[House Report 105-820]
[From the U.S. Government Publishing Office]



                                                 Union Calendar No. 461

105th Congress, 2d Session  -  -  -  -  -  -  -  - House Report 105-820


 
       HEPATITIS C: SILENT EPIDEMIC, MUTE PUBLIC HEALTH RESPONSE

                               __________

                             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, 
DAVID M. McINTOSH, Indiana             DC
MARK E. SOUDER, Indiana              CHAKA FATTAH, Pennsylvania
JOE SCARBOROUGH, Florida             ELIJAH E. CUMMINGS, Maryland
JOHN B. SHADEGG, Arizona             DENNIS J. KUCINICH, Ohio
STEVEN C. LaTOURETTE, Ohio           ROD R. BLAGOJEVICH, Illinois
MARSHALL ``MARK'' SANFORD, South     DANNY K. DAVIS, Illinois
  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 
DAN MILLER, Florida                  (Independent)
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


                         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.


                            C O N T E N T S

                               __________
                                                                   Page
  I. Summary..........................................................1
 II. Background.......................................................2
III. Findings.........................................................4
 IV. Recommendations.................................................13



                                                 Union Calendar No. 461
105th 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\
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    \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\
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    \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.

                                
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