Center for Drug Safety and Effectiveness
Center for Injury Research and Policy
January 13, 2016
Tom Frieden, MD, MPH
Director, Centers for Disease Control and Prevention
Debra Houry, MD, MPH
Director, National Center for Injury Prevention and Control
Dear Drs. Frieden and Houry:
Today, more than fifty Americans will die from prescription opioids, and many more
lives will be shattered by these products. There is an epidemic of injuries and
deaths from prescription opioids in the United States. This public health crisis
frames our comments on the CDC’s proposed Guidelines.
We recently led an effort at the Johns Hopkins Bloomberg School of Public Health
to release a set of comprehensive recommendations, entitled “The Prescription
Opioid Epidemic: An Evidence-Based Approach.” We have submitted this report to
the Docket. Our recommendations were developed by a diverse group of national
experts including clinicians, researchers, government officials, injury prevention
professionals, law enforcement, lawyers and patient representatives. In addition to
supporting prescribing guidelines similar to the one the CDC proposes, we also
recommend changes to the way medical students and physicians are trained,
prescriptions are packaged and dispensed and monitored, first responders are
equipped to treat overdoses, those with addiction are identified and treated, and
communities are enabled to promote prevention. Comprehensive and coordinated
approaches to opioid-related injuries, addiction, and deaths offer the greatest
promise for reducing the incredible morbidity and mortality from these products.
These issues are urgent. At the current rate, about 15,000 Americans die from
overdose with these products every year. The epidemic has occurred in plain sight,
the trend lines are unmistakable even as far back as early 2000’s. Unfortunately,
the response of the federal and state governments, as well as health systems and
clinical communities, has been far too slow.
The CDC’s Guidelines focus on the initiation of opioids in primary care, a critical
area where clinicians urgently need more guidance. We are aware that CDC has
come under criticism for taking on this issue. Some have alleged the CDC’s
approach is not sufficiently evidence-based and may reflect the bias of a select
group of experts focused on opioid safety at the expense of effectiveness.
615 North Wolfe Street, W6035 • Baltimore, Maryland 21205 • www.jhsph.edu/cdse • [email protected]
Center for Drug Safety and Effectiveness
Center for Injury Research and Policy
We appreciate this opportunity to express our unqualified support for CDC’s
engagement in this area. We urge you to make appropriate changes based on
public comment and release the guidelines to the clinical community as soon as
possible.
Strength of the recommendations is well justified
Contrary to what some have claimed, the recommendations provide sufficient
scientific support to justify their strength, and the quality of evidence upon which the
“strong” recommendations are based is consistent with the standards for other
similar guidelines in clinical practice.
The topics that these guidelines address are never going to be subject to multiple
large, multicenter randomized trials, and even if they were, there would be such
bias in those trials based on recruitment that they would be difficult to apply to large
populations. A big part of the problem is that much of the “evidence” used for so
many years to promote opioids was paid for and promoted by the pharmaceutical
industry, and almost none was relevant to chronic opioid use. Despite how
frequently some argue that guidelines like these may hurt patients’ access to
effective pain treatments, there is absolutely no evidence to support such
assertions.
False dilemma between Guideline and high quality pain care
Much of the opposition to the Guidelines has been based on a faulty premise,
namely, that CDC’s dissemination of a set of recommendations will somehow harm
or jeopardize the care of those living with pain. This is a false dilemma that
presupposes there are only two options – reducing prescription opioid use or
maintaining patients’ access to beneficial treatments. There are multiple options for
doing both. In addition, the Guidelines are focused on opioid initiation in primary
care. They are not focused on those with cancer or who may be using opioids for
palliation or end-of-life care. Similarly, they are not focused on those who have
well-controlled chronic pain on therapeutically appropriate opioid regimens, nor on
those who may already have opioid dependency or addiction or otherwise not have
satisfactory clinical alternatives to prescription opioids. High quality care for those
with chronic pain is not jeopardized by guidelines such as these; in fact, it demands
it.
Greater need for transparency among those criticizing the guidelines
Another set of concerns raised by critics has to do with lack of transparency and
opportunity for public input. We support maximum transparency in all aspects of the
Guideline development process including the composition of the CDC’s expert
groups, and efforts to maximize the opportunity for relevant stakeholders to
participate. This is particularly important because as some have observed, in the
615 North Wolfe Street, W6035 • Baltimore, Maryland 21205 • www.jhsph.edu/cdse • [email protected]
Center for Drug Safety and Effectiveness
Center for Injury Research and Policy
absence of higher quality evidence, the Guidelines reflect a greater degree of
expert opinion than would otherwise be the case. In this setting, it is important for a
diversity of experts to be represented in the process. However, in this spirit, it is
also important for those opposing the idea that CDC can play a constructive role in
this area to disclose whether they have conflicts of interest, such as having
received payments from manufacturers of the medications in question.
Too often those involved in conversations about opioids fall into an unproductive
dichotomy. Those suffering from chronic pain who use opioids under medical
supervision to achieve some relief from their debilitating conditions are pitted
against those seeking to reduce the pain and suffering associated with prescription
opioid misuse, abuse, addiction, and overdose.
The simple fact is both sides should be able to agree that opioids have a place in
pain treatment, that the death toll from these drugs is too high, and that
interventions to reduce the risks and maintain the benefits are urgently needed.
We fully support the CDC’s efforts to establish meaningful Guidelines, and we
believe the recently proposed recommendations are consistent with the evidence
and do not represent any conflict between the laudable goals of improving the
safety of clinicians’ opioid prescribing and improving the quality of care for those
living with chronic pain.
Respectfully submitted,
G. Caleb Alexander, MD, FACP
Co-Director, Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg
School of Public Health
Alex Cahana, MD
Affiliate Professor of Science, Technology, Nursing and Health Studies, University
of Washington
Sydney M. Dy, MD, MSc
Associate Professor, Department of Health Policy & Management, Johns Hopkins
Bloomberg School of Public Health
John L. Eadie
Public Health and PDMP Project Coordinator, National Emerging Trends & Threats
Initiative, National HIDTA Assistance Center
615 North Wolfe Street, W6035 • Baltimore, Maryland 21205 • www.jhsph.edu/cdse • [email protected]
Center for Drug Safety and Effectiveness
Center for Injury Research and Policy
Shannon Frattaroli, PhD
Associate Professor, Department of Health Policy & Management, Johns Hopkins
Bloomberg School of Public Health
Andrea C. Gielen, ScD, ScM
Professor and Director, Center for Injury Research and Policy, Johns Hopkins
Bloomberg School of Public Health
Patrick Gleason, PharmD, FCCP, BCPS
Director of Health Outcomes, Prime Therapeutics
Andrew Kolodny, MD
Senior Scientist, Heller School for Social Policy and Management, Brandeis
University
615 North Wolfe Street, W6035 • Baltimore, Maryland 21205 • www.jhsph.edu/cdse • [email protected]
Center for Drug Safety and Effectiveness
Center for Injury Research and Policy
About the Johns Hopkins Center for Drug Safety and Effectiveness
Pharmaceuticals play a vital role in the health and longevity of millions, yet many
challenges prevent their optimal use. The goal of the Center for Drug Safety and
Effectiveness is to improve the safe and effective use of medicines. Drawing on the
combined expertise of the Johns Hopkins Bloomberg School of Public Health
and the Johns Hopkins School of Medicine, the Center serves as a nexus for
individuals at Johns Hopkins who are involved in research, education, clinical
programs and public service to improve prescription drug use and pharmaceutical
policy in the United States and around the world.
About the Johns Hopkins Center for Injury Research & Policy
Since 1987 the Center, based at the Johns Hopkins Bloomberg School of Public
Health, has led the effort to redefine injury as a pressing public health problem,
promote injury prevention as a scientific discipline, save lives, and reduce disability
from injuries -- like those caused by motor vehicles, violence, prescription drug
overdose, and fires. The Center conducts groundbreaking research, trains students
and practitioners, and collaborates with government, nonprofit, and corporate
partners worldwide. Our mission to close the gap between research and practice is
accomplished by measuring the incidence and impact of injuries, determining the
underlying causes, creating effective solutions, and translating evidence-based
research into effective policies and programs.
About the Johns Hopkins Bloomberg School of Public Health
As a leading international authority on public health, the Johns Hopkins Bloomberg
School of Public Health is dedicated to protecting health and saving lives. Every day,
the Bloomberg School works to keep millions safe from illness and injury by
pioneering new research, deploying its knowledge and expertise in the field, and
educating tomorrow’s scientists and practitioners in the global defense of human life.
Founded in 1916 as part of the Johns Hopkins University, the Bloomberg School of
Public Health is the world’s oldest and largest independent school of public health.
For 20 years, it has been ranked the No. 1 school of public health in the nation by
U.S. News & World Report.
About Johns Hopkins Medicine
From the 1889 opening of The Johns Hopkins Hospital, to the opening of the School
of Medicine four years later, there emerged the concept of combining research,
teaching and patient care. This model, the first of its kind, would lead to a national
and international reputation for excellence and discovery. Today, Johns Hopkins
uses one overarching name—Johns Hopkins Medicine—to identify its entire medical
enterprise. This $6.7 billion system unites the physicians and scientists of the Johns
Hopkins University School of Medicine with the health professionals and facilities
that make up the broad, integrated Johns Hopkins Health System.
615 North Wolfe Street, W6035 • Baltimore, Maryland 21205 • www.jhsph.edu/cdse • [email protected]