes unnecessarily prescribed. The pills, given to patients to prevent suicide thoughts and
tendencies, may actually lead to suicidal thoughts and suicide.
Read more: http://naturalsociety.com/drug-deaths-now-outnumber-traffic-fatalities-in-us/#ixzz1phKdK4YG More Deaths from Pharmaceutical Painkillers than Cocaine and Heroin Combined Read more: http://naturalsociety.com/drug-deaths-now-outnumber-traffic-fatalities-in-us/#ixzz1phKty8Kw Drugs May Cause 5 Times More Side Effects Than Previously Thought
.'A team of researchers from Stanford University School of Medicine have developed such a system. Using acomputer generated algorithm, graduate student Nicholas Tatonetti and Stanford professor Russ Altman, MD, PhDsorted the millions of reported side effect cases within the database to group together patients with similar lifestyles,medical histories, and/or prescriptions. This process makes it easy to determine the cause of the side effect orreaction, and is also a great way to learn more about adverse drug interactions that may not yet be acknowledged. Two separate databases were created to organize the findings of this research and both are available to the public.
The first, OFFSIDES, discovered an additional 329 side effects on average for each of the 1,332 drugs that
were studied - nearly 5 times the 70 or so potential reactions that are listed on the average drug insert. '.
http://www.sott.net/articles/show/243391-Drugs-May-Cause-5-Times-More-Side-Effects-Than-Previously-Thought FDA Approves Drug For Multiple Sclerosis
Federal health regulators have approved the first pill to treat the underlying causes of multiple sclerosis, a debilitatingnervous system disorder that has traditionally been treated with injectable drugs.
The Food and Drug Administration approved Swiss drugmaker Novartis' treatment Gilenya to reduce relapses inpatients with multiple sclerosis, who experiences loss of balance, muscle spasms and other movement problems.
Multiple sclerosis causes the body's immune system to attack the protective coatings of the brain and spinal cord.
Gilenya works to reduce a type of white blood cell that often attacks the nervous system.
Wall Street analysts expect sales of Gilenya to top $1 billion. Total U.S. sales of multiple sclerosis drugs exceeded$5.9 billion last year, according to health care data firm IMS Health.
"Gilenya is the first oral drug that can slow the progression of disability and reduce the frequency and severity inMS," said the FDA's director of neurology products, Russell Katz.
The FDA reviewed the drug under a priority timetable reserved for groundbreaking therapies.
In June, an FDA panel decided 25-0 that Gilenya helps reduce relapses of multiple sclerosis.
Despite the overwhelming endorsement, panelists also had questions about side effects and said patients should
receive their first dose under doctor supervision because of a potentially dangerous drop in pulse rate.
FDA labeling for Gilenya recommends all patients be observed for six hours after receiving their first dose. The labelalso recommends eye examinations to spot macular edema, a side effect reported in some patients.
About 2.5 million people around the world have multiple sclerosis, with an estimated 400,000 of them in the U.S. Inthe most common form of the disease, patients experience periods of well-being followed by periodic relapses.
Physicians who treat multiple sclerosis are mindful of safety problems with other recent treatments for the disease.
Biogen Idec's drug Tysabri was approved for the condition in November 2004 and pulled from the market the next
year after cases of a rare but lethal brain inflammation in some patients. It was reintroduced in 2006 under an FDA-
approved distribution program.
http://www.huffingtonpost.com/2010/09/22/fda-approves-drug-for-mul_n_734641.html FDA approves first oral drug to slow multiple sclerosis progression
'A failed anti-rejection drug got a new purpose and a new lease on commercial life Wednesday as the Food andDrug Administration approved the medication fingolimod -- to be marketed as Gilenya -- to slow the progression ofdisability in multiple sclerosis patients.
[FDA NEWS RELEASE Sept. 22, 2010
.'Patients using Gilenya should be monitored for a decrease in heart rate upon starting the drug. Gilenya may alsoincrease the risk of infections. Cases of serious eye problems (macular edema) have occurred in patients taking thedrug and an ophthalmologic evaluation is recommended.
The most frequent adverse reactions reported by patients taking Gilenya in clinical trials include headache, influenza,diarrhea, back pain, elevation of certain liver enzymes and cough.'.] At the same time, physicians who conduct MS research and care for patients with the neurodegenerative disordercautioned that potential safety issues that arose in clinical trials will require continued monitoring. Dr. Robert P. Lisakof Wayne State University said the drug, which suppresses the immune system, appears to carry some increased riskof infections. And some patients in early trials experienced breathing problems.
The Swiss drug giant Novartis, which makes Gilenya, had already abandoned its effort to seek FDA approval of a
higher dose of the drug, after several clinical trials found it raised the rate of serious side effects without offering
patients greater improvement in their symptoms.
The newly approved drug works differently than other MS therapies currently in use. It reduces the circulation and
the penetration into the brain of immune cells that cause inflammatory damage to brain cells and the fatty sheaths
that protect the connections between them. In relapsing-remitting multiple sclerosis, which accounts for the majority
of cases worldwide, episodes of inflammation in the brain leave lesions that can result in progressively disabling
problems with mobility and cognition.
One clinical trial presented in support of the drug's approval request showed that compared with subjects taking a
dummy pill, patients who took fingolimod had roughly half the number of MS relapses annually. A second trial
compared relapse rates in subjects taking fingolimod with those of subjects taking the injectable beta-interferon
therapy currently in widest use. That trial showed those on Gilenya had almost half the annual rate of relapse of
those taking the drug Avonex. But Novartis' efforts to show that subjects taking Gilenya suffered fewer brain
lesions were inconclusive.
Such a "disease-modifying" approach falls far short of the elusive MS cure that patients and physicians have
sought. But reducing relapses brings measurable benefits for MS patients, because each episode typically results in
cumulatively greater disability.
Because it is a "highly welcomed alternative to injections," Gilenya is predicted to become a leading treatment for MSin a market expected to reach $2.4 billion in 2019, according to Trung Huynh, an analyst with the market researchfirm DataMonitor.
http://articles.latimes.com/2010/sep/22/news/la-heb-ms-drug-092210 Study Shows Cladribine and Fingolimod Cut Relapse Rate in MS Patients
April 30, 2009 (Seattle) -- Two new oral drugs cut by about half the relapse rate in people with multiple sclerosis(MS).
If approved by the FDA, the drugs -- cladribine and fingolimod -- would become the first treatments for MS that don'tinvolve regular injections or infusions.
In one study, about 80% of MS patients who took the chemotherapy drug cladribine were relapse-free for two yearsvs. 61% given placebo.
In a second study, 80% to 84% of MS patients taking the immune-suppressing drug fingolimod were relapse-freeafter one year of daily treatment, compared with 67% of those taking the standard injectable MS drug Avonex.
Either drug will meet a huge unmet need as "a lot of patients refuse to go on treatment right now because it involvesinjections," says Lily Jung, MD, medical director of the neurology clinic at the Swedish Neurology Institute in Seattle.
Jung was not involved in either study.
Both studies were presented at the annual meeting of the American Academy of Neurology.
Cladribine Fights Multiple Sclerosis
Cladribine, already licensed for treating leukemia under the brand name Leustatin, suppresses the autoimmune
responses thought to cause MS. In MS, T cells -- the "generals" of the immune system -- go haywire and order
attacks on the myelin sheaths that surround and protect the brain cells.
"Cladribine damages the ability of the T cells to reproduce and proliferate," Jung says.
The new phase III study involved about 1,200 patients with the relapsing form of multiple sclerosis, characterized byrepeated relapses with periods of recovery in between. They suffered from the disease for an average of six to sevenyears, and all had at least one relapse in the year before entering the study.
Fingolimod (Gilenya) also suppresses the autoimmune responses thought to cause MS, but in a different way. It's a
molecule that locks T cells inside the lymph nodes, so they can't float around in the bloodstream and make their way
to the brain and spinal cord. It was originally designed to help prevent organ rejection in kidney transplant
patients, but that didn't work out very well, Jung says.
In that phase III study, more than 1,200 patients with the relapsing form of MS received one of two doses offingolimod or Avonex daily for one year.
They suffered from the disease for an average of seven years, and all had an average of two relapses in the twoyears before entering the study.
Compared with patients who were taking Avonex, those taking fingolimod were 38% to 52% less likely to suffer arelapse in a year. They also had fewer new lesions and fewer lesions overall than those on the injectable drug.
The study wasn't long enough to show an effect on disability, says study head Jeffrey Cohen, MD, of the
Cleveland Clinic.
The most common side effects were head colds, headache, and fatigue. But there were also eight cases of skin
cancer and four cases of breast cancer. It is unclear whether the drug was responsible for the events.
Jung again cautions that longer-term data are needed. Fingolimod is a potent inhibitor of immune responses andpatients are being watched carefully, she notes.
Two other large studies of fingolimod are still ongoing, with results expected later this year. Drugmaker Novartis,
which funded the current trial, hopes to apply for FDA approval by the end of 2009.
http://www.webmd.com/multiple-sclerosis/news/20090430/2-new-drugs-may-fight-multiple-sclerosis GILENYA
(fingolimod)
Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod is 2-amino-2-[2-(4-
octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below:
Fingolimod hydrochloride is a white to practically white powder that is freely soluble in water and alcohol and solublein propylene glycol. It has a molecular weight of 343.93.
GILENYA is provided as 0.5 mg hard gelatin capsules for oral use. Each capsule contains 0.56 mg of fingolimodhydrochloride, equivalent to 0.5 mg of fingolimod.
Each GILENYA 0.5 mg capsule contains the following inactive ingredients: gelatin, magnesium stearate, mannitol,
titanium dioxide, yellow iron oxide.
How is Multiple Sclerosis Treated?
Currently there is no cure for multiple sclerosis (MS), but there are facets of the disease that have recognizedtreatments and which can be very effective: The standard treatment for significant acute exacerbations is the use of steroids, which exert powerful anti-
inflammatory effects. Steroids reduce inflammation at the site of new demyelination, allowing return to normal function
to occur more rapidly and reducing the duration of the exacerbation. The current favored steroid regimen is methyl-
prednisone administered intravenously in high doses for three to five days with, perhaps, subsequent tapering lower
oral doses of prednisone for one to two weeks. The use of steroids is not believed to have any effect on the
long-term course of the disease
Symptoms of multiple sclerosis, such as fatigue, spasticity (muscles stiffness/spasms), bladder problems, tremor,visual problems and emotional disorders, can often be markedly improved with appropriate medications and therapy.
The following summaries common treatments for MS symptoms: Symptom Affected MS Patients Possible Treatments
Fatigue 50% amantadine (Symmetrel)
pemoline (Cylert) Spasticity 60% exercise for mild cases
baclofen (Lioresal)
tizanidine (Zanaflex)
diazepam (Valium)
Bladder problems (urgency, incontinence) 67% bromine (Pro-Banthine)
oxybutynin (Ditropan)
Desmopresson (DDAVP)
Maprotiline (Ludiomil) Tremor 70% weight applied to affected limb
carbamazepine (Atreol, Tegretol)
Visual problems (optic neuritisâ€"inflammation of nerves, uncontrolled eye motions, double vision) 50%
methylprednisolone (Medrol) for optic neuritis
clonazepam (Klonopin) for uncontrolled motion
Emotional disorders (depression, mood swings) 25-50% amitriptyline (Elavil)
desipramine (Norparmin, Pertofrane) imipramine (Tofranil)
A number of new drugs have recently been approved for use in MS which have some effect on the frequency andseverity of exacerbations and the number of lesions as seen on magnetic resonance imaging.The effect onprogression of disability remains unclear.
Interferon Beta: at this time interferon beta is considered effective only in relapsing-remitting MS.
http://www.imaginis.com/multiple-sclerosis-treatments/how-is-multiple-sclerosis-treated Multiple sclerosis is an inflammatory disease affecting the brain and spinal cord. It results in episodes of neurologicaldeficit which recover (relapses) as well as accumulation of sustained disability with the passage of time.
Corticosteroids are potent anti-inflammatory drugs. It is postulated that long-term use of steroids may reduce theaccumulation of disability. The reviewers found three studies addressing this issue. A meta-analysis showed a trendtowards a beneficial effect of long-term corticosteroids on accumulation of disability; however only two small studiescontributed to this result. It was not possible to reliably comment on the effect of long-term corticosteroids on thefrequency of relapses. Side effects were poorly documented. Therefore rigorous randomised controlled trials of thistreatment are warranted.
http://summaries.cochrane.org/CD006264/the-long-term-use-of-anti-inflammatory-corticosteroids-for-treating-multiple-sclerosis Corticosteroids (commonly referred to as "steroids") are hormones normally produced in the human body by theadrenal glands. They have a number of physiologic effects on different organ systems, but are most widely used fortheir anti-inflammatory actions. These steroids are different from the anabolic steroids used by athletes and others to enhance muscle development and strength.
Treatment for MS Attacks
Steroids were among the first agents used to treat MS and remain the treatment of choice for managing acuteexacerbations, (also called relapses or attacks). Some steroid medications, such as prednisone, are generally given orally. Others, such as methylprednisolone (Solu-Medrol®) and dexamethasone (Decadron®) are given intravenously (IV).
Not all MS exacerbations require treatment. For any attack that is significantly impacting a person’s ability to function
at home or at work, most MS specialists recommend a 3-5 day course of high-dose intravenous steroids. Data from
clinical studies suggest that this short course of high-dose, given intravenously, provides maximum benefit with
fewest side effects. Although some MS specialists prescribe oral rather than intravenous steroids, the data
supporting the use of oral steroids remains controversial at this time.
There is no evidence to suggest that continuous steroid administration slows progression of MS or improves
symptoms over a long period of time. The side effects of long-term continuous steroid use are serious and
well-documented. These include stomach ulcers, weight gain, acne, cataracts, osteoporosis (thinning of the
bones), deterioration of the head of the thigh bone, and chemical diabetes.
Oral steroids that have been taken over a long period of time should never be stopped abruptly, since they cansuppress the body's own steroid production by the adrenal gland. Gradually tapering the dose downward beforediscontinuation of the medication allows the body time to normalize production.
http://www.nationalmssociety.org/about-multiple-sclerosis/what-we-know-about-ms/treatments/medications/corticosteroids/index.aspx The Multiple Sclerosis Society of Ireland (MS Ireland) has called on the government to make available in
Ireland a controversial drug that it believes would much more effectively treat some forms of the disease.
The call, echoed by the drug’s manufacturer, follows the decision by the National Institute for Health and ClinicalExcellence (NICE) in the UK to recommend that the drug, fingolimod - known by its brand name Gilenya - , beavailable on the National Health Service (NHS) for some patients with a form of MS.
It comes less than two months after a European Agency opened an investigation in to whether the medicine
played a role in the deaths of at least 11 patients. The European Medicines Agency (EMA) is due to give an
update on the safety of the medicine next month, the Wall Street Journal reports.
http://www.msrc.co.uk/index.cfm/fuseaction/show/pageid/1309 Fingolimod was shown to cross the blood brain barrier.
Fingolimod accumulated in the brain of rats, dogs, and monkeys after multiple oral dosing.
Degeneration of nerve fibres in the heart and in Auerbach's plexus of the stomach was also identified at the highdose in one dog study.
The initiation of Gilenya* treatment resulted in dynamic effects which were observed within hours following the firstdose. The prinicipal dynamic effects were transient decreased heart rate, .
The co-administration of anti-neoplastic, immunosuppressive, or immune modulating therapies along with Gilenya* isnot recommended due to the risk of additive immune system effects. Caution should be taken when switchingpatients from long-acting therapies with immune effects such as natalizumab or mitoxantrone. Patients should bereminded of the potential for increased risk of infection due to the risk of additive immune system effects ofcorticosteroids.
During and for up to 2 months after treatment with Gilenya* vaccination may be less effective. The use of liveattenuated vaccines may carry the risk of infection and should therefore be avoided.
Due to the potential for additive effects on the PR interval prolongation and heart rate decrease that occur whenGilenya* treatment is initiated, treatment initiation in patients taking PR interval prolonging and heart rate lowering drugs (e.g. antiarrhythmics, beta blockers, calcium channel blockers) should be done with caution.
Because Gilenya* treatment initiation may result in QTc prolongation, use of Gilenya* in patients taking other QTcprolonging drugs should be avoided. If initiation of treatment with Gilenya* in patients taking other QTc prolongingdrugs is deemed necessary, it should be done with caution after an assessment by a healthcare professional withexpertise in cardiovascular disease.
The efficacy of Gilenya* was primarily assessed through two Phase III controlled studies which included a two-year,placebo-controlled study (Study D2301) and a one-year active-control study (Study D2302).
The benefit/risk assessment of Gilenya* for the treatment of adult patients with the relapsing-remitting form of multiplesclerosis must consider the long-term benefit which a patient may receive by reducing inflammatory disease activityand disability progression while also considering the known short-term and potential long-term safety risks associatedwith Gilenya* treatment.
Based on the Health Canada review of data on quality, safety and efficacy, Health Canada considers that the
benefit/risk profile of Gilenya* is favourable for the treatment of adult patients with the relapsing-remitting form of
multiple sclerosis to reduce the frequency of clinical exacerbations and to delay the progression of physical disability.
Because the long-term safety profile for Gilenya* has not been determined at this time, Gilenya* is generally
recommended for MS patients who have had inadequate response to, or are unable to tolerate, one or more
therapies for multiple sclerosis.
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2011_gilenya_137516-eng.php TESTING FOR THE PRESENCE OF MYCOPLASMA IN YOUR BODY THE POLYMERASE CHAIN REACTION
TEST
Information is not generally available about this agent, because first of all, the mycoplasma is such an infinitely smalldisease agent. A hundred years ago certain medical theoreticians conceived that there must be something smallerthan the bacteria and the virus, which are the most common living forms of disease agents. This pathogenicorganism is so infinitely small that normal blood and tissue tests will not reveal the source of the disease. Your doctormay diagnose you with Alzheimer's and he will say, "Golly, we don't know where Alzheimer's comes from. All weknow is that your brain begins to deteriorate, cells rupture, the myelin sheath around the nerves dissolves, and soon." Or if you have chronic fatigue syndrome, the doctor will not be able to find any cause for your illness withordinary blood and tissue tests. This mycoplasma couldn't be detected until about 30 years ago when they developedthe polymerase chain reaction test in which they examine a sample of your blood, remove damaged particles, andsubject that damaged particle to a polymerase chain reaction. This causes the DNA in the particle to break down.
Then they place it in a nutrient which causes the DNA to grow back into its original form. If they get enough of it theycan recognize what it is, and determine whether brucellosis or another kind of agent is behind that particularmycoplasma.
THE BLOOD TEST
If anybody in your family has myalgic encephalomyelitis, fibromyalgia, multiple sclerosis, or Alzheimer's, you can send
a blood test to Dr. Les Simpson in New Zealand. If you are ill with these diseases, your red blood cells will not be
normal donut-shaped blood cells capable of being compressed and squeezed through the capillaries, but will swell up
like cherry-filled donuts, which cannot be compressed. The blood cells become enlarged and distended because the
only way the mycoplasma can exist is by absorbing preformed sterols from the host cell. One of the best sources of
preformed sterols is cholesterol, and cholesterol is what gives your blood cells flexibility. If the cholesterol is taken out
by the mycoplasma, the red blood cell swells up, doesn't go through and the person begins to feel all the aches and
pains, and all the damage it causes to the brain, the heart, the stomach, the feet and the whole body because blood
and oxygen is cut off. And that is why people with fibromyalgia and chronic fatigue syndrome have such a terrible
time. When the blood is cut off from the brain, punctate lesions appear, because those parts of the brain die. It will
get into portions of the heart muscle, especially the left ventricle, and those cells will die. Certain people have cells in
the lateral ventricles of the brain that have a genetic predisposition to admit the mycoplasma, and it causes the
lateral ventricles to deteriorate and die and this leads to multiple sclerosis which will progress until they are totally
disabled and frequently die prematurely. It will get into the lower bowel and parts of the lower bowel will die and
cause colitis. All of these diseases are caused by the degenerating properties of the mycoplasma.
BLOOD VOLUME TEST
You can also ask your doctor for a blood volume test. Every human being requires a certain amount of blood perpound of body weight, and it has been observed that people with fibromyalgia, chronic fatigue syndrome, multiplesclerosis and others do not have the normal blood volume their body needs to function properly. Doctors aren'tnormally aware of this. This test measures the amount of blood in the human body by taking out five cc, putting atracer in it, and then putting it back in the body. One hour later take out five cc again and look for the tracer. Thethicker the blood and the lower the blood volume, the more tracer you will find. The analysis of one of my clientsstated: "This patient was referred for red cell mass study. The red cell volume is 16.9 ml per kg of body weight. Thenormal range is 25 to 35 ml. per kg." This guy has 36% less blood in his body than the body needs to function". Andthe doctor hadn't even known the test existed.
UNDOING THE DAMAGE
The body undoes the damage itself. The scarring in the brain of people with chronic fatigue and fibromyalgia will be
repaired. There is cellular repair going on all the time. But the mycoplasma has moved on to the next cell. In the
early stages of a disease, doxycycline may reverse the disease. It is one of the tetracycline antibiotics, but it is
not bactericidal; it is bacteriostatic. It stops the growth of the mycoplasma, and if it is stopped long enough, then the
immune system takes over. (Nicholson, G.L., Doxycycline treatment and Desert Storm, JAMA, 1995, 273: 618-619),
GULF WAR RESEARCH Professor Garth Nicholson, Ph.D., of the Institute for Molecular Medicine is one of the top
experts on mycoplasma. He has been given an $8 million grant to study 450 Gulf War veterans, because Gulf War
illness is caused by the mycoplasma. Dr. Les Simpson has done most of the research in detecting the disease by the
polymerase chain reaction blood test. You may contact Dr. Nicholson at 15162 Triton Lane, Huntington Beach, Ca,
92649-1401, tel 714-903-2900.
In summary, there is a disease agent that is called a mycoplasma. All of these neuro-degenerative systemic diseasesare caused by a particle of a bacterial DNA, a mycoplasma, that enters into the cells of living organisms and takesthe cells apart, sterol by sterol, leaving scar tissue, and causing all the range of symptoms that you see in peoplewith these diseases. The military and the National Institutes of Health and the government are all dedicated tokeeping this mycoplasma as covert as they possibly can.
You may contact Donald Scott at: 190 Mountain St., Ste. 405, Sudbury, Ontario, Canada P3B 4G2. 705-670-0180.
Note: Dr. David Webster at Sudbury General Hospital, a wonderful person, with whom I have had conversations
about these awful diseases can tell your doctor about the Blood Volume test. Article Information Volume 23 Issue 6
June,2000 Search Top of Form
(NaturalNews) It's not just the cancer industry that keeps you away from non-pharmaceutical and non-invasivetreatments that actually work for complete recovery or reversal. The Multiple Sclerosis Society works with Big Pharmaand the AMA (or whatever national doctor's union) to make sure MS remains incurable but costly.
Dr. Wahls was a very active female martial arts athlete who became a physician and started up a family with twochildren. Then she was diagnosed with progressive MS, which lived up to its name by getting worse, regardless ofthe expert mainstream medical treatment she received.
Around the time she was almost completely disabled, she decided to research on her own - using the internet. Sherealized that the mitochondria in her cells, especially in the brain and nervous system, were damaged from lack ofnutrition. She started supplementing accordingly and got positive results.
But that wasn't enough. She decided to research more to determine which nutrients were in which foods and create atotally dietary approach to help her recover from MS. (1) She had anticipated that there were other nutrients within awhole food approach to improve her health even more (http://www.youtube.com/watch?v=KLjgBLwH3Wc).
Medical mafia victim Donna McFarland found her MS solutions with an obscure, marginalized physician in Oregon,Dr. Roy Swank, MD, Ph.D, the head of neurology at the Oregon Health Sciences University.
Dr. Swank's decades-old commitment to reversing MS had led to nutritional solutions. From this new doctor/patientrelationship, Donna did reverse her MS to lead a normal life, as Dr. Swank had promised. (2) After Dr. Swank passed away at 98 years of age, Donna got involved with another doctor using Dr. Swank'snutritional philosophy. Dr. John McDougal had even met Dr. Swank before he passed away, and he started his ownHealth and Medical Clinic based on nutrition for all diseases and ailments. (3) http://www.naturalnews.com/034983_Multiple_Sclerosis_cures_nutrition.html

Source: https://preventdisease.com/news/pdf/AStudyOfMultipleSclerosis2.pdf