TM

Centers for Disease Control and Prevention National Center for Injury Prevention and Control

Less Is More

Len Paulozzi, MD, MPH

2014 CSTE Annual Meeting, Nashville, TN, June 25, 2014

Health care spending per person versus

life expectancy at birth by country, 2011*

0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000 9,0006567697173757779818385

Chile

Mexico

Health Spending per Capita, US$ PPP

Year

s

Norway

Portugal

*Or nearest year.Source: OECD Health Statistics 2013, http://dx.doi.org/10.1787/health-data-en; World Bank for non-OECD

countries.

USA

Where the United States spends more than other countries, 2012

Treatment United States Rate

Rank Among 40OECD Countries

MRI exams 98 per 1,000 2nd

CT exams 265 per 1,000 3rd

Tonsillectomy 254 per 100,000 1st

Coronary bypass 79 per 100,000 3rd

Knee replacements 226 per 100,000 1st

Caesarean sections 33 per 100 live births

6th

Source: Organization for Economic Cooperation and Development (OECD) Health Data 2012

Thesis Too much health care for some parts of the

population We pay costs in terms of negative health

effects We get fewer benefits than we realize Focus on pharmaceuticals

34% of global spending on medications

5% of world population

Spending on drugs, United States, 2011

IMS Institute, 2012. The global use of medicines; outlook through 2016.

6

Total prescription rate, United States, 2007-2012

2007 2008 2009 2010 2011 201210

11

12

13

14

15

16

Pres

crip

tion

s pe

r pe

rson

Source: IMS Vector One® National (VONA) Extracted July, 2013

Increase from 13.1 to 13.5 prescriptions per person from 2007 to 2012.

Percent of population using 3+ prescription drugs in past 30 days by

sex and year

Males Females0

5

10

15

20

25

30

9.4

13.914.8

20.419.122.5

1988-94 1999-2002 2007-2010

Perc

ent

Source: NHANES. Cited in NCHS, Health United States, 2013Percents are age-adjusted, all ages are included.

Percent of population using 3+ prescription drugs in past 30 days

by race/ethnicity and year

White Black Hispanic0

5

10

15

20

25

30

12.4 12.69

18.916.5

11.2

22.420.7

15

1988-94 1999-2002 2007-2010

Perc

ent

Source: NHANES. Cited in NCHS, Health United States, 2013Percents are age-adjusted, All ages are included.

9

Adverse Drug Reac-

tions

Adverse Drug Events

Adverse Drug

Reactions

Examples of drugs associated with adverse drug events/reactions

I. AntibioticsII. Spinal steroid injectionsIII. Fen-phenIV. Opioid analgesics

I. Antibiotics Clostridium difficile infections

250,000/yr in hospitalized patients Antibiotic resistance Adverse events

E.g., allergic reactions Antibiotics among the most frequent causes of adverse

drug events among U.S. hospitalized patients

Fridkin et al. Vital signs: improving antibiotic use among hospitalized patients. MMWR 2014;63:194-200.

Penicillin resistance in S. pneumoniae isolates by income, Atlanta, 1994

2,50

0

7,50

0

12,50

0

20,00

0

30,00

0

42,50

0

62,50

0

87,50

0

125,0

00

010203040506070

Median household income ($)

Pct r

esis

tant

isol

ates

X2 for trend: 15.17, p = 0.002

Chen et al. Geocoding and linking data from population-based surveillance and the US Census to evaluate the impact of median household income on the epidemiology of invasive Streptococcus pneumoniae infections. Am J Epidemiol 1998;148:1212

Unnecessary antibiotics 30% of antibiotics received by hospitalized

adult patients outside of critical care unnecessary1

Among outpatient visits for acute respiratory infection in one state, 68% resulted in an antibiotic prescription Of those, 80% “unnecessary” according to CDC

guidelines 2

1. Hecker et al. Arch Intern Med 2003; 163:972-978.2. Scott et a. J Fam Pract 2001; 50:1-10.

II. Spinal steroid injection Fungal infections associated with

contaminated methylprednisolone injections, 2012-2013

749 cases, 61 deaths, in 20 states1

59% female, median age 64 Most injections epidural, most for low back pain2

1. Smith et al. NEJM 2013;369:1598-16092. Chiller et al. NEJM 2013;369:1610-1619

Who gets epidural steroid injections (ESI)?

Study of geographic variation in Medicare patients with back pain, 2001 1

ESI rate not associated with prevalence of back pain

ESI rates vary 8-fold by state 4% in Alabama 0.5% in Hawaii Highest rates in South

ESI rates vary 18-fold by health referral region 17% patients in Palm Springs, CA 1% patients in the Bronx, NY City

1. Friedly et al. J Bone Joint Surg 2008;90:1730-1737.

Effectiveness of epidural steroid injections

Cochrane review of injection therapy for subacute and chronic low back pain, 2012: “Insufficient evidence to support use of injection

therapy.”1

Systematic review and meta-analysis of epidural corticosteroid injection in the management of sciatica, 2012: “[Injections] offer only short-term relief of leg pain and

disability for patients with sciatica.”2

1. Staal. Cochrane Collaboration at www.thecochranelibrary.com2. Pinto. Ann Intern Med 2012; 157:865-877

III. Obesity drugs: The binge and purge of fen-phen

Surgeon General’s Report on Nutrition and Health, 1988 Over 30 million Americans overweight Recommends treating like any other chronic disease

“Actual Causes of Death” paper in JAMA by CDC authors, 1993 300,000 deaths due to diet and activity patterns

McGinnis.et al. JAMA. 1993;270(18):2207-2212.

Hunt for a drug to treat the chronic disease of obesity

1992 Clinical trial of fenfluramine and phentermine N =121, mostly women 34 weeks in length Intervention arm lost 30 lbs, placebo lost 10 lbs.

1996 Dex-phenfluramine (Redux) by Wyeth Dextro isomer of fenfluramine introduced because

fenfluramine was coming off patent FDA approved it for moderately to severely obese people

for long-term maintenance—first drug to get that labelWeintraub. Clin Pharmacol Ther 1992;51:615-618

Frenzy of fen-phen sales As in the trial with 30 lb weight loss, doctors

prescribed Redux (fenfluramine) with amphetamine (phentermine) to balance Redux’s sedating effect

Combination called “fen-phen” Three weeks after Redux approval, doctors

writing 85,000 prescriptions per week Fen-phen “pill mills” multiply Eventually, up to 5 million Americans took

fenfluramine or Redux

Time Magazine 9/23/96

TIME: “Redux really seems to work. But is it too good to be true?”

DHHS recommendations on fen-phen

Novem ber 14, 1997 / Vol. 46 / No. 45

Cardiac Valvulopathy Associated with Exposure to Fenfluramine or Dexfenfluram ine: U.S. Department of Health and Human Services

Interim Public Health Recommendations, November 1997

Unnecessary anorexiants Wyeth’s own studies of Redux:

Intervention group lost 5% of body weight Placebo group lost 2%

3% difference = 6 pounds lost Weight regained after drug use stopped Used by many people who were not obese

IV. Opioid analgesics The beginning: 1986

“The present survey… provides suggestive evidence that opioid medication can be safely and effectively prescribed to selected patients with relatively little risk of producing the maladaptive behaviors which define opioid abuse. Given the paucity of data, however, this course must be pursued cautiously.”

Portenoy et al 1986; Pain 25:171

Chronic Use of Opioid Analgesics in Non-Malignant Paine: Report of 38 Cases

Russell Portnoy and Kathleen Foley

OxyContin sales, 1996-2002

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

1996 1997 1998 1999 2000 2001 20020

1,000,0002,000,0003,000,0004,000,0005,000,0006,000,0007,000,0008,000,000

27

Rates of opioid overdose deaths, sales and treatment admissions, U.S., 1999-

2011

National Vital Statistics System, DEA’s Automation of Reports and Consolidated Orders System, SAMHSA’s TEDS

99 00 01 02 03 04 05 06 07 08 09 10 11012345678 Sales KG/10,000 Deaths/100,000

Rate

Drug overdose death rates by race and ethnicity, United States, 1979-2011

Note: Includes overdose of all types of drugs. Source: National Vital Statistics System

79 81 83 85 87 89 91 93 95 97 99 01 03 05 07 09 1102468

1012141618

White BlackNonHispanice White Hispanic White

Dea

th r

ate

per

100,

000

Lack of effectiveness of opioid use for chronic pain

Women’s Health Initiative Study: Women 50-79 with chronic pain followed 3 years Baseline opioid use associated with

• no improvement in pain • worsened physical functioning1

Chronic opioids for osteoarthritis “Small to moderate benefits of opioids… Outweighed by large increases in the risk of adverse

events.”2

Data on long-term safety and efficacy of opioids are limited.3

1. Braden 2012. J Pain 13:64-722. Nuesch, 2010. Oral or transdermal opioids for osteoarthritis of the knee or hip (Review) Cochrane

Collaboration at www.thecochranelibrary.com3. Noble 2008. J Pain Sympt Management 35:214

Common themes across examples Increasing use of drugs treating chronic

conditions, e.g., back pain, obesity Drugs marketed for “public health

problems” Drugs tested for much shorter times than

they were used in practice Evidence base for long-term effectiveness poor Limited data on long-term risks

Used for patients with milder disease than labeled

White women at greatest risk of drug use

Conclusions Adverse events from health care significant

public health problems Benefits > risks? Limited appreciation early of possible

unwanted consequences of new medical technology

Re-apportion care in our communities so more goes to people who really would benefit from it

Len Paulozzi, MD, MPHlpaulozzi@cdc.gov

The findings and conclusions in this report are those of the author and do not necessarily represent the official position of the Centers for Disease Control and Prevention/the Agency for Toxic Substances and Disease Registry. The presenter has no conflicts of interest to report.

Thank you