Beware harm to federal health agencies

By Jon Bigelow • Executive Director of the Coalition for Healthcare Communication

The confusion and infighting that has marred the response to the COVID-19 pandemic reduces public support for and confidence in preventive measures encouraged by public health experts. It also threatens the effectiveness, scientific integrity, and reputation of key federal health agencies, potentially inflicting long-lasting damage. Consider a few examples:

Moving the data: On July 15, the Trump administration instructed hospital systems and providers to no longer channel to both the Centers for Disease Control and Prevention (CDC) and the Department of Health and Human Services (HHS) their data on COVID-19 cases, hospitalizations, deaths, test results, and so on. Instead, the data is now to be sent only to a newly launched data portal at HHS. 

Since 1946, the CDC has been the focal point for monitoring the spread of diseases in the United States. The CDC has built deep expertise in analyzing disease trends as well as strong connections with similar agencies in foreign governments. During this pandemic the CDC’s data base has been the most accessible and accurate source of information for the public and for others analyzing issues such as availability of hospital or ICU beds.

The initial explanation offered for the sudden change, that it will help HHS better allocate needed supplies and resources, is not convincing; HHS already had access to the CDC data. A second purported reason – that the manual entry needed for getting data into the CDC database is too cumbersome – seems disingenuous; yes, there should be a better method, but the HHS replacement also relies on manual data entry and the change requires hospitals across the country, already stretched for resources during the pandemic, to reconfigure systems for reporting. 

A realistic possibility is that the Trump administration wants better control over the data. HHS is “exploring the best way to make this information available to the public,” according to Chief Information Officer Jose Arrieta, but has not promised full access to researchers and the public.

Administration officials claim that the reported numbers of COVID-19 cases and deaths are overstated (although leading experts believe the contrary, and a July 21 report in JAMA Internal Medicine suggests that COVID-19 infections may be two to 13 times higher than reported). No one benefits when data is manipulated or hidden; we need the most accurate information possible to make sound clinical, logistical, and economic decisions in this or any public health emergency. To sideline the CDC data base sets a dangerous precedent.

Watering down safety advice: Repeatedly over recent months, draft CDC guidelines for public health – wearing masks, avoiding large gatherings, etc. – have been delayed or rewritten by the administration. This summer, the flashpoint has become recommendations on how and whether to reopen classrooms this autumn.

This pressure on the CDC risks substituting politics for science. It leaves local leaders planning for the school year in communities across the country caught in the middle. It confuses the public about what is, or is not, important in preventing the spread of COVID-19. It is counterproductive to the fight to contain this pandemic.

“Shooting the messenger:” Recent efforts to impugn the integrity of respected public health leaders, such as Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, do not help to protect the public. Our nation’s public health depends on dedicated scientists and leaders – Dr. Fauci and many others not so widely known – who work at the CDC, Food and Drug Administration (FDA), and National Institutes of Health to develop policy based on science and data. This and any administration would be wise to follow their evidence-based recommendations, not treat them as adversaries. 

Advancing drugs based on anecdote: From 2010 to 2019, the FDA issued fewer than 75 Emergency Use Authorizations (EUAs), which allow use of an unapproved drug (or an approved drug for unapproved indications) in an emergency where there are no approved or available alternatives. So far this year, the FDA has issued well over 100 EUAs to allow use of various products or drugs in the context of the COVID-19 pandemic. This raises practical questions: Is the FDA, at current staffing levels, capable of adequately vetting all of the requests for EUAs? Especially with pandemic travel restrictions, can the FDA adequately monitor manufacturing quality for those agents coming from foreign countries? 

And is the FDA caving to political pressure with some of these EUAs? Many believe the EUA for hydroxychloroquine and chloroquine to treat COVID-19 patients was based on sketchy evidence and spurred by political pressure; indeed, the FDA has since withdrawn that EUA as it becomes evident that early reports of efficacy were overblown and adverse effects are significant. That there is now widespread speculation about a premature vaccine EUA as a pre-election “October surprise” reduces the credibility of the approval process, despite FDA Commissioner Dr. Stephen Hahn’s best efforts. 

Prioritizing speed above all else: Coordinating federal support for developing COVID-19 vaccines makes great sense. But the very name given this effort, Operation Warp Speed, points to a major risk: While we all hope a vaccine can be developed quickly, efficacy and safety should be prioritized over speed. Rolling out an ineffective vaccine (or worse, one with significant adverse reactions) will not halt the pandemic and would set back public confidence in any future vaccination effort against COVID-19, not to mention feeding the broader anti-vaxxer effort and damaging pharma’s reputation. White House officials, including the President, speak often about a vaccine becoming available for use this winter. Public health authorities push back a little, suggesting later in 2021 is more likely. Many experts outside the government point out that rolling out a vaccine in under four years would set a new record for vaccine development and that the logistics of manufacturing and administering enough doses to immunize a significant proportion of the population will take a long time.

We are likely to be living with the COVID-19 pandemic for many months or years, and outbreaks of other infectious diseases are always a threat. We at the Coalition for Healthcare Communication support the free flow of, and unfettered access to, accurate and credible medical information. As health communications professionals, we should be wary of measures that weaken our public health agencies’ ability to keep science at the core of decision making.