Big Alterna and the Ties That Bind

By Karen Ernst

Editor's Note: Voices for Vaccines does not and never has accepted any government or pharmaceutical funding. The organization is supported 100% by individual member donations.

Recently, an anti-vaccine blog put together 11 Facts about Voices for Vaccines claiming to show that we are a “front group” for Big Pharma/the CDC. The blogger drew up charts showing the connection between various people (the charts were wrong) and included a map to show how close our fiscal agent was to the CDC (2.6 miles!). Yet, I work in my little (messy) rambler 1,120 miles away from this supposed vortex of evil, busily not being directed or controlled by the Task Force for Global Health, the CDC, Emory, or Big Pharma (or the reptillian overlords).

All the conspiracy theories and convoluted logic about supposed and unproven influence by the CDC and pharmaceutical companies on a parent-led vaccine advocacy group makes it that much more interesting that the National Vaccine Information Center is indelibly tied to the hugely influential Big Alterna figurehead Joseph Mercola. Unlike any fiscal connection alleged between Voices for Vaccines and the CDC or Pfizer or any pharmaceutical company, the fiscal ties between NVIC and Mercola are factual, and I want to explore them with you here.

If you are a person who lives a normal life and only thinks about immunization when you bring your child in for his well-child check, the National Vaccine Information Center might sound like a good thing. It might sound positive to have information about vaccines in one convenient “center” for the whole nation.  The problem is that NVIC is definitely anti-vaccine. They have even gone as far as promoting a conspiracy theory about high school kids who created a film about immunization in an after school program. (Shockingly, like football and yearbook, this program was advised by adults, thus prompting the conspiracy theory.)

In addition to the billboards NVIC buys across the United States asking motorists to “Know the Risks and the Failures” of immunization, NVIC also spends a great deal of time and energy opposing a great deal of vaccine-related legislation. They are even opposing proposed legislation that would provide information about vaccines and record students’ vaccination status.

For an organization that claims it is not anti-vaccine but is rather “pro-informed consent,” opposing information seems odd.

Except that they are anti-vaccine and pro-misinformed consent.

I had assumed for a long time that this was the entire story, until the day (two days actually) the NVIC website went down and in its place:

It turns out, the NVIC website is provided as an in-kind donation from Mercola.com.

If the VFV website went down, I do not know what would appear there, but to be clear, VFV pays for its website from its own funds which comes from individual donors. The Task Force for Global Health is listed as the owner of our domain name because, as our fiscal agent (we are not yet our own 501(c)3 so do not have ready access to our bank account), they actually issued the check using the funds we raised for Voices for Vaccines.

So, which websites does Mercola provide funding for? (A hat tip to the Skeptical Raptor for this next part.)

Click here for a larger image

Most interesting in this list of domains owned by Mercola.com is the number of them selling something. Bath products! Tanning beds! Water filters! Why would someone selling such an odd mish mash of home products care about helping an anti-vaccine organization promote their misinformation?

Perhaps because there is money to be made off of parents who eschew immunizations out of fear of what they see as “unnatural.” Make no mistake, parents seeking natural health alternatives make big bucks for Big Alterna. And Joseph Mercola, the doctor behind Mercola.com, is near the top of those cashing in.

Let’s review: the National Vaccine Information Center claims not to be anti-vaccine, but in favor of informed choice about vaccine, but as an organization they have made documented efforts to make it more difficult for parents to receive information about vaccines. They do not want schools to know who among their students is vaccinated (even in the case of outbreaks), and they do not want high school students to pursue documentary filmmaking about topics that interest them.

I believe Theresa Wrangham or even Barbara Loe Fisher, the women heading NVIC, believe the misinformation they promote, but if they believe they are not anti-vaccine, they are seriously delusional. And if they believe that Joseph Mercola is providing them with a website because he has a heart of gold, they should know that he probably bought that gold.

For a couple years now, I have sat on my slightly-too-tall IKEA chairs at my old computer fielding accusations about my connections to Big Pharma and the CDC, who apparently want to force parents to immunize their children because there’s money in it, and because the’re evil. (Note: you cannot buy tanning beds or supplements from VFV, the CDC, Emory University, or the Task Force for Global Health.) This strange theory is promoted enthusiastically by NVIC.

And I’m not even sure what that is. Hypocrisy? Willing ignorance? Arrogance? I’m genuinely curious about what drives NVIC’s willingness to schlep out the Pharma Shill gambit while simultaneously being a Big Alterna Shill.

But the public should not be fooled. This isn’t a story of the little guy who is desperately seeking alternative health options in a world of cruel public health bullies trying to take away the little guy’s freedoms. This is a story about a well-oiled, well-funded machine. A machine that wants to keep you scared--that demands that you look at their information but no one else’s. A machine that would harass children and their teachers in order to obscure the truth about immunization and to sell you a tanning bed.

Letter to an Anti-Vaxxer from a Pro-Vax Mom

By Amanda Z Naprawa

I am pro-vaccine.

Vaccines are one of the greatest medical breakthroughs of the twentieth-century.  I believe vaccines  should be mandatory, except for a few very limited exemptions.  That because vaccines save lives. They prevent complications from disease by preventing the disease itself -- complications like blindness, deafness, infertility, paralysis. I am fully vaccinated. My children are vaccinated according to the recommended schedule. We all get flu shots every year.    

I'll say it again and without hesitation: I am pro-vaccine. 

You, on the other hand, are anti-vaccine. You may also be a beautiful celebrity or a best-selling author of childcare books. You may be the president of a "vaccine information group" or the leader of your local "clean living" club. But you are also anti-vaccine.  Please stop referring to yourself as "pro-informed consent" or "pro-safe vaccine" or any other name that tries to hide the truth of your position.

Individuals who urge parents to avoid vaccinating their children based on a slew of myths are anti-vaccine.  If, in the face of dozens of peer-reviewed, scientifically sound studies, you continue to scare parents into believing that vaccines cause autism, you are anti-vaccine.  If you use your good looks and flashy smile to convince parents that vaccines are more harmful than the diseases they aim to prevent, you are anti-vaccine. If you smile benevolently upon chickenpox parties, and mock concerns over the spread of measles, you are anti-vaccine.  If you threaten the scientists and doctors who have worked to create vaccines with bodily harm and death, you are anti-vaccine. If you bully high school students for making a documentary exploring the anti-vaccine movement, then, yes, you're anti-vaccine.

You are anti-vaccine, not "pro-informed consent."  If you were really for "informed consent," then you would push accurate information. True informed consent  requires that the relative risks, benefits and  uncertainties for each alternative treatment option be given to the patient.  When my child gets a vaccine,  my physician gives me an information sheet filled with all the benefits and potential risks of each vaccine.  I vaccinate my child knowing that the vaccine will offer significant protection against serious illness, and that my decision to vaccinate comes with a very, very small risk of some side effects.  I am fully informed.

If you were really pro-informed consent, then you would be giving the true risks of vaccines and the true benefits of vaccines.   You would tell parents --honestly -- that some vaccines carry an extremely small risk of seizure. You would also tell parents -- honestly -- that there is simply no evidence (aside from anecdotal, post-hoc stories) that vaccines carry a risk of autism.  You might tell parents, that you really really hoped that autism could be explained by vaccination (we would all like a simple explanation for autism)  but its not.

You claim to be pro-informed consent.  Informed consent requires that you give accurate, unbiased information necessary to make an informed medical decision.  If you were really  pro-informed consent, you would tell parents that the diseases that vaccines prevent are real. They are scary. They are dangerous.  Yes, many people have had diseases like measles and survived without lasting harm.  But why take the risk? Why let your child suffer an illness that is preventable? In the pre-vaccine era, 400-500 children died a year from measles. Per year. In contrast, 142 people have been compensated for measles vaccine-related injuries over the last eight years.  That's information that a parent can use to make an informed decision about vaccination. That's pro-informed consent.  But that is not what you are about. You minimize the death of children from vaccine-preventable disease by "putting them into perspective."

You are so proud of your accomplishments in increasing awareness of the alleged dangers of vaccination. You have worked so hard to increase the number of states with exemptions to mandatory vaccination. You have tirelessly spread the news that the government cannot be trusted, that vaccine manufacturers cannot be trusted, and that the average vaccine-friendly pediatrician cannot be trusted either.  You have made money, sometimes lots of it, selling the idea that vaccines are dangerous and should be avoided.

There's a name for that. And its got nothing to do with informed consent.

Amanda Z Naprawa is an attorney and graduate student in the Masters of Public Health program at University of California, Berkeley. She believe in promoting immunization through the dissemination of accurate information about vaccine safety. She is the author of various articles, including "Don't Give Your Kid That Shot: The Public Health Threat Posed by Anti-Vaccine Speech and Why Such Speech is Not Guaranteed Full Protection Under the First Amendment." 11 Cardozo Pub. L. Pol'y & Ethics J. 473 (Summer 2013)

Invisible Threat: Speaking Up

In recognition of the national launch of the Invisible Threat movement on May 1st, 2014 the Moms Who Vax blog is participating in a blog relay to raise awareness of the threat the film explores—the anti-vaccine movement. Each day, a different blogger discusses his or her personal perspective of the film as part of an exciting ten-day countdown to a kick-off event for the film, which will be attended by national legislators at the Capitol Visitors’ Center in Washington, D.C.  You can follow along to find out how you can join us in this movement, arrange for a local screening of Invisible Threat, and continue our fight against infectious diseases.

Karen Ernst

Teenagers are amazing people. If you want to view the world through a lens of optimism and idealism, ask for a teenager’s perspective. My other career--the one I began long before I had children or embarked on my mission to get parents to pitch in and help prevent disease outbreaks--is teaching. I began my adult life as an English teacher and became who I am today because I spent my hours learning along with the teenagers who populated my classroom and my life.

So I am difficult to surprise with news about how incredible teens can be. Stories in the media detailing how these young people are transforming our world through their activism and creativity often feel like merely revealing the spirit of what it means to be on the cusp of adulthood.

But a group of student-film-makers has surprised me. By delving into the world of vaccine-preventable disease and rationally examining the claims of the anti-vaccine movement, the student-creators of Invisible Threat have done what many adults fail to do: discover the objective facts about vaccines. Before all of us pro-vaccine parents go patting ourselves on the back for arriving at the truth about immunization, we need to recognize that these teens have also gone above and beyond what most of us do. They’ve chosen to speak publicly about the importance of vaccination.

Most vaccinating parents are not telling their stories. Some of us are afraid to cause discord in our families and so we don’t speak up. We have looked at the science, but don’t want to start debate because it’s just not our area of expertise. So we remain silent, and by our silence we allow the anti-vaccine voice to be the default voice of parents.

The Invisible Threat filmmakers faced steep challenges when creating their documentary. They came to the topic green: with no experience with any vaccine-preventable disease, and largely unaware of the anti-vaccine movement, they read materials both for and against vaccines. They sought out experts and got their opinions. The interviewed anti-vaccine parents. They discussed among themselves what all the information meant and came to a conclusion that was both reasonable and in line with the scientific consensus: vaccines are safe and save lives.

Invisible Threat follows the evolution of their thoughts on vaccines, but behind the scenes, these students faced the same obstacles that we vaccine advocates face. Lisa Posard, parent volunteer and executive producer, explained that when news about the topic of this documentary first came out, anti-vaccine bloggers wrote about the teenagers. Anti-vaccine activists even called their school to try to convince them not to do the film.

Despite this harassment, the students were adamant that they would not be bullied out of tackling vaccines. These young people have done the hard part, and we can do something easy right now. We can invite our senators and representatives to an event on May 1st at 10am in Washington D.C. to discuss the issues behind the documentary.

Invisible Threat is a fantastic documentary, and we are fortunate the filmmakers had the moral fortitude to stand up to those who were trying to shout them down. Next time we are tempted to be quiet about vaccines because we don’t want to make enemies or because we aren’t up-to-date on all the latest science or because it takes effort and we are busy, we need to remember that making a difference means taking a risk. It might mean we have to hearken back to our youth and our days of idealism, when standing up for something was critically important. And what could be more critically important than the health of our children and our communities?

You have the ability to make a difference in our fight against infectious diseases. Follow the Invisible Threat Blog Relay and find out how you can be a part of the movement. Tomorrow's post will be hosted by MOMentumNation.  And be sure to like the Invisible Threat Facebook  and follow the filmmakers on Twitter @InvisThreat.

And here's what my letter looks like...

In the post below, I urged you to write to Colorado legislators to express your support of HB1288 and to counteract the anti-vaccine rhetoric with which they've been deluged. Putting my money where my mouth is, here is what I've written. It's not perfect, it's not polished, but it's from the heart. Yours can be too!

Dear Senators,

My name is Ashley Shelby, and I am a mother of two. I am moved to write you today because it has come to my attention that you are receiving a great deal of contact from anti-vaccine parents and activists regarding HB1288, which strengthens immunization rules for the state that will protect children and infants, individuals going through immuno-suppressive therapies like chemotherapy, and the elderly from needless suffering. These anti-vaccine activists often refer to their beliefs as having to do with personal choice, personal liberty, informed consent, and other terms that mask the fact that they want the right to not vaccinate their children while still enjoying the public spaces, like schools, where their decision could harm others. To me, anti-vaccine parents who fight against HB1288 are like people who feel it's their right to shout "fire" in a movie theater, a right which has been denied by courts for decades. Your freedom may not infringe on my safety--and that's exactly what anti-vaccine parents are doing, so far without any obstacles thrown in their path. Their "personal liberty" is making it hard for me to exercise my own.

I am speaking up because these individuals do not represent parents. In fact, they are a vocal fringe group, who have an impact because of the nature of herd immunity. Although the overwhelming majority of parents support vaccines, even if five percent of parents choose not to vaccinate, diseases like measles, mumps, and pertussis gain a foothold in our communities. And they have. You are no doubt aware of the measles clusters in California and New York, the mumps outbreak in Ohio, and the pertussis cases all across the country. The majority of these cases started with and were spread by unvaccinated individuals. 

Please help parents protect their children from vaccine-preventable disease by voting yes to HB1288. Parents still have the right not to vaccinate their children--they just can't send them into schools and day cares. Voting no to HB1288 is not a vote for personal liberty. It's a vote that indicates that people can endanger public health with absolutely no consequence to themselves, and all the risk on the shoulders of people who are forced to share a public space with them. 

Thank you for considering my point of view.

Don't Let Anti-Vaccine Movement Sink Colorado Bill

Editor's Note: I made a mistake in my initial post--Colorado is not trying to eliminate personal belief exemptions (I wish)--the bill simply adds an educational component. 

We need your help.

Colorado is trying to strengthen immunization rules by adding an educational component to personal belief exemptions. These exemptions are the manner in which anti-vaccine parents can opt-out of vaccines and still enroll their children in schools and day care facilities, putting children and vulnerable members of our community at risk of vaccine-preventable diseases. We've seen the result of these exemptions: measles outbreaks, mumps outbreaks, devastating pertussis outbreaks that have killed infants.

And while support for the measure is strong in Colorado's House, its Senate is less likely to pass the bill, titled HB 1288, "Strengthening Personal Belief Exemptions for Immunization Requirements."
Part of the reason is because legislators are being deluged by phone calls and e-mails from anti-vaccine activists, purporting to represent parents. What's more, they are framing this debate as one over personal liberty. Missing from their arguments is the idea that with personal liberty comes personal responsibility, something anti-vaxxers do not exercise, and which is harming public health and the communities in which they live. Unfortunately, it turns out that several state legislators have bought into this personal liberty argument--and with the majority of the calls and e-mails they are receiving being from anti-vaxxers, they are more and more likely to vote against this important bill. 

Let's help. One approach is to talk about recent outbreaks of vaccine-preventable disease and how lack of immunization has lead to needless suffering. Another approach is to take apart the personal liberty argument that the anti-vaxxers are now using to stop this bill. Where does personal liberty bump up against the needs of the community--the anti-vaxxers want the right to yell "fire" in a crowded theater. 

The Colorado Senate State, Veterans, and Military Affairs Committee will vote on the bill on Monday.

Once passed by this Committee, as is likely, the bill will be considered by the full Senate. It here that the bill looks to be in trouble, when it reaches the full Senate. 

This is where you come in. Please contact Colorado Senators as soon as possible to urge them to support House Bill 1288. Here is the CO general assembly senate directory:  Colorado General Assembly Senate Directory

Because the majority of calls and e-mails right now are angry anti-vaxxers, all Senators, even the ones who look like they will vote yes, need to hear from you. Encouragement for those likely to vote yes, reasoned and compelling (and personal) words for those likely to vote no. Here is the list of senators we believe are most in need of a call or e-mail.

Senator Cheri Jahn (D); Cap: 303-866-4856 E-mail: cheri.jahn.senate@state.co.us

Senator John Kafalas (D) Cap: 303-866-4841; E-mail: john.kefalas.senate@state.co.us

Senator Mary Hodge (D): Cap: 303-866-4855; E-mail: mary.hodge.senate@state.co.us

Senator Jeanne Nicholson(D): 303-866-4873 E-mail: jeanne.nicholson.senate@state.co.us

Senator Ellen Roberts (R)Cap: 303-866-4884 E-mail: ellen.roberts.senate@state.co.us

Senator Bernie Herpin (R)Cap: 303-866-6364; E-mail: bernie.herpin.senate@state.co.us

Senator Steve King (R) Cap: 303-866-3077; E-mail: steve.king.senate@state.co.us

Senator David Balmer (R) Cap: 303-866-4883 E-mail: david.balmer.senate@state.co.us

If you have any questions, please contact Stephanie Wasserman, Executive Director of The Colorado Children's Immunization Coalition at Stephanie.Wasserman@childrenscolorado.org   

Telling Anti-Vax Parents They're Wrong Only Makes Them More Anti-Vax

By Karen Ernst

Today, a study in the Journal of Pediatrics seemed to point out that what pro-vaxxers are trying to do is all wrong.  It might seem to suggest that debunking vaccine-autism myths, explaining relative risks of disease, and demonstrating the effects of vaccine-preventable disease is ineffective.  

The study tried to influence parents’ decisions about vaccines using four strategies, all utilizing online resources: correcting misinformation about the MMR-autism myth, giving information about the risks from vaccine-preventable diseases, presenting first-person narratives about children who had contracted VPDs, giving visuals of those risks. After being presented with one of these four strategies, parents were surveyed about how much more likely they were to choose an MMR for their children.  The information used came from the CDC, although the source of the information was not given to the parents surveyed.  The parents participating in this study came to the study with a wide variety of beliefs about vaccines, and almost none of them left with their beliefs being changed.

In short, the Pediatrics study found, in summary, that:

1. Showing ardently anti-vaccine parents proof that vaccines don’t cause autism only made them less likely to vaccinate.

2. Explaining the risks of vaccine-preventable diseases does not increase the chances that parents would agree to the MMR in the future.

3. Showing parents visuals about disease risk or giving them stories about children suffering from vaccine-preventable diseases did not make them more likely to vaccinate their children.

Those findings seem pretty damning for the pro-vaccine message, but I think we should take heart.  There is so much this study didn’t cover, and so much we can do that would work. Here are my thoughts on the findings:

1. Anti-vaccine parents have a broad range of concerns about vaccines beyond the vaccine-autism myth. Hitting one discussion point only irritates their sense of “they don’t get us.” The study might also fail to nudge ardently anti-vaccine parents because there is no human component, and the targeted parents have no opportunity to feel that someone took the time to genuinely hear out their concerns and address them in a personalized way.

2. Emphasizing risks often feels to parents like “fear-mongering,” and parents who refuse vaccines might feel that they are able to continue refusing vaccines since they live in communities with high vaccination rates where the risk of their child actually contracting a vaccine-preventable disease is low.  Just the other day on our Voices for Vaccines Facebook page, one mother commented, “I do not vaccinate, but would definitely consider it if traveling overseas.”  Anti-vaccine parents believe that their risk for contracting diseases is greater where those diseases are endemic, and trying to convince them that their children are at risk for complications from diseases they are unlikely to catch at home is problematic.

Conversely, anti-vaccine parents are likely to disbelieve in herd immunity. As Amy Parker’s mother once did, anti-vaccine parents often rely on organic foods and healthy living to protect their children from diseases that are often airborne and highly contagious. Those of us providing the cover of herd immunity to their children only make it easier for them to continue to delude themselves into believing that their lifestyle is the deciding factor. And because allowing children to become ill to prove our point is wrong in every sense of the word, it’s simply unlikely that anti-vaccine parents will change their minds due to fear of risk from disease.

In reality, what these anti-vaccine parents are doing is increasing the risk that these diseases will come back and that someone will suffer from a serious complication.  The parent who already vaccinates does so not only out of concern about serious complications, but also because they want to prevent illness in their children. But only ardent pro-vaccine parents are typically also passionate about the power of protecting her whole community.  However, maybe we can use pride in protecting the community not as a way to motivate parents to vaccinate but to motivate vaccinating parents to take pride in their actions and speak up about them.

3. Images and stories about children in peril because of disease only makes parents look for other dangers.  I call this the “Law and Order: SVU” effect, named so because after I have watched episodes of this show where children were in peril, I tend to see dangers for my children everywhere--beyond the scope of the subject of the episode.  

The researchers call this the “danger-priming effect.”  Priming parents for danger doesn’t make them more likely to take the solution you are offering, according to this theory.  It makes them more likely to look for dangers everywhere, including in that syringe you are holding out to them.

4. This study was limited in what it could reasonably do to ease fears about immunization because it was online and impersonal. There’s simply no way to quantify all of those conversations that occur on the playground among parents or around the Thanksgiving table or even between friends on Facebook.  

Parent-to-parent communication is entirely different than the communication in this study.  Think about what we know about ardently anti-vaccine parents:  They are more likely to believe conspiracy theories and thus less likely to believe officially sanctioned scientific evidence.  They are more likely to have a social network guiding them toward vaccine refusal, and providing them positive social reinforcement for their decisions.  The cold, impersonal online survey has no chance for success in the mind of a parent whose decisions are socially reinforced and are based on a distrust of official stances.

So what can we, as pro-vaccine lay-advocates, do? Are we likely to make parents less likely to vaccinate through our advocacy?  

I do not believe so.  In fact, I think lay-advocates--everyday parents and citizens--are key. Recent research shows that normalizing immunization works.  So let’s do that. Let’s let people know that we happily vaccinate our children because we understand the science behind it is clear and because we value our children’s health.

And vaccinating is normal.  Well over 90% of parents vaccinate on-time. If anti-vaccine parents feel that their position is being reinforced by their social network, then we as parents are not doing our job to protect our children and their friends. If every parent with fully vaccinated children simply stated that their children were vaccinated on-time, there would be a groundswell. The voices of these parents would drown out the fear-mongering and lies of the anti-vaccine movement, and concerned parents would feel more confident to join our ranks.

In other words--speak up. It just might work.

Informed Consent and Vaccines

By Dorit Reiss

The process of informed consent is more regulated for vaccines than for most medical treatments or drugs. Still, anti-vaccine activists often use “informed consent” as part of their general attack on vaccines. Parents, they say, are not given appropriate information about vaccines and their risks, so they cannot make an informed decision about them. That claim is incorrect.

When I teach my students about informed consent and vaccines, I use the Vaccine Information Sheet (VIS) - the basis of informed consent in this area – as a model, because it is a reasonably good form. To understand why, you need to first understand what informed consent means, and how it works in the context of vaccines.

The Basics of Informed Consent

Informed consent has two parts: the patient has to consent, or agree, to a treatment, and the consent has to be made after the patient has been given sufficient relevant information. Our system values patient autonomy very, very highly. With a few narrow exceptions (court order, emergency, lack of capacity to consent), a doctor may not provide treatment to a non-consenting patient. Even if the lack of treatment will kill that patient. An adult in sound mind has the right to choose death over treatment. A doctor providing treatment without consent may be liable for a battery (see Schloendorff v. Society of New York Hospital, 211 N.Y. 125, 105 N.E. 92 (1914).) However well-intentioned the doctor, she may not give treatment without consent.

For a child, the consent of the child’s legal guardian  - usually the parent – substitutes for the child’s consent. There are some exceptions to that – doctors may treat children in an emergency when no parent is around; a state may mandate treatment over a parent’s opposition, through legislation or court order, in some circumstances; and most states allow adolescents to consent to certain treatment without parental permission.

Informed consent cases are different. In those cases, the patient actually consented to the procedure. The claim, however, is that that consent was flawed, because the patient did not have complete information. It is a claim that the doctor was negligent in providing the information necessary for the patient to fully understand the situation and make an informed decision (Natanson v. Kline, 350 P.2d 1093 (1960)). To evaluate informed consent, courts use one of two approaches. Some courts compare the information provided to the patient to the information a doctor in good standing would provide—what is customary in the profession to give. This is referred to as the professional standard, or the physician standard. It requires expert testimony on the standard in the profession.

Other courts ask the jury to compare the information given to the patient to what a reasonable patient in the plaintiff’s shoes would consider important. This is referred to as the patient standard or the material risk standard.

If a patient underwent a treatment without informed consent, a doctor may be liable for harms arising from that treatment – even if the treatment was performed properly, even if there was no medical malpractice.

Informed Consent and Vaccines

What would a person need to know to give informed consent to a vaccine under this rubric (or what would a parent need to know to give informed consent to vaccinate a child, which is the more common situation)? A parent would need to know “the nature of the treatment” – that the child is getting a vaccine, whether it’s injected or oral; the “risks and benefits” of the treatment – the benefits of the vaccine, in other words, the risks from the disease we vaccinate against; the risks of the vaccine – potential side effects; and alternatives, which do not really exist for vaccines.

In 1986 Congress passed the National Childhood Vaccine Injury Act. The act did a number of things, but the important part for our purposes is that it required the Secretary of the Department of Health and Human Services to

“develop and disseminate vaccine information materials for distribution by health care providers to the legal representatives of any child or to any other individual receiving a vaccine set forth in the Vaccine Injury Table. Such materials shall be published in the Federal Register and may be revised.” (§300aa-26).

The materials developed require – for their initial preparation and any revision – a 60-day notice and comment process with the public, and consultation with “the Advisory Commission on Childhood Vaccines, appropriate health care providers and parent organizations, the Centers for Disease Control and Prevention, and the Food and Drug Administration.”(id – see http://www.law.cornell.edu/uscode/text/42/300aa-26).

Today, any health care provider administering a vaccine is legally required to provide these materials to the individual – or a guardian, in the case of a child – before giving the vaccine.

These materials – referred to as the Vaccine Information Sheets – can also be found on the CDC’s website. 

Examining one selected at random – the DTaP Vaccine Information Sheet - the VIS opens with “Why get Vaccinated” - including a description of the diseases, who should or should not get the vaccine, and the potential risks from the vaccine. It also provides instructions of what to do if, after the vaccine is administered, a reaction develops,which include calling your doctor or going to an emergency room, reporting the reaction to the Vaccine Adverse Event Reporting System, and information about the compensation mechanism.

In short, a parent reading through the Vaccine Information Sheet should get a good sense of why the vaccine is given, what are its benefits and risks, and additional information, such as what to do if there’s a problem. This seems to cover the requirements of informed consent. The hope is that the recipient of the VIS will read it before the vaccination. Of course, all doctors can do is provide the information. It is the responsibility of the patient or her legal guardian to read it.

Anti-vaccine Claims and Responses

Anti vaccine activists like to claim that no informed consent is given before vaccinating. As explained above, these claims are incorrect. These individuals base their claims on three arguments, none of which is valid.

First, they suggest parents should be given the vaccine insert as part of the consent process. Second, they claim parents are not told that vaccines can cause a range of  side effects (side effects that have not been scientifically documented and, in the case of some, have been disproven) such as SIDS or autism. Finally, they criticize the fact that parents are often not informed of the ingredients before being the vaccine is administered.

I will take these objections one at a time.

Not giving the insert:

The insert – of a vaccine or a drug – is not a good document to base informed consent on. The insert is a legal document, heavily regulated by the FDA. It has substantial useful information, but can also mislead the patient (see: http://www.skepticalraptor.com/skepticalraptorblog.php/vaccine-package-inserts-debunking-myths/ for a detailed discussion of inserts). In relation to informed consent, at least two problems make inserts inappropriate: they do not explain the benefits of the procedure; and they must legally list any problem that occurred after the product was put on the market, whether or not causally related to the vaccine. The combination of not mentioning the benefits and mentioning unrelated bad outcomes can make the vaccine look much worse than the reality – substantial benefits and low risk – and misinform parents.

Not mentioning “side effects” like autism and SIDS

However much anti-vaccine activists would like to believe otherwise, extensive scientific studies have examined whether vaccines cause autism or SIDS– and no connection was found. That is why these risks are not mentioned on the Vaccine Information Sheet. Mentioning risks that are not supported by evidence is not promoting informed consent: it’s undermining it.

Not Providing Parents with a List of Ingredients

A list of ingredients is not part of informed consent requirements for any drug. If a patient has a known allergy to an ingredient, or a potential allergy, they should, of course, be notified of the presence of that ingredient. But otherwise, a list of ingredients alone – in the abstract – does not promote the patient’s understanding of the risks or benefits of a procedure, and does not advance the patient’s ability to decide if the procedure’s benefits outweigh the risks. It is therefore not a proper part of the informed consent discussion.

The informed consent process for vaccines is carefully regulated and thought through. A serious effort is made to provide patients with the information they need in a short, accessible format. As long as the healthcare provider performs the legal duty of providing the Vaccine Information Sheet before vaccinating, the patient – or parent – has before them the information necessary to make an informed decision.

Certain parents, because of language problems or other problems, may need more help, and should receive it; but that is true of any informed consent process.  It does not mean the process itself is in any way flawed.    

Author's Note: I'm grateful to Nathan Boonstra, Ashley Shelby, and Alice Warning Wasney for their corrections to previous drafts.

Dorit Reiss is a professor of law at the University of California. She has published writings on administrative law, and recently wrote "Compensating the Victims of Failure to Vaccine: What are the Options" Dorit is a member of Voices for Vaccines' Parent Advisory Board.