The Legacy of the Lost Vaccine

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Go to fetchpet dot com slash save right now for your free quote. That's fetchpet dot com slash save When I was learning how to make radio, I had a day job in the file room at my aunt's family medicine practice outside of San Francisco They were old school and didn't really do computers So there was just a pile of paper, taller than I was of faxes, doctor's notes, checkups, prescriptions, just Everything And as I filed that mountain of paper I saw the community that they had built at that doctor's office The generations of families visit after visit, living their lives trrusting their health and their loved ones with my aunt's care So it resonates with me when VJ Skand describes his work as a family physician take care of newborns to ninety and I say stop at ninety because if you're ninety, you don't need me VJ has been a family doctor in a little town in Connecticut ever since he first drove up there with his wife in the nineteen eighties And we fell in love with the place. It was a small, charming town where you have a couple of very nice ends on main street and just, you know, it' a lovely spot right there on the Connecticut shoreline at the bottom of the Connecticut River This town was special the center of a newly uncovered disease that VJ had only really read about in textbooks Old Lime is the place where I started my practice of medicine It's also the place where Lyme disease was first discovered in this country and uh It's consumed much of my life The story of Lyme disease is long and winding It's an old disease that's spread across much of the northern hemisphere But in nineteen seventy six, a Yale professor, Dr. Allan Steer, was the first to pin it down to ticks in Lyime, Connecticut and give it its name Over the last fifty years, Lyme disease has impacted millions of lives. and has become one of the fastest growing insect spread diseases in the United States This Isn't that story This is VJ Story of how a disease and the search for answers can become a career community Alike I'm Meredredith Hadnot And this is unexplainable. So When did Lyme disease tip from like something that was kind of theoretical to becoming a part of your everyday life and your practice as a doctor very quickly in the mid nineteen eighties When the media reports started to come out, there was there's a Quite a lot of anxiety. So I started to get phone calls in my office almost every day. I almost speent an hour before going home at the end of the day returning phone calls parents who asked me what to do about their kids Bes And so and so all of a sudden we had a we had a snowballing of Interest, anxiety Breath. Need for understanding Diagnosis and treatment How did it feel for you to be a family practice doctor? Like you said, treating everybody from the infant to the grandma in the households and also be at this like epicenter of Lyme disease in this country It was a lot of fun. It was a lot of fun It was a lot of fun because how many often do you get to be it Doctor and treat stuff that's not only It seems this new. be right in the middle of it. I mean, is the kind of thing where if you've made a phone call to a customer service agent, they asked you what your address was and you said Line Connectut and they said, Oh where the disease is, right? It was a kind of So, you know, as a doctor, it was it was kind of neat to have something that you can uniquely diagnose and be positioned to diagnose it as well as to cure it. Yeah, I feel like it would be a lot less fun if you couldn't cure it Right. And there are there are those cases. One to read a chapter or two in a book about that. as VJ saw more and more patients come into his office with Lyme disease He realized it wasn't always easy to recognize That's because Lyme disease is a chameleon a shapeshifter that's always changing Lyme disease is caused by a corkscrew shaped bacteria that lives in tick's bellies If an infected tick bites you bacteria gets in your skin and starts to spread in a rash. sometometimes in this iconic bullseye shape At this point, VJ says it's often easy to knock out with simple antibiotics But if it gets past the skin, untreated, the Lyme disease bacteria can get into the bloodstream and spread to your heart, your joints, your nervous system VJ treated patients that had half their face paralyzed, patients who passed out because their hearts were beating too slowly The longer a patient had lyme disease, The harder it was to recognize. Lyme disease could look like arthritis. It could look like a summer flu It could look like meningitis. It could be completely asymptomatic and look like nothing at all And VJ was on the front lines treating his patients, his friends, his neighbors. He contributed to dozens of academic papers in his spare time, and he was also moonlighting at the local ER until one day. He got a call I was making rounds in the hospital and The nurse on the floor came up to me and said He d up Iy on the phone he says he's from a drug company Sessie wants to talk to you. drug company. Why is he calling me At the hospital, I'm making rounds. and, I don't know, he says Can you talk to him Okay And I went over to the Nurs' station and I picked up the phone And there was a gentleman there on the phone His name is David Kraus introduced himself and said, you know We've developed a vaccine for Lyme disease that's now ready for phase three, which is the the actual late stage testing to see if it works It had only been through the early phases where you just check to see that it's actually sort of safe to give to animals, thenen you see if it's safe to give to people. And then is it may be safe in a small number of peopleop'les, but you don't to see if it actually works until you know all of those ducks are in order. So anyway, so Kus said, wouldould you be interested in working with us on this vaccine now that we've reached this stage. And I said, wow, that's fascinating. of course And I signed on The drug company was Smith Klein Becham a huge international pharmaceutical company. And this vaccine was Kind of unusual. The thing about Lyme disease is that it takes about a day, maybe two days, after the tick bite, for the bacteria to travel from the tick into your skin And in that time There's a window after the bite but before the transfer So the vaccine does not work on the bacteria in you does is sucks up your blood, which has the antibodies in it kills the bacteria before they can come and infect you. So it fills it in the tick itself. Yes. So here we have a vaccine which This is very unusual because it kills the bacteria. that causeed Lyme disease in the tick before those bacteria can infect you It's almost as if the were vaccinating ticks. Exactly The previous drug trials were promising But now it was time to test this vaccine in the real world. There were going to be dozens of test sites across the country with thousands of patients And where better to test a new Lyme vaccine than in Lye, Connecticut VJ signed up to run a test site as an independent contractor for the drug company That meant he'd be recruiting participants enrolling them in the study and watching over them carefully for the next twenty months Now, as soon as I started the process of recruiting patience couldn't handle the number that started coming in No way It was it was just it was mind boggling. I I put a little out of the newspaper. And u The phone started ringing off the wall, I had to get More phone lines, I had to hire a person just to answer it Within a couple of weeks I cut my work at the hospital in half We ended up recruiting one thousand two hundred Adults. Well, age fifteen and over and had to shut it down Because I couldn't handle anymore. I ended up asking a colleague if he would rent space to me because I needed more space just to see all these patients. I lured a couple of nurses from the hospital and ended up having a large staff to take care of twelve hundred people. So within about six weeks of that phone call from Smith Kline Beacham. I was involved in this study. So it we took the Baton and we ran with it My wife volunteered U I, you know, ethically I'm not the one who did her consent or gave her the shots and In the pediatric study which followed both of my kids received the vaccine and I didn't know and they didn't know whether they were getting vaccinine or placebo. Oh, I had neighbors. I all matterered with people. I had people, you know, the lady who ran the donoughut shop across the road. As she would of course bring donoughuts every time. I have to I have to mention this Years later My son came home and told me He's getting married and The woman he was farrying was one of those kids from the vaccine study from te years earlier. mouth It's a small world And it's fun and it it connects you to people Do you feel like it changed your perspective on the community Yes, in a way, it did because I was Pleasantly surprised to see this so many people. turn out to stick their arms out and have a needle stuck in them. So we gave half of the patients placebo And we gave half the patients vual Lyme disease vaccine And I didn't know what they were getting vaccine or placebo. It's what we call a double blind study. It's the gold standard for studies. then Follow these individuals for couple of years through tick seasons We check them closely to see if they got symptoms of Lyme disease, we checked them in the most intense detail. We drew blood. Gginning of the season End of the season and anyt timee you had an illness. might or might not have been Lyme disease during those two years We drew your blood again. I had a photographer helping me with photographing the skin rashes, patients came down with, et cetera. So we had the guy across the road also next to the bakery who had a photoshop And the Photoshop guy, every time I had a patient with a skin rash, he would go out of his way to get the film deevelop it Overnight provrovide a high quality picture for me to then FedEx to the manufacturer. And so we had the FedEx guy, we had the photo guy, we had the bakery lady bringing the donoughuts. It was it gave me a sense not only of being a physician in the community, but being a part of it in a unique way Beyond the vaccine, the drug company funding fueled VJ's drive to pin down this shapeshifting disease Take for example, the first symptom of Lyme disease The rash Everybody talks about the bullsy If you have twwelve different ways this rash might look. Wait a minute It's not so easy to diagnose. Sometimes the lyme rash can appear in ways that we never imagined We had dozens of different rashes. Anytime a patient in our study had a rash, they'd immediately say, You gott to seeve me doctor I' got to wrash and Be we had the resources of the large pharmaceutical company biopsy those rashes. Nobody in his right mind or even if they had a million dollars would be able to have their patient in their private practice office have their skin lesion biopsy and sent to a lab. but we had. We had to prove if it was really Lyme disease or not So we did a little biopsy from the edge of all of those skin rashes to see if they could find the Lyme disease bacterum in it You would be amazed if the time there were rashations that I had no idea whether they were Lyme disease or not. turned out to be lyme disease. But if we hadn't had the study, we wouldnt never have known We would never have known VJ was managing one of the biggest test sites for this phaseI vaccine trial As a matter of fact, it got so busy I had to stop my private practice completely. He stopped moonlighting at the ER. He stopped working extra jobs in local clinics The study was his life And he was the face of this study for his community. Where' there ever ever for you even the smallest moment of doubt I love that question because being a double blind study, I had no idea whether patients were receiving vaccine or placebo. And as you can imagine, course of those few years where we were blinded Patience out of one thousand two hundred coming down with all kinds of things. whether it's heart attacks. Things that people have in the normal course of their lives when you're adults and I always wondered, gosh, I hope the vaccinees not causing it Fortunately, we had what's called a data safety monitoring board, independent board was not blinded. So they were able to look at all these things that were happening that were sort of worrying me and other investigators and know whether there was a signal or not that the vaccine was involved So fortunately, this data safety monitoring board never called and said, Hey, stop the study. which I wondered, gosh, I hope I hope I'm not doing this VJ had to sit with these open questions Did the vaccine actually work Was it safe? wereere there side effects? VJ monitored his patients for nearly two years, but then The study was out of his hands As you can imagine, the very vast amount of data that were accumulated from all the sites around the country had to be Cated, analyzed, Sliced and diced by statisticians. run by data safety review boards where they're looking at adverse effects that patients had reported throughout the study to see whether they may or may not have been related to the vaccine. So but patients actually became impatient in a way. no p intended because they wanted to know way. And of course, patients, we didn't unblind the study until after it was over. so patients were wondering Did I get the real thing or not Of course it was a game. There were people that say, I know I got the real thing because I felt my arm really ached or I had this achiness the next day or at this little temperature. so I think I've got the real thing. but amazing how often they were wrong Finally, after months of needles and months of waiting, The people of Lyimme got their answer. The study results were published in the New England Journal of Medicine in july nineteen ninety eight sixty six people in the placebo group got Lyme disease that year compared to sixteen cases in the fully vaccinated group prevented roughly eighty percent of cases of Lyme disease that would have occurred people We're vaccinated compared to people who work With over ten thousand patients, this wasn't the biggest of studies, but it was a perfectly respectable phhase three trial showing that there were no major side effects over the twenty months that the patients were monitored Most symptoms from the vaccine, as reported by the study Weere a sore arm A little fever. Nothing a few days and some ibuprofen didn't resolve. I was thrilled. I was thrilled. VJ was a lead author on the paper with scientists from some of the biggest research universities in the country He contributed to textbooks and helped educate doctors around the world about Lyme disease the study over. VJ took on a new role Eicacy Being the physician on the ground there in Lyme, Connecticut, my job was to tell These folks from the FDA whyy we even needed a vaccine for Lyme disease In nineteen ninety eight, VJ and other sponsor representatives for the drug company went to a holiday inn in Bethesda, Maryland to present the vaccine study to an FDA advisory committee This meeting lasted all day going into the weeds of the study design. Eicacy results, the safety data VJ shared what he had learned about the many faces of Lyme disease, how it could look like so many different things often difficult to diagnose may be difficult can have adverse consequences maybe serious and treatable or become chronic And now we have A vaccine that is safe and effective in preventing it What can we do except for Give this to the American people. then the coordinating investigator of the vaccine study Alan Steer shared some new findings of his own Doctor Steer was a big deal He's the one that first discovered that Lyme disease came from ticks decades before And he'd been studying Lime on his own. apart from the vaccine trial He was particularly focused on how Lyme disease impacted the immune system He noticed some cases where people with Lyme disease developed arthritis that was resistant to treatment with antibiotics And he thought the immune system might be involved. It was pretty rare. We're talking about a fraction of a fraction of a percent of people with Lyme disease. And Dr. Steer wanted the FDA panel to know because he thought an even smaller subset of these rare patients with vulnerable immune systems might react differently to the vaccine evenven though the study showed that Thousands of patients, the vaccinated groups and placebo groups, didn't have any significant difference in arthritis side effects So what did this mean for the vaccine and autoimmune arthritis? The FDA panel wanted more clarity and asked for additional testing on long term safety Ultimately, they concluded the vaccine was safe and effective Later that year The vaccine branded with the name Limerx, was approved by the FDA Questions from the advisory panel meeting haunted the vaccine There were some dark clouds on the horizon They were unanswered questions That's after the break When I scraped my car in that parking garage, I was worried that it could be a long process to take care of L like a landscaper's first day trimming a hedge made I have definitely already been here Now was it left right or? laugh. Maybe I'll cut a path out and find my way back It wasn't like that. I filed a claim in under two minutes on the GICO app and they handled it from there. It was taken care of almost as quickly as it helped. It feels good to get help quick. It feels good to GICO. Eczema is unpredictable. But you can blare less with EGlS, a once monthly treatment for moderate to severe eczema. After an initial four month or longer dosing phase, about four in ten people taking EcLlS achieved itch relief and clear or almost clear skin at sixteen weeks, and most of those people maintain skin that's still more clear at one year with monthly dosing EBGlSK a two hundred fifty milligram per two milliliter injection is a prescription medicine used to treat adults and children twelve years of age and older who weigh at least eighty eight pounds or forty kilograms with moderate to severe eczema. Also called a topopic dermatitis that is not well controlled with prescription therapies used on the skin or topicals, or who cannot use topical therapies. EBGlS can be used with or without topical corticoosteroids. Don't use if you're allergic EBGlIS. Allergic reactions can occur that can be severe. eye problems can occur. Tell your doctor if you have new or worsening eye problems. You should not receive a live vaccine when treated with EBGLS Before starting Epglus, tell your doctor if you have a parasitic infection Ask your doctor about EBglS, and visitvglSpot Lillily d. com or call one in hundred Lillily R X or one in hundred five four five five nine seven nine Study and play. Come together on a Windows eleven PC. And for a limited time, college students get the best of both worlds. Get the unreal college deal, everything you need to study and play with select Windows eleven PCs. Eligible students get a year of Microsoft three hundred sixty five preremium and a year of Xbox GamePass Ultimate with a custom color Xbox wireless controller Learn more at windows d. com slash student offer. Law Supplies last ands june thirtieth turnerms at aka. ms slash collllege PC There were two things that changed the course of vaccine medicine in the late nineties First, a British medical journal published a small, now very soundly debunked study connecting the MMR vaccine to childhood autism So here This researcher had his license stripped from him at the end of the day He had the black eye, the journal had the black eye, but the damage was done And then just a few months later anotherother childhood vaccine This one against Rhotavirus was taken off the market because it had a rare but dangerous side effect And so the public perception of bad vaccines took off So We had Perfect storm back then Wait a minute How do you guys know that it's vaccine safe? Look at that MMR. We read about it to the paper This was the beginning of the modern anti Vax movement And the newly approved Lyme disease vaccine, Lymeerx, was one of their first targets One of the things that people were worried about with the Lyme disease vaccine was whether it might cause an unusual form of arthritis related to autoimmunity Scientists were still digging into how the immune system was connected to chronic lyme symptoms like arthritis And so the FDA and the drug company wanted to keep close tabs on a vaccine that used the immune system. to fight Lyme disease A approal, one and a half million people received the live vaccine over the following three years two or three years What happens afterwards? The manufacturer actually collected a large amount of data on the peopleople who received the vaccine after it was approved This is called a post marketing surveillance study And it's common for new drugs Basically it's a trial period to make sure there aren't any side effects that are so rare The other smaller phases of the trial miss them Another retrospective study showed that of the nearly one point five million people who had the vaccine, A few hundred people reported any joint or muscle pain. And fifty nine developed arthritis. A similar number of people would have developed arthritis in a group of one and a half million people who hadn't had the vaccine In the wake of all the other vaccine skepticism unfolding at the time It was a good story A day didn't go byro. I didn't get contact from one of the national or international media asking to talk about vaccine that we heard might be causing Arthritis or other autoimmune problems. How did all this media attention What did it mean for Your patients, wereere they starting to get worried? That's a good question because I These patients covered the whole spectrum We had patients who said Hey I was in the study. I came down with multiple sclerosis doc My neurologist iagnos Do you think it's connected any way to the vaccine? Because I read that there were maybe problems I mean You get stuff and you wonder is it connected Beyond the study Some patients were worried conffused Maybe they had unexplained symptoms they didn't understand or a health carere system that they didn't trust And then some doctors were confused too They were getting mixed messages from the government The CDC recommended that only people at high risk for getting Lyme disease should even consider getting the vaccine Lyme disease was dismissed as a yuppy problem a frivolous concern And the vaccine, which could cost hundreds of dollars, was a luxury Everybody else was doing just fine, wearing long socks doing tick checks and taking antibiotics if they caught it And then The lawsuit started It all happens so fast. Within months of Limerics going on the market A law firm in Philadelphia sued the drug company, claiming over a hundred people experienced bad reactions from the vaccine often citing crippling arthritis And more lawsuits followed that One of the people who enrolled in the class action lawsuit to sue the company and indirectly me was the wife of a doctor colleague of mine at the hospital So it got that close. Pressure ratcheted up, and the FDA called back the advisory panel in two thousand one to go over all of the safety data again. Reports from the time say the meeting was otous By this point, scientists had learned a little more about the interplay between the immune system and the rare treatment resistant Lymearthritis that had originally sparked confusion back in nineteen ninety eight They found that these patients were more genetically vulnerable to getting arthritis with or without getting Lyme disease and that the Lyme disease antibodies weren't necessarily causing an autoimmune reaction I mean, scientists still don't fully understand all of the complexity of Lyme disease and the immune system especially for people with chronic lyme So while there were no absolute definitive answers This research made the hypothetical connection between autoimmune arthritis And the vaccine even more tenuous Once again, the FDA found that Limerx was safe and effective a recommended tool against a significant disease that was spreading fast Sales of the vaccine took a nose dive And by two thousand two The Lyme vaccine just wasn't good business I'll never forget that I'll ever forget that meeting. because I actually almost missed the ferry Gosh That those were the days. There wass a f across the lland Samurs to give this talk about Lyme disease to doctors And There happened to be an accident on route ninety five Sut down the highway On my cell phone, I call the ferry Gosh, arere you running late by any chance It turns out the woman who answered the phone was a patient of vine She recognized my voice This is what happens when you're in a small community. She says, Hey, Doc I know it's you just Get here as soon as you can Fother to parked the car Hand your keys to the attendant and jump on which is what I did So that that in itself was hairy T get on the ferry, we crossed Long Island Sound. and reach this lovely restaurant There's a whole bunch of doctors, about forty of them gathered to hear about the Lye vaccine. and I start my talk always by showing photographs of the disease and just a little education about the disease itself. and then What we did in the study what did we find? How did we do it? Why is it safe, et cetera and how to go about giving it to your patients. So even though I was sponsored by the company that makes the vaccine to give the talk, I spent at least half the time just teaching them stuff about the disease. and that's what's The fun I get out of it So we had a nice dinner and a nice evening and then I was tapped on the shoulder. I think it might have been during dessert. on the shoulder by this person who worked for the pharmaceutical companany said Hllen have a word with you And so we ducked into a hallway And then I find out The vaccine's been pulled I just gotten through a lecture to about forty physicians The vaccine and how great it was for their patients And I found out the end of that meal after that Meeting the vaccine was withdrawn. The drug company, now Glaxosmith Klein, after a merger, said that they were expecting so few sales that it just wasn't worth manufacturing the vaccine anymore They settled the lawsuits without admitting any wrongdoing and covered legal fees without paying any other damages It was like Limerics had never happened FJ was shocked Here's something that I had invested many years of my life into I'd given up my private practice I really had devoted many years of my life to Not only doing the study, but doing it well. And and you know, you wanted to do something in a way that you knew you could hang your hat on it. you knew at the end of the day, it wasn't because're you're checking off boxes and yeah, this patient have this blood test. No, it was it was your life What did we lose when we lost this vaccine in two thousand two We lost a very valuable ool that came into existence because of incredibly complicated and careful science which had been conducted over years by Truly, truly dedicated brilliant scientists with all stripes microbiologists, immunologists regular family docs, all kinds of people. peopleople in the lab creating the vaccine. we had people who were putting together the data for us or opening the FedEx packages or there are just thousands and thousands of people who devoted told ours So this vaccine coming into being and we knew it was safe, we knew it was effective. We knew it worked And yet this had happened. Llimerx wasn't a perfect vaccine, but now there are a lot of unanswered questions because of how it ended Qions that could have only been answered with follow up studies and closely monitoring millions of people taking the vaccine And in a lot of ways We're living in the shadow of Limrics This was a big win for the Nascent Anti Vax movement They had the power to face down a giant pharmaceutical company and get a vaccine poulled by going around the official government systems And now They are a big influence within those very same government systems I wouldn't want to bring out a new vaccine this year with the current administration in terms of vaccine acceptance. You know, is it worth it For years, Limmerx has been seen as a cautionary tale of science communication gone wrong How mixed messages can confuse people and lose the trust of communities that this science was supposed to help But for VJ, it's more personal than that becausecause for him This science was a part of bringing his community together Even years later, I can say, even at way after the studies ended I'll meet people on the street who will say Wow, those for the tastes We remember what they call the Lime study O twenty five years after the LimM study Pfizer and a French drug company, Valnava are testing a new Lyme disease vaccine based on similar science. And as of this spring Pfizer is planning on submitting the vaccine to regulatory authorities This episode was produced by me, Meredith Hodnock. It was edited by Lelissa Sop Christiana Nayala did the mixing and we collaborated on scoring with music from Noem Hasenfeld Melissa Hirch, check the facts Joanna Slatarov and Sally Helm are having fun in the sun And thanks as always to Brian Rznik for co creating the show with Bird Pinkerton and Noam If you have thoughts about the show, we would love to hear from you. Please email us at unexplainable at vox d. com And if you'd like to support this show and the journalism that Box does, you should become a member reallyally easy to do Just go to vox d. com slash members And for those of you who have emailed us to let us know that you signed up to be a member because of unexplainable Thank you. It really means a lot. Thanks also to those of you who've left us a nice review wherever you listen to your podcasts