New Drug Impressive Against Crohn's Disease and Multiple Sclerosis

[Adam's Apple]

But Americans can't get it.

The Search for A Cure
By Lewis A. Fein for Jewish World Review
July 12, 2005

Typically, I write columns about politics or foreign policy, issues that generate passionately supportive or vehemently oppositional feedback. But I am also a person who feels - yes, feels - deeply concerned about an attitude that affects not only my life but the lives of millions of people nationwide.
I have Crohn's Disease, a chronic condition that causes physical pain, weight loss, fever and fatigue. It requires a lifetime of prescription medication and a doctor's care. Yet, my case has its own political message, a metaphor for regulatory change and economic action.

First, let me praise the very existence of an institution like the Food and Drug Administration (FDA). The agency performs a valuable public service, bestowing its credibility upon - or withdrawing its support for - products that grace pharmacies and store shelves throughout the country. The agency provides consumers with needed information about a drug's safety, efficacy, trial history or side effects. A delicate balance nonetheless exists between the FDA's authority and people's medical needs.

The manufacturers of the MS treatment Tysabri, which also has excellent clinical results for patients with Crohn's, stands before the FDA's imperial whims. Despite this medication's impressive history, the public may not purchase this new drug. Awaiting the results of a comprehensive data review -- encouraged by the culture of indecision (or negative action) that predominates throughout the FDA -- punishes the sick.

for full article:
http://www.jewishworldreview.com/0705/fein1.asp

 

[waltky]

MS treatment may be a scam...

Concerns about controversial MS treatment
7 March 2011 - Serious concerns have been raised about a controversial vein-widening treatment being offered to people with multiple sclerosis.

An investigation by BBC Inside Out discovered that one doctor carrying out the procedure in Egypt is not licensed to practice medicine in that country. The BBC understands that in the UK, an NHS GP has been reported to the doctors' watchdog, the General Medical Council, for organising the treatment through his private company at a cost of nearly £8,000. The operation has been dubbed the 'Liberation Procedure' by those who believe it helps relieve the symptoms of MS, an incurable condition.

Unproven treatment

It involves inserting tiny balloons into the body via an incision in the groin. The balloons are fed up to certain veins in the upper body and neck, then inflated to stretch the vessel wider. Some patients also have small metal tubes - or stents - inserted to prop their veins open. The treatment is based on a new and unproven theory that MS is caused by vein blockages which impair the flow of blood from the brain.

This is a radical departure from the mainstream view that there is no known cause of the disease. It is thought that several thousand people with MS may now have been "liberated" at private clinics in countries like India, Poland and Bulgaria. Some have posted before-and-after internet videos showing their apparent improvements. But the MS Society says these results could be down to the placebo effect and the fact that multiple sclerosis symptoms can come and go over time.

Dr Doug Brown, head of biomedical research at the MS Society, says: "One of the complicating factors is the placebo effect where people feel better for going through a treatment process but not necessarily because of the treatment directly. "It's an unproven treatment and until this treatment goes through a clinical trial it is impossible to say if its works and if it is safe for people with MS."

Blocked veins theory queried

 

[geauxtohell]

But Americans can't get it.

The Search for A Cure
By Lewis A. Fein for Jewish World Review
July 12, 2005

Typically, I write columns about politics or foreign policy, issues that generate passionately supportive or vehemently oppositional feedback. But I am also a person who feels - yes, feels - deeply concerned about an attitude that affects not only my life but the lives of millions of people nationwide.
I have Crohn's Disease, a chronic condition that causes physical pain, weight loss, fever and fatigue. It requires a lifetime of prescription medication and a doctor's care. Yet, my case has its own political message, a metaphor for regulatory change and economic action.

First, let me praise the very existence of an institution like the Food and Drug Administration (FDA). The agency performs a valuable public service, bestowing its credibility upon - or withdrawing its support for - products that grace pharmacies and store shelves throughout the country. The agency provides consumers with needed information about a drug's safety, efficacy, trial history or side effects. A delicate balance nonetheless exists between the FDA's authority and people's medical needs.

The manufacturers of the MS treatment Tysabri, which also has excellent clinical results for patients with Crohn's, stands before the FDA's imperial whims. Despite this medication's impressive history, the public may not purchase this new drug. Awaiting the results of a comprehensive data review -- encouraged by the culture of indecision (or negative action) that predominates throughout the FDA -- punishes the sick.

for full article:
http://www.jewishworldreview.com/0705/fein1.asp

It's a -zumab class drug. In other words, a monoclonal antibody, which is what is typically used for autoimmune pathologies.

On the one hand, the OP praises the FDA's procedure for protecting the patients. On the other, he condemns it. He can't have it both ways.

As it stands, it appears it's being approved for a certain indication for Chron's. That doesn't stop a physician from prescribing it "off label" for Chron's.

I'd want to see what sort of "impressive history" it has in regards to Chron's.

 

[waltky]

Mebbe the glandular fever is a pre-cursor to MS?...

Virus and low sunlight 'raises multiple sclerosis risk'
19 April 2011 - Low levels of sunlight exposure have been linked to MS

Low levels of sunlight coupled with glandular fever could increase the risk of developing multiple sclerosis (MS), say researchers. There are many suspected risk factors for MS and the disease is known to be more common away from the equator. The study, in Neurology, suggested that low levels of sunlight could affect how the body responds to infection.

The MS Society said the study, based on hospital admissions data in England, added weight to existing evidence. MS affects about 100,000 people in the UK and is more common in the north of England than in the south.

There are also high levels of both vitamin D deficiency and MS in Scotland, where the MS Society is considering carrying out separate research on a possible link between the two. Around 10,500 people have MS in the country, the highest prevalence of the condition in the world. With MS the protective layer around nerves, known as the myelin sheath, becomes damaged. Messages from the brain to the rest of the body are disrupted, resulting in difficulty moving, muscle weakness and blurred vision.

Light plus virus

 

[waltky]

A “breakthrough” in the treatment of multiple sclerosis...

Researchers Offer Promising New Treatment for MS
June 06, 2013 > Researchers have developed what’s being hailed as a “breakthrough” in the treatment of multiple sclerosis, a crippling autoimmune disease that attacks the outer sheath of nerve cells, eventually disabling many of those with the neurological condition. The new treatment involves sweeping away immune system cells responsible for MS.

In multiple sclerosis, immune system white blood cells, called T cells, become misdirected, attacking the protective myelin sheath on the outside of nerve cells. In healthy individuals, T cells or leukocytes are responsible for destroying tumor cells or those infected with a virus. Myelin speeds the transmission of nerve impulses from the brain and spinal cord to limbs and the optic nerves, which also are insulated with myelin. When the myelin is destroyed, motor neuronal impulses are blocked, resulting in severe disability and blindness in many people with multiple sclerosis. Worldwide, an estimated 2.5 million people are affected by MS.

U.S. and German researchers have developed a therapy that stops the autoimmune attack against myelin in its tracks without impairing the normal function of the immune system, according to Stephan Miller, a microbiologist and immunologist at Northwestern University in Evanston, Illinois. Miller says the experimental treatment targets T cells in the brain that are responsible for the disease. The therapy, Miller says, has a different mode of action from current MS treatments, which suppress the immune system. “They will not only try to down-regulate the autoimmune response that’s actually causing the disease, but will also make patients in the long run susceptible to everyday infections and increased rates of cancer," said Miller. The novel MS treatment involves taking billions of T cells from a patient and engineering them to carry myelin antigens. The approach is similar to the way a vaccine works.

Antigens are harmless proteins from a virus or bacterium that do not cause illness but stimulate the immune system to recognize and destroy disease-causing microbes so a person exposed later to an infection doesn’t become ill. Nine MS patients in Hamburg, Germany were treated with the myelin antigens. Miller says their immune systems considered the engineered T cells to be foreign, disabling and killing the harmful leukocytes “The dead and dying cells to which the antigens are attached get uptaken by cells in the immune system that ends up tricking the immune system into believing that these antigens are no longer dangerous, and will actually turn off the immune response against the antigens rather than turning it on," he said.

The therapy swept away the dead T cells. The experimental treatment reset the patients’ immune systems, halting the leukocytes' attack on the nerve sheaths and reducing the assault on the myelin by 50 to 75 percent. While not a cure for MS, Miller believes it’s a step in the right direction. An article on a promising, new treatment for multiple sclerosis is published in the journal Science Translational Medicine.

Researchers Offer Promising New Treatment for MS

 

[waltky]

A "landmark" drug in treating multiple sclerosis...

Multiple sclerosis drug 'a landmark'
Thu, 22 Dec 2016 - A drug that alerts the immune system is described as a "landmark" in treating multiple sclerosis.

Trials, published in the New England Journal of Medicine, suggest the drug can slow damage to the brain in two forms of MS. Ocrelizumab is the first drug shown to work in the primary progressive form of the disease. The drug is being reviewed for use in the US and Europe. MS is caused by a rogue immune system mistaking part of the brain for a hostile invader and attacking it. It destroys the protective coating that wraps round nerves called the myelin sheath.

The sheath also acts like wire insulation to help electrical signals travel down the nerve. Damage to the sheath prevents nerves from working correctly and means messages struggle to get from the brain to the body. This leads to symptoms like having difficulty walking, fatigue and blurred vision. The disease can either just get worse, known as primary progressive MS, or come in waves of disease and recovery, known as relapsing remitting MS. Both are incurable, although there are treatments for the second state.

Patient with MS​

'Change treatment'

Ocrelizumab kills a part of the immune system - called B cells - which are involved in the assault on the myelin sheath. In 732 patients with progressive MS, the percentage of patients that had deteriorated fell from 39% without treatment to 33% with ocrelizumab . Patients taking the drug also scored better on the time needed to walk 25 feet and had less brain loss detected on scans. In 1,656 patients with relapsing remitting, the relapse rate with ocrelizumab was half that of using another drug. Prof Gavin Giovannoni, from Barts and The London School of Medicine and Dentistry, was involved in the trials and said: "The results shown by these studies have the potential to change how we approach treating both relapsing and primary progressive MS." He told the BBC: "It's very significant because this is the first time a phase three trial has been positive in primary progressive MS." More than 100,000 people are diagnosed with MS in the UK, around one-in-five are progressive.

Dr Aisling McMahon, the head of clinical trials at the MS Society, commented: "This is really big news for people with the primary progressive form of multiple sclerosis. "It's the first time a treatment has shown the potential to reduce disability progression for this type of MS, which offers a lot of hope for the future." The drug is being considered by the European Medicines Agency and the US Food and Drug Administration. But Prof Giovannoni warned that patients in the UK may be disappointed as it may be hard for the NHS to fund everyone getting a drug that is likely to be expenseive. He told the BBC: "I would expect a narrow group of people to be eligible." Dr Peter Calabresi, from John Hopkins University in Baltimore, added: "This is the first drug to show a significant effect in slowing disability progression in a phase three trial in primary progressive multiple sclerosis and therefore represents a landmark study in the field." But he warned doctors to "stay vigilant" because of the risk of side-effects. Weakening the immune system increases the risk of infection and of cancer emerging.

Multiple sclerosis drug 'a landmark' - BBC News