{"id":21504,"date":"2012-03-22T19:18:41","date_gmt":"2012-03-22T23:18:41","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=21504"},"modified":"2012-03-22T20:14:27","modified_gmt":"2012-03-23T00:14:27","slug":"2008-3","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2012\/03\/22\/2008-3\/","title":{"rendered":"

2008…<\/h1>"},"content":{"rendered":"\n

1980 was certainly a big year in America: Ronald Reagan<\/font><\/strong> was elected President; the DSM-III<\/font><\/strong> was published; the IBM PC<\/font><\/strong> was inching towards being released; the Bayh-Dole Act<\/font><\/strong> was signed… <\/p>\n

Huh? What’s the Bayh-Dole Act<\/font><\/strong>? Well, according to commenter<\/font><\/strong><\/u><\/a>, former Pharma Guy, Dan Abshear<\/font><\/strong>, it’s something we ought to know about – but I don’t. First the Wikipedia<\/font><\/strong><\/u><\/a> version:<\/div>\n
\n
The Bayh–Dole Act or Patent and Trademark Law Amendments Act is United States legislation dealing with intellectual property arising from federal government-funded research<\/span>. Adopted in 1980, Bayh-Dole is codified in 35 U.S.C. § 200<\/span>-212, and implemented by 37 C.F.R. 401. Among other things, it gave U.S. universities, small businesses and non-profits intellectual property control of their inventions and other intellectual property that resulted from such funding. The Act, sponsored by two senators, Birch Bayh of Indiana and Bob Dole of Kansas, was enacted by the United States Congress on December 12, 1980. Perhaps the most important change of Bayh-Dole is that it reversed the presumption of title. Bayh-Dole permits a university, small business, or non-profit institution to elect to pursue ownership of an invention in preference to the government.<\/sup><\/strong><\/div>\n<\/blockquote>\n
Now from a blog post from four years ago by Dan Abshear<\/font><\/strong>: <\/div>\n
\n
The Human Injury of Lost Objectivity:<\/font><\/strong><\/u><\/a>
An Insider’s Look into the Corruption of Clinical Trials<\/font><\/strong><\/a><\/sup>
Brain<\/font>Blogger<\/font><\/strong>
By Dan Abshear
April 25, 2008<\/font><\/strong> <\/div>\n

<\/p>\n

If I were to rate the corruptive tactics performed by big pharmaceutical companies, the intentional corruption of implementing fabricated and unreliable results of clinical trials would be at the top of the list. Pharmaceutical companies manipulate the trials they sponsor because of their power to control others involved in the process largely absent of regulation. This is a matter of requiring authenticity and, more importantly, assuring the safety of the public health.<\/p>\n

Decades ago, clinical trials were conducted in academic settings that focused on the acquisition of knowledge and the completely objective discovery of novel medicine. Then, in 1980, the Bayh-Dole Act was created, which allowed for such places to profit off of their discoveries that were performed for pharmaceutical companies in the past. This resulted in the creation of for-profit sites, called Contract Research Organizations (CROs), which are composed of community research sites with questionable investigators void of necessary experience or quality regarding their research purpose and ability. Since they are for-profit, the trials conducted at CROs are sponsored by pharmaceutical companies that control and manipulate all aspects of the trial. This coercion is done by various methods of deception in subtle and tacit methods. As a result, research in this manner has been transformed into a method of marketing, which includes altered results of the trial to favor the sponsor’s medication. Their activities are absent of true or applied regulation, and therefore have the autonomy to create whatever they want to benefit the collusive relationship between the site and the sponsor.<\/p>\n

Further disturbing is that once the trials are completed, the medical articles are then written by ghostwriters, who are not identified and acknowledged by the sponsor, and are not trained in clinical research overall, as they are simply freelance writers. How often ghostwriters are utilized by pharmaceutical companies remains a mystery. This activity removes accountability and authenticity of the fabricated clinical trial even further. The corruptive act is finally completed by the sponsor hiring an author to be placed on the trial that likely had no involvement with the trial, and, along with others, was paid by the sponsor. To have the trial published, the sponsor pays a journal, along with the promise of purchasing thousands of reprints of the study from the journal. Again, how often this process is performed is unknown, yet frequent enough to create hundreds of such false writers and research sites to support the industry. So benefits of medicine studied in such a malicious way can potentially harm patients and their treatment options. The purchased reprints are distributed to the sponsor’s sales force to share the content with prescribers — your doctor.<\/p>\n

Such misconduct impedes research and the scientific method with frightening ethical and harmful concerns. Our health care treatment with medications is now undetermined in large part in such situations, as well as the objectivity that has been intentionally eliminated regarding the trust in the scientific method in this type of activity illustrated in this article. More now than ever, meds that are removed from the market are given black box warnings. Now I understand why this is occurring.<\/p>\n

The pharmaceutical industry needs transparency and disclosure in order to correct what we have historically relied upon for conclusive proof — the scientific method. More importantly, research should not be conducted in a manner that the sponsor can interfere in the ways I described in this article. We should call for independent sites with absolutely no involvement with the drug maker. And clearly, regulation has to be enforced not selectively, but in a complete fashion. Public awareness would be a catalyst for this to occur, after initially experiencing a state of total disbelief that such operations actually are conducted by such people, of course. We can no longer be dependent on others for our optimal health. Knowledge is power, and is also possibly a lifesaver.<\/strong><\/sup><\/div>\n

<\/p>\n

[see also MUST READ – Dan Abshear writes: You have now been sampled<\/font><\/strong><\/u><\/a> from June 15, 2008]
<\/sup><\/div>\n<\/blockquote>\n
Well, I’m going to have to look into the Bayh-Dole Act<\/font><\/strong> and its implications. I wondered how the CRO industry came into being. But first, I just want to point out that April 25, 2008<\/font><\/strong> was a lifetime ago. Our economy was having a bobble and Bush was giving away "Stimulus Checks" – everything was going to be just fine. Charlie Nemeroff was Chairman of Psychiatry at Emory. Alan Schatzberg was Chairman of Psychiatry at Stanford. Joseph Biederman of Harvard was the king of the Bipolar Child world. Martin Keller was Chairman of Psychiatry at Brown University. All I knew of Senator Grassley was from his religious right connections with "The Family." I was a retired guy in the Georgia Mountains working on an exciting project identifying Cherokee Indian Bent Trees from before the Trail of Tears when my back began to act up and I was a month or so away from finding myself in an operating room as an emergency, thirty years after my first surgery. I didn’t know what a CRO was. I didn’t know what ghost-writing meant, at least in Medicine. We hadn’t yet heard a peep out of Robert Spitzer or Allen Frances about the DSM-5 Revision process. It might as well have been 1941 compared to now.<\/div>\n

<\/p>\n

Yet when I read this old blog post from that time, it sounds as if it could’ve been penned yesterday. At the time it was written, I knew none of this, but Dan Abshear sure did. Many still don’t, but we’re not flying so blind as we were back then. Dan hasn’t had the best of times in the intervening years, but is now <\/font><\/strong><\/u><\/a>on <\/font><\/strong><\/u><\/a>the mend<\/font><\/strong><\/u><\/a>. I wish him the best and really appreciate the link and the tip. I wish this piece had been on the front page of the New York Times on April 25, 2008. Now, on to the Bayh-Dole Act<\/font><\/strong>…<\/div>\n","protected":false},"excerpt":{"rendered":"

1980 was certainly a big year in America: Ronald Reagan was elected President; the DSM-III was published; the IBM PC was inching towards being released; the Bayh-Dole Act was signed… Huh? What’s the Bayh-Dole Act? Well, according to commenter, former Pharma Guy, Dan Abshear, it’s something we ought to know about – but I don’t. […]<\/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_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-21504","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/21504","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=21504"}],"version-history":[{"count":21,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/21504\/revisions"}],"predecessor-version":[{"id":21519,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/21504\/revisions\/21519"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=21504"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=21504"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=21504"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}