Associate Editor’s Commentary: PEEKABOO—ETASU!

Risk management cannot exist without a more holistic understanding and acceptance of the ‘‘Responsibility of Risk.’’ Risk management means more than Risk Evaluation and Mitigation Strategies (REMS) and tactics, and more than validated methodologies and therapeutic registries. It is not about the management of risk, but assuming the mantle of responsibility. Risk management cannot solely be about doing what is necessary to get a product approved and abiding by outdated adverse event reporting mechanisms. We need more than MedWatch and MedGuides. Accepting the responsibility of risk means that we must stop being translucent and start being transparent. Risk management is more than just doing what we’re told, of being in compliance. We know better. The responsibility of risk is a shared responsibility. It must be more than what the FDA expects from industry and more than what industry expects from the FDA. It is what all parties to the public health conversation must expect from themselves, which means going far beyond anything to do with marketing or sales or stock price or legislative authority. It means doing what’s right in addition to what is required. The responsibility of risk, therefore, means doing what’s in the best interest of the patient fully and completely and beyond what is required—even when it is contrary (or viewed as such) to short-term sales and marketing objectives. If we allow either profit or politics to trump the best interests of the public health, we should change jobs. Abraham Lincoln said that patents ‘‘add the fuel of interest to the passion of genius.’’ To paraphrase, accepting the responsibility of risk adds the fuel of interest to the passion for serving the public health. The responsibility of risk means appreciating and actualizing the philosophy of the safe use of drugs. For example, the responsibility of risk means not just detailing—but detailing the label. Traditional risk management means finding ways to avoid risk, to mitigate it. That is certainly important, but it’s tactical— and very 20th Century. In the 21st Century we have to invent new strategies, which starts with embracing risk just as we embrace benefit. Otherwise all we are left with is an inadequate system of early safety signal communications. The responsibility of risk is global. Acknowledging the responsibility of risk means embracing the urgency for harmonized global pharmacovigilance. Other than that, it’s pretty easy and straightforward.