Rachel's Precaution Reporter #110
Wednesday, October 3, 2007
From: The New York Times (pg. B1) ........................[This story printer-friendly]
September 22, 2007
ANALYZING FAILURE BEFOREHAND
[Rachel's introduction: 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.]
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 ..........................................[This story printer-friendly]
October 1, 2007
LEAD-PAINT SUIT MAY THIN BURDEN OF PROOF
[Rachel's introduction: 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.]
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 ..................................[This story printer-friendly]
October 1, 2007
CANADA'S BLOOD SUPPLY 'SAFE AS ANYWHERE,' SAYS AGENCY'S CEO
[Rachel's introduction: 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.]
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 ..............................[This story printer-friendly]
October 2, 2007
THIMEROSAL UNLIKELY CAUSE OF NEUROPSYCHOLOGICAL DEFICITS
[Rachel's introduction: 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.]]
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 ............................................[This story printer-friendly]
September 23, 2007
GLOBAL WARMING HYSTERIA OR FREEDOM AND PROSPERITY?
[Rachel's introduction: "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.'"]
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 ..............................[This story printer-friendly]
September 25, 2007
SUPES TO VOTE TODAY ON BLUE ANGELS BAN
[Rachel's introduction: 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.]]
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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