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Implementation

PERSPECTIVE

It Did Happen Here: Fear And Loathing On The Vaccine Trail

Abstract

 
Adverse publicity that placed undue emphasis on a possible connection between autism and the measles-mumps-rubella (MMR) vaccine and vaccines containing thimerosal made parents in the United Kingdom reluctant to allow their children to receive the vaccine. The same concerns have played themselves out in the U.S. Food and Drug Administration’s decision to recommend removal of thimerosal from other vaccines, even as the individual autism claims have been rejected. That recommendation, based on unsubstantiated safety concerns, reveals a deep-seated institutional overreaction that is more likely to cost lives than to save them.

Bad news will crowd out good, especially when a product hailed for its life-saving benefits is credibly charged with a safety risk. No deep knowledge of cognitive psychology is needed to see why anxious parents may well believe that it is better to be safe than sorry and thus refuse to use the vaccine for children for whom, on balance, it promises a strong net, if hidden, benefit. The losses at the outset are only statistical, but that changes when children who contract measles, mumps, or rubella are rushed to the emergency room. At that point, dramatic true information can drive out dramatic false information, so that some belated balance is restored to the vaccine market—here measured by the fraction of parents willing to allow vaccination for children in the high-risk age group of 19–35 months.

The second part of Colgrove and Bayer’s tale recounts the failure of the autism scare to make headway in the United States on the strength of the same evidence that had proved so damaging in the United Kingdom. Evidently, the U.S. press did not bite on the stories to the same degree as did its British counterpart. Whatever makes Americans unconcerned about the genetically modified organisms that convulse Europe may exert influence here as well. In addition, the U.S. system of compulsory vaccinations for public school and day care students helped keep the percentage of vaccinated children higher here than in the United Kingdom.

Vaccines: Public Goods, Private Liabilities

Top Vaccines: Public Goods, Private... Stop Using Thimerosal? NOTES

 
There is, of course, a standard public-goods justification for promoting vaccinations of highly contagious diseases, via subsidy and perhaps even coercion.⁴ Quite simply, the vaccinated person tends to think only of the losses to himself or his immediate family, but not of the losses to total strangers. A subsidy reduces the private costs of compliance, while compulsion increases the costs of noncompliance. The upshot is that either method can close the gap between private and social costs and increase the levels of vaccination, but the former is preferable.

The courts and vaccine use. In dealing with the rate of vaccinations, Colgrove and Bayer did not mention tort or no-fault liability for the adverse consequences of vaccines. That issue does not seem to have been much of a concern in the United Kingdom, where a panoply of defenses makes it hard for any product liability case to succeed in court. But within the U.S. framework, the question of causation of injury is often vetted in a judicial or administrative setting, where exactly the same kind of unreliable information that scared British parents can trigger official overreaction.

The false attribution of harm to a vaccine not only results in a miscarriage of justice in the individual case, but it also alters for the worse the incentives of key players throughout the system, thereby aggravating the public-goods problem. Firms that are wrongly tagged with the liability now have an added incentive to cut back or eliminate their production and to increase the costs of the products that remain in the market. Nor are ordinary people immune from the mistaken verdicts. With cases of death or serious injury, no one believes that the law ever awards sufficient compensation to leave the aggrieved party indifferent between his ex ante and ex post positions. Death itself is a sufficient counterexample to the general proposition, as are many serious, lifelong neurological disorders. In the face of well-publicized negative liability decisions, ordinary people will rightly perceive themselves as undercompensated by the tort system and will therefore be more reluctant to undergo vaccination. The combination of unwilling sellers and unwilling buyers can generate a lethal mix for tort awards driven by poor information.

Nor is this problem eliminated now that we have moved, sensibly enough, to a partial no-fault compensation system under the National Childhood Vaccine Act of 1986.⁵ That system will cut down on sellers’ exposure and thus help keep them in the market. But since the protection of the statute does not cover adult injuries, the defects of the tort system still survive in some cases. Even with the childhood cases, it is crucial that people have confidence in the soundness of the individual verdicts in light of their incentive effects. Thus, if the large damage awards of the tort system leave people thinking that they are undercompensated, then the smaller awards under this no-fault system could magnify this effect, further reducing vaccine use.

Insistent question of causation. Historically, alas, this goal has not been systematically achieved. Within the confines of the traditional tort system, the insistent question of causation-in-fact has proved to be the soft underbelly of the entire liability system. Causation-in-fact is the lawyer’s fancy way of asking whether the activities undertaken by the defendant (or his products) brought about the plaintiff’s injury. In the routine case of traumatic harm, the problem scarcely surfaces, for no one doubts that a blow to the skull was the cause of death. But the tort system works best with discrete and visible processes that work at eye level. Vaccines, like all chemicals and pharmaceuticals, operate not at the visible but at the molecular level. In this setting, it is much more difficult to identify the cause of any particular consequence, owing to the number of possible influences that might be operating at the molecular level. Ideally, we hope for some typical, or signature, condition so that causation does not have to be examined separately in each case.⁶ The medicine that causes a rare kind of cataract not otherwise found in ordinary people would present an easy case of causation. The entire swine flu episode of the 1970s resulted in huge program payoffs under the Swine Flu Act, precisely because certain syndromes, such as Guillain-Barré and transverse myelitis, occurred with sufficient frequency to make tenable the plaintiff’s case on causation.⁷

The ability to identify some signature disease applies only when the claim is for an adverse side effect. It will not work in those cases where the claim is that the vaccine caused the very condition that it was intended to protect against. Just this problem arose in the decisive decisions of Davis v. Wyeth Laboratories and Reyes v. Wyeth Laboratories, in which the question of whether the plaintiff’s polio was caused by the Sabin live virus vaccine was held to a jury question, even when the statistical evidence strongly suggested that the wild strain of the virus—the fear of which had spurred on the immunization program in the first place—had already infected the plaintiff.⁸ The upshot was that the excessive findings of liability meant that many more people were injured for failure to take the vaccines than from the vaccines themselves, so much so that between 1975 and 1990, the price of the commonly used diphtheria-tetanus-pertussis (DTP) vaccine increased on the order of 2,000 percent, of which 96 percent went toward the costs of litigation.⁹ The indirect costs undoubtedly were substantial as well. In one sense, therefore, the dislocations in the vaccine market did take place, albeit for reasons different from those in the United Kingdom.

Stop Using Thimerosal?

Top Vaccines: Public Goods, Private... Stop Using Thimerosal? NOTES

 
Lest we think that these issues of false attribution are past, it is worth noting that the medical evidence that silicone implants are responsible for any of the assortment of ailments for which they have been attributed is wholly worthless, yet the liabilities generated by these claims were large enough to generate billions in settlements and judgments, with commensurate lawyers’ fees.¹⁰

Fortunately, it does not look as though this kind of mistake has been replicated in the claims processed under the National Vaccine Injury Compensation Program (VICP), which has undertaken an investigation of the relationship between thimerosal and autism. A priori, one reason to be skeptical of the evidence that thimerosal was responsible for autism is that the disease itself is in all likelihood not a single disease entity, but rather a complex set of conditions that operate by overlapping or different mechanisms for which there is still no definitive diagnostic test. Doubtless that background information led to the rejection of each of the 140 claims for autism/thimerosal decided in the past three years. The bad news is that the number of claims brought in this class was only 40 in 2001, but rose to 1,363 in 2002 and then to 2,090 in 2003 before the adverse decisions reduced the total number of new claims filed to 835 for the first ten months of 2004.¹¹ The weakness of the causal evidence appears to have blocked these individual claims.

It is more difficult to assess the relative success of the non-autism/thimerosal claims. These claims have averaged only about 125 per year over the past eighteen years, with only modest fluctuations.¹² This pool, however, yielded a 43 percent success rate over the eighteen-year period (695 over 1,621), a percentage that has remained virtually unchanged over the past four years. I have no competence to pass on the soundness of these individual determinations, but one hopes that they are correctly decided, for the U.S. Food and Drug Administration (FDA) recently recommended removal of thimerosal for use in recommended vaccines. Unfortunately, the FDA’s report reads as if it has again adopted the worst-case scenario in evaluating product safety. The Special Review Committee concluded that "the evidence is inadequate to either accept or reject a causal relationship between thimerosal exposure from childhood vaccines and the neurodevelopmental disorders of autism, attention deficit hyperactivity disorder (ADHD), and speech or language delay."¹³

That just does not cut it as a reason to recommend removal. The substantial benefits of using vaccines are ignored: Fewer shots mean higher compliance rates and lower administrative costs, which translate into lives saved. The risks of alternative approaches are not discussed, and the mystery of how individual non-autism claims were resolved only deepens. Let us hope there are satisfactory answers to these queries, for otherwise, the exaggerated response of vaccine risks that Colgrove and Bayer observed in the United Kingdom might have happened here after all. That reaction comes not in public response but in administrative behavior: Exaggerated fears unnecessarily have limited the use of life-saving vaccines. Intelligent British parents can ignore the scare, but no one in the United States can sidestep the debate. Just when will the FDA get the message that small risks have to be tolerated for larger ones to be avoided?

Editor's Notes

 
Richard Epstein (repstein{at}uchicago.edu) is the James Parker Hall Distinguished Service Professor at the University of Chicago Law School, and the Kirsten and Kirsten and Peter Bedford Senior Fellow at the Hoover Institution, Stanford University, California.

The author thanks Alix Weisfeld, University of Chicago Law School, Class of 2006, for her helpful research assistance. All errors are, of course, the author’s own.

NOTES

Top Vaccines: Public Goods, Private... Stop Using Thimerosal? NOTES

 

1. J. Colgrove and R. Bayer, "Could It Happen Here? Vaccine Risk Controversies and the Specter of Derailment," Health Affairs 24, no. 3 (2005): 729–739.[Abstract/Free Full Text]
2. A.J. Wakefield et al., "Ileal-Lymphoid-Nodular Hyperplasia, Non-Specific Colitis, and Pervasive Developmental Disorder in Children," Lancet 351, no. 9103 (1998): 637–641.[CrossRef][ISI][Medline]
3. Institute of Medicine, Immunization Safety Review: Vaccines and Autism (Washington: National Academies Press, 2004).
4. IOM, Financing Vaccines in the Twenty-first Century: Assuring Access and Availability (Washington: National Academies Press, 2004), 39–45.
5. National Childhood Vaccine Act, 42 U.S.C., sec. 300aa (maximum recovery of $250,000 in death cases; complex awards in other cases).
6. See K. Abraham, "Individual Action and Collective Responsibility: The Dilemma of Mass Tort Reform," Virginia Law Review 73, no. 5 (1987): 845–907.
7. The Swine Flu Act, Pub. L. 94-380, 42 U.S.C., sec. 247b(j)-(1) (1976); and Unthank v. United States, 732 F.2d 1517 (10th Cir. 1984) (noting that the government did not contest a finding of tranverse myelitis, for which there was "abundant evidence," at 1518).
8. Davis v. Wyeth Laboratories, 399 F.2d 121 (9th Cir. 1968); and Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 1974).
9. P. Huber, "The Hazards of Public Risk Management in the Courts," ColumbiaLawReview 85, no. 2 (1985): 277–337 (illustrating whooping cough); and R. Manning, "Changing Rules of Tort Law and the Market for Childhood Vaccines," Journal of Law and Economics 37, no. 1 (1994): 247–275.
10. For an early exposé, see M. Angell, Science on Trial: The Clash of Medical Evidence and the Law in Breast Implant Cases (New York: W.W. Norton, 1996).
11. Health Resources and Services Administration, National Vaccine Injury Compensation Program, "Post-1988 Monthly Statistics Report," 28 January 2005, www.hrsa.gov/osp/vicp/monthly_stats_post.htm (3 March 2005).
12. Ibid.
13. U.S. Food and Drug Administration, Thimerosal in Vaccines, 6 January 2005, www.fda.gov/cber/vaccine/thimerosal.htm (3 March 2005).

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