Vaccination informed consent – more anti-vaccine rhetoric from ICAN

In a misleading “White Paper,” the anti-vaccine organization, Informed Consent Action Network (ICAN) argued that “eliminating vaccine exemptions and curtailing criticism is unethical and un-American” because, they argue, it invalidates vaccination informed consent. The initial statement is wrong, and the arguments brought to support it are wrong. This article corrects the record.

ICAN’s vaccination informed consent statement

ICAN’s Initial Statement: “. . . eliminating vaccine exemptions and curtailing criticism is unethical and un-American. . .” is wrong, and here are the facts:

vaccination informed consent
Photo by Charlein Gracia on Unsplash

ICAN’s arguments are incorrect:

  1. The pharmaceutical industry has strong incentives to assure vaccine safety. Here are a few points:
    1. Vaccines are not licensed or recommended unless they meet a high level of safety.
    2. A vaccine shown unsafe can be taken off the market.
    3. While there are limits on pharmaceutical companies’ liability, they are not absolute. The same people writing the White Paper claiming companies are immune from vaccines harms are litigating at least one case against a pharmaceutical company for vaccines’ harms.
    4. There is no barrier to using other tools available against pharmaceutical companies in the context of vaccines, such as criminal liability and other civil penalties mentioned in the White Paper. The authors cannot point to such examples not because the tools cannot be used, but because there was no basis to use them.
  2. There is no conflict built into handling vaccine injuries. In fact, the handling of vaccine injury cases is done by separate units from those government agencies that license or recommend vaccines. It is also done through the Court of Federal Claims. It is a collaboration between a specific unit in the Department of Health and Human Services (HHS) and the Department of Justice (DOJ), and separate from the agencies handling vaccine safety. Further, attorneys’ fees and expert costs are covered (unlike in regular courts), and a GAO report found that attorney fees have increased in past years, so petitioners have access to representation covered by the state (pdf). The program provides extensive latitude for petitioners to provide documentation of their claims. In spite of the program’s comparatively low requirements, the rate of compensation is around one per million, most in settlements that do not show causation, reflecting the scientific evidence that vaccines are safe.
  3. HHS scientists have published multiple studies examining vaccines safety, and some of them have pointed to risks. When risks are there, studies raise them. Studies do not raise risks that are not there, nor should they.
  4. ICAN uses a 2000 report to claim members of the committee making vaccines recommendations – ACIP – have conflicts of interests. Since that time, Conflicts of Interests rules have been tightened, and the claim is out of date. ICAN does not point to any recent evidence of conflicts of interests.
  5. HHS has engaged in extensive activities related to vaccines safety in the past decades. ICAN’s claim that HHS did not engage in such activities misrepresents a Freedom of Information Act (FOIA) settlement as showing otherwise when its focus was on administrative reports, not safety activity.
  6. Pediatric vaccines undergo years of testing and are subject to appropriate and thorough clinical trials. As pointed out by HHS, whether an inert placebo is required depends on the specific situation. The expert consensus is that vaccines testing is exemplary. The National Academy of Medicine recently explained that vaccines are tested more, not less, than other products.
  7. Adverse events listed in package inserts are not a good substitute for scientific evidence showing causation. ICAN suggests lists in inserts show just that. While the Code of Federal Regulations was changed in 2006 to require that only adverse events “for which there is some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event” be listed many inserts written before that date make it clear they list events without regard to causality and using those lists to show causation is incorrect.
  8. VAERS reports do not show causation, and using the numbers to claim they reflect vaccines risks while ignoring the fact that they do not show causation, is misusing them, as the VAERS’ page itself states. In relation to a claim that only 1% of vaccines harms are reported, “This Week in Vaccine Hesitancy: April 26, 2019” explained:

“The claim is based on a report analyzing a healthcare system’s possible use of electronic records in making reports to VAERS easier. Citations and rationale for the 1% figure are not given, so it is difficult to know where the number comes from.

Of note: the report analyzed health records from 2007-2010. Since then, VAERS has made online reporting easier, presumably to provide more data to health officials.” 

Finally, VAERS is only one out of four existing systems for monitoring vaccines safety, providing abundant information on vaccines risks. 

vaccination informed consent

  1. A federal system – the Clinical Immunization Safety Assessment Project – has as one of its goals examining special population, including those at high risk of vaccine harms.
  2. Vaccines are evaluated for carcinogenicity, mutagenicity, and infertility in preclinical studies. Most of the times, the evidence is that the risks of any of these from vaccines are extremely low, and there is no need for follow up in animal studies, so following criteria, those are not done. But that is after earlier evaluation.
  3. The reason health authorities point out that vaccines do not cause autism is that extensive data shows that. Only a minority of autism parents still believe the claim of a link.
  4. The National Academy of Medicine, addressing the issue of vaccinated v. unvaccinated study, Concluded it was unnecessary. The Institute explained:

“Recommendation 6-2: The Department of Health and Human Services should refrain from initiating randomized controlled trials of the childhood immunization schedule that compare safety outcomes in fully vaccinated children with those in unvaccinated children or those vaccinated by use of an alternative schedule.

The committee also reviewed opportunities to study groups that choose not to vaccinate their children by use of a prospective cohort study design. However, such a study would not conclusively reveal differences in health outcomes between unimmunized and fully immunized children for two main reasons. First, the sample populations often suggested for study (such as some religious populations) may be too small to adequately power such a comparative analysis, particularly for very rare adverse health outcomes. Such a study would also need to account for the many confounding variables that separate these naturally occurring unimmunized populations from the average U.S. child, including lifestyle factors and genetic variables.

The committee finds that secondary analyses of existing systems are more promising approaches to the examination of the research questions that the committee identified in future studies of the childhood immunization schedule. The Vaccine Safety Datalink (VSD) is a useful collaborative project that could conduct both postmarketing surveillance and longer-term targeted research. The ability to augment routinely collected administrative data in VSD with data from parent interviews and reviews of medical records for a selected study population is an important strength.”

vaccination informed consent

  1. Measles is a dangerous disease.
  2. There is no good evidence showing that measles reduces rates of cancer or heart disease.
  3. As the World Health Organization points out, MMR is a very safe vaccine. The balance of risks between MMR and measles clearly supports vaccinating.
  4. Most measles cases are in unvaccinated individuals, many of whom are children, and not the result of waning immunity.
  5. The pertussis vaccine is not perfect, but it reduces the risk of outbreaks and provides much better protection than not vaccinating. ICAN misrepresents at least one study which compares getting DTaP to getting DTP, not to being unvaccinated, and says children who got DTaP will be more susceptible than children who got DTP to pertussis, not children who got no vaccines at all.
  6. For polio, the inactivated polio vaccine (IPV) also reduces the spread of the disease, if less effectively. There is no basis to claiming the vaccinated are more likely to spread it. In fact, IPV reduced polio dramatically in the United States before the introduction of oral polio vaccine (OPV) and led to stopped transmission in other countries.  OPV is more effective at reducing transmission, but IPV reduces it too, and the claim the vaccinated increase the risk is incorrect.
  7. Transmission of chicken pox by vaccinated children is extraordinarily rare and requires the presence of open lesions. On the other hand, unvaccinated children are at much higher risk of getting the wild virus and when they do, spread it broadly. While there is not complete data on the duration of immunity from the chickenpox vaccine, existing evidence suggests that it offers long-term protection. Using children as human boosters to prevent adults from getting shingles is not only problematic ethically, the evidence is that the rise in shingles is not related to vaccinating. As to the use of the U.K. as an example, each year in the UK children die from chicken pox (an average of 20 a year); it is not clear why that is a good model to follow.
  8. Scientific discussions of vaccines ingredients can be found here

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Dorit Rubinstein Reiss
This article is by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy and the law. 

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.