In the years following FDA approval of direct-to-consumer, genetic-health-risk/DTCGHR testing, millions of people in the US have sent their DNA to companies to receive personal genome health risk information without physician or other learned medical professional involvement. In Personal Genome Medicine, Michael J. Malinowski examines the ethical, legal, and social implications of this development. Drawing from the past and present of medicine in the US, Malinowski applies law, policy, public and private sector practices, and governing norms to analyze the commercial personal genome sequencing and testing sectors and to assess their impact on the future of US medicine. Written in relatable and accessible language, the book also proposes regulatory reforms for government and medical professionals that will enable technological advancements while maintaining personal and public health standards.

While great emergencies are fortunately rare and certainly devastating, the upside is that they are often accelerators of progress. Wars, pandemics, and emergencies have been catalysts for medical innovation out of necessity - a desperate attempt to compensate for the circumstances. They bend the trajectory of discovery in new directions and increase the rate at which certain medical discoveries are made. Chapter 16 is thus about how wars, outbreaks, and other emergencies influence the rate and direction of medical progress. It explores how both World Wars, the pandemic of 1918, and COVID-19 have altered the trajectory of discovery.

The contagiousness of childbed fever was first recognised by Alexander Gordon in Aberdeen in 1795. Epidemics occurred in cities, rural communities and lying-in hospitals. In the USA Oliver Wendell Holmes caused uproar by saying doctors were carriers of disease. In 1848 Semmelweis reduced the death rate in Vienna’s maternity hospital by introducing handwashing but was not recognised until later. In the 1870s panic took hold in England. Midwives were charged with homicide and the hospital death rate in London was 2.6%. In Europe Billroth described the streptococcus and Pasteur showed that it caused puerperal sepsis. In Britain Listerian asepsis transformed surgery and reduced the death rate in lying-in hospitals. In the 1930s Colebrook worked on aseptic maternity practice. In Germany Domagk discovered prontosil and in 1936 Colebrook demonstrated its life-saving effects. Fleming discovered penicillin and Florey and Chain turned it into an antibiotic. Maternal mortality fell rapidly. By 1982-4 antibiotics had abolished deaths from puerperal sepsis but by 2006-8 sepsis was again the leading cause of Direct death and the Reports emphasised the need for constant vigilance.

A 45-year-old presents for a preoperative visit. She reports regular menses that have become increasingly heavy in the past year and have not improved with hormonal management. Three weeks ago, she received a transfusion in the emergency department where imaging was notable for uterine fibroids. She received counseling on treatment options and desires hysterectomy. Her history is remarkable for two full-term vaginal deliveries. She has no history of abnormal cervical cytology or sexually transmitted diseases. Her past medical history is significant for exercise-induced asthma and surgical history for tonsillectomy. She is currently taking combined oral contraceptives, multivitamins, iron, and calcium with vitamin D. She is a non-smoker, does not drink alcohol, and is sexually active with one female partner. She reports a penicillin allergy characterized by the development of hives during prior treatment for a urinary tract infection 10 years ago.

First do no harm’ is a fine principle; however, most medicines worth using have side effects, so it’s important that the prescriber can assess the risk/benefit ratio. This chapter provides examples of good advice (e.g. not to use NSAIDs in renal or liver impairment), overly cautious advice that may be flouted (e.g. cephalosporins in pencillin allergic patients) and advice that may appear overly cautious but should still be followed as there is a safer alternative (e.g.metformin in renal failure).

The Spanish patent system in the twentieth century has been defined by the incorporation of technologies and regulations. Patents have been intermediaries, and their regulation has been subject to complaints, some of which came from abroad. To analyse this reality, I propose two case studies that suggest different patent cultures, subject to specific times and places. The first case, the arrival in Spain of the first North American patents to protect production of penicillins, shows the mediation role patents played. Patents connected practices, languages, and interests from different Spanish and North American professional communities – clinical, industrial, and political – at the end of the 1940s and beginning of the 1950s. The second case, the launch on the market of a Spanish patent for a DNA polymerase, product of research done in a Spanish laboratory and patented in the USA in 1988, shows rather local regulations and the limits on international harmonization. The political, social, and economic changes that protection systems demand differ from one place to another, and do not always coincide with voices calling for harmonization.