Monday, 15 October 2012

ECTRIMS Highlights 2012

In response to a request by one of the readers the following is a list of my ECTRIMS highlights or insights for 2012:

1. Simvastatin 80mg per day reduced brain atrophy and delay disease progression in MSers with SPMS. Where to from here? Dr Chataway will have to find a way of getting funding to do two large phase 3 clinical trials to get the drug licensed for progressive MS. As simvastatin is off-patent this will be almost impossible. The trials required will cost upward of $100M (one commentator said to me close to $500M). This is why we need drugs that have a suitably long patent life so that industry can get involved. For those of you attacking Pharma please remember that at the present time they are the only ones with deep enough pockets and the willingness to take the risks of failing. Big Pharma is simply the only show in town when it comes to taking innovations from the bench to the beside. If you disagree please let me know how; we have a list of at least 10 ideas that need translating.


Chataway, et al. The MS-STAT trial: high dose simvastatin demonstrates neuroprotection without immune-modulation in secondary progressive multiple sclerosis (SPMS) – a phase II trial.

2. CUPID study confirms what we already know that the EDSS is a very poor outcome measure for monitoring progressive MS. MSers with EDSS scores of 6.0 (unilateral support) and 6.5 (bilateral support) on placebo hardly progressed in the study and resulted in the CUPID (THC vs. placebo) study being negative. When the analysis was limited to Msers with an EDSS < 6.0 it was positive implying that THC is neuroprotective in MS. Where to next? We need to develop better outcome measure for measuring disease progression in progressive MS. Dr Jeremy Hobart highlighted this in some detail in his lecture. In short it is time to bin the EDSS and move on. Patient or MSer related outcome measures seem the most promising.

Zajicek. Cannabinoids, symptomatic or disease modifying?

3. Laquinimod has a positive impact on disease progression and brain atrophy despite a weak impact on annualised relapse rate. Similarly, Daclizumab (anti-CD25) has a positive impact on disease progression that is out of proportion to its impact on relapses. Could these two drugs be telling us what we should already know, i.e. that relapses and disability progression are not necessarily linked? These two drugs need further work; finding out about how these drugs work will teach us a lot about progressive MS.

Comi et al. Oral laquinimod in patients with relapsing-remitting multiple sclerosis: clinical effects at 36 months in the open-label extension phase of the ALLEGRO study.

Comi et al. Laquinimod: a new MS therapy with evidence for CNS direct effect.


4. The announcement that a company in Switzerland is developing a treatment that target human endogenous retrovirus (HERV). This is in line with our thinking and would fit under the Charcot Project umbrella. Please watch this space. 

Perron et al. Novel humanised antibody therapy in multiple sclerosis targeting immunopathogenic protein from endogenous retroviral element while preserving host’s immune system. 

Curtin et al. Safety and pharmacokinetics of GNbAC1, a humanised monoclonal antibody against the multiple sclerosis retrovirus envelope protein.


5. Low vitamin D levels predict conversion from CIS to MS, i.e. the second attack. This has implications for clinical practice; we therefore make sure MSers and their families are vitamin D replete all year round. What do we do in clinical trials? Do we measure baseline levels and supplement? Is it ethical to leave MSers in trials with low vitamin D levels? What will vD supplementation do to event rates in trials? The latter will have implications for clinical trials. 

Bjørnevik et al. An age at exposure effect in the association between sun exposure and the risk of MS in Norway and Italy. The EnvIMS study. Ascherio et al. Serum 25-hydroxyvitamin D concentrations among patients in BENEFIT predicts conversion to multiple sclerosis, MRI lesions, and brain volume loss.

6. Alemtuzumab and Daclizumab increase the likelihood of MSers being MS disease activity free (DAF). This is a bit of a hobby horse; I am trying to promote DAF as a treatment target in MS. This was the subject of a recent meeting at the Cleveland clinic and has been commented in detail on this blog. Please ask your neurologist if you are DAF. 


Havrdova et al. The effect of daclizumab HYP on sustained disability progression in the SELECT trial. Giovannoni et al. Increase in proportion of patients free from disease activity following 1 year of treatment with daclizumab high-yield process in relapsing-remitting multiple sclerosis: results from the SELECT study.

Giovannoni et al. Primary results of the SELECTION trial of daclizumab HYP in relapsing multiple sclerosis. Giovannoni et al. Disability improvement with alemtuzumab vs. interferon-beta-1a in relapsing-remitting multiple sclerosis patients who relapsed on prior therapy (CARE-MS II).


7. Treatment of MSers with SPMS or PPMS with natalizumab reduced markers of inflammation and axonal damage in the spinal fluid. However, it did not normalise the levels of neurofilament implying that despite suppressing inflammation in progressive MS we need to find treatments that suppresses ongoing neuroaxonal damage; by doing this we will hopefully slow down progressive MS or hopefully stop continued progression all together. 


Romme Christensen et al. Natalizumab treatment of progressive multiple sclerosis reduces inflammation and tissue damage - results of a phase 2A proof-of-concept study.

8. Several talks confirmed what I already knew that CCSVI does not exist as a clinical entity and that the treatments being offered are dangerous and associated with significant morbidity. It makes you question the ethics of ongoing studies and whether or not governments should take action.

Comi et al. Chronic Cerebro-Spinal Venous Insufficiency (CCSVI) and global venous haemodynamics in multiple sclerosis: the CoSMo study.

Ghezzi et al. Endovascular treatment of CCSVI in patients with multiple sclerosis: clinical outcome of an Italian cohort of 462 cases.

The following are the slides from my ECTRIMS talk minus the slides I cannot show at the request of the investigators. The ECTRIMS committee will be making a recording of this talk available online in the near future.



"Overall the meeting was good; numerous meetings and networking. Some new collaborations and ideas. Very little socialising and very little champagne. I don't recall when last I have felt so tired. I also felt proud of the team; we had a good showing and some of the work we presented is cutting-edge. 

"At a personal level the feedback from my presentations was very positive with a lot of requests for my slides."

64 comments:

  1. Thank you so much for this summary, Prof G, really appreciated. Having been on the active drug in the Simvastatin trial it is disappointing to think that progress will be difficult to make (how ironic!)

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  2. Many thanks for this sumamary.

    One as to ask the question as to why Dr Chattaway conducted this study given that the chance of it moving to Phase III are nil.

    Quite a lot on neuro-protection which is promising.

    Little on repair - disappointing.

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  3. Thank you for the summary.
    Repeating an earlier question, what would you say to a RRMSer who wants to start simvastatin based on Dr Chataway's study?

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  4. New collaborations and ideas sounds good.
    Congratulations on your team's showing

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  5. Many thanks Prof G.

    There seems to be a bit of a catch-22 going on. Researchers are identifying neuro-protective agents, but only pharma able to fund the big trials, but pharma unlikely to fund as will not generate enough returns (as the DMTs do).

    I'd like to see the sums for a phase 3 trial of simvastin. 300 people with SPMS, MRI at start, 1 year and 2 years. Talking £1000 per MRI x 900 = £900,000. Simvastin is dirt cheap - sure company would donate if more business for the future. Need a research neuro for 3 years (half their time) - e.g. Dr Chattaway = £200,000. (assuming consultant neuro gets £130k a year). 3 phd students at £30k each a year = £370k. A couple of nurses / administrators at £30k a year = £180k. Total + £1.6m. Add another £400k. Total = £2m. Heaven's knows why pharma says £500m!

    Little mentions of stem cells / myelin repair.

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  6. Just as an aside, can I say that you really shouldn't feel the need to be defensive over socialising/champagne. Despite the ridiculous criticism of some on here, you don't 'owe' anything to MSers such that you have to justify how you spend your time. I have MS and I am pleased to say I socialise frequently and, whilst I prefer a good red over champagne, enjoy a drink socially and there's no reason you shouldn't combine business with pleasure whilst in the company of colleagues in Lyon. The bitter nasty comments on here really grate.

    Anyway, now that is off my chest (!) I did have a couple of questions about your excellent summary:

    1. No reference to the induced immune tolerance work that MD described as potentially half-way to a cure for MS? Surely that outweighs all that which you have referenced or are we in danger of getting over-excited about this?

    2. Simvastatin - Is the phase II (and problems with getting phase III) enough to consider off-label use for SPMS; given there is little by way of alternative and safety profile is established (and q. good)

    3. Simvastatin - Should this be looked at as a neuroprotector from RRMS alongside immune depletion (for those not in IFNs)?

    4. Is Daclizumab looking like a serious rival to Alemtuzumab? 39% DAF is impressive and better than Alem I think? What are the safety issues with Dac?

    5. Laquinimod - Do you know the atrophy and progression results (the abstract refers to it being "presented" orally)? Given it, I think, has a different mechanism, might laquinimod and BG12 be worth trialling in combination?

    Thanks Prof G!

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  7. Isn't is a leap to say the laquinimod and dacluzimab results mean progression and relapses are not related? Couldn't it just be as simple as relapse = progression; one route is to stop the cause i.e. relapses (Alemtuzumab) another is to not stop relapses (or at least not as well) but stop the effect of the relapse on nerves (eg Laquinimod). The fact some drugs impact on progression but not relapses doesn't mean relapses don't cause progression. The ideal would be to cover all bases - i.e. take a DMT that is proven to reduce relapses and take a DMT that impacts best on progression. Alemtuzumab and laquinimod combination therapy anyone? Or perhaps BG12 if you want the best single drug to cover relapses and potential neuroprotection...?

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  8. Re: "Isn't is a leap to say the laquinimod and dacluzimab results mean progression and relapses are not related?"

    Not a leap of faith at all. There is natural history data that is saying the same thing.

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  9. Prof G,

    I'm a bit confused, are you now saying that relapse and progression are not related? If so, does it not question the treat early / aggressively approach.

    On a separate issue, are there any action points from these conferences I.e. Progression needs to be addressed. Let's focus on this and share findings in 12 months time. If not, all the researchers go back and continue their work (genetics, vit D, mri etc etc) and a year later we're not much further along. Neuroprotection should be priority 1 (given it could halt / slow down disability).

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  10. Re: “For those of you attacking Pharma please remember that at the present time they are the only ones with deep enough pockets and the willingness to take the risks of failing. Big Pharma is simply the only show in town when it comes to taking innovations from the bench to the beside.”
    Right. So once again we’re reminded that Big Pharma is a necessary, no wait, an essential evil. We must endure these corporations holding ill people to ransom, withdrawing essential medication if they can’t profiteer from misfortune. What we need is a paradigm shift. Rather than government allocating our taxes to sustaining debauched market systems, shouldn’t we get them to invest our taxes into supporting research that may help ill people? Just a thought.

    Re: “Could these two drugs (Laquinimod and Daclizumab) be telling us what we should already know, i.e. that relapses and disability progression are not necessarily linked?”

    I’d love to know what the DMT mafia (i.e. MSers that are pro-DMTs because neuros assure them that they’re doing them good) that comment on this blog make of that one? It seems that these guys are so addicted to their corrosive meds that such news will be immediately shot down and labelled as nonsense. One of the reasons why MS is so complex is because relapses and progression run in parallel to each other, hence why current DMTs function in immunology, not progression which materialises independently after the initial onset of CIS.

    At least we know where things stand. All the free flowing wine and expensive pasta meals provided an opportunity for neurologists and pharmaceuticals to chinwag and shoot the breeze. Progress seems so slow and hampered because of a lack of vision that it’s becoming increasingly hard to differentiate ECTRIMS of yesteryears to this year. The same old rhetoric and redundant dispute on the effectiveness of expensive DMTs prevails over anything coming close to true progress and innovation. RRMSers keep on injecting themselves with pointless drugs in the unfounded believe the meds will curtail their disease whilst progressive MSers idly accept that this year will not deliver any fruits, but hey, there’s always ECTRIMS 2013.

    This isn’t an attack on this blog, just a realisation that 2011 will not be the ‘momentous’ year suggested 12 months ago.

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  11. CCSVI and Cosmo study....


    The Cosmo study is flawed and criticized....it's an ultimate effort to dismiss ccsvi.

    The CCSVI doctors whp did a venography confirm 100% vein abnormalities in MS patients..

    Cosmo also tries to stop the Brave Dreams trual of Dr Zamboni.


    CCSVI is ore alive than ever, accumulatins evidence appears tht vein abnormalities can play ba role in neuro degenerative diseases...

    Don't believe these so called ibjective studies, get the facts!!

    Rgds,

    Robert

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  12. "Don't believe these so called ibjective studies, get the facts!!"

    There are no facts without independent objective studies.

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  13. Pro-DMT mafia speaking up:
    Even if SPMS is inevitable, why live with relapses till then?
    The number of relapses now may be irrelevant to disability in 20/30 years.
    But for now, it seems that increments in disability always come after relapses. Meaning that relapses leave behind increases in disability and speed up disability.
    Why not have as normal a life as possible for as long as possible?

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  14. "independent objective studies."

    This guy Comi is the president of the Italian Society of Neurologists. He is the head of the COSMO study (which is about ultrasound in veins) and part of the Ghezzi et al study. At the same he is the head of the Laquinimod trials. If you want to trust his "objective" opinion on CCSVI then do it. A 12 year old wouldn't.

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  15. The DMT mafia and CCSVI mob rule this blog.

    They run rampant here. To question either ones' practices invites hostility and denial.

    However, granted, if DMTs makes the MSer feel better about themselves then who cares, right? The big problem is having the tax payer fund it, putting huge amounts of dough into the hands of greedy pharmaceuticals wanting to profit regardless of the consequences.

    One hopes CCSVI never becomes an NHS funded procedure. Nonetheless, it's not as if Big Pharma will be responsible for ensuring they can profit from it as CCSVI will have to be supplied directly by the NHS, cutting Pharama out of the equation. In that view it's probably a more sincere procedure than the malicious DMTs provided by Big Pharma, though none less pointless.

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  16. There is a simple way of reinstating patent protection for simvastatin so it could be pushed forward (if the will is there).

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  17. " If you want to trust his "objective" opinion on CCSVI then do it. A 12 year old wouldn't."

    Better to trust those who make a tidy sum out of performing venoplasty, eh VV?
    Let's face it you will never believe any negative data on CCSVI and will always weasel on with your "whataboutery". Everyone reading this blog is aware of this so your time might be better spent elsewhere (anywhere).

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  18. Re: "Isn't is a leap to say the laquinimod and dacluzimab results mean progression and relapses are not related?"

    Not a leap of faith at all. There is natural history data that is saying the same thing.

    The natural history studies relate to clinical relapses, which is almost certainly a poor proxy for actual disease activity. That doesn't mean stopping the immune attacks and inflammation - in a serious way rather than 'light' IFN way - won't stop progression. Equally, there is a correlation shown in most studies on early relapse frequency and progression so there is definitely a link, even if it can't be shown to be causitive.

    As the earlier poster mentioned, are you backing away from your early, aggressive approach? It's of massive importance - someone's RRMS might be able to be controlled well, clinically, by eg. BG12 but they might opt for Alemtuzumab instead, say, to try and give more protection from SPMS. If you don't think the two are related then you'd go with an escalation approach to control RRMS enough rather than an early 'nuke' approach with all the side effects?

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  19. I for one enjoy V V's input it helps keep the balance. I don't see the vascular involvement within MS going anywhere soon, I can only see further evidence emerging over the coming years. I'm really excited and looking forward to where it takes us and where it may well, (or not ), fit in with statins , viagra ,the blood transfusion in mice study etc,etc.
    Regards as always.

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  20. VV's blog is the right place to get VV's input. Instead of piggybacking on this one.

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  21. What's needed is for America to take the sickening profit the insurance companies make out of medicine.

    It's awesome that the private insurance companies make American citizens pay so much more for health care per capita than our cousins in single-payer Britain, France, Canada, Australia, Spain, Italy, Ireland etc. etc.

    What's weird though? After single-payer systems were implemented in those backwards nations? Even the conservative politicans who opposed implementation of single-payer came to embrace their universal health care systems as national treasures. I'm not kidding.

    Britain even celebrated its single-payer National Health Service by honoring it during the 2012 Olympics' opening ceremonies. Crazy fucking limeys, am I right?

    Apparently the voters in these ridiculous single-payer nations don't know how much worse their single-payer system is than the far more expensive, private-insurance-company-enriching American system.

    Personally I *love* paying so much more for my health care. I think the Europeans, Australians and Canadians are nuts for paying so much less for their more efficient non-profit systems!

    In fact, I don't know why Americans don't just scrap Medicare at this point! It's the biggest single-payer system in the U.S. and saves seniors billions every year!

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  22. Re: "Right. So once again we’re reminded that Big Pharma is a necessary, no wait, an essential evil."

    Yes, just like the Banks; the economy can't do without them! In general, translational drug development can't do without Pharma. No use complaining and not having a solution. Any suggestions?

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  23. NO CCSVI till theres evidence ,NO evidence till theres trials

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  24. Dear Anon 2:31 pm

    It's the most efficient system economically.

    The US has a high standard of healthcare because you pay more for healthcare than anyone in the world. You even pay more TAXES for healthcare than anyone in the world, because you have to give so much of it to parasite insurance companies.

    But, y'know, so long as you're not commies or anything, carry on wasting your money on a system that's hilariously inefficient.

    Honestly, the US gets most things right, but this is an area where it cuts off its nose to spite its face, privileging ideology over pragmatism. The countries that use a single payer model do so primarily because economists have found that it is the most efficient structure.

    The insurance companies keep using the phrase 'socialized medicine', and you keep playing into their hands.
    The US actually spends more on HEALTHCARE per capita through taxation than any other country. Why? Because the costs of medicare and medicaid are stratospheric, because non-single-payer insurance costs are mind-boggling. The the US ends up with the worst of both worlds: higher health-centric taxation than 'socialist' countries, but with poor returns for their money. It's basically socialism for the insurance companies, to accompany the socialism for Wall St. Brilliant. Keep telling yourself that this is the free market, guys.

    I say this an an Aussie....the US system is much better for the people who can afford it, which is pretty much anyone with a job. Better service, quicker, etc.

    Goverment health care systems like in Australia and the UK have a long waiting list, and a minimum of care. For the same price you would pay instead of being on the waiting list, the money is better spent in the US.

    The problem with the US system is poor people don't matter. They might fix you at an ER, then hit you with crazy debt...which means people don't want to go to the ER.

    At least Obamacare fixes that somewhat, bring the system something closer to the Swiss system.

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  25. Anon 2.37

    Should you do trials when their is no evidence of the clinical entity

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  26. "It makes you question the ethics of ongoing studies and whether or not governments should take action."

    The king of this blog openly questions the freedom of research. Not very liberal, to say the least.

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  27. "Better to trust those who make a tidy sum out of performing venoplasty, eh VV?"

    Wrong again MD2. Trust venography images only. You wouldn't like to have the veins of an MSer. A 12 year old could tell they are NOT normal.

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  28. "For those of you attacking Pharma please remember that at the present time they are the only ones with deep enough pockets and the willingness to take the risks of failing".

    I don't see you urging us to lobby Pharma industry to cut their marketing costs and reduce drug prices. You were very keen on doing it against NICE, though.

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  29. Selective reading from VV, or just a bit of cognitive impairment?

    http://multiple-sclerosis-research.blogspot.co.uk/2011/11/ectrims-red-queen-is-live-and-running.html

    http://multiple-sclerosis-research.blogspot.co.uk/2012/09/drug-pricing-pharma-cartels.html

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  30. Re: "I'm a bit confused, are you now saying that relapse and progression are not related? If so, does it not question the treat early / aggressively approach."

    I am not sure what the exact relationship is between relapses and progression. It is clear that relapse are not good for; a bad spinal cord relapse can leave you paralysed. So suppressing them is a treatment aim. However, rendering someone relapse-free does not necessarily translate into progression-free. All I am saying is that these two drugs appear to have a greater impact on progression than what you would expect from their impact on relapses.

    Until we have the data to say otherwise I will promote and support the early aggressive treatment option. Clearly this is not for everyone; some MSers who fall into the good prognostic group may not want to take the risk. At the end of the day it will have to be individualised!

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  31. Simvastatin, as all statins, are thought to:
    a. improve endothelial function
    b. modulate inflammatory responses
    c. maintain plaque stability
    d. prevent the formation of thrombi.

    So if it is to be minimally helpful in SPMS, where stronger immune modulators have failed, then it must be due to what it does to the blood and the vascular system.

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  32. "Selective reading from VV, or just a bit of cognitive impairment?"

    NICE research Anonymous. Please point us to the phrase "lobby the Pharma industry". Nowhere to be found, right?

    Expressing a disgust against Pharma behavior and at the same time accepting it as the primary mover of medical science, with all the goodies that come together, does not sound as lobbying to me. Ever heard of Janus?

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  33. Re:

    Qu 1. No reference to the induced immune tolerance work that MD described as potentially half-way to a cure for MS? Surely that outweighs all that which you have referenced or are we in danger of getting over-excited about this?

    The trial is too small to draw conclusions and there is little evidence to support their choice of antigens.


    Qu 2. Simvastatin - Is the phase II (and problems with getting phase III) enough to consider off-label use for SPMS; given there is little by way of alternative and safety profile is established (and q. good)

    It is a very high dose and may not be that safe! I think we need more evidence before recommending it. In addition the change in EDSS scores are probably not clinically meaningful: placebo 5.87 to 6.35 vs. Simvastatin 5.75 to 5.93; i.e. placebo-treated MSers deteriorated 0.48 EDSS points compared to 0.18 points if you were on Simvastatin over 2-years. I think these results are a start and deserve further attention.

    3. Simvastatin - Should this be looked at as a neuroprotector from RRMS alongside immune depletion (for those not in IFNs)?

    Too early to call. We need data before making this claim.

    4. Is Daclizumab looking like a serious rival to Alemtuzumab? 39% DAF is impressive and better than Alem I think? What are the safety issues with Dac?

    Please remember that Daclizumab is compared to placebo and Alemtuzumab to interferon-beta. The latter is therefore probably better. However, until we get the phase 3 results of Daclizumab we will not know how effective it is. Based on the data we presented at ECTRIMS it may get better in the 2nd year.

    5. Laquinimod - Do you know the atrophy and progression results (the abstract refers to it being "presented" orally)? Given it, I think, has a different mechanism, might laquinimod and BG12 be worth trialling in combination?

    Yes, I suspect so. But we need data. Hopefully, Teva and Biogen-Idec will spend the money, do the trials, and get the results that we need to make this call.

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  34. Re: "Expressing a disgust against Pharma behavior and at the same time accepting it as the primary mover of medical science, with all the goodies that come together, does not sound as lobbying to me. Ever heard of Janus?"

    I have had discussion with senior management of three MS Pharma companies and they assure me the high prices are okay in the US; politicians are prepared to tolerate high-prices as long as Pharma continues to invest in the USA and innovate. The latter brings in Billions worth of income for the government in jobs and taxes. That may explain why companies such as GSK, Novartis, Pfizer, etc. have closed most of their research labs in the UK and expanded in the US. The so called NICE effect. Economists like to talk about macro-economics, which we in the healthcare industry don't understand. The price differential between the US and the UK for some of the DMTs is staggering; just take Copaxone for example, it costs the NHS ~$8,000 per year per MSer and the Americans $52,000 per year.

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  35. "So if it is to be minimally helpful in SPMS, where stronger immune modulators have failed, then it must be due to what it does to the blood and the vascular system".

    No not necessarily. As you can read it is associated with an anti-inflammatory effect and is doing something else. We have a few ideas and it not something to do with the vascular

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  36. What is happening with Laquinimod. Last indication was that Teva had put development on hold because it was so ineffective in RRMS. Are they going to do studies in PPMS or as an add-on to GA

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  37. "Wrong again MD2. Trust venography images only"....

    Images do not treat you and it is the treatment that costs...again twisting words

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  38. What is happening with Laquinimod

    Ask Prof G there were recent reports of The phase III study, CONCERTO, will be conducted in patients with relapsing-remitting multiple sclerosis on ptorgression and possible combination studies have been reported

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  39. This blog is approving what drug companies have to offer by admitting that more research is needed but condemning CCSVI saying the research should be over.
    I disagree, I have had MS for 18 years and that gives me a lot of experience also a very good idea of what the symptoms are and how they can affect people. I have taken several of the MS drugs including but not limited too Copaxone and Rebif neither helped me in any way, what they did do was make me feel terrible stole my sense of well being and masked the progression, not to mention the pain I endured from the drug and injection site. I quit all drugs in August of 2010 and started to look at other options available to me. In December of 2010 I bit the bullet and tried CCSVI, before I did I had an MRI done so I will have some answers that lord knows the doctors need. CCSVI gave me back 10 years of my life, it did not cure me of MS but it did give me a much better quality of life and lets face it quality of life is very important. I document my symptoms every day and I used to fill a page daily now it takes me a week to fill a page with symptoms.
    I do not want MouseDoctor to attack me (like he/she has to others) for the way I feel but I am also not willing to let a drug sponsored conference spread blatant untruths about CCSVI. I am also extremely disappointed and upset that a doctor whose life's work is to help people is talking in this way to people. I am thankful that my doctors are not this way and I can fire them if they are. I am also thankful that some doctors are keeping up with the newest research and that pharmaceutical companies are trying to help with different conditions. Face it the researchers don't even know what MS is, and that means the doctors don't know either.
    One question, I have not heard anything new about CPN or Lyme disease is it because both can be cured and when are doctors going to do some research into these diseases as being the possible causes of MS symptoms?

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  40. Re: "I disagree, I have had MS for 18 years and that gives me a lot of experience also a very good idea of what the symptoms are and how they can affect people."

    Have you heard about the placebo effect? I suggest you read Ben Goldacre's book Bad Science it explains a lot.

    The problem with CCSVI is that it in now a problem. The evidence that it exists as a distinct entity is very weak therefore any trials to treat it are unethical. What worries is me is the integrity of the original research that described it. The CCSVI story has many similarities to the Wakefield-MMR scare. Wakefield is now a pariah and has been struck-off the medical register in the UK.

    MS and Lyme disease are two different diseases. To make a diagnosis of MS you have to exclude other potential causes. A good neurologist should not get the diagnoses mixed up.

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  41. "Should you do trials when their is no evidence of the clinical entity"

    Huh? That's a neurological point of view...look out of the window, read BNAC studies, read articles from vascular surgeons.

    CCSVI is accepted by the vascular doctors, already in 2010.

    Veins abnormalities are proven, doctors who do the ccsvi treatment a.k.a. venography find 100% vein abnormalities in MS Patients.

    But, you can always listen to the pharma and neurologist...do they really care if a big part of their revenue is gone??

    They ONLY thing that's asked for, are objective trials that are setup in the right way...that is still lacking....unfortunately

    http://www.ncbi.nlm.nih.gov/pubmed/22971467
    http://www.ncbi.nlm.nih.gov/pubmed/22971467
    http://www.ingentaconnect.com/content/maney/nres/2012/00000034/00000008/art00009
    http://www.veinews.com/2012/10/02/update-on-angeiology-and-neck-veins/#

    Read these links...no proof??
    (or maybe a lot od doctors know very little of the bloodflow)

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  42. Should you..is a question. Answer is yes, no maybe etc.
    You should...is a statement

    Thats an important difference

    Your blood pressure is artifically rising

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  43. How about laquinimod as an add on to alemtuzumab for its neuroprotective properties as it appears to have very little immunomodulation, whereas BG12 is an immunomodulator and it may cause concern to add it on to an already immunomodulated MSer?

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  44. "A 12 year old could tell they are NOT normal."

    Ah this wondrous 12 year old again. He/she seems to be a fount of all knowledge. I for one would like to meet him/her!

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  45. Daclizumab seems too dangerous. This article "Safety Issue Puts Daclizumab in Doubt for MS" http://www.medpagetoday.com/MeetingCoverage/ECTRIMS/35315 reminded me of the comments in this old post http://multiple-sclerosis-research.blogspot.com/2011/10/ectrims-daclizumab-results.html

    ReplyDelete
  46. "Your blood pressure is artifically rising "

    It's lowish, always (also comoninmost ms patients) :-)

    ReplyDelete
  47. "politicians are prepared to tolerate high-prices as long as Pharma continues to invest in the USA and innovate. The latter brings in Billions worth of income for the government in jobs and taxes."

    This is just the polished side of the coin. The truth is that both parties in US get heavily sponsored by Pharma. In return they let it have party with other peoples money. There is nothing noble in this agreement. Just a lack of public control.

    ReplyDelete
  48. "Have you heard about the placebo effect?"

    You don't know how an MS symptom feels like, so be careful before dismissing a patients ability in self-perception.

    "The evidence that it exists as a distinct entity is very weak"

    You fall behind the CCSVI literature and tend to trust the wrong people (Comi et al). Oracles are usually blind, but being blind won't make you an Oracle.

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  49. "Oracles are usually blind, but being blind won't make you an Oracle."

    And I suppose in the kingdom of the blind, the one-eyed man is king, which considering your one-eyed approach on the CCSVI issue makes you regal?
    You may have a go at pharma (and some of it is justified) yet are completely sanguine about the conficts of interests of Zamboni et al.
    Strange.

    ReplyDelete
    Replies
    1. MD2 are you foodie? I can't stand blancmange.

      Delete
    2. Not really a foodie. I can't stand blancmange either (wrestling with it or eating it)!

      Delete
  50. I did not want to make these issues about research into CCSVI personal but I have been left with no choice. First it is not placebo like I said I have a previous MRI and one after, along with an eye doctor who does use science to determine my eye health, NO MS in my eyes after angioplasty treatment.
    This is a link to a very well written article with many scientific studies http://dl.dropbox.com/u/66292082/Drugs%20Exploitation%20in%20Multiple%20Sclerosis%2C%20Open%20Letter%20to%20MS%20Society.pdf read it, it is hard to deny. And just for fun this is a link to CafePharma a forum site for the drug reps this will make just about anyone sick even the Nueros. http://www.cafepharma.com/boards/showthread.php?t=510201 These are the facts and it might be time to atart speaking frankly with your patients. Please everyone on this blog read and explore both links.

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    Replies
    1. The first link is a rag circulated months ago......well written?
      Facts correct? I was exposed and Team G was mentioned prominently.

      I did not get a ticking down by David Cameron (UK prime minister for those of you who don't now) but there goes my knighthood..Sir Mouse nice ring to it. Oh well.

      As to the second link I do not try to defend toilet mouth idiots. You find them in every walk of life. As you can post Anonymously who wrote this pharma someone else.

      Delete
  51. this is a link to the newest drug reps talk freely here (Dacizumab)
    http://www.cafepharma.com/boards/showthread.php?t=515235

    ReplyDelete
    Replies
    1. Thanks Angela for showing more potty mouthing from Pharma..its not funny. I'll have words. Hope its not a plant from a disgruntled CCSVIer

      Delete
  52. "yet are completely sanguine about the conficts of interests of Zamboni et al."

    ah, enlighten us....

    ReplyDelete
    Replies
    1. From this article: http://news.nationalpost.com/2011/04/02/zamboni-says-no-con%EF%AC%82ict-in-applying-for-ms-patents/

      "Experts on intellectual property and bioethics say it is not unusual or unethical for academic researchers like Dr. Zamboni to apply for patents around their inventions, but note that it normally means the inventor or someone else wants to make money off the discovery, and suggest he should have pro-actively disclosed any commercial interests.

      Many medical journals now require that study authors reveal patent applications around their research, as well as industry ties, a policy encouraged by the World Association of Medical Editors in its ethics guidelines. At least three of Dr. Zamboni’s major MS papers list competing interests as “none.”"

      Delete
  53. It's shocking, hahaha...get serious...

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  54. @MD2 My name is not Angela, my name is Sharon and it doesn't matter what you say or think, what matters is MY quality of life. You can sit on your high horse all you want it makes no difference to me, but what I don't understand is why are you disrespectful about this and treating people so rudely?
    I did not post swear words, what I posted was the a small look into the way people with MS are treated and the blatant disregard for our well being and future medical issues caused by the MS drugs.
    I read Maria's link and I find it to be no different than any other medical researcher everyone wants to make money not to mention we all know about Blackwell. How would you like to disclose where you get your extra paychecks from or how you make $$ off MS??
    I picture you to be the biggest bully in the playground and a very hypocritical one at that. I do not think that those who live in glass houses should point their fingers at others.
    May I ask why for so many years the vascular theory is like a swear word to the average Neuro, please give me a valid researched reason for dismissing this theory?
    I steer clear of all prescription drugs, not just the ones for MS, the reason is because I have done my research on the Pharma industry going back to when it all started, thanks to the Rockefeller family in the 1930s. Stop treating me like an idiot (that is a very old MS theory) and speak to me with some knowledge and respect actually treat all people with respect you are a doctor not just a commoner. Peace to all no matter how you choose to manage your health.
    I also was diagnosed with MS without a Lyme test or any other tests just an MRI and we all know that is not conclusive, so there are bad neuros out there.

    ReplyDelete
  55. The long exchanges over the last few days leave me drained just by reading them.
    I read the blog to hear from Prof G, MD, etc and also comments from other readers (including those who disagree) because the answers to the comments are informative. But non-stop arguing and shouting doesn't help anyone. It will do nothing to change anyone's thinking.

    ReplyDelete
  56. `I read Maria's link and I find it to be no different than any other medical researcher everyone wants to make money not to mention we all know about Blackwell.`

    Hi Sharon,

    I don´t mind THESE patents, what if Zamboni did NOT patent the new techniques?
    Yes, indeed...somebody else would have done it. And hey, are these exclusively needed techniques?? NO.
    It´s shameful if you patent a medicine for 10 years and you make the price higher and higher. You really think that Tysabri costs 35000 dollar a year per patient?? R and D costs are already covered...

    Regards,

    Rob

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    Replies
    1. No one is saying that doctors or researchers shouldn't patent and make money off their own discoveries. That isn't the issue here. The issue is NOT declaring that they have patented a drug/medical device when they publish in medical journals because it is a Conflict of Interest (CoI) and UNDECLARED conflicts of interests are unethical. Team G has posted about CoIs: http://multiple-sclerosis-research.blogspot.com/2012/09/education-conflicts-of-interestthe-case.html .

      Here's another link about CoIs: http://www.sciencebasedmedicine.org/index.php/conflicts-of-interest/ .

      And just because a neuro/MS researcher has been unethical in disclosing their CoIs the doesn't excuse Zamboni's failure in disclosing his.

      "It's shocking, hahaha...get serious..."

      You don't consider doctors and researchers hiding their CoIs as a serious issue, Rob? Please inform yourself on the subject of Medical Ethics. Then you'll understand why undeclared CoIs not only undermine good science and research, but also our autonomy as patients: http://en.wikipedia.org/wiki/Autonomy#Medicine .

      "It´s shameful if you patent a medicine for 10 years and you make the price higher and higher. You really think that Tysabri
      costs 35000 dollar a year per patient??"

      This price gauging issue has been discussed on the blog: http://multiple-sclerosis-research.blogspot.com/2012/10/exclusive-ms-drug-rebranded-at-up-to-20_13.html . Team G is disturbed by it, too.

      Delete
  57. Hi Maria,

    I understand what you are saying and ofcourse Zamboni made a mistake....let there be no doubt about that.
    But directly afterthe ccsvi discovery (or better: another confirmaion of vein issues in MS) everything is 'used' to criticize it
    - Suddenly, Angioplasty was the most dangerous treatment in the world
    - Improved patients were:
    A: having a placebo effect, and the duration of placebo became flexible where 3 months was formely the max duration
    B: well. it's just the natural behavior of MS
    (remember; many treated patients have more than 2 1/2 years 'placebo' now)
    c: fake
    And, Zamboni was a fool....

    That's why i said 'shocking...bladibla'

    Where do you think the ccsvi research would be if neurology would have cooperated; would have examined improved patients etc etc
    I know patients who were sent away by their neuro...because they improved after a ccsvi treatment....

    But you know....this is not the first time that this happens.

    I have contact with an MS scientist who is also working at a cheap ms medicin that maybe can recover myelin.
    Pharma tried to 'get' him and stop the research...
    (thats why you also cannot find any news about it, but i know...)

    ReplyDelete

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