THE BLOG

Paolo Macchiarini: A Surgeon's Downfall - Could it Happen Here?

15/11/2016 15:27

The infamous case of Paolo Macchiarini has been making headlines around the world as the investigation continues into how one of the world's most respected 'super-surgeons' was allowed to begin an experimental, untested treatment that led to the deaths of seven of the nine people placed at risk.

The full details of the case are widely available, but in summary; Paolo Macchiarini is one of the world's most famous surgeons, who previously worked at the Karolinska Institute in Sweden, the august body whose professors choose the recipient of the Nobel Prize for medicine each year.

Macchiarini was intrinsic in the development and introduction of a new and experimental treatment to use synthetic organs when replacing a patient's trachea (or windpipe). The treatment promised to save lives of those having to wait for a donor organ before a transplant could be carried out.

It also promised to set a precedent for other transplants, establishing a method by which organs could be manufactured rather than harvested from donors - a breakthrough that would revolutionise treatment for a wide range of conditions.

However, five years later, the reputation of both Macchiarini and his former employers is in tatters, with revelations emerging that the vital animal and scientific testing stages were skipped; negative reactions to the treatment ignored; and failures to seek necessary ethical approvals - all safeguards that would have saved lives.

However, the dilemma at the heart of this case is ever-present within medical treatment.

In his defence, Macchiarini explained, "We had a human being that we wanted to save." He also asked, "And in these circumstances what would you do? Do you just leave him dying at that young age? I don't think it's correct."

This is a grey area - where does experimental research end and the medical innovation to save a life begin. Most of us might agree to the longest of long shots if we had no alternative.

This dilemma is at the heart of proposed legislation in the UK - the Medical Treatments (Innovation) Bill. The proposal, which (according to reports) has Government backing, plans to create a national database of seriously ill patients willing to volunteer for experimental treatment.

The proposals stop short of protecting such treatment from clinical negligence litigation - indicating that doctors won't be given 'carte blanche' - but clearly it opens the door for the normal safeguards to be watered down in return for speeding up the path to bringing experimental treatments into use.

Despite the potential benefits of such an approach, Macchiarini's example should give us serious pause for thought. A concern shared by many observers. For example, the previous incarnation of this Bill was vetoed by the Liberal Democrats in the last days of the coalition Government before being resurrected by Conservative backbencher Chris Heaton-Harris MP.

The new legislation has the potential to seriously speed up the path for new drugs to reach the market. We shouldn't underestimate that this also has the potential to make serious money for those involved in research and development.

So how do we strike the right balance?

Firstly, we need to ensure that any treatments offered through such a system have passed through the rigorous legal, medical and ethical checks that ensure risks are recognised and managed. There's a clear distinction between a risk worth taking and turning ill and desperate patients into human guinea pigs.

We also need to establish a means to gain genuine, informed consent from patients and families. If offered experimental treatment, which by its very nature carries increased risk (some of which may be unknown), how can they realistically weigh up the pros and cons to give 'informed consent.'

A very significant burden will be placed on medical professionals to help guide patients through this process, helping them to see past their immediate fear and pain while a potential 'miracle cure' is dangled in front of them.

We must also ensure that medical professionals do not get lost in the desire for innovation and the opportunity to write their names into medical history. Many observers commenting on Macchiarini's case would suggest it was his human flaws that were as much to blame as a breakdown in correct procedure.

In the UK we have an excellent system of safeguards - the MHRA, stringent ethical reviews, specific legislation and a very proactive GMC. We shouldn't simply surrender these without question, driven by the very emotive cases medical professionals see every day.

It's an issue we at Fletchers will be watching carefully, putting the case for patient protection to be given equal weight to our rights as patients to decide our own risks.

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