Anthrax Vaccine Trials for Pediatrics Essay

Anthrax is a serious infectious disease caused by Bacillus Anthracis, a gram positive bacterium that forms spores. A spore is a cell that is dormant but may come to life with the right conditions and become active. These spores can contaminate people like in 2001 when letters containing Anthrax spores were being mailed in a bioterrorist attack and make them severely ill. (White, 2012) Anthrax generally comes from soil and animals. A person can become infected if they come in contact with and infected animal or animal product.Anthrax Vaccine Trials for Pediatrics Essay

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Once they are infected then they can start to show the first symptoms of inhalation. Anthrax starts off with cold or flu symptoms and can include a sore throat, mild fever and muscle aches. As time goes by symptoms include cough, chest discomfort, shortness of breath, tiredness, and muscle aches. It also affects the GI system. Patients may experience nausea, loss of appetite, bloody diarrhea, and fever, followed by bad stomach pain. In the 2001 bioterrorist attack, five people were killed and seventeen were infected. (White, 2012) The purpose for this paper is to discuss the ethical dilemma on running test trials of the Anthrax vaccination prior to administering it on pediatric patients. When it comes to the Anthrax vaccine the problem arises because there are no clinical test trials done on pediatric patients. This brings the ethical issue of Protection of patients in research. (ANA, 2008) The reasons being that there are many hurdles on beginning the process of making sure that children are safe during clinical test trials if it further goes into the trial process, as well as many other ethical dilemmas that revolve around the process itself. Parents are skeptical enough about their children receiving certain vaccines like MMR and Varicella to have their children go through clinical test trials for Anthrax and putting them at risk for unknown side effects. Otherwise like Nicola Klein, director of Kaiser Permanente Vaccine Study Center stated, parents must go through a lot before they can actually approve their child to be involved in any type of clinical trial. They will be informed with a large amount of information regarding risks, benefits and any other type of outcome. (White, 2012) Since children are not responsible for their own clinical decision making the parent would be responsible for making this informed decision regarding their children.Anthrax Vaccine Trials for Pediatrics Essay A nurses responsibility would be to make sure that the parent of the child involved is presented with the accurate information regarding the trial. The parent would then have the right to refuse participation in any clinical trial they do not feel would be beneficial to them or their child. “Michael Anderson, Vice president and Chief Medical officer of UH Case Medical Center and representing the American Academy of Pediatrics states, “It is unethical not to conduct pediatric trials. Failure to examine the vaccine in children would deprive us of valuable data necessary to save children’s lives.” (White, 2012) “According to Robert “Skip” Nelson, senior Pediatric Ethicist in the office of Pediatric Therapeutics of the Food and Drug Administration, it has to meet three relevant principles before going into clinical trial runs.” (White, 2012) First the children should not be enrolled in a clinical trial if the scientific or public health objective can be achieved by enrolling adults. Second, absent direct therapeutic benefit to the children enrolled the risks to them must be low-or no more than a minor increase over minimal a risk, which itself is defined as no greater than the risk that they face in ordinary activities. Lastly, children should not be placed at a disadvantage after being enrolled in a clinical trial, either through exposure or to excessive risk for by failing to get necessary health care. (White, 2012) A study done in San Francisco, California named Dark Zephyr that found that if there were a release of Anthrax spores on the city 7.6 million people would be affected and a quarter of a million of that population would be children. (White, 2012) If there were to be an Anthrax epidemic there would be a treatment for it. The treatment consists of a sixty day antibiotic regimen and once the regimen is finished the person is in need for vaccination to prevent another outbreak. The antibiotic regimen alone is not sufficient enough. It is only a temporary fix. The problem is children enrolled in a “prevent” anthrax trial will not receive direct medical benefits and by benefits they mean knowledge about how best to protect children from anthrax. If trials do go into effect the question is would health care officials be able to gain the trust of the parents. It would be the duty of the health care officials to keep parents well informed with all pertinent information regarding the trials including and not limited to potential risks, benefits and other consequences of the vaccine as predicted from use in adults. The parents must be actively engaged on reporting outcomes and be committed to the goals of the research. Because we are unsure that an Anthrax attack would even happen, it is unclear as to how much of a risk research subjects should be exposed to or whether vaccinations would be better, or more cost effective than an antibiotic regimen. Furthermore the Presidential Commission of study of Bioethical issues concluded that no testing should be considered unless the risk to kids is minimal. They feel that it will put the child at high risk. Also, there is not a chance that a sufficient number of American parents are going to sign up their kids for the safety testing of an Anthrax antidote. They also feel that the exposure the Anthrax is farther down the list then some of the other obstacles a child may face for example, obesity, bullying, and suicide.Anthrax Vaccine Trials for Pediatrics Essay

last Thursday, the Presidential Commission for the Study of Bioethical Issues met in Washington, DC to assess the ethics of a clinical trial on anthrax vaccines for children. Secretary of Health and Human Services Kathleen Sebelius asked the Commission to investigate the issue, after the National Biodefense Science Board (NBSB) voted in favor of pursuing pediatric trials. These trials and other medical countermeasures are intended to prepare the nation in the event of a bioterrorist attack, like the one in 2001 in which letters containing anthrax spores killed five people and infected 17 others. A recent project called Dark Zephyr found that the release of anthrax spores in a city such as San Francisco could result in infection of 7.6 million people, nearly a quarter of which would be children.Anthrax Vaccine Trials for Pediatrics Essay

More than one million adults, mostly member of the military have received BioThrax, the only FDA-licensed vaccine. Side effects include soreness and redness at the shot site, muscle aches, fatigue, headache, and fever, with a few rare but serious allergic reactions. Uncertainty about the severity of similar side effects in children has led some to believe we should continue to rely on the current standard of care for anthrax, antibiotics, three of which are approved for adults and children.Anthrax Vaccine Trials for Pediatrics Essay

But there are drawbacks to using antibiotics alone, as NSBS noted. For one thing, they offer only temporary protection; an individual exposed to anthrax would still need to be vaccinated. But a 60-day regimen of antibiotics would be needed before a vaccine would take full protective effect. Given the difficulty complying with such a long-term antibiotic regimen, and the need for vaccination anyway, the NBSB saw advantages to so-called “pre-event” vaccination and recommended a pediatric vaccination trial.Anthrax Vaccine Trials for Pediatrics Essay

While conducting a trial on an anthrax vaccine for children may well save millions of lives, it raises serious ethical questions. A number of witnesses at the meeting highlighted the fact that we have zero data on how children would react to such a vaccine. Given this scarcity of data, Michael Anderson, vice president and chief medical officer of UH Case Medical Center and representing the American Academy of Pediatrics, argued that it would be unethicalnotto conduct pediatric trials. He believed a failure to examine the vaccine in children would deprive us of valuable data necessary to save children’s lives.Anthrax Vaccine Trials for Pediatrics Essay

Several other witnesses were more cautious, particularly since the necessity of such a vaccine is uncertain. Robert “Skip” Nelson, senior pediatric ethicist in the Office of Pediatric Therapeutics of the Food and Drug Administration (FDA), questioned whether a pediatric trial of an anthrax vaccine would meet the FDA’s ethical standards. He highlighted ethical framework that the FDA uses to evaluate pediatric trials, emphasizing three relevant principles. Children should not be enrolled in a clinical trial if the scientific or public health objectives can be achieved by enrolling adults. Absent direct therapeutic benefit to the children enrolled, the risks to them must be low –or no more than a minor increase over minimal a risk, which itself is defined as no greater than the risks that they face in ordinary activities. And children should not be placed at a disadvantage after being enrolled in a clinical trial, either through exposure to excessive risks or by failing to get necessary health care.

Children enrolled in a”pre-event” anthrax trial will not receive direct medical benefit. The benefits–knowledge about how best to protect children from anthrax–would be accrued by future generations. Given the uncertainty of an anthrax attack even occurring, it is not clear how much risks research subjects should be legitimately exposed to or whether vaccination is more effective, or cost-effective, than an antibiotic regimen.Anthrax Vaccine Trials for Pediatrics Essay

To justify such a study, one would have to presume that an attack is almost certain and that the studies will yield scientific and medical benefits. Even if we can agree on the certainty of a bioterrorist risk and the value of scientific knowledge gained through studies, it remains to be answered who should be enrolled in the clinical trials.Anthrax Vaccine Trials for Pediatrics Essay

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One suggestion at the Commission meeting was that those most at risk of attack, such as military families or individuals living in likely terrorist targets such as Washington, DC or New York City, should be recruited for clinical trials first. Whether this or another approach is pursued, a number of justice-based concerns arise related to the distribution of risks and benefits. James Hodges, professor of health law and ethics at Arizona State University, laid out 10 core principles to help frame emergency public health ethics. These principles lead to consideration of which populations are most vulnerable and those that are most likely to benefit, as well as the equity, transparency, and fairness of scarce resource allocation.Anthrax Vaccine Trials for Pediatrics Essay

Pediatric trials would also lead to a number of practical and logistical considerations, which also have ethical underpinnings. Nicola Klein, Director of Kaiser Permanente Vaccine Study Center, highlighted some of them. Given the great weight of the decision parents must go through to approve clinical research on their child, she said, parents must be robustly informed about potential risks, benefits, and other consequences of the vaccine as predicted from use in adults; be actively engaged in reporting outcomes; and be committed to the goals of the research. Parents, and children as they get older, must also trust the research process.

Klein also emphasized that while financial and other incentives can be used to encourage participation and compliance of subjects, it must not lead to coercion or pressure. Unlike children with cancer or a rare disease who might be enrolled in an experimental clinical trial with the prospects of extending life or finding a cure, consent to an anthrax vaccine trial appears to be almost entirely altruistic.Anthrax Vaccine Trials for Pediatrics Essay

Ethical considerations aside, what struck me most about the meeting was the extent to which it seemed as though the Commission was being called upon to issue a “rubber stamp” of ethical approval. The NBSB recommendation stated that approval of pediatric anthrax vaccine studies “should be referred to an appropriate review board to formally address the ethical considerations.” In addition to seeking input from ethicists, NBSB also requires public representation in the decision process. After undertaking an ethical assessment, it said, “HHS should develop a plan for and conduct a pre-event study” of anthrax vaccines in children. It is no surprise that the Commission is the body most suited to undertake such an ethical examination, but should a favorable finding by the Commission fully legitimate pediatric trials?Anthrax Vaccine Trials for Pediatrics Essay

Given the speaker presentations and subsequent discussions among members of the Commission, I would be surprised if the research is given the ethical green light, but what if it is? Should we be entrusting such a decision, with a great deal of questions still unanswered or even yet known, to one advisory body? As David DeGrazia, professor of philosophy at George Washington University, said when asked if he would approve “pre-event” vaccine trials, we do not yet have a clear enough idea of the probability of a bioterrorist attacks, the associated risks, or the complexity of the situation.Anthrax Vaccine Trials for Pediatrics Essay

Furthermore, if NSBS is truly concerned about “public representation” and input on ethical issues, the Commission meeting was little evidence of that. Of those in attendance who asked questions, only one was not a member of the scientific, medical, or academic community–she was a mother who expressed concern about such a study after witnessing adverse side effects of vaccinations in her own children. While laypersons are invited to submit official comments to the Commission, those most likely to do so are probably strong opponents on one side or the other, not representative of American citizens who might be called upon to volunteer their child for a study.Anthrax Vaccine Trials for Pediatrics Essay

I have great admiration for many members of the Commission, but to give them alone the power to stipulate the proposed trials as ethical or not troubles me. Unlike previous tasks given to presidential commissions over the last few decades, which called for largely advisory recommendations, the resulting report in this case could have a more direct impact on whether research proceeds.

Ultimately the decision by the Commission about how to weigh the ethical considerations at stake will likely come down to weighing the risks, burdens, and uncertainty associated with ”pre-event” pediatric anthrax trials against the risks to public health and bioterrorism preparedness of not getting out ahead of threats. This is not an easy balance, but I am of the mind that we should be more concerned about the former than the latter. There will always be threats to our national security and public health posed by individuals with nefarious intentions, but to proceed further down the path of assuming the risks of an anthrax attack than we need to seems premature at this time.Anthrax Vaccine Trials for Pediatrics Essay

Imposing potentially undue health risks on children is not necessary given our uncertainty of needing such precautions. Those risks should only be assumed by our children and society in the event of an anthrax attack. Unless that happens, we should continue to rely on antibiotics as the standard of care. Given the complexity and uncertainty surrounding this issue today, this seems to be the most ethical and socially responsible approach.Anthrax Vaccine Trials for Pediatrics Essay