On Jan. 14, Schering-Plough released preliminary results of its ENHANCE clinical trial, finding that Vytorin (Zocor/Zetia) did nothing more than generic Zocor alone to slow the progression of plaques—in the carotid arteries of a smallish number of patients with a familial form of hypercholesterolemia who had previously been on statins.
Unfortunately for the manufacturers, most consumers—and seemingly many doctors—never got beyond the hyphen in that last sentence.
The press was awful, and often confusing or overly simplistic. But one thing was clear: Merck and Schering-Plough were the bad guys in the media narrative.
This was true, in part, because the companies sat on the results of the two-year study—completed in 2006—and contemplated switching the clinical endpoint, freezing out the lead investigator in the process and fueling suspicion among reporters. Merck and Schering-Plough explained that their interpretation of the results had taken longer than expected due to the difficulty of reading the 30,000 ultrasound images of carotid arteries and 10,000 images of femoral arteries.
Could earlier disclosure of the findings—and/or the reasons for the delay in presenting data— have helped mitigate the damage to the brands? Hard to say, said communicators, though all agree that the greatest possible transparency is always best.
“We all have to be asking ourselves: Are we being as forthcoming as we could be?” said Susan Isenberg, EVP, Edelman Health in New York. “Because the bar is set so much higher with the swirl of events in the last 18-24 months —not only in healthcare but in the world of business generally.”
Pharmas with unhappy news to communicate start out at a deficit, said Mike Rinaldo, senior partner and co-chair of the global health practice at Fleishman-Hillard. “Right now, the lack of trust between the public and the industry is such that there's a rush to judgment and any little misstep, people tend to believe the worst,” said Rinaldo.
And while companies may strive for greater transparency, sharing evolving data from a complex trial like ENHANCE is no simple matter. “Situations like this are never as black and white as they're portrayed in the media,” said Rinaldo. “A company has to share data in a responsible way, and in full context. A data release is always an incredibly complicated situation. There's a lot of people involved, a lot of moving parts you're trying to coordinate, and doing what's in the best interest of everyone involved isn't always the clear path it might seem to be for those on the outside. ”
Another factor is the news media's love of a good scandal story —and its increasing disdain for in-depth reporting on complex scientific matters. One agency PR exec who attended the ACC told me her client was all but shut out of coverage, despite presenting important trial results, by the focus on Vytorin. “Why did The New York Times send just a business journalist and not a science reporter?” she fumed, “Because science has become a business, but at the end of the day, this is a medical conference!”
You can chalk that up, in part, to the decades-long downsizing of newsrooms. Big pharmaceutical companies make for great villains when harried reporters on tight deadlines go casting stock characters.
And then there's the old newspaperman's maxim: If it bleeds, it leads. ENHANCE-gate has been a bloodbath for Merck and Schering-Plough. Whether the wounds were self-inflicted or caused by Congress, the press and a few influencers in the medical community will probably be the topic of case studies for years to come.