How a debate over patient consent rules led to a book on vaccine history


The story of how cancer cells belonging to Henrietta Lacks were used, without her consent, became one of the most important foundations of research was told in the 2010 book “The Immortal Life of Henrietta Lacks. But less-known is the story of how another key set of cells was developed from fetal tissue and used in vaccine testing on patients without their consent.

Meredith Wadman tells this story of controversy in her 2017 book, “The Vaccine Race: Science, Politics, and the Human Costs of Defeating Disease.” She found the story just by reading a letter-to-the-editor about patient consent in the publication Science.

The 2012 letter, from researcher Leonard Hayflick, noted that while the Henrietta Lacks cells were getting all the attention, he had gotten cells from an aborted fetus to develop a cell line used to develop vaccines, and his cells had been the subject of an intellectual property dispute with the National Institutes of Health.

“I read this letter, and it jumped off the page at me,” explained Wadman on how she found the story. “How had this not already been a book? You have an aborted fetus, the use of cells from a fetus to prevent infectious diseases and an intellectual property dispute.”

From that point forward, Wadman became passionate about telling the story. She interviewed Hayflick and dozens of other researchers involved in the development of vaccines in 1960’s and uncovered the backstory of how Hayflick created his cell line, called WI-38. This cell line has been and is currently used widely in medical research and was used to develop not only vaccines but in research on aging.

WI-38 cells were the basis of research for rubella, rabies, chicken pox, measles, polio, hepatitis A, shingles and adenovirus vaccines. Before the vaccines were made available to the public in the 1960s, however, some of the safety testing was conducted on orphans, prisoners, and children in homes for juvenile delinquents.

“I was surprised and aghast by how ubiquitous the use of powerless [patient] populations was [for research] ,” Wadman said as she delved more deeply into the dark side of research.

In 1964, the U.S. signed international ethics guidelines pledging that human subjects must freely consent to be part of experiments, but it wasn’t until 1974 that Congress passed the National Research Act, which began the path for codifying federal rules on patient consent.

The question of how far researchers must go to get consent from the use of patient’s biological material has continued, spurred by the Henrietta Lacks story. Last year, the Health and Human Services department’s Office of Human Research Protections updated its guidelines for researchers using patients’ biological material.

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