Therapy, regulation, insurance
I find it odd that, with so many responses, no one has addressed the
issue of how the intended use of a trial outcome affects the choice of
The dialogue so far assumes that the question is therepeutic: Should
a doctor recommend one therapy over another?
The reality is that another important use of randomized trials is for
regulation and insurance. Randomized trials are required for a drug to be
legal, and for a drug or procedure to be paid for by insurance. The
proper analogy to make is not whether it is sensible to use a parachute
before jumping out of an airplane in the absence of randomized trials.
The more relevant analogies are:
1) Is it proper for insurance companies to help pay for the cost of
parachutes? (For this analogy to work, we must assume that it is known
before takeoff that the plane will crash, and that it must take off
anyway.) For the answer to be "yes", we should require more proof of
efficacy than for the therapeutic question.
2) Is it proper for the government to forbid the use of parachutes
in the absence of randomized trials? For the answer to be "yes", we
should require more proof of inefficacy than for the therapeutic question.
The discussion of the parachute question has focused on the question
of effectiveness, without any mention of the regulation which (if this
were a serious medical issue) would be the main outcome of the discussion.
Likewise, many debates about controversial drugs have a clear answer
if you realize that the question being asked is not just "is this drug
effective?" but also "should use of this drug be legal?" The debate takes
place framed as if it were a debate about therapy; the results are used as
if it had been a debate about regulation; and the result is too much
Competing interests: No competing interests