http://forhealthfreedom.org/Publications/Monopoly/hr820.txt
51 351 CC
1998
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, DC
DAVID M. McINTOSH,
Indiana
CHAKA FATTAH, Pennsylvania
MARK E. SOUDER, Indiana
ELIJAH E. CUMMINGS, Maryland
JOE SCARBOROUGH, Florida
DENNIS J. KUCINICH, Ohio
JOHN B. SHADEGG, Arizona
ROD R. BLAGOJEVICH, Illinois
STEVEN
C. LaTOURETTE,
Ohio
DANNY K. DAVIS, Illinois
MARSHALL ``MARK''
SANFORD, South Carolina
JOHN F. TIERNEY, Massachusetts
JOHN E. SUNUNU, New
Hampshire
JIM TURNER, Texas
PETE SESSIONS, Texas
THOMAS H. ALLEN, Maine
MICHAEL PAPPAS, New
Jersey
HAROLD E. FORD, Jr., Tennessee
VINCE SNOWBARGER, Kansas
------
BOB BARR, Georgia
BERNARD SANDERS, Vermont (Independent)
DAN MILLER, Florida
RON LEWIS, Kentucky
Kevin Binger, Staff
Director
Daniel R. Moll,
Deputy Staff Director
David A. Kass,
Parliamentarian and Deputy Counsel
Lisa Smith Arafune,
Deputy Chief Clerk
Phil Schiliro,
Minority Staff Director
SUBCOMMITTEE ON HUMAN RESOURCES
CHRISTOPHER SHAYS,
Connecticut, Chairman
VINCE SNOWBARGER, Kansas
EDOLPHUS TOWNS, New York
BENJAMIN A. GILMAN, New
York
THOMAS H. ALLEN, Maine
DAVID M. McINTOSH,
Indiana
TOM LANTOS, California
MARK E. SOUDER, Indiana
BERNARD SANDERS, Vermont (Ind.)
MICHAEL PAPPAS, New
Jersey
THOMAS M. BARRETT, Wisconsin
------ ------
DENNIS J. KUCINICH, Ohio
EX OFFICIO
DAN BURTON, Indiana
HENRY A. WAXMAN, California
Lawrence J. Halloran,
Staff Director and Counsel
Anne Marie Finley,
Professional Staff Member
Jesse S. Bushman,
Clerk
(II)
LETTER OF TRANSMITTAL
House of Representatives,
Washington, DC, October 15, 1998.
Hon. Newt Gingrich,
Speaker of the House of Representatives,
Washington, DC.
Dear Mr. Speaker : By direction of the
Committee on Government
Reform and Oversight, I submit herewith the committee's seventh
report
to the 105th Congress. The committee's report is based on a study
conducted by its Subcommittee on Human Resources.
Dan Burton,
Chairman.
(iii)
?
C O N T E N T S
I. Summary
1
II. Background
2
III. Findings
4
IV. Recommendations
13
Union Calendar No. 461
105 th Congress
Report
HOUSE OF REPRESENTATIVES
2d Session
105 820
HEPATITIS
C: SILENT EPIDEMIC, MUTE
PUBLIC HEALTH RESPONSE
October 15, 1998.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
Mr. Burton, from the Committee on Government Reform and Oversight,
submitted the following
SEVENTH REPORT
On October 8, 1998, the Committee on Government
Reform and Oversight
approved and adopted a report entitled, ``Hepatitis
C: Silent Epidemic,
Mute Public Health Response.'' The chairman was directed to
transmit a
copy to the Speaker of the House.
I. SUMMARY
Called ``the silent epidemic,'' the spread of
Hepatitis
C Virus [HCV]
infection has evoked a Federal public health response almost as
mute.
Hepatitis
C poses a daunting
challenge to public health. Chronic
infection can linger without symptoms for more than 20 years, then
produce profound health consequences, including liver failure and
cancer. There is no preventive vaccine or universally effective
treatment. Up to 10,000 will die this year from the disease. That
number
could triple in the next two decades, according to the Centers for
Disease Control and Prevention [CDC].\1\
\1\NIH Consensus Development Statement ``Management of
Hepatitis
C,''
Mar. 24 26, 1997 (in subcommittee files).
HCV has now spread to an estimated 4 million
Americans. Eighty-five
percent of those infected develop chronic liver disease and about
10 to
20 percent develop cirrhosis of the liver about 20 years after the
onset
of infection.\2\
HHS estimates the total societal cost of
Hepatitis
C at more than $600
million per year.\3\
More than a million persons received HCV infected blood and
blood
products.\4\
Most are unaware of their infection.
\2\ Public Health 2000: Hepatitis
C--The Silent Epidemic,
105th Cong.,
2d sess., p. 6 (subcommittee hearing, Mar. 5, 1998) (prepared
statement
of Surgeon General David Satcher).
\3\Ibid, p. 6.
\4\Ibid, p. 6.
They need to be told. They need to be tested.
Many will need
treatment, and many will need to learn how to prevent further
spread of
the disease to their spouses, sexual partners, and household
members.
But HHS plans to ``look back'' for people
infected through blood have
sputtered, and little has been accomplished. Disease reporting and
surveillance is uneven. Research into HCV is uncoordinated.
Education on
prevention and treatment has been undertaken primarily by private
sector
organizations.
Unless confronted more boldly, more directly, and
more loudly by the
Department of Health and Human Services [HHS], the threat posed by
Hepatitis C
will only grow more ominous. As we learned when the
Human
Immunodeficiency Virus [HIV] breached our public health defenses,
scientific uncertainty, cultural biases and bureaucratic inertia
can
thwart the actions needed to repel an elusive viral invader.
In a 1996 oversight report, this Committee
recommended HHS take steps
to notify the 300,000 or more Americans known to have been infected
with
Hepatitis C
through blood before 1990.\5\
To date, that has not been done. The time for pondering the
appropriate, pro-active public health response to
Hepatitis
C is past.
The time for aggressive implementation is at hand.
\5\ Protecting the Nation's Blood Supply from Infectious Agents:
The
Need for New Standards to Meet New Threats, 10th Report by the
Committee
on Government Reform and Oversight, Aug. 2, 1996.
Findings in brief:
1. The Federal response to the
Hepatitis
C epidemic has lacked
focus
and energy.
2. The proposed HCV ``look back'' is too limited.
3. Private organizations, with some Federal
assistance, have taken
the lead in HCV public education efforts.
Recommendations in
brief:
1. a. The Secretary of Health and Human Services
should take the lead
in coordinating the Federal public health response to the
Hepatitis
C
epidemic, including implementation of a research plan.
b. The Department of Defense should test
recruits, active duty
personnel and those about to be discharged for
Hepatitis
C infection.
c. The Department of
Veterans Affairs should conduct additional
studies of the prevalence of HCV in veterans populations.
2. The Hepatitis
C look back plan should
be expanded.
3. Federal educational campaigns on HCV infection
should be launched
immediately.
II. BACKGROUND
The Centers for Disease Control [CDC] estimate
that at least 4
million Americans are infected with the
Hepatitis C Virus
[HCV], which
was formerly known as ``non-A, non-B
hepatitis.'' HCV is a liver disease
agent found in the blood of infected persons. Infection may occur
through intranasal exposure (cocaine use), injection of street
drugs,
accidental needle stick injuries to health care workers,
transfusion of
infected blood and plasma products, transplantation of solid organs
(such as kidney, liver, heart), kidney dialysis, maternal to fetal
transmission and through exchange of bodily fluids.
Secondary transmission to spouses and maternal
transmission to
fetuses in utero has been documented, but the extent of
transmissibility
is not known. In addition, more than 40 percent of infected persons
do
not have histories of risk factors, suggesting a possible unknown
route
of transmission. There is no vaccine to prevent the disease and NIH
estimates that vaccine development will take at least a decade.
CDC estimates that 28,000 180,000 new HCV
infections occur each year.
Only 25 30 percent of infections are symptomatic. Many HCV infected
individuals are not aware of their infection until signs of liver
failure appear, often decades after infection. This has prompted
some to
call HCV, the ``silent epidemic.''
Hepatitis
C is responsible for an
estimated 8,000 10,000 deaths
annually in the United States. According to current estimates, more
people will die of HCV in the year 2000 than will die of AIDS.
An estimated 1 million Americans received blood
from a donor who
subsequently tested positive for Hepatitis
C.\6\
Of these people, CDC estimates 700,000 may have tested
positive with
the first generation anti-HV test which was introduced in 1990. The
first generation test had a higher false positive rate than later
generation tests and there was little confirmatory testing
performed in
this group of tested donors.\7\
A more precise ``second generation'' HCV screening test
became
available in 1992.
\6\Written communication from Centers for Disease Control to
subcommittee staff, Sept. 15, 1998 (in subcommittee files).
\7\Ibid.
CDC concedes,
it is not possible to estimate the TOTAL number of
living persons with
transfusion associated HCV infection from
the look back estimates,
since these estimates do not extend
before 1990. CDC has
estimated that approximately 300,000 of
the 4 million living
anti-HCV positive persons acquired their
infection from blood
transfusion.
CDC arrived at this estimate using the National
Health and Nutrition
Examination Survey [NHANES] data and
Sentinel Counties
surveillance data concerning the proportion
of HCV infections that
were transfusion associated at various
time periods.\8\
\8\Ibid.
Treatment of HCV is usually with interferon and
approximately 12 15
percent of individuals will clear the infection with the first
treatment. There is some evidence that individuals with HCV who do
not
respond to the first treatment may be able to clear the infection
with a
second round of treatment, or with higher dosages of interferon or
combinations of drugs. Many infected persons do not develop
symptoms.
Others, however, will develop severe cirrhosis of the liver, which
will
require a liver transplant or be fatal. Cirrhosis caused by HCV
infection is the primary reason for liver transplants in the United
States.
In the 104th Congress, the Committee issued a
report entitled,
``Protecting the Nation's Blood Supply from Infectious Agents: The
Need
for New Standards to Meet New Threats,'' (House Report 104 746)
which
contained several recommendations including one to require the
Department of Health and Human Services to ensure that the
estimated
300,000 living recipients of blood and blood products who may have
been
infected with Hepatitis
C Virus before 1990 are
notified of their
potential infection so they might seek diagnosis and treatment.
III. FINDINGS
1. The Federal response to the
Hepatitis C epidemic
has
lacked energy and focus
Since 1989, when the
Hepatitis C Virus
[HCV] was first unmasked,
federal public health agencies have often pondered, but never
implemented, a comprehensive response to this insidious infectious
agent.
The FDA's Blood Products Advisory Committee [BPAC]
considered whether
patients who received the HCV infected units should be notified of
their
exposure (a.k.a. ``look back'') on all of the following dates:
October
31, 1989; January 17 18, 1991; September 26 27, 1991; March 12 13,
1992;
March 25 26, 1993; December 2 3, 1993; and December 15 16, 1994.
However, the BPAC did not take action on this issue, even though
treatment options were available to infected persons if they had
been
told of their infection.
The FDA's July 19, 1996, Guidance Memorandum\9\recommended
quarantine and disposition of certain prior
collections of blood and blood components from
donors who tested repeatedly reactive to HCV
antibodies. At that time, FDA did not recommend
notification of
recipients of blood from donors who subsequently test positive for
anti-HCV, because ``no clear consensus on the public health benefit
of
such action had emerged.''\10\
\9\July 19, 1996, memorandum from Director, Center for Biologics
Evaluation and Research to All Registered Blood and Plasma
Establishments (in subcommittee files).
\10\``Guidance for Industry: Supplemental Testing and the
Notification
of Consignees of Donor Test Results for Antibody to
Hepatitis
C Virus
(Anti-HCV),'' background section, Mar. 20, 1998.
In testimony before the Human Resources [HR]
Subcommittee on October
12, 1995, HHS Secretary Donna Shalala committed that the HCV look
back
notification would be the first issue considered by the new HHS
Advisory
Committee on Blood Safety and Availability [NACBSA]. NACBSA
reviewed the
notification issue at its meetings 2 years later, in April and
August
1997.
At the August 12, 1997, meeting, a look back was
recommended by the
Committee for individuals who had received blood which had tested
positive for HCV on the second generation screening test
implemented in
1992. Some members of the NACBSA\11\
wanted a more extensive look back, feeling that a less
comprehensive
approach was unethical because many infected individuals would not
be
contacted by a look back triggered only by HCV donors detected
after
1992.\12\
CDC did not provide an estimate of how many of the 1.1
million
Americans who received potentially HCV-infected blood did so before
1992. However, CDC concludes the possibility of transmission was
much
higher before the 1992 introduction of more effective screening and
testing.
\11\Dr. John Penner, Dr. Arthur Caplan, Dr. Dana Kuhn, Dr. Ronald
Gilcher, and Ms. Tricia O'Connor.
\12\Aug. 31, 1997, letter from NACBSA member John Penner
M.D., to NACBSA
Chairman Arthur Caplan, Ph.D., (in subcommittee files).
The NACBSA recommendation was reviewed by the
Public Health Service
[PHS] operating divisions (FDA, CDC, NIH, et cetera) prior to its
presentation to the Blood Safety Committee on November 4, 1997, and
December 3, 1997. The recommendation was communicated to Secretary
Shalala on December 22, 1997.
The recommendation was discussed with HHS Deputy
Secretary Kevin
Thurm on January 13, 1998, and with the Secretary on January 22,
1998.
Secretary Shalala communicated her decision to accept the
recommendation
to NACBSA Chairman Arthur Caplan on January 28, 1998.
On March 5, 1998, HHS Surgeon General David
Satcher announced the HCV
look back and education plan in testimony at a Human Resources [HR]
Subcommittee hearing. He testified that HHS has ``established a
comprehensive plan to address this significant public health
problem. It
is our intention to reach effectively as many people at risk as we
can.''\13\
\13\Testimony of Dr. David Satcher, HR Subcommittee hearing, Mar.
5,
1998, p. 7.
On February 11, 1998, Dr. John Eisenberg, HHS
Acting Assistant
Secretary for Health and acting chairman of the Blood Safety
Committee,
requested specific responses with time lines from the FDA, CDC, and
the
Agency for Health Care Policy and Research [AHCPR] on the status of
the
agencies' HCV notification and education plans.
The FDA response was the publication of a
Guidance to Industry on
March 20, 1998, in the Federal Register. \14\
The guidance recommended that blood banks identify past
donors of blood
who have tested positive for HCV antibodies on the 1992 second
generation test and notify the hospital blood banks and transfusion
services that units taken from those donors may be infected. The
hospital should then notify either at-risk patients or their
doctors
directly by September 20, 1998.
\14\``Guidance for Industry: Supplemental Testing and the
Notification
of Consignees of Donor Test Results for Antibody to
Hepatitis
C Virus
(Anti-HCV),'' Federal Register, Mar. 20, 1998.
The CDC and AHCPR responses were received by HHS
on April 10, 1998,
and further discussed at the June 18, 1998 Blood Safety Committee
meeting. HHS pledged to undertake additional public education
campaigns
to notify additional persons who may have received HCV-infected
transfusions. HHS pledged to evaluate the success of the direct
notification efforts and committed to take additional, unspecified
steps
to identify other at risk groups for HCV infection.
Surgeon General Satcher, who had been asked by
the Secretary to lead
the notification and look back efforts,\15\
stated in a letter to Chairman Shays that,
\15\Testimony of Dr. David Satcher, HR Subcommittee hearing, Mar.
5,
1998, p. 6.
responses from the public, notably from America's
Blood Centers (ABC), the
American Association of Blood Banks
(AABB), and the American
Red Cross (ARC) were received on May
19 and 20, 1998. I met
with the leadership of the American
Association of Blood
Banks, as representatives of these other
organizations, on May 24,
1998. In response to these and other
communications, FDA
announced plans to revise its Guidance to
Industry at the Blood
Products Advisory Committee meeting on
June 18, 1998,
specifically in the areas of additional testing
of donor samples and
implementation time frames.\16\
\16\Sept. 18, 1998, letter from Surgeon General David Satcher to
Chairman Shays (in subcommittee files).
CDC organized a Consultant's Conference to plan
implementation of the
HCV education initiative on July 15 17, 1998. A followup workshop
for
industry, cosponsored by ABC, AABB, and ARC was held on August 25
26,
1998, and suggestions arising at this workshop were communicated to
the
Department on September 9, 1998. On October 16, 1998, CDC will
publish
``Recommendation for the Prevention and Control of
Hepatitis
C Virus
[HCV] Infection and HCV-Related Chronic Disease'' in Morbidity and
Mortality Weekly Report.
On September 8, 1998, FDA withdrew the March 20,
1998, ``Guidance for
Industry: Supplemental Testing and the Notification of Consignees
of
Donor Test Results for Antibody to
Hepatitis C Virus
(Anti-HCV).''\17\
Unexpectedly, no other guidance was issued in place of the
first
guidance and the agency did not commit itself to a date certain for
re-issuance. The agency's action removed FDA's recommendation that
blood
establishments should begin notifying consignees within 6 months of
the
date of publication of guidance (i.e. by September 20, 1998)
concerning
results of donations tested prior to the date of implementation of
the
guidance.
\17\FDA web site announcement (www.fda.gov/cber/whatsnew/htm),
Sept. 9,
1998.
At the HR Subcommittee's September 9, 1998
hearing, Chairman Shays
asked FDA Acting Commissioner Michael Friedman for a status report
on
the HCV look back and education campaign. Dr. Friedman responded,
``. .
. the commitment given by Dr. Satcher, not just on the part of FDA
but
on the part of the entire Health and Human Services, indicated a
serious
organization-wide commitment and look-back campaign.''\18\
\18\ Blood Safety: Minimizing Plasma Product Risks, 105th Cong., 2d
sess., p. 22 of original transcript (1998) (testimony of Dr.
Michael
Friedman).
FDA's Office of Blood Research and Review
Director Jay Epstein, M.D.,
stated, in response to a question from Chairman Shays about the
status
of hospital identification of HCV infected transfusion patients,
that,
``FDA published a guidance in March of this year which directed the
blood organization to identify the units where the donor
subsequently
was learned to . . . [seroconvert] to
Hepatitis C. The
process of
tracing those records, we believe, has been ongoing since that time
. .
.''\19\
\19\Testimony of Dr. Jay Epstein, HR Subcommittee hearing, Sept. 9,
1998, p. 24 of original transcript.
At no point during the hearing did any FDA
witness volunteer that the
March 20, 1998, Guidance to Industry on HCV look back had been
withdrawn
the day before. Blood collection organizations were notified by FDA
of
the impending withdrawal of the guidance by telephone call on
August 28,
1998.\20\
Consumer groups such as the American Liver Foundation and the
Hep C
Connection were not notified of FDA's action in advance.\21\
No written notices were sent by FDA of the agency's
instructions to
blood banking organizations and no written records were kept of
these
exchanges.\22\
\20\AABB Weekly Report, ``HCV Look back Update,'' American
Association
of Blood Banks newsletter, Sept. 4, 1998, Bethesda,
MD, vol. 4, No. 34,
p. 1.
\21\HR Subcommittee staff telephone conference call with Allan
Brownstein, executive director, American Liver Foundation, Sept.
10,
1998, and with Ann Jesse, executive director, Hep
C Connection, on Sept.
14, 1998.
\22\HR Subcommittee staff conversation with Melinda Plaisier,
Deputy
Associate Commissioner for Legislative Affairs, Sept. 10, 1998.
Dr. Epstein also testified that, while the blood
banks had told the
agency that letters to recipients had been sent, FDA had no
independent
verification that this had occurred and was simply relying on the
industry's verbal assurances that identification of suspected
HCV-infected units had been achieved. Dr. Friedman acknowledged
that no
recipient of HCV-infected blood products has yet received a letter
informing him or her of possible infection.
On September 23, 1998, FDA issued a revised
``Guidance for Industry:
Current Good Manufacturing Practice for Blood and Blood Components:
(1)
Quarantine and Disposition of Units from Prior Collections from
Donors
with Repeatedly Reactive Screening Tests for Antibody to
Hepatitis
C
Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of
Consignees and Blood Recipients of Donor Test Results for
Anti-HCV.''
The revised guidance grants blood establishments another 6 months
from
the date of issuance of the guidance to begin notifying consignees
(i.e.
March 23, 1999). FDA recommends that this notification be completed
within 18 months of the date of publication of the guidance. This
guidance suggests, but does not require, that individuals who
received
potentially HCV-infected blood and blood products should be
notified by
March 23, 2000.
In testimony at the June 18, 1998, FDA Blood
Products Advisory
Committee [BPAC], Dr. Hal Margolis, Director of CDC's
Hepatitis Branch
described HHS' view of the HCV look back.
Basically it has been our perception and our
assumption that, in fact,
the targeted look back is something
that is primarily going
to be conducted by the blood industry,
both by the blood
collection agency as well as the transfusion
services. In fact, as far
as public sector programs, that is
something that PHS, other
than the guidance and much of the
supporting educational
material, has not put together a major
effort or plans for
conducting.\23\
\23\Transcript of June 18, 1998, Blood Products
Advisory Committee
meeting, p. 21 (in subcommittee files).
The National Institutes of Health [NIH] have
conducted an equally
sluggish and fragmented approach to research on HCV. Basic research
on
Hepatitis C
is conducted at NIH by seven different Institutes:
the
National Cancer Institute [NCI], National Heart, Lung and Blood
Institute [NHLBI], National Institute of Diabetes, Digestive and
Kidney
Diseases [NIDDK], National Institute of Allergy and Infectious
Diseases
[NIAID], National Institute of Drug Abuse [NIDA], National
Institute of
Alcoholism and Alcohol Abuse [NIAAA], and the National Center for
Research Resources [NCRR].
Research moneys have increased during the last 3
fiscal years from
$25,300,00 in fiscal year 1997, to an estimated $29,835,000 in
fiscal
year 1998, to an estimated $34,405,000 in fiscal year 1999. These
figures include both intramural and extramural funding. NIH did not
keep
Hepatitis C
funding figures prior to 1997, according to the NIH
Budget
Office.\24\
\24\Feb. 26, 1998, correspondence from NIH Congressional Affairs
Office
to HR Subcommittee staff (in subcommittee files).
In contrast, one pharmaceutical company alone
spent $25 million in
1996 on HCV research.\25\
Dr. Teresa Wright, medical advisor to the American Liver
Foundation and
director of the Liver Clinic at the San Francisco VA Hospital, told
subcommittee staff that HCV research is largely ``pharmaceutical
company
driven'' due to the large potential market for HCV therapies.
\25\Sept. 18, 1998, letter from Audrey Wright Spolarich, Health
Policy
Analysts, to Subcommittee staff (in subcommittee files).
Consumer groups such as the American Liver
Foundation have criticized
the allocation of resources to hepatitis
programs by HHS. They feel
hepatitis transmission and treatment
research funding is not
commensurate to the threat the disease presents to public
health.\26\
\26\Statement of Dr. Teresa Wright, American Liver Foundation, HR
Subcommittee hearing Mar. 5, 1998, p. 65 73.
On July 22, 1997, the House Committee on
Appropriations included
report language to accompany the NIH appropriations bill which
noted
that ``the March 1997 Hepatitis
C [HCV] consensus
conference made
significant new research recommendations that affect several NIH
Institutes and, therefore, requests that the Office of the Director
play
a role in coordinating this research in order to most effectively
respond to the HCV epidemic.''\27\
\27\House Report 105 205, ``Departments of Labor, Health and Human
Services, and Education, and Related Appropriation Bill, 1998,'' p.
100.
NIH established the coordinating committee on
February 12, 1998. Dr.
Anthony Fauci, Director of NIAID, chairs the committee.
NIAID is attempting to develop an HCV
preventative vaccine. However,
NIAID researchers told HR Subcommittee staff that a vaccine is at
least
10 years away due to the variety (21) in genomic types of the HCV
virus.
NIAID has proposed a strategic plan for
Hepatitis
C research to guide
NIAID programs in this area. NIAID recently established 4
Hepatitis
C
Cooperative Research Centers at Stanford, University of Texas
Medical
Center at Galveston, University of Southern California and the
University of Washington. In 1997, the NIDDK developed a long range
strategic plan for liver disease research, which includes
Hepatitis
C.
The Strategic Plan for Liver Disease Research was transmitted to
Congress prior to submission of the fiscal year 1999 budget, as
requested by the House and Senate Appropriations Committees.\28\
\28\Department of Health and Human Services, National Institutes of
Health, ``Liver and Biliary Diseases Strategic Plan,'' March 1998
(in
subcommittee files).
It is noteworthy that the National Institute
on Drug Abuse [NIDA]
spent the most NIH resources and continues to spend the most
resources
on HCV research, which may reflect an institutional bias within HHS
that
HCV is a disease of injection drug users. This bias may have worked
against early recognition of HCV as a broader public health
problem.
The Centers for Disease Control and Prevention
[CDC] have developed a
comprehensive, nationally-focused plan for the prevention and
control of
HCV infection, entitled ``A Prevention and Control Plan for
Hepatitis
C
Virus Infection.'' Components of the plan include counseling and
testing, professional and public education, surveillance,
epidemiology
and laboratory investigation, and evaluation. CDC estimates that
the
plan will cost $48 million. The plan was submitted to HHS on April
14,
1998, but was not discussed by the HHS Blood Safety Committee due
to HHS
refusal to commit the requested funds to this CDC program.\29\
\29\HR Subcommittee staff conversations with Dr. Eric Goosby, HHS
Office
of HIV/AIDS and with Marc Smolonsky, Office of the Assistant
Secretary
for Legislation, Sept. 18, 1998 (notes in subcommittee files).
Note:
Total CDC spending on HCV Public Education Activities for fiscal
year
1998 was $716,894 (in subcommittee files).
To date, CDC conducted an educational satellite
teleconference for
primary care physicians on November 22, 1997, with subsequent
distribution of a conference audiotape to 200,000 medical
professionals
in the summer of 1998. CDC has assisted private organizations such
as
the American Liver Foundation, Hepatitis
Foundation International and
the National Association of County and City Health Officers in the
development, evaluation and dissemination of educational materials
for
populations at risk of HCV infection.
VA spent $11,546,423 on HCV from fiscal years
1988 1997, primarily on
drug trials. In addition,
the VA Cooperative Studies program is currently
planning a large-scale
treatment trial to determine whether
interferon can prevent
progressive liver disease in veterans
infected with
Hepatitis
C Virus. The study will
include more
than 500 veterans at 17
VA medical facilities nationwide.
Enrollment of patients is
expected to take 3 years, and each
veteran enrolled will be
treated for 4 years. The total
duration of the study is
expected to be 7 years. Final
approval of the study is
pending. In addition, VA, in
collaboration with the
Department of Defense, is planning to
issue an RFP [request for
proposals] for studies on emerging
pathogens including
Hepatitis
C. This initiative is
supported
by funding in the DOD
budget for VA/DOD collaborative
research.\30\
\30\Feb. 27, 1998, fax from VA to HR Subcommittee staff (in
subcommittee
files).
VA researcher Dr. Gary
Roselle published the
first large study of HCV
infection in VA patients in November 1997. In a mandatory survey of
VA
health care facilities, the number of HCV antibody positive
patients
increased as follows:
6,612 in 1991
8,365 in 1992
14,097 in
1993
18,854 in
1994 (the last year with published data).
He concluded, ``This represents an increase of more than 285%
during
the 4 year period.''\31\
\31\Gary A.
Roselle, Linda H. Danko, Charles L. Mendenhall
``A Four-Year
Review of Patients with Hepatitis
C Antibody in Department
of Veterans
Affairs Facilities,'' Military Medicine, 162, 711 714, 1997.
Since most veterans are not treated in VA medical
facilities, the
actual incidence of HCV infected veterans is undoubtedly much
greater.
VA has not conducted widespread surveillance to ascertain the
number of
infected veterans.
There is much speculation that Vietnam era
veterans, now in their
40's and 50's, are at much greater risk of HCV infection due to
heavy
transfusion activity during the Vietnam war. Dr.
Roselle concluded, ``Of
particular interest to the VHA [Veterans Health Administration] is
the
possible relationship of HCV disease with service in Southeast Asia
during the Vietnam era. Although HCV strain differences may not be
useful for determining specific sources of infection, amplification
of
this blood-borne pathogen (e.g. transfusions) among the troops is a
conceivable explanation for a number of HCV infected persons
identified
in this study. Further epidemiologic data will be required before
this
issue and that of service connection can be resolved.''\32\
\32\Ibid.
Former Surgeon General C.
Everett Koop is among physicians who have
called for an HCV screening program for all U.S. military
personnel.
In May 1997, Senator Richard
Shelby (R AL) asked the Pentagon to look
further into the possibility that immune globulins may have spread
HCV.
The Pentagon did not agree to study the issue and Senator Shelby
inserted the following report language in the 1998 Department of
Defense
Appropriations bill: ``The Department of Defense shall determine
rates
of hepatitis C
infection among personnel who served in deployments
overseas or who received blood plasma products from individuals
infected
with hepatitis
C and provide counseling and access to treatment
for
personnel as needed.''\33\
\33\Senate Report 105 45, Committee on Appropriations, Department
of
Defense Appropriation Bill, 1998.
DOD provides an exit physical for retiring and
discharged service
personnel. Diagnosis of a medical condition is a basis for
eligibility
for lifetime treatment in military hospitals and for a
service-connected
disability for treatment in VA facilities.
DOD does not routinely include a test for HCV
infection in the blood
series done at the exit physical or during annual physicals,
although
new recruits are tested for HCV infection if they report a history
of
hepatitis or are symptomatic of the
infection.
The omission of the HCV test ensures that
military personnel with
undiagnosed chronic HCV miss the opportunity for early detection
and
treatment of the disease. Also, DOD does not have an accurate
estimate
of the prevalence of HCV in the military. As a result, veterans
cannot
establish a service connection for HCV infection contracted in
military
service and are therefore not entitled to treatment for HCV or
related
liver disease in VA facilities.
DOD stated in a fact sheet produced in July 1997
that, ``HCV
infections among military service members mirror those observed in
the
United States civilian population . . .'' New recruits, like other
young
people, have lower than average HCV infection rates. DOD policy is
to
screen or treat when clinically indicated, despite the fact that
Hepatitis C
rarely manifests acute symptoms.
Military service does involve exposure to some
known risk factors for
transmission of HCV such as: contact with HCV infected blood in
training, in combat and through transfusions; medical and surgical
care;
service in regions with high rates of HCV infection such as Asia
and
North Africa; tattoos and IV and non-IV drug use.
DOD cites studies in which military members did
not have increased
incidence of HCV infection. Those studies found no evidence that
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