Legacy of an ill-fated vaccine (book excerpt: The Cutter Incident)

In his book, Philadelphia infectious disease expert Paul Offit, MD, details how a bad vaccine from Cutter Laboratories paralyzed and killed people 50 years ago.

By Paul Offit, MD, amednews correspondent — Posted April 10, 2006

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On the morning of Friday, November 22, 1957, two and one-half years after the Cutter incident, the case against Cutter Laboratories began in the Alameda County Courthouse in Oakland, California. In a large, plain room lacking murals, wood paneling, or an imposing dais, [family attorney Melvin] Belli linked Cutter Laboratories to his client. He showed that Cutter made a vaccine that was shipped to City Pharmacy in Santa Barbara, California; that William Oliver, Anne Gottsdanker's pediatrician, bought Cutter's vaccine from City Pharmacy; that Anne received Cutter's vaccine by injection into her right upper thigh; that Anne was paralyzed ten days after the injection; that type 1 polio virus was present in Anne's intestines; and that the vaccine that Anne received contained live virulent type 1 polio virus.

Anne sat in the courtroom while her father told the jury what happened during the family's drive back home from Calexico to Santa Barbara, eight days after she had received Cutter's vaccine: "She vomited while she was in the car and said that her head hurt terribly. When we got to El Cajon we stopped off at a medical clinic and saw the physician there, a Dr. Myer. I carried her in. He advised us to get to Santa Barbara as quickly as we could. In the afternoon we saw Dr. Oliver [who] told me that he suspected polio. She began to have considerable pain, not so much in the neck any more, but in the right leg. Then there was pain in the left leg, and we noticed that she couldn't even sit without help."

After Robert Gottsdanker stepped down from the witness chair, Belli turned to Anne and asked her to walk for the jury. Wearing a red sweater to hide her back brace, Anne couldn't hide that both legs were severely paralyzed. "Do I have to show them?" she asked her mother. Using her crutches and brace and under the gentle urgings of her mother and Melvin Belli, Anne haltingly, gamely tried to walk. Later a chilling exchange between Belli and Anne's doctor, Herman Kabat, revealed just how badly Anne had been hurt by Cutter's vaccine:

Belli: And have you any prognosis that you can give the Ladies and Gentlemen of the jury on Anne? What is going to happen to her?

Kabat: She has permanent and complete paralysis of her right [leg].

Belli: Will that get any better?

Kabat: No.

Belli: Will that leg grow equally with the other leg?

Kabat: We don't expect it to, no.

Belli: Any surgery for that?

Kabat: If the shortening is enough it would be necessary to carry out a procedure, a surgical procedure on the left leg to decrease the rate of growth of that leg so that the difference of the [legs] will be less.

Belli: How about the other leg?

Kabat: The other leg has muscles that are severely paralyzed and others that are only partly paralyzed.

Belli: Do you expect to get any improvement of that leg?

Kabat: I wouldn't think so.


In this next excerpt, Dr. Offit discusses the decrease in production of vaccines after the jury found Cutter was not negligent but still liable for harm caused by its product.

Unfortunately, despite protections afforded by the National Vaccine Injury Compensation Program, pharmaceutical companies are gradually abandoning vaccines. In 1957, when Cutter Laboratories made a vaccine that wasn't safe, twenty-six companies were making five vaccines. In 1980, when the first lawsuits against the makers of pertussis vaccine were filed, seventeen companies were making eight vaccines. In 2004, four big companies (GlaxoSmithKline, Sanofi-Aventis, Merck, and Wyeth) were making twelve vaccines. Although some of this decrease can be accounted for by merger, most is the result of dropouts. For example, Eli Lilly and Parke-Davis -- the two large companies that made Jonas Salk's polio vaccine for the 1954 field trial -- eventually abandoned vaccines. Of the twelve vaccines routinely given to young children, seven are made by a single manufacturer; only one vaccine is made by more than two companies. Because fewer companies make vaccines, limited supplies and scant reserves are available to meet a crisis. Events surrounding the influenza vaccine between 2003 and 2005 are particularly instructive.

The news media rarely report the yearly epidemic of influenza in the United States, but in 2003 the epidemic started early, and television reports of children dying from the disease were common. People were desperate to get an influenza vaccine. Unfortunately only one big pharmaceutical company, Aventis, made it. In 2003 Aventis made 48 million doses, and Chiron, a small British vaccine manufacturer, made 35 million doses. When the epidemic hit, the number of people who demanded vaccine greatly exceeded the supply. Because reserves were small, a vaccine shortage resulted. Many people who wanted and needed the influenza vaccine early in the epidemic couldn't get it. Between October 2003 and April 2004, 36,000 people died from influenza; 152 were children.

Problems with the influenza vaccine continued one year later. In 2004 Aventis made 55 million doses, and Chiron, in an effort to avoid the shortfall in 2003, made 48 million doses. But Chiron had a manufacturing problem, and all 48 million doses were withdrawn before the start of the influenza season. As a consequence, the United States entered the 2004 season knowing that about 30 million people who had been immunized the previous year would not be receiving influenza vaccine. The CDC, the FDA, and pharmaceutical companies were all blamed for inefficiency, and during the presidential debates on October 13, 2004, both candidates accused each other of failing to provide the nation with needed vaccine.

The shortage of influenza vaccine is just one example in what has been a steady, unrelenting procession of vaccine shortages. Between 1998 and 2004 severe shortages occurred for the diphtheria, tetanus, pertussis, measles, mumps, rubella (German measles), pneumococcal, influenza, and varicella (chickenpox) vaccines; there have been shortages in nine of the twelve vaccines routinely recommended for all children. Every one of these shortages resulted in a delay in the receipt of vaccines, and some children never caught up when vaccine became available.

The pneumococcal vaccine shortage was particularly damaging. First licensed in the United States in 2000, the pneumococcal vaccine protects children against disease caused by pneumococcal bacteria. Before the vaccine was available in the United States, every year pneumococcus caused tens of thousands of cases of severe pneumonia, meningitis, and bloodstream infections in young children. Thousands of children died or were left with permanent brain damage because of pneumococcus. Only one company (Wyeth) makes the pneumococcal vaccine for children. By August 2004 the shortage of pneumococcal vaccine was so severe that the CDC recommended rationing it. Instead of the recommended four doses in the first and second years of life, the CDC recommended that children receive only two doses. Although studies showed that a four-dose schedule clearly prevented pneumococcal infections, a two-dose schedule had never been tested to see if it worked. In mid-2004 a sixteen-month-old boy was hospitalized in Philadelphia with severe pneumonia caused by pneumococcus. His parents had been told by their pediatrician that he couldn't get all four doses of the pneumococcal vaccine because of the shortage. Despite adequate antibiotic therapy and heroic supportive measures, the boy's pneumonia worsened, and he died from the disease. The pneumococcus isolated from the child's blood was a type that could have been prevented by the vaccine. If the vaccine were made by several companies, children wouldn't have to rely on the production efficiency of one company to save their lives.

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Author Q&A

What is the Cutter incident's longest-lasting impact?

The Cutter incident opened a legal door that caused many pharmaceutical companies to abandon vaccines in the late 1970s and early 1980s. The birth of liability without fault for pharmaceutical companies following Gottsdanker v. Cutter Laboratories lowered the bar for liability, making vaccines a very unattractive product. By the time the government responded, with the National Childhood Vaccine Injury Act in 1986, many companies had permanently abandoned vaccines.

Was it just the Cutter trial that has stopped companies from making vaccines, or have there been other incidents that have made companies shy away from producing vaccines?

Certainly, pharmaceutical companies have abandoned vaccines over the last 50 years. There were in 1957 about 26 pharmaceutical companies that made vaccines. By the early 1980s, there were 18. Today, there really are four big companies that make them. ... When Cutter went to court, it was the birth of liability without negligence. That lowered the bar for what it took to find companies liable for their products.

Is today a more critical time than ever before for new vaccines to be produced? If, so, why?

I don't think it's a more critical time. A hundred years ago was a more critical time with children routinely dying of diphtheria and measles. Children were hurt while in the mother's womb by viruses like rubella, which caused severe birth defects. The vaccines that were introduced in the 20th century are probably the most significant contributors to our increasing life span. The 20th century saw Americans' life span increase by 30 years, and much of that increase was due to vaccines.

What do you think would need to change today for companies to more actively produce new vaccines?

For companies to actively pursue vaccines, society would have to value prevention. Currently, less than 3% of the health care budget is spent on prevention. We just never think things like heart attacks, strokes, colon cancer, breast cancer or infectious diseases are going to happen to us. We are guided wrongly by this myth of invulnerability. When we value prevention, pay for prevention, companies will be more likely to actively pursue the research and development of vaccines.

What's needed to ensure that there are enough vaccines to avoid a flu vaccine or other shortage?

The simple thing to do is to just extend the Vaccine Injury Compensation Program, which is cover all vaccines independent of whether they're universally recommended, make sure that the unborn child is covered when the strategy is one of maternal immunization and to not allow these lawsuits to get to state court, which could be disastrous. More important than just liability protection, the government needs to create mechanisms to make it more interesting for these companies to spend the money on research and development to make these products.

Interview by Damon Adams

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