Anti-Vaccinationists: A case study in pseudoscience

1. Anti-Vaccinationists:A case study in pseudoscience Donald Miller, Pharm.D. Professor and Chair, Department of Pharmacy Practice NDSU

2. What is Science? • The scientific method is a self-correcting method of making and testing hypotheses through experiments (or the best available methods) that can be readily verified or rejected. • At least ideally, science is an objective approach in which the best available evidence is accepted, regardless of whether it is consistent with one’s prior beliefs. It also critically compares rival theories rather than seeking to prove one specific theory. • Science is a method – not a belief system. Its strengths are the ability to make predictions, openness to peer review and the performance of experiments that challenge beliefs and working hypotheses.

3. Science vs Belief • Science involves peer review to protect against influence of personal biases in doing and interpreting studies. • Scientists regard constructive criticism of their ideas and hypotheses as standard operating procedure. • Scientific research is not about proving the “truth”, but about testing our understanding of the truth by testing the alternatives. Paradigms are modified or even rejected once a better understanding of reality comes along. The entire body of evidence must be considered. • Communities of faith naturally look for confirmation of their beliefs, not for improvement of their understanding.

4. What is Pseudoscience? • The selective use, and misuse, of scientific evidence to support a predetermined conclusion or point of view (typically based on ideology or authority), rather than the unbiased use of evidence to draw logical conclusions. • Sometimes called “junk science.” Junk science also refers to badly done research that is set up to support a predetermined outcome. • But the term junk science has been hijacked by pseudoscientists and politicians to disparage any evidence with which they disagree. • Pseudoscientific conclusions typically do not change with new evidence. Since evidence is used selectively to support an argument anyway, new evidence may be ignored or dismissed.

5. Legal Analogy • If you were selected for a jury you would be obligated to weigh all the evidence both for and against the defendant. • Lawyers for each side would take a pseudoscientific approach of presenting the best selective evidence for their side, but the judge and jury must be impartial. • Assume there are ten witnesses to a car accident – 2 say the first car was speeding and 8 say it was traveling at a normal speed before the crash. The police must interview all witnesses and then all must be allowed to testify. • If only testimony of the first 2 is considered we are being biased and pseudoscientific.

6. Why Are People Attracted to Pseudoscience? • Humans are not naturally critical thinkers or adept at using evidence – most people judge a proposition by whether it makes sense or feels right. • Pseudoscientific explanations of phenomena tend to be much simpler and more emotionally satisfying than complex explanations. • We are also highly egocentric – using our personal experience and the beliefs of our friends and family to judge what seems right. • Furthermore, we are highly disposed to preserve our current beliefs rather than to challenge them.

7. Background on Vaccinations • Established by Edward Jenner with vaccination for smallpox in late 1700’s. • Polio vaccine in 1950’s • Very cost-effective (cost saving) • Consistent with preventative medicine • Vaccinations have been called the most important single contributor of any medical advance to reduced global morbidity and mortality1 1. JAMA 2002;288:3155-58

8. Today’s Vaccines • U.S. policy set by the Advisory Committee on Immunization Practices, an advisory group to the U.S. Public Health Service and the CDC. • Additional guidelines by American Academy of Pediatrics and American Academy of Family Physicians. • Childhood vaccinations series recommended for measles, mumps, rubella, varicella, polio, diptheria, tetanus, pertussis, haemophilus influenza type B, pneumococcus, hepatitis B, rotavirus, and HPV. • Adult vaccinations recommended for measles, mumps, rubella, tetanus, diptheria, varicella, hepatitis B, plus populations at risk of hepatitis A, influenza, and pneumococcus.

9. Efficacy of Vaccines • Smallpox and polio have been completely eradicated in the U.S., while incidence of several other diseases such as measles and pertussis have been reduced by 98-99% compared to their baseline annual incidence. • Protect both the individual and the community • Yet almost 50,000 people/year die in the U.S. from vaccine preventable diseases.1 1. Ann Intern Med 2007;147:735-7

10. So Why Would Anyone Oppose Vaccines? • Individual rights and distrust of government (childhood vaccines are mandatory for school enrollment) • Distrust of organized medicine and belief in alternative “natural healing” paradigms. • Actual adverse effects • Sore arms, fever, flu-like illnesses, Guillain-Barre Syndrome (1.8 cases/million) • Older pertussis vaccine often caused fever, crying, limpness, and occasionally seizures. • Actual infection with virus - the Cutter incident • Alleged adverse effects • sudden infant death syndrome (SIDS), autism, multiple sclerosis, vague claims of neurologic disorders.

11. The Cutter Incident • Initial Salk vaccine developed with inactivated polio virus and was successful in field trials • In conversion to mass commercial distribution, Cutter Laboratories produced a vaccine in which some virus was still active, leading to 164 cases of paralysis and 10 deaths • Cutter was found legally liable, though not negligent (establishing a precedent that still inhibits vaccine manufacturers) • Getting the disease itself is still a remote risk with all vaccines that use live (attenuated) virus, thus immunocompromised patients cannot receive them.

12. Risk Benefit of Vaccines • Actual risks of vaccines are well known and are much less than the risks associated with the corresponding diseases that are prevented. • Costs of adverse effects can be compensated by the vaccine adverse events reporting system (VAERS) • Accurate information readily available through pediatricians and government web sites

13. Tactics of Pseudoscientific Opponents of Vaccination • Appeals to morality • Conspiracy theories • Appeals to free choice • Appeals to authority • Scientism • Appeals to emotion (anecdotes) • Errors in logic • Deception and outright lies

14. Appeals to Morality • New vaccines (Gardasil, Cervarix) are licensed for human papilloma virus, the leading cause of cervical cancer. Optimal vaccination must occur prior to sexual activity, but conservatives oppose this as encouraging sexual activity. • Two vaccines (varicella, rubella) were developed from viruses originally grown in human cell cultures from aborted fetuses. No ongoing embryo destruction occurs. • Interestingly, even 2 centuries ago, early opponents of vaccination felt it was immoral because it interfered with God’s plans.

15. Conspiracy Theories • A common tactic of pseudoscience is to talk of a conspiracy by organized medicine to hide the “true” risk of vaccines. • In fact, the established risks of vaccines are easy to find in the literature and are publicized by the Centers for Disease Control at http://www.cdc.gov/vaccines/vac-gen/side-effects.htm

16. Appeals to Freedom, “Informed Choice” or “Free Choice” • A free, informed choice requires accurate information – not something that anti-vaccination web sites generally provide. • Critics of mandatory vaccinations fail to understand the role of public health in protecting populations. Individual freedoms may be reasonably limited to protect the greater public (e.g. public smoking bans, quarantine) under the 10th amendment’s police power granted to states.1 1. Stewart AM. NEJM 2009;361:2015-17

17. Appeals to “Authority” • Celebrities and peripheral “scientific” figures

18. Scientism • The use of, and belief in, the trappings of science (big words, p values, journal citations, etc.) to give the false impression of accuracy and honesty. • Most anti-vaccine web sites are slick and convincing to an uninformed user. • Journal citations are frequent (and the sheer volume superficially impressive), but are almost all outdated, selective, or used to support statements not implied by the actual reference. E.g. http://thinktwice.com/s_autism.htm

19. Claims That Several Vaccines At Once Can “Overwhelm” the Immune System • Todays vaccines mostly use highly purified and specific viral proteins, in comparison to the nonspecific proteins or whole viruses formerly used, so the total “burden” of immunologic stimulation is minimal and has not increased. • In addition, children are naturally exposed to many infectious agents that provide a high number of antigenic viral and bacterial proteins. NEJM 2008;358:2089-91

20. Emotional Appeals Through Anecdotes • Web sites often contain personal stories and pictures of children allegedly injured by vaccines, as well as pictures of menacing needles. • E.g., http://www.nvic.org/Vaccine-Memorial.aspx • Anecdotes are misleading because there is no way to know if the alleged adverse effect is related to the vaccine (confusing association with causation). • Even if a vaccine did cause the injury, anecdotes give no sense of how common the injury is, or the overall risk/benefit ratio.

21. From http://thinktwice.com/faq.htm#8 • In #10, down three. “A lot of adult vaccines are really problematic too. I was recommended by a travel clinic to have the Japanese encephalitis vaccine for a luxury trip to India and Nepal. We're retired and this is the trip we've dreamed about. I went in on September 24 and had shot 1 of 3. They do a before and after blood pressure check. Before was 130/80. After was 140/80. Ten days later, I returned for shot 2. Before was 150/80. The nurse said she didn't want to administer it so I went home. The doctor said to go ahead and complete the series. I didn't. A week later my blood pressure was up to 160/80. Then yesterday it was 170/80, and they gave me a prescription for medication.”

22. Errors in Logic • Association between events assumed to mean causation (vaccinations are given around the time in life when autism can first be diagnosed and SIDS occurs. • Recall bias. It is normal to want to find a cause for unsettling events – and one may inaccurately recall the onset of an event like autism, multiple sclerosis, etc. to coincide with the vaccination.

23. The Autism Controversy • Since vaccines are given at about the same age that autism is able to be diagnosed, naturally many diagnosed children will have received one or more vaccines very recently. An apparent spike in autism cases has occurred since the 1980’s. • The link between MMR vaccine and autism received wide publicity in 1998 with publication of 12 cases of children developing gastrointestinal and developmental problems shortly after vaccination (Lancet 1998;351:637-41) The authors hypothesized that the vaccine or its thiomersal preservative were causative. • The speculation caused a collapse of confidence in the vaccine and thiomersal, especially in Great Britain.

24. The Autism Controversy • Not only was speculation of cause and effect inappropriate, the study and publication took place about 8 years after vaccination and involved parents’ recollection of events. • Several prospective studies subsequently found no association between the vaccine and autism or other problems. • The publication was retracted in 2004 after coauthors discovered that the main author had been paid by an organization to look for evidence to support a lawsuit over immunizations. • Thiomersal has been gradually removed from vaccines, not due to proven harm, but to increase acceptance of vaccines and assure the public that everything possible is being done to assure safety (but new cases of autism continue to occur!).

25. The Autism Controversy • Similar controversies have existed about DPT vaccine and Sudden Infant Death Syndrome, hepatitis B vaccine and multiple sclerosis, HiB vaccine and childhood diabetes, anthrax vaccine and Gulf War Syndrome, etc., all without confirmation. • Such scares are typically precipitated by clusters of the disease in question, where people look for associations to explain the cluster. What is not generally appreciated is that apparent clusters of any disease can occur at random from time to time, with no causal etiology at all.

26. Outright Lies and Distortions • Claims that vaccines are ineffective or just temporarily effective. • Claims that vaccine policy is motivated by enormous profits to the vaccine industry and individual physicians. • Adverse effects of vaccines are underreported (implying a cover-up) • Claims that vaccine preventable disease have declined for other reasons such as improved nutrition or hygiene. • The majority of people who get disease have been vaccinated

27. Outright Lies and Distortions • The credo “Vaccines are more dangerous than the disease”. • This is true only in so far as vaccines have largely eliminated many diseases. From an individual perspective, the actual dangers of each disease are considerably higher than the risks associated with the corresponding vaccine. • From a societal perspective, the current rarity of the diseases may in fact mean that more persons are injured by vaccines than the corresponding diseases. But this is the price we pay for keeping the diseases rare.

28. Outright Lies or Distortions • Claims that vaccine-associated illnesses have no spontaneous cause. (But all the alleged illnesses – such as autism - do, in fact occur spontaneously and without clear precipitating causes). • Claims that vaccination in general, or too many vaccinations, weaken the immune system and causes autoimmune diseases. • Claims that disease outbreaks in unvaccinated areas are rare or exaggerated by the media. • Claims that vaccines are loaded with extra toxic ingredients like aluminum.

29. Outright Lies and Distortions • Blatant distortions such as citing an article that actually says mumps is now more common in older people than children, and twisting it to falsely claim that mumps is now more common among the elderly than prior to vaccinations. • Even attacks on the germ theory of disease!

30. From http://thinktwice.com/faq.htm#8 • “Recently vaccinated children do carry the disease germ and are able to spread it to other children. Many so-called epidemics are initiated and spread in this manner, even though the unvaccinated are blamed. …some ‘authorities’ argue that parents who do not vaccinate their children reap the benefits without taking the risks -- a curious argument since they also argue that such parents are irresponsible by unnecessarily exposing their children to greater risk by choosing not to vaccinate”.

31. From http://thinktwice.com/angry.htm “Regarding polio, over 95% of the population can be exposed to the poliovirus and will not contract polio. This indicates that the poliovirus is not responsible for the illness that is associated with it. The health of the organism is the more significant factor. Doctors should be more concerned with promoting health than pushing drugs”.

32. Conclusions • Vaccines in general are very safe and effective. The risk of adverse effects is greatly exaggerated by irresponsible parties. • The distinction between scientific evaluation of claims and pseudoscience is crucial for all educated persons to understand.

33. Additional Anti-Vaccination Web Sites • http://www.gulfwarvets.com/anthrax.htm • http://nyvic.org/nyvic/ And pro-vaccine information sites • http://www.pathguy.com/antiimmu.htm • http://www.immunizationinfo.org/ • http://www.jennymccarthybodycount.com/Jenny_McCarthy_Body_Count/Home.html

34. Further Information • General recommendations from ACIP http://www.cdc.gov/mmwr/pdf/rr/rr6002.pdf • Immunization Action Coalition http://www.immunize.org/safety/index.htm • Lo B, Katz MH. Clinical decision making during public health emergencies: Ethical considerations. Ann Intern Med 2005;143:493-8. • Wolfe RM, sharp LK, Lipsky MS. Content and design attributes of antivaccination web sites. JAMA 2002;287:3245-8 • Davies P, Chapman S, Leask J. Antivaccination activists on the world wide web. Arch Dis Child 2002;87:22-5.