Sunday, 8 November 2015

ResearchSpeak: what does the future have in stall?

Can we predict the future or is about setting priorities and changing the future? #MSBlog #MSResearch #ResearchSpeak

"Just got back from the MS Trust meeting in Windsor and promised to put up my slides on SlideShare (see below). On the way to Windsor we were pulled up by the traffic police to let a cavalcade of cars go by. As the cars swept by my wife saw Prince Phillip sitting in the back of one of the Range Rovers, the Queen was in the seat next to him. We assume they were returning to Windsor castle from London. On our return from Windsor this afternoon we heard on the radio that the Queen had led tributes to the UK's war dead at the annual Remembrance Sunday service in central London this morning. At least the MS Trust and all the attendees at this year's meeting are good company when it comes to working weekends."


11 comments:

  1. Can I ask why you bother to continue to go on and on about Clabridine? Is it a pride thing because you were involved in development/trials and the drug got vetoed you feel a dent in your collective pride?
    Is the drug better than Alemtuzumab/Tysabri/Rituxumab/orceliuamab?
    If not? Honestly what is the point? I wasn't 'more effective drugs' not drugs that are on a par with the above. None of the results you have published would imply that Clabridine is any better, so forget the knights and the pride and move on to working on more effective &a less risky drugs please..

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    1. Is the drug better than Alemtuzumab/Tysabri/Rituxumab/orceliuamab?
      Safer, CNS penetrant, more convenient and cheaper

      Better than beta interferons, copaxone, aubagion, tecfidera (probably) and fingolimod (no worse)

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    2. Re: "Can I ask why you bother to continue to go on and on about Clabridine?"

      Because Merck will be resubmitting a new licensing application to the EMA to get a license to use it in Europe. Why what has changed? A lot. Firstly, the malignancy signal is much better, the outlier was the low rate in the placebo arm and not the treatment arm. There is now much more data to support the licensing application: (1) the clarity extension study, (2) the ORACLE or CIS study, (3) the ONWARD (add-on to Rebif) study and (4) the registry data. In addition, the EMA environment has changed since alemtuzumab (Lemtrada) got a liberal first-line license. So yes, I will continue to go on about cladribine as it has several very appealing attributes as a treatment for MS. In fact this class of drugs is very appealing and includes oral fludarabine.

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    3. Re: "Re: "Can I ask why you bother to continue to go on and on about Clabridine?"

      DrK tried to get a head-2-head study of cladribine vs. alemtuzumab off the ground; if it had got funded I wouldn't have be surprised if cladribine-treated MSers do as well as alemtuzumab-treated MSers. Remember these are both induction agents and retreatment is only necessary if there is a recrudescence of disease activity after the second course.

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    4. So it is a pride thing then. Because you were involved in development of a drug that.got pulled off market you want proof that you were right and the regulators were wrong.

      Head to head study, you already have it. Take your two year Clabridine vs two year Alemtuzumab. You don't need to fund another head to head when the data is all there for people to see.

      The sad thing is that you are convinced this drug is the white knight, it's just not. So what if Merck are trying to relicence it. The price will go up 1000% if licenced.

      I agree MD - better than a load of drugs that were not that effective in the first place, yet drug companies continue to do studies vs interferon just to prove their drugs are more effective that the least effective drug out there. You as academia have a part to play in that travesty as well.


      It's a shame pride is more important that patients..

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    5. "It's a shame pride is more important that patients.."

      Vent away but you're tilting at the wrong windmills. We are very proud of our work but to suggest that that's more important than pwMS is frankly insulting. The interests of pwMS is paramount, first, last and always.

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    6. Why don't you mention the possibility of Cladribine being of benefit for PwPPMS? If I have one criticism of this blog, it is that PPMS is not mentioned enough. But that's all I'm interested in, it's kind of a selfish standpoint. Not that I am the only PwPPMS on the planet, mind you.

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    7. Dear Sterntaucher
      We are well aware of the potential value of drugs for people with pwmS. I believe we have a number of pwPPMS on clabribine as the hospital would not fund rituximab. Sodo you offer nothing or if they have MRI activity offer them something.

      I believe all MSers would value from a DMT and some more than others. However until the cost effective issue is dealt with that is not going to happen for pwMS unless a genric becomes available.

      ProfG mentions fludarabine but one could equally mention clofarabine (This I believe is sat on a shelf in the genzyme locker

      "You don't need to fund another head to head when the data is all there for people to see" That is not what the regulators said, they said they want another trial.Merck did not want to do one...will they get away with it when they go back to the EMA. This maybe why there is no mention of going bad to the FDA.

      You as academia....esqueeze me...You are wrong to think I have the power to stop this.

      Maybe you should ask the FDA why they are supporting placebo trials still

      Pride more important than patients...if only you knew

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    8. Come on mate,

      Look at the risks of serious side-effects with these other treatments in comparison, AND, their efficacy. For example, if Cladribine were on the market I would much rather take it over Lemtrada any day and avoid the risk of secondary autoimmunity, or avoid the PML risk of other meds. Or avoid the inconvenience of having to deal with treatment effects on a daily basis.

      Have you not paid attention to the nature of prescribing around new DMDs? More options are better, every condition (including MS) is served better by having multiple effective treatment options available. Unless someone can reduce the risk of secondary autoimmunity with Lemtrada then Cladribine still looks like a better option for many PwMS.

      I find it interesting that another "Anonymous" blogger comes out with an aggressive post and questions pride?!

      I mean sure, having the ability to post anonymously is likely to increase "fringe-posters" for the purpose of stimulating discussion, or give them the opportunity to ask questions freely ( like this one I guess?).

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    9. Not to mention the risk of rebound disease with some of the other meds.

      Sure, Lemtrada would be great if it weren't for the risk of renal failure, thyroid disease, thrombocytopenia etc!

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  2. it’s not venting, its questioning if all the effort is really worth it. 4 years ago when there were hardly any tablet medications and the only mainstream mab was nataluzimab, there was a massive place in the market for this drug, but now, with Fingolimod a tablet with the same effectiveness, Alemtuzumab, Natalizumab, oreeliuzmab and potentially daclizumab available or coming, do you really think there is need for another drug that has similar effectiveness as the above? (Unless it is sold at the $1000 price point you keep talking about - which it won't more likely minimum £25K)

    I just feel there is more opportunities with newer treatments.. I also think with HSCT currently being the documented most effective treatment in MS if you spent as much time campaigning about the most effective treatment it is much more likely to become available in the UK. (Rather than saying patients should create the buzz)

    I also don't understand why if Cladribine was so good why there is not buzz in the Neuro community or the MS Societies like their was with Alemtuzumab and Orceliuzmab

    I am a PwMS, and I think this blog is very good. But the Cladribine undertone seems unnecessarily biased IMO

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