A new report criticizing the use of seeding trials to drive pharmaceutical marketing efforts and jump-start sales could have far-reaching implications for pharmaceutical companies, research sites and clinical trials in general.
The report, published last week in the Annals of Internal Medicine, finds that a 1999 clinical study conducted by Merck was primarily to enhance a marketing campaign, rather than to test side effects of the painkiller Vioxx as Merck had maintained.
The clinical trial in question was designed to compare Vioxx to other popular painkillers, but, after reviewing internal Merck records, the report’s authors determined that the study had clear marketing objectives of which participants were not informed.
“I think it’s quite clear, looking at the documents and looking at the body of evidence, that it was primarily a marketing exercise… I think if [Merck was] upfront about the purpose of the trial, many people wouldn’t have participated,” said Kevin Hill, M.D., a Massachusetts psychiatrist and the study’s lead author.
Regulations require that every study be accurately and fully described in terms of purpose and goal, but that isn’t always done, said Arthur Caplan, Ph.D, director of the Center for Bioethics at the University of Pennsylvania.
“I think people in the industry had felt, well, maybe you can get away with running these kinds of seeding trials. Who’s going to find out, nobody’s bothered … it’s kind of a no harm, no foul thing. But if it shows up in litigation that you didn’t do what you were supposed to do in designing the trial and getting consent from subjects or approval from IRBs [institutional review boards], you open yourself up to a huge amount of liability … I think it will have a chilling effect that way,” Caplan told CW Weekly.
Caplan does not anticipate new regulations in this area, but he does see an increased emphasis on enforcement, and, as a result, many sponsors may decide that studies conducted just for the sake of marketing development are not worth the risk. Marketing studies will likely become supplements to larger studies, rather than being stand alone, both Hill and Caplan predicted.
“There’s nothing inherently wrong with doing a marketing study—you can—but it’s hard to get somebody to say, ‘OK, I’m going to agree to sign up for a study so we can figure out if doctors are more likely overall to prescribe A than B.’ Most people don’t want to be bothered with that … but if you put this kind of a question—what influences prescription behavior—next to a legitimate science question, that’s how I think these studies will trend,” Caplan said.
As a result of this report, sponsors and sites may want to take a close look at their current active trials to ensure that they’ve been forthright about each study’s purpose.
“Investigators bear responsibility along with the other groups in asking what they’re signing up for. It’s certainly difficult to turn down, for many investigators, the financial accoutrements of trials like this and also the prestige that goes along with it. But I think that if people are asking questions—if they’re asking, ‘Is this a seeding trial?’ then this practice will wither away,” Hill said.