{"id":12056,"date":"2011-08-15T09:01:16","date_gmt":"2011-08-15T13:01:16","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=12056"},"modified":"2011-08-15T11:45:39","modified_gmt":"2011-08-15T15:45:39","slug":"the-corruption-rule","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2011\/08\/15\/the-corruption-rule\/","title":{"rendered":"the corruption rule…"},"content":{"rendered":"
I suppose there’s something confirming in reading  about the pharmaceutical industry’s invasion of psychiatry. Back in the 1980s when it all started, I smelled a rat, but didn’t know what was happening. It drove me a little crazy, and I ended up fleeing to private practice because I didn’t know what else to do, never really understanding quite what was going on. I was just too naive to even imagine where things were heading. Now, looking backwards, it’s clearer, but it’s also disillusioning. I find this piece particularly disheartening: <\/div>\n
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Feds Probe Payments In Overseas Drug Trials<\/font><\/strong><\/a>
Pharmalot<\/font><\/strong>
By Ed Silverman
August 9th, 2010<\/div>\n

As promised, the US Justice Department – along with the US Securities and Exchange Commission – is paying closer attention to interactions between the pharmaceutical industry and foreign governments. In recent months, at least five big drugmakers have received letters as the federal government seeks to uncover any violations of the Foreign Corrupt Practices Act, which forbids US companies from bribing foreign government officials…<\/sup><\/p>\n

Among the countries cited are Brazil, China, Germany, Greece, Italy, Poland, Russia and Saudi Arabia, according to Main Justice, which notes that the Arnold & Porter law firm recently issued a client advisory indicating the probe is also exploring whether drugmakers and clinical trial organizations pay off third-party investigators to finesse research data. Why? A recent report by the HHS Office of Inspector General noted that eight percent of marketing applications to the FDA in 2008 relied exclusively on foreign data, 80 percent of approved marketing applications for drugs and biologics relied on at least one foreign clinical study, and 78 percent of all human subjects were enrolled at foreign sites.<\/font><\/strong><\/sup><\/p>\n

“The number of third party contracts with CROs, academic and health care facilities, and investigators provides a high-risk area for potential violations. The US government is particularly interested in any corrupt payments that may have wrongfully influenced the reliability or integrity of data emerging from any trial, and companies may find themselves facing critical legal issues if approval of products rested on the results of studies that DOJ deems corrupt,”<\/font><\/strong> Arnold & Porter attorneys wrote, adding the “DOJ has recently taken the public position that many investigators, foreign clinicians, and laboratory workers will be deemed ‘foreign officials’ for purposes of the FCPA”…<\/sup><\/div>\n<\/blockquote>\n
Back in March, when I was trying to get up to speed on the Clinical Research Industry and the Clinical Research Organizations [the clinical research industry: cross purposes…<\/font><\/a><\/strong><\/u>], I ran across their professional Organization, ACRO<\/font><\/strong>. Back then, I wrote: <\/div>\n
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Looking over the ACRO<\/font><\/strong><\/u><\/a> [Association of Clinical Research Organizations] web-site, it seems to be standard industry-specific trade organization fare. Their central thrust is Globalization<\/font><\/strong>. In fact the policy page<\/strong><\/a><\/u> seems organized around the topic:<\/div>\n