In July, the federal government proposed new rules governing the protection of human participants in medical studies.
But as University of Minnesota bioethics professor Carl Elliott notes in a commentary published Friday in the New York Times, those rules will do nothing to protect people who volunteer for medical studies from an unethical marketing ploy of the pharmaceutical industry: “seeding trials.”
“In a typical seeding trial,” writes Elliott, “a pharmaceutical company will identify several hundred doctors and invite them to take part in a research study. Often the doctors are paid for each subject they recruit. As the trial proceeds, the doctors gradually get to know the drug, making them more likely to prescribe it later.”
In other words, these studies are not about science. They’re all about marketing. Their primary purpose is to get more doctors to prescribe the drug.
“In an age of for-profit clinical research, this is the new face of scandal,” Elliott says. “Pharmaceutical companies promote their drugs with pseudo-studies that have little if any scientific merit, and patients naively sign up, unaware of the ways in which they are being used.”
Seeding trials can be dangerous, Elliott points out. Three participants died (and five more experienced heart attacks) in the Advantage study, a seeding trial by Merck for the now notorious and drawn-from-the market painkiller Vioxx. And earlier this summer, as Elliott also notes (and as I reported in Second Opinion), the Archives of Internal Medicine published a scathing indictment of a 1990s seeding study conducted by Parke-Davis (now part of Pfizer) for the anti-seizure drug Neurontin (gabapentin).
“The investigators were inexperienced and untrained, and the design of the study was so flawed it generated few if any useful conclusions,” writes Elliott. “Even more alarming, 11 patients in the study died and 73 more experienced ‘serious adverse events.’ ”
Elliott calls for a revamping of institutional review boards (IRBs), the federally empowered committees that are supposed to make sure that clinical studies are safe for participants and ethically sound. As Elliott points out, IRBs are not usually equipped to judge or even identify seeding trials.
“Even worse,” he says, “many IRBs are now themselves for-profit businesses, paid directly by the sponsors of the studies they evaluate. If one IRB gets a reputation for being too strict, a pharmaceutical company can simply go elsewhere for its review.
The current IRB system “should be replaced with an oversight system that is financially and administratively independent of the research it oversees,” says Elliott. “The system must have the power to impose sanctions, and its responsibilities must extend to fraud, bribery and corruption.”
“Many patients volunteer for research in the hope that the knowledge generated will benefit others,” he adds. “When a company deceives them into volunteering for a useless study, it cynically exploits their good will, undermining the cause of legitimate research everywhere.”
You can read Elliott’s commentary on the Times website. (FYI: If you’re not a Times subscriber, clicking on the link will count toward your monthly quota of free articles.)