(Apologies readers for glitches with punctuation; there is a gremlin at play in the system)

Risk communication is one of the greatest challenges facing any public health agency; done badly it can cost lives, money, and reputations.

That’s according to a new guide released by the Food and Drug Administration (FDA) and US Department of Health and Human Services, Communicating Risks and Benefits: An Evidence-Based User’s Guide.

Its 242-pages includes chapters on ‘best guesses’ at best practices, communications design, and advice on implementing evidence-based communication.

It distinguishes risk communication from public affairs/PR communication by its commitment to accuracy and its avoidance of spin, although in Croakey’s experience these things are not always so neatly clear-cut.

One of the messages is that health/regulatory agencies need to understand their perceived credibility and trustworthiness with the public for practical planning for effective communications.

One of the more interesting chapters (5) is by patient advocate Musa Mayer, who writes powerfully of her own experiences with breast cancer and the many challenges facing patients when it comes to weighing up potential benefits and harms of treatment options.

She describes how the media promoted an unproven stem cell transplant treatment for advanced breast cancer in the 1990s, leading to tens of thousands of women having an unproven and toxic treatment. She writes:

When the randomized trials were finally completed at the end of the decade – the definite studies that had languished for years, accruing at a snail’s pace because of the prevailing belief that the transplants worked – no benefit over standard chemotherapy could be found. By then, the treatment itself had killed thousands of women, many more than it helped.

Mayer argues that the “warlike” language surrounding cancer is not helpful, as it may encourage overly aggressive treatment and burden end-of-life decisions with “the shame-inducing freight of ‘surrender’ and ‘giving up the fight’.” Military metaphors also reflect an “entrenched belief that stronger, more arduous treatment must be better”. She says patients need better information about the potential downsides of treatment.

Many of the drugs cancer patients take are highly toxic. Not only do they make us sick and tired and bald while we are taking them, but they can damage our hearts and other organs, and cause secondary cancers in the years that follow. Although we appreciate the protective instincts that lead our health care professionals to simplify and soft-pedal toxicities, sparing us these scary possibilities is fundamentally untruthful and leads to decisions in which we do not fully participate and may later regret. What we really need are the tools that can help us make sense of potential benefits and potential harms.

Similar themes are also raised (Chapter 18) by Gary Schwitzer, publisher of the watchdog website, Health News Review. While his critique of health journalism is familiar and largely depressing, he also describes increasing opportunities for health journalists to train up in doing a better job of scrutinising evidence. He also says some news organisations are lifting their game, citing the advent of regular columns devoted to evaluating the evidence in new studies or analysing claims made about benefits of health care interventions, including the Wall Street Journal Research Report.

He says: “These are small but encouraging signs of progress. By publishing regular columns, these news organizations are delivering a powerful message to their readers that evidence must be scrutinized and that claims of efficacy and safety in health care interventions must be evaluated carefully.”

The guide also includes an interesting chapter from Dr Nancy Ostrove, who previously worked at the FDA, and makes many points relevant to Australian health agencies and regulators.

She says there are many barriers to ensuring the public have evidence-based information, including that evidence inevitably evolves and is often uncertain, and is built from imperfect methodologies. She says: “For example, the decision to approve a sponsor’s request to market a new prescription drug, biologic, or novel medical device relies on data from randomized controlled clinical trials. These data enable clear inferences about causality, but only for the populations, circumstances, and specific questions studied. Uncertainties remain about how well the data predict a product’s effectiveness and safety when prescribed and used under real world conditions – in untested populations and circumstances.”

She also says it is a challenge for the FDA to be perceived as trusted and credible given that its operations rely on sponsors’ fees – an issue regularly also highlighted as a concern about the TGA. She says some members of the public believe the “FDA is now too dependent on industry and cannot be trusted to give independent reviews”.

Other constraints affecting the FDA’s ability to communicate include laws protecting sponsors’ intellectual property rights. As a result, FDA often cannot communicate about a certain product without the sponsor?s prior approval.?

One snippet in the book that I found quite alarming – particularly given that there is a chapter on shared decision making – was in a section about the benefits of regular cervical cancer screening. One of the authors wrote:? ?The public health imperative for adult women is clear: Get screened. Indeed, many doctors feel so strongly about this that they withhold birth control pills until women get their annual Pap screening.? ?It was odd to see such a bombshell without any wider ethical discussion.

Meanwhile, other interesting snippets/quotes from the report:

? Approximately 50% of Americans cannot accurately calculate a tip (from a section on health literacy and the failure of much health communication).

? Playwright George Bernard Shaw famously commented: The single biggest problem in communication is the illusion that it has occurred.

? “The core lesson learned is that the intended users (of health communication) must be co-creators and testers of the communications.”

? The Centers for Disease Control and Prevention (CDC) offers a free online overview course Health Literacy Training for Public Health Professionals.

If any Croakey readers have feedback about the guide, please share your comments below. As you can see below, there has already been some Twitter-based critique.

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Update: Thanks to the Croakey reader who promptly sent in a link to this August 14 article on the Peter Sandman Risk Communication website, Explaining and Proclaiming Uncertainty: Risk Communication Lessons from Germany’s Deadly E. coli Outbreak.

The article deconstructs the outbreak and related public communications and media coverage in considerable detail. It says the four lessons from this case study are:

1. When talking about uncertain risks, you have to do more than acknowledge the uncertainty. You have to proclaim it. This is new knowledge for us, after decades of simply advising clients to acknowledge uncertainty.

2. You have to do more than proclaim that you are uncertain; you have to proclaim how uncertain you are – where you are on a scale from “I’m taking a shot in the dark here” to “I’m almost certain but there are still a few remaining doubts to clear up.”

3. And you have to distinguish your level of uncertainty now from your (or other people’s) level of uncertainty earlier. “This isn’t like when the Hamburg Institute thought it might be Spanish cucumbers.” “We have a lot more evidence linking the outbreak to sprouts today than we had just a few days ago.”

4. Finally, you have to do it all in a way that comes across as human. “We wish we could nail the source of the outbreak with certainty. That’s what consumers want. It’s what the food industry wants. It’s what we want. We may get close closer than we are today. But total certainty, sadly, is beyond what epidemiology can accomplish.”

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