Study asks, "Would you take a risky flu vaccine?"
As the two dozen or so posts on the topic over the past few months suggest, there's a lot of attention being given to the development of vaccines in response to a possible avian flu pandemic. Much of the media focus of late has been on allocation strategies, largely in response to the Emanuel/Wertheimer piece in Science several weeks back (our most recent related post is here).
Largely ignored in all this is that the medical (and political) climate during anything even approaching a 'worst-case scenario' would mean that a vaccine would be hurried through development and clinical testing years more quickly than any in recent history. As a result, clinical trials would include fewer subjects, and lengths of follow-up would be well below the minimum numbers normally required for licensure. It's overwhelmingly likely that, if needed in an emergency, our understanding of an avian flu vaccine's safety profile will be far less clear than would be acceptable in normal conditions.
How would a vaccine be received by the public in these circumstances? That's the topic approached (in a slightly different way) by Zikmund-Fisher, et al., in a paper in the current issue of the Journal of General Internal Medicine ("A Matter of Perspective: Choosing for Others Differs from Choosing for Yourself in Making Treatment Decisions," 21:618-622 -- free abstract, subscription required for full text). The researchers asked subjects to consider a scenario in which they faced a 10% chance of death from a (particularly severe) flu virus. However, a vaccine exists that would provide complete protection against the virus, but would itself carry a 5% chance of death as a result of vaccination. Asked to respond if they would support vaccination in this scenario, subjects were randomly assigned one of four roles: patient, parent of a small child, physician advising a patient, or public health director setting policy.
The results: Support for vaccination varied widely, depending on the role subjects were asked to assume. 48% of 'patients' would choose the vaccine, 57% of 'parents', 63% of 'physicians', and 73% of 'public health directors'. WebMD has a detailed story about the study with comments from its authors.
It's hard to imagine a scenario so dire that a vaccine known to have a 5% chance of causing death would ever be made widely available (but nothing's impossible, presumably). Also, it should be noted that the early pandemic flu vaccines being developed suggest a far more palatable safety profile (as we wrote here).
Actually, the questions asked in this study are easier than those we would likely face in a real pandemic. Here, the precise risk of the vaccine was presumed to be known, as was the precise risk of rejecting the vaccine. In reality, neither would be even the least bit certain, making the decisions faced by patients, parents, physicians, and health officials alike all the more difficult amid the chaos of a public health emergency.
Largely ignored in all this is that the medical (and political) climate during anything even approaching a 'worst-case scenario' would mean that a vaccine would be hurried through development and clinical testing years more quickly than any in recent history. As a result, clinical trials would include fewer subjects, and lengths of follow-up would be well below the minimum numbers normally required for licensure. It's overwhelmingly likely that, if needed in an emergency, our understanding of an avian flu vaccine's safety profile will be far less clear than would be acceptable in normal conditions.
How would a vaccine be received by the public in these circumstances? That's the topic approached (in a slightly different way) by Zikmund-Fisher, et al., in a paper in the current issue of the Journal of General Internal Medicine ("A Matter of Perspective: Choosing for Others Differs from Choosing for Yourself in Making Treatment Decisions," 21:618-622 -- free abstract, subscription required for full text). The researchers asked subjects to consider a scenario in which they faced a 10% chance of death from a (particularly severe) flu virus. However, a vaccine exists that would provide complete protection against the virus, but would itself carry a 5% chance of death as a result of vaccination. Asked to respond if they would support vaccination in this scenario, subjects were randomly assigned one of four roles: patient, parent of a small child, physician advising a patient, or public health director setting policy.
The results: Support for vaccination varied widely, depending on the role subjects were asked to assume. 48% of 'patients' would choose the vaccine, 57% of 'parents', 63% of 'physicians', and 73% of 'public health directors'. WebMD has a detailed story about the study with comments from its authors.
It's hard to imagine a scenario so dire that a vaccine known to have a 5% chance of causing death would ever be made widely available (but nothing's impossible, presumably). Also, it should be noted that the early pandemic flu vaccines being developed suggest a far more palatable safety profile (as we wrote here).
Actually, the questions asked in this study are easier than those we would likely face in a real pandemic. Here, the precise risk of the vaccine was presumed to be known, as was the precise risk of rejecting the vaccine. In reality, neither would be even the least bit certain, making the decisions faced by patients, parents, physicians, and health officials alike all the more difficult amid the chaos of a public health emergency.
Labels: Pandemic flu
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