Medical Research Ethics and Wakefield's Controversy

This assignment provides an in-depth analysis of the ethical controversy surrounding Andrew Wakefield's medical research, specifically his 1998 study that falsely linked MMR vaccines to autism. The assignment highlights how Wakefield's actions were in direct contravention of the Helsinki Declaration, which emphasizes the importance of informed consent, non-maleficence (do no harm), and respect for persons. It also examines how Wakefield's research was plagued by methodological flaws, including the use of outdated and flawed diagnostic criteria. The assignment concludes that Wakefield's actions were a clear example of unethical medical practice and had serious consequences for public health. It is essential reading for students of medical ethics and researchers in the field.

Bio-Professional Andrew Wakefield
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Table of Contents
1.0 Introduction...........................................................................................................................3
2.0 Analysis.....................................................................................................................................3
3.0 Conclusion.................................................................................................................................7
4.0 Reference Lists..........................................................................................................................8
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1.0 Introduction
Andrew Jeremy Wakefield was a disgraced British medical researcher, who got struck off
UK medical register for his fraudulent paper in 1998. In his research paper he claimed that there
was a link between mumps, measles and rubella (MMR) vaccine with autism and bowel disease
(Brown 2012). After his publication of the research paper other researchers could not reproduce
Wakefield’s findings to establish link between MMR vaccine and autism. Wakefield was born in
the year 1957 to a family where his mother was general practioner and father a neurologist. He
went to become fellow of the Royal College of Surgeon after passing from King Edward’s
School in Bath and Imperial College School of Medicine. Wakefield with 12 other authors in
1998 wrote a paper regarding 12 children with autism. The paper was published in Lancet and
established that no casual connection was proven (Godlee 2011). He called for a press
conference where he asked hospitals to withdraw MMR vaccine until more research in the area
can be conducted. His misconducted for falsified report was criticized as ‘science by press
conference’. Various news channels including BBC stressed the fact that scare regarding MMR
vaccination had risen from the press conference. Following controversy, Wakefield had to resign
as because the research could not be established.
2.0 Analysis
The research paper published by Wakefield could not be established by other researchers
hence was deeply criticized. Reporter Brain Deer of Sunday Times criticized Wakefield’s
financial conflict of interest which remained to be undisclosed even when his co-authors
withdrew their interpretations (Deer 2011). Deer’s numerous findings formed the basis for
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inquiry against Wakefield and two other colleagues. His finding’s reflected that children with
autism were subjected to unnecessary invasive medical processes as lumbar punctures and
colonoscopy without ethical approval. GMC tribunal with a five member body figured various
charges including four dishonesty and 12 times abusing developmentally challenged children.
The panel established that Wakefield had failed his duties as a responsible consultant, acting
against interest patients.
The Declaration of Helsinki was developed by the World Medical Association (WMA)
based on certain ethical principles for the purpose of conducting medical research on human
subjects or data or materials. According to WMA Declaration of Helsinki – Ethical Principles for
Medical Research involving Human Subjects, there are a set of research ethics procedures
(Flaherty 2011). The several declaration made has been accepted by several countries of the
world providing a guiding statement of ethical principles involving human data and material. The
principle addressed in the Declaration is for physicians primarily. Wakefield’s research needed
to follow these principles as its procedures involved human subjects.
As per the Declaration physicians are responsible for safeguarding and promoting well-
being and health of patients involved in medical research (Nicholson 2012). It is assumed for this
purpose a physician will dedicate full knowledge and conscious in fulfillment of duty. This
general principle was not followed by Wakefield as he did not care for promoting health of
special children.
It is said that medical research is conducted with humans for analysing causes, effects,
developments, improvement, therapeutic and preventive interventions (Rao 2011). These
interventions has to be evaluated for understanding regarding their safety, efficiency,
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effectiveness, quality and accessibility. This clause of the declaration was also overridden by
Wakefield in the light that he made lumbar punches and colonoscopy on autism patients.
All medical research is conducted as per ethical standards for promotion and ensuring
respect for humans for the purpose of their rights and health (wma.net Retrieved on 28th
February 2018). None of the procedures followed by Wakefield suggests that he followed ethical
procedures and had intentions of protecting health or rights of his human subjects.
Wakefield had conducted his research without considering consent of the children or their
parents (Deer 2009). He ignored these principles as they were autistic children. However, as per
Declaration of Helsinki physicians are liable to protect integrity, life, health, dignity, privacy,
confidentiality and right to personal information with subjects involved in the research.
Physicians were also asked to consider legal, ethical and regulatory norms along with
standard of practice involving humans. This principle needs to be abided in their countries as
well as compliance has to be present as per international standards. None of the international or
national regulatory, legal and ethical requirements should be eliminated for protection of human
subjects as per the Declaration. Wakefield had failed to comply by any such standards whether
national in the UK or international in nature.
Apart from Sunday Times, Lancet also published Wakefield’s findings, which retracted
1998 publications of these findings. Lancet had found that elements of the research paper had
been falsified, as its Editor-in-chief Richard Horton commented that the paper had been cheated.
Following Lancet’s retraction, Wakefield was stopped from practicing medicine in the UK and
the Lancet was also barred from publishing medical reports in the UK (Eggertson 2010).
Following editorial section on fraud committed by Wakefield, Lancet established that the
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children in his resear ch did not suffer from inflammatory bowel disease. Based on Wakefield’s
findings of the MMR vaccine leading to autism, the usage of the vaccine declined greatly. This
led to emergence of previously controlled diseases, which was against the Declaration’s
principle, which aims at protecting health of humans. It was also established that Wakefield did
not obtain consent from his subjects or their parents prior to conducting his tests and research on
them.
It is said as per the Declaration that any type of Medical research has to be conducted to
minimize possible harm on the environment (Dyer 2010). In this contest it can be said that
keeping Wakefield’s research in mind various people stopped from using of MMR vaccines,
which led to outbreak of previously controlled diseases. This was possibly the biggest harm that
his publications or research could do to the population.
A physician conducting Medical research involving humans has to do so incorporating
scientific education and ethics with appropriate qualifications and training. While conducting any
type of research on patients or healthy volunteers, supervision of a qualified and competent
physician is necessary. Wakefield though a qualified medical professional did not follow any
type of ethical proceedings in his research. There are allegations against him that he had made
substantial profits during this venture.
In medical research, physicians needs to ensure that research is combined with medical
care of patients. This will be able to generate diagnostic, preventive and therapeutic value
amongst health of patients, who serve as research subjects. As per this principle Wakefield
needed to combine care along with his research, which was not followed by him. There also
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needed to be adequate treatment and compensation for subjects that have been harmed from
participating in the test.
3.0 Conclusion
It can be understood from the above analysis that Wakefield did not follow any ethical procedure
as per Helsinki Declaration. None of his procedures followed ethical procedure hence his
research could not be accepted. His proceedings were rejected by all ethical and medical bodies
and he was held liable for his conduct. Following such allegations, he had to resign from his
duties.
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4.0 Reference Lists
Brown, K.F., Long, S.J., Ramsay, M., Hudson, M.J., Green, J., Vincent, C.A., Kroll, J.S., Fraser,
G. and Sevdalis, N., 2012. UK parents’ decision-making about measles–mumps–rubella (MMR)
vaccine 10 years after the MMR-autism controversy: A qualitative analysis. Vaccine, 30(10),
pp.1855-1864.
Deer, B., 2009. MMR doctor fixed data on autism. Sunday Times.
Deer, B., 2011. How the vaccine crisis was meant to make money. Bmj, 342, p.c5258.
Dyer, C., 2010. Lancet retracts Wakefield's MMR paper. BMJ: British Medical Journal
(Online), 340.
Eggertson, L., 2010. Lancet retracts 12-year-old article linking autism to MMR vaccines.
Flaherty, D.K., 2011. The vaccine-autism connection: a public health crisis caused by unethical
medical practices and fraudulent science. Annals of Pharmacotherapy, 45(10), pp.1302-1304.
Godlee, F., Smith, J. and Marcovitch, H., 2011. Wakefield’s article linking MMR vaccine and
autism was fraudulent.
Rao, T.S. and Andrade, C., 2011. The MMR vaccine and autism: Sensation, refutation,
retraction, and fraud. Indian journal of psychiatry, 53(2), p.95.
Nicholson, M.S. and Leask, J., 2012. Lessons from an online debate about measles–mumps–
rubella (MMR) immunization. Vaccine, 30(25), pp.3806-3812.
wma.net Retrieved on 28th February 2018, 'WMA DECLARATION OF HELSINKI –
ETHICAL PRINCIPLES FOR MEDICAL RESEARCH INVOLVING HUMAN SUBJECTS',
https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-
research-involving-human-subjects/.
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