Vytorin Study Shows it is no Better Than Generic, Congressional Investigation Continues

By January 16, 2008Drug Safety

After a two-year wait, the makers of the cholesterol drug Vytorin finally released the results of a study that showed the drug is no better than the generic for reducing plaque buildup in the carotid arteries. In fact, Vytorin did slightly worse. And Vytorin is ten times more expensive than the generic alternative.
Vytorin combines the cholesterol drug Zetia and generic statin drugs. It is jointly marketed by Merck and Schering-Plough. The results were released from a study known as the ENHANCE trial which ended nearly two years ago.
In an interview with WebMD, Dr. Steven E. Nissen, a cardiologist, chair of cardiovascular medicine at the Cleveland Clinic, and past president of the American College of Cardiology, called the findings a “stunning reversal for Zetia and Vytorin.”
Nissen added:

“Zetia works only by blocking the absorption of cholesterol, but it has not been shown to produce any health benefits. I have been skeptical of these drugs from the beginning because I wasn’t sure that Zetia’s mechanisms of cholesterol lowering would produce the same benefits we see with statins.”

This amounted to the second piece of bad news for Vytorin. A congressional committee recently launched an investigation into the reasons behind the delay in releasing the study results.
Rep. John Dingell, D-Mich, and Rep. Bart Stupak, D-Mich, the leaders of the investigation for the Committee on Energy and Commerce subcommittee, issued a joint statement after the study results were released.
Dingell said:

“Today’s announcement that the ENHANCE study failed to find any positive benefit from the addition of Zetia to a common, inexpensive, generic therapy raises concerns that attempts were made to mask the minimal value of this new drug. Additionally, Merck and Schering-Plough’s delay in releasing study results, as well as their attempt to manipulate the data is, quite frankly, suspicious.”

Stupak added:

“In light of today’s results, which were released nearly two years after the ENHANCE trial ended, it is easy to conclude that Merck and Schering-Plough intentionally sought to delay the release of this data.”

The congressmen vowed to press on with the investigation.
This study and the investigation highlight on ongoing problem in the pharmaceutical industry. Drug companies understand that once the patent on a prescription drug expires profits drop. To boost income and fight off generic competition, drug companies may combine the effective generic drug with a new prescription drug and market the combination as more effective than the stand-alone generic alternative. As the study in Vytorin shows, those claims don’t always hold up.