Surely one in 17 deaths is a high percentage and must be taken seriously.   I've not heard of anyone following a CAPi [5] dying...

Michèle (UK) GFAi [6]: Wheldon CAP 1st May 2006. Daily Doxyi [7], Azi MWF, metroi [8] pulse. Zoo keeper for Ella, RRMSi [9], At worse EDSSi [4] 9, 3 months later 7 now 5.5 Wheldon CAP 16th March 2006

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Michèle (UK) GFAi [6]: Wheldon CAPi [5] 1st May 2006. Daily Doxyi [7], Azi MWF, metroi [8] pulse. Zoo keeper for Ella, RRMSi [9], At worse EDSSi [4] 9, 3 months later 7 now 5.5 Wheldon CAP 16th March 2006

Or going bankrupt paying for treatment, Michele!

The difference between what we do and what we are capable of doing would suffice to solve most of the world’s problems. Mohandas Gandhi

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The difference between what we do and what we are capable of doing would suffice to solve most of the world’s problems. Mohandas Gandhi

Yes, you'd think they would also view 1 in 17 as a high proportion!  Instead of backing off though, they want to rush it to market! 

Joyce~caregiver-advocate in Dallas for Steve J (SPMSi [10]).  CAPi [5] since August 06, Cpni [11], Mpn, B. burgdorferi, systemic candidiasis, EBVi [12], CMV & other herpes family viral infectionsi [13], elevated heavy metals, gluten+casein sensitivity. 

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Joyce~caregiver-advocate in Dallas for Steve J (SPMSi [10]).  CAPi [5] since August 06, Cpni [11], Mpn, B. burgdorferi, systemic candidiasis, EBVi [12], CMV & other herpes family viral infectionsi [13], elevated heavy metals, gluten+casein sensitivity. 

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Yeah, but with injectable M.S. treatments starting around $20,000 a year (the less said about efficacy, the better), there's just too much money to be made with an oral treatment to let a few deaths slow you down. 

I'm sure there are more than a few out there whose attitude is that the people who die in these trials don't really count since they were going to end up being crippled anyway.   

CAPi [5] for M.S. since 8/2007. Currently: 100 mg Dox. (2 x day), 250 mg Zithi [15] (3 x week) ceased 3/2008, restarted 5/2008, 150 mg Roxi (2 x day) starting 3/2008, ended 5/2008. Ninth pulse metronidazolei [8] completed 6/7/2008.

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CAPi [5] for M.S. since 8/2007. Currently: 100 mg Dox. (2 x day), 250 mg Zithi [15] (3 x week).  Fifteenth pulse metronidazolei [8] + INHi [16] completed 11/22/2008.

They've given the drug to hundreds of people, so this isn't one out of just seventeen. Even if it were, it wouldn't be statistically significant. An unexpected death from infection could happen in any trial, including one of CAPi [5], due just to random chance. (There may be features of a death from infection that make it particularly ominous, though. The report linked to above didn't mention any such features, but we may be hearing more.)

Thomas McPherson Brown, who for decades treated patients with rheumatoid arthritis with antibioticsi [17], all the while watching the latest 'wonder drugs' appear, have their day, then get revealed as blunder drugs which didn't help in the long run, had a good statement about drugs based on autoimmune theories, which I'll quote approximately as: "There is a lot of room for happy accidents in medical research, but nobody ever found the north pole by going south." It's reasonable to expect fingolimod to fail, too, eventually -- but it hasn't yet done so: one death in a trial isn't enough to constitute failure.

In any case, the trials they're doing are part of an approval process that takes something like a decade; there is no unusual haste involved.

 If you are looking at safety aspects and comparing it to CAPi [5]... it seems pretty significant to me. It seems to make the clear point that its meant to..

 

CPNi [11] pcri [18] and antibody positive , treating MS, CFSi [19], TMJ, trigeminal neuralgia, IBS neutropenia, pus found in facial bone, Doxy 100x2, zithro 250x1 alternate days. Metroi [8] pulses each month.

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CPNi [11] pcri [18] and antibody positive , treating MSi [1], CFSi [19], TMJ, trigeminal neuralgia, IBSi [20] neutropenia, pus found in facial bone, Doxyi [7] 100x2,Doxy 200x2 zithro 250x1 alternate days. Metroi [8] pulses each month.

Looking at the report of the phase II MSi [1] trial, one thing that popped out at me was that this drug, as its intended effect, reduces the number of circulating lymphocytes to 20-30% of their original level. That does not sound at all healthy.

(They're not being complete idiots about this; they did monitor infectionsi [13] as side effects, and indeed found a large increase in upper respiratory infections, among other things.)

Perhaps this new drug is opening the way for the CPni [11] (re upper respiratory infectionsi [13]) to harm patient who already have compromised immunity.

CFIDSi [21]/ME 32 yrs, FMSi [22], IBSi [20], EBVi [12], CMV, Cpn, chronic insomnia, Lymes, HME, Natural HRT peri-M, NACi [23] 2.5 gm, 6-07 Doxy 200 mg day pm, Azith 375 mg M/W/Fday, Pulse#10 1000 mg 3 days & 750mg 2 days, 5-17-8

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CFIDSi [21]/ME 32 yrs, FMSi [22], IBSi [20], EBVi [12], CMV, Cpni [11], chronic insomnia, Lymes, HME, Natural HRT peri-M, NAC 3 gm, 6-07 Doxy 200 mg day pm, Azith 375 mg M/W/Fday, Pulse#15 750 mg X 5 days 11-1-08

That sounds likely, and might inadvertently cause the researchers to find it's cpni [11] that's growing and causing the lung infectionsi [13]! We can hope something good comes of this study, even if it's roundabout. Hope it doesn't kill anyone else while they figure it out, though.

The difference between what we do and what we are capable of doing would suffice to solve most of the world’s problems. Mohandas Gandhi

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The difference between what we do and what we are capable of doing would suffice to solve most of the world’s problems. Mohandas Gandhi

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Since Cpni [11] parasitizes lymphocytes, reducing their numbers conceivably could help with a Cpn infection. It's not going to help with most other infectionsi [13], though. (It wasn't just upper respiratory infections that increased; also diarrhea.)

In any case, blaming the disease on the patient gives them a license to be nasty to patients, as in: "You have an autoimmune disease, so we're going to have to suppress your immune system in one way or another to solve it. What did you expect from us? We're just doctors, not miracle workers; we cannot make bread without flour, or make wine out of water."

A week is about how long it'd take for them to look into the death and see whether it looked like an ordinary accidental death from infection, or like something more ominous. But even a more ominous sort of death, as happened with Tysabri, didn't stop that drug from being approved.