This is a truly bizarre book. Somehow the author Paul Offit, MD, believes that telling a gripping story about the massive scientific, regulatory and industrial failures that lead to hundreds of thousands of people in 1955 being injected with a vaccine containing live polio viruses which resulted in thousands of people paralyzed for life and hundreds of deaths, would persuade people now that vaccine manufacturers should be shielded from any legal liability for their products. That in a nutshell is the purpose of this book.

The first 130 pages tells the compelling story of the development of the polio vaccine and how a batch of polio vaccine made by Cutter Laboratories actually gave people the disease it was designed to prevent. This section is followed by a forty-page analysis of the legal consequences of the Cutter incident that verges on incoherence. Here Offit seems to make the classic mistake of physicians who assume they are the leading authority in the room on all subjects. Somehow Offit believes that a fundamental injustice to the vaccine industry occurred when juries found that Cutter Laboratories was liable for the damage created by their product. In Offit's analysis, as long as the pharmaceutical company thought the vaccine was safe, injured people should have no legal recourse. It would seem obvious that shielding firms from liability creates exactly the kind of environment where Cutter-type incidents would breed.

This section is followed by a brief polemic, more of a rant, filled with factual errors, demanding the laundry list of political favors lusted after by the pharmaceutical industry. These demands go far beyond "tort reform," the pharmaceutical industry is calling for the repeal of basic constitutional rights and the undermining of basic principles of American law to suit the short-term profit needs of a generously campaign-donating industry.

While stating his academic and hospital associations, the book fails to disclose significant and relevant details of Offit's own financial and business dealings. In addition to being the leading vaccine promoter in the US, just google him, he is also a vaccine developer and business partner with Merck, GlaxoSmithKline and the Children's Hospital of Philadelphia, who collectively own a rotavirus vaccine that was recently overcame a major milestone to licensure.

In the late 90s a rotavirus vaccine, not Offit's, was approved by the Advisory Committee on Immunization Practices (ACIP), the federal board that decides which vaccines are added to the federal "recommended schedule." Offit already had his vaccine under development and he also happened to sit on the ACIP when the rotavirus vaccine was approved. This type of conflict of interest, which would probably be a felony in the securities industry is standard operating procedure in the vaccine industry. Approval by the ACIP usually guarantees that a vaccine will become mandatory to attend school in most states and provides an immense guaranteed market for any vaccine. It also assures that the vaccine will be extended full liability protection. Shortly after the rotavirus was introduced it was quickly discovered that it destroyed the intestines and killed a number of people. It was quickly withdrawn, yet another vaccine created epidemic.

The rotavirus incident, just like, Cutter, pointed out a basic fact of vaccine development, a sufficiently large sample to detect adverse reactions that may happen is small subset of people is almost never used, so the general public is used as guinea pigs on unproven vaccines. Interestingly, Offit mentions not a word about rotavirus in this book.

Offit would have all vaccine injuries relegated to the current vaccine courts. These courts were created in the late eighties to adjudicate injuries related to vaccines in the "recommended schedule" of shots. Offit ignores the complete breakdown of the federal vaccine courts. According to the federal government's own data there are tens of thousands of serious injuries, illnesses, disabilities and deaths directly caused by vaccines every year. Yet only a few hundred cases a year are ever decided by the vaccine courts and only a third are decided in favor of the injured party. Yet this is where Offit says all vaccine injury cases should be adjudicated.


This is necessary, advocates for the pharmaceutical companies like Offit, argue because out of control juries and trial lawyers have crippled the vaccine industry, and are responsible for the periodic shortages in vaccines. As proof Offit claims that there are only four vaccine manufacturers left. This is nonsense. First, there are more than ten manufacturers in the US alone making vaccines currently licensed by the FDA, just check their website. Second, consolidation of the vaccine industry into a few giant pharmaceutical behemoths is a worldwide phenomena occurring in countries where there is nothing like the American tort system. Most recently Aventis Pasteur and Sanofi merged to create a primarily French giant, and Swiss giant Novartis gobbled up Chiron, the manufacturer of the 48 million contaminated flu vaccines last season. It also can't explain why there are more than 300 different vaccines currently under development.

Further, vaccine manufacturers have had complete legal immunity in the US since 1988 when the vaccine courts were created. How can there be a tort crisis in an industry that cannot be sued? Name one other industry that faces no liability for defective products? And the cause for shortages has far more to do with the ineptitude of the bureaucrats at the CDC who determine vaccine production numbers than any mythical liability crisis.

All in all this is a fascinating book. I would think that vaccine rights advocates would be delighted with this book and the PR departments of the vaccine manufacturers are probably working overtime on damage control. How Offit could have concluded that this argument would help him and his allies achieve their political goals is a complete mystery.

In 1952, the United States suffered its worst ever polio epidemic, with 58,000 people affected. The race was on to perfect a vaccine that would bring this scourge under control. In 1955, following several breakthrough, a vaccine was created, and a huge trial was conducted, involving some 800,000 children, of whom 600,000 were given the vaccine (the rest were given a placebo). However, it quickly became apparent that something had gone wrong. Before all was said and done, 40,000 children contracted polio, 200 were permanently paralyzed, and 10 died. The race was on to find out what had gone wrong.

1955 was still the dawn of the vaccine era, and there was much to be learned. However, in the aftermath of the vaccine, liability law was changed in a way that seemed minor at the time, but has resulted in a dearth of vaccines and vaccine makers. Do you want to know why 2004 witnessed a shortage of flu vaccines? Read this book and find out!

Overall, I must say that I found this book to be quite fascinating. The author does a good job of retelling what happened, and what its ramifications were and are. It seems quite ironic that something that went wrong at the dawn of vaccines is bringing the era of vaccines to a close! If you want to know how we got from that seemingly glorious era of ever new vaccines, which seemed to promise a disease free future, to day, then you must read this book. I highly recommend it!

Are you aware of the real reasons there has been a chronic shortage of flu vaccine in the U.S. for the past several years? Are you concerned that there is the very real possibility of a major flu pandemic that could rival the 1918 outbreak that claimed 675.000 lives in this country? Would you be interested in learning why most pharmaceutical companies are no longer involved in the manufacture of essential vaccines? Paul Offit, M.D. sheds a great deal of light on these matters in "The Cutter Incident". Offit recalls a long forgotten series of events from the polio epidemic in the mid to late 1950's that has resulted in the serious shortage of vaccines that we are seeing today. The consequences of these shortages and our inability to respond to an unexpected epidemic have the potential to be devastating to our nation.
I think that it is fair to say that most Americans take a rather
dim view of the major pharmaceutical companies. These attitudes are really not that difficult to understand when one considers that these firms have been the target of all manner of accusations and frivolous charges by trial lawyers, public advocacy groups, assorted politicians and various media outlets over the past several decades. Certainly some of these criticisms are warranted but as Dr. Offit points out in "The Cutter Incident" many of these accusations proved to be totally without basis. As a result of costly and time consuming litigation, many companies simply chose to discontinue the production of the vaccines that are essential to the health and well-being of so many Americans. A half century ago there were more than two dozen companies engaged in the manufacture of various vaccines. Today that number has dwindled to a mere four! This is an extremely unfortunate and potentially dangerous set of circumstances that could have far reaching implications if a serious outbreak of disease were to occur.
"The Cutter Incident" just might change the way you view many of these issues. Beware of the lawyers and the politicians with an ax to grind. There is another side to this story and Dr. Paul Offit lays it all out in this thoughtful and well-written book. Our system is broken and needs to be fixed and time is of the essence! "The Cutter Incident" is a great way to get yourself up to speed on these very timely issues. Highly recommended!

No single medical advance has had as much a positive effect as the devlopment of vaccines. However, thee are now only 4 companies involved with vaccines in the USA and little vaccine R&D.

This shortage is the result of the 1955 Cutter Incident in which Cutter Labs released a defective polio vaccine that had a deadly virus that out of 700,000 distributed vaccines, crippled 200 and killed 10. The resulting court case resulted in a chilling effect as far as future vaccine development is concerned.

This book chronicles the behind-the-scenes drama of a company that took a noble product, the polio vaccine, and screwed everything up. This book shows what can happen when a company fails to follow the required safe production protocols for a medicine. This very well written book helps you understand just why so few resources are allocated towards new vaccines.

The book provides an interesting window into health challenges of the early & mid-20th century. Offit discusses both our successes and failures in developing vaccines and in doing so provides much historical context. The book will be of interest to anyone who likes reading about medical history.

I don't have much time to read books and I skim many. Offit's book was so engaging, I found myself reading most of it word-for-word.

The book is indexed and is well referenced, with both a bibliography and chapter notes. As the book has a strong scientific foundation, the various anti-vaccination quacks won't like it. Despite its scientific basis, medical terms are defined and the text will be readily understood by non-technical people.

Whereas many disease history books tend to lose steam after a main incident is described (i.e., some of the 1918 flu books) or have trouble maintaining a story devoted to one disease (i.e., some of the smallpox books), Offit's book remains interesting through to the last chapter. In fact, everyone in the medical field should read the second-to-last chapter "Cigars, Parasites, and Human Toes" on the current state of health and law (in fact, I think the book should be required reading for anyone in health policy or health care fields.)

The book has many interesting historical nuggets: For example, despite the best medical technology of the time, Calvin Coolidge's son died from a simple infected blister. Who today would worry about dying from a blister? These stories help illustrate the difference between now and then when it comes to infectious disease. As a Professor who teaches risk assessment, I particularly liked the insights the book provided that help explain why seemingly rational educated people risk the health of their kids by not vaccinating them. It's both an important book and an interesting one.