|
Buyers Up · Congress Watch · Critical
Mass · Global Trade Watch · Health Research Group · Litigation Group
Joan Claybrook,
President
Leading Medical Experts Fault Arbitrary, Outdated
Medical Criteria in Asbestos Bill
Flawed Standards Will Deny Compensation to Many
Legitimate Victims of Asbestos Disease
Four of the country’s leading
experts in the diagnosis and treatment of asbestos diseases are
opposing the medical standards that claimants must meet to qualify
for coverage under the $140 billion trust fund set up by the
asbestos bill, S. 852, to compensate individuals injured by exposure
to the toxic mineral. These clinicians and researchers are:
Michael Harbut, MD, MPH, FCCP,
Chief of the Center for Occupational and Environmental Medicine,
Co-Director of the National Center for Vermiculite and
Asbestos-Related Cancers at the Karmanos Cancer Institute and past
chair of the American College of Chest Physicians. According to Dr.
Harbut, who currently treats over 2,000 individuals a year, most of
whom suffer from asbestos-related diseases, the bill would exclude
over 40 percent of his patients despite the fact that their
illnesses are clearly attributable to asbestos exposure. Dr. Harbut
contends that one former iron worker he has treated for about eight
years, and who recently required a double lung transplant, would not
have qualified for relief under the bill until perhaps two years
ago, when his condition was already so advanced that there was
little hope of saving his lungs.
Philip J. Landrigan, MD, MSc, DIH,
Chair of the Department of Community and Preventive Medicine at
Mount Sinai School of Medicine (the department founded by Dr. Irving
J. Selikoff, renowned "Father of Asbestos Research in the United
States"), which has been the major provider of diagnostic services
to over 12,000 workers at the Ground Zero site of the World Trade
Center destruction. According to Dr. Landrigan, a board-certified
specialist in occupational medicine (among other specialties) and a
member of the National Academy of Sciences’ Institute of Medicine,
tens of thousands of legitimate lung cancer victims would be shut
out of the fund by the bill’s medical criteria.
Alan C. Whitehouse, MD,FCCP,
Senior consulting physician at the Center for Asbestos Related
Disease in Libby, Montana, and the pulmonary specialist who first
identified asbestos-induced disease among W.R. Grace miners and
factory workers in Libby. According to Dr. Whitehouse, whose
patients are largely community members with no direct occupational
exposure but who nevertheless developed asbestos diseases because of
the toxic dust deposited by the W.R. Grace mine and factory into the
air and soil, the bill’s medical criteria would exclude 90 percent
of the individuals he treats, knocking them down to the lowest
disease category, "Level 1,"where they are only entitled to x-ray
and lung function tests once every three years.
L. Christine Oliver, MD, MPH, MS,
FACPM, Assistant
Clinical Professor of Medicine at Harvard Medical School and
Associate Physician of Pulmonary and Critical Medicine at
Massachusetts General Hospital. According to Dr. Oliver, who
has spent years treating asbestos victims, thousands of exposed
individuals who have demonstrated abnormalities on chest x-rays and
are therefore at significantly increased risk of developing cancer
will be denied vital long-term follow up because of the limitations
on medical monitoring in the Level 1 category. These individuals may
be prevented from discovering they have cancer until it is too late
to stall or reverse the progress of the disease.
And that’s not all. The American Thoracic Society has published criteria that
disagree considerably with the medical criteria in the bill,
although they do not take a position for or against the legislation.
The American Public Health Association, a membership
organization consisting of over 50,000 public health professionals,
also disagrees with the medical criteria put forth in the bill.
What is at Stake
The staggering scale of the asbestos
epidemic that has already sickened or killed hundreds of thousands
of people in the U.S. is underscored by the number of potential
victims: some 27.5 million workers exposed to asbestos on the job
from 1940-1978, and who in turn contaminated their own families;
thousands of residents of Libby, Montana, where asbestos-tainted
vermiculite was mined and manufactured into Zonolite insulation for
70 years; hundreds of thousands of people living in the 28 sites
nationwide that received 80 percent of the vermiculite mined in
Libby from 1964-1980, and those living in the remaining 172 sites
where vermiculite was used in factory processing; the residents of
over 30 million houses in the U.S. that, according to the EPA, still
have vermiculite insulation; the thousands of New Yorkers living and
working in proximity to the site of the World Trade Center’s
destruction.
An analysis conducted in 1982
projected up to 9,700 cancer deaths each year of workers
occupationally exposure to asbestos, and an estimated total 500,000
worker mortalities between 1967 and 2030. But this did not include
sickness and death from non-malignant asbestos diseases, nor the
full range of potential occupational victims (such as demolition and
renovation workers), or those exposed to risks after 1979. And, it
only covered workers. Some 10,000 people died of asbestos-related
diseases in 2003 alone, and because of the 20-50 year latency period
between toxic exposure and manifestation of symptoms—and the fact
that asbestos was not strictly regulated until 1986—experts now
predict that the peak for both malignant and non-malignant forms of
asbestos-related diseases will not be reached until 2018.
Disease projections vary widely, ranging from 750,000 to 2.6 million
future claims of sickness and death associated with asbestos.
A 2003 Congressional Budget Office estimated some 1.7 million claims
over the next three decades.
What the Experts Say
Summary
The bill’s medical standards are
designed to exclude hundreds of thousands of otherwise legitimate
asbestos-poisoned individuals from compensation. The aforementioned
specialists in occupational medicine with particular expertise in
the effects of asbestos contamination maintain that S. 852 uses
arbitrary, outdated medical criteria to define asbestos-related
disease that are not based on or are inconsistent with current
medical and scientific knowledge. The legislation:
Requires x-ray evidence of
disease instead of more technologically accurate, sensitive and
readily available methods such as CT scan, defines disease based
on pre-1995 thinking that has since been conclusively disproved,
sets fixed exposure thresholds contrary to epidemiological
evidence, arbitrarily reduces benefits to smokers and fails to
recognize injuries to consumers and residents living in
proximity to asbestos processing plants.
Rejects most of the criteria for
determining the existence and extent of asbestos-related disease
established by the American Medical Association Guides to the
Evaluation of Permanent Impairment—standards widely accepted
by the medical community and used by 42 states and some Canadian
provinces as the basis for workers compensation claims.
Ignores the recommendations of
the American Thoracic Society (ATS), which were developed over
the course of three years by the preeminent experts in the field
of lung disease, as set forth in its Guidelines for the
Diagnosis and Initial Management of Nonmalignant Diseases
Related to Asbestos.
Relies on the term "substantial"
as a determinant in a variety of contexts, a word that has no
commonly understood meaning in the medical community, nor
definition in medical literature or in the bill itself. This
means that an administrator will be left to make a decision
tantamount to medical diagnosis, which should be made by a
physician.
Those excluded will lose their right
to seek compensation in court for the harms inflicted by companies
that knowingly exposed them to a powerful human carcinogen. As
diagnosed sufferers of asbestos-related diseases (although not
eligible for financial assistance under the bill) they will be
unable to obtain health or life insurance. Some will be unable to
continue in their current trade or to work at all. The cost of their
continuing medical care—which for someone stricken with asbestosis
could be several thousand dollars a month for oxygen alone—will
ultimately be borne by taxpayers, if at all.
What follows is a detailed critique
of the bill’s medical criteria compiled from the testimony,
statements and letters to Senate Judiciary Committee members by the
aforementioned experts:
Diagnosis based on crude, outdated technology
1. X-rays are a poor substitute for CT scans
The bill almost completely relies on
x-rays and a limited set of pulmonary function tests—a more than
century-old, forced breathing test—as the basic diagnostic tools
and, by extension, determinants of a claimant’s compensation level.
Studies comparing x-ray with CT scan technology, have conclusively
shown that the x-ray is a comparatively crude way of diagnosing
asbestosis. CT scans are about 33 percent more sensitive in
detecting interstitial disease, and over 50 percent more sensitive
in detecting pleural disease.
X-rays fail to diagnose many victims
of lung disease caused by inhalation of asbestos fibers. One reason
is that asbestosis—a progressive, sometimes fatal disease that
leaves its victims dependent on external oxygen supplies for
survival—can be present in the lung even though the x-ray is normal
using the ILO classification system specified in the bill. The ATS
guidelines affirm the use of high resolution CT scanning for
diagnosis of asbestosis when the chest x-ray is normal. As described
in numerous peer-reviewed publications and in the ATS report,
high-resolution computer tomography (HRCT) is now widely accepted as
a diagnostic tool for asbestosis and asbestos-related lung scarring.
Recent studies show that readers using a scoring index for HRCT were
more accurate and reliable in the diagnosis of asbestosis than when
using plain chest x-rays. The most notable study concluded that "the
examined HRCT scoring method proved to be a simple, reliable, and
reproducible method for classifying lung fibrosis and diagnosing
asbestosis also in large populations with occupational disease, and
it would be possible to use it as a part of an international
classification."
Expert consensus supports this conclusion.
Nevertheless, there is only limited
call in the bill for use of HRCT technology. The cost for HRCT
diagnosis compared to x-rays may be a concern, but there is every
reason to believe affordable prices for HRCT scans can be achieved,
especially as the volume of such scans would grow if the technology
were permitted beyond the narrow fashion now contemplated by the
bill. Some treating centers have already managed to get the cost
down to just a few hundred dollars per CT scan.
2. Mesothelioma diagnosis remains elusive
The bill fails to require the use of
sufficiently sophisticated technology to diagnose mesothelioma,
cancer of the lining of the abdominal or chest cavity, which is so
difficult to detect accurately that a large number of cases go
undiagnosed until after death. Mesothelioma cases are the most
expensive for industry to compensate. The only documented cause of
mesothelioma is asbestos exposure; although it is often referred to
as a rare disease, the 2,500-4000 cases of mesothelioma diagnosed
annually kill more people in the U.S. than ovarian cancer. PET
scans, which can be more sensitive than CT scans, should be
incorporated into the diagnostic criteria of the bill. Flexibility
to allow for serological diagnosis should also be included in the
bill. A blood test field tested in the U.S. and already in use in
Australia has proven very sensitive in diagnosing the disease. U.S.
clinical trials for blood tests for mesothelioma are occurring right
now at the Karmanos Cancer Institute in Michigan. Individuals at
risk of mesothelioma would be barred from offering the results
provided by such emerging technology under the bill.
Diagnosis based on arbitrary criteria inconsistent with the
current state of medical knowledge
1. Barriers to proving asbestos-related lung disease
The bill requires bilateral
pleural disease—thick scarring on the lining of both lungs—in order
to establish that asbestos exposure is the cause of illness.
Moreover, the scarring, which resembles an orange rind, must be of a
certain width and be associated with specific breathing impairment.
The dimension and impairment requirements have no basis in medical
literature. And as acknowledged by the ATS in its guidelines,
pleural scarring associated with asbestos almost always
begins unilaterally—in just one lung—and often progresses unevenly.
Thus, the bill would exclude from compensation, at the very least,
individuals in the early stages of asbestosis.
2. Flawed lung function testing
The bill requires abnormal
spirometry—a test of the ability to blow air in and out—for a
diagnosis of asbestosis, despite the fact that individuals with
asbestos-related disease do not necessarily evidence spirometric
abnormalities. For example, a construction worker who suffers from
obstructive lung disease caused by dust and welding fumes may also
suffer from restrictive lung disease due to asbestos exposure on the
construction site. The worker may not exhibit abnormal spirometry,
however, because the obstructive-restrictive combination can produce
an overall normal spirometric test result.
Exposure criteria are unreasonably rigid
1. Minimum exposures exclude valid cases
The bill sets minimum durations of
exposure to asbestos in order to establish valid claims of
asbestos-related disease. For example, there is a minimum
5-weighted-year duration of asbestos exposure to support a diagnosis
of asbestosis. There is an 8-12 year requirement of exposure to
establish asbestos causation in the case of lung cancer. There is no
support for strict exposure thresholds in medical or scientific
literature. On the contrary, evidence points to situations where,
under some exposure conditions, a one-month occupational exposure to
asbestos can markedly heighten the risk of lung cancer and increase
the risk of asbestosis-related death.
2. Unreasonable discounting of exposure after 1976 and 1986
The bill discounts exposure based on
the years during which it occurred, counting each year of exposure
after 1976 as only half a year, and after 1986 as one-tenth of a
year. The rationale for this is presumably the reduced opportunities
for toxic exposure after these dates due to the implementation of
OSHA and EPA regulations. There is, however, no medical or
scientific basis for the discount formula used in the bill, nor any
other discount formula. Furthermore, the formula is ludicrous on its
face: an individual with colorectal, laryngeal, esophageal,
pharyngeal or stomach cancer whose exposure occurred after 1976
would need 105 years to meet the criteria for a valid claim,
according to Dr. Philip Landrigan.
Impairment criteria run counter to AMA guidelines
1. Important medically-accepted tests are left out
How well an individual’s lungs are
working can be measured accurately and reliably with pulmonary
function testing. The diagnosis of asbestosis depends in part on
characteristic findings of physical exam, pathology, chest x-ray or
CT scan, but impairment must be measured with appropriate pulmonary
function testing. The AMA Guides states that each worker
should undergo spirometry and DLCO—a measure of the lungs’
efficiency in transferring oxygen into the blood stream—as part of
the evaluation of lung impairment, and exercise testing can add
additional information if needed. Using a combination of forced
vital capacity (FVC), forced expiratory volume in one second (FEV1),
DLCO, and oxygen consumption on exercise testing (VO2max)
when needed, the patient is placed into one of four levels.
The asbestos bill refers to the AMA
Guides and includes spirometry, but omits DLCO and oxygen
consumption on exercise testing—both of which are important
and readily available tests that the AMA has determined are reliable
and essential to determine how badly a person’s lungs are impaired.
As a result, individuals with asbestosis may have to wait until
their disease is advanced before they can qualify for treatment.
Causative criteria unreasonable and unscientific
1. Outdated reliance on "markers" excludes legitimate cancer
victims
Versions of the bill in 2003 and
2004 provided three levels of compensation for victims of
asbestos-related lung cancer: Level VII, for lung cancer victims
with 15 years of substantial occupational exposure, but whose x-rays
showed no "markers" of non-malignant asbestos-related disease; Level
VIII, for victims with lung cancer whose x-rays showed pleural
disease; and Level IX for lung cancer victims with x-rays showing
asbestosis. S. 852 has eliminated compensation under the old Level
VII criteria for exposure in the absence of radiographic "markers,"
a determination that, based on Congressional Budget Office
projections will potentially remove more than 40,000
asbestos-related lung cancer victims from coverage.
Provisions recently added to the
2005 bill would allow some of the lung cancer victims without
radiographic "markers" to use CT scans to show that they have
asbestosis, but the bill does not specify that victims with pleural
disease can also use this more sensitive and specific diagnostic
test to show their disease and exposure. CT scans have been proven
in scientific studies to identify pleural disease or asbestosis in
approximately half of individuals without such findings on x-rays,
and that about half of these identified by CT scans will have
asbestosis and half will have pleural disease. Thus, the net result
of the bill as introduced is that 25,000 – 30,000 asbestos lung
cancer victims previously covered may not be eligible for
compensation.
Numerous studies show that there is
a dose-response relationship between exposure to asbestos and the
risk of lung cancer, with increasing exposure leading to increasing
risk of disease. There is no know safe level of exposure to
asbestos. Workers at U.S. government facilities get an environmental
pay differential if their job exposes them to airborne asbestos,
regardless of the concentrations or length of time of exposure, so
long as protective measures have not been implemented to eliminate
the potential for injury.
With 15 years of substantial occupational exposure to asbestos, lung
cancer can be attributed to that exposure—it should not be necessary
to document underlying non-malignant asbestos disease as well. More
importantly, while workers with asbestosis have a two-to-four-fold
higher risk of lung cancer than asbestos exposed workers without
asbestosis, asbestosis is merely a surrogate measure of exposure:
significant asbestos exposure is required to cause asbestosis. Since
1995, scientific studies have clearly demonstrated that asbestosis
itself is not a necessary intermediary for development of
asbestos-related lung cancer. Thus, current medical thinking rejects
the threshold requirement of a radiographic "marker" to prove that
lung cancer has been caused by asbestos. As a secondary matter, even
where there is asbestosis, lung disease may not meet the still
further hurdle of being bilateral, as already discussed.
2. Smokers are unfairly punished
The bill reduces the ability of lung
cancer patients with a history of asbestos exposure and who smoked
to receive the same level of compensation as those who did not
smoke, despite the well-documented synergistic effect of these two
carcinogens. People exposed to asbestos are five times more likely
to develop lung cancer than those not exposed. Smokers run a 10-fold
risk of developing lung cancer compared to non-smokers. But a smoker
who is also exposed to asbestos has 55 times the risk of developing
lung cancer. To exclude a lung cancer sufferer with a history of
occupational exposure to asbestos solely because the victim smoked
is unreasonable because it implies assumption of a significantly
heightened risk that, in fact, could not have been known by the
victim: even those who would have been aware that smoking posed a
danger would not have had knowledge of the synergistic combination,
a fact that remains in the province of medical professionals and is
not commonly advertised. It is prejudicial because it singles out
smokers but ignores the synergistic interaction of other
environmental carcinogens, such as drinking arsenic-contaminated
well water, with asbestos exposure. It is unfair because it allows a
corporation that concealed the dangers of smoking from consumers to
blame a given individual’s lung cancer on occupational contact with
asbestos, and a corporation that concealed the dangers of asbestos
from workers to claim that the same individual, who was an employee,
got lung cancer from smoking—thus exempting bad actors from legal
liability. Finally, to arbitrarily attribute a smoker’s lung cancer
to smoking rather than asbestos because there is no radiographic
"marker" of exposure, i.e., pleural disease, flies in the face of
epidemiological evidence as described above.
3. Consumers and bystanders are left out
The bill only compensates those who
were occupationally exposed to asbestos—and then, only if in contact
with asbestos for more than 5 years—and the family members of
exposed workers. It does not, for example, compensate the high
school kids in factory towns across the country who unloaded boxcars
filled with vermiculite ore to earn money over their summer
vacations and now, maybe 20 years or more later, have developed lung
disease. It makes no provision for individuals harmed by
non-occupational exposure, other than the residents of Libby,
Montana. The EPA currently has 28 nationwide factory site "hot
spots" under priority surveillance to determine the health effects
of asbestos exposure. These sites received 80% of the Libby, Montana
vermiculite ore sent to a total 200 factories in the U.S. where the
toxic material was processed for use in consumer goods. The
remaining 172 sites are of secondary interest to the EPA, but are
also included in its surveillance plan. None of the community
members exposed to asbestos dust from factory exhaust and particles
transmitted widely by workers on their clothing and skin in any of
these 200 towns will be covered under the trust fund.
Also excluded from qualifying for
benefits are consumers who purchased and indifferently used and
disposed of some 3,000 commercial products containing asbestos,
including people who did their own automotive repairs such as
replacing brake linings. Nor does the bill include occupants of 30
million houses nationwide containing asbestos-laden insulation in
their attics, the health consequences of which have as yet been
unexplored—although it has been established that there is no safe
level of exposure to asbestos. It leaves out the hundreds of
thousands of New Yorkers who have lived and worked in the vicinity
of Ground Zero from the World Trade Center’s destruction forward.
The bottom line is that because the medical criteria rely on
occupational exposure thresholds, they exclude millions of
individuals who unwittingly incurred the risk of disabling and
potentially fatal disease by purchasing products or living in
communities with asbestos-related industries.
Contacts
Michael Harbut, MD, MPH, FCCP,
Chief, Center for Occupational and Environmental Medicine;
Co-Director, National Center for Vermiculite and Asbestos-Related
Cancers, Karmanos Cancer Institute; Clinical Assistant Professor,
Internal Medicine, Wayne State University. (248) 547-9100 (w), (248)
506-8871 (c), (248) 367-8265 (beeper), M1har@aol.com.
Philip J. Landrigan, MD, MSc, DIH,
Chair, Dept. of Community and Preventive Medicine, Mount Sinai
School of Medicine. (This is New York’s largest clinical facility in
occupational medicine and one of the nation’s largest research and
training programs in occupational health, established by Dr. Irving
J. Selikoff, known as the "Father of Asbestos Research in the United
States." This department was the major provider of diagnostic
services to Ground Zero workers in the aftermath of the World Trade
Center destruction, examining over 12,000 workers, many of whom were
exposed to asbestos.) (212) 241-4804 (w), phil.landrigan@mssm.edu.
L. Christine Oliver, MD, MPH, MS,
FACPM, Assistant
Clinical Professor of Medicine, Harvard Medical School; Associate
Physician, Pulmonary and Critical Medicine, Massachusetts General
Hospital. (617) 232-1704 (w), (617) 312-7219 (c),coliver@ohiinc.com.
Alan C. Whitehouse, MD,FCCP,
Senior consulting physician at the Center for Asbestos Related
Disease, Libby, Montana and the pulmonary specialist who first
identified asbestos-induced disease among workers in the W.R. Grace
mine and manufacturing plant at Libby. (509) 999-5500 (c), (509)
276-1342 (h), (406) 293-9274 (Libby CARD clinic), acw1@sisna.com
###
Public Citizen is a
national, nonprofit consumer advocacy organization based in
Washington, D.C.
For more information,
please visit www.citizen.org
|