Anthrax Vaccine Trials for Pediatrics

Anthrax Vaccine Trials for Pediatrics 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. 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 atta ck, 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 st ated, 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. 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. â€Å"Michael Anderson, Vice president and Chief Medical officer of UH Case Medical Center and representing the American Academy of Pediatrics states, â€Å"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) â€Å"According to Robert â€Å"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 w ere 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 â€Å"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 consequence s 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. References American Nurses Association. Code of Ethics for Nurses with Interpretative Statements. Accesses November, 2008 at: http://nursingworld.org/MainMenuCategories/ThePracticeofProfessionalNursing/EthicsStandards/CodeofEthics.aspx Center for Disease Control and Prevention. (2006). Anthrax: What you need to know. Emergency Preparedness and Response. Retrieved from: http://www.bt.cdc.gov/agent/anthrax/needtoknow.asp White, Ross. (2012). Anthrax Vaccine Trials for Children: Precautionary or Premature? Bioethics Forum blog. Retrieved from: http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=5852&blogid=140terms=anthrax+vaccine+trails+for+children%3a+precautionary+or+premature+and+%23filename+*.html