Health and Human Services by STUDIO Gannett

SPECIAL EDITION

U.S. DEPARTMENT OF

FREE

HEALTH & HUMAN SERVICES

2015 EDITION

Pulse of America FROM THE TOP Q&As with the leaders of HHS, CDC, NIH

COST OF CARE Research, hospitals’ and pharmacies’ bills of health

OUTBREAK’S PATH A graphic look at how measles spread

SLIMMING DOWN The nation fights an obesity epidemic

USA TODAY SPECIAL EDITION

CONTENTS

SPECIAL EDITION

U.S. DEPARTMENT OF

HEALTH & HUMAN SERVICES

AFFORDABLE CARE After five years, mixed feelings toward Obamacare remain

ALEX WONG/GETTY IMAGES

UP FRONT

7 10

ONE YEAR IN HHS Secretary Burwell reflects on her first year on the job HOW IT WORKS A look at the agencies that make up HHS

RESEARCH

CASH FLOW Personal and governmental health spending

THE COST OF CARE Hospital financing, by the numbers

17 20

FUNDING SHORTAGE NIH Director Collins searches for answers CASH ADVANCES Research funding has been flat for years

IN THE LABS Scientists struggle to persevere as money dries up

PRECISION MEDICINE A new, more exacting way to determine proper care

USA TODAY SPECIAL EDITION

If travel were a sport, Iâ&#x20AC;&#x2122;d be MVP. #igotthis #roadwarriors

Go elite or go home. See travel trends, maximize your points, and get the tips you need to never wait in line again.

roadwarriorvoices.com SPONSORED BY

USA TODAY SPECIAL EDITION

CONTENTS

HEALTH CARE & POLICY

This is a product of

DIRECTOR

Jeanette Barrett-Stokes jbstokes@usatoday.com

GERM FIGHTERS CDC Director Frieden talks Ebola, measles, other epidemics

SPREAD OUT Diagramming a fast-moving measles outbreak

HEALTHY KIDS Federal/state programs provide insurance for underserved children

SEEING CLEARLY Bringing transparency to health care prices

ONLINE SHOPPING It’s “buyer beware” when it comes to Internet pharmacies

DRUG APPROVAL How the FDA gets drugs to market

SURGE CAPACITY Hospitals, health care workers prepare for contagious diseases

A WEIGHTY MATTER Obesity is taken seriously as a public health issue

OBESITY NUMBERS How many Americans are too heavy?

UPDATING THE MENU New dietary guidelines are expected later this year

CREATIVE DIRECTOR

Jerald Council jcouncil@usatoday.com MANAGING EDITOR

Michelle Washington mjwashington@usatoday.com CREATIVE MEDIA MANAGER

Christine Neff cneff@usatoday.com EDITORS

Nikki Dobrin Chris Garsson Elizabeth Neus Lori Santos Amanda Shifflett

JOHN MOORE/GETTY IMAGES

DESIGNERS

Marlece Lusk Gina Toole Saunders Lisa M. Zilka INTERNS

Alexa Rogers Hannah Van Sickle

DAMIAN DOVARGANES/ASSOCIATED PRESS

CONTRIBUTING WRITERS Matt Alderton, Mary Helen Berg, Chrystle Fiedler, Dan Friedell, Diana Lambdin Meyer, Nancy Monson, Peggy J. Noonan, Eric Schechter, Adam Stone

CONTRIBUTING PHOTOGRAPHERS Lisa Buser, Doug Kapustin, Dan MacMedan, Jacob Slaton

ADVERTISING

THE REST OF THE STORY

VP, ADVERTISING

Patrick Burke | (703) 854-5914 pburke@usatoday.com NIAID

ACCOUNT DIRECTOR

Justine Goodwin | (703) 854-5444 jgoodwin@usatoday.com

DISEASE AS ART A microscopic look

ISSN#0734-7456 A USA TODAY publication, Gannett Co. Inc. USA TODAY, its logo and associated graphics are the trademarks of Gannett Co. Inc. or its affiliates. All rights reserved. Copyright 2015, USA TODAY, a division of Gannett Co. Inc. Editorial and publication headquarters are at 7950 Jones Branch Dr., McLean, VA 22108, and at 703-854-3400.

ON THE COVER

For accuracy questions, call or send an e-mail to accuracy@usatoday.com.

The Department of Health and Human Services and its $1 trillion budget has a multifaceted mission.

PRINTED IN THE USA LISA BUSER

PHOTOS: THINKSTOCK; LOGO; DEPARTMENT OF HEALTH AND HUMAN SERVICES

USA TODAY SPECIAL EDITION

@BNightengale

HE GETS YOU SO INSIDE THEIR HEADS YOU CAN ALMOST TASTE THE CHAW. With unprecedented access to baseball’s major players, USA TODAY MLB columnist Bob Nightengale will give you insight into the game you can’t find anywhere else.

usatoday.com/bobnightengale NEWS

SPORTS

LIFE

MONEY

Smarter. Faster. More Colorful.

TECH

TRAVEL

OPINION

WEATHER

USA TODAY SPECIAL EDITION

Health and Human Services Secretary Sylvia Mathews Burwell leaves a meeting with governors in February in which they discussed the Supreme Court case against the Affordable Care Act. CLIFF OWEN/ASSOCIATED PRESS

OVERSEEING

HEALTH HHS Secretary Burwell reflects on a year in office

By Erik Schechter

T’S BEEN ALMOST A year since Sylvia Mathews Burwell was nominated as secretary of the Department of Health and Human Services (HHS) — she was sworn in on June 9, 2014 — and during that time, she’s had to tackle a multitude of challenges. From presiding over the continuing enrollment of Americans in the new Health Insurance Marketplace set up by the Affordable Care Act (ACA) to speeding development of Ebola vaccines to pushing the new Precision Medicine Initiative launched in January, Burwell has endured a baptism by fire. Replacing Kathleen Sebelius (who resigned after coming under criticism for failures with the fall 2013 rollout of the ACA

insurance market), Burwell had served as director of the Office of Management and Budget (OMB). Before joining the Obama administration, she was president of the Walmart Foundation in Bentonville, Ark., and had held several roles in the Clinton administration as well. USA TODAY spoke with Burwell about the ACA, its impact, lessons learned and how elements of it were marketed to the American people; the January resignation of Marilyn Tavenner, administrator of the Centers for Medicare and Medicaid Services and the person responsible for launching the ACA website, healthcare.gov; and attempts to combat obesity and measles in the United States, while helping fight Ebola, too. CO N T I N U E D

USA TODAY SPECIAL EDITION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Burwell and other senior HHS officials serve Thanksgiving lunch to employees at Washington, D.C. headquarters in November 2014. The department employs more than 76,000 people nationwide.

What impact has the Affordable Care Act had so far, and what aspect of it are you most proud of? BURWELL: With regard to the Affordable Care Act, there are three fundamental things: Quality, access and affordability. ... In the area of quality, we’ve seen important improvements — whether it’s reductions that have been occurring in (patient) re-admission, whether that’s the fact that people no longer face lifetime limits or annual limits in their care, or that pre-existing conditions are no longer something that can keep you out (of an insurance policy). In the area of affordability ... when one looks at the question of employer-based care, what you see is that the premiums are growing at some of the lowest rates we’ve seen. Last year’s rate was tied with 2010 for the lowest rate in terms of premium growth for families since 1999 when the data was starting to be collected. With regard to overall health care costs, if we look at per capita health care costs in the periods of 2011, ’12 and ’13, we see some of the lowest growth in decades, and if you think about the questions of affordability

for the taxpayer, if we look at the projected increases in spending and Medicare that were to occur and compare them to what actually (has) happened, that’s $116 billion in savings. ... The other area is the uninsured, and we know that about 16.4 million adults are no longer uninsured, and that is historic progress. Over the past 12 months, we’ve seen the exit of Marilyn Tavenner, a bumpy rollout and questions about inflated enrollment numbers. How did that impact initially the credibility of the rollout, and how have you dealt with overcoming that bumpy start? One (thing) is, I think, making sure that the conversations about this topic connect to actual facts, numbers and substance. ... That’s why I started with the quality, affordability and access, and then connecting that to the numbers and things we see. ... Many people probably don’t remember that the closing of the donut hole — that was a payment issue that had to do with drugs, many of which were for seniors — that has had benefits in over $10 billion in terms of savings for people.

And with regard to this (newest) open Institute of Technology (MIT) professor enrollment, we did a number of things. One, of economics and ACA consultant we incorporated the learnings from the Jonathan Gruber’s comments that the first period of open enrollment. The second administration misled the public on the thing was focusing deeply on making sure Cadillac plans (set to begin in 2018)? that we were focused on the customer and I have been on record ... about how much the consumer, and that I disagree with the things meant making sure that that were said because I the website was up and have faith and confidence running; it meant doing in the American people, “Measles ... is things like taking the new and what I believe the Afsomething where applicant screens from fordable Care Act is about 76 screens down to 16 (is) adding transparency we know we screens; it meant things and an ability for consumhave a highly like making sure that ers to make quality ... people using mobile decisions when they have effective vaccine (devices) could come to that information. that works.” the (Health Insurance) Marketplace easier. But is the Cadillac plan — Sylvia Mathews Burwell Then the third thing a tax on insurance was making sure that we policyholders? built on the great team Having come from the that was in place. ... You probably know that private sector, I know that the plan that the we created a CEO of the Marketplace and CEO of my company or me, as an officer of hired that person. We brought on a deputy, the company, received is exactly the same, and Marilyn helped see us through the so this is something that applies to a very second open enrollment. limited and specific set of people who have plans in companies that are distinct in very What is your reaction to Massachusetts large ways from the other plans. Is it a tax

USA TODAY SPECIAL EDITION

The Affordable Care Act has been a large focus of Burwell’s first year on the job. Left, she announces the Transforming Clinical Practice Initiative, an $840 million, four-year program that is part of the ACA to help doctors improve care.

or is it a fee? To be honest, this is a Treasury issue, not an HHS issue. What is the Precision Medicine Initiative, what do you hope to achieve by it and what is its significance? The Precision Medicine Initiative is an effort to make the investment in science and research that will allow us to move to the next level of both treatment and prevention of disease and promoting health. And what that means is using science to help us understand your own genetic makeup and how that interacts with diseases before they happen and when they happen. For example, cancer is a place where what we’re learning is (that) it isn’t as much about the type of organ cancer you have, but it’s about the type of cancer you have, and when we can study and understand that tumor, then we can use specific treatments for your tumor. And precision medicine and the investments that the president announced and is asking for are to do a couple of things. One is to create a cohort of a million people (volunteer research subjects) so that we have the information of a large group of people so that we can study and understand. When there are questions, you have a large group of information that you can use and all that information ... will be privately protected and secure. The second thing is focusing on cancer ... because cancer is a place where we’re already seeing that progress. What role did Health and Human Services play in the recent Ebola outbreak? We played a role across the entire department, just about. ... Ebola is something where contact-tracing the people who have been exposed is a very important part of controlling the disease, and so the CDC (Centers for Disease Control and Prevention), from the very early stages, was on the ground in West Africa. For most of the period, we’ve had over 200 folks on the ground working together with USAID (U.S. Agency for International Development) and the Department of Defense and others every day, working on making sure that people understand and can use the (CDC) labs ... to test people with Ebola and to teach and to support those countries in doing the tracing of the individuals so that they can stop the spread of the disease. In addition, the assistant secretary for preparedness and response, together with the FDA (Food and Drug Administration) and the NIH (National Institutes of Health), are all important parts of the progress we’re making on therapeutics; things like ZMapp, the drug that could treat Ebola, as well as making sure that we are working on a vaccine. The FDA certainly played a role during this entire crisis as we move into trials for these drugs, but also the FDA played an important role when drugs were needed, (creating) very fast turnarounds and approvals in special ways for drugs ... so that they could be used by hospitals that

CHIP SOMODEVILLA/GETTY IMAGES

JACQUELYN MARTIN/ASSOCIATED PRESS

Burwell greets Amber Brantly, right, wife of Ebola survivor Dr. Kent Brantly, before a White House event honoring U.S. health care workers fighting the disease last October. were caring for Ebola patients here in the U.S. In addition ... we’re now at a place where we have 10 regional centers (in the U.S.) to treat Ebola. We have a series of assessment hospitals across the United States and have done a lot of training of front-line hospitals so they know to recognize (symptoms) if someone comes in; they ask the right questions so that they can then turn that person over to an assessment hospital. Speaking of vaccinations, how successful have we been in beating back discredited links to autism and getting people to take measles shots? As with most things, we can do better. ... What’s most important is for people to

understand (that) measles, unlike the topic you and I were just discussing with Ebola, is something where we know we have a highly effective vaccine that works to prevent the disease and ... it’s safe. But should vaccinations be a matter of parental choice? Some parents give reasons (why) they don’t want to do it, but as a starting point, most schools require that you have an up-to-date vaccination record; that is one of the things that you’re asked to provide. The issue of how and who makes decisions ... while we work on the national level, these decisions, in terms of the specificity of the enforcement, is a state-based issue.

Let’s talk about the new dietary guidelines. How are you approaching them? Obesity, heart disease and diabetes are three of the most dangerous, from a health perspective, and costly things that we, as a nation, face. So thinking about how we ... provide the consumer with the information and the choices that they can then make ... quality choices (to) lead healthier lives (is important). You may have heard of an effort we have called Million Hearts. It’s an initiative by HHS to prevent 1 million heart attacks and strokes by 2017, and it brings together communities, health systems, not-for-profits, federal agencies and private sector partners from across the country, and recently we recognized 30 public and private health care practices and systems as hypertension control champions. It’s also related ... to a topic you and I discussed at the beginning, which is the Affordable Care Act, and moving from coverage to care. The entire effort (is) about making sure that people get that coverage that you and I talked about, but then they need to move to care, understanding the tools that they have to have (to enjoy) healthier lives. What’s the backup plan if the Supreme Court rules against the ACA? As we have said, we are confident in our argument and believe that the text, structure and history of the law make clear that tax credits are available to people in all states. One needs to think about the three fundamental things that would occur if the (Supreme) Court decides for the petitioners: First, there would be an increase in the number of the uninsured. Millions of people would lose their tax credits and no longer be able to afford coverage. Second, without tax subsidies, healthy people are less inclined to buy insurance, so the individual insurance market would have a disproportionate number of sick people in it, driving up premiums, including for Americans in individual insurance market plans outside of the federal (Health Insurance) Marketplace in federal marketplace states. Third, states would revert back to the time when the only option for the uninsured was to seek care in hospital ERs; those uncompensated costs would be passed on through the system, further driving up insurance costs for everyone. We know of no administrative actions that would undo the massive damage to our health care system that would be caused by an adverse decision.

USA TODAY SPECIAL EDITION

Commerce Labor Interior Treasury Justice Energy Homeland Security Housing and Urban Development State Education Veterans Transportation Agriculture Defense Health and Human Services

$9.8 billion $13.2 billion $13.2 billion $14.3 billion $28.7 billion $30 billion $41.2 billion $49.3 billion $50.3 billion $70.7 billion $73.5 billion $94.7 billion $156 billion

CABINET AGENCIESâ&#x20AC;&#x2122; BUDGETS How the HHS budget request compares with those of other Cabinet agencies for 2016

$585 billion

HEALTH AFFAIRS HHS touches the lives of all Americans By Elizabeth Neus

HE CABINET DEPARTMENT WITH the largest budget, the Department of Health and Human Services (HHS) and its more than 76,000 employees have the enormous job of improving the nationâ&#x20AC;&#x2122;s

health care, encouraging and funding medical research and new treatments, and promoting the well-being and health of all Americans. Its annual budget topped $1 trillion in fiscal year 2015 for the first time, and the 2016 request for $1.1 trillion makes up approximately one-quarter of the entire $4 trillion U.S. budget proposal.

OFFICE OF THE SECRETARY

Includes the Office of Health Reform, responsible for overseeing the implementation of the Affordable Care Act.

$1.1 trillion

USA TODAY SPECIAL EDITION

HEALTH AGENCIES

HUMAN SERVICES

CENTERS FOR DISEASE CONTROL AND PREVENTION CDC.GOV

FOOD AND DRUG ADMINISTRATION FDA.GOV

NATIONAL INSTITUTES OF HEALTH NIH.GOV

The high-profile CDC tracks and responds to disease outbreaks and other health emergencies. Its disease detectives watch out for everything from the yearly flu epidemic to bioterrorism and recently took the lead on the Ebola crisis in West Africa and the resulting small outbreak in the U.S. If there’s a poster in your office telling you how to cover your mouth when you cough or encouraging vaccinations, it’s probably from the CDC. A staple of popular culture, a fictional version of its HQ was blown to smithereens in The Walking Dead.

The FDA was born in 1906 with the passage of the Pure Food and Drug Act, which banned the sale, manufacture and transportation of adulterated and/or unsafe food, medicines and drugs. Today, the division, with an annual budget of more than $4 billion, and its staff of 14,000-plus is tasked with ensuring the safety of food and drugs as well as medical devices and cosmetics — and it’s also in charge of the regulation of tobacco.

The oldest division within HHS, established in 1887, the NIH and its 27 institutes and centers are the focal point for U.S. medical research. It’s the largest source of medical research funding in the world, providing money for research at more than 2,500 universities as well as to its own scientists. Its NIH Clinical Center blends high-quality care with the latest in experimental treatments.

AGENCY FOR HEALTHCARE RESEARCH AND QUALITY

AGENCY FOR TOXIC SUBSTANCES & DISEASE REGISTRY

SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION

AHRQ.GOV

ATSDR.CDC.GOV

SAMHSA.GOV

AHRQ provides evidence-based treatment guidelines that help make health care safer and more effective. Its website is an easy portal to practical information for patients.

Part of the Centers for Disease Control and Prevention, this small agency researches hazardous materials, assesses sites for public health risk and provides information about exposure to toxic substances.

Let the agency tell it: Its mission is to “reduce the impact of substance abuse and mental illness on America’s communities.” Its website provides links to suicide-prevention hotlines and other means of finding help.

HEALTH RESOURCES AND SERVICES ADMINISTRATION

INDIAN HEALTH SERVICE

HRSA.GOV

IHS.GOV

The health-oriented cousin of the human services-directed Centers for Medicare & Medicaid Services, HRSA provides health care to areas that are impoverished, isolated or otherwise lacking in doctors. It recruits and trains doctors and other health professionals (including nurses, homeopathic practitioners and dentists) for those underserved areas, and works to improve health care services in general for needy people.

Part of the Department of the Interior from 1921 to 1955, the IHS is in charge of getting federal health care services to Native Americans. It serves 1.9 million people from 566 federally recognized tribes in 35 states.

ADMINISTRATION FOR CHILDREN AND FAMILIES ACF.HHS.GOV

This division, established in 1991, focuses on making families, children and individuals stronger economically and socially. Its best-known program is perhaps Head Start, but it also works on issues ranging from foster care to violence prevention, human trafficking and refugee resettlement.

CENTERS FOR MEDICARE & MEDICAID SERVICES CMS.GOV The slice of HHS that gets the biggest piece of the department’s budget ($897.35 billion in 2015), this division oversees Medicare, the federal portion of the state Medicaid programs, the Children’s Health Insurance Program (CHIP) for un- or under-insured children and the Health Insurance Marketplace, aka healthcare.gov, where you buy coverage through the Affordable Care Act.

ADMINISTRATION FOR COMMUNITY LIVING ACL.GOV

The newest HHS division, formed in 2012, is a blend of offices that worked on aging and disability issues. It makes sure that those populations have access to adequate health care and community support.

USA TODAY SPECIAL EDITION

EXPLANATION OF BENEFITS Where health care money comes from ... and where it goes

U.S. health care spending amounted to about $2.5 billion in 2013, or about $9,255 per person, the most recent figures available show. About $1.9 billion of that was paid for by some form

of health insurance; the rest came straight out of patients’ pockets. Health care spending overall accounts for 17.4 percent of the gross national product. Here’s a look at who pays, and for what:

THE TOP 10 CONDITIONS/SERVICES ON WHICH U.S. HEALTH CARE DOLLARS ARE SPENT: (This includes all money spent on a condition, not just the money that patients or insurance pay.)

TOTAL PERSONAL HEALTH EXPENDITURES, 2013: $2.5 billion Other thirdparty payers and programs*: $221.2 million (including $3.6 million from Indian Health Services)

Out of pocket: $339.4 million

Health insurance: $1.9 billion

Medicare: $550.5 million

Medicaid: $410.8 million ($236.7 million federal; $174.1 million state/local) Private health insurance: $846 million

State Children’s Health Insurance Program (CHIP): $11.3 million ($7.8 million federal; $3.5 million state/local) Department of Defense: $35.9 million

Circulatory system diseases (heart attacks, high blood pressure, etc.): $234.5 billion Miscellaneous, non-specific symptoms: $206.9 billion

HEALTH INSURANCE

*INCLUDES WORKSITE HEALTH CARE, WORKERS’ COMPENSATION, SCHOOL HEALTH CLINICS AND OTHER FEDERAL/STATE/LOCAL PROGRAMS

Department of Veterans Affairs: $53.4 million

Source: Centers for Medicare & Medicaid Services

Musculoskeletal problems (arthritis, back pain, etc.): $169.9 billion Nursing homes: $152.3 billion

PER CAPITA STATE HEALTH EXPENDITURES BY REGION, MOST TO LEAST EXPENSIVE, 2009:

Respiratory diseases (asthma, pneumonia, etc.): $143.9 billion Endocrinal diseases (diabetes, high cholesterol, etc.): $125.6 billion Nervous system diseases (epilepsy, Alzheimer’s, etc.): $119.6 billion Cancer and other tumors: $116.1 billion Genitourinary disorders (urinary or reproductive disorders, including infertility): $111 billion Injury and poisoning: $109.8 billion

Source: U.S. Department of Commerce

ILLUSTRATIONS: THINKSTOCK; INFOGRAPHIC; JERALD COUNCIL

1. New England, $8,783 2. Mideast, $7,970 3. Plains, $7,085 4. Great Lakes, $6,852 Source: Centers for Medicare & Medicaid Services

5. Southeast, $6,506 6. Far West, $6,361 7. Southwest, $5,936 8. Rocky Mountains, $5,810

USA TODAY SPECIAL EDITION

THE COST OF CARE How the money flows through hospitals

FUNDING SOURCES Non-patient** 2.2%

Uncompensated care* 6.1%

HOSPITAL COSTS

Wages and benefits 59.2% Private payer insurance 34%

Medicare 39.7%

OTHER SERVICES

Utilities 2.3% Professional liability insurance 1.2% All other, laborintensive 3.7%

Other services 20%

All other, nonlabor intensive (postage, phone bills, etc.) 3.7% Professional fees 9.1%

Medicaid 16.3%

Prescription drugs 6.3%

NOTE: MAY NOT ADD TO 100% DUE TO ROUNDING

Other products (food, medical instruments, etc.) 14.4%

Other government 1.8% *CHARITY CARE AND BAD DEBT EXPENSE **PARKING LOT FEES, CAFETERIA, GIFT SHOPS, ETC. NOTE: MAY NOT ADD TO 100% DUE TO ROUNDING

THE TOP 10 STATES FOR HOSPITAL JOBS

Hospitals employ more than 5.5 million fulland part-time workers in the United States. 520,641 439,222 343,203 294,524 285,487 282,039 241,429 210,019 182,811 175,654

1. California 2. New York 3. Texas 4. Florida 5. Pennsylvania 6. Ohio 7. Illinois 8. Michigan 9. Massachusetts 10. North Carolina

Source: American Hospital Association 2014 TrendWatch Chartbook American Hospital Association

OUTPATIENT CARE

Hospitals have been switching to more outpatient care over the last two decades as insurance companies change payment policies for inpatient care:

Gross Inpatient Revenue

73% 72% 70% 69% 67% 67% 66% 65% 65% 65%

Gross Outpatient YEAR Revenue

1993 1994 1995 1996 1997 1998 1999 2000 2001 2002

27% 28% 30% 31% 33% 33% 34% 35% 35% 35%

Gross Inpatient Revenue

YEAR

Gross Outpatient Revenue

65% 64% 63% 62% 62% 61% 59% 58% 57% 56% 55%

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

35% 36% 37% 38% 38% 39% 41% 42% 43% 44% 45%

THINKSTOCK

USA TODAY SPECIAL EDITION

Dr. Francis Collins, director of the National Institutes of Health, manages an agency with a $30 billion budget.

CHRISTIAN, SCIENTIST NIH’s director leads a multifaceted life

By Elizabeth Neus

R. FRANCIS COLLINS’ SPARE, three-paragraph biographical sketch on the National Institutes of Health’s website hardly tells his story. The current NIH director has been on teams that identified the genes for cystic fibrosis, Huntington’s disease, neurofibromatosis (aka elephant man’s disease), and the premature-aging disease progeria. He led the unprecedented federal

effort to map the human genome — a working draft was announced in 2000 and the map was completed in 2003. A winner of the Presidential Medal of Freedom, the nation’s highest award for civilians, in 2007, he took the job at NIH in August 2009. A guitarist and cyclist (motor- and bi-) who tries to average 10,000 steps a day, Collins, 65, attracted attention in 2006 with the publication of his book, The Language of God: A Scientist Presents Evidence for Belief. Few scientists admit religious

belief publicly; Collins’ best-selling book dashed stereotypes. He was included on The New Republic’s list of “Washington’s most powerful, least famous” people in 2011, but was among the famous people included in the farewell singalong on the last episode of The Colbert Report. Collins runs an agency of more than 20,000 people with a budget of about $30 billion, and that budget is on top of his list of priorities. CO N T I N U E D

DOUG KAPUSTIN

USA TODAY SPECIAL EDITION

President Obama visits with Collins at a lab on the NIH campus in 2009. Collins still works in his own lab when he can, studying diabetes and the premature-aging disease progeria.

The big issue with NIH is funding, research funding. It was startling to see how flat it’s been in the last 10 years or so. How do you make that stop? COLLINS: That’s the question, isn’t it? We had that wonderful doubling from 1998 to 2003, but essentially, since then, our budgets have been flat. And inflation is eroding away at our ability to use the funds that we do have. And of course sequester took a big bite out of our funds as well. We lost a billion and a half dollars … when that kicked in. So if you go through the consequences, we’re down about 23 percent below where we were in 2003, 12 years ago, as far as our purchasing power for research. That makes this a very tough time for all those capable visionary investigators out there in the universities and the institutes all over the country who depend on NIH to review their grants and to give them support if they score well. But scoring well used to mean being in the top third, and then you would get funded (i.e., one in three grants would get funded). Now you have to be much better than that, about the top sixth. ... Science itself is going great. It’s the support of science that’s going badly. This has been going on for a couple of administrations and a couple of varieties of Congress by now, so you can’t necessarily call it a partisan thing. I think medical research has never been a partisan issue, and may it never be. I think you’ll see broad support in terms of words spoken about research from either house, either party. The problem is it’s all caught up in this tangle about what we’re going to do about our budget overall, and we’re part of the non-defense discretionary budget. When things get tight, that’s where people go to try to make cuts. And some of those cuts maybe have been legitimate, but when it comes to medical research, we’ve already pretty much done everything you can imagine ... and now we’re really cutting into bone.

JIM WATSON/AFP/GETTY IMAGES

Are there alternative sources of funding springing up? Yes, but they don’t anywhere near add up to what we‘ve lost. The federal government has been the largest supporter of biomedical research of the basic sort in the United States, and that’s been an incredible American success story since World War II. And yes, we do look around for every other possible source of funds. We have collaborations with the private sector on a larger scale than ever in the past. I helped start something called the Accelerated Medicines Project, which involves 10 pharmaceutical companies working with NIH investigators, splitting the cost 50/50 ... This is focused on Alzheimer’s disease, type 2 diabetes, rheumatoid arthritis and on lupus. ... I think it’s a great model, but it doesn’t make up at all for all the other things that we’ve lost ground on. We also work more closely

now with philanthropies than ever, but most philanthropies are pretty focused, oftentimes on a particular disease. What can you say to scientists who are worried about this? I get emails almost every day, some from people who are already out there working as principal investigators in labs but whose grants just missed the pay line and who are wondering, “Am I going to have to leave and do something else?” Some (are) even more wrenching, actually, from trainees who are post-docs, for instance, or physicianscientists who are doing a fellowship, all with their dreams ... and now they’re not sure that path is there for them any more. ... That’s the resource that we count on most. It’s not just equipment or fancy reactions in a test tube, it’s the people who have the ideas that are critical to our future, and we

are at risk of losing a whole bunch of them. And there’s such an emphasis on STEM. We want to fill the pipeline, but then where are these people going to go? Is there anything in the pipeline that looks even vaguely hopeful? I would like to believe there is. I’m an optimist and generally will kind of look for some signs of progress until it’s hopeless, and it’s not hopeless, certainly when you see the increasing willingness of leaders in the Congress to say, “We’ve got to do something about this situation.” Let’s talk for a minute about the Precision Medicine Initiative. There’s been a lot of work in that area already — Not in a coherent, visionary way, which is what this initiative represents. It’s

USA TODAY SPECIAL EDITION

To raise awareness of the need for research support, Collins jammed with Aerosmith’s Joe Perry, right, as part of a “Rock Stars of Science” event sponsored by the Geoffrey Beene Foundation in 2009.

NIH

President Clinton congratulates Collins at the White House prior to announcing the completion of the first draft of the entire human genome in June 2000. STEPHEN JAFFE/AFP/GETTY IMAGES

coherent and visionary in two ways. One is the number of kinds of data that you want to accumulate on individuals, the other is just the sheer size. Nobody’s dared to talk about a cohort of a million people, and now we are. But what kinds of data would you collect? Yeah, sure, there would be some genomic information, but there would also be electronic health records, there would also be opportunities to look at environmental exposures, there would be opportunities to take advantage of wearable sensors that are becoming increasingly available — my Fitbit, I’m a user now for five years, I was on the leading edge of all this — and many others like this that increasingly allow you to do pretty impressive monitoring of what somebody’s doing and how their body is responding, but which haven’t really been put to the test in a large-scale effort to see how (people) change health behaviors.

Is the goal to get a broad change in health behaviors or to be able to treat Person A for Disease B? All of the above. If you have a million people, whatever Disease B is, there are going to be quite a lot of people who are in that situation, and you have the opportunity to see what’s actually working and what isn’t. You have the chance also to figure out what are the risk factors that led that person to get Disease B in the real-world setting, which we haven’t been able to do. How do you translate it down into individual medical care? It seems like it might be so personalized that it might be expensive, and then you get into other issues. One of the good things is that the genomic part of it is getting so cheap that that part of the analysis is almost to the point of

being a rounding error in the study, because DNA testing keeps dropping by orders of magnitude. To get a complete genome done is in the neighborhood of a couple thousand dollars. It used to be about $400 million, so that’s quite a drop. And (your genome) doesn’t change for the most part, if you’re talking about your circulating blood cells, so you do it once and you’re done. ... You might want to do other kinds of analyses to see whether something’s happening. ... But those things are not going to be limiting in terms of the cost involved. So you’d be able to get more medications like the breast cancer drug that treats one specific form of breast cancer. Exactly. ... This is basically providing a starting point for almost everything you want to do in clinical research, with participants at the center of the effort, making a decision they want to be part of it, they want to be consulted about how it goes, they want to be asked to take part in other studies that are built upon this foundation. So is there a way to sign up for this yet? Not yet, because we don’t quite know what the actual cohort is going to look like. ... But I certainly hope that once the dust settles on that, there will be a portal for people who just want to be part of this to sign up.

One thing that’s always fascinated me about you is the fact that you tell people you’re religious, and I have never understood why people have a problem with that. (laughs) Well, some people do, still, but I think most people are OK. Certainly in the scientific community, though, there are some who think that’s an inappropriate topic for a scientist to be discussing. Most people in the general public, though, are interested in what science has to offer, and the majority of them also are people who believe that the spiritual side is important to consider, and many of them are themselves people of faith. They may assume that most scientists are atheists, but they’d be wrong. About 40 percent of us are people who believe in a personal God, and I happen to be in that 40 percent. Is there anything at this point that you’re proudest of achieving as director of NIH? I can probably think of things in your pre-NIH years, but what about this current job? Gosh. I would point to the founding of the National Center for the Advancement of Translational Sciences (NCATS), which is the first new component of NIH in many years, built upon the idea that we could speed up the process of going from basic science to clinical benefits if we had a focused hub of activity, and that’s really been a gratifying development. I’d point to the Brain Initiative ... which is also truly groundbreaking. It will stretch out over the next decade to figure out how the circuits in the brain do what they do, which is pretty fundamentally exciting and important for all kinds of reasons. And I guess I’d put the Precision Medicine Initiative on that list, having had it now announced by the president. That’s really gratifying to see such strong support from him, and with the chance now to turn that into a program that I think will be yielding phenomenally interesting and important results over many years to come.

USA TODAY SPECIAL EDITION

MORE SCIENTISTS, LESS CASH As more scientists apply for grants in a tighter financial pool, a lower percentage of research projects win money.

DOLLARS FOR DOCS Billions are spent on medical research, but added funding is rare By Elizabeth Neus

ederal research funding soared during the 1990s, but has been flat for the last decade. About 540 universities and other research institutions received grants in fiscal year 2015 covering 244 diseases or other health-related topics. Johns Hopkins University received the most research funding, with 237 awards worth $130.3 million.

Year 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

Applications 24,151 26,408 27,798 28,368 30,068 34,710 40,861 43,069 45,688 47,455 43,467 43,142 45,983 49,592 51,313 49,581 51,073

Success Rate 31% 32% 32% 32% 31% 30% 25% 22% 20% 21% 22% 21% 21% 18% 18% 17% 18%

Source: National Institutes of Health

THE FUNDING PLATEAU

$21.0 billion

$7.7 billion

*1995

2014 *ALL YEARS FISCAL

Source: National Institutes of Health

THINKSTOCK

USA TODAY SPECIAL EDITION

SCIENTIFIC METHODS

Evaporating funds are leading to emptier laboratories By Peggy J. Noonan

The University of Virginia School of Medicine is one of the many teaching institutions that has been adversely affected by the lack of increase in federal research funding.

R. ANINDYA DUTTA RUNS the University of Virginia School of Medicine’s department of biochemistry and molecular genetics. He and his team conduct research that focuses on understanding what keeps muscles healthy, and information that can help people with muscle-weakening diseases, who have been confined to bed for long periods of time or who are merely aging. But these days, their

JOSH BARNEY/UVA HEALTH SYSTEM

focus is less on the research than it is on the money. “In both the lab and the department, we are spending much more time writing and rewriting grant applications,” said Dutta. “The chances of funding are low.” And this is for a team whose research grant application in 2008 received a score of “exceptional” from the National Institutes of Health (NIH) and “produced a ton of work leading to high-quality publications,”

Dutta said. When the lab applied for re-funding in 2012, expecting to sail through the process, the grant failed to receive a high-enough score to win funding. It has been reviewed four times since then and still has not been approved. UVA gave Dutta a year’s worth of gap funding to keep the project going, but he said there’s only enough money for “one very brave Ph.D. student working on it”

USA TODAY SPECIAL EDITION

IN THE FIELD

CROWDSOURCING FOR A CURE

CROWDRISE.COM

Ebola researcher Erica Ollmann Saphire turned to crowdfunding to raise money for equipment, and is now looking for help paying an aide.

In 2014, the NIH awarded a five-year grant of about $28 million to find an antibody cocktail to fight Ebola. The project involved researchers from 15 institutions, led by Scripps Research Institute professor Erica Ollmann Saphire. “It’s a global collaboration,” Saphire said. Her laboratory gets $2.5 million of the NIH grant, but that isn’t enough — so she turned to crowdfunding. Her Cure Ebola fundraiser on CrowdRise.com won “overwhelming support” and brought in enough money to buy a key piece of equipment for her lab that will help her process the hundreds of samples they receive from around the world. Her Outsmart Ebola Together project in partnership with IBM’s World Community Grid harnesses “idle time” computing power from more than 680,000 volunteers’ personal computers and mobile devices around the world. Pooling their downtime forms a virtual supercomputer that can dramatically accelerate the research. Now Saphire’s crowdfunding site (crowdrise.com/cureebola) is attempting to raise about $175,000 to hire a postdoctoral fellow with computational experience to analyze that vast amount of data and identify the most promising leads for more testing. — Peggy J. Noonan

instead of the three or four more experienced scientists and additional postdoctoral fellows he would normally have. “I cannot begin to tell you how discouraging this situation is for the trainees — the undergraduate students, the Ph.D. students and postdoctoral fellows,” he said. “The pipeline for future discoveries — the future scientists — is being cut.” This is the state of American medical research after years of flat funding. From 1995 to 2005, the money available from the NIH to fund research at American universities and medical centers increased from $7.7 billion to $20 billion, but has hovered around that figure ever since. The number looks high, but the NIH has lost 22 percent of its purchasing power as a result of those flattened budgets, which aren’t keeping up with inflation — and because Congress has also instituted mandatory cuts for non-defense spending, said Dr. Francis Collins, NIH director. Where one in three grants once won approval (and money), now it’s only one in six. “We are in a difficult spot,” Collins said.

“Scientific progress is accelerating, (but) this wonderful engine of discovery, the American biomedical research community, is running on limited fuel.” Other nations are still investing in medical research. Asia’s research funding tripled from $2.6 billion to $9.7 billion between 2004 and 2012, according to a report published Jan. 13 in the Journal of the American Medical Association, as U.S. funding failed to keep pace. Recent surveys suggest that as many as 18 percent of scientists are considering leaving the U.S. because of the dwindling grant resources, Collins said. Some labs are trying to make creative end runs around the problem by crowdsourcing funding. Scripps Research Institute professor Erica Ollmann Saphire turned to CrowdRise.com to buy a key piece of equipment needed for her Ebola research, and she continues to enlist volunteers through IBM’s World Community Grid who donate computer time to create a supercomputer that accelerates the research work. And the Cystic Fibrosis Foundation

funded a small biotech firm itself to research drugs to fight the deadly inherited lung disease, and earned more money for more research by selling the rights to the resulting drugs. But these private funding resources tend to tilt research to specific topics rather than broad discovery and basic science. And even those scientists who still attempt to get traditional federal funding may shift to research that provides rapid, solid results or show better, more immediate prospects for success, rather than science that might not pay off immediately. Overall, “we’re looking at a roughly 10 percent decrease in the number of competitive research project grants (from the NIH for fiscal year 2015, which ends Sept. 30),” said David Moore, senior director of government relations for the Association of American Medical Colleges, which represents 141 medical schools and 400 teaching hospitals and health care systems. “For a young person who’s really bright, CO N T I N U E D

JACKSON SMITH/UVA HEALTH SYSTEM

Dr. Anindya Dutta’s lab has only enough money to keep running for a year.

USA TODAY SPECIAL EDITION

UNIVERSITY OF PITTSBURGH

Deyana Lewis, left, a Ph.D. candidate in human genetics, explains her study on the genetic factors of tooth decay at the University of Pittsburgh Graduate School of Public Health Dean’s Day, which celebrates the work of young scientists.

really interested in science — they can do the math. That’s a very powerful disincentive. “It’s even more concerning for physicianscientists, MDs or other health professionals who want to become researchers, because they have a longer career path,” he added. “You go to medical school, then have research training, then generally have some sort of residency training and at the end of that, (you’re facing) $200,000, $300,000 in debt (with) tenuous prospects.” John Wilkinson IV, an assistant professor of anatomy and pathology at the Joan C. Edwards School of Medicine at Marshall University in Huntington, W.Va., knows that story too well. He plans to leave his position at Marshall in June to become a science writer. He had taken a position at Marshall in 2007 that emphasized teaching over research as a shield from the funding problems, but when he tried to return to research, the late start in the field and his lack of tenure caused insurmountable hurdles that couldn’t be overcome. He doesn’t want to move to another city for family reasons. “We have graduate students at our school who are working for half pay, who have to work outside jobs,” Wilkinson said. One of his students is experiencing an academic Catch-22: He is having trouble getting grants because he doesn’t have enough published research papers, but he also can’t get the money to do more research and publish more papers. “The achievement that celebrates their work

and dedication, the publication of their results, may prove to be impossible,” Wilkinson added. The NIH is looking at possible new avenues to free up or create additional research funding. It’s created the Pioneer Award Program as well as New Innovator Awards to encourage more transformative, out-of-the-box research. In some cases, it’s flipping the way it looks at grants: “We basically bet on the researcher instead of on the specific, detailed project,” Collins said. The agency is also considering “emeritus grants” that would ease senior scientists out of the lab and into administration or teaching to make more funding available for younger researchers. “Right now, many senior investigators just keep applying (for grants) because they don’t know what else to do,” he said. Universities are searching for ways to continue stop-gap funding for their researchers between grants. At the University of Pittsburgh, its large financial base — Pitt has relationships with 23 local and regional hospitals as well as hospitals in Europe and Asia — enables it to provide bridge funding for researchers who are awaiting grant approval, as well as grants for young scientists who have trouble cracking the grant code. “We have skin in the game,” said Dr. Arthur Levine, dean of the University of Pittsburgh School of Medicine. “Having made investments in these investigators over the years, we cannot sacrifice the return on our investment ... (And) if I don’t keep their labs going, basically it will abort the careers of people who have already contributed greatly to health and to discovery.”

IN THE FIELD

SCIENCE ON A SHOESTRING “NIH funding was probably the most significant form of funding we have in biomedical sciences,” said Patrick Grant, an associate professor in the department of biochemistry and molecular genetics at the University of Virginia School of Medicine. His lab is working on epigenetics, an emerging field of science exploring non-inherited genetic changes and how they affect the well-being of a cell. A better understanding of how cellular processes go wrong could lead to new therapies for cancer and debilitating neurological diseases such as Alzheimer’s, Parkinson’s and Huntington’s. But Grant’s funding dried up, and last year, his lab staff was reduced from 14 people to two — one of whom is Grant. Over the last couple of years, he said, UVA has lost numerous scientists as a result of reduced funding. “I’m lucky,” he said. “I just got notification that I will get some funding beginning this summer from the NIH, (but) now I have to build from the bottom up again.” It’s a real shame, he said, to see colleagues having to wind down their research, but “if there are no jobs to be had, how are they going to pay their mortgage?” he asked. “How are they going to put food on the table?” — Peggy J. Noonan

USA TODAY SPECIAL EDITION

PRECISION MEDICINE

THINKSTOCK

Developing health care as individual as you are By Chrystle Fiedler

VERYONE IS DIFFERENT, BUT doctors tend to treat everyone the same, even though what works for one patient won’t necessarily work for another. It’s like being given the same prescription for glasses or medication or the same type of blood in a transfusion, no matter your weight, your health history or your age. But what if your doctor had the ability to tap into a worldwide data bank that would help provide an individualized treatment protocol just for you? It’s in the works, and it’s called

precision medicine. President Obama is asking for $215 million for his initiative to help fund federal and science agencies that will build a knowledge network to provide more effective cures for disease. “Precision medicine is about pulling together data about genes, microbiomes, environment, and lifestyle factors to reveal the mechanism of disease at the level of the individual to be able to provide a targeted treatment,” said Keith Yamamoto, the vice chancellor for research and executive vice dean of the School of Medicine at the University of California, San Francisco (UCSF). “It’s a revolutionary way to look at research,

health and health care.” The goal is to integrate all of this information in a way so that every scientist, researcher or clinician working with patients will be able to access it through a “knowledge cloud,” modeled like Google Maps with multiple layers. These layers will include different types of biological information including the genome, population studies, individual experiences and other factors. Researchers will be tasked with filling in the gaps, finding relationships within the information and developing new hypotheses to test and new ideas for CO N T I N U E D

‘‘

MANDEL NGAN/AFP/GETTY IMAGES

Tonight, I’m launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes — and to give all of us access to the personalized information we need to keep ourselves and our families healthier.” — President Obama, State of the Union Address, Jan. 20, 2015

USA TODAY SPECIAL EDITION

HOW TO PARTICIPATE

The National Institutes of Health plans to create a group of about 1 million volunteers that will form the basis of the Precision Medicine Initiative, but hasn’t yet decided how to recruit them. The volunteers will provide medical information in a host of ways:

ELECTRONIC HEALTH RECORDS

With the volunteers’ permission, researchers will examine their medical records and history in order to spot trends. ERIC RISBERG/ASSOCIATED PRESS

WEARABLE SENSORS

Fitbits and other devices may be used to track realtime information about health.

MEDICAL TESTING

Patients’ electronic medical records, kept at doctors’ offices, may be used to research health trends as part of the Precision Medicine Initiative.

diagnosis and therapeutic decisions for clinicians. “It will provide a depth of information that will allow diagnosis and therapeutic decisions to be made at the level of the individual rather than the statistical groups that they are now,” said Yamamoto.

A SHIFT IN FOCUS

Blood tests, genome mapping and more will look at underlying causes and possibly catch early signs of disease. Get the latest on the Precision Medicine Initiative at nih.gov/precisionmedicine; you may also sign up there for email alerts.

THINKSTOCK; FITBIT; THINKSTOCK

This shift in focus is essential, and will change the paradigm of medicine, and in turn the way patients are treated. It will mean studying disease at the molecular mechanism level rather than focusing on organs and symptoms. This is possible because of advances in science — specifically, the ability to sequence the human genome, the alphabet that forms the gene for every trait in the human body. “A personalized approach on the level of the individual is not new,” said Dr. Francis Collins, director of the National Institutes of Health. “But the prospect of applying this concept broadly has been dramatically improved by the recent development of large-scale biologic databases (such as the human genome sequence) … and computational tools

for analyzing large sets of data.” One of the initiative’s biggest priorities is cancer genetics, an area of inquiry that has already resulted in big wins for melanoma, lung and colon cancers, and it will move to other diseases like heart disease and diabetes. “Cancer is the focus because we can work with the genomic mutations and drugs that can block that protein from acting,” said Jon Retzlaff, the managing director of science policy and government affairs at the American Association for Cancer Research. Patients with various types of cancer, including breast, lung and colorectal cancers, now undergo molecular testing before treatment, but precision medicine could take this to a whole new level. “Hopefully, this initiative will help patients get the best-matched therapy based on the individual results of their tumor testing,” said Dr. David Hyman, acting director of developmental therapeutics at Memorial Sloan Kettering Cancer Center in New York. “It will make us more nimble about the way we combine therapies.” A precision medicine approach is

even more important for rare diseases such as adrenal cancer where there are fewer researchers and clinicians to gather genetic data. “Adrenal cancer is rare, so we realized that we needed to work together,” said Dr. Gary Hammer, the director of the endocrine oncology program at the University of Michigan Comprehensive Cancer Center. Recently, Hammer teamed up with German researchers on a study published in the medical journal Lancet Oncology in April 2015. In the study, most of the adrenal cancer patients who received the drug linsitinib showed no improvement, but researchers did notice that a small subset of patients did, and the cancer was kept in check for two to four years. Linsitinib blocks the insulin receptor pathway, which plays a role in how adrenal cancer develops. “It’s a very promising era,” said Hammer.

TAKING THE INITIATIVE NATIONWIDE

The goal of the Precision Medicine Initiative is to build knowledge networks in two key areas — cancer

USA TODAY SPECIAL EDITION

WHERE THE MONEY WILL GO u$130 MILLION to the National Institutes of Health (NIH) for development of a voluntary national research cohort of a million or more volunteers to propel understanding of health and disease and set the foundation for a new way of doing research through engaged participants and open, responsible data-sharing.

ANNE RYAN; DANIEL SONE/NCI

DANIEL SONE/NCI

The National Cancer Institute will work to identify the genetic triggers for cancer in hopes that the research will result in more targeted treatments.

and neurological diseases with the help of patients or “partners,” along with researchers, institutions and academic medical centers. If Congress approves the $215 million Obama has asked for in the 2016 budget, $130 million will go to NIH and $70 million to the National Cancer Institute (NCI). “It’s very helpful to have the president, the NIH and the regulatory authorities recognize precision medicine as a promising avenue for developing better treatments for our patients,” said Hyman. “It helps us to continue our efforts.” The NIH will set up a national research cohort of a million volunteers to share information including medical records, gene profiles, and environmental and lifestyle data. “It will help us get a sense of the general molecular fingerprint of various diseases,” said Hammer. The NCI, part of NIH, will build on work identifying genomic drivers in cancer and developing more effective treatments, and establishing a “cancer knowledge network.” “What’s exciting to me and many doctors is the investment in understanding the genetic drivers of

specific cancers and other diseases and developing an infrastructure for data sharing,” said Hammer. Another $10 million will go to the FDA for database setup and to review the regulations to support the initiative, and $5 million will go to the Office of the National Coordinator of Health Information Technology (ONC) to make sure the data is transmitted and shared by patients, researchers and clinicians while protecting patient privacy.

KNOWLEDGE IS POWER

“The more we know, the more we’ll be successful in driving health costs down,” said Yamamoto. “Precision medicine will enable doctors to eliminate prescription drugs to people whom it isn’t helping and help eliminate costly clinical testing. It will also bring down the cost of prescription drugs.” Knowing more about a drug’s mechanism and its effect will also make it more likely that drug companies will fund Phase III trials and provide a drug that will help more patients or a subset of patients. A blue-ribbon panel recruited by the NIH has been working on designing and

Patients will be able to volunteer to participate in the Precision Medicine Initiative, enabling researchers to examine their personal medical records. Genetic and other medical testing will also be part of the process as scientists look for population trends in how diseases develop and how well treatments work.

guiding the program and is scheduled to report in September 2015 to Collins, who led the federal project to sequence the first human genome 15 years ago. Work on building the million-person cohort would begin in January 2016. Before you know it, you may be asked by your physician or medical center to volunteer and possibly provide data. “Numbers really matter,” Collins said. “The way we do this now, of course, is you try to go out and find those rare individuals with that kind of ... cancer. It’s really hard to find (enough patients) and it takes forever to enroll patients.” Medical centers like UCSF and Memorial Sloan Kettering have realigned their approach for care and treatment on this model. Ultimately, what is good for one person, will be good for all. “This initiative will push the field forward in terms of developing new treatments for everybody by making the critical observations in individual patients,” said Hyman. “It’s the individual patients who benefit from initiatives like this but they also teach us how we can bring these strategies to the community and help everyone. It’s a very hopeful time.”

u$70 MILLION to the National Cancer Institute (NCI), part of NIH, to scale up efforts to identify genomic drivers in cancer and apply that knowledge in the development of more effective approaches to cancer treatment. u$10 MILLION to the Food and Drug Administration (FDA) to acquire additional expertise and advance the development of high-quality, curated databases to support the regulatory structure needed to advance innovation in precision medicine and protect public health. u$5 MILLION to the Office of the National Coordinator of Health Information Technology (ONC) to support the development of interoperability standards and requirements that address privacy and enable secure exchange of data across systems. Source: White House

USA TODAY SPECIAL EDITION

SHAKE CDC chief fights battles from epidemics to public health issues

Dr. Tom Frieden, director of the Centers for Disease Control and Prevention, updates a congressional committee on the West African Ebola epidemic in August. JEWEL SAMAD/AFP/GETTY IMAGES

By Adam Stone

F THERE IS A threat to public health, the director of the Centers for Disease Control and Prevention (CDC) has probably stared it down sometime in his career. Dr. Tom Frieden has studied measles and typhoid, and in the 1990s led campaigns to contain tuberculosis in New York City and India, helping to save more than 3 million lives along the way. He’s spearheaded efforts to dramatically cut smoking, eliminate trans fats from the U.S. diet and open up electronic health records.

Since signing on to his present role in 2009, Frieden, 54, has kept up the pace in the face of myriad challenges, including smoking, obesity and most recently, the 2014 outbreak of Ebola in West Africa, the largest in history, which infected more than 25,000 people and killed more than 10,000 of them. Four people were diagnosed in the U.S. with Ebola connected to the African outbreak, and one of them died. Frieden also received the 2014 Julius B. Richmond Award, the highest honor given by the Harvard School of Public Health. In presenting the award, Dean Julio Frenk called him “someone who has shown us

again and again what it means to make the impossible possible.” His tenure has not been without criticism. U.S. Rep. Paul A. Gosar, R-Ariz., called for his resignation during the Ebola epidemic, saying in a statement last year, “Frieden has failed to lead and has shown gross incompetence in his actions or lack thereof to prevent the spread of Ebola domestically.” In a wide-ranging interview, Frieden addressed the challenges of Ebola, the risk of resisting vaccines, the diminishing efficacy of antibiotics, and many other issues. CO N T I N U E D

USA TODAY SPECIAL EDITION

Would you describe one or two of CDC’s latest accomplishments? FRIEDEN: What stands out is the Ebola response, which is the most intensive mission in CDC’s

history. Although there is much more we and our global partners must do to get to zero new cases and end this terrible epidemic, there have been many remarkable accomplishments by CDC and other partners in the international response over the past year. More than 800 of our agency’s staff have been deployed on more than 1,500 missions in West Africa, working more than 40,000 person-days. They helped organize the overall response, improve patient detection and care, travel to some of the most remote villages on Earth to trace patient contacts, find and stop chains of disease transmission and communicate effectively with patients, health care workers, policymakers and the public. What has CDC learned in the course of the Ebola response? Where has the agency succeeded, and what might you do differently in the future? During the past year, I have gained an even deeper appreciation and respect for the scientists and public health professionals at CDC. After three visits to see our work in West Africa firsthand, my chief impression is that the impact of expert CDC staff in the field cannot be overstated. WHO (the World Health Organization) recognized and reported the Ebola outbreak in March 2014, and CDC had expert teams on the ground within a week. This outbreak “We saw that a huge, has been different than anything the world has fast-growing epidemic seen before: an explosive such as this one Ebola epidemic in densely populated urban requires a massive and areas across multiple rapid response. And countries, with more than 10 times as we saw what happens many cases as all prior when precious time is known Ebola outbreaks combined. lost scaling up efforts.” We saw that a huge, — Dr. Tom Frieden fast-growing epidemic such as this one requires a massive and rapid response. And we saw what happens when precious time is lost scaling up efforts. Before the next health threat strikes, the world needs to build and maintain the capacity for early detection of outbreaks and rapid response scaled to the size of the threat. This means both strengthening the ability of each country to find, stop and prevent health threats, and also reinforcing global capacity to support countries which are overwhelmed by a health crisis. What is CDC doing in response to the is-

CHIP SOMODEVILLA/GETTY IMAGES

Frieden greets Guinea President Alpha Conde before a meeting on the Ebola crisis in Washington in October. The CDC has taken an active role in helping the three countries hardest hit — Guinea, Liberia and Sierra Leone — battle the epidemic.

YOUSSOUF BAH/ASSOCIATED PRESS

In Guinea last August, Frieden got a tour of a Doctors Without Borders care center after the virus re-emerged even though local doctors thought they had it under control. sues surrounding the measles outbreak and those who choose not to vaccinate their children? Vaccines have saved hundreds of millions of lives. In some communities, vaccines have become a victim of their own success, because the diseases they prevent have become unfamiliar to people and the need for vaccination is less apparent. We understand parents are concerned about any medicine or vaccine given to their child. That is why we provide full and open information about all vaccines and all decisions made about vaccinations. The bottom line is that vaccines save lives. That

is why I get my own kids vaccinated, and why we speak with doctors and community leaders to provide accurate information about vaccine benefits and risks so we can all be protected. What concerns do you have regarding the rising popularity of electronic cigarettes with kids? What will CDC be doing to address the issue? If e-cigarettes actually help people quit smoking regular cigarettes, that would be good. But the data shows that they are likely getting a lot of kids hooked on nicotine. And a lot of adults who try them in an attempt to

USA TODAY SPECIAL EDITION

One of the CDC’s priorities is to prevent antibiotics from losing their effectiveness in curing disease. CDC microbiologist Tatiana Travis examines one bacterium to see whether it still responds to a particular antibiotic. DAVID GOLDMAN/ASSOCIATED PRESS

quit end up using these products in addition to smoking regular cigarettes, rather than using them as a tool to quit smoking. The bottom line about e-cigarettes: They are tobacco products and they are addictive. The epidemic of obesity: What is CDC’s role? What can be done? Is it time to regulate the Big Mac? Obesity is a serious problem for America. There are real effects on real lives. The increase in obesity is driving increases in diabetes. There are things that can be done at every level of society to reduce obesity. One thing we can all agree on is the need for more physical activity — the closest thing we have to a wonder drug. That can be as simple as taking three 10-minute walks each day. Increasing physical activity pays off in so many ways. Even if people don’t lose any weight, it will make them healthier, reduce blood pressure, reduce risk of diabetes and cancer and improve mood. Each community needs to make decisions

“We understand parents are concerned about any medicine or vaccine given to their child. That is why we provide full and open information about all vaccines and all decisions made about vaccinations. The bottom line is that vaccines save lives. ” — Dr. Tom Frieden

about how to give our kids the best chance to grow up healthy. What is the next big, looming threat to public health? America and the world are facing a crisis: the potential end of the era of effective antibiotics. Drug-resistant infections are a threat to everyone’s health, and the threat is growing. Each year, at least 23,000

Americans are killed by these infections, and another 15,000 die from an antibioticassociated infection called C. difficile. Drug resistance is a ticking time bomb that threatens our health and well-being. Much of modern medical care — cancer treatment, medications for arthritis, transplant, dialysis and more — depends on the ability to cure infections that are a common complication of treatment. If we

lose effective antibiotics, we could lose the ability to safely give many life-saving treatments. Any initiatives planned for the coming months? Upcoming projects you’d like to talk about? In addition to continuing to do everything in our power to get to — and stay at — zero cases of Ebola in West Africa, we are focused on reducing drug-resistant bacteria in the U.S. The (Obama) administration has a governmentwide initiative to address antimicrobial resistance. The CDC component of this plan includes prevention programs, outbreak surveillance and control, antibiotic use and resistance monitoring and better use of antibiotics by both doctors and patients. CDC, if funded by Congress, can reduce the number of Americans infected with the deadliest organisms by half over the next five years.

USA TODAY SPECIAL EDITION

SCENARIO 1 If a person infected with measles walks into a room of 20 vaccinated people, chances are that one of those vaccinated people will contract measles. If that person goes into another room of 20 people, one person will probably be infected. If that person goes into another room of 20 each, just one more person will be infected. So the chain of infection is limited. There are few targets for the virus, and the spread is kept under control.

<< SCENARIO 2

PATIENT ZERO

But if a person infected with measles walks into a room of 20 people, only 85 percent of whom are vaccinated — that’s only three unvaccinated people; not many, right? — the spread can explode. Three people infect nine more people, who infect 27 more people, who infect 81 more, who infect 243 more, and so on, in multiples of three. “It quickly consumes the population,” said Dr. Mark Sawyer, a professor of pediatrics at the University of California-San Diego.

Sources: Centers for Disease Control and Prevention; National Center for Biotechnology Information; National Institute for Allergy and Infectious Diseases; Mayo Clinic; American Academy of Pediatrics; Dr. Mark Sawyer.

INFECTED UNINFECTED

Illustration: Thinkstock. Infographic: Gina Toole Saunders.

STOPPING THE

SPREAD SPREAD

HOW ONE CASE OF MEASLES BECOMES 1,000 By Elizabeth Neus

NE UNSUSPECTING PERSON INFECTED with measles goes to one crowded amusement park filled with people from around the world — not all of whom have been vaccinated against the disease — and all virus breaks loose. The so-called “Disneyland” measles outbreak of 2014-15, which infected 147 people in seven states, is just one example of how quickly measles can spread when vaccines aren’t used as a defense. Measles outbreaks are fast and furious; here’s why. The disease is transmitted easily when an infected person coughs or sneezes, or when those viruses linger and a non-immune person breathes them in or touches them. The virus lives in the air or on surfaces for about two hours. Infected people are contagious for about four days before the signature facial rash appears (the rash appears 14 days after exposure), and for another four days after. Ninety percent of susceptible people exposed to the measles virus catch the illness. One vaccine dose is 85 percent effective if given at 9 months of age, and 95 percent effective after the child turns 1. Two doses are 99 percent effective. The first dose is usually given at 1 year of age, and the second between ages 4 and 6.

USA TODAY SPECIAL EDITION

HEALTH POLICY

Cancer survivor VJ Sleight was able to get a new, less expensive insurance policy through the Affordable Care Act, which bars insurers from refusing to sell policies to customers with preexisting medical conditions.

DIAGNOSIS:UNDECIDED Five years into the Affordable Care Act, Obamacare yields blessings, bruises

By Matt Alderton

HE LAW INFORMALLY KNOWN as “Obamacare” is like a bashful caterpillar clinging to the inside of its cocoon. What comes out could be a butterfly or a moth. Five years after it went into effect, however, Americans still don’t know which to expect. VJ Sleight thinks it’s a butterfly. It’s been nearly 30 years since Sleight was first diagnosed with breast cancer. The memory of her treatment, however, feels fresher than the flowers in a hospital gift shop. It’s so vivid, in fact, that even a flicker of remembrance triggers tears. Just the word “chemo” makes her eyes well and her voice quake. “My experience with chemotherapy was horrible,” recalled Sleight, who was just 32 years old when diagnosed. “I had such a

visceral reaction to it that I can’t talk about it without tearing up.” Because the treatment was so toxic the first time, in 1987, it took all her courage for Sleight, now 60, to even consider chemo a second time, which she did when her cancer returned in 2010. When she ultimately decided to forgo chemotherapy and opted for surgery, however, it wasn’t because of fear. It was because of finances, and surgery was relatively less expensive “I had the audacity to survive cancer … and have been unable to get (new) health insurance ever since,” said Sleight, a tobacco treatment specialist from La Quinta, Calif. Her cancer was considered a pre-existing condition, making it impossible for her to qualify for a new policy. She was forced to keep her existing insurance for nearly three decades, a prisoner to its premiums. “Over the years it grew more and more

expensive until, in 2010, my monthly premium was $500 with a $9,000 deductible. That is $15,000 a year — before insurance kicks in … Although I opted out of doing chemotherapy a second time, if cost hadn’t been a consideration, I might have tried it.” She’s now in remission after trying less-expensive treatments. When the Supreme Court upheld the Patient Protection and Affordable Care Act (ACA) in June 2012, Sleight canceled her 25-year-old insurance policy, which she’s since replaced with a new low-deductible plan purchased on California’s state-run health exchange. Because she qualifies for federal cost-sharing subsidies, her premium is half the amount it used to be. “In June 2013, I had an allergic reaction and spent two days in the hospital,” said CO N T I N U E D

DAN MACMEDAN

USA TODAY SPECIAL EDITION

HEALTH POLICY

JOE RAEDLE/GETTY IMAGES

Ariel Fernandez, left, listens to insurance adviser Noel Nogues as he prepares to sign up for insurance coverage under the Affordable Care Act in Miami. More than 11 million people enrolled in coverage for 2015 through the ACA, according to the White House.

Sleight who, because of Even so, public opinion Obamacare, obtained a remains mixed, with 41 If the Supreme stopgap policy insuring her percent of Americans prior to the January 2014 reporting a favorable Court rules launch of health exchanges. opinion of the ACA and against “The insurance bill was 43 percent reporting $32,000, but since I had an unfavorable opinion, Obamacare, already paid my ($1,500) according to The Henry J. deductible, my cost was Kaiser Family Foundation’s there is no $0. So even before the March 2015 Kaiser Health “plan B” to ACA went into full effect, I Tracking Poll. benefited greatly.” The divide is underreplace it. Sleight isn’t Obamacare’s standable. For every story only success story. Since its like Sleight’s, there’s one five years ago, a total of aplike that of Lou Altman, proximately 16.4 million uninsured people a 50-year-old small-business owner from have gained health insurance through the Portsmouth, N.H. When health exchanges ACA, and another 11.2 million have been began enrolling patients in late 2013, he added to Medicaid and the Children’s Health was among the estimated 2.6 million people Insurance Program (CHIP), according to the who received letters that their existing Department of Health and Human Services policies had been terminated due to ACA (HHS). noncompliance. Specifically, Altman’s group “It’s the largest reduction in the plan didn’t cover pediatric services, which uninsured in four decades,” said Dr. Meena is one of 10 “essential health benefits” Seshamani, director of HHS’ Office of Health mandated by Obamacare. Reform, which oversees the Affordable “The ACA has been a true nightmare for Care Act. me,” said Altman, who had to seek new

coverage for himself and his employees. Although it costs him more, the plan he chose offers less coverage. “The president said, ‘If you like your plan, you can keep it.’ Well, that wasn’t true … I’m 50 years old. I have two grown kids, and surgically I’m not having any more. Why do I need pediatric coverage? This is the problem with Obamacare: When you cast a net wide enough to take care of everyone, you end up serving no one.”

WHAT THE HEALTH?

When Congress passed the ACA in 2010, what Obamacare would actually look like was anyone’s guess. With health exchanges now in their second year, the picture is much clearer. As a result of the ACA: uChildren can stay on their parents’ coverage until they’re 26. uIt’s illegal for health insurance companies to cancel patients’ coverage when they’re sick, or to deny them coverage because they have a pre-existing condition. uHealth insurance companies must spend at least 80 percent of their income on health care, allow patients to appeal when their

USA TODAY SPECIAL EDITION

HEALTH POLICY Demonstrators against the Affordable Care Act protest outside the U.S. Supreme Court in March. A ruling on the latest challenge to the law is expected this summer. James Cook of Cleveland, 5, shows support for the Affordable Care Act in front of the U.S. Supreme Court in March. The court is deciding the case of King v. Burwell, which could determine the fate of health care subsidies for as many as 8 million people.

claims are denied (and promise a more rapid response), have the claim reviewed by a third party and fork out for preventive care. uMore low-income people qualify for coverage under Medicaid. uSome small employers are eligible for new tax credits that help them pay for employee health care. uIncentives to attract physicians to practice in underserved areas have been improved. uMedicare doctors are increasingly compensated for quality, not quantity, of care. uPatients who can afford it must purchase health insurance, claim a health coverage exemption or pay a tax penalty. uConsumers may shop for health insurance online via government-run health exchanges. uLow- or moderate-income patients may receive tax credits or cost-sharing subsidies that reduce their out-of-pocket expenses. Plans offered both on and off the health exchanges must cover ambulatory patient services such as a visit to a doctor when you’re sick; emergency services; hospitalization; maternity and newborn care;

MANDEL NGAN/AFP/GETTY IMAGES

ALEX WONG/GETTY IMAGES

mental health services and substance abuse treatment; prescription drugs; rehabilitative services and devices; laboratory services; preventive and wellness services such as checkups as well as chronic disease management; and pediatric services. So far, the ACA has yielded numerous benefits, according to Dr. Cary Presant, a hematologist and oncologist at City of Hope National Medical Center in Duarte, Calif., and author of Surviving American Medicine: How to Get the Right Doctor, Right Hospital and Right Treatment with Today’s Health Care. “What has helped individual patients a lot are payments for prevention and screening, which have increased; the fact that more kids are now insured through age 25 under their parents’ plan, which is important because that’s an age at which primary care physicians can intervene to influence lifelong healthy habits around things like diet, smoking, drinking, drug abuse and exercise; and the fact that there is no preexisting condition exclusion, which has had a dramatic impact on patients who’ve had health problems in the past,” Presant said.

“My general assessment “Prices of health care is that the Affordable goods and services are “When you Care Act is rolling out as growing the slowest they well as can be expected,” have in about 50 years,” cast a net wide echoed Megan McHugh, a said Seshamani, who enough to take research assistant profesalso noted that the rate sor at the Northwestern at which premiums are care of everyUniversity Feinberg School increasing has slowed for one, you end up of Medicine’s Institute Americans with employerfor Public Health and provided coverage. “The serving no one.” Medicine and Emergency average premium for — Lou Altman, smallMedicine. “It is achieving employer-based family business owner its major objective, which coverage (slightly less than is expanding health $17,000) rose just 3 insurance coverage to the percent in 2014, whereas a uninsured.” decade ago there were frequently doubleIn addition to the nation’s uninsured digit premium increases.” rate, which has fallen by more than a third HEALTH CARE HICCUPS since the ACA came into effect, the act has Along with bright spots there are reduced hospital costs, according to HHS. blemishes. Despite its name — the Affordable Because more patients had insurance, Care Act — affordability is one such blemish. including those visiting emergency rooms, “Although there were a lot of promises hospitals saved $7.4 billion in 2014 on made about the cost of insurance going unpaid bills, it reported in March. Meandown, it hasn’t. It’s gone up, and it’s gone while, overall prices for health care goods and services have increased at a 1.6 percent annual rate since the ACA became law. CO N T I N U E D

USA TODAY SPECIAL EDITION

HEALTH POLICY

ALTON STRUPP/THE (LOUISVILLE, KY.) COURIER-JOURNAL

Pharmacy aide Linda Stratton, left, fills longtime patient Viola Hall’s prescriptions at the Eula Hall Health Center in Grethel, Ky. After spending most of her life without health insurance, Hall is now able to afford her medicines.

up substantially,” said Gary Lauer, CEO of private health insurance marketplace eHealth. According to his company’s research, premiums for individuals and families have increased 45 percent and 71 percent, respectively, since 2013. “One reason is that the legislation requires a very broad and very deep set of benefits in all plans. It’s like buying a new car; if you want the great-smelling leather and the upgraded sound system, you’re going to pay more,” Lauer said. Another issue is young people. Presently, 13.2 percent of Americans are uninsured, according to HHS. Although that’s down from 20.3 percent in 2012, the proportion remains higher — 26.7 percent — among young adults aged 19 to 25. “There aren’t nearly as many young people enrolled as there need to be,” Lauer said. “Young people are typically healthier and don’t utilize health care as much. When they pay into the system, it helps balance the cost of covering someone like me, who’s a little bit older and uses insurance more.” Notwithstanding its moral benefits, covering patients with pre-existing conditions has had similar cost implications. “People who don’t have health issues have to help subsidize those who do, so everybody pays an average amount,” explained Presant, who gives Obamacare a “C” for price. “For people

with pre-existing condithem have elected not to tions, that amount is lower participate in the govern“One real than it was before, but for ment marketplace.” problem we many people it’s higher.” Those who are particiEven for the estimated pating, in many cases, have continue to have 26 million Americans who gutted their networks. is confidence in are eligible for subsidies, “The networks that affordability may be insurance companies have the system. illusory. According to a established for years have Everybody is February 2015 analysis changed because they’re by H&R Block, more very nervous about how nervous about ... than half (52 percent) of much costs have gone up,” subsidy recipients were Presant said. “Because they next year.” over-subsidized in 2014 have to provide increased – Dr. Cary Presant, and therefore had to repay benefits, they’ve said, City of Hope National a portion of their subsidy ‘Let’s narrow down our Medical Center — $530 on average — to networks to the providers the IRS. Price has had a who have sent us the negative impact not only lowest cost per patient.’” on premiums, but also on choice. Although Despite promises from the president, there are over 25 percent more issuers on many Americans have been unable to keep the exchanges this year than last, according their doctor. And many, like Altman, have to Seshamani — companies including been unable to keep their plan. According to UnitedHealthcare, Cigna, Humana and Aetna the Urban Institute’s Health Policy Center, have all expanded their health-exchange 18.6 percent of Americans with individual footprint — insurer participation remains health insurance, about 2.6 million people, relatively low, as some providers are loathe said their plan was terminated for 2014 to insure exchange customers. because it did not comply with Obamacare. “The people using the exchanges typically Another 2.2 percent, or 400,000 people, are people who need health insurance. said their plan was terminated for 2015 They’re sick,” Lauer said. “The carriers because it did not meet new coverage don’t want that business, so many of requirements.

USA TODAY SPECIAL EDITION

HEALTH POLICY “One real problem we continue to have is confidence in the system,” Presant said. “Everybody is nervous about what’s going to happen next year — whether they’ll have to get a new doctor or a new health plan.”

‘SUPREME’ DOUBT

In Obamacare’s fifth year, both successes and shortcomings are evident. Whether the former can be preserved, and the latter corrected, ultimately is a question for the Supreme Court, which in June is expected to issue a ruling in the case of King v. Burwell. The lead plaintiff, 64-year-old David King of Fredericksburg, Va., receives federal subsidies that make it possible for him to purchase health insurance he could not otherwise afford. Because he can pay his subsidized premiums, he must purchase health insurance under the ACA’s “individual mandate,” which requires everyone who can afford health insurance to have it. King filed a lawsuit against the federal government arguing that the wording (“established by the State”) of the ACA means that subsidies should be offered only through state-run exchanges, as in individual states. Since Virginia has no state-run exchange, he argued, he should not be eligible to receive a subsidy, rendering him exempt from the individual mandate requiring him to have insurance in the first place. If the Supreme Court rules in King’s favor, as many as 9.6 million Americans who live in the 37 states, including Virginia, that chose not to operate their own ex-

changes and rely on the federally run health exchange would suddenly be exempt from purchasing health insurance and could opt out of it, according to a January 2015 report by the RAND Corporation. The resulting hit to insurance companies’ portfolios could cause them to raise premiums and retreat altogether from government exchanges. “This is a big deal,” McHugh said. “The ACA has withstood so many political, legal and administrative challenges over the past five years, and it’s still standing. But this could be the final blow.” If the Supreme Court rules against Obamacare, there is no “plan B” to replace it, according to Seshamani. “There are no administrative actions that could undo the massive damage to our health care system that would be caused by an adverse decision,” she said. “Therefore, we have no (alternative) plans.” Lauer is more optimistic. “If — and that’s a big if — the Supreme Court rules in favor of the plaintiffs, I think that’s going to give Congress and the administration an opportunity to make some improvements to the law, and I welcome that,” he said. “I don’t think the legislation is going to be repealed or thrown out, nor do I think it should be. … But there’s no doubt in my mind that over the next couple years there’s going to have to be some legislative changes and fixes to Obamacare. I’m not smart enough to know politically how that will occur, but I’m dead certain that it has to, and will.”

President Obama promotes the Affordable Care Act to young viewers on the webcast Between Two Ferns with Zach Galifianakis in March. The show, hosted by actor Galifianakis, right, airs on humor website Funny or Die.

OBAMACARE 101

WHITE HOUSE

WHAT IS IT?

Obamacare is the nickname given to the health care reform law that was passed in March 2010. Otherwise known as the Patient Protection and Affordable Care Act, or ACA for short, it was designed to reform the U.S. health care system by improving the quality and affordability of health insurance, lowering the population’s uninsured rate by increasing access to health insurance via public and private health exchanges, and reducing the cost of health care for individuals and the government.

WHAT ARE “HEALTH EXCHANGES”?

Health exchanges are marketplaces where individuals who don’t have employersponsored coverage can purchase health insurance. Obamacare establishes for the first time public health exchanges, which are sponsored by the government. There are currently 14 state-run and 37 federal-run exchanges. Health plans offered on all of them are regulated by the government and are eligible for government assistance in the form of tax credits or subsidies that can reduce premium costs for income-qualified buyers. Health plans offered on private exchanges must meet the same standards of care as those on public exchanges, but do not qualify for government assistance.

WHO QUALIFIES FOR GOVERNMENT ASSISTANCE?

Government assistance is based on income. In most states, anyone making less than 400 percent of the Federal Poverty Level (FPL) qualifies for a tax credit. Those making less than 250 percent of the FPL qualify for subsidies. Those making less than 138 percent of the FPL may be eligible for Medicaid.

WHAT TYPES OF PLANS ARE AVAILABLE?

Obamacare establishes five types of “metal plans”: Bronze, Silver, Gold and Platinum, plus another tier called Catastrophic. Gold and Platinum plans offer more coverage than Bronze and Silver plans, but have a higher price. All plans cover at least 10 “essential health benefits” mandated by Obamacare: Ambulatory patient services; emergency services; hospitalization; maternity and newborn care; mental health services and substance abuse treatment; prescription drugs; rehabilitative services and devices; laboratory services; preventive and wellness services and chronic disease treatment; and pediatric services. The Catastrophic plan pays for less than 60 percent of care, and is available only to people younger than 30 or who have a hardship exemption (they’re homeless, for example, or have experienced some other kind of personal or financial catastrophe).

HOW DO I ENROLL?

JOE RAEDLE/GETTY IMAGES

Darko Tomelic, left, and Andrea Viteri, speak with insurance agent Roberto Villacreses, right, in Miami about coverage available through the Affordable Care Act. The Obama administration hopes that young consumers will sign up in large numbers to keep plans affordable.

Those seeking health insurance must enroll during the annual “open enrollment” period, which for 2016 begins Nov. 1, 2015, and concludes Jan. 31, 2016. Enrollment in public plans can take place online at HealthCare.gov, by phone at 800-318-2596, in person or by mail. Individuals facing special circumstances, including life events such as marriage or the birth of a child, may qualify for a special enrollment period outside of open enrollment.

USA TODAY SPECIAL EDITION

HEALTH POLICY Michelle Shope’s grandson, Connar, was able to have his hearing restored through surgeries covered by the Children’s Health Insurance Program.

JACOB SLATON

CHIP-PING I AWAY

By Nancy Monson

Programs provide children with much-needed health insurance

program did. Good thing, too, since Connar was N 2003, MICHELLE found to have hearing SHOPE of Poyen, loss at 36 months and Ark., was raising two needed two surgeries. daughters, ages 5 Now in the fifth grade, and 17. She thought the 11-year-old has she was done caring recovered his hearing and for babies — that is, is thriving. until her 17-year-old “Without health care became pregnant. coverage, the cost of the — Sen. Sherrod Brown, Shope and her husband surgeries would have D-Ohio assumed custody of their been devastating for our grandchild, Connar, when family,” Shope said. he was a few months old, ARKids First is one of but found themselves in the lurch when it many state-run programs that fall under the came to his health care needs. umbrella of the federal Children’s Health “It was a rude awakening to find out Insurance Program, commonly known as that even though we had legal custody of CHIP. Established in 1997 and reauthorized Connar, our private insurance company in 2009 with bipartisan support, CHIP was wouldn’t cover him because he wasn’t our created to fill a critical gap in kids’ health biological child,” Shope recalled. Luckily, CO N T I N U E D the ARKids First public health insurance

“We can’t turn our backs on health coverage that allows children to grow into healthy, active adults.”

USA TODAY SPECIAL EDITION

HEALTH POLICY

TANIA SAVAYAN/THE (WESTCHESTER, N.Y.) JOURNAL NEWS

Advocates for children’s health insurance programs say that better coverage for young mothers and their new babies can lead to healthier adults.

care coverage: It insures children whose parents have incomes that are too high to make them eligible for Medicaid but who can’t afford to buy private coverage. In fiscal year 2013, 8.4 million kids were covered by CHIP and annual spending totaled $13.2 billion. By most accounts, CHIP has been wildly successful, halving the rate of uninsured children in the U.S. from 14 percent to 7 percent from 1997 to 2012, according to a report by the Kaiser Family Foundation. Although benefits differ from state to state, CHIP usually offers free preventive care in the form of routine check-ups and vaccines. Doctor visits, dental and vision care, lab tests and X-rays, emergency services and prescriptions are also included, but some states charge a monthly premium or require co-payments for these services.

OVERLAPPING PROGRAMS

Health insurance programs that target low-income uninsured children include CHIP, Medicaid and the Affordable Care Act

(ACA) subsidized health “There is no cap on care exchanges. the number of people “Without health CHIP is structured as who can be enrolled in care coverage, the a block grant from the Medicaid or how much federal government to the the federal government cost of the surgeries states. Currently, about will pay,” explained 70 percent of CHIP’s cost Elisabeth Wright Burak, would have been is paid by the federal senior program director devastating for our government; the other for the Center for 30 percent is paid by the Children and Families family.” states. If states max out at the Georgetown — Michelle Shope, whose on their allotted funding, University Health Policy grandson is covered by CHIP they are required to pay Institute. 100 percent of the cost of Lastly, ACA health care insuring their low-income exchanges are available children or take them out of the CHIP in all states, either through state-run program. exchanges or via the federal government’s Medicaid, in contrast, is an entitlement portal. They are subsidized via tax credits program. That means if a child is eligible for to eligible individuals and make mandated coverage according to an individual state’s insurance possible for Americans who don’t income qualification standards, the child have access to affordable insurance plans can be enrolled in Medicaid and the federal through their employers. government provides matching funds to the Each state has been given flexibility in state for that coverage — about 57 percent how it administers the CHIP and Medicaid of the cost. programs, according to Wright Burak. States

USA TODAY SPECIAL EDITION

HEALTH POLICY advocacy organization for health care can set up a free-standing CHIP program, consumers. “We’ve seen extraordinary expand their Medicaid program using CHIP improvement in insurance rates for kids dollars to include uninsured children or around the country since the inception of create a combined CHIP-Medicaid program. CHIP, and that’s why it’s so important that Most states have opted for a combination we not go backwards.” program and many have branded it for their If the federal government had not state, she said: ARKids First in Arkansas, renewed funding for CHIP, the states would for instance, HUSKY in Connecticut and have to take on the full cost of the program, BadgerCare Plus in Wisconsin. which would have left many children Like Medicaid, CHIP uses federal poverty uninsured or their families facing higher level guidelines to determine eligibility for co-pays and/or premiums. services. The federal mandate for CHIP is a Not all advocates and policy experts minimum of 138 percent of the federal povwere in agreement that CHIP should be erty level, but most states have extended extended. Dennis G. Smith, a managing the eligibility range; approximately 90 partner at McKenna, Long & Aldridge LLP percent of children in CHIP are in families in Washington who helped design the whose income is below 200 percent of the original CHIP program and ran the federal federal poverty level. The White House says Center for Medicaid and State Operations that means a family of four making $41,700 from 2001 to 2008, believed it would be or less gets free CHIP coverage; a family better to eliminate CHIP funding and absorb making $70,650 or less pays a reduced low low-income children cost; families making over into the ACA health care $70,650 pay full cost for exchanges. the insurance. “We’ve seen “It makes the most Wisconsin’s Badgerextraordinary sense to have kids and Care Plus is one example parents together under of a highly successful improvement in the same coverage,” he program. A blended CHIP insurance rates for said. “You also want the and Medicaid program, youngest and healthiest BadgerCare Plus insures kids around the people in the health 801,000 people, includcountry since the insurance pool to keep ing 435,734 children costs down, and that’s whose families earn up inception of CHIP.” kids.” to 300 percent of the — Ron Pollack, Families USA Wright Burak saw a federal poverty level, said couple of problems with Kevin Moore, the state’s that approach. First, the Medicaid director. health care exchanges were created to The program is designed to ensure that insure adults rather than kids. “CHIP is a as families’ incomes change, and thus their great deal and was designed with pediatric eligibility for public insurance, coverage for benefits in mind,” she said. “While it seems both children and adults continues in as logical to move kids to exchange coverage seamless a way as possible. “Now, parents with their parents, research shows that don’t have to worry about whether their families are going to pay more for that kids are eligible for CHIP or Medicaid. They coverage in terms of premiums and co-pays, just know they’re covered,” Moore said. and they’re not going to get as much in A NEWLY CERTAIN FUTURE terms of benefits as they do in CHIP.” After some maneuvering, both the House In addition, one provision of the ACA and the Senate agreed earlier this year to known as the “family glitch” — which extend CHIP past its funding cutoff of Sept. makes a spouse and children ineligible for 30, 2015, enabling it to exist through 2019. tax credits if one parent receives health President Obama signed the bill — which insurance through an employer — will lock passed by a remarkable, bipartisan vote of many children out of affordable health 92-8 in the Senate — in late April. exchange coverage. “We can’t turn our backs on health “If CHIP goes away,” she said, “two coverage that allows children to grow into million kids could be caught in this family healthy, active adults,” said Democratic Sen. glitch and end up uninsured due to cost Sherrod Brown of Ohio, who is sponsoring issues.” a Senate bill that would extend funding for Eventually, most parties seem to agree four years rather than two. There is some that the way forward will likely involve urgency, as state governments must begin absorbing kids into the ACA health care planning for the continuation or elimination exchanges — but in the future, rather of federal funding for their children’s than today, according to Wright Burak. “If programs this summer. exchange coverage gets as good as CHIP is “Most advocates want funding extended for kids, then CHIP might not be necessary for four years so it matches the authorizaanymore,” she said. tion period for CHIP through 2019,” said But right now, “CHIP sits in an awkward Ron Pollack, executive director of Families place between Medicaid and the ACA health USA, a national nonprofit, nonpartisan exchanges.”

FEDERAL POVERTY LEVELS 2015 Determined by income plus number of people in household

1 2 3 4 5 6 7 8

$11,770 $15,930 $20,090 $24,250 $28,410 $32,570 $36,730 $40,890

For families and households with more than 8 people, add $4,160 for each additional person. Poverty thresholds above are for the 48 contiguous states and Washington, D.C.; thresholds for Alaska and Hawaii are higher. Source: Department of Health and Human Services

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Via social media (and #enroll365), federal officials make an effort to remind people that they can sign up for health coverage at any time.

USA TODAY SPECIAL EDITION

CLEARLY

THINKSTOCK

Bringing transparency to health care costs By Erik Schechter

S YAN TSIRKLIN TELLS it, his wife’s 2011 cesarean section and the delivery of their twin daughters at St. Luke’s-Roosevelt Hospital Center in New York City went without a hitch. However, the health care costs were baffling. For example, he only discovered after the delivery that, while the hospital itself was part of the network covered by his insurance, the anesthesiologist was not, and hit him with a surprise bill for $5,500. In the hospital, Tsirklin shared a semiprivate room with his wife. His insurance agreed to pay $4,800 a day (the price for a two-patient room), while he kicked in an additional $800 a day. Though he only paid a small portion of the total cost, he found the numbers mind-boggling — it costs $6,000 per

Patients are often confused by the wide range in prices for medical care, even for treatments that may rely on the exact same equipment — such as magnetic resonance imaging, left — but may cost more at one clinic than another.

night, for example, to stay in a three-bedroom luxury apartment that takes up half a floor in the Waldorf Astoria. “I get that there’s a nurse, there’s a this, and there’s a that,” he said, “but does it really cost $5,600 a night to maintain all that? How much of that is really pure profit?”

MYSTERY NUMBERS

Indeed, how does health care pricing work in the United States? For many, there seems to be no rhyme or reason — there is certainly no evidence that prices correlate to value, said Zack Cooper, assistant professor of health policy and economics and director of the Institution for Social and Policy Studies at Yale University. For example, a $2,000 MRI is not twice as good as a $1,000 MRI. For the most part, prices paid by policyholders depend on secret negotiations between individual insur-

KELLY WILKINSON/THE INDIANAPOLIS STAR

USA TODAY SPECIAL EDITION

ers and doctors and hospitals. The more powerful the insurer, the better the discount it gets off the list price set by a hospital’s chargemaster, the list of prices that a hospital uses as a starting point for negotiations. Those prices are generally higher than the insurance company is willing to pay. But hospitals tend to have the upper hand in these interactions because establishing a multistory medical facility is not as easy as, say, opening a competing pizzeria, so it’s difficult for insurance companies to make an end run. “Building a hospital comes with massive capital costs and it takes time,” Cooper said. On top of that, there has been medical group consolidation in recent years, said Clare Krusing, director of communications for America’s Health Insurance Plans (AHIP). Last year, there were 98 transactions (mergers, acquisitions, joint ventures and member substitutions) as compared with 66 in 2010, according to an analysis by Kaufman, Hall & Associates, LLC. This gives doctors more negotiating power as well. None of this used to matter to patients. “Back in the day, when people had very extensive insurance, there was no particular reason for an individual to care,” said Martin Gaynor, an economics and health policy professor at Carnegie Mellon University. But with the rise of high-deductible health plans (HDHP) beginning in 2006, people are paying for more of their care, and the lack of transparency thwarts price shopping. Medicare and Medicaid patients, of course, still pay very cheap rates. That’s because, in the case of Medicare, the federal government dictates compensation rates, which, said Cooper, is a few percentage points above cost, and nonprofit hospitals — which account for 60 percent of all institutions — must accept these patients. (Medicaid is a joint federal-state program, so its payment policies vary by state.) So is everything above Medicare prices an example of extreme price inflation? Not necessarily. According to Melinda Hatton, general counsel for the American Hospital Association (AHA), hospitals lose money on government programs. For example, in 2013, hospitals received only 88 cents for every dollar spent on Medicare patients and 90 cents for those with Medicaid. Still, there are reasons to be cautious with these numbers. First, for-profit hospitals are not obliged to take Medicare and Medicaid patients, but they do so at the same rate as nonprofits (around 40 percent to 55 percent of all patients). Second, the number is a national average that can be skewed by just a few badly run hospitals. Third, calculating the “real” cost of personnel, equipment usage, etc., is always tricky. “In the health care system, everyone is loose and faster with numbers,” said David Newman, executive director of the Health Care Cost Institute, which tracks health care costs. “I can make sure that a hospital appears on paper to be losing money — I

DON PETERSEN/ASSOCIATED PRESS

Chronic or serious illnesses can lead to a pile of confusing medical bills. Cancer patient Patti Tyree, above, displays the bills for her care in 2011.

can simply increase the salaries (of hospital employees and management) until they lose money.” Finally, besides those covered by private policies or public programs, there are the working poor who have not yet signed up for Obamacare. For this third group, which isn’t eligible for the various discounts negotiated by plans and programs, the artificially high chargemaster rate can be devastatingly real, and hospitals have not been bashful about sending bill collectors after patients and even putting liens on their homes. For its part, the AHA contends that hospitals have been saddled with $459 billion in unpaid bills since 2000. In addition, Hatton said, “hospitals are required to post their financial assistance policies prominently for patients, which makes it clear that patients are not expected to pay full charges.” However, the generosity of those policies can vary.

PULLING BACK THE CURTAIN

Even those with insurance can get hit by chargemaster rates if treated, even unknowingly, by an out-of-network doctor at an in-network facility. Gaynor said this practice of surprise, or balance billing, is “particularly

egregious in ERs.” Indeed, the Center for Public Policy Priorities found that in Texas, 21 percent to 58 percent of in-network hospitals had not a single in-network ER physician. For its part, the AHA blames outdated antitrust policies for limiting how hospitals and doctors collaborate on business practices. “It’s really hard for hospitals to know what arrangements these outside physicians have with insurance companies,” Hatton said. The call for transparency, however, goes beyond surprise bills. People also want to understand where all the money is going. According to the Organisation for Economic Co-operation and Development, an international economic group, the U.S. spent $8,745 per capita on health care in 2012. That’s easily more than double the money spent on health care in European social democracies, which have either a single-payer system (the government sets prices) or an all-payer system (providers and insurers come together to agree on common rates). In fact, Lynn Quincy, associate director of health reform policy at the Consumers Union, a nonprofit consumers organization, said that when factoring in Medicare, Medicaid and tax credits to employers, U.S. taxpayers spend more per capita in public funds than their European counterparts — and in return get care of “uneven quality.” Part of the issue is that the health care business is big business. “Everyone in the system is relatively well-compensated. I’ll include myself in this one. I’m not picking on anyone,” said HCCI’s Newman. Then there are the administrative costs of insurance, of tests ordered just to avoid malpractice lawsuits and a fee-for-service model that encourages doctors to ring up the register, said Cooper. But there’s also a “big unit-price problem,” Quincy said. “It’s not that there are so many more MRIs (each year). It’s that we are being charged more for it.” The rationale for these prices needs to be questioned, she said, “because when the curtain is pulled back a little bit, you’ll see the high-priced providers often lowering the prices because they’ve been outed.” Krusing, from AHIP, would also like to see more transparency on the ballooning prices for prescription drugs (although insurance companies are not exactly rushing to make their own secret deals with hospitals public). Quincy noted that the U.S. has been making slow steps toward transparency. For example, New York recently passed an anti-surprise bills law, while a bill being considered by the Oregon state Senate mandates that hospitals share pricing information with the public. But still more can be done. “If you gave me a magic wand, I would put in robust all-payer claims data sets in every state,” she said, “so we can see that landscape.”

Online Transparency

TOOLS

The rise of high-deductible health plans (HDHP) is forcing more Americans to pay a larger share of their own medical care. But turning patients into consumers requires giving them the means to price shop. Enter online transparency tools. San Francisco-based Castlight Health offers its Castlight Enterprise Healthcare cloud platform to large companies looking to transition workers to HDHPs in order to better control costs. According to Dr. Jennifer Schneider, Castlight’s chief medical officer, companies already pay $620 billion in health care costs, and the numbers keep growing. Castlight’s cloud-based solution, released in 2010, features a Yelp-like page so company policyholders know the out-of-pocket cost for any given service and can compare in-network provider prices. “Employees can get personalized, out-of-pocket prices, review their past spending, see reviews and ratings for medical providers they use,” Schneider said. Castlight helped Kraft Foods Group reduce the number of emergency room visits made by its workers at a turkey processing plant in Newberry, S.C. Others have entered the enterprise market. The Health Care Cost Institute (HCCI) in February rolled out a transparency tool called Guroo, which offers a free service to the general public. David Newman, HCCI executive director, compares it to shopping for a car on Edmunds.com. Users can find the “reference price” for a medical procedure in their city or state. Right now, Guroo users can search 78 different procedures for price information. This data is pooled from insurance companies Aetna, Assurant Health, Humana and UnitedHealthcare, which, in a major step for industry collaboration, are supporting the HCCI initiative, making it one of the largest public consumer databases. In all, Guroo can draw upon 3 billion medical claims, but “even with 3 billion claims, it’s not enough data to offer everyone in the country price transparency,” Newman said. HCCI plans to gradually add procedures and localities to its database. Also, by early next year, users with participating policies will be able to conduct personalized searches. — Erik Schechter

USA TODAY SPECIAL EDITION

:*@% (!##%/ -:*== +*=@A *.,1 0,;# (',57 #3#;/798.! ";,0 $,0#:78& +,28&/ (.$ 79# 0(;4#7:% 7, :+,;7: (.$ #.7#;7(8.0#.7 (.$ 4.,1 65:7 19(7 7, :(/ 7, :#8-# 79# 0,0#.7)

&E0F.E<9 617 )-* +5&*? <CC 8%B-

-25/+-

=!$%

:58%?

-,<>67>A $<;67>A :E>7 'E.E>43.A

+%'"

+/*D%=

52!8!58

B%*+"%/

USA TODAY SPECIAL EDITION

BUYER

BEWARE

Online pharmacy deals might save you money, but cost you your health By Adam Stone

LI SCHROER WAS 23 years old when she got sick. Really sick. A lot of pain. Couldn’t leave the bathroom. The doctors called it “irritable bowel,” but admitted they didn’t really know what the cause was. “I was under stress, starting my first career, feeling overwhelmed and suddenly I started having migraines, body aches. I had such major cramping I couldn’t get out of bed,” Schroer recalled. “I kept wondering if maybe it was just stress. Maybe it was just me.” Here’s what actually happened, as near as anyone can tell: Schroer had switched insurance companies and the new insurer would not cover her maintenance dose of the allergy medication Allegra, which required a prescription at the time. Her doctor suggested she buy it online. “It was remarkably cheaper, maybe 10 percent of what it would have cost through insurance, if they had been willing to cover it at all,” she said. “I’m an intelligent person. I come from an educated family,” said Schroer, now a 30-year-old family therapist in Denver. “But I took my doctor’s advice. You listen to your doctor.” Lots of people do; they listen to their doctors and friends. They heed professional-looking emails that show up periodically. They order meds online — and many of these people, nobody knows how many, get sick.

LeBrian Donnelly, who works in global security for the pharmaceutical company Pfizer, holds fake Viagra, Lipitor and Aricept, left, next to the real thing. Many online pharmacies sell unsafe counterfeit drugs.

BIG BUSINESS

Of the 35,000 to 50,000 online drug sellers operating today, about 97 percent are illegitimate and do not comply with U.S. standards, according to the social welfare organization Alliance for Safe Online Pharmacies (ASOP) (safeonlinerx. ROBERT DEUTSCH

CO N T I N U E D

USA TODAY SPECIAL EDITION

Food and Drug Administration scientists can examine prescription drugs for harmful substances. This researcher uses a portable device designed to be used early in the manufacturing process.

FOOD AND DRUG ADMINISTRATION

com). The larger online pharmacies take in between $1 million and $2.5 million a month, and roughly one in six American consumers has bought medicine through this avenue and without a prescription. Most of these drug Most people sellers operate from overseas, said Libby know it is wrong, Baney, ASOP’s executive if not outright director. They work in countries like India, illegal, to access Mauritius, Turkey, Russia drugs without a and China. They hide behind proxy servers to prescription. mask their true locations. They function in “rogue affiliate networks,” a term used to describe organized crime. Indeed, it takes a sophisticated organization to set up procurement methods, distribution chains and payment systems.

While U.S. pharmacies are licensed at the state level, Web-based sellers dodge that issue by claiming they adhere to local laws where they operate, thus making them immune to U.S. laws. It’s a legal gray area. But those laws are there for a purpose, advocates said. When it comes to state licensure, “part of that is in making sure people get the right drug at the right time, that they know how to take it, they are protected to the best of my ability as a pharmacist,” said Diane Darvey, a licensed pharmacist and director of federal and state public policy at the National Association of Chain Drug Stores. Most people know it is wrong, if not outright illegal, to access drugs without a prescription. Working on the “too good to be true” theory, one might expect a reasonable person to be suspicious of a website claiming to sell controlled drugs without a doctor’s orders at deeply discounted prices.

So why do they do it? What motivates the consumer to take the plunge into these murky waters? After all, without the consumers the whole issue would likely go away. The reasons are manifold.

WHY WE BUY

To understand the why, it helps to know the “what.” People go online for the things insurance may not cover: infertility meds, for instance. Or they buy drugs that they must take long term, making even co-pays prohibitive, such as medicines for heart disease. Some order “lifestyle” drugs like Viagra online out of embarrassment, while others refill antibiotics out of convenience. Almost half the counterfeit drugs sold on the Internet in 2010 were for weight loss, according to the World Health Organization. There does not seem to be a common theme among these medicines. Yet some

USA TODAY SPECIAL EDITION

HOW TO SPOT THE FAKES Bogus pharmacies proliferate on the Web, and they can be hard to differentiate from legitimate enterprises. Here are some tips from the FDA: FRAUDULENT ONLINE PHARMACIES: uOffer prices too good to be true uRequire no prescription uReach out via unsolicited email u“Ship worldwide” LEGITIMATE SITES: uRequire a valid prescription to order uHave a state license to operate uHave a pharmacist available for consultation uMay be tied to a bricks-and-mortar pharmacy — Adam Stone

FOOD AND DRUG ADMINISTRATION

The CD-3 device invented by FDA scientists is being used in Asia and Africa to screen for counterfeit or poorly made malaria drugs. self-diagnosing and self-medicating; people would say the thread that ties them all who for one reason or another don’t want together lies not in the maladies themselves, but rather in a system that is failing to go to the doctor but are pretty sure they to meet consumers’ needs. think they know what they need. It’s a dangerous practice, even without the added Even with about 10 million more people now covered as a result of the Affordable risk of filling one’s own “prescription” from an unknown source. Care Act, “there absolutely still are issues of access and the cost of medicine,” said Marjorie Clifton, executive director of the LEGIT FIXES? advocacy organization Center for Safe On the other hand, just because a pharInternet Pharmacies (CSIP). “There still are macy fills orders online, that doesn’t mean people who may not have access to a doctor there is anything untoward in the works. and who are self-prescribing.” After all, some of the biggest pharmacies Part of solving the in the country — CVS problem of illicit pharmaand Walgreens included cies “is about creating — operate websites Of the 35,000 to a system that makes where patients can refill medicine available at an prescriptions, or even 50,000 online drug affordable cost,” order new ones. sellers, about 97 she added. Some have looked for Not everyone legitimate fixes through percent do not agrees. Look at Japan, government. A decade comply with U.S. for instance. Despite ago, before becoming universal health care, secretary of the Departstandards. Internet pharmacies are ment of Health and a thriving business there. Human Services (HHS) “This is not necessarily in 2009, then-Kansas an access or cost issue. This is a convenience Gov. Kathleen Sebelius joined three other issue, a continuation of our desire to buy states (Illinois, Wisconsin and Missouri) in things online,” Baney said. authorizing a prescription-drug importation Sometimes it’s simply a matter of program as a way to lower costs, the first

in the nation to allow citizens to purchase lower cost, safe prescription drugs from state-approved pharmacies in Europe and Canada. The program sputtered out after the Food and Drug Administration (FDA) blocked the sale of certain prescription drugs from Canada. In early 2015, Chief Judge Nancy Torresen of the U.S. District Court in Portland, Maine, ruled that federal law superseded the 2-year-old Maine Pharmacy Act. That act had allowed the state’s residents to purchase prescription drugs from approved pharmacies in Canada, the United Kingdom, New Zealand and Australia. So government oversight of overseas drug sourcing does not seem to be the answer. How, then, to put a stop to illicit imports? The FDA believes public awareness will make a dent. The agency launched BeSafeRx two and a half years ago as a way to alert consumers to the hazards of online pharmacies. The campaign offers tips for identifying legitimate online pharmacies and informs buyers of secure ways to buy medicine via the Internet. “We are educating consumers about how to buy online safely,” said Ilisa Bernstein, deputy director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We also have our office of

criminal investigations working to dismantle the criminal enterprises behind some of these websites, and we work with other government agencies, industry and our foreign counterparts. It is a global effort.” In addition to international cooperation and consumer awareness, some would like to see the information technology industry play a part in shutting down the websites. The Internet registries, payment processors, search engines and social networking sites, “all of those points along the Internet distribution chain can and should take voluntary action against entities that knowingly take part in illegal activities that endanger patients,” Baney said. As for Ali Schroer? Fortune shone upon her. In the midst of her illness, her sister came to visit, and was startled to see her refilling her prescription online. “Don’t you know what I do for a living?” the sister asked. Schroer only knew that her sister, Libby Baney, was some kind of lawyer. She had no idea she was related to a leading safe-drugs advocate. Schroer stopped taking the meds immediately, and within six months had fully recovered. She confronted the doctor who had sent her online. He seemed indifferent. “I was extremely lucky,” Schroer said. “But then I think about an older population, my parents and my grandparents. Where are they getting their medicine from?” Baney takes the whole episode as evidence that the population as a whole must be better educated. “This can happen to anybody, and it can happen under your nose,” she said.

USA TODAY SPECIAL EDITION

By Elizabeth Neus

JUST SAY YES

HE PROCESS TO GET a new prescription drug to market is neither quick nor cheap. A Tufts University study in 2014 found that the average development cost is more than $2.5 billion; the industry group PhRMA, the Pharmaceutical Research and Manufacturers of America, estimates that research and development can take at least 10 years for one successful drug. Fewer than 12 percent of medications even make it to the clinical trial phase, the point at which the U.S. Food and Drug Administration (FDA) becomes involved. For the last decade, the FDA has approved an average of 27 new drugs each year; in that same period, the number of applications for new drug approval ranged from 18 to 41 per year. (Over-the-counter medications go through a different process because there are so many more of them; more than 300,000 are currently on the market.) First step for the drugmakers once the research and testing is complete: to file

Manufacturers hope the FDA approves their new medications

an application with the FDA asking for “investigational new drug” (IND) approval. The FDA reviews the plan to make sure the proposed human studies (known as “clinical trials”) are ethical and safe. Once the company gets its IND, then the clinical trial phase begins. This is broken into three steps: ▶ Phase 1 trials, which focus on the safety of the drug. It’s where side effects are discovered, as well as how patients’ bodies process the drug. Fewer than 100 healthy people are usually enrolled in this phase. ▶ If the drug is determined to be safe and its side effects acceptable, it moves on to Phase II, in which the researchers try to determine how well the drug actually works. Some patients in the trial take the drug, while others are often given a placebo that should have no effect. While the patients —

who usually have a pre-existing particular disease or condition — aren’t told which one they’re taking, they are informed that a placebo is a possibility. This phase usually involves up to hundreds of patients. ▶ If the drug seems to be doing the job that the researchers had hoped, it enters Phase III. With the help of thousands of volunteers, researchers compare the medication and dosage to existing drugs to see if it’s better, study the drug in a variety of groups of people (women, for example, or African Americans) to see if it works differently and continue to evaluate safety and effectiveness. This process can take up to six or seven years, and can be stopped at any point — if the drug’s side effects turn out to be too severe to be worth it to a patient, or if it doesn’t seem to have any effect on a disease.

THINKSTOCK

Once the clinical trials are complete, the drugmaker applies for a “new drug application,” or NDA. This is the formal request for FDA approval to market and sell the drug in the United States. The company must include information on how it will label the drug, data from all of its studies, directions on how the drug will be taken and more. The FDA can take up to two years to review the NDA; sometimes the FDA calls meetings of advisory committees to get more input on the drug and to hear what non-FDA experts think. The FDA has long heard complaints that this process takes far too long, and the agency has come up with ways to expedite the matter. (Its own website does note that the existence of these four new approval tracks “implies speed,” and warns that that may not exactly be the case.) No matter the length of time involved, once the FDA issues an approval, the drugmaker is free to begin selling its medication. The FDA is still involved, however — regulating advertisements, inspecting factories and gathering information on problems that arise in the “post-market” phase.

USA TODAY SPECIAL EDITION

Hospitals and health clinics in Liberia were temporarily overwhelmed during the Ebola epidemic that began in 2014, which affected nearly 12,000 people and killed 4,600 in the country of 4.2 million. U.S. hospitals have stepped up preparations for a similar outbreak, taking lessons from Ebola.

JOHN MOORE/GETTY IMAGES

USA TODAY SPECIAL EDITION

SURGE CAPACITY

Ebola reminds U.S. hospitals of the need for advance planning

By Dan Friedell

S OF THE END of April, the World Health Organization (WHO) had counted nearly 11,000 deaths due to the Ebola virus outbreak in Guinea, Liberia and Sierra Leone that began in December 2013 and peaked in the fall of 2014. Not only were residents and visitors to those countries infected, but the disease spread on a smaller scale to three neighboring African countries and even crossed oceans because of easy international travel. Outside Africa, Ebola cases were detected in three countries, with four patients diagnosed in the United States, including one who died — Thomas Eric Duncan, a visiting Liberian whose symptoms developed after his arrival stateside. Yet Duncan’s illness was missed, even though he arrived in a Dallas emergency room on Sept. 25 with a 100-degree fever — a classic Ebola symptom — and eventually let a nurse know he’d just come from Africa. Two of Duncan’s nurses at Texas Health Presbyterian Hospital Dallas, Nina Pham and Amber Vinson, also contracted the disease. And health professionals say it’s lucky that more people — both among those working at the hospital and people he interacted with in the community before returning to the hospital five days later with obvious Ebola symptoms — were not affected. It’s easy to point fingers at the different agencies that could have prevented Duncan, 42, from leaving the hospital that initial night, but the more important task is to figure out what the U.S. health care industry learned from the battle with Ebola that could make a difference the next time an emergency arises. Ebola, while extremely deadly, is not the most contagious type of pathogen. For example, it’s not airborne, it’s thought to be hosted by animals (fruit bats) and only passed on to humans through close contact

The first person to contract Ebola in the U.S., Nina Pham, 26, was a nurse who cared for Thomas Eric Duncan. ALEX WONG/GETTY IMAGES

Nurse Amber Vinson, 29, another member of Duncan’s Texas medical team, was treated at an Atlanta hospital.

Dr. Craig Spencer was exposed to Ebola while working in Guinea, but developed symptoms at home in New York.

DANIEL SHIREY/GETTY IMAGES

with infected animals such as chimpanzees. Dr. Tom Frieden, the director of the Centers for Disease Control and Prevention (CDC), said Duncan’s symptoms could have easily been linked to Ebola if the hospital staff had paid more attention to his recent arrival from Liberia — the No. 1 piece of information that should have kept him at the hospital and elicited more careful treatment. Duncan would have been put into isolation either at that hospital or in another set up to handle contagious diseases, and Pham, Vinson and anyone else who needed to treat Duncan would have worn more protective gear.

NEW VIGILANCE

SPENCER PLATT/GETTY IMAGES

After the Duncan episode, protocols were updated nationally. Currently, anyone arriving in the U.S. from West Africa — even the head of the CDC — is met by a public health “ambassador” who provides him or her with a thermometer, cellphone and contacts at the local health department. The returnee must report his or her temperature twice a day for 21 days, and if a fever is noted, a response plan is already in place. Craig Spencer, a New York City doctor and the last U.S. Ebola patient, was exposed while treating patients in Guinea; he discovered he’d become ill during the 21-day monitor-

ing process. “As long as the outbreak continues in West Africa, we may be facing other potential cases,” said Frieden, who has gone through the 21-day process twice himself. “(The returnee reporting) system has allowed us to greatly reduce the risk of someone (unknown to health professionals) showing up at an emergency room having been sick (already) for a few days.” So vigilance at U.S. borders is key. But health organizations such as the WHO, the CDC and Doctors Without Borders must also be able to respond to suspicious outbreaks outside the U.S. and work with local health agencies to treat them swiftly at the source, he added. “The bottom line of the past year in the Ebola fight is how important it is that we help countries around the world strengthen their systems that can find, stop and prevent emerging threats,” Frieden said. “We’re only as safe as the weakest link.” Athalia Christie, a public health analyst at the CDC’s Center for Global Health, is among those on the ground in Liberia. Christie has been working in Monrovia, the capital, since August with only a few breaks to return to her home base of Washington, D.C. She was one of a handful of passengers on a Delta Air Lines flight that delivered the first experimental doses of the Ebola drug ZMapp to West Africa last summer. “I’ve spent a lot of my career in difficult places. Most of my time has been in Somalia, South Sudan and Pakistan,” she said in a phone interview from Liberia. “And this was by far the most challenging experience I’ve had, but also the most rewarding.” Christie and other health care professionals spend their careers planning for worst-case scenarios, but hoping they’ll never have to deploy their knowledge. At the same time, when something serious does happen, they get to do the work CO N T I N U E D

USA TODAY SPECIAL EDITION

JENNIFER SIMONSON/MPR NEWS VIA ASSOCIATED PRESS

After two Texas nurses who thought they’d been adequately protected contracted Ebola from a patient last October, medical professionals across the U.S. took extra training in how to safely don and remove biohazard gear.

they’ve been waiting a lifetime to do. It’s an uneasy balance. “Every job I have ever had helped prepare me for this,” said the 43-year-old, who mostly works on global health policy for the agency. “I’ve had to use every skill — whether it’s management, supervision, technical skills, surveillance, risk communication, policy, partner coordination — the whole spectrum of my skills. That’s incredibly rewarding. (But) it’s a grueling pace, and I think the transition back to regular work is not going to be easy.” If Christie and her colleagues had been able to execute everything they’d learned in their health care careers perfectly when news of the first African cases surfaced in March 2014, it’s possible no one in the U.S. would have been affected by the outbreak. But it’s one thing to have a plan in mind; it’s another thing to seamlessly execute it. “Especially at the beginning, a lot of it comes down to logistics,” said Christie. “And we need to learn to do things better and faster. (We would have built) Ebola treatment units faster, we would have had more safe burial teams sooner, even very simple things like the provision of

food or water for people in quarantine or adding that what he called a rapid-response precautionary observation — no one is going “medical reserve corps” styled after and to stay in quarantine if they don’t have food possibly working with the military would and they don’t have water — so that’s a very go a long way in future epidemics. “If we basic need. People’s basic needs need to be start now, we can be ready for the next met. We’ve gotten there, epidemic.” but it’s not easy and it A health care took time.” emergency is especially In a March 2015 TED tricky, since it combines “Ebola gets at Talk, Bill Gates — now as the need for a fast some of our bigwell-known for his largeresponse with the need scale health philanthropy to be careful and to keep gest fears because as for his time running people calm during an it can be difficult to Microsoft — made similar ongoing and potentially points and suggested frightening situation. It’s control. ... Anybody solutions. not as easy as responding “We were far slower to the aftermath of a can get sick.” — Jennifer Hanrahan, than we should have tornado or a fire, events MetroHealth Medical Center, been getting the that have clear endings. Cleveland thousands of workers While the Ebola into these countries. And outbreak was scary, it a large epidemic would was naturally occurring, require hundreds of and only spread via thousands of workers. ... There was a lot that person-to-person contact. Thousands was missing, and these things are really a were infected, but it spread more slowly global failure. than the disease would have if it had been “The next epidemic could be dramatically deployed during a war or terrorist attack. more devastating than Ebola,” he said, That’s why weaponized infectious diseases

USA TODAY SPECIAL EDITION Hospitals and first responders regularly practice for emergencies — University of Tennessee nursing student Mary Beth Noles, bottom left, takes part in a mock drill in April. More emphasis is now being placed on protecting health care workers as well as treating patients. In 2003 in Canada, about one-quarter of the cases of the deadly pneumonia known as SARS were health care workers, and three of them died. Hospitals monitored staff closely for symptoms, including workers at Toronto’s Mount Sinai Hospital, below.

MICHAEL PATRICK/KNOXVILLE (TENN.) NEWS SENTINEL VIA ASSOCIATED PRESS

are such a concern: How would we handle hundreds of soldiers being affected by a disease overnight? That’s why the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and investigators like Dr. Thomas Geisbert, a veteran of that organization, have been so keen to follow the Ebola story and contribute to potential cures. Geisbert, a virologist who works at the University of Texas Medical Branch in Galveston, began his career working for USAMRIID; he’s the scientist who first spotted the strain of Ebola made famous in the 1994 best-seller The Hot Zone. While the 2014 Ebola outbreak resulted in a devastating loss of life, it could prove to be a boon for scientists who normally scrape for research funding. If global governments are more proactive in research, clinical drug trials and construction of labs equipped to handle exotic pathogens, Geisbert and his colleagues should be busy for the remainder of their careers.

PROTECTING WORKERS

“Some of these (drugs and treatments) are finally moving forward after having sat

dormant for a while,” he said. “On a global scale, there’s not a huge market for Ebola vaccine. It’s not like cancer or heart disease or influenza. A lot of these philanthropic organizations have stepped up, Ebola has been in the forefront and there’s been a lot of attention. But I’m still concerned that long term it’s going to require government support — not just U.S. government — and people pushing for it.” At the more local level, hospitals like Cleveland’s MetroHealth Medical Center — one of the 49 hospitals in the U.S. designated as Ebola treatment centers by the CDC — are working to stay prepared for Ebola and similar future emergencies. Before SARS, a deadly pneumonia-like disease seen in two dozen countries on four continents, including North America in 2003, there was some level of acceptance that U.S. hospitals would see difficult-tocontrol epidemics, said Jennifer Hanrahan, the chair of the Cleveland hospital’s infectious disease control committee. According to a post-SARS briefing produced 10 years later by the CDC, not a single health care worker in the United States acquired SARS from a patient, but those in

Singapore, Canada and Vietnam were not as lucky. While the successful containment of the disease in the U.S. set a precedent, this country was not able to maintain its track record while treating Ebola patients. It’s a disappointing truth, but it means hospitals must remain even more vigilant. “I think now it’s pretty clear that it’s expected we not have a single case in a health care worker, and in order to do that, you have to have a much greater level of preparedness,” Hanrahan said. After some confusion during the early days of the Ebola outbreak, the CDC clarified guidelines for health care workers for using personal protective equipment, and that kind of clear and repeatable anticontamination instruction is paramount to preventing the spread of any kind of disease, Hanrahan said. “We deal with the flu every year, and very quickly it becomes difficult to stop the spread in the community, and one of the only reasons we don’t have really huge outbreaks every year is that there is a vaccine,” she said. “Influenza kills a lot more people in the United States and abroad

PATTI GOWER/THE GLOBE AND MAIL VIA AP/CANADIAN PRESS

than Ebola, but Ebola gets at some of our biggest fears because it can be difficult to control. And not just people who have underlying diseases, or the elderly, can get sick. Anybody can get sick. … It gets at some really basic human fears and it is a scary illness.” Barry Bloom, an infectious disease expert at Harvard’s T.H. Chan School of Public Health, said the recent fight against Ebola exposed some of the holes in the world’s public health safety net. Some links have been cemented, and others will need to be reinforced. And composing a system that allows all these agencies to work together could, in fact, be more difficult than developing vaccines for all the world’s diseases. In the case of Ebola, for instance, vaccines were in the lab, but weren’t ready to be deployed at a moment’s notice and with the right magnitude. “The tragedy is the research produced tools that could have been effective, but they weren’t ready for use in humans because there was no commercial profit in doing so,” Bloom said. “And that’s a problem someone’s going to have to think about solving.”

USA TODAY SPECIAL EDITION

OBESITY

Lorraine Faulkner, 61, left, and her mother, Maureen Morgan McClure, 80, sold produce at the farmers market in Hernando, Miss., in April. The city started the market in order to get more fresh produce and healthy food into the hands of residents.

USA TODAY SPECIAL EDITION

OBESITY

A SIZABLE BATTLE

Nation’s obesity rates cause alarm, trigger prevention By Diana Lambdin Meyer | Photography by Lisa Buser

N THE WEE HOURS of a Saturday morning, pickup trucks begin to circle the DeSoto County courthouse in Hernando, Miss., their drivers backing into prime parking spaces just as the birds begin to announce the rising sun. Within hours, the courthouse square is joyful bedlam, filled with neighbors chatting with neighbors, a Zumba class taking place on the front lawn, and people swapping ideas for preparing fresh fruits and vegetables. This is the Hernando Farmers Market, with as many as 120 vendors, voted Mississippi’s favorite farmers market for three years by the American Farmland Trust. Despite being in a rural area, access to fresh produce was once more difficult than you would expect. The closest farmers market was more than 25 miles away across state lines, and children lounged around on the couch watching cartoons on Saturday morning. But more significantly, before this farmers market opened in 2008 and the city of

Hernando decided to commit its resources to a healthier community, the local children were among the fattest in the nation. By adding bike trails, new sidewalks, a Parks & Recreation department offering tennis, soccer, football and baseball for youth, and by passing a smoke-free ordinance, Hernando was named “Healthiest Hometown in Mississippi” in 2010 by Blue Cross Blue Shield. KaBOOM!, a nonprofit organization that supports healthy activities for children, has recognized Hernando as a Playful City USA for the past seven years. Playful City USA is a national recognition program that honors cities and towns across the country for taking bold steps that make it easy for all kids to get the balanced and active play they need to thrive. These communities are recognized for their efforts to create more playable, family-friendly cities. “Our residents told us they wanted more options for recreation ... for their children and more opportunities to live a healthy lifestyle,” said Chip Johnson, who has been

mayor of Hernando since 2005, overseeing many of the positive changes that have contributed to the town’s healthier lifestyle. Hernando, sitting just 26 miles south of Memphis, Tenn., is a tiny light at the end of a long tunnel, a bright spot in this nation’s difficult and complex battle against obesity. Mississippi ties for first place with West Virginia as the fattest state in the country, with 35.1 percent of residents identified as obese. In Mississippi, 21.7 percent of children ages 10 to 17 are also obese. That a community in Mississippi can make such a positive turnaround and begin to make headway in the multitude of issues that contribute to obesity is something to celebrate, according to Dr. Mary Currier, the state’s health officer. “We know we have a long, long way to go, but to see the obesity rates begin to plateau and even drop in certain age groups and particular communities is so very exciting,” CO N T I N U E D

USA TODAY SPECIAL EDITION

OBESITY

she said. “If we can develop a culture of health in Mississippi, if we can lose weight here, well, the rest of the country can do it, too.” But here are some of the cold hard facts the nation is facing: v 34.9 percent of American adults are obese and 68.5 percent are obese or overweight. v Nearly 40 percent of American adults ages 40 to 59 are obese. v 20 states have an adult obesity rate of 30 percent or higher. v Six states had significant increases in adult obesity in 2012-13, the most recent data available (Alaska, Delaware, Idaho, New Jersey, Tennessee and Wyoming). v 16.9 percent of children in the U.S. are obese and 31.8 percent are either obese or overweight. Statistics are even more sobering for minorities: v 82 percent of African-American women and 77.2 percent of Latino women are overweight or obese compared to 63.2 percent of white women. v African-American adult obesity rates have gone up by more than 8 percentage points since 2002. v Latino adult obesity rates have gone up by 10 percentage points since 2002. But if you are among those who do not struggle with weight issues, don’t think that this problem doesn’t concern you. Obesityrelated health care costs the nation about $200 million a year and more than $4.3 billion in lost productivity each year. America has a problem and it’s not going to go away easily, nor without the efforts of each of its citizens. “Obesity is not caused by bad genes or a bad diet or lack of exercise or bad policy or egregious advertising by the food industry,” said Peter J. Gillies, founding director of the New Jersey Institute for Food, Nutrition & Health at Rutgers University. “It is caused by all of these things. Obesity is a systems failure in our society, and we are only beginning to unravel the underlying basics

Hernando, Miss., Mayor Chip Johnson recently had a track and workout equipment installed in a field that wasn’t being used. He’s led the charge to battle obesity in his city, located in a state that federal statistics show is one of the two fattest in the nation.

USA TODAY SPECIAL EDITION

OBESITY

A farmers market that sells fresh produce such as these radishes, from a farm just 10 miles away, provides the residents of Hernando, Miss., with a wider choice of healthy foods as they work to lose weight. And children can now play in new parks built specifically to give them safe places to play and get exercise.

of the disease.” Included in the system’s failure, according to Gillies, are unsafe neighborhoods and a lack of safe public places where parents can send their children to play. And when there are no places where parents can conveniently and inexpensively purchase fresh produce, or when parents have no access to education about healthy living or health care at all, the system has failed, he said. “Obesity is one of those diseases where there are no quick fixes, no simple solution, no one right way,” said Gillies. “That’s why we need an interdisciplinary conversation and to take it into the community to give practical suggestions in day-to-day life. It has to be what the community wants and what the community is interested in.” Much of the work of the Division of Nutrition, Physical Activity and Obesity of the Centers for Disease Control and Prevention (CDC) focuses on the community and how to create a supportive environment. Capt. Heidi Blanck of the Commissioned Corps of the U.S. Public Health Service, who leads the division, credits an increased discussion of obesity and related health issues in the media to the documented drops in obesity rates in non-adult age groups. The prevalence of obesity among children aged 2 to 5 years decreased significantly from 13.9 percent in 2003-2004 to 8.4 percent in 2011-2012. Overall, obesity prevalence among children whose adult

head of household understand obesity agree completed college was that the answer is not approximately half that of going to be found in a “If we can develop those whose adult head laboratory. However, a culture of health of household did not there is indeed some complete high school. exciting work being in Mississippi, if Among the contributdone to help address we can lose weight ing factors to drops in the medical side of this the 2-to-5-year-old age epidemic. here, well, the rest group, according to the At the March 2015 of the country can CDC, are reductions meeting of the Endocrine in the juice allowance Society in San Diego, do it, too.” in the Women, Infants where more than 2,000 — Dr. Mary Currier, and Children Special papers were presented Mississippi state Supplemental Nutrition and discussed, one study health officer Program, and a greater indicated that losing as number of children being little as 30 minutes of breastfed until at least 6 sleep per day on weekmonths of age, which has been documented days increases the likelihood of obesity to minimize obesity in preschoolers. by 17 percent and insulin resistance by 39 Blanck is also pleased that daily whole percent. fruit consumption increased in children by “Sleep loss is widespread in modern as much as 67 percent in a seven-year study society, but only in the last decade have we period, although room for improvement realized its metabolic consequences,” said remains. Unfortunately, many of the dietary the study’s lead author, Shahrad Taheri, of changes taking place in children are not Weill Cornell Medical College in Qatar. “Our taking place in adults. findings suggest that avoiding sleep debt “We’re seeing strong patterns that indicould have positive benefits for waistlines cate the message about obesity is getting and metabolism, and that incorporating through to parents, who have made changes sleep into lifestyle interventions for weight in their children’s lifestyle, but somehow loss and diabetes might improve their that wellness message is not translating into success.” their own lives,” said Blanck. And for those Americans who like to The professionals working to better take the easy way out and simply pop a

pill, another study indicates that such a pill may be on its way. It’s called GC-1 at this point and is being tested in clinical trials at the Houston Methodist Research Institute. Obese mice lost as much as 50 percent of their fat mass during studies. Just like there is good cholesterol and bad cholesterol, there is also good fat (brown) and bad fat (white). Basically, the pill helps discern between brown fat and white fat and helps the body convert bad white fat into brown fat that our bodies use for energy. Until recently, scientists thought only animals and human infants had the good brown fat, but new research indicates that adults have it, too, although its effectiveness slows significantly as we age. “Our data demonstrates that GC-1 is a novel fat-browning agent that may have use in the treatment of obesity and metabolic disease,” said study author Kevin Phillips, an assistant member of Houston Methodist’s Diabetes & Metabolic Disease Program. But as Gillies from Rutgers University stated, there is no one pill, no one quick fix, no simple answer to the obesity epidemic that has engulfed the U.S. However, if we take one extra step a day, eat one more piece of fruit or a vegetable each day, and pay closer attention to the issues around us that restrict our abilities to achieve a healthy lifestyle, then we’ll all be a little more like Hernando, Miss., tipping the scales in our favor.

USA TODAY SPECIAL EDITION

OBESITY

GROWING PROBLEM

Obesity in the U.S. continues to climb

More than one-third of U.S. adults and 17 percent of children and adolescents are obese, according to the Centers for Disease Control and Prevention. The medical cost of obesity in the U.S. is about $147 billion per year; an obese person spends on

average nearly $1,500 more annually on medical care than other Americans. Obesity is responsible for some of the leading causes of preventable death, including heart disease, stroke, certain types of cancer and type 2 diabetes. Among U.S. adults, obesity is most prevalent

in the South (30.2 percent), followed by the Midwest at 30.1 percent, the Northeast at 26.5 percent and the West at 24.9 percent. The state with the lowest prevalence is Colorado at 21.3 percent; the highest is a tie between Mississippi and West Virginia, at 35.1 percent.

24.7%

27.2%

23.6%

31%

24.6%

25.5%

29.6%

29.9%

29.4%

24.1%

21.3%

27.2%

33.2%

22.9%

29.4%

31.7%

34.6%

28.3%

35.1%

32.5%

26.3%

33.7%

26.4%

25%

31.1%

35.1%

32.4%

30.3%

30.9%

33.1%

Lowest Highest

30.4%

26.8%

30.4%

31.8%

30%

24.1%

30%

31.3%

29.6%

31.5%

27.3%

25.4%

29.8%

27.8%

26.2%

28.9%

26.5%

26.7%

25%

28.4%

26.4%

22.5 20 17.5

21.8%

15 12.5 10 7.5 5 2.5

Sources: Centers for Disease Control and Prevention; National Health and Nutrition Examination Survey

2 6 2 4 8 0 0 0 4 4 97 198 199 200 200 200 200 200 201 201 -1 119 1 7 71 76- 88- 995 3 0 0 9 0 0 0 0 1 2 19 19 20 20 19 20 20 20

2 - 5 Years

- 11 Years THE 6PERCENTAGE OF 12 - 19 Years OVERWEIGHT/OBESE CHILDREN IN THE U.S.

USA TODAY SPECIAL EDITION

OBESITY

THINKSTOCK

USA TODAY SPECIAL EDITION

OBESITY

THE GREAT FOOD DEBATE New dietary guidelines may put sustainability on the menu

By Mary Helen Berg

AT MORE FRUITS AND veggies but leave room for politics on your plate. After two years of scientific review and public input, a committee of nutrition experts has filed the report that may guide America’s diet for the next five years. The report contains familiar recommendations to eat less sodium, sugar and fat and consume more fruits, vegetables and whole grains. But for the first time, the 2015 Dietary Guidelines Advisory Committee issued broader advice: Eat a healthy diet to help preserve a healthy planet. Overall, the 14-member panel found that Americans should focus on their whole plate, or “healthy dietary patterns,” rather than individual foods or nutrients. The latest scientific studies show that a plant-based diet is more healthy and sustainable than a meat-based diet, according to the 571-page report.

“The major findings regarding sustainable diets were that a diet higher in plant-based foods, such as vegetables, fruits, whole grains, legumes, nuts and seeds, and lower in calories and animal-based foods, is more health promoting and is associated with less environmental impact than is the current U.S. diet,” the executive summary stated. Despite assuring readers that “no food group would need to be eliminated completely to improve sustainability outcomes,” the findings, released in February, set off a great plate debate, prompting cheers from environmentalists and protest from the meat industry, among others. The public comment period was extended by 30 days to accommodate widespread interest in the report. The National Cattlemen’s Beef Association (NCBA) is “very concerned that the committee did not fully review the scientific evidence in this area when they made their conclusions,” said Shalene McNeill, executive director of nutrition research for the

group. “Our focus is to encourage further review of the science so we can make sure that the science that supports lean meat’s role in a healthy diet is considered.” The debate on the guidelines is not surprising, but the reaction this year is especially strong because the committee “chose to use one of those words that just sets people on edge, and that’s ‘sustainability,’” said Marion Nestle, author of Food Politics and professor of nutrition, food studies and public health at New York University. “They looked at the diet as a whole and looked at the kinds of agricultural problems that our country faces, among them greenhouse gases and climate change — there’s no question that beef is the largest contributor to climate change — so recommending that we eat less beef from the standpoint of saturated fat and climate change seemed like a good idea,” said Nestle, who served on the 1995 advisory committee. CO N T I N U E D

USA TODAY SPECIAL EDITION

OBESITY

Amid the extensive response to the to the guidelines report. Hundreds of proposed guidelines: billions of dollars are spent each year to v Thirty senators, mostly Republican, treat chronic health conditions associated signed a letter questioning the “scientific with diet, such as heart disease, cancer and integrity” of the committee’s recommendaobesity. tion to eat less red and processed meats, “This is a nice document, a long report saying the panel went “beyond its purview for nutrition experts, but the main challenge of nutrition and health research to include is how do we get people to eat healthier and topics such as sustainability.” make it easier for them to include making v Congress issued a directive last year these healthful decisions in their everyday demanding that the guidelines “only include life,” said Sarah Ohlhorst, director of governnutrition and dietary information, not ment relations for the American Society for extraneous factors, in the final (version).” Nutrition. v The Heritage Foundation, a conservaDietary advice sometimes seems tive think tank, accused the advisory contradictory, as it can change with each set committee of “hijacking the guidelines,” of guidelines. That’s because the guidelines calling the environmental focus “not just reflect new scientific information, explained deceptive, but dangerous.” Barbara Millen, chair of the 2015 advisory v One hundred environmental orgacommittee and founder of Millennium Prenizations and activists vention, a public health published an open letter information startup. in major newspapers “The relationships “Recommending urging that the sustainbetween diet and health that we eat less ability recommendations become more evidencebe adopted. based and stronger as beef from the v Change.org launched time progresses,” Millen a petition supporting a said. “The volume of standpoint of sustainability component, research, even in a given saturated fat and while the National month, is impressive, and American Meat Institute so the mandate is really climate change countered with a “Hands to look at the evidence seemed like a good Off My Hot Dog” petition. within the interim five The guidelines are years to determine idea.” revised and published evwhether or not there — Marion Nestle, ery five years by a 1990 is evidence that would author of Food Politics congressional mandate. support a change in While Congress does policy.” not formally approve the The guidelines advisory guidelines, it does fund billions of dollars for committee also concluded that: programs that follow them. Federal public v Cholesterol is no longer a “nutrient health, nutrition and food programs such as of concern for overconsumption.” New free school lunches all take direction from evidence shows that eggs, shrimp and other the guidelines. cholesterol-rich foods don’t necessarily The Department of Health and Human contribute to cholesterol in your blood. Services (HHS) and the Department of v Java lovers can enjoy three to five cups Agriculture will jointly review the commitof coffee a day. New evidence shows caffeine tee’s report, develop the final edition of the is associated with a reduced risk of diabetes, guidelines and release them later this year, cardiovascular disease, Parkinson’s disease an HHS representative said. and some cancers. “It is premature to speculate on the v Moderate amounts of alcohol can be specific recommendations that will or will part of a healthy diet. not be included in the next edition of the v Less than 10 percent of daily total Dietary Guidelines,” the representative calories should be from added sugars, and added, noting the committee’s report is less than 10 percent from saturated fats. advisory only. v Food labels should clearly indicate Regardless of what the guidelines eventuthe amount of added sugars in foods and ally say, getting Americans to follow them beverages, and water should be the first is never easy. Despite decades of federal beverage of choice. government advice on healthy eating, about v Taxes on sugar-sweetened drinks and two-thirds of U.S. adults are still overweight high-sodium foods, plus price incentives for or obese and about half have at least one buying fruit and vegetables, may promote chronic, preventable disease, according healthy eating.

THINKSTOCK; USDA

While the 2015 edition of the federal Dietary Guidelines for Americans won’t be finished until later this year, some suggestions are already public — like the one that says three to five cups of coffee a day is OK. A government graphic showing how much to eat from each category of foods based on current recommendations, left, does not include coffee.

USA TODAY SPECIAL EDITION

PRETTY,

SICK

At a microscopic level, germs become art

By Elizabeth Neus

T A SIZE NOT normally visible to the naked eye, the organisms that make us ill create remarkable visual displays. These colorized photos, taken with scanning electron micrographs or transmission electron micrographs that can magnify images as much as 500,000 times, show the unexpectedly beautiful side of viruses and bacteria. 1. Particles of H1N1 flu virus, also known as “swine flu,” triggered a worldwide pandemic in 2009. Surface proteins, which allow the virus to invade unwitting host cells, are in black. 2. Once a leading cause of death in the U.S. but now relatively rare here, the lung disease tuberculosis — caused by Mycobacterium tuberculosis bacteria — still affects about 16 million people worldwide. 3. A white blood cell devours an antibiotic-resistant strain of Staphylococcus aureus bacteria known commonly as MRSA, a stubborn and

dangerous skin infection. 4. Borrelia burgdorferi bacteria cause Lyme disease and is usually spread by ticks. 5. The mosquito-borne Plasmodium parasite that causes malaria, seen in blue next to a red blood cell, infects about 198 million people a year, killing 500,000. 6. Virions (particles) of norovirus clump together, preparing to spread the familiar and vicious gastrointestinal disease, the bane of young children and their families.

ILLUSTRATION; THINKSTOCK; PHOTOS 1, 3, 5, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES; PHOTOS 2, 4, 6, CENTERS FOR DISEASE CONTROL AND PREVENTION

USA TODAY SPECIAL EDITION