Observations on the CDC and ACIP

Constitutionally, States regulate the practice of medicine

For starters, let’s get the usual disclaimer out of the way. The opinions expressed in this essay are my own, and do not claim to represent the opinions of the US Government (USG), the Centers for Disease Control and Prevention (CDC), or the Advisory Committee on Immunization Practices (ACIP). I currently serve as an unpaid volunteer member of the ACIP. What I am observing and learning from serving in that position has informed my opinions. I am embargoed by HHS from speaking about the specifics of internal deliberations, plans, and non-public information provided to me as a volunteer member. Basically, I am bound by a non-disclosure agreement.

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Last week, in the context of being lambasted by Senator Blumenthal for posting three memes (out of about forty, over two different substack posts) that he interpreted (or psychologically projected) as indicating that I was advocating violence against vaccine scientists (of which I am one), the Senator tried to express the nature and purpose of the ACIP. His inferences about the purpose of the ACIP basically parroted the misconceptions about this federally chartered advisory committee (under FACA) that have been promoted by lazy and incompetent corporate media narrative reinforcers. So what is the ACIP? Does it set vaccine policy for the nation, the narrative the Senator seems to believe, and the press so actively promotes?

The ACIP is, by charter, an INDEPENDENT advisory committee only. Just like the name says. It is an Advisory Committee on Immunization Practices. It does not set vaccine policy for the nation.

Who does it advise? The Director of the CDC. Congress has recently determined that the Senate must have advice and approval of the Director of the CDC, which is an enormously cludgy and politicized process. If there is no confirmed Director, then the Secretary of HHS has to step in and receive the recommendations of the ACIP.

The Director of the CDC or Secretary of HHS receives information relating to immunization practices from a variety of sources, including CDC bureaucrats and staff, published literature, policy advisors and virtually any other source of information the Director or Secretary wishes to use. The ACIP is only one source.

The Director of the CDC or Secretary of HHS establishes policy, including federal policy regarding immunization. But the US Federal Government does not regulate the practice of medicine. That is not a responsibility of the Federal Government, as it is not enumerated in the US Constitution. The regulation of the practice of medicine, including vaccine policy, is the responsibility of the states. It is not within CDC or HHS authority, let alone ACIP authority, to establish national vaccination policies. This is a States Rights issue.

This fundamental fact was explicitly clarified in the Supreme Court case of Dobbs v. Jackson Women’s Health Organization (2022). Writing for the majority in Dobbs, Justice Samuel Alito said that the only legitimate unenumerated rights — that is, rights not explicitly stated in the Constitution — are those “deeply rooted in the Nation’s history and tradition” and “implicit in the concept of ordered liberty.” Regulation of the practice of medicine, whether abortion policies or vaccination policies, is not a federal responsibility, it is explicitly the responsibility of the States. If California, Oregon, and Washington states wish to establish separate medical vaccine policies from Florida, that is their right to do so, within the boundaries of the Constitutional rights of individuals.

I personally argue that medical procedure mandates violate US Constitutional protections for the rights of individuals, but to date the Supreme Court differs on that. The historic Supreme Court case authorizing vaccine mandates is Jacobson v. Massachusetts, decided in 1905. The Court upheld the authority of states to enforce compulsory vaccination laws as a valid exercise of their police power to protect public health and safety. But again, this is a States rights issue. The CDC has no Constitutional authority to regulate the practice of vaccination. So obviously neither does the ACIP. When Senator Blumenthal (or corporate media) indicates otherwise, what this reveals is a profound ignorance of Constitutional law.

Like happens all across the Federal Government, the Feds exert control over matters that they are not constitutionally authorized to control via funding policy. CMS (Medicare/Medicaid) policies, the Vaccines for Children program, and more recently, aspects of the Obamacare legislation created federal mechanisms (individual and group mandates) for influencing the availability and pricing of vaccines within the States, and it is via these mechanisms that the US Federal Government (and CDC) exerts Constitutionally illegitimate indirect control on State vaccine policies.

The Vaccines for Children (VFC) Program was authorized by the Omnibus Budget Reconciliation Act of 1993 (OBRA). This act was passed in response to a measles epidemic between 1989 and 1991, which highlighted significant gaps in childhood immunization, particularly among children who lacked health insurance or could not afford vaccinations. The VFC program became operational on October 1, 1994, and is formally known as Section 1928 of the Social Security Act. Also related to this is the The National Childhood Vaccine Injury Act (NCVIA) of 1986 (42 U.S.C. §§ 300aa-1 to 300aa-34), which was signed into law by United States President Ronald Reagan as part of a larger health bill on November 14, 1986. NCVIA's purpose was to eliminate the potential financial liability of vaccine manufacturers due to vaccine injury claims to ensure a stable market supply of vaccines, and to provide cost-effective arbitration for vaccine injury claims. These are examples that illustrate how good intentions often go awry, particularly when the Federal Bureaucracy gets involved in “interpreting” congressional intent. What you get, again and again, is systematic and systemic mission creep. Incremental exertion of more and more control. The metaphor that the Vampire must be invited in through the door comes to mind. And that is precisely what has happened with the CDC.

Back in the day, years ago, when I was regularly attending ACIP meetings as an observer and was an invited participant in the CDC Influenza Vaccine industry advocacy group, it was regularly acknowledged that the CDC had to be very careful to only provide advice to the States, and could not attempt to set policy. All of that caution seems to have gone to the wind since then, particularly during COVID. Now the CDC bureaucracy seems to have become convinced that they have both authority and mission to set medical policy throughout the USA, and have acted via a number of ways to do so, not the least of which is via promotion of outright propaganda and censorship.

Returning to the ACIP, the mission and authority of the ACIP derives by charter under the Federal Advisory Committee Act (FACA). The Federal Advisory Committee Act (FACA) was created by Public Law 92–463.2 . This law was enacted on October 6, 1972, and is formally titled "An act to authorize the establishment of a system governing the creation and operation of advisory committees in the executive branch of the Federal Government, and for other purposes". FACA committees are empaneled to serve in providing fully independent advice (quite literally) to the President, or to those appointed officers that POTUS designates. FACA committees do not set policy. And they are specifically intended to be independent from the bureaucracy.

The Federal Advisory Committee Act defines advisory committee as "any committee, board, commission, council, conference, panel, task force, or other similar group" that dispenses "advice or recommendations" to the President of the United States, and excludes bodies that also exercise operational functions. They are provisional bodies and have the advantage of being able to circumvent bureaucracy and collect a range of opinions. Committees composed of full-time officers or employees of the federal government do not count as advisory committees under FACA. ACIP members serve as volunteer, part-time “Special Government Employees” and so are not excluded under this provision.

Per Wikipedia, and consistent with my reading of the ACIP charter and training received by the CDC as an ACIP member:

In drafting FACA, legislators wanted to ensure that advice by the various advisory committees is "objective and accessible to the public" by formalizing the process for "establishing, operating, overseeing, and terminating" the committees. The Committee Management Secretariat at the GSA is charged with monitoring compliance.

In particular the Act restricts the formation of such committees to only those which are deemed essential, limits their powers to provision of advice to officers and agencies in the executive branch of the Federal Government, and limits the length of term during which any such committee may operate. Further, FACA was an attempt by Congress to curtail the rampant "locker-room discussion" that had become prevalent in administrative decisions. These "locker-room discussion" are masked under titles like "task force", "subcommittee", and "working group" meetings, which are less than full FACA meetings and so they do not have to be open to the public. FACA declared that all administrative procedures and hearings were to be public knowledge.

Specifically excluded from public transparency are the “working group” meetings, in which “working group” members (which may include industry- ergo Pharma in the case of ACIP- representatives) must include both one or more members of the parent ACIP, but can include any others whose opinion or advice are deemed relevant to the topic. The proceedings and minutes of ACIP working group subcommittee meetings are not transparent to the public. The proceedings of full FACA-authorized ACIP meetings are open and transparent.

Much has been spoken and written about “industry capture” and “Conflict of interest” of the ACIP. Conflict of interest (COI) does not require direct financial conflicts, those are just one particularly overt example. To illustrate, if one represents an institution or organization that receives significant funding or exerted influence by the Pharmaceutical Industry, that is a COI. Virtually every single large medical specialty organization in the United States receives significant funding from the Pharmaceutical Industry. So all those representing those organizations have one form of COI.

What I have observed is that the ACIP has been structurally captured by the CDC bureaucracy. Historically, it has not been allowed to be independent, in direct and seemingly intentional contravention of the intent of the FACA legislation that provides the authority for empaneling the ACIP. What I observe is that the CDC “leaders” such as Dr. Demetre Daskalakis (see for example this post) repeatedly insisting that the ACIP has no authority to examine conclusions obtained by CDC staff and bureaucrats concerning data or data interpretation concerning safety and effectiveness of vaccine products. It was Daskalakis that actively obstructed (for weeks) the “Terms of Reference” (bureaucratic language for scope of work) for the ACIP COVID vaccines working group because he objected to the scope of topics to be investigated, discussed, and reported on. The position has basically been that CDC conclusions are not allowed to be reviewed and discussed. They must be accepted as fact. To do otherwise was asserted by CDC leadership as “politicizing The Science”.

Demetre Costas Daskalakis (born 1972/1973) is an American infectious disease physician and gay health activist who served in leadership roles at the US Centers for Disease Control and Prevention (CDC) from 2020 to 2025. At the CDC, he was director of the National Center for Immunization and Respiratory Diseases (NCIRD) and was previously director of the Division of HIV Prevention at the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. During the administration of Joe Biden, he was appointed deputy coordinator of the White House's mpox response to the 2022–2023 outbreak of the disease.

Wikipedia

The “capture” of the ACIP - explicitly intended and chartered through FACA to be a source of independent advice (independent of the bureaucracy) to the President or his designee- has been multifactorial. The “medical society” and “academic” institutions from which the ACIP has historically drawn membership have often had both direct and indirect conflicts of interest that tie these members back to the Pharmaceutical Industry. But more directly, the CDC bureaucracy itself has captured the ACIP by controlling agendas, content, providing biased presentations that have more to do with marketing and propaganda than scientific data, and attempting to avoid any review or scrutiny of the methods and practices that the CDC bureaucracy uses to draw its own conclusions and advice. Often these conclusions and advice have been proven wrong, but nevertheless the CDC uses its resources (like the CDC foundation) and Public Relations infrastructure (including its website and MMWR publication) to promote to the general public as well as medical service providers unsubstantiated, non-peer reviewed opinion that is little more than propaganda. Historically, the CDC bureaucracy has captured the ACIP by controlling agenda, scope, information sources, and membership. The ACIP, rather than being a fully independent source of advice to the President and his designees, has become a lapdog to the CDC bureaucracy, completely subverting the intent of the FACA legislation. It is not the Secretary of HHS that has “politicized” the ACIP, rather historically, it is the CDC and the medical professional societies that have done this.

Furthermore, the CDC has become obsessed with pharmaceutical interventions (primarily biologicals including vaccines and monoclonal antibodies) for meeting its chartered purpose - infectious disease control and prevention. The historic record is clear - vaccines should be only one component of a comprehensive approach to infectious disease control and prevention, with the biggest historic impact involving more mundane things like water purity and safety as well as nutrition and general health of the population. If the agency (and the discipline of “public health”) is to persist, it must be brought back in alignment with the actual “scientific” data

Historically, how has CDC and ACIP acted to set “vaccine policy” across the United States? The short version is via the legal-medical process of establishment of “standard of care”. Technically, medical “standard of care” is a regional matter. Standard of care in Boston is not the same as standard of care in rural New Mexico. In the case of vaccine policies, “standard of care” derives from the sum of regional physician, medical society, state and federal recommendations. Physicians who provide services or medical interventions inconsistent with local “standard of care” basically do so at their own legal risk. This is not the same as “off label” prescriptions. “Off label” use of medicines or procedures are allowed, but there must be documented informed consent between the medical care provider and the patient.

In sum, ACIP absolutely does not have either authority nor mission to “set vaccine policy for the United States”. Setting policy and standard of care involves an interaction between the US Federal Government, State Government, and state authorized health care practitioners (which may include pharmacists in some states). The regulation of the practice of medicine is the responsibility of State governments, not the Federal government. From the perspective of the Federal Government, this role is specifically the responsibility of the Executive branch (POTUS and/or designee). The regulation of vaccine policy and standard of care is explicitly among the duties of the States. It is not the responsibility of the CDC or the ACIP. And this is not subject to modification based on vague notions of equity or federal promotion of availability.

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