As presented with minor modification
Oral testimony by:
Jack E. Henningfield, Ph.D.
Vice President, Research, Health Policy, and Abuse Liability
Pinney Associates
and
Professor, Adjunct, Behavioral Biology
Department of Psychiatry and Behavioral Sciences
The Johns Hopkins University School of Medicine
Sidney H. Schnoll, M.D., Ph.D.
Vice President, Risk Management Services
Pinney Associates
and
Karen K. Gerlach, Ph.D., M.P.H,
Senior Scientist and Co-Director, Clinical and Behavioral Research
Pinney Associates
To:
Food and Drug Administration
Public Hearing and Request for Comments:
Impact of Approved Drug Labeling on
Chronic Opioid Therapy
February 7-8, 2013
Bethesda Marriott Hotel
[Docket No. FDA–2012–N–1172]
Good morning. I am Jack Henningfield, Vice President for Research, Health
Policy and Abuse Liability at Pinney Associates, and Adjunct Professor of
Behavioral Biology at The Johns Hopkins University School of Medicine. I
have been involved in drug addiction research and policy over four decades.
I prepared my comments with input from Dr. Sidney Schnoll and Dr. Karen
Gerlach. Dr. Schnoll is a world recognized expert in addiction medicine and
pain treatment Dr. Gerlach is an epidemiologist and public health leader
formerly with the National Cancer Institute, the CDC and the Robert Wood
Johnson Foundation. We care about families suffering from opioid abuse
AND people suffering with pain.
PinneyAssociates helps pharmaceutical companies develop and market drugs
to minimize the risks of abuse and overdose. I am neither representing nor
speaking on behalf of any client today. I am here at the expense of
PinneyAssociates.
Our main message is to caution FDA about the adverse public health effects
from regulatory actions that hinder patient care without actually addressing
opioid abuse and overdose.
There are several points on which we think most agree and thus serve as a
foundation for action:
1. Opioid medications are vital for the treatment of many types of pain
2. Effective and safe patient care requires responsiveness to the individual
needs of each patient
3. Most prescription opioid abuse does not occur among those who have
been prescribed these drugs
4. Most overdose deaths involve multiple drugs including alcohol
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5. Proposals to improve care and reduce abuse should be evidence-based
These points underlie our concerns about the labeling recommendations
under consideration today.
We do have a science base for effective action. This includes strategies to
identify patients at elevated risk of abuse and how to manage their pain,
strategies to minimize overdose risks, prescription monitoring programs, and
the development of abuse deterrent opioids.
We should also heed the recommendations of the 2011 Institute of Medicine
report on pain and its care. The IOM concluded that a “population-level
prevention and management strategy” is needed to address pain treatment
and mitigate the risks of non-medical opioid use. Ensuring appropriate use,
storage, and disposal of prescription opioids are challenges that must be
more effectively addressed by the FDA, industry, healthcare providers,
patients, law enforcement, and the public together.
Let me briefly review the evidence supporting petitioner proposals and other
actions. We provide additional analysis in our written submission.
First, there is no evidence that arbitrarily limiting the maximum daily
prescribed dose of opioid analgesics will deter unethical prescribing. This
action would more likely have a chilling effect on ethical medical
practitioners and hurt people with pain. Arbitrarily setting a maximum dose
will impede individualized patient care. Furthermore, the data show that the
dose of a prescribed opioid is not typically the main cause of overdose
deaths. These deaths often involve concomitant use of other drugs such as
alcohol and benzodiazepines.
The petition, at times conflates opioid abusers and pain patients. But
patients and opioid abusers are not the same people. Most people being
treated for pain do not and will not abuse opioids. Conversely, most abusers
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get their opioids outside of the health care system – probably without labels.
The 2009 National Survey on Drug Use and Health showed that nearly 70% of
non-medical users obtained their opioids from family or friends: 17%
obtained the opioid from 1 or more doctors; and, 9% purchased them from a
friend, dealer, or the internet.
Furthermore, most opioid-related deaths involve multiple drugs. Our
colleague Dr. Ed Cone analyzed 1,014 oxycodone-related deaths and found
only 3.3% (n=30) of these deaths involved oxycodone alone. 96.7% involved
at least one other drug that may have contributed to the death. These
included benzodiazepines, alcohol, cocaine, and other opioids.
A 2010 study of opioid-related emergency department visits by Braden and
colleagues “did not observe a clear dose response effect”
Such studies emphasize the differences in nonmedical users and patients.
They support the need for improved prescriber and patient education that
emphasizes the risks posed by these drugs, proper use including dose
titration, and improved patient monitoring.
Reducing overdose outside of medical care will require stronger efforts by
substance abuse control programs including increased access to drug abuse
treatment.
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The new FDA guidance on abuse deterrent opioids is encouraging and likely
to accelerate the development of beneficial opioids with reduced abuse
potential. This guidance reflects the evidence that the formulation of a drug
affects its safety and abuse potential. There are a variety of approaches in
the pipeline, and FDA should use this regulatory tool to foster the
development of potential advances to serve people in pain and reduce nonmedical use and overdose.
Patient care could be improved and abuse reduced by more effective
education of health care providers, patients, and their family members and
caregivers. One challenge here is that target populations have diverse
educational and cultural backgrounds. Educational efforts must be formally
evaluated to ensure they are working as intended.
FDA is also considering recommendations to reschedule hydrocodone
combination products to Schedule II. We believe this will do little to deter
abuse and will likely adversely affect the treatment of people with pain. We
encourage FDA to pursue alternatives to rescheduling and relabeling in
collaboration with the Institute of Medicine and major health professional
and patient advocacy organizations.
In conclusion, we are encouraged by several ongoing and emerging efforts.
More must be done to address prescription opioid abuse and the broader
problems of opioid and other drug abuse. But changing labels is not the
answer to better patient care or control of opioid abuse and overdose. More
effective education is vital. We must match the diversity of opioid-using
populations and problems with evidence-based risk management. New
medications and formulations are already showing signs of benefit. We look
forward to working with the FDA and others to find effective solutions to
these problems.
PinneyAssociates, Inc.
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