In a 1998 publication in a well-respected British medical journal, “The Lancet”, Dr. Andrew Wakefield drew attention to a possible link between the combined measles, mumps, and rubella vaccine with colitis and autism spectrum disorders. The article later to be found fraudulent and was retracted in its entirety in 2002 created news stories of growing opposition to the combined immunization.
In reaction to this coverage, vaccination rates dropped in the United Kingdom and an increase of measles and mumps resulted with permanent injury and fatalities (Pepys, 2007) Through the work of investigative ournalist of the Sunday Times, Brian Deer, multiple ethical violations promulgated by Andrew Wakefield have been uncovered including undisclosed conflict of interest and manipulating evidence. In May of 2010 the General Medical Council in the UK found Wakefield guilty of serious professional misconduct and band him from practicing medicine in the UK.
Multiple studies involving a correlation between immunizations and autism have found no link. Summations of the studies conducted by the Cochrane Library in 2012 involving 14,700,000 children also established no link (Demicheli, 2012). The actions of Andrew Wakefield and the decisions by the Royal Free Hospital that held a press conference that supported the original paper along with the news organizations that provided coverage offer a learning opportunity of how unethical behavior can have grave consequences for society.
This case prompted reviews on the need for increased vigilance of adequate ethical review committees and oversight within the medical field, scientific publication, and news reporting. As Flaherty summed up in his review, “this was the most damaging medical hoax of the last 100 years”. Flaherty, 2011) At the center of the MMR controversy is the article published by Andrew Wakefield and 12 coauthors that warned of a possible link between the triple vaccine and colitis and autism spectrum disorder. This article was based on 12 children referred to the Royal Free Hospital.
Pointing to symptoms occurring right after the MMR immunization, 8 parents or physicians linked the autism to the combined shot. Biopsy findings were used by Wakefield to support his concern. A press conference at the Royal Free Hospital in London lent support to the paper. A video ews release to broadcasters prior to the press conference called for stopping the combined vaccination in favor of a single shot for each. Even Wakefield’s mentor, Roy Pounder stated “In hindsight it may be a better solution to give the vaccinations separately,. When the vaccinations were given individually there was no problem. (BBC News 2007).
These statements had no bases in scientific evidence. Ethical missteps by several stakeholders led to the unfortunate decrease in immunizations and to a mumps epidemic in UK by 2005 with over 5000 cases reported in the first month. In order to evaluate these missteps a look at the four fundamental questions Dr. Paine proposed in his article “Ethics: A Basic Framework” will be used.
To pursue an ethical mindset our primary character, Andrew Wakefield would be asking the question, “Is the action consistent with the actor’s basic duty? and the converse, “Does it respect the rights and other legitimate claims of the affected parties? ” (Paine, 2007) The investigative reporting by Brian Deer showed Wakefield’s lack of duty to both the children of the study, reporters, the hospital and the general population. It had been iscovered that Wakefield did not inform the patients of the use of the biopsy findings which is a clear breach of a researcher’s duty and the patients right to be informed.
The journal editors of The Lancet, the coauthors and the public who heard the story were never informed of a conflict of interest that was present when, “Wakefield had received ? 5,000 from Legal Aid Board solicitors seeking evidence to use against vaccine manufacturers, that several of the parents quoted as saying that MMR had damaged their children were also litigants. “(Wikipedia). Additional revelations that Wakefield had pplied for patents on rival vaccines to the MMR and would have benefited greatly if these new vaccines were to be shown safer. (BBC doc. 2004) was not made known.
The third fundamental question that Dr. Paine proposes is, “Does it reflect best practices? As a researcher and doctor, Wakefield certainly knew the imperatives of statistical significance in drawing conclusions and having valid sample populations in order to make correlations. To use the observations of these few patients and the minimal biopsy findings as a basis to give a press conference and publish a paper would work against such est practices. His additional publications that came out as reviews in 2001, Wakefield made claims that biopsy’s had shown measles virus had been found in tissue samples of children with autism.
This further added fuel to the anti-immunization sentiment and reduced immunizations given and clearly violated best practice mentality. A final question to be asked is, “Is it compatible with the actor’s own deeply held commitments? ” At some level the oath of the doctor to do what is best for the patient upon reflection should have prompted alternative choices given an ethical mindset. The cultural basis f the hospital he worked at could have influenced his choices, as even his mentor was complicit in not holding to commitments and best practices and other doctors rushed to a judgement of cause and effect with little evidence.
A bias toward protecting personal honor may be inherent in those that fail to be open to factual evidence and cannot find balance in weighing legitimate findings against previous perspectives. Their morality is skewed to protect themselves rather than that which may harm society. Had Wakefield tried to maintain objectivity early on with the three main tests as provided by Professor Paine in terms of visibility, generality, and legacy different choices may have happened and he may have broaden his viewpoint to consider collateral effects and impact on others.
Another stakeholder in this story is the Royal Free Hospital that allowed the press conference and press briefings. From our assigned reading, “Fostering an ethical organization from the bottom up and the outside in,” the lack of an ethical infrastructure, formal systems, informal norms, and a work climate associated with ethical decisions, provided an environment for ethical missteps to occur. If the hospital had a strong ethics review committee that had to be consulted on matters of public information, a balanced review of the facts may have prevented such a press conference from occurring.
As the organization that employed Dr. Wakefield with duties to its patients and the public it would benefit from procedures that would evaluate any publications of its member doctors and counter any claims that did not live up to best practices in the pursuit of offering the best health service to its patients. To the credit of some of the coauthors of the article that Wakefield nitially published, upon learning of the conflict of interest of the money that was contributed, they pulled their names from the publication. Such individuals displayed ethical behavior rooted in their personal values.
But on one level they acted as Mr. McCoy and the his climbing team in “The Parable of the Sadhu”. They did something that answered their internal moral compass but did not put themselves out on a limb or that would interrupt their own personal goal. Another choice they could have made was to be an internal check for the organization they worked or. They could have demanded evidence and clear scientific proof that was replicated to make sure the patients that they cared for and the information other doctors would use was based on best practices.
The question of how reflective the hospital was of the ethical concerns that this raised is in doubt. The fact that Dr Wakefield while a doctor at Royal Free Hospital additionally published reviews three and four years later based on the same evidence does not point to a system that monitors, investigates, and does root cause analysis of ethical failures. It as also discovered that “normal clinical histopathology results generated by the Royal Free Hospital were later changed in the medical school to abnormal results published in The Lancet” ( Deer, 2010).
Development of a culture that has strong informal practices and active participation of constituents down the line of the organization should be a goal of the hospital to build ethical decision making. To empower all staff to question an action that could have ethical consequences drives good practice in an organization. Another actor in this controversy was the organization behind the British medical journal The Lancet that published the article. The original article was partially retracted in 2004 and fully retracted in 2010 with the editor stating the journal had been deceived.
It seems the journal conveniently waited till Andrew Wakefield was disbarred as a physician till the retraction occurred. Similar to the hospital it did not have a strong ethical culture in place. It certainly was not fulfilling its duty to the readers that depended upon this respected journal to deliver valid perspectives or to challenge information that it previously published. Where was its rganization value system that did not question the statements of Wakefield based on the results of 12 patients?
A strong ethics review board that required verifiable data in order to approve publication of an article may have uprooted the falsified results before great harm had occurred in this case. An ethics committee that as Professor Paine puts it, “understanding key aspects of the action-its intended purpose its description, and its likely consequences-is thus an essential step in the analytic process. ” Random checking of stories for violations of ethical standards held by the journal would begin o move the organization to protect the rights of its readers and fulfill its duty of responsible publishing.
In a similar manner the media played a role as a stakeholder in giving the unethical practices of Wakefield and some of his colleague’s added impact. The ethical dilemma for media occurs when the pursuit of viewers and ratings conflict with providing fact based proper information that will serve the public good. Sensational stories that elicit strong emotions, such as the harm caused by drug makers on innocent people, and preying on the fear of harm to children, gain viewers. The careful weighing of where the information comes from and the validity behind it are not as colorful a story line.
In the coverage of Wakefield’s implications, it has been reported that the affair degenerated to, “science by press conference”. (Moore, 2006) The public was left with the impression that the basis for implicating the triple immunization to autism was a strong as the counter argument. In this regard it abdicated its duty as free press in seeking the truth in all matters to benefit and protect the republic from authoritative overstep and holding the actors it is reporting on to ethical standards society requires.
The remedies as were pointed to at the hospital and the journal, the media must also turn to. In addition the appointment of a strong Ombudsman to keep true to a commitment to the public for responsible reporting should be made if not present. It is ironic that once Wakefield had been disbarred, a poll stated that 62% of the people believed that the media did not conduct responsible reporting on health issues in the UK. Unethical behavior can have long term negative consequences for any business.
The stories and conduct of Andrew Wakefield and some colleagues eventually was addressed by the General Medical Council who is responsible for ethic violations and licensing of doctors in the UK. The resolution of the link between MMR vaccine and autism was not addressed by the Council. The GMC had determined that, “Wakefield was found to have acted dishonestly and irresponsibly and to have acted with callous disregard for the children involved in his study, conducting unnecessary and invasive tests”.
Boseley, 2010) In addition, “The panel found that the trial was improperly conducted without the approval of an independent ethics committee, and that Wakefield had multiple undeclared conflicts of interest”. (Rose, 2010) While the first meetings of the GMC concerning the affairs of Wakefield occurred in July of 2007, its ruling was not issued till January of 2010. It seems the wheels of justice turn slowly, with further harm to the greater good happening in the delay. Having an accelerated process to determine ethical violations would benefit all parties who had their rights negated.
In addition if not already in place I would recommend the appropriate governmental authorities that oversee the ethical standards of publications, the media, and hospitals should produce “Dear Colleague Letters” to address the expectations of ethical standards in those fields with advice on best practices, and current research that leads to the highest ethical standards. Reflection time for even the GMC to analyze its own ethical behavior would set the standard for all parties it oversees to adhere to this best practice.
The ethical lapse in the Link of Combined MMR vaccine to colitis and autism spectrum by Andrew Wakefield caused significant harm to countless children and families across the world. Building strong ethical stai and frameworks within organizations and within each individual builds the counter weight to a lapse in judgement. With a great framework of questions that guide our decisions, we not only are aware of the different ethical lenses we see the world but agree on standards that we all are beholden to for the benefit of society.