One of the most useful skills I learned in high school was how to write book reports without reading the whole book. It saves a lot of time and is almost guaranteed to get you an A. This confession is prompted by the fact that I haven't read Guinea Pigging by Carl Elliott. I have, however, read an excerpt in The New Yorker, and I have an alibi: Amazon.com didn't list it.
Using anecdotes plus background data, the author tells a story that represents more bad news for the pharma industry, throwing doubt on the trustworthiness of the data that FDA, doctors and patients rely on for the safety of prescription drugs.
He describes the extent to which contract research organizations (CROs) have replaced academic health centers in clinical research and hence in the recruitment of study subjects for Phase I. The CROs' obvious objective is to get the contract fulfilled on time, and that requires speedy recruitment of volunteers, the role that used to be played primarily by medical students. The easiest way to do that is to pay them…and pay them well.
As a result, “the relationship between testers and test subjects has become…a business transaction,” Elliott says. “This raises an interesting ethical question: what happens when both parties involved in a trial see the enterprise primarily as a way of making money?”
In answer to his rhetorical question, he cites some horrible examples. In 2006, he reports, what had been the largest drug-testing site in North America was shut down when it was revealed that it was paying undocumented immigrants to sign up, that the medical director had no license to practice and that the ethical review board was headed by the wife of the CRO's vice president.
Another study Elliott cites called for stringent dietary restrictions. One of the participants is quoted as saying that they got so hungry that one of them broke into the food closet. “We were just gorging ourselves at 2 am on Cheez Doodles.” Was there no supervision? Apparently not in what the same whistleblower describes as “the Animal House of research units.” For his services, he was paid $7,500. Not bad for five admittedly uncomfortable weeks, and no wonder that over the years he has enrolled in more than 20 studies.
In some cities, Elliott goes on, there are communities of “semi-professional research subjects who enroll in one study after another.…For them, ‘guinea pigging,' as they call it, has become a job.”
Then the author debunks the supposed safeguard for the integrity of clinical studies: the FDA requirement that they be approved by an institutional review board, but “now that most studies take place outside academic settings, research sponsors can submit their proposed studies to for-profit IRBs.”
Elliott, a professor of pediatrics at the University of Minnesota, concedes that if companies had to rely on altruism, “studies on healthy subjects would probably come to a halt.” In his conclusion he does not belabor industry, but does express concern about the health of the guinea pigs…and about the reliability of the data.
Those will seem like reasonable questions and pharma companies that outsource clinical research have cause to worry—both about their sales and reputations. Perhaps they should read this book.
Warren Ross is editor at large of MM&M