|
Lynora Saxinger, an infectious-disease specialist and professor of medicine at the University of Alberta, says the situation is poised to get worse. Ticks love humidity, and warmer temperatures caused by climate change are forcing them to head north. A 2017 government report found that, if current climate trends continue, Lyme-carrying blacklegged ticks will keep spreading, which makes the need for a solution all the more urgent. So why has it taken scientists so long to develop a new vaccine especially when the technology already exists?
When LYMErix first hit the market, it was a novel development. The vaccine administered in three doses and recommended for people ages fifteen to seventy used the Borrelia burgdorferi surface protein to stimulate an immune response and create antibodies in a person’s bloodstream. Unlike traditional vaccines, which trigger a response after a host has already been infected, LYMErix attacked the disease directly in ticks. The acquired antibodies were essentially a Lyme elixir that could kill the bacteria in a tick’s gut before it could be transmitted.
Given the positive data that emerged from clinical trials, which included more than 10,000 people, coupled with the growing concerns of Lyme disease in endemic areas, like Connecticut and Massachusetts, drug makers and epidemiologists didn’t anticipate much controversy around the vaccine, says Robert Aronowitz, a professor of social sciences at the University of Pennsylvania who authored a paper on the fall of the Lyme vaccine. But, once LYMErix got FDA approval, the CDC’s Advisory Committee on Immunization Practices (ACIP), which recommends vaccines for clinical use, gave it a lukewarm review: a “should consider” recommendation for people at high risk and a “may be considered” recommendation for those exposed to areas where ticks live. As Aronowitz wrote in his paper, some scientists considered the shot to be a “yuppie vaccine” that was manufacturer and consumer driven. At the time, the assumption was that it was primarily of interest to anxious suburbanites who “will pay a lot of money for their Nikes and their Esprit and shop at L.L. Bean,” wrote Aronowitz. It wasn’t that the ACIP was questioning the science; they just didn’t see any urgent need for the vaccine.
“That kind of recommendation matters in terms of whether a vaccine could be reimbursable by an insurance company,” says Telford, now a professor at Tufts University’s Cummings School of Veterinary Medicine. In the US, where the shot was being developed, that reception mattered even more. “This vaccine was not reimbursable by insurance; it was an elected vaccine.”
Telford says that the weak recommendations led to concerns around limited interest something researchers had already been grappling with, since Lyme is a treatable disease and was, therefore, viewed as less serious. This created a self-fulfilling prophecy for SmithKline Beecham, which, with its misdirected marketing efforts, alienated many of those who were interested in the vaccine. Instead of trying to sell the vaccine to health care providers, the pharmaceutical company advertised directly to consumers, like gardeners, golfers, and even people who barbeque outdoors. It seemed like their strategy was to try to make people more worried about being exposed to Lyme. One TV ad at the time included the line “I never thought I was a target for Lyme disease . . . until I found out you can get it in your local park, in your own backyard, or even mowing the lawn.”
Around the same time, anti-Lyme vaccine sentiment was bolstered by citizen-advocacy groups concerned with raising Lyme “awareness.” While there was initial interest in the vaccine, some members claimed that, in clinical trials, scientists used narrow, objective criteria for what constitutes a Lyme disease diagnosis by including symptoms like rashes, headaches, neck stiffness, and neurological problems. For those who believed chronic Lyme symptoms were often misunderstood or ignored, this meant that many suffering patients were now essentially being told that they needed to meet specific criteria to be diagnosed, which might prevent them from getting the treatment they needed. In response, these groups began to lobby decision makers like the National Institutes of Health. Their aim was to influence not only how much money should be devoted to their cause but also to sway what exactly researchers should be studying. Tension was brewing between scientists and Lyme advocates. In a 1997 op-ed for the New York Times, scientist Alan Barbour wrote, “Basing their arguments on anecdotes and unsubstantiated information, they want to be coaches as well as boosters. Yet they are not qualified to call the plays. . . . Is this really how we want science to be conducted? Those who suffer from Lyme disease are better served by letting scientists do their jobs.”
Bad press continued to plague the vaccine after a string of lawsuits were filed against the LYMErix maker in the early 2000s that alleged the vaccine did not mention the possibility of developing arthritis. Early studies showed that when the surface protein the same one used in the vaccine was injected into the joints of hamsters, they could develop arthritis. In humans, however, this was never proven to be a real threat. Lawyers argued that, regardless of what the science showed, people should have still been warned of the theoretical risks. In other words, the suits had little to do with any real adverse reactions but, instead, with the wording around them. “In the hearings, a lot of people claimed that they got something like Lyme disease from the vaccine, and even though clinical trials did not show much in the way of unusual, rare reactions, individuals’ claims in the hearings coalesced with an antipathy to the vaccine,” Aronowitz explains. Research has shown that the rare stories about someone suffering an adverse reaction are more “sticky” than real-world data. In other words, one bad headline can often be enough to convince people that a vaccine is too dangerous, even if there’s overwhelming research showing otherwise which is exactly what happened with LYMErix.
With its reputation in a shambles, the vaccine’s sales dropped to around 10,000 doses in 2002 from 1.5 million in 1999. Connaught Laboratories, which was working on developing another Lyme disease vaccine at that time, saw what happened with LYMErix and voluntarily withdrew its project. Trying to convince people that it was safe, they decided, would be too difficult. That sentiment persisted through the following years, and no vaccine ever hit the market.
North America’s rejection of the Lyme disease vaccine is hardly unique. As early as the end of the eighteenth century, after the smallpox pandemic killed millions of people, scientists were met with skepticism after creating one of the first-ever vaccines to fight the disease. While times were different and the technology was new, the reasons for the pushback overlap with the same arguments vaccine skeptics make today: a refusal due to religious beliefs, anger over vaccine mandates (the UK mandated smallpox shots for all children in 1853), and a general distrust of medical authorities.
Public perception of vaccines went on to create a slate of problems for the DTP diphtheria, pertussis (whooping cough), and tetanus vaccine in the 1970s and ’80s. After a 1974 report from a UK hospital alleged that children who had been vaccinated against DTP suffered neurological conditions, such as convulsions and muscle weakness, people began to doubt whether the vaccine was really safe. TV reports highlighting the controversy emerged alongside noisy parent anti-vax groups, leading to confusion over the vaccine’s benefits. Despite the fact that the risk of the disease was far more dangerous than the shot itself, the media made many parents believe that it was too risky, and they refused to get their kids immunized. Vaccine uptake slowed, and soon after, there were “near-epidemic outbreaks” of whooping cough in several parts of the US and Europe.
|
