Transcript Number of Months from End of Data Year to Data Release

Less Is More
Len Paulozzi, MD, MPH
Centers for Disease Control and Prevention
National Center for Injury Prevention and Control
2014 CSTE Annual Meeting, Nashville, TN, June 25, 2014
TM
Health care spending per person versus
life expectancy at birth by country, 2011*
85
83
Norway
81
Years
79
Portugal
Chile
77
USA
75
Mexico
73
71
69
67
65
0
2,000
4,000
6,000
8,000
Health Spending per Capita, US$ PPP
10,000
*Or nearest year.
Source: OECD Health Statistics 2013, http://dx.doi.org/10.1787/health-data-en; World Bank for non-OECD countries.
Where the United States spends more
than other countries, 2012
Treatment
United States Rate
Rank Among 40
OECD Countries
MRI exams
98 per 1,000
2nd
CT exams
265 per 1,000
3rd
254 per 100,000
1st
79 per 100,000
3rd
Knee replacements
226 per 100,000
1st
Caesarean sections
33 per 100 live births
6th
Tonsillectomy
Coronary bypass
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
Spending on drugs, United States, 2011
5% of world
population
34% of global spending
on medications
IMS Institute, 2012. The global use of medicines; outlook through 2016.
Total prescription rate,
United States, 2007-2012
Prescriptions per person
16
15
14
13
Increase from 13.1 to 13.5
prescriptions per person from
2007 to 2012.
12
11
10
2007
2008
2009
2010
2011
2012
Source: IMS Vector One® National (VONA) Extracted July, 2013
6
Percent of population using 3+ prescription
drugs in past 30 days by sex and year
30
1988-94
1999-2002
2007-2010
25
22.5
Percent
20
14.8
15
10
20.4
19.1
13.9
9.4
5
0
Males
Source: NHANES. Cited in NCHS, Health United States, 2013
Percents are age-adjusted, all ages are included.
Females
Percent of population using
3+ prescription drugs in past 30 days by
race/ethnicity and year
30
1988-94
25
1999-2002
2007-2010
22.4
20.7
18.9
Percent
20
16.5
15
15
12.6
12.4
11.2
9
10
5
0
White
Black
Source: NHANES. Cited in NCHS, Health United States, 2013
Percents are age-adjusted, All ages are included.
Hispanic
Adverse Drug Events
Adverse
Drug
Reactions
9
Examples of drugs associated with
adverse drug events/reactions
I.
II.
III.
IV.
Antibiotics
Spinal steroid injections
Fen-phen
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
Pct resistant isolates
70
60
X2 for trend: 15.17, p = 0.002
50
40
30
20
10
0
2,500
7,500
12,500 20,000 30,000 42,500 62,500 87,500 125,000
Median household income ($)
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.
2.
Hecker et al. Arch Intern Med 2003; 163:972-978.
Scott et a. J Fam Pract 2001; 50:1-10.
II. Spinal steroid injection




1.
2.
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
Smith et al. NEJM 2013;369:1598-1609
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.
2.
Staal. Cochrane Collaboration at www.thecochranelibrary.com
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 label
Weintraub. Clin Pharmacol Ther 1992;51:615-618
Frenzy of fen-phen sales

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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: “Redux
really seems to
work. But is it too
good to be true?”
Time Magazine 9/23/96
DHHS recommendations on fen-phen
November 14, 1997 / Vol. 46 / No. 45
Cardiac Valvulopathy Associated
with Exposure to Fenfluramine or Dexfenfluramine:
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%
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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
Chronic Use of Opioid Analgesics in
Non-Malignant Paine: Report of 38 Cases
Russell Portnoy and Kathleen Foley

“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
OxyContin sales, 1996-2002
8,000,000
7,000,000
6,000,000
5,000,000
4,000,000
3,000,000
2,000,000
1,000,000
0
1996
1997
1998
1999
2000
2001
2002
Source: United States General Accounting Office: Dec. 2003, “OxyContin Abuse and Diversion and Efforts to Address the
Problem.”
Rates of opioid overdose deaths, sales and
treatment admissions, U.S., 1999-2011
8
Sales KG/10,000
Deaths/100,000
Treatment Admissions/10,000
00
04
08
7
6
Rate
5
4
3
2
1
0
99
01
02
03
05
06
07
09
10
11
National Vital Statistics System, DEA’s Automation of Reports and Consolidated Orders System, SAMHSA’s TEDS
27
Drug overdose death rates by race and
ethnicity, United States, 1979-2011
White
Black
NonHispanice White
Hispanic White
Death rate per 100,000
18
16
14
12
10
8
6
4
2
0
79 81 83 85 87 89 91 93 95 97 99 01 03 05 07 09 11
Note: Includes overdose of all types of drugs. Source: National Vital Statistics System
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 13:64-72
2. Nuesch, 2010. Oral or transdermal opioids for osteoarthritis of the knee or hip (Review) Cochrane Collaboration at
www.thecochranelibrary.com
3. Noble 2008. J Pain Sympt Management 35:214
Common themes across examples
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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

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Used for patients with milder disease than labeled
White women at greatest risk of drug use
Conclusions

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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
Thank you
Len Paulozzi, MD, MPH
[email protected]
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.