51 351 CC

1998

Union Calendar No. 461

105th Congress, 2d Session House Report 105 820

SEVENTH REPORT

by the

COMMITTEE ON GOVERNMENT

REFORM AND OVERSIGHT

October 15, 1998.--Committed to the Committee of the Whole House on

the State of the Union and ordered to be printed

?

COMMITTEE ON GOVERNMENT REFORM AND OVERSIGHT

DAN BURTON, Indiana, Chairman

BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California

J. DENNIS HASTERT, Illinois TOM LANTOS, California

CONSTANCE A. MORELLA, Maryland ROBERT E. WISE, Jr., West Virginia

CHRISTOPHER SHAYS, Connecticut MAJOR R. OWENS, New York

CHRISTOPHER COX, California EDOLPHUS TOWNS, New York

ILEANA ROS-LEHTINEN, Florida PAUL E. KANJORSKI, Pennsylvania

JOHN M. McHUGH, New York GARY A. CONDIT, California

STEPHEN HORN, California CAROLYN B. MALONEY, New York

JOHN L. MICA, Florida THOMAS M. BARRETT, Wisconsin

THOMAS M. DAVIS, Virginia ELEANOR HOLMES NORTON, Washington, DC

DAVID M. McINTOSH, Indiana CHAKA FATTAH, Pennsylvania

MARK E. SOUDER, Indiana ELIJAH E. CUMMINGS, Maryland

JOE SCARBOROUGH, Florida DENNIS J. KUCINICH, Ohio

JOHN B. SHADEGG, Arizona ROD R. BLAGOJEVICH, Illinois

STEVEN C. LaTOURETTE, Ohio DANNY K. DAVIS, Illinois

MARSHALL ``MARK'' SANFORD, South Carolina JOHN F. TIERNEY, Massachusetts

JOHN E. SUNUNU, New Hampshire JIM TURNER, Texas

PETE SESSIONS, Texas THOMAS H. ALLEN, Maine

MICHAEL PAPPAS, New Jersey HAROLD E. FORD, Jr., Tennessee

VINCE SNOWBARGER, Kansas ------

BOB BARR, Georgia BERNARD SANDERS, Vermont (Independent)

DAN MILLER, Florida

RON LEWIS, Kentucky

Kevin Binger, Staff Director

Daniel R. Moll, Deputy Staff Director

David A. Kass, Parliamentarian and Deputy Counsel

Lisa Smith Arafune, Deputy Chief Clerk

Phil Schiliro, Minority Staff Director

SUBCOMMITTEE ON HUMAN RESOURCES

CHRISTOPHER SHAYS, Connecticut, Chairman

VINCE SNOWBARGER, Kansas EDOLPHUS TOWNS, New York

BENJAMIN A. GILMAN, New York THOMAS H. ALLEN, Maine

DAVID M. McINTOSH, Indiana TOM LANTOS, California

MARK E. SOUDER, Indiana BERNARD SANDERS, Vermont (Ind.)

MICHAEL PAPPAS, New Jersey THOMAS M. BARRETT, Wisconsin

------ ------ DENNIS J. KUCINICH, Ohio

EX OFFICIO

DAN BURTON, Indiana HENRY A. WAXMAN, California

Lawrence J. Halloran, Staff Director and Counsel

Anne Marie Finley, Professional Staff Member

Jesse S. Bushman, Clerk

(II)

?

LETTER OF TRANSMITTAL

House of Representatives,

Washington, DC, October 15, 1998.

Hon. Newt Gingrich, Speaker of the House of Representatives,

Washington, DC.

Dear Mr. Speaker : By direction of the Committee on Government

Reform and Oversight, I submit herewith the committee's seventh report

to the 105th Congress. The committee's report is based on a study

conducted by its Subcommittee on Human Resources.

Dan Burton,

Chairman.

(iii)

?

C O N T E N T S

I. Summary 1

II. Background 2

III. Findings 4

IV. Recommendations 13

Union Calendar No. 461

105 th Congress

Report

HOUSE OF REPRESENTATIVES

2d Session

105 820

HEPATITIS C: SILENT EPIDEMIC, MUTE PUBLIC HEALTH RESPONSE

October 15, 1998.--Committed to the Committee of the Whole House on

the State of the Union and ordered to be printed

Mr. Burton, from the Committee on Government Reform and Oversight,

submitted the following

SEVENTH REPORT

On October 8, 1998, the Committee on Government Reform and Oversight

approved and adopted a report entitled, ``Hepatitis C: Silent Epidemic,

Mute Public Health Response.'' The chairman was directed to transmit a

copy to the Speaker of the House.

I. SUMMARY

Called ``the silent epidemic,'' the spread of Hepatitis C Virus [HCV]

infection has evoked a Federal public health response almost as mute.

Hepatitis C poses a daunting challenge to public health. Chronic

infection can linger without symptoms for more than 20 years, then

produce profound health consequences, including liver failure and

cancer. There is no preventive vaccine or universally effective

treatment. Up to 10,000 will die this year from the disease. That number

could triple in the next two decades, according to the Centers for

Disease Control and Prevention [CDC].\1\

\1\NIH Consensus Development Statement ``Management of Hepatitis C,''

Mar. 24 26, 1997 (in subcommittee files).

HCV has now spread to an estimated 4 million Americans. Eighty-five

percent of those infected develop chronic liver disease and about 10 to

20 percent develop cirrhosis of the liver about 20 years after the onset

of infection.\2\

HHS estimates the total societal cost of Hepatitis C at more than $600

million per year.\3\

More than a million persons received HCV infected blood and blood

products.\4\

Most are unaware of their infection.

\2\ Public Health 2000: Hepatitis C--The Silent Epidemic, 105th Cong.,

2d sess., p. 6 (subcommittee hearing, Mar. 5, 1998) (prepared statement

of Surgeon General David Satcher).

\3\Ibid, p. 6.

\4\Ibid, p. 6.

They need to be told. They need to be tested. Many will need

treatment, and many will need to learn how to prevent further spread of

the disease to their spouses, sexual partners, and household members.

But HHS plans to ``look back'' for people infected through blood have

sputtered, and little has been accomplished. Disease reporting and

surveillance is uneven. Research into HCV is uncoordinated. Education on

prevention and treatment has been undertaken primarily by private sector

organizations.

Unless confronted more boldly, more directly, and more loudly by the

Department of Health and Human Services [HHS], the threat posed by

Hepatitis C will only grow more ominous. As we learned when the Human

Immunodeficiency Virus [HIV] breached our public health defenses,

scientific uncertainty, cultural biases and bureaucratic inertia can

thwart the actions needed to repel an elusive viral invader.

In a 1996 oversight report, this Committee recommended HHS take steps

to notify the 300,000 or more Americans known to have been infected with

Hepatitis C through blood before 1990.\5\

To date, that has not been done. The time for pondering the

appropriate, pro-active public health response to Hepatitis C is past.

The time for aggressive implementation is at hand.

\5\ Protecting the Nation's Blood Supply from Infectious Agents: The

Need for New Standards to Meet New Threats, 10th Report by the Committee

on Government Reform and Oversight, Aug. 2, 1996.

Findings in brief:

1. The Federal response to the Hepatitis C epidemic has lacked focus

and energy.

2. The proposed HCV ``look back'' is too limited.

3. Private organizations, with some Federal assistance, have taken

the lead in HCV public education efforts.

Recommendations in brief:

1. a. The Secretary of Health and Human Services should take the lead

in coordinating the Federal public health response to the Hepatitis C

epidemic, including implementation of a research plan.

b. The Department of Defense should test recruits, active duty

personnel and those about to be discharged for Hepatitis C infection.

c. The Department of Veterans Affairs should conduct additional

studies of the prevalence of HCV in veterans populations.

2. The Hepatitis C look back plan should be expanded.

3. Federal educational campaigns on HCV infection should be launched

immediately.

II. BACKGROUND

The Centers for Disease Control [CDC] estimate that at least 4

million Americans are infected with the Hepatitis C Virus [HCV], which

was formerly known as ``non-A, non-B hepatitis.'' HCV is a liver disease

agent found in the blood of infected persons. Infection may occur

through intranasal exposure (cocaine use), injection of street drugs,

accidental needle stick injuries to health care workers, transfusion of

infected blood and plasma products, transplantation of solid organs

(such as kidney, liver, heart), kidney dialysis, maternal to fetal

transmission and through exchange of bodily fluids.

Secondary transmission to spouses and maternal transmission to

fetuses in utero has been documented, but the extent of transmissibility

is not known. In addition, more than 40 percent of infected persons do

not have histories of risk factors, suggesting a possible unknown route

of transmission. There is no vaccine to prevent the disease and NIH

estimates that vaccine development will take at least a decade.

CDC estimates that 28,000 180,000 new HCV infections occur each year.

Only 25 30 percent of infections are symptomatic. Many HCV infected

individuals are not aware of their infection until signs of liver

failure appear, often decades after infection. This has prompted some to

call HCV, the ``silent epidemic.''

Hepatitis C is responsible for an estimated 8,000 10,000 deaths

annually in the United States. According to current estimates, more

people will die of HCV in the year 2000 than will die of AIDS.

An estimated 1 million Americans received blood from a donor who

subsequently tested positive for Hepatitis C.\6\

Of these people, CDC estimates 700,000 may have tested positive with

the first generation anti-HV test which was introduced in 1990. The

first generation test had a higher false positive rate than later

generation tests and there was little confirmatory testing performed in

this group of tested donors.\7\

A more precise ``second generation'' HCV screening test became

available in 1992.

\6\Written communication from Centers for Disease Control to

subcommittee staff, Sept. 15, 1998 (in subcommittee files).

\7\Ibid.

CDC concedes,

it is not possible to estimate the TOTAL number of

living persons with transfusion associated HCV infection from

the look back estimates, since these estimates do not extend

before 1990. CDC has estimated that approximately 300,000 of

the 4 million living anti-HCV positive persons acquired their

infection from blood transfusion.

CDC arrived at this estimate using the National

Health and Nutrition Examination Survey [NHANES] data and

Sentinel Counties surveillance data concerning the proportion

of HCV infections that were transfusion associated at various

time periods.\8\

\8\Ibid.

Treatment of HCV is usually with interferon and approximately 12 15

percent of individuals will clear the infection with the first

treatment. There is some evidence that individuals with HCV who do not

respond to the first treatment may be able to clear the infection with a

second round of treatment, or with higher dosages of interferon or

combinations of drugs. Many infected persons do not develop symptoms.

Others, however, will develop severe cirrhosis of the liver, which will

require a liver transplant or be fatal. Cirrhosis caused by HCV

infection is the primary reason for liver transplants in the United

States.

In the 104th Congress, the Committee issued a report entitled,

``Protecting the Nation's Blood Supply from Infectious Agents: The Need

for New Standards to Meet New Threats,'' (House Report 104 746) which

contained several recommendations including one to require the

Department of Health and Human Services to ensure that the estimated

300,000 living recipients of blood and blood products who may have been

infected with Hepatitis C Virus before 1990 are notified of their

potential infection so they might seek diagnosis and treatment.

III. FINDINGS

1. The Federal response to the Hepatitis C epidemic has

lacked energy and focus

Since 1989, when the Hepatitis C Virus [HCV] was first unmasked,

federal public health agencies have often pondered, but never

implemented, a comprehensive response to this insidious infectious

agent.

The FDA's Blood Products Advisory Committee [BPAC] considered whether

patients who received the HCV infected units should be notified of their

exposure (a.k.a. ``look back'') on all of the following dates: October

31, 1989; January 17 18, 1991; September 26 27, 1991; March 12 13, 1992;

March 25 26, 1993; December 2 3, 1993; and December 15 16, 1994.

However, the BPAC did not take action on this issue, even though

treatment options were available to infected persons if they had been

told of their infection.

The FDA's July 19, 1996, Guidance Memorandum\9\

recommended quarantine and disposition of certain prior collections of

blood and blood components from donors who tested repeatedly reactive to

HCV antibodies. At that time, FDA did not recommend notification of

recipients of blood from donors who subsequently test positive for

anti-HCV, because ``no clear consensus on the public health benefit of

such action had emerged.''\10\

\9\July 19, 1996, memorandum from Director, Center for Biologics

Evaluation and Research to All Registered Blood and Plasma

Establishments (in subcommittee files).

\10\``Guidance for Industry: Supplemental Testing and the Notification

of Consignees of Donor Test Results for Antibody to Hepatitis C Virus

(Anti-HCV),'' background section, Mar. 20, 1998.

In testimony before the Human Resources [HR] Subcommittee on October

12, 1995, HHS Secretary Donna Shalala committed that the HCV look back

notification would be the first issue considered by the new HHS Advisory

Committee on Blood Safety and Availability [NACBSA]. NACBSA reviewed the

notification issue at its meetings 2 years later, in April and August

1997.

At the August 12, 1997, meeting, a look back was recommended by the

Committee for individuals who had received blood which had tested

positive for HCV on the second generation screening test implemented in

1992. Some members of the NACBSA\11\

wanted a more extensive look back, feeling that a less comprehensive

approach was unethical because many infected individuals would not be

contacted by a look back triggered only by HCV donors detected after

1992.\12\

CDC did not provide an estimate of how many of the 1.1 million

Americans who received potentially HCV-infected blood did so before

1992. However, CDC concludes the possibility of transmission was much

higher before the 1992 introduction of more effective screening and

testing.

\11\Dr. John Penner, Dr. Arthur Caplan, Dr. Dana Kuhn, Dr. Ronald

Gilcher, and Ms. Tricia O'Connor.

\12\Aug. 31, 1997, letter from NACBSA member John Penner M.D., to NACBSA

Chairman Arthur Caplan, Ph.D., (in subcommittee files).

The NACBSA recommendation was reviewed by the Public Health Service

[PHS] operating divisions (FDA, CDC, NIH, et cetera) prior to its

presentation to the Blood Safety Committee on November 4, 1997, and

December 3, 1997. The recommendation was communicated to Secretary

Shalala on December 22, 1997.

The recommendation was discussed with HHS Deputy Secretary Kevin

Thurm on January 13, 1998, and with the Secretary on January 22, 1998.

Secretary Shalala communicated her decision to accept the recommendation

to NACBSA Chairman Arthur Caplan on January 28, 1998.

On March 5, 1998, HHS Surgeon General David Satcher announced the HCV

look back and education plan in testimony at a Human Resources [HR]

Subcommittee hearing. He testified that HHS has ``established a

comprehensive plan to address this significant public health problem. It

is our intention to reach effectively as many people at risk as we

can.''\13\

\13\Testimony of Dr. David Satcher, HR Subcommittee hearing, Mar. 5,

1998, p. 7.

On February 11, 1998, Dr. John Eisenberg, HHS Acting Assistant

Secretary for Health and acting chairman of the Blood Safety Committee,

requested specific responses with time lines from the FDA, CDC, and the

Agency for Health Care Policy and Research [AHCPR] on the status of the

agencies' HCV notification and education plans.

The FDA response was the publication of a Guidance to Industry on

March 20, 1998, in the Federal Register. \14\

The guidance recommended that blood banks identify past donors of blood

who have tested positive for HCV antibodies on the 1992 second

generation test and notify the hospital blood banks and transfusion

services that units taken from those donors may be infected. The

hospital should then notify either at-risk patients or their doctors

directly by September 20, 1998.

\14\``Guidance for Industry: Supplemental Testing and the Notification

of Consignees of Donor Test Results for Antibody to Hepatitis C Virus

(Anti-HCV),'' Federal Register, Mar. 20, 1998.

The CDC and AHCPR responses were received by HHS on April 10, 1998,

and further discussed at the June 18, 1998 Blood Safety Committee

meeting. HHS pledged to undertake additional public education campaigns

to notify additional persons who may have received HCV-infected

transfusions. HHS pledged to evaluate the success of the direct

notification efforts and committed to take additional, unspecified steps

to identify other at risk groups for HCV infection.

Surgeon General Satcher, who had been asked by the Secretary to lead

the notification and look back efforts,\15\

stated in a letter to Chairman Shays that,

\15\Testimony of Dr. David Satcher, HR Subcommittee hearing, Mar. 5,

1998, p. 6.

responses from the public, notably from America's

Blood Centers (ABC), the American Association of Blood Banks

(AABB), and the American Red Cross (ARC) were received on May

19 and 20, 1998. I met with the leadership of the American

Association of Blood Banks, as representatives of these other

organizations, on May 24, 1998. In response to these and other

communications, FDA announced plans to revise its Guidance to

Industry at the Blood Products Advisory Committee meeting on

June 18, 1998, specifically in the areas of additional testing

of donor samples and implementation time frames.\16\

\16\Sept. 18, 1998, letter from Surgeon General David Satcher to

Chairman Shays (in subcommittee files).

CDC organized a Consultant's Conference to plan implementation of the

HCV education initiative on July 15 17, 1998. A followup workshop for

industry, cosponsored by ABC, AABB, and ARC was held on August 25 26,

1998, and suggestions arising at this workshop were communicated to the

Department on September 9, 1998. On October 16, 1998, CDC will publish

``Recommendation for the Prevention and Control of Hepatitis C Virus

[HCV] Infection and HCV-Related Chronic Disease'' in Morbidity and

Mortality Weekly Report.

On September 8, 1998, FDA withdrew the March 20, 1998, ``Guidance for

Industry: Supplemental Testing and the Notification of Consignees of

Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV).''\17\

Unexpectedly, no other guidance was issued in place of the first

guidance and the agency did not commit itself to a date certain for

re-issuance. The agency's action removed FDA's recommendation that blood

establishments should begin notifying consignees within 6 months of the

date of publication of guidance (i.e. by September 20, 1998) concerning

results of donations tested prior to the date of implementation of the

guidance.

\17\FDA web site announcement (www.fda.gov/cber/whatsnew/htm), Sept. 9,

1998.

At the HR Subcommittee's September 9, 1998 hearing, Chairman Shays

asked FDA Acting Commissioner Michael Friedman for a status report on

the HCV look back and education campaign. Dr. Friedman responded, ``. .

. the commitment given by Dr. Satcher, not just on the part of FDA but

on the part of the entire Health and Human Services, indicated a serious

organization-wide commitment and look-back campaign.''\18\

\18\ Blood Safety: Minimizing Plasma Product Risks, 105th Cong., 2d

sess., p. 22 of original transcript (1998) (testimony of Dr. Michael

Friedman).

FDA's Office of Blood Research and Review Director Jay Epstein, M.D.,

stated, in response to a question from Chairman Shays about the status

of hospital identification of HCV infected transfusion patients, that,

``FDA published a guidance in March of this year which directed the

blood organization to identify the units where the donor subsequently

was learned to . . . [seroconvert] to Hepatitis C. The process of

tracing those records, we believe, has been ongoing since that time . .

.''\19\

\19\Testimony of Dr. Jay Epstein, HR Subcommittee hearing, Sept. 9,

1998, p. 24 of original transcript.

At no point during the hearing did any FDA witness volunteer that the

March 20, 1998, Guidance to Industry on HCV look back had been withdrawn

the day before. Blood collection organizations were notified by FDA of

the impending withdrawal of the guidance by telephone call on August 28,

1998.\20\

Consumer groups such as the American Liver Foundation and the Hep C

Connection were not notified of FDA's action in advance.\21\

No written notices were sent by FDA of the agency's instructions to

blood banking organizations and no written records were kept of these

exchanges.\22\

\20\AABB Weekly Report, ``HCV Look back Update,'' American Association

of Blood Banks newsletter, Sept. 4, 1998, Bethesda, MD, vol. 4, No. 34,

p. 1.

\21\HR Subcommittee staff telephone conference call with Allan

Brownstein, executive director, American Liver Foundation, Sept. 10,

1998, and with Ann Jesse, executive director, Hep C Connection, on Sept.

14, 1998.

\22\HR Subcommittee staff conversation with Melinda Plaisier, Deputy

Associate Commissioner for Legislative Affairs, Sept. 10, 1998.

Dr. Epstein also testified that, while the blood banks had told the

agency that letters to recipients had been sent, FDA had no independent

verification that this had occurred and was simply relying on the

industry's verbal assurances that identification of suspected

HCV-infected units had been achieved. Dr. Friedman acknowledged that no

recipient of HCV-infected blood products has yet received a letter

informing him or her of possible infection.

On September 23, 1998, FDA issued a revised ``Guidance for Industry:

Current Good Manufacturing Practice for Blood and Blood Components: (1)

Quarantine and Disposition of Units from Prior Collections from Donors

with Repeatedly Reactive Screening Tests for Antibody to Hepatitis C

Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of

Consignees and Blood Recipients of Donor Test Results for Anti-HCV.''

The revised guidance grants blood establishments another 6 months from

the date of issuance of the guidance to begin notifying consignees (i.e.

March 23, 1999). FDA recommends that this notification be completed

within 18 months of the date of publication of the guidance. This

guidance suggests, but does not require, that individuals who received

potentially HCV-infected blood and blood products should be notified by

March 23, 2000.

In testimony at the June 18, 1998, FDA Blood Products Advisory

Committee [BPAC], Dr. Hal Margolis, Director of CDC's Hepatitis Branch

described HHS' view of the HCV look back.

Basically it has been our perception and our

assumption that, in fact, the targeted look back is something

that is primarily going to be conducted by the blood industry,

both by the blood collection agency as well as the transfusion

services. In fact, as far as public sector programs, that is

something that PHS, other than the guidance and much of the

supporting educational material, has not put together a major

effort or plans for conducting.\23\

\23\Transcript of June 18, 1998, Blood Products Advisory Committee

meeting, p. 21 (in subcommittee files).

The National Institutes of Health [NIH] have conducted an equally

sluggish and fragmented approach to research on HCV. Basic research on

Hepatitis C is conducted at NIH by seven different Institutes: the

National Cancer Institute [NCI], National Heart, Lung and Blood

Institute [NHLBI], National Institute of Diabetes, Digestive and Kidney

Diseases [NIDDK], National Institute of Allergy and Infectious Diseases

[NIAID], National Institute of Drug Abuse [NIDA], National Institute of

Alcoholism and Alcohol Abuse [NIAAA], and the National Center for

Research Resources [NCRR].

Research moneys have increased during the last 3 fiscal years from

$25,300,00 in fiscal year 1997, to an estimated $29,835,000 in fiscal

year 1998, to an estimated $34,405,000 in fiscal year 1999. These

figures include both intramural and extramural funding. NIH did not keep

Hepatitis C funding figures prior to 1997, according to the NIH Budget

Office.\24\

\24\Feb. 26, 1998, correspondence from NIH Congressional Affairs Office

to HR Subcommittee staff (in subcommittee files).

In contrast, one pharmaceutical company alone spent $25 million in

1996 on HCV research.\25\

Dr. Teresa Wright, medical advisor to the American Liver Foundation and

director of the Liver Clinic at the San Francisco VA Hospital, told

subcommittee staff that HCV research is largely ``pharmaceutical company

driven'' due to the large potential market for HCV therapies.

\25\Sept. 18, 1998, letter from Audrey Wright Spolarich, Health Policy

Analysts, to Subcommittee staff (in subcommittee files).

Consumer groups such as the American Liver Foundation have criticized

the allocation of resources to hepatitis programs by HHS. They feel

hepatitis transmission and treatment research funding is not

commensurate to the threat the disease presents to public health.\26\

\26\Statement of Dr. Teresa Wright, American Liver Foundation, HR

Subcommittee hearing Mar. 5, 1998, p. 65 73.

On July 22, 1997, the House Committee on Appropriations included

report language to accompany the NIH appropriations bill which noted

that ``the March 1997 Hepatitis C [HCV] consensus conference made

significant new research recommendations that affect several NIH

Institutes and, therefore, requests that the Office of the Director play

a role in coordinating this research in order to most effectively

respond to the HCV epidemic.''\27\

\27\House Report 105 205, ``Departments of Labor, Health and Human

Services, and Education, and Related Appropriation Bill, 1998,'' p. 100.

NIH established the coordinating committee on February 12, 1998. Dr.

Anthony Fauci, Director of NIAID, chairs the committee.

NIAID is attempting to develop an HCV preventative vaccine. However,

NIAID researchers told HR Subcommittee staff that a vaccine is at least

10 years away due to the variety (21) in genomic types of the HCV virus.

NIAID has proposed a strategic plan for Hepatitis C research to guide

NIAID programs in this area. NIAID recently established 4 Hepatitis C

Cooperative Research Centers at Stanford, University of Texas Medical

Center at Galveston, University of Southern California and the

University of Washington. In 1997, the NIDDK developed a long range

strategic plan for liver disease research, which includes Hepatitis C.

The Strategic Plan for Liver Disease Research was transmitted to

Congress prior to submission of the fiscal year 1999 budget, as

requested by the House and Senate Appropriations Committees.\28\

\28\Department of Health and Human Services, National Institutes of

Health, ``Liver and Biliary Diseases Strategic Plan,'' March 1998 (in

subcommittee files).

It is noteworthy that the National Institute on Drug Abuse [NIDA]

spent the most NIH resources and continues to spend the most resources

on HCV research, which may reflect an institutional bias within HHS that

HCV is a disease of injection drug users. This bias may have worked

against early recognition of HCV as a broader public health problem.

The Centers for Disease Control and Prevention [CDC] have developed a

comprehensive, nationally-focused plan for the prevention and control of

HCV infection, entitled ``A Prevention and Control Plan for Hepatitis C

Virus Infection.'' Components of the plan include counseling and

testing, professional and public education, surveillance, epidemiology

and laboratory investigation, and evaluation. CDC estimates that the

plan will cost $48 million. The plan was submitted to HHS on April 14,

1998, but was not discussed by the HHS Blood Safety Committee due to HHS

refusal to commit the requested funds to this CDC program.\29\

\29\HR Subcommittee staff conversations with Dr. Eric Goosby, HHS Office

of HIV/AIDS and with Marc Smolonsky, Office of the Assistant Secretary

for Legislation, Sept. 18, 1998 (notes in subcommittee files). Note:

Total CDC spending on HCV Public Education Activities for fiscal year

1998 was $716,894 (in subcommittee files).

To date, CDC conducted an educational satellite teleconference for

primary care physicians on November 22, 1997, with subsequent

distribution of a conference audiotape to 200,000 medical professionals

in the summer of 1998. CDC has assisted private organizations such as

the American Liver Foundation, Hepatitis Foundation International and

the National Association of County and City Health Officers in the

development, evaluation and dissemination of educational materials for

populations at risk of HCV infection.

VA spent $11,546,423 on HCV from fiscal years 1988 1997, primarily on

drug trials. In addition,

the VA Cooperative Studies program is currently

planning a large-scale treatment trial to determine whether

interferon can prevent progressive liver disease in veterans

infected with Hepatitis C Virus. The study will include more

than 500 veterans at 17 VA medical facilities nationwide.

Enrollment of patients is expected to take 3 years, and each

veteran enrolled will be treated for 4 years. The total

duration of the study is expected to be 7 years. Final

approval of the study is pending. In addition, VA, in

collaboration with the Department of Defense, is planning to

issue an RFP [request for proposals] for studies on emerging

pathogens including Hepatitis C. This initiative is supported

by funding in the DOD budget for VA/DOD collaborative

research.\30\

\30\Feb. 27, 1998, fax from VA to HR Subcommittee staff (in subcommittee

files).

VA researcher Dr. Gary Roselle published the first large study of HCV

infection in VA patients in November 1997. In a mandatory survey of VA

health care facilities, the number of HCV antibody positive patients

increased as follows:

6,612 in 1991

8,365 in 1992

14,097 in 1993

18,854 in 1994 (the last year with published data).

He concluded, ``This represents an increase of more than 285% during

the 4 year period.''\31\

\31\Gary A. Roselle, Linda H. Danko, Charles L. Mendenhall ``A Four-Year

Review of Patients with Hepatitis C Antibody in Department of Veterans

Affairs Facilities,'' Military Medicine, 162, 711 714, 1997.

Since most veterans are not treated in VA medical facilities, the

actual incidence of HCV infected veterans is undoubtedly much greater.

VA has not conducted widespread surveillance to ascertain the number of

infected veterans.

There is much speculation that Vietnam era veterans, now in their

40's and 50's, are at much greater risk of HCV infection due to heavy

transfusion activity during the Vietnam war. Dr. Roselle concluded, ``Of

particular interest to the VHA [Veterans Health Administration] is the

possible relationship of HCV disease with service in Southeast Asia

during the Vietnam era. Although HCV strain differences may not be

useful for determining specific sources of infection, amplification of

this blood-borne pathogen (e.g. transfusions) among the troops is a

conceivable explanation for a number of HCV infected persons identified

in this study. Further epidemiologic data will be required before this

issue and that of service connection can be resolved.''\32\

\32\Ibid.

Former Surgeon General C. Everett Koop is among physicians who have

called for an HCV screening program for all U.S. military personnel. In

May 1997, Senator Richard Shelby (R AL) asked the Pentagon to look

further into the possibility that immune globulins may have spread HCV.

The Pentagon did not agree to study the issue and Senator Shelby

inserted the following report language in the 1998 Department of Defense

Appropriations bill: ``The Department of Defense shall determine rates

of hepatitis C infection among personnel who served in deployments

overseas or who received blood plasma products from individuals infected

with hepatitis C and provide counseling and access to treatment for

personnel as needed.''\33\

\33\Senate Report 105 45, Committee on Appropriations, Department of

Defense Appropriation Bill, 1998.

DOD provides an exit physical for retiring and discharged service

personnel. Diagnosis of a medical condition is a basis for eligibility

for lifetime treatment in military hospitals and for a service-connected

disability for treatment in VA facilities.

DOD does not routinely include a test for HCV infection in the blood

series done at the exit physical or during annual physicals, although

new recruits are tested for HCV infection if they report a history of

hepatitis or are symptomatic of the infection.

The omission of the HCV test ensures that military personnel with

undiagnosed chronic HCV miss the opportunity for early detection and

treatment of the disease. Also, DOD does not have an accurate estimate

of the prevalence of HCV in the military. As a result, veterans cannot

establish a service connection for HCV infection contracted in military

service and are therefore not entitled to treatment for HCV or related

liver disease in VA facilities.

DOD stated in a fact sheet produced in July 1997 that, ``HCV

infections among military service members mirror those observed in the

United States civilian population . . .'' New recruits, like other young

people, have lower than average HCV infection rates. DOD policy is to

screen or treat when clinically indicated, despite the fact that

Hepatitis C rarely manifests acute symptoms.

Military service does involve exposure to some known risk factors for

transmission of HCV such as: contact with HCV infected blood in

training, in combat and through transfusions; medical and surgical care;

service in regions with high rates of HCV infection such as Asia and

North Africa; tattoos and IV and non-IV drug use.

DOD cites studies in which military members did not have increased

incidence of HCV infection. Those studies found no evidence that foreign

travel or other geographic risk factors placed military members at

greater rates of infection than non-military personnel.

Veterans who are seeking now to establish a service connection for

their HCV and liver disease are being rejected by the Board of Veterans

Appeals because they cannot show competent evidence of a nexus between

any disease in service and their current HCV. Of 1,599 chronic hepatitis

cases before the panel between 1994 and 1996, only 37 were approved,

according to recent analysis of case data collected by the Board and

made publicly available on CD ROM. The Board's decisions were based

largely on the conclusion that episodes of acute hepatitis during

service were ``healed'' prior to discharged, a conclusion that could be

refuted with a blood test at the time of discharge.

2. The HCV ``look back'' is too limited

HHS estimates that 1,183,537 persons received potentially

HCV-infected blood or blood products. Of that number, only 302,199, or

25 percent, would be directly informed with the look back program

instituted by HHS.\34\

The remaining 75 percent of individuals who had received potentially

HCV-infected blood would not be directly notified and would need to be

informed of their HCV risk through indirect, public notification

programs.

\34\Nov. 17, 1997, memorandum from Drs. Eric Goosby and Stephen

Nightingale, Office of HIV/AIDS Policy, to Dr. John Eisenberg, Acting

Assistant Secretary for Health, p. 4 5 (in subcommittee files).

The reason given by HHS for not requiring look back for individuals

who received transfusions prior to 1992 was that the first generation

test had a high false-positive rate. However, the first generation test

was sensitive enough to be relied upon to detect infection, and many of

those who tested positive were in fact infected and present a risk to

recipients of their blood.

The sensitivity of the first generation test was 84 89 percent, while

the sensitivity of the second generation test was 92 95 percent.\35\

The specificity of the first generation test was 22 percent, while the

specificity of the second generation test was 30 percent.\36\

To reduce the rate of false positives, the second generation test was

conducted using a confirmatory test for the positive results. A

confirmatory test was not available for the first generation test.

\35\Ibid., p. 2 3. Note: ``Sensitivity'' is defined as the ratio of true

positives over true positives plus false negatives. ``Specificity'' is

defined as the ratio of true negatives over true negatives plus false

positives.

\36\S. Kleinman, et al., ``Increased detection of hepatitis C virus

(HCV)-infected blood donors by a multiple antigen HCV enzyme

immunoassay,'' Transfusion, vol. 32, No. 9, p. 807, 1992.

HHS estimates that only 27,500 individuals, of the 1.1 million

Americans who received potentially HCV infected blood and blood

products, received units from an individual with a false-positive

test.\37\

Therefore, HHS' decision against a broader look back is based on the

fact that 2.75 percent of identified persons would not be truly

positive. HHS believes that direct notification of these additional

27,500 persons will result in an estimated cost of $45.9 million to

blood banks and hospital transfusion services.

\37\``Briefing Document on Public Health Service Options for the

Identification of Hepatitis C Virus Infection Among Prior Transfusion

Recipients,'' Mar. 28, 1996 (revised for Sept. 22, 1997, Resolution from

the Advisory Committee on Blood Safety and Availability-ACTION

memorandum by John M. Eisenberg to members of the Blood Safety

Committee) (in subcommittee files).

The look back as proposed by HHS is not consistent with the concept

of a patient's right to know critical medical information, such as HCV

infection. HHS drew an arbitrary line between those who will be notified

and those who will not simply by virtue of the fact that they were

infected before 1992. This critical, public health decision was

determined by the costs to the blood banks and transfusion services of

identifying and contacting 2.75 percent of the cohort.

3. Private organizations, with some Federal assistance, have

taken the lead in HCV public education efforts

Within 2 weeks of the issuance of the Committee on Government Reform

and Oversight's August 1996 oversight report, ``Protecting the Nation's

Blood Supply from Infectious Agents: The Need for New Standards to Meet

New Threats,'' the American Liver Foundation ran ads in USA Today and

other publications advising recipients of blood transfusions prior to

1990 to seek HCV testing.

Since 1996, the American Liver Foundation has spent an estimated $7.5

million on its Hepatitis C public awareness and education program called

``T.H.I.N.K. Hepatitis'' which stands for ``The Hepatitis Information

You Need to Know.'' The program is targeted to the general public,

patients and health professionals. CDC provided $150,000 of support for

this program through a cooperative agreement.\38\

\38\Sept. 11, 1998, letter from American Liver Foundation President Alan

P. Brownstein to Chairman Shays (in subcommittee files).

The Association of State and City Health Officials [ASCHO] received

$50,000 from CDC in fiscal year 1998 to administer focus groups to help

CDC develop CDC materials for providers and at-risk populations. ASCHO

has been approved by CDC for another $75,000 in fiscal year 1999 for

development of additional materials for at-risk populations.\39\

\39\HR Subcommittee staff conference call with Donna Grossman,

Association of State and City Health Officials, Oct. 1, 1998 (notes in

subcommittee files).

The Hepatitis Foundation International [HFI] received $50,000 in

fiscal year 1998 to develop an educational video on Hepatitis B and

Hepatitis C prevention. HFI received verbal notification that CDC will

provide $178,000 in fiscal year 1999 to assist in video distribution

efforts. HFI participated jointly with CDC in a November 1997 satellite

teleconference for physicians.

Several prominent researchers, physicians, and consumers believe that

the lack of a public health campaign has fueled the perception in the

medical community that HCV was strictly an IV drug abusers' disease and

has delayed medical and public recognition of the extent of its spread

throughout all levels of society.

Ann Jesse, now executive director of the Hep C Connection, described

in testimony at the March 5, 1998, hearing how it took over 20 years for

her HCV infection to be diagnosed following a blood transfusion in 1973,

due in part to the perception of her doctors that a 62 year old,

Caucasian grandmother didn't fit the usual profile of an HCV

patient.\40\

\40\Statement of Ann Jesse, HR Subcommittee hearing Mar. 5, 1998, p. 83

85.

Dr. Carroll M. Leevy, director of the Sammy Davis Jr. Liver Institute

in Newark, NJ, described in testimony at the HR Subcommittee's March 5,

1998 hearing that 30 percent of his patients from suburban New Jersey

who are coming in for HCV treatment are without identifiable risk

factors for the disease.

Dr. Leevy also discussed the disproportionate impact that HCV is

having on minority communities, where 3.2 percent of African Americans

and 2 percent of Hispanics are affected in comparison to 1.2 percent of

Caucasians. He recommended a public education campaign with a variety of

educational models to inform at risk individuals of HCV, enable them to

be screened, and provide appropriate support to ensure therapeutic

compliance.

IV. RECOMMENDATIONS

1. a. The Secretary of Health and Human Services should take

the lead in coordinating the Federal public health response to the

Hepatitis C epidemic, including implementation of a research plan.

b. The Department of Defense should test recruits, active

duty personnel and those about to be discharged for Hepatitis C

infection.

c. The Department of Veterans Affairs should conduct

additional studies of prevalence of HCV in veterans populations.

HHS,\41\

DOD and VA should undertake a coordinated research campaign to educate

and reduce the incidence of Hepatitis C. Basic research on epidemiology,

surveillance, modes of transmission, vaccine development and therapeutic

interventions is overdue, poorly planned, and involves several cabinet

departments and numerous Federal agencies. The Federal response is

inadequate to an infection that threatens every American and has already

infected 1 of every 50 adult citizens.

\41\HHS public health agencies include: the Food and Drug Administration

[FDA], the Centers for Disease Control and Preventions [CDC], the

National Institutes of Health [NIH] and the Health Care Financing

Administration [HCFA].

Dr. C. Everett Koop, former Surgeon General, testified at the March

5, 1998, hearing:

We need a coordinated Federal effort that reaches

across the relevant agencies and identifies activities that

can be significant in training physicians, raising public

awareness, and seeking out target populations for screening

and treatment. I believe we have a 5-year window to identify

and treat a significant proportion of the infected population

if we are to head off the huge increase of liver disease I

believe is ahead.\42\

\42\Statement of Dr. C. Everett Koop, HR Subcommittee hearing, Mar. 5,

1998, p. 58.

A comprehensive, interagency HCV research plan should be developed by

HHS, VA and DOD to identify gaps in HCV knowledge and ensure that the

millions of public health research dollars are directed to best meet

public health goals.

At the March 5, 1998, HR Subcommittee hearing, Dr. Koop announced his

``Prescription for Action on Hepatitis C'' which included screening and

treatment recommendations for DOD personnel and veterans. He testified,

``It is my understanding that there has been a lack of attention to this

disease in the Department of Defense or in the Department of Veterans

Affairs where rates of infection are likely to be high and where

screening and treatment can have a positive impact.''\43\

\43\Ibid, p. 56.

He added:

In some studies of veterans entering the Department

of Veterans Affairs health facilities, half of the veterans

have tested positive for HCV. Some of these veterans may have

left the military with HCV infection, while others may have

developed it after their military service. In any event, we

need to detect and treat HCV infection if we are to head off

very high rates of liver disease and liver transplant in VA

facilities over the next decade. I believe this effort should

include HCV testing as part of the discharge physical, and

entrance screening for veterans entering the VA health

system.\44\

\44\Ibid.

A coordinated approach to combating HCV in the military requires DOD

testing of all recruits upon entrance, all active duty personnel and

those about to be discharged. VA, in turn, must initiate additional

studies of prevalence of HCV in veterans populations to detect those

patients most likely to benefit from new therapies and to avoid

increased demand for costlier liver transplants.

2. The Hepatitis C look back plan should be expanded.

HHS should immediately take steps to ensure notification of all

recipients of blood from donors who have tested positive on any HCV

screening test, regardless of date. Infected individuals have a right to

know of their infection. HHS should not draw an arbitrary line between

those who will be notified of their infection after 1992, and those who

were unfortunate enough to be infected prior to 1992.

The vast majority of the 1 million Americans infected by transfusion

were infected prior to 1992. They deserve no less ethical consideration

than those infected after 1992.

3. Federal educational campaigns on HCV infection should be

launched immediately.

In testimony before the Human Resources Subcommittee on October 12,

1995, Health and Human Services [HHS] Secretary Donna Shalala committed

that Hepatitis C would be a top priority for the Department's new blood

safety committees.

In the spring of 1998, the CDC presented the HHS Blood Safety Council

with a comprehensive public education plan entitled, ``Plan to Prevent

HCV Infection and Its Chronic Disease Consequences.'' HHS declined to

include the plan in the fiscal year 1999 HHS Budget Request. HHS also

decided against seeking a supplemental appropriation to fund the plan in

the summer of 1998.

To date, 200,000 physicians have received HCV practice information

kits. HHS should immediately implement broader HCV public education plan

and seek the funding necessary to accomplish it.