A key cardiologist who worked with Merck and Schering-Plough on a comprehensive study on their joint drug Vytorin has begun to speak up about an apparent intentional delay in releasing the research, which showed the $5 billion a year drug was no better than a much cheaper generic.

James Stein, a cardiologist at the University of Wisconsin, who served in an expert panel in the two year ENHANCE Study, has opened up to Forbes about the dubious way in which the data was handled. ENHANCED eventually failed to provide evidence that the ezetimibe/simvastatin combination found in Vytorin was better than simvastatin alone. Simvastatin has already reached generic status and is thus much cheaper.

The researchers, led by Cynthia Jackevicius of the Western University of Health Sciences in Pomona, California, analyzed the effectiveness of ezetimibe, an ingredient that was combined with statin to form Vytorin. Statins are a class of drug that reduce the amount of cholesterol produced in the body, and protect people from heart disease.

Since ezetimibe was combined with statins in July 2004, a large advertising campaign started, which led to an increased number of prescriptions of Vytorin in the US. The cholesterol pill produced by Schering-Plough Corp. and Merck & Co. was prescribed 20 million times last year.

But manufacturers Merck and Schering-Plough announced that the combination did not have results as good as the treatment with statin alone. Although Vytorin did indeed lower LDL levels in some patients, it failed to slow down the progression of cardiovascular clogging as measured by ultrasound.

“I’m an honest guy, and my first obligation is to tell the truth,” Stein told Forbes in an exclusive interview. “Even if it means I’ll probably never get to do a scientific investigation with Schering-Plough again.”

What apparently happened is that the two companies delayed releasing the study in order to avoid damaging their successful cholesterol franchise. It's enough to mention that the Enhance trial had finished back in 2006, and the data weren’t made public until January of this year.

Meanwhile, House of Representatives Energy and Commerce Committee Chairman John Dingell and Rep. Bart Stupak, both Democrats, raised questions about how the two pharmaceutical companies have produced minutes of a key meeting on the drug quite a while after the meeting actually took place. The participants were informed that no minutes or transcripts would be produced, and none were.

However, when later the two companies were questioned by the FDA about the minutes, they wrote them in several stages. "Some parts of the minutes do not accurately reflect the divergence of opinions expressed at the meeting," Stein wrote about the minutes. Merck said that Stein had seen an early draft and the final version provided "a reasonable reflection of what happened" at the meeting, Reuters reports.

The advertising campaign for Vytorin was stopped while the US congressional committee is investigating whether the two companies were aware of the results for a long time before admitting the drug was ineffective.