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News from Cambridge Health Alliance
March 9, 2010
Majority of Drug Studies Fail to Provide Key Information
Doctors Need to Prescribe
Only a third of studies directly compare effectiveness
of available treatments, according to new JAMA study
Cambridge, MA…Only 32 percent of medication studies published
in top medical journals help doctors decide which available treatments
work best. The remainder either examine unapproved medications that
are currently not available to doctors or compare drugs against
no treatment or a placebo, according to researchers at Harvard Medical
School/Cambridge Health Alliance and the University of Southern
California.
The new study, published in the March 10 issue of the Journal
of the American Medical Association (JAMA), provides the first
formal investigation of such drug analyses, called comparative effectiveness
studies. Last year, the U.S. Congress appropriated $1.1 billion
in funding for comparative effectiveness research as part of the
American Recovery and Reinvestment Act.
"Research on new therapies is critical for scientific advancement,
but we also need data that will help doctors use existing therapies
appropriately," said lead author Michael Hochman, MD. "We
need research that addresses questions such as: Which of the more
than 30 blood pressure medications on the market works best and
in whom? Are certain diets and exercise regimens as good as medications
for controlling cholesterol? Is it safe to aim for normal blood
sugar levels when treating patients with diabetes? Such information
is critical for day-to-day medical decision-making."
The authors reviewed 328 medication studies published between June
2008 and September 2009 in six leading general medicine and internal
medicine journals and found that 104 (32%) qualified as comparative
effectiveness studies.
In addition to highlighting the paucity of comparative effectiveness
research, the study also revealed substantial limitations of existing
comparative effectiveness studies. For example, just 11 percent
compared medications with non-pharmacologic therapies (such as lifestyle
changes or surgery), and less than a third compared different medication
strategies (such as the optimal blood sugar target in patients with
diabetes). The rest compared medications with each other.
"Most of the comparative effectiveness studies we reviewed
simply tested whether medication 'x' is better than medication 'y,'
rather than addressing fundamental questions such as: How can we
use this medication more effectively? When is this medication better
than surgery? Which among two effective approaches is the safest?"
said Danny McCormick, MD, MPH, primary care physician at Cambridge
Health Alliance, assistant professor of medicine at Harvard Medical
School, and the study's senior author.
The study also found that just 19 percent of the comparative effectiveness
studies focused on medication safety. In addition, only two percent
included cost-effectiveness analyses - data that would be helpful
to patients, doctors, and insurers (private or government) alike.
The authors conjecture that medication research provides limited
information about existing therapies because the pharmaceutical
industry - which funds the majority of major clinical trials - focuses
its research on the development of new, marketable products rather
than on available medications. Indeed, according to the new research,
almost 90% of the comparative effectiveness studies relied on non-commercial
funding, such as nonprofit foundations or government institutions.
"Many of our nation's research priorities are driven by the
pharmaceutical industry," said Dr. Hochman, an assistant professor
of clinical medicine at the Keck School of Medicine at the University
of Southern California. "These companies, not surprisingly,
focus most of their attention on new therapies. If we hope to increase
the amount and improve the quality of comparative effectiveness
studies, the funding will most likely need to come from government
institutions."
"Characteristics of Published Comparative Effectiveness Studies
of Medications." JAMA. 2010. 303(10); 951-958. Authors: Michael
Hochman, MD, and Danny McCormick, MD, MPH.
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