Have We Become Risk-Adverse – or Risk-Aware?

07 Apr Have We Become Risk-Adverse – or Risk-Aware?

The New England Journal of Medicine published a perspective piece recently on the changing perceptions of pharmaceutical drug safety. As one drug after another comes under significant scrutiny, the regulatory structure – the FDA – is under increased pressure to "do something" about safe drugs.

Where does this call for action come from? As information dissemination is quick and cheap these days, the reports of adverse events can spread like wildfire. Though FDA investigations may drag out, swayed public opinion may be enough to avoid some harmful effects while the investigation proceeds.

Yet somehow this isn’t enough. We don’t necessarily want zero-risk drugs, but we do want to separate the noise of frenzied public opinion from the actualized harms. It’s not that we’re risk-adverse – it’s that we’re risk-aware.

I received an email from a 15 year old girl concerned about this exact issue last week. She closed her email with the simple "what can be done about this issue??" and all I could say to her was to report the adverse event to the FDA, and to talk with her doctor about the event. (The FDA maintains a large database full of specific adverse events associated with various drugs, a major resource in recall and additional warning decisions).

But shouldn’t we work instead toward preventing adverse events, rather than reactively tamping down or disallowing a particular drug’s use? Why allow the drug to be disseminated, both physically to patients and to doctors? Surely our medical doctors have more to do than keep up with the daily flood of drug interactions, FDA decision-making, warnings, and recalls. (An aside: if you’d like to witness the flood I speak of, visit the FDA website and subscribe to their RSS feed for food and drug warnings. But don’t say I didn’t warn you.)

NEJM advocates several steps to change:

• Better scrutiny of the clinical trial data in order to tease out false safety signals
• Allow the FDA to refuse, revise, and revoke drug licenses
• Switch from a qualitative description of drug benefits ("enjoy a better life!") to a quantiative description of drug benefits ("37% of users experienced a reduced symptom when compared to a placebo")
• Match the quantitative benefits of a drug with the quantitative risks of the drug across various populations

We think this may be a good start to avoiding a future of Vioxx, Phen-Fen, Avandia, Chantix, Traysol, Zelnorm…the list goes on and on.