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Debunking the vaccine denier myths of the Argument by Package Insert

©New York Times, 2013

©New York Times, 2013

Revised 6 December 2014 to clarify a few points, improve readability and include a new logical fallacy.

One of the cherished strategies of vaccine deniers is to quote 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. Vaccine deniers consider the package insert to be golden tablets of the Truth™. It’s ironic that these antivaccine groupies rail against Big Pharma, as if they are demon reptilians, but the package insert, written by Big Pharma, is considered gospel.

Just spend 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. Orac has recently proclaimed it “Argument by Package Insert”–it’s almost at the level of logical fallacy. (David Gorski has just named it argumentum ad package insert, so it’s officially a logical fallacy.)

Vaccine package inserts are important documents, but only if the information include therein is properly understood. It is not a document that serves as medical and scientific gospel. But it is a document that can help clinicians use vaccines (or frankly, any medication) properly.

What is a Package Insert?

All of you have probably seen a package insert–it’s a multiple page document that is included with all real medications (as opposed to unregulated alternative medicine), whether prescription or over-the-counter (OTC). Depending on the type of drug, the PI can be 30-40 pages long, although 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. It is not just the printing on the vial or box, the word encompasses almost everything said about the drug, including advertising, PI’s, and yes, the box and printing on vial.

You will hear FDA regulators and individuals in pharmaceutical companies refer to “labeling” all of the time. Labeling is strictly regulated, because it establishes the claims made about the drug or device, how it is to be used, and other pertinent information. 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 in format or quality of information from one PI to another one even for very different classes of drugs. Amusingly, the regulations even state the type and size of font used in the PI.

How is a Package Insert written?

Before we discuss what is actually contained in a PI, it’s important to understand how it is written by the pharmaceutical company’s medical staff, and subsequently reviewed (and hopefully cleared) by the FDA. During the Phase 1, 2 and 3 clinical trials for a new drug, scientific information is collected about the drug–everything from the pharmacology to shelf life to results of the trials.

The Medical or Regulatory Departments (both or individually) of the pharmaceutical company then writes the PI, using the boilerplate language established by the FDA (or other regulatory agencies such as those from Japan or Europe). Note that there is a lot of consistency between all worldwide pharmaceutical regulatory agencies for what is in the PI, so that it is similar across the world. You are not going to find better information in a European PI, though you’ll get to see the Latvian translation of the PI if that thrills you.

In today’s world, part of the purpose of a PI is to protect the pharmaceutical company from legal issues. If the PI says “do not prescribe this drug to someone who abuses alcohol”, and a physician prescribes it to that type of patient, then the company has some protection from a legal action from the patient or physician. The PI is supposed to give a physician or other prescribing healthcare worker the framework to use the medication properly

After the Medical and/or Regulatory departments complete the initial draft of the PI, it is usually passed through different departments of the company for further review, correction and approval. For example, the manufacturing department may not agree with a statement about how the drug or device is manufactured, and it is corrected. Depending on the company up to 10-12 departments may review a single PI, and it could take a few weeks before this process is completed to everyone’s satisfaction. And the approval is not a passive one–a package withe the PI and other information requires a signature from the reviewer before it is passed along. And the signature represents a legal statement that the reviewer agrees with what is written. If a reviewer just signs it without actual review, a future FDA audit or legal issue could place the blame on all reviewers whether they took the time to read it or not.

package-insert-meme

The draft PI is then included with the New Drug Application (NDA) which is the system in the United States through which drug company formally propose to the Food and Drug Administration (FDA) that the agency reviews and clears a new pharmaceutical for marketing in the USA. The FDA reviews the whole application, including all labeling (in the parlance of drug regulation, everything written about the drug, from advertising to the PI to vial labels, are considered “labeling”), data, clinical trials, manufacturing, etc. before determining if it will be approved. The FDA often requests changes to all labeling depending if they agree or disagree on statements. Many times a pharmaceutical company will attempt to add indications, that is the valid reason to use a medication, but the FDA will reject it until more data is accumulated.

PI’s are not static documents. Pharmaceutical companies may add more information, warnings, indications (or contraindications, meaning uses that may harm the patient if used in particular situations), and other information that can be supported by evidence from scientific investigations. Of course, the pharmaceutical company must resubmit its labeling (including the PI) to the FDA for approval of the changes. Contrary to popular belief (including from an amazing number of physicians), a pharmaceutical company cannot change an indication unless it has a new approval from the FDA. Even making a change that allows a medication to be used on children (a pediatric indication) can take years of clinical trials and regulatory review before a change can be made

The FDA spends a lot of time reviewing pharmaceutical labeling, because it has the most direct impact on patients’ health–although not a critical issue with vaccines, contraindications and drug interactions are very important to pharmacists and physicians for many drugs.

What does a Package Insert actually say?

package-insert-freakingAgain, the FDA (and other regulatory agencies) have established regulations on what must be written in the PI. The package insert is necessarily complex and wordy, because it needs to cover a lot of information. To save weight in shipping, and to make it small enough to attach to every individual unit of a product (like a vial, bottle or box), the PI is often printed in tiny fonts on very thin paper. A lot of time is taken by pharmaceutical companies to lay out the document to fit properly.

 

By regulatory code, every pharmaceutical package insert (there are different regulations for devices and equipment) must include the following:

  • Highlights–summarizes the most important information about benefits and risks.
  • Table of contents–because there’s a lot of information there.
  • Boxed Warning (pdf, page 11)–this is usually a large black box in bold print that describes a serious warning about the drug. For example, a drug that might kill someone if used incorrectly in specific situations. Black box warnings are reserved for serious adverse reactions that are tied to specific uses of a medication. Physicians and other prescribers need to know this one thing before all else prior to prescribing a medication. Sometimes a medication is perfectly safe, but may cause serious allergic reactions in some people. As far as I was able to determine, there are no Boxed Warnings on any vaccine ever. Why? Because there is simply no evidence that there is any dangerous and deadly reaction to vaccines.
  • Date of US approval.
  • Description–this section describes the drug in detail including all of its ingredients.
  • Clinical pharmacology–this section describes how the medicine works in the body, how it is absorbed and eliminated, and what its effects are likely to be at various concentrations, critical dose-response relationships (that is, does more of the drug have more of an effect, a fundamental piece of information about how the drug works). This section may also contain results of various clinical trials (studies), explanations of the medication’s effect on various populations, such as children and pregnant women, and other scientific information.
  • Indications and usage–this section describes the uses and indications for which the drug has been cleared by the FDA. Important note–physicians are legally allowed to prescribe medicines for purposes not listed in this section (so-called “off-label usage“), as long as that use is not specifically contraindicated (see below). However, the pharmaceutical company’s labeling may not discuss this off-label use, even if there is scientific evidence supporting it, until the FDA approves it. Recently, there have been major fines levied by the US Department of Justice against pharmaceutical companies that push off-label use through subtle advertising or sales rep conversations.
  • Contraindications–this section probably contains the most important information within all of the verbiage of a package insert. It lists situations in which medication should not be used, for example in patients with certain medical conditions, in children, or other situations.  A good example of contraindications for vaccines is that most flu vaccines are contraindicated for patients with egg-protein allergies. For a physician, this section is as important as the Boxed Warning section.
  • Warnings and precautions–this covers possible serious side effects that may occur with use of the drugs. If the warnings are particularly serious (risk of death, for example), they may be placed in the Boxed Warning section. This section also explains how to use the medication safely, for example stating that “Do not drink alcohol while taking this medication” or other common precautions. It also describes any laboratory tests that may be necessary prior to using the drug. Serious side effects with known, evidence-based causal associations are listed in this section. This section is much more important with powerful therapeutic drugs that often have critical side effects.
  • Nonclinical toxicology–this section describes the potential of carcinogenesis (causing cancer), mutagenesis (causing mutation) or impairment of fertility from the drug. This section has little applicability to vaccines, since they have no carcinogenic, mutagenic, or fertility effect, given that the level of the vaccine’s ingredients’ dosage fall far below the lower threshold of the any dose-response test of these issues. The PI may state some innocuous verbiage such as “no known information” meaning that in the 10-15 years of research and study, no evidence that the vaccine is carcinogenic or mutagenic.
  • Use in specific populations–this describes if and how the drug may be used in the following populations of patients: pregnancy, labor and delivery, nursing mothers, pediatrics or geriatrics.
  • Adverse reactions–this sections lists all side effects observed in all studies of the drug (including post-marketing studies), whether or not it has been scientifically established there correlation between the drug and the side effect. Almost all of these side effects are coincidental observations and are rarely of much concern. This section is the favorite of the vaccine denier, but they do not appreciate the utter lack of statistical evidence of correlation between these reactions and the vaccine. These are simply observations.
  • Drug interactions–essentially, this section describes any interaction this drug may have with other drugs. Not relevant to vaccines.
  • Drug abuse and dependence–this section provides information regarding whether prolonged use of the medication can cause physical dependence. Since vaccine addiction is ridiculous, it’s not very crucial information for vaccines.
  • Overdosage–this section, critically important in lifesaving situations, gives the results of an overdose and provides recommended action in such cases. Not very crucial to vaccines.
  • Dosage and administration–this part provides the recommended dosages with detail for different ages, medical conditions, and size of patients. Very important for vaccines.
  • Dosage forms and strengths–this section lists out the various dosages and strengths of the drug.
  • How supplied–this explains in detail the physical characteristics of the medication including color, shape, markings, etc., and storage information (usually with a range of temperatures). This is important information, especially for vaccines, that’s sometimes ignored. Lots of medications, vaccines included, lose potency if they are overheated or frozen.
  • Patient counseling information–this details information useful for patients including who to contact in an emergency and how to report adverse reactions to the company or to the FDA.
  • Clinical studies–this covers the clinical trials that were performed prior to approval. It does not include anything more current, and some PI’s can be over 10 years old. Most published clinical trials were not done for FDA approval, so aren’t included in any PI’s. I used to consider this a defect of the PI, but with easy access to post-marketing clinical trials through PubMed and other sources, it’s not too relevant.
  • References–this includes all of the citations for clinical trials, pharmacology, and other information related to the drug. Again, it is only as current as the date of the package insert (which is listed at the bottom), so it can be way out of date.

So, that’s a lot of information, but is any of it useful? How does one interpret the information in the PI? Especially for vaccines, which are not truly a therapeutic drug (it doesn’t cure a disease state, but prevents it), and which has ingredients in levels that are below the level of detection in a dose response study.

But what can we learn from a package insert?

The information in a package insert can be used in a manner to help treat a patient. Vaccine deniers idolize vaccine PI’s as some biblical statement about the dangers of vaccines. Once again, it’s easy to cherry pick information out of a PI if one does not or refuses to fully comprehend how the information in the PI is included.

To a real evidence-based (or science-based) physician, the only useful information in PI for vaccines are (in no particular order of importance):

  • Clinical pharmacology. Knowing this information helps the scientific minded (not a skill set well known in vaccine deniers) how the drugs work. By understanding this section, you begin to comprehend how a drug may treat a disease, but also how it probably isn’t related to a mythical adverse event. For example, knowing how immunizations work, you will realize that intramuscular injections are a perfectly scientific method of inducing an immune response, that there is no logical reason to believe an injection would cause a neurological disorder, and other silly myths. But pharmacology is very hard to understand, so most people ignore it. Pharmacology is probably one of the most complex of the biomedical sciences.
  • Contraindications. There are very few contraindications in vaccines. But the ones that do exist are quite serious. For example, the aforementioned sensitivity to egg proteins in flu vaccines. Or yeast sensitivity for Gardasil. Physicians are very aware of these issues, as are most places, like pharmacies, that do vaccinations.
  • Warnings. These are adverse events that have evidence supporting their causal association with the drug or vaccine. As opposed to the adverse reactions section, which tends to be abused by vaccine deniers, this section is where solid, repeatable scientific data is located. The FDA, by regulation, can mandate a change in the PI to include new warnings as evidence arises. Not a single PI for vaccines mentions autism as a “warning.” Not one.

The most misinterpreted misused section of the PI insert is “Adverse Reactions.” The FDA states that the section should include events “for which there is some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event.” The key word is “believe”, instead of based on evidence. And frankly, anything with serious evidence would be in the Warnings section, so the Adverse Reactions section is a laundry list of observed events that probably have nothing to do with the drug (or vaccine) but remain there so that the pharmaceutical company is covered in case of a lawsuit. Yes, pharmaceutical companies are constantly frightened of litigation, and the package insert is often the first line of defense against those frequent lawsuits. But we digress.

Back to simple math for the vaccine deniers.

The Adverse Reactions section, taken by itself, is the pseudoscientific way of reviewing the data. Here’s what is important:

risks-disease-vs-vaccine

 

The chance of death from these vaccine preventable diseases is 1000X higher than the possibility of known adverse events that are caused by vaccines. And these adverse events do not cause death (despite the myths of the antivaccine crowd). This is real science, where the benefit, saving lives, vastly outweighs any risks, even the nonsense “laundry list” risks that may not have anything to do with the vaccine. If you fall for the Nirvana Fallacy, that is if it’s not perfect, then it’s worthless, then sure, vaccines aren’t perfect so they must be useless.

A fellow skeptic, and thorn in the side of vaccine deniers everywhere, wrote a hysterically funny article about a mythical airline package insert. The adverse events are, of course, death, massive body damage, and more death. But the risk of dying on a flight across the country is 10,000X lower than driving across the country. So if you focus on the adverse events, without understanding the frequency of the risk (let alone the causality), it is absolutely useless. Context matters. Take a single data point out of the context of all other information, and you could “prove” anything. But being a real critical thinker, and using that information along with all other available data, especially data of a higher quality, then you might reach a rational decision.

Conclusions

But the fact is that vaccines save lives, and until such time the vaccine deniers can actually spend the time in getting their Ph.D. or MD, then do research in a world-class laboratory and then publish data that shows either the adverse events are all real and are much higher than stated in the PI, and shows that vaccines have no benefit, the vaccine deniers just have no basis for their claims. They are misinforming and misusing information to support their beliefs, rather than using real science and determine whether all of the evidence supports or nullifies their hypothesis.

Getting real evidence takes real hard work. It takes education, time, sweat, sleeping in labs, sitting at a computer, writing documents, getting yelled at by superiors and peers. It’s hitting dead ends, then finding a way around that dead end. One cannot just pull a package insert out of a box and say “here, I win.” If only it were that easy.

Package inserts have excellent and useful information, important for physicians and other healthcare workers in treating patients. However, package inserts must be read fully, without cherry picking data that supports your point of view. Taking information out of context, without spending the effort to understand it completely, just shows the level of denialism. The anti-vaccinationists are focused on finding any data, no matter the quality, that supports what they want to believe. But if you are truly on the fence about vaccinations, then the adverse events information in a package insert is not the place to start. There is so much information out there, but if you read that information with an open, critical mind, you will find that the scientific consensus strongly supports the safety and effectiveness of vaccines.

One young woman did just that, despite initially being antivaccine. Her open mind lead her to eventually vaccinate her two children. Good for her.

Vaccines save lives, and we have evidence that supports it. And package inserts do not dispute those facts.

 

Visit the Science-based Vaccine Search Engine.

 

Comments (74)
  • http://beginingsinwriting.wordpress.com/ R.w. Foster

    I just discovered this on Dr. Folta’s Facebook page, and thought it would be cool to share with you, Raptor. I’m not sure if you’ve seen it. “There was a poster at the AgCanada14 Conference of good online sources for agriculture information.” https://www.facebook.com/photo.php?fbid=839690939406919&set=a.137700549605965.14548.100000980613760&type=1

    • http://www.skepticalraptor.com/skepticalraptorblog.php Skeptical Raptor

      Yes, I did see it. And I’m so humbled by it. :)

      • http://beginingsinwriting.wordpress.com/ R.w. Foster

        I cheered when I saw that so many folks I respect and admired were acknowledged for their hard work. Now, we need to get you guys recognized by the rest of the nation & world.

  • http://beginingsinwriting.wordpress.com/ R.w. Foster

    My favorite tactic when someone mentions package inserts is to mention the funny AE I caused to be listed on the Cialis insert.

  • Dorit Reiss

    I can’t start to tell you how valuable this is.

    • http://www.skepticalraptor.com/skepticalraptorblog.php Skeptical Raptor

      Thank you Dorit. And that’s why I updated it, because I didn’t realize how many different articles cite it. I try to keep a dozen or so of the most cited articles up-to-date.

  • Pingback: No, the CDC did not just apologize and admit that this year’s flu vaccine doesn’t work * The New World()

  • Mike7106

    http://www.merckmanuals.com/home/brain_spinal_cord_and_nerve_disorders/brain_infections/encephalitis.html

    Merck states “Encephalitis is inflammation of the brain
    that occurs when a virus directly infects the brain or when a virus,
    vaccine, or something else triggers inflammation. The spinal cord may
    also be involved, resulting in a disorder called encephalomyelitis.

    People may have a fever, headache, or seizures, and they may feel sleepy, numb, or confused.

    Magnetic resonance imaging of the head and a spinal tap are usually done.

    Treatment involves relieving symptoms and sometimes using antiviral drugs.

    Encephalitis can occur in the following ways:

    A virus directly infects the brain.

    A virus that caused an infection in the past becomes reactivated and directly damages the brain.

    A virus or vaccine triggers a reaction that makes the immune system attack brain tissue (an autoimmune reaction).”

    Vaccines cause Encephalitis. Encephalitis causes autism.

    • http://www.skepticalraptor.com/skepticalraptorblog.php Skeptical Raptor

      Here’s your stupidity in no particular order:

      1. The mountains of peer-reviewed evidence show us that vaccines are unrelated to autism.

      2. Nothing else matters.

      3. The Merck Manual is incorrect in this matter.

      4. Medline Plus, the official diagnostic guide of the National Institutes of Health does not include vaccines as a cause of encephalitis.

      http://www.nlm.nih.gov/medlineplus/ency/article/001415.htm

      5. The Diseases DB does not include vaccines as a cause of encephalitis in any form.

      http://www.diseasesdatabase.com/ddb22543.htm

      6. Cherry picking one sentence out of an article without actually understanding the point. That is, the virus would have caused the reaction anyways, so the vaccine would not have mattered. If the person had become infected with the virus, it would have lead to the autoimmune disease. That being said, the literature shows no general causal relationship between vaccines of any sort and encephalitis.

      You’re just a cherry picking idiot. Go troll a website that actually tolerates ignorance and stupidity.

      • Mike7106

        You’ve had one too many brain mushing flu shots if you think Merck would posit that in error.

        • Mike7106

          One of the nurses from the Nurses Who Vaccinate FB page said that parents exempting their children from vaccines won’t stop until there is an epidemic. I wonder what she calls a 1 in 70 child autism rate? Or the huge number of asthmatic children. http://www.lung.org/finding-cures/our-research/trend-reports/asthma-trend-report.pdf Current Prevalence Age-specific current asthma prevalence trends are shown in Table 7 . Approximately 25.9 million Americans (including 7.1 million children) had asthma in 2011; a rate of 84.8 per 1,000 population. The highest prevalence rate was seen in those 5-17 years of age (105.5 per 1,000 population). Overall, the rate in those under 18 (94.9 per 1,000) was significantly greater than those over 18 (81.6 per 1,000; not shown ). 11

          • Dorit Reiss

            Since the evidence is that the rate of autism has not actually changed across decades – http://journals.cambridge.org/action/displayAbstract?fromPage=online&aid=9313675&fileId=S003329171400172X – that vaccines do not cause autism or asthma, that point is really not relevant to this discussion. Not vaccinating would not prevent any of these problems – just add preventable diseases on top.

            I would call an epidemic having 10000 cases of whooping cough in California. Back partly because of a vaccine that’s not effective enough and partly thanks to non-vaccinating. Having tens of thousands of cases of measles in Europe. All preventable, because of anti-vaccine misinformation.

          • Mike7106

            When you have absolutely NOTHING just LIE. That’s what “people” like REISS do and have been doing for ever.

          • Dorit Reiss

            If anything I said is inaccurate, please show that.

          • Mike7106

            “Since the evidence is that the rate of autism has not actually changed across decades – ” That’s not just a lie it shows how little you care about the children who have become autistic.

          • Dorit Reiss

            Have you looked at the article above, that calculated the rate of autism over decades and showed exactly that?

            The rate of autism diagnoses has certainly gone up. But that does not mean there are more children with autism. To remind you, we have a broader diagnosis, better awareness, and more services.

      • Mike7106

        Many people ask if vaccines are dangerous.
        “Several viruses including polio, chicken pox, and West Nile are capable of causing encephalitis.

        And, an allergic reaction to vaccinations [11], as
        per the National Institutes of Health, also can cause encephalitis with
        brain swelling. Encephalitis was included as one of the vaccine injuries
        to be compensated for under the 1986 National Childhood Vaccine Injury
        Act. [12]

        Vulnerabilities of the Infant Brain, Uniquely Susceptible to Lipid Peroxidation

        By way of explanation, the term “lipid peroxidation” refers to lipid
        degradation resulting from free radical generation from a series of
        pro-inflammatory chain reactions, which can be very damaging if the
        process is prolonged. “Free-radicals” in turn refer to atoms with
        unpaired electrons, resulting in heightened instability and reactivity.
        The end result of abnormally prolonged lipid peroxidation may be abnormal brain inflammation with secondary brain edema (swelling).

        Of all the organs of the body, the brain is the most susceptible to
        oxidative degradation, commonly referred to “lipid peroxidation.”
        Although an infant’s brain receives 15 percent of normal cardiac output,
        it utilizes nearly 25 percent of the body’s oxygenation. [13] As
        elevated oxygen levels in the environment bring increased risk of
        explosions or fire, comparable physiological risks exist in the brain.
        In addition to being a highly oxygenated organ, the human brain has
        heightened vulnerability to harmful peroxidation because the brain has
        by far the highest fat content of any organ of the body with membrane
        lipids constituting 60 percent of the solid matter. [14] In addition,
        both brain and retina contain a relatively high percentage of the
        omega-3 polyunsaturated fatty acid, docosahexaenoic acid (DHA) [10-20]
        and arachidonic acid (ARA) that serve as a primary building block of the
        membranes of these structures. DHA and ARA are high in energetics, but
        they are far more unstable and vulnerable to pro-inflammatory
        peroxidation (oxidative lipid degradation) than saturated fats. [13-22]

        In essence, the brain might be compared with highly inflammable dry
        grass or brush enclosed in an area with elevated oxygen levels, needing
        only a spark to set off a conflagration of inflammatory lipid
        peroxidation. In all likelihood, vaccine adjuvants provide this spark
        far more often than generally realized.” – See more at: http://www.vaccinationcouncil.org/2011/06/01/vaccines-and-brain-inflammation/#sthash.nkjSQkIi.dpuf

        • Dorit Reiss

          This is an excellent example of why the vaccination council – an anti-vaccine organization – is not a good source. The interesting, but unsupported theory of how the brain functions they provide does not fit the data. The data is that serious problems from vaccines are very, very rare. http://pediatrics.aappublications.org/content/early/2014/06/26/peds.2014-1079.abstract

        • http://www.skepticalraptor.com/skepticalraptorblog.php Skeptical Raptor

          Until you provide scientific evidence equivalent or superior to the vast mountain of evidence that clearly and unequivocally rejects the hypothesis that any vaccine has anything to do with anything on the autism spectrum disorder, please bring it. But taking a 100 year old medical manual or quoting a legal document that has nothing to do with science means to me you have nothing to offer to this conversation but misinformation and ignorance. Good day sir.

          • Mike7106

            The vax machine is a lying machine in league with the MSM. The latest
            blatant lie that has been repeated in commercials, pushing a shingles
            vaccine, by spokesperson Terry Bradshaw and others is that 1 out of 3
            people will get shingles in their lifetime.

      • http://politicoid.us/ Kir (Politicoid)

        For someone who portrays himself as a professional, you seem to have no problem resorting to childish insults. Does attacking people give you a hard on?

    • Dorit Reiss

      If you actually look at the version of the Merck Manual aimed at professionals, they address which vaccines may cause autism. It says: “The most common causes used to be measles, rubella, chickenpox, and mumps (all now uncommon because childhood vaccination is widespread); smallpox vaccine; and live-virus vaccines (eg, the older rabies vaccines prepared from sheep or goat brain).” http://www.merckmanuals.com/professional/neurologic_disorders/brain_infections/encephalitis.html

      In other words, two vaccines no longer in use were associated with encephalitis. In contrast, by preventing other viral infections, the vaccines prevent encephalitis. This actually does not support your claim that vaccines currently in use cause autism. Quite the opposite.

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  • http://skrikvirniks.wordpress.com/ gipsika

    “It is neither optimized for or tested on other platforms, including including Internet Explorer.” YAY! IE is a fossil, I’m with anyone who fails to bother about it! :-D

    • http://www.skepticalraptor.com/skepticalraptorblog.php Skeptical Raptor

      I think calling IE a fossil is giving it more credit than it deserves. LOL

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  • http://www.vacfacts.info/ Lowell Hubbs

    How about vaccine contamination? Should that be of any concern? That is not listed on the vaccine insert, nor anywhere else? In fact it appears that such as the cancer causing SV40 virus will now be with us on this planet forever.

    Simian virus 40 in humans

    Fernanda Martini1, Alfredo Corallini2, Veronica Balatti1, Silvia Sabbioni2, Cecilia Pancaldi1 and Mauro Tognon1*

    Corresponding author: Mauro Tognon

    Author Affiliations

    1 Department of Morphology and Embryology, Section of Cell Biology and Molecular Genetics, School of Medicine, and Center of Biotechnology, University of Ferrara, Via Fossato di Mortara, 64/B. 44100 Ferrara, Italy

    2 Department of Experimental and Diagnostic Medicine, Section of Microbiology, University of Ferrara, Via Luigi Borsari, 46. 44100 Ferrara, Italy

    Excerpts: These results suggest that (peripheral blood mononuclear cells) PBMCs, could be a reservoir and vehicle of SV40 spreading in the tissues of the host and among the individuals. (iii) SV40 sequences were found in urine and stoole samples, from children and adults [84,89,90], indicating that the haematic, sexual and orofecal routes of transmission are likely to be responsible for SV40 horizontal infection in humans.

    http://www.infectagentscancer.com/content/2/1/13

    Advances in Virus Research, Volume 50

    Pages 83 and 84, read. (Also see the study titled, Simian virus 40 in humans, below on this page)

    Excerpted:

    Moreover, blood and sperm fluid may represent important means for spreading of SV40 in humans.

    Indeed in these investigations, (Martini etal;, 1995,1996) 61% of the neoplastic patients positive for SV 40 sequences were of an age excluding exposure to SV 40-contaminated polio vaccines, suggesting contagious transmission of SV 40 by horizontal infection.

    http://books.google.com/books?id=PfO7D8ZoSMkC&pg=PA84&lpg=PA84&dq=sv40+is+contagious&source=bl&ots=AlaWsAkp95&sig=RnycQFX2ucD-3zybHQ07FAIeJYk&hl=en&sa=X&ei=kZLfT5_mA4qc2QXKz6jtCA&ved=0CFoQ6AEwBg#v=onepage&q=sv40%20is%20contagious&f=false

    Polio Vaccine, Simian Monkey Virus and cancer links
    http://www.junkscience.co.uk/2013/08/junk-science-number-61-polio-vaccine-simian-monkey-virus-and-cancer-links/

    Gardasil Vaccine Found to be Contaminated
    http://sanevax.org/gardasil-vaccine-found-to-be-contaminated/

    SANE Vax to FDA: Recombinant HPV DNA found in multiple samples of Gardasil
    http://sanevax.org/sane-vax-to-fda-recombinant-hpv-dna-found-in-multiple-samples-of-gardasil/

    Gardasil Vaccine rDNA Introduced at Coroner’s Inquest
    http://vactruth.com/2012/08/09/gardasil-rdna-coroners-inquest/

    Bombshell Interview Reveals DNA Fragments Discovered 6 Months After Vaccination, (Gardasil) http://vactruth.com/2012/08/16/rdna-fragments-after-vaccination/

    The persistence of HPV DNA fragments and adverse effects in HPV shot recipients
    http://www.examiner.com/article/the-persistence-of-hpv-dna-fragments-and-adverse-effects-hpv-shot-recipients

    Truth About Gardasil, (personal accounts of the harm done)
    http://truthaboutgardasil.org/

    HPV vaccine linked to deaths
    http://www.junkscience.co.uk/tag/dr-chris-shaw/

    Death after Quadrivalent Human Papillomavirus (HPV) Vaccination: Causal or Coincidental?

    Conclusions: Our study suggests that HPV vaccines containing HPV-16L1 antigens pose an inherent risk for triggering potentially fatal autoimmune vasculopathies.

    http://www.rescuepost.com/files/ltshaw-death-after-quadrivalent-hpv-vaccination-pharma-reg-affairs-2012.pdf

    Published on Dec 5, 2012
    Dr. Deisher testifies at the MN House about vaccine safety. She presents research demonstrating a link between the rise in the rates of autism and the use of aborted fetal cells in the production of vaccines. Dr. Deisher is the president and founder of SoundChoice, a non-profit that works to provide safe vaccination alternatives.

    Dr. Deisher testifies on the connection between vaccines and rising rates of autism (2 of 4).

    Dr. Deisher testifies on the connection between vaccines and rising rates of autism (3 of 4).

    Dr. Deisher testifies on the connection between vaccines and rising rates of autism (4 of 4).

    Spontaneous Integration of Human DNA Fragments Into Host Genomes

    Results:

    Spontaneous cellular and nuclear DNA uptake was evident in HFF1 and U937. Spontaneous cellular uptake was seen in NCCIT. DNA uptake in BE (2)-C, M059J, and M059K was not measurable because of high auto fluorescence of the cells. No Cy3 signal was observed in HL-60. The amount of labeled Cy3 human Cot1 DNA incorporation in U937 genomic DNA was 0.0111 +/- 0.0034pg (n=12) per cell in 24 hours, which was approximately 0.167% of total U937 genomic DNA.

    Conclusions:

    This study demonstrates that primitive short DNA fragments (50-300 bp) are spontaneously taken up by HFF-1, U937 and NCCIT cells and inserted into the genome of the monocytic leukemia cell line U937. Hence, vaccines containing residual HERVK and human fetal DNA fragments may contribute to the genomic instability observed in ASD.

    http://soundchoice.org/wp-content/uploads/2012/08/DNA_Contaminants_in_Vaccines_Can_Integrate_Into_Childrens_Genes.pdf

    Autism

    The dangers of using aborted fetal cell lines for vaccine manufacture have been debated by the FDA for over 50 years, and yet they have not done sufficient safety studies. The active component of a vaccine is a virus. Viruses are too large to manufacture in test tubes. Therefore, vaccine manufacturers exploit the natural method of producing virus– they inoculate cells and the cells produce the virus for them. Each vial of vaccine contains contaminants from the cells used to make the virus. When we use animal cells to make viruses, the residual material is not human and so we mount an immune response to it and eliminate it. However, in the case of vaccines produced using aborted human fetal cell lines, we have the dangers of triggering an autoimmune response and insertion of the contaminating DNA to disrupt the child’s own genes.

    In the US, autism has spiked up in 3 distinct years, called changepoints. The first changepoint occurred in 1981, the second in 19881, and the third in 1996. These spikes coincide with the introduction of vaccines that are produced in aborted fetal cells. In 1979, aborted fetal cell produced MMR II was approved in the US. Compliance campaigns brought MMR II use up from as low as 49% for children born before 1987 to over 82% for children born in 1989 and later. A second dose of MMR II was also introduced to the vaccination schedule for children born in 1988 and later. The third changepoint corresponds to the approval of aborted fetal cell produced Varivax (chickenpox) in 1995 (See figure below).

    Read more: http://soundchoice.org/autism/

    For Scientific Data: Homologous Recombination Study
    http://www.cogforlife.org/SCPIIMFARHR.pdf

    Chickenpox Vaccine Use is Highly Statistically Related to Autism Disorder; (using by the way, human diploid tissue in manufacture)
    http://onemoresoul.com/news-commentary/chickenpox-vaccine-use-is-highly-statistically-related-to-autism-disorder.html

    Viral Nucleic Acids in Live-Attenuated Vaccines: Detection of Minority Variants and an Adventitious Virus
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2876658/

    Vaccine Contamination: Pig Virus DNA Found in Rotarix
    http://www.nvic.org/nvic-vaccine-news/april-2010/vaccine-contamination-pig-virus-dna-found-in-rota.aspx

    Autism Epidemic, Is Foreign DNA in MMR II Vaccine Responsible? CBCD Suggests CDC Study Microcompetition Theory
    The Center for the Biology of Chronic Disease (CBCD) believes that the cause of the epidemic is the foreign DNA in the MMR II vaccine.
    http://www.prweb.com/releases/2012/4/prweb9359508.htm

    Toxic Vaccines? CBCD Sends Letter to FDA & CDC on Foreign DNA Fragments in Gardasil and MMR
    The CBCD sent a letter this past week to the offices of the FDA Commissioner, Dr. Margaret Hamburg,and to the offices of the CDC’s director, Dr. Thomas R. Frieden.
    http://www.prweb.com/releases/2012/9/prweb9924299.htm

    Vaccines Contaminated with Mycoplasma’s – by Garth Nicolson

    Garth Nicolson http://www.immed.org has written and published hundreds of peer reviewed medical journal articles. He discusses how vaccines are not tested for mycoplasma contamination’s.

    Microcompetition with foreign DNA and the Origin of Chronic Disease. [Paperback]

    A selection from: Microcompetition with Foreign DNA and the Origin of Chronic Disease
    by Hanan Polansky, August 2004
    http://www.cbcd.net/Hanan%20Polansky%20on%20Theory.pdf
    http://www.cbcd.net/index.php

    Junk Science? Number 71: Big Pharma bias and inaccurate conclusions in vaccine research

    The conclusions drawn in over 80 per cent of flu vaccine global research studies did not hold up to objective scrutiny, according to a report in the BMJ, March 2014. Huge inaccuracy levels like these rightly fuel serious skeptic concerns that flu vaccine benefits are often hyped.

    The BMJ study, which looked at some 274 comparative studies on flu vaccination, found that only a mere 18 percent of the studies were deemed to actually prove what the articles claimed to be their findings!

    Read more:
    http://www.junkscience.co.uk/category/health-2/vaccines/

    • http://www.skepticalraptor.com/skepticalraptorblog.php Skeptical Raptor

      Youtube videos are hardly reliable sources for anything but someone babbling themselves without any reliable sources. It’s like a self-fulfilling source about itself.

      The BMJ story, written a shill for the anti-vaxxers, decided arbitrarily to void any study that had Big Pharma support without any substantial evidence that the quality of a study with or without support had any difference in quality. That’s cherry picking of cherry picking, and is laughable.

      I’ve already dismissed the bogus claims about SV40.

      Really do you have anything original? Cause, you are known spammer on Disqus.

      • http://www.vacfacts.info/ Lowell Hubbs

        You haven’t actually dismissed anything, other than in your own mind. Can you actually address that vaccine contamination information, directly? No you can not? Where are the counter studies showing the confirmation of no such contamination? Where are your studies showing no link to autism, in regard to that contamination issue. The CDC has not even begun to look at any such thing, other than to for the most part deny the existence of any such contamination; and when they are forced to realize its existence by confirmation made by a private lab; they simply deny there is any evidence and nor any scientific proof ever existing, as to and regarding the potential harm to human health.

        Those studies do not exist which you need to refute this information. Where are your Big Pharma studies? Where is the confirmation of the quality of their studies? You can not get any closer to cherry picking than only accepting the so called studies of big pharma and their cohorts? I am telling you right here and now, I want you to produce the comparable counter studies and direct data. Who is disregarding and limiting the data here, you or me? The table is always open. And that was the best you could do. All you ever have is falsely discrediting claims and excuses, for why you have failed and continue to fail to address the actual information.

        And actually it appears that the said analysis of the BMJ study, was quite accurate. http://www.bmj.com/content/338/bmj.b354

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    • http://www.vacfacts.info/ Lowell Hubbs

      This Mama Isn’t Scared of the Shmeasle Measles

      The Schmeasle Facts

      So far, in 2014 there have been 288 cases of measles, no cases of encephalitis, and no death. In 2013 there were 189 cases of measles, no encephalitis and no death. In 2012 there were 54 cases of measles, no encephalitis, and no death. In 2011, there were 22 cases of measles, and you guessed it…no encephalitis, and no death. I could go on, but you get the point. By and large, measles is unpleasant, not deadly.

      In comparison, the same cannot be said for the MMR vaccine. As of March 1, 2012 there were 842 serious injuries following the MMR vaccine and 56 deaths. Since 1990 there have been more than 6,058 serious adverse events reported to the Vaccine Adverse Events Reporting System (VAERS). What’s even more sad is that only 1-10% of cases are actually reported on this database. Oh now I remember, statistics are only important as it relates to measles cases…not MMR adverse reactions. And of course, the global MMR death statistics aren’t important either.

      But measles can cause blindness…so can the MMR vaccine.

      But measles can cause encephalitis…so can the MMR vaccine

      But measles can cause pneumonia…so can the MMR vaccine.

      But if I don’t get vaccinated, I could get measles…If you do get vaccinated you can get measles, both from the vaccine, and later in life when immunity has disappeared. The CDC says that 5-10 percent of people vaccinated with MMR will develop a fever and rash. This means there are 650,000-1,300,000 cases of vaccine-induced measles in the U.S each year based off of the 13-14 million doses given to one-year-olds.

      Read more:
      http://www.livingwhole.org/this-mama-isnt-scared-of-the-shmeasle-measles/

      Measles Shmeasles…(a great common sense read by a mother)
      http://gianelloni.wordpress.com/2013/08/27/measles-shmeasles/#comment-1722

      VRM: Measles Report, (More outbreaks of measles in largely the vaccinated, not the un-vaccinated; and it is quite well referenced)
      http://vaccineresistancemovement.org/?p=13481

      Data Reveals Measles Outbreaks Have Nothing to Do With Non-Vaccination Trends
      http://politicalblindspot.com/data-reveals-measles-outbreaks-have-nothing-to-do-with-non-vaccination-trends/

      Acellular pertussis vaccines protect against disease but fail to prevent infection and transmission in a nonhuman primate model
      http://www.pnas.org/content/early/2013/11/20/1314688110.abstract

      Acellular Pertussis Vaccine May Not Prevent Transmission
      http://www.medscape.com/viewarticle/815247

      Disease outbreaks are concentrated in highest-vaccinated population – Council on Foreign Relations
      http://therefusers.com/refusers-newsroom/disease-outbreaks-are-concentrated-in-highest-vaccinated-population-council-on-foreign-relations/#.U0JTcvldXbZ

      Whooping cough vaccine may not halt spread of illness – NBC News.com
      http://www.nbcnews.com/health/whooping-cough-vaccine-may-not-halt-spread-illness-2D11655363

      NY Measles Outbreak Blamed on Unvaccinated, Despite 90% of Infected Having Been Vaccinated
      http://thefreethoughtproject.com/90-infected-ny-measles-outbreak-vaccinated-scaremongering-then/

      91% Fully Vaccinated Involved in Pertussis Outbreak

      Video on the 2010 Outbreak in California. Notice how the media blame the Unvaccinated while 91% of the cases were Fully Vaccinated.

      http://experimentalvaccines.org/2013/10/09/91-fully-vaccinated-involved-in-pertussis-outbreak/

      Warning to Pregnant Mothers – Toxic Dose of Aluminum in the Tdap

      • James M. Barber

        What a complete asshole. Links to conspiracy theory websites don’t constitute proof. Its very obvious that you don’t have any biochemical training, and that most of your sources are just frightened people trying to make a case for some conspiracy or another.

        • http://www.skepticalraptor.com/skepticalraptorblog.php Skeptical Raptor

          Lowell Hubbs is this blog’s personal troll. He has even put out a YouTube video about me and another contributor here. He’s fun to watch in action.

    • http://www.nurseswhovaccinate.org/ MelodyRN

      These are great answers. Were they answered in a future post?

      • http://www.skepticalraptor.com/skepticalraptorblog.php Skeptical Raptor

        I missed this comment from Dorit. :(

        Now I have to figure out the answers to her questions. Thanks for posting this Melody

      • http://www.skepticalraptor.com/skepticalraptorblog.php Skeptical Raptor

        Done. :)

    • http://www.skepticalraptor.com/skepticalraptorblog.php Skeptical Raptor

      1. The reason why new information isn’t added is because it requires a whole new review process internally and then with the FDA. Revisions to the Package Insert requires medical review, R&D review, legal review, regulatory review, and executive review even before it’s sent to the FDA. The FDA, of course, approved the drug with the research added in the original application. No one wants to make these changes unless there are material data found in post-marketing clinical trials. Then it’s against the law to not make the changes. So there are a number of barriers to even think about making a change.

      2. New inserts probably take a year to update internally. Depending on what is being requested, it can take up to a year for the FDA to approve it. However, if a drug company uncovers a serious issue, say that a particular vaccine is dangerous with someone with red hair and freckles, then a black box warning is required, and the FDA will approve the change within days, even hours.

      3. If I’m reading it right the risk is estimated statistically based on observations during the clinical trial. However, 1 in a million, from a statistical point of view, approaches “this is random.” There is simply no way to detect a 1 in a million effect with 3000 or so patients. I don’t think there’s a way to detect a 1 in a million effect with 1 or 10 million patients. I think, if my statistics are right, you need 100 million patients to see a statistically significant 1 in a million risk. So, if I recall correctly, when a PI includes “1 in a million” it almost means that “we’ve seen it, we’re not sure it’s related to MMR, but if it were, the risk is so small as to be nearly immeasurable.”

      Again, that’s why it’s incredibly amateurish to take package insert data to heart as some sort of “truth.” In fact, much of the language is boilerplate, there’s a lot of “covering your ass” aspects to it for both Big Pharma and the FDA, and it doesn’t represent peer-reviewed science. It represents regulations that require certain information to be added.

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