With the Oscars upon us, it’s time to reflect on something simple. Our brains store information and make sense of the world in stories. This is true in all cultures, all individuals. “She saved my career.” “They worked it out.” Homo sapiens specialize in stories.
Stories are a more basic currency than money. They define individuals, families and companies. “He had a second wife in Italy.” “The farm was sold.” “We sat on the report for a few years and hoped the Mayo Clinic would never figure out what really happened.”

A Familiar Story
Some of the aspects of stories are technical. They can be tricky for non-storyologists to wrestle with. Some facets or narrative are only taught in graduate-level courses. Fortunately, despite our advanced age, we can dimly remember a few fragments of that curriculum and have summed up a few examples here. Story #1 is pretty simple. Story #2 is what the public is hearing over and over. A replay of Story #3 is the one to worry about.
‘60 Minutes’
We’ve tried to make the slides straight forward even for people who don’t dirty their hands with stories every day, as journalists must. Our hope is that the universe will have mercy and give us a new story, one that diverges from some of the recent drug safety patterns. The drug safety story that is being drummed into the heads of the American public is not ... “diligent scientists save lives.” Sorry. You may listen to that story on your iPod, show that story at company meetings. It doesn’t matter. The world outside the industry isn’t hearing it.
This week, as we were watching the “60 Minutes” segment on Bayer’s anticlotting drug Trasylol, we had a nagging feeling. We felt we had seen the same story about a dozen times. That story, to sum it up briefly, is that a promising anticlotting agent was approved more than a dozen years ago. Academics discovered safety issues. Eventually, regulators pulled the drug. It turned out Bayer had forgotten to tell the FDA about a meta-analysis of 60,000 patients.
People in industry understand that it can take time to determine the risks and benefits of any drug. But it will be impossible for people outside the industry to watch the “60 Minutes” episode and have any confidence in the present system. The present system, for better or worse, produces answers on a timeline that generates a story that is very similar to a lot of other stories. That story’s theme is corporate misconduct. The public is going to keep hearing that story until the industry, the FDA or the Congress fiddle with the knobs and dials on the system.
A Litany
We are story experts. Allow us to state the obvious gently. The cumulative effect of hearing so many different versions of the same story—Trayslol, Zyprexa, Vioxx, Ketek, Fosamax, Bextra, Crestor, Avandia, Vytorin, Zetia, Fidelis—is not beneficial to our industry. It is corrosive.

Seen This Movie?
Although it is true that the industry generates thousands of good medicines that are not the subjects of “60 Minutes” investigations, it is not important in story terms. The story has taken on a life of its own. This worries us a good deal. The life sciences depend on the public’s goodwill in the voting booth and in the clinic where its drugs are tested. That goodwill is being spent freely and may be depleted.
As any story sinks in, as it plays out repeatedly, the natural tendency is the same. As we hear the words “Once upon a time,” we know what follows. These days, as anyone reads the words, “The New England Journal has re-examined the data about ...” they have a good hunch about what will follow. The New England Journal understands the inner workings of a story. It’s not clear whether the industry does.
ClinPage sees a regrettable lack of urgency on discovering ways to reinvent the current pharmaceutical story. We see complacency about whether the story line can be changed. We see resignation and anger at the people telling the story. ClinPage believes a new storyline is possible, and here are three ideas about how to make it happen:
Paper must go. No company in the 21st century can respond quickly to CNN or Public Citizen if all of its data is packed in boxes in a remote warehouse managed by Iron Mountain. There is a perception outside the industry that information is hidden away. Better systems to share that information are urgently needed.
The media must be engaged. Until it presents its case better, the industry will be regarded as ethically challenged. In the similar spirit of “bring your kid to work” days, ClinPage is now offering a one-day “bring a reporter to your conference room” event. This is a mock crisis exercise to help forward-looking sponsors of clinical research understand how real journalists think. Role playing is required. It’s guaranteed to help prepare for a meltdown.

Parallel Universe?
Drug safety tools must improve. In the Trasylol case, 22 months elapsed between the first signal in the New England Journal and the drug’s withdrawal. Twenty-two months is a long time. Putting aside the question of what those 22 months might cost Bayer in legal settlements, they will be more expensive in reputational terms for the industry at large. Pharmacovigilance software simply must be better, whether it comes from the Critical Path research or the private sector.
New stories are possible. But the systems and the approach to bad news will have to change. If the industry continues walking down the same road, it could share the fate of nuclear power. That industry also had federal support. Congressional allies. Good intentions. They weren’t enough.
The people behind nuclear power got caught in engineering-speak, in goobledygook press releases, in a web of true and untrue information, in incidents like Chernobyl and Three Mile Island. At a certain point, the nuclear-is-scary story jelled. The collective narrative was locked down. It was clear to the public that nuclear power was dangerous and that the waste had no place to go. Game over. The end.
For the pharmaceutical industry, our professional view as a storyologist is that there is still time to tweak the story. We need a new lede (a storyologist term). A new character or two. Fresh dialogue. It can be done. But the industry may be so comfortable, so departmentalized that it will continue to let its well-spoken critics tell the story of what it is—and isn’t. That would be a pity.



What a thoughtful story with concrete suggestions for addressing the situation. You’ve done a public service!
»» Posted by: bheffner at February 22, 2008 11:39 AM