My
81-Year Old Mom: Drug Safety Expert?
Did
you
see
the
Business
Week
cover
that
blares “Do
Cholesterol
Drugs
Do
Any
Good?” The
story
concludes
that
the
benefits
of
statins
are
overstated
except
among
certain
high-risk
groups.
And
this
is
only
one
concern
recently
raised
about
the
safety
and
efficacy
of
commonly
used
drugs.
Questions
about
the
increased
heart
attack
risk
for
those
who
take
Avandia
to
treat
diabetes,
the
lack
of
benefit
of
Zetia
in
lowering
cholesterol,
and
the
risks
from
the
antipsychotic
drug
Zyprexa
have
all
received
extensive
media
attention.
As
someone
who
has
always
pretty
much
taken
for
granted
the
safety
and
efficacy
of
most
legal
drugs,
I
find
myself
unnerved
by
what
look
like
a
long
string
of
failures:
(1)
failure
on
the
part
of
scientists
to
analyze
data
appropriately;
(2)
failure
on
the
part
of
pharmaceutical
companies,
scientists
and
physicians
to
represent
evidence
clearly;
and
(3)
apparent
failure
on
the
part
of
the
FDA
to
fulfill
its
mandate
to
regulate
the
safety
and
efficacy
of
drugs
and
devices.
|
|
Jessie
Gruman
President
and Executive Director
Center for the
Advancement of Health
|
Most
of us hold on to the naïve notion that if “they” let
us have “it,” it must be OK. But
media coverage suggests we’re vulnerable
because “they” are wily, money-grubbing
corporations or incompetent government bureaucrats,
none of whom has our interests at heart, and
that “it” may be neither effective
nor safe.
For
those who pay some attention to the news, these
stories either confirm that things
really are going to hell in a handbasket or
they escalate alarm: no drugs are safe; few work
as
claimed; health professionals, health plans
and drug companies are not to be trusted.
For
those
who pay little attention to the news, these
stories add to the growing gap between people
who know
that benefiting from health care requires
that they demand good answers to hard questions
and those who slide by, trusting that whatever
drugs
or devices or procedures they use won’t
hurt them – and who passively accept the
consequences.
Some
health policy experts note that despite the wide
variations in knowledge
and assertiveness among patients, the
population is generally healthier now than ever,
so what’s
the difference? Others anticipate that everyone
taking statins will bring that Business Week
article to their next appointment and quiz their
doctor on her reasons for prescribing them.
Neither
view is realistic nor fair. While we
might believe that if only the FDA performed
well and if only
drug companies weren’t so greedy, we could
have confidence in the whole enterprise, this
isn’t going to happen.
So
what is realistic and fair? More to the point,
how vigilant must
we be? What do we need to know – and do – to
get safe, effective drugs?
I
am wary of the expectation that all of us – me, my 81-year-old mom,
and the guy who sells books in the street outside
my office – will now invest hours of our
time becoming sufficiently expert in the intricacies
of clinical trials to challenge our physicians’ prescription
decisions.
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