When It Comes to FDA Communications ...

Perhaps the most important lesson learned from the COVID-19 experience is that American health illiteracy kills. From confusion over the value of wearing protective masks and social distancing (How are viruses transmitted?) to vaccine skepticism (How do vaccines work?), from confusion over the value of hydroxychloroquine (How are data collected and what do they mean?) to doubts about the safety and efficacy of products available through Emergency Use Authorizations (How does the US Food and Drug Administration review process work?), the dearth of health literacy has not only slowed down the US response against COVID-19, it has placed thorny societal problems along the path to victory over the virus. Nature abhors a vacuum—and so does social media.

To restore faith in our public health agencies, and therefore trust in science and vaccines, we must rebuild confidence in vaccines and promote the advances we have made (through the processes and data that support those claims) as well as in the process used to develop, approve, and label, and recommend vaccines for targeted populations. Battling vaccine hesitancy and misinformation is a critical public health challenge that goes beyond just COVID-19. Efforts to reverse the sharp and partisan divides over evidence-based recommendations and the scientific method that support such recommendations must be rigorous, clear, and transparent. This will be difficult and take a long time. But it’s worth it.

Let’s face it, whether it’s harsh truths about climate change or the merits of vaccines against Covid-19, influenza, and childhood illnesses, it’s science — regularly, honestly, and clearly explained — that is sanity’s ultimate home-field advantage.

That’s why the Reagan/Udall Foundation’s new report, “Strategies for Improving Public Understanding of FDA-Regulated Products,” (aka, “How the FDA can win the Information War”) is must reading Why? Because it’s honest. It’s not the beginning of the end. It may not even be the end of the beginning. But it’s a start – warts and all.

Reagan/Udall launched the report at a webinar featuring a collection of medical students (sharing their early experiences with healthcare misinformation), healthcare practitioners, academics, communicators, and other stakeholders. The last speaker, FDA Commissioner Rob Califf gave the report a two-fisted thumbs-up. After Dr. Califf’s remarks, I got to ask him a question:

“Commissioner, l’audace, l’audance, toujours l’audace. You’ve said that, when it comes to battling mis/disinformation, the FDA is in an “asynchronous warfare” situation. Historically, the way to deal with this is to gain the high ground (in this case, “science”) and to find powerful allies to help level the playing field.

In addition to this report’s suggestions regarding improvements to internal FDA communications processes and practices, and with vaccine issues being the sharp tip of the spear, how will the agency more regularly, robustly, and strategically partner with outside stakeholders to identify, develop, and execute targeted public outreach efforts on key issues?”

In the shark-infested waters of post-pandemic health care policy, the FDA needs to “build a bigger boat.

Dr. Califf answered directly that, because of many of the handcuffs that restrain the agency’s actions (he mentioned the Paperwork Reduction Act specifically), would I be willing to help lead an effort to coordinate stakeholders to work with the agency on developing such an outreach effort. I said I’m ready to pick up the gauntlet.

It’s going to be hard. It’s going to be frustrating. There will be victories and defeats. There will be slings slung and arrows shot. But I can’t think of anything more timely or important than, respectfully and forcefully – in language people can understand, appreciate, and absorb -- rebutting made-up, mistaken, and malignant health information. The only thing it won’t be is partisan or political.

As John Adams reminds us, “Facts are pesky things.”

Peter J. Pitts, a former FDA Associate Commissioner and member of the United States Senior Executive Service, is President of the Center for Medicine in the Public Interest and a Visiting Professor at the University of Paris School of Medicine.