On 4 January 2019, the Maine Coalition for Vaccine Choice – a Maine anti-vaccine organization – posted an article about a proposed bill that they called “The Maine Vaccine Consumer Protection Program.” As with the coalition’s previous attempt to pass such a bill, in 2015, the proposal is ill-founded. The premises it is based on are flawed, and the proposals themselves range from directly misleading to not very meaningful.
Problematic premises of the Maine anti-vaccine proposal
The introduction to the proposals suggests that there is a “lack of physician and public health understanding on vaccine safety and efficacy.” There is no good evidence of that. The basis behind this belief appears to be a set of misconceptions about the vaccine injury compensation program (VICP). The article claims:
The 1986 National Childhood Vaccine Injury Act, and the Supreme Court ruling Bruesewitz v Wyeth that sided with Pharma, removed the rights of individuals to sue in cases of vaccine injury and death, and closed the courthouse doors to families with vaccine injured loved ones. Vaccine injury claims were then moved to the Department of Health and Human ServicesVaccine Injury Compensation Program. As a result of this freedom from legal accountability, corruption has taken hold in the US vaccine program…
There are several inaccuracies here. First, individuals are not without rights to sue, though there are limits on that right. Second, there is no freedom for legal accountability in the vaccine program. Third, there is a lot of information on vaccines safety, public health officials are familiar with it, and doctors receive it from their professional organizations in conferences and guidance documents. It just does not match the beliefs of anti-vaccine activists and organizations.
Individuals claiming harms from vaccines are not categorically barred from courts –while the Supreme Court found that individuals are preempted from bringing one kind of claim, design defects, to state courts, individuals can bring other kinds of claims after going through the NVICP or vaccine court. In fact, several anti-vaccine articles drew on two such cases – a tort suit in Tennessee and one in California.
Nor are these individuals denied compensation – they have available a no-fault compensation program, where the legal requirements are less than in the regular courts. While in a regular court, plaintiffs would have to show a design defect or negligence in addition to causation, damages, and other things, in vaccine court, petitioners – as claimants are referred to – only have to show causation and damages. Further, the requirements for causation are relaxed – some cases benefit from a presumption of causation (table injury cases), and others are subject to the Althen standard, which is less demanding than regular causation standards.
While the groups are correct that most claims were dismissed, the dismissed claims included around 5,000 claims about autism, because extensive data shows vaccines are not linked to autism. Further, this fact does not show the program puts claimants at a disadvantage – plaintiffs lose the vast majority of non-asbestos product liability trials in the courts (pdf). As of January 2019, 6,358 out of 18,925 vaccine injury complaints were compensated (pdf), a rate of 34%. The percentage of plaintiffs wins in non-asbestos product liability trials in regular courts was, according to the latest data (pdf), less than 20%.
Nor is the claim of lack of legal accountability correct. First, there is the ability to sue in certain cases. Second, vaccines are subject to regulatory controls which include the ability of the FDA to fine or prosecute manufacturers or pull products off the market. Data about vaccines is also reviewed three times a year by the Advisory Committee on Immunization Practices, and if problems arise, recommendations about vaccines can and have been changed.
Finally, it is not as if public health officials and doctors lack information about vaccine safety. To give one example of many, AAP News often reviews recent vaccine articles, and AAP conferences routinely include a panel about the Red Book, which gives providers guidance on infectious diseases and vaccines, and other panels on immunization issues.
The CDC also produces and distributes materials on the topic, and they are very detailed. Not every official or doctor will be up-to-date on the current information, but many are, and during an outbreak, they would receive additional guidance. The guidance would, however, not reflect anti-vaccine beliefs. It will reflect the most recent data.
The article follows with a number of claims that range from problematic to incorrect. It suggests that the increase in vaccines doses is a problem. The assumption behind this is that giving children more vaccines is a bad thing, but it is probably more realistic to see our ability to prevent more diseases than in the past as a good thing – more protection is better than less.
It argues that the fact that HHS has some patents related to vaccines technology as a problem, that is doubtful – any conflicts of interests from that appear minor. The article then follows with a number of claims of corruption by the CDC and HHS – all of them ill-founded (for space reasons, I will provide the highlights and links to more detailed discussions).
In addition, the allegations against Poul Thorsen, who may have embezzled from the CDC, do not infer corruption by the CDC, rather it’s a crime against the agency. Moreover, Thorsen was not a lead author on any of the major vaccine safety studies authorities rely on – and there’s no argument against his co-authors. A lawsuit against Merck claiming the mumps vaccine’s effectiveness has been overstated. It is still at the fact-finding stage, and does not show corruption by the CDC or HHS – even if Merck did wrong, the effectiveness numbers provided by the CDC do not rely on Merck.
The article refers to several sources criticizing VICP, but that’s not corruption. Even those sources do not suggest VICP failed its mission, and a recent article suggests it’s reasonably successful. Finally, the article refers to a problematic article that claims VICP compensations show vaccines cause autism, even though none of the cases in question were based on the theory that vaccines cause autism, and the VICP expressly said in several decisions it had never compensated for ASD from vaccines.
The proposed program, therefore, is based on highly problematic premises.
Maine anti-vaccine legislation – the proposal
The details of the proposal, as summarized in the post, are also highly problematic, ranging from actively misleading to just not very helpful. The proposal suggests that doctors need to be “educated on the full Vaccine Injury Compensation Table and able to properly screen for and diagnose vaccine adverse events.” The assumptions behind this proposal are that doctors are unable to diagnose harms from vaccines and that the Compensation table is the best tool to help them. Both are flawed.
Doctors are trained to identify problems and trace causation. If a vaccine is one of the possible causes, that’s identifiable – and doctors are aware that some things can be caused by vaccines. But there is no good basis behind assuming they are less able to identify and trace problems related to vaccines than, say, problems related to measles.
And while the table of injuries has some information that could be useful, it’s an administrative document directed to help compensate the plaintiff, it’s hard to update, and it’s not always fully reflective of the current state of the science – a strange choice for a choice of aid. Why not use the algorithm developed for that purpose
Adding information about VICP and the table injury to the Maine Immunization Program’s provider reference manual would not hurt, but is unlikely to be particularly effective, unless there are grounds to think providers use the manual as general reading material rather than a reference book. Nor is there any harm in providing more information to the public about VICP, though since the program is already mentioned on every Vaccine Information Statement that parents receive, it is unclear how much value it would add.
The next proposal, however, is actually harmful, since it’s designed to mislead parents. The article explains that the bill would:
[r]equire a Maine State Vaccine Information Sheet for each vaccine which includes all known side effects be given to patient, per vaccine package insert, table and VICP rulings, remind patients of their right to opt out, and offer step by step instructions on what to do if a vaccine injury is suspected.
A document drawing on sources like that would undermine informed consent by misinforming parents. Vaccine package inserts list things reported after the vaccination but not – or not clearly – caused by it. Similarly, because of the low burden of proof, VICP ruling would not necessarily reflect scientific data and are not a good source for vaccines risks.
The federal vaccine information statements currently required, under federal law, to be given detail the risks, as reflected by scientific data and provide information on what to do if there is an injury. A document that misrepresents the risks of vaccines by including risks not caused by them is not an appropriate substitute. Parents deserve accurate information, not misinformation.
The bill then proposes that:
Maine must establish and uphold the right of medical providers to write a medical vaccine exemption, to decline to recommend or administer a vaccine, to choose not to participate in the state or federal vaccine program, and to advocate for potential vaccine injury cases or act as an expert witness for vaccine injury victims, while remaining free of coercion or punitive action.
The bill would further prohibit Maine from defining medical exemptions or limiting or reviewing them. This appears to be an attempt to protect doctors who want to give ill-founded medical exemptions or refuse to vaccinate patients. Doctors already have leeway to do both – with the only sanction disciplinary action by the medical board, and to my knowledge, there has been no case in Maine on the ground of fake medical exemptions or refusal to vaccinate against doctors. But providing blanket immunity to anti-vaccine doctors against future abuses appears problematic. Similarly, there is no good reason to not define medical exemptions (while leaving some discretion for doctors), or to police abuse there (and legislatures cannot bind future legislatures anyway)
The bill proposes to create a special office for handling vaccine injuries that will support those with vaccine injuries in a number of ways. In the description of what the bill does – reasonably correctly reflecting the content – the Maine anti-vaccine proposal says:
Establish a vaccine injury office in Maine DHHS separate from the Immunization program that will:
Act as an ombudsman for Maine vaccine injury families and clearinghouse for VICP case data.
Evaluate vaccine injury claims.
Provide guidance and a specific process for physicians to follow when a vaccine injury is suspected by their office, or by parents and caregivers.
Provide referrals to doctors who will evaluate and treat.
Provide referrals to attorneys who will file in the VICP.
Recoup MaineCare funds that are spent on vaccine injury cases”.
Establish a complaint and review process for families to ask specific vaccine questions, challenge false vaccine safety and efficacy claims as well as coercion by vaccine providers, and requires DHHS to respond and justify recommendations.
On its face that is not objectionable, but it does require resources – and the authors have not pointed to a problem to justify it. There are multiple sources for families to look up vaccine information, including credible, detailed sites listed by the WHO, and institutions to ask questions in. There is no evidence of a large number of Maine families seeking attorneys for VICP who cannot find them – and if such an office is staffed with competent people, most things that the coalition wants to attribute to vaccines would not be seen as a vaccine injury.
For example, autism is not a vaccine injury. A quick google search for “Vaccine Injury Attorney” brings up multiple firms. Again, there is no big problem in having a list, but there is also no good basis provided for investing scarce resources in this. Even this limited review likely shows readers that the Maine Coalition for Vaccine Choice’s proposal is based on problematic premises, and seeks to put in place problematic rules. The Maine anti-vaccine authors have not made a case for the need for the bill, and there are strong reasons not to adopt provisions that mislead patients, cost resources and do not substantially help public health or individuals.