The Cutter Incident

September 5, 2005
After a wave of books celebrating the 50th anniversary of Jonas Salk's polio vaccine, Offit's troubling account is the first to focus on a largely forgotten aspect—one with negative repercussions 50 years later. In a nuanced examination of a complex story, Offit, a professor of pediatrics and expert in infectious diseases, relates how Cutter Laboratories, one of several pharmaceutical companies licensed to produce Salk's killed-virus vaccine, shipped many lots of vaccine containing live virus, creating a mini polio epidemic: 40,000 children became ill, 200 were permanently paralyzed, 10 died. Offit carefully examines how Cutter was and was not responsible: tests for detecting live virus at the time were simply not sensitive enough, but Cutter departed from Salk's safe production protocols. And while the company knew there was a problem, it failed to notify the government's oversight agency. Cutter faced costly lawsuits that have resulted, according to Offit, in today's vaccine crisis: shortages (think of last year's flu vaccine) due to pharmaceutical companies' unwillingness to risk testing and producing vaccines and face possible litigation. In another example of the law of unintended consequences, Offit shows how "the Cutter Incident" led Salk's vaccine to be replaced by a less safe one: Sabin's live-virus vaccine.

October 15, 2005
Pointing to recent shortages of flu and several childhood-disease vaccines as well as the dearth of new vaccines, Offit says that pharmaceutical companies are staying away from vaccine research and production in droves. He lays responsibility for this lamentable situation on the outcome of a court battle now 50 years old and the subsequent snowballing of legal and legislative reactions. Beginning with a tragic 1955 error at Cutter Laboratories--one of the first companies producing the Salk polio vaccine--that caused polio in thousands, Offit maps the way the courts have handled pharmaceutical liability, the way juries have awarded damages, the federal Vaccines for Children Program and the National Vaccine Injury Compensation Program, and other influences on vaccine development. Those trends and agencies have so inflated the costs and risks relative to probable profits that vaccine production has been discouraged. Offit concludes that, because the U.S. has made risks high and profits negligible, many more children will suffer illnesses that can be prevented.(Reprinted with permission of Booklist, copyright 2005, American Library Association.)