Miller's Lancet Lament

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  • 03/03/2006

Henry Miller minces no words about the current direction of the Lancet and precarious slip/sliding towards the Precautionary Principle.

THE LANCET PRICKS ITSELF
Henry I. Miller

The term “medical journals” elicits automatic respect from most people. Not from me: I read them. I’ve found the editors to be increasingly hubristic and anti-business; and even worse, not to know what they don’t know.

The British journal The Lancet is a case in point. Having previously erred by publishing an obviously flawed paper purportedly showing toxicity of gene-spliced potatoes, another containing wild and irresponsible (but damaging) speculation about the possible dangers of the insecticide DDT, and a commentary about a link between autism and vaccines that contain the preservative thimerosal, The Lancet again has gone off the deep end. This time the issue is the regulation of chemicals in Europe. (What this has to do with medicine isn’t entirely clear, but it illustrates the expansive, do-gooder mindset of the editors.)

The Lancet’s biases are unmistakable: Chemicals bad, regulation good. Therefore, REACH (Registration, Evaluation, and Authorization of Chemicals), the EU’s sweeping plan, which The Lancet believes is “designed to reign in an industry that for decades had placed chemicals on the market with, at best, only irregular government oversight,” is laudable; while any attempts to introduce rigorous scientific and economic analysis into regulation can only be the product of cynical, self-serving interference.

According to The Lancet, REACH was right on track until “European lawmakers met The Lobby. In what some European Commissioners say is the largest lobbying effort in the modern history of the EU, European and American chemical manufacturers orchestrated a multilayered and multipronged lobbying campaign that encompassed all the original 15 EU member states plus the 10 new ones, as well as countries outside the continent such as Japan, Mexico, and the USA.”

In spite of the bad rap that lobbying has gotten recently on this side of the pond, however, all lobbying is neither negative nor motivated by special pleading. At its best, it is a means to educate policymakers about important and sometimes arcane issues.

The Lancet’s sanguine view of REACH is demolished by the meticulously argued, “Europe’s Global REACH,” released last November by the Hayek Institute in Brussels. It concludes that REACH will harm Europe and its trade partners economically — without any convincing evidence of health or environmental benefits.

REACH would extend to all chemicals produced in or imported into Europe the bogus “precautionary principle,” which holds that if the evidence about a product, technology or activity is any way incomplete, it should be prohibited or at least stringently regulated.

Potential risks should be taken into consideration before proceeding with any new activity or product, to be sure, whether it is the siting of a power station or the introduction of a new flame retardant. But what is missing from precautionary calculus is an acknowledgment that even when technologies and products introduce new risks, most confer net benefits — that is, their use reduces other, far more serious hazards. Vaccines have occasional side effects, for example, but they confer net benefits. The danger in the precautionary principle, ­ which in concept is centuries old, is that it focuses exclusively on the risks — often purely hypothetical ones, at that— and diverts consumers and policymakers from seeking possible solutions to known, significant threats to human health. Its overall impacts may be overwhelmingly net-negative.

The costs of REACH’s precautionary approach will be prodigious. The European Commission’s own estimates range up to 5.2 billion euros, but according to a study produced by the Nordic Council, the price tag could be as much as 28 billion. This higher estimate includes both direct and indirect costs, and assumes that the latter may amount to as much as 2.5 times the former.

REACH’s supporters maintain that businesses can absorb this high price tag easily, but the Hayek Institute analysis offers a very different view. Its author, public policy scholar Angela Logomasini, points out that cost estimates that are favorable to REACH are incomplete, fail to consider a host of direct costs, and often completely neglect the indirect costs.

Moreover, REACH’s advocates ignore its disproportionately harsh impact on small businesses and businesses in the newer EU member nations. A study conducted by consulting firm KPMG on behalf of the European Commission concludes: “The heaviest burden will be on SMEs [small and mid-sized enterprises] which cannot consistently fulfill the REACH requirements and so it is predicted that most of them may face financial troubles, may be taken over by bigger ones, or even shut down.”

These prospects should raise serious concerns for Europeans. Small and mid-sized firms represent more than 99 percent of EU businesses, and account for two-thirds of the jobs. The imposition of REACH will increase unemployment and diminish competition — which will lead to less innovation and higher prices.

The Lancet’s take on these monumental costs? “While EU regulation involves unpleasant upfront costs, it also provides predictability and efficiency.” The Hayek Institute’s analysis suggests that REACH will offer few predictable benefits to offset the potentially devastating costs. In a review of the benefits claimed for REACH, Logomasini shows that the “studies” that purport to demonstrate benefits depend more on unsupported assumptions and wishful thinking than on science or logic. The European Commission’s only study of likely benefits from REACH, conducted by Risk and Policy Analysis Limited (RPA) in 2003, addresses occupational exposure to chemicals and attempts to estimate the extent to which REACH would reduce health problems among workers. However, it is based on sketchy, incomplete, and inconsistently collected data assembled from a handful of member governments that is of questionable relevance to REACH.

The RPA report explicitly assumes that problems related to currently known chemical causes will be addressed by existing laws, while REACH will prevent currently unknown health problems from chemicals. But if these cases are unknown, how can we know they are caused by chemicals or are even work-related? Obvious errors and insufficient documentation in the report only compound problems with the study, which makes no mention of having been peer reviewed.

REACH’s presumed benefits are based on the assumption that testing chemicals, filing paperwork, and pursuing politically correct product bans will somehow reduce cancer rates. But as the Hayek Institute analysis makes clear, the vast majority of cancers are not related to chemicals. According to the World Health Organization, the major preventable causes are tobacco use, diet, and infections, which account for 75 percent of cancer cases worldwide. WHO bases these findings on a landmark study conducted by scientists Sir Richard Doll and Richard Peto, which concluded that all environmental pollution might amount to only as much as two percent of cancers.

In the interest of free markets and economic growth, we need global regulatory policies that make scientific sense and that encourage innovative research and development. But by promoting the precautionary principle, EU politicians are performing a disservice. The only winners will be the European regulators, who will enjoy additional power, and the anti-science activists who will have succeeded in erecting yet more barriers to the use of superior technologies and useful products.

The Lancet should narrow its focus and stick to what it does well, assuming that something in that category can be identified.

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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