Sometimes scientific evidence isn’t always taken as truth when first presented. We’ve seen examples of such many times throughout history; for example, it took years for the CDC’s 1964 warning that smoking causes lung cancer to be taken seriously. This same aversion to acknowledging health warnings was apparent in case against the pertussis vaccine, which for years was known to cause adverse effects in children and which could have easily been replaced by a safer alternative. Yet it took decades for the government and manufacturers to not just listen, but take action.
The Early Years
The story of the pertussis vaccine and the push for a safer alternative began in the early 1900s, when scientists first began exploring a vaccine that would prevent the spread of the highly endemic whooping cough (also known as pertussis), which killed thousands of individuals each year. The whooping cough is caused by a bacteria that infects a victim’s respiratory system, leading to frequent coughing, irritation and an increased risk for seizures, among other effects. Given the severity of the disease and its ability to easily spread among individuals, the development of a pertussis vaccine was both welcomed and necessary. Development of the vaccine continued throughout the first half of the 20th century.
The Evolution of a Vaccine
By the mid-1960s, children in most states across the United States began receiving the pertussis vaccine. This vaccine included an active, whole-cell strain of the toxin pertussis necessary for creating needed antibodies. This whole-cell version of the vaccine underwent numerous prior alterations before it was deemed acceptable, yet trials of the final whole-cell vaccine still yielded conflicting results regarding its effectiveness and safety.
The whole-cell version of the pertussis vaccine (DPT) also contained high levels of endotoxins, a fact that manufacturers chose not to make public. In 1961 pertussis vaccine manufacturers were explicitly notified by the International Symposium on Pertussis that the current whole-cell vaccines were correlated to significant neurologic disorders in children who had received the vaccine.
As the Geiers have noted, every year since the 1950s, there have been reports published describing adverse effects like seizures and even sudden death among children who received the DPT vaccine. The scientific community and general public gave increasing attention to these findings throughout the 1970s and 1980s, and evidence continued to mount.
In 1979, the CDC even held meetings to determine if a relationship existed between sudden infant death syndrome and the DPT vaccine; shortly after, the DPT vaccine was recalled from a number of states, yet was reinstated immediately after the recall without a specific explanation. The FDA went so far as to issue an apology to pharmaceutical companies for the recall.
All the while, an acellular version of the vaccine, which included a safer, inactive pertussis strain that would reduce the risk of adverse effects, was available for administration. Yet this safer acellular alternative was not produced by manufacturers, who believed the version to be too costly and difficult to market. Meanwhile, a number of countries outside of the United States were abandoning the whole-cell vaccine for safety reasons and instead using the acellular vaccine.
The Push for an Acellular Pertussis Vaccine
It was only until lawsuits were waged against pharmaceutical companies and those like Dr. Mark and David Geier lobbied for government action that changes began to occur. Mark and David Geier had conducted their own research on the adverse effects of the pertussis vaccine and also found a link between the vaccination and convulsions, fevers, and death among children who had received the vaccine. In addition to his research, Dr. Geier also testified in numerous court cases against pharmaceutical companies. Yet Geier and the petitioners he testified for faced a number of challenges from the Department of Health and Human Resources, as well as the professional opinions of researchers conveniently funded by pharmaceutical companies. Despite these obstacles, in 1992 the FDA officially approved an acellular version of the pertussis vaccine for children at 18 months and 5 years and the whole-cell DPT vaccine was removed from the U.S. market by 2001, though it’s still manufactured and sold to buyers overseas.
As the story of the pertussis vaccine and the Geiers’ experience demonstrate, making a change for the better isn’t always as easy as proving the change is necessary. Often, when research yields evidence unfavorable to government and industry, it can take years, even decades, to shift perspectives and prompt a safer course of action.