Date: 2002/01/13
Sunday Page: 001 Section: BUSINESS Edition: FINAL Size: 607 words
Acne drug a PR hurdle for Roche Treatment has been a constant headache
By ED SILVERMAN STAR-LEDGER STAFF

It was the last thing Hoffmann-La Roche wanted to hear. Three days after a teenage pilot crashed an airplane into a Tampa, Fla., office building, investigators said they had found a prescription for Accutane in his home. The disclosure put Roche, which is based in Nutley, back in the spotlight. Accutane is one of the company's biggest sellers - and biggest headaches. The drug racked up $771 million in sales in 2000, though it continues to be dogged by links to suicide.
Four years ago, regulators forced Roche to put a warning on the Accutane label. Lawsuits and congressional hearings followed. Michigan congressman Bart Stupak appeared on "The Today Show" and blamed the drug for his son's suicide.
The questions and accusations remain, even though there is no scientific evidence to establish a link between the drug and suicide. And as Roche disclosed this week, Accutane patients are statistically far less likely to commit suicide than all other people aged 15 to 24.
Now, with the controversy flaring again, Roche faces a public relations challenge. Given that Accutane is targeted primarily at teenagers, experts suggest Roche become more aggressive in disclosing suicides and improving outreach to parents and teenagers.
"This is going to be a problem," said Al Ries, a corporate image consultant. "Certainly, the crash will probably exaggerate the reaction. But now every parent whose kid is taking it will wonder whether it will be a problem for them, too.
"In public relations, there's a time to shut up and a time to speak up," he said. "They've got to be upfront with everybody and show the numbers. They're going to have to do everything they can to warn teenagers about the possibility of suicidal thoughts." Roche isn't the first big drug maker to face such a PR crisis regarding a medicine. Several years ago, Eli Lilly & Co. was plagued by concerns Prozac may cause patients to become violent. The antidepressant was even the focus of a sensational murder trial in Kentucky in 1994. The standard by which companies often are judged in reacting to these problems is the famous Tylenol disaster. After tampering was discovered, Johnson & Johnson recalled the product, worked closely with authorities and ran extensive ads to reassure consumers.
In response to the Florida crash, a Roche spokeswoman noted that the drug maker recently changed its advertising, began providing informed consent forms to patients and is working with regulators to design a new clinical trial to generate fresh scientific data. "It's really not appropriate to comment on this individual," the spokeswoman, Carolyn Glynn, said.
"But the issue is just as complex today as it was before. And we're continuing to make this a high priority. We certainly take each report seriously. "We're not alone in being puzzled that there's a link - the scientific data doesn't support it, and the scientific experts don't support it. But ensuring the safety and effectiveness of this drug is of critical importance to us." To date, Accutane has been associated with 138 suicides, here and abroad, according to regulators. However, Glynn said the rate of suicides among Accutane users is 1.8 for every 100,000 patients.
This compares with 10.3 suicides for every 100,000 people aged 15 to 24, according to 1999 data from the American Association of Suicidology. Still, "any time you have a product linked to death, it becomes a huge problem for a company," said Steve Fink of Lexicon Communications, a crisis-management expert. "That's the bottom line to watch here." NOTES: Ed Silverman can be reached at esilverman@starledger.com or (973) 392-1542. Etc. BOX: "In public relations, there's a time to shut up and a time to speak up." - AL RIES, corporate image consultant TAG: 2002-3c41e8efa URL: Acne drug a PR hurdle for R