Last week, the Journal of the American Medical Association published a critical piece, titled “Restoring Confidence in the Pharmaceutical Industry.” It laid out a set of four generally common-sense solutions (with one exception) that would indeed bolster faith in data, if nothing else.
The piece called for independent data analysis, independent drafting of publications and public dissemination of data to qualified investigators, all efforts that are ongoing in the industry. The final recommendation was a suggestion that direct-to-consumer advertising be delayed until some point after a drug’s approval, an evergreen topic of debate.
But it wasn’t the black-letter guidance that make the piece worth reading. It’s a single paragraph, presented without any recommendations, that might be most important when considering how to “restore confidence”:
The pharmaceutical industry is confronted by other challenges. Society has become increasingly risk adverse, and patients are less tolerant of even rare adverse outcomes, which may not be detected even in large-scale randomized clinical trials designed as “efficacy studies,” with highly selective populations. But because virtually no drug is entirely safe, rare adverse events are inevitable, and some serious adverse events might not manifest until the drug is used in less carefully selected ‘effectiveness’ patient populations that characterize clinical practice. (Emphasis mine.)
All drugs carry some risk, the question is whether the benefit of treatment is enough to outweigh those risks. This is a dynamic process: some individuals may find, either because of the variation of disease, the variation of genetics or the variation of risk tolerance, that a certain medication isn’t worth the tradeoff. Others may come to
the opposite conclusion. It’s a delicate dance, done in partnership with a health professional; it’s no coincidence that the U.S. Food and Drug Administration sometimes goes years without letting a prescription drug be sold over the counter.One of the fundamental challenges, then, for those of us who work in this industry is trying to educate the public about risk, both what we know and what we don’t know. This isn’t easy work. There is a tendency for people to overestimate rare risks and discount common ones. Understanding variations and confounding information is also difficult, and it is made more so when there is – as is common – incomplete information.
Just because those discussions are difficult doesn’t mean we should avoid them. Every company should be ready for a full discussion of risk with every stakeholder: patients, providers, insurers, advocates, media and other. But this discussion can’t take place in a vacuum. A conversation about risk discussion has to be accompanied by a conversation about benefits. This, too often, gets lost. There is a tendency to talk about a “wonder drug,” ignoring the downside. Then, when new risks emerge, we fail to put those risks into the context of the benefit. No wonder consumers are confused and society is becoming more risk-averse.
Talking about risk is risky, particularly because we, as humans, are so bad at assessing it. But when it comes to restoring confidence, pretending risk doesn’t exist is the riskiest strategy of all.