PeteFree.comMad Cows and Variant Creutzfeldt-Jakob Disease - The New Stature of the Precautionary Principle in European Law and Health Practice
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© April 2001 Peter Free
At BSE’s outset, the EU’s Precautionary Principle had not been tested
The European Union's place on the Precautionary versus “If it is not visibly broken, don’t fix it” spectrum was initially unclear. The Treaty on European Union (1992) [31] stated that Community policy on the environment "shall aim at a high level of protection...based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay." [32] The cautionary tone of this statement was diluted by the words that followed. These require that the Community take into account available scientific/technical data, environmental conditions, potential costs and benefits of action/inaction, and balanced economic and social development across the Community as a whole. [33]
In an attempt at clarification, the European Commission [34] communicated its interpretation of the Precautionary Principle in February 2000. [35] These principles, though advisory, and publicized only toward the end of the mad cow epidemic, appear to have guided the Union's response to BSE. The February Communication recognized that decision-makers are faced with the dilemma of balancing individual and industrial freedoms against the need to reduce the risk of adverse effects to environment and health. [36] The Commission's goal was to avoid misapplication of the Principle as a form of disguised trade protectionism. [37]
Precaution is legitimately triggered "where preliminary objective scientific evaluation indicates that there are reasonable grounds for concern that the potentially dangerous effects on the environment, human, animal or plant health may be inconsistent with the high level of protection chosen for the Community." [38] The Principle presupposes that potentially dangerous effects have been identified, but that the science supporting the predictions is uncertain. [39] The analytical process begins with scientific evaluation that is as complete as possible. [40] Participants identify the degree of scientific uncertainty at each step. [41]
Judging the acceptable level of risk is a political responsibility. [42] Decision-making should be transparent and involve interested parties. [43] Action should be non-discriminatory, consistent with similar measures, based on an analysis of the cost-benefits (of action versus inaction), subject to review, and proportional to the chosen level of protection. [44] The cost-benefit analysis involved is not simply economic, but includes efficacy and public acceptability. [45] Protection of health takes precedence over economic considerations. [46] Last, responsibility for producing more complete scientific evidence should be assigned. [47]
Conventional risk analysis versus precaution ─ BSE in the UK and Western Europe
The British health drama began in November 1986, when the first case of BSE was formally identified in cattle. [48] As with many outbreaks, there is retrospective evidence that visible signs of the outbreak had actually occurred two years earlier. [49] The disease damages the central nervous system, and the animals die. As of this writing, there have been almost 178,000 cases of confirmed or suspected BSE in cattle on more than 35,000 farms in Great Britain. [50] Four million seven hundred thousand British cattle were slaughtered. [51] Ninety-five people contracted vCJD. [52]
In Western Europe generally, almost certainly as a result of the importation of animals or meat and bone meal feed from the United Kingdom, there have been (again, as of this writing) 23 BSE cases in Belgium, 3 in Denmark, 249 in France, 49 in Germany, 587 in Ireland, 2 in Italy, 2 in Liechtenstein, 1 in Luxembourg, 9 in the Netherlands, 509 in Portugal, 32 in Spain, and 367 in Switzerland. [53] Three people in France and one in Ireland have gotten vCJD. [54]
The economic costs have been considerable. One estimate put the governmental cost at about 7.5 billion U.S. dollars in the UK alone. [55] Indirect losses due to trade bans and a decline in the demand for beef are probably impossible to determine accurately.
The BSE epidemic in the United Kingdom is now being controlled, although the size of the vCJD population is likely to grow due to past exposures to BSE. Each year since 1992 brought significant declines in the number of mad-cow infected cattle. The year 2000 figure was about four percent of the 1992 peak.
There is no reliable screening test for vCJD infection that can be used to predict the development of clinical symptoms and thereby forecast the size of the human epidemic to come. [56] As a result, predictive mathematical models must estimate some quantitatively critical factors. For example, the incubation periods for BSE [57] and (apparently) vCJD [58] are relatively long. During incubation, the disease is essentially asymptomatic and unlikely to be discovered absent a screening test. Additional complexity is introduced by the fact that it is unknown how many people were exposed to BSE before the government acted to protect the public from contaminated beef and beef byproducts. It is also unknown what percentage of those exposed will develop disease.
Predictive models depend upon guesswork in these areas. The first suspected human cases surfaced in 1996. If the incubation period in these patients had been 10 to 15 years or more, the population would have been continually exposed to BSE before the government took measures to protect the food supply beginning in 1987. [59] Under this assumption of long incubation, the human epidemic may turn out to be quite large. On the other hand, if incubation in humans is short, then most of the people who had been exposed would have been exposed after protective measures were put in place starting in 1987. In that event, most of those who will become ill will already have done so. A recent calculation, using what is currently known, forecast an upper limit of 136,000 cases in Great Britain. [60]
Could invoking the Precautionary Principle have helped the UK deal with BSE?
Comparing current BSE knowledge [as of April 2001] with what was known in 1986 allows us to ask whether there was enough information available at the beginning of the epidemic to justify invoking the Precautionary Principle as a guide to sound infection control policy. Though precautionary decisions are ultimately political, decision-making in circumstances of uncertainty does not abandon scientific inquiry. [61] Indeed, the physical success of the environmental or health outcome is going to be evaluated in scientific or medical terms.
Political leaders are generally not trained to evaluate the quality of the scientific advice they receive and have to act upon. Similarly, advisor scientists are not often qualified to act with a political appreciation for the competing demands of citizen constituents. Politicians will usually be motivated to ignore mere possibilities of harm, due to the immediately visible costs of opposing it, particularly when they can subsequently claim ignorance as a defense to criticism. Scientists, politically unaccountable, might well be more intervention oriented.
This failure of shared scientific-political language creates problems that the Precautionary Principle is designed to ameliorate. It imposes a decision-making bias that favors preserving and achieving what is most socially valuable. [62] Consequently, scientists, politicians, and entrepreneurs are not left free to err in regard to safety, without first producing proof of how their proposed action will accomplish or enhance the culture’s most desired ends.
BSE is a case in point. Early on in mad cow disease, investigators realized that BSE was similar to a neurological disease in sheep called scrapie. [63] It was also known that the pathogen that caused scrapie, a prion, was of the same general type that caused fatal neurological illnesses in people. There was, however, almost no evidence with which to assess the likelihood of BSE jumping to people. The political choice Her Majesty's ministers ultimately made was predicated on the idea that BSE was more similar to scrapie than to the human illnesses. Since scrapie had never affected people, the government concluded that the risk to humans was too remote to be concerned about. [64]
This political choice cannot be faulted on purely scientific grounds because there was no scientific data to demonstrate that this decision was probabilistically wrong. But the decision can be faulted from a risk-management perspective because its competing alternative (disease transmission from cows to humans) was strong enough to be possible. [65] In other words, scientific data pulled both ways.
The fact that the data pulled both ways is not the same as saying the science that did exist was not helpful. Indeed, what was known was solid enough to design experiments to test the hypothesis that BSE might be transmitted to other species. Since what was known was strong enough to generate competing hypotheses, [66] it should have been strong enough to generate the fear that something precious might be lost if a regulatory government chose the wrong one.
It is this conundrum that the Precautionary Principle was designed to address. Lacking the bias the Precautionary Principle mandates for government action, the United Kingdom jumped the wrong way. The ministers did not ignore scientific data, but they did permit favored scientists to influence them into making a risk-taking choice that scientists outside the inner clique might not have accepted. [67] Indeed, the government-selected scientists did warn that if their non-transmission hypothesis were wrong, there would be a high price to pay. [68]
More important, government assurances that there was nothing to worry about persuaded people that they need not consider protecting themselves against a possible pathogen. [69] That decision should properly have been left to individual citizens, given the scientific uncertainty and the potential personal costs of the health situation. In effect, the government’s (retrospectively) false safety assurances deprived people of the ability to choose to protect themselves by not eating, and not coming into contact with, beef.
Government leaders, arguably, had questionable ethical right to put the economic needs of the beef industry above those of the public’s health. In the absence of democratically-imposed price supports, one can suggest that industry should have been encouraged to deal with the twists to which it is naturally subject. Disease has long been as aspect of farming and food production. There is no weighty reason why the cattle industry should not have been left to manage its BSE image problem by itself.
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Page 6 ─ Page 7 ─ Appendix ─ Footnotes