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.

The Costs of the Fight Against the HPV Vaccine

By Dorit Reiss

This post stems from an HPV thread on the Katie Couric show. When I joined it, was a series of heart-rending stories by parents about the harms they believe the HPV vaccines caused to their daughters. There’s not a lot you can say to stories like these that will not sound heartless and cruel. But, after reading some, I felt that I had to try and speak up. This decision resulted in me spending several hours a day, from the Wednesday before Thanksgiving and through the weekend, commenting and, especially, responding to comments.

The thread on the Katie website is still going strong. I concluded that rather than engaging further I should write a more systematic explanation of why we need to speak up and respond to the claims of harm made against this vaccine, however painful it might be to the parents commenting to hear someone say there is no evidence that the vaccine caused their daughters’ illnesses, and however unpleasant the discussion becomes. Because as real as the pain of these parents and daughters is, without objective evidence of causation, their belief that this vaccine is to blame does not justify rejecting it in the face of substantial scientific evidence supporting its safety.

Let’s start with the basics. The HPV vaccines prevent infection with several strains of a virus that, at worst, can cause cancer. The virus is responsible for nearly all the cervical cancers in the United States and for “90% of anal cancers, 40% of vulvar, vaginal, or penile cancers, and 12% of oral and pharyngeal cancers.” (all data is available here.)

Most HPV infections clear up on their own. Infections can be detected and cancer prevented early with regular pap smears. But HPVis still responsible for tens of thousands of cancers a year and over three thousand deaths a year in the United States alone. Preventing those cancers and deaths seems like a good, important goal.

The vaccines were tested in clinical trials with over 30,000 women for over 7 years and found to have high rates of effectiveness and no serious problems. They cover strains responsible for a large percentage of those cancers. It has already reduced infections. You can find more in depth discussion of the HPV vaccines in a series of excellent posts by the Skeptical Raptor.

Why oppose something that can do so much good? Well, part of the opposition stems from religious objections having to do with a perceived connection between the vaccine and sex. But that was not what this battle was about.

Shortly after the vaccine came out, several parents of girls who suffered medical conditions or died claimed that the causes of their deaths or harm was the vaccine. The stories are both scary and heartrending. And as these stories became public, more parents heard them and started associating their daughters’ illnesses with the vaccine. I do not doubt the real suffering and distress of these families. My heart goes out to them. How can one not sympathize with a parent grieving because a 17-year-old girl is dead, or a teenager in constant pain? 

But feeling for hurting girls, and hurting families, does not mean that one uncritically accepts claims that the vaccine was the cause of their suffering. In fact, the causation claims behind these stories are often extremely problematic. Sometimes, even the temporal connection is weak (e.g. Gabi Swank developing symptoms weeks after the vaccine). The problem is that bad things happen to teenage girls regardless of the vaccine. They can suffer a variety of medical conditions, and sometimes, healthy teens do die. The question in each case like this is: do we have evidence that the vaccine caused the harm? And the answer in these cases is often no. These stories generally do not have medical evidence supporting the connection between the vaccine and the alleged harm. Nor do they suggest a plausible biological mechanism by which the vaccine could cause the harm.

Is there anything supporting them besides the parents’ belief in the harm? Well, a small number of studies looking at a tiny number of cases and conducted by anti-vaccine scientists supported the claims. Each of them when analyzed by scientists was found incredibly flawed. For example, this study by two anti-vaccine activists, looking at the deaths of two girls. This study, by a doctor, looking at one single case, ignoring other possible causes of the harm to the girl in question. Another study was addressed here.

In contrast, not only did the clinical trials – ongoing since at least 2001, covering tens of thousands of participants – not find serious risks, but two large studies addressing the question found none: A Kaiser study with almost 190,000 young women given 350,000 doses of the vaccine that compared harms in vaccinated women to the general rates in the population found no difference; and a Swedish study with hundreds of thousands young women comparing vaccinated and unvaccinated found similar rates.  Over forty million doses of the vaccine have been administered in the United States alone with no clear evidence of problems. Scientists’ best assessment is that the only side effect consistently connected with the vaccine is fainting on the day the vaccine is administered, and local reactions.  

This evidence paints a picture of a very safe vaccine. But the only way to make that point is to point out the weak evidence for the parents’ claims that the vaccine caused harm. This is bound to offend those parents: their belief in the evils of the vaccine is very strong, and they are may have difficulty considering that they may be wrong. In fact, they have been told in no uncertain terms that they are right. In the thread itself, they received support from anti-vaccine activists who rallied to their support, using the tried and true tactic of personal attacks on anyone speaking in support of the vaccine, accusing them of being heartless, shills, trolls, ignorant, Hitler, and so forth. I’m mentioning this as fair warning to parents who may want to jump in: this discussion is often conducted with high levels of vitriol (it’s even worse than French Revolution discussions; and people could be very passionate about the French Revolution).

Most pro-vaccine people do not enjoy dealing with vitriol or having their workplaces contacted, though I am sure there are some people who enjoy the conflict for conflict’s sake. And nobody that I know wants to hurt parents who have already been through so much with their suffering daughters, or who lost a child. But we are not going to stop speaking. And I think it is important for many of us to speak up about the HPV vaccines. It’s the same reason that you should speak up for vaccines generally, but let’s make it specific.

The grieving parents want us to accept their word that it was the vaccine that caused their daughters’ suffering. It is more than natural for them to look for a cause for their misfortune, and the vaccine is an easy target. But most of them have no medical evidence behind their belief the vaccine caused the harm. In some cases there are alternative explanations that their doctors pointed out. Explanations the parents, in their grief and pain, reject. The problem is that with these stories they want to convince other parents to reject the vaccine—that is, to choose not to protect their children against a virus that has been proven to cause cancer.

When that is what we are asked to do, a responsible parent not only can but should demand hard, credible data that the vaccine actually causes the alleged harm. Because there is a cost to not taking the vaccine. A cost in suffering and lives.

And there is no such hard evidence.

When it’s my child for whom I’m making the decision, rejecting a vaccine that can save him or her from needless suffering is a dereliction of duty. I owe my child the best protection available against dangers, health, and otherwise. There are too many things I can’t protect him against. But modern medicine offers a safe, effective prevention against some of the most dangerous types of HPV infections. My child deserves it.

There is a reason to speak up for the sake of these grieving parents, too: they do not deserve to feel guilty for vaccinating their children, or feel betrayed by the system, when the evidence does not indicate that the vaccine caused the illness. We should explain the evidence in the hope of reducing their guilt and anger. And hope some will listen.

Arguing for the safety of vaccines is worth the time and effort it takes, because it’s about our children, their health, and welfare. Vaccines protect them. They’re not perfect, and not 100% risk-free. No medicine is. But vaccines are remarkably effective and compared to pretty much every other drug we have, extremely safe.

So we need to keep asking, and pushing, and demanding. When a parent says the HPV vaccine harmed her child, we must ask for evidence that the harm came from the vaccine. Especially when the story is followed by a warning not to get the vaccine for your child. If someone asks you to leave your child unprotected against a dangerous virus that is completely preventable, tell him or her "I'm sorry, but I can’t make such a choice based on your belief, scientifically unsupported, that the vaccine hurt your child."

For my children’s best interests, I need to follow the data. I don’t want my child to become a cancer statistic.

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

The National Vaccine Compensation Injury Act: 
A Compromise – not an Injustice

Or: Why the Latest Video from the Canary Party is Misleading

By Dorit Reiss

In 1986, Congress passed the National Vaccine Injury Compensation Act (NVICA) creating the National Vaccine Injury Compensation Program (NVICP).  The program attempted to address two problems: the government’s fears that vaccine manufacturers will leave the market due to lawsuits, leaving children and adults vulnerable to preventable diseases and plaintiffs’ desires for a simpler, cheaper, more certain process for compensation. It was a compromise with something for everyone, created with input from, among others, the National Vaccine Information Center, an organization that criticizes vaccine safety and emphasizes vaccine risks.

However, in a new video narrated by actor Rob Schneider, the Canary Party claims that the only reason there is doubt about the link between vaccines and autism is because the NVICA created a system that discriminates against plaintiffs and works completely in favor of pharmaceutical companies, and that it is run by a corrupt government.

The video is wrong pretty much from start to finish. This blog post will address three of its problems: the claim that NVICA is the only thing hiding the link between vaccines and autism; the inaccurate, incomplete depiction of NVICP; and why the claim that using the regular courts instead will benefit plaintiffs is wrong.

No Credible Evidence Supports a Link Between Vaccine and Autism

The Canary Party’s video purports to tell the story of a child named Eric who suffers from “vaccine-induced autism” – but there is no credible evidence that there is such a thing as “vaccine-induced autism.” The Canary Party video offers three pieces of evidence on this, none of which really support the claim. First, it says that as more vaccines were added to the recommended immunization schedule, autism rates “skyrocketed.” The video does not explain why this temporal correlation alone shows causation, or why it is a more convincing correlation than, say, increase in internet usage and raising rates of autism.

It also ignores the evidence suggesting that the increase is because of the change of diagnosis and of detection, not necessarily in incidence. To back this up, the video refers to “dozens” of studies, and the link attached to it refers to a list of studies compiled by Ginger Taylor, the Canary Party’s Vice President. However, that list does not support the claim either: the studies are either seriously flawed, have nothing to do with vaccines, or otherwise do not support the claim, as detailed in posts by blogger Liz Ditz, who thoroughly debunked them.

In contrast, numerous serious studies, some very large scale, have examined whether there is a link between vaccines and autism. No credible study found one. (Here is a partial list.)

Third, the video claims that NVICP compensated cases where a child had autism. But the NVICP never compensated a case on the theory that vaccines caused a child’s autism. Never. In fact, such a claim was soundly rejected by the program in the Omnibus Proceedings. Bailey Banks, whom the video mentioned, was not compensated on a theory that vaccines caused his autism but because vaccines may have caused another problem. The video also refers to a study by Holland, et al, which found 83 children compensated by the program who also had autism, but none of these children was compensated because vaccines caused their autism – they were compensated for other things (e.g. encephalitis). And, in fact, the rate of autism in the population of children with severe vaccine reactions (“vaccine injury”) is actually lower than the rate of autism in the general population.

NVICP Offers Advantages both to Manufacturers and Plaintiffs

The video suggests that NVICA was passed in 1986 as a result of pharmaceutical lobbying with the sole goal of shielding manufacturers from liability, and that it does shield manufacturers from liability. That claim is incomplete. The Act was passed to prevent companies from leaving the vaccine business, because they were leaving, leading to vaccine shortages, putting children and adults at risk. But that was not the only reason.  Plaintiffs were also complaining about the adversarial, prolonged court process and the act looked to simplify that process. In Bruesewitz v. Wyeth, the Supreme Court explains the quid pro quo involved – somewhat similar to the compromise represented in workers’ compensation schemes:  in exchange for shielding manufacturers from liability for some kind of claims – design defects, for example – the plaintiffs received substantial benefits: no show of fault is required, and plaintiff does not need to show the product was “defective” (which they would have to do in a design defect claim). The plaintiff does not have to show causation when claiming one of the injuries listed in the “Vaccine Injury Table."

The process is simplified. Attorney fees are provided for any claim that is not frivolous – including losing claims (the video claims attorney fees are slashed and delayed to “punish” claimants, but brings no evidence to that effect; in fact, the program paid out over 150 million dollars in attorney fees.

In return for the substantial benefits given plaintiffs, manufacturers are shielded from liability for design defects; but they are not invulnerable: they can still be sued for manufacturing defects or warning defects. This is substantial: the worst vaccine-related disaster in modern history, the Cutter Incident, was the result of a manufacturing defect, not a design defect: a vaccine designed to include an inactivated – dead – virus actually included a live poliovirus, permanently paralyzing 200 children and killing ten. That case could still be brought in the regular courts today.

In short, presenting the program as tilting the law in Big Pharma’s favor is wrong. It does protect manufacturers from some kinds of liability; but it offers plaintiffs substantial benefits. The program is also subject to judicial review: decisions can be appealed to the federal judiciary if a plaintiff does not agree with the result.

NVICP Offers Plaintiffs Real Advantages over Regular Courts

The Canary Party's video tries to portray the program as unfairly barring plaintiffs from the much better--as it suggests— judicial process. The video portrays an idealized, inaccurate process of civil court litigation proceedings: some of the problems it points out in the NVICP process will be found in civil litigation too – and that process will include other costs and disadvantages to plaintiffs. 

Comparison of NVICP and Civil Litigation

One advantage the video suggests a civil suit will have over the NVICP program is that plaintiffs will have their own “private lawyer,” (although the lawyers representing the plaintiffs are, like the lawyer in a civil suit, retained by the plaintiffs and are, in fact, “private lawyers” too) who will not have to rely on being paid from the program’s funds. But will that benefit plaintiffs? The video suggests that payment through the program fund hampers getting representation. But the usual arrangement in civil litigation for tort suits would be a contingency fee. Why would lawyers be more willing to take vaccine injury cases when they only get paid if they win than in a system that pays them even if they lose? And if a plaintiff won, under the usual contingency fee regime, the lawyer would be getting 30-50% of the award. Under NVICP, the plaintiff gets the entire award.

The video laments the lack of a discovery process with the potential to find incriminating documents. Putting aside the fact that discovery can be very costly for the plaintiff, the program does not disadvantage plaintiffs on this count: since plaintiffs do not need to show fault, they do not need incriminating documents.

The video suggests a special master is not objective. But the special master is a lawyer appointed by the Judges of the United States Court of Federal Claims, a federal court whose judges have life tenure. There is no reason to think the special master is any less objective than a federal judge. The video then goes on to suggest that the lack of legal precedent is an issue for the court. The court has issued inconsistent verdicts in the past; but then, civil courts in the United States are not necessarily consistent either. Juries have been known to reach differing verdicts on similar facts. Courts in states across the U.S. reach differing results on matters of law. There is no guarantee that a civil court will be consistent. Precedent only applies within a given jurisdiction’s hierarchy, not across juries, and it does not bind other jurisdictions, or even the highest court of the jurisdiction in question. A move to the civil courts may reduce consistency in results rather than increase it.

Challenges of Civil Litigation

Winning a product liability suit is not easy. A comparative view may be instructive: as early as 1953, the German Federal Supreme Court, the Bundesgerichtshof, of February 19, 1953 (BGHZ 9, 83), awarded no-fault compensation to someone injured by a vaccine, because showing fault – as was required for civil litigation – is very hard. A World Health Organization report found 19 countries that adopted no-fault schemes for vaccine injuries – and in several countries where this was left to the regular courts, “significant public pressure” calls for similar no-fault schemes. It is simply hard to win such a case in civil courts.  

To win, plaintiffs would have to show a vaccine’s design was defective, using one of the existing tests; unlike manufacturing defects, design defects are handled under negligence principles, not strict liability. If the “unavoidably unsafe” category is actually applied to vaccines (the Supreme Court – contrary to what the video says – rejected its application to NVICA in Bruesewitz v. Wyeth, the plaintiff will have to show the manufacturer was actually negligent indesigning the vaccine, not an easy thing to show (although the Idaho court took a different approach to this). 

There would be no table injuries, so plaintiffs would have to show causation in every case, using expert testimony. Given the abundant amount of current studies against the claim that vaccines cause autism, and the lack of credible studies supporting it, the plaintiff is unlikely to be able to do that. 

According to the latest data I found, product liability claims focusing on asbestos win 53% of times, but other product liability claims win 19.6% - and that includes manufacturing defects, subject to strict liability. The chances are high, given the causation challenges, that claims like the hypothetical Eric’s would do much worse, losing the vast majority of the time. 

So, exchanging a civil process for NVICP would be probably make it harder for most plaintiffs to win, would not provide plaintiffs additional process guarantees, and be unlikely to make it easier for them to find a lawyer—and all that at the cost of potentially driving vaccine manufacturers out of the market when some cases – probably not related to autism – do win. 

It’s a great idea, however, if you want to undermine vaccination and bring back vaccine-preventable diseases. It would work great for the one in a million plaintiffs or less who will win and maybe – just maybe - get a larger award than she would in the vaccine court (though even then she would have to split it with her lawyer); but it would not help and may well harm the majority of plaintiffs, and it would not help public health.

For the most part it’s a bad idea all around, based on faulty premises.

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