from Barbara Alving, Acting Director,
National Heart, Lung and Blood
IMMEDIATE RELEASE CONTACT:
September 24, 2004
NHLBI Communications Office(301) 496-4236
Guidelines: The Strength of
the Science Base
the Integrity of the Development Process
from Barbara Alving, M.D., Acting Director,
Heart, Lung, and Blood Institute
letter initiated by the Center for Science in the Public Interest
on the National Cholesterol Education Program (NCEP) to form an
panel to review the Adult Treatment Panel III (ATP III,
for cholesterol management and a 2004 update to these
The September 23 letter, signed by CSPI Executive
Michael Jacobson, PhD, and 34 physicians and researchers, questions the
basis and objectivity of these clinical practice guidelines.
National Institutes of Health and the National Heart, Lung, and Blood
(NHLBI), which coordinates the NCEP, are preparing a detailed
to the letter. The ATP III
recommendations and the update are
on a careful analysis of strong and abundant scientific evidence.
guidelines are objective and the process by which they were developed
its creation in 1985, the NCEP has sought to educate health
and the public about high blood cholesterol as a risk
for coronary heart disease (CHD) and the benefits of lowering
in the prevention of CHD. The
NCEP is a partnership. At its
core is the
Committee, composed of representatives of over 35 partner
including major medical and health professional
voluntary health organizations, community programs, and governmental
The NCEP, under the sponsorship of the Coordinating
has developed a series of science-based clinical guidelines on
management, known as Adult Treatment Panel reports.
These reports are
by a panel of scientific experts and undergo thorough review by
Coordinating Committee and other recognized scientific authorities
III, like the two previous guideline reports from the NCEP, was
on an extensive examination of the scientific evidence by a panel of
scientific experts. This
report has been well received and widely
by the medical community. In
July of 2004, the NCEP issued
update to ATP III, based on an analysis of 5 new clinical trials of
lowering with statin drugs. The
update was drafted by a
group selected for their expertise from the members of the original ATP
and an expert representative of the American Heart Association (AHA) and
the American College of Cardiology (ACC).
The update paper was reviewed
the NCEP Coordinating Committee and by the scientific and steering
of AHA and ACC, and was endorsed by NHLBI, AHA, and ACC.
update offered therapeutic options for the physician's consideration
than firm recommendations for the most part.
This was done in
of the fact that there are a number of ongoing clinical
that will address the benefits of lowering LDL cholesterol well below
recommended goal levels.
CSPI-initiated letter specifically calls into question the ATP III
recommendations for cholesterol lowering in moderately high
women and the elderly who do not have heart disease.
NHLBI affirms the
rationale for these recommendations.
Using all available
trial and epidemiological evidence is a well-founded and widely
approach to the development of clinical practice guidelines.
applies this approach to all recommendations to lower cholesterol - both
changes and medication - as well as to all populations,
women and the elderly.
is abundant clinical trial and epidemiological evidence showing
lowering LDL cholesterol (by statins or other means) prevents heart
in men with or without prior coronary heart disease. In addition, there
considerable evidence from trials of patients with coronary heart
or other high risk conditions that statins benefit women and men, older
patients, and those with and without diabetes.
the coronary arteries is a lifelong gradual process, there is no
basis to believe that cholesterol lowering suddenly becomes beneficial
moment a person has a heart attack. It
is far more consistent with the
body of scientific evidence to hold that cholesterol lowering is
beneficial in people without heart disease, but becomes even more
after a heart attack, when the person's risk for a future heart attack
clinical trials, including the Heart Protection Study, strengthen
III recommendations for older persons, an age group which exhibits the
risk for heart attacks. Regarding
research on women, this same
trial included over 5,000 high-risk women and showed the same
of LDL-lowering therapy as observed in men.
In this trial, over 1,800
had diabetes and they too benefited from LDL lowering.
trials have not included large numbers of moderately high risk women
heart disease), epidemiological studies show that these women
just as likely to develop cardiovascular disease as men.
ATP III thus
the same guidelines to both men and women at moderately high
is imperative that we apply what we have learned from research in
to prevent or delay the development of heart disease, the leading killer
women and men. For tens of
thousands of Americans, including women and
elderly, the first sign of heart disease is sudden death.
policy demands that the significant risk for illness and death in
and the elderly be addressed with science-based prevention
letter also questions the ATP III recommendation that high-risk
with diabetes should be considered for cholesterol-lowering drug
In fact, there is conclusive clinical trial evidence that
drug therapy significantly reduces cardiovascular
for patients with diabetes, both those with and without existing heart
This finding has been amply documented by a major primary
trial in patients with diabetes that was published after the
III update. Once a person
with diabetes develops cardiovascular
the mortality rate is very high, so the objective in diabetes treatment
to prevent the development of cardiovascular disease in the first place.
trials show that cholesterol lowering contributes significantly
attaining this objective.
letter questions the objectivity of ATP III and the update, stating
the recommendations "may not be scientifically justified" since
have had interactions with the pharmaceutical industry.
before that the experts who are most knowledgeable in a subject
are also the same people whose advice is sought by industry, and most
panels include experts who interact with industry.
the guidelines are objective and science-based, NHLBI employs a rigorous
and review process. Expert panel members are carefully
for their scientific and medical expertise and their integrity, multiple
of reviewers scrutinize the drafts of the guidelines from a
of scientific perspectives, and financial disclosure is published by the
journals and organizations are currently reexamining their
to managing disclosure of financial interests.
NHLBI is developing
policy in this area to refine the process for management of potential
summary, the ATP III guidelines and update were developed using a
evidence-based process that has high integrity.
derived from an objective analysis of the substantial scientific
and NHLBI stands behind them. There are several clinical trials in
individuals currently underway. The
results of these trials will help
whether revisions to the current recommendations are
warranted. At that time, NCEP
will consider establishing
detailed information on the issues raised by the letter and the
response to the letter will be made available after the response to the
has been finalized. The ATP III guidelines and update can be found online
is part of the National Institutes of Health (NIH), the Federal
primary agency for biomedical and behavioral research. NIH
a component of the U.S. Department of Health and Human Services. NHLBI
releases and fact sheets can be found online at www.nhlbi.nih.gov
Read also Malcolm Kendrick´s comment