{"id":28904,"date":"2012-10-13T10:00:53","date_gmt":"2012-10-13T14:00:53","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=28904"},"modified":"2012-10-13T11:52:14","modified_gmt":"2012-10-13T15:52:14","slug":"new-open-ness","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2012\/10\/13\/new-open-ness\/","title":{"rendered":"new open-ness?…"},"content":{"rendered":"
\n
\n
GSK pledges transparency on drugs research data<\/font><\/strong><\/u><\/a>
GlaxoSmithKline has set out a new transparency policy that includes sharing information from its studies, as it moves to distance itself from recent multi-billion dollar US fines.<\/font><\/strong> <\/sup>
The Telegraph<\/font><\/strong>
By Jessica Winch
12 Oct 2012<\/div>\n

<\/p>\n

Three months after GSK was fined $3bn [£1.9bn] for fraud related to concealing safety issues, chief executive Sir Andrew Witty said detailed data from its clinical trials would be made available to the scientific community. Britain’s biggest drugmaker will set up an independent panel of experts to review and approve requests from researchers to access the data.<\/font> The move is a first for a pharmaceutical company and Sir Andrew said he hoped the initiative will “catalyse” other firms to follow suit. Sir Andrew said: “We need to take a different approach – one focused on partnership, collaboration and openness. By being more open with our clinical trial data, we also hope to help further scientific understanding.” The new system will start at the beginning of next year. <\/p>\n

Professor Stephen Curry, of Imperial College London, called the announcement a “positive development”. “Any form of openness and transparency in the pharmaceutical company is to be welcomed,” he said. However, he said the scientific community would reserve judgement until it became clear how the process worked in practice. “It’s nice to be optimistic but a drug company is not going to change its stripes overnight,” he said. “These are hard-headed business people. It’s very encouraging but I think we’ll wait to see what actually happens before passing any final judgment.” <\/p>\n

In July this year, GSK reached a record $3bn settlement with the US government after pleading guilty to charges that it had provided misleading information on some drugs, including antidepressant Paxil and diabetes pill Avandia. GSK also announced on Thursday that it will make its library of compounds with potential activity against tuberculosis freely available to researchers. Investment in its Tres Cantos Lab, which allows independent researchers access to GSK facilities, will be doubled to £5m.<\/strong><\/sup><\/div>\n<\/blockquote>\n

I keep reading the reports of GSK’s announcement hoping that one of them will contain some sentence that says something like, "… and allow independent vetting of our analyses of the Clinical Trial data." So far it’s no go. The sense of each report is the same – that they are opening their Clinical Trial data for independent research. That is better than what they had before and it will certainly be useful for people like the Cochrane Group who do independent meta-analyses. But what about someone who reads their article and says:<\/div>\n
    \n
    "I believe this article makes a claim that is not really supported by the data. I smell a rat. I want to do an independent analysis to see if the data is being presented accurately, or whether it has been twisted and tangled like in the ‘old days’ with Paxil Study 329.<\/em>"<\/strong><\/sup><\/div>\n<\/ul>\n
    Would this Independent Panel<\/em> approve such an enterprise? I believe that GSK has a right to protect themselves from me or [Eli Lilly] coming along and using the same techniques they used in Paxil Study 329 to mangle the data making their drug look bad – something a competitor might really do. That’s legit. But what about a Dr. Nissen who suspects that the drug has a CV risk that has not been reported? Or a Dr. Jureidini who thinks they have jury-rigged their primary and secondary variables by some after-the-fact data analysis that misrepresents efficacy? Or a Dr. 1boringoldman who thinks that the Adverse Effect tables are deceitfully presented and manipulated thereby downplaying serious risks? <\/div>\n

    Were I Sir Andrew Witty, I might say, "How can I ever have a blockbuster drug again if I allow you to use my own data against me? Every drug is more toxic than the ads on the television say. You wouldn’t ask your blind date to show up without any make-up.<\/em>" That would be a legitimate retort if he made soap powder or a new disposable razor. I would respond, "But these are toxic chemicals I’m prescribing for depressed children. If I don’t know about the incidence of Akathisia or about the drug withdrawal syndrome, how can I warn the parents of those possibilities in their sad teenager? How will they know that worsening might not be the disease itself but rather an idiosyncratic reaction to the drug?<\/em>" I don’t care if he doesn’t have a blockbuster [drug unless it’s a blockbuster drug that can standup under careful scrutiny]. He’s been Knighted because of his not-quite-really blockbusters. Think what will happen if he gets a real one.<\/p>\n

    I don’t know how to resolve this particular dilemma, but it needs to be discussed. Pretending that there’s not an intrinsic problem in this "new open-ness" is no way to approach it…<\/div>\n","protected":false},"excerpt":{"rendered":"

    GSK pledges transparency on drugs research data GlaxoSmithKline has set out a new transparency policy that includes sharing information from its studies, as it moves to distance itself from recent multi-billion dollar US fines. The Telegraph By Jessica Winch 12 Oct 2012 Three months after GSK was fined $3bn [£1.9bn] for fraud related to concealing […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-28904","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/28904","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/comments?post=28904"}],"version-history":[{"count":15,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/28904\/revisions"}],"predecessor-version":[{"id":28919,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/28904\/revisions\/28919"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=28904"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=28904"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=28904"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}