3.1 Discussion
Only 22 per cent. of respondents reported receiving written information from their health visitor when in fact they would have all received the “Red Book Health Record” for their child which includes vaccine information and the vaccine schedule . This again creates questions of the validity of the information received. They received information but obviously had not read it or did not recall reading it. The only reactions mentioned in the red book are “being grumpy” “fever”, “swelling and redness” at the needle site- that’s it.
In the survey 9 children had more serious reactions and three children 3% of the respondees reported having their child hospitalised described by one parent “My son had extremely high temperature, went white, and then floppy. He was rushed into hospital and later diagnosed with sepsus. One month later he had his second DTP jab and experienced the same reaction”. The mother put two and two togther but was told by doctors that she was wrong, “ the vaccine is safe and the reaction was coincidental”.
Paragraph 4 of the GMC guidance on consent which states that patients “…have a right to information about their condition and the treatment options available to them. The amount of information you give each patient will vary, according to factors such as the nature of the condition, the complexity of the treatment, the risks associated with the procedure and the patient’s own wishes.” Paragraph 10 advises that “you should not withhold information necessary for decision making unless you judge that disclosure of some relevant information would cause the patient serious harm.” One might argue that informing patients of what appears to be insignificant side effects and “frightening” them might potentially cause them and the community serious harm and might be considered a justification for withholding information on adverse effects of the DPT.
The Medical Defence Union (1999) advises that when deciding whether to warn of a particular risk, doctors must consider all relevant facts including “the severity and likelihood of the risk compared with the need for the procedure”. They advise that it may be appropriate to warn of a relatively rare risk for an elective procedure, such as sterilisation or a screening test.
Fitzgerald and Glotzer (1995) assessed information needs of parents regarding childhood immunisation. Parents indicated that they wanted information about many aspects of immunisations and parents with the American vaccine information statements (VISs) reported high levels of satisfaction.
Rogers and Pilgrim (1994) state that it is not enough to supply information to parents because the official promotional literature for vaccination emphasises the rarity of risk of side effects and the effectiveness of vaccines in protecting individuals and in reducing infection outbreaks. It fails to mention the possibility of vaccine failure or that there is a possibility that it could also affect the immune system in a negative way. Government information refuses to question the reliability and authority of primary health care workers as sources of risk assessment on behalf of parents and views parental doubts about immunisation as irrational.
The study raises questions about the obvious lack of understanding and the lack of in depth information available to the public. Only 39 per cent. of respondents knew what the abbreviation “DPT” stood and they knew very little about the diseases being vaccinated against or expected reactions to the vaccine.In fact Thirty five per cent. of the children experienced a reaction mostly fever and rash. Three children were taken to hospital and remained overnight. All these reactions were immediate I did not look at long term effects on immunity.
Both the United States and the UK have systems set up to monitor the rates of adverse reactions. In the United States the Food and Drug Administration (FDA) has the Vaccine Adverse Events Reporting System (VAERS).
The UK monitors the safety and marketing of their medicines and vaccines through the Post Licensing Division of the Medicines Control Agency (MCA). Spontaneous reports of adverse reactions are received from UK doctors under the voluntary ‘Yellow Card’ scheme (Salisbury and Begg, 1996). This data is entered into a national computer database operated by the MCA, where the number, pattern and severity of the reported reactions can be regularly reviewed. At the moment there is no objective way of assessing whether the reaction is as a result of the vaccine, so many reactions must go unreported.
The problem with this scheme is that the reporting of reactions to vaccines is on a voluntary basis. The FDA in America admits that such a system underestimates the occurrence of adverse reactions (Severyn, 1994), with as little as 10 per cent. of those being reported by physicians following immunisation (Cleveland and Eck, 1995). If this is indeed the case, the actual degree of reactions, both in the United States and the UK, remains unclear. In the determination of vaccine effectiveness, the risks are weighted against the benefits. If accurate accounts of reactions existed more research could be conducted on the possible links between these adverse events and the vaccines administered, which in the future may lead to advancements in the immunisation process.
Ashley (1995) praises the Danish system, which has a strict mandatory reporting system. He claimed that the rate of reactions to the MMR vaccine in 15-month-old children occurred in 6 per 100,000, compared to the companies reports of 1 per 30 million. It is vital for parents and doctors to have a better understanding of the risk and the side effects to improve the safety of vaccines in the future.
All ofthe respondents knew what the abbreviation “MMR” stood for compared with only 39 per cent. who knew what the abbreviation “DPT” stood for. The public in general does have basic knowledge about the MMR vaccine.
The greater awareness of MMR obviously reflects the press attention, and raises issues of the quality of reporting and understanding of the issues involved by reporters. Many leaflets have been published on MMR in an effort to restore confidence in this vaccine and these are to be found in doctors’ surgeries. In contrast, there are no leaflets on DPT.
Earlier this year, the Economic and Social Research Council ESRC (2003) published a paper on the media’s role in public understanding of science. They sampled nearly all major science media stories from January to September 2002: 10 per cent. were about MMR. MMR was also by far the most likely science story to generate letters to the press, so people were obviously engaging with the issue, and MMR was by far the most likely science topic to be written about in opinion or editorial pieces. It also generated the longest stories. In fact, it appears that MMR was the biggest, most heavily-covered science story for years.
The ESRC reported that although almost all scientific experts rejected the claim of a link between MMR and autism, 53 per cent. of those surveyed at the height of the media coverage assumed that because both sides of the debate received equal media coverage, there must be equal evidence for each. Only 23 per cent. of those surveyed were aware that the bulk of evidence favoured the supporters of the vaccine.
Anti-vaccination information in the media may cause mothers to question their own decision to immunise their children (Bond et al., 1998). By obtaining the public’s attention the media may cause vaccination rates to potentially decrease even without proven evidence supporting their claims, as was the case in the 1970’s UK pertussis epidemic (King, 1999).
The problem the media faces is how to cover adverse reactions to immunisation. All too often the risks receive all the public attention while the many successes of immunisation programmes go unnoticed (Cohn, 1996). Regardless of the source, the topic of immunisation needs to be presented based on evidence created through appropriate independent research. Unfortunatly resources are not being made available for this kind of research as testified by the fact Andrew Wakefield’s research was stopped at a very early stage because of the effect it was having on the MMR programme (NVIC 2004)
In recent years the public has endured the SARS crisis, the BSE scandal and a foot-and-mouth epidemic. The public is warned of deep-vein thrombosis from air travel, brain cancer from mobile phone radiation, and mutations from genetically modified organisms. To manage the public’s fear of risk, people have to come to terms with some very tricky issues. Can scientists, politicians and the media be trusted to interpret the dangers and benefits of new technologies (Calman, 2002)?
“Vaccination programmes harm a few for the greater benefit of many” (Gillon, 2000). Nevertheless, society has to look at the rights of the individual and how it affects the community. Downie and Calman (1998) ask if it is possible to justify infringing the liberty of the individual to improve the health of others and should restriction be placed on individuals who are potentially a danger to the health of the community. For example banning smoking in public places.
Downie and Calman (1998) state that vaccination against infectious diseases potentially confers great benefit on the community, sometimes at a risk to the individual and it may be necessary therefore to explain the risk honestly before asking for consent before vaccination is carried out on children.
It would appear from this study that parents who responded did not get adequate information regarding the DPT vaccine and they had very little understanding of the vaccine and that GMC guidelines on consent introduced in 1998 have made no difference. If anything, the guidelines have made matters worse regarding peoples understanding of DPT because the perceived problem has been the MMR vaccine and the Government and medical profession have focused their efforts on restoring confidence in MMR to the detriment of other programmes.
Despite the lack of knowledge the vast majority of respondents chose to vaccinate their children. It would have been interesting to have collected some qualitative information regarding peoples’ attitudes to the vaccine, especially as to why they consent to an invasive treatment for their children that they know so little about. Future studies should examine their understanding of risk and their perception of risk in relation to the vaccine. Wensing and Elwyn (2003) recommend using qualitative methods to examine their experiences of health care in more depth. This approach is especially useful in areas that have not previously been studied. They caution that practical approaches to qualitative analysis, such as logging key themes without full transcript analysis, have not been assessed for reliability and validity.
Informed consent is the process by which a fully informed patient can participate in choices about their healthcare, the doctrine of “informed consent” does not currently form part of English law (Hockton, 2002). The nature and scope of duty of a doctor to inform the patient is to be determined by a responsible body of medical oppinion (“Bolam” test). The medical profession now recognises that it owes a comprehensive duty to inform patients about their treatment. Three children in this study were admitted to hospital to the complete surprise of the parents. In two of the cases, doctors said it was coincidental but were unlikely to have known the reason for the reaction.
Edwards (2002) states that the most important goal of informed consent is that the patient has an opportunity to be an informed participant in his health care decisions. It is generally accepted that complete informed consent includes a discussion of the the nature of the decision to vaccinate and an explanation of the relevant risks, benefits and uncertainties related to the decision and most important an assessment of the patients’ understanding of their acceptance of the intervention.
According to the literature and the results of this survey, such discussions do not appear to be happening in the UK. This could be due to lack of funding. Dr Michael Wilks (2002), chairman of the BMA medical ethics committee stated that gaining fully informed consent is fundamental to good quality care but cautioned that “informed consent” requires more time for patients. According to Wilkes (2002), the pressure is on GPs to drive down waiting times and improve access to the health service, providing information is not seen as a priority. He concluded that there is a need for honesty with the public on this issue. There is a “conflict between quality and quantity, which cannot be resolved until we have more doctors.”
According to O’Neill (2002), there is broad agreement that informed consent has become more important in medicine in the last 25 years because medical practice has become more formalised, as have many other areas such as education, financial services and consumer protection. The change has been accelerated because institutions and professions increasingly see informed consent as protection against accusation, litigation and compensation claims, and in cases where it is almost impossible to prove cause and effect unless it happens within 30 minutes of the vaccination they may be less concerned.
The ethical importance of informed consent has become paramount since events at Alder Hey Hospital and the Bristol Royal Infirmary. The Bristol Royal Infirmary inquiry together with the inquiry into the removal, retention and disposal of human tissue from children at the Alder Hey Hospital, underlined the urgent need for changes in the way patients are asked to give their consent, focusing on their rights and the rights of their relatives. Communication of information was the area of greatest compromise in the NHS and the source of most complaints (Coulter, 2002).
The GMC guidelines on the issue of consent: “Seeking Patients’ Consent: The Ethical Considerations” state in the first paragraph that:
“Patients must be given sufficient information, in a way they can understand, to enable them to exercise their right to make informed decisions about their care.”
The Department of Health’s guidance (2004) on consent state:
“In order to make a decision, you and your parents need the doctor or nurse to give you the information about the treatment which they are offering. You should always ask questions if you don’t understand or feel you want to know more.”
In considering how much information a patient requires to be “informed”, O’Neill (2002) points out that the use of excessive medical terminology can undermine the possibility of informed consent. On the other hand, consent that is too vague and general may also fail to legitimise the action. O’Neill suggests achieving a balance by giving patients a limited amount of accurate and relevant information and providing user friendly ways for them to extend their knowledge.
O’Neill believes that it is not difficult to give patients control over the amount of information they choose to receive, by offering easy access to more specific information. Accurate information of varying degrees of specificity can be provided by offering fact sheets, explanatory leaflets, discussion, and time to absorb further information.
Sporton and Francis (2000), in a study of the exploration of the decision making process of parents who choose not to have their children vaccinated, reported that many parents felt that health professionals should provide more balanced information and discuss with parents that immunisation is a choice. Rogers and Pilgrim (1994) found that health professionals were perceived as an obstacle to making an informed choice, rather than a source of advice and information. Bedford and Elliman (2001) refer to the study by Harris et al (2001) which demonstrated a lack of improvement in the knowledge of the contraindications to MMR vaccination among primary health care professionals over a ten year period. If professionals advising parents do not have up to date information it can come as no surprise that some parents are anxious and confused (Pareek and Pattison, 2000).