by Carl F. Cranor. Cambridge: Harvard University Press, 2011. 328 pp. Cloth $35.00. ISBN: 9780674049703.Reviewed by Joshua Hall, Assistant Professor in The Department of Economics, Beloit College. Email: halljc [at] beloit.edu.
pp. 605-607
In Legally Poisoned, University of California-Riverside philosophy professor Carl Cranor makes his case for extensive pre-market testing of commercial chemicals. In addition to his philosophical training, Cranor also has an academic background in physics as well as graduate work in law. This background, combined with several years of researching in the area of science and the law, makes him uniquely qualified to take on this important topic. While researchers in my discipline of economics – scholars such as Werner Troesken (2004; 2006) and Jessica Reyes (2007) – have been investigating the short and long-run effects of environmental toxins such as lead on health and productivity, this work tends to not focus on the law. As a scholar interested in law and economics, I was very interested in reading about the case for a legal regime change with respect to environmental toxins.
After an introductory chapter giving a broad overview of his argument, Cranor starts to develop his case that commercial chemicals are problematic for health and well-being in Chapter 2. The main thrust of this chapter is that we are constantly being exposed to a wide variety of chemical compounds with varying degrees of toxicity. Some of these toxicants such as lead and DDT are fairly well-known because of highly-publicized concerns over environmental contamination. Other chemical compounds such as polybrominated diphenyl ethers (PBDEs) are less well-known despite scientific concerns over their long-term impact on humans, especially children. Given that many industrial contaminants can enter our bodies through the air, skin contact, or ingestion (through contaminated fish, for example) without our knowing it, it is extremely difficult to limit exposure to many toxicants even if an individual wanted to do so. “Nowhere to Hide” is both the title to the chapter and the takeaway.
The third chapter takes the reader through the tools available to identify and estimate the risks to humans from toxicants. Cranor discusses the pros and cons of testing on humans, including case reports, randomized clinical trials, and epidemiological studies. He then goes on to discuss the efficacy of experimental animal studies, including what exactly we can learn about the effect of chemical exposure on humans from tests on animals. Cranor’s view is that experimental studies should be used in a manner similar to the historical use of canaries in coal mines, to ensure that products are safe for humans before being allowed to be used in the marketplace. This is contrary to epidemiological studies and case reports, [*606] which are almost always the result of a post-market testing regime and have the consequences of resulting in people being injured or dying prematurely if an introduced chemical product causes harm to humans. The impact of toxicants on the unborn and young children (discussed in detail in Chapter 4), leads Cranor to advocate for a change in the current legal regime with respect to industrial chemicals, pesticides, and other commercial pollutants.
In Chapter 5 Cranor details the status quo. Currently, 80 to 90 percent of commercial chemical products are not tested for toxicity before entering the market. That is, they are not tested “pre-market” but instead are subject to “post-market” law, such as through a review by a public health agency in response to safety concerns. Most of this chapter deals with administrative or regulatory law, which can be either pre-market (think Food and Drug Adminstration (FDA)) or post-market (think Consumer Product Safety Commission). Another possible approach to regulation is through criminal or tort law. Cranor spends no time on criminal law and some time on tort law, but the majority of the chapter focuses on why post-market science as currently practiced primarily through regulatory law is inadequate to protect the public.
Cranor develops his preferred approach to reducing exposure to toxic chemicals in Chapter 6. Consisting primarily of pre-market testing and licensing laws, his approach is similar to current U.S. law regarding pharmaceuticals, which require pre-market testing by the FDA. Cranor notes that his approach is very similar to the approach adopted by the European Community under the acronym of REACH, which stands for Registration, Evaluation, Authorisation, and Restriction of Chemicals. The pithy summary of REACH is “no data, no market.” Basically, a chemical cannot enter into the marketplace until data is produced showing that it is safe (according to European Union standards).
After detailing some shortcomings of the REACH approach and how it might be improved upon, Cranor finishes the book by making the normative case for a pre-market testing regime in Chapter 7. In doing so, he begins by arguing that had a pre-market testing regime existed in the past, “we would have had a world with no thalidomide babies, no women with vaginal and cervical cancer because of in utero exposure to untested diethylstilbestrol (DES)” (p.208). Perhaps this is true, but the case for post-market testing versus pre-market testing should be, in my opinion, based on comparative institutional analysis. That is, what are the relative costs and benefits of the different institutional regimes? Unfortunately, Cranor does not provide a compelling discussion of the trade-offs between the two regimes.
Consider his discussion of whether we would lose valuable products under a post-market testing regime. In this three-page discussion (pp.239-41) he focuses primarily on the fact that while many chemicals pose life-taking risks, those must be balanced against life-saving benefits. So chlorine, which appears in some circumstances to elevate the risk of bladder cancer, must be weighed against the life-saving benefits of chlorine’s use as a disinfectant. While this description makes it sounds like he is looking at trade-offs, the problem is he is only [*607] looking at health trade-offs: individuals might be willing to trade-off health for consumption benefits. It seems to me that the public policy problem is that individual choices regarding the proper risk/reward ratio might be socially inefficient because of externalities and information asymmetries. Or, to paraphrase Deirdre McCloskey, there might be more to life than Max Health.
Even if we deviate from standard economic analysis of broader tradeoffs and focus only on Max Health, I was unconvinced of Cranor’s case for pre-market testing along this dimension. Recall that he uses the example of FDA testing of pharmaceuticals in building the case for post-market testing of toxicants. There exist, however, well-known trade-offs in the FDA approval process that Cranor completely ignores. This literature goes back to the seminal work of Peltzman (1973), who finds that the pre-market testing regime of the FDA lowers the number of new drugs introduced. A more specific example of the trade-offs that can exist with respect to health in a pre-market testing regime is the case of the FDA and beta blockers. The beta blocker Timolol was approved by the FDA for use in preventing second heart attacks in 1981, although evidence of its effectiveness was known as early as 1974. According to Gieringer (1985, p.190), “The total cost of this seven-year delay could then be put at some 45,000 to 70,000 lives – several times greater than all the casualties resulting from thalidomide and other major new drug disasters.”
The concluding chapter of Legally Poisoned is titled “What Kind of World Do We Want to Create?” This title recognizes that the law contains value choices. While Cranor is convinced that the best world is one with extensive pre-market testing, an inadequate discussion of trade-offs between the pre-market and post-market system leaves me unsure.
REFERENCES:
Gieringer, Dale. 1985. “The Safety and Efficacy of New Drug Approval.” 5 Cato Journal 177–201.
Peltzman, Sam. 1973. “An Evaluation of Consumer Protection Legislation: The 1962 Drug Amendments.” 81 Journal of Political Economy 1049-1091.
Reyes, Jessica. 2007. “Environmental Policy as Social Policy? The Impact of Childhood Lead Exposure on Crime.” 7 B.E. Journal of Economic Analysis and Policy (Contributions).
Troesken, Werner. 2004. Water, Race, and Disease. Cambridge, MA: MIT Press.
Troesken, Werner. 2006. The Great Lead Water Pipe Disaster. Cambridge, MA: MIT Press.
© Copyright 2011 by the author, Joshua Hall.
