Thursday, 9 June 2016

Ethics of the placebo

Solomon AJ, Bernat JL. A review of the ethics of the use of placebo in clinical trials for relapsing-remitting multiple sclerosis therapeutics. Mult Scler Relat Disord. 2016 May;7:109-12.

Randomized placebo-controlled clinical trials have been considered the most rigorous method of evaluating the efficacy of novel treatment interventions. The first effective disease-modifying therapies (DMTs) for relapsing-remitting multiple sclerosis (RRMS) were approved in the 1990s after a number of pivotal placebo-controlled trials. Since then, the ethics of the continued use of placebo in clinical trials of new DMTs for RRMS has been the subject of repeated policy statements and recommendations by international committees. As further data have accumulated demonstrating a reduction in long-term morbidity and mortality with early initiation of DMT, a growing consensus has emerged that further inclusion of placebo arms in clinical trials of novel RRMS therapies is no longer ethical

A growing consensus...really? Tell this to the FDA:-)...how many times do we continue to see placebo arms in MS trials in RRMS?

1 comment:

  1. Funny you should post this Mouse Doc.

    I was at a function just this past evening and this topic sorta came up.

    A speaker was DX'd some 13 years ago w/ RRMS. She went on Betaseron when Dx'd. She was on it for several years w/ its varied flu like side effects. No new activity. Then she ended up loosing insurance, since she had no relapses she went unconcerned. Sometime later she had a relapse. Not much could be done.

    Then she saw a clinical trial for Aubagio and engaged it. Fortunately she did get the real McCoy and has only had one relapse since.

    A discussion did ensue at the table about this.

    These days with Copaxone which is well tolerated available there is simply no excuse for not having patients on a DMT. Sure, perhaps pharma is not too thrilled about having their DMT efficacy values skewed by having "compete" per se with numbers of a relatively well tolerated DMT that has a decent efficacy curve.

    But know what? That is exactly what they should be comparing against.

    Comparing against placebo is just... well, damned unfair. Comparing against the least effective of DMT's (Though apparently Serono wants argue now) is also just not right. Thats preparation for marketing.

    Since they want make marketing materials and presentations as simon simpleton as possible (aka: 30% vs 72% for example) they perhaps need learn to do better marketing. Aka "Twice as effective" or better yet a granular system. Data can be displayed many ways without placing people at risk.

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