Healthy Skepticism Library item: 12457

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Pettypiece S.
Schering-Plough, Merck Probed Over Ads for Vytorin
Bloomberg.com 2008 Jan 16
http://www.bloomberg.com/apps/news?pid=20601087&sid=a7OG9SnYNm7w&refer=home

Full text:

Schering-Plough Corp., Merck & Co. and U.S. regulators were asked by lawmakers for records about advertising for the cholesterol pill Vytorin after a study showed it may not be more effective than an older, cheaper drug.

Representatives John Dingell and Bart Stupak, Michigan Democrats, sent letters today asking Food and Drug Administration Commissioner Andrew von Eschenbach and executives of the drugmakers for documents on the marketing campaign for Vytorin. The medicine combines the older drug, Merck’s Zocor, with Schering’s Zetia.

The requests expand a probe begun last month into whether Schering and Merck improperly handled results from a study of Vytorin. The companies released data this week from the study, completed almost two years ago, showing Vytorin reduced plaque no better than Zocor alone. Vytorin accounts for about 70 percent of Schering’s profit and Zetia is 22 percent of Merck’s; the two drugs had about $5 billion in worldwide sales last year.

``Given the frequency of Vytorin advertisements, it concerns us that a study showing that Vytorin provides no increased benefit was not issued for nearly two years while direct-to- consumer advertisements were carried on the airwaves,’‘ Dingell and Stupak said in a letter to the companies’ chief executive officers.

``This situation raises concerns that the drug companies and their advertisement agencies profited at the significant expense of patients’ health,’‘ the lawmakers said in the letter.

Schering fell 29 cents, or 1.2 percent, to $23.49 at 4 p.m. in New York Stock Exchange composite trading, and Merck gained 17 cents to $58.35. Schering’s stock price has fallen 15 percent since the results from the study, called Enhance, were released Jan. 14.

Consumer Ads

The companies spent more than $200 million advertising Zetia and Vytorin directly to consumers, according to Nielsen Monitor- Plus. The Vytorin television ads, among the most frequently aired, feature people dressed to resemble food items to show that the drug works to lower cholesterol from food as well as that produced naturally by the body due to genetic makeup.

The congressmen are also asking for all communications between the companies and the primary researcher on the study, John Kastelein. They want to know why Kastelein wasn’t present when an outside advisory panel made a controversial decision to change the Enhance study’s goal after it was completed.

The company-sponsored study measured the thickness of the carotid arteries of 720 patients with a predisposition to high cholesterol who took the largest dose of Vytorin over two years. It found ``no statistically significant difference’‘ in plaque buildup in the arteries between those on Vytorin or simvastatin, the chemical name for Zocor, the companies said. A blocked carotid cuts blood supply to the brain, and can cause a stroke.

More Than Zocor

Vytorin lowered cholesterol levels significantly more than Zocor, which is available in low-cost generic form, though that didn’t translate into other health benefits. Patients getting Vytorin had more plaque buildup in their arteries and were more likely to die or suffer heart complications, though the differences between the two groups were small and may have stemmed from chance, the study found.

Doctors became concerned about the study findings after Merck and Schering put out a statement in November saying they would change the main goal of the trial once all the data were collected to expedite the results. They later reversed course, saying they would report all data on the study at a March meeting of the American College of Cardiology, about a year after the results were initially expected to be reported.

Schering said it took longer than expected to analyze the data and that the negative results may be a fluke because of how the study was designed. Schering spokesman Lee Davies said this week that the study looked at Vytorin’s effect on a rare group of patients, those with a specific genetic condition that makes their bodies produce too much cholesterol.

The patients had very thin artery walls because they had previously been taking other cholesterol-lowering pills.