Healthy Skepticism Library item: 12408

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Elliott C.
Guinea-pigging
The New Yorker 2008 Jan 7
http://www.newyorker.com/reporting/2008/01/07/080107fa_fact_elliott

Abstract:

DEPT. OF MEDICAL ETHICS about paying healthy human subjects for participating in drug-safety trials. Writer interviews James Rockwell, who tells him about participating in a paid drug study on September 11, 2001. Rockwell estimates that he has enrolled in more than twenty studies for money. In some cities, the drug-testing economy has produced a community of semi-professional research subjects. For them, “guinea-pigging,” as they call it, has become a job. Discusses how pharmaceutical companies, impatient with the slow pace of academic bureaucracies, have moved trials to the private sector, where more than seventy-per cent of trials are now conducted. Writer also notes that about half of all trials are now conducted outside the United States. Tells about the different phases of clinical trials. Unlike subjects in larger-scale clinical trials, who are usually sick and might enroll in a study to gain access to a new drug, people in healthy-volunteer studies cannot expect any therapeutic benefit to balance the risks they take. This raises an ethical question: what happens when both parties involved in a trial see the enterprise primarily as a way of making money? Discusses the closing down of a drug-test site in Florida run by SFBC International, which had been paying undocumented immigrants to participate under ethically dubious conditions. Few people realize how little oversight the federal government provides for the protection of subjects in privately sponsored studies. Most guinea pigs rely on their wits and on word of mouth to determine which studies are safe. Briefly mentions the hospitalization of test subjects from a test site run by Praxel in England. Writer discusses Frank Abuzzahab, a psychopharmacology researcher who has been disciplined for the injuries or deaths of forty-six patients under his care. Tells about Bob Helms, a veteran of numerous trials, who started a publication called Guinea Pig Zero. Writer compares guinea pigs in drug trials to “model patients” paid to undergo examinations by medical students.

Keywords:
Guinea Pigs; Clinical Trials (Drug Tests); Medical Ethics; Pharmaceutical Industry; Abuzzahab, Frank; Helms, Bob; Institutional Review Boards (I.R.B.s)