Vytorin Study Causes Media Stir, but Are the Concerns Justified? - Pharmaceutical Executive

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Vytorin Study Causes Media Stir, but Are the Concerns Justified?


PharmExec Direct

Merck and Schering-Plough's announcement last week that Vytorin did not show any evidence of reducing fatty plaque buildup in veins and arteries stirred up a lot of complaints from industry pundits who felt that the public was misled by pharma.

There's only one hitch: The two pharma companies never stated that the drug, a cholesterol-lowering combination of Zocor and Zetia, had an effect on plaque.

Pharm Exec. "Vytorin has no benefit versus Zocor in reducing plaque. We don?t even know the relevance of that. The drug was approved for LDL, and it lowers LDL."

The terse reaction comes after the two companies released the results of ENHANCE, a study designed to determine whether the drug could be used to break down plaque buildup. Turns out, it cannot.

However, Vytorin has shown that it can lower LDL more than Zocor, which was the original basis of its FDA approval.

"But why shoot for logic or facts and get in the way of a good drama?" Ryan said.

In addition, Advertising Age on Monday ran with the headline "Vytorin Ad Shame Taints Entire Marketing Industry," with a story stating that the results of the study could lead to a PR disaster. However, at least one expert disagrees.

"The point that the advertising makes is that cholesterol comes from two sources—genetics and foods," said former FCB Health head Mel Sokotch. "Vytorin stops both sources of cholesterol. The Zocor part of the equation works on the cholesterol that the liver produces, and the other component inhibits the body from absorbing the cholesterol that comes by way of food. It works two ways, and that is the way it positioned."

But the damage might have already been done in the court of public opinion. Just as Chantix was lambasted on blogs after reports of psychotic episodes came to light, so too could Vytorin be subject to mass public complaints from patients who feel they have been misled.

"Big Pharma brought the consumer into the dialogue with DTC advertising," said Todd Thiessen of agency Avenue A|Razorfish. "Now it must accept the fact that conversations once limited to the medical community may end up as headlines in the popular media.

"Just as patients can't fully grasp the benefits and risks of a drug from a 30-second TV spot or print ad, they also cannot fully comprehend the design and outcomes of a notable study from a newspaper headline. Both situations tend to focus on extreme outcomes that generate immediate—and frequently unnecessary—actions."

Update: The Associated Press announced late Tuesday that Merck/Schering-Plough have voluntarily pulled all consumer television advertising for Vytorin and Zetia, citing "mischaracterization and misinterpretation of the enhanced trial results." No word on how long the ads will remain off the air.

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