By: Michael Seinberg
In 1975, Dr. Allen Steere was sent to Connecticut to investigate a strange cluster of children who had developed arthritis. After diligent research, Dr. Steere and his colleagues discovered the disease we now know as Lyme disease also finding that ticks were the cause. By the early 1990s, two major pharmaceutical companies were on track to produce a vaccine for the growing threat, and by the mid-1990s clinical trials were underway. Results showed a whopping 80 percent of test subjects became immune to Lyme disease. So what went wrong? Trial lawyers, the media and public hysteria.
The fully tested vaccine was introduced in 1998, and sold very well until people began to claim they got arthritis from it. Despite NO actual clinical data to support those claims, the public began to believe the claims, and as is too often the case, lawyers got involved and started to put a class action lawsuit together. Anti-vaccine groups were formed, and the scientists involved began to receive threats. Dr. Steere had to hire a security detail things got so out of hand.
To make it clear, the Centers For Disease Control and The Food and Drug Administration looked into the anti-vaccine claims but found nothing and recommended those in tick infested areas get the vaccine. But the damage was done, and SmithKline Beecham pulled the vaccine. Pasteur Mérieux Connaught was working on its own vaccine, but never released it as a result.
So here we are in 2013 only able to offer a Lyme vaccine to animals. With cases growing every year from 10,000 confirmed in 1995 to at least 30,000 in 2009, there is a renewed push for a human form of the vaccine. “In my opinion, this is a public health fiasco,” said Stanley A. Plotkin, a pediatrician and infectious disease specialist at the University of Pennsylvania, Philadelphia. “There are well over 20,000 annual cases of Lyme disease and probably more than that. When else do you have a disease with that incidence where you know you can prevent it with a vaccine, but you don’t make it?”
With that sort of growth (Lyme is now the most common tick-borne disease in the U.S.) and the severity of the disease, it would seem that making a vaccine for people would be a forgone conclusion, but that’s not the case. When deciding when to develop a drug, pharmaceutical companies must weigh profit versus legal risk factors. In Massachusetts, where the disease is very widespread there has been a call for the state to step in since private industry appears unwilling or unable to do so.
At a hearing last summer, of the Massachusetts Lyme Disease Commission, veterinarian Sam Telford suggested the state license GlaxoSmithKline’s FDA-approved vaccine. He suggested that it could be produced at a state lab, but Glaxo has not said if they’d jump on board, no doubt waiting to hear from their lawyers. “We all know that the market has changed,” Dr. Telford said then. “People are fed up! This is a terrible situation we’re in, which means that a vaccine still makes sense.”
“I’m personally aware of individuals, who in desperation have gone to veterinarians and remarkably convinced the veterinarian to inject them with the canine vaccine,” said Dr. Gregory Poland a vaccinologist at the Mayo Clinic
While keeping the Lyme vaccine away from humans may prevent lawsuits against pharmaceutical companies, it hasn’t stopped the lawsuits altogether. Just this past March, a Connecticut woman won a $41 million lawsuit against her school for contracting Lyme disease while on a school trip to China. Had the vaccine been available, this woman would likely still have her speech and the lawsuit would have been prevented.
So while lawyers argue over liability and manufacturers worry about class action lawsuits, people – many of them children – are left to suffer if bitten by an infected tick. It’s hard to tell what’s more harmful, ticks or trial lawyers. They’re both making people sick and keeping them that way.