AFTER FOUR DECADES, it’s time to get our summers back.
This time of year in New England should mean beach days, ice cream, hikes in the mountains. Instead, for thousands of residents, year in and year out, it means a debilitating bout of Lyme disease, the often-painful tick-borne bacterial illness that arrived with day-glo in the ’80s — but then, unlike leg warmers, never left.
Just in 2017, there were 5,323 confirmed cases of Lyme in New England, according to the Centers for Disease Control — making the region the epicenter of the disease. Lyme cases peak in the summer months, and in Massachusetts it especially affects children aged 5 to 9 and adults aged 65 to 74, who have the highest incidence rates for the disease.
Even if you don’t catch Lyme disease, you have to worry about Lyme disease — slathering on bug spray, checking your kids for deer ticks, wearing long pants stuffed into your socks.
What’s most irksome about the persistence of Lyme is that the disease is such an eminently solvable problem. In fact, it essentially has been solved — for dogs, who can be immunized against Lyme.
It’ll take two things to end Lyme for people: first, adequate funding for research and prevention, and second, a determination to take the problem seriously.
The truth is that Lyme disease has never gotten the respect it deserves.
When a human vaccine was approved for Lyme in 1998, the federal review board that reviews vaccines gave it a tepid recommendation, and insurers didn’t cover it. One expert questioned the need for a drug for a disease mostly associated with woodsy Northeastern suburbs, brushing it off as a vaccine for “yuppies.” The drug was eventually withdrawn by its manufacturer — leaving Lyme with the dubious distinction as the only widespread illness that used to have an approved human vaccine but doesn’t anymore.
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Other solutions scientists have offered to reduce the population of Lyme-spreading ticks — deer hunts, for instance — usually fall flat. Even as Lyme continues to spread its geographic reach, the public’s priorities couldn’t be clearer: When the choice is between Bambi or bacteria, Bambi almost always wins.
And federal funding is less than robust, according to a report to Congress filed last year, which faulted the government’s financial commitment to Lyme research, finding that spending had “failed to increase as the problem has grown.”
For today’s special section, the Globe contacted Lyme researchers in Greater Boston and the broader medical community, many of whom have spent decades raising awareness of the ailment and seeking effective treatment and prevention strategies. They don’t expect miracles: Lyme research isn’t going to elbow aside spending on major epidemics and global health crises, and they’re thankful just for recent funding increases from federal health agencies. They know mass killing of deer is unlikely.
But as the disease continues to spread, its costs to the health care system — and the broader economy when workers miss work because of Lyme symptoms — have been mounting. Those costs are building a dollars-and-cents case for taking Lyme disease much more seriously as a bona fide public health threat.
The first step, many of the Lyme experts said, is to facilitate the development of a new human vaccine, and ensure it gets a warmer reception than the 1998 vaccine. More research is also needed on the rare cases of patients with post-treatment symptoms, and to better understand the impact of Lyme on children. Finally, researchers say, a sharp focus on ticks themselves — tiny creatures that often brim with big diseases — could yield public benefits that go well beyond just Lyme Disease.
NAMED FOR THE bucolic Connecticut town of Lyme, where it was first described in the late 1970s, Lyme disease is spread by deer ticks, minuscule blood-sucking insects that arrived in force as white-tailed deer repopulated New England after the mid-20th century. Bred on deer, the ticks pick up the infection from mice, and can then spread it to hikers, gardeners, or kids playing in the yard.
Lyme afflicts an estimated 300,000 Americans annually, and CDC data suggests it is especially prevalent among white people (92.8 percent of confirmed and probable cases in 2017) and men (57.9 percent). Potential symptoms include swollen joints, fever, fatigue, and, in 70 to 80 percent of patients, a “bullseye”-like rash around the tick bite. The vast majority of patients recover with a short course of antibiotics. A small minority report longer-term symptoms. Since the disease’s discovery in the late 1970s, two deaths related to Lyme carditis — when the disease reaches the heart — have been reported in Massachusetts, according to the Department of Public Health.
The disease also extracts an economic toll; a 2015 study pegged costs between $712 million and $1.3 billion annually.
Another troubling consequence of the spread of Lyme is less obvious, but perhaps more insidious: because there is so little understanding of post-treatment symptoms that affect a minority of patients, some of them have demanded long-term antibiotic treatments, even though studies have found that long-term antibiotic treatment is ineffective and can actually harm patients and the wider community. Not only can use of antibiotics produce serious side-effects in some patients, but the World Health Organization calls overuse of antibiotics “one of the biggest threats to global health, food security, and development today” because it contributes to antibiotic resistance. The failure to solve one public health problem — the post-treatment symptoms of Lyme disease — is making another, antibiotic overuse, worse.
Related: Stat | Can a new Lyme disease vaccine overcome a history of distrust and failure?
IN 2017, RESEARCH on Lyme disease got about $28 million from the National Institutes of Health, and another $11 million from the CDC, according to last year’s report to Congress. Spending takes the form of grants and technical assistance. The CDC maintains a panel of samples that companies developing tests can request; a new set of tests approved in July that simplify the testing process were developed in part through use of CDC’s panel. The NIH funds early-stage studies on potential vaccines, including novel approaches like vaccinating mice to intercept the disease.
Both agencies fund research into hundreds of other diseases, too — inevitably creating a balancing act of competing priorities. Advocates for more Lyme research point out that flu funding is $263 million from the NIH and $187 million from the CDC — more than 10 times the funding for Lyme.
But the comparison cuts both ways. The flu killed 79,000 people in the United States in the 2017-2018 flu season, and the bug kills between 250 and 1,100 a year in Massachusetts alone.
Even Lyme researchers expressed mixed views on whether funding was adequate. Sam Telford, a professor of infectious disease and global health at Tufts who has worked on Lyme since the 1980s, doesn’t fault the CDC or NIH: “I’d love to have more money, but both of them have supported tick-borne research to a level that is appropriate for their burden. They have all sorts of other disease issues they need to work on, they have to allocate money by public health burden.”
Anthony Fauci, the director of the infectious diseases section at NIH, said spending is determined by public health needs and also opportunity — the agency would increase funding if promising research opportunities arose. In the case of Lyme, he said, if vaccines in early research stages show promise, the agency would be ready to step up spending to support them. He sees supporting vaccine as a top priority.
“Our efforts right now are going into the early stage of various vaccine candidates,” he said. “We’re really trying to jump-start a broader vaccine effort.”
In addition to a new vaccine, researchers said there were still unanswered questions about the infection itself. “Understanding how it works and how it stimulates the immune system are important areas of research that particularly relate to some post-infection symptoms that can be quite severe and even long lasting,” said Allen Steere at MGH, who discovered Lyme.
Then there’s children: even though they account for a disproportionate share of Lyme cases, studies are rarely tailored to that population, said Lise Nigrovic, an emergency pediatrician at Boston Children’s Hospital who served on the HHS panel that wrote the report to Congress.
“Issues around how well the diagnostics work in children have to be investigated,” she said.
Watch: It’s time to take Lyme seriously
STILL, WHILE GOVERNMENT funding will remain important, a number of Lyme researchers told the Globe that in the near term, the single most critical thing the federal government and states can do wouldn’t involve spending any money of their own — but rather, facilitating private-sector investment.
One investment in particular: in the next year or so, Valneva, a pharmaceutical company in France will need to decide whether to commit at least $300 million to phase III trials of its Lyme vaccine, VLA15, which involves testing it on thousands of subjects. If the company goes forward with the trial, and it is successful, in four to five years consumers could have access to the first Lyme vaccine since the original vaccine was pulled from the market in 2002. Unlike LYMErix, the new drug will be available for children as young as age 5 at the time of licensure or shortly thereafter, and ultimately for kids as young as 2.
Although so far tests have been promising, and the same company successfully developed a vaccine for Japanese encephalitis, an investment that size is not a sure thing. There is precedent for companies bailing on Lyme vaccines late in development: the company PasteurMérieux-Connaught put a Lyme vaccine, ImuLyme, all the way through testing in the late 1990s, with successful results, but did not apply for a license to distribute it.
They need to be assured they will recoup their investment. One way to do that, said Stanley Plotkin, a prominent vaccine researcher, would be for state public health agencies to commit in advance to recommending a safe vaccine if it becomes available.
For the company to invest, he said, “they will have to be convinced that people who are the potential targets of vaccination will actually use the vaccine,” he said; commitments from public health authorities “would be an indication that a vaccine would be used.”
Thomas Lingelbach, Valneva’s CEO, said winning recommendations — first from the federal Advisory Committee on Immunization Practices, then states, is a key part of its strategy as it proceeds with its clinical trials. “Any recommendation on the back of that data is exactly what we are hoping for and expect,” he said.
Related: Is ‘chronic Lyme disease’ real?
In Massachusetts, the state could make a vaccine available through its Vaccine Purchase Trust Fund, which pays for standard vaccinations for children. Currently, state law requires a new drug to get recommendation from ACIP first.
That federal advisory board gave the first Lyme vaccine an unusually tepid recommendation back in 1998. At the time, the board said only that its use “should be considered,” amid concerns that an outright recommendation would cause too many people who didn’t really need the vaccine to demand it anyway, saddling providers with unwarranted costs. (One doctor worried that people who “pay a lot of money for their Nikes and their Esprit and shop at L.L. Bean’s will have no consideration for cost-effectiveness when they want a vaccine because they’re going to travel to Cape Cod.”)
Hopefully the worsening of the disease in the two decades since then will convince the committee to be less dismissive if the new vaccine makes it through the FDA’s approval process. A positive recommendation would also make the vaccine available to children at government cost.
ULTIMATELY, THOUGH, EVEN an effective Lyme vaccine would only be a partial public-health victory, warn researchers — and wouldn’t eliminate the need for further research.
Deer ticks often carry not just Lyme disease, but also babesiosis and anaplasmosis. In rarer cases, they may carry tularemia, Rocky Mountain spotted fever, Borrelia miyamotoi, and Powassan virus.
A 2011 paper raised the fear that a Lyme vaccine could even backfire by providing hikers, gardeners, and others exposed to deer ticks a false sense of security: “There is a concern that persons who receive a Lyme disease vaccine may not be as vigilant in protecting themselves against tick bites and, therefore, may be at increased risk of acquiring these other pathogens.”
Powassan virus, in particular, could prove scarier than Lyme. It has no vaccine or treatment and results in death in 10 to 15 percent of cases; victims include a well-known Maine painter, Lyn Snow, whose death from Powassan in 2013 brought attention to the disease. Although the number of cases in the United States is still tiny, a 2017 paper estimated it has increased 671 percent over the last 18 years. “With a significant increase in the number of Powassan cases in the last decade, there is an urgent need for further research and understanding of the virus, the vector, and the disease,” the paper warned.
Some local researchers recommended stepping up research on the ticks themselves.
Linden Hu, a professor of molecular biology and microbiology at Tufts who studies Lyme, said the government should aim to “get the sources under control, like they did with malaria.” In the mid-20th century, the United States tackled malaria not by curing the disease but by aiming at the carrier. The United States virtually eliminated malaria, which once killed hundreds of Americans a year, by drastically reducing the mosquito population.
Controlling ticks doesn’t necessarily mean killing deer — though that remains an option, especially in isolated areas like Martha’s Vineyard. One way to prevent infections, which has won research support from the NIH, would be to develop a vaccine that would react to tick saliva after a bite, blocking transmission of the disease and potentially eliminating multiple tick-borne maladies
Related: ‘The forest is not safe’: How Lyme disease struck fear into the heart of this nature lover
Another approach, currently the subject of an NIH-funded study, would be to vaccinate mice using food laced with an oral vaccine. Then there are more outside-the-box solutions: for instance, one research team is investigating whether genetically modified mice could be created that would be immune from Lyme.
Telford, who is participating in the genetic modification program, said that when he hears Lyme advocates call for a Manhattan Project-style commitment to Lyme, he feels it’s worth aiming higher, and tackling the root cause.
“As a public health person, I have a long term perspective and would prefer the Manhattan Project on — how do we reduce the number of ticks and make our communities a better place for our children and their children?”