There are multiple aspects to the high-profile case of Dr. Paolo Macchiarini, who developed and implanted synthetic trachea in patients, many of whom subsequently died.
Dr. Paolo Macchiarini (1) was previously considered a pioneer in regenerative medicine using trachea implant seeded from patients’ stem cell for transplantation. He was a visiting professor at Karolinska Institute in Sweden from 2010. He is famous for his professional misconduct of unethically performing experimental surgeries on relatively healthy subjects. Most of the patients died eventually. He also worked at the Kazan Federal University in Russia after the medical incident. Regenerative medicine emphasizes the use of cells, genetics, devices and informatics technology. During the same period, the Former US President Barack Obama advocated the precision medicine in 2015. It is defined as an innovative approach that takes into account individual differences in people’s genes, environments, and lifestyles. It is a kind of medical treatment tailored made according to individual needs.
The main reason Dr. Macchiarini’s case drew worldwide attention is due to the fact that his research was unethical. The Nuremberg Code (2), which was developed after World War II in 1947, was based on the Nuremberg trials. Nazi doctors were convicted of the crimes for human experiments on concentration camp prisoners. It gives clear rules about what was legal and what was not when conducting human experiments. Although it has no legal force, it focuses on the human rights of the subjects. It requires prior animal study and avoidance of physical or mental injury. It must be carried out with informed consent, by qualified researchers, with favorable risk and benefit ratio, and free will of stopping to participate at anytime. There is no expectation of death or disabling condition during the research or experimentation. Clearly, Dr. Macchiarini’s experimentation was against the Code and it resulted in death in majority of the subjects. Regenerative medicine is a kind of innovative medicine that must be carried out in an ethical framework. In the UK, Innovate UK funds the development of regenerative medicine in 2015. It has a great potential in both scientific and commercial development. We can say Dr. Paolo Macchiarini’s surgeries are a kind of non-standard treatment and I supported that because every standard treatment comes from a non-standard stage. Even in the UK, we had the Saatchi Medical Innovation Bill in 2015. But we must respect human rights. We set up health research regulations and research ethics committee to investigate the risks and benefits of researches before it was carried out. We have a well-organized health care system to monitor whether a research or experimentation is ethical or not. As for the precision medicine that was advocated at the same period of time, it has leading role in the treatment of cancer and Imatinib is the best example in illustrating the treatment of Philadelphia-chromosome positive leukaemia. Innovate UK also plans to focus and fund the development of precision medicine in 2015.
In this incident, Dr. Paolo Macchiarini was charged because of his unethical experimentation on relatively healthy subjects. Obviously, his behavior was intolerant by the ethical committee of the relevant countries and this leads to the scandal and his investigation by the legal authority. This has bad influence on the development of regenerative medicine but this situation gradually improves with the support of other scientists. The development of precision medicine is relatively smooth and received support internationally.
Governance of innovative medicine is about setting purpose, goal, and objective. The purpose stands for the human intentionality (why are you doing it?). The goal stands for plan (what are you going to do?). The objective stands for the action (how are you going to do it?). In the case of Dr. Macchiarini, he has a good intention of pioneering in the field of regenerative medicine in treating patients with synthetic trachea. He carried out his plan by using stem cell coated synthetic trachea that is a relatively new in the field of regenerative medicine. The problem occurred in the aspect of his action. He carried out the experiment in relatively healthy patients and this leads to many deaths. From both the ethical aspect and the angle of governance, he fails to comply with the rules in innovative medicine.
Concerning the regulation of such kind of innovative medicine, we must first categorize which group does it belong to. According to WHO, medical devices (1) captures everything from simple artifacts, to more sophisticated things, and to complex equipment. Based on Article 1 of the Implantable Medical Device Directive (2007/47/EC), it is a medical device if it is for investigation, replacement or modification of the anatomy or of a physiological process. In this case of regenerative medicine, the stem cell coated synthetic trachea replaces the normal human anatomy of a trachea. So, it is classified as medical devices. In Europe, the lowest risk devices need to declare to the Competent Authority and more complex devices is handled by Notified Bodies that is responsible for the CE marks. According to these regulations, Dr. Macchiarini failed his experiments at its very early stage of development because most of his patients died. So, it does not even able to go through the ethical assessment not to mention about going into the real market. So, this discussion only serves to categorize its innovative technology but the actual regulations of the medical devices do not apply to his case.
1. Annie Sorbie (2017-2018), Governance of Innovative Medicine Seminar 4 Notes: Medicines, Devices & Therapies, University of Edinburgh, Scotland.
2. Graeme Laurie (2017-2018), Fundamental Issues in Medical Jurisprudence Seminar 5 Notes: Health Research Regulation, University of Edinburgh, Scotland.