A lawsuit over the anti-seizure drug Neurontin began in the United States on Monday, with patients, insurance companies and unions accusing the drug manufacturer of aggressively marketing it as pain medication, an unapproved use.

Neurontin, also known by its generic name gabapentin, is approved for use in Canada and the United States to help control epileptic seizures.

Doctors in both countries prescribe gabapentin to control pain. Canadian doctors wrote two million prescriptions for the drug or its generic versions in 2009.

In 2004, Pfizer subsidiary Warner-Lambert settled a lawsuit filed by federal and state drug programs over the marketing of gabapentin, admitting it fraudulently promoted the drug. Pfizer paid $430 million US in penalties and fines, including $152 million to reimburse the drug programs, which had covered the drugs.

In Monday's suit, a new group of claimants says Pfizer misrepresented the drugs as a painkiller and understated its risks.

The drug may help one in four or five people who take it for chronic pain, but it often causes severe weight gain and grogginess, said Dr. Harry Pollett of North Sydney, N.S., who specializes in treating chronic pain.

"It's a so-so drug that can be very helpful in some cases, but it's not all that helpful in a lot of cases," Pollett said.

Gabapentin class action in Canada

On Friday, Justice Paul Perell of the Ontario Superior Court ordered that a lawsuit relating to Neurontin be certified as a national class action except for residents of Quebec.

The London, Ont., law firm Siskinds LLP and the law firms of Dunn and Company and Hanson Wirsig Matheos in Vancouver, are representing the plaintiffs.

Siskands said the court will determine:

• Whether Neurontin is ineffective and/or defective or unfit for the purpose for which it was intended and sold.
• Whether Pfizer breached a duty to warn people or materially misrepresented any of the risks of harm from using Neurontin.
• Whether the class can choose to require Pfizer to account for all or part of the gross revenue or net income received from the sale of the drug.

"We are disappointed with the court's ruling but are gratified that the court struck plaintiffs' claims of improper marketing and promotion of Neurontin," Heather Bisset, manager of corporate communications for Pfizer Canada, said in an email.

Perell also rejected the plaintiffs' efforts to make Pfizer Canada and Pfizer Inc. responsible for sales of gabapentin, the generic version of Neurontin.

In the 2004 suit, the company admitted promoting gabapentin for unapproved uses, including pain, psychiatric conditions and migraine.

Seeking $4 billion

In the civil suit that began in Boston on Monday, patients, insurance companies and unions argued they should be paid back about $4 billion US.

"Even after they lose a $450-million lawsuit, (the drug) still gets widely used and is almost certainly doing more harm than good," Dr. Gordon Guyatt, a professor in the department of clinical epidemiology and biostatistics at McMaster University in Hamilton, said in an interview. "That is clearly a very unsatisfactory response to the situation from the patient's point of view."

Pfizer Inc. disputes the allegations in the lawsuit, saying Neurontin has been used to treat millions of patients safely and effectively.

"This is a case of an insurance company, Kaiser, seeking its money back for a medicine that provided therapeutic value and that its own physicians prescribed using their best medical judgment," Pfizer said in a statement on the off-label use of the drug.

Canadians and their health plans bought $129 million worth of Neurontin and its generic versions in 2009, according to IMS Health, a company that tracks prescribing.

Glen Hutzul of Toronto has tried many medications, including Neurontin, for the chronic pain he's had since a fall eight years ago. Neurontin didn't work for him.

"It seemed when I took the gabapentin the pain became worse in my shoulder," said Hutzul, who, among other things, sings with the choir Guys Like Us to keep his mind off the pain.

Canada has rules

It is illegal in Canada to aggressively market drugs for off-label use — use of a marketed health product for something other than what's indicated on the authorized product label, Health Canada said.

Health Canada oversees the regulation of drugs but has no jurisdiction over how health-care professionals prescribe drugs once they are approved. Health-care professionals use their own medical discretion in prescribing and rely on information from the product label, medical journals, reports or peer-reviewed studies.

Pollett, the Nova Scotia pain doctor, recalled the sales pitch he received at a pain conference in the U.S.

"We were definitely wined and dined and given the big hard sell that we should be using this for pain," he said. "It made it sound like if we weren't using this for pain we weren't really practising good medicine."

Drug company trials have shown that Neurontin reduces pain. But a paper published in the New England Journal of Medicine in November 2009 said the company manipulated the research, burying unfavourable findings and twisting data to make the drug look more effective than it is.

Patients are "desperate for meds, and docs get told that these drugs work, so they prescribe them," said Jocelyn Downie, Canada research chair in health law and policy at Dalhousie University in Halifax.

Both Guyatt and Downie called for greater regulatory oversight by Health Canada on aggressively promoting drugs for off-label use.

"It's falling between cracks, regulatory cracks," Downie said.

"Some increased monitoring and some increased regulation of off-label use would be appropriate," Guyatt said.

Read more: http://www.cbc.ca/health/story/2010/02/22/gabapentin-neurotonin-lawsuit.html#ixzz0gNYpLFnv

CCSVI information resourse

Here are my articles and blogs on CCSVI to get us started:

• What is CCSVI in Multiple Sclerosis?
• What Causes CCSVI?
• CCSVI Presented in an Elegant and Thoughtful Way
• CCSVI Treatment Reports from Patients

UPDATE: Here are some of the links that you have submitted to me by e-mail:

• Controversial Approach to Treating MS (ABC News, San Francisco)
• Petition to the Prime Minister to Make CCSVI Procedure Available in the UK
• Brain blood vessels clue to MS (BBC News)
• Information About Buffalo Neuroimaging Analysis Center (including info on upcoming studies on CCSVI and CCSVI diagnostic testing)
• BNAC CCSVI Newsletter: Volume 1, Issue 1
• Italian doctor heightens interest in MS cause (CBC, with mention of possible upcoming Canadian trial)

MS POEM

Share

Yesterday at 9:20am

MS hides, inside of me,
Invisible to the naked eye.
I can feel the MonSter
Trying to make me cry.

It’s a part of me, it’s true.
That, I cannot forget.
It rears it’s ugly head
And some days are filled with regret.

There are some bad days
You’ll hear me complain.
But if it consumes me,
Then what will I gain?

I am still “Me”,
The pers...on you’ve known.
Even though inside
The disease has grown.

I won’t allow it
To take over me.
To steal my laughter,
My smile or faith in “HE”.

I choose to laugh
About my life.
To handle it with grace
Dignity and less strife.

So laugh with me, smile with me
But please remember this:
There is rarely a moment
That MS does not exist.

But through it all, the highs & lows,
I have my family & friends.
Remember I’m still “Me”.
I will not let MS be my end!

BY: Tammy Caramagno Malkowski

CCSVI, Already a Success...

Saturday, February 13, 2010

CCSVI, Already a Success...

This month, CCSVI exploded onto the MS radar screen, as the Canadian news media picked up on the story and the University at Buffalo released positive results from the preliminary stage of its ongoing imaging study (click here for more info). While the news that Multiple Sclerosis may in fact be of vascular origin has the potential to fundamentally change our understanding of the disease, the CCSVI story contains other vital lessons and implications for patients, researchers, and doctors alike.

Only 10 months ago, the buzz about CCSVI was barely a murmur. The research of Dr. Paolo Zamboni, founder of the CCSVI theory, was largely unknown, and the concept that MS might be a vascular disease would not have been countenanced by the vast majority of MS researchers and physicians. Remarkably, due to the efforts of a very small group of activist patients, led by the wife of an MS sufferer in California, that quiet murmur has grown into a tremendous roar, and rather than scoffing, even the most skeptical physicians are now being forced to take notice.

The uphill battle to get CCSVI serious attention was truly a grassroots effort, spurred on by patients and their loved ones desperate to find answers that mainstream medicine has been unable to provide. The story of CCSVI is one not only of scientific innovation and medical insight, but also that of the growing discontent that the MS community feels for the current state of MS treatments and therapies. To put it bluntly, the MS the status quo just ain't cutting it.

Upon diagnosis, MS patients are usually advised to go on the first-line MS drugs, the injectable interferons. These drugs leave many of those taking them feeling quite sick after every dose, and clinical trials have shown that they are only effective in about one third of the patients taking them. Second line drugs, such as Novantrone and Cytoxan, are immunosuppressive chemotherapy agents known to be toxic, and have potentially fatal side effects. The newer drugs, such as Tysabri, show much greater treatment efficacy than the older drugs, but they too are immunosuppressive, and carry with them the potential for fatal complications, the risks of which appear to increase with the length of time patients continue treatment.

To my mind, despite problematic side effects, the greatest problem with these medications is that they all treat MS by suppressing or modulating the immune system. The fact is that an immune system gone awry is a symptom of MS, a disease whose origin remains unknown. I've used the following analogy before, and it is admittedly crude, but treating MS by suppressing the immune system is like treating a broken leg with painkillers. The symptoms are superficially addressed, but the root cause of those symptoms is ignored entirely. Yes, the current MS drugs can improve a patient's quality of life, and may slow down progression of the disease, but they do nothing whatsoever to address the still unknown underlying mechanism that drives the disease.

The palpable excitement about CCSVI in the patient population speaks volumes to the incredible frustration patients instinctively feel about the current state of MS care, and the desperate need for hope among MS patients. The Internet MS chat rooms and bulletin boards are overflowing with patients that are sick of being sick, and who feel trapped by a medical establishment that seems unable to address their fears and concerns, much less the debilitating illness they are forced to live with every day. They see pharmaceutical companies earning billions of dollars yearly marketing drugs that seem designed more for profit potential than for disease eradication, and doctors whose hands are tied as much by medical dogma as by the lack of treatment options available to them.

The rise of CCSVI should serve as a model of patient self advocacy, and illustrates the absolute necessity of patients educating themselves to the best of their abilities, and to use the knowledge gained to intelligently question at a fundamental level the how's and why's of their treatment choices. Without the efforts of a few incredibly diligent and steadfast individuals, the CCSVI theory would still be languishing in the back pages of a few medical journals, and a theory with the possible potential to significantly alter the perception of MS could very well never have seen the light of day.

CCSVI may prove to be the Rosetta Stone of MS, or it could turn out to be just a curious piece in the MS puzzle. Regardless of the eventual outcome, the brave efforts of a handful of advocates have managed to shake up mainstream medicine, and have opened the eyes of researchers to concepts that had been either entirely neglected or never even previously examined.

A tremendous amount of research will now commence attempting to prove or disprove the CCSVI theory, and along the way many important discoveries, some having nothing to do with CCSVI, will undoubtedly be made. Monoliths such as the national MS societies and large-scale research organizations have been forced into action, all due to the hue and cry of a patient population brimming with righteous consternation.

As a community, those affected by MS must keep the momentum building, and actively take part in efforts to spark the flames of discovery. If you have the means, donate to organizations researching and advocating alternative MS treatment options. If you have the time and physical ability, volunteer to help further those efforts. At the very least, speak up to the powers that be and let your voice be heard.

As patients, we must be the straw that stirs the drink. As unfair as it may seem, the burden of forcing the action ultimately falls upon the shoulders of those that will benefit the most from that action. By simply shining a light on the path towards empowering the MS patient population, CCSVI is already a stunning success.

Like Wheelchair Kamikaze? Please vote it "Best Patient’s Blog". Voting ends Sunday, February 14th at 11:59 p.m. EST. (Click here to vote)

Posted by The Wheelchair Kamikaze at 3:53 AM

The Society shares in the public urgency to expeditiously advance any lead that has the potential of stopping, repairing or preventing MS.

CCSVI Research Funding Timeline
January 12, 2010 – Investigators whose letter of intent meet guidelines are invited to submit full research proposals.
February 9, 2010 – Deadline for proposals.
May 2010 – International panel of experts conducts an expedited review of all applications received through this special request for applications.
June 2010 – Funding decisions announced.
July 1, 2010 – Anticipated start date for funding of any successful research applications.

Taking advantage of the organizations' international scope, the applications will undergo an accelerated review process by an international panel being convened in cooperation with other MS Societies to ensure an expedited, coordinated response. If this hypothesis is confirmed, it could open up new research avenues into the underlying pathology of MS and new approaches to therapy.

Background: In a recent study by Dr. Zamboni and colleagues, the team evaluated abnormalities of blood outflow in major veins draining from the brain and spinal cord to the heart in 65 people with different types of MS, compared with 235 people who were either healthy or who had other neurological disorders. They used sophisticated sonography techniques to detect abnormalities of venous drainage. The investigators reported evidence of slowed and obstructed drainage in the veins draining the brain and spinal cord in many of those with MS. They also reported evidence of the opening of “substitute circles” – where the flow is deviated to smaller vessels to bypass obstructions, and these were often found to have reverse flow (reflux) of blood back into the brain.

The investigators call this venous obstruction “chronic cerebrospinal venous insufficiency,” or CCSVI. The treatment status of the people with MS (i.e., whether or not they were on an MS disease modifying drug) did not appear to influence whether they showed signs of CCSVI. The authors speculated that the reverse flow of blood back into the brain might set off the inflammation and immune-mediated damage that has been well described in MS. This study was published in June 2009 (J Neurol Neurosurg Psychiatry 2009; 80:392-399).

It is proposed, but not yet proven, that CCSVI may be corrected through endovascular surgery. This surgery is being called “liberation therapy” in some reports. One study getting underway was described at the 2009 ECTRIMS meeting in September. It involves a collaboration between researchers in Italy, Buffalo (NY) and Birmingham (AL) who are attempting to treat venous obstruction in 16 individuals using balloon dilation such as has been used for many years to treat blocked arteries.

In a small, open-label study by Dr. Zamboni and colleagues published in December 2009, the team evaluated the safety and preliminary outcomes of vascular surgery (percutaneous transluminal angioplasty) in 35 individuals with relapsing-remitting MS, 20 with secondary-progressive MS, and 10 with primary-progressive MS. (J Vasc Surg 2009; 50:1348-1358) They reported some positive impacts and suggested that controlled trials were necessary to better determine potential safety and benefits of this procedure.

Next Steps: The National MS Society has prompted communications between MS Societies worldwide and leveraged resources to ensure an open exchange of information and a coordinated and expedited approach to conducting and evaluating additional research on CCSVI. On December 16, 2009, the Society released a worldwide Request for Applications to the scientific community to explore CCSVI, and is collaborating with the MS Society of Canada and possibly other societies to convene an international panel of experts to conduct an accelerated review of proposals. We are also working with our sister MS Societies around the world to assure that our research strategies are coordinated. Through an internationally coordinated and expedited review process, new CCSVI research projects are expected to begin July 1, 2010. (See Research Funding Timeline above for more details.)

According to the Buffalo Neuroimaging Analysis Center, although 500 subjects have already been selected for their initial combined transcranial and extracranial venous doppler evaluation study, they are still seeking participants for a larger-scale clinical study with the aim of evaluating the prevalence of venous obstruction in people with MS. This study does not involve treatment of obstructions. The Buffalo investigators released preliminary findings in a press release and plan to continue the study.

To get the quickest answers and most reliable results about benefits and risks of any surgical procedure that might attempt to address blood flow in or out of the brain, it is crucial that such surgery be performed only as part of controlled trials, especially since there have been anecdotal reports of surgical attempts to treat CCSVI in people with MS resulting in adverse events, including one reported death.

Many questions remain about how and when this phenomenon might play a role in nervous system damage seen in MS, and at the present time there is insufficient evidence to prove that this phenomenon is the cause of MS.

Frequently Asked Questions About CCSVI and MS

Q: What is the National MS Society’s view of CCSVI?
A: In trying to find the cause and more effective treatments for a disease as complex and unpredictable as multiple sclerosis, the Society is steadfast in its commitment to pursue all promising avenues of research that can lead to improved treatments and ultimately, a cure. It is important for researchers to think outside the box and we believe Dr. Zamboni has done this. His hypothesis is a path that must be more fully explored and Dr. Zamboni himself has stated that additional research is essential to evaluate it.

Q: Will the National MS Society fund research into CCSVI in MS?
A: The National MS Society is pursuing follow-up research in how CCSVI might be involved in the MS process and we have invited investigators from around the world whose research is relevant to MS to submit proposals to apply for grants that would explore this lead. These applications will undergo an accelerated review process and an announcement on what grants are to be funded will be made in the late spring.

Q: Do the reports of a possible association between insufficient vein drainage and MS mean that MS is caused by venous insufficiency?
A: Based on results published about these findings to date, there is not enough evidence to say that obstruction of veins causes MS, or to determine when this obstruction may occur in the course of disease. Dr. Zamboni's preliminary research reported that 47% of the people who had the blockage in their internal jugular veins treated surgically had a recurrence of blockage by the end of the initial study. This is one of many reasons why additional research into what all this information might mean to the worldwide effort to arrest MS is so important.

Q: If CCSVI turns out to be important in MS, can it be treated?
A: It is too soon to determine how CCSVI might best be treated. Surgical procedures for CCSVI in MS are still experimental and should be undertaken only as part of formal clinical trials that include all of the standard safeguards that are followed in such trials because of known adverse events and at least one death that occurred as a result of a surgical treatment protocol.

Q: How can I get involved in research on CCSVI in MS?
A: A larger-scale clinical study is getting underway in Buffalo, New York and is now recruiting participants nationwide with the aim of evaluating the prevalence of venous obstruction in people with MS. This study does not involve treatment of venous obstructions.

Q: While research is underway to better understand the possible relationship between CCSVI and the MS disease process, why should I not try this endovascular surgery to prevent my MS from worsening?
A: Though this is a decision that patients with MS need to make with their neurologists, we are not recommending experimental endovascular surgery at this time because of known adverse events and at least one death that occurred as a result of the surgical treatment protocol.

For anyone considering endovascular surgery, the following are some of the possible adverse events that need to be considered:
Complications and even death can occur including the risk of infection at the puncture site, risk for damage to the blood vessel, risk of internal or external bleeding if anti-coagulants are used, and, if a stent is inserted in an attempt to keep the vein from narrowing once more, there is a risk that the stent may become dislodged and go to the heart, which could cause death or the need for emergency heart surgery.

Q: I have MS. Should I be tested for signs of CCSVI?
A: We do not recommend testing for signs of CCSVI unless you are involved in a research study exploring this phenomenon, since at this time there is no proven therapy to resolve any abnormalities that might be observed, and it is still not clear whether relieving venous obstructions would be beneficial or safe.

Q: Does CCSVI make the standard treatments of MS meaningless?
A: No. There is ample evidence proving that the FDA-approved therapies for MS provide benefit for people with most forms of MS.

Q: Should the Society be doing more to support the work of Dr. Zamboni, as some people have suggested?
A: Dr. Zamboni has called for more research to move his preliminary CCSVI research forward and the Society is leading the way in advancing that effort. We have reached out to MS scientists from around the world to fund projects that will explore Dr. Zamboni’s leads, have expedited the grant review process, and brought together international MS organizations and experts to share information and move the research process forward. As in all pilot research, Dr. Zamboni’s work has raised as many questions as it has potentially answered. The Society’s role is to help ensure long term that while we are seeking to stop MS and repair the damage done by the disease, we are also working to ensure that whether someone is diagnosed with MS today or ten years from today that there will be safe and effective treatment options available. It is research such as this that has made MS a treatable disease today.

Q: What are some of the questions raised in Dr. Zamboni’s research that need to be explored?
A: Why has venous obstruction recurred in such a large percentage of patients who underwent the endovascular surgery and what does that mean to the disease process for these individuals? Is there abnormal venous obstruction in all people with MS? How do we determine who might best benefit from endovascular surgery? Can Dr. Zamboni’s results be replicated in larger controlled and blinded studies of MS patients? If so, when does CCSVI occur in the course of the disease – is it a cause or effect of the disease process? How can we address the known risks associated with endovascular surgery? Acknowledging the questions that Dr. Zamboni himself has raised only helps in designing the necessary research to secure the needed answers.

Q: Is it true as some people have suggested that the Society’s dependence on money from the pharmaceutical industry is impeding its support of Dr. Zamboni’s research?
A: No. Less than 4% of the Society’s annual income is received from the pharmaceutical industry. The majority of the funds that the Society uses to support our research and service programs come from special events and the donations of private individuals committed to ending MS. Further, we are fast-tracking our efforts to fund research regarding CCSVI and working in partnerships with MS organizations and experts worldwide to better understand and move forward Dr. Zamboni’s findings.

Q. How can I continue to be informed of CCSVI developments as they occur?
A: As new information becomes available about CCSVI, it will be posted on the National MS Society’s Web site, www.nationalMSsociety.org

'I had controversial MS treatment twice'

Graham Satchell Correspondent, BBC Breakfast

Heart surgeon Gianfranco Campalani says the treatment gave him quick results

A team in New York has reported the first results of a trial to test the theory that restricted blood flow in the brain may underlie some of the symptoms of multiple sclerosis.

Gianfranco Campalani knows a thing or two about the vascular system.

He's one of Northern Ireland's leading heart surgeons.

He was diagnosed with multiple sclerosis (MS) in 1986 - it left him with a series of problems in his lower body.

He finds it hard to walk more than fifty yards, or he did until he met an Italian compatriot and fellow vascular surgeon Professor Paolo Zamboni.

New theory

Professor Zamboni has pioneered a new theory of the cause of MS and has suggested a potential new treatment.

MS has always been thought of as an autoimmune disease.

For reasons that are not clear, the bodies' immune system attacks nerve cells in the brain which send messages to the rest of the body.

Professor Zamboni starting investigating MS when his wife was diagnosed with the condition.

He discovered she had constricted jugular veins in her neck.

His theory is that the narrow veins decrease the flow of blood from the head.

Pressure builds up in the smaller vessels in the head leading to deposits of toxic iron from the blood which cause damage in the brain.

He then tested a further 65 patients with MS and found they all had twisted or constricted jugular veins.

Gianfranco was one of those patients.

Chance meeting

They met three years ago in Italy when Gianfranco was visiting his brother - they all come from the same town - and the conversation soon turned to MS.

Prof Zamboni invited Gianfranco to be tested.

What happened at the clinic was electric.

"I nearly kissed him!" Gianfranco said. "It's funny, somebody tells you you've got something wrong and you are so happy.

"Finally you realise MS is not a disease of unknown origin. It's due to these anomalies in the veins which are present from birth."

A year later Gianfranco returned to Italy for treatment.

It was done under local anaesthetic. Gianfranco watched it happening.

Dramatic effect

An angioplasty - a small balloon was positioned in the vein and slowly inflated.

An ultrasound image shows the constricted vein in Gianfranco's neck

When the balloon is removed, the vein - which was constricted - was a normal width and the blood flows more freely.

The effect was dramatic.

"Five hours after the procedure I got up and I walked the corridor without my stick.

"My partner cried.

"She never saw me walking like that.

"I was walking before the procedure but with a lot of difficulty.

"I was not able to lift my leg easily.

"But five hours after the procedure I can walk without my stick, I can lift my leg, my back is stronger I'm taller.

"In the subsequent days and weeks I see that other functions which were not working 100%, they work."

Last year, Gianfranco felt his condition worsen.

He asked colleagues in Belfast to check his jugular veins.

They had both constricted again.

He had a repeat angioplasty in Belfast in October and claims to have improved.

Questions

Yesterday researchers at the University of Buffalo revealed early findings from 500 patients.

They found that 55% of patients with MS had narrow veins in the neck - twice as much as healthy people.

Zamboni's theory and the new research from America raises many questions.

Is this a new explanation for the cause of MS?

Is angioplasty of the jugular veins a potential new treatment ?

Many experts are sceptical.

They say at this stage there is no proof of a causal link between blood flow and MS.

There is uncertainty about the level of pressure needed in the blood vessels in the brain for red cells containing iron to cross the blood brain barrier.

The MS society says there have been no clinical trials of the procedure and much more work is needed.

"We need more investigation - more scientific research into cause and effect," Gianfranco acknowledges.

But for him, Prof Zamboni has opened up a new way of looking at MS and one that has improved his life.

---

2009 MRI CCSVI Pilot Study with MRA and SWI	Print
	A A A

This website is an informational website only.

The recent press exposure for Paolo Zamboni's research into the vascular nature of multiple sclerosis (MS) has generated an unprecedented interest by MS patients around the world. Imaging sites have been inundated with 10,000s of patients seeking answers and contacts. Each site has made an effort to answer each of you individually but this been a drain on everyone's resources. We request that you please review the information below and contact your own doctor and neurologist at this time. Although there are ultrasound and MR imaging methods available to study the body's vasculature, the ability to study this new concept in a coherent fashion will take a lot of important and careful research. Many sites are in the process of getting approval from their local institutional review board (IRB) also known as an independent ethics committee (IEC) or research ethics board (REB). These are committees that have been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects. The research community is doing its best to respond to this new challenge. We will try and keep everyone apprised of the current situation from whatever public information is available at this site. Please be aware that this site does not solicit volunteers for research. Finally, please be patient as the scientific approach must take its course for the benefit and protection of all concerned.

The following is an opinion based on material available in the public domain. "In the last few years, researchers have recognized the presence of increased iron content in the basal ganglia and thalamus. This in itself suggests the possibility of venous damage in MS. But the interest and association of MS with veins dates back to Putnam (1) in the 1930s (and much earlier than this as well) and then later to Fog (2) in 1964 followed by a major decade's long effort to convince people of the role of the mechanical effects of changes in venous flow by Schelling (3). However, more recent evidence by Paolo Zamboni and his team (4) suggests that MS might be caused by a chronic cerebral spinal venous insufficiency (CCSVI). It may be that changes in shear stress can cause a biological response that is very similar to what we see in MS (see for example the work by John Bergan (5)). In fact, it is a logical explanation as to why the entire brain is affected in MS, why the disease tracks backward along the venous drainage system, and why it emanates from the white matter near the ventricles in the drainage of territory of the medullary veins." E. Mark Haacke

BBC News Updated every minute of every day

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Page last updated at 17:17 GMT, Wednesday, 10 February 2010 E-mail this to a friend Printable version Brain blood vessels clue to MS Twice as many patients had constricted blood vessels in their brains More than 55% of multiple sclerosis patients have been found to have constricted blood vessels in their brains, a US study says. The preliminary results are from the first 500 patients enrolled in a trial at the University of Buffalo. The abnormality was found in 56.4% of MS patients and also in 22.4% of healthy controls. The MS Society said it was intriguing but not proof that this caused MS - as one leading expert claims. Testing theory The New York researchers were testing a theory from Italian researcher, Dr Paolo Zamboni who claims that 90% of MS is caused by narrowed veins. These results are intriguing but it is important to remember that although people with MS may show evidence of chronic cerebrospinal venous insufficiency in screening studies, there's no proof as yet that this phenomenon is a cause of MS, nor that treating it would have an effect on MS Dr Doug Brown, MS Society He says the restricted vessels prevent the blood from draining fast enough and injure the brain by causing a build up of iron which leads to MS. He has already widened the blockages in a handful of patients including his wife. MS is a long-term inflammatory condition of the central nervous system which affects the transfer of messages from the nervous system to the rest of the body. The Buffalo team used Doppler ultrasound to scan the patients in different body postures to view the direction of venous blood flow. The 500 MS patients, both adults and children, also underwent MRI scans of the brain to measure iron deposits in surrounding areas of the brain. The full results will be presented at an American neurology conference in April. There were 161 healthy controls. 'Cautious optimism' Robert Zivadinov who led the study at the University of Buffalo, said he was "cautiously optimistic and excited' about the preliminary date. "They show that narrowing of the extracranial veins, at the very least, is an important association in multiple sclerosis. "We will know more when the MRI and other data collected in this study are available." Dr Doug Brown, Biomedical Research Manager at the MS Society, said: "These results are intriguing but it is important to remember that although people with MS may show evidence of chronic cerebrospinal venous insufficiency in screening studies, there's no proof as yet that this phenomenon is a cause of MS, nor that treating it would have an effect on MS. "The next step is to determine what this actually means for MS and an investigation into whether there's any potential therapeutic benefit from treatment will be pivotal for this novel theory."

Had my dopplar scan at Duke yesterday, they are not doing the scan in accodance with the way they do it at the Jacob's medical center in Buffalo. I was very disappointed and now will wait for my next MRI. Roger, and out.

Twice as many patients had constricted blood vessels in their brains

More than 55% of multiple sclerosis patients have been found to have constricted blood vessels in their brains, a US study says.

The preliminary results are from the first 500 patients enrolled in a trial at the University of Buffalo.

The abnormality was found in 56.4% of MS patients and also in 22.4% of healthy controls.

The MS Society said it was intriguing but not proof that this caused MS - as one leading expert claims.

Testing theory

The New York researchers were testing a theory from Italian researcher, Dr Paolo Zamboni who claims that 90% of MS is caused by narrowed veins.

These results are intriguing but it is important to remember that although people with MS may show evidence of chronic cerebrospinal venous insufficiency in screening studies, there's no proof as yet that this phenomenon is a cause of MS, nor that treating it would have an effect on MS Dr Doug Brown, MS Society

He says the restricted vessels prevent the blood from draining fast enough and injure the brain by causing a build up of iron which leads to MS.

He has already widened the blockages in a handful of patients including his wife.

MS is a long-term inflammatory condition of the central nervous system which affects the transfer of messages from the nervous system to the rest of the body.

The Buffalo team used Doppler ultrasound to scan the patients in different body postures to view the direction of venous blood flow.

The 500 MS patients, both adults and children, also underwent MRI scans of the brain to measure iron deposits in surrounding areas of the brain.

The full results will be presented at an American neurology conference in April.

There were 161 healthy controls.

'Cautious optimism'

Robert Zivadinov who led the study at the University of Buffalo, said he was "cautiously optimistic and excited' about the preliminary date.

"They show that narrowing of the extracranial veins, at the very least, is an important association in multiple sclerosis.

"We will know more when the MRI and other data collected in this study are available."

Dr Doug Brown, Biomedical Research Manager at the MS Society, said: "These results are intriguing but it is important to remember that although people with MS may show evidence of chronic cerebrospinal venous insufficiency in screening studies, there's no proof as yet that this phenomenon is a cause of MS, nor that treating it would have an effect on MS.

"The next step is to determine what this actually means for MS and an investigation into whether there's any potential therapeutic benefit from treatment will be pivotal for this novel theory."

CCSVI at UBC MS Clinic - Information and Support

Read the press release -- these people were scanned with ultrasound only. Phase 2 (another 500) will use MRV. The final % of CCSVI vs. non-CCSVI is still to be determined...

26 minutes ago · Report

First Blinded Study of Venous Insufficiency Prevalence in MS Shows Promising Results - UB NewsCenter

www.buffalo.edu

A study by neurologist Robert Zivadinov has shown that the narrowing of extracranial veins is, at the very least, an important association in multiple sclerosis.

Purpose of this website is to explore the hypothesis, and spread awareness on: CCSVI - Chronic Cerebro-Spinal Venous Insufficiency Recently proposed as the cause of Multiple Sclerosis. Diagnosis: Cranial & Neck imaging (CT-Venography, Magnetic Resonance Venography (MVR) or Doppler). Treatment: Angioplasty or stents for jugular stenosis, to restore blood flow out of brain. My Stenosis: I had corrective stent procedure Oct 2009 at Stanford. Details in my blog (updated 01/25/2010) and images. More about me. Alert 12/9/09 - CCSVI Procedures on hold: Procedures on hold in USA, intervention trials beginning. USA: Stony Brook, Georgetown, Duke, Stanford, Univ. South Carolina, The Vascular Group, Albany, NY Canada: Univ. Bristish Columbai, Hamilton/McMaster. Watch for results early 2010 from CTEVD Study Jacobs Neurological Institute, University at Buffalo. Latest news. What you can do to prepare: Make a transition plan with your doctor if using MS immune suppression therapy, in case CCSVI theory is correct. Find a local vascular doctor or interventional radiologist. Doctor list that treats a similar condition, CTOS. You have a right to proper diagnosis, even if treatments are on hold for now. See resources and scan protocols below. Make a post-procedure recovery care plan, based on current level of disability, then a rehab plan to regain functionality. Action you can take to speed the research CCSVI in Multiple Sclerosis: What can I do??? by Joan Beal Direct donations can be made to CCSVI studies gearing up around the world. msliberation.ca has raised $40,000 the first week for Dr. Haacke's study at McMaster University in Canada. What you can do to feel better & slow MS progression while the CCSVI research gets started: Try calming your immune system's reaction to CCSVI damage with Low Dose Naltrexone therapy. Pick your favorite MS diet and stick with it. Quit eating sugar and fructose (Sugar: The Bitter Truth H. Lustig, MD, UCSF). I've tried all of the above and found them to be effective. I've been at this long enough to give advice, so there you have some! Media Coverage The Myths of MS Blogtalkradio, host Elaine DeLack, RN discusses CCSVI, & what may be causing the narrowing of the jugular in MS. CanadianTV, W5 11/21/09 "The Liberation Treatment" CTV's medical reporter Avis Favaro investigates a radical new theory of what causes Multiple Sclerosis and discovers a novel way to treat the symptoms that may provide relief for millions of suffers - a medical discovery made through love. Free to view after broadcast time. The Globe And Mail 11/20/2009 - Researcher's labor of love leads to MS breakthrough The Globe And Mail 11/23/2009 - Canadian MS society to fund research into 'liberation procedure' 12/01/09 Interviews University at Buffalo - Press Release | CTEVD Study Enrollment | Buffalo News | TV News | WBFO Public Radio Science Daily 10/27/09 - Neurologists Investigate Possible New Underlying Cause Of Multiple Sclerosis BBC News 11/27/2009 - Multiple sclerosis 'blood blockage theory' tested, University at Buffalo Research / Clinical Evidence / What is CCSVI? Venous Multiple Sclerosis | CCSVI - Frequently updated research links; what to show to your doctor. Multiple languages. Fondazione HILARESCERE official research website of Prof. Zamboni on CCSVI. Dr. Zambon's most recent publication A prospective open-label study of endovascular treatment of chronic cerebrospinal venous insufficiency. J Vasc Surg. 2009 Dec;50(6):1348-1358.e3. Full Text | PubMed Abstratct. Discussion of Zamboni's findings by Marie Rhodes ThisIsMS CCSVI forum - Read "CCSVI RESEARCH" sticky post, annotated by Marie, with links to papers. MRI CCSVI Pilot Study with MRA and SWI - Dr. Haacke, Wayne State Univ. Presentation on CCSVI research, Wayne State Univ. Good to show your doctor. Illustrative video on CCSVI from Dr. Paolo Zamboni with English narration 10/22/2009. Wikipedia - entry on CCSVI. Patient Evidence, Experiences & Support ThisIsMS CCSVI patient forum - Read "Just the Facts" sticky post first, for plain language explanation. Patient CCSVI Tracking Project at ThisIsMS. Rate your own MS score, MSIS-29 online Multiple Sclerosis Impact Scale (part of the Tracking Project). CCSVI Facebook - breaking news on research & patient advocacy efforts. Get the latest: Google search on CCSVI, or YouTube Patient Blogs: My Hopeful Journey Into Actual MS Recovery - A patient's personal account of CCSVI treatment. CCSVI (the Vascular Theory of MS): Separating Fact from Fiction by The Wheelchair Kamikaze ** Stu's Views & M.S. News **: Blog Links concerning CCSVI What The MS Societies & Doctors Are Saying MSAA Chief Medical Officer, Jack Burks, MD - CCSVI & Multiple Sclerosis The Consortium of Multiple Sclerosis Centers, comment on the Liberation Treatment Where You Can Get the Diagnostic Scans First contact your MS doctor, and ask when they will begin CCSVI scans. Have the radiologist coordinate with a doctor familiar with CCSVI, so the right scans are done. Let the patient coordinator contact your insurance provider for pre-authorization. Multiple Countries & USA, MI: Dr. Haacke, MRI CCSVI Pilot Study and publically available protocols. Dr. Simka & Zamboni's doppler protocol, and the required technician training. USA, NY: CTEVD Study Enrollment Jacobs Neurological Institute, University at Buffalo, ctevd@bnac.net Finding a Doctor for CCSVI a database directory where you can find or submit participating doctors. Diagnostic Scans, & Corrective Procedures (stent/angioplasty) have been performed at: USA, CA: Stanford University, Dr. Michael Dake. Patient Coordinator: (650) 725-3806 As of 12/09/09 procedures no longer available, but you can register for clinical trial starting 2010. Canada: As of Dec 2009, University of British Columbia is seeking to fund a CCSVI trial. Italy: University Bologna Hospital, Dr. Zamboni Ireland: Royal Victoria Hospital, Belfast, Drs Anton Collins, Robin Baker Poland: Dr. Simka, website. Email contact preferred, mariansimka@poczta.onet.pl CCSVI in Multiple Sclerosis CCSVI at UBC MS Clinic - Information and Support Buffalo CCSVI Study CCSVI & Multiple Sclerosis - a cure? CCSVI in MS Toronto ms-ccsvi-uk CCSVI & Multiple Sclerosis - a cure? Esclerosis Múltiple Venosa (CCSVI) CCSVI nella Sclerosi Multipla Sclérose en Plaques Veineuse (CCSVI) Veneuze Multiple Sclerose (CCSVI) Venöse Multiple Sklerose, CVI & SVI, CCSVI

More Great CCSVI Information

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An information platform dedicated to CCSVI and MS, which lists the latest reseach results, shows an overview and offers a forum for discussions around CCSVI.

New era for MS therapy? Paolo Zamboni, University of Ferrara, Italy, presented the rationale and preliminary results of an endovascular treatment for multiple sclerosis on the third day of the CX Symposium.

Prof. Zamboni (University of Ferrara, Italy) showing further venous anomalies in MS patients

Prof Paolo Zambonis revolutionary discovery of exspiratory flow-reversals affecting the inner cerebral veins, matching, in their intensity, the degree of the clinical incapacitations of multiple sclerosis

Periventricular venous flow dynamics effected through breathing
(normally but inspiratory) outflow enhancements in blue; exspiratory flow inversions in red
Mpg showing normal subject
Mpg showing multiple sclerosis; massive exspiratory flow inversions, alternating with phases of turbulent venous return

Critical questions and helpful comments on this website, to be addressed to dr.franz.schelling@aon.at, are highly appreciated!

In view of the given facts we must ask ourselves whether the MS patient's shameless exploitation for an as senseless as profitable drug experimentation, grounded in an illogical MS "definition" and "identification", does not form an ethical issue.

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Fish oil supplements 'beat psychotic mental illness'

The capsules are rich in omega-3 Taking a daily fish oil capsule can stave off mental illness in those at highest risk, trial findings suggest. A three-month course of the supplement appeared to be as effective as drugs, cutting the rate of psychotic illness like schizophrenia by a quarter. The researchers believe it is the omega-3 in fish oil - already hailed for promoting healthy hearts - that has beneficial effects in the brain. A "natural" remedy would be welcomed, Archives of General Psychiatry says. "The finding that treatment with a natural substance may prevent, or at least delay, the onset of psychotic disorder gives hope that there may be alternatives to antipsychotic drugs," the study authors said. If young people can be treated successfully with fish oils, this is hugely preferable to treating them with antipsychotics Alison Cobb Mind Antipsychotic drugs are potent and can have serious side effects, which puts some people off taking them. Fish oil supplements, on the other hand, are generally well tolerated and easy to take, say the scientists. The international team from Austria, Australia and Switzerland tested the treatment in 81 people deemed to be at particularly high risk of developing psychosis. Natural choice Their high risk was down to a strong family history of schizophrenia, or similar disorders, or them already showing mild symptoms of these conditions themselves. For the test, half of the individuals took fish oil supplements (1.2 grams of omega-3 fatty acids) for 12 weeks, while the other half took only a dummy pill. Neither group knew which treatment they were receiving. Dr Paul Amminger and his team followed the groups for a year to see how many, if any, went on to develop illness. Two in the fish oil group developed a psychotic disorder compared to 11 in the placebo group. Based on the results, the investigators estimate that one high-risk adult could be protected from developing psychosis for every four treated over a year. They believe the omega-3 fatty acids found in the supplements may alter brain signalling in the brain with beneficial effects. Alison Cobb, of the mental health charity Mind, said: "If young people can be treated successfully with fish oils, this is hugely preferable to treating them with antipsychotics, which come with a range of problems from weight gain to sexual dysfunction, whereas omega-3s are actually beneficial to their general state of health. "These are promising results and more research is needed to show if omega-3s could be an alternative to antipsychotics in the long term."

SALT LAKE CITY (ABC 4 News) At the end of November a young mother kissed her children goodbye, and boarded a flight with her husband. It was the beginning of a medical journey that she believes has ended with miraculous results. Michelle Colledge was treated for severe Multiple Sclerosis at Johns Hopkins, in Baltimore Maryland. She is just one of 44 patients to receive the experimental High Dose Cyclophosphamide, and may be the last.

Michelle’s husband says his wife’s MS was so severe that several times he was told to prepare for her to die. Current medications available to treat Michelle had failed. Unwilling to give up hope, they researched until they found the work being done at Johns Hopkins. It was that discovery that Michelle Colledge says saved her life, and gave her life. “It feels miraculous to me. I feel like Lazarus rising from the dead. Like was dead, and a prisoner inside my own body and now I am living again.”

In order for Michelle to live, her immune system had to die. At Johns Hopkins, she says she received the High Dose Cyclophosphamide, an older and stronger form of chemotherapy. Thirteen liters, over a course of four days, killed all of her white blood cells. She says,” I like to think of them as assassins. So, they had these instructions that were not correct, that said the brain and the spine was the enemy. So, we killed all of those cells.” Her new immune system took about three weeks to grow. Adam Kaplin M.D, PhD, at Johns Hopkins explains, “It’s a resetting of the whole immune system and these people really genuinely have a new immune system.” That immune system has no memory of MS and no longer attacks the brain and spinal chord.

Michelle says she noticed a difference within days of receiving her last chemo treatment. “The sixth day I could tell. There was clarity to my mind that hadn’t been there in about ten years. It was brilliantly clear, almost sensory overload. It’s like living in a black and white world and then all of the sudden there are all of these colors and noise.” By December 22^nd, her white blood cell count was up, and her immune system strong enough to go home to her family in Utah.

As weeks pass, there have been other life changing improvements. Michelle says sensation has returned. “Losing the ability to feel things is just so devastating. About two weeks after I got back, my husband rubbed my back, just to say goodnight, and I was like hold on, I can feel that!” Michelle says she can now feel hot and cold and no longer has to ask her youngest daughter to check her bathwater with a finger before getting in. She is knitting to help her hands rehabilitate, has taught her little girl to ride a bike, and takes pleasure in the everyday mundane tasks of life. “I’m driving, filling up the gas tank, making dinner. Things that everybody takes for granted, I can do now.”

Michelle’s reversal of symptoms is not uncommon with the High Dose Cyclophosphamide treatment, ninety percent of those who have had it have no evidence of the disease, and forty percent have show improvement in function. Dr. Kaplin says “If you can turn off the inflammation, really stop the immune system from its constant picking at the brain and spinal chord, then there is a healing process.”

But it’s a process that may no be available to others. Large scale clinical trials cost millions and right now, study of the treatment is unfunded. Pharmaceutical companies are not interested in funding it because the patents on the medications being used has already lapsed and there is no money to be made. The National MS Society says it has not been approached to fund the trials needed for FDA approval. Johns Hopkins says it did submit a grant request several years ago but was denied. It hopes to put forth another request in the coming year. A spokesperson says because of the economy donations are down, and it’s uncertain there would be the money needed to fund the Johns Hopkins study. Meanwhile, there is a grass roots effort to bring this treatment to those with MS. You can find out more, and contribute by going to www.cureforms.org

Biogen Starts Human Trial For Drug That Could Repair MS Damage1-27-10 10:46 AM EST

NEW YORK -(Dow Jones)- Biogen Idec Inc. (BIIB) has begin human testing of an experimental drug, dubbed BIIB033, that it hopes will take the revolutionary step of repairing some of the damage done by multiple sclerosis.

Although it is a major step to begin testing in humans, drug development is always risky and it will take years to measure the drug's effectiveness and potential side effects.

Multiple sclerosis, or MS, is a chronic, inflammatory condition that occurs when the body attacks its own myelin, the protective insulation surrounding the nerve fibers, or axons, in the central nervous system. The debilitating disease affects an estimated 400,000 people in the U.S., according to the National MS Society, but current treatments only aim to slow the disease's progression and cannot help repair damage.

Research that focuses on ways to help the body regenerate myelin is growing and scientists around the world are taking several different approaches. Damage to myelin can distort or block messages carried by axons and result in a wide variety of MS symptoms such as vision problems, limb numbness and paralysis.

BIIB033 is an antibody designed to turn off Lingo-1, a molecule that the company believes prevents myelin production in adults after axons are well covered. Blocking Lingo-1 may encourage myelin regeneration, something that occurs in healthy adults, after damage from MS occurs.

The antibody has been shown to be effective in mouse models that are accepted as being useful for mimicking the properties of MS.

The small Phase I study will include 64 healthy volunteer adults in the Netherlands, with the main goal of assessing safety and tolerability, and is expected to be completed in 2011.

The placebo-controlled study will give patients a single dose of the drug and different groups will get different amounts, a standard practice in such early trials that helps determine the optimal dose for later investigation.

The secondary goals of the trial relate to how the body processes the drug and there is no measure of its effectiveness, which is not surprising in such an early study that doesn't actually include MS patients.

MS is an attractive area of drug makers as its often requires lifelong treatment, and MS drugs brought in more than $8.7 billion in 2009 revenue worldwide, according to projections from Bernstein Research.

Biogen is mostly focused on selling MS treatments, including Avonex and Tysabri, which are expected to bring sales of more than $3 billion for 2009.