Senators request more information on Vytorin ENHANCE study
WASHINGTON 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., recently wrote to the chief executive officers of Schering-Plough and Merck and to Kerry Weems, acting administrator of the Centers for Medicare and Medicaid Services, requesting information about the ENHANCE study trial as part of their investigation to determine the possibility of data manipulation.
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, resulted in no significant difference when compared to simvastatin alone. The results were released on Jan. 14.
Dingell and Stupak are investigating an outside panel the companies asked to advise on how to handle the ENHANCE data. The panel recommended changing the trial’s primary endpoints, which could mean manipulation of trial data, the congressmen have said. The lawmakers want to determine if a scientific advisory board, in addition to the outside panel, was created at the beginning of the ENHANCE trial to discuss trial data. They also want to know whether ENHANCE had a data safety monitoring board.
The CMS is supposed to provide the dollar amount spent by Medicare and Medicaid on Vytorin since April 2006. “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 letter says. Dingell and Stupak requested responses from the CMS and the companies by Feb. 4.
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.
FDA halts clinical trial of ALS drug
LOS ANGELES The Food and Drug Administration has told CytRx to stop its clinical trial of the drug arimoclomol, which is being developed to treat amyotrophic lateral sclerosis, or Lou Gehrig’s disease, because of the need for additional analysis of previous animal studies involving the drug, according to published reports.
CytRx said in a release that it has asked for further clarification from the FDA, and said that “arimoclomol has been shown to be safe and well-tolerated after being administered to about 185 study volunteers.”
ALS is a progressive condition that affects nerve cells in the brain and spinal cord.
Study indicates that drive-through can distract pharmacists
COLUMBUS, Ohio A new study in the International Journal for Quality in Health Care has indicated that pharmacists who work at stores with drive through windows are more likely to be distracted and those distractions can lead to processing delays, reduced efficiency and even dispensing errors.
The pharmacists who were surveyed reported that the design and layout of their workplaces has an impact on dispensing accuracy, especially the presence of drive-through window pick-up services. Results also indicate that automated dispensing systems in pharmacies are likely to reduce the potential for errors and enhance efficiency.
Even with stringent internal quality controls, pharmacists nationally make an estimated 5.7 errors per 10,000 prescriptions processed, according to the study, which translates to more than 2.2 million dispensing errors each year.
According to the survey, pharmacists perceive that the drive-through window has the biggest impact on causing pharmacists and their staff to take extra steps (average agreement response of 3.7 on a 5-point scale); reducing efficiency (average response of 3.8); and causing delays in prescription processing (average response of 3.7). The respondents also attributed dispensing errors (average response of 3.2) and communication errors (average response of 3.3) to the presence of a drive-through window.
“A pharmacist or staff member could be responsible for four or five tasks, and serving people at the drive-through window is just one of them,” said Sheryl Szeinbach, the study’s lead author. “Some people seeking the convenience of the drive-through window don’t care about getting information. They just want the medication, and they want it as fast as possible. They should probably think about that and at least look at the medication and make sure it’s OK. And if they have questions, it may behoove them to come into the pharmacy.”