Debunking “The Pro-Vax Argument Lost Me When”

Credible scientific and medical information about vaccines can be gotten from reading the websites of medical organizations and government public health websites, science and medicine textbooks by mainstream publishers and reading scientific review papers in highly credible scientific journals. The material found therein has very often been fact-checked and subjected to peer-review by other experts. Although certainly not infallible, together they represent the best information currently available.

Anti-vaccine activists, on the other hand, primarily rely on misleading information found on conspiracy blogs, YouTube videos and Facebook groups. These are not credible sources. One such blog post that is circulating in anti-vaccine communities is called The Pro-Vax Argument Lost Me When (with the subtitle “They Couldn’t Answer These Questions”) and feature 16 anti-vaccine claims disguised as superficially innocent questions for which the writer wrongly believes science has no answers.

In reality, this is a common denialist tactic called “just asking questions” (or JAQing off) that is based on making overt pseudoscientific claims, but hiding behind the trope that they are “just asking disturbing questions” in an effort to evade scientific objections. The blog post is written anonymously and contains no references to the scientific literature whatsoever. Despite this, it has achieved considerable spread across social media. So without further ado, here are scientific answers to all “questions” asked, backed up by real scientific references.

In addition to these “questions”, the post deploys a few classic anti-vaccine tropes, such as spreading fear about safe vaccine ingredients and pushing misinformation about the history of vaccine-preventable diseases. In reality, vaccine ingredients are safe and well-tested at the doses included in vaccines and the decline of vaccine-preventable diseases is closely associated with the approval and use of the corresponding vaccine. Anti-vaccine activists point to sanitation, but sanitation could of course not first strongly decreasing tetanus and diphtheria and then wait around for decades before strongly decreasing measles or HPV and it important to remember that many vaccine-preventable diseases spread via droplets in the air which is not affected by sanitation. Typically, anti-vaccine activists look at death rates, but vaccines strongly reduces the risk of getting the disease. It has very little effect on the death rate among those who get the disease. Referencing mortality rates is just another smokescreen deployed by anti-vaccine activists to mislead unsuspecting bystanders (Gorski, 2010).

“Did you know that vaccine manufacturers run their own safety studies?”

Medical research is expensive. The research and development costs for a single novel medication is estimated to be somewhere around 1.8 billion USD (Paul et al., 2010). For specific parts of clinical research, a Phase I trial is estimated costs between 1.4 and 6.6 million USD, a Phase II trial is estimated at 7 and 19.6 million USD and doing a Phase III trial is estimated to cost between 11.5 and 52.9 million USD (Sertkaya et al., 2016). This does not even take into account the cost of preclinical research. This estimates are not perfect, but even taking their limitations in mind still means that medical research and development costs a ton of money to carry out.

Who should pay for all of this? The government pays for some of this because it is in the public interest to have new medications for serious medical conditions. However, many substances that initially appear promising in early stages of research fail because they are not effective or safe enough. The taxpayer should not be the only one that carries this cost. The industry itself should be forced to pay for their own ideas and compete with others in the open marketplace of ideas to receive funding by the government. This is the reason why pharmaceutical industry partly funds and carries out their own research. During 2012, the United States paid 119.3 billion USD on biomedical research and development (Chakma et al., 2014). The government paid 48.9 billion USD (~41%) and the industry paid 70.4 billion USD (~59%).

Besides studies funded by vaccine manufacturers, there are studies that are independently funded and not run by pharmaceutical companies. Ironically, there are even vaccine safety studies funded by anti-vaccine activists that vaccines do not cause autism (Gadad et al, 2015).

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Finally, this is a peculiar argument coming from those who defends alternative medicine. Obviously, studies claiming to show that fake treatments work are funded and carried out by alternative medicine companies and activists. Many websites that argue for alternative medicine sells alternative medicine products in their web shops. However, this is often ignored by those who defend alternative medicine, but a standard deceptive trick when attacking vaccines. This hypocrisy alone is not sufficient to refute their claims, but combined with the above arguments, it is.

“That the government passes these drugs based on those studies?”

No, the government critically evaluates a new medication based on the submitted safety studies. If they are found to be deficient, the medication is not approved. The rhetoric behind this question makes it appear as if the government just passively approves whatever is submitted to them. They do not.

In fact, the FDA requires that companies that want to run clinical trials and gain FDA approval must first submit an Investigational New Drug (IND) application to Center for Drug Evaluation and Research (CDER) and wait around one month for the FDA to critically review their protocols. The FDA can interrupt the trial at any point if it finds any problems. After there has accumulated enough evidence for safety and efficacy, a company can submit a New Drug Application (NDA) with all available and relevant information according to FDA standards. The FDA then carries out a comprehensive and critical review of the application. Only when all the necessary steps have been followed can a new medication be approved (FDA, 2015).

“That vaccine manufacturers are protected from legal action for any harm their supposedly ‘safe products’ do?”

No, it is perfectly possible to initiate a lawsuit against a vaccine manufacturer for perceived effects of their products. During 2005, there were at least 300 such lawsuits handled by the United States courts (Offit, 2005).

To understand where this confusion comes from, we must understand a little bit of the history of anti-vaccine movements. They did not start with Andrew Wakefield and his false claims about the MMR vaccine and autism. During the 1970s, anti-vaccine activists pushed the same kind of fearmongering and scientific falsehoods about the pertussis vaccine. This lead to a surge in personal-injury lawyers suing vaccine manufacturers. In just over a decade, 800 such lawsuits had been filed. At one point, judges awarded monetary amounts equal to half of the entire market for pertussis vaccines in a single case. All of this led to the cost of the vaccine increasing by a factor of 100 to 11 USD per dose and more and more domestic pharmaceutical companies stopping production, not just for pertussis vaccines, but also vaccines generally. The United States faced the very real prospect of having no domestic vaccine production. That would be a terrible outcome, because it would mean that the United States could not reliably produce life-saving vaccines to cover the regular vaccine schedule or the threat of pandemics.

The government decided to stop this dangerous development with the National Vaccine Injury Compensation Program (NVICP). This program generously compensates real victims of vaccine complications and has a relaxed burden of proof. To simplify things, it is usually enough for a proposed connection between a vaccine and an alleged complication to be plausible and not refuted by scientific research. This system is preferable because it is faster and easier than suing a pharmaceutical company. For instance, if you lose a lawsuit, you have to pay the legal fees of the other party, but this is not an issue for NVICP.

If parents are unsatisfied with the outcome of these NVICP proceedings, they can go ahead and sue the pharmaceutical company directly (Mariner, 1992). Thus, NVICP does not protect pharmaceutical companies from lawsuits, only offer parents of children with plausible vaccine injury claims compensation. It also keeps vaccine production in the United States from disappearing completely.

“Why have we entrusted the safety of millions of children to the oversight of a group of people whose sole focus is making billion dollar profits?”

We have not. The FDA has oversight over vaccines and they are not focused on making billions of dollars of profits. Vaccines are thoroughly tested and have been shown to be safe and effective before being approved. Even after FDA approval, researchers continue to monitor to see if any extremely rare adverse events occur (CDC, 2015a).

Contrary to popular opinion, vaccines are not that profitable. As we saw before, many vaccine manufacturers were reducing or ceasing production of vaccines because of the low profits involved. The global vaccine market is estimated to be around 22 billion USD per year. This might sound large, but it is less than the alternative medicine industry (34 billion USD per year) and only a few percent of the total pharmaceutical market of over 1 trillion dollar (Lam, 2005; Nuwer, 2013).

It is also much more profitable for pharmaceutical companies to have unchecked epidemics of vaccine-preventable diseases than to sell vaccines. A single dose of the MMR vaccine costs around 20.59 USD (CDC, 2017), whereas the total cost for a single person with measles is estimated to be 142 452 USD if you include all the cost from treatment, contacting contacts that have have been exposed, quarantines, vaccination clinics etc (Dayan, 2005). The direct cost for a single case of meningitis as a measles complication is 30 000 USD (Dayan, 2005).

“Why is a newborn baby vaccinated on day 1 of life against a disease that is primarily transmitted sexually and through needles in drug users?”

Because hepatitis B can be spread via blood and mucosal surfaces. It is not just via sex and intravenous drug users. The virus can survive and be infectious for as much as a week on surfaces, even when there is no blood present. Touching a contaminated surface and then touching mouth or eyes could result in hepatitis B transmission. It is also possible from a mother with hepatitis B to transmit it to the child while giving birth and this happens quite often (CDC, 2016a). Thus, it is important for children to vaccinated after being born.

“Why are babies given vaccines to produce antibodies when they don’t produce antibodies until after the age of 3 to 6 months?”

Not true. Newborn babies can produce an antibody response from birth (Offit, 2002). This myth probably comes from the fact that maternal antibodies only last around 6 months. In some cases, this is even shorter (Waaijenborg et al., 2013).

“Why is the govt telling parents to delay breast feeding and get more vaccines when breast-fed babies produce higher levels of antibodies?”

The reference for this claim is an article on the notoriously unreliable website Natural News. The article they link is Moon et al. (2010) that raised the possibility that breast milk that contain neutralizing antibiotics might reduce the level of protection from oral rotavirus vaccines.

However, this never became an official guideline, so it is wrong to claim that the government is telling you to delay breastfeeding. In fact, as explained in the refutation of this claim provided by Snopes (Mikkelson, 2015), the government is generally supportive of breastfeeding.

“Why are vaccine manufacturers not held responsible when their product injures your child? Why would they need to be protected from the effects of such wonderful products??”

This is a duplicate question. It has already been answered above. They are not protected.

“Why have no double blind, placebo, randomized controlled trials been done on any vaccines? Standard with any other drug. Some might say there have been, but injecting kids with an aluminum-adjuvant ‘placebo’ is not a placebo, it’s injecting kids with a known neuro-toxin.”

Aluminium is one of the most common substance on earth. The aluminum salts used as adjuvants in vaccines have been used safely for almost 80 years and are not neurotoxins. In fact, you get more aluminum from food and water than can be found in vaccines, even if you take into account that less of it is absorbed through diet (Offit and Jews, 2003).

It is commonly believed that a placebo treatment is always just a sugar pill, but this is not accurate. A placebo should be exactly the same as the treatment, just without the active ingredient that is being tested. So for e. g. psychotherapy or the pseudoscience of acupuncture, the control group does not get a sugar pill. Instead they get to talk to an actor and needles that do not penetrate the skin, respectively. This is done to tease out the effect of the treatment and not surrounding factors that have nothing to do with the active component of a treatment.

For vaccines, the control group gets an injection with the almost same contents as the experimental group. The only difference is the antigen that is supposed to stimulate the development of an immunological protection. This is because what is being tested for efficacy and safety is this new antigen. If you did not use this setup, you could not say that the obtained results where due to the antigen.

As for randomized control trials for vaccines, there are plenty of such studies. Just a quick search on PubMed shows around 7000 results for the query “‘vaccine’ randomized controlled trial” restricted to clinical trials.

“Why is the world following the US when they are the most vaccinated population on the planet with the highest rates of infant deaths/SIDS in the western world?”

Correlation is not the same as causation. Ice cream sales and drowning accidents vary together, but this does not mean that one causes the other. It is really due to the outside temperature. Dawn occurs after the rooster crows, but this does not mean that it is the rooster that is causing dawns.

Infant mortality in the United States is mostly caused by things such as premature birth, low birth weight and accidents (CDC, 2016b) and there is no evidence that it relates to vaccines in any way. SIDS has decreased by 40% after the American Academy of Pediatrics recommended that children sleep on their back (Task Force on Infant Sleep Position and Sudden Infant Death Syndrome, 2000). Stratton et al. (2003) carried out a large-scale review of the scientific literature has shown that vaccines are not related to sudden infant death syndrome (SIDS).

“Why are disease outbreaks occurring in populations with 90%+ vaccination rates?”

There are primarily two reasons for this. First, it is because the proportion of vaccinated individuals needed to prevent an outbreak needs to be higher than 90% for some diseases like measles and pertussis (Willingham and Helft, 2014). Second, vaccine refusers tend to cluster geographically, so even though the national level can be very high, the regional and local coverage can be much, much lower for certain areas and cities (Lieu et al., 2015). This increases the risk of outbreaks.

“Why are kids vaccinated against these diseases still catching and spreading them?”

Because no medical product is 100% effective and most vaccines tend to be around 95%+ effective (CDC, 2015b). Because so many people are vaccinated, even a small failure rate of vaccines can mean that there is a certain number of vaccinated people who are still susceptible. This is often not a problem since vaccine failure almost never cluster and they are thus protected by herd immunity. With the addition of concentrated pockets of vaccine refusers, this opens up for an outbreak of vaccine-preventable diseases.

“Why are we scared of non-fatal illnesses that train a child’s immune system how to behave on this planet?”

Before vaccines, measles killed 2 per 1000 children who became sick. Haemophilus influenzae type b killed approximately 1.5-3% before vaccines, even with antibiotic treatment. Diphtheria killed 5-10% of people infected. Tetanus kills around 11% of people infected (CDC, 2015b). These are not “non-fatal” illnesses.

The problems with vaccine-preventable diseases is not just that they can kill, but result in hospitalization and other serious complications. Before vaccines, there were 500 000 reported cases of measles per year (and likely several million cases altogether) with about 1 in 100 getting seizures, 6 in 100 getting pneumonia and 1 in 1000 getting brain inflammation (CDC, 2015b). The amount of suffering from measles every single year before vaccines is almost too high to grasp. Yet this happened, year after year.

Natural immunity is not always better, and natural immunity forces you to experience a dangerous disease with potentially life-long complications. It is not worth it and there are plenty of infections for the immune system of children to handle, as they get 6-8 infections per year during the first few years of life (Offit and Jew, 2003).

“Why are vaccine manufacturers allowed to cut down on antigen and insert cheap and nasty toxic additives that aggravate the injection site?”

Additives are not toxic in the amounts given in vaccines. They are present to typically either enhance immunological responses (adjuvant) or prevent contamination (preservative) by e. g. bacteria and viruses (Offit and Jew, 2003).

In the past, vaccines used to be based on the entire organism that had either been killed off by heat or weakened by artificial selection for strains that were weakened. Progress in biotechnology has allowed scientists to develop new vaccines where the active part is only one or a few pieces of proteins (called peptides). This improves the safety of vaccines (because you only use necessary parts), but since these preparations do not contain the other parts of a bacteria or virus that stimulates the immune system, the response is much weaker if you refuse to use an adjuvant to enhance immunological response. That is the reason why some vaccines contain adjuvants (Petrovsky and Aguilar, 2004). It is not some evil plot, but part of normal medical research to make vaccines even more safer and effective than in the past.

“Why do we need multi-dose vaccines if the number 1 priority of vaccine manufacturers is your child’s safety?”

The use of multi-dose vials boils down reducing costs from production, storage and disposal (Drain, et al. 2003; Lee et al., 2011). This has nothing to do with vaccine manufacturers, but a decision made by the medical community and hospitals.

“Why will no doctor sign a written guarantee for your child’s safety prior to vaccinating them with a product they insist you have?”

That is never done for any treatment ever because there is no such thing as zero risk. If you walk across the street, you could get hit by a car and die. If you drink some water, you could choke on it and die. If you are out playing football, you could die from a congenital heart defect. Like a previous question, this is highly ironic because this demand is never made for alternative medicine quacks.

Conclusion

Anti-vaccine activists do not understand how biomedical research is funded or how new medications are tested and approved. They claim that vaccine manufacturers cannot be sued when this is demonstrably false. They claim that vaccines are highly profitable when they are really not and the U. S. once nearly lost domestic vaccine production. They falsely claim that hepatitis B is only a risk from sex and IV drug use when it can be spread by blood generally. They ignore the fact that babies can produce an antibody response at birth. They flatly deny that there are RCTs of vaccines when plenty of such studies exists and even go so far as to claim that vaccine-preventable diseases are non-fatal. They do not get that adjuvants are needed because vaccine technology has improved.

References

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