NACDS, GPhA respond with guarded optimism to State of the Union address
ARLINGTON and ALEXANDRIA, Va. Two pharmaceutical trade associations responded positively Tuesday to Monday’s State of the Union address by President George W. Bush.
“President Bush offered a forward-thinking policy agenda in his last State of the Union address last night before Congress,” stated Steve Anderson, president and chief executive officer of the National Association of Chain Drug Stores. “We applaud the president’s commitments to expanding access to affordable healthcare options and empowering Americans to receive treatment that best meets their needs.”
Kathleen Jaeger, president and chief executive officer of the Generic Pharmaceutical Association, also praised the president’s vision. “Last night, President Bush stated that ‘we share a common goal: making health care more affordable and accessible for all Americans,’ ” she stated. “The American generic pharmaceutical industry couldn’t agree more.”
Both associations were hopeful, calling on the administration and Congress to recognize the needs of Americans and utilize the services their respective members can offer.
“As our nation grapples with the challenge of reducing skyrocketing health care costs while increasing access to quality care, generic medicines remain the right choice for better health. Generic medicines save consumers and the federal government billions of dollars a year,” Jaeger continued. ““We call upon President Bush and Congress to support measures that increase access to generic medicines. This year, our elected officials have a real opportunity … by enacting legislation to create an effective and efficient approval pathway for biogenerics; approving free trade agreements … that foster the balance between pharmaceutical innovation and generic access; and removing longstanding barriers to access such as authorized generics and citizen petitions.”
“We appreciate the president’s continued efforts to make health care accessible and affordable for patients and businesses,” Anderson stated. “He also acknowledged the importance of promoting health information technology. NACDS and the National Community Pharmacists Association created SureScripts electronic prescribing network in 2001 which is now the largest network to link electronic communications between pharmacies and physicians, enabling the direct exchange of prescription information.”
Anderson tempered his comments with a word of caution, however: “Pharmacy faces challenges with pending Medicaid reimbursement cuts that will alter services that chain pharmacies provide and in some cases, shut their doors. While we are hopeful that the budget will take our concerns into consideration, if past is prologue, we could see even drastic cuts this year that could further impede the industry.”
“The value of pharmacy will only continue to grow in what is becoming an era of patient-centered health care,” he concluded optimistically. “We are hopeful that the administration and Congress will take the concerns of pharmacy into consideration as they work to institute health care policies.”
Jaeger’s statement, too, looked to the future. “In 2008, the economy and health care are top priorities for Americans. We can make the state of our union strong by increasing access to safe, effective and affordable generic medicines,” she stated.
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.”