Vaccine Risk Communication

Identifying Misinformation About Vaccine Safety

2008-06-30T12:55:00.000-07:00

How can you distinguish good information from misinformation? Misinformation often includes one or more of the following elements:

Invalid assumptions. An invalid assumption is something you treat as if it were known to be true or false, when in fact it is not. For example, some parents regard hepatitis B immunization as unnecessary, assuming that this is a disease for which their children are not at risk. This is an invalid assumption (read here to know why).
Logical Fallacies. A logical fallacy is a flaw in an argument that makes the argument illogic or invalid. Some common logical fallacies are ad hominem arguments (attacking those presenting the argument rather than the argument itself); appeals to pity (trying to win support for one’s arguments by appealing to feelings of sympathy or guilt); and arguments from ignorance (claiming that a statement is true only because it has not been proven false, or that it is false only because it has not been proven true) among others.
Ad hoc hypotheses. An ad hoc (literally, "for this") hypothesis is an adjustment made to a theory just for the purpose of salvaging it from being refuted. Ad hoc explanations try to explain findings that do not fit the original theory.
False experts or experts who lack the needed expertise. An expert in one field may be completely ignorant in another field. For instance, an expert endocrinologist may be an expert on diabetes but is not likely to be expert about vaccine safety or immunology. Unfortunately, some who may be experts in one field eagerly make claims about things outside their field of expertise.
Pseudoscience. Pseudoscientific claims cannot be verified by other researchers because they are often ambiguous and not measurable. In most cases, these claims are not submitted to peer review (that is, review by experts) before making them public and the methods are usually difficult to understand, making the observations difficult to replicate. Often, data may be represented to show one outcome when another is the case. Other times the methods that are used are likely to give a predetermined outcome. Only data purporting to support the claims is presented while conflicting data are ignored or discarded.

Press Release: Do Vaccines Cause Autism, Asthma, and Diabetes?

2008-06-12T07:42:00.001-07:00

Do Vaccines Cause Autism, Asthma, and Diabetes?

New Book Helps Parents Weigh the Evidence

June 11, 2008

Contact:
Diana Olson - 703 299 0201

Almost 70% of parents who refuse to vaccinate their children do so because they believe vaccines may cause harm. Indeed vaccines have been blamed for causing asthma, autism, diabetes, and many other conditions--most of which have causes that are incompletely understood. Some parents believe that vaccines can “overwhelm the immune system.

To respond to these concerns about vaccine safety, the National Network for Immunization Information (NNii) writing team of Martin G. Myers, MD, and Diego Pineda have written a book titled, Do Vaccines Cause That?! A Guide for Evaluating Vaccine Safety Concerns.

“The authors of this volume have recognized the absolute need to provide parents with clearly understandable, science-based information about vaccines, immunization, and vaccine safety,” write Samuel Katz, MD, of Duke University and Louis Sullivan, MD, of Morehouse School of Medicine, in the Foreword to the book.

This 272-page book is divided in two sections. The first section tells parents how best to weigh and evaluate what they read or hear about vaccine safety, emphasizing how scientists determine whether a vaccine actually causes a specific effect. The second section deals specifically with vaccine safety concerns such as asthma, autism, and autoimmune diseases, among others. The overall theme is to help parents arrive at conclusions based on science.

Dr. Myers is an internationally recognized vaccine expert and former director of the National Vaccine Program Office. He is presently a professor in the Department of Pediatrics at the University of Texas Medical Branch at Galveston (UTMB). Mr. Pineda has been NNii’s science writer since 2004.

Do Vaccines Cause That?! is available for $14.95 at Amazon.com and DoVaccinesCauseThat.com, where the electronic version is also available for just $12.95.

Do Vaccines Cause That?! A Guide for Evaluating Vaccine Safety Concerns by Martin G. Myers, M.D., and Diego Pineda, M.S. Original edition. 5.5 x 8.5, 272 pages, 12 illustrations. ISBN 978-0-9769027-1-3. $14.95. See our pressroom room for a 300 dpi TIF of the cover. www.dovaccinescausethat.com/pressroom

The National Network for Immunization Information (NNii) provides up-to-date, science based information about immunizations to health professionals, the public, policymakers, and the media. NNii is based at the University of Texas Medical Branch in Galveston and is affiliated with the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, the American Academy of Pediatrics, the American Nurses Association, the American Academy of Family Physicians, the National Association of Pediatric Nurse Practitioners, the American College of Obstetricians and Gynecologists, the Society for Adolescent Medicine and the American Medical Association.

Pertussis: Lessons from a returning disease

2008-06-06T09:48:00.000-07:00

I would encourage you to read this post about whooping cough, not only because it quotes my book, but because it illustrates the point with a passionate voice: not vaccinating is a dangerous gamble. Pertussis (whooping cough) is an ugly disease. Watch the video on the link above to see what it does.

Too Many Vaccines?

2008-06-03T08:12:00.000-07:00

This post was adapted from Do Vaccines Cause That?! A Guide for Evaluating Vaccine Safety Concerns.

In the early 1940s only one vaccine was given routinely: smallpox. Later that decade, the diphtheria, pertussis, and tetanus vaccine began to be given routinely. Now, by the time a newborn is 12 years of age, she will have received 30-35 doses of vaccines to protect her against 34 diseases.

Looking at the number of shots given at each pediatric visit, many parents wonder whether a baby’s immune system can withstand so many immunizations—almost half of the parents in a survey expressed this concern as a reason for not vaccinating their children.(1)

Can a children’s immune system handle all those vaccines? (2-5) The answer seems to be yes it can.

Even though a newborn’s immune system cannot respond to all the different types of foreign materials (called antigens), they do have an incredible ability to respond to an extremely large number and types of antigens.
Compared to 1980—because of newer ways of making vaccines—the number of antigens in vaccines has actually decreased even though more vaccines are given. (2)
Before each of these vaccines can be licensed in the United States, they have to be shown to effectively stimulate the immune system—for all the vaccine components—and to be effective along with all the components of vaccines that would usually be given at the same time.
A number of studies have observed no increased risk of other types of infections after vaccines and some have even shown fewer infections in immunized children.(4, 6 , 7) One study could find no effect on hospital admissions for other types of infections and how many and which vaccines a child had received—among all the children born in Denmark born from 1990 through 2001. (6)

The fact is that vaccines strengthen, not weaken, the immune system. This is true even for newborn infants. On the other hand, a natural infection clearly can weaken a child’s immune system. For example, a previously healthy child with chickenpox (varicella) may become infected with dangerous bacteria, resulting in an infection severe enough to require hospitalization or even cause death. Similarly, a child with measles infection is more likely to develop middle ear infections.

Infants and children are bombarded with germs every day in the air they breathe and the food they eat, but their immune systems are able to handle these exposures. The vaccines that are recommended for all children use only a small portion of the immune system’s “memory.” Scientists estimated that based on the immune system’s capacity to respond, a child could theoretically get 10,000 vaccines in one day and still not “use up” his or her immune ability to respond. (2)

References

1. Daniel A. Salmon, PhD, MPH; Lawrence H. Moulton, PhD; Saad B. Omer, MBBS, MPH; M. Patricia deHart, ScD; Shannon Stokley, MPH; Neal A. Halsey, MD. Factors Associated With Refusal of Childhood Vaccines Among Parents of School-aged Children: A Case-Control Study. Arch Pediatr Adolesc Med. 2005;159:470-476.

2. Offit PA, Quarles J, Gerber MA, et al. 2002. Addressing parents concerns: do multiple vaccines overwhelm the infant’s immune system. Pediatrics. 109(1): 124-9.

3. Hilton S, Petticrew M, Hunt K. 2006. ‘Combined vaccines are like a sudden onslaught to the body’s immune system’: parental concerns about vaccine ‘overload’ and ‘immune vulnerability’. Vaccine 24: 4321-7.

4. Gregson AL, Edelman R. 2003. Does antigenic overload exist? The role of multiple immunizations in infants. Immunol Allergy Clin N Am. 23: 649-664.

5. Gellin BG, Maibach EW, Marcuse EK, et al. 2000. Do parents understand immunizations? A national telephone survey. Pediatrics 106(5): 1097-1102.

6. Hviid A, Wohlfahrt J, Stellfeld m, et al. 2005. Childhood vaccination and nontargetted infectious disease hospitalization. JAMA 294(6): 699-705.

7. Institute of Medicine Immunization Safety Review Committee. Multiple immunizations and immune dysfunction. National Academy Press, Washington, DC, 2002.

Do Vaccines Cause That?!

2008-05-19T10:13:00.000-07:00

Writing a book is hard work, especially about controversial scientific topics. Well, my new book on vaccine safety (co-authored with Dr. Martin Myers) is finally coming out next month.

We tackle the most common concerns about the safety of vaccines and explain what the current science says about them.

Although the release date for the book is June 30, 2008, we have made the e-book version available at DoVaccinesCauseThat.com. Also, people can pre-order the book at Amazon.com and receive a 5% discount.

The VICP and the Autism Rule

2008-03-07T07:47:00.000-08:00

Just a few days ago I was working on an article about the National Vaccine Injury Compensation Program (VICP), so I became very familiar on how the court works. This is an excerpt of what I wrote:

The VICP compensates people a federal court determines to have met legal standards for having been injured by vaccines; these standards do not need to meet the standards of scientific causation. People who file claims are not required to prove negligence on the part of the health care provider or the manufacturer.

Funds from a tax on each dose of vaccine are placed in a trust fund to be used to pay the compensation awards.

The VICP is a no-fault alternative to the traditional tort system. The U. S. Court of Federal Claims decides who will be compensated. Some are compensated based on the Vaccine injury Table.

The Table—developed by a panel of experts—consists of a list of injuries and conditions presumed to be caused by vaccines, and the time periods in which the first symptom of these injuries and conditions must occur after receiving the vaccine. Unless a different cause is found, the court presumes that the condition was caused by the vaccine if the first symptom occurs within the listed time periods.

Earlier this week, a media report started circulating saying that a federal court had conceded that vaccines caused one child's autism. It turns out that the government cannot discuss the details of the case (for obvious privacy issues) so it cannot respond directly to the claims in the media. But here's what the Health Resources and Services Administration said in a press release:

HRSA has reviewed the scientific information concerning the allegation that vaccines cause autism and has found no credible evidence to support the claim. Accordingly, in every claim submitted under the Act, HRSA has maintained and continues to maintain the position that vaccines do not cause autism, and has never concluded in any case that autism was caused by vaccination.

HRSA will present its views on the allegation that vaccines cause autism in an "omnibus" autism proceeding in May of this year. The expert testimony in that proceeding will be available to the public, with the consent of the parties.

So what is this all about? In short, the court conceded that a nine-year-old Georgia girl's mitochondrial condition was worsened by the five childhood vaccines she was given on a single day eight years ago, leading to problems with brain function "with features of autism spectrum disorder."

As I said, all the details have not been released yet, but from my conversations with some of the people involved I assume that the Court awarded the claim based on a condition listed in the Table, such as encephalopathy. If you think about it, many brain function problems can be labeled as leading to ASD features--poor language and social skills, etc.

Does that mean that vaccines cause autism? Hardly, given the overwhelming scientific evidence collected so far that shows no causal association between vaccines and autism.

This is a tricky vaccine risk communication issue, especially with the constraints that HRSA has in discussing the case and the complexity of communicating the role of the child's mitochondrial condition.

Vaccines and Autism: Why it won’t go away (just yet)

2007-11-05T11:00:00.000-08:00

These are some of the reasons why I think the vaccines-autism scare has taken a life of its own, despite the lack of scientific evidence of a cause-and-effect relationship between thimerosal and autism (as well as MMR and autism).

Vaccines have always caused controversy
No established cause for autism
Public mistrust of the current risk assessment and management
Misinformation widely available
Conflicts of interest (perceived and real)
Pseudoscience
Risk perception driven by the media

I will expand about some of the above in future posts.

Vaccine Safety: Dealing with Uncertainty

2007-10-29T07:15:00.000-07:00

The following presentations were delivered at the 2007 annual conference of the American Medical Writers Association (AMWA) in Atlatnta, GA. The session, titled 'Vaccine Safety: Delaing with Uncertainty' included three presentations by Martin G. Myers, MD, Walter A. Orenstein, MD, and myself. The presentations describe how public health decisions are made in the absence of scientific information. Using the examples of the vaccine safety concerns surrounding the first rotavirus vaccine, Rotashield, and the preservative thimerosal, panelists explored the difficulty of communicating uncertainty, the need for making public health policy, and the potential benefits and risks of health policy decisions.

Missing Information About Vaccine Safety, by Martin G. Myers, MD, NNii Executive Director (PowerPoint, 647k)

A Tale of Two Vaccine Safety Concerns: Rotashield (Original Rotavirus Vaccine) and Thimerosal, Walter A. Orenstein, MD, Director, Emory Vaccine Policy and Development(PowerPoint, 942k)

Communicating Public Health Policy During Periods of Uncertainty About Vaccine Safety, by Diego Pineda, MS, NNii Science Writer (PowerPoint, 532k)

Fright Factors and Media Triggers

2007-10-25T09:06:00.000-07:00

I found these two lists in an excellent book edited by Peter Bennett and Kenneth Calman, Risk Communication and Public Health (Oxford Medical Publications). The fright factors will make a risk less acceptable and more worrisome. The media triggers will make a health risk more likely to be featured as a prominent story in the media.

Fright Factors

Risk is involuntary
Risk seen as inequitable
Risk seen as inescapable
Risk is man-made
Hidden and irreversible damage
Damage to children
Risk poorly understood by science
Contradictory statements from responsible sources

Media Triggers

Questions of blame.
Alleged secrets and attempted cover-ups.
Human interest through identifiable heroes, villains, etc. (as well as victims).
Links with existing high-profile issues or personalities.
Conflict.
Signal value: What’s next?
Many people exposed to the risk, even if at low levels (It could be you!)
Strong visual impact (pictures of suffering)

If you look at recent vaccine safety concerns, almost all of these factors and triggers are present. No wonder they make such compelling stories in the newspapers.

The 1999 Thimerosal Joint Statement: A Case of Poor Risk Communication

2007-10-24T08:35:00.001-07:00

The well-known vaccines-autism scare first started in the UK when Andrew Wakefield suggested that the MMR vaccine could be related to autism (this theory has been widely refuted elsewhere). But here in the US, the center of attention has been the mercury-compound thimerosal, which was used as a preservative in many (non-live) vaccines until a few years ago.

If you are not familiar with the history of this issue, you can read more about it here.

I will concentrate on the first official statement recognizing the potential health risk of thimerosal in vaccines: The Joint Statement of the American Academy of Pediatrics (AAP) and the United States Public Health Services (USPHS).

I have met several people involved with the writing of the joint statement and it is obvious that the final text was a compromise, a middle ground between opposite opinions. Some in the group thought that the lack of evidence of harm was sufficient reason to not do anything; others thought the potential risk of harm was enough to warrant the removal of thimerosal from vaccines. Apparently some went as far as suggesting stopping immunizations altogether until thimerosal-free vaccines became available. See also this reference.

To their credit, some things were done right (in terms of risk communication):

The announcement was made early
The scientific uncertainty was acknowledged
There was collaboration between agencies

Some of the words used, however, created confusion. These are a few of examples...

"The recognition that some children could be exposed to a cumulative level of mercury over the first 6 months of life that exceeds one of the federal guidelines on methyl mercury now requires a weighing of two different types of risks when vaccinating infants. On the one hand, there is the known serious risk of diseases and deaths caused by failure to immunize our infants against vaccine-preventable infectious diseases; on the other, there is the unknown and probably much smaller risk, if any, of neurodevelopmental effects posed by exposure to thimerosal. The
large risks of not vaccinating children far outweigh the unknown and probably much smaller risk, if any, of cumulative exposure to thimerosal-containing vaccines over the first 6 months of life."

Note the problem in the highlighted phrase above. If the risk was unknown, how did they know it was much smaller? A casual reader would fairly ask, 'Is there something you're not telling me?'

Without taking into consideration what we now know about the science of thimerosal/ethylmercury and neurodevelopmental disorders, the paragraph could be interpreted in one of two ways:

The risk is really unknown and they're just saying it is "probably much smaller" to calm me down. In other words, they are insulting my intelligence with their overassurance.
The risk is known and they think it is small but they don't want to tell me because I may think otherwise (Oh, my God, the risk is big!). In other words, they are lying.

Hint: the right interpretation is number 1. The problem, of course, is that overassurance is bad risk communication!

Let's look at the next paragraph in the joint statement:

"Nevertheless, because any potential risk is of concern, the US Public Health Service (USPHS), the American Academy of Pediatrics (AAP), and vaccine manufacturers agree that thimerosal-containing vaccines should be removed as soon as possible."

Whoa! That is alarming! If that didn't confuse readers after the previous over assuring statement, I don't know what would.

But don't take my word for it. According to David Kirby, the joint statement did cause confusion among parents. From Kirby's book, Evidence of Harm:

“In their far-flung corners of the country, parents like Liz [Birt], Lyn [Redwood], and Sallie [Bernard] read the statement and arrived at similar conclusions. The government and the AAP were posing an extraordinary contradiction. If thimerosal exposure had been so minimal, and if there was no evidence of harm, then why call for its removal as ‘soon as possible’?” (p.47)

Towards the end of the joint statement, there is another interesting remark:

"Although there is a margin of safety with existing vaccines containing thimerosal, there are steps that can be taken to increase that margin even further. Clinicians and parents can take advantage of the flexibility within the existing schedule for infants born to hepatitis B surface antigen (HBsAg)-negative women to postpone the first dose of hepatitis B vaccine from birth until 2 to 6 months of age when the infant is considerably larger."

Here's one reaction to the above from Kirby's book:

[Albert Enayati:] “Why would they postpone the birth dose if it is so ‘harmless’?”

“Because they know there’s something seriously wrong here,” Sallie said. “They wouldn’t just reschedule a vaccination unless they knew there was a real danger.”

Remember my two possible interpretations above? These people (Sallie Bernard, etc.) picked number 2. It was the wrong interpretation in the end, but still, I don't blame them, given the poor choice of words in the joint statement.

Among others, the authors of the joint statement did not apply these three principles of risk communication (I'm taking these from Peter Sandman):

Don’t over assure—avoid saying, “everything is fine” because people may find it alarming
Let the public know the reasons behind the policy decisions and the dilemmas faced
Be transparent—communication should be candid, clear, and accurate.

Nowhere in the joint statement, the authors discussed the dilemmas faced. For instance, they did not explain the differences between ethylmercury and methylmercury and how there were no guidelines for exposure to ethylmercury. Perhaps they did not trust the public would understand the science. See Paul Offit's criticism of the joint statement here.

In the end, the overassurance and the contradictory statements gave the feeling of a non-transparent communication. If I were to rewrite two of the paragraphs above, this is what I would do:

The large risks of not vaccinating children need to be weighed against the potential but yet unknown risk of cumulative exposure to thimerosal-containing vaccines over the first 6 months of life.
Nevertheless, because any potential risk is of concern, … agree to err in the side of caution and remove thimerosal from vaccines while studies are conducted to assess the potential risk.

Here I acknowledge the uncertainty of the risk without over assuring and explain the policy decision (the removal of thimerosal from vaccines) by appealing to the precautionary principle (err in the side of caution).

Of course, it is easier to write this in retrospect and without a review committee approving or disapproving every word.

I'm not sure whether my version of the joint statement would have had a different effect in the public (risk communication principles do not always warrant success), but perhaps the postmortem review wouldn't have been as harsh as this one!

Why Vaccine Risk Communication?

2007-10-22T13:02:00.000-07:00

As with any drug, vaccines have associated risks with them. No vaccine is a hundred percent safe. Admittedly, most serious adverse reaction to immunizations are very rare. But most people don't know that--or should I say, feel that? Because, to be honest, most of the time people are not afraid of the 'real risks' of vaccines but of the 'perceived risks' of vaccines.

The real risks (those scientifically shown to be associated with vaccines) usually are fever, pain and redness at the injection site, and a crying baby. The perceived risks (not necessarily real and often with little scientific basis) include asthma, diabetes, autism, and a series of chronic diseases. I have discussed the origins and reasons behind these vaccine safety concerns here.

Risk Communication is the communication of the probability and uncertainty that a particular hazard will cause an effect (and of how to manage the risk).

Risk communicators mediate between the experts and the public, between the scientific assessment of risk and the public perception of risk. That doesn't mean that the experts are always right and the public is always wrong. It just means that their views of risk are usually discordant. For instance, scientists define risks in terms of the effect on population, but the public is concerned with the effect on individuals. Thus the need for risk communication.

My work as a medical writer involves writing about vaccine safety issues so, naturally, I'm interested in vaccine risk communication. That's what this blog is about.

I will close this first post with a quote from risk communication expert, Peter Sandman:

“Vaccination proponents are … outraged that the public doesn’t trust them; outraged that vaccination critics keep impugning their competence and integrity; outraged that nonscientists are daring to make their own scientific judgments; outraged that a major public health achievement may be undermined as a result. Just as the opponents’ outrage makes them unable to interpret the data on vaccination safety appropriately, the proponents’ outrage makes them unable to interpret the data on the sources of opponents’ outrage appropriately. This isn’t a fight between hysterical vaccination opponents and calm, rational vaccination proponents. Both sides, at their worst, behave like children — one side shrill, the other patronizing, and neither entirely honest.”