tl;dr: People who had irrational fears of vaccines claimed harms from the Lyme vaccine that probably were not caused by the vaccine. Sales dropped so much that vaccine manufacturers became reluctant to market the vaccine to humans.
Similar irrational fears prompted the development of the "acellular" version of the pertussis (whooping cough) vaccine, which is less effective than the previously used version of the vaccine. Pertussis is a serious illness, and now that many people refuse to use the vaccine, and even the people who use it can only get a type of vaccine that is less effective than the first vaccine,[1] the whole population is needlessly at risk for pertussis outbreaks.
> Similar irrational fears prompted the development of the "acellular" version of the pertussis
Those fears were not in the slightest irrational. People had really really bad reactions to the regular pertussis to the point that people routinely advised new parents not to get it for their children.
The the new version is not as effective, that's true, but people refused the old version, and rightly so - the side effects were much worse.
So what's better a vaccine that doesn't work as well, that people are willing to take? Or a vaccine that works well, but far fewer people are willing to take it?
And on top of that since DTP was given as a unit, people refused the D and T parts as well (the Dr. may or may not have had it separately, but people weren't always so aware that the reactions were from the P, so refused the whole thing).
"Those fears were not in the slightest irrational. People had really really bad reactions to the regular pertussis to the point that people routinely advised new parents not to get it for their children."
Simply not true. You can easily find my citations (including CDC). Please provide yours.
"So what's better a vaccine that doesn't work as well, that people are willing to take? Or a vaccine that works well, but far fewer people are willing to take it?"
The risk from Pertussis is greater than that of DTAP by a lot. This is like suggesting we take away seat belts because some people believe they'll trap them in a burning vehicle.
> The risk from Pertussis is greater than that of DTAP by a lot
The risk from Pertussis TODAY is greater than that of DTaP.
But when aP was first introduced the risk of pertussis was LOWER than the risk of the Pertussis vaccine, for the simple reason that Pertussis was almost unheard of, but bad reactions to the Pertussis vaccine were quite common.
There's a reason they switched to aP you know, it wasn't in order to weaken the vaccine.
Why do anti-vaccine people get so upset when told to produce factual evidence?
The problem is that anti-vaccine sentiment is NOT harmless.
Anti-vaccine sentiment means we now have diseases killing children that were effectively eradicated 20 years ago.
Anti-vaccine sentiment means that we don't have a Lyme disease vaccination because the cost of fighting anti-vaxxers exceeds the profit from selling the vaccine.
So, if we look at the balance, anti-vaccination causes real, demonstrable problems while pro-vaccination has yet to have any demonstrated factual downside.
So, yeah, we now have preventable diseases running amok because the logical community was tolerant about anti-vaccination instead of stomping the anti-vaxxers into the ground like they so richly deserved.
>> People who had irrational fears of vaccines claimed harms from the Lyme vaccine that probably were not caused by the vaccine.
No, people who actually got the vaccine claimed they got arthritis from it. Weather those claims are true or not remains unverified. Of course the clinical trials showed no such side effects, but I doubt they were even looking for that (if I'm really cynical, do you even trust them not to hide that?). So when mass-marketed, alleged issues showed up and they pulled it. This is not different from other drugs that were pulled - and turned out to have actual problems. The fact that vaccine makers are legally protected and they still pulled it says a lot here.
That said, TFA says the anti-vaxers are ready to attack any new lyme vaccine that may come along, and that's unfortunate.
So if the trial was not corrupt then it must have been incompetent? The FDA and CDC investigated and did not find reason to believe that the vaccine caused arthritis, but the unnamed people who reported the arthritis are more believable than all those public servants?
>> So if the trial was not corrupt then it must have been incompetent?
In a sense yes. Clinical trials are not great at finding things like that. Phase 1 is all about determining toxicity - in other words, how much of a substance can people tolerate. Later phases are for determining dosage and effectiveness - how well does it treat a condition, or in this case how well does it immunize a person against infection. If side effects are not reported during the trials or are of low frequency, they may not get noticed at all. In fact, the FDA is starting to look at all-cause mortality for some drugs. For example, does taking something to lower cholesterol actually increase life expectancy (vs does it lower cholesterol which theoretically increases life expectancy). Do you really think they've been looking at all age-related effects (arthritis is one) of taking a vaccine?
I'm not saying the claims against it here are real, but that it is unfair to lump those people into the general category of anti-vaxxers. Especially since they were supposedly vaccinated.
> ... but the unnamed people who reported the arthritis are more believable than all those public servants?
And you can be sure that millions are going to die, not because they are stupid, but because the authorities are reluctant to crack down on the minority among their number that are corrupt.
IF one or two politicians are found to break the law, but get away on a technicality, the people will simply assume that all politicians are crooks. If a couple of scientists sell their integrity to corporate interests and the whole of the scientific community does not respond publicly and in full force, at least ruining the careers of the crooked scientist and suing the corporation for the undermining of the scientific method, people will simply assume that Science(TM) is just another racket to keep them down.
What you are seeing is a crisis of legitimacy. I agree that it is a very unfortunate event, but blaming the messenger is not going to fix it.
> I doubt they were even looking for that (if I'm really cynical, do you even trust them not to hide that?).
The drug companies do not do the data for their clinical trials - a third party supervised by the FDA does. The penalty for hiding data is pretty high.
Well, that's a trust the government debate, but I worked at one of the third-parties and they did a pretty damn fine job of it. Their reputation was pretty important to them.
I was astounded by the cost in a study. Thousands of samples overnighted to the lab with multiple tests run on each. The bill for that alone is staggering.
You shouldn't trust any of them to begin with, but rather grade them on their accomplishments (e.g. eradication of polio). Similarly, you should also have approximately zero trust in anecdotes about unnamed people when making medical decisions.
Or so I heard from some person who I believe to be reliable. Way more reliable than the others.
The trouble with grading people or groups on their accomplishments is that it's only useful if you're evaluating net accomplishments. If, for instance, whoever is responsible for preventing lots of deaths from polio also caused more deaths for other reasons (obviously I'm not suggesting this is the case; it's only an example), I might still be hesitant to trust them.
So in your hierarchy of trust the drug companies are the least trustworthy, the FDA is slightly more trustworthy and random unnamed people are the most trustworthy?
because they aren't for profit? their only reason for existing at all is to keep harmful things from being approved for sale.
I'm by no means saying the FDA is perfect or infallible, far from it. Just that it's super easy to rank them above the drug companies in reliability as to a drugs safety and efficacy.
Curios on the subject. How would a vaccine cause arthritis? I assume they are injecting you with a protein so the body produces antibodies. Could the antibodies/immune response cause arthritis?
Lyme disease can cause a type of arthritis and it was hypothesized that the vaccine might result in a similar autoimmune response in certain genetically-disposed individuals. There are many more details about Lymerix and what happened here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2870557/
[EDIT: Just to be clear though, there was no evidence in the numbers that the vaccine in fact caused arthritis.]
> People who had irrational fears of vaccines claimed harms from the Lyme vaccine that probably were not caused by the vaccine.
If you say yourself that the harms were only "probably not caused by the vaccines"; implying that they might be caused; how can you affirm that the fears are irrational?
This isn't mentioned by the article anywhere and must be part of the cost-benefit analysis for deploying a vaccine, especially one which is to be only 80% effective and requires booster shots.
My younger sister had lyme and was nearly paralyzed before it was discovered. Both of my parents are GPs.
My aunt caught Lyme when visiting us in Europe (note that the European and American versions are different), and had to visit 5 different doctors before she got her treatment. The first two thought she was just overworked. By the third time my uncle (neurosurgeon, living in Europe) suggested she had Lyme. The third and fourth (Canadian) doctors refused to check it. The last one finally was willing to send a blood sample to the lab.
Lyme is very easily missed. It can manifest itself in a way that has nearly no visible symptoms, with only the patient claiming to be in enormous pain.
> Lyme is very easily missed. It can manifest itself in a way that has nearly no visible symptoms, with only the patient claiming to be in enormous pain.
This is absolutely true.
My wife contracted lyme disease just after our son was born. It was originally written off as postpartum symptoms or postpartum depression. By the time it was diagnosed, antibiotics were not effective. She felt so awful from the antibiotics that she quit that course of care and switched to homeopathy. Following the homeopathic care, she has gotten remarkably better--but still feels occasional ill effects, including a food allergy that surfaced after her contracting this disease.
I know it's difficult to figure out an unusual illness of any kind, but there are far too many cases where physicians insist on one diagnosis even when it does not fit the symptoms. I've seen it first hand with family members, where a cancer diagnosis could've been made far quicker if they hadn't wasted time with useless bullshit that was just treating side effects, not the major symptoms.
This baffles me, and makes me very eager for computerized systems which hopefully won't just ignore important facts about the case.
My son was on an island at a retreat, and his neck and head started hurting like crazy. He was instantly diagnosed by his peers, the counselors and the resident nurse. He was ferried/driven 200 miles to a hospital the same day for antibiotics! So it varies to be sure.
Your son, like most people who get Lyme, probably had a bulls-eye rash and/or recalled being bitten by a tick. A bulls-eye rash is enough to diagnose Lyme disease.
Not only that if you start coming down with symptoms of Lyme right after getting bitten by a tick then diagnosis is very trivial. Those who don't have a bulls-eye rash or recollection of tick bites and don't spend a lot of time in the woods have non-specific symptoms such as fatigue and joint pain. Those are the cases that the diagnosis can very easily be missed.
Nowadays Lyme is so common around here that anyone complaining of any non-specific symptoms gets a Lyme blood test. 10 years ago that was probably not the case. A friend of mine went to the doctor with non-specific symptoms and tested positive for Lyme. If her doctors didn't run the Lyme test they would have missed it. They ran the Lyme test even though she didn't spend any time in the woods or remembered any tick bites because they now know to.
If Lyme isn't on the radar of doctors that is a huge problem for diagnosis of some cases. It probably would especially suck for someone who lives in, say, Utah who went to vacation in Maine and didn't recall a tick bite. Your average Utah doctor has probably never even seen a patient with Lyme disease and probably won't think to check for it or ask if you've traveled somewhere where Lyme is common.
Unfortunately, that's not the case in all areas where Lyme is prevalent. On top of that, the standard Lyme test is not very reliable. Living in New Jersey (filled with deer, mice, and ticks) you would think that doctors would be more aware. But it took several different doctors, emergency visits, hospitalizations, and, yes, a negative Lyme test before my wife was finally diagnosed.
The standard reply in the hospital was that even though they had no clue what was wrong with my wife, they were certain that it wasn't Lyme. And since insurance doesn't cover the Igenix tests, we had to pay the $300+ out of pocket.
Like you said, the standard Lyme test is not very reliable. Even if laboratory tests are ordered, labs are still using immunoassays for confirmation of Lyme (ELISA, then a Western Blot), which have relatively poor sensitivity (~70% or lower[1]) due to low serum concentration of Borrelia or possible absence of antibodies—so they can miss one in four true-positive cases. The newer PCR-based assays have much better sensitivity (>70%, maybe closer to 90%[2]), but the assays are not yet in widespread use, are still being proven, and thus are seen only as adjuncts to immunoassays that can provide further evidence of Lyme. It can also take a couple weeks from when the bullseye rash appears (or when the tick bite occurs) for serology to test positive, again due to the Borrelia/antibody concentration being below the limit of detection. Samples tested are also usually blood, which may not be as good as CSF. It's a tricky bug to diagnose in the laboratory, which is why it comes down to the discretion of the clinician and the doctor's knowledge of the patient and his or her history.
It's probably also true that, in part because of sharply increased infection rates, there's a much greater awareness of Lyme disease in the states where it is prevalent than there would have been even just 10 years ago. When I came down with a high fever and various other symptoms, it was the first thing my doctor thought of. (Turned out to be something else I caught while traveling but Lyme and other tick-borne diseases were definitely on his radar.)
The first time I got lyme in like 1995 or so, no one really knew what it was, and these were doctors close enough to Lyme to actually know it as a town. I remember I got passed around the pediatrics office I attended and finally had to go to a specialist in a major children's hospital before it was correctly diagnosed and treated. Its hard to be treated in areas outside normal lyme areas because its most common symptoms are pretty much generic lethargy and pain (the trademark bullseye rash doesn't always make an appearance).
Lyme disease is one of those diseases that present in so many different ways, and often looks like a million different things (see Avril Lavigne's case). Therefore people get sick and are unwell for a very long time before it's finally properly diagnosed. So for those that go outdoors a lot and live in an area with high population of infected ticks, vaccine is a good prevention strategy.
I had Lyme disease several years ago and it was quickly cleared up with antibiotics, but not until after a week of intense fever and migraines, joint pain (as in, all my joints), extreme lethargy, and finally the breakout of ring shaped marks all over my body.
I was one of the lucky ones because it was so easily treatable and I have not had any reoccurring systems, something that is pretty common with Lyme disease.
I don' think that everyone needs to be vaccinated, but I really wish I had been given the choice since I live in a area with lots of ticks and spend a lot of time doing outdoor stuff.
I know around 10 family members and friends who have had it. Over half of them have lasting damage as often people don't realize they have it until they have had it a while. One of them almost died.
If my dog can get it, I should be able to choose to get it, even if its not standard. I pick small ticks off my after every hike, its just a matter of time before I get it.
There's nothing quite like that feeling you get after a hike when you DON'T find any ticks and wonder if it's already latched on somewhere out of sight.
Yeah, I was lucky to develop a spectacular bullseye rash the day after I was bitten and go on antibiotics the day after. For me Lyme was just a few days of fevers in the afternoon then not being able to donate blood for a few years. Many people don't have such obvious symptoms, though.
Good point. The percentage also caught my attention. The article didn't mention any percentages of stage 1 cases versus later stages where long term problems can occur.
The patent for LYMErix has expired [1] and the vaccine is still considered to be safe and effective by the FDA [2]. Someone want to start producing it again?
The tl;dr is that in the US, vaccine manufacturers have no liability for the vaccines they produce and sell. Vaccine injury claims are heard without a jury, and paid out by a special fund which exists due to a per-dose tax on vaccines.
Vaccinations like the one for Lyme being made unavailable isn't a decision based on liability or risk so much as low demand.
FWIW, having been exposed/infected with Lyme disease 3 times, any vaccine would be welcome. Really. I can't stress that enough.
Due to a variety of factors, including deer overpopulation(1), the Lyme disease infection rate in Deer Ticks in New England is ridiculously high. While I was undergoing treatment for the 3rd time, my doctor indicated that probably 25% of ticks in that region carry the disease.
I'd be all for a vaccine. It would be even better if we could vaccinate the deer agains being hosts somehow...maybe in a salt lick?
Eh, I feel like its not so bad after the first few times. I did get bell's palsy last time, and I walked around looking like a stroke victim for a bit, but not that bad all in all.
Didn't get that all the way, but started to. Ah the joys of liking to hike and work in the woods...
Though it is conceivable that the same behavior will get me infected again now that I live in SF instead of CT, the much lower deer population has meant that I've not had a single tick bite in 3 years since living here. The one weekend I went back to visit my mom, I got one helping her clean up fallen tree branches in the lawn whilst being observed by a herd of deer.
You do realize you can just ask your doctor for an acne antibiotics prescription and be immune to Lyme disease, right? Doctors routinely do this for people who work in dangerous areas for Lyme disease, etc..
I didn't realize this. Somehow, this doesn't seem like a good idea to basically be on Doxycycline forever...
Most antibiotics are not effective agains Lyme, since it is a spirochete, and can end up in your spinal fluid.
Last time I had Lyme, I took Doxycycline for 6 weeks. that drug is pretty damn awful to take all the time.
Can you show any data that doctors are prophylactically prescribing antibiotics to people for Lyme? If that is the case, I'd assume that "living in connecticut" is a sufficient risk factor?
I was disappointed over the lack of links in a web(!) article, so I did some research over this comment: Poland notes that since then, Lyme has become more widespread and is now the most common tick-borne disease in the country.
Dr. Gregory Poland works in Mayo Clinic which is based in Minnesota. Here are statistics for Lyme disease in that country:
And some links to the CDC sites about other tick-borne diseases prevalent in the US: http://www.cdc.gov/ticks/diseases/ (most of these also include statistics on incidence and geographic distribution)
A lot of people get confused because the term state can refer to either a federated state (like in the U.S.) or a sovereign state (hence the term, "head of state" for the leader of a country).
Also, it's even more confusing because the states used to be considered different nations, united. Hence why they used to be called "these united states." Just an FYI.
Given that "States" is in our country's name, as well as the fact that they are "United", I think people should reasonably expect that its subdivisions are not called "countries".
The trials seemed to go well but I don't know the status of further trials that could lead to this coming to market. Lyme's a real problem though with sharp increases in infection rates in New England in particular.
A family friend was one of the people who helped develop the Lyme vaccine. He invited my Dad to be part of the trial because my Dad spends a lot of time outdoors. It turned out that my Dad got the placebo during the trial, but they let him get the vaccine after the trial was completed. That was a long time ago. The vaccine has certainly worn off at this point.
Not natural top predators in the ecosystem: explosion of coyotes, deers and deer's ticks.
I'll wish to read some research about tick density in yellowstone after the arrival of the wolf. Is increasing?, decreasing?. Keeping some parts of the park relatively clean of deer's ticks?.
Mmmh, both seem mutually exclusive species, that's interesting...
Lyme is a terrible disease. If not diagnosed early on, it will burrow into neural tissue and becomes very difficult to kill. Symptoms include chronic arthritis, cognitive disorders, chronic pain, dizziness, etc. It's not a disease you want to get.
I strongly believe it was a terrible mistake to remove the vaccine from the market for human use. It seems that it was taken off the market from fear of lawsuits and not because it was proven harmful.
20 years ago, few physicians knew anything about Lyme disease. Even today, physicians don't necessarily recognize Lyme symptoms, but they really ought to; 300,000 people are known to have the disease in the U.S., but it's thought that many thousands of others suffer from Lyme as well but are not diagnosed.[1]
If you diagnose it properly within the first two weeks, the chances are very good that it's completely curable with heavy treatments of antibiotics. If you don't, it becomes much harder to treat. Some have tried IV infusions of antibiotics, with varying degrees of success.
There are strategies that could be applied to greatly reduce the incidence of Lyme disease. For example, reintroduction of the Northeastern timber rattler would help cut down the mouse population which plays a large role in the deer tick's life cycle. One snake can kill dozens or hundreds of mice a year, reducing the tick population by thousands. These snakes were largely eradicated from the Northeast which has probably contributed to a rodent population boom.[2]
Culling the deer population would also greatly help. Several years ago, Monhegan Island in Maine drastically reduced the deer herds with a special hunt, and since that time there have been almost no new cases of Lyme disease reported.[3] I heard of a similar experiment in a county in Connecticut, with similar results. It came up for a vote on Long Island last year to cull the deer population but it was voted down.
Deer are beautiful animals, but their population has exploded in recent decades. In the 1940s there were thought to be about 300,000 deer in the U.S. (I've read actually that there were around 500,000 in the early 20th C., and unrestricted hunting brought that number down to 30,000 by the 1940s, so it's unclear, but drastically fewer than today in any case), and now there are estimated to be over 32 million deer.
Not just Lyme carriers, they are a menace on the roads and an estimated 200 people die every year in car-deer collisions, plus billions of dollars of damage.[4]
Increased hunting permits to reduce the deer population, reintroduction of predators such as cougars, bobcats, black bear, and wolves into their indigenous habitats in the Northeast (coyotes have been thriving and need no assistance), reintroduction of snakes like the timber rattler, and of course tremendous precautions and application of DEET when venturing into the grasslands and woods will all help to reduce Lyme disease.
I would also advocate more research grants to study the spirochete bacteria and find genetic markers needed to make more effective vaccines and treatments. This is an epidemic that people are only beginning to recognize but there are solutions to be found, if we get moving.
Similar irrational fears prompted the development of the "acellular" version of the pertussis (whooping cough) vaccine, which is less effective than the previously used version of the vaccine. Pertussis is a serious illness, and now that many people refuse to use the vaccine, and even the people who use it can only get a type of vaccine that is less effective than the first vaccine,[1] the whole population is needlessly at risk for pertussis outbreaks.
[1] http://pediatrics.aappublications.org/content/early/2013/05/...
http://www.ncbi.nlm.nih.gov/pubmed/22423127