Two researchers have come forward to say they felt intimidated from coming forward when they started to notice health problems with a one-time top-selling drug made by GlaxoSmithKline.
Dr. Mary Money, an internist in Hagerstown, Md., told the company in 2007 of repeated instances of congestive heart failure and dangerous fluid retention in patients taking Avandia, a diabetes medication. Both she and Stephen Lippman, a doctor she worked with on the research, said in interviews that the company failed to take their concerns seriously.
"I felt intimidated; I know she felt intimidated. We both at the time, and still do, think that they were essentially trying to stonewall us and really impede a resolution of the issue."
Money said she felt vindicated last year when Steven Nissen of the Cleveland Clinic published research in the New England Journal of Medicine saying that Avandia could increase the risk of heart attack 43 per cent.
Nissen says GlaxoSmithKline had always treated him respectfully, even when it disagreed with him. Nissen has consulted for several drug companies, including GlaxoSmithKline.
Lippman, however, said there is a problem that needs addressing
"The problem with [the] drug system is that if people on the front line feel that they're going to get humiliated for bringing up questions, they're not going to report things and they are not going to be the canary in the coal mine."
GlaxoSmithKline issued a statement defending itself.
"GSK does not condone any actions that would interfere with an individual's ability to discuss, report or publish adverse events related to any GSK product. As a corporation, we actively train all employees on ethical business practices and compliance with the Rx&D Code of Conduct."
Republican Senator Charles Grassley of Iowa is expected in the next few weeks to release results of an investigation into GlaxoSmithKline's handling of Avandia.
University of Manitoba medical ethicist Arthur Schafer says drug companies attempt to silence doctors and critics in Canada as well, using both threats and offers of research grants for hospitals and universities and lucrative consulting contracts for doctors.
"Threats of lawsuits or threats to go to your employer or actually going to your employer to get you fired or disciplined or silenced in some way are unusual. They happen, but usually for the drug companies, the carrot is more effective than the stick."
The FDA is looking into Avandia and several other drugs linked to heart problems.