WHY DON'T we HAVE A LYME DISEASE VACCINE?

One of the joys of our post-professional lives is our little cottage in the pinky of Northern Lower Michigan, at the fringe of the Sleeping Bear Dunes National Lakeshore. Of all the homes we’ve owned during our fifty years of marriage, it’s the only one we ever built; our daughter designed it for us, so it is uncompromisingly tailored to our needs and tastes. My husband enjoys swimming, kayaking, and cycling in the summer and Nordic skiing in the winter. I like hiking and also love the fresh produce I can buy at local Farmer’s Markets throughout the summer, as well as the many destination restaurants within just a few miles of us. Until the Sleeping Bear Dunes area was voted "the most beautiful place in America” by the viewers of Good Morning America in 2011, the attractions of coastal Michigan were a well kept secret; now the tourists have discovered them, and so long as they treat the land and water with the same respect that we do, we’re happy to share. As a member of my early-morning walking group exclaims at least once a week, “Girls, we live in Paradise!”

Within the last few years, however, a serpent has invaded Paradise. Our beloved Sleeping  Bear Dunes has been officially identified as an "emerging Lyme Disease area," meaning that the  conditions for an epidemic - environmental factors, the vector (the tiny black-legged deer tick), the pathogen (the Borrelia burgdorferi bacterium), and the host (deer and other wildlife) - are actually emerging here even as I write; that is, just a few years ago infected ticks were typically not found here and today they are. Major bummer. The National Park Service has led the way in encouraging tick awareness and is hoping that tucking your pant legs into your socks will become a new fashion statement.

When our daughter enrolled our granddaughter in a sleepover camp just half an hour south of us, she asked about tick precautions and was told they were “too far North” for Lyme Disease to be a concern. Not so! It is important to understand that the disease does not simply fan out from areas where it is already established. Since the pathogen is carried by wildlife including birds, it can emerge wherever environmental conditions are right and deer ticks are present. Consequently, the disease is currently spreading into widely dispersed areas of the country.

Lyme Disease is no joke. Around 30,000 cases per year are reported to the CDC (almost certainly a massive underestimate, probably by a factor of ten) in individuals of all ages in the U.S. alone. Initial symptoms can include rash, headache, fever, fatigue, and joint pain. If antibiotic treatment is delayed or withheld, chronic arthritis, serious neurological difficulties, cardiac problems (sufficient in some cases to require a heart transplant), or even death can ensue.

Unfortunately, detection, diagnosis, and treatment of Lyme Disease are fraught with uncertainty. For starters, the tick bite does not necessarily cause pain or itching so you may not even realize you’ve been bitten. If you do find a tick on your body, you can only guess at whether it's been feasting long enough to transfer the pathogen - if indeed "your" tick carries the pathogen at all. If you develop the telltale bullseye rash (caused by the rash fading near the bite site over time as it spreads progressively outward), then you almost certainly have the disease and antibiotic treatment should be initiated. In many instances, however, the rash is absent or presents atypically, and at that point, depending on your symptom profile and whether you live in an area where the disease is endemic, it becomes a judgment call on your part as to whether to seek treatment, and then on your doctor's part as to how best to proceed.There is no direct lab test for the pathogen in your blood; it can only be detected by the presence of antibodies, which develop later and possibly not at all if you’ve been treated with antibiotics.  Although antibiotic treatment is usually successful, many doctors tend to discount the risk and over-worry about antibiotic use. The overall clinical picture is one of under-treatment.

Last night while we were watching TV, my husband showed me a scab he’d just noticed on his upper arm. Then, when I returned this morning from my walking group outing, he grimly displayed a plastic pill bottle containing a tick he’d found on his underwear. Was the scab he’d scratched the night before from a tick bite? Had the tick he found this morning been attached long enough to cause the disease? We had no way of knowing, but he took his specimen (which will probably live indefinitely, since deer ticks can go for at least a year without food or water) over to our local physician’s office. Because she apparently prefers to err on the side of caution - and perhaps also because she’s been lobbied by the Park rangers - she recommended a course of Doxycycline. 

EXHIBIT A - deer tick

At this point in my narrative, you may be wondering why we have no vaccine against Lyme Disease. After all, surely preventive measures would be preferable to the haphazard and nonstandardized approaches to diagnosis and treatment described above, and would have spared my husband the course of antibiotic treatment he now faces. 

When I first learned that dogs in high-risk areas are already commonly vaccinated against Lyme Disease, I heaved a sigh of relief: A vaccine for humans couldn't be far behind, right? Wrong! It turns out there's already a vaccine for humans, called LYMERix, licensed in 1998, that has proved safe and effective in Phase III clinical trials and has FDA approval - and the manufacturer withdrew it from the market in 2002! Why? In short, "low vaccine uptake, public concern about adverse effects, and class action lawsuits." Self-styled “Lyme advocates” even claimed it caused arthritis, a classic symptom of  the disease itself. There may well have been other factors involved in the withdrawal of the product (the complexity of the dosing schedule, need for further testing in a wider range of volunteers, etc.), but these are exactly the kind of challenges Big Pharma routinely grapples with and solves. Dr. Stanley Plotkin, Professor Emeritus at the University of Pennsylvania, who nearly lost a son to complications of Lyme disease, describes  the lack of an effective vaccine when it is clearly possible to make one as “a public health failure that is shameful for the medical and public health community.” Although newer and perhaps even more effective candidate vaccines are currently under development, obtaining approval may be an uphill struggle given the inauspicious history of LYMErix.

This is an issue that goes far beyond LYMERix. We think of antivaccinator activism as discouraging use of vaccines intended to prevent communicable diseases of childhood, but it also dampens enthusiasm for research and development on other potentially-preventable human scourges that may affect people of all ages, adults as well as children. There's plenty of suffering in this world that we can't prevent; please let's not landmine efforts to develop scientifically sound and effective preventive measures like those that have freed the world of smallpox and dramatically reduced the incidence of polio.