Lipitor, Other Statins May Reduce Risk of Heart
Attack for Men Only, Yet Marketed to Women
Billions of dollars may be being wasted on statin use
by women to lower cholesterol, prevent heart disease
September
17, 2008 – Lipitor has been the top-selling drug in the world and has
accounted for over $12 billion in annual sales. It has been prescribed
to both men and women to lower cholesterol and reduce the risk of heart
attack and stroke in patients with common risk factors for heart
disease. A new study, however, was unable to find “high quality”
clinical evidence documenting reduced heart attack risk for women in a
primary prevention context.
Key Points from Study Abstract
This article
presents:
(1) meta-analyses of studies of cardioprotection of women
and men by statins, including Lipitor (atorvastatin), and
(2) a legal analysis of advertising promoting Lipitor as
preventing heart attacks.
The
meta-analyses of primary prevention clinical trials show
statistically significant benefits for men but not for women,
and a statistically significant difference between men and
women.
The analyses do
not support -
(1) statin use to reduce heart attacks in women based on
extrapolation from men, or
(2) approving or advertising statins as reducing heart
attacks without qualification in a population that includes many
women.
The legal
analysis raises the question of whether Lipitor's
advertisements, which omit that Lipitor's clinical trial found
slight increased risk for women, is consistent with the Food,
Drug, and Cosmetics Act and related Food and Drug Administration
(FDA) regulations.
The analysis
suggests that FDA regulation should not preempt state law
actions challenging advertising that is not supported by
FDA-approved labeling.
Our findings
suggesting inadequate regulation of the world's best-selling
drug also counsel against courts accepting the FDA's claimed
preemption of state law causes of action relating to warnings
and safety. Courts evaluating preemption claims should consider
actual agency performance as well as theoretical institutional
competence.
Billions of
health-care dollars may be being wasted on statin use by women
but the current regulatory regime does not create incentives to
prevent such behavior.
Furthermore, advertising omits label information
relevant to women, according to the report in the Journal of
Empirical Legal Studies.
Theodore Eisenberg of Cornell Law School and Martin
T. Wells of Cornell University assembled studies for a meta analysis of
drugs’ effects on cardiovascular risk, taking into account all relevant
studies reporting risks for both men and women.
Not one of the studies that included women with a
mixture of risk factors for heart attacks provided statistically
significant support for prescribing Lipitor or other statins to protect
against cardiovascular problems.
Pfizer’s claims of clinical proof that Lipitor
reduces risk of heart attack in patients with multiple risk factors for
heart disease does not appear to be scientifically supported for large
segments of the female population.
In addition, Lipitor’s advertising repeatedly fails
to report that clinical trials were statistically significant for men
but not for women.
Unqualified advertising claims of protection
against heart attacks may therefore be misleading. Pfizer’s advertising
also does not disclose critical portions of the Lipitor FDA-approved
label, which acknowledges the absence of evidence with respect to women.
“Our findings indicate that each year, reasonably
healthy women spend billions of dollars on drugs in the hope of
preventing heart attacks but that scientific evidence supporting their
hope does not exist,” the authors conclude.
This study is published in the September 2008 issue
of the Journal of Empirical Legal Studies. Media wishing to receive a
PDF of this article may contact
journalnews@bos.blackwellpublishing.net.
To view the abstract for this article,
click here.
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Journal of Empirical Legal Studies (JELS)
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left scholars, lawyers, and policymakers without basic knowledge of
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have been covered in leading news outlets such as the New York Times,
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Times, and USA Today.
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September
17, 2008 – Lipitor has been the top-selling drug in the world and has
accounted for over $12 billion in annual sales. It has been prescribed
to both men and women to lower cholesterol and reduce the risk of heart
attack and stroke in patients with common risk factors for heart
disease. A new study, however, was unable to find “high quality”
clinical evidence documenting reduced heart attack risk for women in a
primary prevention context.