Balancing benefits and harms in health care

Editor—The theme issue on balancing benefits and harms in health care highlighted the need to create better systems to detect and share information about adverse events associated with newly licensed drugs or drugs used off licence or for indications not supported by evidence from clinical trials.¹,²,³

A new project, CICERO (www.pacehealthsystems.com/cicero.html), proposes to create a global online database to record the outcomes and adverse events related to the use of investigational and newly licensed treatments. The internet offers distinct advantages to paper journals and is not geographically restricted. This is essential because we need to identify potential adverse events early after the global release of new treatments. Unlike clinical trials, internet reporting will be less selective and has the potential to detect events in untested subpopulations. It may therefore generate truer estimates of efficacy and adverse events in the general population.

Figure 1.

Voluntary reporting systems such as the yellow card scheme in the United Kingdom have not proved successful—only 10% of serious adverse drug reactions are reported. The planned NHS information technology program may collect these data in the future, if designed properly, but this program may be dogged by data protection issues, and it is restricted to the United Kingdom. The internet solution should not be hampered by these restrictions, as it can protect patient confidentiality, conform with data protection by using explicit consent from patients, and can be globally targeted to treatments of interest—such as newly licensed drugs.

For this concept to flourish, it requires the support of the medical community; it has to be fully resourced, quality assured, peer reviewed, and free from vested interest. The technology already exists—we are limited only by our lack of imagination.