Tysabri PML CASES JUMP!!

I was shocked to discover that this was reported a week ago. As a Tysabri patient I’d say this new information is rather alarming…:S

And I quote:

Shares of Biogen Idec and its Irish partner Elan dropped this morning after European regulators said they are taking a new look at the risk and benefit of natalizumab (Tysabri) for multiple sclerosis, now that 23 patients on the drug have been diagnosed with a rare, potentially fatal brain infection called PML.

The European Medicines Agency said it has initiated the review to discuss any additional measures necessary to ensure the safety of natalizumab, according to a Reuters report.

The new report was bound to alarm some investors, because 23 cases of progressive multifocal encephalopathy, or PML, is significantly more than the tally of 13 cases the FDA counted last month. Cases of PML have been adding up since the drug was re-introduced to the U.S. market in July 2006 after it was previously withdrawn because of the risk. Despite the chance of the infection, which the FDA pegged at about 1 in 1,000, patients have continued to seek out the treatment, which physicians say is the most effective therapy on the market for multiple sclerosis. (Natalizumab is also approved as a treatment for Crohn’s disease.) More than 46,200 people worldwide were taking the drug at the end of September, Biogen said earlier this week.

Biogen finance chief Paul Clancy told Dow Jones earlier this week that the company will discuss how to communicate the link between long-term use of the drug and increasing incidence of the dangerous side effect.

Regulators might choose to recommend that patients who take the drug for long periods of time take breaks, or “drug holidays,” said analyst Christopher Raymond of Robert W. Baird & Co., in a note to clients this morning. Since so many patients depend on the product to control their symptoms, it’s unlikely that regulators would force it off the market, he said.

“We deem it highly unlikely that either FDA or EMEA would pull Tysabri from the market,” Raymond said. “With PML risk well known, we think the most likely scenario would be additional labeling restrictions suggesting perhaps a drug holiday after an extended treatment period.”

[Updated comment from Biogen Idec.] There isn’t any data that suggests imposing a drug holiday would reduce the risk of patients getting PML, but there is data that shows symptoms of multiple sclerosis return quickly once patients quit taking natalizumab, says Biogen Idec spokeswoman Naomi Aoki. The company is talking with regulators about the best way to update the drug’s prescribing information to reflect the increased risk with extended usage, but even so, the incidence of PML still appears within the stated range of 1 in 1,000 patients, she says.

for more details please see under Links: “PML – 23 new cases”

How to boost your brain’s functions ;o)

Thought the brain’s functions start slowing down and maybe even declining once adulthood is reached..? Think again :o)

Here is a statement from the article I read in Medical News Today (12.10.09). It refers to the research done:

“This provides, to the best of our knowledge, the first evidence for training-related changes in white-matter structure in the healthy human adult brain.”


Great news huh? Well it is. As a matter of fact, the researchers used juggling as the new difficult skill that the volunteers had to learn…and came to the conclusion that “regions of the brain’s white matter that are linked with reaching, grasping and peripheral vision” experienced changes.


“At the end of the training period, the volunteers reached varying levels of juggling skill, but all those who trained and practised showed changes in white matter, suggesting it wasn’t skill attainment that mattered but the time spent training and practising.”

The researchers “hope the study will help develop new treatments for diseases such as MS where central nervous system pathways have become degraded.”

….

“Knowing that pathways in the brain can be enhanced may be significant in the long run in coming up with new treatments for neurological diseases, such as multiple sclerosis, where these pathways become degraded,” said Johansen-Berg.


But they also concluded that it need not be necessarily juggling what you need to learn in order to boost your brain’s activity = )

CCSVI in MS – new findings in the field!!

I recently found something that amazed me… It was brought up during a meeting of experts in Bologna (Italy) on Sept. 8th this year. I’m herein quoting the first part of the press release:

Four main points concerning the relationship between CCSVI and MULTIPLE SCLEROSIS were covered by several experts at a Meeting in Bologna. All the investigations that gave an answer to these 4 fundamental points were coordinated by Prof Paolo Zamboni who discovered CCSVI and its association with Multiple Sclerosis; in some other cases, research was carried out in cooperation between Prof Zamboni and major foreign Universities.

  1. What is the origin of the extracranial cerebral vein stenoses which characterize CCSVI
  2. Are there advanced diagnostic systems capable of identifying which changes are caused by CCSVI in the central nervous system?
  3. Can CCSVI be treated and how?
  4. Can CCSVI therapy improve the clinical outcomes  of MS and affect its prognosis?

— Now you probably wonder what this CCSVI is all about…so what is CCSVI?

Chronic cerebrospinal venous insufficiency… it’s a chronic (ongoing) problem where blood from the brain and spine has trouble getting back to the heart. It’s caused by stenosis (a narrowing) in the veins that drain the spine and brain. Blood takes longer to get back to the heart, and it can reflux back into the brain and spine or cause edema and leakage of red blood cells and fluids into the delicate tissue of the brain and spine. Blood that stays in the brain too long creates “slowed perfusion”…a delay in deoxyginated blood leaving the head. This can cause a lack of oxygen (hypoxia) in the brain. This slowed perfusion has been linked to fatigue in MS patients.

— Any other relations to MS…?

Well, it seems that every MS patient tested so far has it. Over 500 MS patients in Italy have it (tested by Dr. Paolo Zamboni), 45 MS patients in the US have it (tested by Dr. Michael Dake), 6 clinically defined MS patients and 3 probable MS patients have it in Poland (tested by Dr. Marion Simka) and 1000 patients and controls are being tested for it by Jacobs Neurological Institute in Buffalo. In addition, none of the normal patients (controls) tested have it and none of the patients with other neurological diseases have it. Only people with MS!


— How can it be diagnosed..? Experts have also provided an answer to this:

New magnetic resonance (MRI) parameters linked to CCSVI which might in the future bring about a true revolution in the way of diagnosing MS. These new parameters include: quantification of iron deposits and volume assessment of intracranial veins and CSF.”

For more details on the press release follow the CCSVI link under “Links” on the right side ; )

For those of you who are facebooked…there is a whole group on FB dedicated to this. The author seems to have covered the topic rather in-depth… so I’d suggest you to go on FB and simply search for “CCSVI in Multiple Sclerosis”… and thereby keep updated on this particular topic ; )

Never forget… Hope is the last to die!

25.Nov.2009: additional info –> ccsvi brief background story

Fingolimod Trials Update

Good news from a follow-up on the previously-mentioned fingolimod drug (from Medical News Today 1/10/09

Drug manufacturer Novartis has announced further results from its phase III study of the oral pill fingolimod (FTY-720) in people with relapsing remitting MS.

The results are from a two-year phase III study called FREEDOMS trial and show that the tablet can reduce relapses by up to 60% and disability progression by up to 32% in people with relapsing remitting MS.

The results build on trial data announced earlier in the year that showed a reduction in the number of relapses by about 58% in participants taking fingolimod compared to interferon-beta-1a, a standard injectable therapy for the treatment of relapsing remitting MS.

For more details check it under the Medical News Today link ;)

ps. an update on the progress of Cladribine (the second oral drug used for MS) is also available through the same link for the same date.

Keep up the good spirit! : o)