Because of outside pressure, the US licensing committee in charge of approving the Salk polio vaccine did so after deliberating for only two hours without first having read the full research (17). This hasty approval led to the infamous “Cutter disaster”, the poliomyelitis epidemic that was initiated by the use of the Salk vaccine produced by Cutter vaccine company. In the end, at least 220,000 people were infected with live polio virus contained in the Cutter’s vaccine; 70,000 developed muscle weakness, 164 were severely paralyzed, 10 were killed. Seventy five percent of Cutter’s victims were paralyzed for the rest of their lives (18). When national immunization campaigns were initiated in the 1950s, the number of reported cases of polio following mass inoculations with the killed-virus vaccine was significantly greater than before mass inoculations and may have more than doubled in the U.S. as a whole (19). Wyeth was also found much later to have produced a paralyzing vaccine. All other manufacturers’ vaccines released in the 1950s were sold and injected into America’s children and millions of vaccines were also exported all around the world (17).¹⁾

Journalism of Royal Society of Medicine J R Soc Med. 2006 March - Reviewed by Michael Fitzpatrick

In April 1955 more than 200 000 children in five Western and mid-Western USA states received a polio vaccine in which the process of inactivating the live virus proved to be defective. Within days there were reports of paralysis and within a month the first mass vaccination programme against polio had to be abandoned. Subsequent investigations revealed that the vaccine, manufactured by the California-based family firm of Cutter Laboratories, had caused 40 000 cases of polio, leaving 200 children with varying degrees of paralysis and killing 10.

Paul Offit, paediatrician and prominent advocate of vaccination, sets the `Cutter incident' in the context of the struggle of medical science against polio and other infectious diseases over the course of the 20th century. He reminds us that, within a decade of Karl Landsteiner's identification of the polio virus in 1908, an epidemic in New York killed 2400 people (mostly children) and left thousands more with a life-long disability. In the 1950s, summer outbreaks in the USA caused tens of thousands of cases, leaving hundreds paralysed or dead. `Second only to the atomic bomb', polio was `the thing that Americans feared the most'.

Offit provides a gripping account of how the `March of Dimes', inspired in part by President Franklin D Roosevelt's personal experience of polio, raised funds for research and focused national attention on the disease. He profiles leading figures, notably Jonas Salk and Albert Sabin —brilliant, egotistical and flawed characters—pioneers in vaccine development and as scientific celebrities, and notorious for their bitter personal rivalry.

Offit offers a balanced judgement on both the Cutter incident and on the Salk and Sabin vaccines. Reviewing failures in the manufacturing and inspection processes, he exonerates Salk from blame and concludes that `the federal government, through its vaccine regulatory agency… was in the best position to avoid the Cutter tragedy'. Three larger companies produced safe polio vaccines according to Salk's protocol for inactivating the virus with formaldehyde. The lack of experience and expertise at Cutter Laboratories, undetected by the inspectors, caused the disaster.

The Cutter incident had an ambivalent legacy. On the one hand, it led to the effective federal regulation of vaccines, which today enjoy a record of safety `unmatched by any other medical product'. On the other hand, the court ruling that Cutter was liable to pay compensation to those damaged by its polio vaccine—even though it was not found to be negligent in its production—opened the floodgates to a wave of litigation. As a result, `vaccines were among the first medical products almost eliminated by lawsuits'. Indeed, the National Vaccine Injury Compensation Program was introduced in 1986 to protect vaccine manufacturers from litigation on a scale that threatened the continuing production of vaccines. ²⁾