I had the honor and pleasure of chairing the 4th Annual Risk Management and Drug Safety Summit. Here are my opening remarks from Day One (today):
Risk management cannot exist without a more holistic understanding and acceptance of the Responsibility of Risk.
Risk management means more than REMS strategies and tactics, more than validated methodologies and therapeutic registries. It’s not about the management of risk -- it’s about assuming the mantle of responsibility.
Risk management can’t just be about doing what’s necessary to get a product approved and abiding by prehistoric adverse event reporting mechanisms. It’s got to be more than MedWatch and MedGuides. Accepting the responsibility of risk means that we must stop being translucent and start being transparent. It’s more than just doing what we’re told, of being in compliance. Because we know better.
The responsibility of risk a shared responsibility. It must be more than what the FDA expects from industry and more than what industry expects from the FDA. It’s what all parties to the public health conversation must expect from themselves. And that goes 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 fault, dear Brutus, is not in our stars, but in ourselves.”
Let me repeat -- the responsibility of risk means doing more than what is in compliance. The responsibility of risk 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. When we allow either profit or politics to trump what’s in the best interest of the public health – we might as well be selling air conditioners.
Principles, as my father taught me, don’t count until they hurt.
Abraham Lincoln said that patents “add the fuel of interest to the passion of genius.” Well, 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’s important, but its tactical – and very 20th Century. In the 21st Century we have to invent new strategies. And that starts with embracing risk just as we embrace benefit. There should be a journal dedicated to the science of risk – a medical Kabala of Contingency. Otherwise all we’re left with is the anemic and feeble compost of early safety signal communications.
And the responsibility of risk is global. Acknowledging the responsibility of risk means embracing the urgency for harmonized global pharmacovigilence.
Other than that, it’s pretty easy and straightforward.