{"id":4021,"date":"2013-11-04T21:43:59","date_gmt":"2013-11-04T20:43:59","guid":{"rendered":"http:\/\/emilkirkegaard.dk\/en\/?p=4021"},"modified":"2014-10-09T18:50:17","modified_gmt":"2014-10-09T17:50:17","slug":"review-bad-pharma","status":"publish","type":"post","link":"https:\/\/emilkirkegaard.dk\/en\/2013\/11\/review-bad-pharma\/","title":{"rendered":"Review: Bad Pharma"},"content":{"rendered":"<p>https:\/\/www.goodreads.com\/book\/similar\/19171192-bad-pharma-how-drug-companies-mislead-doctors-and-harm-patients<\/p>\n<p>http:\/\/lib.free-college.org\/view.php?id=864114<\/p>\n<p>&nbsp;<\/p>\n<p>Having already read Peter G\u00f8tzsche&#8217;s <em>D\u00f8delig medicin og organiseret kriminalitet: Hvordan medicinalindustrien har korrumperet sundhedsv\u00e6senet<\/em>. Art People, 2013, this book did not bring so much new. However, it did present things better than G\u00f8tzsche did. To be fair, he focused mostly on proving that the farma industry are organized criminals. I agree, but the science is more interesting than reading about 100 different cases of farma companies cheating and getting fines.<\/p>\n<p>&nbsp;<\/p>\n<p>&#8212;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"color: #800000;\">If you\u2019re a nerd, you might think: these files are electronic; <\/span><\/p>\n<p><span style=\"color: #800000;\">they\u2019re PDFs, a type o f file specifically designed to make sharing <\/span><\/p>\n<p><span style=\"color: #800000;\">electronic documents convenient. Any nerd will know that if <\/span><\/p>\n<p><span style=\"color: #800000;\">you want to find something in an electronic document, it\u2019s easy: <\/span><\/p>\n<p><span style=\"color: #800000;\">you just use the \u2018find\u2019 command: type in, say, \u2018peripheral <\/span><\/p>\n<p><span style=\"color: #800000;\">neuropathy\u2019, and your computer will find the phrase straight <\/span><\/p>\n<p><span style=\"color: #800000;\">off. But no: unlike almost any other serious government docu\u00ad<\/span><\/p>\n<p><span style=\"color: #800000;\">ment in the world, the PDFs from the FDA are a series of photo\u00ad<\/span><\/p>\n<p><span style=\"color: #800000;\">graphs of pages of text, rather than the text itself. This means <\/span><\/p>\n<p><span style=\"color: #800000;\">you cannot search for a phrase. Instead, you have to go through <\/span><\/p>\n<p><span style=\"color: #800000;\">it, searching for that phrase, laboriously, by eye.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p>Easily solved by OCR software.<\/p>\n<p><a href=\"http:\/\/en.wikipedia.org\/wiki\/Optical_character_recognition\">http:\/\/en.wikipedia.org\/wiki\/Optical_character_recognition<\/a><\/p>\n<p>&nbsp;<\/p>\n<p>&#8211;<\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"color: #800000;\">Sharing data of individual patients\u2019 outcomes in clinical <\/span><\/p>\n<p><span style=\"color: #800000;\">trials, rather than just the final summary result, has several <\/span><\/p>\n<p><span style=\"color: #800000;\">significant advantages. First, it\u2019s a safeguard against dubious <\/span><\/p>\n<p><span style=\"color: #800000;\">analytic practices. In the VIGOR trial on the painkiller Vioxx, <\/span><\/p>\n<p><span style=\"color: #800000;\">for example, a bizarre reporting decision was made.83 The aim <\/span><\/p>\n<p><span style=\"color: #800000;\">of the study was to compare Vioxx against an older, cheaper <\/span><\/p>\n<p><span style=\"color: #800000;\">painkiller, to see if it was any less likely to cause stomach prob\u00ad<\/span><\/p>\n<p><span style=\"color: #800000;\">lems (this was the hope for Vioxx), and also if it caused more <\/span><\/p>\n<p><span style=\"color: #800000;\">heart attacks (this was the fear). But the date cut-off for mea\u00ad<\/span><\/p>\n<p><span style=\"color: #800000;\">suring heart attacks was much earlier than that for measuring <\/span><\/p>\n<p><span style=\"color: #800000;\">stomach problems. This had the result of making the risks look <\/span><\/p>\n<p><span style=\"color: #800000;\">less significant, relative to the benefits, but it was not declared <\/span><\/p>\n<p><span style=\"color: #800000;\">clearly in the paper, resulting in a giant scandal when it was <\/span><\/p>\n<p><span style=\"color: #800000;\">eventually noticed. If the raw data on patients was shared, <\/span><\/p>\n<p><span style=\"color: #800000;\">games like these would be far easier to spot, and people might <\/span><\/p>\n<p><span style=\"color: #800000;\">be less likely to play them in the first place.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"color: #800000;\">Occasionally &#8211; with vanishing rarity &#8211; researchers are able to <\/span><\/p>\n<p><span style=\"color: #800000;\">obtain raw data, and re-analyse studies that have already been <\/span><\/p>\n<p><span style=\"color: #800000;\">conducted and published. Daniel Coyne, Professor of Medicine <\/span><\/p>\n<p><span style=\"color: #800000;\">at Washington University, was lucky enough to get the data on a <\/span><\/p>\n<p><span style=\"color: #800000;\">key trial for epoetin, a drug given to patients on kidney dialysis, <\/span><\/p>\n<p><span style=\"color: #800000;\">after a four-year-long fight.84 The original academic publication <\/span><\/p>\n<p><span style=\"color: #800000;\">on this study, ten years earlier, had switched the primary <\/span><\/p>\n<p><span style=\"color: #800000;\">outcomes described in the protocol (we will see later how this <\/span><\/p>\n<p><span style=\"color: #800000;\">exaggerates the benefits of treatments), and changed the main <\/span><\/p>\n<p><span style=\"color: #800000;\">statistical analysis strategy (again, a huge source of bias). Coyne <\/span><\/p>\n<p><span style=\"color: #800000;\">was able to analyse the study as the researchers had initially <\/span><\/p>\n<p><span style=\"color: #800000;\">stated they were planning to in their protocol; and when he did, <\/span><\/p>\n<p><span style=\"color: #800000;\">he found that they had dramatically overstated the benefits of <\/span><\/p>\n<p><span style=\"color: #800000;\">the drug. It was a peculiar outcome, as he himself acknowl\u00ad<\/span><\/p>\n<p><span style=\"color: #800000;\">edges: \u2018As strange as it seems, I am now the sole author of the <\/span><\/p>\n<p><span style=\"color: #800000;\">publication on the predefined primary and secondary results of <\/span><\/p>\n<p><span style=\"color: #800000;\">the largest outcomes trial of epoetin in dialysis patients, and I <\/span><\/p>\n<p><span style=\"color: #800000;\">didn\u2019t even participate in the trial.\u2019 There is room, in my view,<\/span><\/p>\n<p><span style=\"color: #800000;\">for a small army o f people doing the very same thing, re- <\/span><\/p>\n<p><span style=\"color: #800000;\">analysing all the trials that were incorrectly analysed, in ways <\/span><\/p>\n<p><span style=\"color: #800000;\">that deviated misleadingly from their original protocols.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p>This is the kind of second-order scientist that was described in the paper:<\/p>\n<p>Nosek, Brian A., and Yoav Bar-Anan. &#8220;Scientific utopia: I. Opening scientific communication.&#8221; <em>Psychological Inquiry<\/em> 23.3 (2012): 217-243.<\/p>\n<p>&nbsp;<\/p>\n<p>This paper is extremely interesting by the way. Read it. Yes, seriously!<\/p>\n","protected":false},"excerpt":{"rendered":"<p>https:\/\/www.goodreads.com\/book\/similar\/19171192-bad-pharma-how-drug-companies-mislead-doctors-and-harm-patients http:\/\/lib.free-college.org\/view.php?id=864114 &nbsp; Having already read Peter G\u00f8tzsche&#8217;s D\u00f8delig medicin og organiseret kriminalitet: Hvordan medicinalindustrien har korrumperet sundhedsv\u00e6senet. Art People, 2013, this book did not bring so much new. However, it did present things better than G\u00f8tzsche did. To be fair, he focused mostly on proving that the farma industry are organized criminals. I agree, [&hellip;]<\/p>\n","protected":false},"author":17,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1727,1935],"tags":[1918,1924,1067],"class_list":["post-4021","post","type-post","status-publish","format-standard","hentry","category-medicine","category-science-politik","tag-innovation","tag-patents","tag-review","entry"],"_links":{"self":[{"href":"https:\/\/emilkirkegaard.dk\/en\/wp-json\/wp\/v2\/posts\/4021","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/emilkirkegaard.dk\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/emilkirkegaard.dk\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/emilkirkegaard.dk\/en\/wp-json\/wp\/v2\/users\/17"}],"replies":[{"embeddable":true,"href":"https:\/\/emilkirkegaard.dk\/en\/wp-json\/wp\/v2\/comments?post=4021"}],"version-history":[{"count":2,"href":"https:\/\/emilkirkegaard.dk\/en\/wp-json\/wp\/v2\/posts\/4021\/revisions"}],"predecessor-version":[{"id":4373,"href":"https:\/\/emilkirkegaard.dk\/en\/wp-json\/wp\/v2\/posts\/4021\/revisions\/4373"}],"wp:attachment":[{"href":"https:\/\/emilkirkegaard.dk\/en\/wp-json\/wp\/v2\/media?parent=4021"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/emilkirkegaard.dk\/en\/wp-json\/wp\/v2\/categories?post=4021"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/emilkirkegaard.dk\/en\/wp-json\/wp\/v2\/tags?post=4021"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}