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Less Is More

Less Is More

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Less Is More

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  1. Less Is More Len Paulozzi, MD, MPH 2014 CSTE Annual Meeting, Nashville, TN, June 25, 2014

  2. Health care spending per person versus life expectancy at birth by country, 2011* USA *Or nearest year. Source: OECD Health Statistics 2013, http://dx.doi.org/10.1787/health-data-en; World Bank for non-OECD countries.

  3. Where the United States spends more than other countries, 2012 Source: Organization for Economic Cooperation and Development (OECD) Health Data 2012

  4. 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

  5. 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.

  6. Total prescription rate, United States, 2007-2012 Increase from 13.1 to 13.5 prescriptions per person from 2007 to 2012. Source: IMS Vector One® National (VONA) Extracted July, 2013

  7. Percent of population using 3+ prescription drugs in past 30 days by sex and year Source: NHANES. Cited in NCHS, Health United States, 2013 Percents are age-adjusted, all ages are included.

  8. Percent of population using 3+ prescription drugs in past 30 days by race/ethnicity and year Source: NHANES. Cited in NCHS, Health United States, 2013 Percents are age-adjusted, All ages are included.

  9. Adverse Drug Events Adverse Drug Reactions

  10. Examples of drugs associated with adverse drug events/reactions • Antibiotics • Spinal steroid injections • Fen-phen • Opioid analgesics

  11. I. Antibiotics • Clostridium difficileinfections • 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.

  12. Penicillin resistance in S. pneumoniaeisolates by income, Atlanta, 1994 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

  13. 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 Hecker et al. Arch Intern Med 2003; 163:972-978. Scott et a. J FamPract 2001; 50:1-10.

  14. 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 Smith et al. NEJM 2013;369:1598-1609 Chiller et al. NEJM 2013;369:1610-1619

  15. 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.

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

  17. 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.

  18. 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. ClinPharmacolTher 1992;51:615-618

  19. 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

  20. TIME: “Redux really seems to work. But is it too good to be true?” Time Magazine 9/23/96

  21. DHHS recommendations on fen-phen

  22. 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

  23. 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.” Chronic Use of Opioid Analgesics in Non-Malignant Paine: Report of 38 Cases Russell Portnoy and Kathleen Foley Portenoy et al 1986; Pain 25:171

  24. OxyContin sales, 1996-2002 Source: United States General Accounting Office: Dec. 2003, “OxyContin Abuse and Diversion and Efforts to Address the Problem.”

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. Thank you Len Paulozzi, MD, MPH lpaulozzi@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.