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IOM Identifies
Link with Chronic Lymphocytic Leukemia, Principi Extends Benefits The latest report findings are similar to the earlier documents with one major change. Update 2002 concludes that there is “sufficient evidence of an association” between herbicides used in Vietnam and chronic lymphocytic leukemia (CLL). Department of Veterans Affairs Secretary Anthony J. Principi has accepted this assessment, and ordered the development of regulations that would add CLL to the list of illnesses presumptively recognized for service connection among Vietnam veterans. VA will be able to begin paying compensation benefits once the regulations are finalized later this year.Principi Acts
Secretary Principi
asked key officials and scientists within and outside VA to evaluate the latest IOM report
and advise him on appropriate action. On
January 23, based on the recommendations he
received and his reading of the report, the Secretary announced that CLL would be added to
the list of presumptively recognized conditions for service connection. “Compelling
evidence has emerged within the scientific community that exposure to herbicides such as
Agent Orange is associated with CLL,” Principi declared. “I’m exercising my legal authority to
ensure the full range of VA benefits is available to Vietnam veterans with CLL.” The Secretary added, “On the modern
battlefield, not all injuries are caused by shrapnel and bullets. This latest IOM study and my decision to act upon
it are the latest examples of VA’s continuing efforts to care for the needs of our
combat veterans.” What the Decision Means The Secretary’s decision means that
veterans with CLL who served in Vietnam during the Vietnam era don’t have to prove
that their illness is related to their military service to qualify for VA disability
compensation. For more than 20 years, VA has
offered special access to medical care to Vietnam veterans for health problems that may
have resulted from Agent Orange exposure. (VA
presumes that all Vietnam veterans were exposed to Agent Orange or other herbicides.) Secretary Principi’s decision will ensure
higher-priority access to care for those veterans with CLL.
Background
The
initial IOM report, entitled Veterans and Agent Orange: Health Effects of Herbicides
Used in Vietnam, dated 1994, was released in 1993.
Updates were issued in 1996, 1999 (identified by IOM as Update 1998),
and 2001 (dated 2000). In addition, the IOM
has released two special reports on Agent Orange, one, published in 2000, regarding the
possible association between herbicide exposure on diabetes, and another, published last
year, on one type of childhood cancer.
In the latest
comprehensive document, subtitled Update 2002,
the IOM, a highly respected, independent, non-governmental scientific review organization
working on behalf of the Department of Veterans Affairs (VA), evaluated all available
scientific evidence from studies of veterans and other groups, to determine what health
problems may be associated with exposure to Agent Orange and other herbicides used in
Vietnam. VA requested that the IOM focus on
CLL in Update 2002 because of concerns raised by some veterans that CLL shares some
similarities with non-Hodgkin’s lymphoma, which has been recognized for service
connection for several years. Update 2002 was
conducted by a 10-member committee of scientists, chaired by Irva Hertz-Picciotto, Ph.D.,
a professor in Department of Epidemiology, School of Public Health, University of North
Carolina, Chapel Hill. Michelle C. Catlin,
Ph.D., a program officer in the IOM’s Board on Health Promotion and Disease
Prevention, was the Study Director. The information that
the committee reviewed was identified through a comprehensive search of relevant
databases, including public and commercial databases covering biologic, medical,
toxicologic, chemical, historical, and regulatory information. More than 9,000 potentially relevant studies were
identified in the searches, and more than 1,000 were reviewed. The committee reported that input received from
veterans and others interested persons at public hearings and in written submissions
served as a valuable source of additional information.
IOM’s Four Categories
In the latest report, the IOM assigned each health
outcome considered in the report to one of four categories based on the amount and quality
of scientific evidence of an association with Agent Orange or other herbicides used in
Vietnam. This was the same procedure used for
prior reports. In making the assignments, the
IOM considered a large range of occupational, environmental, and veterans’ studies.
The four
categories are (1) sufficient evidence of an association, (2) limited/suggestive evidence
of an association, (3) inadequate/insufficient evidence to determine whether an
association exists, and (4) limited/suggestive evidence of no association. Category 1 - Sufficient Evidence of an Association
The IOM included
health outcomes in the first category when a positive association has been observed
between herbicides and the outcomes in studies in which chance, bias, and confounding
could be ruled out with reasonable confidence. In its initial report,
the IOM included five illnesses in this category: soft-tissue
sarcoma, non-Hodgkin’s lymphoma, Hodgkin’s disease, chloracne, and porphyria
cutanea tarda (in genetically susceptible individuals).
In the 1996 update, the IOM lowered porphyria cutanea tarda to the second
category while the other conditions remained in the first.
In the 1996, 1998, and 2000 updates, no additional health outcomes were
included in this first category. The
inclusion of CLL in this category marks the first time that a condition has been added to
this category since the initial report was issued. Category 2 - Limited/Suggestive Evidence of an
Association
The IOM lists
conditions in the second category when the evidence reviewed is suggestive of an
association between herbicides and the outcome but is limited because chance, bias, and
confounding could not be ruled out with confidence. Health
outcomes are included in this category when, for example, at least one high quality study
shows a positive association, but the results of other studies are inconsistent. In the report released
in 1993, the IOM included only three outcomes (respiratory cancers, prostate cancer, and
multiple myeloma) in this category. Six
health outcomes were included in this category in 1996 and 1998. In addition to these three cancers and porphyria
cutanea tarda (mentioned above), the IOM cited acute and subacute transient peripheral
neuropathy in Vietnam veterans and spina bifida in their children. The initial report listed peripheral nervous
system disorders as a group in the third category. In the 1996, 1998, and
2000 updates, the IOM distinguished between acute and subacute transient peripheral
neuropathy and chronic peripheral nervous system disorders (which remained in the third
category). Similarly, the IOM separated spina
bifida from other birth defects (which remained in the third category). In the special report
on diabetes released in 2000, the IOM moved Type 2 diabetes from category three
(inadequate/insufficient evidence to determine whether an association exists) to this one. In Update 2000, Type 2 diabetes remained in
this category. In Update 2002, Type 2
diabetes is included in this category. Another change in this category, made by Update 2000, was the addition of acute myelogenous leukemia (AML) in the children of Vietnam veterans. Under existing law, VA lacks authority to provide benefits or services to these children. AML was previously grouped with other childhood cancers in offspring. Careful analysis of U.S. and Australian studies led IOM to include this rare condition in category 2. However subsequent review by the IOM after Australian scientists discovered an error in their study, resulted in a downgrade to category 3 last year. (For more information on this reversal, see the front page article in the May 2002 issue of the Agent Orange Review), online at www.va.gov/agent orange. Category 3 - Inadequate/Insufficient
Evidence to Determine Whether an Association Exists
Most conditions
evaluated in IOM’s 2002 report (as well as in the earlier publications) were listed
in their third category. The IOM placed
health outcomes to this category when available studies are of insufficient quality,
consistency, or power to permit a conclusion regarding the presence or absence of an
association. Health outcomes for which there
are no available studies would also fall into this category.
The following
outcomes were listed in IOM category three in Update 2002: hepatobiliary cancers, nasal or nasopharyngeal
cancer, bone cancer, breast cancer, female reproductive cancer (cervical, uterine, and
ovarian), urinary bladder cancer, renal cancer, testicular cancer, leukemia (other than
CLL), skin cancer, spontaneous abortion, birth defects (other than spina bifida), neonatal
or infant death and stillbirths, low birthweight, childhood cancers in offspring,
including acute myelogenous leukemia, abnormal sperm characteristics and infertility,
cognitive and neuropsychiatric disorders, motor or coordination dysfunction, chronic
peripheral nervous system disorders, metabolic and digestive disorders (changes in liver
enzymes, lipid abnormalities, and ulcers), immune systems disorders (immune suppression
and autoimmunity), circulatory disorders, respiratory disorders, and AL-type primary
amyloidosis, endometriosis, and the effects on thyroid homeostasis.
The 1996 changes
are the two noted above (that is, the separation of acute and subacute transient
peripheral neuropathy from chronic peripheral neuropathy; and spina bifida from other
birth defects) plus an elevation of skin cancer from the fourth category. Urinary bladder cancer was added to this category
in 1998.
In Update
2000, as a result of the change for acute myelogenous leukemia, the health outcome
“childhood cancer in offspring” was modified to exclude AML. However, as a result of subsequent revision, it
was again included with other childhood cancers in this category where it remains in Update
2002. For Update 2000, at VA’s request, the IOM evaluated the possible relationship between herbicides used in Vietnam and AL-type primary amyloidosis, a condition similar in many ways to multiple myeloma (an illness in category 2). IOM concluded that there was inadequate/insufficient evidence to determine whether an association exists. VA had received several letters from interested individuals suggesting a link with herbicide exposure. In the 2002 report, the IOM added an evaluation of endometriosis and the effects of thyroid homeostasis to this category. Category 4 - Limited/Suggestive Evidence of No Association
Health outcomes
are included in the fourth category when several adequate studies, covering the full range
of levels of exposure that humans are known to encounter, are mutually consistent in not
showing a positive association between exposure to herbicides and the outcome at any level
of exposure. The 2002 report, like
the 1996, 1998, and 2000 documents, puts the following conditions in Category 4:
gastrointestinal tumors (stomach, pancreatic, colon, and rectal cancers) and brain tumors. The only change in 1996 from the first report in
this category was the elevation of skin cancer to the third category. The only change in 1998 was the elevation of
urinary bladder cancer to the third category. In
the 2000 and current updates, there is no change in this category compared with the 1998
IOM update. Research Recommendations
In Update
2002, the IOM also offers several research recommendations. The committee suggests continuing of the Air Force
Health Study of Operation Ranch Hand personnel (the unit involved in the aerial spraying
of Agent Orange), expanding the studies of Army Chemical Corps veterans, and following the
experience of Vietnam veterans as they age, with emphasis on diseases associated with
aging.
The committee
also concludes that certain rare tumors are worthy of further investigation despite
previous evidence of no association. The
committee supported steps that would continue development of collaborative research
programs between U.S. and Vietnamese scientists.
Required
by Public Law 102-4
Under Public Law 102-4, the Agent Orange Act of 1991, within 60 days after the Secretary of Veterans Affairs receives a report on the possible long-term health effects of Agent Orange and other herbicides used in Vietnam from the National Academy of Sciences’ IOM, the Secretary must determine whether a presumption of service connection is warranted for each disease covered by the report. If the Secretary concludes that a presumption of service connection is warranted, he or she must issue regulations within 60 days of this determination. Within 90 days after
the Secretary issues any proposed regulations regarding these diseases, the Secretary must
issue final regulations. Such regulations are
effective the day of issuance. If the Secretary
determines that a presumption of service connection is not warranted, he or she, within 60
days of the making the determination, must publish in the Federal Register a notice of that finding. The notice must include an explanation of the
scientific basis for the determination. Earlier VA Responses
IOM reports on
Agent Orange have had a significant impact on VA compensation policy, as documented in the
next four paragraphs. The 1993 and 1996 IOM reports resulted in substantial changes in VA policy. On July 27, 1993, the day the IOM released its first report, then VA Secretary Jesse Brown announced that Hodgkin’s disease and porphyria cutanea tarda would be added to the list of conditions presumed to be service-connected for veterans exposed to herbicides in Vietnam. (VA presumes that all Vietnam veterans were exposed to such herbicides). Two months later,
after further review of the IOM document, Secretary Brown announced that multiple myeloma
and respiratory cancers would be added to the list of conditions presumed to be
service-connected for veterans exposed to herbicides in Vietnam.
After reviewing
the 1996 IOM update, Secretary Brown concluded that acute and subacute transient
peripheral neuropathy (if manifested within 1 year of exposure to an herbicide in Vietnam
and resolved within 2 years of onset) and prostate cancer should and would be added to the
list of conditions presumed to be service-connected for veterans exposed to herbicides in
Vietnam. In 1996, when the IOM
found an association between herbicides used in Vietnam and the birth defect spina bifida
in the children of Vietnam veterans, VA sent draft legislation to Congress (enacted, with
modification, as part of Public Law 104-204 in September 1996) to provide for certain
benefits and services for these children. Update 1998 and
Update 2000 did not result in changes in compensation policy. The IOM’s special 2000 report on Type 2
diabetes resulted in that condition being added to the list of presumptively recognized
conditions for service connection. As a condition in
Category 1, CLL was a relatively easy and non-controversial call under the guidelines
established by Congress. Historically, all
conditions in that category have promptly been recognized for service connection. All illnesses in the second category have
ultimately been recognized as well. Report on the Internet, Also Available for Purchase Copies of this report are available from the National
Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055. The
telephone numbers are (toll-free) 1-800-624-6242 and (in the Washington, DC, metropolitan
area) 202-334-3313. The Internet address is www.nap.edu. IOM
Reports Will Continue
The IOM will be
re-evaluating existing scientific evidence and assessing new information regarding the
possible long-term health consequences of herbicide exposures. Based upon the results of the most recent report,
VA has requested that the IOM take a careful look at other forms of leukemia in their
2004 update. UPDATE: the 2004 update to the study (released March
2005) says HCL is a rare form of CLL- it is on page 334 of the update and is
easily accessed through the IOM homepage www.iom.edu/report.asp?id=25476
under "Reports".
The IOM was
chartered in 1970 by the National Academy of Sciences to enlist distinguished members of
the appropriate professions in the examination of policy matters pertaining to the health
of the public. The Institute acts under
responsibility given to the Academy by its congressional charter to be an adviser to the
Federal Government and, upon its own initiative, to identify issues of medical care,
research, and education. For information
about the IOM, see www.iom.edu. The January 23, 2003 VA news release on the Secretary’s action related to CLL can be found at www.va.gov/opa. |