Human experimentation and ethics at Essendon Football Club

The news that the AFL has charged James Hird, and other members of the Essendon Football Club's management staff (including the club doctor, Bruce Reid) with bringing the sport into disrepute should surprise no-one.

Despite Hird's protestations, this was always the most likely outcome. Essendon captain Jobe Watson's revelations that he had been injected with the banned substance AOD-9064 in unprecedented quantities couldn't have been overlooked.

And the equally concerning claim that some sort of a sports science experiment had been conducted at Essendon was too plausible to be ignored. Whether we will ever know the full details or not, it's clear that something went badly wrong.

When the AFL sits down to consider the extent to which Essendon officials brought the game into disrepute, I hope they will consider the wider ethical implications of what has occurred.

In many regards, the issue of whether the Essendon players received a boost from the program is irrelevant. The reality is we don't know whether AOD-9064, thymosin beta-4 or CJC-1295 enhances performance.

The chances are that they don't work, or if they do, we don't know whether it's purely down to the placebo effect. But that's not the point.

Those who prescribed the drug and those who condoned its use neither had evidence for its safety nor its efficacy. The clinical trials of AOD-9064 only established that it was an inefficient anti-obesity drug. And that was within bounds that appear to have been fantastically exceeded in the Essendon program.

The bottom line is that due to a lack of evidence, no-one could be sure whether it was safe to administer AOD-9064 in large quantities to a group of fit young footballers. Neither could anyone predict the outcome.

To understand just how serious the Essendon case is, it helps to know something about the evolution of medical ethics over the last 150 years.

A short history of medical ethics

Once upon a time, medical ethics mainly consisted of a code that regulated the behaviour of medical practitioners towards each other. And it insisted on the significance of the Hippocratic Oath to place patients first.

This held right of way into the 20th century – doctor's were supposed to treat each other with respect, not to steal each other's patients, or criticise other doctors' diagnoses or treatments; they also promised to treat their patients as best as they could.

But the Second World War and its aftermath changed all that. One of the many Nazi atrocities that came to light during the Nuremberg trials was that of horrific human experimentation undertaken by a number of doctors.

During their trial, the defendants argued that they broke no laws when conducting these experiments. The defence was rejected by the Nuremberg judges.

In handing down their sentence in 1947, the judges put forward a code they believed should guide human experimentation. This was later enshrined and extended in the World Medical Association's Declaration of Helsinki (1964).

The key elements of Nuremberg and Helsinki were an insistence on the welfare of the patient and the absolute necessity of informed consent.

The Helsinki Declaration has gone through several revisions, but recalling the words of the first article of the Nuremberg Code should put the Essendon case into perspective:

The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion.

Does it apply?

Make no mistake, this was a group of vulnerable young men, no matter how strong or tough. They were immersed in a culture that places loyalty to the club at a premium, coached and mentored by one of the club's greatest legends, and overseen by a highly respected doctor.

It's not too strong to suggest that their freedom of choice was curtailed, or that subtle and not-so-subtle forms of fraud, deceit and duress were part-and-parcel of the administration of the program.

Over time, the Helsinki Declaration's iterations paid more attention to experimental design and research protocols. This is hardly suprising given the many scandals that occurred around the testing and introduction of new drugs in the post-war period.

Between 1959 and 1961, for example, contaminated polio vaccine was tested on babies at Victorian orphanages. And the thalidomide disaster in the early 1960s was one of the many instances that catalysed the introduction of new protocols insisting on ethical conduct in the design and implementation of clinical trials.

We know that the pharmaceutical industry has often rorted the system. But to run a clinical trial and put it through the wringer of regulatory approval involves adherence to detailed protocols insisting on informed consent and the protection of participants.

As far as we know, there was no ethical clearance for what occurred at Essendon. Nor was there anything other than a purely speculative hypothesis about what a failed anti-obesity drug might do to enhance performance.

Ethically, this is a failure of governance on every level. It cuts against the gains that were made by the introduction of the Nuremberg Code and the successive revisions of the Helsinki Declaration – gains that were won at the cost of human lives and human rights.

It's plausible that affected Essendon players might argue that their human rights have been contravened by this tawdry "experiment". And it would be fitting for this to be recognised and no penalties attached to their part in the affair.

The case of those who oversaw or condoned the administration of the "supplements" program is altogether different. Here ignorance is no defence and, unless the AFL acts accordingly, they too will be party to the abuse.

James Bradley, Lecturer in History of Medicine/Life Science, University of Melbourne

This article is republished from The Conversation under a Creative Commons license. Read the original article.