Double arm transplant: innovation or research?
This July, in Munich, the world’s first double arm transplant was successfully carried out on a Karl Merk, a farmer who lost both arms six years ago in a work related accident. While it’s clear that the patient is making excellent progress three months later , it does raise some pretty compelling issues around what constitutes “research” versus “innovation”.
Transplant, as a surgical procedure, is no longer an innovation. The first kidney transplant was carried out in 1954 and the first heart was transplanted in 1967. So that makes transplant, as a surgical procedure, a pretty commonplace approach to a number of diseases and conditions.
But in even the most commonplace surgeries, innovations have to happen. Why? Well, first and foremost, they have to happen in order to further science, save more lives and make surgery easier, shorter and more efficient. However the burning issue is not why innovations have to happen but how they happen. Often, innovative approaches to common surgical procedures happen “on the fly” in the operating room, out of urgent need. Surgical teams have to make “on the spot” decisions if someone’s anatomy is not as advertised, for example, or someone’s physiology simply will not work with the planned surgical procedure. At times like this, there might be time to leave the operating room, approach a waiting family and get a quick consent from the designated substitute decision maker or proxy to change the procedure. In an emergency situation, however, sometimes innovations are the only way to save someone’s life quickly and a new approach to an old problem is carried out, hopefully letting the patient know later on what went on while they were on the operating room table. Key life saving surgical procedures have been developed this way – as a “one off” at first, then afterwards, developed as a research protocol, studied and evaluated through a formal clinical trial.
Obviously, the double arm transplant in Munich was not an “on the fly” innovation – it was, it seems, a well planned and carefully executed surgical procedure that likely, underwent peer and ethics review. (Note that there is a standard treatment for tragic loss of limbs – the fitting of working prostheses – a treatment that is not without its problems, challenges and ongoing discomfort for patients). But it’s important to realize that while the lines between innovation and standard treatment are quite clear, the lines dividing innovation and research are less well delineated and often involve significant risk of harm alongside yes, great potential for benefit. In Mr. Merk’s case, two arms are definitely better than none. So the risk of having two non-prosthetic, fully human arms attached and then undergoing months of physiotherapy and years of anti-rejection therapy will likely be worth the potential benefit. However, it should be very clear to everyone, including and hopefully most of all, Karl Merk, that this innovative approach is still “research”.