Ethics of the MMR controversy

Introduction:

In February 1998 Dr. Andrew Wakefield from London’s Royal Free Hospital suggested a link between the combined MMR vaccination and autism (Guardian, 2008). This link was widely reported by the media, causing parents to doubt the safety of vaccinating their children. As a result there was a huge campaign by the Health Protection Agency to reassure parents that the vaccine was indeed safe, but public opinion is still divided and this lack of vaccination has created a window for infection (General Medical Community, 2009) and a steep rise in reported cases of Measles.

This essay will review the ethical implications of Dr. Wakefield’s work and those involved in the unfolding MMR Controversy.

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Should the paper have been published?

Did the people and organisations involved act ethically?

The Media:

Despite the minor nature of Dr. Wakefield’s paper “Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children” the press ran with its findings, using headlines such as “Fresh safety fears raised over MMR jab”, “New MMR link found to autism”, “MMR fears gain support”, “MMR – risk of brain disorders?”- from the Daily Mail – gaining support from previous ministry aides, columnists and writers (Smith 2004). Even in 2001 the Blairs’ (the then Prime Minister and his wife Cherie) were asked if Leo, their youngest son, had been given the MMR vaccine, and refused to answer (Goldacre, 2008); lending further credence to the idea that the vaccine was unsafe.

It has been stated by the BBC (BBC, 2003) that the public believed that the debate over the MMR vaccination was split equally, with G P’s and medical practitioners taking both sides and only 23% aware that the evidence was clearly in support of the combined MMR vaccine. The study was undertaken by Cardiff University between January and September 2002 and surveyed over 1,000 people. With close scrutiny paid to over 2,000 media (papers, radio and TV) reports. The survey concluded that 48% of people feel that journalists, should not (until findings are backed by further investigations and studies) report alarming research – however this is still a minority view. Professor Lewis of Cardiff University’s School of Journalism, Media and Cultural Studies released the following statement:

“The research also has implications for the debate about fairness in journalism, suggesting that legal definitions of impartiality in broadcast journalism should not be interpreted in a simplistic fashion,” – BBC, 2003.

Further research, such as that by Chen and DeStefano (1998), quite clearly states that misinterpretation of Dr. Wakefield’s research could have been avoided by clarifying the difference between causality and association – but the lack of such definition to the media and public can partially be blamed for the ensuing state of affairs.

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However the MMR scandal does not end with Dr. Wakefield’s paper; further articles such as “MMR jab ‘new autism link'” published by the Sun (Thornton, 2003) or “New fear over MMR link with rising Autism” by the Telegraph (Adams, 2007) are still fuelling the debate and causing public concern years after the initial study was published in the “Lancet” Journal. Doubt is occurring despite a massive coordinated effort by the biomedical community to debunk such research – showing the grip that this “story” has had on the population for over 10 years.

Some articles have been published in the media criticising the way in which the MMR controversy has been handled although these are far and few between, such and article would be the O’Neill’s “The media’s MMR shame” from the Guardian, 2006.

The Researchers:

Dr. Andrew Wakefield may have been the public face of the MMR scare but he was not alone in completing the study that started it all, the full list of names sites 13 co-writers, their names and roles are listed in the original journal article:

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“A J Wakefield was the senior scientific investigator. S H Murch and M A Thomson did the colonoscopies. A Anthony, AP Dhillon, and S E Davies carried out the histopathology. J Linnell did the B12 studies. D M Casson and M Malik did the clinical assessment. M Berelowitz did the psychiatric assessment. P Harvey did the neurological assessment. A Valentine did the radiological assessment. J Walker-Smith* was the senior clinical investigator.” (Wakefield et al. 1998)

Edited to include full Surname – original citation refers to “J W-S”

It has to be asked if key personnel involved with controversial aspects of the study acted ethically and trying to answer this question can only be answered by investigating senior team members and their respective roles separately.

Dr. Andrew J Wakefield:

In March 2004, Dr. E Harris (opposition politician), first raised the issue of unethical behaviour (on Dr. Wakefield’s part) during the study. As head of the study (“Senior Scientific Investigator” (Wakefield et al., 1998)) Dr. Wakefield would have had to have sought permission from the Royal Free Hospital’s ethics board before commencing his studies. It was alleged by Harris that, after approval was granted, Wakefield changed the methodology to include lumbar punctures involving sedation (unknown, 2004). This public outing of Dr. Wakefield’s proposed misconduct and subsequent complaints by Harris resulted in an enquiry by the General Medical Council, unearthing more damaging claims (General Medical Council, 2010).

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It was found that children were subject to unnecessary colonoscopies, lumbar punches and barium meals (without approval), that Wakefield was not allowed to treat children and children were enrolled that did not fit the strict conditional prerequisites of the study (Boseley, 2010).

But Dr. Wakefield’s short comings were not simply confined to the methodology of the study; he was also found have conflicting interests – something that was not declared in the paper submitted to the Lancet journal. In 1997 Wakefield had filed a patent (on behalf of Royal Free Hospital) for a vaccine against measles and for treating IBD (Inflammatory Bowel Disease), he had (in February 1998) applied for ethical approval to trial a new measles vaccine under a new company called “Immunospecifics Biotechnologies Ltd”and been found to have paid children £5, at his son’s birthday party, to take unethical blood samples (Boseley, 2010).

Further research regarding Wakefield’s conflicting interests, in particular his involvement with “Immunospecifics Biotechnologies Ltd”unearths some controversial evidence, the proposed CEO of the aforementioned company was the father of child 10 (a child involved in the study), with Wakefield and this gentlemen to share equity of the company. It was found that Wakefield and Walker-Smith applied for permission and started trials of an alternative therapy “Transfer Factor”, that was to be produced by “Immunospecifics Biotechnologies Ltd” on child 10, also deemed;

“abuse of [Wakefield’s] position of trust as a medical practitioner”

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text and quotation; (DeeTee, 2010).

The basis for Wakefield’s “Transfer Factor” treatment can be found in the work of Dr. Herman H Fundenberg (author of “Dialysable lymphocyte extract (DlyE) in infantile onset autism: A pilot study.”, published in discontinued fringe journal “Biotherapy”(Fundenberg, 1996)) a discredited and indefinitely suspended American doctor, who has admitted to treating patience at home with his own bone marrow. Fundenberg not only provide the basis research for “Transfer Factor”, he is cited as co-inventor on the filed patents (Deer, 2004).

Dr. Wakefield’s involvement in the MMR Controversy did not go unnoticed and in 2001 the Telegraph ran “Anti-MMR doctor is forced out”, reporting that he was asked to leave his post at the London Free Hospital; he cited unpopular research results as reasoning. Since then Dr. Wakefield has worked for the “International Child Development Resource Center” in connection with a Christian ministry called the “Good News Doctor Foundation”. He maintains that his results are accurate (BBC, 2010). As a consequence of the General Medical Council’s findings Dr Wakefield has been found guilty of misconduct and could be struck off as a result (Rose, 2010).

References:

• Guardian. (2008). Timeline: MMR controversy. Available: http://www.guardian.co.uk/society/2008/dec/02/health-medicalresearch. Last accessed 15 Feb 2010.
• General Medicine Community. (2009). Imposing Measles Epidemic Due to MMR Controversy. Available: http://stanford.wellsphere.com/general-medicine-article/imposing-measles-epidemic-due-to-mmr-controversy/603680. Last accessed 15 Feb 2010.
• Smith, J. (2004). The Real MMR Conspiracy. Available: http://www.independent.co.uk/opinion/commentators/joan-smith/the-real-mmr-conspiracy-545872.html. Last accessed 16 Feb 2010.
• Goldacre, B. (2008). The Media’s MMR Hoax.Available: http://www.badscience.net/2008/08/the-medias-mmr-hoax/. Last accessed 16 Feb 2010.
• BBC. (2003). Parents ‘misled’ by media over MMR. Available: http://news.bbc.co.uk/1/hi/wales/north_west/3038607.stm. Last accessed 16 Feb 2010.
• Chen, R & DeStefano, F. (1998). Vaccine adverse events: causal or coincidental?. The Lancet. 351, 611-612.
• Thornton, J. (2003). MMR jab ‘new autism link’. Available: http://www.thesun.co.uk/sol/homepage/news/article78818.ece. Last accessed 17 Feb 2010
• Adams, S. (2007). New fear over MMR link with rising autism. Available: http://www.telegraph.co.uk/news/uknews/1556883/New-fear-over-MMR-link-with-rising-autism.html. Last accessed 17 Feb 2010.
• Wakefield et al. (1998). Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet. 351 (1), 639-641.
• unknown. (2004). The Single Injections, and Dr. Wakefield’s Lack of Ethics. Available: http://www.fatherslobby.com/vaccinations/single_injections.html. Last accessed 17 Feb 2010.
• Boseley, S. (2010). Andrew Wakefield found ‘irresponsible’ by GMC over vaccine scare. Available: http://www.guardian.co.uk/society/2010/jan/28/andrew-wakefield-mmr-vaccine. Last accessed 17 Feb 2010.
• “DeeTee”. (2010). The GMC on Wakefield. Available: http://layscience.net/node/924. Last accessed 17 Feb 2010
• Fudenberg HH.(1996). Dialysable lymphocyte extract (DLyE) in infantile onset autism: a pilot study. Biotherapy 1996; 9: 13-17.
• Deer, B. (2004). Royal Free’s autism pill partner, Herman Hugh Fudenberg, wasn’t fit to prescribe. Available: http://briandeer.com/wakefield/hugh-fudenberg.htm. Last accessed 17 Feb 2010.
• General Medical Council. (2010). Fitness to practice panel hearing: 28 January 2010. Available: http://www.gmc-uk.org/static/documents/content/Wakefield__Smith_Murch.pdf Last Accessed 17 Feb 2010.
• Rose, D. (2010). Fall of Andrew Wakefield, ‘dishonest’ doctor who started MMR scare. Available: http://www.timesonline.co.uk/tol/life_and_style/health/article7006525.ece. Last accessed 17 Feb 2010.
• Fraser, L. (2001). Anti-MMR doctor is forced out. Available: http://www.telegraph.co.uk/news/uknews/1364080/Anti-MMR-doctor-is-forced-out.html. Last accessed 17 Feb 2010.
• BBC. (2010). Profile: Dr Andrew Wakefield. Available: http://news.bbc.co.uk/1/hi/3513365.stm. Last accessed 18 Feb 2010.
• O’Neill, B. (2006). The media’s MMR shame. Available: http://www.guardian.co.uk/commentisfree/2006/jun/16/whenjournalismkills. Last accessed 18 Feb 2010.