The Responsibility of Risk

  • by: |
  • 11/01/2011

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.

Thank you.

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

Blog Roll

Alliance for Patient Access Alternative Health Practice
AHRP
Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog