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19 september 2010
T
he last
few years haven’t been thebest for the business of medical re-search. There was the Sanofi-Aventisresearcher in California who was arrested waving a loaded handgun; police found apackage of cocaine stuffed in his under- wear. There was the psychiatric researcherin Oklahoma City whose medical licence wassuspended after he infected two patients with genital herpes, and who was invest -igated by the FDA after he barred a re-searchsubject from leaving his clinical trialfacility. In Miami, investigative reportersfor
Bloomberg Markets
magazine discoveredthat a contract research organisation calledSFBC International was testing drugs onundocumented immigrants in a rundownmotel; since that report, the motel has beendemolished for fire and safety violations.Several pharmaceutical companies have beencaught up in controversial cases of suicide,such as that of Dan Markingson, a youngman who stabbed himself to death whiletak ing Seroquel in an AstraZeneca trial at the University of Minnesota, and Traci John-son, who hanged herself in a study of Cym-balta at the Eli Lilly trial site in Indianapolis.Britain had its own disaster at Northwick Park Hospital in north-west London, wheresix healthy subjects nearly died in a ‘first inman’ study of a monoclonal antibody. AndPfizer has spent longer than a decade deal-ing with the fallout of a study in Kano,Nigeria, in which 11 children died during a
The Mild Torture Economy 
Carl Elliott 
Medical Research for Hire:The Political Economy of Pharmaceutical Clinical Trials
by Jill Fisher.Rutgers, 257 pp., £23.50, January 2009, 978 0 8135 4410 6
When Experiments Travel:Clinical Trials and the Global Search for Human Subjects
by Adriana Petryna.Princeton, 258 pp., £18.95, June 2009, 978 0 691 12657 9
The Professional Guinea Pig:Big Pharma and the Risky World of Human Subjects
by Roberto Abadie.Duke, 184 pp., £15.99, October, 978 0 8223 4823 8
 
29 september 2010
meningitis trial allegedly rigged to show that the antibiotic Trovan was superior to acompetitor’s drug. The Trovan case has wound its way through various courts for years, generating millions of dollars indamages and a stubborn public relationsproblem for Pfizer.It is time for a ‘rebranding’ campaign,according to the Center for Information andStudy on Clinical Research Participat ion.CISCRP is a non-profit group funded by pharmaceutical companies, academic healthcentres and contract research organisat ions.According to CISCRP, the public imageof the pharmaceutical industry ranks along-side that of used-car dealerships and tob-acco companies, and too often the mediaportray pharmaceutical research as ‘decept -ive and evil’. So CISCRP has launched a new public relations initiative, called ‘Medicalheroes can be found in everyday places.’Funded by the pharmaceutical company EliLilly and orchestrated by Ogilvy Health- world, the purpose of the initiative is totransform the image of the clinical trial vol-unteer from ‘guinea pig’ to ‘medical hero’.CISCRP has produced a slick public serviceannouncement; it is sponsoring ‘clinical re-search education days’ all over America; andit is distributing posters, DVDs and shiny ‘Medical Hero’ badges to research subjects.Apparently the strategy is working: subject recruitment is up in areas where the cam-paign has run. Even bioethicists are pitch-ing in. A team from the Department of Clin-ical Bioethics at the National Institutes of Health recently argued in the
 Journal of the American Medical Association
that signing upfor clinical trials is a prima facie moral duty owed by every citizen.Over the past twenty years or so, without much fanfare, clinical research has under-gone a remarkable free-market conversion.Until the early 1990s, most pharmaceuticalresearch on human subjects was conductedby physicians in universities and teachinghospitals. (The FDA, which must approvedrugs before they can be marketed, doesn’t conduct clinical trials itself.) However,pharmaceutical companies have been insearch of cheaper, more efficient venuesand today about 70 per cent of clinical trialstake place in the private sector, often inthe offices of private physicians or at de-dicated sites. Clinical research has becomea multibillion-dollar global industry, spawn-ing spin-off businesses that barely exist -ed25 years ago, from patient recruitment firms and medical communication agenciesto for-profit research ethics boards. Themost important new players are contract research organisations (CROs) such as Par-exel, Quintiles, PPD and Covance, whichhave built themselves into corporate giantsby taking up the management of clinicaltrials. The research that many of us usedto imagine as a humanitarian enterprise,carried out by selfless scientists and fund-edby Pink Ribbon campaigns and ‘Racefor the Cure’ marathons, is actually a thor-oughly Taylorised corporate system, out-sourced and streamlined for maximumefficiency.It is striking just how little is knownabout the new clinical trials industry. Partly this is because it is so widely dispersed.Back in the old days, if you worked in amedical school or teaching hospital, you
 
39 september 2010
could often get a feel for a clinical trial sim-ply by walking down the hall. Now youmight need to go to India or Uzbekistan.Even if you restricted yourself to domesticstudies, you would log a lot of miles tryingto visit all the various stations in the pro-duction line. The trial itself might takeplace at fifty different sites, ranging fromIvy League teaching hospitals to a businesspark near Toronto airport. The ethics com-mittee approval would probably come fromOlympia, Washington; the subject recruit-ment could be managed in Dallas, Texas;and the trial results might be written up inPrinceton, New Jersey. It is no wonder only industry insiders seem to know exactly  what is going on. When
Bloomberg
reportersdiscovered that SFBC International waspaying immigrants to be test subjects in adilapidated former Holiday Inn in Miami,SFBC had recently been named one of thebest small businesses in America by 
Forbes
magazine. The Holiday Inn testing facility  was the largest in North America, and hadbeen operating for nearly ten years beforeinspectors noticed there was anything wrong.Lodged somewhere between the secrecy and the scandals is the work of a new gen-eration of ethnographers who are quietly studying the way the clinical trials businessoperates. What interests Jill Fisher, AdrianaPetryna and Roberto Abadie is not so muchthe occasional outrage uncovered by in- vestigative reporters, or even the formalregulation of clinical trials. They are moreconcerned with the everyday pressures andmoral choices facing the workers who manthe production line: the private-sector phys-icians who conduct the trials, the study monitors and trial co-ordinators who over-see them, and the research subjects whotake experimental drugs, often in exchangefor free medical care or a wage. What doesclinical research look like when everyone isin it for the money?For a start, it looks a lot less like science.‘I do not do original research; I do con-tractresearch,’ says a private physician- researcher in
Medical Research for Hire
. A con-tract researcher does not come up withoriginal ideas, or design research proto-cols, or analyse research results, or writethem up for scientific publications. All of this is done by the pharmaceutical company or its hired specialists. What a contract re-searcher does is recruit subjects, monitortheir clinical care and sign off on the paper- work. Not a lot of original work is done,and in some cases, not much work at all(a running joke has it that physicians doclinical trials in order to improve their golf games). The industry term for these near-absent physicians is ‘phantom investig-ators’. Usually they will ‘come in on a daily basis, on most days, and they’ll sign off onall the things they need to sign off on, seeany patients they need to see, and they’regone,’ a study monitor says to Fisher. Theresearchers are usually on-site for no morethan an hour or two a day.Contract researchers may not do muchintellectual work, but this doesn’t meanthey are not well paid. A part-time contract researcher conducting four or five clinicaltrials a year can earn an average of $300,000in extra income. In 2000, a full-time clinicaltrial site earned an average of $1.6 million.
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