FDA evaluation of Vytorin study not due until mid-2008
WASHINGTON The Food and Drug Administration has stated that it will take up to six months to evaluate trial data on the ENHANCE study before deciding if it will take regulatory action on Merck and Schering-Plough’s cholesterol drug Vytorin, after it receives the final study report from the companies.
The ENHANCE trial has been the subject of a congressional inquiry that has expanded to include direct-to-consumer advertisements, Medicare payments, company executives’ stock transactions and the relationships between drug companies and nonprofits.
After considering all the information, the FDA will then determine if any regulatory action is warranted for Zetia, a drug used in Vytorin’s formulation or Vytorin itself. In addition, the agency may consider revising its approval process for drugs that lower LDL cholesterol.
The FDA said it does not see any reason to change Vytorin’s labeling based on the ENHANCE study so far but told physicians and patients to consider all information when making prescription choices.
CCA, AIMp join forces to speak for British chains
NOTTINGHAMSHIRE, England The Company Chemists Association and the Association of Independent Multiples announced Monday that they are establishing a joint venture to undertake policy development and representation on behalf of the membership of the two bodies. “Multiples” is the U.K. equivalent of U.S. “chain stores.”
“Pharmacy representation is going through a period of unprecedented change. Multiple pharmacy is becoming an increasingly significant player in the UK community pharmacy sector,” observed Digby Emson, the chairman of CCA. “Over the last few years, it has become clear that AIMp and the CCA share a lot of common ground.”
The collaboration will be formally structured as a jointly owned company, “The CCA & AIMp Ltd.,” which will draw resources and manpower from both organizations to undertake a jointly established work program, focused on the development of shared policy positions and representation of the multiple perspective within pharmacy and externally with key health care stakeholders.
“This is an opportunity for both organizations to build on their strategic fit with much closer collaboration. Together, CCA and AIMp represent over 60 percent of the market. We have seen over the last year that through collaboration, we both benefit and have increased influence,” said Steve Williams, the chairman of AIMp. “AIMp and the CCA have different roots, and will continue as organizations in their own right, but wherever possible in the future we will be speaking, through CCA & AIMp Ltd, with one voice.”
“This joint venture provides a vehicle for us to collaborate more closely and to ensure that there is stronger voice for multiple pharmacy in both NHS and professional policy making moving forward,” added Emson. “We see this development as a win-win for both our organizations—and the sector as a whole. “
Merck, Schering-Plough respond to Congressmen’s issues with Vytorin trial
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.”