FROM OVERSIGHT TO OVERKILL

INSIDE THE BROKEN SYSTEM THAT BLOCKS MEDICAL BREAKTHROUGHS—AND HOW WE CAN FIX IT

A carefully reasoned and disturbing portrait of potential hazards of excessive regulation.

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Medical research is being stymied by the institutions charged with ensuring its safety, according to this exposé.

Whitney, a Baylor College of Medicine physician and bioethicist, pens a stinging critique of institutional review boards—the panels of scientists at universities and hospitals charged with vetting research proposals to ensure that human subjects are protected. They were created in 1974 to protect people from grossly abusive experiments, such as the infamous, decadeslong Tuskegee Study that withheld lifesaving treatment, resulting in more than 100 deaths. However, in the present day, Whitney argues, these boards have become so bureaucratic and risk-averse that they’re impeding important research projects. One board, he notes, demanded that a doctor submit an extensive bibliography on safety issues for a study that had no participants at all, as it consisted of analyzing proteins in leftover urine samples from a kidney-stone clinic. Equally absurd, he asserts, are extensive consent forms, full of dense legalese, which participants must understand before signing. In one study of the benefits of commonly prescribed anti-clotting drugs for cardiac patients, he says, subjects were asked to read and sign four-page consent forms while experiencing the early stages of heart attacks. Whitney ties such dysfunctional elements to the federal Office of Human Research Protections, whose dictates, he says, drive the excesses of such boards. In one incident that he spotlights, the office tried to stop a study aimed at preventing infections when implanting center-line tubes because the doctors and nurses involved didn’t also sign consent forms along with their research subjects. The upshot of all of this, Whitney asserts, is that crucial studies are being delayed or abandoned at a high cost for patients whose lives might be saved by faster research.

Whitney, who served on a Stanford University institutional review board in the 1990s, brings a canny insider’s perspective to a convoluted issue. He deftly analyzes the ethics that underpin board dysfunctions, noting that they fixate on trivial risks without balancing them against the needs of patients who need lifesaving treatments—or granting subjects the moral autonomy to take measured risks for greater humanitarian ends. Also, he’s shrewdly critical of the sorts of regulatory box-checking that affects every step of the review process. These problems can be hard to see in the obscure nuances of complex scientific studies, and Whitney does an admirable job of teasing them out and clarifying them for an audience of laypeople. He conveys all of this in a prose style that’s lucid, down-to-earth, and tartly entertaining: “I am sure that, acting alone, no single member could reach this level of crazy. It took a village,” he writes of a board that saw a potential threat of AIDS or smallpox in a study that involved swabbing the skin of healthy volunteers and rubbing the swabs on other healthy volunteers in order to explore changes in the microbiome.Overall, this is a telling study of administrative overreach that makes a case that institutional imperatives sometimes eclipse rational purposes.

A carefully reasoned and disturbing portrait of potential hazards of excessive regulation.

Pub Date: April 4, 2023

ISBN: 9781953943217

Page Count: 316

Publisher: Rivertowns Books

Review Posted Online: Feb. 28, 2023

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ELON MUSK

Alternately admiring and critical, unvarnished, and a closely detailed account of a troubled innovator.

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A warts-and-all portrait of the famed techno-entrepreneur—and the warts are nearly beyond counting.

To call Elon Musk (b. 1971) “mercurial” is to undervalue the term; to call him a genius is incorrect. Instead, Musk has a gift for leveraging the genius of others in order to make things work. When they don’t, writes eminent biographer Isaacson, it’s because the notoriously headstrong Musk is so sure of himself that he charges ahead against the advice of others: “He does not like to share power.” In this sharp-edged biography, the author likens Musk to an earlier biographical subject, Steve Jobs. Given Musk’s recent political turn, born of the me-first libertarianism of the very rich, however, Henry Ford also comes to mind. What emerges clearly is that Musk, who may or may not have Asperger’s syndrome (“Empathy did not come naturally”), has nurtured several obsessions for years, apart from a passion for the letter X as both a brand and personal name. He firmly believes that “all requirements should be treated as recommendations”; that it is his destiny to make humankind a multi-planetary civilization through innovations in space travel; that government is generally an impediment and that “the thought police are gaining power”; and that “a maniacal sense of urgency” should guide his businesses. That need for speed has led to undeniable successes in beating schedules and competitors, but it has also wrought disaster: One of the most telling anecdotes in the book concerns Musk’s “demon mode” order to relocate thousands of Twitter servers from Sacramento to Portland at breakneck speed, which trashed big parts of the system for months. To judge by Isaacson’s account, that may have been by design, for Musk’s idea of creative destruction seems to mean mostly chaos.

Alternately admiring and critical, unvarnished, and a closely detailed account of a troubled innovator.

Pub Date: Sept. 12, 2023

ISBN: 9781982181284

Page Count: 688

Publisher: Simon & Schuster

Review Posted Online: Sept. 12, 2023

Kirkus Reviews Issue: Oct. 15, 2023

BEYOND THE GENDER BINARY

From the Pocket Change Collective series

A fierce, penetrating, and empowering call for change.

Artist and activist Vaid-Menon demonstrates how the normativity of the gender binary represses creativity and inflicts physical and emotional violence.

The author, whose parents emigrated from India, writes about how enforcement of the gender binary begins before birth and affects people in all stages of life, with people of color being especially vulnerable due to Western conceptions of gender as binary. Gender assignments create a narrative for how a person should behave, what they are allowed to like or wear, and how they express themself. Punishment of nonconformity leads to an inseparable link between gender and shame. Vaid-Menon challenges familiar arguments against gender nonconformity, breaking them down into four categories—dismissal, inconvenience, biology, and the slippery slope (fear of the consequences of acceptance). Headers in bold font create an accessible navigation experience from one analysis to the next. The prose maintains a conversational tone that feels as intimate and vulnerable as talking with a best friend. At the same time, the author's turns of phrase in moments of deep insight ring with precision and poetry. In one reflection, they write, “the most lethal part of the human body is not the fist; it is the eye. What people see and how people see it has everything to do with power.” While this short essay speaks honestly of pain and injustice, it concludes with encouragement and an invitation into a future that celebrates transformation.

A fierce, penetrating, and empowering call for change. (writing prompt) (Nonfiction. 14-adult)

Pub Date: June 2, 2020

ISBN: 978-0-593-09465-5

Page Count: 64

Publisher: Penguin Workshop

Review Posted Online: March 14, 2020

Kirkus Reviews Issue: April 1, 2020

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