PHARMACY

Merck, Schering-Plough respond to Congressmen’s issues with Vytorin trial

BY Adam Kraemer

WHITEHOUSE STATION and KENILWORTH, N.J. On the heels of a letter from Rep. John Dingell, chairman of the Committee on Energy and Commerce, and Rep. Bart Stupak, chairman of the Oversight and Investigations Subcommittee, both D-Mich., to the chief executive officers of Schering-Plough and Merck, requesting information about the ENHANCE study trial, both companies have responded.

Merck and Schering-Plough said Monday that they strongly object to mischaracterizations about the ENHANCE trial on their combined medication, Vytorin. “While the ENHANCE trial was time consuming and took longer than originally anticipated to complete, our companies acted with integrity and good faith in connection with the trial. We took numerous actions to assure the quality of the reading of the ultrasound images,” said Thomas Koestler, president of the Schering-Plough Research Institute. The ENHANCE study compared the drug Vytorin to the generic drug simvastatin, both of which are used to treat patients with high-cholesterol. The study showed that Vytorin, which is a combination of Zetia and the generic simvastatin (Zocor), resulted in no significant difference in reduction of heart attacks or strokes when compared to simvastatin alone. The results were released on Jan. 14.

The Committee on Energy and Commerce began an investigation into the ENHANCE trial on Dec. 11, 2007. The investigation was launched following concerns that, although the ENHANCE trial ended in April 2006, the data had not yet been released. “We are seriously concerned that while the manufacturers may have known that Vytorin was ineffective, huge sums of taxpayer dollars may have been spent on this expensive drug,” the Congressmen’s letter said.

The companies claim the delay came from the time-consuming examination of the results. “ENHANCE began in October 2002 and the last patient visit occurred in April 2006. Following that, the study required the meticulous examination of approximately 30,000 ultrasound images of the carotid arteries and 10,000 ultrasound images of the femoral arteries,” the companies responded. Examination of these images was a challenging process and the companies say the data analysis took significantly longer than expected. Numerous steps were taken in 2006 and 2007 to address quality issues and finalize the data analysis.

The companies have said they look forward to participating in rigorous scientific debates on this important issue in the months ahead. “More than 20 years of clinical research has demonstrated that lowering LDL cholesterol, along with a healthy diet and other therapeutic lifestyle changes, is the cornerstone of lipid treatment for patients at risk for heart disease. Vytorin and Zetia are important treatment options that can help appropriate patients lower their LDL cholesterol,” said Koestler. “We are committed to conducting clinical research with the highest integrity and quality, and reporting the results as quickly as possible.”

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ACC speaks out in favor of waiting for results of further Vytorin trials

BY Drew Buono

WASHINGTON With all the fallout from the ENHANCE trial regarding Merck and Schering-Plough’s cholesterol drug Vytorin, there is one positive show of support for the drug and it comes from the American College of Cardiology, according to published reports.

The ACC issued a statement saying that “major clinical decisions [should] not be made on the basis of the ENHANCE study alone [as it deserves] serious thought and follow-up.” The overall incidence rates of cardiac events were nearly identical between both treatment groups and both were generally well tolerated, the statement said, so “there should be no reason for patients to panic.” It added that the ENHANCE trial “is an imaging study and not a clinical-outcome study,” and that conclusions should not be made until three large clinical-outcome trials are presented within the next two to three years.

But, there are still many who feel the drug is unsafe and has been since it was put on the market. Sidney Wolfe, director of Health Research Group at Public Citizen, said that “we first warned against using Vytorin in December 2004” and suggested people should wait at least seven years before taking the treatment as it was not a “breakthrough” drug.

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GSK, TB Alliance renew partnership for tuberculosis treatment

BY Drew Buono

LONDON and NEW YORK GlaxoSmithKline and the Global Alliance for TB Drug Development have renewed their joint research program that is designed to improve the treatment of tuberculosis. The collaboration began in 2004 and currently includes some projects that may produce new medicines to attack Mycobacterium tuberculosis, which causes tuberculosis.

The deal has been extended for an additional three years to research tuberculosis and malaria. So far under the deal, the collaboration has seen two drug discovery projects, out of five, in non-clinical studies to have potential benefits in fighting persistent forms of mycobacterium tuberculosis and thereby offer better chances of shortening treatment duration, which currently takes about six months to complete.

“We are encouraged by the success of our pioneering work with GSK, which has nearly doubled the number of TB drug discovery projects in our pipeline,” said Mel Spigelman, TB Alliance director of research and development. “This collaboration is advancing the TB Alliance’s mission to develop revolutionary, faster and better TB treatment regimens by exploring new ways to attack the disease.”

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