After linking five deaths to a defective defibrillator wire, Medtronic announced it would stop making the Sprint Fidelis lead. The company’s release doesn’t use the word “recall,” but the FDA’s statement does. Because of surgical complications, the wires should not be immediately removed; but some patients may need them “adjusted.” Medtronic stock plunged and the company said it would lose up to $250 million in sales. Medtronic said approximately 235,000 patients currently have the leads implanted in their bodies; at a time point of 30 months, 2.3 percent break, versus a 0.9 percent failure rate for another Medtronic wire. (Some of the leads are used in defibrillators made by other manufacturers). In a rare testimonial to a company’s handling of a crisis, the FDA’s head of medical devices, Daniel Schultz, tells the Wall Street Journal: “The difference from a few years ago is we’ve had a much more cooperative relationship with the company.” That was a reference to Merck’s handling of Vioxx and a similar recall of a Guidant product.

Pharsight Corporation, a leading provider of software and regulatory services for optimizing clinical drug development, announced that Lars Lindbom has joined as a senior associate scientist in Pharsight’s Strategic Consulting Services (SCS) group, based in Europe. Shawn O’Connor, president, chief executive officer and chairman of Pharsight, said: “The addition of new expert staff in both the SCS and RAS business units will further enhance our ability to address the full spectrum of client needs in modeling and simulation.”

EmPower Research, a consultancy, released a study of the Indian contract research organization (CRO) industry. The report titled “Indian Contract Research Industry (CRO-nicles)” outlines the industry’s current position, trends, challenges and outlook. There are opinions from the leading industry executives and details on key services, personnel and financial data.

TrialStat, a Canadian electronic data capture (EDC) company, announced that its chief scientist, Khaled El Emam will speak at the Adaptive Clinical Trial Designs conference in Toronto tomorrow. El Emam is an engaging speaker; he will discuss how EDC can play a role in enabling clinical researchers to use adaptive clinical trial designs.

The Danish IT consultancy NNIT, in collaboration with software company Atira has refined an IT product to ease the registration and publication of medical research. According to NNIT project manager Pia Ingels, the Pure system is the first to give the pharmaceutical companies a single entry of information on clinical trials of a drug from the initial clinical tests until scientific publications on the finished product.

With user fees from industry, the FDA is sponsoring a modest pharmaceutical research center. The goal of the Reagan-Udall Foundation, recently approved by Congress, is to improve the development of drugs and medical devices. The agenda of the center will be partly independent and partly shaped by FDA. It’s not that Congress forgot that the new institute’s mandate overlaps with the mission of another relatively new nongovernmental body, the Critical Path Institute; the new center simply has different political backers. One day, we hope, each of the 50 states will have its own pet research institute dedicated to improving drug discovery.

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