Scientific Education and Ethics for Medical Research

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.

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 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.

The Declaration of Helsinki Principles

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, 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 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.                        

Procedures Followed by Wakefield

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 needed to be adequate treatment and compensation for subjects that have been harmed from participating in the test.                            

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.

References

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/.