Monday, 28 April 2014

RRMS- Placebo Controlled Trials are they Ethical

There are currently over 9 different licensed therapies for the treatment of relapsing-remitting multiple sclerosis.

In the Year 2014 is it really ethical to undertake placebo-controlled trials for a number of years in relapsing-remitting MS?

Why, because we should know that a substantial number of people will develop relapse and accumulate damage and possible deficit as a result?

How many more MS pharma-sponsored trials are going to be placebo-controlled?

Should ethical committees take a stance on this?

Is it ethical to go to countries to do trials were there is no access to DMT,  just so pharma can use placebo to get clearer results

Should Neuros say no,there are hundreds that don't..is it ethical not to do it?

Maybe whilst Neuros are Sipping Mai Tais at the American Academy of Neurology AAN meeting in America they could mull this Over.


4 comments:

  1. I think placebo controlled trials are unethical in the area of DMTs in this day and age. However, wasn't that one of the reasons ie that alemtuzumab hadn't been tested against a placebo, that the FDA gave for initially rejecting it?

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  2. http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=1792853&highlight

    Placebo-controlled trials in RRMS are still alive and kicking ProfG. 600 people on nothing. What do you think ProfG?

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    Replies
    1. It is a complex problem in UK. Some people are not eligible to receive DMT because of the strict conditions that NICE set to receive them, despite being an RRMSer. So the option may be nothing verses going on a trial with a 1 in 3 chance of getting nothing but having the benefit of being on a trial. Whilst not affecting relapse rate much the drug appears to have benefit on brain shrinkage but less affect on relapse, because it works via a pathway that blocks a molecule that is important in innate immune response activation that may drive nerve damage.

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    2. They are testing quadruple dose there (1.2 mg) as well. Maybe it could have some benefit on relapses too, 0.3 they tried initially had almost no effect, and 0.6 have some, may be 1.2 will work for them

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