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.

In the Media, A Bad Day for Vaccines

By Karen Ernst


I write this at the end of a bad day in the media for vaccines. It’s not that there was bad news about vaccines; it’s that the good news was ignored in lieu of anti-vaccine misinformation. The most disappointing of these media stories occurred on Katie Couric’s daytime talk show, Katie.


For weeks, the Canary Party (a group of anti-vaxxers who have actually formed a political party based on being anti-vaccine) have been shopping around an anti-HPV vaccine video on the heels of the cancellation of Congressional Oversight Committee hearing they had so hoped for. Katie Couric and her producers, in a cynical attempt to buoy her dismal ratings, bit.


To say I am disappointed in Couric would be an understatement. Since losing her husband to colon cancer 15 years ago, Couric has championed cancer prevention through colonoscopies. That she would allow a ratings ploy to trump journalistic integrity on the subject of a vaccine that prevents tens of thousands of HPV-related cancers each year in the U. S. boggles the mind.


The segment began with Canary Party Executive Committee member Emily Tarsell describing the death of her daughter, Christina, eighteen days after she received the Gardasil vaccine. Truly, nothing is as traumatic and devastating as losing a child in the prime of her life. The need for answers is more than understandable, it is necessary; and I can even understand parents seeking answers in and holding fast to a theory that makes sense to them, even if the theory doesn’t hold up scientifically. I want to be absolutely clear that I do not blame those parents for this. Instead, I blame the anti-vaccine movement for exploiting their stories in order to support their own wrong-headed ideas about immunization.


But because she brought her daughter’s story to a large, public forum, it is fair to investigate it to see if Emily Tarsell’s account holds up to scrutiny. Many facts surrounding Christina’s death are unavailable because Emily Tarsell is seeking compensation from the National Vaccine Injury Compensation Program. However, this court order from the NVICP judge indicates that the story does not support the theory that Christina died from an HPV-vaccine reaction. In it, the judge notes that despite Emily’s recall of her daughter’s unusual fatigue, “there is no evidence suggesting that Christina was so tired (or fatigued) that her health affected her daily activities.  For example, none of [those] who observed Christina while she was in Maryland . . . asserts that she changed plans due to tiredness.”


In fact, the findings note that Christina seemed anything but fatigued: “While in New York, Christina worked her part-time job for 18.75 hours.  On Thursday, June 17, 2008, Christina stayed up until midnight or 1:00 A.M. having dinner with her apartment mates.  Her apartment mates did not tell the police officers investigating Christina’s death that she appeared unusually tired.  Her apartment mate’s recollections suggest that, to their knowledge, Christina was normal.” In this document, there is also evidence that Christina may have suffered from a preexisting heart condition, but there was never a definitive cause of death.


Next up on Katie, Couric handed the floor over to Dr. Diane Harper, who made a number of spurious claims about HPV vaccines. The first claim was that HPV vaccines only offer protection for five years. Initial studies, however, do not support Dr. Harper’s claim, some showing that an HPV vaccine can offer protection for at least 8.5 years. And we may find that the vaccine offers protection for much longer as more evidence rolls in.  


Dr. Harper also asserted that pap smears are sufficient in detecting pre-cancerous cells which, she claimed, are 100% curable. However, between 2004 and 2008, 26,000 HPV-related cancers were diagnosed each year in the United States. 11,500 of these cancers were cerivcal cancers. In 2010, nearly 12,000 women died from cervical cancer. Despite Dr. Harper’s optimistic view of cervical cancer screening, it is far from perfect, and it would be vastly better to prevent infection than to try to cure the results of it.


Dr. Harper’s subsequent instructions that parents weigh the benefits and the risks of the vaccine is only sage advice if parents are receiving accurate information about the benefits and risks. The benefits, of course, are preventing cancer and death. The risks, as Couric presented them, were completely out-of-whack. A study of nearly one million girls who had received HPV vaccines found no significant health risks involved.


And it only got worse.  After talking to Dr. Harper, Couric provided air time to yet another anti-vaccine leader--this time SaneVax director Rosemary Mathis. SaneVax has a history of promoting misinformation and particularly horrible science. Inviting Mathis as a guest on a show about vaccination is the equivalent of inviting my kindergarten-age son as an expert on Tokyo because of his interest in Godzilla.


But it couldn’t all be a big commercial for anti-vaccine propaganda could it?  There must be hope because this is Katie Couric, right? As somewhat of a reprieve, Dr. Mallika Marshall provided some wonderful and accurate information about HPV and its vaccine. And she was brilliant. She was followed by a mother-daughter pair who endorsed the HPV vaccine.

The segment ended with Dr. Harper encouraging parents to get their daughters gift certificates for pap smears for their 21st birthday and Dr. Marshall encouraging parents to vaccinate.


Couric may have considered this balanced coverage since she presented two sides about this vaccine. But you probably know that I’m not going to let her off the hook that easily.


In 1998, Andrew Wakefield hoodwinked journalists into reporting on a shiny new theory about vaccines causing autism. As you might remember, it was all a grand fraud from which Wakefield continues to profit. And the media helped him, even after studies were rolling in discrediting the theory that vaccines cause autism, the media continued to structure their news stories to create balance. On one side, a family that claimed their children became autistic because of vaccines. On the other side, people in lab coats saying this just could not be the case. The anecdote too often trumped the evidence, as often happens in cases of false balance. CJR’s Curtis Brainard discussed how these “subtly bad” media reports perpetuate myths about vaccines. These myths threaten us all.

Katie Couric’s television show threatened the lives of young girls and boys. Because their parents are being frightened away from a safe and important vaccine, there will be men and women in the future who will die from HPV-related cancers, and who could pass HPV on to unwitting partners. Today, Katie Couric gave the anti-vaccine movement a huge forum, and I am already mourning the lives that will be affected because of it.

Science Illiteracy in the Daily Paper

As a former journalist, I find myself embarrassed by my profession more and more these days--and more and more grateful for the handful of news outlets that still adhere to journalistic ethics and a true understanding of "balance" in the discipline.

Today, November 10th, 2013, the Concord (NH) Monitor-News chose to accept an advertisement (and payment) from National Vaccine Information Center, the most notorious anti-vaccine group in the country, to run this embarrassment.

If you don't know why it's an embarrassment, that's okay--the unfortunate reality is that most people wouldn't, and that's what makes it so insidious. The whole "the flu shot gave me the flu" canard is pretty well entrenched in this country.

The flu shot does not give you the flu. It can't. It's physically impossible. Why? Because flu vaccines administered by needle are made with inactivated flu viruses (not infectious--dead) or no flu vaccine virus at all, which is how recombinant influenza vaccines are made.

That's what makes this advertisement from NVIC so laughable. It's like saying that the earth is warming because the American Girl Company is retiring "Molly, 1944." It's actually not laughable. It's maddening. It's maddening because I'm of the opinion that NVIC actually knows this is inaccurate information, but knows that it builds on an existing misconception that can bloom, for them, into general distrust of vaccines: their end-goal.

But I'm truly sickened by the editorial standards at the Concord Monitor-News. That it would allow such bald scientific illiteracy into their pages speaks volumes about the paper's approach to truth. And for a journalistic outlet, that is shameful. I've made my opinion known via Twitter this evening, and plan on following up with a letter tomorrow. I recommend you do the same. The Concord Monitor-News' Twitter handle is @ConMonitorNews.

If you'd like more information on the flu vaccine, check out the CDC's primer on the vaccine.

If you'd like to know why it's so crucial for children, in particular, to get the flu vaccine, check out this story in USA Today.

NOTE: I just noticed that an ad is playing on this site. I have no idea why and am working to sort it out. I apologize for this.

Speak Out Against Legislative Hearing on Vaccine Injury Compensation Program

Editor’s Note: Anti-vaccine organization Age of Autism has been working overtime to dismantle the federal government’s Vaccine Injury Compensation Program because they are frustrated that claims of vaccine injury in the form of autism have not been found valid by that program. Instead, they want to try to sue by taking their “case” to small claims court, where they can attempt to convince a jury of peers (read: most likely individuals not trained in science or medicine) that vaccines caused their child’s autism. They have been pressuring legislators to support their goals and have instructed members to contact their local representatives about this matter. They have succeeded in getting a hearing in the U.S. House of Representatives.

We’d like for parents and providers to speak out against this by writing e-mails to their state representatives today. Below is an example written by one parent to her local state representative. You can find your representatives here. To be effective, your note or phone call should be made today or tomorrow (11/6 and 11/7). Please note that Age of Autism has asked its members to call legislators today to urge them to attend this meeting, in which parents of children with autism will be testifying about how they believe their children received autism from a vaccine--a claim that has been proven, again and again, to be without merit.

Dear [Legislator]:

The anti-vaccine group Age of Autism intends to hold a hearing tomorrow about the Vaccine Injury Compensation Program.  Their intent is to dismantle the program so that they can bring their case to small claims court in hopes that a jury will find for them what science has already thoroughly disproven.  Despite the clear science that vaccines do not cause autism, chronic disease, allergies, ADHD, etc., it's always possible that a jury not savvy in the science would give out an award, which would threaten our immunization program.  Of course, this poses a real threat to our children who are currently protected from such scourges as measles, polio, and the like.

The Vaccine Injury Compensation Program benefits the children who, because of very rare bad luck, suffer an adverse reaction from vaccines.  These reactions are sometimes so rare that it is difficult to prove that vaccines caused the reaction. However, the benefit of the VICP to them is that the burden of proof there is far lower than it would be in small claims court. They are far more likely to receive compensation through "Vaccine Court" than they would be anywhere else.  Thus, the VICP benefits not only the health of our communities but also the children who may have been injured by a vaccine. 

A University of California-Hastings Law Professor writes on these issues in far more depth than I can cover here.  If you are interested, you can read more about the VICP here: [http://momswhovax.blogspot.com/2013/09/the-national-vaccine-compensation.html].  And you can read more about the term "unavoidably unsafe," which is often misused, here: [http://momswhovax.blogspot.com/2013/09/the-national-vaccine-compensation.html].

Thank you so much for your time.

[Your Name and City]

Vaccines and "Unavoidably Unsafe Products"

By Dorit Reiss

Those of us engaged in vaccine-related discussions online often hear vaccine critics claim the Supreme Court has declared vaccines “unavoidably unsafe” and thus incredibly dangerous. The critics are doubly wrong. First, the Supreme Court has said no such thing. Second, in the law’s eyes, an unavoidably unsafe product is not a “super-dangerous” product.  Quite the opposite, an unavoidably unsafe product is a product whose tremendous benefits justify the reasonable risks it poses.

What is an "unavoidably unsafe” product?

Normally, in the United States, a person only has to pay damages if they caused harm to someone else with fault—in other words, if they acted negligently or intentionally. In the area of products liability, however, the United States adopted a different approach.

In 1965 the American Law Institute published the Restatement (Second) of the Law of Torts, §402A. Section 402A was an attempt by the ALI – a nonprofit organization of lawyers, judges and academics - to rationalize a growing number of court decisions holding manufacturers and sellers of defective products liable to the consumers their defective products injure.  It adopted a standard of liability without fault when a business sells a product “in a defective condition unreasonably dangerous to the user or consumer or to his property.”

The qualification was important: not every product that causes harm is defective.  Well-made knives can cut fingers, and even the best whiskey can get you drunk!   To be defective, a product had to be unreasonably dangerous, either because it was poorly made, or because consumers weren’t aware of its dangers, or because a different design could have made the product safer.

Restatements are very influential (though not binding), and section 402A was quickly adopted by pretty much every state.

The Restatement’s drafters wanted to provide certain products with additional protection against liability, because although those products, too, carried risks, they provided especially high benefits.  The Restatement’s drafters expressed this idea in a comment to section 402A; namely, comment k:

Unavoidably unsafe products: There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.

The last sentence is the important one: A vaccine whose benefits outweigh its risks is not unreasonably dangerous or defective – even if the risks are as frightening as those attributed to the Pasteur vaccine, let alone modern vaccines, with their much lower risks.

In retrospect, the Restatement’s drafters could have chosen better language to capture the idea that a product or a drug can be valuable even it if poses some risk to its users (and indeed, the drafters of the Restatement (Third) of Torts: Product Liability did away with the “unavoidably unsafe” language while preserving the same idea:   

Saying a product is “unavoidably unsafe” makes it sound like the product is a bad one, when what the drafters meant was precisely the opposite: the comment was meant to apply only to ethical drugs or vaccines, i.e. where the benefits outweigh the risks.  But courts understood.  Some courts (California, New York, Alabama) adopted comment k wholeheartedly, exempting all properly manufactured prescription drugs and vaccines from strict liability.  Others applied comment k selectively, requiring a case-by-case determination that there is no safer alternative design for a drug or vaccine before finding the risk unavoidable (Idaho, Colorado, Hawaii).  Some courts, inevitably, are unclear or take an intermediate position (Florida, Georgia, Indiana). 

The message comes through clearly: these products are beneficial enough that society wants to encourage their manufacturing. Therefore, while strict liability would be applied to most products, a manufacturer that prepared a drug or vaccine carefully and warned consumers of its risks should not have to pay for the side effects of a drug or vaccine whose benefits outweigh the risks unless that manufacturer can be shown to have been negligent.

In other words,  “unavoidably unsafe” is the opposite of “unreasonably dangerous” in the Restatement’s categorization. It justifies a more favorable treatment because of those products’ extraordinary benefits.

What Did the Supreme Court say in Bruesewitz?

Regardless of the real meaning of the term “unavoidably unsafe,” it is understandably disturbing to parents to hear that the Supreme Court described the vaccines given to their children using that scary term. Fortunately, it didn’t.

In a case from 2011, Bruesewitz v. Wyeth , the Supreme Court discussed whether the National Childhood Vaccine Injury Act of 1986 (NCVIA) preempts tort suits for product design defects at the state level. The NCVIA created an administrative compensation scheme, in many ways quicker and easier than a court procedure. The question was whether a plaintiff who claims that she was injured because the vaccine was designed in an unsafe manner is limited only to the special compensation scheme, or can also sue in state courts (specifically, plaintiff claimed that she should have been given the shot with the acellular pertussis vaccine, rather than the whole cell pertussis vaccine).

While section 402A of the Restatement (Second) Torts did not distinguish between types of defects directly, today’s product liability jurisprudence distinguishes between three types of defects a product might have. Manufacturing defects are situations where the product is not up to the standard set by the manufacturer itself: when it deviates from its intended design. In the vaccine content, an example is the infamous Cutter Incident, in which a polio vaccine supposed to contain an inactivated virus ended up containing a live virus, paralyzing 200 children and killing ten. The product was designed to have an inactivated virus; it had a live one; the manufacturer did not meet its own standards. For manufacturing defects, the courts apply strict liability.

Another type of defects is a design defect. Under this theory, a plaintiff must prove that there is an alternative design that is safer than the current design. In the vaccine context, plaintiff may claim that using the Oral Polio Vaccine (OPV) that includes a live virus and carries a small risk of paralysis is less safe than using the Inactivated Polio Vaccine (IPV) which does not carry that risk. To make a long story short, while some courts still talk about strict liability when handling these kinds of suits, they are currently handled under negligence principles.

The last type of defects is a warning defect, also handled under negligence principles. A warning defect, for example, would be not warning that a product needs to be stored in a certain temperature, or not warning against a risk.

The NCVIA clearly allows children injured by a vaccine to sue the manufacturer in the regular courts if the vaccine was poorly made or lacked appropriate warnings.  Does it also allow children to sue in state court if the vaccine was poorly designed?

The question was how to interpret §300aa-22(b)(1) of the act, which says:

“No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”

The plaintiffs – and two dissenting Justices – argued that when Congress used the word “unavoidable,” it meant to invoke comment k’s concept of the “unavoidably unsafe” product, as interpreted by courts applying it using a case-by-case approach.  Under this approach a product isn’t unavoidably unsafe if there’s a way to design the product that would eliminate the risk of side effects.  Therefore, the plaintiffs claimed Congress meant for plaintiffs to have the opportunity to sue a vaccine’s manufacturer if they could prove that an alternative design would have eliminated the risk of harm.

The majority of the Supreme Court, in a five-justice decision written by Justice Scalia, disagreed.   What Congress meant when it said manufacturers are not liable for side effects that were “unavoidable” was that manufacturers are not liable for the side effects of vaccines that are properly prepared and accompanied by proper directions and warnings.  As Justice Breyer explained in a concurring opinion, Congress deliberately decided that if plaintiffs could sue manufacturers over the way vaccines were designed, drug manufacturers threatened by frequent lawsuits would stop making needed vaccines. Congress was not willing to accept that result.

The majority opinion in Bruesewitz expressly rejected the idea that by using the word “unavoidably” Congress meant to invoke comment k:

“… there is no reason to believe that [the Act] was invoking [comment k]. The comment creates a special category of ‘unavoidably unsafe products,’ while the statute refers to ‘side effects that were unavoidable.’ That the latter uses the adjective ‘unavoidable’ and the former the adverb ‘unavoidably’ does not establish that Congress had comment k in mind. ‘Unavoidable’ is hardly a rarely used word. Even the cases petitioners cite as putting a definitive gloss on comment k use the precise phrase ‘unavoidably unsafe product’; none attaches special significance to the term ‘unavoidable’ standing alone.” 

The court is very clear: it’s rejecting the application of the term “unavoidably unsafe” to the Act.  Neither Congress nor the Court thinks vaccines are “unavoidably unsafe” in the way vaccine critics mean to suggest.

Conclusion:

Comment k does use the Pasteur rabies vaccine to illustrate what it means by “unavoidably unsafe” and the dissenters in Bruesewitz v. Wyeth do rely on comment k to argue Congress meant for plaintiffs to have a chance to prove that an alternative design would have made the vaccine safer.  What the vaccine critics have missed -as Justice Breyer’s concurring opinion in Bruesewitz explains – is the principle behind comment k.  If a product – like a vaccine or a drug – is “unavoidably unsafe”, the product is NOT defective, and the product’s manufacturer is not liable for the products’ inherent risks (though the plaintiff may still be eligible for compensation through the administrative program). “Unavoidably unsafe” products are products that are so valuable – have so many benefits – that the risk associated with their use is justified.  If the Supreme Court had applied this term to vaccines, it would have reaffirmed what most scientists and doctors know: the benefits of vaccines far, far outweigh their small risks.

Author's Note: I am very grateful to the people who read my post for accuracy and for grammatical edits: Marsha Cohen, David Jung, David Levine, Kathy McGrath, Paul Offit, Robert Schwartz, Madeleine Ware, Alice Warning Wasney and Kelly Wessel. All errors are, of course, my own.

More Anti-Vax Billboards

Voices for Vaccines let us know that raging anti-vaccine organization National Vaccine Information Center is at it again, with billboards up in New Jersey. This time, the company to contact is Lamar Advertising, out of Louisiana. Their comment form will only allow for 512 characters. I shortened my lettter, but here is how it originally read. I will be sending this as an e-mail to Lamar executives as well. Please consider voicing your concerns. 


Dear Lamar,

As a parent, I am sickened by your decision to allow noted anti-vaccine organization "National Vaccine Information Center" to advertise through your network of billboards. You may not be aware, as I was not when I was a new parent, that NVIC promotes and propagates misinformation about the safety of vaccines. They actively campaign against childhood immunizations, which have singlehandedly been responsible for keeping devastating vaccine-preventable diseases out of our communities. 

Because of NVIC's misinformation campaign, we have seen more and more parents choosing not to vaccinate--and the result has been heartbreakingly predicable: children are contracting vaccine-preventable diseases like pertussis, measles, and mumps. Children have been hospitalized and many, mostly infants, have died. Vaccines are incredibly safe and keep our children healthy. To allow an organization like NVIC to advertise through Lamar billboards is a reckless decision that I urge you to reconsider, for the good of the community, and all children--including yours.

National Do Anything Except Watch the View Day: Tdap Edition

Over the summer, ABC Network made the cynical decision to hire anti-vax mouthpiece Jenny McCarthy to replace Joy Behar on its long-running daytime talk show, The View. While momentarily surprised that venerable journalist Barbara Walters would take a seat next to someone as scientifically illiterate as McCarthy, who plays fast and loose with facts, I quickly remembered that the business of television is not the business of ethical journalism. In the former, controversy and outrage are believed to result in an uptick in the Nielsen ratings. The decisionmakers at ABC--and I have reason to believe Barbara Walters was not one of them--clearly believe that the universal condemnation that followed the announcement that McCarthy had been tapped will lead to curiosity-seekers tuning in to see if McCarthy embarrasses herself again on the topic of vaccines.

But this tactic is a risky one. It's failed before, and I wager that it will fail again. We saw this happen just last month with Kris Kardashian's cringeworthy talk show, Kris. It was recently canceled after a six-week run, despite the network bosses betting on the big reveal of Kim Kardashian's baby and an appearance by Kanye West to draw viewers. It didn't happen. The difference between hiring Kris Kardashian and ABC putting Jenny McCarthy at the table on The View is considerable. Kris's show will be, and perhaps has already been, forgotten. ABC, on the other hand, has seen its reputation damaged--badly. At a time when the network is clamoring for more viewers, its gamble on McCarthy has lead so far only to widespread criticism, not just from parents (12,000 of whom signed a petition protesting the hire--which resulted in absolutely zero response from ABC), but also from media critics. No one praised this as a brilliant move to draw viewers.

This leads me to Voices for Vaccines' fantastic National Do Anything Except Watch the View Day on September 9th, the first day McCarthy will appear. (Disclosure: I am one of the VFV administrators, but I did not come up with this wonderful idea--Karen Ernst did). The idea behind it is to send a message to ABC--but, more important, the real world beyond the halls of the network--that we are not interested in McCarthy, her views on vaccines (or on Botox, which she's injected into her face, or on Syria, for that matter), and that we know desperation when we see it. To make this thing stick, Voices for Vaccines is encouraging people across the country to snap a picture of what they are doing INSTEAD of watching The View tomorrow. Working? At a playdate? Grabbing coffee? Watching paint dry? Getting a vaccine? Once you've snapped that photo, Tweet it to @voices4vaccines with the hashtag #notwatchingtheview. Consider adding @abcnetwork to your Tweet. If you like Facebook better, post your photo to the Voices for Vaccines' Facebook page. Need more information? Check out Voices for Vaccines' press release on National Do Anything Except Watch the View Day.

As for me, and my family, we have big plans for September 9th that do not include watching The View. School. Work. And the Tdap vaccine booster for my husband, because he wants to protect our newborn niece and our asthmatic daughter, for whom pertussis would be devastating.

Shillin' Ain't Easy (or Profitable)

By Karen Ernst

World's Worst Couch

I usually find the “Pharma Shill” gambit funny.  It makes me chuckle because I am usually accused of being a so-called pharma shill while sitting on my couch.

Let me introduce you to my couch.  It is nearly twelve years old and has served us well.  It used to have two reclining parts, but those parts stopped working a few years ago.  Because it has been used as a trampoline, some of the springs are broken and there’s a deep indent where one would sit.  I fill in the indent with a Patrick Star pillow, pictured at right.  I won’t give you all the gory details about my couch, but suffice it to say, three boys and one dog have lived with this couch, and they have sometimes been ill.

As you can see, my accomodations and interior design are both very glamorous and clearly part of the "Pharma Shill" lifestyle. 

It is seated in this couch that I have read accusations from anti-vaccine activists and parents that I am being paid by pharmaceutical companies to write comments on Facebook.  I’ve also read that the first-person pro-vax parent stories that appear on both the Moms Who Vax blog and Voices for Vaccine’s Parents Who Vax blog are written on the sly by Ashley Shelby and myself, both of whom have, apparently, “deep ties to pharma lobbyists in Minnesota.”  This would be news, of course, to the very real people who have contributed to our blog over the years. And it's news to Ashley and me, who have yet to even meet a pharma lobbyist in Minnesota.

For the record, neither Ashley nor I have ever received a penny from pharmaceutical companies. Not through Voices for Vaccines (which does not accept contributions from pharmaceutical companies or from the government), not through Moms Who Vax (which, unlike NVIC, accepts no advertising and which has an annual yearly budget of $0), and not for commenting on Facebook. The latter accusation strikes me as particularly bizarre. After all, vaccines account for less than 2% of pharmaceutical companies’ profits. Why would they waste any of that money paying people to write comments on social media, especially when more than 90% of us vaccinate our children already?  It defies logic. But then again, logic has never been the anti-vaxxer's strong suit.

And so they persist, even in the face of the facts.  For the past few weeks, the Vermont Coalition for Vaccine Choice has grown obsessed with Voices for Vaccines, reposting nearly every link we post on their own Facebook page.  Their Facebook page has also been home to suppositions about our fundraising--false assumptions, which I corrected back in May.  I replied and was able to get them to issue a semi-apology and (later, not pictured) a partial retraction.

However, they were so attached to tantalizing idea of Voices for Vaccines employing me as a "Pharma Shill" that they promote the idea, even after apologizing for having made a false statement.

It was all just annoying and eyeroll-inducing, even funny at times, until Ashley and I decided to take on Jenny McCarthy. Apparently, former playmates are sacred cows in anti-vax land.  As of this writing, our Facebook post has 1,980 comments, many of which from anti-vaxxers who are sure that the petition to keep Jenny McCarthy off TV’s The View is some sort of Big Pharma plot.  

And again, people were certain that we were Big Pharma Shills.  Ginger Taylor, whose writings include disparaging Seth Mnookin for being a long-recovered heroin addict, dubbed us “Voices of Vaccines,” I’m assuming because she thinks we are in the thrall of pharmaceutical companies (though her little syntactical sleight of hand is actually hilarious: I'd love to hear the sound of a vaccine's voice).  Then, my favorite mansplainer, Robert Schecter, also made an appearance to ask on as many threads as possible: "Who funds voices for vaccines?"

When I told him Voices for Vaccines is funded by individual small donations, he persisted, not believing my answers and making up his own.

Marsha McClelland sent out an Action Alert asking for more anti-vaccine comments on the thread.  She herself came to the thread many times to tell us her case was closed and to declare victory, but before doing so, she let us know how Pharma hires people to “pose as having sick children due to non vaccination.”  

(The “there are usually underlying reasons” portion of her comment is particularly troubling because I don’t believe that any child deserves to die from a VPD, whether or not that child has an underlying condition.)  She also tagged Erwin Alber.

Erwin Alber is an interesting case.  He as a New Zealander who runs the “Vaccination Information Network” where he promotes the idea that vaccines cause homosexuality and where he falls prey to his own confirmation bias and purposely fabricated graphs.  One of his favorite ploys is comparing vaccination to Nazi experimentation.  Reasonable Hank has dubbed him “The World’s Worst Person” for visiting a whooping cough memorial page to “educate” grieving parents about the horrors of vaccination. There’s no way to overstate how deeply disturbing Erwin Alber's tactics are.

And so I was dismayed when Erwin took Ginger’s bait and appeared on the Voices for Vaccines page, telling us all that we were Nazis, pharma shills, delusional, and insane.  Fortunately for me, he stole one of VFV’s photos, so I was able to ban him with clear conscience.

At that point, the strangest anti-vax infestation ensued.  It began on Erwin’s page, where several people “knew” all about the Big Pharma money connection to VFV.

They came to the VFV thread, per Erwin’s instructions, and they didn’t realize that they shouldn’t also spread their crazy there.  

Anti-vaccinationists are quite convinced that people only advocate for immunizations because they are being paid by Big Pharma (which apparently is too stingy to buy me a new couch.)

The irony, of course, is that people to profit directly from others being afraid of immunizations, and so have a substantial interest in keeping that fear alive. Homeopaths, such as the “Meat Sweats” homeopath Ashley and I heard at the Minnesota Immunization Rule hearing, sell “cures” to “vaccine injuries” that are too vague to even be given a diagnosis.  In other words, they make money selling plain water to people who are frightened by the internet into believing that an illness was caused by vaccines.  Dr. Mercola lives in a multi-million dollar mansion, a showy display of the wealth he’s accumulated by selling completely unregulated supplements, tanning beds, juicers (even though he tells people not to drink fruit juice), and countless other items to people afraid of immunizations.  Dr. Sherri Tenpenny makes money from selling t-shirts and access to articles she did not write to people who are scared by the falsehoods about vaccines she promotes on her DVDs, which she also sells. 

Worst of all are people like Andrew Wakefield and Keri Rivera who sell unproven and sometimes dangerous “cures” for autism to parents who are frightened into believing that vaccines “damaged” their children and made them autistic.  Lastly, Jenny McCarthy.  Let’s face it:  Jenny McCarthy’s career was in the tank before she began protests to “Green Our Vaccines.”

People who profit from fear of immunization (not necessarily those listed above) come together through organizations like the Natural Health Freedom Coalition and the Council for Responsible Nutrition who hire lawyers and lobbyists to ensure that the laws regulating their products and practices are as lax as possible and to fight against any attempt in states to tighten vaccine exemption laws (or in the case of Minnesota, simply modernizing its rule).

The casual anti-vaccine parent has been convinced by these forces that they are collectively the Davids fighting the Goliath of Big Pharma, and that anyone who wants to dispute anti-vaccine misinformation or make their communities safe from preventable disease outbreaks is paid by Goliath.  But that’s not really true at all--none of it is.  Sure, Big Pharma is Big.  However, Big Alterna is big business, too, and they are well-organized.  They take advantage of people’s fears, their inability or unwillingness to properly perform a risk analysis, and their fears of having their freedom limited.  Anti-vaccine parents like to believe they are enlightened and informed because they’ve done their “research,” but really, they’ve just bought into the lies of a well-oiled machine.

Fortunately, for pro-vaccine parents, we don’t need Big Pharma to organize us.  We can organize ourselves and follow the science independent of Big Pharma. But we do need pharmaceutical companies to make our vaccines.  They are not evil for making a profit (albeit small) from the work they do, and the work they do is important.  Without them, millions of children would die each year.  Big Alterna can’t touch that.