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Rapid Responses: Rapid Responses published:
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Avoiding coercion today may assist pandemic preparedness tomorrow
- Nick A Wilson (1 November 2008)
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Further points to consider in mandatory influenza vaccination of healthcare workers
- Stephen B Lambert (10 November 2008)
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Is mandatory vaccination such a benign paternalism?
- Dr Viera Scheibner PhD (20 January 2009)
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Re: Further points to consider in mandatory influenza vaccination of healthcare workers
- George Hall (20 January 2009)
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Nick A Wilson, Senior Lecturer University of Otago, Wellington, New Zealand
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A key argument of Isaacs and Leask [1] is that mandatory immunisation for seasonal influenza may alienate staff and damage morale. There is a risk this effect could extend beyond seasonal influenza to pandemic influenza preparations and response. The availability of human H5N1 vaccines, which can induce heterotypic immunity, now means it is possible to prime individuals at the highest risk (eg, health workers) [2]. But there needs to be high levels of support from those health workers if optimal use is to be made of both pre-pandemic vaccines and pandemic vaccines, and even the pre-pandemic use of pneumococcal vaccine [3]. The importance of pandemic preparedness makes it highly desirable to avoid coercive approaches around seasonal influenza immunisation that may prejudice health workers against such measures. Instead, the emphasis should entirely be on making seasonal influenza immunisation extremely easy for these workers ie, freely delivered at a convenient time and place. References 1. Isaacs D, Leask J. Should influenza immunisation be mandatory for healthcare workers? No. BMJ 2008;337:a2140. 2. Jennings LC, Monto AS, Chan PK, et al. Stockpiling prepandemic influenza vaccines: a new cornerstone of pandemic preparedness plans. Lancet Infect Dis 2008;8:650-8. 3. Gupta RK, George R, Nguyen-Van-Tam JS. Bacterial pneumonia and pandemic influenza planning. Emerg Infect Dis 2008;14:1187-92. Competing interests: None declared |
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Stephen B Lambert, Medical Epidemiologist Queensland Paediatric Infectious Diseases Laboratory, Royal Children's Hospital, 4029, Queensland
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Many thanks for publishing the for(1) and against(2) sides of mandatory influenza vaccination of healthcare workers (HCWs). Both sides do a good job of canvassing the arguments, but there are some key issues not covered by either side that are worth further exploration. These are: 1. The ethics of HCW autonomy to reject influenza vaccine cannot be discussed in isolation; 2. Use of encouragements to improve HCW influenza vaccination coverage is not cost-effective compared with mandatory vaccination; and 3. Failure to act to protect workers and clients from a potentially fatal danger would be simply unacceptable in any other workplace, breeches current workplace health and safety laws, and would result in serious fines and other penalties for those who knew of the risks and failed to act. As a starting point, neither side acknowledged that HCW vaccination is more significant than similar, increasingly common, workplace programs in factories and offices: the key difference being that, unlike childhood vaccination programs, the primary aim of HCW influenza vaccination is not protection of the individual being vaccinated, but protection of patients. Individual protection is a secondary, but necessary, benefit: it is through individual protection that nosocomial transmission of influenza to all patients, but particularly the vulnerable, and their carers is restricted. The John Stuart Mills quote cited by Isaacs and Leask, therefore, supports the prospect of a mandatory program, rather than opposes it.(2) The further arguments against mandatory vaccination, namely: that it is ethically unjustifiable because it infringes HCW civil liberty and autonomy, and acutely so because vaccination currently breeches the boundary of the skin; and that failure to comply resulting in dismissal, further infringes a HCW’s right to freedom to work and ensure financial security, are both not supported by current practice. Such claims may be valid if it were possible to focus on the individual rights of HCWs in a vacuum, to the exclusion of the rights of all others. Unfortunately, it is not possible to do so. Any ethical assessment of the issue requires a balancing of all competing rights: the rights of the patient to enter a safe healthcare environment must be considered. Given that influenza epidemics are real and recurrent events, why should we give individual HCW autonomy preference over our patients’ right to a safe healthcare environment? All Australian States and Territories’ Health Departments have mandatory hepatitis B vaccination requirements for those who are not immune and are responsible for providing patient care. Individual autonomy to choose against this is not catered for: the choice the individual makes is to be protected and employed, or not employed. This infringement on a person’s right to work and earn a living in this specific environment is not met by strong or reasonable objection, and neither should mandatory influenza vaccination. HCWs need to exercise their right to chose at a more fundamental level: do they chose to work in healthcare and do all they can to minimise the risk to those under their care, or do they chose to work elsewhere? It is a modern reality that the cost-effectiveness of alternate methods for the delivery of any healthcare program must be considered. Increasing HCW influenza vaccination coverage is possible using combinations of incentives and requiring signed declination. The results achieved are better than when such approaches are not used, but they do not reach the coverage achieved with mandatory requirements.(1) Further, I would argue that the cost of implementing such incentives and hurdles would be higher than the standard delivery and follow-up required with a mandatory program. Better coverage at a cheaper delivery price makes the mandatory program superior on both counts alone, and is thereby a dominant approach in health economic terms. This is without considering the cost savings from reduced staff absenteeism and prolonged inpatient stays. Most developed industrialised countries have Workplace Health and Safety Laws that require, in one form of words or another, that workers are not only free from death, injury or illness caused by any workplace, but that they are also “...free from risk of death, injury or illness caused by any workplace”.(3) Influenza is an annual and predictable workplace danger in all healthcare settings: it diminishes the safety of patients and HCWs, can prolong hospitalisation of any patient, and can cause serious morbidity and mortality in both the vulnerable and the normally healthy – including HCWs. This risk can be minimised, if not removed entirely, by the application of universal workplace immunisation. It is simply unacceptable to allow individual HCW autonomy to be given precedence over workplace safety. As a risk management action, hospital superintendents and others managing any healthcare institution should ask their lawyers for a legal opinion about whether voluntary influenza workplace vaccination programs for HCWs meet the local requirements imposed on them as a “person in control of a relevant workplace area” by workplace health and safety laws. The ethical, health economic, and, indeed, legal arguments all point to healthcare institutions requiring, as opposed to recommending, that their workers receive influenza vaccine. Why is it that we continue to allow optional influenza vaccination of HCWs with its associated low coverage? The unfortunate fact of the matter is that we have become lazy in prosecuting the case for mandatory HCW vaccination. Healthcare institutions accept the arguments of personal freedom over patient safety because it is easier to stick with the status quo, and avoid upsetting staff. But if, in some healthcare settings, vaccinating eight HCWs is all that is required to prevent one patient death during moderate influenza seasons,4 how can we continue to allow individual staff, without a serious and documented medical contraindication, to refuse? Stephen Lambert sblambert@uq.edu.au References 1. Helms CM, Polgreen PM. Should influenza immunisation be mandatory for healthcare workers? Yes. BMJ 2008;337:a2142. 2. Isaacs D, Leask J. Should influenza immunisation be mandatory for healthcare workers? No. BMJ 2008;337:a2140. 3. Workplace Health Safety Act 1995 (QLD). s22. Accessed at: http://www.legislation.qld.gov.au/LEGISLTN/CURRENT/W/WorkplHSaA95.pdf. 4. Hayward AC, Harling R, Wetten S, Johnson AM, Munro S, Smedley J, et al. Effectiveness of an influenza vaccine programme for care home staff to prevent death, morbidity, and health service use among residents: cluster randomised controlled trial. BMJ 2006;333:1241. Competing interests: Stephen Lambert has been a co-investigator for industry-sponsored vaccine studies, received a travel grant to attend a conference, and been a member of vaccine advisory boards for GSK and Novartis. |
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Dr Viera Scheibner PhD, Scientist/Author Retired Blackheath NSW Australia
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Dear Editor, I am a bit surprised that there were so few rapid responses to the issue of whether influenza (or any other) vaccination should be mandatory for healthcare workers (or anybody else for that matter). As I see it, there are several points to consider. 1. Are the flu vaccines actually effective in preventing influenza? 2. Are the flu vaccines safe? 3. Is there ever a good reason to force any medication or presumed prophylactic onto anybody? 4. Is there ever any good reason for one person to be treated for the benefit of another person? To summarily address the above issues, one has to go back in history of the flu vaccines. We have to start with the USA. The seventies of the twentieth century, and more particularly 1976-1979, was a momentous time for vaccination because childhood vaccination became effectively mandatory by individual states, one by one, enacting laws requiring presentation of the evidence of vaccination for enrollment to pre-schools and schools. It was also the time when flu vaccination became a pushed issue for adults. In February 1976, an alleged human infection with a swine influenza virus occurred in five recruits at Fort Dix, a military camp in New Jersey. The antigenic composition of the virus was interpreted as a major antigenic shift and doctors expected a pandemic to occur imminently. On March 13th the Director of the Center for Disease Control (CDC) presented to the Assistant Secretary for Health the recommendations of the Advisory Committee on Immunization Practices (ACIP) on a proposed total nationwide vaccination programme. President Ford signed into law the bill authorising $135 million for a comprehensive influenza vaccination programme. From June to September 1976, a complex public-private vaccination delivery system was set up, reaching its full potential on and after October 1. Many private doctors refused to participate in the programme because of the liability implications. By the end of November, various manufacturers had produced some 150 million doses of the vaccine. Right from the beginning, this plan had one major flaw: the new virus strain showed no capability of epidemic spread. Nevertheless, some 40 million adults were vaccinated. Within four months, there followed the occurrence of hundreds of cases of Guillain-Barre syndrome paralysis in vaccinees (Marks and Halpin 1980), with a number of deaths. Some 4000 law suits were lodged seeking compensation for the damage sustained. Some three billion dollars were paid out in compensation. On December 16, 1976, the Public Health Service elected to place a moratorium on all influenza vaccines pending reassessment of vaccine risks. The moratorium was lifted on 9 February 1977 for all groups at "highest risk of fatal disease from infection" with the then currently prevalent influenza A and B. People have short memories. Despite the swine flu debacle, vaccination against influenza continued and in January 1978-March 1981, during and after the 1978-1979 vaccination campaign, 575 cases of Guilain- Barre Syndrome (GBS) were reported by participating neurologists in the national GBS surveillance system. The incidence was highest in the fifty to seventy four year olds. Victims experienced respiratory and gastrointestinal illness before the symptoms of ascending paralysis appeared. Sixty seven percent of the total number of vaccinees reported receiving an A/New Jersey (swine) influenza vaccine in 1976 before being revaccinated two years later (obviously sensitised by the previous dose). The influenza epidemic which followed unabated in 1979-80 despite the mass "immunization" programmes, not only was not stopped but was most probably precipitated by weakening and sensitising large numbers of vaccinees to the very illness the vaccines were supposed to prevent. The situation is immortalised by Hurwitz et al. (1981) and Kaplan et al. (1983), and Poser (1985). Moreover, in July 1976, a pneumonia-like epidemic occurred among members of the American Legion who had attended a meeting in Philadelphia (Friedman 1978). There were an estimated 180 cases with 29 deaths. This was only a proverbial tip of the iceberg. Many other sporadic outbreaks of what became the Legionnaire's disease (named after members of the American Legion)occurred all over the United States. In England (Macrae et al. (1979) some 84 cases with 18 deaths were reported between January 1976 and September 1978. During 1980-82, some 1300 cases of illness compatible with the Legionnaire's Disease were studied in Spain (Otero et al. 1983). In 1992, reports of the disease with a number of deaths especially in Sydney, Australia, occurred. It was not coincidental that these outbreaks followed a vigorous advertising campaign encouraging people to take the 'flu shots'. According to Daily Telegraph Mirror, September 1992), the family members of the victims who died claimed that their relatives were given flu injection shortly they became violently ill with the symptoms characterised by fever, cough, pneumonia, headache, nausea, vomiting and diarrhoea, dizziness, disorientation, loss short term memory and hallucinations and became cyanotic, and developed breathing difficulties, tremors of the limbs and renal failure. Legionella pneumophila (the genus name coincidental) microorganism was allegedly isolated from the victims. Legionella is a ubiquitous commensal, just as golden staph, and only becomes virulent in individuals whose immune system was seriously suppressed, such as by vaccines. The dangers and ineffectiveness of flu vaccines have been known from the 1940s. Curphey (1947) described fatal allergic reactions due to influenza vaccine. Smith (1974) reported on the failure of vaccination in the control of influenza in the post office workers. Warren (1956) described encephalopathy due to influenza vaccine. Cherrington (1977) described locked-in syndrome after "swine flu" inoculation; Weintraub (1977) reported on paralytic brachial neuritis after swine flu vaccination; Martilla et al. (1977) studied haemagglutination inhibiting antibodies to four influenza virus strains in blood serum specimens of 20 patients with postencephalitic and 55 patients with idiopathic Parkinson disease and their age-matched controlls. The postencephalitic group was similar to the idiopathic Parkinson group with regard to the influenza antibodies. Saah et al. (1986) studied the effectiveness of vaccination against influenza in a retrospective cohort study in a New York City nursing home and examined the occurrence of pneumonia and its related mortality over three consecutive influenza seasons. They concluded that vaccination did not affect pneumonia-related mortality. "This study also suggests that estimates of mortality due to pneumonia should include deaths that occur up to 60 days after onset of pneumonia; shorter follow-up may overestimate the protective effect of vaccination". Saito and Yanagisawa (1989) described acute cerebellar ataxia after influenza vaccination with recurrence and marked cerebellar atrophy. Gavaghan and Webber (1993) described a 48-year old asthmatic patient who eight days after the second flu vaccine (the first was given in 1986 "without ill effect") developed pronounced myalgia followed by polyarthritis with a large urticarial eruption on her right shoulder. On cessation of the steroids, she developed myositis, arthralgia and a very significant urticarial reaction with gross tissue oedema and pressure on her peripheral nerves, treated again with steroids. Sveral days after the steroids ceased, she developed a severe vasculitis of both lower limbs with polyarthralgia, myositis, and massive urticaria (biopsy showed massive eosinophilic infiltrate through all the tissues and around the blood vessels). Brown and Bertouch (1994) described rheumatic complications of influenza vaccination in three patients who have developed systemic lupus erythematosus, polymyalgia rheumatica and rheumatoid arthritis respectively. Drinka et al. (1997) described large outbreaks of influenza A and B in nursing homes despite high resident vaccination rates (80% or higher), even when the vaccine strain was matched to the circulating strain. They concluded that "Future efforts are needed to develop vaccines that provide greater protection and to improve staff vaccination rates". Finsterer et al. (2001) described a case of a 70-year old previously healthy man who developed a common cold with headache, treated with aspirin. Despite this infection, he was vaccinated against influenza 5 days after the onset of his symptoms. Immediately after vaccination, he developed a newly located severe headache, fever, facial oedema, and high blood pressure. He became very ill, which required hospitalisation. In hospital, he also developed blurred vision, proptosis, pain on eye movement, and weakness of the right upper limb. MRI of the cerebrumn revealed cavernous sinus thrombosis and on day 5 also proptosis and chemosis of the right eye, bilateral ptosis, spontaneous nystagmus, weakness of abducens muscle, and peripheral facial palsy on the right side, and his visual acuity further deteriorated. Giant cell arteritis was confirmed by the temporal artery biopsy findings. After antibiotics failed, corticosteroid therapy was initiated and relieved all the abnormalities during the following days. Only slight weakness of the right upper extremity persisted. My personal comment? What a waste of effort and money and other resources in a predictable and preventable situation. Even though some recipients of flu (and other) vaccines do not have serious symptoms, there is no guarantee that the next dose will not elicit serious reaction and even death. There is also no evidence that flu vaccines, just as other vaccines, would actually prevent the recipients from contracting the flu. Flu viruses, just as bacteria and other microorganisms, are ubiquitous (just where does the first case come from?). Flu is not a deadly disease per se; it is only potentially dangerous in immunosuppressed and malnourished people (and overworked healthworkers). With this uncertainty, mandating flu (and all the other) vaccines is only an illusion and could amount to a life of misery and even death sentence. The traditional, very large, doses of sodium ascorbate powder are more likely to do the trick without any deleterious side effects. References Marks JS, and Halpin TJ. Guillain-Barre syndrome in recipients of A/New Jersey influenza vaccine. JAMA; 243 (24): 2490-2494. Hurwitz ES, Schonberger LB, Nelson DB, and Holman RC. 1981. Guillain-Barre syndrome and the 1978-79 influenza vaccine. NEJM; 304: 1557-1561. Kaplan JE, Schonberger LB, Hurwitz ES, and Katina P. 1983. Guillain- Barre syndrome in the United States, 1978-1981: additional observations from the national surveillance system. Neurology; 33;May: 633-0637. Poser CM. 1985. Swine influenza vaccination. Arch Neurol; 42: 1090- 1092. Friedman HM. 1978. Legionnaire's disease in non-legionnaires. Ann Intern Med; 88: 294-302. Macrae AD, Appleton PN, and Laverick A. 1979. Legionnaire's disease in Nottingham, England. Ann Intern Med; 90: 580-583. Otero MR, Anda P, Fernandes MV, Casal J, and Najera R. 1983. Legiinnaire's disease in Spain. Lancet; 2 April: 759. Curphey TJ. 1947. Fatal allergic reactions due to influenza vaccine. JAMA; 133 (15): 1062-1064. Smith KWG. 1974. Vaccination in the control of influenza. Interim report to the Director of the Public Health Laboratory Service on a collaborative study with the Post Office. Lancet; 10 August: 330-333. Warren WR. 1956. Encephalopathy due to influenza vaccine. Arch Intern med; 803-805. Cherrington M. 1977. Locked-in syndrome after "Swine flu" inoculation. Arch Neurol; 34: 258. Weintraub MI. 1977. Paralytic brachial neuritis after swine flu vaccination. Arch Neurol; 34: 518. Marttila RJ, Halonen P, and Rinne UK. 1977. Influenza virus antibodies in parkinsonism. Arch Neurol; 34: 99-100. Saah AJ, Neufeld R, Rodstein M, La Montagne JR, Blackwelder WC, et al. 1986. Influenza vaccine and pneumonia mortality in a nursing home population. Arch Intern Med; 146: 2353-2357. Saito H, and Yanagisawa T. 1989. Acute cerebellar ataxia after influenza vaccination with recurrence and marked cerebellar atrophy. Tohoku J Exp Med; 158: 95-103. Gavaghan T, and Webber CK. 1993. Severe systemic vasculitic syndrome post influenza vaccination. Aust NZ J Med; 23: 220. Brown MA, and Bertouch JV. 1994. Rheumatic complications of influenza vaccination. Aust NZ J Med; 24: 572-573. Drinka PJ, Gravenstein S, Krausse P, Schilling M, Miller BA, and Shult P. 1997. Outbreaks of influenza A and B in a highly immunized nursing home population. J Fam Practice; 45 (6): 509-514. Finsterer J, Artner C, Kladosek A, Kalchmayr R, and Redtenbacher S. 2001. Cavernous sinus syndrome due to vaccination-induced giant cell arteritis. Arch Intern Med; 161: 1008-1009. Competing interests: None declared |
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George Hall, Retired physician EX1 2HW
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Many of us remain unconvinced of the alleged efficacy of 'flu vaccination- a belief borne out by the belated admission that it doesn't work in those most in need of protection, the sick and elderly. Now we are asked not only to swallow the assertion that inoculating health workers might do the job, but that this should be compulsory. A look at the paper quoted in support of this (Hayward et al, BMJ 2006; 333:1241)reveals the extraordinary omission of any record of the 'flu (or suspected flu) rates in the staffs of the nursing homes with high and low vaccination rates. If we don't even know that, the extended conclusions about the effect on the inmates seem a bit excessive. Also, as is often the case in this sort of study we have no information about whether the deaths or the 'flu like illnesses were in fact due to properly identified influenza infection. Whatever one's feelings about the relative merits of duty or utility ethics, to impose draconian conditions on employment on the basis of this level of evidence would be totally unjustifiable- unethical, in fact! Competing interests: None declared |
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