FDA Opioid Policy Steering Committee Workshop

Silver Spring MD

Appeal to the FDA: Cease, Halt and Refocus

Richard A Lawhern, PhD

Co-Founder and Corresponding Secretary
Alliance for the Treatment of Intractable Pain

January 30, 2018

 Take-Away Points
 FDA is Chasing the Wrong Opioid Crisis
 FDA REMS Will Harm Many, Help Almost None
 FDA Should Stand Down from Further Regulation
 Take a Breath Before Doing Even More Harm
 Refocus on Recall and Revision of CDC Opioid
Guidelines
 Politically Biased Against Opioid Therapy
 Weak Evidence for Most Recommendations
 Dangerously Incomplete on Opioid Metabolism
Pill Counting and Supply Restriction Aren't Working
 The Wrong Opioid Crisis
 Overdose Deaths Are Dominated by Street Drugs
– Heroin, Imported Fentanyl, Diverted Morphine,
Methadone
 ~75%+ Addicts Start with “Prescription” Drugs and Alcohol
• Most Drugs Diverted, Not Prescribed by Doctors
 Typical New Addict and Typical Pain Patient Are Different
People
 Addicts = Adolescent and Early-20s Males
• Chronic unemployment, family trauma, mental-health issues.
• Medically under-served.
 Patients = Women Age 40 and Older (60/40 ratio or higher)
• Accident trauma, failed surgery, fibromyalgia, neuropathy, CRPS,
Arachnoiditis
• Older women whose lives are stable enough to see a doctor for pain
are rarely addicts
 FDA REMS Questions
1. Specify Dose Limits?
2. How To Ensure Compliance, Measure Outcomes?
3. Nationwide Prescription History Database?
4. How to Assess Outcomes, Impact of PMDP?
5. Additional Patient Education Requirements?
6. Additional Patient Storage Safety Measures?
7. Unit of Use Packaging?
8. Mechanism for Patient Drug Returns?
 1. Specify Drug Amount Thresholds
For Additional Risk/Benefit Reviews?

 CDC Guidelines Already Specify 50/90 MMED Thresholds

- Weak Evidence, Conflations, Omissions
- Failed to Consider Opioid Metabolism, Polymorphism
- Guarantee Failure of Therapy for ~30% of Pain Patients
 Guidelines Created Hostile Regulatory Environment
- Doctors Leaving Pain Management
- Thousands of Patients Deserted, Discharged, Tapered
- Disability and Suicide Rising, Particularly Among Vets
 There is No One-Size-Fits-All Patient or Treatment Plan
- Dose Limitations, Rigid Pill Counting Directly Harm Patients
- Frequent Physician Revisits Help Few, Harm More
 2. Ensuring Compliance, Measuring Outcomes
 Compliance Would Require Frequent DEA/State
Monitoring of All Physicians and Pharmacies
 Pain Patients Are A Small Minority Among Addicts
 The Dominant Public Narrative is a Mythology
 Few Patients Quickly Become Addicted
 Few Doctors Are Casual About Prescribing
 Major Drug Distribution Firms and Pill Mills Are A
Much Larger Problem
 Washington Post and 60 Minutes Reports
 More Doctor Regulation Is NOT A Useful Answer
 3. A National PDMP?
 Done Naively, National PDMP Will Cost 100s of Millions and
Produce Nothing
 Defense Integrated Military Human Resource System
(DIHMRS) 1995-2010
 Integrate 50 Existing Incompatible State PMDPs? Sorry, No!
 Replace With Top-Down Federal Data Architecture
 Populate With 50 Custom Translator Programs
 Encrypted High Speed Networks, Real-Time Biometric ID
Systems in All Doctor Offices, Pharmacies
 Secure Data Servers, Backup in All US Counties
 Patient Protections from “Doctor Shopping” False Alarms
 Require 60-Second Access and Processing
 High Value Target for Insider Corruption / Data Thefts
4. Assess Impact of Natl PDMP Requirement?

 Impact On Addiction, Opioid Deaths Likely Too

Small to Measure
– Doctor Shopping Contributes Too Little
• False Alarms Damage Patients
– Broad Error Limits on 90% Conf Intervals
 Impact on Doctors & Patients Predictable,
Major
 More Doctors Leaving Pain Management
 More Patients Discharged, Deserted, Coerced
 More Patient Disability, Medical Decline, Deaths
 5. More Patient Education?
 Pain Patients Are Mostly NOT the Problem!
 Doctors No Longer Casual About Opioids
 Few Pain Patients Are Addict “Drug Seekers”
 More Time Spent = Higher Cost for Fewer Patients
Treated
 Revised Med School Curricula Needed
 Pain is #1 Reason Why People See a Doctor
 100 Million-Plus US Citizens Have Pain Every Year
 WHO Ladder of Pain Treatment ~ 1980
 Workup Can Detect Patients At Risk for Abuse
• Urine Test Cost, False Alarms Must Come Down
 May 2017 FDA Workshop on Physician Education
 6. Improve Patient Storage of Opioids?
 Diversion From Home Is An Issue
 Surveys Don't Assess Theft vs Sharing by Family
 Burglars, Kids Target Medicine Closets
 BUT: Addiction Not Sustained From Home
Sources
 Larger Issue = Mass Corporate Diversion to Pill Mills
 An Idea for Patients Treated 60 Days+
 Armored, Secured “Pill Safe”
 Medicine closet insert, bolted through wall studs
 Biometric locks keyed to patient / designated proxy
 Should Cost <$200 in Full Scale Manufacture
 7. Unit of Use Packaging?
 Limited Utility in Patient Safety
– Few OD deaths among current patients (<8%)
– Impact dwarfed by other variables
• Depression, anxiety, sedation, poly-pharmacy
 Crowding Pharmacy Secure Storage
 No One-Size-Fits-All Patient Or Treatment
– Not even within a single diagnosis
– Many patients well managed >2500 MMEDD
 8. Patients Return Unused Pills?

 Current Hostile Regulatory Climate Discourages

Returns
 Automated Appointment Notification Systems Could
Follow Patients, Encourage Returns
 Police Stations or Pharmacies With Secure Storage
Are Logical Points of Return
– Problematic in inner cities, rural areas
 Community Centers, Doctor Offices Aren't Secure
Enough
 FDA Needs to Re-Focus
 FDA Is Now Chasing the Wrong Opioid Crisis
 Over-Regulation May Make the Real “Crisis” Worse
 Drive more doctors out of pain management
 Drive more patients into disability, death
 Veterans Administration a particular problem
 Practice standards demand zero opioid use
 2016 CDC, VA Guidelines Must Be Suspended, Rewritten
 Led by pain management doctors in community practice
 Publicly transparent process including patient
advocates as voting members of writers group
 CDC Opioid Prescription Guidelines Profoundly Flawed
 Lack of Long Term Studies of Opioid Effectiveness Conflated
With Lack of Long Term Effectiveness
 Omitted 2010 Cochrane Review, other reports
 Major Weaknesses in Medical Evidence
 Arbitrary and weakly supported risk/benefit review
threshold → coerced tapering down of patients
 Naïve Over-Confidence in “Alternative” Therapies
 AHRQ Systematic Review on Non-Invasive, Non-
Pharmacological Therapies, 12/2017 Draft
 Trials Literature Very Weak, Reliability Doubtful
 Variable Opioid Metabolism, Polymorphism Not Addressed
 Dangerous Inconsistencies in MMEDD Models Ignored
 Plea to the FDA: “Take a Breath!”
 Dominant Public Narrative on Opioid Meds is Wrong
 Fewer than 10% of chronic pain patients at risk to
addiction
 Lost in the noise among millions of other addicts
 Addicted patients are unrepresentative
• should not drive regulatory policy
 Alternatives to CDC Guidelines Point the Way
 Federation of State Medical Boards April 2017
 No explicit dose limits or thresholds
 FDA – and DEA – Stand Down From Persecuting
Doctors and People in Pain
 Required Reading
Stephen A. Martin, MD, EdM; Ruth A. Potee, MD, DABAM; and Andrew Lazris, MD, “Neat, Plausible, and Generally
Wrong: A Response to the CDC Recommendations for Chronic Opioid Use.” Medium.com, September 7, 2016

Richard A. Lawhern, “Warning to the FDA – Beware of ‘Simple’ Solutions in Chronic Pain and Addiction”, National Pain
Report, June 1, 2017

Bob Tedeschi, “A ‘civil war’ over painkillers rips apart the medical community — and leaves patients in fear,” Stat News,
January 17, 2017

Carl L. Hart, “People are Dying Because of Ignorance, not Because of Opioids,” Scientific American, November 1, 2017.

Maia Szalavitz, “Opioid Addiction Is a Huge Problem, But Pain Prescriptions Are Not the Cause.” Scientific American, May
10, 2016

Jeffrey A. Singer, MD, “Let’s Stop The Hysterical Rhetoric About The Opiod Crisis,” Cato Institute, August 31, 2017

Jacob Sullum, “Opioid Commission Mistakenly Blames Pain Patients for Opioid Crisis” Reason Magazine Blog, November
2, 2017

George Knapp, “The Other Side of Opioids,” Coast to Coast AM Radio interviews, November 26, 2017

George Knapp, “The Other Side of Opioids” on Las Vegas Live, Television News Channel 8, Las Vegas. December 30, 2017

Josh Bloom, Ph.D., “The Opioid Epidemic in 6 Charts Designed to Deceive You”, American Council on Science and Health,
October 12, 2017, Hashtag #OurPain

Jeffrey Miron, “Do Opioid Restrictions Reduce Opiod Poisonings?” Cato At Liberty – Cato Institute, February 17, 2017

Michael E Schatman and Stephen J Ziegler, “Pain Management, Prescription Opioid Mortality, and the CDC – is the Devil in
the Data?” Journal of Pain Research, October 20, 2017

Jeffrey Fudin, Mena Raouf, Erika L Wegrzyn, Michael E Schattman, “Safety Concerns With the Centers for Disease Control
Opioid Calculator, ” Journal of Pain Research, December 18, 2017

Agency for Healthcare Research Quality - Comparative Effectiveness Review, “Noninvasive, Nonpharmacological Treatment
for Chronic Pain: A Systematic Review,” (Draft circulated December 2017).
Backup Slides
 Who Are We?
 Alliance for the Treatment of Intractable Pain
 ~200 Doctors, Nurses, Other Healthcare
Professionals, Writers, Knowledgeable Patients
and Caregivers
 All Volunteers – No Financial Conflicts of
Interest
 Reach ~80,000 by Email, Twitter, Facebook
(Web page pending)
 Advocate for ~3 Million Chronic and Intractable
Pain Patients Managed on Opioid Analgesics
The Death Toll (2015)