Properly evaluating vaccine mortality

The public’s concern about adverse events, especially death, immediately or soon after vaccinations is very disruptive to vaccine uptake, leading to increased morbidity and mortality of vaccine-preventable diseases. For example, a 2009 Japanese study that showed 107 deaths following H1N1 influenza A vaccination, assumed a causality between the vaccine and the deaths without any evaluation of background rates of of deaths, which would help indicate whether there was any significance to the death rate or even if its related to the vaccination. 

Chen RT. Evaluation of vaccine safety after the events of 11 September 2001: role of cohort and case-control studies. Vaccine. 2004 May 7;22(15-16):2047-53. Review. PubMed PMID: 15121321.

Chen RT. Evaluation of vaccine safety after the events of 11 September 2001: role of cohort and case-control studies. Vaccine. 2004 May 7;22(15-16):2047-53. Review. PubMed PMID: 15121321.

It has been demonstrated that passively reported data, that is data that isn’t actively investigated by trained researchers, cannot be used to assess causality. In an active investigation, it was found that only 2 of the 107 deaths had an autopsy performed, and most of the others had other underlying diseases and conditions that were causally related to the mortality events. Furthermore, 15 million people were vaccinated with the H1N1 seasonal vaccine, and it would be expected that there would be >8000 deaths during the 20 days after vaccination using a crude mortality rate in Japan. Though it would still be a misuse of statistics, but there really is more evidence that the H1N1 vaccination lowered the death rate from 8000 to 107 post vaccination. 
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How pseudoscience tries to fool you

Pseudoscience-smellsI always get suspicious when someone makes an argument with the statement of “it’s been proven to work”, “the link is proven”, or, alternatively, they state some negative about scientifically supported therapies. Typically, I hear these kinds of statements from the pseudoscience pushing crowd. For example, real science has debunked the “there is a proven link between vaccines and autism,” a common and popular pseudoscientific belief.  Or that most alternative medicine (CAM) therapies work based on numerous logical fallacies that suspends reason, and accepts “belief” in the therapy, something that evidence-based medicine just doesn’t do.

So, I decided to put together a rather substantial treatise on science vs. pseudoscience. We’ll explore what exactly makes an idea scientific (and spoiler alert, it isn’t magic), and contrary to real science, what makes an idea “pseudoscientific.” So sit down, grab your favorite reading beverage, because this isn’t going to be a quick internet meme. I intend to show you exactly how pseudoscience, whether it’s creationism, vaccine denialism, alternative medicine, or whatever you want to debunk, lies. Yes, lies.
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New 13-valent pneumococcal vaccine is safe

pneumonia_355pxA recent study, published in the journal Vaccine, provided evidence that the new 13-valent pneumococcal conjugate vaccine (PCV13) is as safe as the previous version, the 7-valent pneumococcal conjugate vaccine (PCV7). The newer version of the vaccine, introduced in 2010 after clinical trials, protects against a broader range of pneumococcus (Streptococcus pneumoniaea significant human pathogenic bacterium) subtypes. These studies show that the new version did not increase  the risk for any serious adverse events related to the vaccine.

Pneumococcal disease is a serious health care issue, especially for children and adults with certain risk factors. Pneumococcal disease can lead to various serious diseases like pneumonia and bacterial meningitis, or less serious ones like otitis media. Unfortunately, pneumococcal disease can be fatal. In some cases, it can result in long-term problems, like brain damage, hearing loss, and limb loss.
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“False balanced” reporting of autism-vaccine manufactroversy

In the real world of science-based medicine, the link between autism and vaccines (particularly, the MMR vaccine for measles, mumps and rubella) has been thoroughly debunked, quashed, and discredited. In the delusional world of the vaccine denialists, the link between autism and vaccines is based on MrAndy Wakefield‘s paper alleging a connection between MMR and autism that has been retracted by the Lancet medical journal.

Then why is there even a debate about this manufactroversy (a manufactured or invented controversy)? Well, researchers actually examined this false controversy in a recently published article, by Graham Dixon and Christopher Clarke of Cornell University, in Health Education Research. They investigated how the news media and journalists try to “falsely balance” their reporting about the debunked link between vaccines and autism. The journalists create this false balance, “despite a strong medical and scientific consensus backed by rigorous epidemiological studies indicating no link between autism and vaccines.” Dixon and Clarke also state that “research suggests that journalists in the United Kingdom and United States often report this controversy by presenting claims both for and against a link in a relatively ‘balanced’ fashion. In some cases, so-called ‘falsely balanced’ reporting fails to mention which claim is supported by a scientific consensus.” An overwhelming scientific consensus, by the way.
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New Mexico removes fake religious objections from vaccine exemptions

As I discussed previously, the pendulum is swinging against the so-called “philosophical exemption” against vaccination, which allows parents to not vaccinate their children based on the “just because I don’t want to” principle. They don’t even have to support their exemption with a discussion with a healthcare worker who might explain the risks of their decision.

According to an article in the Las Cruces Sun-News, New Mexico state law says that residents can exempt their children from immunization for two reasons: 1) medical issues that might make the vaccination unsafe (often called medical exemptions) or 2) vaccinations conflict with the family’s religious beliefs (religious exemptions). Apparently, according to the article, “the New Mexico Department of Health wants to keep it that way.”
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Court says that fake religious vaccine exemptions are not protected by the First Amendment

In April, 2010, a Federal District Court in New York denied a mother’s bid for a religious exemption to New York state’s mandatory vaccination rules. According to the article in the New York Law Journal, “Martina Caviezel, a self-proclaimed pantheist, sought a preliminary injunction allowing her to enroll her 4-year-old daughter in a Great Neck, N.Y., pre-kindergarten without getting the shots the state says the child needs. Caviezel relied on Public Health Law §2164(9), which exempts children from the requirement whose parents or guardians “hold genuine and sincere religious beliefs which are contrary” to vaccination.”

Around September 2009, Caviezel submitted the New York exemption form to the school  requesting that her youngest child be exempt from the requirement that children be vaccinated against measles, mumps, rubella and other diseases. The school principal told her that her request would likely be denied. Caviezel  declined to meet with school superintendent to further discuss the exemption. She then sued after her request was denied, alleging civil rights violations.
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Religious exemptions to vaccines elevates whooping cough rates

 

©Centers for Disease Control and Prevention, 2012

©Centers for Disease Control and Prevention, 2012

According to a new study published in Pediatrics, the number of New York state parents who skipped at least one required vaccine for religious reasons has increased over the past decade. And New York counties that had this increase in religious exemptions to vaccinations also had more  whooping cough (Bordetella pertussis, or simply pertussis) cases, even among children that had been fully vaccinated.

For this study, the researchers tracked data from the New York State Department of Health on both religious exemptions and new whooping cough cases. Children were reported as having a religious exemption if they had been allowed to skip at least one required vaccine for non-medical reasons. 

The key results from the study were:

  • The overall state annual mean rate of religious exemptions increased significantly from 0.23 % in 2000 to 0.45% in 2011, almost doubling the rate over the decade.
  • The prevalence of religious exemptions varied greatly among counties with no obvious trends, although all of the counties around New York City showed large increases in religious exemptions.
  • Counties with mean religious exemption rates of >1% reported a higher incidence of pertussis. For counties with higher exemption rates, the rate of pertussis was 33 per 100,000 compared to counties with lower exemption rates, which had a pertussis infection rate of 20 per 100,000. The researchers determined that this difference was statistically significant.
  • In addition, the risk of pertussis among vaccinated children living in counties with high exemption rate increased with increase of exemption rate among exempted children, also statistically significant.

The increase in whooping cough rates is particularly troubling since unvaccinated children not only put themselves at risk, but also those who have been vaccinated (as result of the lower effectiveness of the currently available pertussis vaccine). Also, as the exemption rate increases and there is a lower than expected effectiveness of the vaccine, the herd immunity becomes weaker.
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Court decides parent’s refusal to vaccinate kids is not “free exercise of religion”

©friendlyatheist.com, 2012

©friendlyatheist.com, 2012

The US District Court for the Northern District of Ohio has ruled (pdf) that a parent’s refusal to vaccinate her children against diseases is not a “free exercise” of religion, and is tantamount to neglect.

 

In April 2010,  the Tuscarawas County (Ohio) Jobs and Family Services (TCJFS) took custody of the children of Charity and Brock Schenker as a result of a domestic violence matter between the parents. TCJFS determined that the children were “neglected and dependent” and worked out case plans for the parents which included psychiatric evaluations, drug testing and supervised visitation of their children. When TCJFS asked about the children’s immunizations, according to Secular News Daily, “Mrs. Schenker claimed she had religious objections to immunizations. The court informed her that the immunizations would be ordered.”

As a result of recommendations of court-ordered psychiatric evaluations and positive random drug tests, Mrs. Schenker (who subsequently divorced her husband) visitations were terminated, and TCJFS filed a motion for permanent custody of her children in August 2011. According to the Secular News Daily, “the county laid out as evidence a number of instances in which Schenker did not comply with orders, refused home inspections, and more. But Schenker sued with eight claims, including conspiracy claims and, most significantly, claims that her First Amendment right to free expression of religion was violated.”
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Comparing effectiveness of two types of pertussis vaccines

whooping-cough-cocoonOver the past year or so, there have been several outbreaks of whooping cough (Bordetella pertussis), including one that reached epidemic levels in Washington state, which has been considered one of the worst pertussis outbreaks in the USA during the past several decades. The disease lead to 18 infant deaths from whooping cough during 2012.

The original DTP vaccine (diphtheria, tetanus and pertussis) became available in the USA in 1948 and was critical to dropping the number of cases of whooping cough from 260,000  in 1934 to less than a few thousand per year in the 1990′s. The original vaccine contained what was called “whole-cell” pertussis, which includes all of the antigens of the pertussis bacterium, partially because it wasn’t understood (and to some extent still not fully understood) which antigens on the bacteria actually induce the proper immune response to have the body destroy a pertussis infection. 
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Updated: make religious vaccine exemptions more difficult to obtain

flu church vaccineA recent report indicated that US state legislatures are beginning to pass laws that make it more difficult for parents to obtain so-called personal exemptions to vaccinations before children attend public schools. According to the author, Tara Haelle, “Each US state sets its own vaccination policies, and most will not generally allow children to attend public school unless they have been vaccinated against diphtheria, tetanus and pertussis (whooping cough)hepatitis B; the Haemophilus influenzae bacteriummeasles, mumps and rubellapolio; and varicella (chicken pox).” In general, most states require that students meet the Centers for Disease Control and Prevention schedule (pdf) for children between 0 and 6 years old, which is set by the Advisory Committee on Immunization Practices.

All states allow legitimate medical exemptions from the immunization schedule before a child enters school, because of certain medical conditions that might make vaccinations problematic for young children. Some of these medical issues are: allergies to some of the components in the vaccines, immunocompromised conditions, family history of seizures, and other issues outlined in the General Recommendations on Immunization of the Advisory Committee on Immunization Practices. These medical exemptions are extremely rare, but are very important. A licensed medical doctor is the only one that should provide this exemption.
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Consequences of not vaccinating–Report 5

A baby died in Florida from whooping cough (Bordetella pertussis) last week. According to the report, “officials said the family chose not to vaccinate their child. Some parents are choosing not to fully vaccinate their children because they worry there is a link between the vaccinations and autism.” Of course, there is no evidence that vaccines cause autism.

Let’s place the blame for this death right where it belongs, right at the feet of  MrAndy Wakefield, the de-licensed physician, who caused the drop in MMR vaccine uptake through his fraudulent claim that MMR caused autism. Wakefield is a horrible excuse for a human being, and probably should take responsibility for this and many other deaths that resulted from his fraudulent and retracted study claiming that vaccines cause autism.

Parents have a moral obligation to vaccinate their children.

We have a moral responsibility for the health of our children and this has to dominate any other belief systems we hold. Even worse, by not vaccinating children, we are putting other people’s children at risk, as well as our own. If another child dies of measles, or whooping cough, or meningitis, and was infected by our own, non-vaccinated child, are we partly responsible?

And they should start by ignoring Wakefield’s lies. Because vaccines would have saved this baby’s life.

 

Use the Science-based Vaccine Search Engine.

Key citations:

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Waterloo, Ontario deals with unvaccinated students

The Waterloo Region (an area of southern Ontario, Canada) health department is responsible for the enforcement of a new law (pdf) that requires parents to provide immunization records for their children by 7 May 2013. And according to the CBC, over 1700 high school students received suspensions notices, hand delivered by school principles, this week unless their vaccination records are updated by 7 May.

Of course, the department of health allows medical exemptions for vaccinations, along with the unconscionable religious and personal exemptions to getting children vaccinated. Can’t win them all, but at least this part of Canada is attempting to deal with unvaccinated students by making them provide the records. 

Vaccines save lives.

Use the Science-based Vaccine Search Engine.

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Consequences of not vaccinating–Report 4, meningitis and education

college_meningitisThis is the fourth in a series of reports about actual consequences from not vaccinating against infectious diseases. The reports are all based on verifiable reports from health agencies and/or articles published in high impact peer-reviewed journals. 

Bacterial meningitis is a usually severe inflammation of the protective membranes covering the brain and spinal cord, known collectively as the meninges. While most people with meningitis recover, it can cause serious complications, such as brain damage, hearing loss, or learning disabilities. For example, in the United States, about 4,100 cases of bacterial meningitis, including 500 deaths, occurred each year between 2003–2007.

There are several pathogens that can cause bacterial meningitis including Haemophilus influenzae (most often caused by type b, often called Hib), Streptococcus pneumoniae, group B StreptococcusListeria monocytogenes, and Neisseria meningitides. Depending on the pathogen, bacterial meningitis is highly contagious, especially among groups that are in enclosed areas such as schools, college dormitories and other such situations. There are other types of meningitis, viral, fungal, parasitic and non-infectious, but they are significantly different than bacterial meningitis, about which is the focus of this article.
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No link between vaccines and Guillain-Barré Syndrome

© CBS Atlanta, 2013

© CBS Atlanta, 2013

One of the arguments made by vaccine denialists is that vaccines cause significant increases in nervous disorders, and they point to the vaccine’s Package Insert (PI) as “proof”. Setting aside the misuse of the information in a PI, there seemed to be some evidence that there was a slight increase in the rates of  Guillain-Barré syndrome (GBS) following vaccinations, although the risk was far outweighed by the benefit of preventing deadly diseases. Guillain-Barré syndrome is an autoimmune disorder of the peripheral nervous system, where the immune system appears to attack nerves involved in movement, although sometimes it attacks respiration and other functions. Guillain-Barré syndrome is usually preceded by a viral or bacterial infection, such as the flu. It is a serious condition, which often takes several months for full recovery. About 80% of those who contract the disorder recover fully with treatment.
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Vaccine package inserts–debunking the myths

©New York Times, 2013

©New York Times, 2013

One of the cherished strategies of the vaccine deniers is to use the package insert (called a Patient Information Leaflet in EU countries and Instructions for Use in the case of medical devices) to “prove” that vaccines are dangerous. Spend anything more than a couple of minutes in discussion with an anti-vaccinationist, and you’ll get a reference to a particular vaccine’s package insert (PI) as “proof” that it is dangerous, contains dangerous stuff, or is just plain scary. 

There are a lot of myths about what PI’s are and aren’t, and what information in them may or may not be useful. It’s time to look at what a PI is and what it really says.

What is a Package Insert?

All of you have probably seen a package insert, it’s a multiple page document that’s included with all real medications, whether prescription or over-the-counter (OTC). Depending on the type of drug, it can be 30-40 pages long, though most are printed on one huge sheet of very thin paper, so that it can be folded tightly and placed in each box that over-packages the drugs container (vial, bottle, etc). 

In general, package inserts are part of what is called the “labeling” of the drug, which means all the verbiage that pharmaceutical company may say about the drug. You will hear FDA regulators and individuals in pharmaceutical companies refer to “labeling” all of the time. Labeling is strictly regulated and it includes everything from the box in which the drug is shipped to any print or video advertising. Even what sales reps say to physicians in a sales call is covered by the drug’s labeling. In the USA, the Food and Drug Administration has established very strict rules in the Code of Federal Regulations (CFR) on what can be and cannot be stated in the package insert. There is very little variance from one PI to another one even for very different classes of drugs. The regulations even state the type and size of font used in the PI. 
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Andrew Wakefield–you sir are a disgusting, vile excuse for a human being

mmr-lancet-stfrontpageA large outbreak (or epidemic) of measles has hit over 700 people in Wales over the past few weeks according to NHS Wales. And since there are 6000 children who are unvaccinated against measles in this area, the outbreak will continue to increase in size, since measles is a highly contagious disease. This type of epidemic should not be happening in a modern, advanced country like the UK.

Well, who or what is to blame for ? Well, according to a UK newspaper, The Telegraph, “what actually caused the drop in vaccination uptake which led to Swansea was the autism scare, started and repeatedly stoked by Wakefield, abetted (it must be admitted) by the media.” Yes, that MrAndy Wakefield whose fraudulent paper alleging a connection between MMR and autism which was retracted by the Lancet, is at fault here.
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Consequences of not vaccinating a child–Report 1

pox partyVaccine deniers love to say that many (and some say all) vaccine preventable diseases are not dangerous, so why even take a tiny risk of an adverse event with vaccines to prevent these innocuous, harmless diseases. The problem with that belief is that it is simply untrue.

The CDC reported last week about a previously healthy 15 year old girl in Ohio who died from a chickenpox (Varicella zoster virus), a disease that is generally prevented by the varicella vaccine. The adolescent girl was admitted to a hospital after three days of a rash consistent with chickenpox with the last day experiencing fever and shortness of breath. The young girls was started on antibiotics and antifungals, to treat any concurrent infections, but she died three weeks later. The girl was current (or close to current) on her other vaccinations, MMR, DTaP, and Hib, but lived in an area that with low uptake of varicella vaccinations. Because deaths from chickenpox are so rare (about 100 people die of chickenpox every year in the USA), but not unknown, the Ohio Department of Health undertook a thorough investigation and concluded that the girl died from chickenpox, and there were no other comorbidities, including leukemia (which might have suppressed her immune system).

The complications from chickenpox occur mostly in susceptible groups such as infants, pregnant women, and immunocompromised individuals. Some of the more serious complications are:

  • dehydration
  • pneumonia
  • bleeding problems
  • infection or inflammation of the brain (encephalitis, cerebellar ataxia)
  • bacterial infections of the skin and soft tissues in children including Group A streptococcal infections
  • blood stream infections (sepsis)
  • toxic shock syndrome
  • bone infections
  • joint infections

It was very difficult to read the article. Most of the young girl’s organs failed, and she was in respiratory distress when she died. I cannot imagine being a parent watching what happened over three weeks while she was in the hospital. I can only imagine that the parents are beating themselves up over not having her vaccinated.

For those parents who are engaging in Pox Parties, where parents deliberately infect their children with flu, chickenpox and other vaccine-preventable diseases, understand that you might be putting your child at risk of dying. Please don’t do it.

Vaccines do save lives. 

Use the Science-based Vaccine Search Engine.

Key citations:

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Vaccines saved lives–scientific evidence

There are many canards propagated by vaccine denialists to support their personal beliefs (or denialism) about the safety and effectiveness of vaccines. One of their more popular beliefs is that vaccines didn’t end many of the deadly diseases, but improved sanitation, healthcare, nutrition or magical fairies (also known as homeopathy) ended these diseases. There is even a subgroup of these believers who think that the CDC, historians, and everyone else is lying about the epidemics that existed prior to vaccinations–let’s call this group history deniers.

So, is there scientific evidence that vaccines actually ended these epidemics? Yes there is, and it’s unequivocal. Unless you want to deny history, and somehow all of the health care records and epidemiological information was faked. 
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The one study to rule them all–the vaccine denier’s dream

clinprc(3)If you spend any time in the “debate” (actually, one side has scientific evidence and the antivaccination side denies all science, so to avoid falling for a false equivalency, debate gets scare quotes), you’ll hear every dumb argument to deny science. But one thing that you’ll see repeatedly from the vaccine deniers is that they would support vaccinations if there were better clinical trials

The problem with the vaccine denier’s clinical trial proposals is that they are a moving target, relying on a form of the Argument from ignorance, claiming that if we can’t absolutely “prove” that vaccines are safe, then it must be absolutely unsafe. For example, there are dozens of articles, including one of the latest (published here and discussed here). 

My good friend Allison Hagood, co-author of Your Baby’s Best Shot: Why Vaccines Are Safe and Save Lives, wrote a commentary about the antivaccine community’s perfect clinical trial. Follow along! (Allison’s commentary is presented in whole, but I’ve edited the formatting and added links where necessary).
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How vaccines saved millions of lives

Infographic: How People Died In The 20th Century

 

Over 5.2 billion people died in the 20th Century. Although the 20th Century ended a mere 13 years ago, from a statistics standpoint, we know we will probably die of different diseases (and other less natural causes) than our forebears. The causes of death evolve over time as medicine improves, science ameliorates risk, lifestyles change, environments shift, and politics reshape our world. British data journalist David McCandless (of Information is Beautiful) created this fascinating infographic based on a project, commissioned by the Wellcome Trust, a U.K. charity devoted to human health, called Death in the 20th Century, which shows us, graphically, the leading causes of mortality from 1900 to 2000, worldwide. 

Some of the numbers are shocking. Humanity is the cause of nearly 1 billion (or just short of 20%) of the deaths in the 20th Century. These numbers include war, murders, religious intolerance, suicide, and other deadly crimes that humans perpetrate against one another. Maybe the 21st Century will knock that number down, though I doubt any of us are optimistic given the way this century has started.

But the most interest information is in the Infectious Disease section. Nearly 1.7 billion people have died from infectious diseases. Some of the more interesting numbers are:

In the 21st Century, the numbers of deaths from these diseases will probably be in the few thousand worldwide. Why? Because of vaccines. Not better sanitation. Not better health care facilities. But because of vaccines.

And in the 21st Century, as more vaccines are developed and brought to market, many of these infectious diseases will be less of a problem. 

Vaccines saves lives. Literally hundreds of millions of lives.

Use the Science-based Vaccine Search Engine.

 

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