Vaccine Injuries from The MMR, A Review of VAERS

If you’ve seen some of the arguments from the anti-vaccine groups out there, you’ve probably seen their claims that the Vaccine Adverse Events Reporting System (VAERS) is some kind of a cornucopia of “evidence” that vaccines are bad. I’ve examined VAERS for you before, but mostly having to do with the HPV vaccine. VAERS is a reporting system to which everyone and anyone can report. You can go file a report right now if you want to. You can tell them that you turned into the Hulk after you got your vaccine or something.

Does VAERS give clues that something is happening because of a vaccine? Yes. Does it give evidence that a vaccine is bad or has caused death and destruction? No.

VAERS is what is called a “passive surveillance system” because those on the other side of the system don’t need to spend time and energy in looking for cases. It’s a cost-efficient way of doing surveillance for adverse events. However, once they get enough blips on the radar (enough reports that are similar), epidemiologists get to the task of looking deeper into the cases, looking for more cases, and then conducting a case-control study to see if odds of being vaccinated are different between cases and controls of a particular outcome. If the case-control study says that there is evidence that the vaccine is strongly associated with some sort of outcome, more evidence is gathered and a decision is made to act.

Contrary to anti-vaccine zealots’ claims, people at CDC really do care, and they really do want vaccines to be as safe and effective as they can be. This although they know that nothing is 100% safe nor 100% effective.

In recent days, there has been a claim on the internet that the MMR vaccine has been responsible for 108 deaths since 2005 while measles hasn’t killed anyone in the US since 2000. First, let’s look at the claim that measles hasn’t killed anyone in the US. Remember that measles was eliminated in the US around that time, so it stands to reason that there haven’t been that many cases of measles overall, so there wouldn’t be that many deaths. But what do the data say?

According to table #2 in this document, there were two deaths from measles in 2009. There were other years with deaths as well, but, for the purposes of the claim that there have not been deaths from measles in the United States in recent years, it’s case closed.

So what about the 108 deaths from the MMR? Let’s look at VAERS with the knowledge that, one, the reports can be put in by anyone at any time and for any reason, and, two, a report is not evidence of causality between vaccine and the outcome. A report is merely a “signal” in the “noise” that there was some sort of an event after a vaccine, not necessarily because of it.

After asking for all reports with an outcome of “death” going back to 1990 and associated with all known measles vaccines, I received 235 reports. Here are some of the details I found:

“On 05/07/1990 patient went to the Doctor and had a physical, which the doctor said he was in good health and doing well for his age and he also received 2 vaccinations MMR and DPT. He was congested and had a fever after receiving his shots. I gave him infant Tylenol during the day and before I put him to sleep. At 7am approximately 12 hours later I found patient in his bed not breathing and without a pulse. I performed CPR but patient died. The coroner determined that the cause of death was SIDS.”

That one had a one-day onset, but not much more information was given. Is this one report enough? Remember, there have been tens of millions of doses of MMR given in the United States. Let’s look at some more reports:

“On 31DEC90 experienced shock, renal failure, fever, convuls & pneumonia. Hospitalized & lab testing revealed a positive assay for toxic shock synd, septic shock, & disseminated intravascular coagulation. MD stated pt’s sxs not d/t vaccinatn”

This one happened 9 days after the vaccine. Could it have taken that long for such an outcome to happen? Let’s keep looking:

“Infant febrile morning of 5/18/2006 around 5:30 a.m. No other S/S per parent. Parent administered tylenol. Midday infant began seizing, mom called 911, infant transported and later pronounced dead at hospital. 7/19/06 Received death certificate which stated COD as pulmonary edema due to protracted febrile seizure. 7/28/06 Received tag-2 report from PCP. Family had moved to another state. Records accompanying report included vax records, Death Summary from ER & Autopsy Report. COD stated as non-cardiogenic pulmonary edema as the result of febrile seizures/ss”

This one happened six days after the immunizations. It’s interesting to me because so many anti-vaccine parents have stated that they want their children to have a fever, and even a febrile seizure, because it’s the “natural way” to deal with infections. Still, let’s keep looking:

“[Name] was given DPT/MMR/OPV while still on anitbiotic Pedizole and tassii organdin for otitis & bronchitis. He appeared happy & well until he died in his sleep. Shots were given on 5DEC89.”

This one happened 24 days after the immunizations. Could it have taken that long for the death to happen? Or was this child given the vaccine and then, about three weeks later, sick with otitis and bronchitis that got complicated? We’ll never know because we will never have access their private medical information. So let’s keep looking:

“adm to hosp 31AUG95 w/3wk hx progressive non prod cough,SOB & fevers;devel abd pain,diarrhea;lost 30lbs;pt had multiple diagnostic studies,devel pleural effusion,viral pneumonia & measles pneumonia;”

Oh, measles pneumonia? After receiving the MMR vaccine? This must be a red flag, right? Well, no… The rest of the report tells us that, sadly, this person had a CD4 count of less than 10 due to advanced HIV/AIDS. They were a hemophiliac, and that was likely how they were infected with HIV. (It’s the 1990’s, after all). Also, the vaccine was given four years earlier. It is very possible that this person’s immune status allowed them to catch measles at a time when measles was very active in the United States.

This one is interesting:

“”Brother states patient developed “”Transverse myelitis”” from the MMR vaccine then the patient “”Fell down and died””. Developed paralysis in legs one week after shot. 8/11/08-records received for DOS 12/12/07-1/6/08- DX: Paraparesis secondary to transverse myelitis. Death secondary to pulmonary embolism. Admitted for evaluation of lower extremity weakness for 2-3 weeks, with shooting pain in feet on 12/14/07-balance difficulties noted, tingling in left upper extremity prior to hospitalization Upgoing plantar reflex noted on right side, lower extremity reflex loss at ankles and left patella. Autopsy refused by family.””

Was it the MMR? It was given in September of 2007 and the person died in January of 2008. I mean, since the brother says so, it must be true, right? Let’s look at the rest of the evidence:

“Lung cancer 2 years with chemotherapy 8/11/08-records received- NCV abnormal evidence of primary muscle disorder. Glucose elevated, AST and ALT elevation of 144 and 177. MRI normal. CSF leukocytosis. Culture negative. on 1/6/08 began hypo” (Report cuts off.)

Do you think that maybe, just maybe, the lung cancer may have caused a pulmonary embolism? Is it possible that the cancer may have metastasized and caused the nervous system injuries that led to his condition? Nah. It was the MMR vaccine.

Here’s a 49 year-old male:

“Per translator client died 2 to 3 hrs. after receiving vaccines on 7/2/09. Autopsy is pending to determine cause of death. Due to language barrier unable to get more information.7/21/09-Nancy with Med Exam office called with preliminary COD: Coronary Artery Disease with no other significant conditions contributing to death. 8/13/09 Cause of Death: Coronary artery disease. Manner of death: Natural. Autopsy report summary of findings: I. Atherosclerotic cardiovascular disease. A. Calcific coronary artery disease, marked, involving three major vessels and left main. B. Aortic atherosclerosis, mild to moderate. II. Nephrosclerosis. III. Right rib fractures consistent with resuscitation efforts.”

It wasn’t the clogged arteries, ladies and gentlemen… It was the vaccines. It’s always the vaccines.

I could keep going, but you know where this goes. Someone had a vaccine, then something bad happened to them, and then someone filed a report because it must have been the vaccine, nothing else. Anti-vaccine activists will tell you that this is all ignored by CDC. However, if you look at the reports, you can see that the names of the vaccine manufacturers and lot numbers, when available, are presented right in the reports. Furthermore, you can see from the reports that CDC personnel took the time and made the effort to follow-up on all of these cases, even the ones where someone called them and had a chip on their shoulder. Why? Because they care. They wouldn’t be doing the work that they do if they didn’t.

Look, there are going to be times when someone will have a bad reaction to a vaccine, any vaccine. But these reactions are extremely rare. If they do happen, it is even more rare that it ends in death. Has someone ever died from a vaccine? I’m sure someone has. It is not unreasonable to think that it has happened. But it is unreasonable to think that it is so common that it is going to happen to me or you tomorrow or the day after if we get a vaccine. What is more likely to happen is the death or permanent injury of a child if we don’t vaccinate, if we don’t protect the herd.

The difference between them and us

I was talking to an anti-vaccine activist the other day, and she said that scientists, doctors, and anyone else who believed in the science of vaccines were “blindly devoted to the religion of vaccines.” I almost laughed in her face, but I was trying to be civil. After all, the woman had ventured into an institution of higher knowledge to have this debate. She was like a fish out of water as it was clear that she had no formal training in science, and she admitted to those present that she knew all she needed to know through her experience of being a mother of a child with autism.

I’ve never been tossed an easier softball for me to hit out of the park, but I just sat there and listened to what she had to say. She began her tale by telling us about her “stolen” child and how that child is now 5 and starting kindergarten. (More on how weird that sounded in a little big.) According to her recollection, her child was developing perfectly normal until he got his MMR vaccine at one year of age. It took her child two months before he started walking when most kids walk at 12 months, she said. Surely, it was the MMR vaccine that caused that delay.

She repeated other things we’ve heard from anti-vaccine activists. Her child cried for days and days until she took him to the doctor. Her child didn’t look her in the eyes. Her child watches television for hours during the day and can’t fall asleep unless she gives him an iPad to play with. Oh, and her child has allergies against everything and anything that she feeds him. She now feeds him nothing but organic chicken and vegetables. Anything else and he develops nausea, vomiting, diarrhea, constipation… Both? Yes, she said he gets both at the same time.

But her child is 5 and in kindergarten, but is somehow “stolen”? Again, all softballs, but I didn’t bite. None of us did. It wasn’t a fight we wanted to have.

She ended her presentation to us with a set of slides about the so-called “CDC Whistleblower” and the “cover-up” of data. In her conclusion, she asked us to be “skeptical” of those who are “blindly devoted to the religion of science” and to check out the information from the National Vaccine Information Center, an anti-vaccine group that wants to feed children anti-vaccine candy this Halloween. The woman then asked for any questions, and I couldn’t resist.

“Did you read the Wakefield paper from 1998?” I asked. After a brief pause, and after seeing that I pulled out the paper, she said that she did not. “In it,” I said, “the authors conclude that there is no association between autism and enterolytic colitis.” The expression on her face changed from amusement to anger in three seconds flat. I continued, “You told us not to trust those who blindly follow science, but what about those who blindly follow Andrew Wakefield’s…”

“DOCTOR Wakefield,” she interrupted.

“Andrew Wakefield’s ‘gut feelings’,” I said. “Are gut feelings better to follow than evidence?”

“Give me that,” she said as she reached for the now-retracted Wakefield paper. She scanned the paper to the part where I had highlighted the conclusion:

“We did not prove an association between measles, mumps, and rubella vaccine and the syndrome described. Virological studies are underway that may help to resolve this issue”

The woman exploded into a barrage of accusations about me altering the paper (denial), telling me that she hated people like me who had “taken away” her child (anger), stating that if only follow-up studies to Wakefield’s were done so we all would know the truth (they were done, and also, bargaining), and then tears started rolling down her eyes (depression).

If the words in parentheses look familiar to you, it’s because they’re 4 of the 5 stages of grief. The only stage she did not display was acceptance. The woman was quiet and sitting, holding the paper between her hands, sobbing. The host thanked her for being here and we filed out of the room.

I felt like a jackass for making a woman cry. Women crying get me upset, and I honestly wanted nothing but to hug the woman and tell her that everything was going to be okay. But I think she would have completely snapped.

The difference between them and us, people who believe in anti-vaccine theories and us who don’t, is that we take the time to review the literature. We cross all the T’s and dot all the I’s. Because, in our world, being proven wrong or having someone find out that we lied or altered the data is the equivalent of social death. Just ask Wakefield, and, now, BS Hooker. They are pariahs who have either altered the data or failed to present it in an honest fashion. They may even be lying when they say that there was a “cover up” by CDC. Mark my words when I tell you that neither will ever be taken seriously by people who make policy decisions about vaccines and/or autism. And the people who follow them? Those people will never be taken seriously and be challenged on their assertions because they don’t read the papers, don’t do the homework, and don’t take the tests.

I’d like to thank the person who organized that meeting. They went to great lengths to get the woman in question to give the presentation to a group of us in northern Virginia. And that woman, if you are reading this, please know that we did not intend to deceive you into looking so foolish. You did that all on your own, and I hope you see things for what they are and not what groups like NVIC want you to believe.

Reading For Comprehension

Humor me and read the following abstract of a study:

Background The GARDASIL long-term follow-up (LTFU) study is an ongoing extension of a pivotal randomised, placebo-controlled, double-blind, 4-year study to investigate the safety, immunogenicity, and effectiveness of quadrivalent Human Papillomavirus vaccine (qHPV) on the incidence of HPV 16/18-related cervical intraepithelial neoplasia (CIN) 2 or worse in 16–23-year-old women (Protocol 015).

Methods Follow-up of subjects will be accomplished in two ways: (1) registry-based follow-up for effectiveness data as well as safety data including but not limited to deaths, cancer, and hospitalisations; (2) active follow-up for blood collection for immunogenicity assessments at years 5 and 10 of the LTFU study. Effectiveness and safety analyses will occur approximately 2 years following completion of Protocol 015 and approximately every 2 years thereafter for 10 years. The current report represents the first of these efficacy and safety analyses. Cohort 1 included approximately 2700 subjects who received qHPV vaccine at the start of Protocol 015. Cohort 2 consists of approximately 2100 subjects who received placebo at the start of Protocol 015 and qHPV vaccine prior to entry into the LTFU. Vaccine effectiveness against HPV 16/18-related CIN 2 or worse was estimated by calculating the expected incidence of CIN 2/3 or worse in an unvaccinated (placebo) cohort using historical registry data. The primary analysis approach was per-protocol.

Results There were 1080 subjects that contributed to the follow-up period out of a total of 2195 eligible subjects in the per-protocol population in Cohort 1. In these subjects there were no cases of HPV 16/18-related CIN 2 or worse observed. There were also no cases of HPV 6/11/16/18-related CIN, vulvar cancer, and vaginal cancer observed. However, the follow-up time in person-years is insufficient to make a definitive statement about the effectiveness of the qHPV vaccine for the current time period.

Conclusions The qHPV vaccine shows a trend of continued protection in women who were vaccinated up to 7 years previously, although there is as yet insufficient data to confirm that protection is maintained. The qHPV vaccine continues to be generally safe and well tolerated up to 6 years following vaccination.”

You can go ahead and re-read it if you didn’t quite catch something. Continue reading

The continuing hunt for who I am

I’ve tangled with anti-vaccine activists for a while now. It all started when I had to investigate a possible death from pertussis and I found out that the parents were misinformed about the whooping cough vaccine by one of those groups that have the word “information” in them. This was right before the 2009 flu pandemic. When that happened, I was appalled by the number of people even within healthcare and public health who were dubious of the H1N1 vaccine and were also misinformed by an “information” group and others who advocated for people to “do their own research.”

When I started this blog, I decided to make myself anonymous because of the experiences of a friend who was harassed and threatened with lawsuits by a couple of anti-vaccine people. He made the mistake of putting his name out there for the world because, he reasoned, if everyone knew who he was, they would believe his statements more than if he was just another nameless person. Me? I don’t care if you believe me or not. I care if you believe the facts I am presenting you, so I try to back them up with references and links whenever possible. This has worked well for me, but I got cocky.

I posted on this blog and on Facebook a picture of a wall sign from work. It was a picture showing the floor where I worked and where the office was, more or less. That was a mistake. I was told yesterday that someone called to ask if “Reuben Gaines” or “Edward Jenner” (my pseudonym on Facebook) worked there. When the person taking the call answered in the negative, the person making the call (a man with a foreign accent) complained that someone (me) was impersonating an epidemiologist.

I have two or three ideas of who the caller was, and I can’t help but wonder the obsession with finding out who I am in real life. Do they want to hurt me? My family? Do they want me out of a job? None of those things would ever stop te world from turning and science/medicine from moving forward. Even if I die right this instant, children would still get vaccinated and they would still not get autism from their vaccines. So why try?

The answer is simple. They’re trying because it distracts me from writing about the anti-vaccine and anti-science issues of the day, from being one more dissenting voice they have to contend with. That, and I believe that they want to have a monster under the bed, or a windmill, to be fearful of and fight against. Fear and anger are together the wind under their wings.

To those who continue to pry into who I am and what I do, I issue you a challenge. Counter my evidence and my facts and leave the personal out of it. Because, I assure you, you will not like it once you get to know me if you are an irrational, mindless anti-vaxxer. I can dish it out with the best of them. So shit or get off the pot, so to speak, and come at me with science, bro.

The Quack’s Worst Nightmare

I apologize that I have not been posting as much as you’d like me to. You know how crazy things get once the kids go back to school. Those schools and daycares start reporting “outbreaks” of sniveling, snotty kids. Then we have to investigate, write up reports, make recommendations, and piss off parents when we tell them their under- and unimmunized buttercups are to stay home. And then there are the responsibilities in academia that I managed to throw onto my plate. (Lecturing is not easy.)

Anyway, I wanted to talk to you today about the things we see and the things we don’t see. There used to be a time when we believed that it was “miasmas” that caused diseases like cholera. John Snow came along and proved it was water, but he didn’t prove that it was bacteria. That would come later with Pasteur and Koch. Still, John Snow used the available evidence to disprove a theory/belief, even when he didn’t have all the answers.

This is the issue with autism. We know what it physical and neurological representations are, and we know that vaccines don’t cause it. We just don’t know what does cause it and, if possible, how it can be treated or cured. To be honest, I do not believe that it can be cured. It would be wonderful to see a developmentally delayed child catch up immediately to their peers and live a “normal” life. But that’s not the case. Continue reading

Don’t defend the science, refute the lies, expose the liars

When I read an anti-science screed, I usually want to fire right back with something like “you’re lying” or “you’re full of it,” but I’ve found this to be non-productive. It’s non-productive because the person writing the screen is 99% of the time sold on the anti-scientific concepts that they are displaying in their writings (or speeches). It’s also non-productive to fight anti-science with science because science really doesn’t need to defend itself. In the end, one way or another, science gets proven right.

There was a time when people thought the Earth was the center of the known universe. Then Galileo proposed that the sun was the center of our solar system, based on scientific observations of the movement of celestial bodies, he was accused of heresy. It would take some time, but his theories were tested and found true. If we were still locked into the way of thinking of that era, we wouldn’t have a space program that yielded us things like satellite communications, GPS, or even dried ice cream. Yes, people died for these scientific beliefs, but the science they adhered to was proven true. Continue reading

Those who have eyes but won’t see (UPDATED)

I woke up this morning to two very different bits of news that really put the world in perspective. First, a friend of mine delivered a talk on how research studies are carried out and how people in the field of mental health should “analyze” them, no pun intended. It was a good talk, and I could tell that it was difficult for him to explain to his audience the difficult concepts of biostatistics and research studies. These are difficult concepts, as my friend put it.

See, there is a hierarchy to research studies. Graphically, that hierarchy looks like this:

Screen Shot 2013-07-20 at 11.13.15 AM

It’s in the shape of a pyramid to distinguish the amount of these types of studies out there. There are a ton of editorials and way fewer systematic reviews. However, systematic reviews are better than all other studies (from an evidence point of view) because they’ve adjusted for biases and other internal and external threats to validity. Epidemiological studies (Case-Control, Cohort, and Randomized Controlled Trials), are in the middle of the pyramid, and they’re how we go from case series to systematic reviews. Epidemiology, as you can see, is what holds the whole goddamn thing up.

This is how reasonable, science-oriented people see evidence. We trust editorials and case series, but we need that science to make sure that what we’re seeing is not based on our own biases and is not the result of chance. Just ask Wakefield how it went when he went backwards and issued his “expert opinion” that the MMR caused autism when his case series paper showed no association between the two things. Even people who are not scientists want to make sure that policy is driven by evidence. Otherwise, you’re just doing things because they feel good, and the chances of failure are multiplied endlessly when you do that.

(CONTENT IN THIS SECTION DELETED AT THE REQUEST OF KAREN ERNST)

Copyright infringements aside, the intent of this woman, as you can see, is to (once again) collect anecdotes from people who are convinced that vaccines “stole” their children. So I went on Facebook and asked a pertinent set of questions, as you can see:

“I know that some pro-vax “sciency” people are probably going to give you a hart time for this, but, personally, I’m looking forward to [how] you collect the data, analyze it, and present it to us. Quick question: Where will you draw the control group from? People who have not been harmed by vaccines? [An anathema to antivaxxers.] And how will you collect THAT data? Or are you going the case series route? ‘Cos case series don’t really rank well in the hierarchy of evidence.”

Now, I’m only making an assumption here, but I bet you dollars to doughnuts that “DK,” who commented after me, went to look at what “hierarchy of evidence” meant, and made what is perhaps the most idiotic statement from an anti-vaccine activist I’ve read this week (besides the ramblings of some petulant kid). As you can see above, she wrote:

“Individual cases and even (horrors) stories are part of the pyramid of evidence based medicine. Epidemiological studies are not. True, individual case histories are at the bottom of the pyramid, but there they are.”

Read it again: “Epidemiological studies are not.”

I must be seeing things. Because I see “case control,” “cohort,” and “randomized clinical trials” right there. Am I crazy?

Of course I’m not. Ren saw the same thing in his presentation yesterday. The people who attended saw the same thing. When I studied for my MPH, my professors and my colleagues saw it.

We all [expletive] saw it!!!

Except for the people who have eyes and won’t see.