Monday, January 20, 2014

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

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.

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: 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.

Friday, January 3, 2014

How Anti-Vaxxers will Help the Pro-Vax Movement in 2014

For anti-science movements, such as the anti-vaccine movement, conspiracy theories are lifeblood. In fact, many of these movements would not survive if it were not for their unique kind of science fiction so implausible it would make Philip K. Dick blush. The anti-vaccine movement survives on several of these conspiracy theories, most of them so far-fetched that the majority of reasonably intelligent parents who read about them can dismiss them out of hand.

For example, we have the worldwide conspiracy of pharmaceutical companies, every government on the face of the earth, the global medical community, all medical schools, medical journals and other medical organizations, every state public health department, the Centers for Disease Control, the FDA, the Gates Foundation---and I'm out of breath. That conspiracy claims that vaccines are dangerous, but this aforementioned cabal somehow organized in the shadows, away from the prying eyes of the public and a scandal-hungry media, to whitewash the dangers of vaccines and act as if they are live-saving interventions. As someone who volunteers for a non-profit, I can tell you that it takes my partner weeks to schedule a simple phone call between the five members of our Scientific Advisory Board. Chances are, a conspiracy this vast--the largest conspiracy in the history of humanity, by the way--is the stuff of science fiction. But, as I said earlier, most science fiction writers would realize that no reasonable reader of fiction could suspend disbelief long enough to buy into such an idea.

Anti-vaxxers, on the other hand, do nothing but suspend disbelief. Anti-vax organization, National Vaccine Information Center (which tries to trick parents by naming itself in a way that makes it seem objective), has been trying to convince visitors to its Facebook page that Voices for Vaccines is a "pharmaceutical front group" because Paul Offit is on the Scientific Advisory Board. I'd like to know how that actually works. Dr. Offit receives no royalty from his rotavirus vaccine (which, incidentally, has saved hundreds of thousands of lives, particularly in the developing world). He is, in fact, a vaccine pioneer. Naturally, we'd like someone with that level of knowledge about vaccines and vaccine-preventable disease to look over our posts before we publish them, unlike National Vaccine Information Center, which relies on people who have no medical or science backgrounds, to write their propaganda. We choose to include the most knowledgable people in the world of infectious disease because we care about, you know, truth and science. And they come to Voices for Vaccines as volunteers, receiving no pay for their advice and bringing absolutely no pharmaceutical money to the endeavor. We are a small organization, led by parents and sustained entirely by small donations from our members.

I can state unequivocally that Voices for Vaccines has never taken money from a pharmaceutical company. Ever. Now, by not taking pharmaceutical money, we are not suggesting that organizations that do are somehow in those companies' pockets. They are not. However, we chose not to muddy the waters, because that would only give an AVers an opportunity to create doubt. But magic realism is immune to facts. If they don't like the facts, they make up their own. As they've done with Voices for Vaccines--an organization that terrifies them to such a degree that they and Age of Autism are beginning to publicly writhe and froth, even attacking pro-vaccine parents. (Reading the Age of Autism post should offer a reasonably objective reader a peek into the paranoia-soaked brain of the most strident anti-vaxxers). I am confident that once the mainstream media notices these ad hominem attacks, the negative publicity that results from news coverage will scare new parents away from the anti-vaccine camp. After all, if they are willing to publicly attack ordinary parents like Karen Ernst for simply choosing to speak up for a public health intervention, how reasoned and reliable can their information--and their leaders--be?

I've publicly challenged NVIC and Age of Autism to produce proof of pharmaceutical payments to our grassroots, volunteer, parent-led organization. It has yet to do so.

Another conspiracy is that doctors are always "pushing" vaccines on new parents because they are getting the big bucks from pharmaceutical companies. I think most of us know where the big bucks are when it comes to pharmaceuticals--after all, we're bombarded by ads for these products during NFL Sunday and reruns of The Bourne Identity. Erectile dysfunction drugs, drugs for conditions seen in later middle age, such as rheumatoid arthritis, and drugs for mental health issues. I have yet to see a commercial from a pharmaceutical company for a childhood vaccine. The reality is that vaccine companies don't make much money from vaccines. And "Big Pharma's" largesse doesn't extend to secret under-the-table payments to your local pediatricians. Suggesting otherwise will immediately make a reasonable parent suspicious of the organization or person making such a suggestion. Especially when their pediatricians are rolling in to the clinic in their Honda Civic.

But here's why I know that pro-vaccine advocates are going to have a great 2014, and why the anti-vaccine movement is in a state of disarray. Not only is there a great deal of infighting among the more visible members of the anti-vaccine movements, it also has suffered some staggering defeats, especially in the latter part of 2013. For example, the vaccine hearings that were going to be headed by Darrell Issa, who has enjoyed nearly $40,000 in donations from the anti-vaccine Canary Party, were called off after Issa and his staff were bombarded with calls from concerned constituents. Another example was what happened when Katie Couric sacrificed her journalistic integrity for ratings on her fast-sinking talk show (which was canceled a couple weeks later) by doing a sensationalistic segment on the HPV vaccine. The outcry was nearly universal; media outlets that had once given anti-vaccine activists equal time in stories about vaccines criticized Couric and her producers; and even Couric distanced herself from the show.

The anti-vaccine movement knows its in trouble, and that's why it has been pushing its conspiracy theories even harder now. Not so long ago, it could act as if it were a legitimate movement questioning the drug safety. But the media, and, increasingly, parents, have caught on. The fatal flaw in their bet on the success of conspiracy theories is that the more detailed their theories, the more strident they sound in promoting them, the crazier they sound. It becomes less and less likely that a concerned parent will buy into the theories. When they engage in activities, such as actively working to ban Facebook users who comment on vaccine stories, they come across as defensive and nutty. Parents see that pro-vaxxers do not work this way. You will not see a pro-vaccine Facebook page "ban" a user who spouts anti-vaccine rhetoric. Why? Because the more these people talk, the more damage they do to their cause--and, crucially, the more opportunities they offer pro-vax voices to correct their misinformation with facts and science, giving parents questioning vaccines on the page a chance to weigh both sides.

Here's what you will not find coming out of the pro-vaccine movement: Conspiracy theories. Attempts to censor conversations about vaccines (this would work against us, because we welcome vaccine-hesitant parents into the fold; we want to answer questions, not shut them down). Personal attacks. Baseless accusations, such as Karen and I field on a regular basis, that we are "in the pocket of Big Pharma."

Parents notice this. And this is why the anti-vaccine movement is going to continue to lose relevance and visibility. So when a group of anti-vaxxers have decided to build a brand-new conspiracy theory that Voices for Vaccines' parent-contributor Amy Parker, a mother from northwest England who wrote about her experience growing up unvaccinated, is actually a CDC mole because a woman with the same name collaborated with Paul Offit on something, it will do far more harm to their cause than it will to ours. In order for this idea to gain traction with a parent, she would have to suspend disbelief enough to believe that Karen and I know this Amy Parker at CDC (whom I've never heard of), convinced her to write this false first-person account of growing up in an idyllic Lake District community in northwest England, tweak the language enough to make it sound like it's written by someone born and raised in England, then steal a picture of some unsuspecting mom off the internet to go with the story--and then, after all that subterfuge, use the CDC mole's real name.

Logic and reason have never been the strongest aspects of the anti-vaccine movement, and parents are catching on. UPDATE: We are now fielding e-mails from people telling us that anti-vaxxers have told them Amy Parker "does not exist." Keep it coming, please.

My fervent hope for the anti-vaccine movement in 2014 is that it will keep the conspiracy theories coming. That it will continue attacking parents who are pro-vaccine. Keep working on that picaresque that has everyone who vaccinates his or her child and then chooses to speak out about it being the "Pharma Shill." Fan the flame that keeps that vast, worldwide conspiracy of silence about "the dangers of vaccines." Keep it coming, because it's swelling the pro-vaccine ranks every day.

Author's Note: I want to make clear that the criticism of the anti-vaccine movement in this piece deals with anti-vaccine activists, not the more "casual" non-vaccinating parents whose decision not to immunize their children is made out of concern, fear, and misunderstanding. I get it. I was almost one myself.