Will artificial intelligence widen the therapeutic gap between children and adults?

The impending rise of artificial intelligence(AI)-powered healthcare offers exciting hope for improved care and outcomes in children with serious illnesses.1 The historical precedent in healthcare,however,suggests that advancements in adult care do not necessarily result in proportional progress in pediatrics.This disparity was first noted in the mid-20th century when tragedies that involved drugs with well-studied and known adult safety profiles,such as sulfonamide elixir and thalidomide,resulted in harm to children due to limited pediatric clinical trial inclusion.2 As a result,legislation in 1962 required drug companies to include package labels that restricted or dissuaded the use of medications in children that were not properly studied in this population.2 Subsequently,physicians became reluctant to prescribe many medications,and pharmaceutical companies had little incentive to enroll children in trials as an unfavorable result could negatively impact sales in the adult market,and a successful outcome would only marginally increase the market pool.3 This lack of access led Dr.Harry Shirkey to describe children as"therapeutic orphans"in 1968.2 After more than half a century of legislation aimed at increasing pediatric representation in research and drug development(Figure 1),enrollment of children in clinical trials remains disproportionately low,4 with children included in as few as 12%of trials for diseases with a burden equal to,or greater in,the pediatric versus adult population.

Experiments that led to the first gene-edited babies: the ethical failings and the urgent need for better governance

The rapid developments of science and technology in China over recent decades, particularly in biomedical research, have brought forward serious challenges regarding ethical governance. Recently, Jian-kui HE, a Chinese scientist, claimed to have "created" the first gene-edited babies, designed to be naturally immune to the human immunodeficiency virus(HIV). The news immediately triggered widespread criticism, denouncement, and debate over the scientific and ethical legitimacy of HE’s genetic experiments. China’s guidelines and regulations have banned germline genome editing on human embryos for clinical use because of scientific and ethical concerns, in accordance with the international consensus. HE’s human experimentation has not only violated these Chinese regulations, but also breached other ethical and regulatory norms. These include questionable scientific value, unreasonable risk-benefit ratio, illegitimate ethics review, invalid informed consent, and regulatory misconduct. This series of ethical failings of HE and his team reveal the institutional failure of the current ethics governance system which largely depends on scientist’s self-regulation. The incident highlights the need for urgent improvement of ethics governance at all levels, the enforcement of technical and ethical guidelines, and the establishment of laws relating to such bioethical issues.

Improving the Level and Quality of Ethics Review in Chinese Medicine and Integrative Medicine

Three features of ethics review in Chinese medicine（CM） and integrative medicine（IM） were put forward in this paper. It is consistent with the principles of ethical review in Western medicine; it has to be compliant with the laws of CM and IM; emphasis should be laid on the review of clinical practice facts and experience. Three problems were pointed out. The characteristics of CM and IM are not distinctive enough, operation procedures need to be refined and effectiveness remains to be improved. Based on the mentioned above, seven measures were proposed to improve the level and quality of ethics review in CM and IM, including better brand awareness, considerable tolerance, treatment based on disease differentiation and syndrome differentiation, scientific review and toxicity and side effects of CM, perfection of the ethics review system, reasonable procedures of ethics review and more specialized ethics review workers.