Introduction

Drugs already developed have brought tremendous benefits: preventing hospitalizations, eliminating surgeries, or getting a patient out of an institution. And even more important are the benefits of these medicines in terms of saved lives, reduced suffering, and more productive and fulfilling lives.1 Scott Gottlieb, M.D., Deputy Commissioner for Medical and Scientific Affairs, Food and Drug Administration, March 2006

Introduction

Introduction
As the U.S. population grows and ages, health care needs are expanding. Diseases that affect the elderly are increasingly prevalent. Health care spending is quickly rising. Prescription medicines improve health and health care finances by saving lives helping avert surgeries and trips to the ER preventing disability improving quality of life The context: growing population, aging Baby Boomers, and growing prevalence of chronic disease.

Changing Demographics of the U.S. Population, 20002100

140,000 120,000 Population (in Thousands) 100,000 80,000 60,000 40,000 20,000 0 2000 2010 2020 2030 2040 2050 2060 2070 2080 2090 2100

65 Years and Older 85 Years and Older

Data source: U.S. Census Bureau2

Projected Alzheimers Disease Prevalence,* 20002100

30,000

25,000 Number of Cases (in Thousands)

Ages 6574 Ages 7584 Ages 85 and Over

20,000

15,000

10,000

5,000

0 2000

2010

2020

2030

2040

2050

2060

2070

2080

2090

2100

*PhRMA projections calculated by applying current prevalence rates to population projections.

Data sources: U.S. Census Bureau2; Hebert et al.3

Chronic Diseases Projected to Become More Prevalent

Prevalence of Diabetes Is Projected to Nearly Double 20002030
35 30.3 30 U.S . Prevalence (in Millions) 25 20 15 10 5.76 5 0 1980 2000 2030 17.7

Data sources: Wild et al.4; Centers for Disease Control and Prevention5

Health Care Costs: 19652004

$2,000,000 $1,800,000 $1,600,000 Dollars (in Millions) $1,400,000 $1,200,000 $1,000,000 $800,000
Hospital Care Research and Construction* Personal Medical Equipment and Nonprescription Drugs Nursing Home and Home Health Care Net Cost of Private Health Insurance, Administrative Costs, and Public Health Programs**

$600,000 $400,000 $200,000 $0

Prescription Drugs Doctors, Dentists, and Other Professional Services

'65

'70

'75

'80

'85

'90

'95

'00

'04

* Now revised to Structures and Equipment ** Now revised to Government Public Health Activities

Note: Total health care expenditures for 2004 were $1.9 trillion.

Data source: U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of the Actuary6

Extending Life
They can mean an extra three months or five months or a year another Christmas with the family, another season to plant a garden, another passage in the life of a child. 7
Donna St. George on new targeted cancer therapies, The Washington Post

Extending Life

Extending Life
New medicines play a significant role in the life expectancy gains made in the United States and around the world. Research indicates that new medicines generated 40% of the two-year gain in life expectancy achieved in 52 countries between 1986 and 2000.8 Since the new HIV/AIDS drugs of the mid-1990s, the U.S. death rate from AIDS dropped about 70%.9 Since 1971, our arsenal of cancer medicines has tripled. These new drugs account for 5060% of the increase in six-year cancer survival rates since 1975.10 Advances in heart disease and stroke medicines save over 1 million U.S. lives each year.12

U.S. Life Expectancy Continues to Climb

Men 82 80 77.6 Life Expectancy (in Years) 78 76 74

Women 79.7 78.8 79.9

74.3 71.8

74.5

72 70 68 66 64

70.1

[O]ver the last century, the value of gains in life expectancy seen in the U.S. is greater than the total value of all the measured growth in our economic output. New drugs are no small part of this medical miracle. Mark B. McClellan, M.D., Ph.D., September 200313

197981

198991

2000

2002

Data source: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics14

10

New Medicines Increase Longevity

They Account for 40% of Increase in Life Expectancy
2.5 Number of Years Increased Longevity

Increase in Longevity Due to New Drug Launches Total Increase in Longevity

2.0

1.96 1.65

1.5 1.07 1.0 0.76 0.57 0.5 0.23 0.12 0.0 1988 1990 1992 1994 0.30 0.45 0.56 0.62

1.37

0.70

0.79

1996

1998

2000

Data source: Lichtenberg8

11

U.S. AIDS Deaths Drop Dramatically with Introduction of New Medicines

18 16 Deaths Per 100,000 People 14 12 10 8 6 4 2 0 5.3 4.9 16.2

1995
(HAART treatment approved)

1999

2002

Data source: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics14

12

Medicines Prevent Cancer Recurrence

New Breast Cancer Drug Greatly Reduces Recurrence and Death (5 to 10 Years After Diagnosis in Postmenopausal Women)
Percent of Patients Projected Over 4 Years

Breast Cancer Recurrence or Death

14% 12% 13% 7% 6%

Deaths Due to Breast Cancer

6.6%

Percent of Patients

10% 8% 6% 4% 2% 0% 7%

5% 4% 3% 2% 1% 0%

Death Rate Almost Halved

3.5%

Placebo

New Drug

Placebo

New Drug

Note: Study halted early in order to provide the drug to all participants. Data source: Goss et al.15

13

Increased Use of Medicines Reduces Risk of Death After Major Cardiovascular Events
Disease Management Program Increased Use of Medicines
0%

Reduction in Risk One Year After Program Start

-5%

-10%

-15%

-20% -23% -25% Heart Failure

-19% -21%

-20%

Coronary Heart Disease

Heart Attack

Coronary Artery Bypass Graft

Data source: Lapp et al.16

14

Newer Drugs Reduce Risk of Death

Patients Taking Medicines Approved More Recently Are Less Likely to Die
5% 4.4%

Probability of Death During 20002002

4%

3.6% 3.0%

3%

2.5%

2%

1%

0%

Pre-1970

1970s

1980s

1990s

Approval Date of Drugs Consumed

Data source: Lichtenberg17

15

Better Quality of Care for Elderly Patients Increases Survival

In This Study, Quality Care Often Included Appropriate Use of Medicines
Number of Subjects Who Have Survived 200 175 150 125 100 75 50 25 0 0 200 400 Days
Data source: Higashi et al.18

Low Quality Score (<Median) High Quality Score

After 500 days, the patients were 36% less likely to die if they had care that rated 10% higher

600

800

1,000

16

New Drug Increases Brain Cancer Survival Rate

Temozolomide Is the First New Drug in over 30 Years to Treat Glioblastoma, a Severe Form of Brain Cancer

Temozolomide plus Radiation

14.6

Radiation Alone

12.1

10

15

Median Survival (in Months)

Data source: Stupp et al.19

17

Preventing the Need for Care: Hospital, Emergency, and Long-Term Care
The share of drugs in future medical spending is likely to increase sharply. But even without full cures, drugs that greatly delay the onset and severity of major diseases will reduce expensive and unproductive time spent in hospitals, nursing homes, and under the care of family members. 20
Gary S. Becker, Ph.D., University of Chicago Professor and 1992 Nobel Laureate

3 Preventing the Need

For Care

Preventing the Need for Care

Innovative new medicines make it possible to prevent or slow the progress of many diseases and avoid costly hospitalization and invasive surgery. Between 1980 2000, the number of days Americans spent in the hospital fell 56%. Americans avoided 206 million hospital days in 2000.21 A new Alzheimers drug slows the progression of cognitive decline and delays nursing home entry by 30 months.22

Antihypertensive Medicines Have Prevented Deaths and Hospitalizations

Study Quantified Impact of High Blood Pressure Drugs on the U.S. Population 19992000 WITHOUT Antihypertensives We Would Have Seen:
Life Expectancy MEN Life Expectancy WOMEN Blood Pressure Deaths Hospitalizations 0.5 Years Lower 0.4 Years Lower 10%13% Higher 86,000 Additional 833,000 Additional

Data source: Long et al.23

20

New Drugs Reduce Visits to Hospital and ER

Asthma Management Program Improves Outcomes for Children with Asthma
90% 80% 70% 85%

Before Program After Program

Percent of Patients

60% 50% 40% 30% 20% 10% 0% 35%

55%

30%

ER Visits

Hospitalizations

Data source: Munzenberger and Vinuya24

21

Medicines Allow Patients to Remain Independent Longer

New Alzheimers Medicine Delays Need for Costly Nursing Home Care
80 73 Months

Average Number of Months Until Nursing Home Placement

70 60 50 40 30 20 10 0 43 Months

Less Use of Medicine (<5 mg/day, <8 Weeks Treatment)

More Use of Medicine (>5 mg/day, >36 Weeks Treatment)

Data source: Provenzano et al.22

22

New Drug for Crohns Disease Reduces Need for Health Care Services
Surgeries and ER Visits Reduced
0% Percentage Decrease with Use of Drug

-11% -20% -18% -16%

-40% -43%

-60% -66% -80%

Hospital Gastrointestinal ER Visits Admissions Surgeries

Outpatient Visits

Endoscopy

Data source: Rubenstein et al.25

23

AIDS Hospitalizations Dropped

With Introduction of New Medicines in 1996
Number of HIV Cases in Eight-State Sample Number of Hospital Admissions by HIV Patients

200,000 167,948 150,000

Prevalence rose due to decreased mortality

Number of Patients

131,718

100,000

114,885

77,694 50,000

Hospital admissions fell by one-third

0 1996 2000

(HAART began being widely used)

Data source: Hellinger26

24

Hepatitis A Incidence Falls to Historic Lows with Increased Use of Vaccine

In 1999, It Was Recommended That Children in 17 States with Higher Than Average Hepatitis A Incidence be Vaccinated Routinely

Drop in Incidence
States Not Routinely Vaccinating Children States Routinely Vaccinating Children Overall 53% 88% 76%

Data source: Wasley, Samandari, and Bell27

25

Improving Patients Health and Quality of Life

New drugs allow children with rheumatoid arthritis to walk and to go to school. New drugs shrink cancerous tumors and they control the advance of HIV. They prevent or halt heart disease, slow the progression of multiple sclerosis, and cure infectious diseases. 13
Mark B. McClellan, M.D., Ph.D., Then-FDA Commissioner, September 2003

4 Improving QoL

Improving Quality of Life

New medicines make life better for patients. New cancer therapies improve treatment for patients: Fewer side effectsthey do not kill healthy cells More convenientgenerally pills rather than intravenous (IV) drugs A recent study of inner-city children with asthma enrolled in a disease management program (that included appropriate medications) experienced significant quality of life improvements.24

Disability Rates Declining for Seniors, 19821999

27% Percent Disabled (Over Age 65)

26.2%

This 25% drop is attributed in part to investment in new medical technologies, such as medicines
24.4%

24% 22.5%

21% 19.7%

18% 1982 1989 1994 1999

Data sources: Manton and Gu28; MEDTAP International, Inc.21

28

Quality of Life and Life Expectancy Improve with Increased Spending on Pharmaceuticals
Study Shows DALE* Increase with 10% Increase in Pharmaceutical Spending Across 21 Countries
Disability-Adjusted Life Expectancy (DALE) (in Days) Increase with 10% Increase In Drug Spending
70 60 50 40 30 20 10 0 62 51

Increase in Days (Women)

Increase in Days (Men)

Mean Increase for Adults over Age 60 in 21 OECD** Countries

*Disability-Adjusted Life Expectancy **Organization for Economic Cooperation and Development
Data source: Miller and Frech29

29

New Drug for Multiple Sclerosis Produces Significantly Better Results for Patients
80% 70% 60% Percent of Patients 50% 40% 40% 30% 20% 10% 0% 8% 25% 43% Placebo Drug

67%

64%

Worsening Disability Admitted to Hospital

Relapse During Study Period

Data source: Hartung et al.30

30

Medicines Help Prevent Disability Due to Arthritis

Rheumatoid Arthritis Drug Treatment Reduces Chance of Advanced Disability
25% Percent Having Advanced Disability After 54 Weeks of Treatment 23%

20%

15% 11% 10%

5%

0%

Older Drug

Older Drug + Newer Drug

Data source: Wong et al.31

31

New Medicine Improves Quality of Life (QoL) for Patients with Schizophrenia
Schizophrenia Patients Treated with New Drug Report Significantly Better QoL Than Patients Receiving Older Drug
18 16 Mean QoL Score over 24 Weeks (Based on Standard QoL Scale) 14 12 10 8 6 4 1.7 2 0 Placebo Older Drug Newer Drug 4.9 15.5

Data source: Hamilton et al.32

32

Medicines Reduce Complications of Diabetes

Diabetes Patients Treated with Medicines Are Less Likely to Develop Other Health Problems
70% 60% 50% 40% 30% 20% 10% 0% Treated Untreated 55% 52% 42%

59%

Percent of Patients

Lipid Disorders

Essential Hypertension

Data source: PharMetrics33

33

Controlling Health Care Costs

High-price new drugs may be the cheapest weapon we have in our ongoing struggle against rising overall medical expenses.34 J.D. Kleinke, Medical Economist and Author, Chairman, Health Strategies Network

5 Care Costs

Controlling Health

Controlling Health Care Costs

New medicines help patients lead longer, better lives and control overall health care spending. For every dollar spent on newer medicines in place of older medicines, total health care spending is reduced by $6.17.35 Every additional dollar spent on health care in the United States over the past 20 years has produced health gains worth $2.40 to $3.00.21 Heart failure patients who receive betablocker therapy had treatment costs $3,959 lower than those of patients who did not take these medicines.36

Using Newer Medicines Results in Savings of $111 per Treated Condition

$40 $18 $20 Cost Per Treated Condition $0 -$20 -$40 -$60 -$80 -$100 -$120 -$140 Extra Cost of New Drugs -$129 Non-drug Medical Costs Savings -$111 Overall Health Care Savings

Net Savings of $111

Data source: Lichtenberg35

36

Drugs Help Control Hospital and Ambulatory Costs

Patients with Bipolar Disorder Who Consistently Took Mood Stabilizers Had Reduced Health Care Costs
$1,000 Change in Annual Costs per Patient $0 -$1,000 -$2,000 -$2,329 -$3,000 -$4,000 -$5,000 -$6,000
Ambulatory Savings Hospital Savings Drug Costs Nursing Home Care Costs Other Savings Total Health Care Savings

$430

$522

-$52

-$3,614

-$5,044

Note: Data may not sum to total due to rounding. Data source: Li, McCombs, and Stimmel37

37

Greater Adherence to Medicines Decreases Total Health Care Spending

Diabetes: Drug Adherence and Total Medical Spending
$16,000
Estimated return on investment (ROI) for 20% increased adherence to diabetes medicines: $1 on medicines = $7.10 in savings

High Cholesterol: Drug Adherence and Total Medical Spending

$10,000
Estimated ROI for 20% increased adherence to cholesterol medicines: $1 on medicines = $5.10 in savings

Total Medical Spending

Total Medical Spending

$14,000 $12,000 $10,000 $8,000 $6,000 $4,000 $2,000 $0

$15,186

$8,000

$11,200

$11,008

$9,849

$6,830

$6,000

$9,363

$5,509

$6,676

$4,000

$6,377

$2,000

$0 119 2039 4059 6079 80100 119 2039 4059 6079 80100

Adherence (%)

Adherence (%)

Note: Adherence is the extent to which patients take medicines as prescribed, in terms of dose and duration. Data source: Sokol et al.38

38

$4,780

Patients Taking Medicines for Heart Failure Incur Lower Health Care Costs
Beta-Blockers Reduce Total Treatment Costs for Heart Failure by $3,959
$60,000

Total Treatment Cost

$52,999

$49,040 $50,000

$40,000 Patients Not Taking Beta-Blockers

Data source: Cowper et al.36

Patients Taking Beta-Blockers

39

Medicines Produce Valuable Health Gains for Heart Attack Patients

$45 $40 $35 $30 Value $25 $20 $15 $10 $5 $0 Beta-Blockers Statins in All Heart Attack Survivors Overall Treatment of Heart Attack $1.00 $1.00 $1.00 $1.10 As high as $9.44 $38.44

Spending Value of Health Gains for Every Dollar Spent

Medicines Only

Data source: MEDTAP International, Inc.21

40

Increased Use of Medicines Reduces Overall Health Care Costs

Mental Health/Substance Abuse (MH/SA) Spending per Patient Fell as Drug Spending Increased, 19921999
$140

Spending per Covered Life per Year

$120 $17.10 $100 $80 $55.20 $60 $40 $20 $0 $42.70

Psychotropic Drug Spending Inpatient MH/SA Spending Other MH/SA Spending

$45.60

$25.30

$24.10

1992
Data source: Mark and Coffey39

1999

41

Disease Management Program Increases Use of Diabetes Medicines and Reduces Total Health Spending
$8,000 $7,000 Mean Cost per Patient per Year (in 2001 U.S. Dollars) $6,000 $6,096 $5,000 $4,000 $3,000 $2,000 $1,000 $0 Baseline Year 1 Year 2 Year 3 Year 4 Year 5 $1,584 $724 $1,440 $889 $3,596 $3,492 $1,572 $1,409 $3,283 $2,815 $1,702 $894 $1,027 $1,170 $1,393 $666 $488

Insurance Claims Diabetes Prescriptions Other Prescriptions

Follow-Up (12-Month Intervals Following Baseline)

Data source: Cranor, Bunting, and Christensen40

42

Heart Failure Disease Management (DM) Program Reduces Hospitalizations and Overall Costs
Hospitalizations Down 19% with DM Program Hospitalizations per 1,000 Patients
1,600 1,400 1,200 1,000 800 600 400 200 0 Baseline After One Year in Program

Overall Spending Down 28% with DM Spending

$1,400

$1,331

Dollars per Member/per Month

1,410 1,149

Total Expenditures per Member/per Month Drug Expenditures

$1,200 $1,000 $800 $600 $400 $200 $0 Baseline

$959

$78

$89
After One Year in Program

Data source: Clarke and Nash41

43

Strengthening the Economy

Over the last half century, improvements in health have been as valuable as all other sources of economic growth combined.42 Kevin Murphy, Ph.D., and Robert Topel, Ph.D., University of Chicago economists

6 Economy

Strengthening the

Strengthening the Economy

Continued discovery of new medicines helps strengthen the U.S. economy because workers can go back to their jobs sooner and are more productive when they are at work. 50% of migraine patients receiving a drug injection returned to work within two hours, compared to only 9% of workers who received a placebo.43 Allergy patients receiving non-sedating antihistamines are more productive than those receiving sedating antihistamines.44 Better use of available depression care would allow employers to recover up to 8.8 million absentee days per year.45

Medicines Improve Productivity and Save Employers Money

New Migraine Medicine Produces Productivity Savings That Far Outweigh Drug Costs
$100 $0 $43.78

Monthly Costs Monthly Savings

-$100 -$200 -$300 -$400 -$435.00 -$500 Monthly Drug Costs per Employee Treated Monthly Employee Savings per Employee Treated

10 : 1 Benefits : Costs

Data source: Legg et al.46

46

Better Treatment for Depression Saves Employers Money

Productivity of Consistently Employed Subjects
85%
Percent of Maximum Productivity in Past Two Weeks
Productivity increases worth $1,982 to employers per depressed employee each year

Absenteeism of Consistently Employed Subjects

25
Hours Work Lost in Past Month
Absenteeism reductions save employers $619 per depressed employee each year

80%

20

15

75%

10

70%

65% 0 6 12
Months

0 18 24 0
Usual Care Enhanced Care

12
Months

18

24

Data source: Rost, Smith, and Dickinson47

47

New Medicines for Arthritis Improve Functioning and Productivity

40% 35% 35% 30% Percent of Patients 25% 20% 20% 15% 15% 10% 5% 0% -5% -2% Improvement in Reported Disability Improvement in Improvement in Work Reported Physical Productivity Functioning 3% 0.5% Patients Receiving Newer Drug Patients Receiving Older Drug Patients Receiving Placebo 22% 18% 14%

Data source: Strand et al.48

48

More Effective Treatment of Alzheimers Disease Could Save Billions

Combined Medicare and Medicaid Savings from Effective Treatment of Alzheimers Disease
$1,200
$1,167

Projection with Treatment Investment

Projected Spending (in Billions) $1,000

Current Projection (without Treatment Investment)

$778

$980

$800
$593 $443

$653

$600

$553 $416

$400
$261 $216 $184 $184 $200 $156 $155 $112$112

$332 $235 $183

$314

$0

2005

2010

2015

2020

2025

2030

2035

2040

2045

2050

Data source: The Lewin Group49

49

Then & Now

50

Drugs, both prescribed and over-the-counter, are an increasingly important component of health care. New drugs, and new uses for older drugs, are improving health outcomes and quality of life, curing some conditions, preventing or delaying disease, and hastening recovery.51 National Center for Health Statistics, Health, United States, 2004, with Chartbook on Trends in the Health of Americans

7 Then and Now

Then and Now

Its easy to forget, but not very long ago the treatments we might today take for granted hadnt yet been developed. Perhaps there werent any medicines at all for the disease, or those that did exist werent very effective or had serious side effects. The contrast between treatments of yesteryear and today highlights how far we have come, as well as the importance of continued innovation.

Leukemia
Then
If you had been diagnosed with chronic myeloid leukemia (CML) in 1999, chances were that you would not be alive today. Just 3 out of 10 patients survived for even five years. In the meantime, you had two daunting treatment options: a high-risk bone marrow transplant or daily injections of interferon, the side effects of which have been compared to having a bad case of the flu every day of your life.

Now
You can take a daily pill that has a good chance of driving your cancer into remissionnormalizing your blood count with few, if any, side effects. The new medicine targets CML on a molecular level, so it affects only the enzyme responsible for the disease. The tremendous effectiveness and precision of the approach is heralded as the wave of the future.

HIV/AIDS
Then
If you were diagnosed with AIDS in 1990, you might expect to live for only 26 months. During that time, you would be likely to contract a number of opportunistic infections that would make your remaining days unpleasant and painful. The only treatment available had to be taken every four hoursaround the clockand had serious side effects.

Now
Thanks to the approval in 1995 of protease inhibitorsand further advancements in new medicines and combination therapies in the decade sincethe AIDS death rate in the U.S. has fallen by 70 percent. If diagnosed today, a range of treatment options (including different combinations of drugs) might be able to keep you symptomfree for years to come.

52

Schizophrenia
Then
Between the 1950s and the 1980s, the antipsychotic medications available to treat schizophreniaa devastating mental illness affecting approximately 1 percent of the populationwere a double-edged sword. On the one hand, they helped control symptoms like hallucinations and paranoid thoughts. But they also had unpleasant side effects, like muscle stiffness, tremors, and abnormal movements that grew worse over time.

Now
Thanks to new medicines introduced in the 1990s, people living with schizophrenia can now manage their condition more effectively than ever, and with fewer side effects. These medicinesdubbed atypical antipsychotics to distinguish them from earlier, typical drugsalso help people whose schizophrenia had not previously responded to treatment, making it possible for them to leave institutionalized care, return to work, and lead more normal lives.

High Cholesterol
Then
Although high cholesterol was recognized as a key risk factor for cardiovascular disease in the 1970s, there were no good ways to reduce it. The best drug available was a grainy powder called cholestyramine. Patients mixed it with juice, but it tasted like sandone patient said it was like drinking Miami Beach. Taking it was so unpleasant that it was prescribed for only the most severe cases.

Now
Millions of people now control their cholesterol, and reduce their risk of heart disease, by swallowing a small pill just once a day. A new class of medicines, statins, was introduced in 1987 and offers a safe and effective way to lower cholesterol. One NIH official, Dr. Claude Lenfant, even said that if all patients took statins according to guidelines, heart disease would no longer be the No. 1 killer.

53

Alzheimers Disease
Then
If you or a loved one started exhibiting symptoms of Alzheimers disease 12 years ago, there were no medicines for you to take. All you could do was hopethat your decline into dementia would be slow, that your memory and independence would last as long as possible, that someone would come up with an effective treatment.

Now
There are three different classes of medication available to help treat the symptoms of Alzheimers disease and even slow its progression. If you were diagnosed today, you could take an active role in treating your illness, retaining mental functions and independence for longer. More innovations are needed, but the rapid progress of the past two decades has made a difference in the lives of families nationwide.

Ulcers
Then
Thirty-five years ago, treating an ulcer meant painful surgery that brought with it the risk of life-threatening infection and more ulcers in the future. Along with surgery, doctors often recommended weeks of bed rest, a mild fatty diet including boiled milk, and increased tobacco use, in an effort to stop the suspected culprits: a stressful lifestyle and spicy food. But none of these remedies made much difference to ulcer sufferers.

Now
In the late 1970s, new medicines were developed to heal the lining in the stomach or duodenum, making it possible for the first time to treat ulcers effectively without surgery. With the discovery that the bacterium H. pylori causes the vast majority of ulcers in 1982, doctors are now able to treat ulcers both quickly and permanently by targeting the real root of the problem bacteria.

54

Organ Transplant
Then
In the 1950s and early 1960s, patients needing an organ transplant were in a tragic bind. Transplants were surgically possible, but the bodys immune response rapidly rejected organs donated by unrelated individuals. People either died or led greatly diminished lives.

Now
Thanks to anti-rejection medicines that were developed in the 1960s and 1980s, tens of thousands of Americans have received transplants of a wide variety of organs and are able to prolong their lives, regain their health, and maintain their independence.

55

Sources
1. S. Gottlieb, speech before the 30th International Good Manufacturing Practices Conference (Athens, GA), 14 March 2006, http://www.fda.gov/oc/speeches/2006/gmp0314.html. 2. U.S. Census Bureau, Tables np-t3-a through np-t3-h, Projections of the Total Resident Population by 5-Year Age Groups, and Sex with Special Age Categories (Washington, DC: U.S. Census Bureau, 2002), http://www.census.gov/population/projections/nation/summar y. 3. L. E. Hebert et al., Alzheimer Disease in the US Population: Prevalence Estimates Using the 2000 Census, Archives of Neurology 60, no. 8 (2003): 11191122.

Sources

Sources
4. S. Wild et al., Global Prevalence of Diabetes: Estimates for the Year 2000 and Projections for 2030, Diabetes Care 27, no. 5 (2004): 10471053. 5. Centers for Disease Control and Prevention, Data and Trends, National Diabetes Surveillance System, 6 October 2005, http://www.cdc.gov/diabetes/statistics/prev/national/ tablepersons.htm. 6. U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of the Actuary, National Health Expenditures Data, 28 February 2006, http://www.cms.

Sources

Sources
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Sources

Sources
10. F. R. Lichtenberg, The Expanding Pharmaceutical Arsenal in the War on Cancer, National Bureau of Economic Research Working Paper No. 10328 (Cambridge, MA: NBER, February 2004). 11. D. L. Hoyert et al., Deaths: Final Data for 2003Health EStats 19 January 2006, http://www.cdc.gov/nchs/products/pubs/pubd/hestats/finaldeath s03/finaldeaths03.htm (accessed 2 May 2006). 12. G. Kolata, Gains on Heart Disease Leave More Survivors, and Questions, The New York Times, 19 January 2003, p. 1. 13. M. B. McClellan, speech before the First International Colloquium on Generic Medicine (Cancun, Mexico), 25 September 2003, http://www.fda.gov/oc/speeches/2003/ genericdrug0925.html.

Sources

Sources
14. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics, Health, United States, 2005, with Chartbook on Trends in the Health of Americans (Hyattsville, MD: NCHS, 2005), http://www.cdc.gov/nchs/hus.htm (accessed 24 February 2006). 15. P. E. Goss et al., A Randomized Trial of Letrozole in Postmenopausal Women After Five Years of Tamoxifen Therapy for Early-Stage Breast Cancer, The New England Journal of Medicine 349, no. 19 (2003): 17931802. 16. J. M. Lapp et al., Improvements in 1-Year Cardiovascular Clinical Outcomes Associated with a Hospital-Based Discharge Medication Program, Annals of Internal Medicine 141 (2004): 446-453.

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