Professionalism/Andrew Wakefield and the MMR Vaccine

Background
Andrew Wakefield is a former surgeon and medical researcher at the Royal Free hospital in London, England. In 1998, he published a highly controversial paper in The Lancet that suggested further research into a possible connection between the mumps, rubella, measles (MMR) vaccine and autism. In an effort to temper a potentially visceral public response to such a controversial claim, the Royal Free held a press conference in February with a balanced panel of proponents and skeptics of the research results. This panel of experts included Andrew Wakefield himself, who took the opportunity at the lectern to proclaim the MMR vaccine unsafe for children, far surpassing the conclusions of the paper. He urged parents to vaccinate their children with single-shot vaccine alternatives to MMR, effectively setting off what would later be known as the MMR vaccine controversy.

For years after his 1998 publication Wakefield fiercely defended his research from skeptics, and his reputation as a leader in the fight against "Big Pharma" grew. However, in 2004 information began to surface regarding conflicts of interest and fraudulent research practices in relation to Wakefield's original 1998 paper. These findings led to deeper investigation that culminated in the revocation of Wakefield's UK medical license after the General Medical Council's longest "Fitness to Practise" trial in its history. Additionally, The Lancet announced its complete retraction of Wakefield's 1998 paper. All but two of Wakefield's co-authors also retracted their association with the paper in 2004.

Wakefield himself never changed his stance against the MMR vaccine, and to this day he maintains a large following among members of the anti-vaccine movement.

Consequences of the MMR Vaccine Controversy
The introduction of the MMR vaccine in the UK in 1988 was extremely successful, changing measles from a common and extremely infectious disease affecting up to 500,000 people each year to something contained and rarely seen. Between November 2012 and July 2013, however, 1219 cases of measles were documented in the Swansea area of the UK. This epidemic was blamed on the extremely low vaccination rates in the area; between 1995 and 2003 the uptake of the MMR vaccine in Swansea dropped from 95 percent, the requirement for herd immunity against measles, to just 67.5 percent. This decline in the acceptance of the MMR vaccine is arguably due in part to the long-running anti-vaccination movement and Wakefield's fraudulent denouncement of the vaccine in 1998.

Measles, mumps, and rubella and may resurface in the future as Wakefield continues his anti-MMR stance.

Participants
In order to more fully examine the ethical structures involved, an analysis of each participant and his or her respective role is necessary. The major players in the controversy are listed below. Excluded is Wakefield, who is profiled above.

Brian Deer
Brian Deer is an investigative journalist for The Sunday Times of London. His investigations, primarily in the field of medicine, have won him acclaim. One judge at the 1999 British Press Awards, where Deer was recognized as the Specialist Reporter of the Year, commented that Deer was probably "the only journalist in Britain that polices the drug companies."

Deer has been credited with bringing the Andrew Wakefield scandal to light through his meticulous work. His investigation began with a routine assignment at The Times in late 2003 and expanded to a full-fledged investigation after evidence of fraud came to light. Deer interviewed parents of children discussed in the Lancet paper, reviewed medical histories, and examined Wakefield’s funding sources to construct a full picture of Wakefield’s work. In February 2004, he published the first in a series of articles exposing Wakefield’s scientific malfeasance. This article, along with subsequent revelations by Deer, led to the retraction of Wakefield's co-authors. His investigative work in the Wakefield case continued for seven years and was a major contributing factor to Wakefield’s loss of medical license.

A 2004 libel suit by Wakefield presented an obstacle to Deer’s investigation, but it also allowed Deer to access confidential medical records as a part of court proceedings. The evidence that he found within strengthened his case against Wakefield, who soon dropped the libel case.

Deer received heavy criticism for his investigation of Wakefield. Many people viewed Wakefield as a hero for his anti-vaccine work and questioned Deer’s motives. Keith Olbermann listed Deer as one of his “Worst People of the Week” in a 2009 show, Wakefield himself publicly attacked Deer, calling him a “hitman” in a 2011 interview, and many independent websites branded him as a liar.

Deer’s perseverance paid off with an endorsement of his investigation by the British Medical Journal and a British Media Award for Outstanding Journalism in 2011.

Richard Horton
Richard Horton has served as the editor of The Lancet since 1995. As editor, he was ultimately responsible for the publication of Wakefield's 1998 paper. His response to ethical concerns surrounding Wakefield's work has been criticized. In February 2004, Horton was briefed about the major ethical violations by Wakefield. Rather than independently investigating the claims, Horton took the word of Wakefield and his two primary co-authors and cleared their names. He publicly stated that he did "...not judge that there was any intention to conceal information or deceive editors, reviewers, or readers about the ethical justification for this work and the nature of patient referral." However, as the investigation by Brian Deer and the GMC proceeded, he changed his view: "It was utterly clear, without any ambiguity at all, that the statements in the paper were utterly false."

Richard Barr
From 1973-1998, Richard Barr was a solicitor for Dawbarns Solicitors in Norfolk (now Fraser Dawbarns Solicitors LLP). A self-proclaimed specialist in clinical negligence, he heavily pursued the link between MMR and autism. This passion brought him to a parent-led organization called Justice, Awareness, and Basic Support (JABS). JABS became a voice for parents who believed that their children had contracted autism via MMR and, in addition to Barr, also boasted the membership of Andrew Wakefield in its early years. Barr used this organization to approach Wakefield about potential research on the issue, offering £150/hour plus expenses to pursue evidence for this case in February 1996. This external payment of Wakefield was heavily scrutinized as a conflict of interest in later years, implicating Barr as a co-conspirator. When questioned, Richard Horton denied knowledge of the involvement of Barr, yet JABS produced documents in 2008 suggesting that the account was made known to not only Horton but others on the Lancet staff. This revelation raises high-level questions about the ethics of pre-approved "conflicts of interest."

Arie Zuckerman
At the time of the Wakefield experiments, Arie Zuckerman had transcended his role in virology at the Royal Free to become the Dean of the Medical School. He was present at the first press conference with Wakefield and immediately countered his claims, asking the media to avoid tarnishing the reputation of MMR. Zuckerman also began a series of internal memos expressing concern over Wakefield's study and ultimately confronted Wakefield's co-author Dr. John Walker-Smith with the financial conflict of interest manifest in Richard Barr's contributions.

Brent Taylor
A Professor of Community Child Health at the Royal Free, Brent Taylor was contacted several times by Zuckerman. This correspondence examined the ethical qualms Zuckerman had regarding the ethics of Wakefield's experiments, particularly their impacts on the children involved in the study. Taylor expressed concern to Zuckerman in internal memos but also made the scientific community aware of his concerns with his first-authored June 1999 publication of "Autism and measles, mumps, and rubella vaccine: no epidemiological evidence for a causal association" in The Lancet. This report detailed a 498-case study carried out by Taylor and six other researchers which concluded "Our analyses do not support a causal association between MMR vaccine and autism. If such an association occurs, it is so rare that it could not be identified in this large regional sample." Wakefield publicly condemned this study, saying that Taylor and his team "ignored the rules" and were "inappropriately didactic in their conclusions, despite the weakness of their method and the contradictions in their data."

Wakefield's Co-authors
The 1998 Lancet article had thirteen total authors. All were associated with various subdivisions of the Royal Free, including Pediatric Gastroenterology, Child and Adolescent Psychiatry, Neurology, and Radiology. While all co-authors supported the 1998 paper's intentionally vague claim that "chronic enterocolitis in children...may be related to neuropsychiatric dysfunction" and that "further investigations are needed to examine this syndrome and its possible relation to this vaccine," they did not support Wakefield's subsequent claims that MMR was the direct cause, particularly at the Royal Free press conference immediately before publication. In 2004, 10 of the 12 co-authors (all but John Linnell and Peter Harvey) wrote "Retraction of an interpretation," which was also published in The Lancet. Wakefield, Linnell, and Harvey countered with "MMR - responding to retraction" one month later.

Conclusions
Upon analysis of the case presented here, the authors have drawn the following conclusions relating to professional ethics. Because debate is still ongoing and Wakefield's supporters still maintain his integrity, new evidence should spur further discussion about these contentions.

Andrew Wakefield’s fraudulent research led to the MMR vaccine scare, and the failures of the organizations and people around him allowed his work to have such a wide impact. His co-authors had an opportunity to review his work, but they failed to question his research methods. In failing to do so, they fell victim to the bystander effect. The Lancet also failed in its duty to promote scientific integrity. Even after its senior management was briefed about Wakefield’s unethical research, they chose to protect Wakefield rather than investigate the claims. Editor Horton showed a lack of integrity by publicly promoting research integrity while privately sweeping ethics allegations against his journal under the rug.

Two people in this case demonstrated professionalism. Taylor acted professionally by alerting his superiors at the Royal Free Hospital about the ethics violations that he suspected in Wakefield’s work. He then used his skill as a researcher to refute Wakefield’s claims from a scientific perspective. Brian Deer also showed qualities of a professional by pursuing his journalistic work with determination. His meticulous research revealed financial conflicts of interest and outright fraud that had gone unnoticed for six years, and he weathered public criticism and lawsuits to persevere with his investigation. Taylor and Deer used their respective skills to expose the truth, and for that reason they exemplify professionalism.