To Improve Public Trust, the CDC Should Embrace Nuance

It is my pleasure to introduce this guest post by Joseph Marine. He is the author of popular prior posts including: Why Doctors Should Learn to Stop Worrying and Love MAHA. Here, he gives clear guidance for how the CDC can work to restore the trust that the agency forfeited with idiotic guidance, such as: 2 year olds should wear a mask, and kids should sit 6 feet apart on the bus.

Vinay Prasad MD MPH

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A recent controversy was generated by a revelation from vaccinologist Paul Offit during an interview with ZDoggMD. Regarding a past discussion with Dr. Fauci about whether the US government should target high risk groups with covid boosters or the entire population, Dr. Offit stated: “He [Fauci] said, No, you're right. We should target high risk groups. He said the problem is the minute you say that, it becomes a nuanced message. And a nuanced message is a garbled message. If you really want to make sure those groups get vaccinated, then you recommend it for everybody.”

According to Dr. Offit, it appears that the former NIAID director was willing sacrifice truth for the sake of messaging – a classic technique of propaganda. He was also apparently willing to expose children to a risk of adverse effects from vaccination they did not need in order to get more shots into the arms of more high-risk patients – a reversal of societal ethical norms, in which adults should be expected to protect children. Putting aside the ethics and efficacy of such an approach, is this a rational concern? Is a “nuanced” message really a “garbled” message?

In cardiovascular medicine and most other medical fields we embrace nuance. We regularly target medical, surgical, and device therapies to high-risk groups. We would find the idea of implanting every person with an implantable defibrillator or a left atrial appendage occlusion device just to ensure that more high-risk patients receive one to be a bizarre and dishonest approach to medical care. We are in fact expected to personalize treatment to each patient, customizing risk and benefits to their situation, engaging each in a shared decision-making discussion, taking account each patient’s goals and preferences.

With public confidence in the CDC and its childhood vaccination schedule tanking because of the pandemic fiasco, it is urgent that the next administration take steps to reverse the decline. Here are several suggestions to bring CDC policy more in line with the positions of other medical organizations and the ethics of medical practice in the US:

1. Stratify recommendations. This is the practice of the cardiology societies and most other medical professional organizations. Guidelines published by the American College of Cardiology (ACC) and the American Heart Association (AHA) utilize tiered recommendations for therapies as follows:

Class I: A strong recommendation for which benefits far exceed risk for most patients in the absence of contraindications

Class IIa: A moderate recommendation for which benefits usually exceed risks and the therapy is reasonable in most patients

Class IIb: A weak recommendation for which benefits of the therapy are less certain, but benefits may exceed risks for some patients

Class III: The therapy is not recommended, either because it is not beneficial, or it has been shown to be harmful

One advantage of such a system is that it communicates to health professionals and the public differing degrees of confidence that underlies therapeutic and preventive health advice. Political leaders would also be less likely to turn weaker Class II recommendations into universal mandates. Under the above scheme, primary covid vaccination in high-risk groups in 2021 would have been a Class I recommendation, while boosting healthy children in 2024 would be (at best) a IIb recommendation.

2. Grade evidence for recommendations. Most readers of Sensible Medicine are aware of the fact the medical evidence comes in different degrees of rigor and reliability, ranging from expert opinion and anecdotal observations to meta-analyses of large randomized controlled trials (RCT). Recommendations based on stronger evidence are less likely to be changed in the face of future trials or observations, while recommendations based on weak evidence rest on shakier ground. The ACC/AHA guidelines use the following scale:

Level of Evidence (LOE) A: High-quality evidence from two or more RCTs, metanalyses of high-quality RCTs, or one or more RCTs corroborated by high-quality registry studies

LOE B-R: Moderate-quality evidence from one or more RCTs or meta-analyses of moderate-quality RCTs

LOE B-NR: Moderate-quality evidence from nonrandomized, observational or registry studies and/or meta-analyses of such studies

LOE C-LD: Studies and/or meta-analyses with limitations of design or execution or physiological or mechanistic studies in human subjects

LOE C-EO: Consensus of expert opinion based on clinical experience

Grading the evidence used to make recommendations communicates to health professionals and the public the reliability of the science behind health advice. It also indicates areas where the research community should work to provide more or higher-quality evidence. As with Class II recommendation, political leaders would be less likely to create mandates from recommendation based on weaker evidence. For much of 2020, for example, masking recommendations in adults were based on (weak) C-LD evidence, while evidence for masking young children was (at best) C-EO.

3. All guidance should be authored. During the covid pandemic, several of the CDC’s most controversial recommendations were anonymous. The standard practice for most medical professional organizations is for guideline writing group members to be named in publication. The CDC should do this as well. Putting one’s name and professional reputation behind a health recommendation leads to greater care and thought, while anonymity can serve as a shield for carelessness and sloppy thinking.

4. Minimize and enhance transparency of conflicts of interest. The cardiology guideline development process has rigorous rules for transparency regarding conflicts of interest (COI) and relationships with industry (RWI). The next CDC Director should take a careful look at the CDC’s existing COI/RWI policies to enhance public confidence in their decisions. Given the controversy over the covid vaccine approval and recommendation process, the CDC should consider disallowing anyone with financial relationships with the vaccine industry from participation on its Advisory Committee on Immunization Practices (ACIP) panel. Steps should also be taken to reduce public perception of a “revolving door” between high-level CDC positions and the pharmaceutical industry.

5. Stop talking about “misinformation.” During the covid pandemic, the term “misinformation” was weaponized to marginalize doctors and scientists who disagreed with US government health policies. The CDC should minimize use of the term and stick to asserting what it believes to be facts, allowing discussion and debate to play out in public forums and the medical scientific community.

6. Reassess the Vaccine Adverse Event Reporting System (VAERS). The CDC and FDA jointly manage the VAERS database as a vaccine safety reporting system. As of March 2023, over 19,000 deaths after covid inoculations were reported to VAERS. While this is a small percentage of people injected and the CDC continues to insist that the covid shots are “safe and effective,” the large number of reports of adverse events have stoked concerns among critics that the agency was unable to quell. Challenging the accuracy of VAERS data as a means to defending the safety of the shots calls into question the purpose of the database and what alternatives could better identify safety signals. CDC should undertake a reassessment of VAERS and the entire process of post-market monitoring of vaccine safety in a way that addresses the valid concerns of its critics.

7. Develop a statement of ethical principles. The covid pandemic was marked by a widespread abandonment of medical ethical principles and basic human rights which alienated large swaths of the public. The public health community should have learned from the infamous Tuskegee Syphilis study that compromising these principles can damage public trust for decades. The CDC should convene an expert panel to review the mistakes of the pandemic and craft a forward-looking statement of ethical principles to guide CDC and public health actions in the future. This statement should affirm the critical importance of free and voluntary informed consent, respect for individual rights and American legal tradition, avoidance of censorship and fear-based messaging, and open acknowledge of unknowns and harms of interventions.

8. Embrace a holistic view of public health. Throughout most of the pandemic, US public health officials acted as if “health” was defined simply as freedom from a positive covid test. The World Health Organization (WHO), while making many errors during the pandemic, provides a much better one: “A state of complete physical, mental, and social well-being, and not merely the absence of disease or infirmity.” The CDC needs to embrace this broader, more holistic definition of health and keep it at the forefront of its efforts, especially during perceived emergencies.

In summary, the key to regaining trust is for the CDC to better demonstrate that it trusts the public. These are a few suggestions for the CDC to strengthen public confidence in its recommendations and actions. I welcome readers’ thoughts on these and others that the next Director should consider.