NAVIGATION BAR for RICHARD WILSON"S PAGES
|
Science and Law |
||||
Science and the Law
SOUND SCIENCE IN THE COURT ROOM
Page last updated May 2nd 2008 NAVIGATION BAR FOR THIS PAGE
|
Introduction |
||||
Introduction
This is a "working page." It is constantly "under construction" and also constantly under destruction. It started on March 9th 2002 and received international attention within a few days. On this page we hope to have information about various issues where "junk science" has been used and must be replaced by sound science whenever possible. Please suggest additions and subtractions.
The Atlantic Legal Foundation is dedicated to helping ensure that whenever science is used in a courtroom that it shall be sound science. On behalf of the Atlantic Legal Foundation the web master of this page requests any and all information, in ANY format but preferably electronic for ease of use, that can help us. This information can be links to other sites, references to scientific (even unscientific) data, published papers, whether peer reviewed or not, articles, comments and court cases. An example of the type of information we hope to provide can be seen on the arsenic web site at arsenic.ws.
Even before lawsuits
became so popular, the Nobel
Prize-winning chemist Irving Langmuir
suggested criteria to identify what he called pathological, or
fraudulent,
science (now called junk science). Society should ignore claims
of hazard
when:
1. The maximum effect is observed by a process of barely detectable
intensity,
and the effect is largely independent of the
intensity of the apparent causal agent.
2. The effect remains close to the limit of detectability.
3. Claims of great measurement accuracy, or of profoundness, persist in
the
face of mounting evidence to the contrary.
4. Theories are put forward that fail the test of being the simplest
explanation for the available information.
5. Criticisms are met by ad hoc explanations: the proponents "always
have
an answer -- always."
Another more succinct criterion is: "The skeptics attack the facts, or the science, but the junk scientists resort to ad hominem attacks on the skeptics."
The following non inclusive list of situations where society must be wary of junk science has been prepared by the Science Advisory Council of the Atlantic Legal Foundation. Please suggest additions.
If you have a legal case involving one of these issues that could benefit from the help of the Atlantic Legal Foundation please contact the general counsel. The Atlantic Legal Foundation has represented many distinguished amici in cases before the courts. The most important were probably the trilogy of briefs, Daubert, Joiner, and Kumho Tire, presented to the US Supreme Court in cases establishing the role of scientific experts and the admissibility of proffered testimony.
In Daubert, a lady
took the
drug Bendectin during pregnancy and blamed
her
child's birth defects on the drug. In the resultant law suit, an expert
proffered an unpublished "reanalysis" of previously published human
statistical studies (a "meta analysis") and purported to show that it
was "more likely than not" that the Bendectin
caused the problems. In remanding the case the Supreme
Court
mentioned (on pages 593 and 594) several non-exclusive criteria by
which such
proffered testimony may be judged. None of the items in the list are
absolutely
necessary; nor is any individual item conclusive:
1. Has the theory been tested or can it be
tested? In
other words, is it falsifiable?
2. Has the theory been peer reviewed and published?
3. What is the known or potential risk of error?
4. Has the theory been generally accepted in the relevant scientific
community?
5. Is the theory based on facts or data of
a type
reasonably relied upon by experts in the field?
6. Does the testimony have probative value
that
is greater than, or not outweighed by, a danger of unfair prejudice,
confusion
of issues, or misleading the jury?
Joiner was an engineer who had worked with transformer oil containing PCBs, and who alleged that the PCBs were the cause of his small cell lung cancer. The testimony of two supposed "expert" witnesses were rejected by the district court, accepted by the appeal court, and finally rejected by the U.S. Supreme Court because it did not "rise above subjective belief or unsupported speculation." The Court held, inter alia, that the proffered testimony must be not only relevant but also reliable. In addition the Supreme Court emphasized that a lower court may "on its own motion or on the motion of any party" appoint an expert to serve on behalf of the court, and this expert may be selected as "agreed upon by the parties" or chosen by the court to aid in the gate keeping role. This is sometimes arranged in a preliminary panel. Such a procedure has become known as a "Daubert Hearing."
In Kumho Tire, an automobile tire which everyone concerned agreed had a tread which was badly worn (nearly bald), exploded, and caused a crash in which a personas killed. An "expert" claimed that since he knew of no other obvious cause of the tire failure, the cause must be a manufacturing defect. His testimony was rejected by the circuit court and accepted by the court of appeals who argued that Daubert did not apply because "engineering is an art and not a science." The U.S. Supreme Court rejected this suggestion, and argued further that the less scientific the evidence, the more the cautions that the Court had expressed in the Daubert judgment must apply.
There are many discussions of
these three
important decisions. Here I refer to a whole web site devoted to Daubert and its implications.
There is
now a proposal to incorporate Daubert
priciples into administrative
law. This is discussed in a whole issue
of "Law and
Contemporary
problems." ICTM also has a n interesting comparison of scientific and legal certainty.
However it is important to address the concerns of others who disagree.
Also the Office of Management and Budget
proposes that all agencies should carry out a formal
analysis of
Regulatory proposals.
A recurring theme in many of the cases where the
Atlantic
Legal Foundation has submitted a brief, is
that the
existence of a statistical correlation between two variables does not,
by
itself, imply a causal connection. This
is well illustrated
in an
article by Dr H. Sies in Nature
(volume 332
page 495; 1988) where he plots in the following figure the number of
brooding
storks in Germany (bottom line; open squares), and the number of new
born
babies (top line; closed squares), by year from 1965 to 1980.
Then he shows in the next plot the excellent correlation between those
two
variables. Any 4 year old will tell you at once that storks bring
babies. A more sophisticated 20 year old might calculate the
correlation
coefficient (which is well over 0.9) and note that the correlation is
exceptionally good. But he might also remind us that the data also might suggest that babies bring
storks. If the x axis is changed to the concentration of
some
pollutant, and they axis to incidence of some ailment, some judges and
juries
might jump to a premature assignment of causality. More mature
scientists, such as those represented by the Atlantic Legal Foundation,
would be
more cautious.
Another recurring
theme is the importance of
understanding the scientific procedures for assigning causation.
A group
of amici successfully raised this issue in
both Kennedy
and in Navarro.
(Kennedy
Opinion) (Navarro
opinion). There is a great confusion in some quarters
between
"Differential Diagnosis" - the deciding between differnt
diseases which might have similar symptoms, and assignment of Causation
- the
assignment of a probable cause for a disease once the diagnosis has
been
made. If , for example,
the
diagnosis is Measles, the cause is obvious: an
infection. If cancer, the cause may be far less
obvious. Indeed most cancers have no known
cause. A recent
paper describes the distinction.
Providing incomolete information is often as misleading as providing bad information.. Of course the ordinary legal procedures should cope with that. For example in a recent conference a puzzled judged asked "If there is a cancer found in a worker in a workplace and then a second cancer is found, am I not entitled to let the jury know that?" The simple answer is of course Yes, but it must be in context. Much medical research starts with an speculation by an observant physician. This is not proof. He then publishes the interesting observation in a journal, to see whether other physicians have seen similar occurrences. If, for example 30 physicians note that they have, this is ground for caution, but is not proof and not, by itself a reason for assigning blame. It should be a reson for conducting a proper epidemiological study. Even if a subsequent case-control study shows an effect, many past situations show that there can still be excellent reasons to question the resuult until a full cohort study has been performed. If an expert witness denies or waffles about this context of the simple statement he is clealy misleading whoever he is talking to. Hopefully not talking to a jury. ICTM has an interesting electronic article on speculative vs fact based evidence .
Among the most important
misconceptions
that is common in the lay public is that many cancer clusters exist
that are
evidence of environmental pollution. These misconceptions occur in
legal
liability cases mentioned throughout this page. A
recent web
page from the
.
It has been
said that the science of
epidemiology
started, when Dr. Snow
marked cases of
cholera upon a map and found that they clustered around a particular
(water)
pump. Since then looking for clusters is clearly in the public mind.
Clusters
of infectious diseases are often found-such as the cluster of
legionnaire's
disease at a hotel in
To have a cancer
cluster one needs to have a high
exposure
localized to the group containing the people who get the cancer. This
can occur
in occupational settings but is rare in the environment where exposures
are
more diffuse. The clusters that have been claimed to exist are usually
due to
chance or to some common lifestyle factor. In 1990, Neutra
suggested 8 characteristics that might enable one to distinguish real
clusters
from false ones (Neutra, remembering
Cervantes' Don
Quixote, calls the procedure distinguishing giants from windmills). The
more of
these characteristics a cluster shows, the more likely it would be that
a multicommunity investigation would be
fruitful.
1. There are
at least 5
cases and the relative risk is very high (e.g. 20 or more).
2. The disease is one, like mesothelioma,
for which an (almost) unique and detectable class of agents has been
responsible in the past, or for which the pathophysiological
mechanism is well understood.
3. The agent is persistent in the
environment and can be measured there (there are relatively few such
agents).
4. The agent is persistent in, or
leaves a
physiological response in, the bodies of those who have been exposed,
and (the
response) is rare in the normal population, so that it can be used as
an index
of exposure.
5. There is heterogeneity of
exposure
within the neighborhood so that the effect of exposure can be assessed.
6. The plausible route of exposure
is such
that subjects would be able to assess their own relevant exposure on a
questionnaire
or it
could be reconstructed from records.
7. It would be feasible to carry
out a multicommunity study consisting of
several similarly
exposed and some unexposed communities.
8. The cluster represents an
as-yet-uninvestigated, endemic space-time cluster. This suggests a
stable,
persistent problem and perhaps a persistent agent to be found in the
environment.
There are various examples of cancer clusters,
although few
can be explained by exposure to environmental agents; the others have
not been
explained. Outcroppings of erionite in a
Turkish
In the above paragraphs the word "cluster" was
used to describe a small group of people closely related by
something-usually
geography. This is distinct from a group of people with the same
ailment in a
larger region. In
There have been claims since the 1970s that low intensity magnetic fields cause leukemia or brain cancer. They have constantly been refuted by scientists and others have just as constantly brought up new information.
In 1990 it was
estimated that these claims had
already
cost the
The issues at stake are large. The physics of electromagnetic fields is one of the best established and precise of scientific studies. Cells obey all the laws of physics and chemistry. No scientist has proposed an acceptable mechanism whereby electromagnetic fields of low intensity can have an appreciable effect on a biological system. By acceptable is meant of course that it has acquired scientific acceptance in the field. Even appliers of the "Precautionary Principle" must not ignore this. Secondly the epidemiological criteria (the Hill attributes) often used in discussing epidemiological principles in the court room are not satisfied.
A detailed comment on a draft report by NIEHS which was close to calling ELF a carcinogen was made by the master of this web page. The final report was improved. The Atlantic Legal Foundation also commented .
See also:
"Electromagnetic Fields and the Law",
R. Wilson and M.S. Kaufman, in Science and the Law,
The issue has
partially opened again (but so far
without
lawsuits) with a report from the state of
We propose to assemble a list of references, cases and published papers.
John Moulder maintains an up to date site concerning this issue
DOE
database on measurements in various places
CDC
databases
NIOSH
procedures manual for measuring electromagnetic fields
The
Canadian Health Ministry's report on electromagnetic fields
A report from International
Agency
for Research on cancer : (IARC summary of volume 80)
Proceedings
of NIOSH/DOE Workshop on "EMF Exposure Assessment and Epidemiology: Hypotheses,Metrics, and Measurements".
Breast implants can obviously cause irritation at the place that they are located it was claimed that silicone breat implants caused a variety of other diseases including cancer. The industry was slow to address this clain which went to the courts and bankrupted the principal manufaturer. No valid scientific proof of causation was adduced and it is now widely believed that the claims were fals. The most complete discussion of the issue of Breast Implants is the book "Science on Trial" by Dr Marcia Angell (excerpt, speech at the National Press Club). The Atlantic Legal Foundation has only become involved in the last 2 years with a brief before the Supreme Court of Oregon in JENNINGS. Although in this case the Supreme Court of Oregon did not follow the advice of the amici, the case was referred back to the earlier court and amici may find another opportunity to express their views.
It is interesting that a special committee has recommended (in October 2003) to the FDA that silicone breats implants be allowed once more.
Molds have been known for centuries. We are all exposed to molds of some sort. Anyone who worked near the Pharmacology Laboratory in Less clear is what
should happen, and what the
landlord's
responsibility should be when there is a smell but no visible sign of
dampness,
yet dampness with concomitant mold spores may be present between the
walls.
(Of course the smell could also be a dead rat or dead cat).
These
are independent of the effects of mold. The issues, in which the
Atlantic
Legal Foundation are interested, are the claims of disease and or
general
deterioration of health as a consequence of dampness or mold. ALF
emphasize that not only is it crucial to establish causality, but also
to be
clear that the disease is being objectively diagnosed and not merely
reported.
ALF has represented a group
of
distinguished amici in a brief
submitted to the Massachusetts Superior Court in a workmen's
compensation case
(the case of Theresa
Canavan).
This case
involved "multiple chemical sensitivity" or MCS. MCS is a
widely reported disease. An important
paper,
with more detail in a report to the Agency for
Toxic Substances and
Disease
Registry (ASTDR) (report number
PB96-187646) shows that 6.3% of
people in a
.
There seems to
be
little doubt that there are a number of allergens associated with
dampness.
Molds can be among them. About 1990 evidence was adduced
that the
mold Stachybotrys chartarum
is the source of the problems.
The evidence for
this is weak, and has not get stronger.
This
evidence is briefly discussed in a public statement of the
The
state of
A conference,
sponsored by the International Center
for Toxicology and
Medicine,
on "Mold
Medicine - Mold Science" was held in
In June 2004, the
List of Mold Websites.
It has been reported that there are now over 100,000 websites about mold. We report on only a fraction of them here.
Atlantic
Legal Foundation mold web site
(www.moldscience.org)
Academic Mold Sites
"Correcting Misapplications of Science in Personal
Injury
Claims: A Periodic Report with Supporting Citations."
(ICTM) new collection of
electronic
reports available via email/this link.
A recent legal
review can be downloaded here
Our expert on the
Science Advisory
Board is Dr Ronald Gots
Dr Gots' short paper on
Mold
Misinformation .
Dr Gots has a longer
paper:
"
Mold and
Mold Toxins: The Newest Toxic Tort" 8 Journal of
Controversial Medical Claims 1
(2001)
A Mold
Page from Stanford University
Kansas State
University report
on controlling mold
Government
Mold Sites
A congressional
hearing on molds
CDC Environmental Health Services: Water
Damage
CDC on Pulmonary
problems and also in
infants
EPA: Healthy
Indoor
Air for America's Homes
EPA: Mold Resources
EPA: Mold
Remediation in Schools and Commercial Buildings
California's information
page on mold
New York City Department of Health “Guidelines
on
Assessment and Remediation of Fungi in Indoor Environments”
Newark
City's
Fact Sheet
state
of
Minnesota's report on Mold in Homes
Minnesota Department of Health: Another report on
Mold in
Homes
North Carolina's mold information
page
Report
by Harriet H. Amman, PhD, DABT Department of Health State of
Washington
Texas Department of Insurance mold page
General sites that mention Mold
: Center for Disease
Control and
Prevention (CDC), National
Center for
Environmental Health
American Board of
Industrial
Hygiene: Certified Associate Industrial Hygienist
General Site American
Indoor Air Quality Council
National Jewish Medical and Research Center on molds
Managing
a mold
invasion (by Conservation Center for Arts and Historic Artifacts)
Toxic
mold research reports by Ontario tenants.
The Allergy
Buyers Club
We deliberately leave out sites which seem to be badly identified or seem to be nothing but advertising for lawyers. We would be happy to list remediation options and links to clean up organizations.
Other Mold sites
A government document
on trends in drug related emergency room visits
The FDA
official site; a warning
by Dr Reder of FDA; Qand A on oxycontin
from FDA
NIH
site on
use and misuse of prescription drugs.
Testimony by the head of the Drug
Enforcement
Agency (DEA); another
DEA link
The legal firm of Pitcoff and Riff
discuss oxycontin and advertise
for clients
See also the web
site
of the American Enterprise Institute
Lockheed Workers
At
Lockheed
aviation many people worked on the Stealth Bomber and used many epoxy
materials. The Exact composition was secret and no detailed harm
was
proven. Nonetheless thousands of workers sued. The cases
were
originally in one class action but were later bifurcated
and compensation was awarded to
many of them. The
case in
one group depended on the "expert testimony" of one person which was
challenged by many distinguished scientists in
a brief presented by the Atlantic
Legal Foundation.
Although
not specifically stated, the court in its decision
agreed with the amici. So also
did the appeal court, but at the present time the matter is being
appealed by the plaintiff to the Supreme Court of California. ALF
is representing a group of amici in this case supporting the decision
of the lower courts.
Various EPA and NRC regulations are concerned with radioactivity and the doses produced by radionuclides as pollutants. Scientists have done a lot of work to calculate what the dose is under various circumstances. Early calculations were too pessimistic by a factor of five. The EPA still use the old pessimistic formula but NRC use a new formula. This is important because the cost of unnecessary cleanup of water supplies, and costs of additional protection for Yucca mountain, run into billions of dollars. EPA argues that to change the formula, even for new regulations, would mean changing hundreds of early regulations. Others say "good: change them".
On December 7th 2000 the EPA promulgated "National Primary Drinking Water Regulations; Radionuclides"; in the Federal Register, (Volume 65, Number 236)] [Page 76707-76753]. This web page master had made two (very similar)"public comment(1)" "public comment(2)" which, as usual for EPA, were not acknowledged and seemed to have no effect. At issue are standards for radium, uranium and several beta and gamma emitters. The regulation was challenged by a group of organizations: City of Waukesha, Nuclear Energy Institute, National Mining Association and Radiation, Science and Health Inc with several intervenors. The US Court of Appeals, DC circuit, number 01-1028, dismissed the case in spring 2003. The web page master believes that the issue will certainly come up again.
There are several
situations arise where radiation
exposure
is at low intensity and consequently the doses are small. The
cases in
the above two examples are two of them. An interesting, even
fascination,
scientific disagreement arises. Is there linearity and the risk
remain
finite (but small) at low doses? Does the risk go to zero below a
threshold dose? Does it matter? This web site manager
has an annotated
set of references on the subject
primarily for scientists. Professor Ed. Calabrese
has been
active in raising the
issue
in
proper scientific fora.
He has a
newsletter - Biological Effects of Low Level Exposures He has also held several
conferences on non-linearity in
biological systems - whether
stimulated by
radiation or by other insults such as chemical carcinogens. The
most
recent was held in
Meanwhile in Kennedy a group of distinguished amici argue that in many situations it does not matter. In this case, exposure was so low, even under extreme postulates, that the risk was negligible in either case. This argument was accepted by the appeals court which reversed a decision by a three man panel of the same court. In another case, a group of distinguished amici point out that the radionuclides (mainly radioactive iodine) emitted at Hanford nuclear reactor (mostly during 1945) produced doses that were too low to cause any effect that is measurable by the best epidemiology. In no group of people was it shown to be "more likely than not" that their thyroid problems were caused by this radiation. A three man panel of the appeals court held that this decision of the district court was improper and remanded it. The amici agreed with the district court that plaintiffs would have to surmount this hurdle before a case could be made and requested the court of appeals review the district court decision en banc. The full appeals court declined to review the case, and the case is now back with he district court.
A very important issue is the compensation being paid to former DOE and other workers who may have been exposed to radiation during cold war activities. The issue is the Probability of Causation when a cancer has arisen which could have been caused by radiation if the dose is high enough. The procedures for deciding whether and to whom to award compensation are generous to the worker. They reward ignorance. 91% of lung cancers become compensable, an unbelievably high figure. 100% are compensable when the cigarette smoking status is unknown! When there is no information about the primary cancer again, most of the applicants are compensated. Indeed Ignorance is Bliss! While it may be proper to give generous compensation, it is grossly improper and dangerous to claim that it is being done in a scientifically defensible manner. The statement by Ms Elaine Chou of the Department of Labor that "Many of these workers developed cancer and other serious diseases because they were exposed to radiation .... in the course of doing their jobs." should NOT be taken to imply that there is scientific proof of that statement.
ALF scientists expect to monitor the situation to ensure that the procedure is not extended to areas beyond those specifically authorized by Congress.
On 17th January 2003, the European Parliament called for a moratorium on the use of depleted uranium (DU) munitions by EU and NATO members citing the "Precautionary Principle." This will have profound public and legal implications in which ALF will, no doubt, become involved. No legal situations have yet arisen but if they do, ALF will probably wish to become involved. On this section of the "sound science" web page I discuss with links and references some of the issues involved.
The name uranium is
given to chemical element 92
and
exists in two common "isotopic" forms with different atomic weights,
U235 and U238. U235 easily undergoes nuclear fission and is used for
nuclear
fuel - either for bombs, or for nuclear electric power stations.
After
removal of much of the Uranium 235, Depleted Uranium (DU) has much less
commercial value than the original chemical. About 200,000
tons of DU
are easily available world wide. At
one time
uranium was used in denture ceramics. The fluorescence increased the
whiteness. This has now been phased out, but the exposure to
the wearer
was small. (0.05 mRem
or 0.5 microSv per year, about 1/4000 of
the annual
background dose). There are other industrial
uses.
Depleted Uranium was also used as a counterweight for some aircraft and
was
involved in two aircraft crashes (and subsequent fires). In one
an
Israeli Cargo jet crashed into houses in
DU is available in metal form which is dense and
hard.
DU is almost twice as dense as lead and has the ability to self-sharpen
on
impact with armor, thus making it ideally suited for use as a kinetic
energy
anti-armor penetrator.
The US and
Depleted Uranium,
being the same chemical element
as
natural Uranium, has the same chemical properties and the same chemical
toxicity. Any radiological hazard of Depleted Uranium will be
less than
that of natural uranium (for the same amount
absorbed in tissue) because the major radioactive emissions from
natural
uranium come from the isotope U235 which is present in smaller quantity
in
Depleted Uranium. It is well known that a block of uranium metal
produces a very small hazard. For example, in 1945-1950,
Professor Sir Francis Simon of Oxford University, used a large block of
uranium on his desk as a paper weight.
This webmaster copied him with a small chunk. One of the first
Atomic Energy
Commissioners, Professor Robert Bacher,
told this webmaster that
in 1945 he handled with his bare hands every piece of metal in the
There was a report of the European Commission, but that is no longer available at this address. ( European Commission Report http://europa.eu.int/comm/environment/radprot)
The Royal Society of
the
The links to the "Post
Conflict" Reports of the
United
Nations Environment Program (UNEP) on:
Bosnia and Herzegovina
Serbia and Montenegro
seem not to work. But I find on the IAEA site the:
Final
Kosovo Report
IAEA
report on Kuwait and the Gulf war is also available
UNEP is holding a meeting during the first week of April 2005 in Amman
Jordan, to begin their post conflict report on DU in Iraq.
Report of US Department of
Defense
NATO has a list of
communications
and reports
Rand Corporation study on effects of the Gulf war (Volume 7) “A review of the
Scientific Literature as it pertains to Gulf War Illnesses,” Naomi
H.
Harley, Ernest C. Foulkes, Lee H. Hilborne,
Arlene Hudson, and C. Ross Anthony, Depleted Uranium report
MR-1018/7-OSD.
A whole issue of J.Environmental
Radioactivity,
volume 64 discusses DU; I especially note a review article
"Properties, use and health effects of depleted uranium" J.
Environmental Radioactivity, 64:93-112 (2003)
International Atomic Energy Agency page
on
Depleted Uranium:
The
International Nuclear Information System (INIS) run by IAEA
INIS search engine
with
several thousand references on DU:
US Office of the
Special
Assistant for Gulf War Illnesses (OSAGWI) DU library
These
reports all seem to agree that the widespread claims that DU has
increased
leukemia and other diseases among the veterans and the local population
are
groundless. A few personnel inside a struck military vehicle
struck by a
shell, who miraculously survived the more ordinary hazard of war, might
ingest
enough material to cause chemical toxicity effects on the kidneys.
There
does not seem to be enough inhalation exposure to the evaporated
material for
the alpha particles to cause observable increases in lung cancer.
Nonetheless, on 24th January 2003, the European
Parliament
called for a moratorium on the manufacture and use of depleted uranium
(DU)
munitions citing the "Precautionary Principle" - a somewhat vague
term which nonetheless is the official foundation of their
environmental
policy. They claimed that NATO’s use of such weapons during the
war
in
Knee-jerk reactions by
prosecutors can increase pain
"It is a bad time to be in pain. Last week, the maker of OxyContin, a high-strength narcotic analgesic, agreed to pay $635 million. "The typical "Oxy" abuser is not a pain patient taking medication as prescribed, but rather a committed substance abuser." The problem isn't OxyContin, but its misuse by people abetting a desire to get high. ion to settle charges of "misbranding" brought by the United States Attorney for the Western District of Virginia. "Scores died as a result of OxyContin abuse and an even greater number of people became addicted," said U.S. Attorney John Brownlee. The drug company, Purdue Frederick, admits that its sales force underplayed the abuse potential of OxyContin. And, yes, the company should have acted more quickly to clamp down on overpromotion and to issue strong warnings in the face of overdose deaths. But the real public-health damage here comes from the pitched campaign conducted by zealous prosecutors and public-interest advocates to demonize the drug itself. This is tragic because OxyContin has been a godsend for millions of patients with searing, unremitting pain from chronic back problems, rheumatoid arthritis, neurological disorders and other dire afflictions." " Doctors already wary of scrutiny by the Drug Enforcement Administration will become even more skittish about giving adequate doses of OxyContin or prescribing it at all." "Unlike its opioid cousins, such as morphine or codeine which wear off in four to six hours, OxyContin is slow-release and lasts up to 12 hours. Longer action means steadier blood levels, an important feature when pain is constant and severe." "In 2001 the NY Times Magazine described how addicts--not severe, chronic pain patients--ground an intact pill into quick-acting pharmaceutical grade opiate. It takes five seconds to effect the transformation--and not much longer to create an addict."
Two films of court
cases where science
was ignored
Two court cases had sufficient general interest that major popular films were made. These films clearly influence public perception. The first was about a leukemia cluster in
The second was about traces of chromium in the well water of a few residents of Hinkley, a small
Hexavalent chromium, when inhaled by workers in chromium plating plants, has caused lung cancer in the past, but according to the Iris website of EPA "No data were located in the available literature that suggested that it is carcinogenic by the oral route of exposure" at any dose. The International Agency for Research on Cancer (IARC), a UN body, stated likewise in "IARC Monographs on the Evaluation of Carcinogenic Risks to Humans Volume 49 (1990)" and also notes that even animal data do not indicate a large risk by ingestion either. More recently data have been published that show that ingestion of small amounts of chromium do not influence the natural chromium levels in the body. (Finley, B.L., Keger, B.D. Katona M.W Gargas, M.L. Corbett, G. C., and Paustenbach D.J., (1997) “Human Ingestion of Chromium VI in Drinking Water: Pharmokinetics Following Repeated Exposure: Toxicology Applied Pharmacology 142:151-159) From a scientific point of view that should have been the end of the discussion.
648 people sued for some billions of dollars in a class action and blamed the small exposure for dozens of symptoms, ranging from nose bleeds to breast cancer, Hodgkin's disease, miscarriages and spinal deterioration. There was not even a statistical association such as that of figures 1 and 2. Rather than face the uncertainty of a jury trial, Pacific Gas & Electric Company decided to accept arbitration.. The result was the largest verdict in a tort case in
Asbestos
Asbestos is the name given to a group of naturally occurring minerals and was widely used starting in the late 19th century as a fire retardant. Indeed the very name came from the Greek "will not burn". It is now given by general unstated consent to a group of materials that are regulated in commerce. Each chemical exits in two forms: fibrous (asbestiform) and non fibrous. The fibrous form can produce toxic lung damage, asbestosis, lung cancer, and for some asbestos types, mesothelioma. The group has two subgroups that are distinguishable under electron microscopy. One causes amphiboles, the other, serpentine asebtos does not cause amphiboles. Amphibole asbestos was widely used in the shipyards and navies of the second world war. Chrysotile, a form of serpentine asbestos, has more recently been used in buildings although all types are now either banned or avoided as much as possible in commerce.
In 1986 The US Environmental Protection Agency issued guidelines for risk assessment in which it was explicitly assumed that all asbestiform types had the same potency for causing cancer regardless of chemical type. These guidelines have been widely used to guide regulations, and in court cases used for claiming damages and in other public documents. In the intervening 18 years much information has surfaced that shows that the assumption of equality does not hold, expecially for mesothelioma. In 2003 the U.S. E.P.A. acknowledged that the potecies can be different: “For mesothelioma the best estimate of the coefficient (potency) for chrysotile is only 0.0013 times that for amphibole and the possibility that pure chrysotile is non-potent for causing mesothelioma cannot be ruled out by the epidemiology data.”
Many scientists, public policy analysts and the courts have been slow to grasp the implications of this newer evidence. For example mesothelioma has a latency of 40+ years, and anyone contracting mesothelioma may have been exposed 40 or more years before but wants to blame someone now. Among men there is evidence that male mesothelioma incidence in the USA has quadrupled since 1940, and that is usually attributed to asbestos exposure - probably to amphibole asbestos exposure before 1970. Yet often a victim, searching for a deep pocket and unable to sue the US navy, blames a manufacturer of chrysotile. Assuming the above (EPA) statement of the science is correct, chrysotile would not normlly even be considered a partial cause of mesothelioma. On the other hand, as I have pointed out in a paper involving amphiboles, a person exposed to amphibole asbestos, such as in Libby, Montana, has a larger risk for mesothelioma than suggested by the 1986 calculation which was based on an average of all asbestos types.
Controversial issues on which good scientists disagree.
AThe Atlantic Legal Foundation does not wish to enter into issues on which there is legitimate scientific disagreement even when they have a major impact on public policy. However, the Atlantic Legal Foundation has an important role to play to ensure that the scientific discussion remains legitimate and is not misused. Issues so far include:
Anti-ballistic
Missile Systems
This is an
extraordinarily serious issue. Claims have been made by no
less
than the President of the United States that Americans can be protected
by an Anti-Ballistic Missile system (ABM). Bethe and Garwin
in 1968 wrote in Scientific Amercan claiming that it is false
Richard Wilson wrote an
article about the
recent proposal for a system in Poland and the Czech republic, and an article by the late
"Pief" Panofsky appeared in
the San Francisco Chronicle just after he died. The danger
is that the people of the world will be persuaded erroneously that
there is a
technical solution to a problem that demands the best diplomacy of
which the world is capable.
Corn Based Ethanol
For 30 years corn
distributors such as Archer-Daniels-Midland have suggested that ethanol
be used instead of gasoline to reduce imports and reduce carbon-dioxide
caused climate change. While they were lobbying outside the
House of Representatives 30 years ago this webmaster was testifying to
a committe inside that almost as much carbon dioxide is emitted
in pesticide manufacture
and
other agricultural activities as the carbon in the gasoline it would
save. The uncertainty of the calculation has
improved, but the conclusion is the same as discussed by Michael
McElroy Michael McElroy reported on this in
the
Harvard Magazine in November 2007. Reports by Julia King on low
carbon cars released by the UK Government in
2008,
Part I , and Part II, agree.
Nonetheless the corn growers persuaded the US
government to subsidize corn based ethanol. Fortunately
this error is slowly being realized in the world. The same
argument does not apply to the same extent to cellulose based ethanol,
but in 2008 it is not yet economically viable.
Arsenic
Arsenic in
Global
climate change:
Although a Nobel Peace Prize was awarded in 2007 for advertising that
the climate is changing, there remain
some scientists who disagree. Here we merely link to the
10+ year old report The
Intergovernmental Program on Climate Change (IPCC3) (the"official
view")
IPCC3 working group
1,
IPCC3 working group 2,
IPCC 3 working group 3,
and the more recent (2006) report which overcomes some of the problems
of the earlier study.
IPCC
4 working group 1, IPCC4 Working group 2
IPCC4 working group III
There is a discussion group of skeptics about
climate
change and a report
of skeptics in March 2008
Center for the Study of Carbon
Dioxide and
Global Change.
Particulate
air pollution
at low levels. Is there a threshold below which
particulate levels do no harm? This is discussed in the book by Wilson and Spengler , and especially in Chapter 9 by Evans
Please bring to our attention any other important issue.
Appeal
These pages cost money. Taking cases cost money. Any contribution to these costs, big or small, should be sent to the treasurer of the Atlantic Legal Foundation, Steven Harmelin Esq., at Dilworth Paxon LlP, 1735 Market St.32nd floor, Philadelphia, PA 19103-7395. Gifts of appreciated securities are welcome.
Atlantic Legal Foundation main page
Atlantic Legal Foundation
Mold web page (www.moldscience.org)
Annapolis Center for
Science and
Public Policy
Harvard Center for Risk
Analysis tries
to be balanced
"Correcting
Misapplications of Science in Personal Injury Claims: A Periodic Report
with
Supporting Citations."
(ICTM) new collection of electronic reports
available via
email/this link.
American
Council
on Science and Health (ACSH) studies and issues reports
on
science issues related to health
ACSH has a new "blog"
or weblog page
The George C. Marshall
Institute
is committed to investigating the facts behind global climate
change, and
problems surrounding the
politicization of
science in this area
The Competitive Enterprise Institute often
has
useful articles.
Junk Science (run
by
Steven Milloy) is a deliberately
provocative
site which raises a flag when the authors feel that the science is
incorrect
Medical quackery is exposed in "Quack Watch" by Steven
Barrett, MD
Michael Fumento
writes about incorrect or exaggerated newspaper articles on health
Tech Central Station
is
a web site that complains about many things - including a lawsuit
against
MacDonald's for encouraging Obesity.
The Union of Concerned Scientists best known for their
activities
opposing nuclear power, tries to raise a
cautious
approach to many scientific issues
Wilson and Crouch book on Risk Benefit
Analysis
Home page (http://phys4.harvard.edu/~wilson) of the master of this web page
