andrew_gelman_stats andrew_gelman_stats-2010 andrew_gelman_stats-2010-411 knowledge-graph by maker-knowledge-mining
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Introduction: I just read this article on the treatment of medical volunteers, written by doctor and bioethicist Carl Ellliott. As a statistician who has done a small amount of consulting for pharmaceutical companies, I have a slightly different perspective. As a doctor, Elliott focuses on individual patients, whereas, as a statistician, I’ve been trained to focus on the goal of accurately estimate treatment effects. I’ll go through Elliott’s article and give my reactions. Elliott: In Miami, investigative reporters for Bloomberg Markets magazine discovered that a contract research organisation called SFBC International was testing drugs on undocumented immigrants in a rundown motel; since that report, the motel has been demolished for fire and safety violations. . . . SFBC had recently been named one of the best small businesses in America by Forbes magazine. The Holiday Inn testing facility was the largest in North America, and had been operating for nearly ten years before inspecto
sentIndex sentText sentNum sentScore
1 Elliott: Over the past 20 years or so, without much fanfare, clinical research has undergone a remarkable free-market conversion. [sent-16, score-0.419]
2 Until the early 1990s, most pharmaceutical research on human subjects was conducted by physicians in universities and teaching hospitals. [sent-17, score-0.629]
3 (The FDA, which must approve drugs before they can be marketed, doesn’t conduct clinical trials itself. [sent-18, score-0.805]
4 ) However, pharmaceutical companies have been in search of cheaper, more efficient venues and today about 70 per cent of clinical trials take place in the private sector, often in the offices of private physicians or at dedicated sites. [sent-19, score-1.232]
5 But the system has changed: What does clinical research look like when everyone is in it for the money? [sent-25, score-0.419]
6 A contract researcher does not come up with original ideas, or design research protocols, or analyse research results, or write them up for scientific publications. [sent-28, score-0.652]
7 What a contract researcher does is recruit subjects, monitor their clinical care and sign off on the paperwork. [sent-30, score-0.749]
8 It’s not at all clear to me that this doctor should be doing research; maybe he or she should be monitoring and taking care of the patients in the study. [sent-34, score-0.422]
9 If the original research is being done at the lab, why not use on-site doctors who can focus on clinical care of the patients. [sent-36, score-0.778]
10 Usually they will ‘come in on a daily basis, on most days, and they’ll sign off on all the things they need to sign off on, see any patients they need to see, and they’re gone’ . [sent-42, score-0.399]
11 A part-time contract researcher conducting four or five clinical trials a year can earn an average of $300,000 in extra income. [sent-47, score-0.845]
12 Even an ordinary office visit will be paid at twice the usual rate if the visit is part of a research study. [sent-51, score-0.396]
13 Elliott writes: Ready to recruit patients are sick people who can easily be persuaded to enrol in clinical trials, often because they are so poor that they have no better alternative. [sent-64, score-0.595]
14 For years the demand for research subjects has been growing, driven not least by the sheer number of clinical trials being conducted in the desperate search for new blockbuster drugs. [sent-68, score-0.922]
15 Many of these places have established a foothold in the industry as ‘rescue countries’: drug companies go there when they need data quickly – when their trials in the West have failed to show the drug is effective, for example . [sent-74, score-0.819]
16 Until the mid-1970s, this usually meant prisoners; today the trials are done mainly on the poor, who sign up for the money. [sent-80, score-0.465]
17 The most lucrative studies are longer trials testing the safety of new drugs, with lots of in-patient time and plenty of unpleasant medical procedures. [sent-89, score-0.495]
18 If subjects are harmed by the drugs they take, they have no right to compensation, and they may well have to pay their own medical expenses. [sent-94, score-0.678]
19 According to a survey published in the New England Journal of Medicine, only 16 per cent of the policies issued by academic health centres in the US offer free care to research subjects injured in trials. [sent-95, score-0.523]
20 by enrolling in trials they can get drugs that they could not otherwise afford – never mind that the drugs are experimental, or may be placebos. [sent-100, score-0.885]
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