‘You Bet Your Life’ Review: The Dangers of Finding a Cure New medical procedures, new drugs, new vaccines—as welcome as they are—inevitably involve risk, especially in the early stages.By David A. Shaywitz
In the fall of 1937, Joan Marlar, a 6-year-old girl in Tulsa, Okla., was diagnosed with strep throat and given an elixir containing a wondrous new medicine, sulfanilamide—an antibiotic hailed by Time magazine not long before as “the medical discovery of the decade.” Over the next week, Joan was racked with nausea; she became weak and tired. Her kidneys shut down, and she lapsed into a coma. Nine days after her diagnosis, she was dead.
The culprit: the medicine she had been given to cure her. The liquid used to dissolve the antibiotic, it turned out, had poisoned her kidneys. The manufacturer had never tested the product for safety—and at the time wasn’t legally obliged to do so. Prodded by this disaster, Congress passed a law in 1938 mandating the safety testing that might have saved Joan and the 104 other Americans who died from the toxic remedy.
The sulfanilamide story is one of a series of prismatic examples shared by Paul Offit in “You Bet Your Life.” Medical progress, he shows, is choppy and uneven, lurching forward in response to a new insight, then stuttering as unexpected limits are revealed.
When Christiaan Barnard, a South African surgeon, performed the world’s first heart transplant in 1967, Dr. Offit notes, he “became an international celebrity.” And the transplant recipient, a 54-year-old grocer named Louis Washkansky, was briefly “the world’s most famous patient”—though he died several weeks after the operation. Other surgeons were inspired to attempt the procedure. but hope soon turned to despair when, like Washkansky, most recipients died within a year. Life magazine ran a cover story in 1971 titled “The Tragic Record of Heart Transplants.” Yet technology continued to advance, and outcomes gradually improved. Today around 2,300 heart transplants are performed every year in the U.S., and the average length of survival is now 15 years.
Dr. Offit, a pediatrician, vaccine expert and prolific author, is exquisitely attuned to the burden shouldered by the earliest recipients of medical treatments and technologies. Many such patients, like Washkansky, are on death’s door and wouldn’t survive without a new treatment, yet often they don’t survive even with it. The evolution of blood transfusion offers an especially poignant example of this trade-off. Without question, the ability to collect, store and share human blood—gradually achieved in the early 20th century—revolutionized surgery and saved the lives of thousands of warfighters and other trauma victims. Yet Dr. Offit reminds us that transfused blood—contaminated with viruses, including hepatitis B, hepatitis C and HIV—would kill thousands of recipients before screening tests were available. Today the risk of getting a known virus from a blood transfusion is minuscule; but given the ever-present possibility of new pathogens, the risk is not zero. “When do we cross the line into relative certainty?” Dr. Offit asks. “Do we ever cross it?” Such questions remind us of the fraught ambiguities with which we continuously wrestle.
While risks in the first stages of medical innovation fall primarily on the patients, a heavy toll can be exacted on scientist-practitioners as well. Dr. Offit cites the historian Bettyann Kevles describing a 1920 gathering of radiologists: Because of radiation damage, “so many attendees were missing hands and fingers that when the chicken dinner was served no one could cut their meat.”
The hazards of emerging technologies, Dr. Offit observes, have led to key regulatory requirements; he cites historian Michael Harris’s observation that “the history of drug regulation is written on tombstones.” At the same time, 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.”
Dr. Shaywitz, a physician-scientist, is a digital-medicine and technology adviser and a lecturer at Harvard Medical School.
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