{"id":60682,"date":"2015-10-15T19:20:55","date_gmt":"2015-10-15T23:20:55","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=60682"},"modified":"2015-10-15T19:20:55","modified_gmt":"2015-10-15T23:20:55","slug":"setting-things-right","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2015\/10\/15\/setting-things-right\/","title":{"rendered":"setting things right…"},"content":{"rendered":"\n
This is a very important story about Data Transparency and about the Pharmaceutical Industry’s attempts to derail it. In January 2012, the European Medicines Agency<\/font><\/em> [the European version of the FDA] announced that it was going to release the raw data submitted for approval publicly and proceeded to do just that. Cheers were heard throughout the halls of the academies of right-thinking medicine. The optimists among us even hoped that it was the beginning of the end for the Pharmaceutical Companies getting away with treating the data from Clinical Trials as private possessions for their eyes only, and regulatory agencies abetting their secrecy. In the three and a half years since then, the story has had as many plot twists as La Femme Nikita<\/font> and the House of Cards<\/font> combined. I have a crude timeline of the high points with selected references «here<\/a>».<\/div>\n

Two American Pharmaceutical Companies [Abbvie<\/font> and Intermune<\/font>] sued and the data flow stopped. Things were at a standstill, but then the suits were magically withdrawn and the aforementioned academic halls again filled with hope and joy. But when the details were revealed, the data release plan had been remarkably constricted. There was again an uproar. The EMA was accused of making compromises that destroyed their planned program. The European Ombudsman got involved. And the EMA came back this way some, but postponed definitive action. Meanwhile, the European Union had a new President who planned to put the EMA under Commerce rather than Health. Sabers were once more rattled, and he recanted, scrapping his planned change. <\/p>\n

Then [truth is stranger than almost anything], the Director of the EMA, Guido Rasi, the man who had gotten all of this started, was thrown out of office because of some technicality in his original appointment. The ship was again at sea without a captain. Then Dr. Rasi was renominated to the post in January and the final decision is due any day now. <\/p>\n

If you got lost in all the details [which is easy to do], in summary, this is this is a definitive battlefield for data transparency and the control of the corruption that has contaminated medical science. If independent investigators have the same access to the raw data from Clinical Trials as the regulatory bodies like the EMA, that puts a strangle-hold on PHARMA<\/font>‘s ability to spin their studies. It could return the academies of right-thinking medicine towards their scientific rather than some interferring commercial standards. It’s the biggest of deals because it skips all the hurdles and potholes created by PHARMA’s attempts to maintain control of data. And not surprisingly, PHARMA has mounted a prodigious campaign to derail it. By my read, Dr. Rasi is a good guy who has the right vision and is an important ingredient in how all of this will ultimately play out: <\/div>\n
\n
<\/div>\n
European Medicines Agency’s Management Board nominates Guido Rasi as Executive Director<\/a><\/div>\n
Executive Director to be appointed following hearing at European Parliament<\/font><\/strong><\/div>\n
01\/10\/2015<\/div>\n

The European Medicines Agency’s [EMA’s] Management Board has nominated Professor Guido Rasi as the Executive Director of the Agency. At an extraordinary session on 1 October, the Board selected Professor Rasi from a shortlist of candidates provided by the European Commission. Professor Rasi has been invited to give a statement to the European Parliament’s Committee on the Environment, Public Health and Food Safety<\/a> [ENVI] on 13 October 2015. The appointment of the new Executive Director will only be made after this session. An information sheet explaining the process for the appointment of the EMA Executive Director<\/a> is available. A photo and biography<\/a> of Professor Rasi are also available.<\/p>\n

Following his nomination, Professor Rasi said, “I am honoured to have been nominated as EMA’s Executive Director and am grateful for the opportunity to continue our efforts to make the Agency fit for the challenges ahead. I am enormously proud of the Agency and its network. Looking to the future, we must continue to meet patients’ legitimate expectations for access to new and safe therapeutic options. This requires that the medicines authorisation process not only supports the early stages of research and development, but also strives to make the best possible use of real world data throughout a medicine’s lifecycle.”<\/p>\n

Following Professor Rasi’s nomination, the Chair of the Management Board, Professor Sir Kent Woods said, “The Management Board is pleased to announce the nomination of Guido Rasi as Executive Director of EMA. The decision of the Management Board is the result of a robust recruitment process over the last months. We look forward to Professor Rasi resuming his leadership of the Agency.” Deputy Executive Director Andreas Pott will continue to lead EMA operations and to legally represent the Agency until the new Executive Director has officially taken up his duties.<\/div>\n<\/blockquote>\n
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Guido Rasi set for return as EMA executive director<\/a><\/div>\n
PMLive<\/font><\/strong><\/div>\n
by Dominic Tyer<\/div>\n
7th October 2015<\/div>\n

Nearly a year after his leadership of the European Medicines Agency [EMA] was prematurely annulled by a European Court, Guido Rasi is set to return to his role as its executive director. The European Union Civil Service Tribunal’s ruling came after a case was made against the EMA’s 2011 selection of Rasi<\/a> and left deputy executive director Andreas Pott in charge. <\/p>\n

Now the EMA’s management board has nominated Rasi for his old job, selecting him from a shortlist of candidates provided to it by the European Commission. Before his appointment can be confirmed Rasi must face a hearing at the European Parliament, as well as its Committee on the Environment, Public Health and Food Safety on October 13, on his proposed appointment. Rasi said: “I am honoured to have been nominated as EMA’s executive director and am grateful for the opportunity to continue our efforts to make the Agency fit for the challenges ahead…<\/div>\n<\/blockquote>\n
Of course, Dr. Rasi in just one piece on the chessboard, but in this moment, he’s a pretty important piece [as is the European Ombudsman, Emily O’Reilly]. The Pharmaceutical Industry has shown us that they will go to any lengths to maintain the status quo that they have exploited to the tune of billions while significantly undermining rational medical care by turning our patients into markets for their wares. A win in this battle would go a long way towards setting things right…<\/div>\n","protected":false},"excerpt":{"rendered":"

This is a very important story about Data Transparency and about the Pharmaceutical Industry’s attempts to derail it. In January 2012, the European Medicines Agency [the European version of the FDA] announced that it was going to release the raw data submitted for approval publicly and proceeded to do just that. Cheers were heard throughout […]<\/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":[5],"tags":[],"class_list":["post-60682","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/60682","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=60682"}],"version-history":[{"count":6,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/60682\/revisions"}],"predecessor-version":[{"id":60690,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/60682\/revisions\/60690"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=60682"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=60682"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=60682"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}