The Cutter Incident: How America's First Polio Vaccine Led to the Growing Vaccine Crisis

Once the media started pondering the likelihood of an Avian Flu pandemic, it was inevitable. Last week, it finally happened: in a speech given at the National Institutes of Health, President Bush outlined a $7.1 billion strategy to prepare for a pandemic influenza outbreak. And while his hypothetical budget included hefty amounts earmarked for stockpiling drugs, boosting the nation's vaccine-making capabilities, and enabling state and local governments to prepare emergency outbreak plans, Paul Offit, M.D., says the most critical part of the speech did not have a dollar sign in front of it.

"The most important point Bush made was that the U.S. must approve liability protection for the makers of lifesaving vaccines," says Dr. Offit, chief of the Division of Infectious Diseases and the Maurice R. Hilleman Professor of Vaccinology at the Children's Hospital of Philadelphia. "Needless to say, it unleashed a storm of controversy. But the harsh reality is that pharmaceutical companies will not make new influenza vaccines if they're not protected from litigation. Period. And without vaccines, the rest of the plan will do little to protect us from a pandemic."

Currently, it is legally prohibitive for U.S. pharmaceutical companies to create new influenza vaccines, like those that prevent pandemic disease. The reason why can be traced to a 1957 legal ruling Dr. Offit explores in his new book, The Cutter Incident: How America's First Polio Vaccine Led to the Growing Vaccine Crisis (Yale University Press, October 2005, ISBN: 0-300-10864-8, $27.50). Essentially, a biological disaster involving a vaccine produced by Cutter Laboratories of Berkeley, California, spawned litigation that led to a "liability without fault" jury ruling--and vaccines became the first medical product almost eliminated by lawsuits.

Here's what happened: in 1955, five companies stepped forward to make Jonas Salk's new formaldehyde-inactivated polio vaccine. One of them--the aforementioned Cutter Laboratories--failed to completely inactivate the virus in their vaccine. As a result,120,000 children were inadvertently injected with live, dangerous poliovirus; 40,000 developed mild polio, 200 were permanently paralyzed, and 10 were killed. It was one of the worst biological disasters in American history.

No one is arguing that the Cutter incident wasn't a terrible tragedy, says Dr. Offit. It was. But the fact that the jury found Cutter not negligent but financially liable for their product may have been a worse one. Their decision set in motion a chain of events that resulted in the problem we now face: no U.S.-based company even makes influenza vaccine . (We buy our influenza vaccine from three manufacturers based in England, Belgium, and France.)

"What too many people don't realize is that all medical advances come with a risk of mistakes, sometimes fatal ones," reflects Dr. Offit. "The Cutter incident and other tragedies like it are part of that evolution. Like it or not, we learn as we go. No amount of suing is ever going to change that. The question is, are we willing to let the likelihood of human error prevent us from even trying to eradicate future pandemics?"

Surely Dr. Offit isn't suggesting that people injured by vaccines should have no legal recourse . . . is he? Of course not. He simply wants lawmakers to arrive at a sane compromise, one that protects pharmaceutical companies from frivolous litigation and still compensates people for those rare times when they really are harmed by vaccines.

The answer, he believes, is expanding the "vaccine court" that was established two decades ago to save the vaccine industry from total elimination.

"Congress passed the National Childhood Vaccine Injury Act in 1986, an act that included the Vaccine Injury Compensation Program," says Dr. Offit. "Now, when people claim to be harmed by vaccines, they take their case to vaccine court where a panel of scientists, epidemiologists, and clinicians review data and decide whether the claim is valid. The system brings reason and fairness to decisions about vaccine safety."

"Vaccine court works because it greatly lessens the randomness, bias, and lack of complex medical knowledge that characterize many juries," he adds. "We already know the model works, so why not extend it to protect against the unlikely possibility of harm caused by a pandemic-influenza vaccine?"

And make no mistake: such a pandemic is coming, says Dr. Offit.

"Historically speaking, the bill is about to come due," he says. "If past cycles of infectious disease hold true, another disaster will hit at some point in the next two decades. I hope our politicians, lawyers, and other decision-makers will stop squabbling and work together in time to get a vaccine ready. Otherwise, young Americans will find out firsthand what an influenza pandemic is like--and that's something all the lawsuits in the world won't be able to stop."

About the Author:
Paul Offit, M.D., is chief of the Division of Infectious Diseases and the Maurice R. Hilleman Professor of Vaccinology at the Children's Hospital of Philadelphia. He is also professor of pediatrics at the University of Pennsylvania School of Medicine.

About the Book:
The Cutter Incident: How America's First Polio Vaccine Led to the Growing Vaccine Crisis
By Paul Offit, M.D.
Published in October 2005
By Yale University Press
$27.50 hardcover, 240 pages, 25 black and white illustrations