CiRA　Reporter

With the coronavirus pandemic, you may have seen the term ‘unproven/unapproved’ more often in news reports about therapeutic drugs and vaccines. However, we may need to consider what exactly ‘unproven/unapproved’ treatment means.

In the Japanese context, unproven treatment means a treatment that is not covered by public health insurance. For example, some unproven treatments are provided within the national health system, such as evaluation treatments (advanced medical care, clinical trials, etc.), where the aim is ultimately to have the national insurance system cover them, whereas others are provided at the discretion of the physician outside the system. The latter involves a variety of cases, such as when a treatment approved for one disease is used for another disease, when a patient with a serious disease that has exhausted conventional treatment options tries a treatment that has never been provided before, and when a patient receives medical treatment at a clinic outside the public health system.

These treatments may, at first glance, give the impression of an advanced treatment. However, the safety and effectiveness of the treatments have not yet been proven scientifically, and there have arisen serious cases of patients developing health problems depending on how the treatments are administered and handled.

Although the fact of having unproven treatments in itself is not exactly a problem, as mentioned above, it is important to identify the background and reason that the treatment is unproven and the need for such a therapy. Before deciding whether to receive the unproven therapy, for instance, the results and side effects of the treatment and the availability of other treatment options should be examined. It is also essential to confirm the risks and benefits and scientific evidence of the treatment compared with other options, as well as the systems in place to deal with those risks.

In the case of treatments for previously unknown infectious diseases, such as COVID-19, and the development of new therapies, such as using iPS cells, the proposed treatments are initially unproven. When it comes to developing drugs that are urgently needed to save many lives or to establish future treatments for patients who have no other treatment opinions, it is necessary to calmly watch the process leading up to its approval. The current pandemic may have provided us with an opportunity to consider how we should face unproven treatments undergoing the process of development.

　Illustration by Mindy Takamiya