Information revealed last month to a Congressional committee relating to drug trials is very disturbing. The lead outside investigator on a crucial trial of two widely used heart drugs said in an e-mail message last July that Merck and Schering-Plough, the companies that make the drugs, were deliberately delaying the release of the trial results “to hide something.” The companies failed to release the preliminary results of the trial, called Enhance, until January. That was almost two years after the trial was finished. When the results from the trials were finally released, they showed the drugs, Vytorin and Zetia, did not work to reduce plaque in arteries.
The results led a panel of cardiologists to recommend that the drugs be used only as a last resort. The new information was contained in e-mail messages to executives at Schering-Plough that were released on March 31st by Senator Charles E. Grassley of Iowa, the ranking Republican on the Senate Finance Committee. The committee has been investigating the delay in the release of the Enhance trial results. The controversy over the way that Merck and Schering-Plough handled the Enhance trial, as well as their heavy promotion of Vytorin and Zetia, has made lots of folks in the medical community very uneasy. The drugs are used to lower cholesterol and are among the most widely prescribed medicines in the United States, with sales of $5 billion last year.
The Enhance investigator, Dr. John J. P. Kastelein, also complained last July that Merck and Schering had failed to consult him on the reasons for the delay. He threatened to resign as the main study investigator. As we know from the barrage of television commercials, Zetia lowers cholesterol by blocking its absorption in the intestine. Vytorin combines Zetia with simvastatin, another cholesterol-lowering drug, which is sold under the brand name Zocor. Dr. Kastelein, a Dutch cardiologist and scientist, was hired by Merck and Schering to conduct the Enhance trial. The trial consisted of images of the arteries of 720 patients taking either Vytorin — the combination of Zetia and Zocor — or Zocor alone. Because Vytorin lowers cholesterol more than Zocor alone, apparently the companies believed that the trial would show that patients who took Vytorin had less growth of plaque in their arteries than those who took Zocor. It’s widely known that arterial plaque is closely correlated with heart attack and strokes.
The trial ended in April 2006, and its results were initially expected in late 2006 or early 2007. But the companies repeatedly delayed releasing the results of the trial saying publicly that many of the images of the arteries were unclear and might need to be re-examined. That excuse is now highly suspect. According to his email messages, Dr. Kastelein had by July 2007 become upset with the companies for the delays. The next day, according to the text of the messages released by Senator Grassley, Dr. Kastelein complained that the companies seemed to be trying to slow the release of the results by including data that was not relevant and would take more time to compile. Dr. Kastelein’s messages have raised new concerns over the nearly two-year delay in the release of the Enhance results.
Dr. Krumholz and three other cardiologists told more than 5,000 people at the annual American College of Cardiology scientific convention that Vytorin and Zetia should not be used except as a last resort. The two major cardiology associations seconded those recommendations. The proof that a drug actually cuts the risks of heart attacks and strokes requires an expensive, multiyear clinical trial enrolling 10,000 or more patients. Those studies, called “outcomes trials,” have been conducted for statins. As you know, they proved that patients taking statins do have a reduced risk of heart disease. Interestingly, no such outcomes trials exist for Vytorin and Zetia. In 2006, four years after Zetia reached the market, Merck and Schering began enrolling patients in their own outcomes study, which compares people taking Vytorin with those taking Zocor alone. But the results of the trial are not likely to be available until 2012, or possibly later. I am not sure what the FDA will do as a result of this controversy, but the agency has an obligation to look into the matter. After all – the FDA is supposed to protect public health and safety when it comes to drugs.
Source: New York Times
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.