30 November 2019 | New Scientist | 5HIGH ideals have a way of seeming like
high hurdles when time is running out.
If someone you love has been told they
have just months to live, and there is a
drug that might offer them even a few
months more, it suddenly matters less
that the drug isn’t cost-effective, or that
it was approved on the basis of a small
trial and its risks and benefits remain
unclear. What matters is that it might
buy precious time right now.
Such dilemmas are why the US Food
and Drug Administration (FDA) and
similar agencies around the world aim
to strike a balance between efficacy and
expediency, speed and safety when it
comes to approving new medications.
In the 1970s, it took the FDA nearly three
years to usher a new drug through its
evaluation process. But in response to
public demand after the AIDS crisis ofthe 1980s, the agency began to introduce
expedited approval processes to get new
medicines to market much faster.
Today, there are several methods used
to speed things up, and more than half
of medicines are now evaluated through
some kind of expedited pathway. To payfor the staff to keep up the pace of
approvals, however, the FDA has come
to rely more heavily on pharmaceutical
industry fees – and accepts those funds
in exchange for keeping to set timelines.
The trouble is, the kind of research
needed to ensure that drugs are safe and
effective takes time. Faster approvalsmay be based on smaller studies or
measure things that are proxies for
the desired effect. Medication that is
rushed to market in this way is more
likely to be withdrawn later over safety
concerns or to turn out not to work as
intended (see page 34).
There is a growing group of researchers
raising the alarm over this trend. They
don’t dispute the need for quicker access
to new treatments or pretend that it is a
straightforward problem to solve. And
they don’t expect regulatory agencies
to do it without help from companies.
Fortunately, there is no shortage of ideas
about how to strike a better balance.
That balance is critical, because if
the drugs you take to get better could
actually cause you harm, then he
system meant to protect you just
isn’t working. ❚A critical balance
Fast access to new medicines shouldn’t mean endangering health
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“ When your time is running out,
it suddenly matters less that
a drug was approved on the
basis of a small trial”EDITORIAL
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