Forfatter Emne: Tysabri  (Læst 43039 gange)

Offline PiaB

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« Svar #60 Dato: 16 Februar 2012, 18:56:33 »
Hej Helle.

Du skriver hjernehindebetændelse, det er så vidt jeg ved menigitis, og det er hjernebetændelse, noget helt andet, som JC-brugerne kan få.

Kh Pia
Attackvis MS siden 2005 - Blære, balance, føleforstyrelser i benene og gangdistanceproblemer, Mulig EDSS på 4,5. Tysabri i 2 år uden attacker -Ameds den 29/10

Offline Bjarne Fonnesbech

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« Svar #61 Dato: 19 Februar 2012, 12:33:50 »
Hej Helle - hej Pia,

Ja, jeg ved ikke hvad jeg ville gøre, hvis jeg var dig, Helle. Vi mennesker er jo individuelle og reagerer som sådan på medicin, så hvis neurologerne anbefaler dig at prøve, så er det måske "go for it". Og så selv vurdere efter et stykke tid.
Vi kender jo til 7. og sidst bedst vore egne kroppe.

Pia: Meningitis er helt klart en hjernebetændelse og vist også den farligste. Den er dødelig mener jeg.

Anyway, så vidt jeg kan læse på Scleroseforeningens hjemmeside (en ældre nyhed fra 2010), så er det den hjernebetændelse, der hedder PML man kan udvikle via JC-virus. Tjek det her link:

http://www.scleroseforeningen.dk/da/Service/2011/2010/behandlingskriterier-for-tysabri-anbefales-aendret.aspx

Ved ikke om vi bliver klogere af det her ...  :-\.

Kh Bjarne
ms-diagnose i 2002. SPMS / PPMS ? Liberated 13.1.2011 i Indien. F/U i Indien d. 11.9.11.
HSCT behandling i Mexico juni/juli 2016.

Offline Bjarne Fonnesbech

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« Svar #62 Dato: 23 Februar 2012, 16:17:43 »
Hej igen-igen,

Ved ikke om nogen har hørt det her. Men man skulle kunne få Tysabri i 1/2 år (Altså 6 gange) og først derefter udvikler man JC-virus. Så der skulle ikke ske noget ved at prøve Tysabri.

Nogen som har hørt om dette ?

Hilsen Bjarne
ms-diagnose i 2002. SPMS / PPMS ? Liberated 13.1.2011 i Indien. F/U i Indien d. 11.9.11.
HSCT behandling i Mexico juni/juli 2016.

Offline Jesob

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« Svar #63 Dato: 04 Juni 2012, 06:54:16 »
Tysabri kobles nu også til Herpes type I

Fra FB:

Cold Sores (herpes), Natalizumab (Tysabri) & Brain Infection - via CCSVI in Multiple Sclerosis– “this is marie-further evidence that suppressing immune function is problematic http://www.ncbi.nlm.nih.gov/pubmed/22048950?dopt=Abstract

So a person who...'d been previously been exposed to herpes type I (cold sores) then had natalizumab ended up with the cold sore virus in the brain....that's not good” http://www.ncbi.nlm.nih.gov/pubmed/22048950?dopt=Abstract

In this case report we describe the first non-fatal herpes simplex virus encephalitis (HSE) case with natalizumab for multiple sclerosis (MS). A 36-year-old woman, previously treated with immunomodulatory and immunosuppressive drugs for MS, developed acute encephalitis after 6 monthly natalizumab perfusions. Brain imaging demonstrated suggestive bi-temporal lesions. Herpes simplex virus type-1 DNA was detected in cerebrospinal fluid. The patient improved gradually after a 21-day course of intravenous acyclovir, but neuropsychiatric changes remained 5 months later. Our non-fatal case of HSE and other reported cases of herpes infections provide evidence of an increased risk with natalizumab and point to the need for clinicians to maintain awareness.

http://www.facebook.com/#!/pages/Ven%C3%B6se-Multiple-Sklerose-CVI-SVI-CCSVI/117471578700

Jacob
« Senest Redigeret: 04 Juni 2012, 06:56:45 af Jesob »
Jessie: MS diagnose jan. 11, har nok haft MS i mange år... og Fibromyalgi.
Liberatet på Medanta i Delhi, Indien d. 20.4.11
Tungmetalforgiftning, EDTA og Demoval behandling.
Jacob: Jessie´s mand, rask.

Offline Lisa.T

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« Svar #64 Dato: 04 Juni 2012, 12:49:15 »
Jacob, jeg sætter lige dit link ind så det virker. Men man kan kun se det, hvis man er på FB:



https://www.facebook.com/pages/Ven%C3%B6se-Multiple-Sklerose-CVI-SVI-CCSVI/117471578700
SPMS'er, dx 1997, kørestolsfræser. Har aldrig fået medicin. Selvbedømt EDSS 7. Liberated i Indien d. 8.11.2010 - små bitte forbedringer.
Siden 1.1.2012 på TW's diæt - 100%. 1. juni 2013 startet D-vit. kur.

Offline Jesob

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« Svar #65 Dato: 13 ſeptember 2012, 19:51:02 »
Mere om Herpes og Tysabri (Natalizumab)

From Medscape Medical News
Documented CNS Infections Accompanied Natalizumab Use

September 10, 2012 (San Francisco, California) — At least 17 patients taking natalizumab have experienced serious herpes simplex or varicella zoster infections since November 2004, researchers reported here at the 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy.

Most of the patients underwent long hospitalizations and received systemic antiviral therapy; 2 died.

The risk for central nervous system (CNS) infection is already included in the labeling of natalizumab, but this research confirms the danger, first author Andrew J. Fine, PharmD, a pharmacists at the US Food and Drug Administration (FDA), told Medscape Medical News. "This shows that this problem is occurring," he added.

Natalizumab, a recombinant monoclonal antibody used in the treatment of multiple sclerosis and Crohn's disease, binds to the alpha-4 subunit of the alpha-4 beta-1 and alpha-4 beta-7 integrins expressed on all leukocytes except neutrophils.

Natalizumab reduces the adhesion of leukocytes to the surface of endothelial cells in the blood–brain barrier. This hinders their passage into the CNS, which reduces the intensity of the ongoing inflammatory reactions that cause clinical symptoms.

At the same time, in patients with multiple sclerosis, natalizumab decreases the cerebrospinal fluid ratio of CD4+ to CD8+ but has little effect on the ratio of CD4+ to CD8+ in the peripheral blood.

This weakens immune defenses in the CNS in general, and in particular raises the risk for multifocal leukoencephalopathy caused by the John Cunningham polyomavirus, Dr. Fine explained.

The drug also interferes with the passage of CD8+ T cells into the brain, he said. Preclinical studies suggest that CD8+ T cells weaken the viral reactivation in peripheral ganglia and protect against overwhelming CNS infections.

To determine whether the drug makes patients more vulnerable to CNS infections, Dr. Fine and his colleagues searched the FDA Adverse Event Reporting System from November 2004 to June 2012 for all serious natalizumab postmarket adverse-event reports.

They found 17 reports of confirmed herpes virus infections, only 5 of which had been reported in the literature.

Of these 17 cases, 10 occurred in the United States. Fourteen were in female patients. Nine were reported since 2011.

Nine patients suffered encephalitis, which was the most common clinical symptom, followed by meningitis, which affected 6 patients.

All but 1 patient was hospitalized. Four were admitted to the intensive care unit. Two patients underwent blood transfusions to remove the natalizumab rapidly from their systems. Two patients died and 2 had neurologic sequelae.

Natalizumab was discontinued in 15 patients and continued in 1; for the remaining patient, disposition ws not known.

Dr. Fine said it is important for physicians to be aware of the risk for this type of infection, not only with natalizumab but also with other monoclonal immunosuppressant drugs.

"These are latent viruses that are fairly common," he said.

The finding came as a surprise to Stefan Schwartz, MD, a senior hematologist at Charité University in Berlin, Germany. "I didn't know about these complications," he told Medscape Medical News.

There is no national registry for these types of postmarket adverse events in Germany, he said. Although the viruses are common, he recommends that all patients taking natalizumab be tested for them.

Dr. Schwartz and Dr. Fine have disclosed no relevant financial relationships.

52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC): Abstract T-342. Presented September 9, 2012.

http://www.medscape.com/viewarticle/770588

Jacob

Jessie: MS diagnose jan. 11, har nok haft MS i mange år... og Fibromyalgi.
Liberatet på Medanta i Delhi, Indien d. 20.4.11
Tungmetalforgiftning, EDTA og Demoval behandling.
Jacob: Jessie´s mand, rask.

Offline Jesob

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« Svar #66 Dato: 28 Januar 2013, 22:50:18 »
Her er lige en update, sakset fra Facebook

Tysabri drug creator warned of "fatal flaw"

As we begin 2013, there are 323 pwMS with documented cases of PML, and 69 have died from this brain infection linked to the JC virus and Tysabri use.

link
http://chefarztfrau.de/?page_id=716

The risk of PML is now estimated at 11 per 1,000 patients

http://www.fda.gov/drugs/drugsafety/ucm288186.htm

Patients are now tested for the JC virus before beginning therapy.  But many do not realize that just because you are JC- does not mean you will remain that way.  It is possible to become JC+ after beginning treatment.

Illustrating the need for follow-up testing, Bloomgren and colleagues noted the case of one patient whose initial blood sample was negative for JC virus antibodies. Another sample taken 13 months later was positive and the patient developed PML a few weeks later.

http://www.medpagetoday.com/clinical-context/MultipleSclerosis/32743

I've been reading about this online, as people who believed they were JC-, are now testing JC+ and are having to terminate Tysabri infusions.  They are experiencing a rebound of the immune system and ending up worse off than they were before.

A lethal MS relapse after Tysabri withdrawal
http://www.ncbi.nlm.nih.gov/pubmed/23100404

more on the Tysabri rebound effect--
http://ms.about.com/od/treatments/a/The-Tysabri-Rebound-Effect.htm

Another problem is that PML looks like an MS relapse.  It is very hard to tell the difference until after death.  Natalizumab is the drug name for Tysabri.

The patient developed subacute onset of bilateral blindness following his 44th dose of natalizumab. Ophthalmologic examination was normal, the brain magnetic resonance imaging was not suggestive of PML, and cerebrospinal fluid analysis did not reveal the presence of JCV DNA. The patient was subsequently treated for a presumed multiple sclerosis relapse with high-dose corticosteroids. Two weeks after his 45th dose of natalizumab, he developed hemiplegia that evolved into quadriparesis. Repeated magnetic resonance imaging and cerebrospinal fluid studies were diagnostic for PML. Postmortem histopathological analysis demonstrated PML-associated white matter and cortical demyelination.

http://www.ncbi.nlm.nih.gov/pubmed/23338729

Diagnosis of PML can be confounded in patients with multiple sclerosis (MS) if new demyelinating lesions develop, and the sensitivity of existing diagnostic tests is less than ideal. In the case presented here, four samples of cerebrospinal fluid were negative for JC virus DNA by polymerase chain reaction, yet brain biopsy eventually proved positive by immunohistochemistry.

http://www.ncbi.nlm.nih.gov/pubmed/23252596  

Please know that I am not a doctor.  I am simply the wife of a man with MS.  Whatever I write here can and should be discussed with your doctors.  I put the following information together for my husband last year, after his neurologist suggested he try Tysabri, even though his MS has been stable for 6 years.  She no longer recommends Tysabri for him, and has told him to "keep doing what you're doing."   If Tysabri is working for you and you love it, this note is not for you. It's for the thousands of newly diagnosed and those who have other options.  All of the following is true, from actual interviews with the doctors who first trialed Tysabri.  Print it out, print out the press releases and studies, talk over all your options with your doctors.  

Everything in the note is sourced.  Click on the blue letters that say "link" to go to articles, research and other sources.  
And be well.

+++++++++++++++++++++++++++++++++++++

June 2012

It's important to go back in time and note that one of the creators of Tysabri, Dr. Lawrence Steinman, realized the potential dangers of this treatment and warned the FDA not to approve it.

From a press release in 2006--Stanford Doctors Spotlight Fatal Flaw in MS Drug Trial

Steinman was involved early on in the development of the drug, publishing on its effects in 1992. Even then, he had suspicions that the drug’s mechanism of action — blocking the entry of immune cells into the nervous system — might also make patients more vulnerable to infections. Indeed, PML is an infection that usually affects people whose immune systems are compromised.

“It was a shocking development that a drug that had so much promise and so many potential benefits ended up causing two deaths and one very serious injury,” said Steinman. “It is kind of a cruel Greek drama, something that may be more beneficial than anything yet developed for multiple sclerosis, but yet may be far more dangerous than those other approved drugs.”

In fact, the inventor and co-author warned about Tysabri returning to the market in 2006.  They questioned the wisdom of the FDA's approval of this drug.

But Steinman and Langer-Gould expressed reservations about the drug returning to the market. They noted that its effects, while impressive, are in general not much better than what is seen with other available drugs: The risk of relapse dropped from an average of two relapses every three years using other approved multiple sclerosis drugs to one every three years with Tysabri.

“Do you want to expose someone to the risk of death for eliminating one relapse every three years?” said Steinman. “I say no.”

“I’m not sure if it is wise to re-approve it,” added Langer-Gould. “The question is, will the FDA rise to the occasion and admit their mistake and try to prevent future mistakes or are they going to ignore it?”

link to press release
Here is an interview with Stanford neurologist Annette Langer-Gould,  co-author of the Lancet paper on Tysabri, about why she spoke up after her patient developed PML in a clinical trial---the title is "So Not Worth It."

Profoundly affected by her experience with this patient, Langer-Gould, a Stanford clinical instructor, now advocates testing new drugs only on people who have exhausted their other treatment options and who have indications that their disease is progressing.

So in March, when an FDA advisory committee recommended that the drug be returned to the market, she took action. She approached multiple sclerosis specialist Lawrence Steinman, MD, a Stanford neurology professor, about writing an article arguing that if a drug has a known risk of death, it should be given only to those patients who are likely to suffer severe disability from their disease. That is almost the reverse of what happened in the Tysabri trials, which excluded the most severely affected patients.

Her biggest concern is that some patients who want to take drugs such as Tysabri might be acting on unrealistic fears about their prognosis and are poorly informed about the drug’s dangers.

(note: drugs are tested on less disabled RRMS patients, rather than more progressive patients,  because pharma knows these patients have natural remissions, and this favorably effects the drugs' results.  This is the "natural course of the disease" argument used against positive results for venoplasty for CCSVI--yet not against drugs.)

link

Sadly, history has shown us, the FDA ignored these warnings about Tysabri.  As a matter of fact, they approved Tysabri by a vote of 12-0.  At the time, it was said that Tysabri "waltzed through FDA approval."  The independence of the FDA panel was called into question by the legal team of one of the patients who died.

link

According to a New York Times article in March 2005-

Dr. Steinman said he had expressed his apprehensions about the drug in speeches and in an article in the journal Science in July and had been asked by Biogen executives to tone down criticism of the drug.

link

And just this January, the FDA granted a label modification with a more specific warning for Tysabri, so that it can continue to be sold- making Tysabri a "blockbuster" drug.

The Food and Drug Administration approved the revision that would help doctors identify patients with the highest and lowest risks of developing deadly brain infections linked to the drug, the agency said today in a statement.

The label change may push Tysabri’s global sales to $2.5 billion to $3 billion by 2016, Michael Yee, an analyst at RBC Capital Markets in San Francisco, said in an interview yesterday. Without the modification, sales may have reached $1.5 billion to $2 billion that year, Yee said. Biogen, based in Weston, Massachusetts, and Dublin-based Elan split the drug’s revenue.

link to Forbes article

And deaths and injury from central nervous system PML, herpes encephalitis, CNS lymphoma, metastic melanoma, cryptococcal meningitis and other assaults on unwitting PwMS continue daily.  It is not enough to know your JC virus status.  We are only at the tip of the iceberg understanding the long-term implications of this drug.  Most of these neurologic infections do not show up until after two years of therapy.

link to Tysabri and herpes encephalitis

link to Tysabri and Melanoma

link to Tysabri and meningitis

link to Tysabri and CNS Lymphoma

At Jeff's yearly neurologist appointment (which he needs to continue his copaxone treatment), his doctor again tried to talk him into beginning Tysabri infusions.  Even though Jeff has no active inflammation, no new lesions, no new MS progression, and has only healing since venoplasty three years ago, with normal gray matter on MRI---his neurologist utilized scare tactics to make him doubtful about his future.

 "You are a man, you are bound to progress faster.  It's simply the facts.  Tysabri is the best medication we have.  You should start it now to prevent future damage"

Jeff said, thanks, but no thanks.

In light of this sales pitch, the continuing and growing numbers of those with PML (242 with the disease, 52 deaths as of May), and Marie's post on the neurological activation of the herpes virus in the brain of someone on Tysabri---I think we need to go back and document the history of this drug.  I suggested to Jeff that he print out Steinman and Langer-Gould's warning and bring it to his neuro next year.  I hope this information might help some of our readers.  Please share it with your friends and caution them.  

Because the inventor of Tysabri thinks it might be too risky for you to take it.  He would know.

Joan

https://www.facebook.com/permalink.php?story_fbid=473402246050368&id=110796282297#!/notes/ccsvi-in-multiple-sclerosis/tysabri-drug-creator-warned-of-fatal-flaw/10150921616067211
https://www.facebook.com/permalink.php?story_fbid=473402246050368&id=110796282297/notes/ccsvi-in-multiple-sclerosis/tysabri-drug-creator-warned-of-fatal-flaw/10150921616067211
https://www.facebook.com/permalink.php?story_fbid=473402246050368&id=110796282297/notes/ccsvi-in-multiple-sclerosis/tysabri-drug-creator-warned-of-fatal-flaw/10150921616067211#!/notes/ccsvi-in-multiple-sclerosis/tysabri-drug-creator-warned-of-fatal-flaw/10150921616067211

Der mangler en del links i artiklen, jeg prøver at lægge dem ind senere...

Jacob
« Senest Redigeret: 29 Marts 2013, 08:57:40 af Jesob »
Jessie: MS diagnose jan. 11, har nok haft MS i mange år... og Fibromyalgi.
Liberatet på Medanta i Delhi, Indien d. 20.4.11
Tungmetalforgiftning, EDTA og Demoval behandling.
Jacob: Jessie´s mand, rask.

Offline Jesob

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« Svar #67 Dato: 11 Februar 2013, 20:23:32 »
Artikel fra The Lancet:
Ocrelizumab in multiple sclerosis: risks and benefits

Original Text
Abhijit Chaudhuri aI have several concerns about the clinical trial by Ludwig Kappos and colleagues (Nov 19, p 1779)1 of the monoclonal antibody ocrelizumab in relapsing-remitting multiple sclerosis.

First, I disagree that ocrelizumab has a benign safety profile. The death of a patient in the high-dose group was the direct effect of a drug that has been widely associated with a serious risk of infection in other studies.2 The natural history of multiple sclerosis3 suggests that the ultimate cause of death in these patients is infection; immunosuppression could potentially accelerate the process.

Second, the outcome data did not show a dose-response relation. This finding, and the time course of treatment response, make it highly unlikely that escalation of B-cell depletion by immunotherapy alters the natural course of multiple sclerosis.

Third, the putative benefit from immunotherapies in multiple sclerosis is largely driven by MRI markers that do not correlate reliably with long-term disability. Kappos and colleagues did not provide scores on the expanded disability status scale at weeks 24 and 48, so it is not possible to make a comparison with baseline scores. Of interest is that there was no difference in serious relapse of multiple sclerosis between the treatment groups.

One must use extreme caution in accepting the published trial data as proof of the concept of B-cell-driven pathogenesis in multiple sclerosis. Indeed, most authors of this paper were also involved with the clinical trial of B-cell-targeted treatment with atacicept that was terminated by the sponsor because of serious worsening of disease in the treated groups (ClinicalTrials.govNCT00642902).

The lessons from the clinical trial of natalizumab4 seem to have been forgotten too quickly: nearly a quarter of more than 200 patients with natalizumab-induced progressive multifocal leukoencephalopathy are dead and most of the rest are severely disabled by the drug rather then their disease. Quo vadis multiple sclerosis?

I declare that I have no conflicts of interest.

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2960508-X/fulltext?rss=yes

Jacob
Jessie: MS diagnose jan. 11, har nok haft MS i mange år... og Fibromyalgi.
Liberatet på Medanta i Delhi, Indien d. 20.4.11
Tungmetalforgiftning, EDTA og Demoval behandling.
Jacob: Jessie´s mand, rask.

Offline Jesob

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« Svar #68 Dato: 29 Marts 2013, 09:03:57 »
Mercola artilkel fra 2010

MS Drug Continues to Cause Disastrous Side Effects

Why is Tysabri Even Back on the Market?

Tysabri first hit the market in November 2004 under an accelerated program the FDA reserves for drugs it believes will have “extraordinary benefits” to patients. It was touted as the “miracle” drug for MS because the results from the first year of clinical trials showed that MS patients who took Tysabri for one year had a 66 percent reduction in relapses compared to those who took a placebo.

But this wonder drug, which was slated to bring in $2 billion in annual sales within its first few years after release, turned out to have a very dark side.

Tysabri is a type of drug known as a monoclonal antibody, meaning it is derived from a mouse antibody that has been genetically engineered to mirror a human antibody (antibodies are proteins that help your body fight infection).

It is given every four weeks by infusion directly into a vein, where the antibodies bind to immune system cells, inhibiting them from crossing over from the bloodstream to the brain.

Tysabri blocks this movement by attaching to alpha 4-integrin, a protein on the surface of immune T cells that normally enables them to pass through the blood-brain barrier.

However, if destructive immune system cells break free of the bloodstream, they can reach your brain, gastrointestinal tract and joints and cause severe damage.

Trading MS for a Deadly Brain Infection

Sure enough, three months after Tysabri first hit the market it was pulled because one in 1,000 people who took it during clinical trials developed progressive multifocal leukoencephalopathy (PML), a rare brain infection that results in death or severe disablement.

Dr. Lawrence Steinman, a Stanford University professor and an MS specialist who has developed MS drugs himself, said he repeatedly warned the FDA of the potential for serious immune-system side effects with Tysabri and drugs like it prior to approval.

Nonetheless, in June 2006 the FDA made yet another counterintuitive decision -- the type that make absolutely no logical sense, and for which the FDA is becoming increasingly known for.

They voted that Tysabri be returned to the market.

Now, nearly four years later, the FDA has added a new label warning to Tysabri, warning health care professionals and patients that the risks of PML increase as more infusions are received. The drug may also cause liver damage.

If you have MS, it is my strong recommendation to not accept these drugs, or the other commonly prescribed MS drugs like prednisone or interferon, as they can seriously harm your health.

http://articles.mercola.com/sites/articles/archive/2010/02/25/ms-drug-continues-to-cause-disastrous-side-effects.aspx

Jacob
Jessie: MS diagnose jan. 11, har nok haft MS i mange år... og Fibromyalgi.
Liberatet på Medanta i Delhi, Indien d. 20.4.11
Tungmetalforgiftning, EDTA og Demoval behandling.
Jacob: Jessie´s mand, rask.

Offline Jesob

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« Svar #69 Dato: 26 April 2015, 20:38:15 »
Tysabri and MS.  With longer follow-up:  even more toxic than suspected.

http://www.ncbi.nlm.nih.gov/pubmed/25897454

Post-marketing data confirm the adverse effects identified in clinical trials, including serious and life-threatening opportunistic infections, particularly progressive multifocal leukoencephalopathy in about two per thousand treated patients (an incidence twice as high as initially estimated), and potentially severe hypersensitivity reactions. An increased risk of cancer in the long term cannot be ruled out. Post-marketing data also show that natalizumab can cause severe liver damage. In addition, natalizumab withdrawal because of progressive multifocal leukoencephalopathy almost always triggers an immune reconsti- tution syndrome that can lead to neurological complications or even death. In practice, regardless of the severity of multiple sclerosis, it does not seem reasonable to expose patients to the many serious adverse effects of natalizumab for such an uncertain benefit.

http://ccsviinms.blogspot.dk/2015/04/independent-review-of-new-ms-drugs-must.html
Jessie: MS diagnose jan. 11, har nok haft MS i mange år... og Fibromyalgi.
Liberatet på Medanta i Delhi, Indien d. 20.4.11
Tungmetalforgiftning, EDTA og Demoval behandling.
Jacob: Jessie´s mand, rask.