{"id":4553,"date":"2010-12-13T11:33:45","date_gmt":"2010-12-13T16:33:45","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=4553"},"modified":"2011-11-03T22:25:52","modified_gmt":"2011-11-04T02:25:52","slug":"message-in-a-bottle","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2010\/12\/13\/message-in-a-bottle\/","title":{"rendered":"message in a bottle…"},"content":{"rendered":"
There was a time not so long ago when there was no Internet for most of us, no instant access to the data that now streams into my log cabin in the Georgia Mountains even when it’s 18º and the snow is falling like it thinks it belongs here. Tim Berners-Lee introduced html<\/em> and the world-wide-web<\/em> in 1994, and within a few years, our Library of Alexandria in the Sky<\/em> began to grow. But things happened before it got up there, so there are times when the details just aren’t apparent, no matter how creative your Google. I’m stuck on one of those frustrating quests right now – looking for details from the Olde Kingdom of the late 1980’s and early 1990’s.<\/div>\n

I’ve been fixated on the story of the marketing of the SSRI, Paxil, by SmithKline Beecham<\/font><\/strong> now GlaxoSmithKline<\/font><\/strong>. It was introduced around 1992, and the story as I know it picks up in November 1993 when Scientific Therapeutics Information<\/font><\/strong> [STI<\/font><\/strong>], a marketing\/ghost-writing firm put together an Advisory Board Meeting<\/font><\/strong><\/a> <\/font><\/strong><\/u><\/font><\/strong>in Palm Springs lead by Dr. Charles Nemeroff, Chairman of the Department at Emory. The story thereafter involving conflicts of interest, unreported income, sponsored CME, ghost-writing, outright lies, etc. [a syllabus of unethical marketing and twisted science] is well documented in these pages and elsewhere on the Internet. While it’s clearly not the only example of the aggressive intrusion of Pharmaceutical Marketing into the science of medicine, it’s unusual in that that GSK<\/font><\/strong> didn’t really seem know their own drug. Paxil stood out among the SSRIs as problematic at every step of the way. It may have a clinically devastating withdrawal syndrome in a number of patients, making it very hard to discontinue – and is described by many as addictive. It is probably more likely to be associated with suicidal thoughts as a side effect, particularly in teens. It is ineffective in children or adolescents. It appears to cause birth defects when given during pregnancy or breast-feeding. I use indeterminate phrases like may have<\/em>, is described by many as<\/em>, probably more likely to<\/em>, and appears to cause<\/em> because the studies are very confusing, and many may or may not have been<\/em> jury-rigged under industry direction. <\/p>\n

GSK<\/font><\/strong> was recurrently faced with disappointing science in a highly competitive market. They twisted the science to fit their high hopes for a "blockbuster" – accentuating the positive [or near positive], eliminating the negative, and failing to even acknowledge the lackluster in between. The result hasn’t been pretty. But we all know that. What’s hard to fathom is how little they seemed to actually know about their drug in the first place. They wanted to extend their approval to children, adolescents, women in the reproductive process. Paxil let them down in all three domains, and they didn’t seem to see that coming. They’ve paid some for their misbehavior, and they’re still vulnerable to a lot more liability – not only for the toxicity, but for their attempts to ignore it or cover it up. <\/p>\n

So back to my Internet searching dilemma. I got to wondering how Paxil made it through the FDA the first time around without more of its down-side being flagged in the process. And then I remembered reading about the most unscrupulous pair of academicians there may have ever been – two doctors at the University of Georgia in Augusta – Chairman of Psychiatry Richard Borison<\/font><\/strong> and his Pharmacologist sidekick Bruce Diamond<\/font><\/strong>. I’ve written about them before [repressed memories…<\/font><\/a><\/strong>, the perfect storm…<\/font><\/a><\/strong>, a “we” problem…<\/font><\/a><\/strong>]. Here’s an abbreviated reminder: <\/div>\n
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Scientific Fraud: …Richard Borison<\/a><\/strong>
Alliance for Human Research Protection<\/font><\/strong>
29 October 2006<\/font><\/strong><\/div>\n

In 1997, the Wall Street Journal reported "Between 1988 and 1996, companies including Abbott Laboratories Inc., Hoechst AG, Warner-Lambert Co., Pfizer Inc. and Sandoz showered [Borison] and Dr. Diamond with contracts for more than 160 studies." In at least 44 trials, the WSJ reported,  Borison and Diamond contracted commercial ethics committees [IRBs] – "including  one in Olympia, Washington." The two researchers "had been active in the development of many successful drugs, and they were good recruiters," says William Kennedy, vice president of Zeneca Inc., of Wilmington, Delaware, which hired them in 1990 to test Seroquel, a schizophrenia drug. "Among other companies, Johnson & Johnson hired the men to test Risperdal, its new schizophrenia medicine, and SmithKline Beecham PLC had them evaluate Paxil, a now-popular antidepressant.<\/font><\/strong>"…<\/sup><\/p>\n

The drugs’ manufacturers were not alone in being complicit in failing to stop the fraud. The institutional review boards [IRBs] whose legal responsibility is to act as gatekeepers to protect the safety and rights of human subjects, provided oversight on paper only.  Furthermore, the FDA failed to question the integrity of Borison’s data from antipsychotic, antidepressant, and Alzheimer’s drug trials<\/font><\/strong> – even after the agency had itself uncovered that he had made fraudulent claims in 1984…<\/sup><\/p>\n

The fraud committed by Borison and Diamond has had enduring influence – their 50 odd articles continue to corrupt the scientific literature and their fraudulent data which the companies submitted to the FDA helped bring to market highly toxic drugs<\/font><\/strong> whose severe adverse effects are shortening the life-span of those for whom they are prescribed…<\/sup><\/p>\n

The Borison-Diamond case opens a Pandora’s box raising well grounded suspicions that companies have submited fraudulent data to the FDA and have succeeded in obtaining approval for marketing.<\/font><\/strong> How does the FDA interpret the Food Drug and Cosmetics Act requirement that prior to gaining marketing approval companies must provide "substantial evidence of safety and efficacy from adequately controlled trials"? Neither the FDA nor the manufacturers of drugs tested by Borison have denied the likelihood that fraudulent  clinical trial data submitted by Borison and Diamond was included in the data set submitted to the FDA. That data resulted in the approval of hugely profitable drugs whose risks far outstrip any benefit.<\/font><\/strong><\/sup><\/div>\n<\/blockquote>\n
The story of these two characters paralleled the Duke and the King that Mark Twain’s Huck Finn and Jim met on their raft trip down the Mississippi – notorious flim·flam men [archives<\/font><\/strong><\/a>]. <\/div>\n
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Excited bargain hunters packed the hall in Augusta, Ga., in December 1998 for one of the weirdest auctions of all time.  On the block were items from antiques and paintings to suits of armor worth a fortune. They all belonged to the town’s infamous Richard Borison and Bruce Diamond.  They no longer need this old stuff; it doesn’t work with their new d\u00c3\u00a9cor.  Pharmacologist Diamond, now in prison, was convicted on 53 counts, including practicing medicine without a license and prescription fraud. 48 Hours Correspondent Susan Spencer reports. "I liked the money," Diamond explained. "It was almost like an addiction to see how much you can make. It was like a game." Over eight years, he and his partner, psychiatrist Dr. Borison, raked in more than $11 million, turning human drug trials into their personal money machine.  They pretended to be doing the trials for the Medical College of Georgia, where they both were on staff, but they kept payments meant for the college for themselves.  In the process, they deceived some of the top drug companies in the country, to say nothing of the patients they put at risk…<\/font><\/strong><\/sup><\/div>\n<\/blockquote>\n
It’s not possible that the clinical trials run by these two guys were valid. From the stories, I suspect their results were in the nether-world between fact and fabrication, but I gather that piece of the story never came to light. They just didn’t talk much about what they did. <\/div>\n

I expect that my question is by now obvious. Did Borison and Diamond run the clinical trials for SmithKline Beecham’s Paxil that were used to get it approved by the FDA?<\/font><\/strong> How about AstraZeneca’s Seroquel? Johnson & Johnson’s Risperdal? The AHRP article above hints that was true, but I can’t find anything on the Internet that’s in the frozen sky above Georgia that nails the answer to that question. It’s such an obvious question that it’s hard to believe somebody doesn’t know the answer. <\/p>\n

The implications of my question are obvious. Was Paxil put on the market based on questionable [at best] information from the start? extending this tale of deceit back to the dawn of time [pre-Internet]? Why can’t I find the answer? Am I an inadequate googler, or is it a question that someone doesn’t want answered? So consider this post a message in a bottle<\/em>, floated into the ether in hopes that somebody knows…<\/div>\n
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There is another possibility. Now it’s down to 14º and my computer is in the least well heated room in this cabin. Maybe cold fingers are hampering my searching skills. My message in a bottle<\/em> comment still holds…
<\/sup><\/div>\n","protected":false},"excerpt":{"rendered":"

There was a time not so long ago when there was no Internet for most of us, no instant access to the data that now streams into my log cabin in the Georgia Mountains even when it’s 18º and the snow is falling like it thinks it belongs here. Tim Berners-Lee introduced html and the […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","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-4553","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/4553","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=4553"}],"version-history":[{"count":1,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/4553\/revisions"}],"predecessor-version":[{"id":15752,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/4553\/revisions\/15752"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=4553"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=4553"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=4553"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}