Deciding Which Risks to Take

It is always risky to use a new treatment before all the evidence is in, but it is also risky to let a serious illness go undetected. Paul Offit has written a book about the long and risky history of medical innovations and how to decide which is riskier.

Hundreds of children have been saved every day by the vaccine that Paul Offit co-developed. He is a doctor at the Children's Hospital of Philadelphia and a vaccine expert. He has written several books on vaccines and is branching out to address other topics.

Every medical breakthrough has exacted a human price and some people will die if they wait for better evidence.

These tragedies will be repeated if we don't learn from history. In April 2020 the FDA granted an Emergency Use Authorization to hydroxychloroquine for the treatment of COVID-19, but no study had ever found that it worked. After only two months, the FDA withdrew its approval. Many people refused to take the new coronaviruses vaccines because they were not risk-free. It was a choice to have long-term disabilities and die.

Offit shows us the history of several medical innovations, including heart transplants, blood transfusions, anesthesia, biologicals, antibiotics, vaccines, x-rays, and chemotherapy. Offit fleshes out the story with details that were new to me, even though I knew about the history of these innovations.

There are transplants.

Most of the early heart transplants failed, but the patients were not gambling with their lives, because their lives were at an end. The recipients seemed to accept any risk. I knew effective transplants had to wait for technological advances and drugs that could prevent rejection, but I hadn't realized the importance of one impediment: there were no accepted criteria for brain death. The criteria for brain death were supported by the Pope. A third of patients on the waiting list for a heart transplant will die while waiting. Offit hopes that pig hearts can be changed so they can be used in humans.

There are blood transfusions.

The first three blood transfusions from animals to humans were done in 1667 and they seemed to work. The second case was a drunken butcher who was paid to take blood from a lamb. After the procedure, he jumped off the table, butchered the lamb, and ran to a local bar to get drunk.

The fourth patient died, and the surgeon was tried for murder. The patient's wife was executed for poisoning her husband. The Pope banned transfusions for the next two centuries because of the publicity around this incident. After the problems of clotting and infections were solved, the routine of transfusions became routine. Blood typing proved that Charlie Chaplin was not the father of his mistress' child, but since it was new, blood type evidence was not allowed in court. All Hell fell apart. The risk of a blood transfusion is minimal but not zero, thanks to better safety precautions and better screening.

There is anesthesia.

John Snow was the doctor who identified the cause of the epidemic and stopped it by removing the handle of the Broad Street pump. I was surprised to learn that he was the same doctor who gave Queen Victoria chloroform, which made many other women accept pain relief for labor. chloroform was more dangerous than ether or nitrous oxide, but it was still used for decades.

There were tetanus from the antitoxin.

The blood of a horse named Jim was successfully used to supply many batches of antitoxin. Balto was the sled dog who rushed the antitoxin to Nome. The lab personnel were told to discard Jim's blood samples after he developed tetanus. 13 children in St. Louis died because of human error when tetanus-laden blood was mixed with safe blood. There were other innocent victims. The death rate in Chicago increased by 30% because people elsewhere were frightened by the disaster in St. Louis.

The disaster was caused by the Sulfanilamide.

Hitler refused to allow Gerhard Domagk to travel to Sweden to receive the prize for discovering the effectiveness of the antibiotics. The active ingredient in diethylene glycol was dissolved by the Massengill company to make a liquid preparation for children. They did not test it for safety. By the time they realized diethylene glycol was a poison, 105 people had died. The Food, Drug, and Cosmetics Act was passed to prevent similar disasters, but the Massengill company was never held accountable. It was fined $26,000 and had to pay over $150,000 to settle damage claims.

There is a vaccine for the vaccine of the vaccine of the vaccine of the vaccine of the vaccine of the vaccine of the vaccine of the vaccine of the vaccine of the vaccine of the vaccine of the vaccine of the vaccine of the vaccine of the vaccine of the vaccine of the vaccine of the vaccine

The vaccine saved many lives, but it also caused a man-made epidemic with tens of thousands of cases of paralysis, hundreds of them permanent, and 10 deaths. The first vaccine against the disease was developed in 1934 and 1935. Both resulted in paralysis and were withdrawn. After 20 years, anyone dared to try again.

The vaccine worked, but one manufacturer had to recall their product after two specific lots had paralyzed 51 children and killed 5, and 74 unvaccinated family members had been paralyzed. Ten people had died from the disease. Offit explains why: Salk made a false assumption about the straight-line virus inactivation curve, Cutter used an inferior glass filter, and they let the filters sit in a refrigerator for weeks. The Scale-Up incident shows some of the things that can go wrong when new vaccines are mass-produced by different companies.

The campaign switched to the oral vaccine. It was easy to administer and effective, but it could change into aviruses that were similar to natural ones. In 2000 the US switched back to the safer Salk inactivated vaccine, which only occurs in one of every 2.4 million doses.

X-rays.

Radiologists were slow to appreciate the risks of radiation, even though x-rays were an incredibly useful aid to diagnosis. When the chicken dinner was served, no one could cut their meat because so many attendees had missing hands and fingers. I remember seeing x-ray machines in shoe stores when I was a child, but they were banned in the 70s.

There are other risks.

Chemo and gene therapy are two potentially risky innovations covered by Offit. He shows them with fascinating stories. A large tumor at the base of the man's skull was the cause of his hoarseness, eye pain, and inability to speak or swallow. Radiation treatment was not helpful. He gained back most of the eighty pounds he had lost after treatment with a new drug. He was well enough to return to New York by 1948. The Yankees uniform has the number 3 on the back and they are going to attend the 25th anniversary of Yankee Stadium. His name was Babe Ruth.

Risk is unavoidable.

No treatment is risk-free. He says that people should use all of the information available to make the most informed, clear-eyed, and dispassionate decisions. Even the simplest choices involve risk.

There is a chapter on living with uncertainty at the end of the book. Disasters of history are sure to be repeated if we don't learn from them. Unfortunate tragedies are not prevented. Some people think that therapy is worth a shot when someone is sick or dying. Offit reminds us that if a medicine doesn't work, it can only hurt.

The book is very worthwhile.

Offit's research is thorough and perfect. He is a great writer and a great storyteller.

This book will inform you and entertain you, and it will give you a lot to think about for your future decisions about medical technology. I highly recommend it.