"Consumer-Led Charity" Lobbying Your Legislator About Vaccines

Chances are this summer your state's congressmen and women received a letter from a "non-profit, consumer-led charity" urging them to take note of an "urgent need for reform."

That "charity" is National Vaccine Information Center. The "urgent need for reform" refers to state vaccine laws. 

For anyone unfamiliar with National Vaccine Information Center, it is the preeminent anti-vaccine organization in the United States, extremely well-funded by big donors such as Joseph Mercola. You may have seen their billboards in large cities across the country warning parents of the dangers of vaccines. The organization presents itself as a consumer advocacy group, and perhaps once upon a time it might have been. However, it has morphed, under the watch of Barbara Loe Fisher, into one of the most notorious anti-vaccine groups in the world, and it specializes in cloaking its true intentions with proclamations about "vaccine safety" and "personal choice," when its true mission is to make vaccination completely optional and to eliminate any state requirements making it harder for a parent to get her unvaccinated child into daycare, schools, afterschool programs, or any other public space where public health is of particular importance. 

One of the richer sentences from the letter NVIC sent congresspeople, and which I'm going to talk about briefly, is this one: "NVIC does not make vaccine use recommendations and supports the legal right for adults and parents of minor children to make informed vaccine choices." The latter half of this sentence is an exercise in redundancy, which, I suppose, they feel is worth spending millions of dollars on--informed consent is already assured and part of the medical experience of anyone seeking a vaccine. The first half is a falsehood. ThinkTwice Global Vaccine Institute, which advises against vaccination, lists NVIC as a trusted source of information.  Fisher's own blog betrays her true feelings about vaccines, bearing the motto: "If the State can tag, track down and force citizens against their will to be injected with biologicals of unknown toxicity today, there will be no limit on which individual freedoms the State can take away in the name of the greater good tomorrow."

And whenever states begin considering strengthening immunization rules, NVIC is right there, making a stink, usually in the name of "personal rights" and "informed consent."In fact, that kind of opposition to better immunization rules on a state level is a core purpose of the organization. Think about that for a minute: this is an organization that devotes its time and considerable capital to making it easier for unvaccinated children to mingle with the public in public spaces, such as schools and daycares.

I bring this up because over the summer, National Vaccine Information Center sent letters and a slickly produced "book" to congressmen and women in Washington, which NVIC termed a "legislative guide." That guide was titled "Reforming Vaccine Policy & Law." That guidebook indicates to the legislators who receive it that there is an "urgent need for reform of existing state vaccine laws." Translated, this means that NVIC feels that immunization requirements for children entering school, day cares, and for health professionals caring for the elderly and immunosupressed or immunocompromised (such as children with heart defects, anyone going through chemo, etc) are unacceptable. This, even though the vast majority of states have either a religious, medical, or conscientious objection clause in their rules. 

Personally, I find NVIC's hubris (or perhaps cluelessness?) fascinating: to launch a campaign to weaken immunization rules at a time when the country is grappling with outbreaks of vaccine-preventable diseases, such as measles, mumps, and pertussis. There's no sign that the effort has worked, but the onus is on those of us who care about public health to make sure our legislators are informed about the true intentions of this "consumer-led charity" that warns of an impending crisis of personal liberty (i.e. the closing of certain personal exemption loopholes in some state immunization rules). It would take but a moment to write a quick e-mail to your local representative and senator just to say, hey, you may have received a letter and legislative guide this summer from a group purporting to be an "independent clearinghouse for information on infectious diseases and the science, policy, law, and ethics of vaccination" (a line straight out of NVIC's letter). However, I would like to clarify for you the organization's true position. A simple search of NVIC online or even on this blog will reveal countless examples of NVIC's attempts to dissuade parents from vaccinating. 

While I feel confident legislators grappling with immigration reform, budget issues, and the war on terror are probably not inclined to give NVIC's mailing a second thought, it's never good to let NVIC go unchallenged if you live in a state with pending changes to immunization rules. 

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)

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.

Taking Back "Informed Consent"

Pediatrician Richard Pan also happens to be the California state legislator responsible for introducing AB 2109, which will make getting a vaccine exemption for philosophical reasons a touch more difficult (the bill will require a parent to get a sign-off from a health provider indicating that the health provider outlined the risks of not vaccinating).

The uproar among California’s vociferous but small anti-vaccine community has been predictable, but one thing Dr. Pan mentioned in a wonderful conference call Every Child By Two set up last week has stuck with me. He said it’s time for the pro-vaccine community to “take back the term ‘informed consent.’” I was thunderstruck by his comment.

Yes, I thought to myself, of course! Anti-vaxxers tell new parents that immunization laws trample on their rights as parents to make medical decisions, without mentioning that their choice not to vaccinate their children tramples on the rights of everyone around them to a healthy life. The code word for their opposition to vaccines is often “informed consent.” So what is informed consent? A simple Google search will bring up articles and web pages from a number of very official-sounding websites, which are actually anti-vaccine organizations (National Vaccine Information Center, Vaccine Information Center, etc), and there you will learn that doctors like to jab kids full of toxins at every well-child check and they like to keep the contents of those shots super secret. Therefore, the parents are not informed.

This claim is, of course, without merit. Vaccine ingredients are publically available, and the Vaccine Information Sheets (VIS) provided at well-child checks, along with supplemental sheets each provider may choose to give parents, contain transparent information about what is contained in each shot. The same cannot be said of other injections regularly given during doctor’s appointments, like antibiotics for children suffering from illness, for example. Of course the anti-vaccine activists don’t make mention of this fact.

The truth is that the raising the flag of “informed consent” with regard to vaccines is like American women marching in the streets in 2012 demanding the right to vote. We already got it. Only the anti-vaccine activists have misapplied the term to their desire to not vaccinate their children and put the community at risk.

But there is one scenario in which “informed consent” has not been fully implemented, and it has nothing to do with the ingredients of a vaccine. It has to do with informing parents of what can happen if they choose not to vaccinate. And telling them in clear, transparent language. Informing parents that not vaccinating their children can lead to serious illness, disability, and even death. As a new parent, I was not informed of this. I did not hear the words “risk” from my pediatrician except in describing the “risks” of the vaccine itself—fever and soreness. What if I had been “informed” that not vaccinating my child could put my child at risk of developing a potentially fatal illness, or even a long hospital stay? What if I had been told that not vaccinating my child would put the kid down the street with leukemia at serious risk? Or the one in my playgroup with a gelatin allergy? Maybe I would not have delayed my son's MMR vaccine for three months. Maybe, after each well-child check, I would have run to my social network and reminded my fellow parents why vaccination was so crucial.

In fact, the failure of informed consent is not that doctors and vaccine manufacturers do not inform parents about what is in vaccines and the risks of the immunizations. The failure is that parents have not been adequately informed of the risks of not vaccinating. And so Dr. Pan is right. It’s time to take back the term informed consent and apply it to something real: the risks of not vaccinating.