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ALABAMA PSYCHIATRIC PHYSICIANS CONFERENCE APRIL 8-10, 2016 SANDESTIN GOLF AND BEACH RESORT

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ALABAMA PSYCHIATRICPHYSICIANS CONFERENCE

APRIL 8-10, 2016SANDESTIN GOLF AND

BEACH RESORT

Prescribing Chronic Opioids Regulatory Implications.

WHAT IT WAS LIKE, WHAT HAPPENED AND WHAT IT IS

LIKE NOW

James Harrow M.D. Ph.D.Medical Director

Alabama Physician Health Program

No Disclosures

Dr. Harrow has no disclosure of real or apparent conflict related to the content of

this presentation.

Objectives

(1) To describe the history of prescription opioid abuse.

(2) To identify factors which have contributed to prescription opioid abuse in America.

(3) To summarize risks of prescribing controlled substances for chronic, non-life threatening conditions.

(4) Postscript

Psychiatrist Dr. Narendra Nagareddy from Georgia, is accused of overprescribing opiates and benzodiazepine to his patients.

Raided: Following a raid by Drug Enforcement Administration agents on Thursday, Dr. Narendra Nagareddy was arrested at his office in Jonesboro.

A doctor in Georgia has been labelled “Dr. Death” after he was arrested on suspicion of overprescribing prescription medication to his patients.

Of the 36 patients that have died within psychiatrist Narendra Nagareddy’s care, 12 have been killed from an overdose on prescribed medication.

Following a raid by Drug Enforcement Administration agents on Thursday, Dr. Nagareddy was arrested at his office in Jonesboro.

Nearly 40 federal and local agents raided his offices, before they seized assets from his home.

“He’s charged with prescribing pain medication which is outside his profession as a psychiatrist and not for a legitimate purpose for the patient,” said Clayton county district attorney Tracy Graham Lawson.

Since his license was issued in 1999, the doctor has received several online complaints referencing his prescription methods.

Aside from the criminal charges, the Clayton County District Attorney's Office has also applied to seize Nagareddy's assets under the Racketeer Influenced and Corrupt Organizations Act.

WHAT IT WAS LIKE

“Opium teaches only one thing, which is that aside from physical suffering, there is nothing real."

"There is always a need for intoxication: China has opium, Islam has hashish, the West has woman.“

André Malraux

(1901-1976)MAN'S FATE

Opium Poppy Papaver somniferumThe Plant Of Joy

Cut Pod With Raw Latex(Poppy tears, lachryma papaveris)

A Short History Of Opiumc.3400 B.C.

The opium poppy is cultivated in lower Mesopotamia. The Sumerians refer to it as Hul Gil, the “joy plant.”

c.1300 B.C.

In the capital city of Thebes, Egyptians begin cultivation of opium thebaicum.

c.460 B.C.

Hippocrates, "the father of medicine", dismisses the magical attributes of opium but acknowledges its usefulness as a narcotic and styptic in treating internal diseases, diseases of women and epidemics.

1300’s Opium disappears for two hundred years from European historical record. Opium had become a taboo subject for those in circles of learning during the Holy Inquisition. In the eyes of the Inquisition, anything from the East was linked to the Devil.

1500The Portuguese initiate the smoking of opium. They discovered the effects were instantaneous.

1601Ships chartered by Elizabeth I are instructed to purchase the finest Indian opium and transport it back to England.

1680English apothecary, Thomas Sydenham introduces Sydenham's Laudanum, a compound of opium, sherry wine and herbs. His pills along with others of the time become popular remedies for numerous ailments.

1700The Dutch export shipments of Indian opium to China and introduce the practice of smoking opium in a tobacco pipe to the Chinese.

1750The British East India Company assumes control of Bengal and Bihar, opium-growing districts of India. British shipping dominates the opium trade out of Calcutta to China.

1799China's emperor, Kia King, bans opium completely, making trade and poppy cultivation illegal.

1800The British Levant Company purchases nearly half of all of the opium coming out of Turkey strictly for importation to Europe and the United States.

Elizabeth Barrett Browning

The English Victorian poet Elizabeth Barrett Browning initially took laudanum to treat her childhood spinal tuberculosis. She became a lifelong addict. However, for her opium was a source of poetic inspiration; and letters between Elizabeth and her husband Robert Browning abound with images of scarlet poppies.

1803

Friedrich Serturner of Paderborn, Germany discovers the active ingredient of opium by dissolving it in acid then neutralizing it with ammonia. The result: alkaloids -Principium somniferum or morphine.

1816

John Jacob Astor of New York City joins the opium smuggling trade. His American Fur Company purchases Turkish opium then ships to Canton. Astor later leaves the China opium trade and sells solely to England.

1839

Lin Tse-Hsu, imperial Chinese commissioner in charge of suppressing the opium traffic, orders all foreign traders to surrender their opium. In response, the British send expeditionary warships to the coast of China, beginning The First Opium War.

1843

Dr. Alexander Wood of Edinburgh administers morphine with a syringe. He finds the effects of morphine on his patients instantaneous and three times more potent.

1856

The British and French at war with China in the Second Opium War. China is forced to pay another indemnity. The importation of opium is legalized.

1874

English researcher, C.R. Wright first synthesizes heroin, or diacetylmorphine, by boiling morphine over a stove.

1895

Heinrich Dreser working for the Bayer Company finds that diluting morphine with acetyls produces a drug without the common morphine side effects. Bayer begins production of diacetylmorphine and coins the name "heroin." Heroin would not be introduced commercially for another three years.

Early 1900s

The philanthropic Saint James Society in the U.S. mounts a campaign to supply free samples of heroin through the mail to morphine addicts who are trying give up their habits.

1905

U.S. Congress bans opium.

Dec. 17, 1914

The passage of Harrison Narcotics Act to curb drug (especially cocaine but also heroin) abuse and addiction. It requires doctors, pharmacists and others who prescribed narcotics to register and pay a tax.

William Stewart HalsteadThe "father of American surgery" took morphine for the last thirty years of his extremely successful life. From 1889, William Stewart Halsted was first chief of the Department of Surgery at Johns Hopkins Hospital. In 1892 he was promoted to Professor of Surgery. Halsted's drug habit was revealed in William Osler's posthumously published The Inner History of Johns Hopkins Hospital. Few of Halsted's colleagues had any idea that their brilliant mentor was addicted to morphine. Halsted had ready access to inexpensive, high-grade morphine. So he did not encounter some of the problems common to users of street narcotics in prohibitionist society.

1964

Methadone maintenance began as a research project at the Rockefeller University in 1964, under the joint direction of Dr. Vincent P. Dole and Dr. Marie E. Nyswander.

1970

Comprehensive Drug Abuse Prevention and Control Act of 1970 regulates manufacture, importation, possession, use and distribution of certain substances. Created the five Schedules of controlled substances.

2000

The Drug Addiction Treatment Act permits physicians who meet certain qualifications to treat opioid addiction with Schedule III, IV and V narcotic medications that have been specifically approved by the Food and Drug Administration for that indication.

Prior Opioid Addiction Epidemics

1. Late 1800s: MorphineMainly middle classFemale > Male

2. Early 1900s: Heroin (pharmaceutical grade)First generation Italians, Jews, IrishMale > Female

3. 1950s-1970s- Heroin (illicit)African American/Latinos Male > Female

“God's Own Medicine”Sir William Osler

Morphine, 9-14%, opiate analgesic , named after Morpheus, the Greek God of dreams.

Codeine, 0.5%, opiate analgesic.

Thebaine, 1.5-0.3%. Important intermediate for the synthesis of semisynthetic opioids e.g. Buprenorphine.

Papaverine 1%, smooth muscle relaxant.

(Poppy Seeds) UDS--Opiate, Morphine, Codeine.

Opium Alkaloids

OpioidsMorphine

Codeine

Thebaine

Diacetylmorphine (Heroin)

Hydrocodone (Vicodin)

Oxycodone (Oxycontin)

Oxymorphone (Opana)

Hydromorphone (Dilaudid)

Naturally occurring opiates or opioids

Semi-synthetic opioids

Metabolism Of Opioids

The Mesolimbic Reward Pathway

The Reward Pathway

Why Do People Like Opioids

Extremely powerful psychotherapeutic effects which are likely much stronger than the pain relieving effects.

Relieve the emotional distress of pain.

Excellent at relieving anxiety and treating depression for a limited time.

Treatment of choice for short-term, end of life situations.

Current Preferences of Drug SeekersShort acting narcotics: oxycodone, hydrocodone

Used fentanyl patches; 28-84% of drug remains in used patches

Tramadol alone or in combination

Sustained release drugs

Heroin increased availability

US Consumption of Global Supply of Opioids:2010

55% of all morphine

56% of all hydromorphone

80% of all oxycodone

99% of all hydrocodone

Americans represent 5.2% of the earth’s population(International Narcotics Control Board 2011 Report)

111 Tons Dispensed in 2010!!!

69 tons of pure oxycodone

42 tons of pure hydrocodone

(NSDUH, 2011 reported in CDC Vital Signs, January 2012)

Alabama Consumption of Opioids

#1 prescribed drug in Alabama 2012 Hydrocodone/acetaminophen

(ProPublica Report, 2013)

WHAT HAPPENED

A Drug Looking For a Disease

The Eye of the Perfect Storm…

The use of opioids for chronic non cancer pain (CNCP)

The Fifth Vital Sign

Industry-Funded Organizations Campaignedfor Greater Use of Opioids

Pain Patient Groups

Professional Societies

The Joint Commission

The Federation of State Medical Boards

How the Industry Frames the Problem

Source: Slide presented by Lynn R. Webster MD at FDA meeting on hydrocodone up scheduling, January 25th, 2013.

Opioid Manufacturers Continue to Advertiseas Safe and Effective for Chronic Pain

How Many Americans Have Chronic Pain

“moderate to severe chronic pain that limits activities and diminishes quality of life”

25 million Americans

(Annals of Internal Medicine. Position Paper.2015;162:295-300)

Opioid addiction is rare in pain patients.

Physicians are needlessly allowing patients to suffer

because of “opiophobia.”

Opioids are safe and effective for chronic pain.

Opioid therapy can be easily discontinued.

Industry Funded Education Emphasizes:

Industry Marketing

Purdue “aggressively” promoted the use of opioidsfor use in the “non-malignant pain market.”

Targeted primary care.

“Risk of addiction much less than 1%.”

1998 training video sent to thousands of physicians.

(OxyContin Marketing Plan, 1999; Purdue Pharma, Stamford, CN, 1999)

Industry Marketing

Pseudoaddiction: Describes patients whomanifest aberrant, drug-seeking behavior.

“Result of untreated pain, not addiction.”

Recommended treatment: dose escalation.

Problem: how to differentiate from addiction orhyperalgesia?

Industry Maxim

Opioids are safe and effective for chronic pain.

Opioid addiction is rare in pain patients.

Opioid therapy can be easily discontinued.

Opiophobia: causes patients to needlessly suffer.

Introduction of OxyContin: 1996

Active ingredient: oxycodone

Manufactured by Purdue Pharma

$44 million in sales in 1996

(OxyContin Marketing Plan, 1999)

Dollars Spent Marketing OxyContin 1996 - 2001

› Source: United States General Accounting Office: Dec. 2003, “OxyContin Abuse and Diversion and Efforts to Address the Problem.”

OxyContin Sales 2010

$3.1 billion in sales in 2010

Over $17 billion in sales 2000-2010

(IMS Health, National

Prescription Audit

December 2010)

Purdue Pharma Pays $634.5 Million

US Senate investigation resulted in guilty plea on

May 10, 2007.

Misled regulators, doctors and patients about the

enormous addiction and abuse potential of OxyContin.

Opioid Prescriptions Dispensed per Year(Oxycodone and Hydrocodone)

Opioid Prescriptions Dispensed by RetailPharmacies United States, 1991 - 2011

76 78 8086

9196

100109

120

131139

144151

158

169

180

192201 202

210219

0

50

100

150

200

250

1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

Nu

mb

er o

f Pre

scri

pti

on

s (i

n m

illio

ns)

Year

WHAT IS IT LIKE NOW

Prescription Drug Abuse Affects Everyone Prescription medications are among the

top substances abused by 12th graders in the past year.

In 2011, more than 4,500 young people per day abused a prescription drug for the first time.

All ages are affected.

Older Americans

2009: approximately 1 U.S. infant born per hour with signs of drug withdrawal.

55 to 94 percent of neonates exposed to opioids in utero experience withdrawal.

People taking high daily doses of opioids. People who “doctor shop.”People using multiple substances like opioids,benzodiazepines, other CNS depressants, illicit drugs.Low-income people and those living in rural areas.Medicaid populations.People with substance abuse or other mental healthissues.

High Risk Populations

White AG, Birnbaum HG, Schiller M, Tang J, Katz NP. Analytic models to identify patients at risk for prescription opioid abuse. Am J Managed Care 2009;15(12):897-906. Hall AJ, Logan JE, Toblin RL, Kaplan JA, Kraner JC, Bixler D, et al. Patterns of abuse among unintentional pharmaceutical overdose fatalities. JAMA 2008;300(22):2613-20. Paulozzi LJ, Logan JE, Hall AJ, et al. A comparison of drug overdose deaths involving methadone and other opioid analgesics in West Virginia. Addiction 2009;104(9):1541-8. Dunn KM, Saunders KW, Rutter CM, Banta-Green CJ, Merrill JO, Sullivan MD, et al. Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med2010;152(2):85-92. Bohnert AS, Valenstein M, Bair MJ, Ganoczy D, McCarthy JF, Ilgen MA, et al. Association between opioid prescribing patterns and opioid overdose-related deaths. JAMA2011;305(13):1315-1321.

Pain Patients

“DrugAbusers”

63% admitted to using opioids forpurposes other than pain

35% met DSM V criteria for addiction

.

This is a false dichotomy as aberrant druguse behaviors are common in pain patients

92% of opioid OD decedents were prescribed opioids for chronic pain.

Toxicology Results in Chronic PainPatients on Opioid Therapy

Emergency Department Visits Related toMisuse or Abuse United States, 2004-2010

0

200,000

400,000

600,000

800,000

1,000,000

1,200,000

1,400,000

1,600,000

2004 2005 2006 2007 2008 2009 2010

Nu

mb

er o

f ED

Vis

its

Year

Illicit Drugs Pharmaceuticals Opioid Pain Relievers Benzodiazepines

Primary Substance of Abuse at TreatmentAdmission – United States, 2000-2010

0

2

4

6

8

10

12

14

16

18

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Ad

mis

sio

ns

per

10

,00

0 P

op

ula

tio

n

Year

Alcohol only Alcohol w/secondary drug Heroin

Other opiates Cocaine Marijuana/hashish

Stimulants Other drugs

Opiate-Related Admissions to SUD Treatment(Rates per 100,000 population >12; non-heroin)

Rates for opiates were 400 % higher in 2010 than in 2000.

Rates increased in every year from 2000-2010.

TEDS 2012

62

Prescription Drugs: Primary Driver ofOverdose Deaths in U.S. (2010)

Jones et al. JAMA 2013; and CDC/NCHS 2010. 

Drug Overdose Deaths by Major DrugUnited States, 1999-2010

0

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000

18,000

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Nu

mb

er o

f Dea

ths

Year

Opioids Heroin Cocaine Benzodiazepines

All Prescription Drug Overdose Deaths,United States, 2001-2014

0

5,000

10,000

15,000

20,000

25,000

30,000

Total Female Male

Source: CDC Wonder

All Illicit Drug Overdose Deaths, United States, 2001-2014

0

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000

18,000

20,000

  Total   Female   Male

Source: CDC Wonder

Cocaine Overdose Deaths, United States, 2001-2014

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

  Total   Female   Male

Benzodiazepine Overdose Deaths, United States, 2001-2014

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

9,000  Total   Female   Male

Prescription Opioid Overdose Deaths,United States, 2001-2014

0

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000

18,000

20,000  Total   Female   Male

Source: CDC Wonder

Drug Overdose Deaths Involving Opioids, byType of Opioid, United States, 2000-2014

Opioid Overdose Death Rates by AgeGroup United States 1999-2011

Rates of Opioid Overdose Death Rates, Sales, AndTreatment Admissions, United States, 1999-2010

0

1

2

3

4

5

6

7

8

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Rat

e

Year

Opioid Sales KG/10,000 Opioid Deaths/100,000 Opioid Treatment Admissions/10,000

Unintentional Overdose Deaths Involving Opioid Analgesics Parallel Per Capita Sales of Opioid

Analgesics in Morphine Equivalents by Year, U.S1997-2007

0100200300400500600700800

0

2000

4000

6000

8000

10000

12000

14000

'97 '98 '99 '00 '01 '02 '03 '04 '05 '06 '07

Source: National Vital Statistics System, multiple cause of death dataset, and DEA ARCOS

* 2007 opioid sales figure is preliminary.

Number of Deaths

Opioid sales (mg/person)   

73

Motor Vehicle Traffic, Poisoning, and DrugPoisoning (Overdose) Death Rates

United States, 1980–2010

NCHS Data Brief, December, 2011. Updated with 2009 and 2010 mortality data.

0

5

10

15

20

25

1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010

Dea

ths

per

10

0,0

00

po

pu

lati

on

Year

Motor Vehicle Traffic Poisoning Drug Poisoning (Overdose)

Morbidity and Mortality with PrescriptionPain Medication Abuse

2004-2011: Increases in Emergency Department visits related to opioid analgesic misuse:

Men: 159% Women: 146%

2010: Deaths related to opioid analgesic use: 16,651 (313% increase over past decade); most deaths involved opioids + other drugs/alcohol

For every death, there were:o 11 treatment admissionso 33 Emergency department visitso 880 non-medical users

CDC, 2013, SAMHSA TEDS, 2001-11, SAMHSA/DAWN, 2011

Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)

Primary non-heroin opiates/synthetics admission rates,by State (per 100,000 population aged 12 and over)

Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)

Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)

Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)

Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)

Number of Prescriptions for Opioids Per Person, United States, 2012

Unintentional Drug Overdose DeathsUnited States,1970-2007

Unintentional Drug Overdose DeathsUnited States,1970-2007

Unintentional Drug Overdose DeathsUnited States, 1970-2007

Unintentional Drug Overdose DeathsUnited States,1970-2007

Unintentional Drug Overdose DeathsUnited States,1970-2007

Heroin Overdose Deaths United States 2001-2014

Heroin Addiction and Overdose Deaths,United States, 2002-2013

Rate of Past Year Heroin Use Increasing 2003: 314,000 users

2012: 669,000 (80% increase in 5 years)

2013: 681,000

Trending upward as prescription drugs become less available.

75% of heroin users report previous abuse of opioid pain medication.

Conclusion and Relevance: Our data show that thedemographic composition of heroin users enteringtreatment has shifted over the last 50 years such thatheroin use has changed from an inner-city, minority-centered problem to one that has a more widespreadgeographical distribution, involving primarily white menand women in their late 20s living outside of large urbanareas. JAMA Psych 5/14v

Opioids for CNCP: Quality of Evidence

Patient Selection and Risk Stratification: low quality.

Initiation and titration of chronic opioid therapy: low quality.

Use in high risk patients: low quality.

ALL are based on low quality evidence.

(2009 American Pain Society Guidelines)

Opioids for CNCP: Quality of Evidence

High dose therapy(≥120 morphine equivalents/day):

low quality.

Driving and work safety: low quality.

Treatment of breakthrough pain: low quality.

ALL are based on low quality evidence.

(2009 American Pain Society Guidelines)

Opioids for CNCP: Quality of Evidence

No prospective study has clearly demonstrated long-term safety or long-term efficacy, in terms of functional improvement.

No prospective study has clearly demonstrated long-term analgesia.

Long-term benefits for chronic pain have not been established.

(2009 American Pain Society Guidelines)

Efficacy of Opioids for Dental Pain AfterWisdom Tooth Extraction?

2013 quantitative systematic review in the Journal of the American Dental Association.

“325 mg of acetaminophen (APAP) taken with 200 mg of ibuprofen provides better pain relief than oral opioids.”

(National Safety Council WHITE PAPER, 2014)

Opioids for Treatment of Back Pain?

2013 journal article in Spine.

Patients “initially” treated with opioids (for lumbar disc herniation) had a higher rate of surgery and a greater chance of being on opioids four years later but no significant change in overall outcome.

(National Safety Council WHITE PAPER, 2014)

Long Term (>16wks.) COT for CNCP“..No high quality evidence on the efficacy of COT

for CNCP.” no RCT lasting >3mos

“Until 2003, opioid addiction associated with the treatment of CNCP was clearly a neglected topic of publication.”

Long-term Opioid Treatment of Chronic Nonmalignant Pain: Unproven Efficacy and Neglected Safety. Kissin, Igor Journal of Pain Research, 2013:6 513-529

Has Pain Gotten Better

“Americans suffered as much disability from back pain in 2010 as they did in 1990 before the escalation in the prescribing of opioids.” (Murray, 2013)

A 2008 JAMA study found that:

“…from 1997 to 2005, there was no improvement in self-assessed health status, functional disability, work limitations, or social functioning among respondents with spine problems.” (Martin et al., 2008, p. 661)

“I think that after 20 years of a failed experiment that there are not many people supporting this except for the die-hards and the pharmaceutical industry.”

Jane C. Ballantyne, MD FRCAProfessor, Univ. of Washington

Source: New York Times, April 9, 2012. “Tightening the Lid on Pain Prescriptions.”

New England Journal of Medicine 1980Jan10;302(2):123.

R & D Costs for New Drugs

Why are prescription medications so expensive???

“Drug companies spend 19 times more on marketing than Research & Development.”

(BMJ 2012; 345:e4348)

Are Drugs Profitable?

2012 US Senate Investigation May 8, 2012

“allegations of a network of national organizations and researchers, (including physicians, pain societies and regulatory agencies) with financial connections to the makers of narcotic painkillers.

…helped create a body of dubious information favoring opioids “that can be found in prescribing guidelines, patient literature, position statements, books and doctor education courses.”

Citizens Petition to FDA: July 2012 1.“To exercise its regulatory responsibility” Strike the term "moderate" from the indication for non-cancer pain.

2. Add a maximum daily dose, equivalent to 100 milligrams of morphine for non-cancer pain.

3. Add a maximum duration of 90-days for continuous (daily) use for non-cancer pain.

FDA ResponseSeptember 10, 2013

“Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.”

ER/LA Opioids no longer indicated for moderate pain.

Warnings about Neonatal Abstinence Syndrome.

FDA ResponseOctober 24, 2013

FDA to recommend to DEA to reschedule hydrocodone from schedule III to schedule II.

“This determination comes after a thorough and careful analysis of extensive scientific literature, review of hundreds of public comments on the issue, and several public meetings…”

FDA Response:

October 25, 2013

Approves Zohydro ER

Pure hydrocodone in capsule form, with no abuse deterrent.

FDA ignores Advisory Committee recommendation against approval December 7, 2012 which had voted 11-2 against approval.

FDA Approves Zyhydro ER Bob Rappaport, MD director of the FDA's Division of Anesthesia, Analgesia, and Addiction Products:

"Many patients in the U.S. suffer from untreated or poorly treated chronic pain. Further limiting access to potential treatments is not the answer when new treatments are critically needed.”

"I firmly believe that the benefits of this product outweigh its risks."

Latest Evidence… 2014 AmericanAcademy of Neurology Position Paper

Opioids for chronic, noncancer pain

“No substantial evidence for maintenance of pain relief over longer periods of time, or significant evidence for improved physical function.”

(Franklin, 2014)

Latest Evidence… 2014 AmericanAcademy of Neurology Position Paper

“The risks for chronic opioid therapy for some chronic conditions such as headache, fibromyalgia, and chronic low back pain likely outweigh the benefits.”

(Franklin, 2014)

US Opioid Epidemic Fueled by Prescribing Practices

The United States is facing the worst "man-made epidemic"of opioid abuse in the history of modern medicine, and it isthe direct result of poor research and outdated teachingpractices, according to a leading pain expert.

The most important step toward reversing the epidemic ofprescription opioid abuse is to stop prescribing opioids forthe wrong indications.2015, Gary Franklin, MD, MPH, vice president of Physicians forResponsible Opioid Prescribing

“Reality is a crutch for people who can't handle drugs"

George Bernard Shaw(1856 - 1950)

I'll die young, but it's like kissing God"

Lenny Bruce

POST SCRIPT

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More than 90% of people who overdosed onprescription painkillers can still get refills, study says.

Physician Convicted of MurderDoctor convicted of murder after three patients overdosed on 'crazy and outrageous' amount of painkillers she prescribed

Dr. Hsiu-Ying 'Lisa' Tseng was convicted of murder after three of her patients overdosed on painkillers she prescribed

The second-degree murder convictions of Dr Tseng were the first against a U.S. doctor for recklessly prescribing drugs

A dozen of Tseng's patients died, though prosecutors only brought three murder charges

Tseng barely kept any records on the three men until she was contacted by the Medical Board of California

Tseng also ignored pleas from family members of patients who demanded she stop prescribing drugs to them

By ASSOCIATED PRESS and DAILY MAIL ONLINE REPORTER

PUBLISHED: 21:13 EST, 30 October 2015 | UPDATED: 18:30 EST, 31 October 2015

'Pill Mill' doctor pleads guilty to moneylaundering and drug distribution

MONTGOMERY, AL (WSFA) -A physician in Montgomery has pleaded guilty to conspiring to distribute oxycodone and money laundering, according to George L. Beck Jr., the United States Attorney for the Middle District of Alabama.According to Attorney Beck, 48-year-old Francisco Huidor-Figureoa pled guilty to one count of conspiring to distribute oxycodone and one count of conspiring to commit money laundering. During the plea hearing, Dr. Huidor-Figureoa admitted to working as a doctor at a "pill mill", which is a medical clinic created to sell pills unlawfully, illegally, and for no medical reason.

Dr. Huidor-Figureoa was the sole physicianemployed by the EMED Medical ManagementCorporation, which operated a "pill mill" in Opelikabetween 2012 and 2013. Officials say while workingat the "pill mill", Dr. Huidor-Figureoa soldoxycodone to pill dealers with fraudulentprescriptions when there was no medical purpose.Dr. Huidor-Figureoa also assisted the "pill mill's" twoowners, Erik Torres and Marc Adam of SouthFlorida, in laundering the money generated fromthe prescriptions.

The United States District Attorney's office for theMiddle District of Alabama says Dr. Hudior-figureoa knew that the recipients of these illegal pillsdid not need the medicine and that the recipientsintended to either abuse the pills or sell the pills toothers who would abuse them.Dr. Huidor-Figueroa faces up to 20 years in prisonfor each count. He also faces a maximum fine of$1,000,000 for conspiring to distribute oxycodone.For the money laundering conspiracy count, themaximum fine he could pay is $500,000 or twice thevalue of the property involved in the transaction,whichever is greater.

Case Presentation66 year old male with the following medical diagnoses:

1. Type II insulin dependent diabetes mellitus

2. Hypertensive vascular disease

3. Hyperlipidemia

4. Peripheral arterial disease

5. Suspect coronary artery disease

6. Carotid artery disease

7. Osteoarthritis

8. Chronic alcoholism

9. Diabetic peripheral neuropathy

10. Bilateral total knee arthroplasties

11. Chronic pain syndrome

12. Moderate opioid use disorder

Prescribed hydrocodone in 2006 to 2008 from seven physicians.

September 2008 prescribed Fentanyl 100 ugm every three days for three months.

Patient continued to drink alcohol.

He was seen in follow up by his physician in March and June 2009

Medications:

1. Clonidine o.4 mg HS

2. Cymbalta 60 mg QD

3. Demadex 20 mg QD

4. Glucovance 5/500 mg BID

5. Zestril 20 mg QD

6. Zocor 40 mg QD

7. Levemir insulin 50 units QD

8. Fentanyl patch 100 ugm Q3days

June 8, 2009 the patient was found dead in his home sitting in a chair.

Personal physician called and notified.

Autopsy and complete forensic drug testing ordered by physician.

Family refused and descendent cremated.

June 2011 plaintiff attorney notified physician for complete copy of medical record.

Law suit filed in county court naming pharmaceutical company and physician as defendants in wrongful death claim.

Case kept in Alabama State Court by naming physician to prevent trial in Federal Court

Late 2012 pharmaceutical company settled with plaintiff for $25,000.00

Case against physician summarily dismissed in March 2013

Cost of defending case against physician $150,000.00

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We seek to put more heart and soul back into addiction medicine.

We are all passionate in our belief that psychosocial and spiritual interventions are always important and that medication management alone is not adequate.

We also believe that prescribing medication for opioid addiction without providing and/or prescribing other psychosocial and spiritual interventions falls far short of “best practice” for an addiction medicine specialist.

We are believers in the great benefits of 12 step recovery modalities in facilitating long-term recovery.

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