Every so often the stories break through--human drug research subjects who have been denied protections and sometimes been exploited. In 2005, Vladimir Yuri Zhirakarov, a homeless person in Houston who supported himself by enrolling in clinical trials, died from an adverse reaction to a drug given in a clinical trial at Fabre Research Clinic. Fabre was a contract research organization (CRO) that had its own business partner and lawyer on its Institutional Review Board, the body that monitors the safety of its treatment protocols for human subjects.
Around the same time, SFBC International, a contract research organization whose Institutional Review Board was owned by a vice president's wife--nice--was caught in a sordid clinical trial scheme recruiting undocumented immigrants for clinical trials next to the $62-a-night Sun 'n Surf motel and a strip club advertising "Full Nudity."
On a given day, 100 Spanish volunteers would arrive to sign up for clinical trials paying from $25 a day to as much as much as $6,900 for seven months said news reports. One man agreed to be intubated with an endoscope for $50; another was testing the antibiotic rifalazil for $200. A third agreed to try a schizophrenia medicine for $2,000. Participants slept six to a room in double-decker beds.
Such "human guinea pig" research produces bad medicine since many of the SFBC subjects were participating in as many trials as they could but no database revealed the cross overs. Even when subjects enroll in non-concurrent studies--one study after another--results are skewed because of chemical half lives and drug interactions. It also, of course, risks "harm to the participants,'' said Greg Koski, M.D. after the news of the SFBC trials broke. Dr. Koski formerly ran the Office of Human Research Protection at the Department of Health and Human Services."
The US is not the only place where unethical research takes place. In 1999, a CRO in Canton Basel, Switzerland was caught exploiting subjects from Estonia, Poland and other eastern European countries including the war-torn former Yugoslavia. The consent forms were not even in languages the recruits understood and the principal investigator of the trials, who served as both CRO director and IRB director, was not even licensed to practice medicine. At least 20 residents of a homeless shelter in Grudziadz, Poland, died in a flu trial for which they were paid as little as $2, reported Vanity Fair, and which may not have realized they were participating in.
And then there are the tests for immune suppressing drugs like the top-selling Humira. In 2010, researchers announced an unexpectedly high number of deaths in subjects injected with Humira in rheumatoid arthritis trials----6 deaths out of 515. Most of the deaths said investigator Josef Smolen, M.D., of the Medical University of Vienna, occurred in non-industrialized countries where use of immune suppressors like Humira are not as common and researchers were not familiar with the risks.
"Site investigators may not have appreciated the potential seriousness of infections associated with such treatments and so may not have reacted swiftly when patients developed possible infections," said a medical report in seeking to explain the deaths. Despite the deaths, the overseas trials were not stopped and reports even read, "Except for the early deaths, the trial has yielded favorable interim results." Other than that, how did you enjoy the play Mrs. Lincoln? Dr. Smolen reported a financial relationship to Humira's manufacturer Abbott (now AbbVie).
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