U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON : 

For sale by the Superintendent of Documents, U.S. Government Printing Office

Internet: bookstore.gpo.gov Phone: toll free (866) 512–1800; DC area (202) 512–1800

Fax: (202) 512–2104 Mail: Stop IDCC, Washington, DC 20402–0001

56–578 PDF 2010

THE DOMESTIC EPIDEMIC IS WORSE THAN WE

THOUGHT: A WAKE-UP CALL FOR HIV PREVENTION

HEARING

BEFORE THE

COMMITTEE ON OVERSIGHT

AND GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED TENTH CONGRESS

SECOND SESSION

SEPTEMBER 16, 2008

Serial No. 110–215

Printed for the use of the Committee on Oversight and Government Reform

(

Available via the World Wide Web: http://www.gpoaccess.gov/congress/index.html

http://www.house.gov/reform

(II)

COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM

HENRY A. WAXMAN, California, Chairman

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

BRIAN HIGGINS, New York

JOHN A. YARMUTH, Kentucky

BRUCE L. BRALEY, Iowa

ELEANOR HOLMES NORTON, District of

Columbia

BETTY MCCOLLUM, Minnesota

JIM COOPER, Tennessee

CHRIS VAN HOLLEN, Maryland

PAUL W. HODES, New Hampshire

CHRISTOPHER S. MURPHY, Connecticut

JOHN P. SARBANES, Maryland

PETER WELCH, Vermont

JACKIE SPEIER, California

TOM DAVIS, Virginia

DAN BURTON, Indiana

CHRISTOPHER SHAYS, Connecticut

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

MARK E. SOUDER, Indiana

TODD RUSSELL PLATTS, Pennsylvania

CHRIS CANNON, Utah

JOHN J. DUNCAN, JR., Tennessee

MICHAEL R. TURNER, Ohio

DARRELL E. ISSA, California

KENNY MARCHANT, Texas

LYNN A. WESTMORELAND, Georgia

PATRICK T. MCHENRY, North Carolina

VIRGINIA FOXX, North Carolina

BRIAN P. BILBRAY, California

BILL SALI, Idaho

JIM JORDAN, Ohio

PHIL BARNETT, Staff Director

EARLEY GREEN, Chief Clerk

LAWRENCE HALLORAN, Minority Staff Director

(III)

C O N T E N T S

Page

Hearing held on September 16, 2008 ..................................................................... 1

Statement of:

Gerberding, Julie, Director, Centers for Disease Control and Prevention,

accompanied by Kevin Fenton, Director, National Center for HIV/AIDS,

Viral Hepatitis, STD and TB Prevention, Centers for Disease Control

and Prevention; and Anthony S. Fauci, Director, National Institute

of Allergy and Infectious Disease, National Institutes of Health, accompanied by Thomas Insel, Director, National Institute for Mental Health,

National Institutes of Health ....................................................................... 14

Fauci, Anthony S. ...................................................................................... 36

Gerberding, Julie ....................................................................................... 14

Holtgrave, David, Ph.D., professor and chair, Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health;

Adaora A. Adimora, M.D., Division of Infectious Diseases, University

of North Carolina School of Medicine; George Ayala, Psy.D., research

health analyst, RTI International and AIDS Project Los Angeles;

Heather Hauck, director, AIDS Administration, Maryland Department

of Health and Mental Hygiene; and Frank Oldham, Jr., president,

National Association of People with AIDS .................................................. 89

Adimora, Adaora A., M.D. ........................................................................ 111

Ayala, George, Psy.D. ................................................................................ 127

Hauck, Heather ......................................................................................... 138

Holtgrave, David, Ph.D. ............................................................................ 89

Oldham, Frank, Jr. ................................................................................... 155

Letters, statements, etc., submitted for the record by:

Adimora, Adaora A., M.D., Division of Infectious Diseases, University

of North Carolina School of Medicine, prepared statement of .................. 113

Ayala, George, Psy.D., research health analyst, RTI International and

AIDS Project Los Angeles, prepared statement of ..................................... 129

Davis, Hon. Tom, a Representative in Congress from the State of Virginia, prepared statement of ........................................................................ 11

Fauci, Anthony S., Director, National Institute of Allergy and Infectious

Disease, National Institutes of Health, prepared statement of ................ 39

Gerberding, Julie, Director, Centers for Disease Control and Prevention,

prepared statement of ................................................................................... 17

Hauck, Heather, director, AIDS Administration, Maryland Department

of Health and Mental Hygiene, prepared statement of ............................. 140

Holtgrave, David, Ph.D., professor and chair, Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health,

prepared statement of ................................................................................... 92

Oldham, Frank, Jr., president, National Association of People with AIDS,

prepared statement of ................................................................................... 157

Waxman, Chairman Henry A., a Representative in Congress from the

State of California: ........................................................................................

HIV epidemic profile ........................................................................................ 79

Prepared statement of ...................................................................................... 4

(1)

THE DOMESTIC EPIDEMIC IS WORSE THAN

WE THOUGHT: A WAKE-UP CALL FOR HIV

PREVENTION

TUESDAY, SEPTEMBER 16, 2008

HOUSE OF REPRESENTATIVES,

COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM,

Washington, DC.

The committee met, pursuant to notice, at 10:08 a.m., in room

2154, Rayburn House Office Building, Hon. Henry A. Waxman

(chairman of the committee) presiding.

Present: Representatives Waxman, Kucinich, Tierney, Watson,

McCollum, Sarbanes, Speier, Davis of Virginia, Shays, and Turner.

Also present: Representative Waters.

Staff present: Caren Auchman and Ella Hoffman, press assistants; Jen Berenholz, deputy clerk; Zhongrui ‘‘JR’’ Deng, chief information officer; Miriam Edelman and Mitch Smiley, special assistants; Earley Green, chief clerk; Karen Lightfoot, communications

director and senior policy advisor; Karen Nelson, health policy director; Leneal Scott, information systems manager; Naomi Seiler

and Tim Westmoreland, counsels; Lawrence Halloran, minority

staff director; Jennifer Safavian, minority chief counsel for oversight and investigations; Ellen Brown, minority legislative director

and senior policy counsel; Jill Schmalz, minority counsel; Molly

Boyl and Adam Fromm, minority professional staff members; and

Brian McNicoll, minority communications director.

Chairman WAXMAN. The committee will come to order.

We are here today to discuss some alarming developments in the

fight against HIV and AIDS in the United States.

The Centers for Disease Control and Prevention recently announced that the HIV epidemic in the United States is growing at

a rate far greater than was previously thought. The new figures

are a stark reminder that the HIV epidemic is far from over, and

that we must take new and urgent steps to strengthen our national

HIV prevention efforts.

The first cases of what later came to be identified as AIDS were

reported in Los Angeles in 1981. Over the next 2 years, the case

reports accumulated, and we learned that a distinct syndrome was

being diagnosed in different populations all across the country. By

the mid-1980’s, there were an estimated 130,000 new infections

every year in the United States.

As infections increased, so did our investment in HIV prevention

efforts. Even before the virus called HIV was identified as the

cause of AIDS, CDC experts had figured out the transmission

2

routes and issued early recommendations for the prevention of infection. The Federal Government started investing significant

amounts of funding in prevention and education efforts nationwide.

These investments paid off, and the infection rate dropped dramatically, but this is a job that is never done. This was recently

demonstrated in dramatic fashion when CDC reported that the real

infection rate is much higher than we thought. Over the past 10

years, CDC’s official estimate for annual new infections have been

about 40,000, but last month CDC announced that, in fact, there

were over 56,000 new HIV infections in 2006. The higher figure

was due to improved counting methods, not to an actual jump in

infections, but it tells us that the epidemic in the United States is

and has been growing faster than we had thought.

The message these new findings send is clear: We are not doing

enough to limit the spread of this deadly disease.

What is more, we are still seeing severe disparities in HIV’s impact on different populations. Men who have sex with men constitute 57 percent of new infections. Blacks, who make up about 12

percent of the total population, account for 45 percent of new HIV

infections. Hispanics are also disproportionately affected.

Part of the problem is that the Federal Government has not been

doing enough for HIV prevention in the United States. In adjusted

dollars, the CDC’s HIV prevention budget has dropped more than

20 percent since 2002. This year the administration actually asked

for a $1 million decrease in HIV funds. This didn’t make sense to

me, so I asked the Centers for Disease Control to prepare a budget

that reflects not what the White House wanted, but rather the

agency’s professional scientific judgment of what it would take to

fully implement effective HIV prevention in the United States.

As we will hear today, the administration asked for less than

half of what CDC’s scientific professionals estimate is necessary for

effective HIV prevention. Instead of listening to its own experts,

the administration requested that Congress fund HIV prevention

programs at far lower levels.

What is even more senseless is that by underfunding prevention,

the Nation will incur greater treatment costs down the road. It is

indisputable that evidence-based HIV prevention saves money in

addition to saving lives by avoiding the high cost of medical care

and lost productivity. But on this issue the administration apparently prefers to be penny wise and pound foolish.

We are here today to learn from some of our Nation’s top HIV

prevention experts what a truly robust national HIV prevention

program would look like. We will hear from leaders at CDC and

NIH about how they are attempting to roll out effective programs

and research potential new ones. We will discuss barriers to evidence-based HIV prevention, like the Federal needle exchange ban

and this administration’s stubborn and irrational focus on abstinence-only programs. And because HIV infections don’t occur in a

vacuum, we will hear recommendations from all of our witnesses

on how the Federal HIV prevention response should address the societal factors that contribute to risk, including poverty, homelessness, racial and gender inequality, homophobia, and stigma related

to HIV status.

3

I look forward to a constructive discussion of these questions

today, but one point should be clear from the outset: The status

quo simply isn’t acceptable. We undermine public health, betray

some of America’s most vulnerable citizens, and allow the further

spread of a deadly and still incurable disease by failing to invest

in proven prevention methods. We aren’t doing everything we can

and should, and I hope this hearing will be the first step in returning the necessary spotlight, resources, and political will to HIV prevention efforts in the United States.

[The prepared statement of Chairman Henry A. Waxman follows:]

4

5

6

7

8

9

10

Chairman WAXMAN. Before recognizing our very distinguished

panel of witnesses, I want to recognize the gentleman from Ohio

Mr. Turner for an opening statement.

Mr. TURNER. Thank you, Mr. Chairman. Thank you for holding

this hearing to examine new data on the incidence of HIV infection

on the United States. We appreciate your longstanding dedication

to public health issues and your abiding commitment to meet the

many challenges posed by the AIDS epidemic.

Using a more sensitive surveillance tool, the Centers for Disease

Control found 56,300 new HIV infections in 2006. That is a 40 percent higher incidence than previous estimates. The upward adjustment does not reflect an acceleration of the epidemic, but a more

precise capability to establish between recent and longer-term infections. So it still appears the epidemic has, in fact, plateaued in

terms of new infections per year over the last decade, but at a

markedly higher rate than we thought.

With this new knowledge about the path and the scope of the

epidemic, public health officials can better target efforts to prevent

the spread of the virus that causes AIDS. How to bring those prevention tools to at-risk groups has always been a challenge at every

level. This more accurate data should inject a renewed sense of urgency into the Federal, State, local, and private-sector partnerships

working to stop the spread of HIV. But behind the figures lurks

one deadly fact: No prevention strategy works on a person who

doesn’t know he or she is infected.

At any given time, it is estimated fully 25 percent of Americans

carrying HIV have not been diagnosed. They are far more likely to

engage in high-risk behaviors that expose still others to the silent

infection. Breaking that silence, research has proven, the power of

information is a barrier against the virus.

Once diagnosed and properly counseled, HIV-infected individuals

are significantly less likely to engage in behaviors that put others

at risk. That leaves public health officials to confront the hard

questions: Who should be offered testing? How often? And who

pays for any broader HIV screening that might detect latent or unknown infections?

HIV/AIDS is not curable, but it is treatable. With the tools at our

disposal, we need not consign thousands of our fellow citizens each

year to the devastation of preventable HIV infection.

Since its outbreak, the United States has played a leading role

in research and treatment of HIV and AIDS. One of the witnesses

today, Anthony Fauci, is a recognized leader in unlocking the lethal

mechanisms by which the virus attacks the immune system.

This is an important hearing about the implications of this new

CDC data for public health officials and public policymakers. Mr.

Chairman, I appreciate your attention to this issue.

Chairman WAXMAN. Thank you very much, Mr. Turner.

[The prepared statement of Hon. Tom Davis follows:]

11

12

13

Chairman WAXMAN. For our first panel, we are pleased to have

Dr. Julie Gerberding, who has been the Director of the Centers for

Disease Control and Prevention since 2002. In this role she has led

the CDC in its mission of health promotion and disease prevention

in the United States and abroad.

Dr. Gerberding has contributed to numerous peer-reviewed publications and textbook chapters, and to guidelines and policies on a

range of health issues, including HIV prevention. She has served

on Federal and non-Federal advisory councils, including the CDC’s

HIV Advisory Committee, and teaches infectious disease medicine

at both Emory University and the University of California at San

Francisco.

We want to welcome you back to the committee, Dr. Gerberding,

and we are pleased that you are here, coming right from Texas

where you have been trying to deal with the tragic consequences

of the hurricane.

Dr. Gerberding is accompanied by Dr. Kevin Fenton, who, since

2005, has served as the Director of CDC’s National Center for HIV/

AIDS, Viral Hepatitis, STD and TB Prevention. He leads the U.S.

Government’s HIV surveillance and prevention efforts, interacting

with State and local agencies, community organizations and researchers nationwide. Dr. Fenton has worked in HIV research, epidemiology and prevention since 1995, including as Director of the

HIV and Sexually Transmitted Infections Department at the

United Kingdom’s Health Protection Agency.

Dr. Anthony S. Fauci has served as the Director of the National

Institute of Allergy and Infectious Diseases at the National Institutes of Health since 1984. He oversees a broad range of research

on the prevention, diagnosis, and treatment of infectious diseases,

including HIV/AIDS. He continues to conduct his own research on

immune-mediated and infectious disease, and has contributed to

over 1,000 scientific publications.

Dr. Fauci served as one of the key advisors to the White House

and the Department of Health and Human Services on AIDS

issues, and is a member of The National Academy of Sciences, the

American Academy of Arts and Sciences, and the Institute of Medicine. Dr. Fauci has testified on numerous occasions before this committee and other committees that I chaired in the Congress since

the early 1980’s.

And we are happy to have you here as well.

Dr. Fauci is accompanied by Dr. Thomas Insel, the Director of

the National Institute for Mental Health at NIH. In that role Dr.

Insel oversees the agency’s research on behavioral prevention

methods for HIV.

We are pleased that all of you are here today. It is the practice

of this committee that all witnesses who testify before us do so

under oath. So if you would please rise and raise your right hands.

[Witnesses sworn.]

Chairman WAXMAN. Your prepared statements will be in the

record in full. We would like to ask each of you to make your oral

presentation in around 5 minutes. We will have a clock that will

allow you to see when the 5 minutes is up. It will be green for 4

minutes, yellow for 1 minute, red when the 5 minutes has passed.

And we won’t be strict on it, but we would like that to be a guide,

14

so that when you see the red light, since we have many witnesses

yet to come, we would like to ask you to try to reach your conclusion so that we can ask questions and hear from the other witnesses as well.

Dr. Gerberding, we are pleased to have you.

STATEMENTS OF JULIE GERBERDING, DIRECTOR, CENTERS

FOR DISEASE CONTROL AND PREVENTION, ACCOMPANIED

BY KEVIN FENTON, DIRECTOR, NATIONAL CENTER FOR HIV/

AIDS, VIRAL HEPATITIS, STD AND TB PREVENTION, CENTERS FOR DISEASE CONTROL AND PREVENTION; AND ANTHONY S. FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASE, NATIONAL INSTITUTES

OF HEALTH, ACCOMPANIED BY THOMAS INSEL, DIRECTOR,

NATIONAL INSTITUTE FOR MENTAL HEALTH, NATIONAL INSTITUTES OF HEALTH

STATEMENT OF JULIE GERBERDING

Dr. GERBERDING. Thank you very much.

I would like to start with my first slide, which is a reflection on

Ike striking in Galveston. I did visit the hurricane territory yesterday, and for the record I would like to acknowledge the tremendous

effort of State health commissioner Dr. Lehi and the whole pantheon of experts in public health across the State that are performing miracles.

I think we all recognize that hurricanes represent urgent public

health threats, and when people recognize an urgent threat, they

hold nothing back in responding to it. Unfortunately, on the next

slide we have another urgency, and that is the urgent reality of

HIV/AIDS in America. Last month I spent 2 weeks at San Francisco General Hospital taking care of patients, and on my service

I had two undiagnosed AIDS patients die; I had several individuals

come in with the opportunistic infections that we started seeing in

1981 when I was an intern. And in that community, we learned

that there is an epicenter of HIV transmission among men who

have sex with men, and particularly among African Americans.

Similarly, I visited Oakland earlier this year, and found to my

astonishment—and found an even grimmer situation in terms of

HIV transmission in that community.

On my next graphic I tried to represent the progress that we

have made despite these current situations. And we are currently

proposing federally a $24.1 billion HIV budget for all AIDS-related

activities at the Federal level. Of that, 4 percent is reflected in

CDC’s prevention budget. And I think over time we have had some

good news. We are definitely seeing people live longer with HIV,

and many are thriving despite the complications of the drug treatment and everything else that having a chronic illness represents.

In addition, we have made tremendous progress in perinatal

AIDS, in reducing the incidence among injection drug users and

among heterosexuals at high risk.

We have also seen the rate of transmission decline over time.

That means for every 100 HIV-infected individuals, the number of

new people that they infect has continued to drop precipitously

since the early phases of the epidemic.

15

And, finally, I think studies do show that prevention interventions can work. We have evidence of efficacy in at least 49 behavioral interventions, and several others are on the docket for coming

forward.

Let me just quickly show you the pictures of what these statistics

look like. The red line here is the number of people in America living with HIV, and the blue line are the number of new cases that

were reported that precipitated this hearing. And you can see that

although the number of people with HIV in our country continues

to increase, the number of new infections is holding steady over the

past several years and declining as the large picture in the United

States; meaning that our interventions are successful, or we would

see that blue line go up commensurate with the red line.

On the next graphic, you can see the picture of perinatal transmission, again, evidence that prevention can work.

On the next graphic, the picture of what is happening recently

among people at high-risk heterosexual contact. And I could repeat

that for injection drug users and others.

But on the next graphic we have the sobering statistic that is my

frame for the urgent reality that we are facing, and this is the incidence rates going up among men who have sex with men in the

United States.

On the next graphic I show some statistics that were released

last week which really reflect a detailed understanding of the epidemiology of this risk, showing that while overall the majority of

men who have sex with men and get HIV infection are White,

there is disproportionate representation of African Americans, and

particularly young African Americans and Hispanics. They are represented here way out of proportion to their prevalence in society.

And on the next graphic we have the rates of HIV infection

which use as the denominator the number of people in our society

in those categories. So you can see that African Americans have an

infection rates that is about seven times that of Whites, and Hispanics have a rate that is about three times that of Whites across

America.

So this is very serious information, and it tells us where we need

to target our prevention interventions.

So let me conclude by telling you what I think are the priorities

for those prevention interventions. We have submitted a long professional judgment. We have tried to put everything in there we

could think of. We understand the reality of the budget, but we

wanted you to know what the universe of possibility might be. So

on the first slide, I am trying to summarize some of those interventions that relate to finding the leading edge of the epidemic.

The information we just published is the first time we have ever

been able to say in real terms, where is the infection now, and how

bad is it going, and who is getting it? So we need to expand our

ability to do that so that we have that information at the community level and can target those interventions that do work for those

individuals.

We also need to integrate services. It is great that we have representatives from mental health, substance abuse, and a broad continuum, because there is a syndemic of these factors that come together in the concept of social justice and in social determinants of

16

health that we have to address if we are going to be successful

here. And we need to conduct not just individual interventions, but

social marketing campaigns.

On the next graphic I am emphasizing the importance of finding

the people who are infected. This is Epidemiology 101, but it is

something that we still haven’t been able to do successfully in this

disease. Twenty-five percent of infected people still don’t know they

have the virus. So we need to expand access to rapid testing. And,

in particular, our Federal facilities need to move to support the

CDC guidelines and allow screening for HIV, using the protocols

that we have recommended for the routine screening. We also need

to have better tests, and we need to focus those tests on finding

people early, hopefully as they are seroconverting, because that is

the time when they pose the biggest transmission risk, and we are

missing them, and they are highly infectious, and they account for

a disproportionate part of the epidemic.

Now, my last graphic, I mentioned those aspects that relate to

the need for new tools. We don’t have all the answers here. I wish

we did. We have been working on it, but our research budget hasn’t

really allowed us to update and modernize our toolkit.

One area in particular, given the difficulties we are having with

the vaccine, are the preexposure treatment trials to determine

whether or not taking HIV drugs before you are exposed could result in an overall health benefit and a reduced risk of infection.

CDC is conducting three of those studies and are collaborating on

a fourth, and I know NIH is doing one, too, as well. So we are hoping that could put a new biomedical toolkit or two in our toolbox

while we are working on some of these other measures that we

think are important.

I just want to make one final point here. AIDS is a social disease

as much as it is a viral disease, and part of bringing people to accept prevention is to create that expectation in an environment of

hope. Many of the people who are getting this infection now are

functioning in a society that offers them very little hope for education, economic, or social attainment, and if we don’t address the

underpinnings of the problem, we are never going to be able to get

where we need to be as a Nation.

So thank you for allowing me to explode with a lot of information

in a very short period of time. But we are very, very passionate

about this and very committed to this issue.

Chairman WAXMAN. Thank you. It is very helpful information.

[The prepared statement of Dr. Gerberding follows:]

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

Chairman WAXMAN. Dr. Fenton, you are just here to answer

questions?

Dr. FENTON. That is right.

Chairman WAXMAN. Well, we will have questions for you.

Dr. Fauci.

STATEMENT OF ANTHONY S. FAUCI

Dr. FAUCI. Thank you, Mr. Chairman and members of the committee. Thank you for giving me the opportunity to testify before

you here today on the role of the NIH research endeavor in HIV

prevention, the subject of this hearing. I guess the slides don’t

work, so we will go with the—are they up? OK. There they are.

OK. On the first slide shown on the board there, I want to just

emphasize that since the very early days of HIV that you described

in your opening statement, in the summer of 1981, there have been

some spectacular advances in AIDS research ranging from the initial discovery of the virus to the delineation of the pathogenesis,

natural history, but, importantly, treatment.

Now, treatment has been one of the more spectacular successes

in the development of now over 25 drugs that have transformed the

lives of HIV-infected individuals. The results of this have been

quite impressive.

On the next slide is a review paper showing the results of the

first decade of HIV written up in the Journal of Infectious Diseases

that there is a conservative estimate of about 3 million lives—years

of life have been saved in the United States alone from 1996

through 2005 on the basis of the accessibility of treatment, particularly the combinations of therapies. This has been repeated and

verified in Europe, Australia, and Canada.

Now, that is the very good news. But the subject of the hearing

is what is still going on? So on the next slide, just to reiterate what

Dr. Gerberding had said, we still have a major ongoing problem

globally and even here in the United States with over one-half million deaths, 1.1 million people infected with HIV, and, as underscored by Dr. Gerberding, 25 percent of them are unaware that

they are infected. And we know the majority of infections come

from an individual who does not know that he or she is infected,

transmitted to another individual.

And an example is something that is very close to home. We

make rounds three times a week at our clinic, up at the clinical

center at the NIH, and just last week a patient was presented to

me, a resident of the District of Columbia, 38 years old, who presented for the first time with advanced tuberculosis, central nervous system lymphoma, and CB4 count of 3, which is about as low

as you can get in a viral load. That person clearly was infected for

many years, has now compromised his own ability to be treated because he is so advanced, and who knows how many people that

person exposed, mainly because he did not know that he was infected.

Now, on the next slide, what about prevention? The NIH and its

multiple institutes, particularly our institute, NIAID, NIMH,

NIDA, Child Health, and others, have been heavily involved in prevention research. And when I say prevention research, it’s to try

37

and get some of the scientific facts that would help inform some of

the activities that are implemented so well by the CDC.

On this slide we show that if you include vaccine, behavioral

change, and microbicides, about 38 percent of the NIH budget is

devoted to prevention activities. And I just want to spend a minute

to underscore some of the proven strategies as well as those that

are still investigational and for which we have remaining challenges on the next slide.

Proven HIV prevention strategies again underscores what Dr.

Gerberding mentioned, that prevention does work when it is applied and implemented. For example, preventing sexually transmitted disease, cognitive behavior interventions when applied have

been shown to work. Behavioral changes regarding sexual transmission are paramount in its prevention. Condom promotion. In a

study, a group of studies that were sponsored by the NIH just a

year and a half ago on adult male circumcision in an international

basis, predominantly in sub-Saharan Africa, showed anywhere

from a 55 to 65 percent prevention in males who were circumcised

that lasted for 3 to 4 years of followup and likely much more.

The prevention of blood-borne transmission. Clearly needle exchange programs work. There is no doubt about that. Drug treatment programs, methadone and related programs have been shown

in a number of studies by the CDC and by NIDA and NIH to work.

And probably the most dramatic success story is the prevention

of mother-to-child transmission, by treating the mother during

pregnancy and the baby soon after delivery, and most recent studies, weeks to months of breast feeding have been truly a great success story.

The next slide.

There are also some investigational prevention strategies, some

of which are in the process of being proven, others that are still

challenging. The first is the prevention and treatment of coinfections, such as tuberculosis, malaria, and other sexually transmitted

diseases. Not all STDs, or sexually transmitted diseases, when you

treat them result in a decrease in HIV transmission, but some do.

And we are now continuing our studies to try and delineate that

a little bit more clearly.

We have been challenged by topical microbicide studies. The initial studies over the past several years have proven not to be effective. They were the first generation of studies that did not incorporate specific anti-HIV drugs; they were merely chemicals that

would block transmission, but not in a specific anti-HIV manner.

The products that are currently in the pipeline we are cautiously

optimistic about.

The last two I want to close on is antiretrovirals as prevention

and vaccines. By an antiretroviral as prevention, we mean that if

you treat people who are infected, you could theoretically and in reality decrease their ability to transmit to others. You can talk

about population studies; if you treat enough people in a population, you will get the mean viral load in the population low

enough that you might decrease the incidence; but even more potentially exciting is what we call PrEP, and Dr. Gerberding mentioned that on one of her slides, or preexposure prophylaxis. There

is a large study conducted by the CDC, several other studies, some

38

of which are conducted by the NIH, looking at a large number of

individuals to see if, in fact, this treatment prior to infection would

significantly block transmission.

And then there is vaccines, which in the history of viral diseases

are generally the Holy Grail of how you stop the transmission of

a viral infection. We have not been successful thus far. As shown

on this slide, at the last meeting this summer in Mexico city of the

International AIDS Society, we discussed some of the remaining

challenges and the reality that we will not have an HIV vaccine at

least for several years at best. I am cautiously optimistic that we

will, but up until the time that we do, we are going to be left with

the prevention measures that were discussed by Dr. Gerberding

and myself and in your own opening statement, Mr. Chairman.

So in the last slide, I want to emphasize that point; that when

we talk about prevention, it is not unidimensional, and it is not

one-size-fits-all. We refer to it as a comprehensive prevention toolbox, of which a vaccine would be a major contribution. But even if

we get a vaccine that is effective, we would still have to rely very

heavily on the other prevention measures that have been discussed

in our various statements.

So I will close here, Mr. Chairman, and be happy to answer any

questions.

Chairman WAXMAN. Thank you very much, Dr. Fauci.

[The prepared statement of Dr. Fauci follows:]

39

40

41

42

43

44

45

46

47

48

49

50

51

52

53

54

55

56

57

58

59

60

61

62

63

64

Chairman WAXMAN. Dr. Insel, do you have a statement?

Dr. INSEL. No statement, just to go on to questions.

Chairman WAXMAN. OK. I want to start off the questions for you,

Dr. Gerberding. I want to ask about CDC’s HIV prevention goals

and its budget.

In January 2001, and I understand this was before your tenure

as Director, CDC released a document called HIV Prevention Strategic Plan Through 2005. At the time, the working estimate of annual new infections per year in the United States was 40,000. The

agency called this number relatively stable, but unacceptably high,

and stated that a new strategic plan for HIV prevention was essential.

In this 2001 document, what was CDC’s target for reducing annual new HIV infections?

Dr. GERBERDING. I would want to let you know that although I

was not the CDC Director during this period of time, I was on an

advisory committee before I went to the Center, before I went to

CDC, so I participated in the earliest phases of that development.

And the expectation optimistically at that time was a 50 percent

reduction in the number of new infections, to be able to drive the

infection rate down to 20,000. At that time we didn’t have a lot of

evidence to model or base those figures on, but we believed that if

we did everything we knew how to do, we could strive for that. It

made sense to create a stretch goal, and obviously we didn’t make

it.

Chairman WAXMAN. Because if we look at 2005, fast forward 5

years later, CDC’s estimate of annual new infections at that point

was still 40,000 a year, and the figure hadn’t budged. Why do you

think that nothing changed? Was it—what is your assessment?

Dr. GERBERDING. I think it is complicated, but there are two factors that probably play a pretty big role. One is the fact that our

earlier estimates were made before we recognized the benefits of

drug treatment. And so what happened was we suddenly had a

larger and larger and larger number of people in our country with

HIV who presented a transmission risk to other people because

they were surviving instead of dying from the disease. So it was

a positive factor, but it clearly made our earlier estimates fairly irrelevant.

The second thing is that I don’t think we adequately controlled

for the generational effect. So as new young people come into the

risk environment, they don’t behave—kids are not little adults.

They don’t behave the way we would expect more mature people

who have lived through their friends dying to behave. And so we

saw increased infection rates, as we are still seeing today, among

the youngest people. So our estimates did not adequately adjust for

the generational problem of new cohorts at risk.

Chairman WAXMAN. When we look at the CDC budget in 2001,

there was a steady growth in the prevention part. And by that

time, in 2007, CDC’s HIV prevention budget actually dropped in

adjusted dollars by 20 percent. So while we didn’t see the decrease

we had hoped for, we saw, in fact, a steady level, which would be

that—a failure of the prevention efforts to succeed.

65

At that point, CDC put a document forward extending its HIV

prevention through 2010. And what was the goal in that document,

if you can tell us?

Dr. GERBERDING. I would have to go back and review that particular estimate.

Kevin, maybe you can answer that question.

Dr. FENTON. Thank you very much for that question.

In the 2007 revision of the HIV prevention strategy, what we

were attempting to do is to identify shorter-term goals for HIV prevention as well as looking at goals which were achievable within

the resources that we had at CDC. One of the experiences we had

from 2001 to 2007, as you mentioned, was the fact that our budget

remained relatively flat over that time, so it was crucially important that we looked at what was achievable in the next 3 years.

In the meantime——

Chairman WAXMAN. And the numbers that you found that you

thought was achievable was, rather than 50 percent, down to 10

percent; Is that right?

Dr. FENTON. That is correct.

Chairman WAXMAN. And was that 10 percent goal modeled on

the fact that you saw a decrease in the prevention side of the HIV

budget?

Dr. FENTON. It was modeled on the realities of the existing prevention budget as well as the availability of better information, better surveillance information, better data on incidence which we

knew were forthcoming in the next few years.

Chairman WAXMAN. And how much did the administration request for HIV prevention for this next fiscal year, 2009?

Dr. GERBERDING. The request in the proposed budget is less than

the request from last year by a percent or so. So it is a reduction.

Chairman WAXMAN. As I understand, that is $752.6 million?

Dr. GERBERDING. I believe that is correct.

Chairman WAXMAN. Now, according to your professional judgment budget, the funding that CDC needs to conduct appropriately

scaled-up domestic HIV prevention programs and research for

2009, I understand, is $1.63 billion; is that right?

Dr. GERBERDING. If we were able to walk out the door today and

do absolutely everything that we knew how to do to full scale, it

would be expensive, and those numbers reflect that kind of bestcase scenario. I think we also recognize we couldn’t go from where

we are to where we would like to be as fast as we probably reflected in our budget estimates, but we wanted to give you the flavor that the scale here is one challenge. The ‘‘what to do’’ is the

other challenge.

Chairman WAXMAN. Well, and just to look at where we are and

where you would like us to be and where do you think the money

could wisely be spent, the administration is proposing half of what

CDC’s experts say is necessary. And, in fact, that is an actual decrease of $1 million from fiscal year 2008. So the proportion, it appears to us, for domestic HIV funding for prevention would be

around 5 percent.

Dr. GERBERDING. I think the figure for the large request for do- mestic HIV, the $24.1 billion overall that has been requested includes about a 4 percent prevention budget, at least according to

66

the analysis that we have been able to review from Kaiser. So it

is a very small piece of the overall budget. And I think the concept

of a dime of prevention is worth a dollar of cure is what we need

to relook at, especially now that we have these new incidence data.

In addition, we know that it is cost-saving to prevent HIV because

it is so expensive to treat.

Chairman WAXMAN. You are telling us that information. Did you

tell the President? Did you tell the Secretary of HHS? Did anyone

in the administration ever come and ask you over the last 6 years

what you and your expert colleagues believed and what you would

need in order to turn the domestic epidemic around?

Dr. GERBERDING. We have had a lot of briefings on this subject.

And I think one of the challenges that I face at CDC is my own

expert judgment, that it isn’t going to be enough to just do more

of the same. We have to really step back and say, you know what?

If you keep doing the same thing over and over again, it doesn’t

matter how big you do it, you are not really going to solve the problem.

So not only do we need to expand what we know can work, we

have to find new things. And so I really want to emphasize that

the research for new tools is also a very, very big part of this. And

I am sure that Dr. Fauci would agree with that, that there is more

we need to know and not just more that we need to do.

Chairman WAXMAN. Well, just to conclude my questioning here,

you can’t do more of the same with less money, even if some of the

same things you were doing were successful.

Dr. GERBERDING. Unless you are a magician.

Chairman WAXMAN. And if you could get new tools, that would

be great. But you may not be able to even do the new tools if your

prevention budget is decreasing and the population of people being

infected is even more than we expected.

Dr. GERBERDING. What I am really also—and what I have asked

Dr. Fenton to do is to look at whatever the pie is, whatever the investment that we have, and make absolutely sure that whatever

we are doing with it, we are getting the absolute maximum out of

it that we can. We may need to rebalance. We would like to have

more, but we may need to also rebalance what we are doing to

make sure that it is making the biggest difference.

Chairman WAXMAN. Thank you very much.

Mr. Davis.

Mr. DAVIS OF VIRGINIA. Of course, Congress appropriates the

money, not the administration. So this Congress has the authority

to move those numbers up or down appropriately, don’t they?

Dr. GERBERDING. That is correct.

Mr. DAVIS OF VIRGINIA. OK. And are we spending more internationally on AIDS prevention and treatment than we are nationally now?

Dr. GERBERDING. We are spending more internationally for the

President’s emergency program as well as the global fund.

Mr. DAVIS OF VIRGINIA. So basically we have seen more funding

for AIDS and HIV prevention and treatment, but it is going internationally instead of——

Dr. GERBERDING. May I just qualify that for a statement?

Mr. DAVIS OF VIRGINIA. Please.

67

Dr. GERBERDING. Because as I said, our total Federal budget for

HIV is $24-some billion a year because of the mass investment that

we make in treatment naturally. So we are not spending $24 billion internationally a year.

Mr. DAVIS OF VIRGINIA. Now, a full 25 percent of individuals

with HIV, I think, are unaware of their infection, and these individuals account for about 50 percent of new infections?

Dr. GERBERDING. It is about—it is probably close to 50 percent.

We know that once people find out what—I think it is actually 58

percent. The undiagnosed people are accounting for about 60 percent of the infections that we are seeing. But we are also learning

more recently that probably early infection is a special subset of

that group. And so people who are newly infected don’t recognize

it, aren’t getting tested as they develop the systems of the conversion illness, are highly infectious with great——

Mr. DAVIS OF VIRGINIA. How long does it take after the contact

that you’re infected and can pass it on? Is it a matter of hours?

Days?

Dr. GERBERDING. It is not hours, but it happens faster than we

realize now that we have more and more sensitive tests. So although the antibody test may not become positive for many days,

the virus is replicating very early on after exposure. And that is

why people can transmit even though they don’t know they have

it.

Mr. DAVIS OF VIRGINIA. I recently spent about 10 days in Africa

touring some of our facilities that were there on AIDS prevention.

One of the problems there is the people that have it now are getting medical care, they are keeping mothers from passing it to their

kids, they are able to live seminormal lives. But over there, the

men are just not as likely to go in and turn themselves in, and

there is still a lot of denial in Africa. Is there anything similar in

the United States?

Dr. GERBERDING. There are many comparable social issues. One

of them is shame; the people are ashamed to have the infection.

The other is stigma; they are punished if someone else finds out

they have it. And then the third is ignorance. There are still many

people in this country and around the world who don’t recognize

the risk and don’t understand that their behavior puts them at

risk.

Mr. DAVIS OF VIRGINIA. Now, I understand that 38 percent of the

individuals, roughly, with newly diagnosed HIV are now developing

full-blown AIDS within a year of diagnosis. For these individuals,

prevention, testing, and treatment strategies don’t seem to have

worked. What do you see? Is there a granular understanding of

this population, what leads to this outcome in people who are being

diagnosed and then moving quickly to AIDS?

Dr. GERBERDING. Well, the HIV diagnosis is happening perhaps

years after the infection has occurred at the time people are beginning to develop symptoms. So it is a failure to diagnose, a failure

to reach out and get yourself tested, or a failure for health professionals or people you encounter in——

Mr. DAVIS OF VIRGINIA. But that is a diagnosis question and

waiting so long?

68

Dr. GERBERDING. So, D, the diagnosis of the prevention paradigm, has to be a strong emphasis.

Mr. DAVIS OF VIRGINIA. Now, as the epidemic has progressed, the

perception of HIV/AIDS has changed. The success of effective treatments may have the downside of creating a sense of complacency

about HIV/AIDS impact. What are the Federal efforts that are

under way in order to address complacency and correct some of

these misconceptions? Anything that we can do?

Dr. GERBERDING. We need to do so much more than we are doing

right now. We need to get AIDS back on the radar screen. We need

to highlight the fact that this isn’t just something that happens underground; this is something that is still posing a threat to college

students and to young men and women across our Nation’s fabric.

We need to engage community leaders. We need to engage popular

opinion leaders. We need to make it clear that it is not a problem

‘‘over there,’’ it is a problem at home. And all you have to do is look

at the statistics in the metropolitan D.C. area to see a picture that

would suggest we have nothing to be complacent about.

Mr. DAVIS OF VIRGINIA. It’s remarkable, the medical progress

that has been made in this area over the last 10 years. I was very

surprised. I mean, people who were diagnosed, now it is no longer

a death sentence if you take your medication regularly. We are

being able to stop it from being passed on to kids and the like. I

mean, getting treatment now, if you are HIV-positive, going and

getting treatment is literally a lifesaver, Isn’t it?

Dr. GERBERDING. Treatment is lifesaving. And this is hard to

say, but as much as we want people with HIV infections to live and

thrive and survive, it is not good to have HIV. These drugs are

hard to take. They are fraught with complications and side effects.

It is not easy to have HIV and take these drug treatments for a

lifetime.

Mr. DAVIS OF VIRGINIA. And it is expensive.

Dr. GERBERDING. And it is expensive. And it isn’t a disease that

anyone should want to have, and it is certainly not a disease that

we should accept as just part of our advanced society. We still need

to prevent this disease.

Mr. DAVIS OF VIRGINIA. For the uninsured who are diagnosed

HIV-positive, obviously having to take the medication is, what,

$1,000 a month. What would it be?

Dr. GERBERDING. It depends very much on which regimen you

are taking. And there are, fortunately, right now so many good

choices that there are a variety of options and a variety of cost factors. But it is not inexpensive. It is one of the most expensive

chronic diseases to treat and manage.

Mr. DAVIS OF VIRGINIA. OK.

Chairman WAXMAN. Thank you, Mr. Davis.

Mr. Tierney.

Mr. TIERNEY. Thank you, Mr. Chairman.

Thank you all for your testimony here. You have testified about

the importance of implementing evidence-based prevention programs, so I want to ask a few questions tying it in on the evidence

behind some of our policies that affect the prevention programming.

69

The new CDC incidence numbers show that injection drug use

directly accounts for about 12 percent of the new infections. The

sexual partners, the children of injection drug users are also indirectly at risk.

There is scientific consensus that needle exchange programs reduce the transmission of HIV and other infectious diseases without

increasing the rate of drug use. Needle exchange programs also

connect people to important health and social services, including

drug treatment. These are conclusions that have been reached, as

far as I understand it, based on evidence of at least 18 groups of

experts and the most prominent professional and public health societies in the world, including the CDC and NIH. Just recently,

when the CDC published its August data, the authors noted that

infections among injection drug users dropped 80 percent, and they

stated that, among other factors, one reason was that drug users,

and I quote, have reduced needle sharing by using sterile syringes

available through needle exchange programs or pharmacies.

So despite this overwhelming mountain of evidence, every year

the Labor-HHS Department appropriations bill includes provisions

banning the use of Federal funds for the needle exchange programs. So it looks like other programs around the country and

communities and States are doing all that they can do, private people, but they are not really being supported by the Federal Government.

So, Dr. Fauci, let me start with you, if I could. In your professional scientific judgment, does the public health evidence support

the Federal ban on funding needle exchange programs?

Dr. FAUCI. No, it doesn’t. Actually, I was part of a group that I

helped cochair years and years ago to look in a somewhat metaanalysis way of all the data that you referred to asking the two

questions, A, does needle exchange help promote illicit drug use;

and, B, does it impede or block in many respects the transmission

of HIV? And the answer to both of those questions were: It doesn’t

increase the injection drug use, and it does prevent HIV infection.

So the scientific data are really rather firm and totally convincing that injection drug use and the transmission of HIV through

injection drug use can be decreased significantly by needle exchange programs.

Mr. TIERNEY. Dr. Gerberding and Dr. Fenton, in your professional scientific judgment, do you agree with Dr. Fauci?

Dr. GERBERDING. I agree. And I also ran a bridge program to

needle exchange in San Francisco, from San Francisco General

Hospital, so I had a chance to see first-hand.

I want to emphasize the word you used, though, ‘‘program,’’ because it isn’t just the needle, it is the surrounding education, the

reduction in partners and sharing and so forth. So it has to be done

in the context of the overall program. And my understanding is

that there is actually for CDC a congressional prohibition on using

any of our appropriated dollars for needle exchange. So we need to

work on this.

Mr. TIERNEY. That was the dilemma that I was pointing out.

Dr. Fenton, do you also agree?

Dr. FENTON. I concur.

70

Mr. TIERNEY. OK. So let me move on now and ask a question

about programs for youth. The new CDC data shows that almost

a third of the new infections occur with people under the age of 30.

There’s been a number of comprehensive sex education programs

that appear to show a reduction of HIV or HIV risk behaviors

among young people. But aside from a small amount of money in

CDC’s Department of Adolescent School Health, there doesn’t appear to be any Federal funds dedicated to comprehensive sex education. In the meantime, we spend about $1.5 billion on abstinenceonly until-marriage programs.

I am aware that no evidence that this kind of narrow program

decreases HIV risk. In fact, a longitudinal, independent, congressionally mandated study that came out last year found that the

programs had no impact at all on teen behavior compared to the

control group. In April, we heard from the American Public Health

Association, the American Academy of Pediatrics, and others that

these programs are not supported by evidence.

So, I want to ask each of you individually, in your professional

scientific judgment, do you believe that evidence at this time supports abstinence-only until-marriage programs as an effective intervention to reduce HIV risk among youth? Dr. Gerberding.

Dr. GERBERDING. Let me say that I have spent a great deal of

time in preparation for this hearing reviewing those data, and I

agree with the conclusions that there is no evidence of benefit from

the 10 abstinence-only programs that have been evaluated. And in

looking at the comprehensive curricula programs, there is more evidence of benefit, at least in terms of benefit, in knowledge. And

hopefully STDs in the long term—although we have never studied

an impact on HIV.

But I also want to emphasize that there are many in the STD

world of science who believe that delaying the entree to sexual behavior is a good and very important part of a comprehensive program. So, abstinence is not a dirty word, but programs that deal

with youths’ sexual health need to bring to them the entire compendium of tools that we know they may need in their efforts to

protect themselves.

Mr. TIERNEY. Dr. Fenton.

Dr. FENTON. I agree with the statements of Dr. Gerberding. I

know of no evidence supporting the effectiveness of abstinence-only

until-marriage programs in preventing STDs or HIV incidence

among young people. And I also support and concur with Dr.

Gerberding’s statement regarding the role of comprehensive sex

education programs as an effective tool or as part of an effective

program toward better sexual health among our youth.

Mr. TIERNEY. Dr. Fauci.

Dr. FAUCI. Yes, I agree also. It is pretty clear that if you look

at abstinence only in a vacuum, that there is no data to indicate

that decreases transmission of HIV or other sexually transmitted

diseases.

But, again, to underscore what Dr. Gerberding says, as part of

a comprehensive program where you try to delay the sexual debut,

but you also inform people of what you need to do if you do not

practice abstinence has to go along with that; otherwise, alone in

a vacuum, it doesn’t work.

71

Mr. TIERNEY. Let me, if I can, conclude by asking, has Health

and Human Services ever asked any of you for your opinion on

these two subjects?

Dr. GERBERDING. We have had many briefings on this subject,

and say that as the data have come forward, it has only been recently that we have had evaluation studies pulled together to really

ask the question. From a CDC standpoint, our total investment in

abstinence every year is about $2.2 million, and I actually wish 15

years ago we had made a much bigger investment because we

would know the answers to the questions that we are finally now

being able to surface. So we erred, perhaps, in retrospect, in not

going into this with an open mind and doing those kinds of programmatic, innovative evaluation programs in the first place.

Mr. TIERNEY. I would be comforted if the budget reflected the

error and changed around and moved some of that money to a

more effective place. But we’re going to have to fight for that one,

I think. Thank you.

Chairman WAXMAN. Mr. Shays.

Mr. SHAYS. Thank you.

A number of years ago, I chaired the committee that oversaw

HHS, and we had Donna Shalala come before us because HHS had

failed for a year to get the committee together that was to begin

to describe how we—and determine how we could protect the blood

supply. We had 25,000 hemophiliacs who died. And I never saw it

as my purpose to go after the Clinton administration, nor do I

think it is my purpose here to go after the Bush administration.

But I am really puzzled that this would in any way be a political

issue.

I would like to know from both our key witnesses have you found

in any way that the administration has been unresponsive in trying to deal with this AIDS epidemic?

Dr. GERBERDING. I would like to say that my intersection with

both Secretaries that I’ve worked for as individuals, as well as staff

from the White House that I have encountered on the issue of domestic and international AIDS, has come to me to ask for science,

they have come to me to ask for the data. I don’t personally feel

that I’ve come under any pressure to comply with a particular policy.

Mr. SHAYS. Have you found them unresponsive?

Dr. GERBERDING. No, I haven’t. That has not been my experience.

Mr. SHAYS. Dr. Fauci, have you found them unresponsive?

Dr. FAUCI. No, I have not. They’ve listened, several administrations, the current administration, the Clinton administration, and

the——

Mr. SHAYS. I mean, it seems like it’s the one area where politics

has kind of not been part of it, so I would hate to introduce it now.

What you have basically said to us is the upward adjustment

does not reflect an acceleration of the epidemic, but a more precise

capability to distinguish between recent and long-term infections.

So isn’t it clear that we have new information, and when there is

new information, we need to respond to it? Dr. Fauci.

Dr. FAUCI. Yes. As we get new information, we certainly do need

to respond to it, and that is the reason for the intensification.

72

Mr. SHAYS. Isn’t this new information that we are learning? I

mean, we are learning that with the epidemic hasn’t gone up, it is

just that our statistics were not as accurate as they could be, correct?

Dr. FAUCI. Yes. As Dr. Gerberding has mentioned, and I will obviously leave for her to comment on that, the new, more sophisticated and accurate counting measures indicate that the incidence

or number of new infections per year is higher than we had

thought it was. But it has been stable since the 1990’s, so it has

not gone up. It is just higher numbers because of better counting.

Dr. GERBERDING. The new information is based primarily on new

testing activities in the States as well as new tests. What it tells

us is that there is no room for complacency; 55,600——

Mr. SHAYS. Absolutely, there is no room for complacency. The

issue is that we have new information, and from this new information we can better act on it, correct?

Dr. GERBERDING. That is exactly why——

Mr. SHAYS. Now, do either of you appear before the——

Chairman WAXMAN. If you will forgive me. I know it is your 5

minutes, but it seems to me you haven’t let a witness complete a

sentence yet. And I know you only have a limited time, but I would

be glad to yield.

Mr. SHAYS. I am sorry, I just have a number of questions, but

I am delighted to have you continue.

Dr. GERBERDING. I think the important message here is that we

need to be able to have this kind of information at the community

level, because it tells us right where we need to go. This data tells

us nationally we need to go to men who have sex with men, African

Americans and Hispanic people, and do a lot more than we are

doing right now in those targeted populations. But in communities

there will be even more specific information that can tell us how

to use the resources we have to get the most benefit from it.

So you are absolutely right. This information has to—it tells me

that we need to reframe what we are doing. And I have asked Dr.

Fenton to bring in experts and really look at our portfolio as it exists in light of this new information, and say where are we and

where should we be.

Mr. SHAYS. And I congratulate both the chairman and ranking

member, because I know they worked together in having this hearing. This is a huge piece of information. It really isn’t political information, it is new knowledge, based on new science, and we need

to respond to it.

I would like to make sure, do you either, any of the four of you,

make presentations before the Congress on funding requests?

Dr. FAUCI. Yes. We defend the budget every year at our appropriations hearing in front of the House and the Senate.

Mr. SHAYS. And you are never required to say something that is

not true before those hearings, correct?

Dr. FAUCI. Correct.

Mr. SHAYS. So in other words, if a committee member asked you

a question about your funding needs, you would be very candid

with them; is that not correct?

Dr. FAUCI. Yes.

Mr. SHAYS. Is that correct?

73

Dr. GERBERDING. Yes.

Mr. SHAYS. So if someone on the committee said, is this enough

money to do your job, and you said—you didn’t think it was, you

would tell them, well, we think we need more; and if we had more,

we would put it to this use. Is that correct?

Dr. GERBERDING. Well, Mr. Shays, there is the reality as an

agency head, and I know Dr. Fauci feels this as an institute head,

we can always think of good ways to spend money to do more than

we are doing. But we also have to respond to the realities of the

budget proposals that are put in front of us. But when you ask me

for my professional judgment, I give you my very best answer, unconstrained by any other realities.

Mr. SHAYS. So any member on that committee who says, do you

need more money in these areas, and how you would use it, you

would let them know?

Dr. GERBERDING. I tell the truth.

Mr. SHAYS. Thank you.

Ms. MCCOLLUM. Mr. Chairman, if I may, as an appropriator on

that committee.

Mr. SHAYS. Sure.

Ms. MCCOLLUM. I think what Dr. Gerberding said was honest,

but I think it honestly needs to be said that she comes in and she

does her job as an utmost professional. She is very, very honest,

as everyone is from CDC, NIH. But they all defend—they all defend the President’s priorities and the President’s choices.

Mr. SHAYS. Right. And then you, as a member of the committee,

feel very inclined to ask very candid questions. And I know that,

based on the testimony, that they would give you a candid response

in return.

Ms. MCCOLLUM. And then if we do anything, it is called an earmark by the President.

Mr. SHAYS. So I will just conclude by saying, in the end this was

a budget agreed to by a Democratic Congress, suggested by a Republican President. It is a bipartisan budget. And in the end, we

have to work together to come up with the best conclusions.

Thank you very much.

Chairman WAXMAN. Without objection, the Chair would like to

recognize himself for an additional minute. Hearing no objection.

Dr. Fauci and Dr. Gerberding, as I understand it, when you come

before the Congress, you are defending the budget submitted by the

administration; isn’t that correct?

Dr. FAUCI. Correct.

Dr. GERBERDING. Correct.

Chairman WAXMAN. Now, unless you are asked what your professional judgment might be, you are there to represent the administration.

Dr. Gerberding, when I asked you questions earlier, you indicated that you thought that you should have had more money in

the prevention efforts going all the way back to the beginning of

your time. And I asked you about whether you heard from people

in the administration, the President, Secretary, and others, whether they asked you what you really needed. You said you had lots

of meetings held with superiors who discussed these needs.

74

I would like to ask you for the record to submit documents and

any other further information about the meetings you had to tell

them what you thought you needed to prevent the epidemic from

increasing in scope.

Dr. GERBERDING. I will do my best to resurrect that.

I must also say that HIV isn’t the only place that we have gone

to say we are concerned about.

Mr. SHAYS. Would the gentleman yield for a slight intervention?

Chairman WAXMAN. Certainly.

Mr. SHAYS. Thank you.

I just want to make sure for the record, was this new data available—and I don’t know what the answer is. But was this new data

that is available today available when the President and Congress

were presenting their—doing their last budget?

Dr. GERBERDING. The new data were published in August, at the

beginning of August of this year.

Mr. SHAYS. This year. So it was not available either to the President or to Congress?

Dr. GERBERDING. That’s correct.

Mr. SHAYS. Thank you.

Chairman WAXMAN. In your developing your CDC budget do you

start from scratch from what you believe is needed or do you receive a preset total from HHS or the Office of Management and

Budget into which you must fit your goals?

Dr. GERBERDING. I think, like every agency, we’re given some parameters. They vary from year to year. When I started, we were

given parameters for increases. Recently, we have been given parameters to have scenarios for a modest increase, a flat line or a

reduction. And we go forward with different versions of our request

based on what parameters are finally selected by the administration to present the final budget to Congress. I also present our request to the formal budget council in the Department, and that is

a factor that the Secretary weighs when he looks at all of the agency budgets in aggregate, because he has to finally bring the budget

forward.

Chairman WAXMAN. Now, when all is said and done, your budget

now for domestic HIV prevention is around 5 percent, and that’s

a drop in the percentage you’ve had in previous years, isn’t that

correct?

Dr. GERBERDING. I’m not sure of the 5 percent figure, but most

of our domestic HIV money is for prevention. But the amount of

money that our government is spending on prevention is still hovering at about 4 percent of the total.

Chairman WAXMAN. OK, thanks.

Ms. Speier.

Ms. SPEIER. Thank you, Mr. Chairman.

I had the opportunity recently to spend some time at Gilead

which is a company in my district. And I’m going to preface my

questions based on that fact, because they provided me with information that I thought was pretty astonishing. One is that, of the

50,000 new HIV individuals in America, the vast percentage of

them are African American women. Now that seems to be different

from what you provided today. But their concern to me was that

75

African American women are the highest increase in those contracting HIV. Is that not the case?

Dr. FENTON. No, that’s incorrect. The majority of new HIV infections are occurring among men, and the majority of those are

among men who have sex with men.

Ms. SPEIER. So the women, then, the African American women

are an increasing number?

Dr. FENTON. What you may have heard is that the largest proportion of women who are newly infected with HIV are African

American women. So they account for nearly a substantial proportion, more than half, or just about half of the new infections which

are occurring in women in the United States. And then you have

smaller proportions of infections occurring among Hispanics and

White women; that may have been the statistic they were referring

to.

Ms. SPEIER. What was most amazing to me was the regime now

for drugs has been reduced, at least with Gilead’s work, to 1 pill

a day, as opposed to 9 or 10 pills in which patients oftentimes will

not take one of the pills because it is upsetting physically to them.

And by being able to just take one pill, you’re getting greater compliance.

What they impressed upon me was the importance of testing, because as I think one of my colleagues earlier said, it is not a death

sentence anymore. In fact, being diagnosed with HIV means that

you can in fact have a full life, a full life expectancy. It is just being

tested early, being diagnosed early and getting the drugs and following the regime that is offered; is that not the case?

Dr. GERBERDING. That is the case. The one pill has many drugs

in it.

Ms. SPEIER. Correct.

Dr. GERBERDING. But they are able to combine them into a single

tablet.

Ms. SPEIER. So listening to them and listening to you it seems

to me that we need to do two things, one is augment the testing

that goes on in this country everywhere. Two, we require all other

countries to come up with National HIV AIDS plans if they are

participating in PEPFAR, but we don’t have a national plan; is that

true?

Dr. GERBERDING. We have a national strategy, and we are committed to updating it in light of the new incidence information that

we are receiving.

We also in, I think in December, Kevin, will be publishing a new

update on interventions that work that we can incorporate into the

national strategy.

Ms. SPEIER. So testing, what do we do to augment testing in this

country?

Dr. GERBERDING. There are some things we are doing right now.

One of the biggest advances is the rapid test, that allows people to

be tested in non-medical environments. We are really pushing hard

to make testing a routine part of medical care so that when you

come in, you get tested. I was so pleased to see this in action at

San Francisco General, it is night and day compared to even 5

years ago, but that’s not happening everywhere. It is particularly

not happening in VA hospitals and Federal facilities yet because

76

they have regulations that have to be changed in order for that to

happen. But we need to make testing universally accepted and acceptable in all kinds of nontraditional environments.

Ms. SPEIER. Would it make sense to make Medicaid funding contingent on participating in a program where testing is done uniformly?

Dr. GERBERDING. Well, I would like to see us work with CMS

around support for screening, because ultimately screening will be

cost effective for CMS and HRSA and the other federally funded

health programs, so I think that is an important lever that we

want to pull. And we are working on how to get those regs

changed.

Ms. SPEIER. Finally, in terms of microbicides, that was heralded

some years ago as being an outstanding opportunity for us to address the issue, particularly in places around the world, Africa in

particular. It appears in your testimony that I just read that there

has been some disappointing results in the clinical trials. Could

you expand on that please and tell us where you are going with

microbicides?

Dr. GERBERDING. The clinical trial so far with the available compounds have been disappointing. They have failed to prevent and

in some cases may have actually enhanced transmission because of

irritation in the mucosal tissues in contact with the microbicide,

but that doesn’t mean that we won’t find compounds that work.

And there are studies ongoing right now in animal models and

early clinical studies looking at both vaginal as well as rectal

microbicides. So this is a very important area for investment. It is

one of those new tools that I’m trying to make a plea for working

collaboratively with NIH, of course, as well as FDA.

Dr. FAUCI. Most of those studies, Ms. Speier, were done with

microbicides that don’t have a specific anti-HIV drug in it. The second generations are those that are now incorporating drugs that

specifically block the virus, so the issue that Dr. Gerberding mentioned is one we still haven’t overcome, is the propensity toward

vaginal irritation which can sometimes paradoxically make things

worse, but also there has not been potent anti-HIV drugs in the

compounds, which now the second and third generations ones that

we feel a little bit more optimistic about now are ones that do contain those compounds.

Ms. SPEIER. And my last question, Mr. Chairman, to both of you,

if you were being asked today how much money we should be

spending in the United States on HIV and AIDS, how much would

that budget be?

Dr. GERBERDING. We have submitted that for the record, our professional judgment without constraint. And as Kevin and I sat

down and walked through that budget, I think we recognize that

this isn’t just a CDC question, it has to include the NIH, it has to

include SAMHSA for mental health because we can’t solve this

problem without doing more for mental health and substance use.

And we need to addressthe correctional facilities, because a disproportionate part of the population at risk is in correctional environments. So we only have a piece, and we probably need to sit

down together as a collaboration and really think through a true

77

national strategy, and that’s what we are proposing to do as these

new data become available.

Ms. SPEIER. Give us a number nonetheless.

Dr. FAUCI. I can give you an NIH number. Our budget, as you

know, has been essentially flat for the last 4 or 5 years. So we have

$29-plus billion in research that we’ve—that we spend, which is a

substantial amount of money. The difficulty is if you have no increases for several years in a row, you’re really looking at a 3.2

percent decrease per year in actual real money in the sense of inflationary index. So you are looking at a minus 12, 13 or plus percent decrease over a period of 5 years. So when people ask us, in

our professional judgment, which I will give you now, that if you’re

looking at what we could use and spend quite well, the NIH budget

is $2.9 billion for AIDS on a budget that’s $29 billion for all of NIH,

so it is a little more than 10 percent. With a $2.9 billion budget

for the NIH for AIDS, we could spend about $3.35 billion.

Chairman WAXMAN. Thank you, Ms. Speier, your time has expired.

Ms. McCollum.

Ms. MCCOLLUM. Thank you, Mr. Chair.

People are dying every day in this country because of AIDS, and

the numbers continue to increase despite the fact that AIDS prevention works. And I know this all too well, because I recently lost

a friend from AIDS. It was a story that could go with maybe not

being tested quick enough. It is a story that you could talk about

fear and discrimination, but it also includes the Federal Government and the State of Minnesota not doing what it could do to support people who are on anti-retro viral treatment and the stress

that these individuals go through when their treatment is threatened or cutoff and then they find themselves scrambling for treatment.

We’re here today because we need to get our energy back into the

need for HIV prevention and education efforts, and I appreciate

sincerely the testimony of the panel. We know that there are populations now that are more at risk than other populations. We’re

here today because the CDC’s report found out this that there were

60, excuse me, 56,000 new HIV infections last year focused in racial and ethnic minorities; that’s 70 percent of new cases. This is

also true of Minnesota, and I wish Mr. Shays was still here. Maybe

he’ll come back.

Minnesota has recorded the highest number of HIV cases seen in

the last 10 years in 2007. With 325 new cases, gay, bisexual men

are the highest group impacted with 77 percent of all cases. Minnesota also is facing higher increases among young men and among

Latina women. We know that the HIV rate in African American

men and in the immigrant population is 20 times higher than the

statewide average.

Mr. Chair, I would—I’ll submit some issues for the record, but

one thing that was brought up in a question was, well, this is new

because we’re testing better. Well Minnesota’s been testing since

1985, so it is going up in Minnesota. I’m—I—I want to ask you,

again, do you think the only reason why you’re seeing rates increase in the populations that I have mentioned and across this

78

country, the only reason is because testing is more effective, knowing that States submit records to you on a regular basis?

Dr. GERBERDING. I regret if I implied that we thought the reason

for the number that this was related to testing. This number is a

new number because we have a new diagnostic test that allows us

to tell when somebody was infected, so we can distinguish very old

infections from recent infections, so that’s the test element of the

number. But the number that we are reporting today and the back

calculations that we did using the new methodology of extrapolation over time allows us to recognize that we’ve been misunderstanding the true incidence for a long period of time. In part it is

complicated and I would be happy to sit down an walk through

some of the science of it. But is not that we are doing more testing,

and you’re right Minnesota was one of the first to have HIV reporting and the first to take an aggressive perspective on that. But,

nevertheless, even in Minnesota, there are undiagnosed people and

there is ongoing transmission.

Ms. MCCOLLUM. Thank you.

One of the people who took it to the street, took it to public officials was a wonderful person, our State epidemiologist, Dr. Michael

Osterholm, who made sure that we kept track of records. And some

people called him an alarmist for going out and talking about it at

the time. I think the alarm needs to go off again, and so I thank

you again for your report.

Mr. Chairman, the Minnesota Department of Health Federal

CDC HIV prevention grant has been reduced by 8 percent in the

past 5 years. Federal CDC STD prevention grants, which is also a

precursor that’s been used, has been reduced 4 percent since 2003.

That’s despite the number of STD cases has risen 14 percent since

2003.

Mr. Chair, I’m going to submit some information into the record

from the State of Minnesota and the profile of HIV epidemic. I will

be around if there’s an opportunity for more questions. I originally

wasn’t going to spend my time so much talking about Minnesota,

but I wanted to, for the public, clear up any misunderstanding that

might have been what these statistics are really indicating to us,

and that’s to wake up and to start getting correct information, and

to let today’s youth know that treatment is not a cure; it is not a

cure.

Thank you, Mr. Chair.

Chairman WAXMAN. Thank you very much, Ms. McCollum.

We will be, without objection, we will be pleased to receive the

information for the record that you would like to submit.

[The information referred to follows:]

79

80

Chairman WAXMAN. Ms. Watson.

Ms. WATSON. Thank you, Mr. Chairman.

I just want to clarify something that was said, and I’ll direct this

toward you, Dr. Fenton, as I understood, HIV is spreading more

quickly among African American women than any other group. Is

that correct or not correct?

Dr. FENTON. HIV infection is spreading at the greatest rate

among gay and bisexual men. In fact the data shows that they are

the only group where we have seen consistent and sustained increases in HIV incidence since the early 1990’s.

Ms. WATSON. Then, let me go back, because after the virus was

spread—I mean, identified around 1980, 1981, it was believed to be

among White males having sex with males. It seemed that there

was attention given to that segment of society, and things improved, and that’s where the funding was going. Maybe 10 years

later, there was data showing that it was moving quicker among

African American women, coming from partners who injected themselves.

As I understand that, there is a disproportionate toll on African

Americans, males, females at this time, and they account for 12

percent of the population but 45 percent of the new infections in

the year 2006. Is that true?

Dr. FENTON. That’s true.

Ms. WATSON. OK, I might have missed this part of your testimony, so let me just refer back to it. But can you tell us more

about what CDC is doing in terms of the Heightened National Response to address HIV and AIDS in the African American community?

Dr. FENTON. Thank you. I would be delighted to tell you about

that. The Heightened National Response is an initiative which was

started in 2006, and it brings together CDC, our Federal partners

and our partners and leaders in the African American community

to focus on the epidemic among African Americans and to accelerate our prevention efforts.

And the Heightened National Response is built on four key pillars. The first is to expand HIV testing within the African American community. The second is to expand the reach of our prevention services; in other words, to scale up effective prevention interventions with African Americans so we know it will have an impact

on the epidemic. The third is to mobilize the African American

community. And we have been really working with a range of

amazing African American leaders to focus and to bring the conversation back to HIV and the importance of community leadership

on HIV/AIDS. And the fourth pillar is on research, to ensure that

we are investing in research for and by African Americans, so that

we’re looking at culturally competent prevention interventions

moving forward.

Ms. WATSON. Now, the main points that you are describing to us,

did you get new funding to be able to implement?

Dr. FENTON. No, this is a great example of what Dr. Gerberding

said of looking at our existing prevention portfolio and having to

make tough decisions to realign our existing prevention dollars into

what we believe are urgent threats or urgent realities and to deal

81

with the matters at hand. And so this is part of the activities that

we have to do in the current environment.

Ms. WATSON. Well, going back and looking at the history because

I chaired the health and human services in the California Senate

for 17 years. I was there when we identified the virus, and I was

there when money flowed in to address White males having sex

with White males. I was there, too, when we discovered that it was

moving among the African American female community. And I

never saw the funding keep pace with the spread. So I will expect,

in trying to reach your goals to reduce the rate of infection, that

you have not been able to reach those goals of reducing the rate

of infection among that population.

Dr. FENTON. Well, actually, we do know that the transmission

rate of HIV has been declining in the United States. There are

more people living with HIV, but——

Ms. WATSON. But what about African Americans? I really want

to see zero in, because this was a great concern. I carried the needle exchange program for years. I was called on the carpet by, particularly, the ministerial community. I had to go to San Francisco

and sit in the hot seat. And it was very, very difficult to have an

understanding that if we do a needle exchange, at least we take a

dirty needle out. And at that time, as Dr. Gerberding has said, that

we’re able then to give information about treatment and at the

point of exchange. And that program only was adopted after Willie

Brown took over, and I was gone at that point.

But I’m still concerned as to what is happening in that community. And I’m still concerned about resources. And I would like to

know the status of mobilizing the community—I know we are

working through a lot of our churches now. Could you just add to

that, please?

Dr. FENTON. Sure. It has been an amazing couple of years in

which we’ve brought leaders from all walks of life into the African

American community to dialog with us and to plan with us. Leaders from the African American faith communities, from the academic sector, from the business sector, from grassroots organizations who have come to Atlanta to talk about their activities and

their plans and look at ways is in which CDC can accelerate efforts

toward prevention. This has been a new way for us to work as an

agency. It is an important way for us to work as an agency moving

forward.

Ms. WATSON. If I might take just another minute, Mr. Chairman.

Chairman WAXMAN. Without objection, the gentlelady is yielded

another minute.

Ms. WATSON. In the African American community, our churches

are the place where people come together. And that is a route that

I think should be more focused on. And if we had the necessary

budget items, and this is something I have in mind, to impact those

who are appropriators, we really need to—and I understand also

that HIV/AIDS is spreading among Hispanic Americans now,

where it wasn’t as heightened as, 10 years ago, as it appears to be

now. So I think that we need a special program expanded to deal

particularly in the African American community with our churches

and other community programs.

With that, I will say thank you, Mr. Chairman.

82

And thank you, Dr. Fenton.

Chairman WAXMAN. Thank you, Ms. Watson.

Mr. Sarbanes.

Mr. SARBANES. Thank you, Mr. Chairman.

Thanks to the panel.

I would imagine that just about any condition can be treated or

involves sort of two prongs at least in your strategy combat it. One

is sort of behavioral modification. The other is treatment. So—but,

obviously, there are certain kinds of conditions, diseases and so

forth where that interplay is more relevant and elastic.

And—so I had a couple of questions. Is there any evidence, or

can you describe how progress on the treatment front may have

contributed to some backsliding on sort of the behavioral practice

or modifying behaviors up front? And if that has happened, you

know, how do you address that? What are the strategies for—to

maintain the intensity and focus on both strands without having

them sort of contribute to going in the opposite direction with the

other? And along those lines, and this is my only question, so then

I ask you all to just jump in, are there conditions or diseases that

have been good reference points for you to look at where the analogy is strong enough, in terms of what we are dealing with HIV

and AIDS, of what’s happened in terms of how we’ve managed

those is instructive in terms of the strategies that we’re trying to

employ with respect to HIV and AIDS?

Dr. GERBERDING. I’ll start. I think that the risk period for people,

all other things being considered, for the highest chance of transmitting to others is very early after infection and then again very

late in infection when the viral load is very high. But you can

transmit at any time. So if treatment is successful in suppressing

viral load, it stands to reason that people would be less infectious

to others during that period of time. They also tend to change their

behavior when they know they are infected and protect other people as a consequence of their disease.

But we are experiencing anecdotal and I think more systematically a cohort of people who have falsely been reassured that their

lives are going to be unaffected by this treatment, and so there is

some complacency and some recidivism and increase in risk behavior. And we see that by indicators such as the incidence of rectal

syphilis going up in some populations where there has been an increase in unsafe sexual practices, so that is a phenomenon.

There is—it is very difficult to find a good analogy to HIV in the

context that you’re asking the question. To some extent, TB is like

that. You have to treat it for a long time, and people become less

infectious when they are in treatment. They can be falsely reassured by the therapy early on and be less conscientious about infecting the people in their households, but AIDS is a pretty unique

infectious disease, a chronic infectious disease for which we have

a chronic infectious disease treatment. And so we’re kind of learning as we go with this one.

Dr. FAUCI. Just to underscore what you said about the perceptions. The perception of something not being as bad as we decades

ago thought it was, if you look at the environment that we’re in,

we used to have hospices and 20 to 40 percent of the hospital beds

83

in some cities were occupied by people with HIV infection. It is

mostly an outpatient disease right now.

The public perceptions that put on the face of someone with HIV,

if you look at some of the advertisements for some of the drugs, you

open up medical journals and you page through the first 10 pages

and they have these extraordinarily healthy looking people rock

climbing saying, I’m doing very well on my Atripla or on my, whatever drug combination they are on, and it really creates a false impression that we’ve been trying to underscore here, and Dr.

Gerberding mentioned it actually formally in her presentation, is

the issue that it is a bad thing to get HIV infected. Even though

with all the very, very effective drugs we have, it is not a good

thing. It’s difficult to take the medications. It is a lifelong disease.

If you stop, we have shown as others have, that the virus bounces

right back, and at this point, we have not been able to cure it.

Mr. SARBANES. Would you attribute any of the increase that has

been talked about here today to this sort of misperception, or is it—

I’m sure it is hard to draw a straight line.

Dr. FAUCI. No, I think there is no question in our mind that

when people practice risk behavior, if you question them and talk

about it with them, a significant amount, I can’t give you a number, is due to the feeling that it isn’t as bad as it was back in the

early 1980’s. Of course, there was an incredible amount of fear. If

you were in New York City or San Francisco or Los Angeles or

some of the other cities, the fear among the community, particularly among the gay community, was palpable. There is much less

of that now because of the perception that we can treat it very well.

Chairman WAXMAN. Thank you, Mr. Sarbanes.

Without objection, Representative Maxine Waters, who is not a

member of our committee, will be allowed to sit with us and enter

a statement in the record and to ask questions. Without objection,

that will be the order.

Ms. WATERS. Thank you so much, Mr. Chairman. I am just so

pleased that you are holding this hearing and I would like to thank

you and Ranking Member Tom Davis for this hearing today.

I’d just like to give a little bit of background and ask a few questions.

Many people in the Black community have long suspected that

the epidemic was worse than our Nation’s leaders thought it was,

even before the CDC’s new estimates were released. We knew that

African Americans accounted for about half of all of the new AIDS

cases, and we knew that HIV/AIDS was having a profound impact

on African Americans.

In 1998, we sounded the alarm in the halls of Congress on April

24, 1998, while I was the Chair of the Congressional Black Caucus,

the CBC held a brain trust which was sponsored by Congressman

Louis Stokes. During that brain trust, those same members were

shocked by the presentation of Bennie Primm, the executive director of the Addiction, Research and Treatment Corp. Dr. Primm’s

presentation described the state of HIV/AIDS crisis in minority

communities, particularly the Black community.

On May 11, 1998, the CBC held a meeting that brought together

many public health workers, AIDS activists and representatives

from all over the country to tell us about the impact of the HIV/

84

AIDS in minority communities. That same day, the CBC called for

President Bill Clinton to declare a public health emergency to combat the crisis in minority communities.

In the fall of 1998, Lou Stokes, Donna Christensen and I met

with Donna Shalala, the Secretary of Health and Human Services,

to discuss the crisis. We agreed that what we really needed was not

a declaration of a public health emergency but rather money for

programs to address the crisis.

On October 28, 1998, the CBC held an event to roll out the Minority Aids Initiative. The event featured the participation of President Clinton, Secretary Shalala and representatives of HIV/AIDS

organizations from around the country.

At the 1998 roll out, we announced that the Minority Aids Initiative would receive an initial appropriation of $156 million in fiscal

year 1999. The minority AIDS initiative grew significantly over the

next 5 years, but since then, funding has remained stagnant at

about $400 million per year since fiscal year 2003, and at some

points, it dropped below the $400 million.

Having said that, African Americans again have been seriously

and disproportionately affected by HIV/AIDS. There are more than

one half million African Americans living with HIV/AIDS today. African Americans account of about half of all the new AIDS cases,

although only 12 percent of the population is Black. African American women represent somewhere between 66 and 75 percent of all

the new AIDS cases among women. And African American teenagers represent 69 percent of all the new AIDS cases among teenagers. I could go on and on with this.

Are you shocked about this crisis? Are you bothered about this

crisis?

Let me start with Dr. Julie Gerberding. Does this information

shock you?

Dr. GERBERDING. I, as I said before you were here, I believe this

is an urgent situation. Am I shocked by it? I’m certainly not happy

about it.

Ms. WATERS. Do you think it’s a crisis?

Dr. GERBERDING. I think it is a crisis.

Ms. WATERS. Mr. Fenton, are you shocked? Do you think this is

a crisis?

Dr. FENTON. I’m saddened, and CBC has portrayed this as an severe and ongoing crisis among the community.

Ms. WATERS. Do you do think it is a crisis?

Dr. FENTON. I do.

Ms. WATERS. Dr. Anthony Fauci, do you think it is a crisis?

Dr. FAUCI. Yes, I do, Ms. Waters.

Ms. WATERS. OK, given we all believe this is a crisis and these

statistics and this information is shocking, what do you recommend?

Dr. GERBERDING. I would be happy to share the professional

judgment budget that we have presented to this committee with

you, which I think reflects three major focal areas. One is to know

not just who got it then or who is getting it now, but who is going

to do get it if we don’t act and invest in the systems that tell us

what to do about that. Second is to get everybody diagnosed who’s

85

had it, so they can benefit from treatment. And the third is to put

a significant effort into new research——

Ms. WATERS. How long have you been at CDC?

Dr. GERBERDING. Six years.

Ms. WATERS. Six years? You heard my background on how I created the Minority Aids Initiative. I created that because we needed

to focus on building capacity and getting communities that had little or no resources involved in RFP processes. We’ve been working

very hard, and I come here, and I hear you, Mr. Fenton, talk about

all this great work you’re doing with minority leaders and minority

communities. I don’t know about it. I’ve been involved in this issue

for a long time, having created this and watching the incidence of

HIV/AIDS grow in African American communities across the country.

And I want to know, because I don’t get a sense that you really

feel this is a crisis. And when you tell me that, well, I submitted

a budget, take a look at the budget, how have you sounded the

alarm? What have you done to deal with this growing crisis? Do

you see what I just said about African American teenagers from 13

to 19-years old representing 69 percent of all the new AIDS cases

among teenagers? Doesn’t that bother you?

Dr. GERBERDING. Mrs. Waters, we will be briefing the Black Caucus this afternoon, but if you would be able to participate in our

enhanced initiative, we would love to have your voice because we

need to get leaders involved in helping us——

Ms. WATERS. No, no, no, no, no.

Dr. GERBERDING. We need your help.

Ms. WATERS. No.

Excuse me, Mr. Chairman.

I am involved and I have been involved. And the Black Caucus

has been screaming to the top of its voice for help. We just got one

portion of this reauthorized with Ryan White. The other portions

of the funding that we struggle with are not even official in the

budget. What are you going to do about just getting CDC portion

authorized? It is spread out among several of these agencies, including CDC and NIH and SAMSA. And I don’t see any leadership

from—I don’t see any leadership from you.

Now, I know that you think I’m being a little bit harsh, and I

am. I happen to be an African American woman. I don’t want gays

and lesbian and African American men and women fighting about

who is worse off. We are all worse off. And I don’t like it when I

go out into the communities and I see all of these little groups

struggling and fighting, and the way you deal with the discretionary money. We need some leadership.

And I’m so pleased that I am able to be here today, Mr. Waxman,

and I thank you for indulging me in my frustration.

Chairman WAXMAN. Thank you very much.

The gentlelady’s time has expired.

Dr. Fenton and Dr. Gerberding, one—once CDC identifies effective programs, the next step is to disseminate them to the States.

How does CDC identify effective programs?

Dr. GERBERDING. I would like to ask Dr. Fenton to take on this

in detail, but just to tell you that there is a two-step process. One

is to review the evidence of efficacy by expert scientists who are in

86

a position to make those judgments, and we respect that, and to

get that up in the compendium, which will be updated again. But

in addition, there is a process of diffusion where we work with an

organization that trains and helps disseminate people. Right now,

there is a bottleneck in the training, so that’s one of the issues we

addressed in our professional judgment budget.

Chairman WAXMAN. So you have a research time that applies a

methodological review of studies of existing programs. They identify the ones that are found to work. You put it up on the compendium. Isn’t that right?

Dr. GERBERDING. Yes. And we expect the grantees who receive

our dollars when they are developing programs to use those programs that are proven to be effective. But in order for them to successfully implement them, they often need training and support,

and that’s one of the areas that we are not able to keep up with

right now.

Chairman WAXMAN. When the compendium was first released in

1999, CDC said it would update it annually as effective new programs were identified, and CDC’s experts did identify a number of

additional programs that work, but as I understand it, you said

there is a bottleneck. CDC did not issue annual updates to the

compendium; is that right?

Dr. GERBERDING. I can’t go back to 1999, but we have done two

updates since I have been the director of the CDC. It is a little

hard to do it annually because the data from these programs

doesn’t come forward that fast, but I think we are accelerating our

ability to do that.

Chairman WAXMAN. When did CDC last issue an update on the

compendium?

Dr. GERBERDING. 2007.

Chairman WAXMAN. Did CDC attempt to get HHS approval to release an updated compendium prior to that time?

Dr. GERBERDING. I believe we did.

Chairman WAXMAN. And what was the response from HHS?

Dr. GERBERDING. I would have to ask Kevin, who wasn’t the director at the time, to go into the details of this, because I don’t

know all the steps involved. We can provide that paper trail for

you. But to suffice to say that it was not a speedy process.

Chairman WAXMAN. OK. Well, I’d like the answer to that question for the record. I’d also like to know why didn’t HHS approve

any updates of the compendium until 2007?

Dr. GERBERDING. I can’t answer that.

Chairman WAXMAN. OK.

Dr. GERBERDING. But I can say, in the recent years, we’ve had

I think a much more accelerated process, and I’m satisfied that we

are able do it in a timely way now. I hope we will have the update

for 2008 before the end of this calendar year.

Chairman WAXMAN. Well, it took 8 years to update the list with

crucial information about programs that have been shown to save

lives. And I’m concerned that instead of encouraging effective HIV

prevention, HHS seems to have been standing in the way. In fact,

the committee asked CDC for a list of dates for which the compendium and other important HIV prevention documents were submitted to HHS for clearance and when they were actually released.

87

And my understanding is that the committee hasn’t gotten a response because CDC’s response is still in clearance at HHS.

Does CDC provide training or technical assistance for implementing the programs it identifies?

Dr. GERBERDING. Yes, we do.

Chairman WAXMAN. And how many organizations are currently

on the waiting list?

Dr. GERBERDING. About 2,000.

Chairman WAXMAN. So 2,000 organizations out there want to

provide identified effective HIV prevention programs, but they are

still on a waiting list. I think that’s unconscionable given the statistics we’ve been hearing about today, and I think we need to address it.

Dr. Gerberding, just a clarification of your testimony, you suggested earlier that one of the reasons that you lowered your prevention goals is that there are more people with HIV living because

of treatment, but the data for 2000 estimated 945,000 people living

with HIV, and for the data for the most recent year, we find

around a million people. This is about a 5 percent. Does a 5 percent

increase in people living with HIV produce an 80 percent decrease

in your goal and a 20 percent decrease in funding for prevention?

Dr. GERBERDING. I’m not going to be able to do that math in my

head, but I think what you’re getting to is, you know, what is the

full picture of the recalibration? And, again, I was on the advisory

committee when we were struggling to develop that first 50 percent

reduction. We recognized at that time that there was a bell shaped

survival curve for HIV, so the projections were that we would see

an excalation in death rates, and that was factored into the projection of the transmission. So it was a—I don’t want to say it would

be easier to prevent if there were fewer people living because that

isn’t our public health goal, but the calculus was different then.

And that’s not the only reason, as I already said, but that is one

of the factors——

Chairman WAXMAN. Well, I asked that question——

Dr. GERBERDING [continuing]. Different as opposed to now.

Chairman WAXMAN. Because I was troubled by the answer you

had given earlier so I just wanted to pursue that point. And I

thank you for responding.

This panel has been very helpful. I think it is unfair to criticize

the four of you for what you are trying to do. I think you’re trying

to do the best you can, and you’re trying to do as much as you can

without sufficient funds and without the barriers to your efforts

being removed. And the purpose of having you here is not to criticize you but to try to be constructive in working with you to be

sure that you have the ability to do the job, because we are all very

concerned and frustrated that there are so many people whose lives

are at risk and will be lost unless we in government do what’s

needed. And if it is not coming from the U.S. Government, it is not

going to happen at all. I thank each of you for your testimony

today.

I want to now call forward the witnesses for our second panel,

Dr. David Holtgrave. We will wait a minute and have the second

panel come forward.

88

We’re pleased that you are here today, and I want to introduce

those of you on the second panel.

Dr. David Holtgrave is founding Chair and professor at the Department of Health, Behavior and Society at the Johns Hopkins

Bloomberg School of Public Health. He has served as director of behavioral and social sciences at the Emory Center for AIDS Research and as director of intervention research at CDC’s Division

of HIV/AIDS Prevention. Dr. Holtgrave has focused on the efficacy,

effectiveness and economic evaluation of a variety of HIV prevention interventions, contributing to over 175 professional publication.

Dr. Ada Adimora is associate professor of medicine at the University of North Carolina School of Medicine and adjunct associate

professor of epidemiology at the School of Public Health. She has

been the principal investigator on multiple CDC and NIH funded

research projects and has published extensively on the epidemiology of HIV in America, with a focus on African Americans. Dr.

Adimora a practicing clinician and a fellow of the American College

of Physicians.

Dr. George Ayala works as a research psychologist and public

health analyst at RTI International’s Urban Health Program in

San Francisco, CA; and is also the executive officer of the Global

Forum on Men Who Have Sex with Men and HIV. He is the former

director of health promotion, community research, and capacity

building at AIDS Project LA where he managed HIV prevention

technical assistance and research. A clinical psychologist by training, Dr. Ayala’s research focuses on the mechanisms through which

social discrimination impacts health.

Heather Hauck is the director of Maryland Department of Health

and Mental Hygiene AIDS Administration, leading statewide public

health efforts to reduce HIV transmission in Maryland and to help

Marylanders with HIV/AIDS live longer, healthier lives. Ms. Hauck

is currently Chair-elect of the National Alliance of State and Territorial AIDS Directors. She has served as the section chief of the

STD/HIV section for New Hampshire and as a consultant on HIV

program issues for hospitals, national associations and State public

health agencies.

Frank J. Oldham, Jr., is the executive director for the National

Association of People with AIDS. He has spent over two decades as

a leader in HIV policy, administering HIV programs for the cities

of New York and Chicago, and working in numerous AIDS service

organizations. Mr. Oldham has served and is currently serving on

several planning and other policy bodies, including the New York

City Commission on AIDS; the National Minority AIDS Council;

CDC’s 5-year strategic planning committee; and Lambda Lesbian

and Gay Community services.

We are pleased to have you here today. I want to inform you

that, in this committee’s practice, all witnesses who appear before

us do so under oath, so we’d like to administer and oath to you if

you would please stand and raise your right hands.

[Witnesses sworn.]

Chairman WAXMAN. The record will indicate that each of the witnesses answered in the affirmative.

Your prepared statements will be in the record in full.

89

We’d like to ask, however, that you limit the oral presentation

to 5 minutes. And we will have a clock that will tell you, for 4 minutes, it is green; and the last minute, it will turn orange; and when

the time is up, it will turn red.

Dr. Holtgrave, let’s start with you. There is a button on the base

of the mic. Be sure it is pressed so we can hear you.

STATEMENTS OF DAVID HOLTGRAVE, PH.D., PROFESSOR AND

CHAIR, DEPARTMENT OF HEALTH, BEHAVIOR AND SOCIETY,

JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH;

ADAORA A. ADIMORA, M.D., DIVISION OF INFECTIOUS DISEASES, UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE; GEORGE AYALA, PSY.D., RESEARCH HEALTH ANALYST, RTI INTERNATIONAL AND AIDS PROJECT LOS ANGELES; HEATHER HAUCK, DIRECTOR, AIDS ADMINISTRATION,

MARYLAND DEPARTMENT OF HEALTH AND MENTAL HYGIENE; AND FRANK OLDHAM, JR., PRESIDENT, NATIONAL

ASSOCIATION OF PEOPLE WITH AIDS

STATEMENT OF DAVID R. HOLTGRAVE, PH.D.

Mr. HOLTGRAVE. Chairman Waxman, Representative Davis and

distinguished members of the committee, thank you for the opportunity to speak with you.

Today’s hearing is truly urgent. CDC’s HIV incidence estimate

suggests that there is a new infection every 91⁄2 minutes in the Nation. There is an AIDS-related death every 33 minutes. The ratio

in ethnic health disparities are staggering. And the lifetime HIV

care and treatment costs for one person can easily top $275,000.

Because of the new incidence estimates, one might ask two key

questions: Are HIV prevention programs effective, and are they delivered at a sufficient scale in the United States? My answer will

be yes to the first question and no to the second. To assess prevention effectiveness at the National level, we must examine HIV

transmission rates. Obviously, HIV is spread from a person living

with the virus to someone who is HIV negative. The transmission

rate is the number of new HIV infections in a year divided by the

number of people living with HIV in that year. As seen in this first

slide the HIV transmission rate dropped from over 92 in 1980 to

6.6 in 1991.

On the second slide, we see that the transmission rate stayed at

roughly this level until 1997 when, after the advent of new therapies, the transmission rate actually went up temporarily to 7.5.

Thereafter it declined once again.

In 2006, the transmission rate appears to be just under 5. This

means over 95 percent of persons living with HIV in the United

States are not transmitting the virus to someone else in a given

year.

Another key measure of prevention success is the difference between what we observed in the HIV epidemic and what would have

occurred had prevention programs not been in place in slide three.

From the beginning of the epidemic through 2006, I estimate very

conservatively that roughly 362,000 infections were prevented in

the Nation and over 3.3 million quality adjusted life years were

saved.

90

There is a clear relationship between HIV prevention program

funding and incidence, as seen in the fourth slide. The bottom line

is that, in terms of HIV prevention investment, the Nation gets

what it pays for. One must be concerned, therefore, that when adjusted for inflation, CDC’s HIV prevention budget has fallen over

19 percent since fiscal year 2002, and in real dollar terms, the investment in the Minority AIDS Initiative is also in decline.

Further, CDC’s data shows that a small fraction of gay men in

need of HIV prevention services report receiving them. Clearly our

investment in prevention is lacking. We must therefore scale up

the use of evidence-based HIV prevention tools already at our disposal even as we hope for new intervention, such as a vaccine. As

seen in slide five, some currently available evidence-based HIV prevention interventions are readily available to us. What’s most important to emphasize is that we possess the technology to influence

HIV-related risk behaviors, and an extensive scientific literature

leaves very little doubt on that point.

So what is the right level of investment? I estimate that CDC’s HIV prevention budget, now at $0.75 billion, needs to increase to

about $1.32 billion per year and remain, on average, at that level

for about 4 years at least so as to undo the damage done since fiscal year 2002 and to address HIV prevention needs in the United

States.

What new services could be delivered at this higher level of investment? On the sixth and final slide, I list some of these. I believe it would provide sufficient resources to field the new very

large-scale targeted HIV counseling and testing campaign; a nationwide public information and anti-stigma campaign; intensive

client-centered, evidence-based prevention services for the minority

of persons living with HIV who engage in any risk behavior that

could result in transmission; in brief, the science-based intervention for 15 million HIV negative persons at risk of infection.

What public health impact would this achieve? After 4 years of

heightened service delivery, the United States could reduce HIV

transmission rates by 50 percent and HIV incidence by 50 percent.

Further, we could achieve and maintain a 90 percent level of

serostatus awareness of persons living with HIV. This is a great

fiscal investment. The cost per infection averted via this new

heightened response would be roughly $27,000, and that indicates

the prevention programs could easily save more medical resources

than cost to implement.

But accountability is key. The proposed intensification of these

programs must be accompanied by a quick but careful review of

current HIV prevention resources across the Federal Government,

and we need a national AIDS plan. Further, the performance of all

HIV prevention resources should be summarized in an annual report card so that mid-course corrections can be made.

In conclusion, we are at a historic crossroads in the HIV Epidemic in the United States. Doing more of the same will achieve

more of the same. And as asserted by a recent report of Black

AIDS Institute, the United States is indeed being ‘‘left behind.’’ But

we can find the national will to scale up evidence-based HIV prevention programs sufficiently to change the course of the epidemic

in the United States once and for all.

91

Thank you, again, sincerely for your strong interest in HIV prevention.

[The prepared statement of Mr. Holtgrave follows:]

92

93

94

95

96

97

98

99

100

101

102

103

104

105

106

107

108

109

110

111

Chairman WAXMAN. Thank you very much, Dr. Holtgrave.

Dr. Adimora.

STATEMENT OF ADAORA A ADIMORA, M.D.

Dr. ADIMORA. Thank you for this opportunity to speak with you.

I have been asked to testify concerning HIV epidemiology in the

United States, particularly with respect to African Americans, and

structural and social forces that affect individual and community

vulnerability HIV.

These are some of the essential concepts. First, individual level

sexual behavior, such as partner number and condom use, don’t

completely explain racial disparities in the U.S. HIV rates. Second,

sexual network patterns are critical in the spread of HIV throughout the population.

A sexual network is a set of people who are linked directly or indirectly through sexual contact. The distribution of network characteristics that promote population HIV spread, like concurrent partnerships and sexual mixing patterns, appears to differ by race in

ways that increase HIV transmission among African Americans.

Third, social forces and social contacts that is social macroeconomic and other features that are outside the individual’s control contribute to sexual network patterns that spread HIV. So

some potential pathways between HIV and several social forces are

relatively clear. For example, residential segregation by race supported by structural mechanisms, like mortgage lending practices,

concentrates poverty in the segregated group.

Segregation may especially influence young people’s HIV risk

since residence often dictates school districts which influence adolescents’ social and sexual networks. Also the sex ratio, the ratio

of men to women, is a key determinant of the structure of the networks. The sex ratio among African Americans is strikingly low

due to high mortality among Black men and is further decreased

by high incarceration rates.

The relative scarcity of men contributes to low marriage and

higher divorce rates. There is a strong association between being

unmarried and having concurrent partnerships. Poverty, another

force, works with the low sex ratio to help destabilize marriage and

makes marriage less feasible in many Black communities.

The disproportionate incarceration of Black men dramatically affects sexual networks in Black communities. Incarceration disrupts

existing partnerships, making it more likely that each partner will

have concurrent partnerships. While inmates are in prison, they

can join gangs and forge new long-term links with antisocial networks. These new links can then connect members of high-risk sub

groups to previously low-risk people and their networks. High incarceration rates contribute to increased unemployment in poor minority communities, shrinking the number of financially viable

male partners as well as the absolute number of men.

Rod Wallace showed how macro level forces shape social contacts

and AIDS death rates in a New York City borough. In the 1970’s,

New York’s fiscal crisis prompted city agencies to embark on a deliberate policy of planned shrinkage of the populations in Black and

Hispanic neighborhoods. The plan involved withdrawing critical

city services, including fire fighting services, from poor areas that

112

already had high fire rates. So neighborhoods burned. Many people

moved to other parts of the borough, and social networks and community structure were disrupted. What was presumably not anticipated when these policies were implemented were the changes in

the geography of drug abuse that resulted from this migration and

the resulting upsurge years later in HIV.

So, finally, the pathways between social forces and HIV suggest

that continuing to focus prevention efforts solely on individual risk

factors and individual determinants won’t significantly impact HIV

rates among Blacks in the United States. Certainly the search for

and implementation of effective biological and behavioral interventions must continue and must certainly be funded. However, public

health research must also take into account the social forces that

are driving the extraordinary racial disparity in HIV rates in this

country.

I believe several steps, among others, should be taken immediately. First, the HIV epidemic among African Americans should

be formally declared a national emergency, and moreover, the

United States should act as if the epidemic is a true national emergency by developing and appropriately funding an effective domestic HIV plan that addresses not only biological and behavioral

interventions but also the epidemic’s social and economic roots.

This will require involving clinicians and public health researchers

as well as experts in sociology, economics, political science, criminal

justice and other disciplines.

Second, incarceration affects the health of Black communities.

Attention should be given to the markedly disproportionate incarceration of Black men.

Third, comprehensive sex education can be effective in reducing

risky sexual behavior and should be given in schools.

Thank you very much.

[The prepared statement of Dr. Adimora follows:]

113

114

115

116

117

118

119

120

121

122

123

124

125

126

127

Chairman WAXMAN. Thank you very much, Dr. Adimora.

Dr. Ayala.

STATEMENT OF GEORGE AYALA, PSY.D.

Dr. AYALA. Chairman Waxman and distinguished committee

members, thank you for this opportunity to speak with you today

on the critical topic of HIV prevention in the United States. It is

my privilege to be here with you today.

Presently HIV prevention in the United States lacks the resources and comprehensiveness that will significantly drive down

HIV incidence rates, as has been demonstrated by my esteemed

colleague Dr. Holtgrave. I ask that you consider the following: Serious HIV-related health disparities often fueled by stigma and discrimination continue to undermine HIV prevention efforts in communities of color. Men who have sex with men continue to make

up the majority of new HIV infections nationally, across race and

ethnicity, with Black and Latino men especially hard hit. Only four

of the CDC’s 49 recommended evidence-based interventions specifically target gay men, and only one of them is designed to address

the needs the gay men of color.

In addition, and just as important to consider, are these facts:

Substance abuse, prevention and treatment are underfunded and

not routinely viewed as integral to overall HIV prevention efforts.

Structural interventions are not commonly researched or endorsed,

even when sound science support their broadbased adoption, as has

been the case with multi-component syringe access and disposal

programs.

Other than new HIV treatments, we have not yet harnessed the

full potential of other promising biomedical interventions, including

pre-exposure prophylaxis and microbicides. And many sciencebased prevention interventions are difficult for community-based

providers to implement because they were tested under research

conditions that are different from real-life settings or tested on populations other than those currently most vulnerable to HIV infection.

While HIV testing and treatment are crucial in our fight against

AIDS, a singular focus on testing and treatment is inadequate and

narrows an already sparse continuum of prevention strategies. We

need a comprehensive national HIV prevention plan in the United

States. At its core, such a plan would, one, work to eliminate disparities in health access and stigma associated with HIV, drug use,

and homosexuality. The personal benefits of knowing one’s HIV

status early are lost on those who must overcome the significant

barriers to treatment and persistent stigma that keep so many

away from care.

Two, target interventions to those most at risk to HIV exposure

and keep a steady and respectful focus on the prevention needs of

gay and bisexual men, substance users and women at sexual risk.

The alternative is that we accept silence and denial about sexuality, drug use and economic and equality, permitting stigma and

discrimination to compromise our provision efforts.

Three, ensure that priority be given to expanding social science

and intervention research aimed at gay and bisexual men, especially men of color.

128

Four, make the prevention and treatment of drug and alcohol addiction central to our HIV prevention efforts. The risk for HIV infection is heightened by drug and/or alcohol abuse.

Five, research and adopt community-sensitive structural interventions to compliment behavior modification programs. Structural

level changes buttress the gains and behavior change made

through individually geared prevention interventions by addressing

the social factors that were addressed by my colleague Dr. Adimora

that underline HIV vulnerability.

Six, support continued HIV treatment, vaccine and other biomedical interventions that are safe, ethical, and show promise of

efficacy.

And finally, seven, balance the policy of promoting pre-packaged

evidence-based HIV prevention interventions by supporting and

evaluating more localized bottom-up and collaborative HIV prevention strategies. It is critical to respect on-the-ground responses to

the HIV/AIDS epidemic by protecting local control over how HIV

prevention strategies are developed, researched, prioritized and implemented.

In closing, HIV prevention efforts in general have not received

the funding needed to make them ubiquitous and continuous, nor

have our resources been adequately targeted to reach those at

highest risk for HIV infection. We need a comprehensive national

HIV prevention plan in the United States that clear clearly calls

for culturally relevant, multilevel combination approaches that are

well funded, targeted and sustained over many years.

Thank you.

[The prepared statement of Dr. Ayala follows:]

129

130

131

132

133

134

135

136

137

138

Chairman WAXMAN. Thank you very much Dr. Ayala.

Ms. Hauck.

STATEMENT OF HEATHER HAUCK

Ms. HAUCK. Good afternoon, Mr. Chairman, Representative

Davis, members of the committee.

Thank you for inviting me to participate on this very distinguished panel.

State Health Department AIDS directors appreciate that this

committee is focusing on domestic HIV prevention activities, especially in light of the CDC’s release of new HIV incidence estimates

and the alarming rates of infection among African Americans and

gay and bisexual men of all races and ethnicities.

I will focus today on describing State Health Department HIV

prevention portfolios, including the central importance of HIV/

AIDS surveillance. I will also share key recommendations from

State AIDS directors for an HIV prevention response to end the

epidemic in our Nation.

State Health Department HIV directors are responsible for implementing comprehensive HIV prevention care and treatment

strategies in our States. We are stewards of more than half of

CDC’s $692 million budget for domestic HIV prevention surveillance programs, as well as significant State resources.

All States implement CDC’s required HIV prevention program

components, such as HIV counseling, testing, and referral, partner

services, health education risk reduction, community planning, and

program evaluation. Over the past 6 years, however, CDC’s funding

to State and local health departments has decreased by $30 million. For many States, especially medium and low prevalence

States, this decline in Federal funding has resulted in significant

reductions in core components of HIV prevention services. At the

same time, there has also been an increased directive from CDC to

focus resources on HIV testing. When faced with such directives

and funding reductions, States are forced to eliminate effective

interventions that are needed to prevent HIV transmission in our

regions or among our populations.

HIV prevention efforts must be aligned to meet the needs of

those who bear the greatest HIV/AIDS burden in the United

States. As the recent CDC HIV incidence estimates clearly illustrate, African Americans, men and women, and gay and bisexual

men of all races and ethnicities are significantly impacted by HIV.

State and local health department HIV programs work to eliminate

health disparities based on race, ethnicity, gender, sexual identity,

and class.

In Maryland, our data show that HIV largely disproportionately

impacts African Americans, regardless of transmission risk category, and therefore we prioritize the reduction of health disparities among racial and ethnic communities as a cross-cutting theme

for all of our HIV initiatives.

A central activity of State HIV prevention programs is measuring

and describing the epidemic through HIV surveillance activities.

These activities are essential to understanding our local HIV

epidemics so that we can then target HIV prevention activities appropriately. These data also determine the allocation and distribuVerDate 11-MAY-2000 15:22 Sep 09, 2010 Jkt 000000 PO 00000 Frm 00142 Fmt 6633 Sfmt 6633 U:\DOCS\56578.TXT KATIE PsN: KATIE
139

tion of resources for HIV care and treatment via the Ryan White

Program.

The CDC has been unable to adequately sustain funding for core

surveillance or for projects such as the incidence surveillance

projects which led to the new estimates released in August. For example, Maryland’s total budget for HIV/AIDS surveillance was reduced by 40 percent in the last year, and the State is no longer

funded for incidence surveillance.

The loss of surveillance funds in the States jeopardizes our ability to know the populations most impacted by the HIV epidemic:

in Maryland, heterosexuals ages 30 through 49, disproportionately

African American and living in the Baltimore metro area, Prince

George’s and Montgomery Counties. If we can’t describe our

epidemics, we can’t plan effective HIV prevention strategies and

interventions appropriate for our local communities. The CDC

needs additional funding to restore and expand incidence surveillance and to shore up core surveillance across all jurisdictions.

AIDS directors articulated our vision for America’s prevention response in a new blueprint for the Nation, Ending the Epidemic

Through the Power of Prevention, and copies have been made

available to the committee.

Three key elements are required to successfully reduce the number of new HIV infections. One, adequately fund CDC’s HIV prevention and surveillance program at the level of at least $1.3 billion annually. Two, significantly invest in interventions that work

to prevent infection, including research to develop new population

specific interventions, access to sterile injection equipment, enhanced program in correctional settings, and establish a comprehensive sexuality education as the standard. Three, meaningfully invest in programs that support HIV prevention, including

STD treatment, hepatitis vaccinations, substance abuse prevention

and treatment, mental health services, housing, and expanded research for biomedical intervention.

State and local health departments know that HIV prevention

works, and we know that health department, health care providers,

businesses, faith leaders, community based organizations, and persons living with HIV and AIDS must all be equipped with adequate

tools and resources to help prevent new infections.

Thank you again for holding this important hearing and for your

thoughtful consideration of our recommendations to increase access

to HIV prevention interventions provided by State and local health

departments. I look forward to answering any questions you may

have.

Chairman WAXMAN. Thank you very much.

[The prepared statement of Ms. Hauck follows:]

140

141

142

143

144

145

146

147

148

149

150

151

152

153

154

155

Chairman WAXMAN. Mr. Oldham.

STATEMENT OF FRANK OLDHAM

Mr. OLDHAM. Chairman Waxman and the entire Oversight Committee, people living with HIV/AIDS thank you for your demonstrated leadership and an opportunity to speak with you about

the state of HIV prevention in the United States of America.

As a trusted and representative voice of more than 1 million people living with HIV/AIDS in America, I say with great confidence

that we know our status, and that has enabled us to save lives.

HIV-related stigma and homophobia, homo-hatred continue to result in disproportionate HIV incidence among gay and bisexual

men, Black and Hispanic men and women, and individuals challenged by poverty, incarceration, and mental illness. As a Black

gay man, a person living with AIDS, and as a proud American, I

ask, is this acceptable in our America?

HIV prevention can only succeed through access to evidencebased interventions, accurate information and education, protected

and voluntary HIV testing and screening services, effective use of

care—HIV care and treatment as prevention, reduced stigma, and

increased support for sero status disclosure, and by addressing

structural, systemic, and economic barriers that continue to perpetuate HIV vulnerability among the most marginalized groups of

Americans.

This is the basis of support for our communities’ call for a national AIDS strategy that is coordinated, evidence based, outcome

driven, and inclusive of people living with HIV/AIDS.

We have heard testimony from the Centers for Disease Control

that annual HIV incidence has been as much as 40 percent higher

in the past 15 years. Prevention efforts have been flat-funded in

our country for more than two decades, and the Minority AIDS Initiative has not been funded adequately to address the real HIV

needs in communities of color.

As we increase resources for minority AIDS initiatives, we must

be sure to hold organizations that receive MAI funds accountable.

We must scale up HIV prevention in America to an annual investment of $1.3 billion. This investment will prove to those at increased risk for HIV that we care about their lives.

We hope that this will be a priority for the next administration. In the meantime, we urge an initial investment of $200 million for

fiscal year 2009. The AIDS communities consent to this request.

Eight years of abstinence only until marriage programs has had

dire human consequences. HIV risk reduction strategies such as

comprehensive sex education and syringe exchange programs have

been proven to reduce HIV infections; yet, these interventions have

not received the requisite level of Federal funding. It is imperative

that we make decisions based in science and don’t sacrifice lives

and waste already constrained resources on programs that have

been proven to be ineffective.

The vast majority of individuals aware of their status are making

decisions about their health and behavior that are not contributing

to the spread of HIV. And I repeat, that are not contributing to the

spread of HIV. Diagnosis, care, and treatment is effective HIV prevention, and our lives depend on it. This is all the more reason why

156

we must ramp up our efforts to make sure people are aware of

their HIV status.

Sixteen years ago, the National Association of People With AIDS

launched National HIV Testing Day, because we believe that taking an HIV test makes it possible for people to protect themselves

and their loved ones. NAPWA supports increased in targeted testing at-risk populations, routine opt out screening for HIV in medical settings, and strongly believes there is an obligation to link people who test positive to high quality care, treatment, and support

services. The Kaiser Foundation continues to report that 45 to 55

percent of those with HIV are still not in care; 45 to 55 percent of

people who have HIV are not in care.

Whether by the passing of the Early Treatment for HIV Act or

efforts to reform health care, America must ensure access to comprehensive and coordinated care for all persons living with HIV/

AIDS. Aggressive research and treatment advances have helped

more people live with HIV than ever before. The benefits of this research extend beyond HIV.

CDC needs more resources to do the requisite research and work

on the ground. HRSA, the National Institutes of Health, and the

substance abuse and health agencies also need appropriate resources to identify new research opportunities and collectively further expand the toolkit of prevention strategies.

Perceptions of stigma directly impact an individual’s willingness

to be open about their HIV status. NAPWA invites more leadership

from all sectors of American society in life to increase the visibility

of people living with HIV and AIDS, and opposes stigmatizing or

negative language toward them. This is especially true in minority

communities, in gay communities, and all communities challenged

with social and economic inequality. The critical issue of AIDS in

America must be a priority for all of us.

NAPWA supports HIV prevention activities that are culturally

and gender specific. NAPWA supports community mobilization

strategies for all communities disproportionately impacted by this

disease, and will launch the first National Gay Men’s HIV Awareness Day on September 27th, later this month, in Raleigh, North

Carolina. They will seek to accomplish increased awareness about

the needs of gay men for HIV prevention, care, and treatment, forums to strategize effective responses to the epidemic in our community. We ask your support on this historic day, Gay Men’s HIV

Awareness Day, September 27th. Thank you.

Chairman WAXMAN. Thank you very much, Mr. Oldham.

[The prepared statement of Mr. Oldham follows:]

157

158

159

160

161

162

Chairman WAXMAN. I thank all of you for your testimony. Dr.

Holtgrave, you prepared for us your idea of what a budget should

be for HIV prevention, and it seems like what you’ve suggested is

pretty much in the same ball park as what CDC said to us was

their best professional judgment. Would you say that is an accurate

statement?

Mr. HOLTGRAVE. I would say so. I would say there are more

points of agreement probably than disagreements. I think that the

central message probably from both is that we need to substantially scale up our investment in HIV prevention. And, also, that

it is achievable to think about reducing transmission rates and incidence by 50 percent in the United States, and that it will take

some years to do so. I think some of the difference in terms of the $1.3 billion versus,

say, the $1.7 billion or so that CDC called for is that they have

some research funding, some activities on STD, TB, and hepatitis,

which are very important, but that allows for some of the difference. And also, I think we could even be a little bit more aggressive and achieve the 50 percent reduction a bit sooner than CDC

has estimated. But, again, I think there is much more to agree

than disagree between the two estimates.

Chairman WAXMAN. But both you and CDC suggest that we

could be preventing many more HIV infections than we are doing

now, as well as increasing the proportion of people who know their

HIV status, which of course goes together.

Do you think that the two estimates reflect a general consensus

among HIV experts that better outcomes are within reach, even

based on current knowledge?

Mr. HOLTGRAVE. I believe so. I think there is a general consensus

scientifically that we have an outstanding array of tools, some of

which that Dr. Fauci mentioned earlier, that are available to us

now. And we need to make sure that we are using those tools. We

must develop vaccines, we must develop microbicides. But we need

to use immediately what we have available at our disposal.

Chairman WAXMAN. Thank you.

Dr. Adimora, I thought your presentation was very interesting.

You presented a perspective that I hadn’t heard before within the

African American community. One of the aspects of the African

American community, especially those who have HIV and AIDS, is

that they live—many of them, if not most of them, live in poverty.

How does poverty contribute to HIV risk for African Americans?

Dr. ADIMORA. There are a variety of pathways between poverty

and HIV and population HIV transmission. In fact, I would consider this to be consider the culprits to be not only poverty, but also

racial discrimination.

Among the pathways that I mentioned were segregation. And I

mentioned some of the ways by which it works in terms of structuring people’s social and sexual networks. Particularly alarming is

the way in which it can structure the sexual networks of youth.

Another issue concerning poverty is homelessness. Homeless people

are particularly at risk for HIV. I mentioned just a few of the potential structural interventions that could be implemented, but I

think that attention to homelessness and improved housing is certainly a major consideration, and that relates certainly to poverty.

163

Another issue is incarceration, given the disproportionate incarceration of Black men. And I think that it is important, in thinking

about incarceration, there is sometimes a tendency to start talking

about mandatory testing in prison. Certainly everyone should have

available to them a means for learning their HIV diagnoses and for

appropriate treatment; but in addition, I think that incarceration

is actually a major symbol of racial discrimination and oppression

in this country, and there needs to be—significant attention needs

to be paid to because of the myriad of consequences that it is having—well, certainly it is wrong in the first place. But the other

issue is that it is clearly having an impact on the health of people,

particularly Black people.

Chairman WAXMAN. You mentioned incarceration in your original presentation to us. And you said, not only are people getting

HIV when they are incarcerated, but that there is a social disruption that imprisonment causes. I thought that was an interesting

point. Do you see bias, racial bias as well as discrimination among

gay and bisexual men in the Black community as factors that are

important for us to take note of?

Dr. ADIMORA. Unquestionably. There are pathways between racial discrimination and HIV infection. This is beyond a matter of

simply social justice because that is a good thing. The absence of

social justice is a major root cause of many of the racial disparities

in health that we are seeing in the United States, and specifically

of HIV infection.

Chairman WAXMAN. Dr. Ayala, do you have recommendations on

how programs should take into account the specific needs of gay

and bisexual men of color?

Dr. AYALA. As I said in my testimony, very, very few of the recommended prevention interventions are specifically designed or

geared to men of color, gay men of color.

I think we have to do two things. One, we have to invest in a

greater research portfolio that build HIV prevention interventions

that are specifically geared to gay, gay men of color. And the second thing is that we should take what we have available and tailor

them for use in the communities, both for the target population in

question, but also with consideration to the needs of providers who

have to ultimately implement the interventions.

Chairman WAXMAN. Ms. Hauck, at the State level, you stated

surveillance measuring and monitoring the HIV/AIDS epidemic is

crucial to HIV prevention efforts. The surveillance data not only

helps you understand the epidemic but appropriately targeting resources. And I understand that Maryland was among eight States

that actually lost funding, and you mentioned this in your opening

statement, to conduct the kind of new incidence measurements in

which the CDC based its recent estimates.

What has been the impact of this cut on Maryland and other

States?

Ms. HAUCK. Thank you for the question. What happened at the

State level was that our surveillance activities had been integrated.

So we certainly received funding for core surveillance, which is

really the basics of HIV surveillance and AIDS surveillance. And

then we received these—funding for these projects. And we had inVerDate 11-MAY-2000 15:22 Sep 09, 2010 Jkt 000000 PO 00000 Frm 00167 Fmt 6633 Sfmt 6633 U:\DOCS\56578.TXT KATIE PsN: KATIE
164

tegrated all of the activities, so that we were really gathering information in a holistic way about our epidemic.

When you start to peel off special projects that have been integrated into your core surveillance activities, you are no longer able

to fully fund the staff that are gathering the information, you are

not able to do the data collection that we need to the level that we

need the data in order to accurately describe our epidemic. So we

may be missing some important components, like risk transmission

categories, like race, like ethnicity, as well as potentially missing

cases, because it is a rather intensive process to gather this information through our surveillance activities.

So I think over time, what you will see is that States aren’t able

to sustain even our core surveillance activities, which again allow

us to describe our epidemics, and, therefore, use that funding to allocate, distribute, and plan prevention as well as care and treatment services in our jurisdictions.

Chairman WAXMAN. CDC presented to us their professional judgment of what the budget should look like; and they would request

more funding to strengthen behavioral and clinical surveillance activities in the States. Do you think that they have adequately funded that aspect, in their professional judgment, budget?

Ms. HAUCK. The National Alliance of State and Territorial AIDS

Directors certainly states that at least an investment of $35 million

in additional funding for surveillance is needed to both restore the

cuts in surveillance that we’ve seen over time and to really bring

all the jurisdictions up to standard operating budgets.

Chairman WAXMAN. Dr. Fenton in the first panel testified about

the importance of integrating HIV services with services for other

sexually transmitted diseases. I want to ask you about that at the

State level.

Since 2000, the rate of syphilis in the United States has increased by 76 percent. As you know, this epidemic is primarily concentrated in the southeastern region of the United States among

heterosexual African Americans and men who have sex with men.

What will the States need to do to eliminate syphilis in these impacted populations? And, should those efforts be coordinated with

HIV prevention efforts?

Ms. HAUCK. Thank you for asking the question, Mr. Chairman.

I’ll answer the first part first.

Yes, the CDC’s budget for STD prevention has suffered many of

the same declines that the HIV prevention budget has suffered

over the years. Maryland is a southern State as well, and has certainly seen a significant syphilis epidemic, especially in Baltimore

City and Prince Georges County, among African Americans, particularly men who have sex with men, and heterosexuals. And yet

our funding has not kept pace with our need to address the syphilis

epidemic in our State and certainly the majority of States that

have had a syphilis epidemic. So I would say that the increase in

resources is also needed. And we do integrate and do need to continue to integrate STD prevention and HIV prevention at the State

level and at the local level.

Many of the clients who come to seek services certainly need to

be given similar messages, similar education, similar screening,

and need to receive that in a holistic manner when they walk in

165

the door of a clinic or an emergency room or a community-based

organization, and we need the resources to enable the clients to receive those services at the time when they see them. Thank you.

Chairman WAXMAN. Thank you. We have infection rates continuing to rise among men who have sex with men, and in the meantime, discrimination and marginalization of men who have sex with

men remains widespread.

Mr. Oldham, how does discrimination on the basis of sexual orientation affect gay and bisexual men who are living with HIV? And

have any national campaigns in the U.S. HIV prevention directly

addressed this kind of discrimination?

Mr. OLDHAM. There have been campaigns from community-based

organizations, such as Gay Men’s Health Crisis, the L.A. Gay and

Lesbian Center in Los Angeles, and AIDS-Positive Los Angeles.

However, there has not been the governmental campaigns. Like,

for example, we have National Black AIDS Awareness Day, Chairman Waxman, we have National Hispanic AIDS Awareness Day

and a number—there are 12 of them.

Even though the new CDC numbers indicate that gay men of all

ethnic backgrounds make up the bulk of the epidemic and the loss

of life in the epidemic, we do not even have a Gay Men’s HIV/AIDS

Awareness Day, which is why NAPWA is launching this on the

27th, to make sure that gay men are aware and are involved in

this epidemic and not complacent about it themselves, and the rest

of society deals with the issues of homophobia and homo-hatred, as

barriers to HIV prevention and care services for gay men.

Chairman WAXMAN. I want to thank all of you on this panel for

your presentation and your willingness to answer questions. We

may have members submitting to you additional questions, which

you may respond to in writing for the record, because I know many

members had a lot of things that they wanted to pursue but there

are so many competing things going on that not everybody can be

here.

I think the purpose of this hearing has been to sound an alarm,

because we have an increasing HIV epidemic in the United States.

It is different than where we were in the early days, but it is very

much with us. And unless we set a high priority to do the things

we know that will work and to try to research and develop new

ways of approaching the epidemic, we are going to fall further and

further behind.

We know that when budgets are sent to us, they are budgets

that are developed ultimately by the budget people in the administration. They may get the input from the agencies and the experts,

but they are trying to figure out their overall priorities. And the

overall priority for this administration has not been to deal with

the HIV/AIDS epidemic in the way that we need to, to stop and

prevent the transmission of this disease.

That is why I was pleased to have CDC and NIH present to us

what their best professional judgment would be. It is always different when you ask that than what they have to say to us when

they are making presentations before Congress, because then their

presentations have to be consistent with the views of the administration in which they serve.

166

Well, I think that presentation to us and your expanded discussion of the groups that are primarily affected and all the complications that we need to be aware of is going to help us face this epidemic and, I hope, to defeat it. Thank you very much for your presentation.

That concludes the presentations at this hearing, and we stand

adjourned.

[Whereupon, at 12:33 p.m., the committee was adjourned.]

Æ