Center to pursue ethical, informed vaccine policies
Center to pursue ethical, informed vaccine policies
Balancing patient autonomy, public safety key
The life cycle of a vaccine — from discovery and production through distribution, rationing, and replacement — can span a quarter-century, involve health professionals worldwide, and raise ethical issues every step of the way. But there was no centralized effort to promote policy and ethics around vaccine discovery, use, and global public health — and so the Center for Vaccine Ethics and Policy was created.
"As a number of new vaccines are entering public health and clinical practice, it is more important than ever to have clear, accurate information about vaccines and their critical role in public health," according to Paul Offit, MD, a founding member of the center and head of infectious diseases at Children's Hospital of Philadelphia. The center, he adds, "will make an important contribution to clear thinking about vaccine policy, safety and ethical issues, and by doing so, help parents, patients, clinicians, and public health professionals make informed choices and use vaccines more effectively."
The center is the offspring of the 18-month-long Ethics of Vaccine project begun at the University of Pennsylvania School of Medicine's Center for Bioethics. The project aimed to examine the field of vaccine development and use, and propose an ethical framework to help guide researchers, pharmaceutical companies, public health agencies, health care providers, and citizens regarding vaccines and their safe, effective, and ethical use.
"The new Center for Vaccine Ethics and Policy will engage the entire vaccine life cycle from a global perspective," says David Curry, executive director of the center. Importantly, he adds, the center also will address the policies that prevent vaccines from actually being used for years as developers negotiate the required maze of approval.
"Particularly frustrating is the time it takes for getting a vaccine to the people," Curry says. "It may take 20 to 25 years — an entire generation — before a vaccine is making the impact it could or should be making.
"In an age when you can FedEx a vaccine and have it someplace overnight, something's amiss when policy and government impede the impact that vaccines can make. That seems like something that should be addressed and improved on."
Pandemics obvious, but not only, focus
When the Ethics of Vaccine project was introduced in 2006, its founder, Arthur Caplan, PhD, of Penn's Center for Bioethics, commented that just as Hurricane Katrina revealed the nation's weaknesses in emergency preparedness, the threat of avian influenza was pointing out potential weaknesses in our approach to vaccines.
Curry, in discussing the new Center for Vaccine Policy and Ethics, says vaccines designed to curb pandemic diseases are certainly one of the center's areas of interest — but that's only part of the center's mission.
"We saw influenza as a good lens through which to look at vaccines, but our interests are not solely on that," Curry says.
There is an ethical imperative for policy to accelerate the development and delivery of needed vaccines of all kinds, Caplan says, to provide safe, affordable, and effective access for all people, regardless of circumstance or geography.
The idea of ethics in vaccine is not new, but is picking up steam as an integral part of the vaccine cycle, Curry says.
Staff for the vaccine ethics project at the Penn Center for Bioethics recently contributed a chapter on ethics for the 5th edition of Vaccines (Plotkin, Orenstein, Offits, eds; Elsevier, 2008). This is the first time a chapter on ethics has been included in the internationally consulted reference text.
The Penn Center is not alone in noting the potential for ethical crises surrounding vaccines. In 2007, James C. Thomas, MPH, PhD, an epidemiologist at the University of North Carolina School of Public Health, Chapel Hill, published research into the pandemic preparedness plans of all 50 states, the District of Columbia, and the federal government, and found some critical weaknesses shared by all — notably a plan for addressing, ahead of time, the ethical issues that might arise.
"When a crisis happens, it exacerbates disparities, and people who are vulnerable are, by definition, vulnerable, and they need to be given extra vigilance," according to Thomas. Working against their favor, he notes, is the "two-list" model of ensuring vaccines and antivirals for the physically vulnerable and those needed for public order, both of which stand to overlook other vulnerable populations.1
And the thought given to what to do in the time between when a virus is identified and when the antivirals and vaccines are available for it "is disproportionate to the number of issues we'll be facing," Thomas adds.
Such questions are just what Curry and other center staff hope can be addressed by this coordinated effort.
"The area of vaccine ethics generally has not had the kind of attention that ethics in other [clinical] areas has had — it's somewhat of a new field," he notes. "So we're trying to attract visiting scholars, post-doctoral [candidates], to make sure vaccines and immunizations are given adequate focus."
Challenged by crisis of confidence
Another important challenge faced in the area of vaccines is public misunderstanding and fear about vaccines, Curry says.
"To help address this challenge, among our early programs is a series of public forums [in partnership with the Franklin Institute] around vaccines," he says. At the first of the forums, held in early 2008, patient autonomy and freedoms vs. public responsibility to curb the spread of disease was explored. Specifically, the issue of government mandates for certain childhood immunizations and immunization of health care workers was addressed.
The forums — and the center — will provide a mechanism for those on the front lines of public health to contribute to policy debates and ethical discussions that emerge across a vaccine's life cycle, Curry added.
"There is a trendline that suggests that with easy ways to opt out or be exempted from immunization requirements, public health stability is being eroded, leading to things like the outbreak of measles that we saw in San Diego," Curry continues.
The Centers for Disease Control and Prevention, in the Feb. 29, 2008, issue of Morbidity and Mortality Weekly Report (MMWR), noted that 12 cases of measles had been reported in San Diego within a one-month period (January and February).2
"The San Diego import-associated outbreak, affecting exclusively an unvaccinated population and infants too young to be vaccinated, serves as a reminder that unvaccinated persons remain at risk for measles and that measles spreads rapidly in susceptible subgroups of the population unless effective outbreak-control strategies are implemented," according to the MMWR.
(Editor's note: Information about the center can be found at www.centerforvaccineethicsandpolicy.org.)
References
- Thomas JC, Dasgupta N, Martinot A. Ethics in a pandemic: A survey of the state pandemic influenza plans. Am J Public Health 2007;97:S26-S31.
- Centers for Disease Control and Prevention. Outbreak of Measles — San Diego, California, January-February 2008. MMWR2008;57:203-206.
Sources
For more information, contact:
- David R. Curry, MSLS, executive director, Center for Vaccine Ethics and Policy; visiting scholar, Center for Bioethics, University of Pennsylvania. Phone: (267) 251-2305.
- James C. Thomas, MPH, PhD, associate professor of epidemiology, University of North Carolina School of Public Health, Chapel Hill. E-mail: [email protected].
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