Abstract

In the event of a widespread biological attack involving smallpox, it may not only be morally permissible, but morally obligatory, to dispense with the ordinary requirements of informed consent for vaccination. The government should also commit to educating the public about the vaccine, distributing the vaccine efficiently and fairly, and ensuring access to health care to those who experience adverse events as a result of vaccination. In addition, the government should provide a program of financial compensation for any persons who experience permanent disability as a consequence of vaccination and for the families of those who die as a result of vaccination.

In recent months, there has been considerable controversy in the United States over what policy the nation should adopt with respect to smallpox vaccination. Advisory committees and commentators differ about who should be vaccinated, when they should be vaccinated, and whether individuals should have access to the vaccine even if the government determines that the threat of a biological attack involving smallpox is not sufficient to warrant vaccination of the general public [1–3]. Recently, President George W. Bush announced his policy decision. Vaccination of the military began in late 2002. Vaccination of health care “first responders” and other emergency personnel began early in 2003. The general public will have access to the vaccine after sufficient doses have been licensed, which is expected sometime in 2004. In the interim, provisions will be made for members of the public to be vaccinated with the unlicensed product, if they so wish. With the marked exception of those for the military, all vaccinations, including those of first responders, are to be voluntary [4]. Although there has been substantial criticism of the President's policy [5, 6], virtually all parties to the debate agree with the President that, insofar as vaccinations should go forward, they should be voluntary [7,8]. This consensus is not surprising. Respect for individual choice is a foundational value of both American society and medical and public health ethics. Moreover, compared with other widely used vaccines, the adverse event profile for smallpox vaccine is problematic. It is estimated that, for every million vaccinations, there will be 1–2 deaths, 14–52 life-threatening reactions, and ∼1000 serious but not life-threatening reactions [9]. Recent reports of cardiac events occurring after vaccination have further complicated this picture [10].

But what if there is a biological attack involving smallpox and thus a national emergency? Does it still make moral sense to conduct a voluntary vaccination program? The answer to this question turns, in part, on whether a commitment to voluntariness necessarily entails an obligation to obtain informed consent for vaccination. In addition, the answer lies in striking the appropriate balance between respect for the autonomy of individuals and the benefits that will accrue to the nation as a consequence of an efficient vaccination program. The more rapidly that individuals are vaccinated, the more likely it is that we will be able to limit the spread of infection.

In this article, we argue that, during a national emergency, it may not only be morally permissible, but even morally obligatory, to dispense with the duties of informed consent, even in a context in which compulsory vaccination is not itself justifiable. At same time, however, we argue that the government should ensure that anyone experiencing an adverse reaction has unfettered access to first-rate medical treatment, and that financial compensation be provided to those who experience a permanent injury and to the families of those who die as a result of vaccination.

Voluntariness and Consent

Whether one evokes the language of respect for individual choice, autonomy, self-determination, or liberty, the concept that individuals should be able to decide for themselves what medical treatments they receive is now deeply embedded in American culture. In medicine and public health, this value has been enshrined in the practice of soliciting informed consent. Properly honored, the practice of soliciting informed consent obligates health care providers not only to provide patients with detailed information about the risks of, potential benefits of, and alternatives to the proposed treatment, but also to take reasonable steps to ensure that patients understand this information and have an opportunity to make a meaningful decision.

All of these steps take time, however, and time will be an incredibly scarce resource in the context of a national emergency. Consider, for example, the smallpox vaccination plan disseminated by the Centers for Disease Control and Prevention (CDC; Atlanta, GA) in September 2002. This plan is designed to address how the public health infrastructure should respond if the nation is attacked. The plan provides for an informed consent procedure that requires individuals to watch an informational video and to complete multiple forms in advance of vaccination with what is assumed to be an unlicensed product [11]. What the plan does not do, however, is place highest priority on what is arguably the most important moral consideration in the context of a smallpox attack: minimizing harm and suffering by containing the epidemic. Although a limited outbreak of smallpox may not require a large program, depending on the nature of the attack, containing the epidemic may require vaccinating as many people as possible, as quickly as possible. Insofar as attending to informed consent procedures comes at the expense of this objective, it may not only be morally permissible, but morally obligatory, to dispense with standard consent practices.

The potential devastation of a smallpox attack puts what is a frequent tension between efficiency and informed consent in the starkest and perhaps easiest terms. Rarely are the costs of soliciting informed consent so potentially significant or the benefits of increased efficiency so consequential. The overriding importance of the public health and homeland security objective is not, however, the only justification for dispensing with informed consent practices in the context of a smallpox attack. Arguably, many if not most of the “informed consents” obtained during a crisis are likely to be, in important respects, meaningless. During a national emergency, when the nation is experiencing a smallpox attack, many people are likely to be preoccupied with getting vaccinated and not with learning about the risks of vaccination. When people are tense, at best, and panicked, at worst, how likely is it that anything approximating valid informed consent will be obtained? If some persons were to die because others were given the time to participate in consent procedures, that would be wrong. If the consents so obtained meant nothing, it would be not only wrong, but tragic.

Respect for individual choice is a core value for public health policy; however, public health, unlike medicine, has a long tradition of privileging public good over individual liberty. A standard question in public health policy is whether a program should be voluntary or mandatory. The policy problem is not so black and white, however. For example, there is a world of moral difference between a program in which people are physically compelled to participate and one in which people are fined or denied benefits if they fail to participate, even though both programs may be designated as having mandatory policies [12]. Public health has long accepted the moral injunction to use the least restrictive policy capable of achieving a program's objective [13]. For example, in many circumstances, programs that use fines are viewed as less restrictive of liberty and thus as morally preferable to programs that physically coerce. Similarly, even if it is morally justifiable in the event of a smallpox attack to dispense with informed consent practices, it does not follow that people should be vaccinated against their will or even that no efforts should be made to facilitate informed choice. Quite the contrary.

Presently, the public harbors significant false beliefs about both smallpox vaccine and smallpox disease [14]. In anticipation of the vaccine's becoming available to the public early in 2004, the government is already taking steps to educate the public about the risks and potential benefits of smallpox vaccine. Although it is therefore likely that the public's general understanding of both the disease and the vaccine will improve in the months to come, the government should not rely on the public's general understanding in the event of an attack. Instead, the government should develop, in advance, educational materials that provide information about the vaccine and the disease that is specific to an attack. These materials should be publicized continuously on television, the radio, and the Internet in the event that an attack occurs. Without affirmative duties to obtain informed consent, the emergency smallpox program envisioned here would not be voluntary in the fullest sense. However, the program would be voluntary in that individuals would present to vaccine centers of their own accord and would likely arrive at the centers with some basic understanding of what it means to be vaccinated. Given the cursory attention often paid to informed consent in clinical settings, it is possible that people appearing for vaccination may be no less informed than are many patients when they authorize medical procedures. Thus, we are not calling for a policy in which individuals would be required to be vaccinated but, rather, for a policy that dispenses with informed consent practices.

It is a separate moral question whether there are any circumstances in which it would be morally justifiable to have a fully mandatory policy in which people are compelled to be vaccinated for smallpox. There is also the related issue of how public health authorities should respond if, in some communities, residents react to an attack by staying home, despite government calls to appear at vaccine centers, either because they are afraid to go outdoors or because they do not trust the vaccination program. Such complex questions of ethics and public policy need to be debated now, when there is opportunity for reflection and public dialogue, rather than at the moment of crisis.

Compensation: The Other Half of the Compact

Thus far, we have argued that it may be morally preferable, if not obligatory, to dispense with practices of informed consent in the event of a smallpox attack. For a mass vaccination program to be fully ethically defensible, however, several additional pieces need to be in place [15–17].

Regardless of the consent policy, the system for distributing the vaccine has to be fair. In a recent public opinion survey, >70% of respondents believed that wealthy and influential people would be vaccinated first if it was not possible to vaccinate everyone quickly, whereas 22% believed that the vaccination program would discriminate against black persons [13]. These data suggest the worrisome conclusion that, in the event of an attack, many Americans simply would not trust the government to distribute the vaccine fairly. What counts as a just system for allocating vaccine in an emergency is not necessarily obvious. Criteria for distribution, including whether any individuals or groups should have privileged access to vaccine, need to be available for public deliberation now, in advance of a crisis.

Every effort also must be made to ensure that vaccine-related harms are kept to a minimum. Insofar as vaccine immune globulin (VIG) is determined to be useful in the management of adverse events, there should be a sufficient national stockpile of VIG, as well as of vaccine. Medical treatment of adverse events should be ensured and should be first rate. There should be no financial or insurance barriers to such treatment. Rather than create special structures to deal with the medical consequences of a bioterrorism attack, the better solution would be to embed such a guarantee within a functional structure of universal access to medical care.

In addition, we believe that it would be both prudent and ethically preferable for the nation's policy to include financial compensation for persons who experience permanent injury and for the families of those who die as a result of vaccination. Should the United States sustain a smallpox attack, it will be in the interests of the nation for the population to be vaccinated as quickly as possible. A smallpox epidemic would have devastating consequences, not only in terms of loss of life and injury, but also in terms of economic disruption and strategic vulnerability. The government will encourage individuals to be vaccinated—particularly in locations where the first cases appear—not only to protect the people themselves, but also to advance a vital national purpose: containing the epidemic.

Thus, in a morally relevant sense, individuals will be asked to be vaccinated, not only because it is in their personal interest, but also to advance the interests of the nation as a whole and to protect others from the spread of infection. Indeed, in some cases, it may not be in the strict best interest of individuals to be vaccinated, but they will be urged to be vaccinated nevertheless. This mix of self-regarding and other-regarding justifications is common to vaccination programs generally, as it is in many instances of clinical research involving human subjects. One standard social mechanism for resolving the moral problem that emerges when some of us bear risks so that all of us can benefit is the mechanism of providing consent. If individuals knowingly and voluntarily assume the risks, the moral problem is thought to be at least partially solved. This line of reasoning is, for example, a central moral underpinning of research involving human subjects. Whatever role consent plays in justifying risk, however, is not applicable to the emergency policy we propose here. Moreover, even when it is likely that the person as well as society will benefit, as is the case with smallpox vaccination and participation in some human research, and even when valid consent is obtained, as a matter of justice and of prudence, many argue that those persons who are actually harmed by the risks they assume should nevertheless be compensated [18].

In a postattack scenario, many people may have to be vaccinated, including sizeable numbers of individuals who are at increased risk of experiencing a vaccine-related adverse event. Some will die, and others will have permanent injuries. In the absence of a government compensation program, it is likely that those who will be permanently harmed by the smallpox vaccine will have to bear the full economic cost of their burden by themselves. Whether or to what extent disability and life insurance policies will apply is unclear. Recovery through the tort system will not be an option. In US common law, in a mass immunization situation without a physician acting as a “learned intermediary,” the manufacturer is liable to the consumer for any injuries incurred if the manufacturer either prepared the vaccine improperly or failed to provide adequate warnings. In this case, however, to ensure that there is a sufficient supply of smallpox vaccine, the government has indemnified the manufacturer. Individuals could, in theory, sue the federal government, but, unless the injury was a consequence of something like defective vaccine, it is extremely unlikely that such a suit would be successful.

How we respond to the losers in the vaccine lottery may have a significant effect on how the nation recovers after the event. Providing compensation to those who experience permanent harm should advance our collective interests in healing the national trauma of a smallpox attack and in standing together as one people. Building compensation into the policy acknowledges that we are all in this together and that the government's commitment to the citizenry is not only to provide security for the homeland, but also to ensure that, if an attack occurs, the consequent burdens will not fall solely on the unlucky.

This line of reasoning applies not only to those who experience events as a consequence of vaccination programs conducted after the biological attack, but also to the participants in any smallpox vaccination program in which the government is calling on individuals to be vaccinated in the interests of the nation, including the newly announced programs to vaccinate military personnel and health care workers. The same kinds of arguments could also be used to justify providing compensation to those who experience adverse events associated with secondary exposure to the vaccinia virus consequent to a government program. A related question is whether the government should provide financial compensation to persons who sustain permanent injury or die in association with smallpox itself, rather than the vaccine. Arguments based on compassion, solidarity, and justice can all be bolstered to support the inclusion of victims of smallpox in such a program.

What should a compensation program look like? One example, which is by no means uniformly viewed as successful, is the National Vaccine Injury Compensation Program (NVICP), which was established by Congress in 1986 in response to a crisis in the supply of childhood vaccines when many manufacturers left the market. The NVICP was designed to “ensure adequate compensation” [19] to injured childhood vaccine recipients—and to shield manufacturers from excessive and unpredictable liability [20]—by establishing an alternative to litigation. The centerpiece of the program is a “vaccine injury table” that lists covered vaccines [21] and injuries. (Note that the vaccines covered by the program are deemed “childhood vaccines” because they are generally to be administered during childhood; adults as well as children may be plaintiffs. For example, a case of polio that a parent sustains from contact with an orally vaccinated child would be covered. Vaccines on the chart include those for diphtheria, tetanus, pertussis, hepatitis B, varicella, rotavirus, and several others.) Persons who experience covered injuries within specified time periods after vaccination are presumed to be eligible for compensation; persons who experience injuries that are not listed may also be compensated if the evidence supports the claim. An injured victim who survives can receive compensation for the costs of that injury; if the victim dies, the estate can receive a death benefit of up to $250,000. Victims or their families can still sue manufacturers, but only after first working through the NVICP, and they may not receive awards from both the program and a private settlement or litigation.

The NVICP has been lauded [22] and criticized [23] for its effects on injured children and their families. (The US Department of Justice, which administers the NVICP program, asserts, “Over the past twelve years, the VICP has succeeded in providing a less adversarial, less expensive and less time-consuming system of recovery” [22]. However, one commentator argues, “By most accounts, the system of relief provided by the NCVIA [National Vaccine Injury Compensation Act] is certainly not expeditious and may not be fair” [23, p. 357]) It is by no means the perfect model for what we propose here. For example, we have argued that the costs of medical treatment for adverse events should never be borne by patients, and thus, unlike the NVICP, our proposal would not include these costs as part of a compensation program. There are also important questions of equity with respect to the level of financial compensation that should be provided. The NVICP offers one precedent; the September 11th Victim Compensation Fund offers another [24]. Both programs are morally similar to the smallpox context in some respects. The continuing controversy surrounding the September 11th Victim Compensation Fund underscores the importance of determining, now, in the advance a tragedy, both the justification for compensation and the proper structure and process for determining the amount of the awards [25, 26]. Without a clear articulation of the policy purpose served by a compensation program, including its moral grounding, the sorts of bitter debates about fairness that surround the September 11th Victim Compensation Fund are likely to occur again.

The Social Compact

The use of smallpox as a weapon is a terrifying prospect. The likelihood of its ever being deployed is, we hope, small. However, at the same time, the government must plan for this contingency in a morally responsible fashion. We are arguing for a compact between the government and the public. In the awful event of a smallpox attack, the public should be willing to support a vaccination program without the ordinary constraints of informed consent, for the good of the nation. In exchange, however, the government should commit to educating the public about the vaccine, distributing the vaccine efficiently and fairly, and ensuring first-rate and free medical care when adverse events occur. In addition, the government should provide compensation for those who are permanently harmed by the vaccination program. The compensation system should be designed in advance of a tragic event. With proper forethought, this system could serve as a model for how the nation should respond to civilian injuries that are the consequence of bioterrorism or other acts of war.

Acknowledgments

We would like to acknowledge our colleagues at the Center for Civilian Biodefense Strategies, Bloomberg School of Public Health, Johns Hopkins University (Baltimore, MD), and the Greenwall Foundation for providing the forum within which to explore and refine our ideas on this topic. In particular, we would like to thank Tara O'Toole and Tom Inglesby. We also express our gratitude to Mark Green and D. A. Henderson for their thoughtful critiques of earlier versions of this manuscript.

References

1
Bicknell
W
The case for voluntary vaccination policy
New Engl J Med
 , 
2002
, vol. 
346
 (pg. 
1323
-
5
)
2
Wharton
M
Strikas
RA
Harpaz
R
, et al.  . 
Recommendations for using smallpox vaccine in a preevent vaccination program: supplemental recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Healthcare Infection Control Practices Advisory Committe (HICPAC)
MMWR Recomm Rep
 , 
2002
, vol. 
52
 
RR-07
(pg. 
1
-
16
3
Annas
GJ
Bioterrorism, public health and civil liberties
New Engl J Med
 , 
2002
, vol. 
346
 (pg. 
1337
-
42
)
4
Stevenson
RW
Stolberg
SG
Bush lays out plan on smallpox shots as “a precaution.” New York Times
 , 
2002
pg. 
1
  
14 December
5
Mack
T
A different view of smallpox and vaccination
N Engl J Med
 , 
2003
, vol. 
348
 (pg. 
460
-
3
)
6
Bozette
SA
Boer
R
Bhatnagar
VC
, et al.  . 
A model for smallpox-vaccination policy
N Engl J Med
 , 
2003
pg. 
348
 
7
Frist
W
Deciding who is protected against smallpox
New York Times
 , 
2002
pg. 
15
  
9 August
8
Gregg
J
Let the public choose on smallpox vaccine
Washington Post
 , 
2002
pg. 
B07
  
6 October
9
Centers for Disease Control and Prevention
Smallpox vaccine fact sheet
 , 
2003
 
10
Centers for Disease Control and Prevention
Adverse events following smallpox vaccination—United States, 2003
MMWR Morb Mortal Wkly Rep
 , 
2003
, vol. 
52
 (pg. 
278
-
82
)
11
Centers for Disease Control and Prevention
Smallpox response plan and guidelines
 , 
2002
 
12
Faden
RR
Kass
NE
Powers
M
Faden
RR
Geller
G
Powers
M
Warrants for screening programs: public health, legal, and ethical frameworks
AIDS, women and the next generation: towards a morally acceptable policy for HIV testing of pregnant women and newborns
 , 
1991
New York
Oxford University Press
(pg. 
3
-
26
)
13
Gostin
LO
Public health law: power, duty, restraint
 , 
2000
Berkeley, CA
University of California Press
14
Blendon
RJ
DesRoaches
CM
Benson
JM
Herrmann
MJ
Taylor-Clark
K
Weldon
KJ
The public and the smallpox threat
N Engl J Med
 , 
2003
, vol. 
348
 (pg. 
426
-
32
)
15
Taylor
HA
Faden
RR
Ethical considerations in the formation of smallpox vaccine policy
Biosecurity and Bioterrorism: Biodefense Strategy, Practice and Science
 , 
2003
, vol. 
1
 (pg. 
47
-
52
)
16
Kass
NE
An ethics framework for public health
Am J Public Health
 , 
2001
, vol. 
91
 (pg. 
1776
-
82
)
17
Childress
JF
Faden
RR
Gaare
RD
, et al.  . 
Public health ethics: mapping the terrain
J Law Med Ethics
 , 
2002
, vol. 
30
 (pg. 
170
-
8
)
18
Institute of Medicine
Responsible research: a systems approach to protecting research participants
 , 
2002
Washington, DC
National Academy Press
 
19
National Childhood Vaccine Injury Act of 1986 (P.L. 99-660). HR Rep. No. 99-908, 99th Cong., 2nd Sess. 26 September
 , 
1986
20
Scafer v. American Cyanamid Co., 20 F. 3rd 1,4 (1st Cir. 1994).
 
21
US Department of Health and Human Services
HRSA Office of Special Programs
National Vaccine Injury Compensation Program
  
22
US Department of Justice
About the National Vaccine Injury Compensation Program
  
23
Scott
E
The National Childhood Vaccine Injury Act turns fifteen
Food Drug Law J
 , 
2001
, vol. 
351
 (pg. 
351
-
65
)
24
Department of Justice
September 11th Victims Compensation Fund of 2001
  
25
Korbert
E
The calculator: how Kenneth Feinberg determines the value of human lives
The New Yorker
 , 
2002
 
26
Belkin
L
Just money
New York Times Magazine
 , 
2002
pg. 
92
  
section 6

Comments

0 Comments