[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\
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\1\ NIH Consensus Development Statement ``Management of Hepatitis
C,'' Mar. 24-26, 1997 (in subcommittee files).
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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.
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\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.
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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.
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\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.
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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.
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\6\ Written communication from Centers for Disease Control to
subcommittee staff, Sept. 15, 1998 (in subcommittee files).
\7\ Ibid.
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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\
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\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\
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\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.
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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.
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\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).
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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\
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\13\ Testimony of Dr. David Satcher, HR Subcommittee hearing, Mar.
5, 1998, p. 7.
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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.
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\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.
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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,
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\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\
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\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.
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\17\ FDA web site announcement (www.fda.gov/cber/whatsnew/htm),
Sept. 9, 1998.
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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\
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\18\ Blood Safety: Minimizing Plasma Product Risks, 105th Cong., 2d
sess., p. 22 of original transcript (1998) (testimony of Dr. Michael
Friedman).
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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\
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\19\ Testimony of Dr. Jay Epstein, HR Subcommittee hearing, Sept.
9, 1998, p. 24 of original transcript.
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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\
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\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.
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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\
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\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\
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\24\ Feb. 26, 1998, correspondence from NIH Congressional Affairs
Office to HR Subcommittee staff (in subcommittee files).
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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.
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\25\ Sept. 18, 1998, letter from Audrey Wright Spolarich, Health
Policy Analysts, to Subcommittee staff (in subcommittee files).
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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\
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\26\ Statement of Dr. Teresa Wright, American Liver Foundation, HR
Subcommittee hearing Mar. 5, 1998, p. 65-73.
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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\
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\27\ House Report 105-205, ``Departments of Labor, Health and Human
Services, and Education, and Related Appropriation Bill, 1998,'' p.
100.
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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\
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\28\ Department of Health and Human Services, National Institutes
of Health, ``Liver and Biliary Diseases Strategic Plan,'' March 1998
(in subcommittee files).
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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\
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\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).
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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\
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\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
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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.
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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\
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\32\ Ibid.
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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.
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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.
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\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).
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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.
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\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.
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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.
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\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).
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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\
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\38\ Sept. 11, 1998, letter from American Liver Foundation
President Alan P. Brownstein to Chairman Shays (in subcommittee files).
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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\
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\39\ HR Subcommittee staff conference call with Donna Grossman,
Association of State and City Health Officials, Oct. 1, 1998 (notes in
subcommittee files).
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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\
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\40\ Statement of Ann Jesse, HR Subcommittee hearing Mar. 5, 1998,
p. 83-85.
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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.
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\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].
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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\
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\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\
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\43\ Ibid, p. 56.
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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\
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\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.