My friend Carl Elliott, who teaches bioethics at the University of Minnesota and who has written some of the most perceptive articles about medicine and Pharma, was kind enough to send me a copy of his recent piece in the New Yorker (Jan. 7), "Guinea-Pigging."
Most of what the article addresses is not directly pertinent to this blog. Elliott is concerned with the underclass in the US that makes a career of volunteering to participate in research trials for pay, and wonders about the ethical implictions of this system of populating research trials--and the adequacy of our present systems of oversight. The trials in question are for the most part Phase I trials if they involve drugs--trials of drug safety carried out on healthy subjects. (You cannot make a "career" of enrolling in Phase II and III trials because as a rule, you have to suffer from the disease in question to be eligible. )
Here and there, the article shines a light on issues that directly relate to the medicine-Pharma interface. The implication seems to be that when you take the existing stew of ethically suspect factors--cynical subjects doing it just for the money, and an equally cynical system of research review boards that are committed to pretending that it's not about the money and that people volunteer for research out of altruistic motives--and then add the incredible financial pressure that drug companies experience to enroll subjects as quickly as possible into trials, so as to extend the new drug's market and patent life--you get even more bizarre ethical challenges. Elliott reviews a number of recent scandals, commenting, "not all drug companies are especially selective about the researchers they hire. For example, the F.D.A. asked the drug company Sanofi-Aventis to perform new studies of the antibiotic Ketek, which was suspected of causing liver failure. Reports later revealed that the top-recruiting investigator...tested the antibiotic on clients in a weight-loss clinic that she ran in Alabama. She was sentenced to five years in Federal prison for fraud. Another top-recruiting investigator was arrested when the police found him carrying a loaded semiautomatic handgun, and hiding cocaine in his underwear." Elliott previously had described a psychiatrist who continued to supervise drug trials, receive payments from a dozen or more drug companies, and even receive a Distinguished Life Fellowship from the American Psychiatric Association--all after being disciplined by the Minnesota state licensing board over "reckless, if not willful, disregard of the patients' welfare" in the injuries or deaths of 46 research subjects in trials he was supervising.
When the industry, above all else, is paying for speed and not quality in research; and if you want to apply for a job doing research trials for drug companies, I guess you don't send in a CV or a resume; just send them your rap sheet.
Elliott C. Guinea-pigging. New Yorker, January 7, 2008: 36-41.