“Unanticipated Tragedies Are Unpreventable, No Matter How Many Regulations”

(p. A15) Dr. Offit acknowledges the limits of regulatory fixes, noting that, while regulatory guidelines are important, “unanticipated tragedies are unpreventable, no matter how many regulations, training programs, fines, and penalties are put in place.” He contrasts the tragic death in 1999 of 18-year-old Jesse Gelsinger in an early gene-therapy study—aimed at remediating a rare enzyme deficiency—with the triumphant experience of Emily Whitehead, a girl with leukemia treated 11 years later at the same university with genetically manipulated T-cells. Gelsinger’s death has been ascribed to protocol deficiencies, conflicts of interest and inadequate regulation, but “a closer look,” Dr. Offit writes, “shows that the only difference between the outcomes of Emily Whitehead and Jesse Gelsinger were luck and timing.” The specific supportive approach used by Whitehead’s doctors to address a life-threatening complication of her T-cell infusion stemmed directly from the lessons learned during Gelsinger’s ordeal. We recognize successes, Dr. Offit laments, but “never the failures that made those successes possible.”

One anxiety suffusing every page of “You Bet Your Life” is what to make of the Covid-19 vaccines. Dr. Offit, a member of the FDA’s vaccine advisory committee, has been described in The Wall Street Journal as “an outspoken advocate of the science and value of vaccinations,” including the Covid-19 vaccine. He has described its clinical-trial data as “enormously reassuring” and has seen little evidence of “a very rare, serious side effect that would be something that would cause a long term problem.” Yet his review of the history of vaccination and of its complexities evokes surprising empathy for the vaccine-hesitant. He recounts the early days of the Salk polio vaccine, which saved lives yet also tragically transmitted the disease to some patients when the product was inadequately prepared by one of its manufacturers. He notes that “the first vaccines aren’t always the best, safest, and last” and regrets the “disturbing show of hubris” by the Covid vaccine developers.

Ultimately, Dr. Offit emphasizes, we need to come to terms with the fact that all medical technologies carry risk—as does the decision not to avail oneself of them. “A choice not to get a vaccine is not a risk-free choice,” Dr. Offit notes. Either way, he says, “you’re gambling”—so “choose the lesser risk.”

For the full review, see:

David A. Shaywitz. “BOOKSHELF; The Dangers Of Finding a Cure.” The Wall Street Journal (Tuesday, Nov. 09, 2021): A15.

(Note: the online version of the review has the date November 8, 2021, and has the title “BOOKSHELF; ‘You Bet Your Life’ Review: The Dangers of Finding a Cure.”)

The book under review is:

Offit, Paul A. You Bet Your Life: From Blood Transfusions to Mass Vaccination, the Long and Risky History of Medical Innovation. New York: Basic Books, 2021.

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