{"id":34132,"date":"2013-03-12T22:32:16","date_gmt":"2013-03-13T02:32:16","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=34132"},"modified":"2013-03-12T22:32:16","modified_gmt":"2013-03-13T02:32:16","slug":"the-light-of-day","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2013\/03\/12\/the-light-of-day\/","title":{"rendered":"the light of day…"},"content":{"rendered":"
"For some reason, the [American] people I meet in my country are not the same as the ones I knew in the United States. A mysterious change seems to come over Americans when they go to a foreign land. They isolate themselves socially. They live pretentiously. They’re loud and ostentatious.<\/em>"<\/strong><\/sup><\/div>\n
The Ugly American<\/em> -1958<\/strong><\/sup><\/div>\n

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Sometimes, a book title takes on a larger meaning than the book itself. The Ugly America<\/a>, [1958] was made into a feature film with Marlon Brando [1963] and it lives on as a moniker to the crude American capitalist overseas who exploits the locals<\/em>, even though that’s not exactly the theme of the book. I thought of it when I first looked into the Clinical Research Organizations<\/a>, reading the ACRO "white paper" about how globalized clinical trials were good for<\/em> developing countries. It smelled like rotten fish to me for two reasons: it reeked of exploitation and I wondered about the usefulness of clinical trials in countries where the problems aren’t in the DSM but rather in their disparate sociology [see slumdog trials: on a war footing…<\/a>]. …<\/div>\n
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Trial Deaths, But Little Compensation In India<\/a>
Pharmalot<\/font><\/strong>
By Ed Silverman
March 12th, 2013<\/div>\n

As India attempts to craft new rules for governing clinical trials, another report focuses attention on an underlying problem plaguing both regulators and the pharmaceutical industry – the number of patient deaths attributed to trials and the contentious issue of compensation by drugmakers. To wit, as m<\/strong><\/sup>any 2,868 deaths occurred during trials between 2005 to 2012, although only 89 have been attributed directly to the studies. However, compensation was paid in just 45 cases. Last year, 16 of 436 deaths among participants were attributed to trials, although compensation was paid in only two cases.<\/strong><\/sup><\/p>\n

These sorts of patterns last month prompted the Indian Supreme Court to harshly criticize regulators for shoddy oversight and enforcement. An amended rule would require the Drugs Controller of India to ensure trials are conducted with good clinical practices, approved by ethics committees, registered before patients are enrolled, provide annual status reports and report adverse events with 10 days of occurrence [back story<\/a>]. Compensation, however, is causing tension. India’s Central Drugs Standard Control Organization wants to require drugmakers and contract research organizations to make payments determined by the Drug Controller General of India within 30 days of injury or death. If payment is not made, CDSCO can cancel a trial and ban the drugmaker or CRO from conducting studies in India.<\/strong><\/sup><\/p>\n

As we reported last month, the Association of Clinical Research Orga<\/strong><\/sup>nizations reacted by saying India would become “an extremely difficult and risky place to do business… ACRO is in the process of assessing the political, legal, regulatory and business climate in India with the hope that we can form a strategy to move forward.” We also wrote that clinical trials conducted by global drugmakers and their proxies have generated increased scrutiny in recent years as the pharmaceutical industry seeks to run studies in countries with lower costs and populations where patients are not exposed to as many medications that can confound results. India has been a prime example.<\/strong><\/sup><\/p>\n

However, the country may be losing its edge. The domestic market was worth about $485 million in 2011, according to the Frost & Sullivan market research firm, which predicts this could double to $1 billion by 2016. And the relatively low cost of conducting trials and a fast-growing population of 1.2 billion should mean that India remains a desirable destination. But less than 1.5 percent of global trials take place in India, according to the Indian Society for Clinical Research. Nonetheless, the large pool of willing trial participants almost guarantees that drugmakers and CROs will not lack for subjects. The government, however, is trying to make clear that greater accountability is required. For instance, the number of patients deaths linked to clinical trials between 2005 and 2007 was small – a total of just 11 – but compensation was never paid in any of these cases.<\/strong><\/sup><\/div>\n<\/blockquote>\n
"as many 2,868 deaths<\/em>" is kind of an attention grabber. And as for ACRO, "As we reported last month, the Association of Clinical Research Organizations reacted by saying India would become ‘an extremely difficult and risky place to do business… ACRO is in the process of assessing the political, legal, regulatory and business climate in India with the hope that we can form a strategy to move forward.’<\/em>" I’m going to be suggesting that from the sound of things, it’s "an extremely difficult and risky place<\/em>" to be a subject in an American Pharmaceutical Company’s Clinical Trial. But it says something about how different Clinical Trials look up close than as Mean HAM-D Scores on a glossy LOCF graph.<\/div>\n

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A year or so ago, I ran across another aspect of the CRO reach that was a bit outside of my comprehension – direct access to electronic health records: <\/div>\n