Note: the following transcript is a radio script and contains audio cues and other quirks (including imperfect grammar) of the medium. It may contain typos.
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BIG THOUGHTS
Up here in the Northeast, Lyme disease scares people. It scares them so much that I’ve heard parents talking about not letting their kids go out in the woods. I heard a woman once waffle over whether her grandkids should be allowed in their backyard.
People want some kind — any kind — of protection.
May: One of the questions that I’m asked almost more than anything else… why can my dog be vaccinated against lyme disease but I can’t? Why can’t they come up with a human version? And of course the answer is we have a human version… or we had a human version…
[mux]
Meghan May teaches about infectious disease at the University of New England, and she’s here to tell us the story of LYMErix. The vaccine developed by the giant multinational pharmaceutical company Glaxow Smith Kline that was released in 1998, but pulled from the market in 2002.
Meghan May: The development of LYMErix was a really interesting point in vaccine technology because it was among the first human vaccines that was approved for use that was completely synthetic.
A synthetic vaccine… faster to make. Easier to control. Need a Quick vaccine refresher, by the way? Vaccines work by stimulating your immune response, usually by injecting a tiny amount of dead or weakened pathogen into your blood. But LYMErix was different.
Meghan May: It was the first of what we would kinda call a smart vaccine.
Remember how in the third episode we told you that the Lyme spirochete is covered with a tiny forest of spikes...
… called outer surface proteins?
Alan Barbour [37] - Spikes… or I would say it’s more like a forest with trees, the canopy on top.
Well, don’t ask me on the specifics on how, but the creators of LYMErix isolated one of those proteins, and then genetically engineered a bunch of ecoli bacteria so that they would produce it.
Meghan May: And you have given them this one gene that encodes this one protein that you want to make… and you let those organisms sit back and kick out a ton of that protein and then you purify it and that becomes your vaccine.
Sounds so simple when she says it doesn’t it? Well, here’s another fact about the vaccine that seems too good to be true. The researchers picked an outer surface protein that is only active BEFORE the bacteria gets into your body…
Meghan May: The second the tick takes blood from an immunized person, the antibodies in that immunized person are going to bind up the spirochetes inside the tick so it never even would get into the infected person.
By the way, Meghan says that feature? It wasn’t intentional...
Meghan May: no it was an accident! [laughs]
One of the world’s first synthetic, smart vaccines… a marvel of modern medicine. There were however, drawbacks. Significant ones. it took three shots before you were fully immunized… it wasn’t approved for kids under 15… it was kind of expensive and not covered by insurance…
But it worked. The vaccine was somewhere between 78 and 92 percent effective, and in those cases the Lyme bacteria never even got out of the tick.
So what happened??
[nbc news clip]
[patient zero mux]
What happened to the Lyme Vaccine? As is so often the case in Lymeworld, the vaccine was a victim of history. A casualty of circumstance. It was in the wrong place at the wrong time.
So Why did it go away, and what would it take to bring it back? In this bonus episode We’ll tell you.
I’m Taylor Quimby.
And this is Patient Zero.
So what happened to LYMErix? As you might have guessed, after hearing that newsclip… SOME people who got the vaccine started to complain of side effects.
Clip: But jenny marra has this advice for people considering getting it.
Marra: Don’t it’s not worth it. You’d be better off getting lyme disease.
The side effects weren’t the sort of thing you might expect from a vaccine… a sore arm and a light, passing fever… Rather, these side effects actually sounded a little bit like Lyme Disease.
Meghan May: The reports stated that these patients were having sudden onset arthritis, and the reports were associating that with having received doses of LYMErix.
Clip: How much has it changed your life?
Marra: I don’t have a life anymore
But these reports were coming from news stories… and from physicians who were already skeptical of the mainstream science on Lyme disease.
Meghan May: so were’ talking about in the media or patients reporting to physicians.
Clip: Dr. Charlene DeMarco, an Osteopathic physician who specializes in treating Lyme disease says she often sees people with terrible permanent reactions to the vaccine.
DeMarco: I know of at least 700 that have been hurt by this vaccine.
Meghan May: It’s actually a really important point that we weren’t seeing reports in medical literature. That were based on studies that were done at population levels, that’s actually a really important point.
Clip: and many medical experts point out that individual stories, no matter how powerful, do not prove cause and effect….
Anecdotes in medicine, and epidemiology, are tricky business. It’s important to listen of course - but the range of patient experiences is vast… and in order to know anything for sure, careful studies have to be conducted to ensure that there isn’t something else causing the problem.
Meghan May: Because later on, of course, studies were done because if this were a side effect that was causing harm to patients, everybody of course wanted to know about that.
In the case of Lymerix, studies didn’t support the idea that the arthritis that some people were experiencing actually had to do with the vaccine.
[clip: no large study has found a danger to the vaccine. But a panel of experts that advises the FDA found the story so compelling that it asked the agency to carry out a large scale investigation of possible harmful effects of the vaccine
Following the negative media attention, the FDA and the CDC went back over their data. They found that only 59 cases of arthritis had been reported to a federal database that tracks reactions to vaccines… 59… out of one-and-half million.
Meghan May: Yes some patients did have sudden onset arthritis after being immunized, however, the rate that that happened was no different than the general population’s rate of sudden onset arthritis.
In other words, it looked like a coincidence… the number of people who suddenly got arthritis after taking the vaccine, was the same as the number of people who suddenly get arthritis in normal daily life. Humans are hard-wired to look for connections, and so that sort of coincidence has a way of sounding fishy - but this sort of thing can happen when millions of people are taking a drug, or vaccine.
Just to be safe, the company designed a follow-up study that would closely track 75,000 recipients of the vaccine. But…sales of the vaccine were plummeting, and they were only able to recruit a fraction of the study participants they were hoping for. At this point, here were larger forces in motion … another story that was inadvertently tanking the Lymerix vaccine.
Meghan May: The mid-nineties was where we had that publication from Andrew Wakefield.
You may have heard of this publication. Sometimes it’s called the Lancet study… it’s infamous.
Meghan May: The pub that shall not be named. That’s the one.
It claimed to have found a link between autism and the Measles, Mumps and Rubella vaccine. It was later retracted, and even revealed the author had committed fraud… distorted the data so it would prove his point... but the damage was done.
Meghan May: It really exploded onto the public scene and you suddenly had people who were hyper aware and extremely concerned and really just doubting the safety and efficacy of vaccines and then at that same moment you have… oh and this new one! This causes arthritis!
This was a key moment in the anti-vaccine movement. LYMErix, this innovative new vaccine using a new technology involving genetically engineered ecoli and specific synthetic proteins could not have come at a more fraught time.
Lawyers for patients who believed the vaccine had given them arthritis filed a class action law suit and the media frenzy ratcheted up.
Sales took a nosedive..
Meghan May: Just it was well more trouble than it was worth. And so… they said, just forget it we’re pulling it off the market.
[mux]
The class action suits against the manufacturer ended the way most class action suits do, by the way. The company settled… admitted no wrong-doing, the patients never saw a dime, but the lawyers collected over a million dollars in fees.
[mux]
If there are lessons to be learned from this fiasco… now’s the time to learn them. There’s a new Lyme vaccine being developed by a French company, which mimics the same protein as LYMErix, and has been put on the fast track by the FDA. Another treatment, called Lyme PReP, is in the works as well… it’s essentially synthetic antibodies, that you’d get injected every year.
Mark Klempner, at the University of Massachussetts Amherst is behind Lyme PRep.
Mark Klempner: To me the most important lesson learned is to keep everyone well informed of what you’re doing, what you know, when you know it, all orf those kinds of things because… that’s how you build trust.
But there’s something bigger here that needs to be absorbed. It’s not just that researchers need to be transparent.
If my reporting on Lyme has revealed anything, it’s that the slow and iterative process of epidemiology leaves dissatisfied patients in its wake left and right , even if gets to the right answer in the end.
Which means… maybe medicine needs to find a new way to relate to patients. Needs to learn to speak their language…
Meghan May: If I were in charge of making a policy for a new lyme disease vaccine, a perspective that I would almost certainly draw on is my perspective as a mom. It’s not just that I would have to say, “this is an appropriate decision for children between five and ten.” I would have to say, “is this what I would want for my five and ten-year-old and how would I explain this to the other moms of their five and ten year old friends. And I think that piece is what’s sometimes missing. But it’s a really… honestly it’s a really important one.
One of the things that I’ve learned in reporting this series is that a lot of diagnoses that people get — erythema migrans, erythema circinatum, patellar effusion — are just latin names for symptoms — migrating rash, circular rash, swollen knee.
Fancy words that preserve the aura of medical authority, but don’t actually give patients the information they need to make a choice.
Meghan May: I think as scientists we used to have that built-in credulity. In that people tended to give the suggested guidelines the benefit of the doubt and I don't think that’s the world we live in anymore, quite honestly.
Like it or not… we live in Lymeworld now, and ignoring it won’t make it go away.
[patient zero mux]
This bonus episode of Patient Zero was produced, and reported by Sam Evans-Brown, and me, Taylor Quimby.
Sam Evans-Brown is Patient Zero’s senior Producer.
Erika Janik is Executive Producer.
Graphics by Sara Plourde.
Maureen McMurray is Director of Content.
If you’ve got questions, concerns, or comments about Patient Zero - we want to hear from you. Email us at patientzero@nhpr.org.
Patient Zero’s Theme was composed and performed by Ty Gibbons.
Additional music from Blue Dot Sessions.
Patient Zero is a production of New Hampshire Public Radio.