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
A short, smart analysis of perhaps the most famous passage in American history reveals its potency and unfulfilled promise.
Words that made a nation.
Isaacson is known for expansive biographies of great thinkers (and Elon Musk), but here he pens a succinct, stimulating commentary on the Founding Fathers’ ode to “life, liberty, and the pursuit of happiness.” His close reading of the Declaration of Independence’s second sentence, published to mark the 250th anniversary of the document’s adoption, doesn’t downplay its “moral contradiction.” Thomas Jefferson enslaved hundreds of people yet called slavery “a cruel war against human nature” in his first draft of the Declaration. All but 15 of the document’s 56 signers owned enslaved people. While the sentence in question asserted “all men are created equal” and possess “unalienable rights,” the Founders “consciously and intentionally” excluded women, Native Americans, and enslaved people. And yet the sentence is powerful, Isaacson writes, because it names a young nation’s “aspirations.” He mounts a solid defense of what ought to be shared goals, among them economic fairness, “moral compassion,” and a willingness to compromise. “Democracy depends on this,” he writes. Isaacson is excellent when explaining how Enlightenment intellectuals abroad influenced the founders. Benjamin Franklin, one of the Declaration’s “five-person drafting committee,” stayed in David Hume’s home for a month in the early 1770s, “discussing ideas of natural rights” with the Scottish philosopher. Also strong is Isaacson’s discussion of the “edits and tweaks” made to Jefferson’s draft. As recommended by Franklin and others, the changes were substantial, leaving Jefferson “distraught.” Franklin, who emerges as the book’s hero, helped establish municipal services, founded a library, and encouraged religious diversity—the kind of civic-mindedness that we could use more of today, Isaacson reminds us.
A short, smart analysis of perhaps the most famous passage in American history reveals its potency and unfulfilled promise.Pub Date: Nov. 18, 2025
ISBN: 9781982181314
Page Count: 80
Publisher: Simon & Schuster
Review Posted Online: Aug. 29, 2025
Kirkus Reviews Issue: Oct. 1, 2025
BOOK REVIEW
BOOK REVIEW
BOOK REVIEW
SEEN & HEARD
A moving meditation on mortality by a gifted writer whose dual perspectives of physician and patient provide a singular...
A neurosurgeon with a passion for literature tragically finds his perfect subject after his diagnosis of terminal lung cancer.
Writing isn’t brain surgery, but it’s rare when someone adept at the latter is also so accomplished at the former. Searching for meaning and purpose in his life, Kalanithi pursued a doctorate in literature and had felt certain that he wouldn’t enter the field of medicine, in which his father and other members of his family excelled. “But I couldn’t let go of the question,” he writes, after realizing that his goals “didn’t quite fit in an English department.” “Where did biology, morality, literature and philosophy intersect?” So he decided to set aside his doctoral dissertation and belatedly prepare for medical school, which “would allow me a chance to find answers that are not in books, to find a different sort of sublime, to forge relationships with the suffering, and to keep following the question of what makes human life meaningful, even in the face of death and decay.” The author’s empathy undoubtedly made him an exceptional doctor, and the precision of his prose—as well as the moral purpose underscoring it—suggests that he could have written a good book on any subject he chose. Part of what makes this book so essential is the fact that it was written under a death sentence following the diagnosis that upended his life, just as he was preparing to end his residency and attract offers at the top of his profession. Kalanithi learned he might have 10 years to live or perhaps five. Should he return to neurosurgery (he could and did), or should he write (he also did)? Should he and his wife have a baby? They did, eight months before he died, which was less than two years after the original diagnosis. “The fact of death is unsettling,” he understates. “Yet there is no other way to live.”
A moving meditation on mortality by a gifted writer whose dual perspectives of physician and patient provide a singular clarity.Pub Date: Jan. 19, 2016
ISBN: 978-0-8129-8840-6
Page Count: 248
Publisher: Random House
Review Posted Online: Sept. 29, 2015
Kirkus Reviews Issue: Oct. 15, 2015
PERSPECTIVES
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