Nothing is beyond consideration, it seems. In a series of hastily arranged interviews to do as much damage control as possible, Schering-Plough execs are scrambling. And so Fred Hassan, Schering-Plough's ceo, tells
The Wall Street Journal that he doesn't have immediate plans for big changes, but "we will take tough actions if tough actions are needed...If revenues are going to be permanently impaired, then we would need to size the company to line up with that size." In other words, more layoffs.And Deepak Khanna, general manager of the Merck/Schering-Plough joint venture that markets Vytorin and Zetia, told CNBC that a letter is going out to docs to explain their view of the Enhance study, which was skewered by Yale University's Harlan Krumholz in a panel at the American College of Cardiology conference on Sunday. He flatly suggested Vytorin should no longer be considered first or second-line therapy, helping to send Schering-Plough shares down 26 percent and Merck shares down 15 percent.
"We're very disappointed we didn't have the appropriate scientific debate or discussion at ACC," Khanna complained to CNBC, adding that the drugmaker will also lobby managed care and pharmacy benefit managers to maintain Vytorin's formulary status. "Our sales force and medical-affairs group have been well prepared about what this study is and how to talk about it. We're going to be very transparent and make sure physicians have all the information they need to understand that lowering LDL is an important goal." Here's the video.
The irony is that Khanna emphasizes the word transparent. That's the last description many would use to describe the way Schering-Plough and Merck handled the Enhance study of Vytorin - they delayed releasing the study for nearly two years; never appointed an independent board; briefly changed the primary endpoint without consulting the primary investigator, John Kastelein; and some Schering-Plough execs sold huge amounts of stock. Congress, as you may recall, is now conducting an investigation in search of - transparency. Of all things.
5 Comments
Khanna's outrage is miniscule compared to the outrage that every physician should have in regard to the way Merck and Schering tried to 'manage' their way out of a less than significant drug trial. Who would believe anything these people have to say at this point?
This does seem bad.
Drugs have risks and benefits. In this case SP and Merck took a long time, too long a time, to fess up to the whole story on the benefits (or lack thereof). It's behavior like this that drags the whole industry down.
Busted!
The focus on lowering LDL easy to sell ;as opposed to clinical event reduction is what allows this to occur
This study didn't even look at "clinical event reduction." It examined plaque build-up, as a sort-of theoretical bridge between LDL and heart-attacks.
It takes a long time to get a drug approved, and all during the approval process a company's buring patent life. I don't have any problem with the FDA approving drugs based on well-established biomarkers. If you actually force the industry to show important clinical changes for some drugs in some theraputic areas pre-approval (like heart-attack reduction), then you really reduce the incentive to innovate.
However, a company has a responsibility to disclose their trial results in a reasonable amount of time. That's where SP and Merck messed up.