Two articles, which are quite typical...
Another one bites the dust, previous reports show
over 50% of medical papers are fraudulent,
Dr Mullen, will get a slap on the wrist and well,
its business as usual..
The second article is about faulty implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) defibrillators, BUTBUT, its business as usual.."Shocking"
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MIST investigator accused of submitting false data to conferenceReed Miller
Manchester, UK - Dr Michael Mullen, formerly of the Royal Brompton Hospital, London, UK, is accused of submitting an abstract that he knew to contain incorrect data, according to a BMJ report [1].
At a UK Medical Practitioners Tribunal Service hearing in Manchester beginning October 22, Mullen will face charges that he submitted false information from the Migraine Intervention with STARflex Technology (MIST) trial to the XXI Nordic Congress of Cardiology in Oulu, Finland in 2007. The data interpretations submitted in this abstract had also been presented at the American College of Cardiology conference in 2006, and Mullen knew they were incorrect, the General Medical Council (GMC) alleges.
Mullen is one of two MIST investigators under investigation by the GMC over alleged misconduct in that trial. As previously reported by heartwire, the lead author of the MIST paper published in 2008, Dr Andrew Dowson (Kings College Hospital, London, UK), is set to face a Medical Practitioners Tribunal Service fitness-to-practice hearing.
Dr Peter Wilmshurst (Royal Shrewsbury Hospital, UK) refused to put his name on the MIST paper, because he was not shown all of the trial data and because the MIST paper published in Circulation did not include any information from his review of the trial's echocardiograms. Wilmshurst's echo review showed a higher residual shunt rate than the 6% reported in the MIST manuscript.
In 2009, Mullen told heartwire that Wilmshurst's review was "unsafe" and therefore should not have been included in the manuscript, but Wilmshurst retained emails showing that the echo review, requested by NMT Medical, was originally Mullen's idea.
After Wilmshurst told heartwire about his concerns with MIST, NMT Medical tried to sue Wilmshurst for libel. The lawsuit was dropped when NMT went bankrupt in 2011.
www.theheart.org/article/1457891.do?utm_medium=email&utm_source=20121011_EN_Heartwire&utm_campaign=newsletterheartwire home
St Jude knew of Riata lead flaws at end of 2005, says WSJ New York, NY - St Jude Medical first became aware of potential insulation problems with its Riata defibrillator leads as early as the end of 2005, according to an article in the Wall Street Journal yesterday [1].
As long covered by heartwire, the Riata leads were "recalled" by the FDA at the end of 2011; the company had stopped selling them a year earlier following a warning issued to doctors after four published case reports of the problem between 2008 and 2010. The leads were used with both implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) defibrillators, and the problem identified—premature erosion of the insulation of the leads—so-called "inside-out abrasion"—meant that the devices could potentially fatally malfunction, causing delivery of inappropriate shocks or failing to deliver a shock at all.
A St Jude internal audit seen by the newspaper confirmed 246 cases of any type of insulation breach, including normal wear and tear, and 32 of the 246 leads examined were damaged enough to inhibit lifesaving shocks, writes Christopher Weaver. But at that time, the company had sold more than 120 000 Riata leads in the US, and the audit concluded in 2008 that the chance of device malfunction was "remote."
The FDA inspected the St Jude facility that makes leads twice, in 2006 and 2009, ruling out any manufacturing problems in 2006 and reviewing the company's insulation audit during the second inspection and deeming it "adequate."
St Jude isn't accused of any misconduct; it simply followed standard industry practice, says the newspaper. But the Riata incident shows that the US monitoring system for devices already on the market should be overhauled, Weaver argues. He interviews some physicians who encountered cases of the lead problem from 2006 through 2009—none of which resulted in patient deaths—and who either discounted them as one-offs or reported them to the company, which indicated they were isolated events. The doctors say that had the firm publicized the fact they had encountered this issue earlier, there might have been more vigilance in reporting the problem.
Don't leave things to chance, strengthen regulations on device tracking
A St Jude spokesperson told the WSJ that the company promptly reported individual Riata cases to the FDA, which publishes abridged versions of adverse-event reports in an online database (Manufacturers and User Device Experience [MAUDE]). But this system of voluntary reporting—with limited information on the adverse event made public—makes it hard to detect problems, Weaver writes in his article.
"It's difficult to distinguish the signal from the noise," Dr Joshua Rising, director of the Pew Charitable Trust's device-safety program, tells the paper. And Dr Harlan Krumholz (Yale University, New Haven, CT) comments: "It's incumbent on the companies to start sharing information early between themselves and the medical community. We can't leave it to chance whether or not we discover problems."
Since 2008, the FDA has begun requiring postmarket studies of defibrillator leads and is working on a nationwide system of unique, bar-code-like identifiers to track device failures, the paper adds. Meanwhile, St Jude is studying about 11 000 patients who have its current generation of leads. Although the company claims it has solved the insulation problem with this generation, a paper published in August in Europace suggests this may not be the case.
Commenting to heartwire at that time, Dr Laurence Epstein (Brigham and Women's Hospital, Boston, MA) said: "The whole issue speaks to a total inadequacy in our current system for device tracking. The fact that the only mandatory reporting is if somebody died because of a device is ridiculous. There should be mandatory reporting for any failed device. In addition, hospitals and physicians do a horrible job of reporting and returning products."
For its part, the FDA tells the WSJ that the agency investigates adverse events routinely when device problems could cause serious injuries or be violating regulations or when staff believes initial reports require more detail. A senior FDA official who has been involved in discussions with St Jude over the past two years says that decisions to recall products or issue public statements are made on a case-by-case basis. There's "not a magic number, there's not a line in the sand. We look at the available data," he told Weaver.
Thousands of patients still have devices with the Riata leads, and in mid-August, the FDA recommended that such individuals obtain an X-ray or undergo other diagnostic imaging to check for possible lead-insulation problems that may necessitate extraction.