Wednesday, 28 May 2014

Are placebo controlled trials for RRMS ethical?

How about Are placebo-controlled trials for RRMS ethical?

Surely an academic PI on a pharma trial or a pharma bod should be able to defend this position or maybe the people on the ethical review panels could make a case.
Pharma hunts in packs and once one company gets a hit, others will follow. 

First we had Gilenya (fingolimod) and then Siponimod (BAF312) for a different slice of the pie, but lurking in the wings we have ceraimod ONO-4641), Ponesimd (ACT-12880) and the other MODs called RPC1063 and GSK2018682, etc, etc.

They all have a similar mechanism of action and so target-related side effects may be similar. Probably they will be more or less the same price, as there seldom seems to be price competition. Some may be better than others, so give it an edge, others will be better marketed. They should be about 50% effective at blocking the annualised relapse rate. Some may get a first line licence in contrast to the current second line in Europe for Gilenya. Now that Alemtuzumab is there it will be hard to make the case that an S1P modulator is less safe than alemtuzumab

Probably all will go through a placebo controlled trial. 

Should I "Get real and wakeup and smell the roses" and accept that this is morally fine or should the regulators extract a cost for the use of "have not" volunteers and make these new kids on the block use an active comparator.

If you were a "have" why would you accept nothing but the placebo effect,when you could get something that works to some extent.

It would cost more to do active comparator but the regulators do not care about cost, 

You could do a superiority trial against less effective agent it may boost numbers required  because the comparator drug will have an affect but more "have nots" get access to a drug designed to sell to the "haves". It may bethat the increase in numbers make thestudy non viable any statistician out there care to put figure on this

Or should they be made to do a non-inferiority trial against say fingolimod (You accept fingolimod works and then power the study so show that it is no worse than fingolimod). This could be marketing suicide if it was worse, but if it looks worse people would not want it anyway. However, this type of study takes a better moral high ground in an era when there are many active drugs

However, how long is it until the (Gilenya) patents die and the first chemical generic becomes available, will the price tumble, as its cost is peanuts. I suspect the generic biologicals will not be that much cheaper. 

Will there then there be "have nots" to do placebo on ..probably or will pharma have moved on to pastures new by then and no new MS drugs.

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