The nurse herself represents the public healthofficials. Though she is not implementing a mandatory vaccinationprogram, her stated goal is to inoculate 100% of thepopulation. As mentioned above, she has the assistance oflocal law enforcement and she is quite persistent. Rafe Hollister,the stubborn farmer, represents those within the community whooppose or resist mandatory vaccination programs. His reasonsinitially rest on a general reluctance to stray from naturalmedicine. In this way he represents the contingent of society thatscientists and medical researchers will always find difficult toconvince of any developments in the medical field. In many ways, heis comparable to the plaintiff in . Andy and Barneycan be seen as the arms of the state that are entrusted withcarrying out the general vaccination plan. Their varying styles canbe seen as varying state requirements and enforcement options forvaccination.
So, we would take a random group of 6000 children, half would be injected with saline, half with the flu vaccine. We wait for 12 months after the flu season. But wait, we’re intentionally exposing kids to flu who could have been vaccinated. Not Institutional Review Board would approve that.
As stated above, the FDA’s role in protectingthe safety and effectiveness of vaccines does not end at thelicensing stage. Before any vaccines from a particular lot canbe released, the manufacturer must typically submit samples forpotency, safety, and purity testing. Periodic facility inspections also continuefor the duration of the license. Furthermore, formal post-market studies maybe conducted in order to identify problems that would not show upin pre-market clinical testing. These tests are referred to as Phase 4 testsand are not mandatory, but can help identify problems that may onlyoccur very infrequently. Post-marketing surveillance programs areimportant because manufacturers are “never going to be ableto do studies big enough to detect risks that might happen at alevel of one in 100,000 or one in 1 million.”
Once the clinical trials are completed, the FDA canexamine the results of the tests to determine whether the vaccineis safe and effective enough to be placed on the market. At any point in the process, the FDA may haltongoing studies if safety concerns require such action. The FDA also reviews the data from thestudies and inspects the manufacturing facility. At this point the vaccine may belicensed.
With the WHO’s official determination that an influenza pandemic is under way, the Department of Health and Human Services reports that influenza is confirmed to be spreading in the United States and that several deaths have occurred; further, with large-scale public vaccination programs remaining weeks away, public health officials are strongly recommending the immediate implementation of some restrictive measures to help slow the spread of the infection. Soon many localities have closed community centers and schools and canceled all large public gatherings and events.
Moreover, states have not been completely left toimplement the recommended immunization schedule. Though school requirements are still a statematter, national public health officials are typically able toenact their recommendations through federally funded immunizationplans. These plans require states to implement andenforce federally recommended immunization requirements before thestates can receive federal funds. The current recommended vaccination scheduleappears below.
Below is a series of questions to each about each of the three (3) scenarios, and well as a final set related to ethical issues during pandemics. Each requires some thoughtful reading and responding.
Scenario 1: First Set of Questions
1. What are your initial thoughts and feelings about this scenario?
2. What do you think are the most important considerations for Maria in making her decision?
3. Would your opinion change if the day care center was dosed? Why?
Scenario 1: Second Set of Questions
1. What do you think of the clinical group’s decision?
2. Do you think society has an obligation to health care workers in the event of a pandemic outbreak?
3. In your view, is the health status of a health care worker an acceptable reason for that individual to not respond to a pandemic virus?
4. Should health care providers face consequences for refusing to show up for work?
5. If no, why? If yes, what sorts of penalties do you think would be fair?
Scenario 2: First Set of Questions
1. What are your initial responses to this situation? What is your gut reaction?
2. What are the most important considerations in this scenario?
3. What are the features of this case that you find the most compelling?
Scenario 2: Second Set of Questions
1. Have your initial responses to the situation changed in light of this added information?
2. Are there any considerations that you find significant in this additional information?
3. Is there anything compelling about this development?
4. Do these personal details about the two patients’ lives affect your perspective?
Scenario 3: First Set of Questions
1. What are your initial thoughts and feelings about this situation?
2. What do you think were the most important considerations for the family in making their decision?
3. What features of this case do you find most compelling?
Scenario 3: Second Set of Questions
1. What do you think of Diana’s decision?
2. Do you think people should face consequences if they don’t follow an order of quarantine? If yes, what sort of penalties do you think would be fair?
3. Is there anything compelling about this development? The US government has now declared a state of emergency.
Scenario 3: Third Set of Questions
1. Have your responses to the situation changed in light of this new information?
2. What do you think of the public health authority’s decision to detain Diana?
3. Do you think society has obligations to those ordered into quarantine?
4. Is there anything compelling about this development?
Ethical Discussion Questions
1. What are the ethical problems for health professionals, public administrators, and community members presented in each of the three cases?
2. What were the competing or conflicting ethical principles or values in each case?
3. What are the possible negative or positive consequences of the actions taken by those involved in each case?
4. Review the ethical guidelines above. Which of these do you think are most important? Explain.
While school vaccination requirements have beencredited with bringing about the control and elimination of manydevastating childhood diseases, critics have continued to voiceconcerns and raise legal and political challenges to the entireprocess of mandatory vaccination.
Many existing school vaccination laws were enactedin response to the transmission of measles in schools in the 1960sand 1970s. State legislatures at that time were influenced by thesignificantly lower incidence rates of measles among schoolchildren in states that strictly enforced vaccination requirementsand school exclusions in outbreak situations without significantcommunity opposition. Rather than having health departments requireimmunization in emergency conditions, legislatures acted to preventdisease by mandatory immunization as a condition of enrollment orattendance in schools or licensed day care facilities.
One last thing. Peter Doshi is an HIV/AIDS denier, and has made his “belief” (unsupported by any science whatsoever) public by along with some 2000 other scientists, artists, engineers, government lackeys and other individuals with no scientific background in virology and immunology (like Doshi himself).