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Dear Sir Iain, Have you read the latest scandal on Roche? This article is from the Financial Times. You can read the associated MHRA Report on Roche at the following weblink: June 21, 2012 10:37 pm Roche did not report US patients’ deaths By Andrew Jack in London Roche failed to inform regulators of reports of illness and death in as many as 80,000 US patients who received the Swiss pharmaceuticals group’s medicines over the past 15 years. In a report on unprecedented failures in “pharmaco-vigilance”, the UK Medicines and Healthcare Products Regulatory Agency highlighted a series of “deficiencies” at Roche. The data could change regulators’ assessment of the risks and benefits of its medicines and lead to the withdrawal of drugs from the market or a change in the guidance to doctors. The reports – which include 15,161 deaths of US patients – related to the full range of drugs provided by Genentech, Roche’s US subsidiary, distributed by its “patient support programme” through which it offers its products to patients who are uninsured or underinsured. There were other failings identified by regulators with data on suspected side effects in 23,000 other patients and 600 participants in clinical trials. Sir Kent Woods, chief executive of the regulator, said: “Roche’s actions are unacceptable and our investigation has identified that Roche’s reporting systems are inadequate.” The Swiss company said: “Roche acknowledges it did not fully comply with regulations and appreciates the concerns that can be caused by this issue for people using its products.” Genentech produces such cancer treatments as Avastin and Herceptin, as well as Lucentis to treat age-related macular degeneration, which causes blindness. The European Medicines Agency, which made public the findings, cautioned: “There is at present no evidence of a negative impact for patients and while the investigations are being conducted there is no need for patients or healthcare professionals to take any action.” It said some of the suspected side effects may have been reported to regulators by others such as patients directly or their doctors. Roche said that the data on side effects and other reports of patient health collected by the outside contractor it uses to run its support programme had not been entered into its own database and not passed on either to US or European regulators. “This was definitely unintentional,” the company said, adding that it had initially identified problems in its reporting systems last December and all of its work re-examining the data would be completed by January next year. Failures in Roche’s manufacturing were previously highlighted in 2007 in a European regulatory inspection on its HIV drug Viracept. Copyright The Financial Times Limited 2012. >________________________________ >From: Iain Chalmers <[log in to unmask]> >To: [log in to unmask]; "Lehman, Richard" <[log in to unmask]>; [log in to unmask] >Sent: Tuesday, 3 July 2012, 16:26 >Subject: RE: GlaxoSmithKline to pay $3B in largest healthcare fraud settlement in US history > >I actually feel very sorry that the current management of GSK is having to field the consequences of the appalling, greedy actions taken under the previous CEO – Jean Pierre Garnier. In several ways since Garnier’s departure, GSK has actually been ahead of the rest of the industry in committing to openness. See Tom Jefferson’s contrast between the way that GSK responded to a request for data on neuraminidase inhibitors and the disgraceful way that Roche has responded. And note: the Regius Professor of Medicine in this town in on the board of Roche. Iain > > >________________________________ > >From:[log in to unmask] [mailto:[log in to unmask]] On Behalf Of Ash Paul >Sent: 03 July 2012 16:19 >To: Lehman, Richard; [log in to unmask]; PATH Group >Subject: Re: GlaxoSmithKline to pay $3B in largest healthcare fraud settlement in US history > >Dear Richard,Every believer in evidenced-based medicine should read the full judgment (link to it given right at the bottom of this email), it's incredible and it makes me seriously wonder whether the pharmaceutical industry is just as bad as the banking industry today, and whether we can trust it at all.I quote a single line from the judgment proper:"The sales force bribed physicians to prescribe GSK products using every imaginable form of high-priced entertainment, from Hawaiian vacations [and] paying doctors millions of dollars to go on speaking tours, to tickets to Madonna concerts," said US attorney Carmin Ortiz. > http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2012/06/WC500129047.pdf