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RAPS' Latest | 14 October 2016 | By Edward Tabor, MD
The following is an insightful review of a compilation of essays featuring new, somewhat obscure information about science, regulatory and healthcare products.
There can be no more delightful way to learn a few extra regulatory concepts than by reading a book written by Max Sherman. Eclectic Science and Regulatory Compliance: Stories for the Curious is Sherman's second book of essays on regulatory science. A few years ago, when I read his earlier volume of essays, I kept thinking, "I hope Max Sherman writes more of these," and now he has done so.
Each essay is fascinating; many of them start with a medical discovery and interpret the regulatory implications. For instance, an essay on the experimental use of fecal transplantation to treat pseudomembranous colitis provides a discussion of the issues FDA has had to address in order to regulate this bizarre therapy under an IND. Another essay on the drugs and devices used to treat George Washington's terminal illness makes one glad that FDA keeps such products off the market in the 21st century.
Many essays discuss recent medical discoveries that have captured Sherman's interest. Some discuss only regulatory topics, such as essays on the use of mathematics in regulatory science, quality control from an industry perspective, and the responsibility of regulatory professionals to get involved in teaching regulatory science.
The scientific topics clearly reflect Sherman's fascination, and he transmits this to the reader. He often writes, "I was amazed to find …" It is clear that he knows that we the readers also will be amazed and surprised. One example is his essay on the possible use of the python as an animal model for studying cardiac drugs – an ideal animal model in that it only needs to be fed twice a year and might provide a model to study hyperlipidemia. After a python swallows a large mammal (using its expandable, dislocatable jaw), a python's serum triglyceride levels can rise to 50 times normal, but with no excessive fat deposits in the vessels of the heart. Another article about treating bladder cancer by infusing BCG, a live tuberculosis vaccine, into the bladder, results in the organisms binding to cells on the bladder wall and inducing an immune response against the tumor cells. Sherman tells us that this was suggested as long ago as 1929 as a result of the observation that tuberculosis patients don't get cancer as often as healthy individuals do.
Some of the essays cover really new concepts in thinking. One of these examines "bioinspiration" the process of looking at functions of structures in plants or lower animals to find new principles for devices to meet human needs. Another examines the use of "mindfulness training" to reduce the occurrence of human errors, i.e. teaching the art of paying attention to avoid making mistakes in the hospital or in any of our human mental or physical tasks.
This is a great book for regulatory professionals who are interested in the intersection of regulation and science. It would also make a great gift to give to colleagues on special occasions.
Eclectic Science and Regulatory Compliance: Stories for the Curious contains 36 short, well-written articles packed with interesting facts. Topics include: the animal kingdom, pythons, ticks, octopuses and giraffes; the human senses of smell, vision and touch; featuring famed scientists as John Snow, Joseph Lister and Lewis Thomas. For more than a decade, Regulatory Focus readers have enjoyed Max Sherman's search for new and surprising facts. There are some "ah ha" moments and some laughs, as well. Unlike most RAPS publications, Eclectic Science is light reading and of interest to both scientists and the general population. This is a follow-up to Sherman's first book, From Alzheimer's to Zebrafish: Eclectic Science and Regulatory Stories, published in 2012.