Improving Vaccine Policy Making: A Dose of Reality – Dorit R Reiss and Paul A Offit

This post is a preprint of an article to be published in Vaccine entitled “Improving Vaccine Policy Making: A Dose of Reality.” The authors are Dorit Rubinstein Reiss, Ph.D., Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), and Paul A. Offit, MD, Professor of Pediatrics, Division of Infectious Disease, The Children’s Hospital of Philadelphia, The Perelman School at the University of Pennsylvania.

This article’s full citation is:

Reiss DR, Offit PA. Improving Vaccine Policy Making: A Dose of Reality. Vaccine. 2020 February 5. doi: 10.1016/j.vaccine.2020.01.036.

This preprint (see Note 1) is being published here, with permission from Professors Reiss and Offit, as a public service because it is an important part of the discussion on vaccine policy.

Improving Vaccine Policy Making: A Dose of Reality

In a recent article, Drs. Poland, Tilburt and Marcuse pointed out the problem of aggressive, uncivil behavior by vaccine opponents (Poland, G.A., J.C. Tilburt, E.K. Marcuse, “Preserving Civility in Vaccine Policy Discourse—A Way Forward,” JAMA doi: 10.1001/jama.2019.7445).

The authors correctly highlighted two concerns. First, that “shouting, threats, and other disruptive behaviors” undermine transparent debate and democratic processes. Second, that these behaviors often lead to defensive responses and pushback by clinicians and public health officials, preventing real dialogue in areas of scientific uncertainty and value differences.

However, while the article is titled “A Way Forward,” it does not actually provide such a way – because the authors’ arguments are built on several incorrect premises and because they misunderstand how political interactions work in practice.

The authors define those who “reject all vaccines,” those who are “misinformed or who have misconceptions” about vaccines, and those who are “hesitant” about vaccines as “vaccine skeptics.”

The heart of skepticism is doubt. But the vocal opponents are not doubters: they think they know the answers. They aren’t vaccine skeptics; they’re vaccine cynics. They refuse to accept any licensed or recommended vaccine as safe, even where a mountain of evidence exists.

In fact, everyone involved in the licensure, recommendation, and administration of vaccines is more of a vaccine skeptic than strident opponents. They are trained to be skeptics.

Experts who sit on the FDA’s Vaccine Related Biological Product Approval Committee, the CDC’s Advisory Committee on Immunization Practices, and the AAP’s Committee on Infectious Disease will not license or recommend a vaccine until the data on safety and efficacy are robust, internally consistent, and most importantly, reproducible. They doubt until a high bar is surmounted. Only then will their skepticism abate.

The authors worry that voices like that of John Salamone, whose son suffered paralysis from the oral polio vaccine, will be lost in the cacophony of the current debate. However, John Salamone influenced the CDC’s switch from OPV to IPV in the late 1990s, when the cultural debate about vaccines was often as mean-spirited and polarizing as it is today.

Further, the notion that a real vaccine safety issue, such as the oral polio vaccine causing permanent paralysis, will be lost ignores the role of the CDC’s Vaccine Safety DataLink (VSD), which is constantly on the lookout for rare vaccine safety problems in post-marketing and phase IV studies. The work of the VSD makes missing any real vaccine safety issue extremely unlikely, especially when coupled with the other monitoring systems in place (PRISM, CISA and VAERS).

The authors argue that “public health authorities have a responsibility to balance their authority to protect public health and individual freedom protections.” But in current debates the aggressiveness of these minority groups usually means that extensive weight is given to their preferences, often to the detriment of public health. The individual right for which these vocal groups fight is the right not to protect their children from disease and make schools less safe for other people’s children – not a constitutionally protected right, and one of dubious legitimacy.

The authors’ main contribution is to suggest “principled pluralism” should be used to engage vaccine safety. However, given the behavior of vaccine opponents who participate in legislative hearings, the notion is unrealistic.

Three features of these groups prevent principled pluralism: unwillingness to compromise, a worldview based on incorrect information, and anger as a driving force.

For example, in 2019, legislators in the state of Colorado proposed a bill to change the process of obtaining non-medical exemptions. Colorado has a comparatively low immunization rate, costing the state many millions of dollars. The bill would have required parents who wanted a non-medical exemption to submit a form in person to state or local health officials.

Although the Colorado bill did not remove any exemptions, anti-vaccine activists mobilized and responded aggressively. Hearings involved hundreds of angry parents expressing hostility to the bill.

The legislator proposing it received death threats, and immunization advocates – including parent advocates – were personally attacked and threatened. At no point was there an effort by opponents to compromise, offer improvements, or suggest another way to move forward in the face of low rates. The bill received the needed votes, but ended up dying a procedural death when Senate Democratic Leadership did not schedule it for a final vote.

In 2019, the state of Washington experienced a relatively large measles outbreak, almost all in unvaccinated children. In response, legislators proposed a bill that removed the personal belief exemption for the MMR vaccine.

This was a modest bill, addressing only the MMR vaccine, while leaving the state’s religious exemption alone. Still, anti-vaccine activists fought it, staging large demonstrations with impassioned, angry speeches and targeting parents and advocates who testified as well as legislators with personal attacks and threats. They flew in anti-vaccine leaders from across the country to testify, including Toni Bark and Robert F. Kennedy, Jr.

At no point did they offer an alternative to help raise rates or deal with the outbreaks. There was no dialogue or effort to compromise, only rallies calling for “separation of pharma and state”.

Finally, in 2019, Nevada proposed legislation creating a standardized vaccine reporting form that would be shared with state public health officials. This would not have tightened exemptions, but would have fixed a lack of information about vaccination that makes it harder for public health officials to predict, prevent, and respond to outbreaks.

Vaccine opponents prepared large demonstrations including bringing signs and baby ashes, demonizing the leader of the advocacy group, and raging at legislators. Again, opponents refused to provide or consider any alternatives to address public health concerns about lack of information and delayed response to outbreaks.

We understand that these are not the people that Drs. Poland, Tilburt and Marcuse had in mind when they argued for principled pluralism. But these are the people who come to the table to challenge stronger vaccine policies or promote policies that can reduce vaccine rates.

What can actually be done?

First, and most importantly, elected officials need to be prepared for the level of passion and animosity these discussions generate. They need to be provided with accurate information about the science behind vaccines and poling data about public views on vaccines in the state and in their relevant locality.

Just as important is strict, even-handed enforcement of rules of conduct, strong reaction to improper behavior, and an assurance that groups representing the pro-vaccine majority can speak unthreatened. Supporters – including, for example, parents concerned about the risks that unvaccinated children pose to their immunocompromised child – are reluctant to testify or share their child’s story publicly when the result is receiving messages attacking them in crude language or public sharing of their personal contact information.

Advocates for public health should make sure there is someone representing the pro-vaccine voice at these hearings. Otherwise, legislators will have a skewed view of what most parents think. Most people in the United States support vaccines. If aggressiveness from opponents masks that fact, policy makers act on partial, inaccurate information.

We need to provide those with concerns about vaccines with a meaningful opportunity to be heard. But we also need to prevent behaviors that stifle discussion and allow those who support the science of vaccines to express their views without fear of reprisal.

Citations

  1. Cataldi JR, Armon C, Barton M. et al. Vaccine Preventable Diseases in Colorado’s Children. [February 2019] 
  2. Washington State Department of Health. Measles 2019.
  3. Bahouth B. Immunization Data Bill Inspires Passionate Testimony. Nevada Capital News. February 15, 2019.
  4. Jennifer Solis, “Vaccine Hesitancy” hindering Nevada’s Response to Outbreaks. Nevada Current. February 20, 2019. 

Notes

  1. Preprints reflect the last proof of the article but do not include the final edits and formatting that would be found in the published article. This article, “Improving Vaccine Policy Making: A Dose of Reality,” was slightly reformatted to allow for easier reading on mobile devices. I also embedded links to allow readers to quickly find underlying information. 
The Original Skeptical Raptor
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