A growing concern for properly conducted clinical experiments involving pharmaceuticals at universities was addressed in a survey published Oct. 24 by the New England Journal of Medicine.
The study found that pharmaceutical companies were controlling experiments involving their drugs conducted at 108 university medical laboratories, according to Duke University Prof. Kevin Schulman, author of the survey.
Pharmaceutical companies can be "very restrictive in publishing the results of clinical studies," said Jay Marchwinski, University Medical Center laboratory administrative director.
The University conducts clinical studies with student volunteers to collaborate with other universities "so results won't be skewed," Marchwinski said.
Although larger laboratories perform experiments to confirm the final results for pharmaceutical companies, Marchwinski suspects several drug-clinical studies take place at the University at all times, he said.
Pharmaceutical companies often do not promote guidelines in clinical studies at universities, Schulman said.
According to Schulman, pharmaceutical companies have the final say in publishing the results of the studies.
If a study does not promote the best interest of the company they could choose to suppress the results, which could threaten the safety of participating volunteers, he said.
Researchers at schools such as the University have "felt powerless in dealing with pharmaceutical companies," he added.
Because of pharmaceutical restrictions in clinical studies, scientists cannot pursue a "higher level of research ethics," he said.
He added that students who volunteer for medical studies often do so to help other people.
They have a right "to know that the [clinical study] trial will be published," he said. Results should be "public domain."
Pharmaceutical Research and Manufacturers of America, an organization representing major pharmaceutical companies, said it has taken steps to protect the best interest of university researchers.
PhRMA "put in place guidelines to address some of the concerns expressed by the study," on Oct. 1, PhRMA Spokesman Jeff Trewhitt said.
We wanted to "reaffirm our commitment to timely and appropriate research data," Trewhitt said.
PhRMA intends to give researchers, such as those at the University, more control over their clinical studies to protect volunteers and the best interests of the studies, he said.