"Vaccine Whistleblower"? More like the next Andrew Wakefield in the making.

“Vaccine Whistleblower”? More like the next Andrew Wakefield in the making.

This post addresses some legal issues raised in the Vaccine Whistleblower book. The first part explains whistleblower protections and how Dr. Thompson’s allegations fit into them. The second part addresses Dr. Thompson’s suggestion of an independent research agency. The third part explains why the book’s claim that school mandates violate international human rights is incorrect.

A note on the book: Chapters 1 is an executive summary of Chapters 2-5, the interview transcripts; Chapters 6-12 are the author Kevin Barry’s thoughts on what should be done. (Note that Dr. Gorski has also discussed this book from the perspective of the science.)

Prologue: to set the scene

The “Vaccine Whistleblower Book” has four transcripts of telephone conversations between William Thompson and Brian Hooker, recorded between May 1, 2014 and July 28, 2014.

Hooker has elsewhere stated that these conversations were only four of over thirty conversations between Thompson and Hooker. Hooker asserts these conversations began in November, 2013, and that Thompson initiated the conversations. It is not clear if these four recorded conversations were the only ones during that time frame, or what was discussed in the non-recorded conversations.

William Thompson was a co-author on a number of vaccine-safety studies published by the CDC. The most salient one for this discussion is (hereinafter DeStefano 2004):

DeStefano F, Bhasin TK, Thompson WW, Yeargin-Allsopp M, Boyle C. Age at first measles-mumps-rubella vaccination in children with autism and school-matched control subjects: a population-based study in metropolitan Atlanta. Pediatrics. 2004 Feb;113(2):259-66. PMID 14754936

It is not clear why Thompson became concerned enough to reach out in 2013 about a paper that had been published almost a decade previously.

Part I: Whistleblower protections in the United States:

When a federal employee discloses wrongdoing that he or she has a “reasonable belief” falls into certain categories in the United States, the law protects the employee from retaliation by the agency he or she exposed (or tried to expose). That’s the heart of whistleblower protections. It’s important to remember that both the Whistleblower Protection Act and the Whistleblower Protection Enhancement Act seek to provide broad and strong protections to employees disclosing wrongdoing, and Congress clearly signaled a desire to interpret doubts in the disclosing employee’s favor — though that does not translate into automatic protection.

It’s also important to point out that these protections only come into play if there was alleged retaliation by the agency in response to a disclosure.

An employee does not claim whistleblower status in abstract. An employee discloses information about wrongdoing; then, if the agency retaliates, whistleblower protections provide a remedy to the employee (there are a number of other contexts in which we use the term whistleblower that are less relevant here).

How do these whistleblower protections apply to Dr. Thompson?

Disclose to whom?
Dr. Thompson did not go higher up in CDC, to another agency, to the administration, to Congress or the press directly. What he did do is have a long series of phone conversations with a private citizen — Dr. Brian Hooker — in which he complained about his colleagues’ conduct. But that does not negate the protections: they come in to force, with some exceptions that don’t apply here, regardless of to whom the disclosures were made (5 U.S.C. § 2302(b)(8)(A)).

That said, if Dr. Thompson’s goal was to correct wrongdoing, his choice of channel to correct it was strange, to say the least. According to the transcripts, Dr. Thompson only hired legal representation in May 2014, when the possibility of his involvement becoming public was raised (p. 24, chapter 3). So he didn’t have the benefit of legal counsel when he decided to call Dr. Hooker initially. But if you think there is serious wrongdoing in your agency and you want to effectively redress it, is calling an individual that is not only part of the administration but is in many ways an outsider the best way to do so? Dr. Thompson could have hired legal counsel in 2013, or done a Google search on, for example, whistleblower, government and wrongdoing — the first result of which is the Office of Special Counsel whose mandate includes protecting whistleblowers. He could have gone to the press. He could have tried a number of things that would be more effective than calling Dr. Hooker, even if he thought Dr. Hooker had some connections to members of Congress. It may be unfair to criticize Dr. Thompson in hindsight — he may not have thought of this or been well informed on how to report alleged government misconduct — but it is still a strange choice.

Do his allegations fall into protected categories?

In 2012, to broaden protection for whistleblowers, Congress passed the Whistleblower Protection Enhancement Act (WPEA). Relevant to us, section 110 of the Act applies whistleblower protections to scientists that seek to disclose acts they reasonably believe consist of “censorship related to research, analysis, or technical information that cause, or will cause, gross government waste or mismanagement, an abuse of authority, a substantial and specific danger to public health or safety, or any violation of law.” Censorship is defined as: “any effort to distort, misrepresent, or suppress research, analysis, or technical information.” Dr. Thompson claims he saw acts of suppressing research and analysis that could be directly related to the public health, to harm to children. If his belief is reasonable, whistleblower protections would apply to him.

What is reasonable belief, and Did Dr. Thompson have it?

Reasonable belief asks:

whether, given the information available to the whistleblower, a person standing in his shoes could reasonably believe that the disclosed information evidences one of the identified conditions in the statute.

from The U.S. Office of Special Counsel’s Role in Protecting Whistleblowers and Serving as a Safe Channel for Government Employees to Disclose Wrongdoing, drawing on these cases: Fitches v. Dep’t of the Air Force, 82 M.S.P.R. 68 (1999); Gores v. Dep’t of Veterans Affairs, 68 M.S.P.R. 100 (1995)

The information does not have to be true, and the focus is on the whistleblower’s state of mind, not the listener. The whistleblower’s motives — for example, a desire to get even with a co-worker — do not negate the protection and are not directly connected to the reasonableness of the belief.

Given the holes in the facts in the book and my lack of familiarity with the day-to-day realities of the scientific process, I cannot really assess whether Dr. Thompson had reasonable belief that his co-authors engaged in “any effort to distort, misrepresent, or suppress research, analysis, or technical information.” I would assume his belief was sincere, but I don’t know if it was reasonable. All I can say is that there is a good chance that an administrative official or judge that does not have a background in science will, given the intent to make whistleblower protections broad, give Dr. Thompson the benefit of the doubt — if his agency acted against him and whistleblower protections were needed.

So far, there is no indication the CDC acted against Dr. Thompson, so there was no retaliation to trigger the protections in the Act. It’s important to note that if there is reasonable belief by the employee that he is disclosing something that falls under the headings in the act, the agency has a heavy burden to support any action against him. If there is evidence that the disclosure was a contributing factor in the act against the employee, and knowing about the disclosure and the action being close in time to the disclosure can create such a case (as can other types of evidence), the agency:

can avoid liability only if it demonstrates by clear and convincing evidence that it would have taken the same action in the absence of the whistleblowing.

It makes sense, therefore, that the CDC will be very careful not to take actions that could be seen as retaliation against Thompson if they believe his claims could possibly meet the standards in the whistleblower protection acts.

One more point on this deserves addressing. On page 111 Mr. Barry, the book’s author, claims that Dr. Thompson needs to be subpoenaed to testify before Congress because “it is unlikely that his attorney, an expert in whistleblower cases, would allow him to testify unless compelled.” It’s not quite clear why Mr. Barry thinks that. First, Dr. Thompson is an adult; he doesn’t need permission to testify, though he would be wise to listen to the experienced legal counsel he hired. Second, if his goal, as suggested in the transcripts, is to achieve meaningful reform, why wait for a subpoena? As his lawyer, who specializes in these areas, could have pointed out, the OSC can require an investigation by the agency and then make recommendations to Congress and the CDC. Neither is bound by the OSC’s recommendations, but recommendations by a specialized agency focusing on whistleblowing will almost certainly have an impact. And if Congress decided to investigate before the OSC is done, it could. If the CDC wanted to retaliate, whistleblower protection would come into play with or without a subpoena.

Why wait?

The only explanation I can think of is that Dr. Thompson thinks he may be criminally liable for something, and thinks a subpoena would guarantee immunity. It won’t, however. The only situation in which a subpoena would mean immunity is if Dr. Thompson was forced to testify after asserting a Fifth Amendment claim before Congress. Congress can grant immunity, or partial immunity (meaning Dr. Thompson can still be prosecuted, but not using his own testimony), but doesn’t have to, and it’s not an automatic part of a subpoena. These are two separate things.

Part II: Thompson’s suggestions for reform of vaccine safety oversight

On page 69 to the book, Dr. Thompson explains his suggestion for solving the problems he identifies in CDC’s decision making. He says:

It would end this way. That you would end up with an agency like the National Transportation Safety Board. You know, the FAA; then there’d be NTSB. The FAA is responsible for regulating all sorts of things, but then when an accident happens, you bring in the NTSB. So, you would have the equivalent of an NTSB-like organization that would do vaccine safety studies independently.

Dr. Thompson suggests an institutional solution to the problem he identified. Institutional design is a well-accepted — and heavily studied — part of public administration. But both Dr. Thompson’s problem definition and his proposed solution seem simplistic. Dr. Thompson — and the authors of the book — seem to think the problem is that the CDC has complete control over studying and monitoring vaccine safety, which enables the agency to rig results, and that there is a lack of independence (from industry, presumably?) that motivates it to actually do so. Thompson also seems to think a separate agency will solve the independence problem. Neither part is correct.

Vaccine safety monitoring is done by multiple actors

Even in the United States alone, vaccine safety is handled by more than one body, with a complex interaction both at the federal and state level. To give a simplified and partial picture, the FDA regulates licensing of vaccines, including governing clinical trials, pre and post licensure safety and effectiveness studies, labeling, manufacturing quality, and so forth. A CDC advisory committee recommends vaccines that are then approved by the CDC Director for specific populations. Even there, it’s not the CDC staff, but an advisory committee made of experts and a consumer representative, that makes recommendations which the head of the CDC confirms, and recommendations are also made, on that issue, by the American Academy of Pediatrics and the American Academy of Family Physicians. Federal advisory committee are heavily regulated by the Federal Advisory Committees Act, which among other things imposes requirements of transparency. The Advisory Committee on Immunization Practices debates in public and provides detailed, heavily referenced recommendations that are then published (though often a while after they are made): nothing is hidden. The recommendations draw on studies not only from the United States but from the entire world. And those are recommendations: they do not automatically translate into mandates in any state, though they certainly influence the mandates.

In other words, the CDC is not a classic regulatory agency at all. It certainly has an influence on vaccine usage; but it’s not the CDC that can fine manufacturers for wrongdoing or oversees clinical trials. The CDC has additional roles — vaccine distributor; information provision to the public; a role in programs funding vaccines for certain populations; monitoring vaccine usage; and a responsibility for preventing diseases beyond vaccinating alone, for example, via monitoring cases. None of these make it a regulatory agency in the classic sense, and it has not been treated or studied as one.

A large part of the CDC’s role in vaccine regulation is close to NTSB’s role in air safety — research and investigate and recommend after the fact, though Dr. Thompson is right that it is more involved in actually handling vaccines and their influence than NTSB is. But the CDC is still probably closer to NTSB than FAA in this comparison. FDA is the main regulatory agency.

The CDC has a role in monitoring vaccine safety. Part of that role is doing studies. Another is that the Vaccine Adverse Events Reporting System is partly managed by the CDC. But the CDC is not alone in handling vaccine safety: the FDA has a part in that, as does the Institute of Medicine, a private body. Vaccine safety studies post-licensure (which are massive) are done through the Vaccine Safety DataLink. And the studies and results are collected and analyzed primarily by academic researchers independent of the CDC. Researchers in other countries also do studies, and other governments also monitor vaccines, with the information coming from multiple directions.

The diffusion of responsibility between several actors prevents each single actor from completely controlling the information on vaccine safety. The fact that many studies are done abroad also limits the ability of the CDC to control the information. Why would creating one specialized agency guarantee more accountability than a variety of actors that can check each other?

Independence and its feasibility

The second concern those promoting the CDC whistleblower story have is that the CDC’s personnel is too involved with industry in some way — a claim certainly made by Mr. Kennedy in his forward (p. xix) and by Mr. Barry himself (p. xxi and 6). It may be that this is part of Dr. Thompson’s concern.

If that’s what is on his mind, Dr. Thompson should ask himself where members of NTSB come from. According to the board’s website there are currently four members of the board. One previously served with the FAA, one has served with both the CDC and the American Automobile Association; the third was a professional pilot for three decades and worked in regulatory affairs in US Airways; and the fourth had a long career with an airplane manufacturer. The last two, in other words, came from industry, and the Chair came from the FAA.

Reality check: in a specialized area, the majority of people involved in regulation and policy would often have served in more than one role and moved between the players. That’s because their expertise will be sought out. Specialized training takes a long time and is then often sought out by different actors. And often experts have to get hands-on experience somewhere, and in a specialized field the options are limited. And you often want the people regulating to have a mixture of theoretical knowledge and hands-on experience in the area.

You do not want people with no background in air safety having the major say in regulating it or investigating accidents, because lack of expertise, however good the intentions, can easily lead to bad results in a technical area that have real safety implications. For exactly the same reason you do not want people who do not understand infectious diseases and the vaccines that prevent them having the main say on regulating or monitoring them, because they will get it wrong, potentially with very, very bad results. Experts can get it wrong too — but hopefully, much less often. Is there a risk of corruption? Of course. That’s why we want multiple actors and divisions of labor, as well as mechanisms of accountability in place. That’s why you want to think about designing incentives. But you will not be able to get rid of interconnections between the players in a specialized field. Not going to happen, not without sacrificing expertise and knowledge, again, with potentially much, much worse consequences.

Thinking that you can create a magically independent agency to regulate vaccine safety and populate it with people that know what they are doing but do not have connections to industry or other government agencies involved with vaccines is simply unrealistic.

Even if there was extensive evidence of corruption and wrongdoing of the CDC — and the book has not provided that — creating another agency is no panacea, and has very real costs, monetary and in terms of the coordination that will need to happen with that agency. Some more sophisticated thought would be needed to truly analyze what, if any, are the problems with CDC and how to solve them.

Part III: School Mandates and Human Rights

On pp. 128-129 (Chapter 11: First Principles and Moral Courage), Barry argues that freedom from vaccination — and in that case explicitly the freedom of a parent to refuse vaccination for her child — is a human right. This is not the first time we have heard that argument — it was made by Ms. Holland in her article in the book Vaccine Epidemic, chapter 1. Here, as there, it’s used as an attack on school mandates, claiming they violate informed consent. The twist added in Vaccine Whistleblower is to base the opposition on what Barry interprets Dr. Thompson to have disclosed. The passage reads:

If a state is going to force its judgment on a citizen or a parent regarding vaccination (a preventative medical intervention), the safety studies supporting those vaccines must be rock solid. According to Dr. Thompson, the studies are anything but rock solid. The quality of vaccine safety studies is insufficient to support mandatory vaccination.

Given what Dr. Thompson has disclosed, parents should not be removed from the decision-making regarding the health of their children. Parents know their own children’s and their own family’s health history better than their pediatricians and their elected representatives. Parents also know their religious beliefs and their personal relationships with God better than pediatricians, their elected representatives, and employees of their school districts.

The initial premise is incorrect in several ways; and the additional claim also doesn’t hold water.

Whose rights?

First, while I would agree that generally an adult of sound mind should not be forced physically to undergo any medical procedure, including vaccination, though there may be consequences to such refusal (such as quarantine or limiting access to some jobs), the protections do not apply in the same way to children — who do not have a choice either way. This discussion is not about bodily autonomy — which is why the comparison to rape made by anti-vaccine activists is not just reprehensible but incorrect. The question here is the extent of parental rights to make medical decisions for their child.

The view that parents have a human right to refuse vaccination for their children is problematic. Parents usually have a right to make medical decisions for their child — but that right is not, and for some time has not been, absolute — and that’s a good thing. Children are no longer property of their parents, to break and use as the parents will. Modern thinking raises three reasons to support the rights of parents to make those decisions (for a more complete discussion, see “The Rights of the Unvaccinated Child: The Legal Framework“).

First and most important, a child is — generally correctly — considered cognitively unable to make those decisions. Someone has to make them for the child, and in most circumstances it’s the parent who stands as the child’s agent, and makes decisions for the child, since usually the parent can be trusted to represent the child’s best interests.

Second, the parent usually has the responsibility to cover costs of treatment and to deal with the child in many ways. With such responsibility should come the power to make decisions that fit the family’s means and abilities.

Third, we respect privacy of the family and its autonomy, and want to minimize government interference in it. Most iterations of the “my child, my choice” argument seem to emphasize the third reason — but that is, clearly, much weaker than the first.

The main reason to give parents rights is because we hope and believe that usually parents will be the best person to protect the child’s interests. The child is an autonomous being, and children have rights. Parental rights are already limited and regulated by the state. Parents cannot starve or abuse the child. Parents cannot, in California, leave a young child unattended in a car. There are already clear limits on parental powers over a child’s welfare. Given the dramatic imbalance between the risks of vaccinating and the risks of not vaccinating, the state has the authority to step in in this area, too.

If anything, the human right at issue here is the child’s right to health, the right to be protected against preventable diseases via the simple, safe precaution of vaccinating. Not the right of the parent to deprive their child from such protection because they subscribe to anti-vaccine misinformation.

Indeed, in Prince v. Massachusetts, the seminal case about the limits of religious rights when it comes to children’s welfare, the Supreme Court, in a statement that wasn’t part of the ruling but has been incredibly influential, based its support of forced vaccination in part on that:

[a parent] cannot claim freedom from compulsory vaccination for the child more than for himself on religious grounds. The right to practice religion freely does not include liberty to expose the community or the child to communicable disease or the latter to ill health or death.

Prince v. Massachusetts, 321 U.S. 158, 166–67 (1944)

And in another case from New York, a court found not vaccinating against measles, during an outbreak, can amount to medical neglect. (In re Christine M., 595 N.Y.S.2d 606, 616 (N.Y. Fam. Ct. 1992)).

To be clear, my view is that as long as dangerous diseases are reasonably under control in the United States, as long as the threat is not immediate, the state usually should not intervene and force vaccinating. But that’s not because the state does not have authority to intervene. It’s because parental rights, for the reasons above, matter, and where we can respect them without irreversible harm to the child, we should. We have other ways to increase immunization rates besides forcing unwilling parents to vaccinate, and as long as rates of non-vaccination are kept low, herd immunity can protect children. We should avoid the most extreme step unless the child is at immediate risk.

But the state can and should use other means to increase rates, to protect all children and others who may be harmed by disease — including, perhaps especially, children whose parents deny them vaccines.

School mandates are not force vaccinating

Furthermore, school mandates are not “force vaccinating”. Yes, it can seem intrusive and hard to parents who find homeschooling very difficult. But there is a difference in the degree of state intervention and the level of coerciveness. Contrary to some of the language we have heard, school immunization mandates do not mean anyone will be coming to the house of parents with a gun and force vaccinating, or throwing parents in jail. It’s just not direct coercion.

Even if we acknowledge parental rights to refuse vaccination in most circumstances, that does not mean they have a corresponding right to send that child to school unvaccinated and risk other students’ health. School immunization mandates are a traditional public health policy in the United States, dating back to the 19th century, and they have been upheld by every court, state or federal, that ruled on them, because even the strongest formulation of parental rights does not give a parent a right to impose the risk of disease they choose for their own child on others or their children. Your child is not the only one at school; low vaccination rates make schools less safe for others; and a parent does not have a right to make that choice for other parents and their children.

School mandates and Dr. Thompson’s claims

As to the claim that Dr. Thompson’s allegation are an argument against mandates — first, it’s not clear that Dr. Thompson’s claims undermine even the 2004 paper, as Dr. Gorski’s review of the book demonstrates. Second, the 2004 paper is not the only one on MMR, and is not actually a “principal” one, in spite of the book’s claims; even for MMR, it’s one of many studies — and a small, localized study, with substantially less power than, for example, the large scale Danish or Finnish studies. Third, even if the alleged connection had power, and if the 2004 paper was the only or principal paper on MMR, it would be relevant, at most, for African American boys who received the MMR between 18-36 months: so if an African American boy was not vaccinated on time, the solution is simple: vaccinate after the age of 36 months, where no correlation was found. It certainly does not support the wholesale exemption of children from immunization mandates, something that would increase the risk of disease in schools.

Contrary to the author’s claims, the transcripts do not negate the science examining if there’s a link between MMR and autism, or vaccines and autism generally. They are not an argument against school immunization mandates — a traditional policy, aimed at making schools safer.


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Dorit Reiss is a law professor in the UC Hastings College of the Law. She received her LLB from the Hebrew University and her Ph.D. from the Jurisprudence and Social Policy program in UC Berkeley. She first became interested in vaccine-related issues after her first son’s birth when she discovered through parenting blogs that there was an anti-vaccine movement. Over the last few years she has become more involved in activism and writing related to vaccine law and policy.

 

 

Posted by Dorit Reiss

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