The drugmakers suspended the ads for a week after a study revealed the cholesterol med is no more effective than a high dose of Zocor, which along with Zetia is contained in the combo therapy, theAssociated Press reports. The ads tell viewers that about the genetic and dietary causes of high cholesterol - "food and family" - and show "family members" interspersed with food.
"We've made the decision to voluntarily and temporarily suspend direct-to-consumer broadcast advertising in light of mischaracterization and misinterpretation of the Enhance trial results," says Skip Irvine, a spokesman for the Merck and Schering-Plough joint venture, but he declined to elaborate. Zetia TV ads were also yanked, however, he says Vytorin and Zetia print ads will continue.
The Enhance study of 720 patients was meant to show how well Vytorin reduced plaque buildup in neck arteries in people whose genes gave them extremely high cholesterol. Instead, it showed the $100-a-month Vytorin pill was no more effective and perhaps a bit worse than Zocor alone, which is sold as a generic for a third as much. The drugmakers last week released only limited data from the study, which ended in April 2006, under withering criticism that the primary endpoint was briefly changed without the knowledge of the lead investigator.
For their part, Merck and Schering-Plough blamed the delay in releasing the data on the complex analysis, but critics accused the drugmakers of first trying to change how the results were analyzed, then foot-dragging because the two drugs bring in several billion dollars a year.
The drugmakers, by the way, took the rare step of releasing partial results in a press release rather than issuing full data in a scientific journal or medical conference. The press statement was released after a congressional committee began probing the delay, "the use of misleading statements in direct-to-consumer advertisements" and stock sales by Schering-Plough execs. The American College of Cardiology and the American Heart Association quickly put out a statement saying patients should not panic and that further research is needed to determine the best cholesterol-cutting strategy.
UPDATE: In an investor note this evening, Credit Suisse analyst Catherine Arnold called the move prudent: "If the ads will not likely lead to increased prescriptions for the companiesâ€™ brands in the short-term, there is no reason to continue to invest in them until the controversy subsides," she writes. "With the Washington backdrop having a negative bias to industry DTC ads, and in the face of a congressional inquiry that was first concerned with the conduct of the Enhance study and now includes the DTC advertising campaign, continuing TV ads would add fuel to the fire started by members of Congress, (for instance, Bart Stupak) who already feel like the company may not be acting responsibly."