MedWorm provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest medical blog items that have been tagged with 'david graham'. Sat, 03 Sep 2011 02:49:10 +0100 http://www.medworm.com/index.php?rid=3896091&cid=t_112255_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZvLxhdlArQ8%2F Avandiagate, as some have called it, appears to be never ending. In the latest twist, a letter and accompanying memo that GlaxoSmithKline wrote and distributed at the behest of the FDA is now itself the subject of a flap because some experts say the contents are misleading. And this occurs just as the agency gets set to decide the fate of the controversial Avandia diabetes pill, The New York Times writes. The letter was supposed to bring doctors up to date on two things - the outcome of a recent FDA advisory committee meeting about Avandia, which the panel decided should remain on the market but with restrictions, and a decision by the FDA to halt Glaxo’s TIDE clinical trial designed to assess cardiovascular risk when compared with the rival Actos drug (background here and here). The... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3896091 Mon, 23 Aug 2010 18:41:16 +0100 3896091 http://www.medworm.com/index.php?rid=3746986&cid=t_112255_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F-CbIiY0mVwQ%2F This report could change the Avandia game entirely. For one, if Marciniak’s view is widely held at the FDA (or it’s widely shared among its advisory committee), then we no longer have a case in which the clinical trials point one way and the observational evidence points the other way. More important, because Marciniak is a CDER reviewer, we no longer have a case in which the FDA’s ‘trialists’ are entirely at odds with its ‘observationalists.’ In other words, Marciniak’s memo may create doubt among many CDER medical reviewers who favor randomized clinical trials but who may come to doubt GSK’s credibility in running them. That kind of loss of trust can be severely destructive for a company. As far as I can tell, Marciniak’s voice is a new one in this debate, and combine... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3746986 Mon, 12 Jul 2010 13:09:05 +0100 3746986 http://www.medworm.com/index.php?rid=3706599&cid=t_112255_83_f&fid=34856&url=http%3A%2F%2Finsidesurgery.com%2F2010%2F06%2Fdiabetes-drug-avandia-reported-increased-heart-risks%2F Two large studies published in the Journal of the American Medical Association (JAMA) detail the increased cardiovascular risks including stroke and heart attack associated with taking the diabetes drug Avandia (rosiglitazone). One of the studies was led by Dr. David Graham of the FDA. (Source: Inside Surgery) Inside Surgery blogs http://www.medworm.com/rss/comments.php?id=3706599 Tue, 29 Jun 2010 04:53:48 +0100 3706599 http://www.medworm.com/index.php?rid=3706994&cid=t_112255_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FennOAQ5bM08%2F Just three weeks before what is certain to be a tense FDA advisory committee meeting, the study showing the Avandia diabetes pill increases the the risk of stroke, heart failure and death compared with Takeda Pharmaceutical’s Actos has been peer-reviewed and published (see this). This is the same paper that was leaked to us earlier this month (see here) and now appears online at the Journal of the American Medical Association web site. The study, which evaluated data from 227,571 Medicare patients between 2006 and 2009 with an average of 74.4 years, found there 1,746 heart attacks, of which 21.7 percent fatal; 1,052 strokes and 7.3 percent fatal; 3,307 hospitalizations for heart failure, including 2.6 percent that were fatal; and 2,562 deaths for all causes. Although the analysis sh... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3706994 Mon, 28 Jun 2010 14:18:07 +0100 3706994 http://www.medworm.com/index.php?rid=3672034&cid=t_112255_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7CpBD1Qpr10%2F Once again, a battle looms over the cost of treating wet age-related macular degeneration. An unpublished study shows Medicare can save more than $500 million annually by using Avastin, instead of Lucentis to treat the illness, The Wall Street Journal reports. The disclosure underscores a heated debate that has embroiled federal officials and Genentech, which sells both drugs, for years. Why? Avastin is not approved to treat the eye disease, which is a leading cause of blindness among the elderly. Lucentis is approved, but Avastin is much cheaper. For instance, the study found Avastin, which is used in 65 percent of Medicare patients but only 40 percent are treated with Lucentis. But Medicare paid $537 million for Lucentis in 2008 and only $20 million for Avastin, the Journal writes. Put a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3672034 Thu, 17 Jun 2010 13:13:18 +0100 3672034 http://www.medworm.com/index.php?rid=3648798&cid=t_112255_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIMny61PkBdU%2F A new observational study comparing the controversial Avandia diabetes pill found an increased risk of various cardiovascular problems compared with Actos, a similar drug but one that hasn’t raised as many concerns. Yet one co-author, FDA reviewer David Graham, recently wrote top FDA officials over concerns that agency supervisors hadn’t given clearance for the study to be submitted for publication. (You can see Graham’s email to FDA commish Margaret Hamburg further down). The May 28 draft manuscript indicates the authors reviewed records of 227,571 Medicare patients with an average age of 74.4 years who were followed for up to three years after starting either of the two pills. The results - GlaxoSmithKline’s Avandia increased the risk of stroke by 27 percent; hear... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3648798 Thu, 10 Jun 2010 16:07:11 +0100 3648798 http://www.medworm.com/index.php?rid=3652693&cid=t_112255_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIMny61PkBdU%2F A new observational study comparing the controversial Avandia diabetes pill found an increased risk of various cardiovascular problems compared with Actos, a similar drug but one that hasn’t raised as many concerns. Yet one co-author, FDA reviewer David Graham, recently wrote top FDA officials over concerns that agency supervisors hadn’t given clearance for the study to be submitted for publication. (You can see Graham’s email to FDA commish Margaret Hamburg further down). The May 28 manuscript indicates the authors reviewed records of 227,571 Medicare patients with an average age of 74.4 years who were followed for up to three years after starting either of the two pills. The results - GlaxoSmithKline’s Avandia increased the risk of stroke by 27 percent; heart fail... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3652693 Thu, 10 Jun 2010 15:33:43 +0100 3652693 http://www.medworm.com/index.php?rid=3290991&cid=t_112255_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FzmPNNoYg-CQ%2F Avandia is needlessly causing hundreds of cases of heart attacks and heart failure each month, according to confidential government reports, The New York Times writes. Moreover, if every diabetic taking Avandia were given Actos instead, about 500 heart attacks and 300 cases of heart failure would be avoided each month. The pill was linked to 304 deaths during the third quarter of 2009, and a report by the FDA’s David Graham and Kate Gelperin concludes the pill should be yanked (Graham said this in 2007 - look). Some FDA officials want Avandia withdrawn because they believe a safer alternative exists, the Times adds, noting others insist studies offer contradictory info and Avandia should remain an option. GlaxoSmithKline, which makes the pill, says it studied Avandia extensively and ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3290991 Sat, 20 Feb 2010 15:29:18 +0100 3290991 http://www.medworm.com/index.php?rid=3290989&cid=t_112255_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F02%2Fgsk-avandia-rosiglitazone-should-be.html Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market.The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.More from Gardiner Harris at the NYT (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3290989 Sat, 20 Feb 2010 04:55:00 +0100 3290989 http://www.medworm.com/index.php?rid=1046801&cid=t_112255_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F189324560%2F Congress last month passed the FDA Amendsment Act, which among other things, promotes tracking of adverse reactions after a drug is approved and in wide use, a move that pharma fought for years. But questions remain about whether that is a substantive fix or a public-relations move by the FDA and industry designed to fend off stronger government demands, The Seattle Times writes. Graham, an FDA medical reviewer who sought whistleblower protection in early 2004 after the agency investigated leaks about links between antidepressants and teenage suicides, tells the Times that the bureaucratic leopard shows the same spots. He also created a furor by linking Vioxx to a huge number of heart attacks and then testified before a Senate committee that the agency wasn’t protecting Americans. Mo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1046801 Fri, 23 Nov 2007 13:12:04 +0100 1046801 http://www.medworm.com/index.php?rid=765960&cid=t_112255_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F138829358%2F David Graham, the controversial FDA medical reviewer who criticized the agency’s handling of Vioxx, believes an FDA advisory panel should urge that Glaxo’s Avandia get pulled off the market, Reuters reports. The meeting gets under way momentarily. In slides prepared for his remarks, Graham states that Avandia increases the risk of cardiovascular problems such as heart attacks, while a rival drug, Takeda’s Actos, doesn’t. There is “no evidence of major clinical health benefits” from Avandia and leaving it on the market may “cost thousands of lives,” according to slides for a presentation to be given today by David Graham, a Food and Drug Administration safety scientist. In briefing documents, senior FDA officials say they don’t know if A... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=765960 Mon, 30 Jul 2007 13:55:51 +0100 765960 http://www.medworm.com/index.php?rid=545814&cid=t_112255_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2007%2F04%2Fmerck-arcoxia-clearly-killing-people-in.html Food and Drug Administration whistle-blower David Graham isn't giving up.He's not content with helping to keep Merck's drug Arcoxia (the son or daughter Vioxx, depending upon who you read) off just the U.S. market, because that still leaves 63 countries in which the arthritis medication is sold.Graham, of the agency's Office of Surveillance and Epidemiology, warned an FDA advisory panel Thursday that Arcoxia would be "a potential public-health disaster" because it raises heart attack and stroke risk. The panel voted 20 to 1 against recommending approval of Arcoxia, which critics have likened to Vioxx, the arthritis drug Merck withdrew in September 2004 because of cardiovascular safety concerns.The FDA typically follows the advice of its advisory panels.Graham said Friday that he wants to f... PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=545814 Mon, 16 Apr 2007 06:00:00 +0100 545814