Class-action lawsuits have begun against Vytorin, a combination of cholesterol drugs Zetia and Zocor. Though the drug is safe for consumers, a study released last week showed that neither drug reduced the buildup of fatty plaque in arteries. The two-year study of 720 patients with hereditary high cholesterol was completed in 2006, but Merck and Schering said they didn't release it for nearly 21 months due to the complexity of the data and their own scientific concerns, which led them to do more research.
The drug makers bought an ad in Sunday's New York Times and another in today's USA Today, among other local newspapers. On one page, the ad states: "Are you taking Zetia or Vytorin? If so, you may be worried about recent news stories questioning the benefit of these medicines ... on the basis of a single study that has generated a lot of confusion."
|This Vytorin ad ran in Sunday's New York Times and in today's USA Today, among other local newspapers.|
Schering-Plough did not respond at press time to inquiries as to how long the print execution would continue, or whether the drugmakers would also run accompanying TV or radio campaigns. The marketers have a microsite where consumers can find information about the study, and the same print ad that appeared in the Times and USA Today is also on the website in the form of a PDF. The agency for the print push could not be determined at press time, but the consumer ad agency for Vytorin is Omnicom Group's DDB Worldwide, New York.
The ad goes on to say that the American College of Cardiology and the American Heart Association agree that lowering bad cholesterol is important, and is signed by Dr. Richard Murray, VP-external medicine and scientific affairs for Merck, and Dr. Richard J. Spiegel, chief medical officer, Schering-Plough. The facing page of the ad contains fair balance information regarding risks and benefits.
Lowers 'bad' cholesterol
That Vytorin continues to lower LDL, or the "bad cholesterol," is not in question. And the drug is indeed safe, unlike Merck's Vioxx, an anti-inflammatory that was found to have increased the risk of heart attack and had to be pulled off the market several years ago.
But the study found that neither Vytorin nor Zetia were any better than generic Zocor in reducing the buildup of fatty plaque in the arteries.
In little more than a week since the study was released, the two companies have taken a beating in virtually every circle, including from medical doctors incredulous that the drug makers sat on the study for more than 18 months; at least two U.S. congressmen who are calling for an investigation into why the "massive advertisement campaign for Vytorin was allowed to continue"; and the general public, still somewhat leery of direct-to-consumer advertising.
Add to that Wall Street, where Schering shares dropped from $27.73 on Jan. 11 (the last business day before the report was released) to $21.28 on Jan. 18, four days after the report was released, and the day CEO Fred Hassan said he would personally buy back $2 million worth of shares. The stock was trading at $20.64 early this afternoon, a loss of 25% from the Jan. 11 close.
Vytorin is part of the lucrative $18 billion cholesterol drug market that includes market leader Lipitor, from Pfizer, and AstraZeneca's Crestor. Vytorin notched $1.5 billion in sales through the first nine months of 2007, according to pharmaceutical research group IMS Health, and Zetia brought in $1.3 billion in sales.
$102 million in spending
The drug makers spent $102 million to market Vytorin through the first nine months of last year, according TNS Media Intelligence, and $83 million on Zetia. The TV ads for Vytorin are consistently among the most-recalled by viewers, according to IAG Research. The campaign from DDB features the opening phrase, "There are two sources of cholesterol -- food and family," and then launches into colorful, quirky vignettes that pair the two elements.
Already, the drug makers are facing legal action over Vytorin. The Great Neck, N.J., law firm Parker Waichman Alonso is one of six firms to have filed a lawsuit seeking, in part, to refund individuals who were prescribed and purchased Vytorin.
The lawsuit alleges the companies misrepresented and withheld significant information in approval submissions and filings with the Food and Drug Administration. It is also claiming the companies misrepresented to the general public the drug's effectiveness in its marketing of Vytorin.