Vytorin records created after the fact

Misleading minutes, swearing execs--just another day at the office for Vytorin's critics. Merck and Schering-Plough face new questions about their controversial Enhance trial as a Congressional committee releases documents that raise "serious concerns" about the companies' delay in reporting the results of that study, which showed that their high-priced combo drug Vytorin did no better at preventing artery-clogging than Zocor alone. The documents--unearthed by the committee in an ongoing probe of Enhance--show friction between Merck and Schering-Plough and questions about why the results weren't reported sooner. At one point, the tensions ran so high, a top Schering exec resorted to, shall we say, colorful language in an email.

But the most obvious question raised by the document dump is this: Why did the companies create minutes for a key meeting--in which experts and company execs discussed changing the study's primary endpoint--a month after the fact? Are those minutes inaccurate, as one participant in that meeting alleges? The minutes suggested that outside consultants recommended changing the endpoint--but James Stein, an imaging expert at the University of Wisconsin, said Merck and Schering-Plough made that choice. "We did not vote on this," Stein said in an email.

Meanwhile, some FDA documents have surfaced, showing just why Merck and Schering-Plough elected to pull Vytorin ads back in January. Apparently, the agency had been asking the joint venture to tone down the ads--which claimed superiority for Vytorin over statin therapy alone--at least since January 23. DTC promotions needed to be revised to show that "Vytorin has not been shown to provide any additional cardiovascular outcome benefits compared to using Zocor alone," the FDA letter said. Reps. John Dingell and Bart Stupak want to know what the company has done to comply--especially given that their deadline is April 24.

- see the M/S-P documents released by Congress (.pdf)
- read the story in Forbes
- see the Wall Street Journal article about the minutes
- check out the DTC item and FDA letters at Pharmalot

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