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#110 -- Pre-Mortems Instead of Post-Mortems, 3-Oct-2007

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Rachel's Precaution Reporter #110

"Foresight and Precaution, in the News and in the World"

Wednesday, October 3, 2007...........Printer-friendly version
www.rachel.org -- To make a secure donation, click here.
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Featured stories in this issue...

Analyzing Failure Beforehand
Here's a precautionary idea from the world of innovative business
management: Do a pre-mortem (instead of a post-mortem) on your
decisions, to try to figure out in advance what could go wrong.
Lead-Paint Suit May Thin Burden of Proof
An important feature of the precautionary principle is shifting the
burden of proof onto those engaged in potentially harmful activities,
rather than requiring the public to "line up the dead bodies." This
important lawsuit takes a step in the precautionary direction.
Canada's Blood Supply 'Safe as Anywhere,' Says Agency's CEO
Both Canadian Blood Services and Hema-Quebec, its Quebec
equivalent, use what's known as the precautionary principle when
making decisions about blood safety issues. In essence, the
precautionary principle means that when there are two or more possible
courses of action, the choice should be the option that affords the
greatest safety -- even in the face of small risk.
Thimerosal Unlikely Cause of Neuropsychological Deficits
Paul A. Offitt, MD (who serves as an advisor to Merck
Pharmaceutical), calls the fallout from the decision to withdraw
thimerosal from vaccines a "cautionary tale:" "Although the
precautionary principle assumes that there is no harm in exercising
caution, the alarm caused by the removal of thimerosal from vaccines
has been quite harmful," he writes. [Of course the precautionary
principle assumes no such thing -- it assumes all alternatives are
carefully weighed. This is just another typical attack on precaution
-- distorting it in order to bash it. --RPR Editors.]
Global Warming Hysteria or Freedom and Prosperity?
"As an author of a book about the economics of climate change, I
feel obliged to say that -- based on our current knowledge -- the risk
is too small and the costs of eliminating it too high. The application
of the so called 'precautionary principle,' advocated by the
environmentalists, is -- conceptually -- a wrong strategy.... I
really do see environmentalism as a threat to our freedom and
prosperity. I see it as 'the world's key current challenge.'"
Supes To Vote Today on Blue Angels Ban
The resolution invokes the "precautionary principle," noting that
the traveling aerobatics show has resulted in the loss of 26 lives due
to accidents in its 60-year history. [The resolution was voted down by
San Francisco's Board of Supervisors.]

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From: The New York Times (pg. B1), Sept. 22, 2007
[Printer-friendly version]

ANALYZING FAILURE BEFOREHAND

By Paul B. Brown

Post-mortems, trying to figure out why a new idea failed, are a common
business process. But wouldn't "pre-mortems" make more sense?

They would, argues Gary Klein, chief scientist at Klein Associates, a
division of Applied Research Associates, which works with companies to
show them how to conduct pre-mortems and "identify risks at the
outset."

"A pre-mortem in a business setting comes at the beginning of a
project rather than the end, so the project can be improved rather
than autopsied," Mr. Klein explains in The Harvard Business Review.

In the pre-mortem, company officials assume they have just learned
that a product or a service they are about to introduce has "failed
spectacularly." They then write down every plausible reason they can
think of to explain the failure. The list is then used to eliminate
potential flaws before the new idea is actually introduced into the
marketplace.

While companies frequently engage in risk analysis beforehand,
employees are often afraid to speak up, fearing they will be seen as
naysayers or will suffer the political consequences of objecting to an
idea that is popular internally.

An exercise that assumes the new idea fails frees people to be more
candid, and can, Mr. Klein writes, serve as a check on the "damn-the-
torpedoes attitude often assumed by people who are overinvested in a
project."

[snip]

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From: USA Today, Oct. 1, 2007
[Printer-friendly version]

LEAD-PAINT SUIT MAY THIN BURDEN OF PROOF

By Greg Toppo, USA TODAY

A 17-year-old Milwaukee boy who was poisoned by lead as a baby faces
off today against the nation's leading makers of lead-based house
paint, hoping to prove that for half a century they knew their product
made people sick.

It's the latest in a long string of lawsuits -- virtually all of them
unsuccessful -- against companies such as Dutch Boy and Sherwin-
Williams, which manufactured the paint Americans used for decades. But
Steven Thomas' trial in Milwaukee could change the nature of product
liability lawsuits.

Thomas' suit was filed in 1999 against Sherwin-Williams, American
Cyanamid, NL Industries -- which marketed Dutch Boy -- and others.
What sets it apart is a 2005 Wisconsin Supreme Court ruling that
Thomas' attorneys don't need to prove the companies manufactured the
specific paint that made him sick. All they have to prove is that the
companies were making lead paint when the homes in which Thomas lived
were built, from 1900 to 1905, that the paint sickened him and that
the manufacturers knew of that danger.

"It's testing out the old theory of liability... that x party did y,"
says Jane Genova, a writer on legal topics who has followed this
litigation for years. "Now with this, you don't have to prove the old
things."

Thomas, who was born in 1990, suffered mental retardation after three
years of exposure to lead dust and chips in two rental homes, court
documents say. He'll require lifetime medical monitoring and is at
high risk for kidney disease, high blood pressure and heart disease,
among other conditions.

A decision in Thomas' favor could bring an explosion in suits on
behalf of children sickened by lead. More than 1,400 Milwaukee
children tested positive for high lead levels in 2006 alone, the
city's health department says. The American Academy of Pediatrics
estimates that one in four U.S. children lives in housing with
deteriorated lead paint.

Given their track records, cases such as Thomas' are long shots. The
first was filed in 1987, and since then more than 100 have followed.
Only five have made it to trial, and only one, in Rhode Island in
2005, has been successful. In that case, the state sued three paint
makers. State officials last month said it will cost about $2.4
billion to clean up hundreds of thousands of lead-painted homes. The
companies are appealing the verdict, in which a jury decided the paint
constituted a "public nuisance" that the manufacturers had to clean
up.

Thomas' legal team says paint makers knew as far back as the early
1900s that lead was dangerous but fought attempts to regulate or ban
it. Paint manufacturers have said in court that they knew lead paint
was dangerous, but that, properly handled, it was safe -- indeed, they
have pointed to federal standards that recommended homeowners use lead
paint because it was durable. Through the 1940s, house paint was up to
50% lead by weight. In 1978, the U.S. government banned lead
altogether from paint.

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From: The Canadian Press, Oct. 1, 2007
[Printer-friendly version]

CANADA'S BLOOD SUPPLY 'SAFE AS ANYWHERE,' SAYS AGENCY'S CEO

TORONTO -- Canadians who need blood or blood products are safer as a
consequence of measures taken in the aftermath of the tainted blood
scandal, a tragedy which led to the revamping of the blood collection
and transfusion system in this country, the head of the agency
responsible for the blood service said Monday.

"The legacy of the tainted blood scandal has been very profound, in
this country and even internationally," Dr. Graham Sher, CEO of
Canadian Blood Services, said in an interview from Ottawa.

Sher wouldn't comment on an Ontario Superior Court ruling acquitting
Dr. Roger Perrault, the former national medical director of the
Canadian Red Cross, and three other doctors of criminal charges
related to the scandal.

But he stressed that there are many more checks in place today to
protect recipients of blood transfusions or blood products from
bloodborne disease agents, known and unknown.

Still, there is no way to ensure that donated blood is risk-free. Sher
insisted: "We've never claimed that it's risk free."

"Our job is to make that risk as low as possible and we've been
extremely successful at that," he said.

"And then the physician must always counsel his or her patient before
a transfusion in terms of what are the risks and what is the benefit.
And you don't get a transfusion unless you absolutely need one."

Sher said both Canadian Blood Services and Hema-Quebec, its Quebec
equivalent, follow the recommendations of the Krever Inquiry and use
what's known as the precautionary principle when making decisions
about blood safety issues.

In essence, the precautionary principle means that when there are two
or more possible courses of action, the choice should be the option
that affords the greatest safety -- even in the face of small risk.

When the blood services learned that the West Nile virus could be
transmitted in blood they worked with the pharmaceutical industry to
ensure rapid development and deployment of tests. This summer -- the
worst ever for West Nile infections in this country -- Canadian Blood
Services found and removed from the blood system 70 blood donations
contaminated with the virus.

A second layer of tests has been put in place for HIV and hepatitis B
and C, Sher added.

And when scientists at the Public Health Agency of Canada discovered
that simian foamy virus can be transmitted through blood, the blood
services added a question to their blood clinic screening
questionnaire aimed at excluding would-be donors who work with or have
contact with primates.

There is currently no test for simian foamy virus, a retrovirus from
the same class of viruses as the human immunodeficiency virus (HIV).
Common in some primates, the virus isn't believed to cause disease in
humans. But diseases caused by retroviruses can take a long time to
develop, and the blood services don't want to take chances, Sher said.

"That's a very good example of where we've applied the precautionary
principle. In fact... we're the only two blood systems in the world
- the two Canadian blood services -- that have a measure in place to
ask donors about exposure to certain types of primates."

The agencies are currently studying the potential threat posed to the
blood system by Chagas disease, caused by a parasite rarely found in
Canada but more commonly found in Central and South America. The
agency believes it may have a test in place for Chagas in 2008.

As another precaution, Canadian Blood Services filters white cells out
of the blood donated to it. White blood cells are immune system
soldiers and can harbour pathogens. They aren't needed for blood
products, Sher said, and it is safer to remove them.

"It's one way of lowering the risk to the recipients," he said, noting
the agency is one of few in the world that takes this added step.

Copyright 2007 The Canadian Press

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From: Medscape Medical news, Oct. 2, 2007
[Printer-friendly version]

THIMEROSAL UNLIKELY CAUSE OF NEUROPSYCHOLOGICAL DEFICITS

By Susan Jeffrey

A new study from the Centers for Disease Control and Prevention
(CDC) does not appear to support a causal association between early
exposure to mercury from thimerosal-containing vaccines or immune
globulins and deficits in neuropsychological functioning among
children now aged 7 to 10 years.

Out of 328 tests assessing these outcomes, the number of significant
associations was about 5%, as would be expected for a chance finding,
lead author William W. Thompson, PhD, from the CDC's Vaccine Safety
Datalink Team, told Medscape Neurology & Neurosurgery.

"So at the end of the day, we think the weight of the evidence does
not support a causal association between thimerosal exposure and 42
neuropsychological outcomes that we tested," Dr. Thompson said.

Their report is published in the September 27 issue of the New England
Journal of Medicine.

However, the authors point out that their study did not look at autism
spectrum disorders and so cannot answer the thorny question of a
causal link there that has been the focus of litigation. This question
is also the subject of 2 Perspective articles in the same issue of the
Journal.

"We have a separate autism case-control study that we're doing that's
assessing whether thimerosal from vaccines is associated with the risk
for autism," Dr. Thompson noted. "That study is ongoing, and we hope
to have a manuscript submitted for publication in the next year."

Thimerosal Removed From Vaccines

Thimerosal has been used as a preservative in vaccines since the
1930s, the researchers write. It is 49.6% mercury by weight and is
metabolized into ethyl mercury and thiosalicylate.

In 1999, the Food and Drug Administration (FDA) estimated that infants
immunized according to the recommended schedule could receive amounts
of mercury in excess of limits set by the Environmental Protection
Agency for exposure to methyl mercury, they note. "As a precautionary
measure, the Public Health Service and the American Academy of
Pediatrics [AAP] urged vaccine manufacturers to remove thimerosal from
all infant vaccines as soon as was practical and recommended that
studies be carried out to understand better the risks associated with
mercury exposure from thimerosal-containing vaccines," the authors
write.

This study is a follow-up to a previous analysis by the CDC published
in 2003, Dr. Thompson said. Using computerized databases from 3 large
health maintenance organizations (HMOs), the previous researchers
found increasing exposure to thimerosal was associated with a greater
likelihood of tics in 1 population and of language delay in another,
but no significant associations were found in the third population
(Verstraeten T. et al. Pediatrics. 2003;112:1039-1048).

In the current study, the authors aimed to have a more rigorous and
comprehensive approach using a similar design to previous studies of
prenatal exposure to methyl mercury from fish consumption, Dr.
Thompson said.

"Our study improved on previous thimerosal studies by enrolling
children on the basis of thimerosal exposure, independent of health
status; prospectively assessing neuropsychological functioning
independently of exposure and healthcare-seeking behavior; and
collecting extensive information on potential confounders, including
medical history and socioeconomic and educational factors that could
influence a child's health and development," the authors write.

They also sought the advice of a panel of external experts, including
vaccine advocacy groups, to compile the outcomes of interest. "In the
end, we had 42 neuropsychological outcomes that we looked at and had
extensive information on vaccine histories," Dr. Thompson said. The
panel also had significant input on review of the results and draft of
the final manuscript, he noted.

In all, 1047 children between the ages of 7 and 10 years were enrolled
from 4 HMOs that participate in the CDC's Vaccine Safety Datalink.
Exposure to thimerosal was determined using computerized health
records, medical records, personal immunization records, and maternal
interviews. They assessed the association between current
neuropsychological performance and exposure to mercury in the prenatal
period, birth to 28 days, and the first 7 months of life.

"Among the 42 neuropsychological outcomes, we detected only a few
significant associations with exposure to mercury from thimerosal,"
the authors write.

"We present 378 tests in the manuscript, and when you run that many
statistical tests, you're likely to get some chance findings," Dr.
Thompson noted. Of the 378 tests, there were 19 statistically
significant associations; 12 of these showed better outcomes with
increasing thimerosal exposure, and 7 associated poorer outcomes with
increasing exposure. The differences were small and mostly sex-
specific.

Statistical significance on 19 tests, about 5% of the total, "is
exactly what you would expect by chance," he said.

However, some of these associations may require further investigation,
he added. One of these was an association of thimerosal exposure and
tics among boys, important because a similar relationship was also
seen in 2 previous studies, including the one by Verstraeten et al.

"We're in ongoing discussions within the CDC and with the National
Center for Birth Defects and Developmental Disabilities regarding
whether we should follow up on that or not," he said. Results from
another ongoing study, called the Thimerosal Italy Study, which is
also assessing tics as an outcome, will give more information on how
to proceed on that finding, he noted.

Thimerosal has been removed from all vaccines with the exception of
some influenza vaccines, Dr. Thompson said. However, parents can
request thimerosal-free vaccines for their children.

Perspectives: Thimerosal and Autism

Researchers in the current study emphasize that their study did not
assess autism spectrum disorders in relation to thimerosal exposure.
In the 2 Perspective articles, a lawyer and a physician look at the
impact that the fear of a potential link with autism has had on the
use of vaccines and on litigation related to this question of
causation.

In one of these, Paul A. Offitt, MD, chief of the division of
infectious diseases at the Children's Hospital of Philadelphia, in
Pennsylvania, calls the fallout from the decision to withdraw
thimerosal from vaccines a "cautionary tale."

"Although the precautionary principle assumes that there is no harm in
exercising caution, the alarm caused by the removal of thimerosal from
vaccines has been quite harmful," he writes. "For instance, after the
July 1999 announcement by the CDC and AAP, about 10% of hospitals
suspended use of the hepatitis-B vaccine for all newborns, regardless
of their level of risk. One 3-month-old child born to a Michigan
mother infected with hepatitis-B virus died of overwhelming
infection."

And there has been other fallout, he writes. The idea that thimerosal
causes autism has given rise to a "cottage industry of charlatans
offering false hope, partly in the form of mercury-chelating agents."

Many parents choose not to have their children immunized for influenza
because some preparations of vaccine still contain thimerosal. "By
choosing not to vaccinate their children, these parents have elevated
a theoretical (and now disproved) risk above the real risk of being
hospitalized or killed by influenza.

"During the next few years, thimerosal will probably be removed from
influenza vaccines and the court cases will probably settle down," Dr.
Offitt concludes. "But the thimerosal controversy should stand as a
cautionary tale of how not to communicate theoretical risks to the
public; otherwise, the lesson inherent in the collateral damage caused
by its precipitous removal will remain unlearned."

In a second Perspective, Stephen D. Sugarman, JD, professor at the
University of California, Berkley School of Law, outlines some of the
process and current state of suits related to the causation question
between childhood vaccines and autism.

Thousands of autism claims are pending, he writes. "In 2002, to
resolve such claims more expeditiously, the VICP [Vaccine Injury
Compensation Program] announced that some test cases would examine the
general causation question, putting aside the question of harm to any
particular child. Although this process was supposed to take only 2
years, the first of 9 test cases was heard just this past summer, with
many witnesses testifying on each side. A special section of the US
Court of Federal Claims administers the VICP, and judges running this
so-called vaccine court are not expected to begin to decide these
cases until 2008. Department of Justice lawyers appear in opposition
to the claimants."

The study was supported by the Centers for Disease Control and
Prevention, in Atlanta, Georgia. Dr. Thompson reports being a former
employee of Merck; disclosures for other coauthors appear in the
paper. Dr. Offit reports serving on the scientific advisory board of
Merck and being the coinventor of the bovine-human reassortant
rotavirus vaccine, RotaTeq, on which he holds a patent.

N Engl J Med. 2007;357:1281-1292, 1275-1277, 1278-1279.

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From: EUportal, Sept. 23, 2007
[Printer-friendly version]

GLOBAL WARMING HYSTERIA OR FREEDOM AND PROSPERITY?

By Vaclav Klaus

[Vaclav Klaus is president of the Czek Republic and a free-market
economist. This is a talk he gave at the Ambrosetti Forum,Villa
d'Este,Italy]

One can tell -- with a high degree of confidence -- what topics are
expected to be raised here, this morning when it comes to discussing
the key challenges of today's world. The selection of the moderator
and my fellow-panelists only confirms it. I guess it is either
international terrorism or poverty in Africa. Talking about both of
these topics is necessary because they are real dangers but it is
relatively easy to talk about them because it is politically correct.
I do see those dangers and do not in any way underestimate them. I do,
however, see another major threat which deserves our attention -- and
I am afraid it does not get sufficient attention because to discuss it
is politically incorrect these days.

The threat I have in mind is the irrationality with which the world
has accepted the climate change (or global warming) as a real danger
to the future of mankind and the irrationality of suggested and partly
already implemented measures because they will fatally endanger our
freedom and prosperity, the two goals we consider -- I do believe --
our priorities.

We have to face many prejudices and misunderstandings in this respect.
The climate change debate is basically not about science; it is about
ideology. It is not about global temperature; it is about the concept
of human society. It is not about nature or scientific ecology; it is
about environmentalism, about one -- recently born -- dirigistic and
collectivistic ideology, which goes against freedom and free markets.

I spent most of my life in a communist society which makes me
particularly sensitive to the dangers, traps and pitfalls connected
with it. Several points have to be clarified to make the discussion
easier:

1. Contrary to the currently prevailing views promoted by global
warming alarmists, Al Gore's preaching, the IPCC, or the Stern Report,
the increase in global temperatures in the last years, decades and
centuries has been very small and because of its size practically
negligible in its actual impact upon human beings and their
activities. (The difference of temperatures between Prague where I was
yesterday and Cernobbio where I am now is larger than the expected
increase in global temperatures in the next century.)

2. As I said, the empirical evidence is not alarming. The arguments of
global warming alarmists rely exclusively upon forecasts, not upon
past experience. Their forecasts originate in experimental simulations
of very complicated forecasting models that have not been found very
reliable when explaining past developments.

3. It is, of course, not only about ideology. The problem has its
important scientific aspect but it should be stressed that the
scientific dispute about the causes of recent climate changes
continues. The attempt to proclaim a scientific consensus on this
issue is a tragic mistake, because there is none.

4. We are rational and responsible people and have to act when
necessary. But we know that a rational response to any danger depends
on the size and probability of the eventual risk and on the magnitude
of the costs of its avoidance. As a responsible politician, as an
academic economist, as an author of a book about the economics of
climate change, I feel obliged to say that -- based on our current
knowledge -- the risk is too small and the costs of eliminating it too
high. The application of the so called "precautionary principle,"
advocated by the environmentalists, is -- conceptually -- a wrong
strategy.

5. The deindustrialization and similar restrictive policies will be of
no help. Instead of blocking economic growth, the increase of wealth
all over the world and fast technical progress -- all connected with
freedom and free markets -- we should leave them to proceed
unhampered. They represent the solution to any eventual climate
changes, not their cause. We should promote adaptation, modernization,
technical progress. We should trust in the rationality of free people.

6. It has a very important North-South and West-East dimension. The
developed countries do not have the right to impose any additional
burden on the less developed countries. Imposing overambitious and -
for such countries -- economically disastrous environmental standards
on them is unfair.

No radical measures are necessary. We need something "quite normal."
We have to get rid of the one-sided monopoly, both in the field of
climatology and in the public debate. We have to listen to arguments.
We have to forget fashionable political correctness. We should provide
the same or comparable financial backing to those scientists who do
not accept the global warming alarmism.

I really do see environmentalism as a threat to our freedom and
prosperity. I see it as "the world's key current challenge."

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From: San Francisco Examiner, Sept. 25, 2007
[Printer-friendly version]

SUPES TO VOTE TODAY ON BLUE ANGELS BAN

San Francisco may ban the Blue Angels air show from performing during
Fleet Week, if Supervisor Chris Daly has his way. Daly's resolution to
ban the popular show goes to a vote of the Board of Supervisors today.


By Adam Martin, The Examiner

A resolution calling for a permanent halt to the Blue Angels' annual
appearance at San Francisco's Fleet Week will go before the full Board
of Supervisors today.

The resolution, first introduced by Supervisor Chris Daly and gaining
co-sponsorship by Supervisors Ross Mirkarimi, Gerardo Sandoval and Tom
Ammiano, invokes the "precautionary principle," noting that the
traveling aerobatics show has resulted in the loss of 26 lives due to
accidents in its 60-year history.

The resolution also notes that the planes' practice runs over The City
cause "ear splitting and nerve shattering" noise that can traumatize
residents, including immigrants from war-torn countries.

Because the Blue Angels fly by invitation, the resolution, if passed,
will likely not stop the show scheduled for next week, but Daly has
said previously that he hopes it will halt future shows.

amartin@examiner.com

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Rachel's Precaution Reporter offers news, views and practical
examples of the Precautionary Principle, or Foresight Principle, in
action. The Precautionary Principle is a modern way of making
decisions, to minimize harm. Rachel's Precaution Reporter tries to
answer such questions as, Why do we need the precautionary
principle? Who is using precaution? Who is opposing precaution?

We often include attacks on the precautionary principle because we
believe it is essential for advocates of precaution to know what
their adversaries are saying, just as abolitionists in 1830 needed
to know the arguments used by slaveholders.

Rachel's Precaution Reporter is published as often as necessary to
provide readers with up-to-date coverage of the subject.

As you come across stories that illustrate the precautionary
principle -- or the need for the precautionary principle --
please Email them to us at rpr@rachel.org.

Editors:
Peter Montague - peter@rachel.org
Tim Montague - tim@rachel.org

:::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

To start your own free Email subscription to Rachel's Precaution
Reporter
send any Email to one of these addresses:

Full HTML edition: rpr-subscribe@pplist.net
Table of Contents (TOC) edition: rpr-toc-subscribe@pplist.net

In response, you will receive an Email asking you to confirm that
you want to subscribe.

To unsubscribe, send any email to rpr-unsubscribe@pplist.net
or to rpr-toc-unsubscribe@pplist.net, as appropriate.

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Environmental Research Foundation
P.O. Box 160, New Brunswick, N.J. 08903
rpr@rachel.org
:::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
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:::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: Rachel's Precaution Reporter #110 "Foresight and Precaution, in the News and in the World" Wednesday, October 3, 2007...........Printer-friendly version www.rachel.org -- To make a secure donation, click here. ::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

Featured stories in this issue...

Analyzing Failure Beforehand
Here's a precautionary idea from the world of innovative business
management: Do a pre-mortem (instead of a post-mortem) on your
decisions, to try to figure out in advance what could go wrong.
Lead-Paint Suit May Thin Burden of Proof
An important feature of the precautionary principle is shifting the
burden of proof onto those engaged in potentially harmful activities,
rather than requiring the public to "line up the dead bodies." This
important lawsuit takes a step in the precautionary direction.
Canada's Blood Supply 'Safe as Anywhere,' Says Agency's CEO
Both Canadian Blood Services and Hema-Quebec, its Quebec
equivalent, use what's known as the precautionary principle when
making decisions about blood safety issues. In essence, the
precautionary principle means that when there are two or more possible
courses of action, the choice should be the option that affords the
greatest safety -- even in the face of small risk.
Thimerosal Unlikely Cause of Neuropsychological Deficits
Paul A. Offitt, MD (who serves as an advisor to Merck
Pharmaceutical), calls the fallout from the decision to withdraw
thimerosal from vaccines a "cautionary tale:" "Although the
precautionary principle assumes that there is no harm in exercising
caution, the alarm caused by the removal of thimerosal from vaccines
has been quite harmful," he writes. [Of course the precautionary
principle assumes no such thing -- it assumes all alternatives are
carefully weighed. This is just another typical attack on precaution
-- distorting it in order to bash it. --RPR Editors.]
Global Warming Hysteria or Freedom and Prosperity?
"As an author of a book about the economics of climate change, I
feel obliged to say that -- based on our current knowledge -- the risk
is too small and the costs of eliminating it too high. The application
of the so called 'precautionary principle,' advocated by the
environmentalists, is -- conceptually -- a wrong strategy.... I
really do see environmentalism as a threat to our freedom and
prosperity. I see it as 'the world's key current challenge.'"
Supes To Vote Today on Blue Angels Ban
The resolution invokes the "precautionary principle," noting that
the traveling aerobatics show has resulted in the loss of 26 lives due
to accidents in its 60-year history. [The resolution was voted down by
San Francisco's Board of Supervisors.]

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From: The New York Times (pg. B1), Sept. 22, 2007
[Printer-friendly version]

ANALYZING FAILURE BEFOREHAND

By Paul B. Brown

Post-mortems, trying to figure out why a new idea failed, are a common
business process. But wouldn't "pre-mortems" make more sense?

They would, argues Gary Klein, chief scientist at Klein Associates, a
division of Applied Research Associates, which works with companies to
show them how to conduct pre-mortems and "identify risks at the
outset."

"A pre-mortem in a business setting comes at the beginning of a
project rather than the end, so the project can be improved rather
than autopsied," Mr. Klein explains in The Harvard Business Review.

In the pre-mortem, company officials assume they have just learned
that a product or a service they are about to introduce has "failed
spectacularly." They then write down every plausible reason they can
think of to explain the failure. The list is then used to eliminate
potential flaws before the new idea is actually introduced into the
marketplace.

While companies frequently engage in risk analysis beforehand,
employees are often afraid to speak up, fearing they will be seen as
naysayers or will suffer the political consequences of objecting to an
idea that is popular internally.

An exercise that assumes the new idea fails frees people to be more
candid, and can, Mr. Klein writes, serve as a check on the "damn-the-
torpedoes attitude often assumed by people who are overinvested in a
project."

[snip]

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From: USA Today, Oct. 1, 2007
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LEAD-PAINT SUIT MAY THIN BURDEN OF PROOF

By Greg Toppo, USA TODAY

A 17-year-old Milwaukee boy who was poisoned by lead as a baby faces
off today against the nation's leading makers of lead-based house
paint, hoping to prove that for half a century they knew their product
made people sick.

It's the latest in a long string of lawsuits -- virtually all of them
unsuccessful -- against companies such as Dutch Boy and Sherwin-
Williams, which manufactured the paint Americans used for decades. But
Steven Thomas' trial in Milwaukee could change the nature of product
liability lawsuits.

Thomas' suit was filed in 1999 against Sherwin-Williams, American
Cyanamid, NL Industries -- which marketed Dutch Boy -- and others.
What sets it apart is a 2005 Wisconsin Supreme Court ruling that
Thomas' attorneys don't need to prove the companies manufactured the
specific paint that made him sick. All they have to prove is that the
companies were making lead paint when the homes in which Thomas lived
were built, from 1900 to 1905, that the paint sickened him and that
the manufacturers knew of that danger.

"It's testing out the old theory of liability... that x party did y,"
says Jane Genova, a writer on legal topics who has followed this
litigation for years. "Now with this, you don't have to prove the old
things."

Thomas, who was born in 1990, suffered mental retardation after three
years of exposure to lead dust and chips in two rental homes, court
documents say. He'll require lifetime medical monitoring and is at
high risk for kidney disease, high blood pressure and heart disease,
among other conditions.

A decision in Thomas' favor could bring an explosion in suits on
behalf of children sickened by lead. More than 1,400 Milwaukee
children tested positive for high lead levels in 2006 alone, the
city's health department says. The American Academy of Pediatrics
estimates that one in four U.S. children lives in housing with
deteriorated lead paint.

Given their track records, cases such as Thomas' are long shots. The
first was filed in 1987, and since then more than 100 have followed.
Only five have made it to trial, and only one, in Rhode Island in
2005, has been successful. In that case, the state sued three paint
makers. State officials last month said it will cost about $2.4
billion to clean up hundreds of thousands of lead-painted homes. The
companies are appealing the verdict, in which a jury decided the paint
constituted a "public nuisance" that the manufacturers had to clean
up.

Thomas' legal team says paint makers knew as far back as the early
1900s that lead was dangerous but fought attempts to regulate or ban
it. Paint manufacturers have said in court that they knew lead paint
was dangerous, but that, properly handled, it was safe -- indeed, they
have pointed to federal standards that recommended homeowners use lead
paint because it was durable. Through the 1940s, house paint was up to
50% lead by weight. In 1978, the U.S. government banned lead
altogether from paint.

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From: The Canadian Press, Oct. 1, 2007
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CANADA'S BLOOD SUPPLY 'SAFE AS ANYWHERE,' SAYS AGENCY'S CEO

TORONTO -- Canadians who need blood or blood products are safer as a
consequence of measures taken in the aftermath of the tainted blood
scandal, a tragedy which led to the revamping of the blood collection
and transfusion system in this country, the head of the agency
responsible for the blood service said Monday.

"The legacy of the tainted blood scandal has been very profound, in
this country and even internationally," Dr. Graham Sher, CEO of
Canadian Blood Services, said in an interview from Ottawa.

Sher wouldn't comment on an Ontario Superior Court ruling acquitting
Dr. Roger Perrault, the former national medical director of the
Canadian Red Cross, and three other doctors of criminal charges
related to the scandal.

But he stressed that there are many more checks in place today to
protect recipients of blood transfusions or blood products from
bloodborne disease agents, known and unknown.

Still, there is no way to ensure that donated blood is risk-free. Sher
insisted: "We've never claimed that it's risk free."

"Our job is to make that risk as low as possible and we've been
extremely successful at that," he said.

"And then the physician must always counsel his or her patient before
a transfusion in terms of what are the risks and what is the benefit.
And you don't get a transfusion unless you absolutely need one."

Sher said both Canadian Blood Services and Hema-Quebec, its Quebec
equivalent, follow the recommendations of the Krever Inquiry and use
what's known as the precautionary principle when making decisions
about blood safety issues.

In essence, the precautionary principle means that when there are two
or more possible courses of action, the choice should be the option
that affords the greatest safety -- even in the face of small risk.

When the blood services learned that the West Nile virus could be
transmitted in blood they worked with the pharmaceutical industry to
ensure rapid development and deployment of tests. This summer -- the
worst ever for West Nile infections in this country -- Canadian Blood
Services found and removed from the blood system 70 blood donations
contaminated with the virus.

A second layer of tests has been put in place for HIV and hepatitis B
and C, Sher added.

And when scientists at the Public Health Agency of Canada discovered
that simian foamy virus can be transmitted through blood, the blood
services added a question to their blood clinic screening
questionnaire aimed at excluding would-be donors who work with or have
contact with primates.

There is currently no test for simian foamy virus, a retrovirus from
the same class of viruses as the human immunodeficiency virus (HIV).
Common in some primates, the virus isn't believed to cause disease in
humans. But diseases caused by retroviruses can take a long time to
develop, and the blood services don't want to take chances, Sher said.

"That's a very good example of where we've applied the precautionary
principle. In fact... we're the only two blood systems in the world
- the two Canadian blood services -- that have a measure in place to
ask donors about exposure to certain types of primates."

The agencies are currently studying the potential threat posed to the
blood system by Chagas disease, caused by a parasite rarely found in
Canada but more commonly found in Central and South America. The
agency believes it may have a test in place for Chagas in 2008.

As another precaution, Canadian Blood Services filters white cells out
of the blood donated to it. White blood cells are immune system
soldiers and can harbour pathogens. They aren't needed for blood
products, Sher said, and it is safer to remove them.

"It's one way of lowering the risk to the recipients," he said, noting
the agency is one of few in the world that takes this added step.

Copyright 2007 The Canadian Press

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From: Medscape Medical news, Oct. 2, 2007
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THIMEROSAL UNLIKELY CAUSE OF NEUROPSYCHOLOGICAL DEFICITS

By Susan Jeffrey

A new study from the Centers for Disease Control and Prevention
(CDC) does not appear to support a causal association between early
exposure to mercury from thimerosal-containing vaccines or immune
globulins and deficits in neuropsychological functioning among
children now aged 7 to 10 years.

Out of 328 tests assessing these outcomes, the number of significant
associations was about 5%, as would be expected for a chance finding,
lead author William W. Thompson, PhD, from the CDC's Vaccine Safety
Datalink Team, told Medscape Neurology & Neurosurgery.

"So at the end of the day, we think the weight of the evidence does
not support a causal association between thimerosal exposure and 42
neuropsychological outcomes that we tested," Dr. Thompson said.

Their report is published in the September 27 issue of the New England
Journal of Medicine.

However, the authors point out that their study did not look at autism
spectrum disorders and so cannot answer the thorny question of a
causal link there that has been the focus of litigation. This question
is also the subject of 2 Perspective articles in the same issue of the
Journal.

"We have a separate autism case-control study that we're doing that's
assessing whether thimerosal from vaccines is associated with the risk
for autism," Dr. Thompson noted. "That study is ongoing, and we hope
to have a manuscript submitted for publication in the next year."

Thimerosal Removed From Vaccines

Thimerosal has been used as a preservative in vaccines since the
1930s, the researchers write. It is 49.6% mercury by weight and is
metabolized into ethyl mercury and thiosalicylate.

In 1999, the Food and Drug Administration (FDA) estimated that infants
immunized according to the recommended schedule could receive amounts
of mercury in excess of limits set by the Environmental Protection
Agency for exposure to methyl mercury, they note. "As a precautionary
measure, the Public Health Service and the American Academy of
Pediatrics [AAP] urged vaccine manufacturers to remove thimerosal from
all infant vaccines as soon as was practical and recommended that
studies be carried out to understand better the risks associated with
mercury exposure from thimerosal-containing vaccines," the authors
write.

This study is a follow-up to a previous analysis by the CDC published
in 2003, Dr. Thompson said. Using computerized databases from 3 large
health maintenance organizations (HMOs), the previous researchers
found increasing exposure to thimerosal was associated with a greater
likelihood of tics in 1 population and of language delay in another,
but no significant associations were found in the third population
(Verstraeten T. et al. Pediatrics. 2003;112:1039-1048).

In the current study, the authors aimed to have a more rigorous and
comprehensive approach using a similar design to previous studies of
prenatal exposure to methyl mercury from fish consumption, Dr.
Thompson said.

"Our study improved on previous thimerosal studies by enrolling
children on the basis of thimerosal exposure, independent of health
status; prospectively assessing neuropsychological functioning
independently of exposure and healthcare-seeking behavior; and
collecting extensive information on potential confounders, including
medical history and socioeconomic and educational factors that could
influence a child's health and development," the authors write.

They also sought the advice of a panel of external experts, including
vaccine advocacy groups, to compile the outcomes of interest. "In the
end, we had 42 neuropsychological outcomes that we looked at and had
extensive information on vaccine histories," Dr. Thompson said. The
panel also had significant input on review of the results and draft of
the final manuscript, he noted.

In all, 1047 children between the ages of 7 and 10 years were enrolled
from 4 HMOs that participate in the CDC's Vaccine Safety Datalink.
Exposure to thimerosal was determined using computerized health
records, medical records, personal immunization records, and maternal
interviews. They assessed the association between current
neuropsychological performance and exposure to mercury in the prenatal
period, birth to 28 days, and the first 7 months of life.

"Among the 42 neuropsychological outcomes, we detected only a few
significant associations with exposure to mercury from thimerosal,"
the authors write.

"We present 378 tests in the manuscript, and when you run that many
statistical tests, you're likely to get some chance findings," Dr.
Thompson noted. Of the 378 tests, there were 19 statistically
significant associations; 12 of these showed better outcomes with
increasing thimerosal exposure, and 7 associated poorer outcomes with
increasing exposure. The differences were small and mostly sex-
specific.

Statistical significance on 19 tests, about 5% of the total, "is
exactly what you would expect by chance," he said.

However, some of these associations may require further investigation,
he added. One of these was an association of thimerosal exposure and
tics among boys, important because a similar relationship was also
seen in 2 previous studies, including the one by Verstraeten et al.

"We're in ongoing discussions within the CDC and with the National
Center for Birth Defects and Developmental Disabilities regarding
whether we should follow up on that or not," he said. Results from
another ongoing study, called the Thimerosal Italy Study, which is
also assessing tics as an outcome, will give more information on how
to proceed on that finding, he noted.

Thimerosal has been removed from all vaccines with the exception of
some influenza vaccines, Dr. Thompson said. However, parents can
request thimerosal-free vaccines for their children.

Perspectives: Thimerosal and Autism

Researchers in the current study emphasize that their study did not
assess autism spectrum disorders in relation to thimerosal exposure.
In the 2 Perspective articles, a lawyer and a physician look at the
impact that the fear of a potential link with autism has had on the
use of vaccines and on litigation related to this question of
causation.

In one of these, Paul A. Offitt, MD, chief of the division of
infectious diseases at the Children's Hospital of Philadelphia, in
Pennsylvania, calls the fallout from the decision to withdraw
thimerosal from vaccines a "cautionary tale."

"Although the precautionary principle assumes that there is no harm in
exercising caution, the alarm caused by the removal of thimerosal from
vaccines has been quite harmful," he writes. "For instance, after the
July 1999 announcement by the CDC and AAP, about 10% of hospitals
suspended use of the hepatitis-B vaccine for all newborns, regardless
of their level of risk. One 3-month-old child born to a Michigan
mother infected with hepatitis-B virus died of overwhelming
infection."

And there has been other fallout, he writes. The idea that thimerosal
causes autism has given rise to a "cottage industry of charlatans
offering false hope, partly in the form of mercury-chelating agents."

Many parents choose not to have their children immunized for influenza
because some preparations of vaccine still contain thimerosal. "By
choosing not to vaccinate their children, these parents have elevated
a theoretical (and now disproved) risk above the real risk of being
hospitalized or killed by influenza.

"During the next few years, thimerosal will probably be removed from
influenza vaccines and the court cases will probably settle down," Dr.
Offitt concludes. "But the thimerosal controversy should stand as a
cautionary tale of how not to communicate theoretical risks to the
public; otherwise, the lesson inherent in the collateral damage caused
by its precipitous removal will remain unlearned."

In a second Perspective, Stephen D. Sugarman, JD, professor at the
University of California, Berkley School of Law, outlines some of the
process and current state of suits related to the causation question
between childhood vaccines and autism.

Thousands of autism claims are pending, he writes. "In 2002, to
resolve such claims more expeditiously, the VICP [Vaccine Injury
Compensation Program] announced that some test cases would examine the
general causation question, putting aside the question of harm to any
particular child. Although this process was supposed to take only 2
years, the first of 9 test cases was heard just this past summer, with
many witnesses testifying on each side. A special section of the US
Court of Federal Claims administers the VICP, and judges running this
so-called vaccine court are not expected to begin to decide these
cases until 2008. Department of Justice lawyers appear in opposition
to the claimants."

The study was supported by the Centers for Disease Control and
Prevention, in Atlanta, Georgia. Dr. Thompson reports being a former
employee of Merck; disclosures for other coauthors appear in the
paper. Dr. Offit reports serving on the scientific advisory board of
Merck and being the coinventor of the bovine-human reassortant
rotavirus vaccine, RotaTeq, on which he holds a patent.

N Engl J Med. 2007;357:1281-1292, 1275-1277, 1278-1279.

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From: EUportal, Sept. 23, 2007
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GLOBAL WARMING HYSTERIA OR FREEDOM AND PROSPERITY?

By Vaclav Klaus

[Vaclav Klaus is president of the Czek Republic and a free-market
economist. This is a talk he gave at the Ambrosetti Forum,Villa
d'Este,Italy]

One can tell -- with a high degree of confidence -- what topics are
expected to be raised here, this morning when it comes to discussing
the key challenges of today's world. The selection of the moderator
and my fellow-panelists only confirms it. I guess it is either
international terrorism or poverty in Africa. Talking about both of
these topics is necessary because they are real dangers but it is
relatively easy to talk about them because it is politically correct.
I do see those dangers and do not in any way underestimate them. I do,
however, see another major threat which deserves our attention -- and
I am afraid it does not get sufficient attention because to discuss it
is politically incorrect these days.

The threat I have in mind is the irrationality with which the world
has accepted the climate change (or global warming) as a real danger
to the future of mankind and the irrationality of suggested and partly
already implemented measures because they will fatally endanger our
freedom and prosperity, the two goals we consider -- I do believe --
our priorities.

We have to face many prejudices and misunderstandings in this respect.
The climate change debate is basically not about science; it is about
ideology. It is not about global temperature; it is about the concept
of human society. It is not about nature or scientific ecology; it is
about environmentalism, about one -- recently born -- dirigistic and
collectivistic ideology, which goes against freedom and free markets.

I spent most of my life in a communist society which makes me
particularly sensitive to the dangers, traps and pitfalls connected
with it. Several points have to be clarified to make the discussion
easier:

1. Contrary to the currently prevailing views promoted by global
warming alarmists, Al Gore's preaching, the IPCC, or the Stern Report,
the increase in global temperatures in the last years, decades and
centuries has been very small and because of its size practically
negligible in its actual impact upon human beings and their
activities. (The difference of temperatures between Prague where I was
yesterday and Cernobbio where I am now is larger than the expected
increase in global temperatures in the next century.)

2. As I said, the empirical evidence is not alarming. The arguments of
global warming alarmists rely exclusively upon forecasts, not upon
past experience. Their forecasts originate in experimental simulations
of very complicated forecasting models that have not been found very
reliable when explaining past developments.

3. It is, of course, not only about ideology. The problem has its
important scientific aspect but it should be stressed that the
scientific dispute about the causes of recent climate changes
continues. The attempt to proclaim a scientific consensus on this
issue is a tragic mistake, because there is none.

4. We are rational and responsible people and have to act when
necessary. But we know that a rational response to any danger depends
on the size and probability of the eventual risk and on the magnitude
of the costs of its avoidance. As a responsible politician, as an
academic economist, as an author of a book about the economics of
climate change, I feel obliged to say that -- based on our current
knowledge -- the risk is too small and the costs of eliminating it too
high. The application of the so called "precautionary principle,"
advocated by the environmentalists, is -- conceptually -- a wrong
strategy.

5. The deindustrialization and similar restrictive policies will be of
no help. Instead of blocking economic growth, the increase of wealth
all over the world and fast technical progress -- all connected with
freedom and free markets -- we should leave them to proceed
unhampered. They represent the solution to any eventual climate
changes, not their cause. We should promote adaptation, modernization,
technical progress. We should trust in the rationality of free people.

6. It has a very important North-South and West-East dimension. The
developed countries do not have the right to impose any additional
burden on the less developed countries. Imposing overambitious and -
for such countries -- economically disastrous environmental standards
on them is unfair.

No radical measures are necessary. We need something "quite normal."
We have to get rid of the one-sided monopoly, both in the field of
climatology and in the public debate. We have to listen to arguments.
We have to forget fashionable political correctness. We should provide
the same or comparable financial backing to those scientists who do
not accept the global warming alarmism.

I really do see environmentalism as a threat to our freedom and
prosperity. I see it as "the world's key current challenge."

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From: San Francisco Examiner, Sept. 25, 2007
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SUPES TO VOTE TODAY ON BLUE ANGELS BAN

San Francisco may ban the Blue Angels air show from performing during
Fleet Week, if Supervisor Chris Daly has his way. Daly's resolution to
ban the popular show goes to a vote of the Board of Supervisors today.


By Adam Martin, The Examiner

A resolution calling for a permanent halt to the Blue Angels' annual
appearance at San Francisco's Fleet Week will go before the full Board
of Supervisors today.

The resolution, first introduced by Supervisor Chris Daly and gaining
co-sponsorship by Supervisors Ross Mirkarimi, Gerardo Sandoval and Tom
Ammiano, invokes the "precautionary principle," noting that the
traveling aerobatics show has resulted in the loss of 26 lives due to
accidents in its 60-year history.

The resolution also notes that the planes' practice runs over The City
cause "ear splitting and nerve shattering" noise that can traumatize
residents, including immigrants from war-torn countries.

Because the Blue Angels fly by invitation, the resolution, if passed,
will likely not stop the show scheduled for next week, but Daly has
said previously that he hopes it will halt future shows.

amartin@examiner.com

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Rachel's Precaution Reporter offers news, views and practical
examples of the Precautionary Principle, or Foresight Principle, in
action. The Precautionary Principle is a modern way of making
decisions, to minimize harm. Rachel's Precaution Reporter tries to
answer such questions as, Why do we need the precautionary
principle? Who is using precaution? Who is opposing precaution?

We often include attacks on the precautionary principle because we
believe it is essential for advocates of precaution to know what
their adversaries are saying, just as abolitionists in 1830 needed
to know the arguments used by slaveholders.

Rachel's Precaution Reporter is published as often as necessary to
provide readers with up-to-date coverage of the subject.

As you come across stories that illustrate the precautionary
principle -- or the need for the precautionary principle --
please Email them to us at rpr@rachel.org.

Editors:
Peter Montague - peter@rachel.org
Tim Montague - tim@rachel.org

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To start your own free Email subscription to Rachel's Precaution
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