{"id":31977,"date":"2012-09-24T12:53:54","date_gmt":"2012-09-24T16:53:54","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=voices&#038;p=31977"},"modified":"2012-09-24T12:53:54","modified_gmt":"2012-09-24T16:53:54","slug":"selections-from-richard-lehmans-literature-review-september-24th","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/09\/24\/selections-from-richard-lehmans-literature-review-september-24th\/","title":{"rendered":"Selections from Richard Lehman\u2019s Literature Review: September 24th"},"content":{"rendered":"<p><em>CardioExchange is pleased to reprint selections from Dr. Richard Lehman\u2019s\u00a0<a href=\"http:\/\/blogs.bmj.com\/bmj\/category\/richard-lehmans-weekly-review-of-medical-journals\/\">weekly journal review blog<\/a>\u00a0at\u00a0<a href=\"http:\/\/www.bmj.com\/\">BMJ.com<\/a>. Selected summaries are relevant to our audience, but we encourage members to engage with the\u00a0<a title=\"Lehman_8282012\" href=\"http:\/\/blogs.bmj.com\/bmj\/2012\/09\/24\/richard-lehmans-journal-review-24-september-2012\/\" target=\"_blank\">entire blog<\/a>.<\/em><\/p>\n<p><strong>NEJM\u00a0 20 Sep 2012\u00a0 Vol 367<\/strong><\/p>\n<p><strong>Punishing Health Care Fraud? (pg. 1082):<\/strong> In the next few weeks, we can look forward to dignified murmurs of offended innocence from the pharmaceutical industry in response to Ben Goldacre\u2019s brilliant and damning new book, <em>Bad Pharma<\/em>. But it is difficult to maintain dignity when caught with your pants down, as GlaxoSmithKline has been over the mis-selling of Paxil and Wellbutrin, and the hiding of safety data relating to Avandia. However, all that\u2019s needed is to pay up $3BN and your pants can quickly be raised and adjusted. Nobody need be called to account, and business can go on as usual: after all, $3bn is about half the profit that these three drugs produced every year while they were being mis-marketed. Here\u2019s a <a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMp1209249\">swingeing perspective piece<\/a> titled Punishing Health Care Fraud\u2014Is the GSK Settlement Sufficient? The answer of course is no. There is nothing to stop fraud continuing as a lucrative business plan, and nothing to bring those responsible to court. And is GSK just a bad apple? No way\u2014there are 25 others who are under special measures, including most of the big names in US pharma.<\/p>\n<p><strong>How Physicians Interpret Research Funding Disclosures (pg. 1119):<\/strong>\u00a0 <a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMsa1202397\">Take a look at this study<\/a> of how US medical interns rate hypothetical studies of new drugs: it\u2019s free to everybody courtesy of Jeff Drazen, who also produces <a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMe1207121\">an editorial that you can read in full<\/a>. Lampytinib, bondaglutaraz, provasinab: what fun to make up drug names like that, and trial designs that varied from a proper large RCT to a footling open-label study with no safety data. Not surprisingly, the interns had little difficulty in grading the quality of these mock-ups. But now comes the interesting bit: they were much less inclined to believe the results if the studies were marked as industry funded. This earns them a lofty reproof from headmaster Drazen: \u201cPatients who put themselves at risk to provide these data earn our respect for their participation; we owe them the courtesy of believing the data produced from their efforts and acting on the findings so as to benefit other patients.\u201d Amen to that\u2014but that\u2019s exactly why we mistrust data that have been gathered and interpreted by people with billions of dollars riding on the result\u2014and who have a track record of deceit. If Drazen wants to show true courtesy to the trial participants, he needs to insist that for every trial published in the <em>NEJM<\/em> there is a full database of raw, de-identified patient-specific data, with the trial protocol and any variations from it, and all other meta-data required to interpret the study, open to all bona-fide investigators. And let\u2019s not forget that the <em>NEJM<\/em> itself has a vested interest in putting a positive spin on industry-funded trials, as it gets a substantial (undisclosed) proportion of its income from the sale of reprints to pharma companies. There have been some terrific responses to this editorial, especially from <a href=\"http:\/\/www.pharmalot.com\/2012\/09\/the-op-ed-a-suggestion-to-restore-faith-in-pharma-studies\/\">Harlan Krumholz<\/a> and <a href=\"http:\/\/blogs.nejm.org\/cardioexchange\/voices\/why-i-applaud-the-skeptical-physicians\/\">Joe Ross<\/a>.<\/p>\n<p><strong>BMJ\u00a0 22 Sep 2012\u00a0 Vol 345<\/strong><\/p>\n<p><strong>Systolic and Diastolic BP and All-Cause Mortality in Those Newly Diagnosed with Type-2 Diabetes:<\/strong> \u201cIt is refreshing to read an article highlighting the risks of tighter blood pressure control in diabetic patients. But we have to remember that it is a retrospective study, so we don\u2019t know when a patient\u2019s glycaemic index breached the diabetes threshold and when patients were diagnosed. Furthermore, who measured patients\u2019 blood pressures and by what method?\u201d It\u2019s really weird that the <em>BMJ<\/em> flagged up and printed this rapid response because it is mistaken on almost every count. <a href=\"http:\/\/www.bmj.com\/content\/345\/bmj.e5567\">This is a database study<\/a> of the blood pressure as measured by UK general practitioners in the first year of diagnosis of type 2 diabetes (from 1990 to 2005), and how it relates to mortality over that period. It tells us nothing about treatment effects. The reason that the glycaemic index of the patients is not reported is presumably because nobody wanted to eat them.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>This week&#8217;s topics include papers on punishing health care fraud, how physicians interpret research funding disclosures, and the association between BP and mortality in those newly diagnosed with type-2 diabetes.<\/p>\n","protected":false},"author":475,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-31977","post","type-post","status-publish","format-standard","hentry","category-general"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/31977","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/475"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=31977"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/31977\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=31977"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=31977"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=31977"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}