'Very Serious' Allegations

When Vytorin was approved by the Food and Drug Administration in 2004, the drug--which combines Zetia (which decreases cholesterol absorption) and Zocor (a lipid-lowering agent now available in generic versions)--was touted as an attractive alternative to statins like Pfizer's Lipitor, the country's top-selling drug. Because of its unique combination, Vytorin was designed to both inhibit the body's own production of cholesterol and block the body's absorption of cholesterol from food. Sure enough, the drug hit $1.9 billion in sales for 2006, becoming a big hit for the companies behind them, Merck and Schering-Plough.

But there's little doubt sales would have been substantially lower had the companies immediately released unfavorable results from a clinical trial of Vytorin that ended in the spring of 2006. The so-called ENHANCE trial, made public this week, found that Vytorin was no more effective than using the generic version of Zocor (simvastin) alone. The delay in releasing the results has attracted the attention not only of patients but politicians. The House Committee on Energy and Commerce plans to hold hearings in the next several weeks. NEWSWEEK's Jennifer Barrett spoke with Rep. Bart Stupak, a Democrat from Michigan, who chairs the Subcommittee on Oversight and Investigations. Excerpts:

NEWSWEEK: You actually began investigating the delay in releasing results from the ENHANCE study last fall. What brought the Vytorin clinical trial to your attention before the public was informed?
Bart Stupak: We have medical people assigned to the staff who had been hearing rumblings in the medical community. Cardiologists, for example, who might have had a patient or two enrolled in the study had sent the information in a long time ago and never heard back about the results. They were wondering: what happened?

The trial ended in April 2006, but the results weren't released until this month. How have Merck and Schering-Plough explained the delay?
They're used a couple different explanations. They've said they used ultrasound machines to get pictures of the participants' plaque levels [the build-up of cholesterol and other substances that, when found in the arteries, can result in heart disease]. They said the ultrasound images were of poor quality and they were trying to get better quality ultrasound. And they've said they didn't have all the information available and that it was biologically implausible. [Skip Irvine, spokesperson for Merck/Schering-Plough Pharmaceuticals, a joint venture of the two companies, responds: "The rigorous study design and analytical process … was time consuming and took longer than we originally anticipated."]

How could the data be "biologically implausible?"
That comment, to us, was the red flag that their study tanked and they were trying to hide that.

When did the companies register the clinical trial on clinicaltrials.gov?
They may have done the basic outline in October [2007] but they didn't put out a release until Jan. 14. They registered the study but not the results.