To: Centers of Disease Control and Prevention of the Department of Health and Human Services
From: Mary Holland, Chair of the Advisory Board, Health Choice
Date: October 14, 2016
Re: Notice of Proposed Rulemaking (NPRM) of August 15, 2016 on the Control of Communicable Diseases
Health Choice is a non-profit, public interest organization, which promotes the right to prior, free and informed consent to all medical interventions, including preventive ones. The United States, joined by192 other countries, recognized and endorsed this principle in the 2005 United Nations Declaration on Bioethics and Human Rights. Health Choice holds the U.S. government to the standards that it embraced in that Declaration.
I serve as the chair of Health Choice’s advisory board. I am an attorney and Research Scholar at the New York University School of Law. I write on vaccine law and policy and have had occasion to testify before several state legislatures, in Congress and the United Nations on these issues. I am also the mother of a vaccine-injured child. I write on behalf of Health Choice based on my professional and personal background.
The Proposed Rule violates the global human rights benchmark in medicine and also violates Constitutional rights to privacy, due process and equal protection. Health Choice strongly opposes the Proposed Rule. No Rule violating fundamental human and Constitutional rights should become law.
Health Choice recognizes that the federal government has legitimate concerns to prevent people infected with potentially lethal diseases, like Ebola, from entering the U.S. It has powers adequate to cope with these threats under existing laws. The failure of the U.S. to cope effectively with Ebola does not appear to have been related to lack of adequate administrative powers, as this Proposed Rule suggests.
The vague and overreaching nature of this Proposed Rule makes it extremely easy to abuse. It seems tailor-made for federal and state officials to detain individuals in biased and unprincipled ways for rashes, sniffles and coughs. How many airlines and bus passengers in winter months will have such symptoms? Millions. Can we for a minute imagine that a Rule which permits 72 hours of lawful incarceration, with no access to a lawyer or appeal, will not be subject to selective enforcement and abuse? Is it likely that this Rule will be applied even-handedly to individuals of all ethnicities and nationalities? Given the United States’ deep-seated problems with biased law enforcement, this Rule would appear to add gas to the fire.
The Proposed Rule places undue emphasis on “post-exposure prophylaxis,” by which it appears to mean vaccination in most instances. Under threat of potential detention during interstate travel, the Rule places people who elect not to vaccinate against so-called vaccine-preventable illnesses, such as measles, chickenpox and flu, under a legal cloud of potential civil and criminal liability. While this may be a sound financial strategy for a pharmaceutical industry with close government relations, this is an abysmal public health strategy. Such coercion violates the core principle of prior, free and informed consent to medical interventions.
In the event “post-exposure prophylaxis” leads to serious injury or death, as is entirely possible, it will be impossible for those so treated to sue the government or the manufacturers of the medical products used. The 1986 National Vaccine Injury Act and the 2011 Supreme Court decision in Bruesewitz v. Wyeth completely immunize industry and healthcare providers from liability. Sovereign immunity would protect government actors. Those apprehended and detained would bear all the risks of these coerced medical interventions.
The Rule’s strong emphasis on measles is grossly inappropriate. While contagious, measles is scarcely a deadly disease in the United States. Indeed, in 1960, three years before the measles vaccine was licensed, the death rate from measles was .2 cases per 100,000.1 But imposing liability on the population for transmission of measles would be lucrative for Merck, which holds a monopoly on the measles vaccine in the United States. While measles is not today on the “detain and quarantine” list, this Rule paves the way. Measles is not Ebola. To treat it in the same way is an insult to common sense and the public health.
Below, I respond to sections where HHS/CDC specifically solicited public comment.
§70.18 Agreements This provision suggests that HHS/CDC can “enter into an agreement with an individual” on public health grounds, but then in the same sentence, suggests that “the individual’s agreement shall not be considered a prerequisite to the exercise of the CDC’s authority under this part.” While in theory you are suggesting individuals can decline to enter into such “agreements,” the right to refuse is specious. Seventy-two hours with no access to one’s family, work or lawyer while being detained at an airport, bus or train station implies no realistic right to refuse. Under an Orwellian banner of “agreements,” HHS/CDC proposes coercion. The verbiage that this is a “means of building trust with the individual” is both laughable and appalling.
You request comments on whether “such agreements are confusing to individuals as they shall not be considered a prerequisite to the exercise of the CDC’s authority.” People will not be confused at all: they will understand immediately that this is a new form of a coercion, plain and simple.
§70.19 Penalties This section describes criminal penalties for violations of quarantine regulations. HHS/CDC specifically requests comment on “whether the penalties…are clearly defined and the circumstances under which such penalties may be imposed.” In response, no, this section does not clearly define the circumstances when the government may impose penalties for quarantine violations or undefined “offenses.” It does not give explicit criteria for the imposition of quarantines. It does not define safe harbor provisions for self-quarantine, which is essential. It also suggests that “an organization found guilty of an offense may be fined.” How can an organization violate a quarantine under a criminal statute? What would be the basis for imposition of any criminal sanction against an organization for a quarantine? This provision, again, is ripe for selective enforcement and abuse.
The 12,000-plus comments you have received so far are overwhelmingly negative. Indeed, I could not find a single one in the Rule’s favor. It seems to have little or no public health rationale yet threatens human and civil rights. This Proposed Rule richly deserves to be abandoned on the scrap heap of history.
Mary S. Holland, J.D.
Chair, Advisory Board,
1 U.S. Department of Health, Education and Welfare. Vital Statistics of the United States, 1960. (http://www.cdc.gov/nchs/data/vsus/VSUS_1960_2A.pdf) Volume II – Morality Part A, Section 5. General Mortality Table 58: Deaths from 255 Selected Cases (Measles). 1963.