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.
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Jessie
Gruman
President
and Executive Director
Center for the
Advancement of Health
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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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