Issues of Risk: MMR Vaccine - Essay Example

?Issues of Risk: MMR Vaccine Introduction Risks are expected incidents in most people’s lives. There are uncertainties in life which imply eventual risks in the health and lives of all individuals. This paper will discuss some of these risks, the concept of risk, including the inactions which can lead to risks. It will also specifically discuss the risks associated with the MMR (mumps-measles-rubella) vaccine. Learning outcomes relating to issues underlying the concept of risk in modern society will initially be discussed. Secondly, an evaluation of how such concept of risk now impacts on policy and practice in the administration of the MMR vaccine will follow. Lastly, the risk assessment will also relate to the issuance of the vaccine in terms of health, education, or social welfare. Concept of risk Risk generally refers to the potential of a chosen action leading to loss or an unfavourable outcome (Cox, 2002). Risk implies that most choices have different outcomes, and that there are potential losses in these choices. Most human activity and behaviour carry with them risks, with some being risks greater than others (Cox, 2002). Risks refer to the possibility of threat of damage, injury, loss, or other unfavourable effects caused by external or internal weakness; such risk may sometimes be avoided by participating in preemptive action (Cox, 2002). In the current context, risks also refer to financial risks. Financial risks imply that the actual return of investment may be lower than the desired return. In any case, such risks include basic risks, capital risks, default risks, exchange rate risk, and settlement risk (Econ-it2, n.d). Workplace risks are also part of the modern conceptualization of risk with hazardous events or incidents possibly causing loss of employment or injury in the workplace. Health risks are also part of the current concept of risk (Econ-it2, n.d). These health risks involve both modifiable and non-modifiable risks with non-modifiable risks including inherent or genetically-based diseases or defects (Ricci, 2006). Modifiable health risks include habit-forming unhealthy behaviour including excessive smoking, excessive eating, excessive drinking, and generally unhealthy eating habits which lead to risks associated with chronic diseases (diabetes, hypertension, cardiovascular diseases, and cancer) (Ricci, 2006). There are negative and neutral concepts of risk. For the negative concept, risk is seen when there is a possibility of suffering the loss where certain levels or goals are not reached on certain activities (Econ-it2, n.d). For the neutral concept of risk, risk is considered a threat, and is also understood in terms of its odds. In effect, the realized impact of any activity may be better or worse than the actual impact. Risk is significantly related to uncertainty in incidents which most people deal with, especially where individuals are not properly informed on what would happen in the future. It is difficult to determine the actual cause and effect results in relation to specific events or incidents. Regardless of the actual cause and results of risk, these incidents are highly unpredictable, but their impact can still be tempered with the appropriate use of preventative measures as well as evidence-based research. Health risks may be managed through primary prevention measures, measures which seek to reduce the early signs of the illness; it can also be reduced through secondary prevention measures, interventions which help manage the signs and symptoms of the disease (O’Brien, 2000). The negative consequences of a diagnosed disease are usually managed through tertiary prevention; it restores functions and decreases the disease-related issues experienced by the individual (O’Brien, 2000). Medical practice demands the careful assessment of risk factors, mostly with individual patients seeking informed consent in relation to secondary and tertiary prevention practices. The health education for the general public would also form part of the primary preventive measures for the risk. Issues underlying the concept of risk in modern society refer to the inadequate measures used in detecting the risk. As such, without adequate detection processes, risks cannot be prevented or managed early (French and Morrison, 2004). Other issues underlying the concept or risk in modern society is the fact that even when the risks are identified, there are also inadequate measures being implemented to manage the risks early. The available measures are also not adequately supported by research (French and Morrison, 2004). The concentration of modern society is not on managing the risk, but on establishing solutions for problems or issues which already arise. In other words, there is an inadequate appreciation of the concept of risk; as a result, these risks are not used as tools in the prevention of issues. MMR Vaccine The MMR Vaccine is a vaccine against measles, mumps, and rubella or German measles. It includes live attenuated viruses for the three diseases and is mostly given through injections (NHS, 2012). This vaccine is mostly given to children about a year old with their second dose before they start their school (four or five years). Their second dose is meant to secure immunity for the group of individuals who do not succeed in reaching immunity from measles following their initial dose. In the US, the vaccine was licensed in 1971 and in 1989, the second dose was licensed (Banatvala and Brown, 2004). It has reached widespread use and application. Its long-term impact and efficacy is still being assessed. The concept of risk impacts on policy and practice, especially in relation to the administration of vaccines (Banatvala and Brown, 2004). Where risks relating to the administration of vaccines are involved, the appropriate precautions must be undertaken in order to minimize such risk and later, to eliminate such risk altogether. Risk determination relates to the process of measuring and quantifying the harm which the risk can cause to individuals or the greater population (Fitzpatrick, 2004). In general, health risks are determined by the specific government agencies, including the Food and Drug Administration, the Centres for Disease Control and Prevention, and the Environmental Protection Agency. More specific health agencies involved in localities are also involved in assessing groups and individuals within their jurisdiction or coverage (Wooldridge, 2007). In the case of the MMR vaccine, the risks are determined by the FDA as they are the specific agency involved in studying and researching the efficacy and impact of drugs, including vaccines (Wooldridge, 2007). The above agencies are government agencies and can be neutral assessors in the efficacy of the vaccines and the assessment of related risks. Their concerns would be related to the welfare of the people, not earning profits. Risk assessment would also be standardized and based on specific regulations and on evidence-based practice. Unlike private health corporations, including pharmaceutical companies, their motives are based on profits (Institute for Vaccine Safety, 2004). Risk assessment by these organizations would therefore be biased and inaccurate. Determinations of risk by the government agencies can however also be compromised by the limited available resources which prevent these agencies from implementing comprehensive and detailed as well as research or evidence-based assessment measures on risks (Institute for Vaccine Safety, 2004). In general however, these agencies are still the preferred agencies in assessing and evaluating risks relating to the administration of vaccines. Although their resources may sometimes be limited, they are still the only agencies equipped with the proper tools and expertise to assess vaccine risks and to ensure accurate and reliable recommendations for parents and other local implementers of health policy (Institute for Vaccine Safety, 2004). There are side effects in the use of the MMR vaccine. Based on the 1998 assessment by the Centres for Disease Control, 1 in 6 children were likely to have fever 7 to 12 days following administration of the vaccine; moreover, 1 in 3,000 were also likely to develop seizures. Due to these side effects, parents believe that the vaccine is unsafe. However, these side effects are mostly considered benign and are acknowledged by medical practitioners as common and expected side effects (CDC, 1998). The benefits of the vaccine are said to still outweigh its risks and the vaccine still has a favourable safety record. It is important for children to receive the vaccine. The decreased incidence of measles implies a decreased possibility for measles outbreak. Moreover, 1 in 1000 cases for measles is related to encephalitis with the risk for children being affected by the disease having increased in recent years (CDC, 1998). The idea that, in relation to MMR, parents are faced with comparable risks of autism or measles is a major part of the MMR vaccine administration (Berger, 2003). There are however limited studies on risks and with the presentation of the risk in a lopsided way by the media, parental concerns over the vaccine have emerged (Berger, 2003). If there was indeed a risk for autism from the administration of MMR, such risk is limited and cannot be measured. In the 1998 paper which triggered the MMR vaccine controversy, Dr. Andrew Wakefield and his colleagues from the Royal Free Hospital in London claimed that based on colonoscopy studies on 12 children with autism, there was also an identified inflammatory bowel disease which was observed among the respondents. The authors also discovered that in eight out of the 12 patients included in the study, the onset of symptoms was observed following the administration of the MMR vaccine. Wakefield, et.al., (1998) went on to discuss how the initial administration of the MMR vaccine gave rise to persistent measles infection in the abdominal area. This then caused the enterocolitis manifested by the patient. The enterocolitis allowed toxic peptides into the blood stream and into the brain, thereby causing the autism (Wakefield, et.al., 1998). The authors however recognized that they were not able to establish a relationship between the MMR vaccine and the autistic enterocolitis problem. The chain of causality is mostly based on analogy and speculation. A second study by Taylor and colleagues (1999) assessed records of 500 children afflicted with autism, born in North London from 1979 to 1998. Authors discovered that the number of cases increased steadily; however, no significant change was seen following the initial introduction of the vaccine. There was also no difference seen in terms of age at diagnosis between those vaccinated before or after 18 months of age, as well as those who never received the vaccine (Taylor, et.al., 1999). No clusters in terms of developmental regression in the time following vaccination were also observed. The authors discovered no causal association between MMR and autism. Other studies by the same group making shifts in their hypothesis based on recommendations made by Dr. Wakefield reached a similar conclusion (Farrington, et.al., 2001; Taylor, et.al., 2002). Other studies from other countries also did not discover a link between autism and the MMR vaccine (Dales, et.al., 2001; Kaye, et.al., 2001). The Scandinavian countries also presented reliable results for the study due to their comprehensive medical records (Peltola, et.al., 1998; Patja, et.al., 2000). A study from Denmark also presented reliable results as their records were from 1991 to 1998 with over 80% having received MMR and 738 being diagnosed with autism registering at similar rates for the non-immunised groups (Madsen, et.al., 2002). In effect, this indicates that there is no relationship between autism and MMR vaccine and there is no association between the age of the patient at the time of the vaccination and the possible manifestation of autism (Madsen, et.al., 2002). Due to these studies, Wakefield revised his hypothesis, claiming that MMR causes some incidents of autism among patients, especially those who are genetically vulnerable and are exposed to unfavourable environmental elements, like food allergy, antibiotic use by the mother, ear infection, and a family history of auto-immune disease, multiple vaccine exposure and exposure to mercury (Edwards, 2001). Even when Wakefield’s hypothesis was discounted in terms of the autism link, the damage has already been done. MMR is still being considered and in some cases, blamed for causing autism. MMR is also being blamed for the insignificant percentage of cases of autism relating to MMR vaccinated individuals. However, such insignificant population of autistic patients do not present straightforward results (Edwards, 2001). Considering that extensive research has failed to uncover the autism link is already strong evidence that the link does not in fact exist. The NHS (2011) also discusses various risks and side effects of the vaccine. They emphasize that these side-effects are generally mild and short-lived with each separate vaccine possible causing side effects which may not manifest at the same time. Common side effects are usually not as common during the second dose as compared to the initial dose (NHS, 2011). From one week to 11 days following the administration of the MMR injection, some children may suffer a mild form of measles and manifests as a rash, accompanied by high temperature, unwell feeling, and loss of appetite. In about three to four weeks following administration of the vaccine, some children have been known to develop a mild case of mumps which manifests with the swelling of the glands in the cheek, neck and under the jaw (NHS, 2011). In some adult women receiving the MMR, about one to three weeks following the administration of the vaccine, symptoms like painful, stiff, and swollen joints have been known to manifest (NHS, 2011). Other risks or side-effects of the MMR vaccine are considered rare. Some of these symptoms include bruise-like spots (NHS, 2011). These are seen as bluish spots or small rashes appearing for about two weeks following administration of the MMR vaccine. It is associated with the rubella component of the vaccine. This reaction is known as idiopathic thrombocytopenic purpura (ITP). ITP has been noted in atleast one in every 24,000 doses of the vaccine administered (NHS, 2011). This ITP is however a greater risk seen in measles or rubella than in receiving the vaccine. It usually disperses on its own without treatment, however like most rashes, medical advice should be sought as soon as it manifests. Other rare side effects from the MMR vaccine include seizures (NHS, 2011). Where seizures do manifest, they usually do so about six to 11 days following the MMR vaccine; it is only known to manifest in 1 in every 1000 doses for this vaccine. These seizures are even less common than actual measles-related seizures. Allergic reactions are also rare side effects of the MMR vaccine (NHS, 2011). Even rarer are severe allergic reactions immediately following the administration of the vaccine. Such rare reaction is only known to appear in about 1 in 100,000 doses of the MMR vaccine (NHS, 2011). Where managed immediately, children are known to fully recover from such severe allergic reaction. Aside from the risks and side effects recognized by the NHS, other risks have also been pointed out by the Centers for Disease Control in the US. In 1 in about 3000 doses, seizures caused by fever have been known to appear, including temporary pain and stiffness of the joints. Temporary low platelet count has also been seen in 1 in 30,000 doses of the vaccine (CDC, 2012). The CDC also acknowledges the severe side effects as discussed by the NHS; it also includes rare problems following the administration of the MMR vaccine, rare side effects which include deafness, long-term seizures, coma, decreased level of consciousness, and permanent brain damage (CDC, 2012). These risks are however very rare that it is difficult to determine if such side effects are actually caused by the vaccine or by other physiological responses. The risk assessment for the MMR vaccine was carried out by private and public agencies. At some point, an independent organization, the National Vaccine Program Office (NVPO) in the United States was established in order to coordinate federal agencies in securing high levels of disease immunization along with the highest level of prevention risks for these vaccines (NVPO, 2008). In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) is the monitoring agency for vaccines, including the MMR vaccine. The NVPO however has been underfunded and some of its functions, including vaccine monitoring have been transferred to other agencies including the CDC and the FDA (MHRA, 2012). These agencies, including the MHRA include individuals who are not affiliated in any of the government agencies. They have no power over the agency’s activities, over funding, research or final decisions. Specifically, the Committee on the Safety of Medicines constantly reviews the safety of vaccines (CSM, 2002). The CSM has evaluated available evidence on the alleged links between MMR and autism as well as bowel disease. Their review was able to establish that the available scientific evidence does not indicate a causal link between the vaccine and autism or inflammatory bowel disease. This conclusion is based on the consensus of various national and international scientific organizations (CSM, 2002). The CSM was able to determine various issues in the 2003 study by Geiers and Geiers, a study claiming an autism and MMR vaccine link. The most significant issue determined by the CSM is on the use of the Vaccine Adverse Event Reporting System (VAERS) data in establishing conclusions on the vaccine actually affecting a medical condition. Reports submitted to the VAERS database does not necessarily indicate whether the vaccine actually caused the health issue (MHRA, 2003). The CSM declared that VAERS data are used in establishing possible vaccine safety concerns, but they do not prove that the vaccine actually caused the problems encountered. Authors have not considered the basic limitations and biases of the data (MHRA, 2003). Bias may relate to stimulated reporting, mostly in terms of the possibility that adverse events would be reported due to publicity gained from alleged adverse effects. For the US, the DTP vaccine is administered at 2, 4, 6, and then at 15 to 18 months while the MMR is administered at 12-15 months (Wood, et.al., 2003). In order to evaluate the neurological elements of the study, the CSM declared that the age of the children should be at similar ranges. The study however does not provide adequate detail on the age of the children during the MMR. Age imbalances are already enough to actually invalidate the results of the study (Wood, et.al., 2003). Data on vaccine usage for the study cannot be utilized to indicate incident rates of possible adverse reactions because the number of children who actually received the vaccines cannot be adequately determined. In general, therefore, the CSM indicates that the results of the study cannot be utilized to establish conclusions relating to the link between MMR or DPT vaccine as well as the development of autism (CSM, 2002). Other studies by the same authors applying similar methods have also been studied by the CSM. The CSM declared however that such type of analysis cannot be applied in declaring and comparing the occurrence of adverse reactions in relation to different vaccinations. In evaluating articles on issues relating to risk communication and media reporting on the MMR vaccine, it was established that the media and the motives of the NHS are strong determinants on how parents evaluate the risk and benefit of the MMR vaccine. Wood and colleagues (2003) utilised questionnaires in order to evaluate the awareness and attitudes of 61 parents on general practices in Birmingham, whose children would be eligible for MMR in the future. Most of the parents were appraised of the specific issues relating to the vaccine with 72% being aware of the alleged relationship of autism and the vaccine; 15% were aware, but were not sufficiently appraised about the actual nature of the vaccine (Wood, et.al., 2003). The outcomes indicate that 44% of parents declare that the controversy made them less likely to consider the vaccine for their child. About 10% of the parents indicated that their child would not be inoculated with the MMR vaccine (Wood, et.al., 2003). In general however, health care providers provided advice for these parents with 40% of these parents considering the health visitor to be a significant determinant in the decisions they make (Wood, et.al., 2003). However, about 55% expressed that the media was most helpful in their decisions regarding MMR vaccination. This supports the role of the media on people’s decisions, that individuals usually consider stories which get the most coverage from the media (Jackson, 2003). In effect, the coverage of the media on MMR vaccines and its autism link has affected parents’ decisions relating to the vaccination of their children. The manner by which the different elements relating to the safety of the MMR vaccine have been handled by the media has caused much suspicion in the health services (Jackson, 2003). It has also made them feel like they are not being given adequate information by the government, enough to make logical and well-informed decisions about the vaccination of their children. As a result, parents are often unwilling to risk the safety of their child on health organizations which are not clear on their goals, as well as their motives (Wood, et.al., 2003). The risk assessment for the MMR vaccine is therefore based on extraneous elements, often exacerbated by the media as well as by the inadequate resources under the disposal of concerned health agencies. Conclusion Risks are an inherent part of most human activities. Health risks are one of the more significant risks which humans are faced with. The MMR vaccine carries with it various risks and side effects. These side effects manifest at different times and mostly at mild intensities. Controversy arose with the study by Wakefield and colleagues indicating a link between autism and the MMR vaccine. Such link has not however been adequately supported by subsequent studies. Moreover, gaps in the Wakefield study indicate the unreliability of the results. The assessment and determination of risk is based on the appropriate and independent health agencies that can accurately evaluate the use of the MMR vaccine and determine its risks. 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