Paul A Offit MD - You Bet Your Life: From Blood Transfusions to Mass Vaccination, the Long and Risky History of Medical Innovation

WERE AT THE DAWN OF A WONDROUS AGE: WE CAN REPROGRAM OUR immune systems to attack cancers that until now had been a death sentence, like those of the brain, pancreas, and lung. We can genetically modify animals (such as pigs) to offer an endless supply of hearts for transplant, eliminating the waiting list for thousands of people. We are close to vaccines to prevent Alzheimers disease, Parkinsons disease, and dementia. Viruses that kill bacteria can be injected into people whose infections are resistant to all antibiotics. Artificial blood can eliminate our reliance on the blood of strangers and its occasional contamination with viruses, known or unknown. A gene-editing system called CRISPR will allow us to reengineer human genes, dramatically lessening the horror of single-gene diseases, such as cystic fibrosis and sickle cell disease.

There is, however, one catch. And its not a small one. As youll see in the pages that follow, virtually every medical breakthrough has exacted a human price. Some might argue that the solution is simple: Just wait until new technologies have been broken in. Wait until the learning curve is over. Those who need a heart transplant, for example, could just wait until all the kinks are worked out before being one of the first to receive a pigs heart. But among the four thousand people currently on the transplant list, about 1,300 will die while waiting. Either way, both those who wait and those who choose a pigs heart are gambling.

I first started working on this book at the beginning of one of the worst pandemics in history. On November 17, 2019, a bat coronavirus made its debut in the human population. The virus was called SARS-CoV-2 and the disease was called COVID-19 ( co rona vi rus d isease-20). Just one year after it had arrived, the virus had infected hundreds of millions of people and killed more than a million, mostly from pneumonia. And it was just getting started.

Although this bat coronavirus was new, human coronaviruses have been around for decades. First identified in the early 1960s, human coronaviruses cause coughs, colds, sore throats, and pneumonia. At our hospital, the Childrens Hospital of Philadelphia, human coronaviruses account for about 20 percent of all respiratory infections during the winter. This bat virus, however, was different.

SARS-CoV-2 was the angel of death in nursing homes, accounting for more than 40 percent of all COVID-19 deaths. For influenza virus, which kills about thirty thousand people every year, nursing homes account for fewer than 10 percent of deaths.

SARS-CoV-2 raged during the summer months. No one had anticipated this. Human coronavirusesas well as other respiratory viruses, such as influenza, that are spread by small droplets in coughs and sneezesare winter diseases. They always disappear during the summer.

SARS-CoV-2 caused some people to lose their sense of taste or smell for weeks at a time. Scientists have now found that the virus can enter the brain through nerves in the nose. Human coronaviruses dont do this. No respiratory viruses do this.

SARS-CoV-2 caused an unusual, multi-organ disease in children that mimicked another disease called Kawasakis (a relatively rare disorder characterized by rash, pink eye, cracked lips, swollen glands, a strawberry tongue, swelling of the hands and feet, peeling of the skin, and occasionally fatal inflammation of the arteries that supply blood to the heart). SARS-CoV-2 also mimicked a disease called toxic shock syndrome, which is as bad as it sounds. No other virus does this to children.

SARS-CoV-2 caused inflammation of the lining of blood vessels (vasculitis), which, in addition to causing liver and kidney disease, increases the risk of strokes and heart attacks. This phenomenon was made all the more amazing by the observation that SARS-CoV-2 doesnt enter the bloodstream. Rather, the virus induces the bodys own immune system to destroy cells that line veins and arteries. Human coronaviruses dont do any of these things either.

Some people who caught and survived SARS-CoV-2 never made an immune response against the virus. This suggested that the virus might be suppressing the immune system, like the AIDS virus. This unusual form of immune suppression was especially true in men, who were twice as likely to die from the disease.

All of these surprises occurred within the first year of the viruss debut. It is likely that more surprises lie ahead.

With hundreds of thousands of people dying from COVID-19, everyone was desperate for a cure. In April 2020, I was selected by Dr. Francis Collins, director of the National Institutes of Health (NIH), to participate on a committee to accelerate the development of vaccines and treatments. I was also a member of the Food and Drug Administration (FDA) vaccine advisory committee. These positions gave me a front-row seat for how people were about to make decisions under uncertainty. Again, there were no risk-free choices. And desperation led to bad decisions.

On April 7, 2020, the FDA approved an antimalarial drug called hydroxychloroquine for the treatment of COVID-19, even though no study had ever found that it worked. Some people, like the president of the United States, reasoned that at the very least it was worth a try. What could be the harm? Unfortunately, any drug that has a positive effect can also have a negative effect. During the next few weeks, several studies showed that hydroxychloroquine neither treated nor prevented COVID-19. Worse, about 10 percent of recipients suffered severe heart arrhythmias, some fatally. Two months later, the FDA withdrew its recommendation. The most disturbing aspect of the hydroxychloroquine disaster was that the drug hadnt gone through the usual process of FDA licensure, which takes about a year of careful, thorough review. Rather, it had been approved under something called emergency use authorizationa faster, less thorough system that would soon be applied to the approval of coronavirus vaccines.