Vaccination Against MMR: Is There A Case For Deepening Debate?

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PUBLIC HEALTH

Vaccination Against MMR: Is There A Case For Deepening Debate?

Primary care, Ethical debate

[This exchange comes from the current online edition of the British

Medical Journal.]

Vaccination against mumps, measles, and rubella: is there a case for

deepening the debate?

Complex issues relating to ethics, values, and the nature of evidence

lie behind the decision whether to give the MMR (mumps, measles, and

rubella) vaccine. Tom Heller, a general practitioner, is uncomfortable with

the evidence that the vaccine is safe. Together with Dick Heller, an

epidemiologist, and Pattison, an ethicist, he explores some of the

processes involved in doctors' decisions about whether to vaccinate.

How Safe is MMR Vaccine?

Tom Heller, general practitioner.

School of Health and Social Welfare at the Open University, Milton

Keynes, MK7 6AA

t.d.heller@...

My duties as a general practitioner include immunising babies and

small children against a range of common diseases. Recently, I have been

increasingly uncomfortable when giving the combined mumps, measles, and

rubella (MMR) vaccine. I find myself wondering if I would submit my own

children for this immunisation if they were currently at that age.

I find it difficult to be certain that the vaccine is as safe as the

authorities say that it is. Somehow, the more strident the experts become,

the less believable I seem to find them. The Department of Health website

(http://193.32.28.83/mmrvac.htm) gives many references and internet links to

the published studies that support its views, but it gives only one

reference that raises the issue of a link between MMR vaccine and potential

adverse reactions.

The partial use of evidence that is apparent within official

pronouncements is echoed by other experts. For example, Elliman and Bedford

focus on possible problems with the research methods of people concerned

about possible adverse effects of the MMR vaccine.1 They do not mention

potential problems with the research that concludes that the vaccines are

safe. In addition, what are we to make of these and other researchers2 who

declare funding from drug manufacturers involved in manufacturing vaccines?

Listening to people and parents

The NHS Plan emphasises the need to give people in receipt of

treatment and services a greater part in the decisions that affect them and

the NHS in general.3 However, for some reason, the choices seem restricted

when it comes to discussing MMR vaccine. But parents remain anxious. Those

with autistic children have become sensitised to the possibility that the

condition may have been caused by an intervention such as vaccination.4

Other parents are convinced of the link between the MMR vaccine and

their child's subsequent development of autism and have formed support

groups and lobbying organisations. In the United Kingdom the main

organisation is JABS (Justice, Awareness, and Basic Support,

www.jabs.org.uk). When does a series of individual observations from

families with affected children count as evidence if each one is dismissed

as an isolated incident?

Professional issues

In the United Kingdom, general practitioners receive a fee for each

child immunised and other payments are triggered for meeting targets.

Missing these targets would have serious consequences for the financial

stability of the practice, and there is considerable pressure on members of

the team to ensure that children are immunised with every recommended

vaccine.

I am not alone in my concern, and possible confusion, about

administering the MMR vaccine. A recent survey of health workers in north

Wales sought to elicit the knowledge, attitudes, and practices relating to

MMR vaccine, particularly the second dose.5 Only 45% of the professionals

(54% of the general practitioners) agreed completely with the policy of

giving the second dose of the MMR vaccine. These professional concerns do

not seem to have greatly affected the numbers of children receiving the

vaccine, and national MMR coverage has only fallen from 91% in 1994-5 to 88%

in 1998-9, although in some districts the uptake is below 75%.6

It is not easy to question authority these days.7 Wakefield,

the author of some of the studies that have questioned the development and

subsequent use of MMR vaccine, has been subjected to personal as well as

professional abuse (www.autism-spectrum.com/vaccine.htm). Perhaps keeping my

head down and not even talking about these issues would be the easiest

option.

Footnotes

Competing interests: None declared.

References

1. Elliman D, Bedford H. MMR vaccine: the continuing saga. BMJ 2001; 322:

183-184[Full Text].

2. Kaye J, Melero-Montes M, Jick H. Mumps, measles, and rubella vaccine and

the incidence of autism recorded by general practitioners: a time trend

analysis. BMJ 2001; 322: 460-463[Abstract/Full Text].

3. Department of Health. The NHS Plan. London: Stationery Office, 2000. (CM

4818-I.)

4. Goldberg D. MMR, autism, and Adam. BMJ 2000; 320: 389[Full Text].

5. Petrovic M, R, Ramsay M. Second dose of measles, mumps and

rubella vaccine: questionnaire survey of health professionals. BMJ 2001;

322: 82-85[Abstract/Full Text].

6. Public Health Laboratory Service facts and figures.

www.phls.co.uk/facts/vaccination/cover.htm (accessed 18 Sep 2001).

7. Hunt G, ed. Whistleblowing in the health service. London: Arnold,

1995.

* *

Validity of the Evidence

Dick Heller, professor of public health.

Evidence for Population Health Unit, School of Epidemiology and Health

Sciences, Medical School, University of Manchester, Manchester M13 9PT

Dick.Heller@...

The basic question is, " what is the real evidence about the dangers of

MMR vaccine? " The evidence for a link between MMR vaccine and the

development of autism is based on a hypothesis derived from an observation

that the parents of eight out of 12 children investigated for

gastrointestinal symptoms and autism associated the onset of autism with the

MMR vaccine.1 There has been no evidence to support the hypothesis.

Several studies have been reported as negating the hypothesis,

although there are doubts about each of these. Some of the studies are

ecological in design; they examine trends in the development of autism with

the trends in use of MMR vaccine. Recently reported studies 2 3 show that

the rise in reported autism over the past decade or so bears no relation to

any changes in rates of MMR vaccination, and this is consistent with other

data showing no epidemiological evidence for a causal association. 4 5 Most

people who have reviewed the evidence have rejected the notion that MMR

might be associated with autism.6-8 A recent review from the US Institute of

Medicine concludes that " the evidence favours rejection of a causal

relationship. " 9

Listening to people and parents

Unfortunately, patients are often not precise at identifying the cause

of their illness, and personal anecdote can do no more than suggest a

hypothesis that needs formal scientific testing: " Hypotheses can become

`facts' long before the critical data are in. " 10 The concern in the

community comes from the difficulty in understanding and expressing

evidence. All we have at the moment is a hypothesis based on anecdote,

without supporting evidence. Any evidence that does exist, however weak it

might be perceived to be, fails to support the hypothesis.

Comparing risk of autism with risk of vaccine preventable diseases

It is difficult to measure, express, and understand risk. The

prevalence of autistic spectrum disorders is 91/100 000 children.11 If as

many as 15% of these children had autism as a result of the MMR vaccine,

7326 children would have to be vaccinated to " produce " one child with

autism. How many cases of mumps, measles, or rubella would the lack of

vaccination of this number of children produce? What would their

complication rates be? Unfortunately, we have not established good

intelligence systems to explore the public health effects of changes in

immunisation.12 We do know that for measles alone, death rates are 1-2 per

1000 infected people in the United States and that 1 in 1000 will get

encephalitis (and some of these will have permanent brain damage).13 If most

children who were not vaccinated developed measles, the complication rates

suggest that discontinuing vaccination would do considerable harm and that

this harm would far outweigh any possible benefit from possibly reducing the

incidence of autism.

These common communicable diseases cannot be eliminated if the levels

of immunisation in the community fall below a critical value. It is a

legitimate concern of those with responsibility for public health to seek to

maintain high vaccination rates.

In summary, I feel that there is no evidence that MMR vaccine causes

autism and considerable evidence to say that it does not. I believe that the

dangers of reducing vaccination on the basis of an unsubstantiated

hypothesis are considerable.

Footnotes

Competing interests: None declared.

References

1. Wakefield A, Murch S, A, Linnell J, Casson D, Malik M, et al.

Ileal-lymphoid nodular hyperplasia, non-specific colitis, and pervasive

developmental disorder in children. Lancet 1998; 351: 1327-1328[Medline].

2. Kaye J, Melero-Montes M, Jick H. Mumps, measles, and rubella vaccine and

the incidence of autism recorded by general practitioners: a time trend

analysis. BMJ 2001; 322: 460-463[Abstract/Full Text].

3. Dales L, Hammer SJ, NJ. Time trends in autism and in MMR

immunisation coverage in California. JAMA 2001; 285: 1183-1185[Medline].

4. B, E, Farrington C, Petropoulos M-C, Favot-Mayaud I, Li J,

et al. Autism and measles, mumps, and rubella vaccine: no epidemiological

evidence for a causal association. Lancet 1999; 353: 2026-2029[Medline].

5. Patja A, kin I, Kurki T, Kallio MJ, Valle M, Peltola H. Serious

adverse events after measles-mumps-rubella vaccination during a fourteen

year prospective follow-up. Pediatr Infect Dis J 2000; 19:

1127-1134[Medline].

6. Nicoll A, Elliman D, Ross E. MMR vaccination and autism. BMJ 1998; 316:

715-716[Full Text].

7. Wise J. Finnish study confirms safety of MMR vaccine. BMJ 2001; 322:

130.

8. R. MMR vaccination and autism. BMJ 1998; 316: 1824[Full Text].

9. Institute of Medicine. Immunisation safety review: measles-mumps-rubella

vaccine and autism. http://books.nap.edu/books/0309074479/html/index.html

(accessed 5 Sep 2001).

10. Gellin BG, Schaffner W. The risk of vaccination the importance of

" negative " studies. N Engl J Med 2001; 344: 372-373[Full Text].

11. R. MMR vaccination and autism. BMJ 1998; 316: 1824[Full Text].

12. Heller RC, Page J. A population perspective to evidence based medicine

" evidence for population health. " J Epidemiol Community Health (in press).

13. JC, Hadler SC, Dykewicz CA, Reef S, L. Measles, mumps,

and rubella vaccine use and strategies for elimination of measles, rubella,

and congenital rubella syndrome and control of mumps: recommendations of the

Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly

Rep 1998; 47(RR-8): 1-57[Medline].

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Dealing with Uncertainty

Pattison, head.

Department of Religious and Theological Studies, Cardiff University,

Cardiff CF10 3EU

Pattisons@...

Some moral theorists would say that Tom Heller is just having an

emotional reaction, but I would say that this kind of discomfort is part of

moral judgment.1 He applies one of the best known tests for assaying the

rightness or wrongness of acts called the golden rule,2 expressing this as,

" would I submit my own children for this immunisation if they were currently

at that age? " He also discusses the voice of authority that says it is safe

to administer MMR vaccine and how his doubts are amplified in inverse

proportion to the experts' certainty. The question is, then, how might his

colleagues and members of the public be helped to live with reality and

limits of knowledge without necessarily abandoning useful public health

practices that may be in their long term interests?

Although the scientists may be deemed to be working on one paradigm of

rationality and correlative enlightenment, ordinary people, including

doctors, have a more complex view of reality. This kind of composite

knowledge is often seen, from a rational point of view, as superstition and

irrationality which needs to be dispelled and destroyed.

You cannot discount another's knowledge even if you may doubt its

scientific value. Making a decision to have a child immunised is a moral

dilemma for parents and this must be respected. Not acknowledging others'

moral dilemmas does not make them go away. There is a crisis of expert

authority and trust in scientific judgment surrounding MMR vaccine and a

crisis of mutual respect. A decision needs to be made about what kind of

evidence counts and how this is weighed and related to lay views of reality.

In doing so, scientists must take care not to treat fear and reservation as

ignorance and then try to destroy it with a blunt " rational " instrument.

I wonder if people know that general practitioners are given financial

incentives to deliver a certain proportion of vaccinations. This again

raises the issue of whether doctors are acting in the best interests of the

individuals or whether they are dancing to a financial tune. We need to ask

whose interests do and should clinicians serve do they focus on individuals,

or is their job to deliver centrally determined, scientifically informed,

health policy?

Risk and power are unequally distributed in this situation. The

government determines the risk management strategy to deal with the diseases

mumps, measles, and rubella. However, it is individual clinicians and

parents who have to implement this strategy and may have to live with its

consequences. The MMR vaccine issue focuses many of our concerns about

ethical and responsive public health in the clinical context in a helpful

way. We are trying to work out what individually respectful and sensitive,

publicly accountable, evidence based clinical practice might look like.

Footnotes

Competing interests: None declared.

References

1. Oakley J. Morality and the emotions. London: Routledge, 1992.

2. Singer P, ed. A companion to ethics. Oxford: Blackwell, 1991.

* *

GP's Response

Tom Heller.

I feel as though I have been through a process which is rather similar

to the explorations that many parents go through at the time of taking

important vaccine related decisions on behalf of their children. My search

for understanding will have to continue. Of course, I respect that the full

weight of the most powerful authority figures in modern medicine have

concluded that MMR vaccine is safe (box), but lingering doubts remain for me

and for many others.

My final thoughts are summed up in the following quotation: " Informed

refusal must remain an acceptable choice in a free democracy, and the

culture of informed consent, with both religious and philosophical

exemption, must be maintained. The difficult balancing act will be in

determining the right of the state to control an infectious disease and the

right of the individual to chose. " 2

References

1. Committee on Safety of Medicines. MMR vaccine: the facts. Current

Problems in Pharmacovigilance 2001; 27: 3.

2. Poland G, son R. Vaccine safety: injecting a dose of common sense.

Mayo Clinic Proceedings 2000; 75: 135-139[Medline]

http://www.bmj.com/cgi/external_ref?access_num=10683650 & link_type=MED.

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