As millions of Americans wrap up their summer activities, a dreaded enemy remains at large: the tick. Each year, there are more than 500,000 new cases of Lyme disease and other tickborne illnesses. Even “gold standard” treatments for the affliction are ineffective for a large percentage of patients and can destroy beneficial bacteria in the gut. The good news is that scientists are making progress in developing a vaccine to ward off Lyme disease. However, a perfectly-good Lyme vaccine called LYMErix has already graced the market—only to be withdrawn by its producer more than twenty years ago following baseless lawsuits and unfounded fears. A new vaccine can keep Americans safe from Lyme disease, but only with the right reforms in place and leaders committed to science and innovation.
Lyme disease should be a relic of the past, not a modern-day excuse to don pricey tube socks. The future of Lyme prevention seemed hopeful in 1998, when the Food and Drug Administration (FDA) greenlit LYMErix. The first-of-its-kind vaccine reduced new infections in vaccinated adults by nearly 80 percent without significant side-effects. Unfortunately, farfetched fears soon dominated the conversation over the new product. A 2006 National Institutes of Health study noted, “Although individuals claimed a wide variety of vaccine side-effects, musculoskeletal complaints such as arthritis dominated. The media put a human face on this suffering by carrying the stories of these ‘vaccine victims.’” But, data from the Vaccine Adverse Events Reporting System shows that arthritis rates in vaccinated patients were not higher than rates in unvaccinated individuals. The vast majority of reported symptoms were minor, temporary, and resolved on their own.
The lack of evidence didn’t stop trial lawyers from declaring war on the vaccine. In 1999, the Philadelphia law firm Sheller, Ludwig & Bailey initiated a class action lawsuit against LYMErix’s maker SmithKline Beecham (SB) alleging that SB failed to warn consumers about the link between arthritis and its vaccine. Despite the FDA further examining the data and concluding that the vaccine was safe, the lawyers remained unsatisfied. SB—which by then had become GlaxoSmithKline—caved to looming legal issues and unrelenting media scrutiny, withdrawing the vaccine from the market in 2002 and settling with plaintiffs’ lawyers in 2003. The lesson is clear: no matter how effective a vaccine or therapy is, or how confident medical professionals and the FDA are in its safety, trial lawyers can use the courts to keep innovative and effective products away from consumers.
Even top health officials in the U.S. have contributed to misinformation about maladies such as Lyme disease and are making vaccine development more difficult. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy (RFK) Jr. has bizarrely stated that Lyme disease is “highly likely to have been a military weapon” and wants to increase regulatory hurdles to the approval of new vaccines.
And, for vaccines geared toward other illnesses, Secretary Kennedy has made it difficult to avoid runaway litigation. A January Reuters report notes that RFK Jr. “played an instrumental role in organizing mass litigation against drugmaker Merck over its Gardasil vaccine,” which provides protection against certain strains of human papillomavirus (HPV). Kennedy tapped a “network of influential lawyers” and built a case on the baseless premise that “Merck had fraudulently advertised Gardasil as safe, overstating its benefits while concealing knowledge of dangerous side effects.” He’s called the vaccine “dangerous and defective” without evidence, undermining a key tool that has saved lives. While Kennedy claimed he will not accept any Gardasil litigation fees as HHS Secretary, he will instead give the fees to his son—a troubling arrangement that raises conflict of interest concerns.
Public health officials such as Kennedy must make clear that conditions such as Lyme disease and HPV are real risks for patients and quit spreading fear and doubt about vaccines. Policymakers should also consider reforming product liability law to limit runaway damages and ensure that safety evidence from agencies such as the FDA gets its day in court. Despite recent encouraging rulings throwing out spurious vaccine suits, current precedent requires it to be “impossible for a private party to comply with both state and federal requirements” for preemption to kick in. This makes it too difficult to argue in court that FDA decisions—no matter how thorough—should win out over onerous local laws and requirements. State and local lawmakers can solve this issue by clarifying that FDA decisions vouching for a product’s safety have the final say in court.
In addition, the Gardasil and LYMErix examples underscore why Kennedy should not be able to undermine the Vaccine Injury Compensation Program (VICP) and other guardrails that serve as a check on power within the government to protect public health and safety. Before the creation of VICP, the number of vaccine manufacturers declined significantly due to risks of lawsuits. Appallingly, under Kennedy’s leadership the HHS awarded a $150,000 contract to an Arizona law firm for “expertise” in the program. That supposed expertise is in manufacturing lawsuits. The resulting lawsuit-friendly environment kills game-changing vaccines and therapies, harming patients in the process.
It's time for a science-based approach that puts patients over pedaling fear. Policymakers must do everything in their power to get promising vaccines and cures to consumers.
Ross Marchand is a senior fellow for the Taxpayers Protection Alliance.
