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Friday, May 20, 2011

Doctor Hubbard theory of MS

Dr. Hubbard's theory of MS
Dr. David Hubbard is a neurologist and founder of the Hubbard fMRI Institute and the Hubbard Foundation. He, and Dr. Jack Burks, were the only neurologists present at the recent CCSVI conference, although many neurologists were invited to attend. This was disappointing, to say the least. One would assume that neurologists would be interested in new research into the blood brain barrier and MS. The first thing to note is that the current theory of MS is still only a THEORY. There is absolutely no proof that rogue t-cells are what cause MS. This is an hypothesis. Dr. Hubbard began by discussing the current autoimmune theory. MS drugs, based on EAE and this theory, have a 30% efficacy rate...about the same as placebo. The reason MS drug trials have to be so large and involve so many participants is that it takes that many people to make any statistical significance. The MS drugs are not a success story. They do NOT prove the autoimmune hypothesis. Dr. Hubbard presented his very important insight into what he believes is causing the white matter lesions and destruction of myelin in the MS brain. It is very different than the current understanding that MS specialists propose with the EAE mouse model and the idea that myelin destruction is caused by an out of control immune system which is attacking itself. Oligodendrocytes are a type of brain cell which form the covering of our axons. They make up the myelin sheath. Dr. Hubbard cites research of Prineas and Barnett, showing that the oligodendrocytes DIE FIRST in MS. They are not dying because of an immune attack of white cells....they die BEFORE the immune system is ever involved. The ologodendrocyte shrinks and dies from the center of the cell. Only later do t-cells come in clean up. Macrophages also come in to clean up, this is a standard response of the body to tissue death. "White cells just don't go chomping on the blood brain barrier...they are invited in." So what is the "unknown factor" that is killing oligodendrocytes and inviting in white cells??? Dr. Hubbard proposes that this "unknown factor" is decreased perfusion, or slowed blood flow thru the brain. (Fans of the page will note that this has been the theory of Marie and myself, too, since the beginning of our journey.) Here's an earlier note on hypoperfusion and MS https://www.facebook.com/note.php?note_id=439394977210 The fMRI studies and Dr. Haacke's blood flow studies are confirming this theory. The thing about perfusion is that it affects both WHITE and GRAY matter. It is affects the ENTIRE BRAIN. MS is a disease of the entire brain....gray matter atrophy and white matter demylination. This theory is the first to address BOTH ASPECTS. White cells are picked up by the edges of the endothelium, roll along and then are invited thru the tight junction to get into the brain's paranchyma. MS is not a disease of an immune system gone awry. It is a disease where white blood cells are responding to injury, and are acting appropriately. CCSVI creates a slowed perfusion, or slow flow of blood in the brain. Decreased perfusion and reduced flow and stagnation in the vein causes a shunting of blood around the abnormal venule, the oligodendrocyte is not getting enough O2 and glucose. The oligodendorcyte dies. Please watch all of Dr. Hubbard's research and listen closely. I believe that this is the answer, and connects all we KNOW and all we can SEE about MS brains. http://www.youtube.com/user/HubbFound#p/u/39/Z1BP_xOQQlY I believe this is MS.... - I thank Dr. David Hubbard for bringing the pieces together as a neurologist. - I thank Marie Rhodes for bringing the pieces together as a medical writer. www.ccsvibook.com And I thank all the researchers who are ready to look at this new theory, take it further and begin the process of ENDING MS. For good. Joan
By: CCSVI in Multiple Sclerosis

Tuesday, May 17, 2011

Skip Navigation LinksHome > April 21, 2011 - Volume 11 - Issue 8 > Skyrocketing MS Drug Prices Hit Patients Hard, Prompting Com...
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Neurology Today:
21 April 2011 - Volume 11 - Issue 8 - pp 1,19,23
doi: 10.1097/01.NT.0000397957.19762.cd
Skyrocketing MS Drug Prices Hit Patients Hard, Prompting Compliance Problems
Shaw, Gina
Back to Top | Article Outline

Neurologists are experiencing the fallout from the steep rise in the cost of MS drugs: Many patients are finding it difficult to comply with their therapy regimen. Among solutions, they recommend governmental intervention in negotiating prices.
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When the first oral drug for multiple sclerosis, fingolimod (Gilenya), first entered the market last fall, neurologists and patients alike experienced sticker shock: the medication was priced at a jaw-dropping $48,000 a year. But, some pointed out, it was the first drug of its kind, with no direct competitors. Perhaps it shouldn‘t be surprising that it came at a premium.

And then the price hikes for other MS drugs followed. Teva's glatiramer (Copaxone) now comes at a rack rate of over $42,000 per year — a jump of nearly 40 percent over prices at the beginning of 2010. Biogen has also raised prices further for both natalizumab (Tysabri) and interferon-beta-1a (Avonex).

Why should older drugs — whose existing prices, one assumes, were already set to cover the costs of bringing the drugs to market in the first place — get a price increase when a new drug comes to market?

Companies want to get the most out of their investment, said Edward Fox, MD, PhD, clinical associate professor of neurology at the University of Texas Medical Branch and director of the MS Clinic of Central Texas. “With the onset of new medications that come at a premium, companies have raised the price of older medications in order not to appear inferior to the new drugs. They look at the price as being meaningful when it comes to expectations. If a certain drug is priced lowest, it must be less worthy somehow.”

Of course, virtually no patients are paying out of pocket the full listed price for these costly medications. “I have 1,400 MS patients and I don‘t have single patient paying full price. I can‘t even conceive of someone with a salary high enough where that would be a consideration,” Dr. Fox said.

But the price increases are still driving more and more people with MS and their families into desperate situations. That's because as the prices paid by third-party insurers have gone up, so too have patients‘ copays and other shared costs. “On a weekly basis, I‘m dealing with patients who have what I would call a medication crisis,” Dr. Fox said. “Many of my patients have copays of between $300 and $800 a month. There aren‘t too many families who can easily absorb that cost.”

Bruce A. Cohen, MD, professor of neurology and director of the Comprehensive Multiple Sclerosis Program at Northwestern University's Feinberg School of Medicine, said that he has a number of patients who are making treatment decisions based primarily on cost.

But that's getting harder and harder to do, said Dr. Fox: “It's become an across the board situation where all of the MS medications are so expensive that you can‘t just switch to a less costly alternative.”



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SA Time: Wednesday, May 18, 2011 12:30:33 AM
Drug that could stop MS discovered

May 9 2011 at 09:24pm
By Fiona Macrae
Copy of st lab


Breakthrough: Scientists are hopeful that they ve found a way of stopping multiple sclerosis in its tracks

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Vitamin D linked to minimal MS risk - study

London - A drug that could stop multiple sclerosis in its tracks has been discovered by scientists.

In a major breakthrough in the battle against the devastating disease, researchers have pinpointed the chemical “driving force” behind MS.

Without it, the disease does not develop. And when it is mopped up, symptoms are greatly eased, even in brains already ravaged by the illness.

The results come from experiments on mice but the researchers say they are “quietly optimistic” that taking the same tack will help people with MS. The first trials on patients are pencilled in for later this year.

The debilitating condition affects 2.5 million people around the world, and can cause blindness and paralysis. Current drugs are not suitable for all and there is no cure.

The excitement centres on two studies published recently which show an immune system chemical called GM-CSF to be the “vital piece in the jigsaw” of MS.

In the healthy body, it is part of our defence against disease, attacking viruses and other invaders. But in MS, it triggers a series of reactions that culminate in “scavenger cells” destroying myelin - the fatty protective sheath around nerve fibres in the brain and spinal cord - which disrupts the transmission of messages from the brain.

When Swiss researcher Burkhard Becher gave an antibody that counters GM-CSF to mice with an MS-like condition, it greatly improved their health.

Professor Becher, of the University of Zurich, said: “It is relatively easy to stop mice from getting the disease, so we waited until they had the disease and were pretty sick. This is similar to the clinical situation - patients don’t go to the doctor because they think they might get MS, they go when they have MS.”

The drug was also given to mice whose disease was similar to the most common form of MS, in which relapses are followed by periods of remission. Here, mopping up the GM-CSF prevented any further relapses, the journal Nature Immunology reports.

Becher said: “We are extremely hopeful but whether this form of therapy will actually help MS patients remains to be seen. Quiet optimism is the way to go.

“I am not sure this is going to work in patients but, based on the mouse data, I believe GM-CSF is a good thing to target.”

A German firm, which has no connections to the professor, is already trying to use antibodies against the chemical to treat rheumatoid arthritis. It plans to start tests on MS patients at the end of this year.

It usually takes at least seven years from when a drug is first tried out on patients until it hits the market.

A second study, from Thomas Jefferson University in Philadelphia, also points the finger at GM-CSF.

Although the chemical was known to play a role in MS, its pivotal contribution was not understood until now.

“This is a very interesting development,” said Dr Doug Brown, of the MS Society in the UK. “It is early days and there is still a lot of work to be done before we fully understand what it means for people with MS, but it is satisfying to see that trials are already planned and we look forward to seeing how these progress.”

Mopping up excess GM-CSF may also help treat other conditions, including diabetes, it is hoped. – Daily Mail

Thursday, May 12, 2011

Avonex Custom Report Avonex Overview
Avonex Adverse Events Reported to the FDA Over Time

How are Avonex adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Avonex, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Avonex is flagged as the suspect drug causing the adverse event.
Adverse Event Categories for Avonex

What are commonly reported adverse events by category for Avonex?
Infections - Pathogen Unspecified
Musculoskeletal And Connective Tiss...
Bone And Joint Injuries
Administration Site Reactions
Gastrointestinal Signs
Coronary Artery
Mental Impairment
Epidermal And Dermal Conditions
Movement Disorders
Anxiety Disorders
Central Nervous System Vascular
Procedural And Device Related Injur...
Depressed Mood Disorders
Bacterial Infectious

This graph shows the top 20 categories of adverse events submitted to the FDA for Avonex, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q4 2010. Adverse events are counted if Avonex is flagged as a suspect drug causing the adverse event.
Most Common Avonex Adverse Events Reported to FDA

What are the most commonly reported Avonex adverse events to FDA?
Influenza Like Illness
Multiple Sclerosis Relapse
Multiple Sclerosis
Condition Aggravated
Gait Disturbance
Urinary Tract Infection
Myocardial Infarction
Pain In Extremity
Balance Disorder
Memory Impairment
Cerebrovascular Accident
Back Pain
Muscle Spasms
Injection Site Pain
Weight Decreased
Muscular Weakness
Injection Site Haemorrhage
Mobility Decreased
Chest Pain
Breast Cancer
Intervertebral Disc Protrusion
Loss Of Consciousness
Breast Cancer Female
Oedema Peripheral
Road Traffic Accident

This graph shows the top 50 adverse events submitted to the FDA for Avonex, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q4 2010. Adverse events are counted if Avonex is flagged as a suspect drug causing the adverse event.

Wednesday, May 11, 2011

You must read and share

Big Pharma Behaving Badly (And Making Me Want to Vomit)

Pharmaceutical industry giant Merck Serono this week paid $44.3
million to settle a lawsuit alleging that the company paid kickbacks
to MS neurologists for prescribing its blockbuster MS drug, Rebif
(click here). The scam allegedly included hundreds of doctors, and
seems to have been centered on the Consortium of Multiple Sclerosis
Clinics (CMSC), a nonprofit corporation that is supposed to help
educate patients. Among its other activities, the CMSC administers the
quarterly NARCOMS surveys, designed to build an ever growing database
on MS and its effects on patients, which are diligently filled out by
thousands of multiple sclerosis patients, including, until now, yours

The lawsuit was brought by a former Merck Serono employee turned
whistleblower, who was fired by the company after expressing disbelief
that such underhanded and blatant misdeeds were going on with the
company’s full knowledge and participation. The entire lawsuit
document is available online (click here), and to save you the
trouble, the good stuff starts on page 6.

We're not talking nickels and dimes here, but huge chunks of cash, on
the order of $25,000 a pop. The CMSC allegedly funneled over $500,000
to various doctors, effectively operating as a money-laundering outfit
for Merck Serono, and the fact that the company settled for $44
million indicates this disgusting scam went far deeper than what is
apparent in the legal document. Unfortunately, by settling the
lawsuit, Merck Serono has effectively prevented all of the gory
details from coming to light, as would've been the case if the suit
had been brought to trial, and thus become public record. The
settlement covers fraud charges regarding Medicare and Medicaid, but
what of the patients that may have been steered into injecting
themselves with a drug that might not have been their best choice by
scoundrels in white lab coats more intent on stuffing their pockets
than following the Hippocratic oath? Where is their justice?

Coming at a time when trust between neurologists and their patients
has become frayed due to the CCSVI controversy, the revelations
provided by the lawsuit and subsequent settlement are especially
revolting. It is simply outrageous that a drug company can get away
with paying physicians kickbacks for prescribing drugs with what
amounts to a slap on the wrist. The terms of the settlement, $44.3
million might sound like a sizable sum, but considering that sales of
Rebif exceed $1 billion a year, the penalty is miniscule.
Additionally, this is most likely only a quick peek under a very big
rock, and it is just a glimpse at goings-on that would shock and
dismay the legions of desperate patients who are the real victims of
these disgusting, dishonest, and deceitful practices.

The fact that this case was settled, and not brought to court, ensures
that the names of most of the players will not be revealed. I'm
tempted to reveal those named in the lawsuit here, but as a settlement
was reached, and no verdict of guilt ever handed down, they remain
simply accused, not convicted. My personal ethics therefore prevent me
from slandering those who might not be guilty as charged, however
unlikely that may be. That's not to say that you shouldn't click the
link (here it is again), read the lawsuit, and find those names for
yourself. In fact, I wholeheartedly encourage you to do so.

Every single doctor and medical professional who received any of these
tainted funds, or participated in distributing them, should be named,
shamed, stripped of their licenses, and thrown in jail. They're a
disgrace, each a pustule on the ass of humanity, and deserve nothing
more than humiliation and degradation. Unfortunately, thanks to the
niceties of a system that too often protects those in positions of
power at the expense of the regular folks who rely on them, the
scoundrels involved will remain anonymous, free to enjoy the fruits of
their despicable actions. Despite our high-minded ideals of justice
for all, far too often there is justice for none.

As for those involved in this medical and legal debacle, and the many
other similar cons we will likely never hear about, may their eyes
fall out. Bastards.