Paul A. Offit MD wrote this 2021 book:
#1: Nature reveals its secrets slowly, grudgingly, and often with a human price. Scientists, clinicians, academicians, and pharmaceutical company executives must stay humble and respect the requisite learning curve that comes with new discoveries.
The development of COVID – 19 vaccines was often accompanied by a disturbing show of hubris. After completion of phase 1 trials, which examined small numbers of volunteers given different doses of vaccines, some company researchers and executives crowed. Moderna (fifteen patients), Pfizer (thirty – five patients), and AstraZeneca (ten patients) claimed that they could now make tens of millions of doses. These bold pronouncements ignored the likely surprises that lay ahead when a handful of recipients gives way to tens of millions of recipients. This lack of humility was especially concerning given that SARS – CoV – 2 had already shown itself to be an elusive, difficult to characterize virus that had provided a number of surprising clinical and pathological problems, not least of which was inflammation of the blood vessels that could damage any organ, including the brain and heart. No other virus had done what this virus was doing. Also, none of the strategies used by these three companies to make a SARS – CoV – 2 vaccine had ever been used to make a vaccine before. Surely, a learning curve lay ahead.
#2: Although federal guidelines lessen the chance of disasters, they will never eliminate them. Unanticipated tragedies are unpreventable, no matter how many regulations, training programs, fines, and penalties are put in place.
#3: Tragedies shouldn’t cause people to lose faith in the scientific endeavor. Science lurches forward in fits and starts, but it inevitably moves forward.
The retrovirus – caused – leukemia tragedy offers another lesson — one that is far more hopeful. In response to the leukemia disaster, researchers modified retrovirus vectors to include an “insulator” gene that eliminated the possibility that the virus could activate an oncogene. The protective gene worked. Researchers at St. Jude’s Children’s Research Hospital in Memphis were able to permanently correct severe immune deficiencies in ten children using this newer, safer retrovirus vector. Years later, none of these children had developed leukemia. Parents can now safely rely on these modified retroviruses to cure single – gene diseases. Yet another breakthrough built on tragedy.
During the Cutter Incident, when more than one hundred thousand children were inoculated with a polio vaccine that contained live poliovirus, tens of thousands were briefly paralyzed, hundreds were permanently paralyzed, and ten were killed. In response, federal regulators shut down the polio – vaccine program for several months until they could figure out what had gone so horribly wrong. When researchers finally did figure it out, better safety tests were put in place and the problem of polio caused by Jonas Salk’s polio vaccine disappeared.
A few months after the Cutter tragedy, polio vaccines were put back on the market. Now, parents had a choice to make. They could either trust that federal regulatory agencies had solved the problem, or they could wait a year or so to make sure that the problem didn’t recur. The choice to wait, however, wasn’t risk free. Poliovirus was still circulating in the community.
#6: Animal testing can be falsely reassuring.
#7: In the end, no matter how well – informed you are about a new technology, you’re gambling. But you’re gambling either way.
