Business Week has an exhaustive look at the science behind statins, especially Lipitor, and concludes few patients need the drugs. Some researchers now suspect the mechanism of action in the statin class may be anti-inflammatory and have nothing directly to do with cholesterol. The story includes interviews with leading cardiologists and epidemiologists who discuss, among other things, a metric called the “NNT.” That’s the total number of patients needed to be treated to ensure that one patient benefits. Low NNTs are good. High NNTs are bad. Antibiotics generally have NNTs of 1. Lipitor’s NNT is 100, Business Week estimates, citing a company ad. “Anything over an NNT of 50 is worse than a lottery ticket,” the University of North Carolina’s Nortin Hadler tells the magazine. (Community physicians apparently don’t know NNTs for frequently-prescribed drugs.) Pfizer declined to be interviewed by Business Week, creating the impression the company won’t bother to defend the blockbuster in the media. Sales of the drug dipped for the first time in 2007.
ResearchPoint, a contract research organization, announced the appointment of Matthew Walker to its leadership team as executive vice president, business development & marketing. Walker will lead strategic and organizational alignment and growth, while coordinating development and positioning of ResearchPoint’s service lines. John Farinacci, president and chief executive officer of ResearchPoint said: “We welcome the strategic vision, leadership, and business savvy Matt brings to ResearchPoint. As the entire industry perseveres to improve the development process, customers are looking to technology to enhance efficiencies and outcomes. We believe that Matt’s insight and experience will bolster ResearchPoint’s ability to accommodate their expectations.”
Kendle announced the appointment of Phillip Davies as VP of its Phase I unit. Kendle’s Phase I units include a clinical pharmacology unit in The Netherlands and a bioequivalence facility in West Virginia. Davies will report directly to founder and CEO Candace Kendle.
Icon announced that its development solutions division has signed a collaboration agreement with the UK based Medicines Evaluation Unit (MEU). The agreement will enable Icon to perform early phase studies in a hospital based environment that has access to specialist equipment and ITU services and will enhance Icon’s respiratory capabilities. Commenting on the agreement Thomas Frey, President of Icon Development Solutions, said: ”We are delighted to have signed this agreement with the MEU, which gives us access to first class staff and facilities. The unit has an outstanding reputation for performing high quality clinical research and its hospital location will give IDS enhanced capabilities to run first-in-man studies.”
iCAD, a provider of computer-aided detection (CAD) solutions for the early identification of cancer, announced an agreement with ACR Image Metrix, a contract research organization. They’ll conduct a multi-reader clinical study of iCAD’s CT Colon product for use with virtual colonoscopy. iCAD will work with ACR Image Metrix to develop and execute a clinical study to support U.S. Food and Drug Administration (FDA) approval of CT Colon CAD. Ken Ferry, president and chief executive officer of iCAD, said: “Working with ACR Image Metrix, a group with significant expertise in radiology clinical trial management, will put us in an optimal position to submit solid clinical data to FDA and meet our goals for this important product line.”
Parexel reported strong quarterly results. Service revenue increased 32 percent to a record $239 million; earnings per share rose 25 percent. The CRO’s order backlog is up 40 percent, to $1.8 billion. During the quarter, more than 60 percent of revenues were earned outside the Americas in Europe and the rest of the world. Josef von Rickenbach, Parexel’s chairman and CEO, said: “Our proven capabilities to compete for and win significant levels of new business leaves us well-positioned to further improve operating margins and drive profitable growth as we go forward.” Here’s the release.
Have a news release? Send it to .
d9A2t49mkex


