Reuters: Regulatory News: Top doctor thinks report on St Jude lead is real

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Top doctor thinks report on St Jude lead is real Jun 14th 2012, 19:17 By Debra Sherman June 14 | Thu Jun 14, 2012 3:17pm EDT June 14 (Reuters) - A leading cardiologist said on Thursday he believes the report filed with U.S. health regulators about a failure of St Jude Medical Inc Durata brand lead wire is real and credible. The public disclosure of the report led St Jude shares to fall 6 percent on Tuesday, even as some Wall Street analysts questioned its credibility. It said the lead conductor became externalized, meaning the wire carrying electricity from the defibrillator to the heart was exposed through its insulation. St. Jude shares remained down about 8 percent from previous trading levels. The safety of St Jude's leads -- wires that transmit electricity to the heart from a defibrillator -- has been in focus since April, when a prominent medical journal published an article by Dr. Robert Hauser that took a critical look at the company's older lead line, called Riata. Hauser, an electrophysiologist at Minneapolis Heart Institute Foundation, told Reuters on Thursday that while he thinks the report that was posted in a Food and Drug Administration database is genuine, the industry may have made too much of it. "It's one case, so it's concerning, but hardly definitive. It just raises the question," Hauser said. "The impact is probably going to be greater than what this case actually represents." Some Wall Street analysts questioned the report's credibility because of the lack of detail and because a copy of it was not sent to St Jude as is usually done. In a research note, Wells Fargo analyst Larry Biegelsen said he had heard from a number of investors who questioned whether the FDA has safeguards in place to prevent fraudulent reports of adverse events. FDA spokeswoman Sarah Clark-Lynn said the agency reviews all reports submitted to its database, but could not say whether the reviews were done before or after the reports are posted online. "There are a number of reasons for the agency to review all reports that come in, including the potential for fraud or the need for additional follow up," Clark-Lynn said. "We strip all privacy information out of the reports prior to posting them on the public database." St. Jude had no comment on Thursday. There are several studies in progress that will shed light on the issue, but there probably won't be any information from those until the end of the year, Hauser said. "When questions are raised, you need to do more work and gather more data," he said. I think (St Jude is) working through it. I don't think they're in denial." He said it will be important to learn whether the erosion is occurring from the inside out or the outside in. Erosion that begins on the outside of the wire is more common. St Jude stopped selling the earlier-generation Riata defibrillator lead in 2010 after product failures were tied to patient deaths. Hauser's article in the medical journal HeartRhythm linked the leads to 20 patient deaths and concluded that the product failed at a higher rate than Medtronic's lead, prompting St. Jude to ask for a retraction. Link this Share this Digg this Email Reprints

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