A carefully reasoned and disturbing portrait of potential hazards of excessive regulation.
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
Review Program: Kirkus Indie
For Howard Zinn, long-time civil rights and anti-war activist, history and ideology have a lot in common. Since he thinks that everything is in someone's interest, the historian—Zinn posits—has to figure out whose interests he or she is defining/defending/reconstructing (hence one of his previous books, The Politics of History). Zinn has no doubts about where he stands in this "people's history": "it is a history disrespectful of governments and respectful of people's movements of resistance." So what we get here, instead of the usual survey of wars, presidents, and institutions, is a survey of the usual rebellions, strikes, and protest movements. Zinn starts out by depicting the arrival of Columbus in North America from the standpoint of the Indians (which amounts to their standpoint as constructed from the observations of the Europeans); and, after easily establishing the cultural disharmony that ensued, he goes on to the importation of slaves into the colonies. Add the laborers and indentured servants that followed, plus women and later immigrants, and you have Zinn's amorphous constituency. To hear Zinn tell it, all anyone did in America at any time was to oppress or be oppressed; and so he obscures as much as his hated mainstream historical foes do—only in Zinn's case there is that absurd presumption that virtually everything that came to pass was the work of ruling-class planning: this amounts to one great indictment for conspiracy. Despite surface similarities, this is not a social history, since we get no sense of the fabric of life. Instead of negating the one-sided histories he detests, Zinn has merely reversed the image; the distortion remains.
Pub Date: Jan. 1, 1979
ISBN: 0061965588
Page Count: 772
Publisher: Harper & Row
Review Posted Online: May 26, 2012
Kirkus Reviews Issue: Jan. 1, 1979
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Alternately admiring and critical, unvarnished, and a closely detailed account of a troubled innovator.
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
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